Robotic Surgery and Nursing 9811605092, 9789811605093

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Gongxian Wang Yu Zeng Xia Sheng Editors

Robotic Surgery and Nursing

123

Robotic Surgery and Nursing

Gongxian Wang • Yu Zeng • Xia Sheng Editors

Robotic Surgery and Nursing

Editors Gongxian Wang Department of Urology The first Affiliated Hospital of Nanchang University Nanchang China

Yu Zeng Department of Operating Room The first Affiliated Hospital of Nanchang University Nanchang China

Xia Sheng Robotic Urology Operating Theatre Changhai Hospital Shanghai China

ISBN 978-981-16-0509-3    ISBN 978-981-16-0510-9 (eBook) https://doi.org/10.1007/978-981-16-0510-9 Jointly published with World Publishing Xi’an Corporation © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publishers, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publishers nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publishers remain neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore

Robotic Surgery and Nursing

Chief Editor 

Gongxian Wang  Xiaochen Zhou

Associate Editor 

Ju Guo  Dongning Liu  Chunhua Tu  Jian Tang

Editor 

 ong Cai  Liping Cai  Wentian Fu  Bing Fu  Longhui Guan  Ju Y Guo Qinqin Hu Shuzhen Huang Yao Jiang Feihong Jiang  Xiaojun Li  Taiyuan Li  Weipeng Liu  Dongning Liu  Jiali Nie  Wenjun Qiu  Changxiu Rao  Hui Song Yali Tan  Jian Tang Chunhua Tu Yongjin Wang Liping Wang Gongxian Wang Juan Wei Zhufeng Xiong Juanhong Xu Qingqin Xu  Xia Xu  Ying Xu  Jinxiu Yan  Yue Yu  Yu Zeng  Jiangjiang Zhang Cheng Zhang Genghua Zhang Meng Zhao Lilan Zheng  Yingyang Zhou  Xiaochen Zhou  Jinhua Zou

Academic Secretary  Ju Guo Drafter

  Yue Yu

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Preface

Surgeries have undergone three historical stages: open surgery, endoscopic surgery, and robotic surgery. Manual operations have been replaced by dexterous robotic arms, ensuring more precise operations and less secondary damage. The question is no longer whether robotic surgery is feasible, promising, and the right direction, but how to quickly acquire robotic surgical equipment, master robotic surgical technology, and how to further improve the efficacy of robotic surgery and the lives of patients. The age of robotic surgery is coming sooner than we expected. In robotic surgery, magnified 3D images allow the operator to see more clearly, and the flexible robotic arms and EndoWrist® technology enable surgeons to be more dexterous and to make more accurate dissections and sutures, with less chance of injury to patients and faster recovery time. However, the establishment of an appropriate and skillful surgical team is one of the key factors for the success of robotic surgery, and the establishment of a skilled operating room nursing team is critical. For this purpose, we have specifically compiled Robotic Surgery Nursing, the world’s first monograph that systematically introduces robotic surgery nursing, with the hope that it can be of help to teams and individuals who are carrying out, will be carrying out or are planning to carry out robotic surgery in the future. The book is divided into two parts. Part I briefly introduces the development history of robotic surgery, surgery room personnel, supplies, safety and quality of nursing, the overall operating mode and performance management, etc. related to robotic surgery. Chapters 2 and 3 elaborate the structural characteristics of surgical robot equipment and instruments, as well as the methods of correct installation and use, maintenance, cleaning, and disinfection. Part II introduces the nursing support in robotic surgery in urology surgery, general surgery, obstetrics and gynecology, thoracic surgery, etc. This book is concise, well-illustrated and is clear and easy to understand. I hope you enjoy it. I would like to express my sincere gratitude for the immense support and help from the American Intuitive Surgical Company and Chindex International, Inc. in the process of compiling this book, as well as the support of all friends who are interested in robotic surgery. The surgical methods and techniques of robotic surgery are still undergoing several innovation and development, and inevitably there are omissions and shortcomings in this book due to the tight schedule. Your comments are highly appreciated. Nanchang, China Nanchang, China  April 2021

Gongxian Wang Xiaochen Zhou

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Contents

Part I 1 Development History of Surgical Robots�����������������������������������������������������������������   3 Gongxian Wang, Yu Zeng, and Xia Sheng 2 Instructions for Use of Da Vinci Surgical Robots ���������������������������������������������������   7 Gongxian Wang, Yu Zeng, and Xia Sheng 3 Cleaning, Disinfection, and Sterilization of Reusable Instruments, Accessories, and Endoscopes in Robotic System�����������������������������������������������������  91 Gongxian Wang, Yu Zeng, and Xia Sheng 4 Personnel Management in the Robotic Surgery Room������������������������������������������� 111 Gongxian Wang, Yu Zeng, and Xia Sheng 5 Quality Management of Robotic Surgical Nursing������������������������������������������������� 117 Gongxian Wang, Yu Zeng, and Xia Sheng 6 Management of Robotic Surgical Supplies��������������������������������������������������������������� 125 Gongxian Wang, Yu Zeng, and Xia Sheng 7 Safety Management of Robotic Surgery������������������������������������������������������������������� 131 Gongxian Wang, Yu Zeng, and Xia Sheng 8 Infection Management in Robotic Surgery Room��������������������������������������������������� 155 Gongxian Wang, Yu Zeng, and Xia Sheng 9 Overall Operating Mode of Nursing in Robotic Surgery Room����������������������������� 159 Gongxian Wang, Yu Zeng, and Xia Sheng 10 Treatment of Nursing and Emergency Situation of Patients Receiving Robotic Surgery in the Recovery Period������������������������������������������������� 167 Gongxian Wang, Yu Zeng, and Xia Sheng 11 Economic Analysis and Performance Management of Robotic Surgery��������������� 173 Gongxian Wang, Yu Zeng, and Xia Sheng 12 Nursing Cooperation for Anesthesia in Robotic Surgery��������������������������������������� 175 Gongxian Wang, Yu Zeng, and Xia Sheng Part II 13 Nursing Cooperation for Robotic Surgery in Urology Surgery����������������������������� 199 Gongxian Wang, Yu Zeng, and Xia Sheng 14 Nursing Cooperation for Robotic Surgery in General Surgery����������������������������� 231 Gongxian Wang, Yu Zeng, and Xia Sheng

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15 Nursing Cooperation for Robotic Surgery in Obstetrics and Gynecology ����������� 281 Gongxian Wang, Yu Zeng, and Xia Sheng 16 Nursing Cooperation for Robotic Surgery in Thoracic Surgery ��������������������������� 291 Gongxian Wang, Yu Zeng, and Xia Sheng

Contents

Part I

1

Development History of Surgical Robots Gongxian Wang, Yu Zeng, and Xia Sheng

At present, the most widely used and famous surgical robot is the “Da Vinci Robot.” The original prototype of the Da Vinci Surgical Robot was developed at Stanford University. In 1987, Dr. Phil Green of the Stanford Research Institute (now renamed SRI International), along with John Bowersox, a surgeon, invented a remote surgical system, then known simply as the “SRI System.” The machine, which allowed doctors to perform operations on soldiers in a remote battlefield, attracted the attention of the Defense Advanced Research Projects Agency (DARPA), which funded its further development. In 1994 Dr. Frederic Moll, who was working for the Director of SRI, Guidant, became very interested in the system. He made several pleas to commercialize “Lenny” (an early Da Vinci Robot) to maximize its value. However, few people were interested in doing so, as everyone was busy trying to make it cooler. Dr. Frederic Moll teamed up with John Freund, who had just resigned from Acoson, to purchase the intellectual property of the “Lenny” robot, after several negotiations with SRI.  Later, in 1995, Intuitive Surgical Devices Inc. was founded with some venture capital and included Field Fund, Sierra Leone, and Morgan Stanley Capital International as investors. Subsequently, several cofounders of the company, as well as Moll and Freund, left the company. The current CEO, Guthart, joined the company in 1996 after working at Stanford Research Institute (SRI). The other company executives are mostly latecomers. Among the current senior executives, Lonnie Smith, Chairman of the Board, and Guthart, Chief Executive, are the big individual stakeholders, with 1.15% and 0.93% stake, respectively. The “SRI System” has G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China

been continuously transformed. It has gone through several iterations, but the nicknames for each generation of prototypes have faithfully followed the “Da Vinci” series. For example, the original Lenny (referring to the young Da Vinci) was later called Leonardo and Mona, and finally named Da Vinci in 1999 when it went into production. Long before the Da Vinci Robot was approved by the US Food and Drug Administration (FDA), there was a company that first obtained market-entry approval—Computer Motion, whose first-generation product “AESOP” was approved by the FDA and entered the market in 1994. AESOP is a voice-controlled robotic arm with seven axis of motion that can simulate the motor function of human arms and replace the surgeon’s assistant required to operate the endoscopes. The robotic arm is controlled with a man– machine coordination system based on the surgeon’s voice commands, that is, a voice recognition system that controls the robotic arm’s motion based on the voice commands given by the surgeon during surgery. The surgeon’s voice commands need to be prerecorded into the voice cards, which are then inserted into the masters (controls) before surgery (Fig.  1.1). In this way, the robotic arm can follow simple voice commands from the surgeon to automatically, quickly, and precisely operate the endoscope during the surgery, adjust it to the optimal position and angle, and transmit clear and steady images to the display. Surgeons can directly observe and control the endoscope to obtain a stable surgical field thus improving the accuracy and safety during surgery. In order to prevent the robotic arm from exerting more force on the human body than necessary, or getting too close to the internal organs, the system adopts advanced safety protection technology, which ensures that it automatically stops working when a dangerous situation occurs. At present, the system is not yet capable of accurately transmitting the robotic arm’s tactile sensation to the surgeon’s hands. The second-generation product, ZEUS Robotic Surgical System, is an endoscopic surgery control system with three robotic arms (Fig. 1.2).

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 G. Wang et al. (eds.), Robotic Surgery and Nursing, https://doi.org/10.1007/978-981-16-0510-9_1

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Fig. 1.1  AESOP system. (a) AESOP robot. (b) Application of AESOP in minimally invasive surgery

a

b

AESOP robot

a

Application of AEESOP in minimally invasive surgery

b

Zeus robot

Zeus robotic console

Fig. 1.2  Zeus system. (a) Zeus robot. (b) Zeus robotic console

In the Zeus Robot-assisted Minimally Invasive Surgical System, three separate robotic arms are installed directly on the operating table, one for operating the camera and the other two for operating a series of surgical instruments, which are controlled by surgeons through two active operating devices. The latest Zeus System is integrated with the Hermes system so that surgeons can directly control additional instruments required during surgery. Cameras, light sources, and other additional instruments can be controlled by voice, pedal, and other human–computer interfaces. Three-dimensional (3D) images can be viewed through a special eyepiece. SurgRob reports that in 2000, Computer Motion preempted Intuitive Surgical Devices Inc. by filing eight patent

lawsuits before it went public; however, Intuitive Surgical and IBM jointly launched a “countersuit” for infringement. Both sides were found guilty of patent infringement in the final judgment, and the federal court imposed a fine of US$4.4 million on Computer Motion. After the verdict was announced in March 2003, Computer Motion came to a compromise and the two sides agreed to a merger. According to Computer Motion, although it was confident that it would eventually win the patent case, it could not compete against IBM, who backed the other side, and did not have the funds to spend on lengthy litigation. The Da Vinci Robot was first sold in Europe because it had not yet been approved by the FDA in the United States. In 2000, Intuitive finally got FDA approval and announced

1  Development History of Surgical Robots

its listing. As mentioned on Intuitive’s website, the name pays tribute to Da Vinci, the Italian painter and inventor who “studied the anatomy of the human body and ultimately designed the first robot in history.” The Da Vinci Robot-assisted Minimally Invasive Surgical System consists of a main console (surgeon console) and a robotic cart (patient cart), as shown in Fig. 1.3. The robotic cart of the Da Vinci System is fitted with three robotic arms attached to a movable base that is connected to the surgical console via cables. The central arm controls the endoscope, while the two peripheral arms control the surgical instruments. The cart is 2 m high, nearly 1 m in length and weighs 544 kg. The cart has wheels and can be moved manually. The cart’s wheels can be locked to prevent it from moving, however, it cannot be fixed to the operating table. In case of external power supply failure, the system is supported by its own power that lasts up to 5  mins. Manual movement of the manipulator requires pressing a button on the arm to loosen all joints and to reposition them. The position of the manipulator can be relocked after the button is released. To ensure safety and maneuverability, the arms are balanced mechanically and electrically. The arms are covered by three conventionally installed sterile plastic bags and cannot be sterilized. Only the sterile trocar and instruments are present in the operating area. Through the 3D viewer on the surgeon console, surgeons can observe three-dimensional images of the surgical field. With the navigation operating system, surgeons can

Fig. 1.3  Da Vinci surgical robotic system

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manipulate the camera control pedal to zoom or move the camera. The master manipulator can be readjusted while keeping the auxiliary manipulator in place with the second pedal (pedal clutch), to ensure the entire device is in the optimal position. The master manipulator is similar in appearance to the auxiliary manipulator. The surgeon’s movements are eventually translated into the motions at the end of the surgical instruments. Except for the ultrasonic scalpel, the ends of other surgical instruments are designed with human-like wrist structure, allowing assistants to replace surgical instruments quickly and easily during the surgery. The ends of surgical instruments have 6 degrees of motion and can mimic the surgeon’s movements thus overcoming the lack of flexibility in traditional minimally invasive surgery. After 16  years of technology development and acquisition, Intuitive now has a huge patent pool. As of December 2015, it had more than 2100 patents in the US and overseas, with another 1500 patents pending. Interestingly, one of the cofounders of Intuitive, Dr. Frederic Moll, left in 2002 to start a new company of his own, but it had to enter into a mutual licensing agreement with Intuitive and contributes 3% of sales as patent royalty. Intuitive Surgical subsequently acquired Neo Guide Systems, which develops robots that enter the surgical site via natural cavities (mouth, nose, etc.) and Luna Innovations, which develops shape sensing technology in the medical field.

6 Fig. 1.4  The era of robotic surgical has came. Create the era of robotic surgical in Jiangxi province

A Wall Street study conducted on the 11th anniversary of Google’s IPO found that Intuitive Surgical was one of only 13 of the 6000 US companies to have had a higher return than Google (1277%). At US$9 a share when Intuitive Surgical went public in 2000, it now trades at US$666 (Fig. 1.4). By the end of 2016, nearly 4000 Da Vinci Surgical Robots were being used in the world, and more than 700,000 patients had been treated with the Da Vinci System. Increasingly, new surgical robots are emerging, such as orthopedic robots, single-hole robots, snake-shaped robots, and ophthalmic robots. Some of these are already undergoing clinical trials, and there have been constant improvements and innovations, which indicates that the era of robotic surgery has indeed arrived (Fig. 1.4).

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Create the era of robotic surgical in Jiangxi province

Surgery has gone through three historical stages: open surgery, endoscopic surgery, and robotic surgery. In robotic surgery, magnified 3D images allow the operator to see more clearly, and the flexible robotic arms and EndoWrist® technology enable surgeons to be more dexterous and to make more accurate dissections and sutures, with less chance of injury to patients and faster recovery time. However, the establishment of an appropriate and skillful surgical team is one of the key factors for the success of robotic surgery, and the establishment of a skilled operating room nursing team is critical. It is thus a historical opportunity and challenge for us to greet this era by establishing mature and standard systems and processes for operating room nursing practices and to constantly improve them.

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Instructions for Use of Da Vinci Surgical Robots Gongxian Wang, Yu Zeng, and Xia Sheng

2.1

 verview of Da Vinci Surgical Robot O System

The Da Vinci Control System for Endoscopic Surgical Instruments is a comprehensive robotic surgical platform designed to perform complicated surgical operations through minimally invasive techniques. The system consists of three main components: Surgeon Console, Patient Surgical Platform, and Image Processing Platform (Fig. 2.1). This chapter introduces the following system components: main components of the Da Vinci System, Da Vinci-e System, and an overview of the Surgeon Console, Patient Surgical Platform, and Image Processing Platform.

2.1.1 Main Components of Da Vinci System 2.1.1.1 Surgeon Console The Surgeon Console (Fig. 2.2) is the control center of the Da Vinci System. Surgeons sitting outside the sterile area of the Surgeon Console can use their eyes, hands, and feet to control the 3D endoscope and EndoWrist instrument via two main controllers and pedals. As observed in the stereoscope, the instrument head appears to align with the surgeon’s hands on the main controllers. This design is intended to mimic the natural alignment of the eyes, hands, and instruments in open surgery, which is conducive to optimizing hand-eye coordination. G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China

The Da Vinci System not only allows surgeons to achieve a degree of dexterity in minimally invasive surgery compared to that of open surgery but provides further control through motion scaling and anti-shake features, minimizing the effects of natural trembling of hands or unexpected movement. The Surgeon Console operator can also choose to change the view from full screen to TilePro™ mode. In TilePro, 3D images of the surgical field and up to two additional images offered by the auxiliary input are displayed. The Surgeon Console is equipped with several ergonomic adjustment devices that can help adapt to a wide variety of body shapes, to provide maximum comfort during surgical procedures.

2.1.1.2 Patient Surgical Platform The Patient Surgical Platform (Fig. 2.3) includes the operating components of the Da Vinci System and mainly supports the instrument arms and camera arms. The system adopts remote center technology. The remote center is the pivot point around which the Patient Surgical Platform’s arms move. Remote center technology enables the system to precisely maneuver instruments in the surgical site while exerting minimal force on the patient’s body wall. The Patient Surgical Platform operator works in the sterile area and assists the Surgeon Console operator to switch instruments and endoscopes and perform other patient-side work. To ensure patient safety, the Patient Surgical Platform operator’s actions have priority over the actions of the Surgeon Console operator. 2.1.1.3 EndoWrist EndoWrist technology is designed by Intuitive Surgical. Compared to unassisted manual operations, EndoWrist allows surgeons to achieve natural mobility and provides a range of motion that is superior to natural motion. This allows for greater accuracy in minimally invasive environment operations. EndoWrist, when used in conjunction with the Da Vinci System, enables faster and more precise suture,

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 G. Wang et al. (eds.), Robotic Surgery and Nursing, https://doi.org/10.1007/978-981-16-0510-9_2

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G. Wang et al. Patient Cart Surgeon Console

Vision Cart

Fig. 2.1  Main components of Da Vinci Endoscopic Surgical Instrument Control system

Fig. 2.3  Patient cart

Fig. 2.2  Surgeon console

2  Instructions for Use of Da Vinci Surgical Robots

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Endo Wrist

Fig. 2.4  Example of EndoWrist instruments

dissection, and tissue adjustment than any other surgical platform. EndoWrist is a multipurpose device that can be supplied in 12, 8, and 5 mm specifications (Fig. 2.4). Please refer to the latest Catalog of Instruments and Accessories (PN 871145) of relevant manufacturers for a complete list of EndoWrist.

Note: Da Vinci System is compatible with Da Vinci’s EndoWrist.

2.1.1.4 Image Processing Platform The Image Processing Platform (Fig. 2.5) is equipped with systematic central processing and image observation equipment. It includes a 24″ touchscreen monitor and also has an adjustable device holder for placing surgical aids such as an insufflator. During surgery, the image observation frame is operated by nonsterile personnel.

2.1.2 Da Vinci-e Surgery System The Da Vinci-e Surgery System is an upgradable configuration of the Da Vinci System and is fitted with a Patient Surgical Platform with three arms, which is a visually distinguishable feature. The Da Vinci-e Surgery System includes an integrated display at the top of the Image Processing Platform, just like the Da Vinci System. However, the monitor does not have touchscreen capabilities and is a passive display system that only provides patient-side display for operating room staff. The Da Vinci-e Surgery System is designed to be upgradable at any time by the staff to the full-­ featured Da Vinci System (single or dual consoles). Table 2.1 summarizes the functional differences between Da Vinci-e and Da Vinci.

Fig. 2.5  Vision Cart

2.1.3 Overview of Surgeon Console This section describes the components of the Surgeon Console, including the masters (hand controls), 3D viewer, touchpad, left and right-side pods, and footswitch panel.

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Table 2.1  The comparison between da Vinci and da Vinci-e Function Endo Wrist⑧ A console touched by doctors OnsileTM Remote control service 3D HD vision system Audio system with two lines TileProTM multi-input display system Telestration Dual console Vision BoomTM Vision system screen Configured video output

da Vinci Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

da Vinci-e Yes Yes Yes Yes Yes No No No No No No

2.1.3.1 Masters The masters (Fig.  2.6) enable the surgeon to control the instruments and endoscopes in a patient’s body. The masters allow the surgeon to move within the natural range of motion and provide ergonomic comfort even during prolonged surgery. Both masters need to be held with the forefinger (or middle finger) and the thumb to use. An operator actuates and controls the EndoWrist by bending or loosening the forefinger (or middle finger) with the thumb and manipulates the instruments and endoscopes inside patients by moving their hands and/or arms. These motions are accurately and ­seamlessly mimicked onto the Patient Surgical Platform, extending the operator’s hands into the surgical field virtually. 2.1.3.2 3D Viewer The 3D viewer (Fig.  2.7) provides video images to the Surgeon Console operator. The ergonomically designed viewing port can support the head and neck, providing greater comfort during prolonged surgery. After the endoscope is turned on, the left and right video channels integrated by the 3D viewer, provide the surgeon with uninterrupted 3D videos, extending the image observation capabilities of surgeons into the surgical field. The 3D viewer also displays messages and icons conveying the state of the Da Vinci System.

Fig. 2.6  Master Controllers

Fig. 2.7  Stereo Viewer

2.1.3.5 Footswitch Panel The footswitch panel (Fig. 2.10) is installed at the bottom of the Surgeon Console, near the operator’s feet, and provides interfaces for various surgical tasks.

2.1.4 Overview of Patient Surgical Platform

2.1.3.3 Touchpad The touchpad (Fig. 2.8) is installed in the armrest center of the Surgeon Console and enables the selection of various system functions.

The components of the Patient Surgical Platform include the Setup Joint, instrument arms, camera arms, and drive motor. For the detailed introduction of the above sections, please refer to Sects. 2.2, 2.5, 2.7, and 2.8.

2.1.3.4 Left and Right-Side Pods The left and right-side pods (Fig. 2.9) are installed on either side of the Surgeon Console’s armrest. The left-side pod provides an ergonomic controls, while the right-side pod provides the Power and Emergency Stop buttons.

2.1.4.1 Setup Joint The Setup Joint (Fig. 2.11) is designed to place the arms of the Patient Surgical Platform and is used to establish a remote center in the surgical field. To facilitate incision placement, the Setup Joint is designed to have limited freedom of motion.

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Fig. 2.8  Touchpad panel

2.1.4.2 Instrument Arms After installing the aseptic drape, the instrument arms (Fig.  2.12) can provide an aseptic operating interface for EndoWrist. Before the surgery, the Patient Surgical Platform operator first places the instrument arms in neutral gear. The instrument arms can be moved with the masters by the Surgeon Console operator. The reasonable design of the endoscopic insertion shaft not only minimizes the possibility of collision at the endoscopic position but enables the Patient Surgical Platform operator to adjust the position of the instrument arms. In addition, a wide motion range of Da Vinci’s arms helps simplify the incision setup and provides the surgeon better access to the patient’s body. The remote center of the instrument arms is indicated by the thick black tape in the instrument casing center. The remote center of the instrument arms is located within the patient’s body wall when the Patient Surgical Platform is connected to the trocar inside the patient. The remote center

should be positioned in such a way as to reduce both incision trauma during surgery and the stress applied to the EndoWrist. The remote center of the instrument arms cannot be moved by the Surgeon Console operator. However, the remote center can be repositioned by the Patient Surgical Platform operator by pressing the port clutch button and repositioning the instrument arms. There are LEDs on top of the arms, which indicate the status of the arms (Fig. 2.13).

2.1.4.3 Camera Arms The camera arm (Fig. 2.14) offers a sterile interface to the 3D endoscope. Before the surgery, the Patient Surgical Platform operator first places the camera arms in neutral gear. The camera arms can be moved with the masters by the Surgeon Console operator. The remote center of the camera arms is located near the camera casing head. On the top of the camera arm is an LED, which provides feedback on the arm status.

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Emergency Stop Button

Power

Fig. 2.9  Left: Ergonomic controls; Right: Power button and emergency stop button

2.1.5.1 Core Components The core component of Da Vinci is the central connection point of the system, via which all systems, auxiliaries, and AV connections are connected. 2.1.5.2 Light Source The light source illuminates the surgical field (Fig.  2.16). Light from the light source is transmitted to the endoscope via optical fiber cables and then projected on to the surgical site via the endoscope. Several front panel controllers installed on the light source can increase or decrease the light output, turn on or off the light. Fig. 2.10  Footswitch Panel

2.1.4.4 Drive Motor The Da Vinci Patient Surgical Platform has a drive motor (Fig. 2.15), which enables the operator to move the cart and position it in the operating room more quickly and easily. The drive motor interface includes a steering column, a throttle, a cart drive enable switches, and a gear switch.

2.1.5 Overview of Image Processing Platform The standard Da Vinci System features a high definition (HD) Image Processing System, consisting of core components, light source, endoscope, HD 3D camera, HD CCU, touchscreen, and cylindrical rack. The Image Processing Platform is equipped with three shelves for placing auxiliary equipment. A single rack can support up to 40 pounds (18.2 kg) of weight, and the total load on all racks should not exceed 60 pounds (27.2 kg).

2.1.5.3 Endoscope The Da Vinci HD Image Processing System adopts either a 12 mm 3D endoscope or an 8.5 mm 3D endoscope with a straight head (0°) or a curved head (30°). Light from the light source is transmitted to the lower shaft of the endoscope via optical fiber cables and then projected to the surgical site. The heat emitted by the optical fiber helps reduce the fogging of the endoscope lens. Video images of the surgical site captured by the endoscope are sent back to the camera via the left and right channels. The camera is connected to the camera control unit (CCU) and the light source (Figs. 2.17 and 2.18). 2.1.5.4 HD 3D Camera The HD 3D camera is designed to have a 60° field of view (FOV). When combined with Intuitive Surgical’s 3D viewer, the Image Processing System can magnify the images seen in open surgery (without a magnifying glass) by 6–10 times (Fig. 2.19).

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Setup Joint Telescoping Axis

Vertical Range of Motion

Fig. 2.11  Setup Joint

2.1.5.5 HD CCD The HD camera control unit (CCU) is connected to the camera by a cable. The CCU controls the collection and processing of images from the camera (Fig. 2.20). 2.1.5.6 Touchscreen The Image Processing Platform is equipped with a touchscreen to control system settings and view surgical images (Fig. 2.21). 2.1.5.7 Cylindrical Rack A pair of cylindrical racks are arranged on one side of the Image Processing Platform and can be used when establishing pneumoperitoneum (Fig. 2.22). The cylindrical racks are fitted with adjustable straps to hold cylinders of various sizes. The lower bracket can also slide inward or outward after the screws on one side are loosened with a screwdriver. A cylindrical rack can support two cylinders, each with a maximum weight of 40 pounds (18.2 kg).

2.2

Fig. 2.12  Instrument Arm equipped with instrument

Configuration of Operating Room

This section describes the optimal arrangement of the Da Vinci System components in the operating room to ensure maximum safety and best ergonomic results, including the positioning of the Surgeon Console, the positioning of the

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Fig. 2.13  The color of the LED on Instrument Arm

Fig. 2.14  Camera Arm equipped with Endoscope

Patient Surgical Platform, and the positioning of the Image Processing Platform.

2.2.1 Surgeon Console Positioning The Surgeon Console is placed outside the sterile area. The handles on either side of the Surgeon Console (Fig. 2.23) can be used for moving or positioning. There are “PUSH” labels near the side handles. Do not push or pull the console from the back or front. Near the top of the strut, there is a label indicating the way to move the console properly. On the two lateral struts are two “no hands” labels, to remind users not to put their hands in those positions on the mobile console (Fig. 2.24).

The Surgeon Console should be placed in the appropriate direction so that the operator can see the surgical field and maintain a clear route for communication with the Patient Surgical Platform operator. The brakes labeled “Brake” are located on either side of the base of the Surgeon Console (Fig.  2.25). The Surgeon Console should be locked when it is set up for surgery. The brake can be applied by stepping on the brake pedal. The lock symbol becomes visible when the pedal is released, indicating that the brake has been applied. Only one brake needs to be pressed to lower the Footswitch Panel. Two brakes should be applied for optimal stability. The pressed brake can be reset by one more press. Both brakes must be released to the lift position to raise the Footswitch Panel and allow movement of the Surgeon Console.

2  Instructions for Use of Da Vinci Surgical Robots

2.2.2 Positioning of Patient Surgical Platform The Patient Surgical Platform must be placed in the sterile area. It is recommended that the Patient Surgical Platform is moved safely by two operators: one is responsible for operating the drive motor or, if the switch is in neutral, pushing the frame, and the other stands on the opposite side to ensure that the arms and frame do not accidentally collide with anything.

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A special space is required for the drape of the Patient Surgical Platform in the room. The Patient Surgical Platform can also be moved to the surgical location after the drape is installed. The area shall be inaccessible to nonsterile items and shall not obstruct any passage. After the Patient Surgical Platform is draped and the patient is in place ready for surgery, with the incision position arranged, the frame can be moved to the sterile area with the drive motor of the Patient Surgical Platform. Patient Surgical Platform brake: if the frame is not in the neutral position, it will automatically brake when the drive motor is not used. If in neutral, the brakes will not be applied automatically until the casing is installed.

2.2.2.1 Drive Motor Operation Caution: Be careful when moving any large equipment.

The drive motor interfaces include the following parts: throttle, throttle enable switch, gear switch, battery status indicator, and installed casing indicator (Fig. 2.26). The top of the control handle of the drive motor is affixed with the label shown below (Fig. 2.27). This label indicates and displays the positions N = “neutral” and D = “drive” of the drive motor’s gear switch. Label text: Move the frame in neutral if not powered. The operation steps of the drive motor are as follows:

Fig. 2.15  Motor-driven steering column

Fig. 2.16  Illuminator and Camera Control Unit

1. First, make sure the power of the Patient Surgical Platform is turned on (Fig. 2.28). Please refer to “standalone mode”

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a

b 386 mm 12 mm

65 mm

554 mm Fig. 2.17  12 mm Da Vinci HD Endoscope

a

b 297 mm 65 mm

8.5 mm

464 mm

Fig. 2.18  8.5 mm Da Vinci HD Endoscope(30°)

for instructions on powering the Patient Surgical Platform when it is not connected to the Surgeon Console or the Image Processing Platform. 2. Make sure the gear switch is in the drive position. 3. Hold the throttle to allow switching and turn it away from or close to you to move the frame in the respective direction (Fig. 2.29).

Fig. 2.19  3D HD Camera

2  Instructions for Use of Da Vinci Surgical Robots

Fig. 2.20  Camera Control Unit and Light Source

Fig. 2.21  Assistant operating on Screen Touchpad

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Hold a reserve gas cylinder

Adjustable belt

Fig. 2.22  Gas cylinder rack

When the throttle enable switch is turned on, the power button of the cart frame flashes green and the drive speed is controlled by the distance the throttle valve rotates.

Fig. 2.23  “PUSH” near Arm Rest on both sides of Surgeon Control

Use Arm Rest on side to move Surgeon Console

Don’t move it from behind

Fig. 2.24  Label on the back of Surgeon Console

Warning: To ensure patient safety, both gear switches must be in the drive (D) position during surgery to keep the drive motor engaged (Fig. 2.30). Note: For safety reasons, the drive motor will not engage when a casing or instrument is installed on the system. The yellow LED on the drive motor interface gives an indication when a trocar or an instrument is installed, and the drive motor is not working. The LED is labeled “Trocar Installed: Cart Drive Disabled.” Note: In case of battery-powered operation, the drive motor may not work with low battery. The battery status indicator shows the amount of charge in the battery. To understand battery LED flashing or red indicators, see the bottom of the drive motor interface: Flashes: The battery needs to be recharged. Red: Low battery for surgery. Note: The battery of the Patient Surgical Platform should be fully charged. Otherwise, the monitor will display an error message. If the Patient Surgical Platform is plugged into an AC power supply, this error can be forcibly ignored.

2  Instructions for Use of Da Vinci Surgical Robots Fig. 2.25  Arm Rest and Brake of Surgeon Console

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Arm Rest

Brake Arm Rest

Fig. 2.26  Drive motor controller and indicator of Surgeon Console

Cannula installation indicator

Battery status indicators

Shift switch

Shift switches

Throttle enable switch Throttle

Fig. 2.28  Power Panel on Patient Cart

Fig. 2.27  Label at top of drive motor’s operation panel

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2.2.2.2 Gear Switch The two gear switches (Fig. 2.30) should be shifted to neutral (N) position when it is necessary to move the Patient Surgical Platform without the drive motor (in case of power failure). In this way, the frame can be moved manually. The two gear switches should be shifted back to the drive (D) position to apply brakes on the Patient Surgical Platform after moving the frame.

Note: The frame can be pushed up to 20 mm in height and 80 mm in width. The cart may be moved manually to exceed the threshold that is too high to be exceeded when driven by the motor. The gear switch should be placed in “N” position (neutral) (Fig.  2.30), and the cart manually pushed over the threshold.

Motor Driver in drive

Motor Driver in neutral

Fig. 2.30  Shift Switches of the motor driver on Patient Cart

2.2.3 P  ositioning of Image Processing Platform The Image Processing Platform is located next to the Patient Surgical Platform, just outside the sterile area. On the shelf of the Image Processing Platform, there are places for auxiliary devices [such as electrical surgical unit (ESU) and insufflator]. Auxiliary devices should be properly placed so that the Patient Surgical Platform operator can easily see and touch the components and touchscreen of the Image Processing Platform. Caution: Be aware of tripping hazards during movement. The touchscreen should be in the home position and the back door (Fig. 2.31) should be closed before moving the cart.

The Image Processing Platform should be sufficiently close to the Patient Surgical Platform so that the motion of the camera cables during surgery is not restricted.

Fig. 2.31  Overturning danger caution sign on the back door of Vision Cart Push tongue down and lock it.

unlocked

Fig. 2.32  Wheel Locks of Vision Cart

All wheels of the Image Processing Platform have locks (Fig. 2.32). These wheel locks should be secured when the frame is in place during surgery.

2.3

System Connection

This section describes the way to connect various components of the Da Vinci System, including power connection, system cable connection, camera cable connection, auxiliary device connection, video and audio connection (Fig. 2.33).

2.3.1 Power Connection Fig. 2.29  The method of driving Patient Cart

The AC power cords of the Surgeon Console, the Patient Surgical Platform, and the Image Processing Platform are

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Fig. 2.33  Example of system cable and connections

Connect CORE Connect Surgeon Console

Table 2.2  The requirements of the power and power cord System components Surgeon console

Cord length 4.6 m 15 ft

Patient cart

4.6 m 15 ft

Vision cart

4.6 m 15 ft

Power requirement 1000 VA continuous 8.4 A at 115 V~ 4.2 A at 230 V~ 1000 VA continuous 8.4 A at 115 V~ 4.2 A at 230 V~ 1500 VA continuous 12A at 115V~ 6A at 230V~

Standby power draw 95 VA 0.8 A at 115 V~ 4.2 A at 230 V~ 75 VA continuous 0.6 A at 115 V~ 0.3 A at 230 V~ 145 VA continuous 1.1 A at 115 V~ 0.55 A at 230 V~

connected to wall sockets. According to Table  2.2, there should be appropriate power supplied by each wall socket:

Note: Before first use, the Patient Surgical Platform should be connected to the wall sockets for at least 14 h to allow the battery to be fully charged. Note: The Patient Surgical Platform should always be powered on even when not in use to ensure that the backup battery is always fully charged. Note: The cooling fan continues to run when either the Patient Surgical Platform or the core component (of the Image Processing Platform) is connected to the AC power supply. This is a normal phenomenon. Caution: Do not use extension cords for any system components.

2.3.2 System Cable Connection The cable for the Da Vinci System (Fig. 2.34) is 20 m (60 ft) in length and should always be connected to the Image Processing Platform.

• The system cables are identical and can be connected to both the Surgeon Console and the Patient Surgical Platform to transmit video, audio, and data while the system is working. The cables are stored on a cable hook on the outside of the Image Processing Platform.

Note: Once the system is connected and powered, the system cable should not be unplugged until the system is completely shut down. Note: The system cable is made of optical fibers. Attention should be paid to avoid bending the cable, as it may damage the cable and prevent the system from working normally. The minimum safe bending radius of the cable is 1 in. (2.54 cm).

2.3.2.1 System Cable Layout The cables should be arranged reasonably to avoid blocking access (including channels for other devices), prevent damage, or cause obstruction or danger. The cables should also be positioned to facilitate the movement of the Patient Surgical Platform between preoperative (when draped) and intraoperative positions (Fig. 2.35). 2.3.2.2 How to Connect the System Cables Remove the protective cable cap and check the cable connector and system socket for any residual foreign matter. The system socket has a protective cover that must be opened. Connect system cables between components as shown in Fig.  2.36. To connect the cables, align the red dot on the cable connector with the red dot on the matching socket, then open the socket cover, and insert the connector. A click sound can be heard if the cable is properly connected. Gently pull

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Fig. 2.34  System Cable

Fig. 2.35  Layout of System Cable

the connector to confirm that the cable is properly installed (Fig. 2.37). Note: The metal protective cap attached to each system cable should always be installed at the cable end before the cable is connected to the system.

2.3.3 Connecting the Camera Cables The camera has two cables: a video cable and an optical cable (Fig. 2.38). The length of the video cable and optical cable is 5.75 m (18.6 ft).

Note: Intuitive sells two different types of camera video cables that are compatible with the Da Vinci System, and they can be easily distinguished by the black or gray ends. This chapter discusses the use of these two types of cables. The cable and camera connector cannot cross the connector on the CCU (camera control unit), that is, a cable with black ends cannot be connected to a system with gray ends. Users should not attempt to use cable systems incompatible with the camera.

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Fig. 2.36  Connect System Cable and Surgeon Console

Red alignment mark

Open socket cover and insert

Pull gently to ensure proper connection

Check and aim at red mark

Fig. 2.37  Connect System Cable

Connect Surgeon Console

Connecct Patient Cart

Connect core:do not remove

2.3.3.1 Connecting Camera Cables Although the cable connection steps for both cameras are basically identical, special attention should be paid to differentiate the black or gray cables.

3. Once started normally, tighten (clockwise) the large metal nut at the cable end. It is a threaded nut, so the joint can be tightened manually. For cables with black ends, tighten the nut until no part of the yellow ring surrounding the nut base is visible, to ensure a good connection.

Note: If you are using the camera cable with black ends and yellow ring, a (male) CCU connector must be matched with the female CCU head with the blue ring.

2.3.3.2 Connecting the Optical Cables Insert the optical cable connector into the light source fiber socket as shown in Fig. 2.40.

Follow these steps to connect the camera cables (Fig. 2.39) 1. Connect the camera video cable to the socket of the camera control unit (CCU). The connector has a key. Therefore, to successfully insert the connector, the arrow on the cable connector must be aligned with the top of the CCU socket, as shown in the figure. 2. Carefully adjust and straighten the joint, tighten the nut and prevent slippage.

2.3.3.3 Maintaining Camera Cables Fiber optic and camera cables are vulnerable to damage due to twisting, pressure, or loosening of connectors due to contamination. Such situations can degrade optical transmission performance, significantly reduce video quality and even lead to cable failure. In order to prolong the life of cables, follow the below instructions for proper maintenance. Keep both ends of the camera cable connected when not in use. In this way, connectors and sockets can be protected from contamination. Use the “S” connector provided with the camera cable to place the optical cable and the camera video cable together.

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Fig. 2.38  Connect camera cable and CCU

Fig. 2.39  Connect HD camera cable Match alignment arrow

The “S” connector places the two cables together in parallel thus preventing excessive bending and twisting when being moved or stored (Fig. 2.41).

Note: Additional “S” connectors, if required, are available from Intuitive Surgical and can be installed by the user. Please contact the Customer Service Department of Intuitive Surgical.

The camera should be stored in a custom mount in the drawer of the Image Processing Platform below the CCU.  The camera cables and wire pairs are loosely anchored, and the excess cables are hung on hooks outside the Image Processing Platform. The hook outside the device is relatively large, which enables the blue system cable and camera cable to be hung simultaneously, as shown in Fig. 2.42.

Tightened screw

2.3.4 Connecting Auxiliary Devices Warning: Do not plug other equipment into the wall power socket of the Image Processing Platform. It may overload the circuit. Note: Da Vinci cannot support two electrosurgical unit (ESU) generators with the same energy mode (e.g., both unipolar) simultaneously. For example, two high-­ frequency devices of the same type (bipolar and bipolar) cannot be activated simultaneously. This means that two bipolar instruments cannot be activated if controlled by a surgeon simultaneously through the left and right masters.

The compatible electrosurgical unit (ESU) can be started after the appropriate high-frequency activation cable is connected to any of the auxiliary connectors behind the core component. A maximum of three ESUs can be connected simultaneously. The cable color is encoded according to the ESU model (Figs. 2.43 and 2.44).

2  Instructions for Use of Da Vinci Surgical Robots

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Store connected cable in the drawer

Fig. 2.42  Store connected camera cable

Fig. 2.40  Connect optical cable Fig. 2.43  Representative auxiliary device cable

Caution: Ensure that only compatible ESUs are connected to the Da Vinci System. Please refer to the User’s Manual on Instruments and Accessories (PN 550675) for a complete list of compatible ESUs. Performance is not guaranteed for cables or accessories not specified in the User’s Manual on Instruments and Accessories. Any system damage caused due to the use of any incompatible ESU is not covered by the warranty. Follow these steps to connect the accessories (e.g., ESU) to the system: 1. Insert the accessory end of the cable into the corresponding channel on the device, as shown in Fig. 2.45. 2. Insert the system end of the cable into any of the three Energy sockets behind the core component (Fig. 2.46).

Fig. 2.41  Cable hook merges camera cables together

Note: If the high-frequency (HF) pumping cable is not available or does not work, the pedal switch provided by the generator manufacturer can be used. In this case, the system does not provide any feedback to the Surgeon Console operator.

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American Wily electrosurgical

Gyrus G400 electrotome

upgrade, for example, when purchasing a second console to support dual console surgery. By default, the system is equipped with a connection slot for video output Aux and a connection slot for audio input (output) on the lower right side. TilePro inputs 1 and 2 are provided by default on the back of the Surgeon Console. Note: Each connection slot of input and output supports only one video format at a time.

Fig. 2.44  Representative EUS settings

The back of the core component supports up to 6 auxiliary connection slots: 2 for video input, 3 for video output, and 1 for audio input (output). Each connection slot is fitted with 3 or 4 connectors, but only one connection can be used at a time. The connection panel on the back of the Surgeon Console has the default TilePro inputs 1 and 2.

Note: The connector on the core component (and other components of the Image Processing Platform) is labeled with light-colored gray words. As shown in the red box in Fig.  2.47, the connector is connected as required, by authorized ISI personnel during system installation and/or maintenance. Caution: Do not touch the patient while touching any connector to avoid the risk of electric shock. Fig. 2.45  ESC connection (back of ESU)

Fig. 2.46  ESC connection (back of CORE)

2.3.5 Video and Audio Connection Note: The connection slots for video input and output, and the four core parts shown on the left in Fig. 2.47 are not available by default (connection slots 1 and 2 for TilePro input and video output in the green box). They are optional supplies provided in case of an

2.3.5.1 Surgeon Console Connection Two connection slots for video input (Fig. 2.48) are located on the back of the Surgeon Console, to enable the use of TilePro on the Surgeon Console. Each connection slot for video input can receive a single DVI (digital video interface), HD-SDI (serial digital interface), or S-video signal. If an update is installed, which makes the connection slot for core optional TilePro input (Fig. 2.47) available, you can use either set, but no more than two sets of TilePro inputs. The system automatically checks the TilePro connection in the following order: first on the Surgeon Console, then on the core components. TilePro input from the Surgeon Console takes precedence when both are used. The connection slots for Video Out L and Video Out R on the Surgeon Console transmit the videos seen by the left and right eyes on the Surgeon Console via the DVI connection. These connection slots work independently of the connection slots of the core component for optional video output 1 and video output 2. The latter is available only when an optional update is installed, and they output video signals that the user can program on the touchscreen.

2  Instructions for Use of Da Vinci Surgical Robots

The audio connection slot supports audio transmission from the Surgeon Console with RCA Line Out, RCA Line In, and a 2.5 mm input/output headset connector.

2.3.5.2 Video Out of Core Components The core components support up to three connecting slots for video output (Fig. 2.47). The video output for all three slots includes icons and text messages displayed on the Surgeon Console. Each connection slot for video output supports one-­ way DVI, HD-SDI, S-video, or composite signals.

Note: The connection slots 1 and 2 for video output are not available by default. They are available only after installing the relevant optional updates, for example, after purchasing a second console to support dual console surgery. Only the connection slot for video output Aux is available by default.

2.3.5.3 Audio In and Out of Core Components The audio connection slot (Fig. 2.47) is fitted with three connectors: 2.5 mm input (output) headset jack: azzudio on the touchscreen is disabled when used; RCA (input); and RCA (output). 2.3.5.4 CCU Video Out Two channels for video output are present behind the camera control unit (CCU). The video output for the left eye (L) and right eye (R) provide surgical images without icons or text messages. They are component videos made up of Y (green port), PR (red port), and PB (blue port) signals (Fig. 2.49).

2.4

Startup and Boot

This section describes the start-up methods for the Da Vinci System components, including standalone mode, system power-on, boot sequence, preparation, and home positioning of the Patient Surgical Platform before the drape is installed.

2.4.1 Standalone Mode The Surgeon Console, the Patient Surgical Platform, and the Image Processing Platform can all be started independently, which is called the standalone mode. The ergonomic control can be adjusted when the Surgeon Console is in standalone mode. The touchscreen function is not available at this time. The arm LED provides no feedback, and the system accessory is not operational when the Patient Surgical

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Platform is in standalone mode and not connected to the Image Processing Platform. The drive motor and clutch button of the Patient Surgical Platform are available when the core components and AC power are not connected.

Note: The operation in dual console mode (use of the second Surgeon Console—refer to dual console surgery) is available if only the system cable for the second console is inserted into the free fiber port behind the core component. No other connection is required except for plugging the Surgeon Console into a dedicated AC power socket. The second Surgeon Console operates exactly as the first Surgeon Console.

All functions of the Image Processing Platform (such as video source, automated registration, and white balance) are available when it is in standalone mode. 1. To start the Surgeon Console or the Image Processing Platform in standalone mode, confirm that the power cord is properly connected, and then press the Power button (Fig. 2.50). 2. To start the Patient Surgical Platform in standalone mode, press the corresponding Power button (Fig. 2.50). There is no need to plug any cable into the Patient Surgical Platform to enter the standalone mode.

Note: There is a grid power circuit breaker (PCB) on the back of the Surgeon Console, the Patient Surgical Platform, and the Image Processing Platform. The corresponding circuit breaker must be switched on (marked “I” next to each switch) to start these subsystems. The core component, light source, and camera control unit (CCU) are also equipped with their own power switches on the back, which must be switched on when starting up. All these subsystems and components should be switched on, and only in special cases should these switches be toggled, for example, when the power supply works abnormally.

2.4.2 System Power-On After the Surgeon Console, the Patient Surgical Platform and the Image Processing Platform are fully connected and plugged into AC power supply, all components can be started by pressing the power button of any system.

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Note: If any component is in standalone mode and is connected to a system cable, the system will power-on itself. Note: The system cable can be connected at any time but cannot be unplugged until the system is completely shut down, once connected. Note: The battery of the Patient Surgical Platform should be fully charged. Otherwise, the monitor will display an error message. If the Patient Surgical Platform is plugged into an AC power supply, this error can be forcibly ignored.

Abnormal conditions, if any, may cause the whole Da Vinci System or a part of the Patient Surgical Platform, the Image Processing Platform or the Surgeon Console to fail to turn on normally, or lead to an automatic shutdown sequence at run time. The former may occur in situations such as faulty power connections, and the latter in situations such as overheating of a system component. This section describes the measures to be taken in such situations. 1. Check AC power connections: In all cases of abnormal power supply, first check the AC power connection by following these steps. (1) Make sure that the respective power cords of the Surgeon Console, the Patient Surgical Platform, and the Image Processing Platform are properly connected to the dedicated AC power socket. (2) Make sure that all grid power supplies connected to the Surgeon Console, the Patient Surgical Platform and the Image Processing Platform are properly switched on (marked “I” beside the switch). These switches are located behind each component near the power supply inlet. Make sure that the EPO (Emergency Power Off) button is not depressed on the Patient Surgical Platform, as it needs to be pressed again before it can be reset. (3) Make sure that the power switches for components, including the core component, the camera control Fig. 2.47  Connect video and audio (back of CORE)

Optional TilePro Input(L) TilePro Input(R) Video Out Bay1 Video Out Bay2

unit, and the light source, are properly set to the open position (marked “I” next to the switch) on the Image Processing Platform. In addition, make sure that the power cords of each component of the Image Processing Platform are inserted into the integrated patch board of the Image Processing Platform. 2. Check the system cable connections: Make sure that the core components are properly connected to the Surgeon Console and the Patient Surgical Platform with the blue system cables. Please refer to the cable connection layout. 3. Power Hard-Cycle: The AC power connection should be checked first if the entire system or if the Patient Surgical Platform, Image Processing Platform, or Surgeon Console do not start up properly after pressing a power button. Follow the steps below to continue the “Hard-Cycle” to turn the whole system on if all AC power supplies are properly connected. (1) Switch off the circuit breakers on the Surgeon Console and the Image Processing Platform (marked “O” beside the switch) and cut off the AC power supply to the Surgeon Console and the Image Processing Platform. Leave these switches off until you are required to switch them on as per the below procedure. (2) The Patient Surgical Platform can operate on battery power even if the grid circuit breakers are switched off; thus, the EPO (Emergency Power Off) button, the big red button behind the Patient Surgical Platform, must be pressed. The EPO button either disconnects the Patient Surgical Platform from the AC power supply or disables the device from the default standby or sleep mode. All the power supplies will be cut off by pressing the EPO button. This button remains partially depressed. After at least 2 s, press the EPO button again to reset it. Then, it will return to the ready position, or the original position, when it is completely released. (3) Switch on the power circuit breakers for the Surgeon Console and the Image Processing Platform (the circuit breaker of the Patient Surgical Platform should already be switched on). After about 30  s, all three

2  Instructions for Use of Da Vinci Surgical Robots

TilePro Inputs(L)(R)

L\R outputs

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Audio

Fig. 2.48  Connections behind Surgeon Console

system components should return to their default standby power state, marked by the amber light on the Power button of the system component. (4) Press any of the Power buttons on the Surgeon Console, the Image Processing Platform, or the Patient Surgical Platform to start the system normally. When trying to start up a single system component in standalone mode, to solve the problem of abnormal power performance, if any, the “HardCycle” power operation should be performed on the applicable components, as described above. 4. Restart from automatic high-temperature shutdown: In normal operating mode (as opposed to maintenance or standalone mode), the entire Da Vinci System is designed to perform automatic and controlled sequential shutdown operation to prevent system damage when a component or subsystem overheats. Once the system detects overheating, it will automatically start a 60 s sequential shutdown operation, and displays a notification message with the countdown time. The sequential shutdown operation cannot be interrupted. The power buttons of all three systems emit an amber light after the operation, indicating that the systems are in their default standby or sleep state. It is recommended to let the overheated parts of the system cool down for 5 min; if possible, resolve the problems that are causing the system to overhead. For e­ xample, make sure that none of the ventilated system covers are blocked, and remove any obstruction from the system that may block the flow of air into and out of the system covers.

Fig. 2.49  Video connection (back of CCU)

Fig. 2.50  System power buttons

Vision cart power button Console power button

Patient cart power button

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Restart the system from the standby state following the usual steps: • Press any one of the system Power buttons. In this way, the system can start up normally. During the sequential startup operation, the Power button LED flashes an amber light when normal and emits a stable blue light after startup. • If overheating reoccurs, the recovery system can be restarted, but it is recommended that you seek help from ISI Technical Support Department to address the root cause of overheating. 5. Restart from standalone “cold mode”: If a single component overheats while operating in standalone mode and shuts down automatically, the power button needs to be pressed three times to restore the component to normal operation. It is called “cold mode,” in which the system components are cooled in case of overheating. The actions when the button is pressed are as follows: • No visible effect is produced with the first press of the Power button. • The system component returns to the standby state with the second press of the Power button, marked by the amber light flashing on the power button every few seconds. • The component starts up normally with the third press of the Power button. • This restart action still applies if a component or system overheats while in maintenance mode. The maintenance mode is reserved for Intuitive Surgical’s maintenance personnel, so this is not something users typically encounter.

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Note: Do not place your face or other objects in the 3D viewer during the sequential startup operation. Do not activate any controller of the Da Vinci System, including clutch buttons, foot pedals, etc. Although most button actions are ignored during the sequential startup operation, some button actions may still cause unrecoverable failure, meaning that the user must restart the system. Emergency shutdown can be used during startup if necessary. When the system beeps, it needs to interact with the system controller. Note: The arms of the Patient Surgical Platform will not move during startup if the system detects that a sterile adapter, instrument, or trocar has been installed before startup. Due to this feature design, the system can remain stationary during the sequential startup operation and securely connect to patients. Note: The instruments should be removed when the system is being started if it is clinically feasible.

The LED on the master arms (all non-homed arms) emits white light after the system integrity test is completed.

2.4.4 P  reparing the Patient Surgical Platform Before Drape Installation Work The insertion axis of each arm should be moved to a vertical position (90°) so that the arms of the Patient Surgical Platform are ready to be fitted with a drape. Make sure

2.4.3 Boot Sequence System integrity tests are conducted during the sequential startup operations. As part of the test, self-tests are conducted on unpositioned masters and all the arms of the Patient Surgical Platform. The main arms should be moved to their starting position and remain there, otherwise the system will not work. If the main arm is blocked, it can be released ­manually and moved to its starting position. The arms of the Patient Surgical Platform are fully deployed and a brief mechanical integrity test is conducted if no trocar is installed and the master arm is not in the home position. The master arm needs to be controlled with a notch clutch button to avoid obstacles during the test. The notch clutch button should be pressed and released after avoiding the obstacles, to allow the test to resume. Fig. 2.51  Stretch Instrument Arm to install a protective cover

2  Instructions for Use of Da Vinci Surgical Robots

that the instrument arm 3 is in front of the column of the Patient Surgical Platform if it needs to be draped (Fig. 2.51). 1. The latch on the Setup Joint closest to the column of the Patient Surgical Platform should be loosened to move the instrument arm 3 from one side of the Patient Surgical Platform to the other side (Fig. 2.52). 2. Move the arm to the other side of the Patient Surgical Platform with the notch clutch button. Make sure to latch the Setup Joint after the arm is fully moved to the other side. The axis of the Setup Joint can be kept locked for more flexible adjustment. Leave the instrument arm 3  in the home position if it is not to be used during the surgery.

Release latch

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2.4.5 Home Position As per the design, the instrument arm is in the home position during transportation and when not in use. The instrument arm in the home position does not move during the sequential startup operation. The instrument arm cannot be started in the home position, and only the clutch and fault state LED work. 1. Follow these steps to place instrument arm 1 or 2 in the home position. (1) Move the instrument arm close to the column of the Patient Surgical Platform. (2) After the instrument arm 1 or 2 is close to the column of the Patient Surgical Platform, the insertion axis of the instrument arm can be fully retracted and fixed in the fully retracted position. 2. Follow these steps to place instrument arm 3 in the home position. (1) Make sure that the first Setup Joint on arm 3 is facing arm 2 (looking to the right from behind). (2) Adjust the position of the Setup Joint as shown in red in Fig. 2.53. (3) Move the insertion axis to a position where it is fully retracted and fixed, and ensure that the instrument arm is hidden under the bottom connector (Fig. 2.54). Move the Setup Joint as close as possible to the column of the Patient Surgical Platform. (4) The instrument arm 3 can be repositioned after it is located behind the column of the Patient Surgical Platform (Fig. 2.54). Move the entire Setup Joint to the lower end of its vertical range of motion.

Fig. 2.52  Move third Instrument Arm

Fig. 2.53  Adjust third instrument arm to stowed position Third instrument Arm

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Fig. 2.54  Third arm is waiting to be stowed

Third instrument Arm

Fig. 2.55  Setup Joint at the lowest range of vertical motion

The arm can be moved with the notch clutch button at any time, to make the instrument arm 3 move from the home position. The arm is ready for use once the notch clutch but-

ton in front of the column of the Patient Surgical Platform is released, and the insertion shaft is opened to prepare for drape installation (Fig. 2.55).

2  Instructions for Use of Da Vinci Surgical Robots

2.5

Installing the Drape

The drape is installed to ensure the arms of the Patient Surgical Platform are sterile and suitable for surgical procedures. This section describes in detail the way to install drapes on the instrument arm, camera arm, camera, and touchscreen (optional). This section includes instructions for drape installation, and operating procedures for installing the drape on instrument arms, camera arms, touchscreen (optional), and on the camera (Fig. 2.56).

2.5.1 Instructions for Installing the Drape To ensure speed, sterility, and safety, draping should be done by two people: a scrub nurse or surgical assistant and a circulating nurse who can handle non-sterile components. The arms should be draped systematically from left to right or right to left. First, install a drape on the instrument arm 3 (no installation is required if the arm is not used).

Fig. 2.56  Install protective cover

Fig. 2.57  Unfold protective cover of Instrument Arm

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Warning: A drape shall no longer be used once its package has been torn or opened, as the drape may no longer be sterile. Note: Intuitive Surgical’s drapes cannot be replaced with general protective drapes. The drapes are available from Intuitive Surgical or local distributors. Each custom drape is specially designed to maintain its sterility and to ensure simple and easy installation.

The circulating nurse should use the clutch button to move the straightened arms so that there is enough operating space around the arms. After an arm is draped, the scrub nurse should move the draped arm away from the undraped arms and prepare to drape the next arm. To drape the Da Vinci system, two or three drapes for instrument arms, camera arm, and for the camera are required. Draping the touchscreen is optional. The drapes can be ordered as a complete set or as individual units. Before surgery, make sure you have an adequate supply of drapes, that is, there should be at least one spare for each drape required, to cope

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with accidental contamination when setting up the system, inserting the endoscope, and when the system is ready for use.

2.5.2 O  perating Procedures for Installing the Drape on Instrument Arms Circulating nurse: Aseptically pass the instrument arm drape to the scrub nurse, while the instrument arm sterile adapter is facing upward. Scrub nurse: Unfold the drape on the sterile surface (Fig. 2.57).

Fig. 2.58  Put protective cover down to Insertion Shaft

Fig. 2.60  Spread out protective cover along Instrument Arm

Fig. 2.59  Insert base, press the top of the button, install Sterile Adapter

Push the top until you hear kala

Base of the Sterile Adapter is assembled here.

2  Instructions for Use of Da Vinci Surgical Robots

Lift the drape cover opening and hold the outside with your thumb and other fingers. Hold the top of the drape with the other hand. Slip the drape down onto the insertion shaft of the instrument arm (Fig. 2.58). Insert a matching black molded piece at the bottom of the sterile adapter. Push the sterile adapter into the instrument Note: The blue belt on the drape represents sterile boundaries. Non-sterile personnel, if any, should not hold the drape beyond the blue belt when assisting in draping.

arm with two thumbs until it clicks to indicate it is properly fixed (Fig. 2.59). Rotate the runner of the sterile adapter until you hear three beeps, indicating that the system has identified the sterile adapter. Remove the two patches in front of the drape.

Note: The blue belt on the drape represents sterile boundaries. Non-sterile personnel, if any, should not hold the drape beyond the blue belt when assisting in draping.

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Hold the edges of the drape opening and drape the instrument arm toward the column of the Patient Surgical Platform (Fig. 2.60). Install the trocar and molded parts. Make sure the molded parts are fixed to the trocar mounting piece (Fig. 2.61). Wrap all the white shield straps around the instrument arm properly and tie each strap together (Fig. 2.62). At this point, make sure that the arm moves without tearing the shield or straps. Bend the blue elastic bar to form a smooth insertion path along the shaft of the instrument arm (Fig. 2.63).

2.5.3 O  perating Procedures for Installing the Drape on Camera Arm Before draping the camera arm, sterile personnel should move the draped arms away from the camera arm, leaving enough walking space between the arms. Follow these steps to begin installing a drape on the camera arm: 1. The circulating nurse hands the camera arm drape aseptically to the scrub nurse, with the arrow facing up. 2. The scrub nurse unfolds the drape on the sterile table and removes the sterile adapter holder (Fig. 2.64).

Fig. 2.61  Place cannula, install Cannula Mount Molding

Wrong: Molding do not covers the tongue process on both sides of bracket.

Right: Molding covers the tongue process on both sides of bracket.

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straps

Fig. 2.62  Secure protective cover with straps

3. Insert one hand into the lower opening of the drape and hold the upper end of the drape with the other hand. Lower the drape to the insertion shaft, then lift the upper part of the drape and slip it into the upper end of the arm insertion shaft. 4. Install the sterile adapter for the camera arm into the camera armrest. Make a slot in the drape to create a space for the endoscope to pass through with the side of one hand. Then firmly push it into the sterile adapter for the camera arm (Fig. 2.65). 5. Hold the edges of the drape opening and drape along the Setup Joint of the camera arm toward the central column of the Patient Surgical Platform (Fig. 2.66).

取下

Fig. 2.64  Unfold protective cover of Camera Arm, remove the white retainer Fig. 2.63  Bend blue flex-strips

Fig. 2.65  Lower protective cover into Insertion Shaft, Install Sterile Adapter

2  Instructions for Use of Da Vinci Surgical Robots

6. Tie the Velcro strap (adhesive strap) to the opposite end near the central column with the hand at the edge of the drape opening. 7. Install trocar and molded parts. Make sure the molded parts are fixed to the trocar mounting piece (Fig. 2.67). 8. Wrap the white drape straps around the camera arm properly and secure the end of the straps with tape (Fig. 2.68). 9. Bend the blue elastic strip to form an unimpeded endoscope path along the insertion shaft of the arm and ensure

Fig. 2.66  Unfold protective cover to Center Column and secure

Fig. 2.67  Install Cannula Mount Molding

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that the camera arm drape is not pulled or torn during system operation (Fig. 2.69).

2.5.4 O  perating Procedures for Installing the Drape on Camera Since the Image Processing Platform and cables are non-­ sterile, a non-sterile person (circulating nurse) is required to assist a sterile person (scrub nurse) in installing the drape

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Fig. 2.70  Install camera to Sterile Adapter straps

Fig. 2.68  Secure protective cover of Camera Arm with straps

Fig. 2.71  Lock and unlock signs

1. The circulating nurse hands the camera drape aseptically to the scrub nurse. 2. The scrub nurse uncovers the drape. Then inserts a hand into the opening end of the drape and grips the camera sterile adapter (Fig. 2.70). 3. The circulating nurse attaches the camera to the camera sterile adapter. The sterile adapter stitches must be aligned with the camera channel, and it is locked in place when it is pressed down and rotated. The icon camera clasp indicates the direction to turn when locking or unlocking the camera sterile adapter (Fig. 2.71). 4. The scrub nurse turns the drape over the camera (Fig. 2.72). 5. The circulating nurse pulls the drape along the cable. Fig. 2.69  Bend blue Flex-strips near the Insertion Shaft

and connecting the camera. The camera itself is not sterile, so it must not be autoclaved. The steps to drape the camera are as follows:

Note: The draped parts and cables on the platform are arranged in an “S” shape, or in a sterile tray to avoid contamination.

2  Instructions for Use of Da Vinci Surgical Robots

2.5.5 O  perating Procedures for Installation of Drape on Touchscreen (Optional)

Note: The blue belt on the drape represents sterile boundaries. Non-sterile personnel, if any, should not hold the drape beyond the blue belt when assisting in installing the drape. Another sterile person is required to assist in installing the drape for the touchscreen due to its large size. Follow these steps to begin installing a drape on the touchscreen.

1. The circulating nurse removes the monitor drape from the aseptic package. 2. The scrub nurse places the drape on a sterile surface with the label facing up. Remove and discard the lining paper (Fig. 2.73). Fig. 2.72  Flip protective cover over camera and pull it along the cable

Fig. 2.73 Unfold Touchscreen Monitor protective cover and remove the lining paper

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3. Place one hand on the opening under the drape and hold its top with the other hand. With the label facing the operator, slip the drape down onto the monitor (Fig. 2.74). 4. Grab the edge of the drape opening and slip the drape all the way down to the base of the monitor arm (Fig. 2.75). 5. Secure the tape around the arm, then tighten the strap around the base of the monitor arm and fasten the cord with the fixer (Fig. 2.76). Tuck the excess cord into a bag near the drape. 6. Align the drape window with the monitor. Press the drape to ensure it adheres smoothly to the monitor surface (Fig. 2.77). 7. Fix the Velcro strap to the side and back of the monitor (Fig. 2.78). Retract the arm to the upright and reposition the Patient Surgical Platform to prepare for surgery after installing the drape. Set up the Image Processing System after installing the drape.

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2.6

 pplication of Image Processing A System

This section introduces the Da Vinci Si™ HD Image Processing System settings and usage method, and includes an overview of image observation, Image Processing System settings, cold light source operation, image observation controller touchscreen operation, touchscreen display adjustment, and image quality problem processing.

2.6.1 Overview of Image Processing System

Fig. 2.74  Hold protective cover down to Touchscreen Monitor

The 3D HD Image Processing System provides high-­ resolution images for the surgeon (on the 3D viewer) and the patient-side assistant (on the touchscreen). The 3D HD endoscope components (endoscope and camera) can be used manually (hand-held like traditional endoscopes) or mounted on the camera arm to assist in preoperative examination (Fig. 2.79).

Note: The Da Vinci System can only be used with cameras, endoscopes, accessories, and image-­ processing equipment approved or supplied by ISI. In this way, the Da Vinci system’s image quality and optimal performance are guaranteed.

Fig. 2.75  Push protective cover back with the opening edge of itself

1. Light source—The light source illuminates the surgical field. The light source’s lamp monitoring module generates a notification when it is time to replace the lamp. 2. Endoscope—The endoscope is fitted with left and right optical channels to capture the surgical field. The light from the light source is projected onto the surgical field through an integrated fiber optic channel. The heat emitted by the fiber optic channel helps prevent fogging of the endoscope lens (Fig. 2.80). 3. Camera—The 3D camera includes two HD video cameras. One camera is for the right optical channel and the other for the left optical channel. The HD Image Processing System provides both widescreen (16-9) views and enlarged views through digital zoom (Fig. 2.81).

2  Instructions for Use of Da Vinci Surgical Robots

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Fig. 2.76  Fixed Taps, Tighten Rope, Tuck the extra rope back

pull

Wrap straps

open

tuck

finish

4. Touchscreen display—The touchscreen display allows the user to observe the surgical field and/or optional video inputs, telestrate the images, and adjust image observation settings and system settings. The touchscreen display is equipped with microphones and speakers to facilitate communication between the surgeon and the patient-­side assistant.

2.6.2 Image Processing System Settings

Fig. 2.77  Make protective cover adhere smoothly to Touchscreen Monitor

Note: Repeated movement during surgery can damage the camera’s cable. Such failures in the cable usually occur close to the camera. Caution: Handle the optical cables carefully. The fiber optic material in the optical cable may be damaged if the cable is excessively bent or twisted. Such damage would greatly reduce the amount of light transmitted through the fiber optic cable (Fig. 2.82).

Warning: Failure to follow approved surgical procedures can result in damage to the endoscope. Improper operations include equipment fall, impact, improper cleaning and disinfection techniques, etc. Damage to the endoscope can cause debris to fall into the patient.

1. Preoperative examination—The glass surfaces of the optical port end and camera end should be cleaned and it should be ensured that they are free of irregularities, stains, residue, or cracks, otherwise the images may be dull and unclear, and there is a risk of component failure during use. The surface of the endoscope must not be damaged or have sharp edges and it should be checked for dents, mechanical and/or thermal defects resulting from the improper use of electrosurgical or other instruments.

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Fig. 2.78  Secure Velcro Straps to the side and back

Fig. 2.79  Vision System components

Store connected camera in the drawer

Surgeon Console

Illuminator connects cable during storage.

Stereo Viewer

Vision

Warning: Do not use defective or damaged endoscopes, including ones with damaged fiber optic surfaces or optical ports, otherwise there is a risk of serious injury to the patient or surgical complications. Warning: Do not look straight at the optical fiber bundle head when the light is on, as the light it emits, like all bright lights, can cause permanent eye damage.

Check the optical port and fiber surface of the endoscope. (1) Hold the endoscope lens end, facing the bright ceiling lamp in the room. (2) Check the optical ports. Every fiber should be bright. (3) Move the endoscope lens end slightly toward the lamp; the optical fiber brightness on the surface of the optical

Endoscope component mounted on Camera Arm (no sheet)

Fig. 2.80 Endoscope

port shows an obvious change. Some optical fibers may remain dark, but this does not have any effect on quality; however, if most of the optical fibers appear dark, the illumination provided to the surgical field will be limited and poor. 2. Installing an endoscope on the camera—The sterile camera adapter must be installed as described in the Operating Procedures for Installing the Drape on Camera before installing an endoscope on the camera. The endoscope

2  Instructions for Use of Da Vinci Surgical Robots

base has legs that allow the user to easily align the base with the channel corresponding to the sterile camera adapter. The steps to install the endoscope are as follows: (1) Hold the endoscope and the camera with the sterile adapter in both hands, to prevent any part from falling. When installing an elbow endoscope, the endoscope installation direction determines whether the endoscope is bent upward or downward by 30°. The system automatically detects and displays this information, irrespective of how the endoscope is installed. If the endoscope is bent upward by 30°, rotate the endoscope to ensure its elbow is on the same side as the camera button. If the endoscope is bent downward by 30°, rotate the endoscope to ensure its elbow is on the opposite side of the camera button. The endoscope base is also labeled, indicating the 30° bending direction and both sides of the endoscope (Fig. 2.83).

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(2) Place the endoscope base on the sterile adapter and rotate the endoscope if necessary, until the endoscope slides down onto the sterile adapter of the camera. (3) Push down the endoscope until it reaches the bottom, then rotate it until it locks. The icon on the endoscope base indicates the rotation direction in which the sterile adapter is locked or unlocked (Fig. 2.83). 3. Camera (viewfinder) settings—The Da Vinci System supports camera/viewfinder settings, including white balance and automatic 3D calibration, which can be adjusted using the camera buttons (Table  2.3, Fig.  2.84). As explained below, a sterile person can perform white balance and automatic 3D calibration operations using only the camera button, without touching the touchscreen.

Note: The touchscreen functions are available in the Da Vinci-e System, which requires setting up the camera/viewfinder on the touchscreen of the Surgeon Console. If you use a Da Vinci-e System, refer to touchscreen-based camera (viewfinder) settings.

4. Activating camera (viewfinder) settings and navigation— The Camera (viewfinder) Settings menu is displayed on

Fig. 2.81 Camera

Fig. 2.82  Examples of improper use of Camera Cable

Fig. 2.83  Schematic of Angle and Lock

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the touchscreen when the Video Settings button on the camera is for more than 1 s, as long as no instrument is in the following mode. The following menu is displayed (Fig. 2.85) when carrying out this operation. This menu is navigated by pressing the near (far) arrow key on the camera. You can directly access the menu via the touchscreen (except to press the “x” button to close the menu). The up arrow is close to the light On (Off) button. Press the up or down buttons to move the list up and down. Press the Video Settings button and then select the appropriate option. “Auto-calibration...” appears on the 3D viewer unless you exit the menu (Fig. 2.86). Exit the Camera (Viewfinder) Settings menu. Select exit from the menu or click the “×” button on the touchscreen. A surgeon cannot enter the following mode unless the calibration has been completed and the menu is closed. 5. Setting white balance—The white balance must be set on the camera before each operation or after each time the camera, endoscope, light module, or light source are replaced. White balance sets the white benchmark for the Image Processing System. The procedures are as follows: (1) Turn on the light by pressing the light on (off) button on the front panel of the camera or light source. The light source must be switched on. When the light source is switched on but the light is off, the word “OFF” is displayed, and the LED on the front panel emits amber light.

The display flashes “OFF” when the light is on. When the light is on, the LED on the front panel turns blue, and the display indicates the light intensity in percentage based on the maximum light intensity. The light intensity can be adjusted by pressing the “−” or “+” buttons, and the adjustment is at a 10% step size. Make sure that the light intensity is adjusted to 100% before moving on to the next step. (2) Point the endoscope at a white object until it covers the entire field (Fig. 2.87).

Note: Do not use gauze. The background formed by gauze is not suitable for white balance.

If the Camera (viewfinder) Settings menu is not displayed, press and hold the “Vision Setup” button on the camera for 1 s to keep the menu open (Fig. 2.88).

Fig. 2.85  Camera/Scope Setup Menu

Table 2.3  The setting button of Video system Legend Video setting

Adjust Configure video

The arrow for adjusting close or far

Navigation menu of focusing

The lamp

Control the lamp

Describe Using the Video setting button to open and choose the setting menu of camera shooting or looking Pressing the focusing button to adjust the focal distance of surgical vision and navigate to the setting menu of camera shooting or looking Pressing this button for 1 s to switch lamp

Fig. 2.86  Stereo Viewer displays words like Auto-Calibration…

Fig. 2.84  Vision Control Button

Illuminator Lamp open/close

Focus Controls zoom/out

Vision Setup

Condition of installing protective cover

2  Instructions for Use of Da Vinci Surgical Robots

Fig. 2.87  Use paper to set White Balance

Fig. 2.88  Open White Balance menu

Fig. 2.89  Camera/Scope Setup on touchscreen (by camera)

Select “White Balance,” use the near and far focus distance buttons to navigate, and then press “Vision Setup” to select the appropriate option. The system completes white balance settings automatically (Fig. 2.89). Alternatively, you can start white balance setting by pressing the White Balance button on the Camera (viewfinder) Settings tab on the touchscreen or touchpad. Press the White Balance button on the touchscreen, select Camera (viewfinder) Settings in the Video Settings tab, and select Camera (viewfinder) Settings in the Video tab. A message is displayed when white balance is complete. A checkmark appears on the white balance option when you return to the menu. 6. 3D calibration of endoscope components—3D images can be adjusted by calibration to accommodate mechanical errors in endoscopes, sterile adapters, and camera assemblies.

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• The Da Vinci System automatically detects the endoscope angle, which is a necessary parameter for calibration. If the system does not detect the endoscope angle, it can be manually selected through the touchscreen. –– Recommendation: All endoscopes and angles should be calibrated before each operation unless the current camera and its sterile adapter continue to be used. The system saves the final calibration result for each endoscope, angle, and camera. Therefore, if you follow this recommendation, the angle can be changed without recalibration during surgery, and the endoscope can be changed when endoscopes at both 0° or 30° upward (downward) angles are used. • If the camera, sterile adapter, and endoscope are not calibrated before surgery, all endoscope angles planned for this new device will need to be recalibrated.

Note: Touchscreen functions are available in the Da Vinci-e System. The camera (viewfinder) settings can be adjusted using the touchscreen of the Surgeon Console. If you use a Da Vinci-e System, the camera (viewfinder) settings can only be adjusted using the touchscreen.

7. Automatic 3D calibration—Automatic 3D calibration can be conducted by pressing a button mounted on the camera. Follow these steps for automatic 3D calibration. Insert the endoscope tip completely into the target calibration module of the endoscope. Use the correct hole and direction according to the tip angle so that the target crosshair is clearly displayed in the center of the touchscreen (Fig. 2.90).

Note: For smooth 3D calibration, the crosshair must be fully aligned on the touchscreen, and the target must remain on the endoscope as long as possible.

If the camera (viewfinder) settings are not enabled, press the “Vision Setup” button on the camera for 1 s to launch the menu (Fig. 2.88). Select “Automatic 3D Calibration,” use the near and far focus distance buttons for navigation, then press “Vision Setup” to select the appropriate option. After the automatic calibration process starts, the touchscreen displays a prompt that the calibration is in progress and the process will be completed in a few seconds. The calibration process cannot be stopped or canceled once started.

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Fig. 2.90  Use universal alignment target for 3D calibration

To exit the camera (viewfinder) settings menu, press the exit button on the menu (Fig. 2.92) or the “×” button on the touchscreen.

Fig. 2.91  Confirm calibration (shown on Touchpad only)

8. Manual 3D calibration—Press the 3D Calibration button on the touchscreen or touchpad to start calibration. If the system is not in the calibration mode, navigate to the Camera (Scope Setup) in the Video or Video Settings tabs. The system switches to calibration mode: Both the touchscreen and the Surgeon Console viewer display the images from the left and right eye channels in clear green and fuchsia, respectively. Insert the endoscope tip completely into the endoscope’s target calibration module (Fig. 2.93). Use the correct hole and direction according to the tip angle so that the target crosshair is clearly displayed in the center of the touchscreen (Fig. 2.94).

Fig. 2.92  Checkmark indicates that action is complete, show only on Touchpad

When finished, the system displays the message, “Is the calibration okay? (Fig. 2.91)”. If you select “Yes,” a checkmark appears against the automatic 3D calibration option in the menu (Fig. 2.92). If you select “No,” no checkmark is displayed. However, the calibration settings remain. If you are not satisfied, you can choose to restart automatic 3D calibration or perform manual calibration through the touchscreen (touchpad) menu. You can set the camera (viewfinder) settings, including automatic 3D calibration, via the Video Settings tab on the touchscreen or the tabs on the touchscreen.

Note: For smooth 3D calibration, the crosshair must be fully aligned on the touchscreen, and the target must remain on the endoscope as long as possible.

(3) Use the near focus (far) key on the camera to bring the image into focus. (4) Touch the arrow on the touchscreen or touchpad to move the green “cross” until it is aligned with the purplish red “cross.” Press Finish Calibration on the touchscreen or touchpad to save the Calibration Settings and exit Calibration mode

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Fig. 2.93  Endoscope tip inserts in Universal Alignment Targets, then aim at the target on the screen

Fig. 2.94  3D calibration

9. Preoperative maintenance of endoscope—Make sure the endoscope is preoperatively heated to minimize fogging before entering the surgical area. Heat one end of the endoscope with a jar of sterile water. Place a piece of gauze on the bottom of the jar to prevent damage to the delicate endoscope.

2.6.3 Operating the Cold Light Source The cold light source and light intensity are shown in Fig.  2.95, and the operation instructions are shown in Table 2.4.

Note: To reduce lens fogging, set the brightness of the light source to 100% and adjust the brightness of the surgical image using the brightness controller via the touchscreen or touchpad to ensure continuous heating of the endoscope. Warning: The temperature of the endoscope when in use may exceed 41 °C. When the light source is on and the endoscope is outside the camera casing, avoid any contact of the endoscope lens with skin, tissue, and clothing, as it may cause damage. Do not attempt to clean the endoscope tip by inserting it into the tissue. If so, the tissue may be damaged due to the high temperature, and burnt deposits may form on the endoscope tip, reducing the light output.

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• The same status icon and additional icon appear everywhere to indicate that the master is activated (with fingers).

Fig. 2.95  Illumination display Table 2.4  Cold light and control Legend The lamp The light intensity

Adjust Switch the lamp Control the intensity of the light

Describe Pressing this button to switch lamp Pressing (+) or (−) button to control the intensity of the light output in 10% steps. Pressing both (+) and (−) button to display the current hours of use

2.6.4 O  perating the Image Observation Controller on the Touchscreen The user can adjust the Image Processing System functions using the touchscreen display. Figure 2.96 shows the overlays on the touchscreen display. It should be noted that several of the overlays are only displayed when required, while some are often or always displayed on the screen.

Note: This section does not apply to the Da Vinci-e System, which does not support touchscreen functions. The integrated display in the Da Vinci-e System is a passive display system for surgical images. With no patient-side images, touchscreen menus, and images, the Da Vinci-e System does not support dual console surgery.

2.6.4.1 Touchscreen Display When a Surgeon Console is used, the touchscreen displays the masters and instrument status in a single status area at the center-top (Fig. 2.97). When two Surgeon Consoles are used, the touchscreen displays the masters and instrument status side by side, at the center-top of the two status areas. This area displays the master and instrument status for the console in use: • The console number or the name of the logged surgeon is displayed at the top. • The left and right masters display the combined instrument name, arm number, and energy status, and turn orange when activated.

Note: In dual console mode, only one status area is displayed in the 3D viewer, and the instrument information of the other console is displayed on the top left. If you select Surgeon Display from the Video Source tab, the Console Display button and icon are displayed on the touchscreen with further options.

2.6.4.2 Accessing the Touchscreen Menu Press the Open button on the lower left corner to display the following menu tabs to adjust the touchscreen (Table 2.5).

Note: The option highlighted in blue is the currently selected option. The grayed-out options are disabled.

After the menu is displayed, the Open button changes to the Close button; press the button to close the menu. The following section introduces what adjustments can be made in each menu tab; however, first we introduce telestration, as it is a function that is always available.

2.6.4.3 Telestration The telestration function is available by default. Regardless of which video source image is displayed, telestration is available on the touchscreen display. For telestration, gently press your finger on the touchscreen display and drag it to draw a color line on the video image. The drawn lines are also displayed on the Surgeon Console viewer and overlap on the video channel (left or right) being displayed on the touchscreen. The surgeon cannot stop the telestration; however, the camera pedal can be pressed to remove it from the image (Fig. 2.98). Erase Button: The Erase button (Table 2.5) is always displayed when telestration is available. Press this button to erase all telestration marks on the touchscreen and Surgeon Console. The telestration marks can also be erased through the following: • By stepping on the camera pedal. • By pinching the camera arm or the Setup Joint of the camera arm. • By changing the endoscope. • By changing video source.

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Single or dual console masters ang instruments status Critical message area/icon

Modal message area

Arm 2data: on left,power on (blue)

Arm 1 data:on right (operating surgeon)

Stowed message area

Menu pop up tab area

Camera message area

Camera angle,zoom rotation indicator

Menu tab area

Fig. 2.96  Touchscreen Monitor Display R/L Status of Master Controller and association

Indicate association

Finger Clutch

Related Arm number

Fig. 2.97  Master Controller and device status area of the console in use

Warning: Telestration is an instructional tool for communication during surgery. Telestration should not be used as a surgical tool, for example, indicating the proposed cutting positions by marking using telestration.

2.6.4.4 Video Source Tab The Video Source tab allows the user to choose which Video Source to display on the touchscreen, which eye channel’s

(left or right eye channel) video image to display, and whether telestration is applied (Fig.  2.99). The following options are available: • Endoscope: Touch the camera icon to display the video image from the endoscope. Video images of the left or right eye channel can be displayed on the touchscreen. Press the L (left) or R (right) button to select which eye channel’s video to display. This L/R option is useful when there is an object blocking the video of either one of the eye channels.

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• TilePro 1 or Tile Pro 2: Press any button to display the video input from TilePro 1 or TilePro 2 connected behind the core component. • Surgeon’s View: Press the button to display the Surgeon’s View. After pressing this button, you may further choose the video image from the surgeon’s left or right eye channel using the L (left) or R (right) button. If two Surgeon Consoles are used, there is another option to choose which console view to display. You can choose to display the console view or icon. Press the close button to exit the surgeon display and menu tabs.

2.6.4.5 Video Settings Tab The Video Settings tab allows the user to adjust the brightness of surgical images, as well as provides advanced video adjustment, camera/endoscope, and video output settings (Fig. 2.100). 1. Advanced video adjustment—The brightness, contrast, red, blue, edge enhancement, and light source can be adjusted using these settings (Fig.  2.101). Press the Restore Factory Settings button to restore the system to the factory’s default settings.

Note: Adjustment of these settings depends on the surgeon’s preference. As with any adjustable video image,

Legend “Turn on” “Turn off” “Delete”

Fig. 2.98  Touchscreen Menu Tabs

Endoscope Close

Fig. 2.99  Video source

• Brightness: Drag this slider to adjust the brightness of the surgical image. This setting adjusts the video brightness and not the actual illumination. • Contrast: Drag this slider to adjust the surgical image contrast. • Red: Drag this slider to adjust the red color of the surgical image. • Blue: Drag this slider to adjust the blue color of the surgical image. • Yellow: Drag this slider to adjust the yellow color of the surgical image. • Edge Enhancement: Drag this slider to adjust the edge enhancement of the surgical image. Increasing edge enhancement (drag to the right) may also increase noise. • Light Source: Drag the slider to adjust the light output sent to the surgical field. The adjustment is based on a 10% step size.

Note: To reduce fogging, the light intensity of the light source is set to 100%. The brightness of surgical images can be adjusted using a lighting slider on the touchpad or touchscreen under Advanced Video Adjustments, to maintain heat to the endoscope lens.

Table 2.5  The information of the button

Surgeon's view

you may find that certain settings affect other settings, and the result is likely to be a trade-off to determine the specific combinations of settings. For example, when adjusting you need to make a trade-off between the glare in one part of the image and the visibility in another. Remember: These settings can be readjusted at any time.

Left/Right

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Fig. 2.100  Video settings

Note: One-channel Video Output is the standard configuration. Optional upgrades support up to two additional video output channels.

2.6.4.6 Audio Tab The user can use the Audio tab to adjust the volume of the touchscreen speaker and mute the touchscreen microphone (Fig. 2.103).

Fig. 2.101  Advanced video settings

• Microphone on and off: The microphone is on by default. You can mute it if required. • Volume adjustment: Use the slider—Drag to the right to increase the volume; or press the volume down (−) or up (+) button to adjust the volume as required.

2.6.4.7 Utilities Tab Inventory management, event logging, and fault handling are accessible through the Utilities tab (Fig. 2.104).

Fig. 2.102  Example of video output options

2. Camera/Scope Setup: These settings are used to adjust white balance and for endoscope registration. If the system does not automatically detect the endoscope angle, it can be adjusted manually. 3. Video Output: Video Output allows the user to specify the Video Output format and image source for up to three video output channels. The default video output Aux is available. Video outputs 1 and 2 are available as part of the optional upgrade (Fig. 2.102).

• Inventory management: Provides a summary of the accessories used in the operation. • View Lamp Life: Browse the elapsed time (hours) of the light module group and select inventory management (on the touchscreen or touchpad). You can view the light module life by simultaneously pressing minus (−) and plus (+) buttons on the light source. • Event Log: Provides access to system event logs, including error logs. • Fault Handling: Displays the system name and system software version. The L (left) and R (right) buttons can be used to display the color bar test pattern independently on the left or right video channels.

2.6.5 Adjusting the Touchscreen Display The hardware controller to adjust the images on the touchscreen display is locked (Fig. 2.105). It is recommended to adjust the video settings on the touchscreen via the Video

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Fig. 2.103  Audio Tabs

Volume adjustment

Fig. 2.104  Utilities Tabs Fig. 2.105 Hardware controller of Touchpad Monitor

Settings tab. Please contact Intuitive Surgical’s technical support personnel if you want to change the display’s video settings.

2.6.6 Processing Image Quality Problems 2.6.6.1 Excessively Bright or Dark Images During surgery, the image needs to be adjusted when the image display is too bright or dark. Specific recommendations are provided below to optimize the display for each situation. 1. Correcting Over-Bright Images Use the Video Settings tab on the touchscreen or touchpad to reduce the brightness to the desired level.

Caution: If the endoscope is being used near tissues, the light source should be adjusted to a lower light output setting. In this way, tissue damage from excessive heat can be prevented. It should be noted that decreasing the light output will lead to grainy images. Note: Do not use the light source to control image brightness, as this may exacerbate the fogging problem.

2. Correcting Excessively Dark Images If possible, move the endoscope closer to the tissue in the surgical field. Check the light guide connection to the light source to make sure there is no loose connection. Increase video brightness: access the Video Settings tab on the touchscreen or Surgeon Console touchpad.

Note: Increasing image brightness may increase noise in the image and reduce its quality.

If possible, clean the endoscope end. Blood or other proteins may accumulate on the inner lens and reduce light output.

2.6.6.2 Correcting Unfocused or “Soft” Images 1. Press the camera pedal and turn the master on the Surgeon Console or press the button on the camera to try to adjust the focus. 2. If possible, clean the endoscope end. Blood or other proteins may accumulate on the inner lens and reduce the light output. 3. Adjust edge enhancement settings to increase image sharpness.

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2.6.6.3 Replacing the Light Module The light module may need to be replaced if the lamp does not switch on or the lighting is dim even at 100% illumination.

2.7

 atient Preparation, Incision P Arrangement, and Connection

Camera Arm port

2.7.1 Instructions for Patient Preparation Patient location varies with the operation and depends on the surgeon’s requirements. The specific approach for positioning the Da Vinci Control System for Endoscopic Surgical Instruments is as follows: The robotic arm should be fitted to the Patient Surgical Platform while ensuring it avoids contact with the patient.

Note: Position the patient before connecting the equipment. It is easier to move the operating table before placing the patient in the surgical position.

2.7.2 P  uncture Incision Layout and Trocar Insertion 2.7.2.1 Instructions on Puncture Incision Layout The puncture incision layout is the key to the success of the Da Vinci surgery. The purpose of the puncture incision layout is to avoid collision between the patient and the robot arm of the Patient Surgical Platform and maximize the range of instrument and endoscope movement. The puncture incision layout varies based on the type of operation and patients and should be fully discussed with experienced surgeons, as improper incisions can cause serious injury to the patients. Please refer to the Instructions on Surgical Procedures published by Intuitive Surgical for some specific puncture incision layouts. Please contact the sales representative of Intuitive Surgical’s local partner company or Intuitive Surgical directly, for Instructions on Surgical Procedures. Figure 2.106 shows an example of the recommended puncture incision layout. The following are general instructions for selecting puncture incision layout. Sometimes other options may be required due to anatomical limitations. • The camera arm puncture incision is arranged so that it is in a straight line with the column of the Patient Surgical Platform and the target anatomical position.

Instrument Arm port

Assistant port

Target anatomical location

Fig. 2.106  Guidance on port placement

• Where possible, the camera arm puncture incision should be arranged 10–20  cm from the target anatomical position. • Da Vinci’s incisions must be spaced at least 8–10  cm apart. • The instrument arm puncture incision should be 10–20 cm from the target anatomical position. • Auxiliary puncture incisions that are not used by the instrument arm should be at least 5  cm from other incisions.

2.7.2.2 Puncture Incision Layout and Inserting the Puncture Trocar The location of the initial puncture incision should be selected based on surgical requirements, the specific anatomical structure, and the type of components used (e.g., combination of endoscope and camera, casing length, etc.). Please refer to the Instructions on Surgical Procedures published by Intuitive Surgical for some specific puncture incision layouts. Please contact the sales representative of Intuitive Surgical’s local partner company or Intuitive Surgical directly, for Instructions on Surgical Procedures. The patient should be prepared, covered with a sterile drape, and placed in the surgical position as per standard protocol. After the pneumoperitoneum is established, mark the location of all instruments and auxiliary puncture incisions. All incisions are located with standard surgical techniques. The camera and endoscope components (not connected to the Patient Surgical Platform) can be used manually to arrange the puncture incision.

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Note: Hold the camera body during operation to avoid the risk of damaging the wire harness.

The Da Vinci instrument trocar may be used with a blunt or bladeless puncture device.

Note: It is recommended to always keep the puncture device head in view (within the visual range of the endoscope video) when inserting the puncture trocar.

For specific applications (e.g., heart and chest surgery), the trocar may be placed while the instrument arm is attached. In this case, the Patient Surgical Platform should be placed before the trocar is inserted. As with all puncture incision arrangements, this work can only be performed while observing endoscopic video images.

Note: In case the puncture trocar is connected to the instrument arm, make sure that the Patient Surgical Platform is located properly, with the instrument arm and the Setup Joint close to the center of its range of motion when inserting the trocar into the patient. Warning: After the Da Vinci System is connected to a patient, the surgical cart must not be moved in any manner, otherwise there is a risk of serious injury.

Fig. 2.107  “Sweet Spot” tab

The Da Vinci System should be disconnected if the surgical cart must be moved during surgery. The system should be reconnected after moving the surgical cart.

2.7.3 Connection Connection refers to the process of moving the Patient Surgical Platform to the operating table and connecting the robot arm of the Patient Surgical Platform to the patient.

2.7.3.1 Positioning the Patient Surgical Platform Cart After the puncture trocar is inserted in the patient, non-sterile personnel (circulating nurse) should operate the drive motor of the Patient Surgical Platform cart and move it to the sterile area. Proper connection is highly important when connecting the Patient Surgical Platform cart. Only one person should give instructions to the circulating nurse on how to avoid possible collision hazards and instruct the circulating nurse when approaching the patient. As the circulating nurse moves the Patient Surgical Platform cart, anatomical references or reference to the room position (e.g., “the reverse of head” or “direction away from the Image Processing Platform”) should be used. Relative terms, such as left or right, should be avoided. Make sure there is enough distance between the camera arm remote center and the column of the Patient Surgical Platform cart so that the cart arm has a better range of motion. This is called setting up a “sweet spot.” To set the sweet spot, move the camera arm so that the blue arrow is aligned between the blue bar in the middle of the camera arm’s Setup Joint (Fig. 2.107).

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Fig. 2.108  Position of Patient Cart when placed above patient’s position

Align Patient Cart frame and Camera Cannula with Camera Port

The Patient Surgical Platform cart can be moved to the patient’s side with a drive motor. When the Patient Surgical Platform’s cart approaches the patient, its column should be aligned with the camera puncture trocar and the target anatomical location (Fig. 2.108). Reposition the Patient Surgical Platform so that the camera arm trocar mount is directly above the camera trocar.

2.7.3.2 Connecting the Camera Arms After the camera trocar mount is located above the camera trocar, immediately use the notch clutch button on the camera arm to move the trocar mount toward the trocar (Fig. 2.109).

Note: Please refer to Moving the Patient Surgical Platform Cart for detailed instructions on disengaging the instrument arm, camera arm, and incision clutch.

Align the trocar mount with the trocar with the clutch button on the camera arm. Make sure to release the camera arm clutch. Make sure to correctly align the drape cylinder with the casing mounting. Use the latch on the casing mounting to connect it to the casing.

Note: The drive motor brake on the Patient Surgical Platform cart is automatically applied when the casing is connected, to prevent the cart from moving during the surgery.

2.7.3.3 Connecting the Instrument Arm (Fig. 2.110) Use the notch clutch button on the instrument arm to bring the trocar mount closer to the trocar. Align the casing mounting with the instrument casing using the instrument arm clutch button. Make sure to release the clutch arm later and lock the arm in place. Make sure to correctly align the drape cylinder with the casing mounting. Use the latch on the trocar mount to connect it to the trocar. Make sure to turn the back end of the instrument arm away from the camera arm. With two arms on one side, make sure the instrument arm closest to the camera arm has sufficient range of motion, to minimize the risk of collision.

Note: After the robot arm of the Patient Surgical Platform is connected, the incision clutch button should be used only for remote center repositioning. Care should be taken to prevent the casing from sliding out of the notch position if the notch clutch button is used. Warning: Once the Da Vinci System is set in place, the trocar is inserted into the patient’s body and the robot arm of the Patient Surgical Platform is connected to the trocar, the operating table should not be moved in any way, otherwise there is a risk of serious injury. The Da Vinci System should be disconnected if the surgical cart must be moved during surgery. The system should be reconnected after moving the surgical cart. Caution: Unexpected instrument motion may occur in case of a collision. Make sure there is enough space for the instrument to move while being used in the patient’s body.

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Fig. 2.109  Detach arm drive mechanism and move it to the docking position

Fig. 2.110 Docking

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2.8

 pplication of Patient Surgical A Platform

2.8.1 O  verview of Patient Surgical Platform Cart The Patient Surgical Platform consists of a Setup Joint, instrument arm, camera arm, EndoWrist, and endoscope component, which can be operated by the user (Fig. 2.111).

Note: Some of the functions of the Patient Surgical Platform are not available during surgery. Nonsurgical functions (e.g., system setup and disassembly) are described in the corresponding sections.

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Caution: Do not touch any harness or mechanical cable on the camera or instrument arm while touching the patient or moving the arm.

The LED at the upper end of the insertion shaft of each instrument and camera arm indicates the status of the instrument and camera arm. The meaning of each color is shown in Fig. 2.112. The corresponding LED icon—an image that replicates the LED state—is displayed on both the touchscreen and the 3D viewer.

2.8.2 M  oving the Patient Surgical Platform Robot Arm 2.8.2.1 Arm Clutch and Notch Clutch Buttons The instrument arm and camera arm should be positioned with the arm clutch and notch clutch buttons (Fig. 2.113).

Caution: Keep your fingers away from the camera arm and instrument arm joints to avoid injury when using the Setup Joint or clutch buttons.

LED quick reference Doctor is not in control Arm or port clutch Guided tool change Doctor is in control

Warning: need intervention (See monitor for details) Waiting: System is working

Error: restart system(See monitor for details)

Fig. 2.112  LED quick reference Fig. 2.111  Instruments mounted to Insertion Shaft

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Fig. 2.113  Port Clutch Button and Arm Clutch Button Arm Clutch Port Clutch

Port Clutch

2.8.2.2 Manual Arm Clutch The instrument and endoscope can be manually placed in the surgical field using the arm clutch button (Fig. 2.113). It can be moved around the remote center; however, the remote center will not move when the arm clutch is disengaged. When the clutch is released, the LED on the arm flashes white alternately. The arm clutch can be disengaged in two ways: • Press and hold: press and hold the arm clutch button, release the brake on the arm and move the arm. When the button is released, the arm is out of clutch mode and the system applies the brake. • Quick click: Alternately click the arm clutch button on the left and right to release the brake on the arm and move it. Click the arm clutch button again to exit the clutch mode.

Note: For the instrument arm, the telescopic insertion shaft should be fully extended when the instrument is removed. It should remain fully extended until the instrument is reinstalled. Caution: To prevent the movement of the insertion shaft when the clutch is disengaged, hold the upper part of the insertion shaft tightly and firmly, and grasp the instrument arm or camera arm when pressing the clutch button on the arm.

2.8.2.3 Notch Arm Clutch for Manual Movement of Setup Joint

Note: The term “notch clutch” is used interchangeably with “sliding-arm clutch.” Both refer to the same button and the action caused by pressing that button, that is, the release of the Setup Joint so that the user can manually reposition the sliding arm.

The incision clutch button can be used manually to move the Patient Surgical Platform Setup Joint. Both the instrument arm and the lower part of the camera arm have two notch clutch buttons, one behind the trocar mounting and the other in the middle of the arm (Fig. 2.113). When the trocar and the joint clutch are released, the relevant arm LED flashes white alternately on both sides. When the trocar and the joint clutch are released, the relevant arm LED flashes white alternately on both sides. If the Setup Joint must be moved, first keep the arm still and then disengage the incision clutch as follows. • Hold the notch clutch button, then release and move the Setup Joint. When the button is released, the Setup Joint exits the notch clutch mode and the brake is applied. Labels appear near the upper notch clutch button (Fig.  2.114). It includes the following English text and its German and French translations. Prompt for disengaging clutch

Note: The arm clutch and the notch clutch can be disengaged simultaneously. If the arm and the notch end clutch on the instrument arm are disengaged simultaneously, the insertion shaft of the instrument arm is locked; this situation does not apply to the camera arm. Note: Disengage the arm clutch to prevent the arm from being controlled from the Surgeon Console. Disengage the camera arm clutch to prevent all arms from being controlled from the Surgeon Console.

2.8.2.4 Accidental Movement of Setup Joint Unexpected movement of the Setup Joint occurs when the brake is overloaded. Multiple factors can contribute to this, including excessive stress on the patient or a collision of the Patient Surgical Platform components (arms, Setup Joints, or adjacent objects). If the system detects unexpected move-

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ment of Setup Joints, the relevant arm LED turns yellow and displays a message on the screen. To clear the error, press the notch clutch button on the arm. This also eliminates excessive force that might be exerted on the patient.

2.8.2.5 Emergency Power Off The Emergency Power off (EPO) button is located behind the Patient Surgical Platform. Press this button to make the Patient Surgical Platform power off completely. The system classifies this as an unrecoverable fault. In this case, the system must be restarted (Fig. 2.115).

2.8.3 EndoWrist Operation Caution: Only use instruments and accessories that are meant specifically for the Da Vinci TM Surgical system and are approved by Intuitive Surgical. Intuitive

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Surgical conducts extensive testing to ensure compatibility of approved instruments and accessories. Compatibility cannot be guaranteed if you use unapproved instruments or accessories. Any damage to the Da Vinci Control System for Endoscopic Surgical Instruments caused by the use of unapproved instruments and accessories is not covered by the warranty.

EndoWrist consists of five main components—Head: terminal actuators of the instrument (such as grasping forceps, electric hooks, scalpels, etc.); Wrist: a wrist joint designed to simulate the human wrist; Lever: rotating arm of the instrument; Release lever: the mechanical mechanism by which the instrument is removed; Instrument case: the joint between the instrument and the sterile adapter of the instrument arm (Fig. 2.116). At the bottom of the instrument case, you can see a series of discs (Fig. 2.117) connected to the EndoWrist by cables. The cable passes through the instrument shaft. The movement of the Surgeon Console master is replicated into the movement of the EndoWrist. When not connected to a sterile adapter, the discs can also be rotated by hand to check cable function or aligned to the wrist for tool insertion. Housing Shaft Release levers Wrist Jaws

Fig. 2.114  Brake release. Hold Arm before releasing

Fig. 2.115  EPO button behind Patient Cart

Fig. 2.116  EndoWrist’s instrument components

Fig. 2.117  Disks in the bottom of the housing

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Sterile Adapter Mount

Insertion Shaft

Cannula

Fig. 2.118  Insertion Shaft, Sterile Adapter, and Cannula when inserting the instrument

1. The interfaces on the instrument arm include three parts: the insertion shaft, the sterile adapter of the instrument, and the trocar (Fig. 2.118). (1) The insertion shaft retracts to enable the instrument to move to the surgical position. When no instrument is installed, the insertion shaft is fully retracted. (2) Sterile Adapter. The sterile adapter is part of the instrument arm shield and acts as a connection point between the instrument and the instrument arm. (3) The trocar is used to make an incision through the patient’s body wall.

2.8.4 I nstrument Installation, Insertion, Removal, and Intraoperative Care 2.8.4.1 Installation Check whether the instrument is damaged, cracked, chipped, or worn. Stop using the instrument if any damage is found. Straighten the EndoWrist by rotating the disc behind the instrument case, and do not directly manipulate the EndoWrist. This ensures that the trocar can be easily inserted and protects the instrument from getting damaged. Insert the instrument head into the trocar and push the instrument case into the sterile adapter. You can hear three beeps if the instrument is properly clamped.

Caution: Make sure the instrument head does not puncture the drape of the instrument arm when the instrument head is inserted into the trocar. Caution: Before proceeding, make sure that all installed instruments are visible in the Surgeon Console view to prevent accidental injury to the patient. Note: When using an instrument through the Surgeon Console (follow-up mode), it uses up some usage time (lifetime) of the instrument. Before entering the follow-­up mode, the remaining usage time of the instrument can be checked without using up the usage time.

2.8.4.2 Plug and Play For newly introduced instruments, new parameters may need to be downloaded to the Da Vinci System. This needs to be done only once for each type of new instrument, and it can take up to 15 s to complete the process. During the download, the arm LED flashes green rapidly, and the system displays a message. Process completion progress is expressed as a percentage. If an error occurs during plug and play, the instrument should be reinstalled (Fig. 2.119). 2.8.4.3 Insertion

Caution: Make sure that the Surgeon Console operator is ready to take control of the instrument before moving it into the sterile area.

After the system has identified the instrument installed on the arm, it can be inserted into the patient either manually or by using the Guided Tool Change function. 1. Manual operation—The first instrument installed on the arm according to this operating procedure must be manually inserted by pressing the arm clutch button (Fig. 2.120). The Surgeon Console operator cannot control the instrument until the instrument is removed from its trocar.

Warning: The instrument may not be immediately visible as it moves from the trocar into the patient’s body. Proper care should be taken when inserting the instrument into the patient’s body manually.

2. Guided Tool Change—When the instrument is inserted into the patient’s body using Guided Tool, the system can

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Fig. 2.119  Instrument insert Cannula Mount and Sterile Adapter

assist the Patient Surgical Platform operator thus providing an efficient and safe instrument insertion method. Guided Tool Change is only useful when replacing the instrument. When installing the next instrument, unlock the insertion shaft and guide the instrument head to a point in front of the previous instrument head (Fig. 2.121). • If Guided Tool Change is enabled, the instrument arm LED flashes white and green alternately on both sides. • If Guided Tool Change is not enabled, the instrument arm LED is solid white and does not flash. In addition, the system displays an icon and message instructing the surgeon to pass the instrument through the trocar head. Guided Tool Changes is disabled in the following situations: • When the instrument arm or the notch clutch button is pressed. • There are any mistakes. • The instrument head is too close to the trocar.

Note: To make a Guided Tool Change, the surgeon should stop looking through the 3D viewer and ensure that no instruments are in motion before they are moved and reinstalled.

Fig. 2.120  Use Arm Clutch manually insert the instrument

After the instrument is successfully inserted (with a Guided Tool Change or a manual clutch), the arm LED turns blue, indicating that the surgeon can control the arm at this point (Fig. 2.122).

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Thoroughly wipe the liquid off the sterile adapter and cover before inserting any other instrument. After surgical procedures, thoroughly clean the device following the cleaning instructions, before using it again. Please contact the technical personnel of Intuitive Surgical as soon as possible in case blood or other fluid is found in the drape. Intuitive personnel will provide guidance on how to fully clean the instrument arm before using it again.

2.8.4.5 Removing the Instrument Make sure the surgeon is ready before attempting to remove the instrument. Fig. 2.121  Guided Tool Change’s schematic diagram

Caution: Surgical removal of instruments should be done with great care and only with the informed and thorough observation of the Surgeon Console operator.

The Surgeon Console operator should do the following before removing the instrument:

Fig. 2.122  Blue LED in Instrument Arm indicates instrument inserted successfully

Note: When an instrument is installed, the instrument arm provides additional grip to ensure that the device does not move during surgery. If force is applied to the arm for more than 300 ms, the system prevents the arm from moving and gives an error signal until the force is eliminated.

2.8.4.4 Precautions Against Fluid Leakage During surgical procedures, EndoWrist can be placed horizontally or obliquely, according to the surgical requirements. As with any laparoscope, such a position allows blood or other fluid to flow through the lever to the proximal end below the instrument position. The EndoWrist is designed to tolerate fluid flow of this nature and minimize fluid leakage at the proximal end. During surgery, if blood or other fluid is found leaking from the instrument and onto the instrument arm drape or sterile adapter, please undertake the following measures: After removing the instrument from the arm, hold it vertically to drain the fluid.

• Make sure the instrument is not in motion and not in contact with the patient’s body. • Straighten the EndoWrist. • Make sure that the clamp is not closed as it is difficult to remove otherwise. • Speak out aloud which instrument the Patient Surgical Platform operator is removing. State the instrument name or arm number (e.g., instrument arms 1, 2, 3). After the instrument is in the removal position, the Patient Surgical Platform operator should press down the release lever on both sides of the instrument case and pull the instrument out, then clean the sterile adapter (Fig. 2.123).

Note: The insertion shaft of the instrument arm automatically retracts when the instrument is removed. If the instrument is not removed on time, the sterile adapter may be reattached to the instrument during retraction of the insertion shaft. In this case, remove the instrument from the instrument arm. Caution: The instrument may be damaged if there is lateral pressure during removal.

2.8.4.6 Emergency Clamp Release In the event of system failure, the instrument can be easily removed through the emergency clamp release mechanism.

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Instrument Release Levers

Telescoping Axis

Grip release cannula 8mm/5mm

Fig. 2.124  Grip Release Socket

For example, if the instrument head is clamping the tissue, the patient-side operator can manually release the clamp through emergency release. The clamp can be manually released as per the following steps: 1. Place the emergency release wrench of the clamp into its release slot (Fig. 2.124). 2. Turn the wrench counterclockwise to loosen the clamp. For small clips, turn the wrench clockwise. 3. Press down the release rods on both sides of the instrument box (Fig. 2.122) and pull the instrument out.

2.8.4.7 Intraoperative Instrument Maintenance To ensure that EndoWrist continues to perform at its highest level, please adhere to the following suggestions: • Clean the instrument head at the time of replacement. • Do not use an instrument to clean other instruments when it is in the patient’s body. • Intuitive Surgical recommends the use of antibonding lubricants to reduce tissue adhesion to the electrosurgical EndoWrist.

2.8.4.8 Frequency of Instrument Use EndoWrist can only be used effectively a predetermined number of times. This characteristic is designed to ensure the reliability and stability of the instrument during its lifetime. Although instruments are designed to be used only a predetermined number of times, some instruments (such as large and small clips) can be activated only a certain number of times.

Note: In case the instrument life depends on the number of times of activation, the times of activation are more than the times of operations. However, large and small clip appliers and other instruments whose life is calculated based on the times of activation, should not be activated without installing the clamps. This means that the clamps cannot be closed as the system cannot know whether the clamps are installed and will deduct the times of activation.

1. Checking the remaining use times—Access Inventory Management on the Utilities tab on the touchscreen or touchpad to view the remaining use times of all instruments in the current surgery. One time of use will be deducted by the system if the installed instrument enters the follow-up mode. If the installed instrument does not enter the follow-up mode, it can be removed without reducing the remaining use times. When an instrument in its last usage time is used, the system displays the message “Instrument will expire after procedure.” In this case, if the remaining use of the instrument reported in the inventory management screen is 0,

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the instrument can still be used during the current operation; however, it cannot be used in the next operation. 2. Expiry and disposal—The instruments are automatically disabled after expiry, making them unusable. Expired instruments must be properly treated in accordance with the laws and guidelines of the country of use.

2.8.5 Patient-Side Operation of Endoscope The Patient Surgical Platform operator is responsible for the installation, insertion, and removal of the endoscope and the maintenance of intraoperative cameras. The operator must handle the endoscope with special care since the instrument is extremely delicate and can be easily damaged if dropped or hit. The endoscope is composed of two main components: interchangeable sterile endoscope. Camera: Video acquisition equipment with drape (Fig. 2.125). The endoscope interface of the camera arm consists of four parts (Fig. 2.126): • Insertion axis: transmits the endoscope to the surgical site. • Sterile adapter of the camera arm: provides a connection point between the endoscope and the camera arm. • Trocar mount: designed to secure the casing in place. • Trocar: provides an incision through the patient’s body wall through which the endoscope is inserted.

2.8.6 E  ndoscope Installation, Insertion, Removal, and Intraoperative Care 2.8.6.1 Installation Follow these steps when attaching the endoscope to the camera arm:

Endoscope operation interface

Fig. 2.126  Display the location of Endoscope interface

1. Make sure the camera control button on the camera is facing the Patient Surgical Platform column. Insert the endoscope head carefully through the camera trocar (Fig. 2.127). 2. Align the speculum with the insertion axis and press the endoscope body into the sterile adapter of the camera arm when the speculum passes through the camera trocar. Make sure the endoscope body is fully installed in place.

Caution: The endoscope may fall out if it is not installed properly. Caution: To avoid thermal damage to the trocar, do not leave the endoscope tip in the plastic endoscope trocar for too long while the light is on.

3. Connect the yellow portion of the camera cable to the strain relief rack on the camera arm (Fig. 2.128).

2.8.6.2 Insertion Use the camera arm clutch to manually introduce the installed endoscope into the patient. 2.8.6.3 Removal 1. Loosen the camera cable from the strain relief rack. Fig. 2.125  Endoscope component

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Fig. 2.127  Install Endoscope to Camera Arm

2.8.6.4 Intraoperative Maintenance Before use, make sure the endoscope head is heated to reduce fogging when it enters the surgical position. The endoscope head can be heated by using a jar of sterile water. Place a piece of sterile gauze at the bottom of the jar to prevent damage to the fragile endoscope head. Strain relief support

Fig. 2.128  Camera cable in strain relief frame without aseptic protective cover

2. Press the release lever on either side of the sterile adapter of the camera arm and gently pull the endoscope trocar up.

Note: Always attach the cable to the strain relief rack when operating the camera. Warning: The temperature of the endoscope during use may exceed 41 °C. When a cold light source is on and the endoscope is located outside the camera trocar, it is necessary to avoid the end of the endoscope from coming in contact with skin, tissue, and clothing as there is a possibility of damage to skin, tissue, and clothing. Do not attempt to cool the endoscope end by inserting the endoscope head into the tissue. Tissues may be damaged by heat, and the endoscope end may also produce charred residue that reduces the intensity of the output light.

2.8.6.5 Replacing the Endoscope Note: Intuitive recommends that you clean the endoscope head immediately after removing it, to prevent the attachment from hardening.

Warning: The connection point between the camera and the endoscope may get hot. Be careful when holding the endoscope.

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Endoscopic procedures can be changed during surgery. The endoscope can be changed using the following steps: 1. Remove the endoscope from the camera arm as per the above instructions. 2. Remove the endoscope from the camera. 3. The installation process is the opposite of the disassembly process. Make sure the head is facing the correct direction if a curved endoscope is used.

2.9

Application of Surgeon Console

2.9.1 Overview of Surgeon Console The Surgeon Console has six main components (Fig. 2.129): • • • • • •

Master (left and right) 3D viewer Touchpad Left box—ergonomic controller Right box—power and emergency shutdown Footswitch panel

Fig. 2.129  Surgeon Console. Footswitch Panel

2.9.1.1 Master The Surgeon Console operator can control the instruments and endoscope of the Patient Surgical Platform with the masters. The master has two main components: a positioning platform and a positioning arm. The positioning platform (Fig. 2.130) is used to move the instrument in a surgical environment. The positioning motion can be divided into three grades of ratio—3:1 (fine), 2:1 (normal), or 1.5:1 (fast). The positioning arm (Fig.  2.130) is used to rotate the instrument head as well as open and close the clamp.

Note: In case the instrument cannot be operated accurately and controllably, please contact Intuitive Surgical’s technical support personnel. Note: If you find that the instrument movement seems abnormal, please contact Intuitive Surgical’s technical support personnel immediately. Within the United States, call the 24/7 hotline at 1-800-876-1310. In Europe, please call +41.21.821.2030.

Fig. 2.130  Locating Cart

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Please refer to the sections on clamp matching, master switch, and surgical controllers for more information about master usage.

2.9.1.2 3D Viewer The 3D viewer provides video images to the Surgeon Console operator. By looking into the viewer, the surgeon can observe 3D images in full screen mode or switch to TilePro™ mode. In addition to 3D images, TilePro™ mode can also display auxiliary images from at most two channels. Icons and text messages overlay the video frame, providing the surgeon with more information. The system provides two-way audio communication by a microphone under the observing port and a pair of speakers under the headrest. Please refer to the video and audio sections for more information on 3D viewer usage and tuning (Fig. 2.131).

Fig. 2.132 Touchpad

2.9.1.3 Touchpad The touchpad is the main control interface of the Surgeon Console (Fig. 2.132). Please refer to the section on touchpad control for more information about its usage. 2.9.1.4 Left Box—Ergonomic Controller The left box is fitted with the ergonomic adjustment controller for the Surgeon Console, as shown in Fig. 2.133. Please refer to ergonomic settings for more information on ergonomic tuning. 2.9.1.5 Right Box—Power and Emergency Shutdown The right box is fitted with Power and Emergency Stop buttons (Fig. 2.134). If necessary, the red emergency stop button may be pressed down at any time to stop the system. When the Emergency Stop button is pressed, the system classifies

Fig. 2.133  Ergonomic Controls on the left

Fig. 2.131  See Video and Audio sections for more information to use and adjust Stereo Viewer settings

Fig. 2.134  Power and Emergency Stop Button on the right

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this situation as a recoverable fault, and the Recover button on the touchpad can be pressed to force the emergency stop signal to be ignored. Please refer to error handling for more details.

2.9.1.6 Footswitch Panel The Footswitch Panel allows the surgeon to control the camera, instrument, and ESU without removing their head from the 3D viewer (Fig. 2.135). Please refer to the relevant sections of the Footswitch Panel for instructions.

2.9.2 Surgeon Console Settings 2.9.2.1 Login The Da Vinci System automatically saves the set value (such as ergonomic settings) adjusted by the user during the last usage, based on the user name; the preference settings are then automatically adopted the next time the user logs in, resulting in better usability. To take advantage of this, it is recommended to log in to the Surgeon Console with your own username (you can skip login, but then your preferences will not be saved). 1. Existing user—Touch an existing username (if any) to log in. Use the arrow keys to scroll up and down if necessary (Fig. 2.136). When selecting the username, the touchpad displays the following screen, prompting you to move the ergonomic adjustment axis of the Surgeon Console (Fig. 2.137). Make sure that no person or object is in contact with the Surgeon Console, and then “Press and Hold to Restore Settings” according to the button prompt. A blue bar indicates the progress if the Surgeon Console adopts the user’s latest ergonomic settings. If the Reverse button is pressed and held, the Surgeon Console reverses its motion and the progress bar retreats. If both buttons are released, the motion stops and the progress bar stops moving. The required button can be pressed again to restart the motion in the corresponding direction. After the Recovery Settings operation is completed, the Recovery Settings

Fig. 2.135  Camera control button and EUS Footswitch Panel

Fig. 2.136  User login

Fig. 2.137  Display on the Touchpad after selecting user

screen is automatically closed and the home screen is displayed on the touchpad. Press Cancel at any time to log in without the current ergonomic settings. 2. Set New User—If you have not logged into the system before, create a user account as per the following steps (Fig. 2.138): (1) Log in with the New User button on the touchpad. The screen displays “New User” (steps 1–6). The first screen of the six steps is to create a New User. (2) Use the touchpad keyboard to enter a username and then press OK. At this point, the system prompts the user on the ergonomic settings process. This process is only required when a new account is set up. The screen displays the following New User (create a New User) screen (Fig. 2.139). The user is now logged in successfully. Any changes made by the user to the system configura-

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tion, such as ergonomic settings, are saved to the user’s profile. The file is then automatically used each time the user logs in. To logout, press the Logout button in the lower left corner of the home screen. 3. Manage Users—Touch the button to navigate to the screen where the user can be deleted.

2.9.2.2 Ergonomic Settings

Caution: Before adjusting the ergonomic controller on the Surgeon Console, make sure there is enough room for the component to move.

Fig. 2.138  Create a new user Fig. 2.139  Display on the Touchpad after creating a new user

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After successfully logging in, any changes made by the user to the system configuration, such as ergonomic settings, are saved to the user’s profile. The file is then automatically used each time the user logs in. Follow these steps to adjust the ergonomics settings of the Surgeon Console as per your preference: 1. Adjust the seat height so that your thighs tilt slightly downward relative to the ground. This ensures that the foot pedal can be easily stepped on. 2. Adjust the armrest height to ensure your forearms rest comfortably on the armrest and your shoulders are relaxed (Fig. 2.140). 3. Adjust the 3D viewer height according to your preference (Fig. 2.140). 4. Adjust the 3D viewer angle according to your preference (Fig. 2.140). An upward tilt will ensure your neck is at a more comfortable angle. A downward tilt allows for better alignment between the hand and the instruments in the 3D viewer. 5. Adjust the Footswitch Panel according to your preference (Fig. 2.140).

2.9.3 Touchpad Controller 2.9.3.1 Overview The home screen on the touchpad displays the instrument arm, camera arm, and energy controller status. In dual console mode, the screen can also be used to surrender or gain control of the instrument arm (Fig. 2.141). • Touch panel menu: gray items are not enabled and cannot be used in the current situation; items highlighted in blue are the selected items.

Fig. 2.141  Surrender or gain control of Instrument Arms in the dual console mode

• Quick Settings button: Three Quick Settings buttons are located in the lower middle of the screen. From the top to the bottom, the buttons indicate the setting of the speculum angle, the magnification level (in the 3D viewer), and the motion ratio, respectively. Touch these buttons to navigate to the interface of the relevant settings; you can adjust the camera/speculum settings, display preferences, and control preferences. • Lock: Touch the Lock button to lock an arm position to prevent accidentally switching to the instrument arm that is being used to perform a static function (e.g., pulling or securing tissue). The instrument arm retains its position when it is locked. The “Lock” button is highlighted in blue when selected to indicate that it is locked. To regain control of the arm, touch the Lock button again.

2.9.3.2 Unlocking the Touchpad When a surgeon places the instrument in the follow-up mode, the touchpad is automatically locked to prevent unexpected operation. Touch the unlock button to reoperate the touchpad (Fig. 2.142). 2.9.3.3 Video The Video tab can be used to quickly adjust brightness, adjust advanced videos, set the camera (speculum), and display preferences (Fig. 2.143).

Fig. 2.140  Adjust Footswitch panels according to user’s preference

1. Brightness—Drag the Brightness slider in the bottom left of the sun icon (Fig. 2.144). Adjust video brightness in the 3D viewer (instead of the actual illuminance) and slide to the right to increase the brightness.

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2. Advanced Video Adjustments—Touch the Advanced Video Adjustments button to adjust the advanced video settings for surgical images.

Note: To what extent these settings are adjusted depends on the surgeon’s preference. As with any adjustable video image, you may find that certain settings affect others, and the user must decide what are the optimal settings based on his/her requirements. For example, adjustments require a trade-off between the glare of one part of an image and the visibility of another. Remember, these settings can be readjusted at any time. Fig. 2.142  Touch the Unlock button to activate the Touchpad

• Brightness: Drag this slider to adjust the brightness of the surgical image. Here, the video brightness, not the actual illumination, is adjusted. • Contrast: Drag this slider to adjust the surgical image contrast. • Red: Drag this slider to adjust the red color of the surgical image. • Blue: Drag this slider to adjust the blue color of the surgical image. • Edge Enhancement: Drag this slider to adjust the edge enhancement of the surgical image. Increasing edge enhancement (drag to the right) may also increase noise. • Cold Light Source: Drag the slider in 10% steps to adjust the actual light output sent to the surgical field. Fig. 2.143  Video settings

Note: To reduce fogging, the light intensity of the cold light source is set to 100% and the brightness of surgical images is adjusted with a lighting slider on the touchpad or touchscreen under Advanced Video Adjustments, to maintain heat to the endoscope lens.

3. Camera/Scope Setup—Touch the Camera/Scope Setup button to set up the camera and endoscope using the Surgeon Console (Fig.  2.145). This is equivalent to using the touchscreen and/or camera setup. Please refer to the steps for setting up the image observation system. • Scope Angle: The scope angle can be specified by touching the corresponding button: a straight endoscope is at 0°; a curved endoscope can be specified at an angle (upward bending) or (downward bending). Fig. 2.144  Advanced video adjustments

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Note: When a new scope angle is selected, the system resets the master to match it with the direction and position of the instrument head. Warning: If you manually select the wrong speculum angle, the instrument motion seems out of place.

• White Balance: Touch this button to adjust the white balance. • Start Calibration: Touch this button to calibrate the camera (speculum) components using the Surgeon Console. Please refer to the calibration of endoscope components for more details.

2.9.3.4 Display Preference • Zoom: Zoom, also known as digital zoom, allows you to zoom in without changing the position of the speculum lens. There are four set values for scaling: Wide, Full, 2×, and 4×. The current settings are displayed on the touchpad under the scope status icon (Fig. 2.146). When adjusting the zoom settings, a navigation window is displayed in the lower right corner of the Surgeon Console image. The navigation window represents a ­widescreen (16:9) image. The blue rectangle indicates the zoom level. • TilePro: Enable the 3D viewer to switch between endoscope view and “TilePro” mode. In “TilePro” mode, two-­ way auxiliary video inputs such as PACS, ultrasound, indoor camera, etc., can be displayed along with the surgical image (Fig.  2.147). The system automatically detects whether any auxiliary video input exists and arranges the TilePro display accordingly. In TilePro mode, the size of the auxiliary image varies with the size of the endoscopic image. As the size of the surgical image changes, the auxiliary image is scaled to fill the remaining display area.

Note: TilePro is disabled unless the system detects an auxiliary video input.

Fig. 2.145  Camera/Scope setup

• Viewer Mode: Enable the 3D viewer to switch between 2D and 3D modes. • Telestration Eye: The images overlaid by telestration, switch between the left eye (L) and right eye (R).

Fig. 2.146  Display Preferences tabs to configure the Stereo Viewer display

Fig. 2.147  TilePro mode

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• Image Depth: Allows the surgeon to better view the fused 3D image at a Normal or Far distance. The system defaults to normal distance.

• Volume: Drag this slider to adjust the volume of the Surgeon Console speaker; move the slider from left to right to turn up the volume. • Mute: Touch this button to mute the microphone on the Surgeon Console.

Note: Please refer to symbols, icons, and text messages for detailed instructions on the icons and text messages overlaid on the 3D viewer.

2.9.3.6 Utilities Account management, inventory management, event logging, and control preferences are available through the Utilities tab.

2.9.3.5 Audio The Audio tab allows the user to adjust the volume and mute the microphone (Fig.  2.148). Follow the below steps to resolve sound echoes:

1. Account Management—This button allows the user to read and write user account information. Users may change the user profile information or delete the account (Fig. 2.149). 2. Inventory Management—Reports the status of the instruments used in the operation. When the surgeon chooses Inventory Management, the inventory is displayed on the 3D viewer, not the touchpad. This list also displays the number of hours used by the lamp module. Scroll the inventory list by pressing the top or bottom of the page (Fig. 2.150). 3. Event Logs—The “Event Logs” button provides access to the system event logs, including error logs. When the ­surgeon presses the Event Logs button, the event logs are displayed on the 3D viewer, not the touchpad (Fig. 2.151). 4. Troubleshooting—Press the button to display the system name and system software version; left (L) and right (R) buttons are available, to display the color bar test pattern independently in the left or right video channel. This function is also available in the troubleshooting screen on the touchscreen (Fig. 2.152).

• Lower the speaker volume on the Surgeon Console and/or touchscreen. • The Surgeon Console and touchscreen are reoriented so that the microphone and speaker do not point at each other. • Increase the distance between the Surgeon Console and the touchscreen. • Turn off any microphone in the Surgeon Console or the touchscreen, and allow the sound from only one direction to be amplified.

Note: Please check the audio settings if it is difficult to communicate with the patient-side assistant.

Fig. 2.148  Audio settings: adjust volume or mute microphone

Fig. 2.149  User can change his/her profile or delete the account

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Fig. 2.150  Roll the Event Logs through Page Up and Page Down buttons

Fig. 2.151  Event Logs displayed in the 3D viewer

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Fig. 2.153  Control Preferences setting

5. Control Preferences—The surgeon can configure the system controller through “Control Preferences” (Fig. 2.153). • Scaling: The positioning motion of the master can be amplified in three gears: Quick—1.5:1, Normal—2:1, or Fine—3:1. The system defaults to Fine gear. • Master Switch Clutching: Release or engage the master switch clutch. • TilePro QuickClick: Start or stop TilePro QuickClick. When this feature is activated, the surgeon can switch to TilePro by quickly tapping the camera pedal. • Haptic Zoom: Start or stop “Haptic Zoom.” “Haptic Zoom” is a digital scaling method with the master in camera control mode; it is off by default. Digital scaling does not move the endoscope head. To use “Haptic Zoom,” step on the camera pedal to enter the camera control mode and then: –– Bring together the master to bring the image closer (digital). –– Separate the master to push the image away

Note: Slight resistance may be felt on the master when adjusting the zoom level.

Fig. 2.152  Troubleshooting settings

(digital). 6. Assign Master Control—Touch the configuration button to launch the assign master control screen; the user can manually associate any master with any instrument arm from this screen (Fig. 2.154). Press the AUTO button to assign the master automatically or use the arrow button to manually assign the master and the instrument arm. When an instrument is reassigned, the system accepts the instrument as per the following: the system notifies and alerts you with an icon

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Fig. 2.154  Auto or manual mode of Master Associations

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Fig. 2.156  WARMING: Maximum of two arms per sides

Note: In dual console mode, any surgeon can use the assign master screen to reassign the instrument to a different master, although other surgeons have control of the instrument. When an instrument is switched, the new instrument is applicable to both consoles. The system notifies the surgeon as usual when there is a reassignment.

The system does not allow users to use three assigned arms simultaneously. The message “using up to two arms on each side” is displayed when a user tries such an operation (Fig. 2.156).

2.9.4 Surgeon Console

Fig. 2.155  Touch ARM SWAP Panel to continue operating

and with the following message after assigning the master control. Your instrument has been reassigned. Tap the “ARM SWAP” pedal with the left foot to confirm and continue the next step (Fig. 2.155).

The surgeon must place their face within the 3D viewer to begin using the surgical controls. The 3D viewer adopts a pair of infrared sensor probes to determine whether the system is in use. The surgeon cannot control the instrument or camera if their face is no longer placed within the 3D viewer.

Warning: The infrared sensor acts as a safety mechanism to prevent the robot arm from moving around the patient when the surgeon’s face is not within the sen-

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sor’s field. Do not artificially interfere with the sensor’s function, as it may adversely affect the safety function.

2.9.4.1 Handle Match Before controlling the instrument, the primary surgeon must first perform “handle-to-instrument matching.” Handle matching (also known as clamp matching) is a safety feature designed to prevent accidental instrument activation. This feature also ensures that articles clamped on nonworking instruments do not fall off accidentally when enabled. The following two steps must be performed to enable handle matching: 1. Support Expected Movement—Use the master to partially close or open the clamps, or slightly rotate the clamps to verify if expected movements are supported, and to see if the main operator handle is synchronized with the instrument (clamp) movements already mounted on the robot arm. 2. Match Grip Angle—After the expected action is supported, the Match Grip Angle of the master must be adjusted to match that of the instrument grip. After matching the grip with the handle, the surgeon can control the instrument. No match grip function (if not matched, the surgeon cannot operate the clamp) is allowed until the instrument head is inserted through the trocar and moved over the trocar end. When the instrument is in the standby state with a matched handle, an icon and text message are displayed, indicating that the handle and clamp have been matched.

Warning: Once in the follow-up mode, the surgeon console operator should not remove their hand from the master until they have lifted their head from the surgeon console 3D viewer (thereby causing the system to exit the follow mode). Failure to follow this operation may cause the master to move out of control, causing serious injury to the patient. Warning: To avoid the danger of electric shock, the surgeon console operator should not touch the patient while using the master.

A slight grip force should be applied to the master when controlling or recontrolling the master (such as when installing a new instrument, when the operator of the robot arm cart beside the patient bed moves the instrument arm or camera arm, and when the instrument arm is converted). This enables the system to align the master clamp with the instrument end, in the 3D viewer.

2.9.4.2 Finger Clutch Pull the finger clutch to separate the master from the instrument it controls. If the surgeon presses the finger clutch to move the master, the instrument will not move with it. Unlike the main clutch pedal, the finger clutch corresponds only to the master on the same side (Fig. 2.157). Thus, when a finger clutch is used, the instrument of the other master is still in the follow-up mode. By using the finger clutch the surgeon can reposition the master properly when it reaches the limit position, freeing up operating space. To regain control, please release the finger clutch and match the grip in a conventional manner.

Note: Match grip is required before applying clamp, and the clamp must be opened more than 90% for smooth clipping. Warning: To ensure patient safety, the surgeon must not perform handle matching for an instrument whose head is not visible in the 3D viewer. Failure to comply with this warning can result in serious injury to the patient. Clamp matching may be performed only after the clamp is seen in the 3D viewer. Note: To ensure patient safety, actions of the operator of the robot arm beside the patient bed take precedence over those of the surgeon at the surgeon console. Any movement of the robot arm cart beside the patient bed by the operator will cause all instruments to exit the follow-up mode. Fig. 2.157  Finger Clutch applied to ipsilateral Master Controller

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• The surgeon can use the Control Preferences feature on the touchpad to turn off the clutch.

2.9.4.3 Footswitch Panel There are two sets of footswitches on the Footswitch Panel. There are three function switches (camera control, master clutch, and arm switch) on the left side of the Footswitch Panel. Four pedals are arranged on the right side of the Footswitch Panel to control the activation of device energy connected to the energy device interface, for example, electric scalpel or electric surgical unit (ESU). The energy ­control pedals are arranged in a pair on the left and right sides (Fig. 2.158). 1. Camera Control and Focus—Step on the camera pedal to convert the master from the instrument controller to the camera (endoscope) controller. In camera mode, simultaneous movements of the two masters (such as pulling in or pushing away, moving from one side to the other, or rotating) by the surgeon translate into corresponding movements of the endoscope. Both masters can be pulled closer to the operator’s eyes, so as to bring the endoscope closer to the surgical field. If the endoscope needs to be rotated clockwise, both the left and right masters can be rotated clockwise simultaneously, similar to a steering wheel action. To adjust the focus, simply grab the master and rotate your wrist in any direction.

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Warning: The instrument end should always be within the surgeon’s field of view.

2. Master Clutch—Stepping on the master clutch pedal causes the master to lose control of the instrument, making it easy to move the master while the associated instrument remains motionless. The pedal cannot be used to clutch a left or right master independently. A master can be separated with the finger clutch. By stepping on the master clutch pedal, the surgeon can reposition the master in a more comfortable position, leaving more room to maneuver the master. All instruments remain in place until the surgeon releases the clutch pedal of the master and matches the clamps in a conventional manner, to resume control. 3. Arm Switch Pedal (Left Kickplate)—Switch control between two related instrument arms of the same master.

2.9.4.4 Energy Control Pedal There is one pair on the left and one pair on the right (Fig. 2.159). 1. The pair of pedals on the right control monopolar instruments (electric hook/electric shear) or ultrasonic knife instruments.

Note: When operating in dual console mode, stepping on the camera pedal causes all instruments to exit the follow-up mode and shuts down the power supply from the other console. When the camera pedal is released, the master restores control of the instrument.

Fig. 2.158  Energy Control Pedals arranged in pairs for both right and left sides

Fig. 2.159  Energy Control Pedal

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2. The pair of pedals on the left controls bipolar instruments (standard or PK clamp). 3. Primary (Blue) and Secondary (Yellow) Pedals—Each pair of pedals includes a lower blue pedal for primary energy control and an upper yellow pedal for secondary energy control. Main Energy (Blue): Activate the main energy control mode of a live instrument, such as the coagulation (Coag) function used by a unipolar instrument. Secondary energy (yellow): Activate the secondary energy control mode of a live instrument, such as the cutting function (Cut) of a unipolar instrument.

2.9.4.5 3D Viewer Display The HD 3D viewer displays the surgical site and provides extended system information via icons and text messages. Figure  2.160 illustrates the display blocks on the display screen of the 3D viewer. Note that many blocks appear only when required, while others always appear on the screen. 1. Power-on Indicator—The yellow-filled lightning icon appears next to the name of the instrument that is energized and ready to launch. It indicates that the instrument is energized and in standby. If for some reason the energized instrument is not ready for use, the lightning icon displays a strikeout line and becomes hollow. 2. Instrument Arm Indicator—It provides the instrument arm number on the same side as the master of the control instrument arm. If the same master is fitted with two arms, the number at the top represents the working arm. 3. Background Color of the Instrument Name and Arm Number • Black: Partially transparent (default), the footswitch sensor does not detect anything. • Gray: Feet are detected on a pair of disabled pedals.

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• Blue: Feet are detected on a pair of enabled pedals. • Yellow: Energy emission. • Camera Indicator: At the top are the 3D viewer display areas, which include the following. –– Camera Angle: Display 0°, 30°↑, or 30°↓. –– Camera Rotation: Provides information on the angle of endoscope rotation relative to the ground. This information is useful for understanding the functional location of the mirror reference coordinate system relative to the anatomy of the patient body. –– Scaling: Displays the zoom level of the current field of view, such as wide, full screen, two times, and four times. –– Foot Pedal Diagram: Provides information that helps to understand the position and status of pedals on the Footswitch Panel. –– Information Area: Provides extended information on the system status. 4. Status Area of Other Console Devices—In dual console mode, the small display area shown in Fig. 2.161 appears on the upper-left of the 3D viewer. • The device status information of the other consoles displayed in this area are: • The console number, or if registered, the surgeon’s name is displayed on the top. • For the left and right masters, name of the relevant device, arm number, and energy status, including the activation adjustment range. • The same status icon can appear anywhere, but the other highlights are the clutch status of the host (finger-­ controlled clutch), shown in the upper-right corner.

Remarks: On the touch panel, the top center area is lined with two icons indicating the status in dual console mode.

2.9.4.6 Foot Pedal Diagram (3D Viewer) When an energized instrument is installed and the ESU supporting that energy type is connected to the system core device, the foot pedal diagram in the bottom center of the 3D viewer displays the type of energized device and the available primary and secondary energy modes (Fig. 2.162).

Fig. 2.160  Touchscreen Monitor Display

Fig. 2.161  Dual console mode (Console 2)

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Note: The system does not map or enable pedals for that type of energized device if the installed energized instrument or the connected electrical surgical unit (ESU) causes the pedal mapping to be undefined. The user is prompted by the system to eliminate ambiguous cases by disconnecting or shutting down an ESU or removing a conflicting instrument.

• For example, if two monopole instruments are installed simultaneously, the system cannot determine which pair of pedals should be mapped to the right, and neither monopole instrument can be activated until one of them is removed. In the case of ESUs, if two energized ESUs supporting monopolar energy instruments are connected to the core device simultaneously, the system disables both ESUs until one of them is turned off or disconnected. • If the system maps an instrument to a pair of pedals on the left or right side, the mapped energy type is displayed on

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the side pedal, and the associated energy mode is displayed next to each pedal icon. The following table shows the possible energy types and related pedal patterns in the pedal switch diagram (Table 2.6). 1. Edge Color—The edges on each side may be blue, gray, or orange: gray indicates that the energy is disabled or the instrument is not ready to launch; blue indicates that the energy is enabled or ready for emission, and orange indicates that energy is being emitted (Fig. 2.163). 2. Background Color of Pedal Area—In addition to the default black, the background color in the pedal area turns blue when one foot is placed on a pair of pedals (in contact or close to) that are enabled, and gray when one foot is placed on a pair of pedals that is not enabled. When the pedal is stepped on, its edges are highlighted in orange whether or not the energy is actually emitted (Fig. 2.164). • Black: Partially transparent (default): the foot sensor does not detect anything. • Gray: Feet are detected on a pair of disabled pedals. • Blue: Feet are detected on a pair of enabled pedals. • Orange: Energy emission

Table 2.6  Power species and Pedal mode

Fig. 2.162  Types of energy devices and available energy modes

Fig. 2.163  Highlight of activated energy device Fig. 2.164  Activated energy device highlighted in orange

Bipolar (on Power pedal the left) Secondary Blank power Main power Bipolar

Pk (on the left) Blank

Monopolar (on Ultrasonic (on the right) the right) Mono cut Min

Pk

Mono Coag

Max

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2.9.4.7 Energy Activation Manifestation The Da Vinci Si System displays the following energy activation manifestations: 1. The system does not support any instrument combination with pedal control of unclear ESU or energy; hence, you cannot control the energy of two energy instruments of the same type simultaneously (e.g., twin poles and bipolar instruments). The system indicates the disabled configuration in different ways depending on the energy source causing the ambiguity. In all cases, the system displays the power-on indicator and does not map pedals with unknown functions. 2. The system can only activate one energy instrument at a time. Stepping on the second pedal stops the first one from launching, and neither can be relaunched until both pedals are released. 3. In dual console mode, if each surgeon controls an energy instrument, the first action of stepping on the energy pedal activates the instrument, while the other actions are locked until the first action is completed. After the first action is completed, the blocked step-down operation must be released and reapplied before enabling it again. 4. In dual console mode, stepping on the camera control pedal stops the powered instruments on the other console (not your own console) and performing this action also causes all instruments on both consoles to exit the follow­up mode, which means they do not move. 5. The system sounds a warning if the pedal is stepped on when the energy cannot be activated.

2.9.4.8 Simultaneous Energy Control: Disabled Combination The system does not map or activate pedals of a type of energy if the installed energy instrument or the connected ESU combination causes the pedal mapping to be undefined. For example, you cannot control two energy instruments of the same type (such as bipolar and bipolar instruments) simultaneously. If a surgeon activates the bipolar energy instrument on both the left and right masters, he/she will not be able to activate energy use on any other instrument. 1. Simultaneous energy control disables the combination— In the Da Vinci Si System, the following types of energy instruments and ESU combinations cannot be used for simultaneous energy control: • Bipolar and bipolar • Monopolar and monopolar • Between bipolar and PK instrument • Monopolar and Harmonic • Two ESU generators of the same type Example: Control two energy instruments of the same type

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When a surgeon controls two energy instruments of the same type simultaneously, neither instrument maps to the pedal, and the energy indicator (lightning icon) and the border of the foot pedal diagram turn gray.

2.9.4.9 Conversion Energy Control: A Combination Available for Joint Use The following functional devices are interchangeable when used in combination, but only two devices associated with the same host control device can be used. • Between monopolar instrument and Harmonic • Between bipolar and PK instruments

Note: Energy conversion is never possible between two bipolar instruments or two monopolar instruments, as they require the same ESU cable.

This combination requires a swap of energy control because the user cannot control both instruments when they are associated with the same master. In this figure, the Maryland bipolar forceps have been installed on the No. 2 instrument arm, the PK anatomical forceps have been installed on the No. 3 instrument arm, and both instrument arms are associated with the left master. Since both energy instruments are on the left master, it is impossible for the surgeon to control them simultaneously. Thus, there can be no energy-control conflict. The surgeon can swap control between the two energy instruments and avoid simultaneously controlling the disabled combination. The energy indicator and foot pedal diagram border are highlighted in blue to indicate that the system allows this combination (Figs. 2.165 and 2.166).

2.9.5 Dual Console Surgery This section describes the control interfaces using two surgeon consoles (Fig. 2.167).

2.9.5.1 Dual Console Connection and Startup To run in dual console mode (using the second surgeon console), simply insert the second console system cable into one of the fiber optic ports available on the back of the main device. No other connection is required except to plug the second surgeon console into a dedicated AC power socket. 2.9.5.2 Comparison Between Two Consoles This section describes the relationship between the touchpad, 3D viewer, and instrument controls when using the two surgeon consoles.

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Fig. 2.165  “Dual Monopolar Scissors” is not an allowed combination

Fig. 2.166  “Monopolar and Maryland Bipolar” is an allowed combination of instruments as indicated by the blue highlight

Fig. 2.167  Dual console

1. Touchpad—With the exception of the Give/Take and Swap All (Swap All) buttons, the arm status area has normal features, and displays the arm status on both consoles. Each surgeon independently controls only the touchpad settings available on his/her console and 3D viewer. For example, one surgeon can use digital zoom

and TilePro on his/her own 3D viewer without affecting the other surgeon’s 3D viewer. 2. 3D Viewer—The 3D viewer operates independently, except for the shared video source with the endoscope, the imagerelated video settings of the surgical area, and the related overlapping blocks of components such as the endoscope

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(e.g., camera rotation indicator). Each 3D viewer displays the overlapping areas of the surgeon-­controlled instruments in their regular locations and displays information about the instrument controlled by the other surgeon near the center of the 3D viewer’s top. Each surgeon can independently adjust their images, including content and settings. For example, one surgeon can apply digital zoom and TilePro to his/her own 3D viewer without affecting another surgeon’s 3D viewer. Additional details about the instrument status of the other console can be viewed by the surgeon. 3. Instrument Control—Control settings for each operating table instrument (especially motion scaling) can be operated independently, and when the instrument control is swapped, the instrument exits to follow-up mode until the controlling surgeon matches the clamp as per the standard manner. After the surgeon gains control, the control settings selected on the console are available. 4. Assign Master—The system allows two surgeons to reassign the instrument to different masters, and this function can continue to be used in dual console mode. The new instrument assignment is applicable to both consoles after instrument switching.

Fig. 2.168  Surrender or gain control of Instrument Arms

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2.9.5.3 Instrument Control After the system detects that two surgeon consoles are being used, the home screen of the touchpad displays the Give/ Take and Swap All (Fig. 2.168) buttons. 1. Give/Take—When the console is controlling, this button displays “Give”; when not controlling, it displays “Take.” Any surgeon can give up or gain control of a particular instrument by touching the Give or Take button. If control is swapped through the Give or Take button, the instrument exits the follow-up mode until the controlling surgeon performs the match grips in the standard manner.

Remarks: In dual console surgery, you can use the Give/Take button on the home screen of the touchpad to give up or acquire the locked instrument arms. The instrument arms remain locked after swapping until they are unlocked on the control panel.

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2. Swap All—Any surgeon can swap the control of the full arm by touching the Swap All button. The energy control over the instrument arms should be followed. After touching the Swap All button, all instruments exit the follow-up mode until the controlling surgeon performs the match grips. Swap All affects all three instrument arms (not the endoscope). However, if the surgeon fails to control one arm before the swap, he/she can only control up to two arms after the swap. The surgeon must match the handles first for both devices, and then the other surgeon matches the handles before swapping; the third arm is still in its original state. In order to take control of the third device, the surgeon must step on the reciprocating pedal (left pedal) of the lower arm as per the standard approach. 3. Lock—The controlling surgeon can use the Lock button to lock the instrument in place and unlock the locked arm to enable control. The current locking status is displayed on both surgeon consoles.

Remarks: In dual console mode, either surgeon can use the Assign Master screen to reassign the instrument to a different master, even if the other surgeon is controlling the instrument. The new instrument assignment is applicable to both consoles after instrument swapping. The system usually notifies the surgeon when a reassignment occurs.

After redistributing the instrument through the Assign Master screen, the system exits the instrument from the follow-­up mode, and notifies and prompts the operator through the following icons and related messages.

2.9.5.4 Camera Control Any surgeon can control the camera arm by stepping on the camera pedal. The first surgeon to do so generally gains control of the camera. When the camera arm is controlled, all the instrument arms exit the follow-up mode, and the powered instrument on the other console cannot be used (Fig. 2.169). 2.9.5.5 Video Control In dual console mode, video settings are shared between the two surgeon consoles and the touchscreen display on the image cart. The video settings are not saved in dual console mode.

Fig. 2.169  Foot panel

2.9.5.6 Virtual Pointer (Dual Console Teaching Aids) A virtual pointer is a software tool used for illustration and is usually used in dual console surgery. The pointer is a three-­ dimensional graphic object with a light blue cone shape that is overlaid on real-time video when activated. The surgeon can use it to point to specific anatomical structures in real-­ time video images during surgery. The surgeon can activate and control a pointer through each master not associated with the instrument arm. In general, unassociated masters are available only in dual console surgery. Both pointers can be activated simultaneously in the usage scenario described below. Since the pointer can only be activated by the master not associated with the instrument arm, you can prepare the following usage scenarios by setting the master assignment and giving up or gaining control of the instrument arms on the designated Surgeon Console. Open Utilities > Control Preferences and touch Configure next to the Master Assignments to set up the master assignment. Use the Give/Take button on the home screen of the dual consoles to give up or gain control of the instrument arm.

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Remarks: The pointer can also be activated in single console mode if the third instrument arm is in the storage position. For example, if arm 3 is in storage, you can associate arms 1 and 2 with the left master, then the pointer can be activated using the right master.

In a typical usage scenario, the supervising surgeon on Surgeon Console 2 (controlling one or no instrument arm) provides guidance to the supervised surgeon at Surgeon Console 1 (controlling two or three instrument arms). The supervising surgeon activates one or two pointers using one or two unassociated masters and then uses each pointer to point on the patient’s body, for the reference of the supervised surgeon while talking to him (Fig. 2.170). 1. A pointer is available for control on each console—In certain less common scenarios, both Surgeon Consoles 1 and 2 have an unassociated master; hence, each surgeon can activate a pointer as required. In this scenario, one surgeon controls the two instrument arms associated with the same master, and the other surgeon controls the other instrument arm so that each console has a master that is not associated with the instrument arm. 2. Usage Characteristics—Virtual pointers have the following usage characteristics: • The surgeon can activate the virtual pointer by closing the grip of the unassociated master. The initial position of the pointer is centered vertically. It should be offset slightly to the right or left with reference to the master in use. The surgeon can close the grips of both masters on the console of the instrument arm not associated with the master and activate both pointers simultaneously. • After the pointer is activated, the master controlling the pointer can move freely. The surgeon can hold the master, keeping the grip closed at all times, to control

Fig. 2.170  Use pointer to indicate the anatomical structure

•

•

•

•

•

the position and direction of the pointer. The pointer end corresponds to the fingertip on the closed grip. The pointer has a 3D effect, creating shadows in the light from the direction you are looking. The pointer gets smaller when it moves away from the user and gets larger when it moves toward the user. The pointer also has left, right, front, and rear vanishing points, and it can be pulled back to the screen as long as the grip is not released. If the grip is released beyond any vanishing point, the pointer reappears in the default position when the grip is closed again. If there are remote guidance tags on the screen, they are cleared when the pointer is activated. Remote guidance is not available when the pointer is activated. You can grab the master with the pointer activated, in order to reposition the master without moving the pointer. The pointer disappears when the surgeon releases the grip or steps on the camera pedal (in camera control mode). After the pointer disappears, the master controlling the pointer can no longer move freely, but can only be clutched normally. On subsequent activation, the pointer appears in its last position, unless it is off-screen. In that case, the pointer reappears at its original position.

2.10 S  hutdown and Storage of Robot System 2.10.1 System Shutdown Preparation 1. Remove the instrument and endoscope from the patient cart. 2. Disconnect the trocar from the instrument arm and camera arm. 3. Press the channel clutch button to remove the instrument arm and camera arm from the patient.

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Fig. 2.173  Remove and handle the drapes properly

Fig. 2.171  Keep Patient Cart away from operating cart

Fig. 2.174  Status of instruments usage

2.10.2 Inventory Management By accessing Inventory Management on the touchscreen or touchpad Utilities tab, you can view the remaining availability of all instruments used during the current surgery (Fig. 2.174). For instruments that fail after a certain number of operations, the system displays the remaining usage or activation time in the right column. Refer to details on how the system tracks usage.

2.10.3 Shutting Down the Da Vinci Si System Fig. 2.172  Remove and clean the accessories

4. Remove the patient cart from the operating table (Fig. 2.171). 5. Remove all sterile system accessories for cleaning (Fig. 2.172). 6. Remove and properly dispose of all drapes (Fig. 2.173).

1. Fold the assembly connector into the cart and prepare the patient cart for storage. The No. 3 instrument arm should be in the storage position (Fig. 2.175). 2. Press the system power button. The system starts the 10-second shutdown process and displays the following information:

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Note: Where possible, system cable connections should be retained, to minimize contamination.

Please follow the below steps to remove the system cable: 1. If necessary, remove nonsystem connections (e.g., auxiliary video and audio cables, ESU, blowers, etc.). 2. Twist the system cable counterclockwise and pull the metal ring backward to disconnect it from the surgeon console and the patient cart. 3. Store the system cable on the side of the image cart.

Note: Install the protective cover immediately to prevent contamination and physical damage to the connector.

2.10.4 System Storage Follow these steps to store the Da Vinci System:

Fig. 2.175  Stow the third instrument arm

• • • •

Preparing to shutdown Preparing to shutdown Press POWER to reverse within MO seconds Press POWER to reverse within MO seconds.

Note: If the system is not restarted within 10 min after shutdown, it considers any subsequent restart as a new operation and the usage times of the instrument is reduced accordingly. Note: When either the patient cart or the core device (image cart) is connected to the AC power supply, the corresponding cooling fan runs continuously. This is normal. Do not use the Emergency Power Off (EPO) button on the patient cart to turn off the cooling fan. Otherwise, the patient cart battery will stop charging.

1. Ensure the storage room complies with the following specifications: A. Room temperature at −10 °C–55 °C. B. Relative humidity at 10–85%, without condensation. 2. Place the patient cart near a wall outlet and connect it to AC power.

Note: To keep the standby battery charged, it is important to keep the patient cart connected to the AC power supply during storage. Failure to do so will result in battery running out of charge. The surgeon console and image cart do not require AC power. Note: The cooling fan continues to operate while the patient cart is connected to AC power. Do not use the Emergency Power Off (EPO) button on the patient cart to turn off the cooling fan. Otherwise, the patient cart battery will stop charging.

2.11 C  leaning and Maintenance of Robot System 2.11.1 Robot System Maintenance

3. It is now safe to disconnect all system cables, but it is recommended to retain the connections to minimize contamination of the connectors.

Preventive maintenance is required and must be performed by an authorized maintenance engineer service representa-

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tive. Except for the lighting device accessory, there are no 2.11.3 Replacing the Lamp Module of the Cold user-serviceable parts among the main system components. Light Source If the system needs maintenance or repair, please call our technical support hotline. Users in the US can call 1-800-­ 876-1310, which is available 24/7. Users in Europe can call Warning: The lights can become very hot when being +41.21.821.2030. used, even if it is for only a short time. After turning off the light, the lamp should be cooled with the internal fan for at least 5 min before turning off the cold light 2.11.2 Robot System Cleaning source. Warning: Only approved lamp modules should be Wet a soft and lint-free cloth with a mild solution of antibacused. The use of unapproved lamps may result in early terial soap and wipe the outer surfaces of system components failure or serious damage. and cables such as the surgeon consoles, patient carts, image Precautions: The lamp module for the lighting device carts, and system cables, as required. Ensure all parts are dry should be replaced once every 1000 h. before use. Please contact Intuitive Surgical’s technical ­support department if fluids (including body fluids) enter the system. CermaxVQ xenon lamp modules can generally work for more than 1000 h. However, it should be replaced once every 1000 h to avoid light output reduction or lamp failure during Precautions: The equipment in the image cart, the surgery. The lamp modules should be replaced in case of the patient cart, and the surgeon console should not come following circumstances: in contact with any liquid. Care should be taken to avoid liquid contact with any electronic equipment of system components. Note: Special care should be taken to avoid liquid contact with the camera and the camera cable. Do not immerse them in any liquid as it may lead to damage. Note: Special attention should be paid to areas where the surgeon console operator is in contact with the system (such as master clamps, 3D viewers, and handrails). Note: The system cables and their sockets contain optical fibers. Only when required by /NTT^/VeSu/^ra/ personnel should the cables and sockets be cleaned by blowing the cable ends with an ordinary dry oil-free canned air cleaner.

Please follow the hospital’s procedures for blood and body fluids. Clean the display with a diluted mixture of mild detergent and water. Use a soft towel or cotton swab. Some detergents may degrade product labels and plastics. Consult your detergent manufacturer to find out if the detergent can be used for labels and plastics. Do not allow the liquid to enter the display.

• Try to turn the light on repeatedly, but it does not work. • There is significantly low light output at the maximum light level setting. When it is necessary to replace the lamp, the whole lamp module must be replaced (Fig. 2.176). 1. Remove Old Lamp Module (1) Press the lamp On (Off) button to turn off the lighting device (Fig. 2.177).

Precautions: Heating parts. Please wait for 10 min to allow the lamp to cool with the internal fan system.

(2) Push inward to open the entrance drawer to the left (front) of the lighting unit (Fig. 2.178). (3) As shown in the figure, grab the handle and pull out the whole lamp module (Fig. 2.179).

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Fig. 2.178  Push inward to open the drawer that stores the lamp module Fig. 2.176  Lamp Module

Fig. 2.179  Pull out the lamp module

876-1310, which is available 24/7. Users in Europe can call +41.21.821.2030 (Fig. 2.180).

2.11.4 Replacing the CCU Fuse

Fig. 2.177  Turn off the lamp module using the on/off button

2. Steps to Insert New Lamp Modules (1) Adjust the orientation of the new lamp module, ensuring the lamp window faces the front of the lighting device while the user holds its bottom. (2) Carefully align the side of the module with the lamp holder slot. Push the module to the bottom until you hear a click, to ensure proper connection. (3) Close the drawer so that it fits perfectly. If you require assistance to replace the lamps, please call our technical support hotline. Users in the US can call 1-800-­

This section contains instructions on replacing the fuse of the camera control unit (CCU).

Note: Under normal usage, the CCU fuse designed by Intuitive will not burn out during the system’s life. In case of CCU fuse blowout, it indicates that there might be a technical fault, which must be rectified by Intuitive staff. Therefore, you cannot start the CCU on your own, and it is not recommended that you replace the fuse by yourself the first time this problem occurs. Please call Intuitive technical support hotline for help. The following instructions are for reference only.

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Fig. 2.180  Carefully align the side of the module with the slot. Push in the module until you hear a click sound indicating the module is properly reinstalled

3. Discovery and Troubleshooting of CCU Power Problems—If all system components except CCU can be started normally, please first check whether the power switches near the power line inlet and on the back of the CCU have been turned on. Then, check whether the main circuit breaker of the image cart is in the open position (marked by an “I” near the switch). Finally, check the image cart to ensure it is connected to a dedicated AC outlet and the system is in startup mode. The fuse cannot be replaced unless the other system components except CCU and the image cart assembly can be turned on normally. If the problem reoccurs, please contact the technical support department of Intuitive Surgical as soon as possible. The following instructions are for reference only. 4. Instructions for CCU Fuse Replacement—Follow these steps to replace the fuse in the camera control unit: (1) For safety reasons, please adhere to the following steps to disconnect the power of the added Wnc/5/ surgical system: 1) When the system is in standby (sleep) mode, turn off the main circuit breaker switch on the image cart. 2) Unplug the power cord of the image cart and other major system components from the wall AC outlet. 3) Turn off the CCU power switch near the power line inlet. (2) Unplug the CCU power cord from the power switch and the power cord inlet near the fuse housing. The correct position of the fuse housing is on the power cord. You cannot remove the fuse housing directly without first unplugging the power cord.

(3) The fuse housing is located on the back of the CCU, between the power line inlet and the CCU power switch. Use one or two extremely small flat-blade screwdrivers to remove any fuse housing containing the fuse. If a screwdriver is used, the thin spring bolts at the top and bottom of the fuse housing must be continuously pried inward. If two screwdrivers are used, each of them should be held with a hand to pry the spring bolts on both sides inward. (4) After unlocking the top and bottom latches, loosen the fuse housing so that you can remove it carefully by hand. Both fuses are in the fuse housing when unloaded. (5) Check both fuses and replace the blown ones, if any. Disconnect the blown fuse. To prevent fire, please use the same type of CCU fuse as follows: • Manufacturer: Schurater AG • Fuse Type: FST, Time Lag (lowly melting type) • Rating: 2A, 250 V (6) Replace the fuse in the fuse housing and reinstall a new fuse along the original direction. The fuse ­housing has a key-type design and hence the fuse cannot be fitted in the wrong direction. Push the fuse in until you hear a click and the fuse is flush with the surrounding surface. (7) Turn on the power switch on the back of the CCU, turn on the main circuit breaker switch on the image cart, and insert the plugs of the image cart and all other system components into a dedicated AC power outlet. 5. About Technical Support—If the system needs maintenance or repair, please call our technical support hotline. Users in the US can call 1-800-876-1310, which is available 24/7. Users in Europe can call +41.21.821.2030.

3

Cleaning, Disinfection, and Sterilization of Reusable Instruments, Accessories, and Endoscopes in Robotic System Gongxian Wang, Yu Zeng, and Xia Sheng

3.1

Overview

3.1.1 Symbols and Definitions Accessory: Components used in conjunction with EndoWrist. Auto Clean: The automatic washer-disinfector is used when cleaning. Endoscope: An automatic camera system specially designed for the Da Vinci Surgical System to observe the patient in vivo. EndoWrist: Automatic surgical instruments used in conjunction with the Da Vinci Surgical System. Manual Clean: The automatic washer-disinfector is not used when cleaning. Built-in Flush Hose: A long plastic hose connected to the main flushing port that carries liquid to the end of the instrument shaft during flushing. Washer-Disinfector (W/D): An auto cleaning device that can handle multiple steps of the cleaning procedure. These steps may include soaking, rinsing, cleaning, heat-based disinfection, and drying.

3.1.2 O  verview of the Three Cleaning Procedures The three cleaning procedures are shown in the flowchart below (Fig. 3.1).

G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China

3.1.3 Notes The following instructions apply to all 8 and 5 mm reusable instruments, accessories, and endoscopes (including fluorescent endoscopes) manufactured and/or marketed by Intuitive Surgical and used in conjunction with Da Vinci, Da Vinci S, and Da Vinci Systems except for Single-Site™ instruments.

Warning: Read all the instructions carefully. Failure to follow instructions properly may result in abnormal product function. Warning: EndoWrist instruments, accessories, and endoscopes can only be handled and operated by trained and qualified personnel. Warning: Please handle with care to avoid mechanical shock or stress that may damage the products.

The cleaning, disinfection, and sterilization of reusable devices is the responsibility of the operator or institution performing the procedure. It is recommended that the instruments, accessories, and endoscopes be cleaned, disinfected, and sterilized as per the listed procedures and parameters. To order a free cleaning and disinfection kit, please contact your clinical sales representative or the customer service department of Intuitive Surgical. This kit includes: One reprocessing instruction, one manual reprocessing wall chart (according to the requirements of each region), three compatibility matrices, one flush port adapter (PN 371470), one faucet connection adapter (PN 920232), and one nylon brush (PN 920233). For further information on cleaning, disinfection, and sterilization of EndoWrist instruments, accessories, and endoscopes, please contact the customer service department of Intuitive Surgical.

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 G. Wang et al. (eds.), Robotic Surgery and Nursing, https://doi.org/10.1007/978-981-16-0510-9_3

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Manual cleaning procedure

Preparation in the operation room

Preparation in the operation room

Transport to disinfection room

Transport to disinfection room

Preparation Soak and Irrigation Wash Spray cleaning Brush Rinse

Ultrasonic cleaning preparation Soak and Irrigate Wash, Brush, Spray cleaning

Scope cleaning procedure

Transport to disinfection room

Scope cleaning Check Scrub Soak Scrub Wash and Dry

Ultralsonic clean: Irrigation and sonication

Use cleaner sterilizer to clean and heat automatically

After ultrasound clean Wash, Brush, Rinse, Disinfect and dry

Chemical disinfection Chemical disinfection Rinse Dry

Inspection, Maintenance, Testing

Inspection, Maintenance, Testing

Inspection, Maintenance, Testing

Packing

Packing

Packing

Sterilization

Sterilization

Sterilization

Storage

Storage

Storage

Fig. 3.1  Cleaning procedures

3.1.4 Preventive and Protective Measures Hospital personnel who come into contact with contaminated or potentially contaminated medical instruments or accessories should follow approved preventive measures. Care must be exercised when handling instruments with sharp protrusions or sharp edges. Appropriate protective equipment should be worn when handling contaminated or potentially contaminated materi-

als, instruments, or accessories. These include surgical clothing, masks, goggles or face masks, gloves, and shoe covers.

3.1.5 Preparing the Detergent Intuitive Surgical recommends the use of neutral to weakly alkaline (pH ≤ 11) and low-foam (for automatic procedures) enzyme-based detergents and automatic washer-disinfector

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detergents. All detergents should be prepared at the required dilution and at the temperature recommended by the manufacturer. Precautions: The concentration of weakly alkaline detergent should not exceed 1%. Warning: Excessive foam due to the mixing of multiple detergents and disinfectants in the automatic washer-disinfector can lead to technical failures during the autocleaning cycle.

3.1.6 General Information and Tips Please note that successful reprocessing of these medical products can only be ensured if the hospital’s reprocessing procedures are validated in advance. The authorized operator or handler is responsible for performing the above validation.

Warning: Take note of the reprocessing restrictions listed in the product specifications for different instruments. Precautions: To avoid the drying of blood or residual tissue, the EndoWrist end must be soaked in cold water or sprayed with neutral enzyme detergent, and the main flushing port must be filled with cold water or neutral enzyme determent after surgery. Please follow the manufacturer’s instructions when preparing and using these solutions.

Auto cleaning is usually superior to manual cleaning; however, please note that Intuitive Surgical has not demonstrated the efficacy of auto cleaning of endoscopes; hence, auto cleaning of endoscopes is not recommended. Dried blood or residual tissue may increase the difficulty of cleaning. The pre-cleaning temperature should not be higher than 55 °C. Disinfectants containing acid, acetaldehyde, or alcohol (alcohol may be used to remove Electro Lube from the instrument ends) should not be used. Disinfectants containing mercury, active chlorine, chlorides, bromine, bromides, iodine, or iodides should not be used. Warning: The use of chemical methods to disinfect EndoWrist is not permitted. Only thermal disinfection is permitted.

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Highly acidic neutralizers or strong alkaline detergents (pH > 11) may cause the laser marking to fade or become unreadable directly or by devices. Residues containing chlorine or chloride may be found in the remnants of surgical procedures, drugs, and saline solutions. These residues may dissolve into the water used for cleaning, disinfection, and sterilization and cause corrosive damage to the products (rust spots, stress corrosion cracking) and subsequent damage. Only processing chemicals that comply with REACH (EC Specifications 1907/2006) should be used. In addition, reprocessing chemicals must be developed, tested, and manufactured in accordance with the 93/42/EEC Medical Product Directives, and should be labeled with the European CE labels. All instructions on temperature, concentration, and exposure time provided by the chemical manufacturer must be strictly followed (please refer to the labels and technical data sheets). Otherwise, the following problems may occur—material appearance changes, such as fading or discoloration of titanium or aluminum, and material damage such as corrosion, cracking, fracture, premature aging, or expansion. • Do not use metal brushes or abrasive materials for cleaning. This may damage the surface or coating. Nylon brushes are recommended. Do not use brushes, pipe cleaners, or any other unauthorized items in the flushing port. This may result in damage or loss of the built-in flush hose. The built-in flush hose is a long plastic hose connected to the main flushing port that carries liquid to the end of the instrument shaft during flushing. If the hose is damaged or falls off, the inner side of the shaft will not be adequately cleaned. • Ultrasonic cleaning equipment with a frequency ≥38 kHz or power density of at least 13W/L are recommended.

Note: The device should be thoroughly inspected before and after each use. Do not use the device if any issue is found during the inspection. Please contact the Customer Service Department of Intuitive Surgical.

When sterilizing EndoWrist instruments and accessories that need to be sterilized and reusable: All instruments should be cleaned and sterilized before first use and after each use. Only neutral to weakly alkaline (pH ≤ 11) enzyme detergents should be used. Do not let blood or residual tissue to dry on any instrument after it is used during surgery or during transportation to the cleaning department. Rinse and soak the instruments in sterile deionized water as required.

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Note: Cleaning the Electro Lube decarbonization solution from any electrocauterization instrument may require additional scrubbing or the use of high-­pressure water spray. Rinsing in an ultrasonic bath or 70% isopropanol may enable the Electro Lube residue to fall off. Proper maintenance and operation are the keys to making surgical devices perform satisfactorily.

3.1.7 F  lush System for EndoWrist Instruments Note: For some instruments, special cleaning instructions may need to be followed. Please refer to the “Supplementary Cleaning Instructions.”

3.2

 utomatic Cleaning of Instruments A (Use of Automatic Washer-Disinfector)

3.2.1 Detergent Warning: The use of chemical methods to disinfect EndoWrist is not permitted. Only thermal disinfection is permitted. Warning: During the cleaning process, only neutral to weakly alkaline (pH ≤ 11) enzyme detergents should be used, except in the operating room. Warning: Only neutral enzyme detergents should be used in the operating room. Note: To avoid excessive foam that may cause technical failure of the automatic washer-disinfector, it is recommended to use the same detergent in both the pre-cleaning and auto cleaning processes.

The location of the flushing port is shown in Fig. 3.2.

3.2.2 Preparation in the Operating Room Note: A flushing port is provided near the end of the monopole surgical bending shears. Water flowing into the main flushing port flows out of the opening; however, some water may flow back into the housing (Fig. 3.3).

Fig. 3.2  Location of the flushing ports

Note: Do not let blood or residual tissue to dry on the instruments. Rinse or soak the instruments with sterile deionized water as required.

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Fig. 3.3  A flushing outlet near jaws of monopolar scissors

All disposable accessories, such as removable ends or end covers should be removed carefully before cleaning, disinfecting, and sterilizing. The instruments should be soaked in cold water or sprayed with neutral enzyme detergents. In addition, a syringe with a Luer connector should be used to inject 15 mL cold water or the same detergent into the main flushing port. Follow the instructions provided by the chemical manufacturer.

Warning: Begin cleaning preparation within 60  min after surgery. It is recommended to begin cleaning preparations immediately after surgery to prevent blood or residual tissue from drying up on any instrument.

3.2.3 Transportation for Disinfection Follow internal hygiene practices and transport the instruments to the Central Sterile Supply Department (CSSD) using appropriate containers.

3.2.4 Auto Cleaning Preparation Note: Please refer to the instructions for any specific preparation required to use a specific detergent (disinfector) in an automated program.

1. Immersion and Infusion—The instruments are com pletely immersed in a neutral to weakly alkaline (pH ≤ 11) enzyme detergent. To infuse the instruments, use a syringe with a Luer connector to inject 15 mL of the same detergent into the main flushing port. Follow the instructions provided by the chemical manufacturer. The concentration of weakly alkaline detergent should not exceed 1%, and the instruments should be soaked for 30 min (Fig. 3.4). 2. Flushing—First, flush the main flushing port at a minimum water pressure of 200 kPa (29 psi) for at least 20 s. Hold the instrument end downward during rinsing; the Endowrist needs to be moved several times during the process. Rinse continuously until all water from the instrument is clear. Repeat this process for the remaining flushing ports, as described above (Fig. 3.5). Flush all ports using Intuitive-supplied Luer connectors connected to desalinated water lines. Rinse each port for at least 20 s.

Warning: The main flushing port is connected to the plastic hose inside the instrument that carries the liquid down the shaft. Make sure that the built-in hose does not fall from the instrument. If the hose falls off the instrument, the instrument should not be used. Warning: Do not use the instrument if water does not flow through all flushing ports. Please contact the Customer Service Department of Intuitive Surgical.

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Fig. 3.4  Soaking and Irrigation:Soak for 30 min

Fig. 3.5 Wash

3.8). Move the EndoWrist several times to complete the full stroke, while ensuring that all surfaces of the instrument end are sprayed. Visually check the instrument end to make sure all residual blood is cleaned away. To avoid liquid spillage, it may be necessary to gently hold the end under water. 4. Brushing—Thoroughly clean the entire exterior of the instrument with running water and a clean nylon brush. Move the EndoWrist intermittently to complete the full stroke during rinsing. Inspect the instruments including the EndoWrist, instrument ends, and all surfaces with holes, for visible dirt. Pay special attention to instrument ends, cables, and pulleys. It is necessary to scrub repeatedly until there is no visible residual dirt on the instrument ends.

Fig. 3.6  Spray cleaning the jaws

3. Spraying the Ends—Spray the instrument end for at least 30 s at the same water pressure to remove any blood or dirt remaining at the instrument end (Figs. 3.6, 3.7, and

Warning: Do not use metal brushes or abrasive materials for cleaning. This may damage the surface or coating. A nylon brush is recommended. Do not use brushes, pipe cleaners, or any other unauthorized items in the flushing port. This may result in damage to or loss of the built-in flush hose, resulting in inadequate internal cleaning.

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Fig. 3.7  Use a magnifying glass to confirm an adequate cleaning

Fig. 3.9  Do not remove the hose

Fig. 3.8 Rinse

Use a magnifier with a magnification of 4 or above to confirm the effect (Fig. 3.9).

5. Rinsing—Rinse the outside of the instrument thoroughly to remove any remaining dirt or detergent. Perform special rinsing on the area where the instrument shaft is connected to the housing (Fig.  3.10). Inspect the external surface of the instrument and pay special attention to the instrument end. The scrubbing step must be repeated in case of any residual dirt.

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Fig. 3.10  Lubricate the Jaws and Wrist

3.2.5 A  uto Cleaning and Thermal Sterilization with the Washer-Disinfector The washer-disinfectors (W/D) must be certified to meet the requirements of Part 1 and 2, EN ISO 15883. A Product Specifications list containing the washer-disinfectors and related procedure parameters that are compatible with the cleaning, disinfection, and drying of the EndoWrist instruments should be prepared. Follow the reprocessing instructions provided by the washer-disinfector manufacturer. Thermal sterilization should comply with the parameters listed in the EN ISO 15883-1 standard to meet the requirements for the A value >600 specified in 4.3.1 of EN ISO 15883-2. Higher values (e.g., A > 3000 in Germany) may be required in case of some regional regulations, which must be followed.

3.2.6 Inspection, Maintenance, and Testing 1. Checking for Dirt—Inspect and view the instrument carefully. Repeat the cleaning procedure in case of any residual dirt. 2. Checking for Damage—Check for visible damage and normal range of movement. Do not use damaged instruments as their functioning may be affected. Please contact the Customer Service Department of Intuitive Surgical. Check long and narrow instruments for bent parts, especially rotating instruments. 3. Checking the Flushing Port Hose—Make sure the built-in flushing hose is not loose. Do not use the instrument if its flushing hose is removed or loosened. The hose is a permanent component of the instrument and should not be removed.

4. Lubricating Ends and EndoWrist—Lubricate the hinged parts of the EndoWrist and instrument ends by using a steam-permeable neutral product (e.g., instrument ­maintenance oil or equivalent lubricant for sterilized surgical instruments) that does not contain silica gel. The expiry date and the dilution concentration specified by the lubricant manufacturer should be followed to guarantee efficacy.

3.2.7 Packaging Packaging materials conforming to the requirements of EN ISO 11607-1 should be used.

3.2.8 Sterilization

Note: Only steam sterilization procedures (fractionation vacuum procedures, steam sterilization, and vacuum drying) are permitted for EndoWrist instruments of Intuitive Surgical. The CSR package should have undergone 3 min sterilization verification and 20 min drying verification at 134–137 °C.

Please follow EN 17665-1 and the instrument manufacturer’s instructions. Also, some regional regulations may require longer sterilization time (e.g., 5  min in Germany and 4  min in countries that follow US regulations), which must be followed. The maximum time for temperature verification is 18 min.

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3.2.9 Storage

3.3.4 Ultrasonic Cleaning Preparation

There are no special requirements. The instruments should be stored in a clean, dry, and dark environment.

1. Immersion and Infusion—The instruments are com pletely immersed in a neutral to weakly alkaline (pH ≤ 11) enzyme detergent. To infuse the instruments, use a syringe with a Luer connector to inject 15 mL of the same detergent into the main flushing port. Follow the instructions provided by the chemical manufacturer. The c­ oncentration of weakly alkaline detergent should not exceed 1%, and the instruments should be soaked for 30 min (Fig. 3.11). 2. Brushing—Thoroughly clean the entire exterior of the instrument with running water and a clean nylon brush. Move the EndoWrist intermittently to complete the full stroke during rinsing. Inspect the instruments including the EndoWrist, instrument ends, and all surfaces with holes, for visible dirt. Pay special attention to instrument ends, cables, and pulleys. It is necessary to scrub repeatedly until there is no visible residual dirt on the instrument ends. Use a magnifier with a magnification of 4 or above to confirm the effect (Fig. 3.12).

3.3

 anual Cleaning of Equipment (Use M of Ultrasonic Pool)

3.3.1 Detergent Warning: During the cleaning process, only neutral to weakly alkaline (pH ≤ 11) enzyme detergents should be used, except in the operating room. Warning: Only neutral enzyme detergents should be used in the operating room. Warning: The use of chemical methods to disinfect EndoWrist is not permitted. Only thermal disinfection is permitted.

3.3.2 Preparation in the Operating Room All disposable accessories, such as removable ends or end covers, should be removed carefully before cleaning, disinfecting, and sterilizing. Note: Do not let blood or residual tissue to dry on the instruments. If necessary, rinse the instruments with sterile deionized water. Warning: You must start the manual cleaning procedure within 60 min after surgery. We recommend that cleaning preparations begin immediately after surgery to prevent blood or residual tissue from drying up on any instrument.

Soak the instruments in cold water or spray with neutral enzyme detergents. To infuse the instruments, a syringe with a Luer connector (please refer to the photo) should be used to inject 15  mL of cold water or the same detergent into the main flushing port. Follow the instructions provided by the chemical manufacturer. The concentration of weakly alkaline detergent should not exceed 1%.

3.3.3 Transporting for Disinfection Follow internal hygiene practices and transport the instruments to the Central Sterile Supply Department (CSSD) using appropriate containers.

Warning: Do not use metal brushes or abrasive materials for cleaning. This may damage the surface or coating. A nylon brush is recommended. Do not use brushes, pipe cleaners, or any other unauthorized items in the flushing port. This may result in damage or loss of the built-in flush hose, resulting in inadequate internal cleaning.

3. Flushing—First, flush the main flushing port at a minimum water pressure of 200 kPa (29 psi) for at least 20 s. Hold the instrument end downward during rinsing; the Endowrist needs to be moved several times during the process. Rinse continuously until all water from the instrument is clear. Repeat this process for the remaining flushing ports, as described above (Fig. 3.13).

Warning: The main flushing port is connected to the plastic hose inside the instrument that carries the liquid down the shaft. Make sure that the built-in hose does not fall from the instrument. If the hose falls off the instrument, the instrument should not be used. Warning: Do not use the instrument if water does not flow through all flushing ports. Please contact the Customer Service Department of Intuitive Surgical.

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Fig. 3.11  Soaking and Irrigation:Soak for 30 min

Fig. 3.12  Use a magnifying glass to confirm an adequate cleaning

Fig. 3.13  Repeat the washing process

4. Spraying the Ends—Spray the instrument end for at least 30 s at the same water pressure to remove any blood or dirt remaining at the instrument end. Move the EndoWrist several times to complete the full stroke, while ensuring that all surfaces of the instrument end are sprayed.

Visually check the instrument end to make sure all residual blood is cleaned away. To avoid liquid spillage, it may be necessary to gently hold the end under water (Fig. 3.14).

3  Cleaning, Disinfection, and Sterilization of Reusable Instruments, Accessories, and Endoscopes in Robotic System

Fig. 3.14 Spray cleaning the Jaws: hold on the Jaws to avoid spilllage

3.3.5 Ultrasonic Cleaning 1. Infusion and Ultrasound—Completely immerse the ultrasonic pool in a neutral to weakly alkaline (pH  ≤  11) enzyme detergent. Then, while the instrument ends are immersed in the ultrasonic tray, use a syringe with a Luer connector to inject at least 15 mL of the isoenzyme detergent into the main flushing port. Immerse the rest of the instrument immediately. Ultrasonic Pool Time: 15  min (Fig. 3.15). • Recommended parameters for ultrasonic pool: • Ultrasonic Performance: 13W/L • Ultrasonic Frequency: 38 kHz or above Note: The temperature of the enzyme bath should not exceed the temperature recommended by the enzyme detergent manufacturer. Precautions: Do not expose the instrument to hydrogen peroxide (H2O2), strong base (pH > 11), or bleach-­ based detergents, otherwise the instrument may be damaged. Precautions: Prolonged ultrasonic cleaning or exposure to detergents may lead to instrument damage.

3.3.6 After Ultrasonic Cleaning 1. Flushing—First, flush the main flushing port at a minimum water pressure of 200 kPa (29 psi) for at least 20 s. Hold the instrument end downward during rinsing; the Endowrist needs to be moved several times during the

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Fig. 3.15  Irrigation and sonication: sonication cleaning for 15 min

process. Rinse continuously until all water from the instrument is clear. Repeat this process for the remaining flushing ports, as described above (Fig. 3.16). Warning: The main flushing port is connected to the plastic hose inside the instrument that carries the liquid down the shaft. Make sure that the built-in hose does not fall from the instrument. If the hose falls off the instrument, the instrument should not be used. Note: Flushing, perfusion, and ultrasonic pool cleaning should be repeated as required until the water is clear. Precautions: Do not use the instrument if water does not flow through all flushing ports, even when the flushing, perfusion, and ultrasonic pool steps are repeated. Please contact the Customer Service Department of Intuitive Surgical.

2. Brushing—Thoroughly clean the entire exterior of the instrument with running water and a clean nylon brush. Move the EndoWrist intermittently to complete the full stroke during rinsing. Inspect the instruments including the EndoWrist, instrument ends, and all surfaces with holes, for visible dirt. Pay special attention to instrument ends, cables, and pulleys. It is necessary to scrub repeatedly until there is no visible residual dirt on the instrument ends. Use a magnifier with a magnification of 4 or above to confirm the effect (Fig. 3.17). 3. Rinsing—Rinse the outside of the instrument thoroughly to remove any remaining dirt or detergent. Perform spe-

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Fig. 3.16 Washing

Fig. 3.17  Use a magnifying glass to confirm an adequate cleaning

cial rinsing on the area where the instrument shaft is connected to the housing. Inspect the external surface of the instrument and pay special attention to the instrument end. The scrubbing step must be repeated in case of any residual dirt (Fig. 3.18).

4. Disinfection—Disinfection shall be performed in accordance with hospital policy and local guidelines. Intuitive Surgical has validated that EndoWrist instruments can be disinfected using thermal sterilization cycles in the washer (sterilizer) system.

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Thermal sterilization should comply with the parameters listed in the EN ISO 15883-1 standard to meet the requirements for the A value >600 specified in 4.3.1 of EN ISO 15883-2. The circulating temperature of thermal sterilization shall not exceed 140 °C. Higher values (e.g., A  >  3000  in Germany) may be required by some regional regulations, which shall be followed. 5. Drying—Dry the instrument thoroughly. Set the instrument up so that its end is facing up to ensure that residual water is drained from the instrument shaft and main flushing port. Blow-dry the flushing port with compressed air. Wipe the surface of the instrument with a microfiber cloth (Fig. 3.19). Accessories: Microfiber cloth or lint-free cloth, compressed air gun

Technologies adopted: Compressed air gun with medical compressed air (Luer adapter); recommended parameter: at a limit 67 ppm V/V for water; oil free (as recommended); oil limit of 0.1 mg/m3.

3.3.7 Inspection, Maintenance, and Testing 1. Checking for Dirt—Inspect and view the instrument carefully. Repeat the cleaning procedure in case of any residual dirt. 2. Checking for Damage—Check for visible damage and normal range of movement. Do not use damaged instruments as their functioning may be affected. Please contact the Customer Service Department of Intuitive Surgical. Check for long and narrow instruments for bent parts (especially rotating instruments). 3. Checking the Flushing Port Hose—Make sure the built-in flushing hose is not loose. Do not use the instrument if its flushing hose is removed or loosened. The hose is a permanent component of the instrument and should not be removed (Fig. 3.20). 4. Lubricating Ends and EndoWrist—Lubricate the hinged parts of the EndoWrist and instrument ends by using a steam-permeable neutral product (e.g., instrument maintenance oil or equivalent lubricant for sterilized surgical instruments) that does not contain silica gel. The expiry date and the dilution concentration specified by the lubricant manufacturer should be followed to guarantee efficacy (Fig. 3.21).

Warning: Lubricate the EndoWrist and ends only.

Fig. 3.18 Rinse Fig. 3.19  Dry: wipe the EndoWrist with a microfiber cloth

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Do not inject oil into the flushing ports.

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3.3.8 Packaging Packaging materials conforming to the requirements of EN ISO 11607-1 should be used.

3.3.9 Sterilization Please follow EN 17665-1 and the instrument manufacturer’s instructions. Some regional regulations may require longer sterilization time (e.g., 5 min in Germany and 4 min in countries following US regulations), which shall be followed. The maximum time for temperature verification is 18 min.

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Note: Only steam sterilization procedures (fractionation vacuum procedures, steam sterilization, and vacuum drying) are permitted for EndoWrist instruments of Intuitive Surgical. The CSR package should have undergone 3 min sterilization verification and 20 min drying verification at 134–137 °C.

3.3.10 Storage There are no special requirements. The instruments should be stored in a clean, dry, and dark environment.

3.4

Endoscope Cleaning Instructions

3.4.1 Detergent Warning: Only neutral enzyme detergents should be used in the cleaning process.

3.4.2 Transportation for Disinfection Follow internal hygiene practices and transport the instruments to the Central Sterile Supply Department (CSSD) using appropriate containers.

Fig. 3.20  Do not remove the hose

Fig. 3.21  Lubricate the Jaws and Wrist

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Rotate the black ring nut to clean the area in between

Precautions: Containers used for transport and storage must be properly secured to protect the endoscope from vibration and sliding. There must be no loose objects in the container. Intuitive Surgical endoscopes should be cleaned and sterilized before each use. Please read the following important information before cleaning products. • The endoscope is not sterilized at the time of shipment. It must be cleaned and sterilized before the first use. • Care should be taken when cleaning and handling the far end of the endoscope. Do not apply excessive force to the far end window and do not use sharp objects or instruments for cleaning.

Precautions: Ultrasonic cleaning is not permitted for Intuitive Surgical endoscopes. Ultrasonic cleaning may damage the endoscope. Precautions: Do not use an autoclave to sterilize 8.5 and 12  mm Intuitive Surgical endoscopes. The autoclave cycle produces high temperatures and sudden temperature changes that can damage the endoscope. Note: The auto cleaning and washing system are not compatible with Intuitive Surgical endoscopes. Note: The temperature should not exceed 70  °C for reprocessing of 8.5 and 12  mm Intuitive Surgical endoscopes. Note: Remove all adapter and light guide cables from the endoscope.

Fig. 3.22 Scrub

3.4.3 Endoscope Cleaning 1. Checking—Check and confirm that the endoscope is not damaged and that all lenses are intact and firmly in place. 2. Scrubbing—The entire exterior of the endoscopes should be thoroughly cleaned with running water and a clean nylon brush. Special attention should be paid to the black ring nuts at the endoscope ends and the back. While scrubbing, rotate the black ring nut to its full stroke to clean the area between the groove and the ring nut (Fig. 3.22). 3. Soaking—Soak the endoscope in a neutral enzyme detergent recommended by the manufacturer. Make sure all parts are completely immersed in the solution. While soaking the endoscope in the enzyme detergent, scrub the entire outside of the endoscope with a nylon brush. Pay

Fig. 3.23 Soak

special attention to the black ring nuts at the endoscope ends and the back. While scrubbing, the black ring nut shall be rotated during its full stroke to clean the area between the groove and the ring nut (Fig. 3.23). 4. Scrub—The entire exterior of the endoscopes shall be thoroughly cleaned with running water and a clean nylon brush. Special attention shall be paid to the black ring nuts at the endoscope ends and the back. While scrubbing, rotate the black ring nut to its full stroke to clean the area between the groove and the ring nut (Fig. 3.24).

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• Check for visible damage (e.g., cover glass missing, bending, and scoring). Do not use a damaged endoscope as its functions or usability may be affected. Please contact the Customer Service Department of Intuitive Surgical.

3.4.6 Packaging Endoscopes must be stored in sterilized containers with appropriate fixtures to protect the endoscopes from vibration and sliding. Packaging must be approved and meet the requirements of EN ISO 11607-1.

3.4.7 Sterilization

Fig. 3.24 Scrub

3.4.4 Chemical Disinfection 1. Chemical Disinfection—After cleaning, hospital personnel needs to disinfect the endoscope to ensure proper infection control and management. Only neutral disinfectants should be used for disinfection. Please follow the manufacturer’s instructions. 2. Rinsing—Rinse the endoscope thoroughly to remove any tissue stains or detergent. Special attention should be paid to the black ring nut area at the rear. It is recommended to rinse with desalinated water. Check the outside of the endoscope. The cleaning procedure should be repeated in case of any residual dirt. 3. Drying Accessories: Microfiber cloth or lint-free cloth, compressed air gun Technologies adopted: Medical compressed air gun with medical compressed air (recommended parameters: water limit of 67 ppm V/V; oil limit of 0.1 mg/m3). Carefully dry the endoscope with a microfiber cloth. Inaccessible sites can be dried with a compressed air gun (Fig. 3.25).

3.4.5 Inspection, Maintenance, and Testing • Inspect and view the endoscope carefully. The cleaning and disinfection procedure should be repeated in case of any residual dirt.

Precautions: After sterilization, the hot endoscopes should not be immediately exposed to air or liquid for cooling. Sudden changes in temperature may damage the endoscope. Precautions: Do not use autoclave sterilization for 8.5 or 12 mm Intuitive Surgical endoscopes. The autoclave cycle produces high temperatures and sudden temperature changes can damage the endoscopes. Note: Please follow the manufacturer’s advice on proper sterilization.

3.4.8 Storage There are no special storage requirements. The instruments should be stored in a clean, dry, and dark environment.

3.5

Supplementary Cleaning Instructions

3.5.1 D  a Vinci HARMONIC and Da Vinci HARMONIC ACE Curved 8 and 5 mm Instruments

Precautions: The Da Vinci HARMONIC curved blades (PN 400169) and the Da Vinci HARMONIC ACE curved blades (PN 400272) are disposable instruments, for disposable use only. These instruments do not require reprocessing.

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Fig. 3.25  Rinse and dry

Fig. 3.26  Clean the interior aspect of the housing using a soft nylon brush through the opening

1. Scrub the outside of the instrument housing with a soft nylon brush. Clean the housing interior via the opening with a soft nylon brush (Fig. 3.26). Rinse the inside of the instrument housing thoroughly with water. Hold the far end of the instrument downward and keep it away from you while rinsing. Rinse continuously until the water from the instrument housing is clear.

Precautions: Do not use the instrument if the water is not clear or does not flow from the housing. If this happens, please contact the Customer Service Department of Intuitive Surgical.

2. Immerse the instrument housing in an ultrasonic pool filled with a neutral to weakly alkaline (pH ≤ 11) enzyme detergent for 15 min. It is recommended to use an enzyme detergent specially prepared for cleaning medical instruments. Prepare the enzyme bath solution according to the chemical manufacturer’s instructions. 3. Scrub the outside of the instrument housing with a soft nylon brush. Clean the housing interior with a soft nylon brush (if 8 mm instrument is used, please clean the opening to which the 8  mm tube is connected, with a flat brush).

4. Rinse the inside of the instrument with water. Hold the far end of the instrument downward and keep it away from you while rinsing. Rinse it continuously until the water from the instrument is clear. 5. Rinse the outside of the instrument housing thoroughly to remove any remaining dirt or detergent. 6. Disinfection and drying: Please refer to the instructions for disinfection and drying. 7. Perform steam sterilization. Refer to “Sterilization.”

3.5.2 EndoPass Reprocessing All flushing ports must be rinsed with high-pressure water during the cleaning process. First, wash the instrument when the cylinder is connected, then take out the cylinder and rinse again. Clear water should be seen flowing from the instrument after rinsing. Do not use the instrument if the water is not clear or does not flow through all flushing ports. If this happens, please contact the Customer Service Department of Intuitive Surgical. 1. Scrub the outside of the instrument and the cylinder with a soft nylon brush. Slide the outer tube when scrubbing and ensure it makes the full motion stroke. 2. Rinse the inside of the instrument with high-pressure water through all flushing ports. Rinse the instrument

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when the cylinder is connected and slide the outer tube during the full motion stroke until the water flowing from the instrument becomes clear. Remove the cylinder and continue to rinse while sliding the outer tube during the full motion stroke, and make sure the water flowing from the instrument is clear. 3. Inject a neutral to weakly alkaline (pH  ≤  11) enzyme detergent into all flushing ports with a syringe to clean the instrument. Then immerse the separated instrument and cylinder in an ultrasonic pool filled with isoenzyme detergent for 15  min. It is recommended to use an enzyme detergent specially formulated for cleaning medical instruments. Prepare AN enzyme bath solution according to the manufacturer’s instructions. 4. Scrub the outside of the instrument and the cylinder with a soft nylon brush. Slide the outer tube when scrubbing and ensure it makes the full motion stroke. 5. Rinse the inside of the instrument with high-pressure water through all flushing ports. Move the outer tube during the full motion stroke and flush the connected and unconnected cylinder as described above. Rinse continuously until the water from the instrument is clear. The flushing ports on the instrument housing are marked with the following symbols: 6. Rinse the outside of the instrument and the cylinder thoroughly to remove any traces of blood, tissue, or detergent. 7. Perform disinfection and drying. 8. Perform steam sterilization. Refer to “Sterilization.”

3.5.3 S  upplementary Cleaning Instructions for 5 Fr.EndoWrist Luer Please follow all the cleaning instructions for EndoWrist instruments. The master Luer at the rear of the instrument replaces the main flushing port (Fig. 3.27).

3.5.4 EndoWrist Stabilizer Reprocessing Follow the below steps to ensure the EndoWrist stabilizer performs optimally: 1. Scrub the outside of the instrument with a soft nylon brush. Move the instrument connector until it completes the full stroke while scrubbing. Carefully scrub the underside of the stabilizer feet. 2. Rinse the inside of the instrument with high-pressure water through all flushing ports (A) and Luer connectors (B). Hold the instrument downward during rinsing and move the Endowrist to complete the stroke. Rinse continuously until the water from the instrument is clear (Fig. 3.28).

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Precautions: Be sure to keep the instrument end down and away from you during cleaning. All flushing ports must be rinsed with high-pressure water. Clear water should be seen flowing from the instrument after cleaning. Do not use the instrument if the water is not clear or does not flow through all flushing ports. If this happens, please contact the Customer Service Department of Intuitive Surgical.

Fig. 3.27  Replace the main flushing port with an “M” Luer at the back of EndoErist

3. Inject a neutral to weakly alkaline (pH  ≤  11) enzyme detergent into all flushing ports and Luer connectors with a syringe, to clean the instrument. Then, immerse the instrument in an ultrasonic pool filled with neutral enzyme detergent for 15 min. It is recommended to use an enzyme detergent specially prepared for cleaning medical instruments. Prepare the enzyme bath solution according to the manufacturer’s instructions. 4. Rinse the inside of the instrument with high-pressure water through all flushing ports and Luer connectors. Hold the instrument downward during rinsing and move the Endowrist to complete the stroke. Rinse continuously until the water from the instrument housing is clear. 5. Rinse the outside of the instrument thoroughly to remove any remaining dirt or detergent. 6. Dry the outside of the instrument with a lint-free cloth after cleaning. 7. Disinfection and drying: Please refer to the instructions for disinfection and drying. 8. Perform steam sterilization.

3  Cleaning, Disinfection, and Sterilization of Reusable Instruments, Accessories, and Endoscopes in Robotic System Fig. 3.28  Flush the interior aspect of instrument with high pressure water through all flushing outlets (A) and luer interfaces (B)

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B

B

3.5.5 Reprocessing of Accessories

Note: All disposable accessories, such as removable ends or end covers, should be removed carefully before cleaning, disinfecting, and sterilizing. Note: Please refer to the automatic cleaner (disinfector) procedures for reprocessing accessories.

1. Thoroughly scrub the outside of the instrument with running water and a soft clean nylon brush, especially all crevices and joints. Rotate the instrument in all directions while scrubbing. 2. Rinse the instrument thoroughly under running water to ensure that all residual stains are removed. If any instrument has a lumen, be sure to flush the lumen under running water. 3. Immerse the entire instrument in an ultrasonic pool filled with a neutral to weakly alkaline (pH ≤ 11) enzyme detergent and conduct ultrasonic vibration for 15 min. It is recommended to use an enzyme detergent specially formulated for cleaning medical instruments, in accordance with the manufacturer’s instructions. The enzyme bath temperature should be close to 45 °C (113 °F), but should not exceed the temperature recommended by the enzyme detergent manufacturer. Regular maintenance is required for proper operation of the ultrasonic equipment. Please refer to the manufacturer’s documents for information on specific ultrasonic cleaning equipment. It is recommended that the ultrasonic cleaning cycle operates at a minimum power density of 13W/L (ultrasonic power output/internal tank volume) and at a frequency of 38 kHz or higher. 4. Repeat Step 1: Scrub the outside of the instrument with running water and a soft clean nylon brush. Rotate and move the instrument in all directions while scrubbing.

5. Rinse the instrument thoroughly to remove any stains or detergent. Visually inspect the exterior of the instrument and pay special attention to cracks. There should be no visible contaminants (e.g., attached dirt) on the instrument. Repeat steps 1 through 5 in case of any visible contaminants on the instrument. 6. Perform disinfection and drying. 7. Dry the instrument completely using a lint-free cloth. If any instrument has a lumen, make sure all water is drained from the lumen. You can dry the instrument by blowing air. 8. Perform steam sterilization.

3.5.6 Reprocessing of PK Instrument Cables Note: The Da Vinci light guide cables usually do not need to be cleaned or sterilized as they are permanently connected to the camera and are protected from dirt during surgery via sterile draping. Precautions: Ultrasonic cleaning is not suitable for light guide cables as it may damage the cables.

1. Disconnect the cable from the generator and instrument. Check the cable for wear or degradation. Do not use cables if there are any signs of wear and tear. 2. Wipe the outer surface of the cable with a warm soap solution (enzyme, sterilization, decontamination) prepared according to the manufacturer’s instructions. 3. Gently remove dirt from the cable crevices with a small diameter round soft brush soaked in detergent. 4. Flush the outside of the cable with running water to remove detergent and other dirt. 5. Visually inspect the outside of the cable for dirt. In particular, thoroughly inspect the columns near the joints. 6. Repeat the above steps if necessary.

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7. Gently dry the cables. • Continue disinfection. Pre-vacuum steam sterilization—complete cycle: Disinfection at 134–137 °C for 5 min is required. • STERRAD 100S Sterilization System—Complete Cycle.

3.5.7 R  eprocessing of Da Vinci and Da Vinci S Light Guide Cables Clean: Immerse the cables into the detergent for cleaning. Do not use synthetic detergents or oil-based soaps as these chemicals may be absorbed into the guide and may leak out, causing tissue reaction. Remove visible stains with a soft nylon brush. Thoroughly rinse the guide with warm water. Finally, rinse it with desalinated water to avoid watermarks.

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1. Disinfection—Do not use sterilization solutions containing peracetic acid or sulfur compounds. Follow the instructions of the sterilization solution manufacturer regarding time recommendations. Do not immerse the guide for more than 10 min. 2. Sterilization—Sterilization of cables using pre-vacuum steam sterilization—complete cycle: at 134–137 °C for 5 min; follow these supplementary instructions: Loosely pack the light guide cables. The small bubbles in the silicone tube may be caused by the pressure difference during sterilization using the autoclave sterilizer. These bubbles will disappear over time without affecting the performance of the guide. If the cables are cooled too fast, the fiberglass may break. The cables should be cooled slowly. No other disinfection method should be used.

4

Personnel Management in the Robotic Surgery Room Gongxian Wang, Yu Zeng, and Xia Sheng

The Robotic Surgery System is a high-tech surgical equipment integrating several modern technologies including 3D imaging, information transmission, remote control, smart instruments, and bionic operation. It is a truly revolutionary surgical tool in the world of minimally invasive surgery. Since Da Vinci Surgical Robots have completely changed the traditional surgical method for surgeons, forming a new treatment method based on tacit teamwork and multidisciplinary integration, it is particularly important to strengthen the management of the surgical team. The surgical team needs to undergo strict training and assessment and should be able to effectively deal with and solve problems related to the robot equipment and consumables, as well as handle various emergencies during robotic surgery, so as to ensure the safety of surgical patients. Therefore, the quality and safety of robotic surgery are directly linked to robotic surgery personnel management.

4.1

 anagement System Related M to Robotic Surgery

4.1.1 M  anagement Methods for Surgical Robots The allocation and management of operating room personnel are designed to ensure appropriate personnel is available for robotic surgery. It aims to strengthen management to complete various tasks and ensure normal operation by medical care personnel in the operating room, so as to achieve the G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China

comprehensive objectives of the operating room. Therefore, reasonable allocation of operating room personnel and management strengthening can reduce human resources and improve operating room efficiency. Due to the high purchase price, maintenance cost, and consumables cost of surgical robots, medical institutions and operating technicians should meet higher requirements. In order to strengthen the management of surgical robots (Da Vinci System) and give full play to the benefits of high-­ tech equipment, medical institutions equipped with surgical robots should, in accordance with the relevant management rules of the National Health and Family Planning Commission (hereinafter referred to as the NHFPC), formulate hospital-­ level work plans and relevant management measures for surgical robots (Fig. 4.1). 1. Set up a leading management team for surgical robots (Da Vinci System) in the hospital, led by the hospital leader and consisting of the heads of relevant functional departments and academic leaders. 2. Set up a surgeon working team for surgical robots, with surgeons from various disciplines. 3. Set up a management team according to the disciplines, specialties, and management responsibilities to achieve classified management and strengthen coordination mechanisms. For example, professional teams can be set up in the urology surgery, general surgery, obstetrics and gynecology, cardiothoracic surgery, and anesthesiology departments (Fig. 4.2) led by the leaders of various disciplines. The director of the facility division should serve as the team leader for equipment maintenance and the management team, and the head nurse of the operating room should serve as the team leader of the operating room management team. It is beneficial to strengthen the coordination and management, to deal with and solve related conflicts and problems when any surgery is arranged and in case of an emergency during surgery.

X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 G. Wang et al. (eds.), Robotic Surgery and Nursing, https://doi.org/10.1007/978-981-16-0510-9_4

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Fig. 4.1  Managing protocols of surgical robots

4. The training and access to robotic surgery by surgeons should be regulated. 5. Rules for the use of surgical robots should be formulated. (1) A special person should be assigned by the operating room to be responsible for the daily maintenance, equipment safety, and surgical cooperation of the surgical robots (Da Vinci). At the same time, the corresponding care, maintenance, safety, operating procedures, records, and other rules and regulations should be formulated and strictly implemented. (2) Any instruments and consumables for the surgical robots should be kept in the operating room, and the corresponding systems for storage, delivery, use, and loss registration should be formulated and strictly implemented. (3) Robotic surgery for each department should be arranged by the operating room. All departments should submit the application form for robotic surgery to the operating room, and the operating room should arrange the robotic surgery according to relevant regulations.

(4) The operating room should prepare corresponding forms, establish and implement rules and regulations on special registration and statistics for robotic surgery, such as instrument loss, machine occupation time, etc., so as to improve the operation efficiency and benefit of surgical robots. These are conducive to strengthening the management of robotic surgery projects, improving efficiency, reducing loss, and ensuring quality. In order to strengthen technical management of cardiac surgery assisted by the robotic surgery system in China, standardize clinical diagnosis and treatment behavior and effectively guarantee medical quality and safety, the NHFPC has successively formulated and issued the Technical Specifications for Cardiac Surgery Assisted by Robotic Surgery System (2012 Edition) and the Technical Training and Management Specifications for Cardiac Surgery Assisted by Robotic Surgery System (2012 Edition), requiring relevant professional and technical personnel who intend to be engaged in cardiac surgery assisted by a robotic surgery system to receive systematic training. It has also proposed future-specific requirements for

4  Personnel Management in the Robotic Surgery Room Fig. 4.2  Establish an anesthesiology team designated for robotic surgery

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training at training bases for robot-assisted cardiac surgery. In 2015, under the leadership of the NHFPC leaders and the academician Sun Yinghao, the Guidelines for Robotic Surgery was compiled, which played an active role in standardizing robotic surgery and promoting healthy development of robotic surgery in China.

4.1.2 S  urgical Personnel Allocation and Access For each department performing robotic surgery, there must be at least one primary surgeon, two assistant doctors with experience in endoscopy or operating room nurses, who will form a robotic surgery team, which shall stay relatively the same during the first 20 operations with new members joining after undergoing comprehensive training. The primary surgeon should be an associate chief physician or a surgeon with higher qualifications. Generally, each operation requires at least three persons, including a primary surgeon, an assistant physician, and a scrub nurse. The primary surgeon must have more than 10  years of experience in open surgery or more than 5 years of experience in laparoscopic surgery and should have obtained a robot-assisted laparoscopic surgeon training certificate. Nurses who participate in robotic surgery should be selected accordingly and should have certain experience working in the operating room, be familiar with the various specialties in open surgery and laparoscopic surgery, and have participated in training related to robotic surgery.

4.2

Training in Robotic Surgery

Thousands of Da Vinci surgical robot systems have been installed across the world and have been used to successfully perform more than 600,000 operations. The types of surgery include urology surgery, obstetrics and gynecology, cardiac surgery, thoracic surgery, hepatobiliary surgery, gastrointestinal surgery, and pediatrics. In future, Da Vinci surgical robot will be applied to more specialties. However, due to the refinement and complexity of robotic surgery technology, there are differences in surgical instruments and methods of use among different specialties, and nurses involved in the operation are also assigned based on specialties. The operating room nursing managers should, based on surgical departments, as well as types and number of operations in the operating room, group the nursing personnel in the operating room according to their professional level, physical condition, and age, and assign them to appropriate robotic surgeries. This process should be followed espe-

cially in the early stage of robotic surgery to promote the smooth functioning of the robotic surgery thereby guaranteeing operation safety while steadily increasing the number of such operations. Robot-assisted surgery differs from traditional surgery. Due to its complex and delicate approach and special operation methods, there are different requirements for the layout, time allocation, personnel responsibilities, and procedures in the operation room, which must be handled by professional team members. These members may include surgeons, anesthesiologists, operating room nurses, engineers, etc. All of them must be qualified personnel who have received systematic professional training on Da Vinci surgical robots. Most of the initial batch of medical personnel to perform robotic surgery in China received professional training and certification at the Chinese University of Hong Kong Jockey Club Minimally Invasive Surgical Skills Centre (MISSC). The Chinese University of Hong Kong Jockey Club Minimally Invasive Surgical Skills Centre is one of the first hospitals to perform Da Vinci robotic surgery in China and is also the first training base for the Da Vinci robotic surgery system in Asia. The Center is equipped with three sets of Da Vinci robotic surgery system to provide high-quality training and practice in minimally invasive surgery for doctors and nurses of different specialties. The courses at the training center cover the general operation of the Da Vinci robotic surgery system and its application in different specialties, including the layout of the operating room, preparation of the surgical system, patient position, positioning routes, and preoperative, intraoperative, and postoperative skills in the use of robots. Trainees are limited to medical team members who will perform robotic surgery in the near future. The training is conducted over 2 days. Daily theoretical lectures and demonstrations are followed by skill exercises or group-­ based animal surgery. Several external display screens and wall-mounted televisions are set in the special training room for Da Vinci surgery, to present the surgical operation pictures from multiple angles and directions. The trainers observe how the trainee doctors and nurses operate the system and conduct operations throughout the entire process thereby finding problems in the operation in real-time, correcting mistakes, and provide instructions. At the later stage of training, the trained nurses must complete the specified operation within the specified time, and the skills acquired are assessed subjectively. Qualified nurses receive the Patient side/First Assistant certificate, meaning that they are eligible to participate in Da Vinci robotic surgery. On February 26, 2017, Shanghai Second Military Medical University Changhai Hospital established an

4  Personnel Management in the Robotic Surgery Room

international training center for Da Vinci surgical robots, which has facilitated increased and faster training of robotic surgeons in China and Asia. With the increase in the number of surgeries and accumulation of experience, the robotic surgery nursing team should continue to be expanded while undergoing training. The training plan for the robotic surgery team can be designed with the help of the robot engineers and surgeons. Therefore, more operating room nurses need to be selected and trained

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to participate in robotic surgery. The robot surgical team should jointly agree on the layout of each system, patient position, type of anesthesia intubation, number and location of robot arms, and selection of electrical surgical equipment and surgical instruments according to different surgical names and methods, develop relatively fixed specifications and processes, and continuously optimize them to achieve more efficient coordination.

5

Quality Management of Robotic Surgical Nursing Gongxian Wang, Yu Zeng, and Xia Sheng

Quality is the foundation of the survival and development of an organization and the core goal of hospital management. As an important place for medical services, the operating room has its professional specialty and high risk. The quality of operating room nursing is one of the important signs to measure the quality of hospital service, as it directly affects the quality of clinical medical treatment, social image, and economic benefits of hospitals. Today, with the continuous development of robotic surgery, how to maintain quality management of robotic surgical care, ensure the steady improvement of the quality of medical care in robotic surgery, and improve the satisfaction of doctors and patients, is one of the central tasks for nursing managers in the operating room, and is one of the main indicators for the evaluation of operating room nursing management.

5.1

 uality Management in Robotic Q Surgery Nursing

With the rapid development of minimally invasive surgical techniques, people’s expectations on physical health have improved, and there are higher requirements for the management of operating room nursing. The nursing work involved in robotic surgery includes not only the preoperative, intraoperative, and postoperative care of patients and the evaluation and management of surgical safety objectives but also the use, management, and maintenance of the environment and robot equipment and other novel issues. The nursing quality in robotic surgery should be improved and perfected G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China

constantly to adapt to the changing situation, and a nursing quality management method based on scenario planning, careful implementation, and overall control should be adopted.

5.1.1 Total Quality Management Total quality management (TQM) refers to the quality-­ centered, participation-based management activities carried out by an organization with the aim to achieve long-term success through customer satisfaction and by benefitting all members of the organization and society. The central task of total quality management is to set up a total quality system with quality as the core and standardization as the focus. This involves setting up the necessary organizational structure, defining the responsibility system, providing the necessary equipment and personnel, as well as taking appropriate measures to control the technical, managerial, and personnel factors that affect the quality of care, in order to reduce, eliminate, and prevent the occurrence of quality defects. In 1978, China introduced total quality management, which has become the most important method in hospital quality management.

5.1.2 T  otal Quality Management in Robotic Surgery Total quality management in robotic surgery nursing should be organized, planned, coordinated, and controlled in accordance with the formation process and law of nursing quality, so as to ensure that robotic surgery care meets established standards and the needs of surgeons and patients. To set up a comprehensive management organization for nursing quality, the first step is to set up the necessary organizational structure, clear responsibility system, and provide the necessary equipment and personnel. The next step is to formulate

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and implement management responsibilities, work systems, standardized processes, quality standards and implement continuous quality improvement. Finally, it is necessary to establish the nursing quality management system and ensure it works effectively so that the technical, managerial, and personnel factors affecting the quality of service are controlled, in order to prevent, reduce, or eliminate quality defects. Therefore, the operating room nursing managers should be clearly aware that ensuring the safety and satisfaction of patients undergoing robotic surgery is an important objective and result of the total quality management of robotic surgery nursing in the operating room. 1. Basic Quality Management—The hardware, software, and supporting conditions for surgical robot equipment are the basis to ensure the quality and safety of robotic surgery. This includes reasonable and effective rules and regulations, personnel allocation, facility environment, business technology, instruments and equipment, operation schedule, and management policies. The important conditions to ensure the smooth operation of robotic surgery projects include the formulation of job responsibilities, standards, contents, and procedures centered on the safety of robotic surgery, gradual improvement of full staff training led by senior personnel on the basis of passing the robot training examination and obtaining the robot operation certificate, the establishment of performance appraisal and personnel management mechanisms for continuous improvement based on the quality and benefit of robotic surgery, as well as comprehensive implementation, which shall be put into practice at the hospital and disciplinary levels (refer to Chap. 4). 2. Link Quality Management—Link quality management focuses on quality defect prevention and control in robotic surgery. It refers to the quality control in the process of robotic surgery care, which is the most dynamic situation

and most prone to quality problems. Compliance, standardization, accuracy, correctness, and comfort of the implementation system and operating procedures in the robotic surgery process vary, depending on whether the regulatory framework and operation process, isolation technique, docking process, robotic surgery teamwork, robotic surgical instruments, prevention and resolution of robot accidents, etc., can meet the quality management requirements. 3. End Quality Management—The most common indicators of end quality management are medical record quality, statistical quality, patient safety quality, surgical care quality, etc. It represents the management level, business level, and technical level of the robotic surgery departments. The final quality of the operating room is mainly reflected in quality indicators, such as the safety of patients undergoing robotic surgery, disinfection and sterilization effect of robotic instruments and objects, infection control during robotic surgery, and the service satisfaction of patients and surgeons (Fig. 5.1). Good quality management in robotic surgery care not only pays attention to the basic and end quality of robotic surgery care but also needs to focus on the quality of links in the implementation of robotic surgery.

5.1.3 Implementing Total Quality Management in Robotic Surgery Nursing 5.1.3.1 Establish a Quality Management Organization for Robotic Surgery 1. Establish a Quality Management Organization for Robotic Surgery—Establish a nursing team leader for the robotic surgery specialty, which is staffed by senior nurses who have obtained certificates to operate robotic

Fig. 5.1  Quality control

Basic quality

Segment quality

Robotic surgery

Terminal quality

5  Quality Management of Robotic Surgical Nursing

surgery equipment. The team should be made up of at least 20 nurses who have been trained and passed the training examination. 2. Develop Quality Management Requirements for Robotic Surgery Care—The head nurse is responsible for preparing overall plans, objectives, and measures for robotic surgery quality management, and the nursing team leader of the robotic surgery department should assess the quality management objectives of the robotic surgery nursing team. All team members must work together to achieve the management objectives.

5.1.3.2 Organize Regular Theoretical and Technical Training on Robots 1. Establish A Plan—The nursing team leader of the robotic surgery department should prepare a year-round training plan for theory and practical skills training in using the robots. The training content includes robot rules and regulations, robotic surgery work, emergency treatment, robotic surgery position, robot instrument cleaning, disinfection, sterilization, robot equipment maintenance and fault handling, etc. 2. Training and Assessment Methods—The training methods include PPT-based teaching, on-site operation, process demonstration, technical rounds, and group discussion. At least one theoretical and operational training should be conducted every month, and one quarterly theoretical and operational assessment should be conducted by the specialist team leader (Fig. 5.2). Fig. 5.2  Staff training

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5.1.3.3 Regular Quality Inspection and Assessment The continuous quality improvement method—PDCA cycle (Fig. 5.3) can be used to analyze and evaluate the effectiveness of robot nursing quality. The PDCA cycle, also known as Deming cycle, was invented by American quality master W.  Edwards Deming for continuous quality improvement. Its main features include ① Big cycles linked with small ones to promote each other. By rotating big and small PDCA circles, link by link, the whole nursing management system is

Evaluation and Modificatio of Robot nursing quality --Cycle PDCA

Fig. 5.3  PDCA cycle

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PDCA cycle proposed by the American master of quality control

Plan: map the goals and clearly indicate the best way to meet them Do: execute the plan as outlined and try solving the difficulties encounterd. Check: conduct quality assessment and summarize the problems Act: take corrective actions to improve the quality

Fig. 5.4  PDCA (Deming) cycle

organically linked to consistently improve the management level and nursing quality. ② It spirals upward. With each cycle, several practical problems are addressed to raise the quality of care to a new level. The next cycle is based on improvements and producing new content and goals to improve the quality of care. ③ The key to the PDCA cycle is the “A” phase. Only through this improvement stage, can the successful experience and failure lessons in the plan be incorporated into the relevant standards, systems, and operating procedures, as a guide and reference for future actions, so as to improve the quality of nursing work and take it to new heights (Fig. 5.4). 1. Plan—Establish quality objectives and capture key links. The planning phase includes listing problems, finding causes, identifying goals, and making plans. The nurses in the operating room should prepare a nursing safety plan based on the preoperative robot examination and according to the disease characteristics and surgical problems of each surgical patient, to ensure the effective implementation of various measures and get feedback after surgery. For example, the placement of robotic surgery positions; the whole process of cleaning, packaging, sterilization, transportation, storage and use of robotic surgery instruments, as well as sterilization effect monitoring, etc. 2. Do—Implement the objectives and solve the difficulties. Proper execution ensures that all tasks are carried out strictly in accordance with the plan and in a controlled manner. For example, the installation time of robots should be reduced. To solve this problem, first of all, the surgical nurses should master how to operate the robots, and the operators should receive appropriate training. All measures are indispensable. 3. Check—Conduct quality assessment and find defects. The purpose of checks is to find out problems, analyze causes, solve problems, and promote all work to achieve

If everyone in the nursing group carries out their work according to cycle PDCA, each segment quality must be guaranteed and the overall level will be improved.

Fig. 5.5  Next Cycle PDCA

quality standards. Scheduled or unscheduled inspection of final quality: whether the surgical nurses have acquired standard skills for operating the robots, whether the robotic surgery position is standard, whether the robotic surgery instruments are used accurately, whether the cleaning and sterilization are thorough and up to standard, etc., as well as the failure causes can be understood by some links such as the rounds by the head nurse, examination by the specialty team leader, and self-­ inspection by nurses. Existing problems, if any, should be promptly solved, recorded, regularly classified, analyzed, and summarized. 4. Action—Improve work measures and nursing quality. Modification in quality tools and improvement of quality standards are the results of the first three steps. Data and problems collected during the implementation should be comprehensively analyzed, and relevant systems should be formulated and corresponding measures are undertaken based on the lessons and experiences, to both correct inappropriate or wrong behavior and prevent similar problems so that existing results can be consolidated. The remaining problems should be classified and summarized to move on to the next PDCA cycle (Fig. 5.5). If everyone in the nursing team carries out their own work according to the PDCA cycle, the quality of the links must be guaranteed, and the overall level of nursing quality must be improved.

5.1.3.4 Establish the Quality Inspection System for Operating Room Nursing Based on the principle of three-level quality control, the head nurse of each department should be responsible for first-level quality control, the head nurse is responsible for second-­ level quality control, and the team leader of each specialty is

5  Quality Management of Robotic Surgical Nursing

responsible for the third-level quality control. According to the objectives of nursing quality management in the operating room, the three-level quality control system should be established by the department, in which the head nurse is responsible for the first-level quality control, the quality ­control team leader is responsible for the second-level quality control, and the specialty team leader is responsible for the third-level quality control. The higher-up quality control organization should provide business guidance and assistance to the lower quality control organization, especially when handling general or exceptional problems. The quality of robotic surgery care can be guaranteed with rounds, and scheduled and unscheduled inspections.

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5.2.2 Quality Assessment The evaluation of nursing quality is to make an objective evaluation of the degree the nursing objectives are met and the effect of nursing work. It is an important measure of nursing quality control to evaluate the quality of nursing based on qualitative and quantitative methods. To evaluate the quality management level objectively, there must be a set of concrete and feasible evaluation methods to measure the management effect. The main evaluation methods for the quality of medical care include evaluation by traditional medical indexes, by three-level quality structure, by total quality management, and by hospital grading management.

1. Evaluating Method by Traditional Medical Indexes— Using this evaluating method, the corresponding statistical indicators can be set based on the data, and the quality and efficiency of medical treatment can be evaluated correctly, timely, and effectively, providing a 5.2.1 Monitoring Method more reliable quality improvement basis for medical quality management. At the same time, in ensuring the Monitoring of the quality of robotic surgery care mainly authenticity, completeness, and accuracy of statistical relies on the inspection and supervision of the implementadata, this method pays special attention to the compation of various rules and regulations on robotic surgery care, rability and significance of statistical data. Its advancompletion of various nursing management indicators, and tages include unified, fixed, and specific medical inspection of the integrity of monitoring data and records. treatment indexes, simple projects (facilitating statistic and analysis), and a certain universality. It is a more 5.2.1.1 Self-Examination and Self-Control practical and acceptable management method. Its disObjective quality inspection consists of subordinate self-­ advantages include postmortem evaluation, passive control and superior periodical key inspection and control. management, and ignoring the role of people and qualThe objective quality inspection involves: ① During robotic ity control in medical activities. surgery, the nurses take strict control of all operations and 2. Three-level Quality Structure Evaluation Method—A strive for the accuracy of each operation. In addition, what three-level quality control network system with medical has been done must be checked to make sure that it is correct personnel as the main body is established to realize the hiand that all mistakes are corrected immediately. ② The erarchical evaluation of quality, which has strong pertirobotic surgery specialty nursing team carry out random and nence and reliable effect. The advantages of this evaluation regular inspection based on the nursing quality indexes of method are that the quality management and evaluation are robotic surgery every month, according to the target items clearly divided into three links, and the responsibility of and requirements, and analyze and rectify the causes of qualquality management is further clarified to facilitate superity deficiencies and problems, so as to continuously improve vision and inspection. The disadvantages are that only the quality of nursing. ③ The nursing group seminar on medical departments control the quality, resulting in a robotic surgery, which is held regularly to find out existing weak sense of participation and service awareness by all and potential problems or factors. staff, and it is not easy to formulate comparable and unified evaluation standards for the quality of medical service. In 5.2.1.2 Quality Inspection case of practical application in China, attention is only paid The nursing department should organize various quality to the quality of the foundation and quality of results; howinspections at irregular intervals to find out problems, proever, the evaluation and management of link quality are pose improvement measures, and ensure that all indicators ignored. meet the standards and requirements. In addition, the inspections by the head nurse and random inspections by the qual- 3. Hospital Hierarchical Management Evaluation Method— This is a method to implement the overall management of ity control team leader ensure that problems in daily work a hospital by setting fixed allocation, standards and evaluaare found and corrected on time.

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 uality Monitoring and Evaluation Q of Robotic Surgery Nursing

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tion methods according to the functions, specifications and grades of the hospital. Its advantages include classification of hospitals, adoption of unified evaluation standards, link between evaluation cycles, hospital development toward standardization and cross-regional large-scale inspection, and it supports survival of the fittest. Its disadvantage is that the personnel quality in implementing and mastering the evaluation method d­ iffers; hence, it is difficult to evaluate at one level, and the evaluation result may be too different from that of the first-level hospital, which is not in line with the realistic significance of hospital evaluation. 4. Hospital Total Quality Management—Hospital total quality management (TQM) has been one of the most effective management methods in recent years. It mainly features objective responsibility system management, medical quality management, nursing quality management, logistics support quality management, medical administration management, political work quality management, etc., among which medical quality management always occupies the core position and is the essence of hospital management. The total quality management evaluation method is the most comprehensive and dynamic quality management and evaluation method.

5.3

 ole of Robotic Surgery Room R Manager in Total Quality Management

In terms of nursing quality management and continuous improvement, special emphasis should be placed on the formulation and implementation of nursing quality assessment standards, assessment methods, and continuous improvement programs. It is necessary to establish a management procedure for robotic surgery nursing, an emergency plan, and a handling procedure for robotic surgery. The nursing activities during robotic surgery should conform to the requirements of nosocomial infection control, and preoperative visit and postoperative support based on the patient care specifications for the robotic perioperative period, to promote and guarantee normal and orderly development of robotic surgery projects. In robotic surgery, the quality of surgical care is the primary concern of operating room nursing managers. The quality of robotic surgery nursing must also be considered and cover the whole department system. The emphasis of total quality management should be to manage the quality of nursing based on participation by all staff, throughout the whole process and in all aspects.

5.3.1 P  lay the Role of a Specialty Nursing Team Leader Robotic surgery has been widely used in general surgery, urology, gynecology, thoracic surgery, cardiovascular surgery, pediatrics, etc. A wide variety of operations and expensive robotic equipment and instruments make the operating room nursing work increasingly demanding. Therefore, a specialty robotic surgery nursing team should be set up and corresponding rules and regulations formulated according to the surgical characteristics of each specialty. The specialty robotic surgery nursing team leader should: ① formulate the training plan and assessment standards for specialty robotic surgery, and carry out training and assessment of the nurses in rotation; ② manage new robotic surgery technology development and training; ③ manage the use, planning, and overall management of robot supplies, as well as in-and-out-of-storage management; ④ manage the use, inspection, maintenance, and overall management of robotic surgery instruments and equipment, special use instruments, and other instruments; ⑤ maintain all kinds of data statistics during robotic surgery, such as operation quantity statistics, robot instrument consumption statistics, and robotic surgery performance management; and ⑥ regularly solicit the opinions of robotic surgery specialists and formulate measures to improve the work based on the opinions.

5.3.2 B  uild a High-Quality Professional Robotic Surgery Nursing Team The core of team spirit is cooperation. To maintain a high level of work quality, robotic surgery should not only have a good system and optimized processes but also have a high-­ quality nursing backbone team. When robotic surgery is just carried out, excellent nurses should be selected from the operating room for exploratory training at the Hong Kong robot training institute, to qualify to participate in robotic surgery. The team responsibilities of the head nurse in the operating room include: (1) improve the nursing support ability during robotic surgery, lead the nursing team to participate in robotic surgery, and actively improve and perfect relevant procedures, systems, and management of robotic surgery; (2) bring into play the knowledge of the robotic surgery nursing team, turn robotic surgery’s goal management into everyone’s working principle and direction, and encourage everyone to participate in the management; (3) pay attention to the growth of every nurse in the robotic surgery nursing team, strengthen the professional identity and sense

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Fig. 5.6  Quality nursing service

Urologic surgery

Thoracic surgery

Robotic Surgery Check with nurse in ward and tie wrist band

Check before entering the operating room

General surgery

Recovery from anesthesia after operation

Gynecologic surgery

Back to ward

Third-party verification in operation room

of belonging, improve team cohesion, and do a good job in the training and assessment of related theories and operational skills of robotic surgery nursing so that the learning curve can be shortened and the robotic surgery working methods and skills can be mastered faster by the nurses. Only in this way can the total quality management of robotic surgery nursing be better managed.

5.3.3 C  ontinue to Carry Out Quality Nursing Activities Quality nursing services mainly include: meeting the basic needs of patients, ensuring patient safety, maintaining patient comfort, helping the psychological balance of patients, helping patient’s family and society understand support robotic surgery, and improving the satisfaction of patients and soci-

ety through quality nursing. The realization of high-quality nursing service in robotic surgery is embodied in ① solving the problem of patients on time; ② perioperative nursing, timely preoperative and postoperative visits; ③ optimizing the robotic surgery process; ④ providing personalized surgical nursing services for patients; ⑤ effectively communicating and serving patients with all heart; ⑥ ensuring patients receive value for money care and treatment; and ⑦ encouraging patients to actively participate in surgical nursing services and management. Personalized preoperative visits should be provided for patients undergoing robotic surgery: preoperative visit cards (Fig.  5.6) and friendly reminder cards should be prepared for all specialties (such as urology surgery, gynecology, and general surgery), targeted postoperative follow-up should be conducted, and robotic surgery should help expand social benefits and not just economic benefits.

6

Management of Robotic Surgical Supplies Gongxian Wang, Yu Zeng, and Xia Sheng

The purpose behind managing operating room items is to make their best use, minimize waste, reduce cost, increase efficiency and maintain performance, extend service life, fully meet the needs of surgery and increase the value of benefits. Surgical instruments are the basic operation tools. The performance of instruments directly affects the operation and even determine its success or failure. Since robotic instruments and consumables are expensive, to ensure the normal, effective, and correct use of robotic instruments, and give full play to their effectiveness, it is necessary to strengthen the management of robotic instruments, consumables, and operation rooms.

6.1

Managing the Robotic Endoscope

The Robotic HD Image Processing System adopts either a 1.2 mm 3D endoscope or an 8.5 mm 3D endoscope with a straight head (0°) or a curved head (30°). Light from the light source is transmitted to the endoscopic shaft via optical fiber and then projected on the surgical site. Video images of the surgical site captured by the endoscope are sent back to the camera via the left and right channels. The camera is connected to the camera control unit (CCU) and the light source. Good management of the endoscope ensures reasonable, full, and effective use. 1. The robotic endoscopes are managed by the specialty team leaders who should number the endoscopes, package and sterilize them separately, and place them in a dedicated storeroom for centralized management. G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China

2. After sterilization, hot endoscopes should not be immediately exposed to air or liquid for cooling. Changes in temperature may damage the endoscope. 3. Autoclave sterilization is not suitable for endoscopes. The autoclave cycle produces high temperatures and sudden temperature changes that can damage the endoscope. Low-temperature plasma and ethylene oxide can be used for sterilization. 4. Before surgery, white balance and 3D effect should be calibrated using calibrators. When calibrating white balance, point the endoscope at a white object to make it cover the whole field of view. When using the 30° endoscope, it is necessary to calibrate it when it is bent at a 30° upward and downward angle. Select the correct hole and direction according to the end angle, and completely insert the endoscope end into the collimator target so that the target and the sub-line appear in the center of the touchscreen. 5. Before use, make sure the endoscope end is adequately heated to avoid fogging when it enters the surgical site. Sterile water can be used in a vacuum cup for heating, and a sterile gauze can be placed at the bottom of the cup to avoid damage to the lens end of the endoscope. 6. Isolation techniques should be strictly implemented during the operation. 7. Refer to the relevant chapters for the use of endoscopes, cleaning, and disinfection.

6.2

Managing the Robot Manipulator

EndoWrist has three specifications: 12, 8, and 5 mm. Intuitive Surgical’s EndoWrist gives surgeons natural flexibility compared with unassisted human hands. Its range of motion is

Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 G. Wang et al. (eds.), Robotic Surgery and Nursing, https://doi.org/10.1007/978-981-16-0510-9_6

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5. After the instruments are installed, one lifetime of the instruments is consumed; hence, you must ensure accuracy before using. Clean the instrument head at the time of replacement. 6. During surgery, place the instrument vertically or horizontally so that blood or fluid can flow through the lever to the proximal end below the instrument. 7. In the event of system failure, the instrument can be easily removed through the emergency release mechanism of the clamp. 8. Cleaning, disinfection, and sterilization should be carried out in accordance with the specifications, and each instrument should be individually packaged to avoid unnecessary pressure, collision, and impact. Fig. 6.1  Emphasis should be made on the training of handling robotic instruments

superior to the natural range of motion, allowing for greater accuracy in minimally invasive environmental operations. The robot instrument, when used in conjunction with the Da Vinci Si System, enables faster and more precise sutures, dissection, and tissue adjustment compared to other surgical platforms. 1. It is necessary to strengthen the training of operators on robot instruments and ensure proper assessment so that everyone can be familiar with the performance, usage principles, operation steps, cleaning, disinfection, and maintenance methods of such instruments (Fig. 6.1). 2. Set up the storeroom and prepare a Registration Book of Equipment in Use and a Registration Book of Base Numbers, to record the daily use, operation, etc., which should be managed by a specially appointed person. 3. Check whether the instrument is damaged, cracked, chipped, or worn. Stop using the instrument if any damage is found. 4. When installing, straighten the EndoWrist by rotating the disc behind the instrument case instead of directly manipulating the EndoWrist so that the trocar can be easily inserted and damage to the instrument can be avoided.

6.3

Managing the Robotic Surgery Room

1. A management system for the robotic surgery room should be established, and the daily management of the surgery room should be assigned to a specially designated person. The operation room where the robots are placed should be equipped with an access control lock, and access should only be allowed through a password and limited to operating room personnel. 2. The surgeon console is the control core of the “Da Vinci” robotic surgery system. During surgery, the surgeon sits in front of the operating table far away from the “operating bed—patient—sterile area,” and observes HD 3D images of the organs and tissues within the surgical field in the patient’s body cavity via a binocular endoscope. The surgeon can use both hands to use the master controls in the surgeon console to issue action commands. Through automatic computer analysis and processing, the action command issued by the surgeon is accurately transmitted to the robotic arm beside the bed, which is used to operate the professional surgical instruments and smoothly conduct the surgery. Therefore, the surgeon console should be placed in a non-sterile area or in a separate auxiliary room; however, the surgeon must be able to see the operating area in case a special situation occurs.

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Fig. 6.2  Position of Patient Cart after surgery

3. The Patient Cart is covered with a professional aseptic drape before surgery, and it is located within the “operation bed—patient—aseptic area.” The imaging system is placed on a video cart outside the sterile area. 4. After surgery, the robot cart is positioned (Fig. 6.2). 5. The robotic surgery system should be maintained regularly and system maintenance is required once every 3 or 6  months. The person in charge should contact the

engineer to arrange the maintenance time and record the maintenance time, details, and result. 6. The robot equipment has a lot of cables, which should be well managed and stored using a wrapping tube. To prevent the operators or instrument cart from trampling or crushing the cables, a pedalboard or special protective cover can be used for protection (as shown in Fig. 6.3). Refer to Fig.  6.4 for the operation steps of winding the robot cables into the wrapping tube.

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Fig. 6.3  Various ways to protect the cables

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Fig. 6.4  Roll the cable in a wrapping tube

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7

Safety Management of Robotic Surgery Gongxian Wang, Yu Zeng, and Xia Sheng

7.1

 verview of Safety Management O in Robotic Surgery

7.1.1 Safety Management in Robotic Surgery Safety management in robotic surgery is a part of nursing management. There are many components in nursing management during robotic surgery, and safety management is an important part. If safety management fails, the high standards of nursing are an empty promise. The goal of safe nursing is to eliminate accidents, reduce errors, and ensure the safety of patients. Safety and zero accident are guaranteed through excellent safety management, strict requirements, implementation of systems, strong measures, good personnel quality, and high technical level. The importance of safety management in robotic surgery is reflected in the following aspects. (1) Safety management in robotic surgery is a means and method to ensure safety Although the importance of safety management and safety in robotic surgery are the same, their meanings are different. The goal or motivation to prevent accidents and ensure safety does not necessarily lead to safety. It also needs the means and methods to ensure the realization of the goal, and safety management is this means or method. You cannot cross the river without a boat, and you cannot guarantee safety without safety management. Therefore, it can be said that without safety management, there is no safety effect. G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China

(2) Safety management in robotic surgery is the guarantee of nursing quality Safety is a direct reflection of the quality of nursing. Safety affects quality, while quality reflects level. The implementation of safe and reliable nursing is not only conducive to the development of medical work but can also promote the physical and mental rehabilitation of patients. Otherwise, it may lead to adverse consequences, and even surgical failure, endangering the life of patients. Safety management in robotic surgery directly guarantees the quality of nursing and reflects the close relationship between safety and quality. (3) Safety management in robotic surgery is an important measure to improve hospital benefit Economic and social benefits are the basis of the survival and development of hospitals. Economic benefit is the tangible asset of hospitals, while social benefit is the intangible asset. Each inspection and operation create a new economic growth point for hospitals, and each patient visiting the hospital is dynamic advertising. If patients receive effective, timely, and safe medical nursing, it will not only reduce patients’ pain and medical expenses, speed up the turnover of beds, and improve the hospital’s medical income but also win the trust of patients and expand the reputation of the hospitals. Therefore, safety management in robotic surgery can improve the two benefits for hospitals.

7.1.2 I mplementing Safety Management in Robotic Surgery 7.1.2.1 Set Up a Quality Organization and Define Monitoring Targets Each department must establish a quality and safety monitoring group for robotic surgery composed of the head nurse, the team leader, and members of the robotic surgery team. The group is responsible for the development of department nursing training plans, quality inspection standards,

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 G. Wang et al. (eds.), Robotic Surgery and Nursing, https://doi.org/10.1007/978-981-16-0510-9_7

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r­egulatory measures, continuous quality improvement, and implementation of performance management, to ensure nursing safety.

7.1.2.2 Keep Ringing the Alarm Bell and Strengthen Safety Awareness Improvement in ideological awareness level is the prerequisite and requirement for competence and quality improvement. Therefore, safety education should be carried out frequently, timely, and repeatedly. Safety training in robotic surgery should be conducted regularly so that team members can learn relevant safety regulations and work systems to understand safety management regulations in robotic surgery, correctly carry out operations, enhance safety consciousness, set up a correct outlook on life and serve patients wholeheartedly, enhance a sense of responsibility and mission ideologically, guard against mistakes in the work, and implement safety awareness. 7.1.2.3 Establish Rules and Regulations and Improve the Management System A system is the work law, the criterion for processing various work, the basis for evaluating work quality, and an important measure to eliminate errors and accidents. Through the establishment of rules and regulations for the management and quantitative standards for quality evaluation, normalization, programming, and standardization of nursing management in robotic surgery can be achieved. Therefore, the establishment of rules and regulations is an important link to ensure safety management in robotic surgery nursing. 7.1.2.4 Strengthen Training and Improve the Quality of Nurses Improving the professional quality of nurses can lay the foundation for the improvement of the nursing level. Keeping in mind the professional characteristics of the operating room, it is of great importance to strengthen the professional training of nurses. Through training and learning, strengthening technical expertise and making up for shortcomings, the professional technical level of the robotic surgery nurses can be fundamentally improved, and the safe technical links can be closed. 7.1.2.5 Conduct Follow-Up Inspection and Strengthen Preventive Measures The robotic surgery head nurse and the team leader should carry out surgical nursing inspection at different stages of the robotic surgery, focusing on examining the nurses’ knowledge of the patient’s surgical information, instruments, items, drugs, equipment preparation and positioning, etc., as well as promptly evaluate the observation results, correct deviations and fix problems, promptly provide supplements,

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and play a real role in predicting, preparing, and controlling operations.

7.1.2.6 Optimize the Combination and Utilize Human Resources Scientifically The deployment and employment of nursing personnel have a direct impact on the quality of nursing. In the work arrangement for robotic surgery, attention should be paid to the cooperation between superiors and subordinates, and ability matching. The second-level management system for team leaders and head nurses should be implemented for key operations to give full play to the potential and creativity of talents at all levels, and to ensure safety and improve efficiency. 7.1.2.7 Analyze Regularly and Improve the Quality of Nursing The robotic surgery safety analysis meeting should be held every month to find potential safety hazards and weak links in the work, and analyze the reasons for existing problems. New corrective measures and implementation measures are required to ensure continuous improvement in nursing quality.

7.2

 afety Nursing Practice in Robotic S Surgery

With the promotion of international hospital management standards (JCI) in Chinese hospitals, China has further deepened and strengthened standardized management of medical institutions. In order to comprehensively evaluate patient condition and surgical risks, and strengthen medical technology management, the Ministry of Health of China issued a number of programmatic documents such as the Measures for Administration of Clinical Application of Medical Technology, the Patient Safety Objectives, the Surgical Safety Verification and the Surgical Risk Assessment, in 2009, requiring medical institutions at all levels to take effective measures to ensure the quality of medical treatment and patient safety. The operating room, as the key department of hospital quality management and a department with high infection risk, has uniqueness and strictness in terms of working environment, operation characteristics, working process, disinfection, and sterilization. In addition to the uniqueness of robotic surgery, it is necessary to strictly regulate safe nursing rules in the robotic surgery room, establish medical technology access rules, establish patient safety monitoring indicators and surgical accident reporting systems, and other relevant systems. It is the fundamental and highest goal in establishing a “surgery safety and safe surgery” guarantee system.

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7.2.1 Medical Technology Classification and Hierarchical Management Medical technology refers to the diagnostic and therapeutic measures taken by medical institutions and their medical personnel for the purpose of diagnosis and treatment of diseases, to make judgment and eliminate diseases, alleviate diseases, relieve pain, improve functions, prolong life, and help patients recover health. The aim is to standardize the right to use technology and implement access management for medical technology.

7.2.1.1 Medical Technology Classification According to the Measures for Administration of Clinical Application of Medical Technology (W. Y. Z. F. C200W18), medical technology is classified into three categories. The first category refers to safe and effective technologies with low risk that can be ensured by routine management by medical institutions. Such technology is managed by medical institutions (hospitals). Most of the surgical specialties fall into this category. The second category refers to medical technologies with definite safety and effectiveness, involving certain ethical issues or higher risks, which are controlled and managed by the health administration departments. Such technologies are cataloged and managed by provincial health administrations. The second category of medical technology currently administered varies from province to province. The first batch of the second category of 12 medical technologies published by the Guangdong Health Department in November 2010 includes interventional diagnosis and treatment of coronary heart diseases, interventional diagnosis and treatment of congenital heart diseases, cardiac catheter ablation, interventional diagnosis and treatment of pacemakers, gynecologic endoscopic surgery, corneal transplantation, cataract phacoemulsification, laser keratorefractive surgery, hemodialysis, peritoneal dialysis, clinical gene amplification test, and medical hyperbaric oxygen treatment. The third category refers to medical technologies that involve significant ethical issues, are associated with high risks, whose safety and effectiveness need further verification and technologies that require scarce resources. The National Health and Family Planning Commission (NHFPC) is responsible for cataloging and strictly controlling such technologies. The first batch of the third category of medical technologies to be approved for clinical application in June 2009 includes homograft transplantation, xenograft transplantation, osteotomy augmentation surgery, denaturation surgery, artificial heart implantation, central nervous system surgery for detoxification, stereotactic surgery for mental illness, radioactive seed implantation therapy, tumor cryotherapy (hyperthermia) therapy, cloning therapy, tissue (cell) transplantation, autologous stem cell and immune cell ther-

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apy, gene therapy, and allogeneic stem cell transplantation, vaccine therapy, destructive therapy with particle generator and other large instruments and equipment, etc. With rapid development of surgical technology, new technologies, new methods, and new equipment are constantly emerging, bringing hope to more patients with difficult and complicated diseases. However, since the safety, effectiveness, medical ethics, and other aspects of some clinical technologies are still controversial, and some medical units do not standardize the application of these technologies without corresponding personnel, equipment, and technical conditions, there could be uncertain consequences caused by the medical technology. Therefore, the implementation of classified management of medical technology can regulate the medical behavior of hospitals at the source, curb abuse and ensure the safety of patients’ lives. This is the significance of classified management of medical technology. The second and third categories of medical technology currently determined will also change and be adjusted with further improvement and development of medical technology.

7.2.1.2 Surgical Grading 1. The principle of surgical grading is to divide specialty operations into four levels according to their risk and difficulty. Primary surgery refers to common operations with low risk, simple process, and low technical difficulty, such as simple gastrointestinal rupture repair, subdural hematoma removal, cystectomy, and lithotomy. Secondary surgery refers to operations with certain risks, general complexity, and technical difficulties, such as gastrectomy, resection of the left hepatic lobe, subarachnoid hematoma removal, and partial cystectomy. Tertiary surgery refers to operations with higher risks, more complicated processes, and relatively great difficulty, such as radical operation for carcinoma of stomach, meningioma resection, and bladder-neck wedge-shaped resection. Quaternary surgery refers to major operations with high risks, complicated process, and great difficulties, such as enlarged radical mastectomy for breast cancer, pancreaticoduodenectomy, cranial base tumor resection, and radical cystectomy for bladder replacement. 2. The types of surgery performed in each specialty are included in the surgical classification catalog according to the principle of classification. The surgical classification catalog is usually determined by hospitals according to the scale, talent, technology, equipment, auxiliary conditions, and other factors, and there may be differences between hospitals. 3. Surgical Authorization of Surgeons—Surgeons with different professional and technical qualifications must be

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authorized before performing operations at different levels. In other words, surgical authorization must correspond to the corresponding surgical grading. Qualified surgeons for tertiary surgery may engage in operations within the scope of the tertiary surgery catalog, but shall not engage in operations beyond the scope of the tertiary surgery catalog. At present, there is no uniform standard for the qualification and authorization of surgeons, and it is formulated by each unit on its own. Generally, it is neither linked to the title, nor changes with the promotion of the title. The significance of implementing surgical grading management is that the operations are classified into four grades according to their difficulty, complexity, and risks; surgeons are given a level of operating authority based on their qualifications and abilities; surgeons with different levels of surgical authority perform only the operations of the corresponding levels as per the surgical catalog. Although today robotic surgery is not performed in all fields of surgery, in the near future, it will inevitably become popular and lead to the third revolution in the history of surgery. In the development stage, it is more necessary to strictly implement the grading access system for surgery, so as to give full play to the professional expertise of surgeons, regulate the medical behavior of surgeons, effectively control surgical risks, and promote the improvement of medical quality and technical progress.

7.2.1.3 Nursing Support Any operating room nurse, as a member of the surgical team, should not only master the medical technology and management requirements of surgical classification but also assist the functional departments of the hospital to supervise the actual implementation of the department. Only in this way can we truly practice medicine as per law and implement effective supervision and control. 1. General nurses should regularly study the classification of hospital medical technology and the standards for surgical grading management, and master the implementation methods and management requirements, twice a year. Such study should be organized at any time in case of newly published secondary and tertiary medical technologies, new regulations, changes in the operating authority of surgeons, and before the entry of new nurses. 2. The operating room should maintain a record in the department of the approval documents of the secondary and tertiary medical technologies permitted to be performed by the hospital, and inform all nurses. 3. The operating room nurses should be aware of the operating authority of surgeons, and the nurses in the specialty surgery coordination group must be familiar with it as well. If a surgeon performs an operation beyond the per-

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mitted level, the nurse should stop it promptly. At the same time, to facilitate the memory of nurses, it is advisable to place a “Surgical Qualification of Surgeons and Surgical Grading Table” in the operating room for inspection and verification by the circulating nurses. 4. Operating room nurses should strengthen oversight on the implementation of medical technology classification and surgical grading systems, and should immediately stop the operation if it is found that any surgeon is performing an unapproved or unqualified operation, and should report the same to the head nurse. The head nurse should promptly report it to the department director and medical department. 5. The operating room personnel should have the right to refuse to arrange any operation if the operation is performed beyond the scope prescribed herein, or if the operation is performed under a fake authority or beyond the permitted level. In case of emergency, such an operation should be reported to the department’s duty director. 6. The head nurse of the operating room should keep close contact with the surgical qualification examination team, medical quality management department and other relevant departments, master the dynamic situation, and actively follow-up and promptly adjust the projects allowed to be used, so as to standardize the qualification of surgeons and technical management of the hospitals.

7.2.2 S  urgical Risk Assessment and Surgical Safety Objectives Surgical operations are extremely risky and dangerous, and surgical errors seriously threaten the safety of patients. In 2007, the World Health Organization (WHO) launched a global patient safety campaign to reduce surgical errors, with the aim to improve surgical safety and save more lives. China also organized experts to draw up the Surgical Safety Checklist and Surgical Risk Assessment Table with reference to the relevant information provided by WHO, as a specific measure to implement the patient safety objectives, centered on the continuous improvement of medical quality and the guarantee of surgical patient safety.

7.2.2.1 Surgical Risk Assessment According to the current international standards for surgical risk classification (National Nosocomial Infection Surveillance System, NNIS), assessment is carried out based on the cumulative scores of the three key variables of incision cleanliness, anesthesia grading, and operation duration. The operations are classified into four levels, namely NNIS0, NNIS1, NNIS2, and NNIS3. The aim is to establish and improve relevant systems and norms through preoperative assessment of the risk factors of surgical patients, and to take

7  Safety Management of Robotic Surgery

preventive measures to effectively avoid surgical risks, improve medical quality, and ensure medical safety. This is one of the most important safety activities to prevent and control infection in hospitals. 1. Classification and Score of Surgical Incision—Incisions can be classified into four categories according to the cleanness, and include types I, II (0 point), III, and IV (1 point). • Type I incision (clean): The surgical field is not contaminated, there is no inflammation around the incision, and the patient does not require airway, digestive tract, urogenital tract, or oropharyngeal intubation. • Type II incision (relatively clean surgery): Operation of respiratory tract, digestive tract, urogenital tract, and oropharyngeal organs without obvious contamination; operation on the scrotum, vagina, appendix, ear, and nose; the patients require airway, digestive tract, urogenital tract, or oropharyngeal intubation. • Type III incision (clean—contaminated surgery): Open, fresh, and unclean incisions; infected incisions after previous operation; incisions that require sterilization intraoperatively (for example, gastrointestinal tract, urinary tract, bile duct contents, and body fluids have a large amount of spillover pollution); significant intraoperative contamination (e.g., open-heart compressions). • Type IV incision (contaminated surgery): Severe trauma; incisions with inflammation, tissue necrosis, or visceral drainage tube. 2. Anesthesia Grade and Score—According to the results of pre-anesthesia visit and auxiliary examination, a comprehensive evaluation of the condition, anesthesia, and surgical tolerance of the patient is made. Currently, the commonly used assessment and grading method for clinical anesthesia is based on the American Society of Anesthesiologists (ASA) criteria for grading conditions, and includes levels I ~ VI. Levels 1 and 2 are 0 point, and levels 3 to 6 are 1 point. • Level 1 (P1): Normal patients, with no systemic disease except local lesions. The patients have an excellent tolerance for anesthesia and surgery and are less risky. • Level 2 (P2): Patients with mild or moderate systemic disease and complete compensatory function. The patients have an excellent tolerance for anesthesia and surgery and are less risky. • Level 3 (P3): Patients with severe systemic disease and still in the compensation range. The patients’ daily activities are limited, but they do not lose the ability to work. They have a weakened tolerance to anesthesia and surgery and are more at risk.

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• Level 4 (P4): Patients with severe systemic disease and incomplete functional compensation. Patients that have been incapacitated and face constant threat to their lives. Anesthesia and surgery for such patients are dangerous and risky. • Level 5 (P5): Dying patients whose lives cannot be sustained for 24 h, with or without surgery. Anesthesia and surgery for such patients are extremely dangerous. • Level 6 (P6): Brain dead patients. 3. Operation Duration—Patients are grouped into T1 and T2 groups based on the operation duration. The operation of T1 group is completed within 3 h, with a score of 0. T2 group operations take longer than 3 h and have a score of 1. 4. Surgical Risk Grading Score and Surgical Risk Assessment Table (Table 7.1)—According to the surgical incision, anesthesia ASA grading, and duration of surgery listed in the evaluation form, the corresponding options should be checked and then the scores calculated. When the total score of surgical risk assessment is 0, it is classified as NNS0; when the total score is 1, it is classified as NNS1; when the total score is 2, it is classified as NNS2; when the total score is 3, it is classified as NNS3. Surgical personnel can formulate and implement corresponding preventive measures according to the degree of surgical risk of patients, to prevent the occurrence of surgical site infection. Furthermore, comprehensive statistics and data comparison can be conducted for the infection rate of surgical sites.

7.2.2.2 Surgical Safety Verification The main purpose of surgical verification is to avoid human error, reduce surgical errors, and prevent surgical-related misreading, especially to prevent wrong surgical patients, wrong surgical sites, and wrong surgical methods. Although the probability of surgical errors is not high, the harm caused, if any, is huge and even catastrophic, so we must pay great attention to surgical errors and be careful. A surgical safety checklist (Table 7.2) should be prepared and three-party surgical verification carried out to ensure the safety and quality management in the operating room are more targeted, instructive, and controllable. 7.2.2.3 Nursing Support 1. Any patient undergoing surgery should undergo surgical risk assessment and surgical safety verification, which shall be jointly checked by the surgeon, anesthesiologist, and circulating nurse. The contents of the checklist can be adjusted or modified with the consent of the hospital; however, the “patient identity, surgical site (specific side), and surgical method” information is required.

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Table 7.1  Surgery risk assessment form

×××Hospital Surgery Risk Assessment Form Name :

Gender :

Age :

Department :

Bed No. :

Inpatient No. :

Anesthesia method : Operation method : Surgeon :

Date of surgery :

I. Cleanliness of the surgical incision site

II. Anesthesia grading (ASA grading)

III. Surgery duration T1: surgery completed within 3

Type I surgical incision site

0

(clean surgery)

P1: normal patient with no systemic diseases except local lesions

0

hours 0 T2: surgery completed over 3

1

hours The surgical field is uncontaminated; no inflammation is found around the surgical incision site, no intubations P2: patient with mild clinical symptoms; i.e.

are present in the airway, esophagus,

0

and/or urethra. The patient shows no consciousness disorder. P3: patient with a severe systemic disease(s)

Type II surgical incision

0

(Relatively clean surgery)

and limitation(s) in daily activities, but no

1

loss of work ability

The patient is intubated in airway,

P4: life-threatening with a serious systemic

esophagus, and/or urethra, with stable

disease(s) and loss of work ability

Follow-up visits: wound healing and infection

1

 Class A healing of the incision  Incision infection, superficial infection

illness condition(s). The patient will undergo vulva, perianal,

P5: dying patient with a critical illness(es)

oral, ear and nose surgeries.

who is near death

1

 Deep infection Place a check "√" in the box corresponding to the evaluation item

Type III surgical incision (clean/contaminated surgical site)

1

Open, fresh, and unclean wounds;

P6: patient who has experienced brain death

1

and then add the score

4. Category of surgeries

incision with infection following a previous surgery; incision requiring disinfection during the

1. Superficial tissue surgery



2. Deep tissue surgery



operation Type IV surgical incision

1

(contaminated surgery) Severe trauma, inflammation of the

surgical incision site, and tissue necrosis. Signature of the surgeon :

3. Tissue transplantation Emergency surgery 4. Lacunar surgery Signature of the anesthesiologist :

 Signature of the circulating nurse :

Surgery risk assessment: cleanliness of the surgical incision ( point(s)) + anesthesia grade (ASA) ( point(s)) + surgery duration ( point(s)) = ( total point(s)) NNISgrading :  0  1  2

3



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Table 7.2  Surgical safety checklist

×××Hospital Surgical Safety Checklist Name :

Gender :

Age :

Department :

Bed No. :

Inpatient No. :

Anesthesia method : Operation method : Surgeon :

Date of surgery : Before anesthesia

Pre-surgery

Before the patient leaves the operating room

Indicate whether or not the patient's name, Indicate whether or not the patient's name, Indicate whether or not the patient's name, gender, and age are correct:

gender, and age are correct:

gender and age were recorded correctly:

 Yes  No

 Yes  No

Indicate whether or not the surgical

Indicate whether or not the surgical

Indicate whether or not the surgical method

 Yes  No

method has been confirmed:

method is confirmed:

was actually confirmed:

 Yes  No

 Yes  No

Indicate whether or not the surgical site

Indicate whether or not the surgical site

Indicate whether or not the surgical medication

and identification are correct:

and its identification are correct:

and blood transfusion were confirmed:

 Yes  No

 Yes  No

 Yes  No

 Yes  No

Indicate whether or not the informed

Indicate whether or not an early warning

Indicate whether or not the surgical

consent for surgery has been signed:

of surgical anesthesia risk exists:

materials were checked correctly

 Yes  No

 Yes  No

Indicate whether or not the informed consent for anesthesia has been signed:

 Yes  No Indicate whether or not the diagnosis was confirmed by surgical specimens:

Statement by the surgeon:

 Yes  No

 Yes  No

Estimated surgery duration 

Indicate whether or not a safety inspection

Estimated blood loss 

of the anesthesia equipment has been

Indicate whether or not the skin is intact:  Yes  No

Surgical concerns 

completed:

Other relevant issues 

Various pipelines:

 Yes  No Indicate whether or not the skin is intact:

Central venous access  Venous access 

Statement by the anesthesiologist:

 Yes  No Indicate whether or not the skin preparation

Anesthesia concerns 

Endotracheal intubation 

Other relevant issues 

Wound drainage 

of the surgical field is correct:  Yes  No

Gastric tube  Urinary catheter 

Statement by surgery nurse:

Indicate whether or not venous access has

Other(s) 

Qualified sterilization 

been established:

Instrument and equipment   Yes  No

Special medication(s) required before and/ Disposition of the patient:

Does the patient have a history of allergy/ allergies?  Yes  No Indicate whether or not the results of the

PACU 

or during the surgery  Other relevant issues 

Ward 

Indicate whether or not any relevant imaging

ICU ward  Emergency room 

data is required:

skin test have been reviewed:

Discharge from the hospital 

 Yes  No

 Yes  No Blood preparation before the surgery:  Yes  No Prosthesis  /implant /imaging data  Other(s) : Signature of the surgeon : Signature of the operating room nurse :

Other(s) :

Other(s) : Signature of the anesthesiologist :

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2. The assessment or check system should be implemented strictly in accordance with the requirements of the checklist, which requires concentration and confirmation item by item. It should be checked immediately in case of any doubt. 3. A “Nursing Records Handover for Surgical Patients” (Table 7.3) should be prepared. The table should be prepared and filled by 2–8 nurses in the ward and signed by the operating room transporter and the ward nurse after checking it item by item at the nurses’ station. 4. If the risk assessment grade of the operation exceeds NNIS2, it necessary to ask for instructions from the department director or for the operation to be evaluated under the guidance of the department director; hospital consultation can be organized if necessary. 5. Strengthen patient identification and surgical site confirmation. ① During the preoperative visit, the circulating nurse should check the identity of the surgical patient (name, age, gender, and ID number), actively ask the patient or family member to state their name and the surgical site, and check the site mark made by the surgeon, in addition to providing routine operation education, psychological support, and answer patient questions. ② When picking up the patient before the surgery, the operating room transporter should check the identity and the surgical site with the patient or his or her family. ③ When picking up pediatric patients and patients with irritability, communication disorder, and unconsciousness, or under general anesthesia or sedation, the patient’s family should be allowed to accompany the patient to the operating room so that the anesthesiologist and nurse can confirm the operation information again. Attention should be paid when checking that the circulating nurse does not say what is to be checked and ask the patient to answer yes or no questions, for example, “Excuse me, is your name Zhang San, or are you going to undergo cholecystectomy?” Instead, the nurse shall ask “May I have your name, please? Can you tell me what kind of operation you are having?” 6. When filling in the table, the handwriting must be clear, all items should be filled completely, and the name of the person filling the table should be signed in full. The table shall be brought back to the department along with the medical record after surgery (Table 7.3).

7.2.3 Observing the Patient Condition Surgery is a process of trauma and stress. Affected by surgical diseases or coexisting diseases, anesthetic methods and anesthetics, surgical trauma, blood loss, and postural changes during the period of surgical anesthesia, patients

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may have physiological changes during surgery or even face life-­ threatening situations. Due to the different stress responses of patients caused by different surgical anesthesia, and the different changes in the condition of the same patient under different diagnosis and treatment states, it is obviously not possible to meet the safety needs of the surgical patients if the operating room nurses continue to follow the traditional mode of surgical support, and prepare items according to the surgical notice. Therefore, in addition to mastering routine surgical procedures and support for robotic surgery, circulating nurses need to understand and master the potential problems related to the individual diseases of patients and the pathophysiological reactions of surgical anatomy and traumatic stress, and know what needs to be focused on in each period, what items should be prepared and how to support the surgery. Precautions and evidence-based nursing interventions are required. This is the basic ability of operating room nurses in clinical work, but can also deeply reflect the quality of operating room nursing.

7.2.3.1 Definition of Intraoperative Condition Observation Intraoperative condition observation refers to the process of comprehensive and systematic evaluation and comprehensive judgment of patients’ intraoperative conditions based on the characteristics of the disease and the key points of the operation, so as to provide the necessary basis for operation, nursing, and complication prevention. 7.2.3.2 Specific Content of Condition Observation Guidelines The content design takes the operation as the main item, and closely combines the disease characteristics, operation key, and nursing question, and is progressive. The following seven aspects (seven points) are the main disease observation guidelines. 1. General Information—General information includes bed number, name, gender, age, ID number, history of present illness and/or existing diseases, surgeon and anesthesiologist, positive results of infection screening, before surgery temperature and pulse, are the basic requirements for comprehensive observation. Each person has a unique ID number, and the “name” is the most basic, important, and reliable marker of patient identification. 2. Name (Site) of Operation—The presence of single organ, symmetrical organ, multiple structures and multiple segments in the surgical site, the name of the operation, and the side and segment, are the key elements of surgical cooperation and the most basic requirements for the prevention of surgical-related errors.

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Table 7.3  Nursing record for operating room patients

×××Hospital Nursing Record for Operating Room Patients Department :

  Bed No. :

  Name :

  Gender :

  Age :

  Inpatient No. :

Operation : Handover contents Admitted from the Emergency Room :  No   Yes Handover time: hr    min    , month     day    ,     year beats/minute, respiratory rate     times/minute

Vital signs: blood pressure    mmHg, pulse rate Handover when entering into the operating

Consciousness: awake   coma   confusion        Venous access:  No   Yes Various pipelines: none   drainage tube   gastric tube   urethral catheter   other(s) Skin condition: intact   other(s) Preoperative preparation: good    poor           Surgical site: Articles brought in: CRF   Medical image film:

room

   PCS   drugs     other(s)

Remarks： Signature of the ward shift nurse：

Signature of the operating room on-duty nurse：

Handover time: hr    min    , month    day    ,     year Vital signs: blood pressure:

   mmHg, pulse rate:    beats/minute, respiratory rate:    times/minute

Blood oxygen saturation:    % Consciousness: awake   conscious   coma   Hand band:  No  Yes Handover after returning to the PACU

Venous access:  No   Yes (upper limb  /lower limb  /jugular  /subclavian  /femoral ) Various pipelines: No   drainage tube   gastric tube   urethral catheter   others Skin condition: intact    others                                  Articles brought out: CRF   Medical image film:

   PCS   drugs     other(s)

Remarks： Signature of the operating room shift nurse：

Signature of the PACU on-duty nurse：

Handover time: hr    min    , month    day    ,    year Vital signs: blood pressure:

   mmHg, pulse rate:    beats/minute, respiratory rate:

   times/minute

Blood/oxygen saturation:    % Consciousness: awake   conscious   coma   Hand band:  No  Yes Handover

Venous access:  No   Yes (upper limb  /lower limb  /jugular  /subclavian  /femoral )

after

Various pipelines: No   drainage tube   gastric tube   urethral catheter   other(s)

returning to the ward

Skin condition: intact   other(s) Articles brought out: CRF   Medical image film:

  PCS   drugs    other(s)

Remarks： Signature of the PACU (or operation room) shift nurse： Signature of the on-duty ward nurse：

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3. Mode of Operation—The trauma caused by different surgical approaches, the impact on the body, and the positions and instruments that need to be placed differ and the difference can be very large. The mode of operation is the basis behind the preparation and use of surgical ­instruments and items, and an important basis for the selection of anesthetic methods. 4. Operation Key—Different surgeries have different surgical procedures, and even if the disease and operation are the same, for different individuals, there are different risks of surgical anesthesia. The operation key refers to the most important part of an operation and varies with each individual. It is the determinant of the success of an operation. 5. Key Points in Observing Condition Changes—The time when hidden trouble is easily exposed during the operation is the most unstable part of the operation and the focus of observation. The anesthesia induction period and awakening period can easily lead to hemodynamic changes. Intraoperative ligation of adrenal artery during an adrenal pheochromocytoma surgery may cause hypertensive crisis or cardiovascular complications. Tumor resection can cause a sharp drop in blood pressure, and even lead to irreformable hypovolemic shock. This is a critical moment for disease change, so it is necessary to be highly focused and continue to carefully observe and evaluate. 6. Surgical Nursing Problem—It is the objective procedural management requirement and the premise and foundation for effective nursing intervention to fully evaluate risk factors such as disease, anesthetic method, and operation key, and find out existing or potential nursing problems. 7. Key Points of Coordination—Coordination and support during robotic surgery is the basis of nursing work. To provide specific and effective nursing intervention and ensure safety of surgical nursing is the embodiment of the core competence of operating room nurses.

7.2.3.3 Implementation Method All nurses who participate in robotic surgery should know the seven key points in observing the patient’s condition and implement evidence-based nursing intervention according to nursing procedures. Nurses should be aware of the entire process of surgical nursing risk factors to predict, prepare, preemptively control, and avoid accidents or panic. Here is an example of an adrenal pheochromocytoma operation. 1. Master the General Information of patients (ID)—The circulating nurses should review the medical records and conduct preoperative visits to understand and master the general information of the patient. It is important to ask the time of oral administration of phenoxybenzamine before surgery, check whether the blood pressure is controlled at 120/80 mmHg and the heart rate is 80/min, to

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evaluate the effect of preoperative dilatation treatment. Routine operations for specific diseases should be reviewed, and it is important to understand the diseases or existing diseases of patients, and the methods and key points of robotic surgery. If adrenal cells contain catecholamines, the pheochromocytoma cells secrete large amounts of catecholamines into the blood without regulation, causing systemic pathological changes and symptoms (such as hypertension and arrhythmia). Adults mainly suffer from paroxysmal hypertension or sustained attacks of paroxysmal hypertension, while children suffering sustained hypertension are more common. Patients with cough, mood swings, and small changes in posture can induce acute hypertension. Intraoperative compression and traction of the tumor can cause hypertensive crisis, and removal of the tumor may lead to a sharp hypotension shock and even life-threatening conditions. Therefore, the focal point of the operation lies in the four stages of effective expansion before operation, controlled hypotension before tumor resection, intraoperative exploration to reduce compression (traction) of the tumor during the intraoperative exploration, and rapid hypertension after tumor resection. During surgery, the central adrenal vein is usually controlled as early as possible to minimize the pulling or squeezing of the tumor, to reduce the influx of catecholamines into the blood. In case of intraoperative hypertensive crisis, the operation should be suspended and sodium nitroprusside and other antihypertensive drugs should be injected intravenously. 2. Identify main nursing problems and prepare robotic surgery items based on the condition observation guidelines—The circulating nurses should make a comprehensive analysis of the patient’s medical history, the type of operation, and focal point of the operation, to identify main nursing problems. For instance, which route to choose for removal of pheochromocytoma (open or endoscopic), how to prevent a sudden increase in blood pressure during preoperative patient placement, and how to ensure rapid and massive blood transfusion before and after tumor resection to prevent hypertensive crisis or hypovolemic shock. Nursing measures should be improved according to the problems, such as gently placing the robots in the surgical position, preparing special instruments for robotic surgery, vasopressor agents, hypotensive drugs, anti-arrhythmia agents, infusion pump, pressurized blood transfusion (liquid apparatus), thermograph, and light-proof syringe or light-proof paper, and placing them in the designated position in the operation room. 3. During the critical period of the surgery, the nurses should closely monitor changes in blood pressure and pulse, keep special instruments, drugs, and pressure perfusion pump on standby, and remain at their post. For example, before tumor resection, the nurses should work with an anesthe-

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siologist to use sodium nitroprusside to reduce blood pressure; after tumor resection, rapid pressurized infusion (blood transfusion) should be performed, and vasopressor agents (adrenaline or norepinephrine, dopamine), and antiarrhythmic agents (lidocaine and propranolol) should be injected according to central intravenous pressure. Proper lighting should be ensured, and the nurses should meet all surgical requirements of the surgeons, and ensure the surgical procedure is conducted stably. The operating room nurses should closely combine the disease characteristics with the focal point of the operation and the operation problem by observing the conditions and providing appropriate guidance, to overcome the inflexibility when working robotic surgery. They should ensure that scattered and independent knowledge points are organically connected, to ensure the operation is conducted smoothly and reduce the effort required during intraoperative work. The nurses should also cultivate the ability to make a comprehensive judgment and consciously use nursing procedures to solve problems. In this way, the professional technical level of nurses can be fundamentally improved.

7.2.3.4 Quality Supervision and Management of Links The quality of nursing depends on quality awareness and monitoring by the nursing team during robotic surgery. Changing the behavioral model of nursing requires a process of selfcultivation and constant stimulation. Therefore, it is necessary to establish a nursing inspection system, carry out continuous awareness education, and strengthen shift supervision, to realize and promote personalized surgical support with the circulating nurses observing and mastering the overall condition of the patients, rather than the earlier method of limited coordination and support during the operation. The inspectors should usually be the head nurses or senior nursing experts. They are responsible for daily shift inspection, guide the nurses regularly through classes, and learn about nurses’ performance by observing, enquiring, examining, and communication. First, observing: before the operation, make a comprehensive survey of the operation room, observe the environment’s cleanliness, and ensure that everything is in order and check the position of items; check the patient’s blood pressure, pulse, and fluid patency and speed; and check whether the patient is positioned properly and stably. Second, enquiring: ask general information before skin incision; before and after tumor resection, ask the nurses about the key points of operation, nursing problems, and preparations. Third, examining: check whether the key inspection measures are implemented, such as drugs, pressure pumps, labels, and rescue records. Fourth, communication: find out and emphasize the key points and matters that require attention related to operation risks, rectify deficiencies, or assist in the nursing work.

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7.2.4 E  stablish Communication Records of Medical Work The success of the surgical procedure is the result of sincere cooperation by the team members. The process of robotic surgery involves coordination and communication between multiple departments, divisions, and links, and it is very common. Therefore, to avoid errors, delays, or incompleteness in information dissemination during medical communication, it is necessary to prepare a “Communication Records on Medical Work” to ensure accurate, complete and effective communication and dissemination of medical work information to patients, and reduce medical care risks. 1. Prepare a “Medical Work Telephone Communication Records.” Design the standard format to record the date, time, content of phone call, the department of the other party, the caller’s work number or name, the recorder’s name, and implementation records. 2. The phone records must be included in the nurse’s shift. On the one hand, the records should inform the processing situation and status of the shift, on the other hand, the records should inform the next shift on items that require follow-up and matters that need attention. In special cases, it is better to give written instructions. 3. All kinds of emergency consultation notices during surgery; examination queries and results of various emergency and rescue cases; queries and replies on various medicines, blood and blood products, instruments and equipment used in rescue; emergency reports of various medical incidents; and other incidents involving the patient’s medical safety, etc., must be recorded. 4. The items recorded in the phone log should be complete, accurate, and simple. 5. During the telephone communication of medical work, the medical personnel should answer (make) phone calls in the specified language, speak clearly, and at a moderate speed. ① Mostly, hospital telephones are set up for the convenience of work. Therefore, any phone call should be answered within three rings and the caller should not be kept waiting. ② When answering calls, first say hello to each other after picking up the receiver and give the name of the department. Secondly, record the department and name of the caller. Record the content of the phone call. Repeat it one last time and ask for confirmation. For instance, “Hello! This is the operating room. Where are you calling from? What’s the matter?” “May I have your department number or name?” “Yes, I’m taking notes.” “I am repeating what you just said...Please confirm whether it is correct and complete. Good bye!”

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③ When making a phone call, first say hello to the other party and give your department and name or work number; second, record the department and name of the listener; third, inform the other party of the contents and requirements of the communication; fourth, ask the other party to repeat it; fifth, make sure you repeat it correctly and end the call. For instance, “Hello! I’m XXX from the operating room. Please ask the duty nurse to respond to this call!”; “Please tell me your department and your name or work number”; “Please record the telephone information”; “Please repeat what I said just now”; “Yes, that’s right, thank you!” 6. When answering a phone call, do not eat and speak, do not repeat what you are writing, or try to speak out aloud your thoughts, as it may confuse the other party. 7. After the call, the person making the call should wait for the other party to hang up and then put down the phone. 8. The head nurse should conduct a weekly routine inspection, promptly comment on work implementation by subordinate personnel, strengthen the importance of telephone communication management, and constantly improve management measures.

7.2.5 Establishing an Execution List of Verbal Orders for Intraoperative Medication In accordance with the national code of practice for medical technology and medical quality management requirements, doctors and anesthesiologists can give verbal medical orders in case of an emergency such as patient rescue, surgery, or when the patient is moderately or deeply sedated. The circulating nurse should record the name of the doctor giving the order and its contents. After surgery, the doctor giving the order should sign the Execution List of Verbal Orders and record the signing time.

7.2.5.1 Current Methods and Problems in the Implementation of Surgical Drug Instructions 1. Verbal Orders—Medication orders verbally given by anesthesiologists or surgeons. The nurse should repeat the oral instructions before executing them, and the anesthesiologist should record them on the anesthesia list after the orders are executed. This approach violates the writing standard of medical records and can easily lead to medication errors; however, it continues to exist in clinical practice. 2. Establish the Execution List of Verbal Orders—After the anesthesiologist and surgeon give the verbal orders for medication, the circulating nurse should fill the Execution List of Verbal Orders, and repeat the contents of the verbal orders before executing. After surgery, the doctor giv-

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ing the orders should sign the Execution List of Verbal Orders and record the signing time. At the same time, the anesthesiologist should record the medication on the anesthesia list. With the implementation of surgical safety goals in 2009, this approach has been implemented in some operating rooms. The advantages of this approach are: It conforms to the writing standards of medical records, the evidence of medication can be relied upon, and the safety assurance is strong. However, the nurse is required to transcribe the verbal orders and get the signatures after the operation, which is time-consuming and is difficult to comply with during a busy operation.

7.2.5.2 Contents and Execution Requirements of the Intraoperative Execution List of Verbal Orders During the operation, the anesthesiologist and the surgeon can give Verbal orders. After a doctor gives an order, the circulating nurse should record its contents in the interim execution list of intraoperative orders. The contents of the verbal order should be repeated aloud, and the doctor giving the order should confirm and sign it before it is executed. After the operation, the doctor giving the order should sign the interim execution form of intraoperative orders and enter the time of signing, to indicate the confirmation and responsibility for executing the medical order. If an electronic order is generated, it should be supplemented according to the record-keeping requirements for electronic orders. If the anesthesiologist prescribes and executes the anesthetics orders, the anesthesiologist can record the order directly in the anesthesia note. After the operation, the circulating nurse must remind the doctor to sign the Execution List of Verbal Orders and take it back to the ward with the medical records. The above requirements and implementation methods, although a little troublesome and time-consuming, can ensure that there is reliable evidence thereby effectively avoiding the risk of medication (especially in case of interim medication orders during the non-rescue period), and also meeting the surgical objectives of medication management requirements.

7.3

 ommon Rules and Regulations C of Robotic Surgery

The system is the work regulation, the criterion for processing various work, the basis for evaluating work quality, and an important measure to prevent errors and accidents. In addition to the rules and regulations commonly used in general robotic surgery, relevant systems should be established to ensure the safety of robotic surgery based on surgical requirements. The rules and regulations established may vary due to different hospital facilities and personnel requirements, but the overall requirements for establishing rules and

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ensuring safety should be consistent. Therefore, hospitals can share the rules and regulations of operating rooms in their respective hospitals with other hospitals, looking at the rules and regulations of our hospital as an example.

7.3.1 R  ules and Regulations Governing the Use of Surgical Robots (Da Vinci System) This system is hereby formulated to strengthen the management of surgical robots (Da Vinci System), ensure reasonable, efficient, and orderly use of high-tech equipment, and comprehensively enhance its performance and benefits: 1. Work under the leadership of the surgical robot (Da Vinci System) management team. 2. The primary surgeon for a robotic surgery should be a doctor who has attended the training course of Da Vinci Robotic Surgery System and has obtained relevant qualifications. Doctors who have not participated in this training but have certain laparoscopic skills can act as assistants during robotic surgery. The operating room has established a robotic surgery cooperation team, and the nurses who participate in the surgery should also be qualified nurses who have received the above training. The operating room personnel should cooperate with the surgeon to collect data and prepare statistics. 3. The operating room should arrange robotic surgery by departments. All departments should submit the application form for robotic surgery to the operating room, and the operating room should arrange the robotic surgery according to relevant regulations. 4. Any instruments and consumables of the surgical robots should be kept in the operating room, and corresponding systems for storage, delivery, use, and loss registration should be formulated and strictly implemented, so as to improve the efficiency and benefit of surgical robots. 5. A special person should be assigned by the operating room to be responsible for the daily maintenance, equipment safety, and surgical work of the surgical robots (Da Vinci System). At the same time, corresponding care, maintenance, safety, operating procedures, records, and other rules and regulations should be formulated and strictly implemented. 6. The surgical robot team should operate the machine according to the operating procedures for surgical robots.

7.3.2 O  perating Procedures for Surgical Robots (Da Vinci System) 1. According to the operation schedule, ensure a reasonable layout of the operation room.

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2. Properly connect the power supply and cables of the Surgeon Console, the Patient Cart, and the Video Processing System. 3. Turn on the power and start machine self-check. During the startup procedure, do not place your head or any object in the eyepiece of the Surgeon Console. Do not touch the Patient Cart until the self-inspection is completed. Do not move the machine until you hear three warning sounds. 4. Properly cover the Patient Cart with sterile protective drapes to prevent contamination. 5. Set the camera lens jacket correctly and adjust the lens. Turn on the light source for the camera lens and calibrate the white balance and 3D eyepiece. Ensure the cable connection of the camera is not loaded or bent at right angles. 6. Bring the patient into the operation room, perform routine surgical preparation, and place the patient in the appropriate position after verification. 7. Punch appropriate Trocar holes based on the type of surgery. 8. Adjust the surgical position according to the surgical requirements. 9. Machine entry: Under the command of the onsite surgeon, the circulating nurse should push the Patient Cart into position. Before pushing the cart, move shadow-less lamps and other equipment away to avoid any impact, and place the card in the D position to fix it. 10. Docking: The console doctor should connect the camera arm and instrument arm to the corresponding Trocar and adjust the position of each robot arm. 11. Insert the lens and place the instruments on arms 2, 3, and 1 guided by the lens. After the instrument is placed in the designated position, assist the surgeon to adjust the lens to the corresponding operation angle (30° upward or downward). 12. The surgeon should adjust the Surgeon Console to maximize comfort, prepare for the operation, and replace the surgical instruments correctly during the operation, as required. 13. In case of emergency (if mis-operation occurs), press the emergency stop button immediately to stop all operations, and immediately remove the Patient Cart with the Trocar, and switch to open surgery if necessary. 14. At the end of the operation, the surgeon should open the instrument mouth and straighten the wrist of the instrument to remove the instrument. After taking out the lens, the scrub nurse should protect the lens and optical cables, remove the endoscope, and deliver the camera and cables to the circulating nurse. Pull out the Trocar, transfer the patient from the Patient Cart, remove the protective drape, and place the arm in place. 15. Power off, store the robot, and keep the Patient Cart charged for 24 h.

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16. Store the robot equipment in a fixed location. The cleaning, maintenance, and disinfection of surgical instruments and lenses are subject to the artificial reprocessing standards for EndoWrist. 17. After the operation, clean the robot equipment, register the service condition, and record the number of usage times.

7.3.3 C  leaning and Maintenance System for Robot (Da Vinci System) Instruments 1. After the operation, promptly record the service condition of the instrument, such as the performance and number of usage times. 2. The nurse participating in the operation should clean the instruments. 3. Clean the instruments correctly according to performance and types, handle them gently, and do not apply pressure while cleaning. 4. Clean and sterilize the instruments according to the reprocessing process for surgical robots (Da Vinci System) (refer to the wall chart for details).

7.3.4 O  perating Room Management System for Surgical Robots (Da Vinci System) 1. The operating room should be equipped with an access control system so that a password is required for access. The password should be changed regularly by the leader of the operating room management team (Fig. 7.1). 2. When the surgeon and nurse need to enter the operating room after the surgical scrub, the circulating nurse should open the door from inside the operating room. 3. The operating room should be off-limits. 4. Special personnel should be in charge of daily hygiene and cleaning, and the daily cleaning and maintenance of

Fig. 7.1  Password or fingerprints required to gain access to the robotic surgery room

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the surgical robot (Da Vinci System) must be carried out by trained nurses. 5. The Surgeon Console, the Patient Cart, and the Imaging System of the surgical robot (Da Vinci System) should be appropriately positioned. Do not change their storage locations randomly. 6. Personnel who have not received training in operating the surgical robot (Da Vinci System) are prohibited from starting the surgical robot and operating it, to prevent damage to the surgical robot caused by mist-operation.

7.3.5 Regulations on Management of Trainees and Interns 1. Ensure the operating room is quiet and tidy. Work conscientiously and responsibly and obey the orders of the management. 2. Abide by the operation management regulations and technical operation procedures. Listen to the guidance of operating room staff. 3. Observe the time of operation and arrive at the designated operation room on time for preoperative preparation. 4. It is strictly prohibited to discard gauze pads or other countable items in the dirt tub (basin) in the operation room, as it may lead to confusion of the count. 5. Do not handle operating room instruments, equipment, or items without permission. 6. Any visitor should be at least 30 cm away from the surgical personnel. Do not walk around in the room, especially near the instrument table or enter non-visitor permitted operating rooms. Do not read, chat, or engage in nonsurgical work in restricted areas. In addition, common rules and regulations of the operating room are listed as follows: The Work System for Operating Rooms, the Safety Management System for Operating Rooms, the Nosocomial

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Infection Management System for Operating Rooms, the Preoperative Visit System for Operating Rooms, the System of Picking up Surgical Patients for Operating Rooms, the Safety Verification System for Operating Rooms, the Surgical Inventory System, the Safety Protection System for Medical Personnel in Operating Rooms, the Surgery Reservation System, and the Sanitation System for Operating Rooms...

7.4

 ursing Management of Adverse N Events in Robotic Surgery

Adverse surgical events refer to any unexpected, unwanted, or potentially dangerous or unsafe events that occur during surgery, including major adverse events or accidents, serious errors, general errors, and hidden problems (similar to errors). Corresponding management regulations and requirements must be established to strengthen the safety management of surgical nursing, improve the ability of operating room nurses to avoid nursing risks, and reduce or avoid the occurrence of adverse surgical events. The system of reporting, registration, and handling of adverse surgical events falls under nursing risk management.

7.4.1 Types of Adverse Surgical Events 7.4.1.1 Major Adverse Events A major adverse event is an unexpected event that causes accidental death or major permanent loss of function of the patient, independent of the natural course or underlying symptoms of the patient’s disease; it is also known as an alert event. Major adverse events include surgical errors (wrong patients, wrong surgical sites, wrong surgical methods), unexpected intraoperative death, unplanned reoperation or surgical complications, transfusion of wrong blood type, missing instruments in the body cavity, misdiagnosis and mistreatment caused by loss of surgical specimens, outbreak of surgical site infection, major organ damage or long-term loss of functional veins, etc. 7.4.1.2 Serious Adverse Events Serious adverse events include severe output reactions and major medication errors such as inadequate preparation of surgical items results in intraoperative pause time of >30 min; repeated search (final count) in case of wrong count of instruments results in delayed closure of body cavity and cranial cavity for >30 min; improper surgical position causing nerve injury, acute pressure sores, or falling from bed; surgical items that are not sterilized to the standard or misuse of unsterilized items; picking up wrong patient or placing patient in the wrong position in the surgical field before ster-

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ilization; moving the patient’s position causes disconnection of catheters; however, there are no adverse consequences; medication errors; burns are caused by the use of electrical equipment; and scalding caused during the warming process.

7.4.1.3 Nursing Errors During the nursing process, errors occur in one or more links, and the errors are not found and corrected on time, resulting in the patient receiving incorrect nursing; preoperative fasting and water-deprivation are not implemented, which leads to a delay or termination of operation; intraoperative gauze dressing is not recorded or unclear; incomplete accessories in the operating bag; sterilized instruments are found to have dirt or blood during use; injury is caused by collision while transporting patients; incomplete de-­ iodization or prolonged immersion skin in disinfectant results in local burns. 7.4.1.4 Nursing Problems (Almost Errors) During the nursing process, errors occur in one or more links; however, the errors are found and corrected before they affect the patient, and the patient does not receive incorrect nursing.

7.4.2 T  reatment of Adverse Events During Robotic Surgery 1. In case of an adverse surgical event, the concerned person should remain at his/her respective post, actively assist the surgeon and anesthesiologist to find out the cause, and quickly evaluate the injury. The concerned person should also actively cooperate with doctors to treat and protect patients and injured personnel, and carefully maintain records and handle the situation to minimize harm or loss. In case of major rescue, it is necessary to initiate the rescue plan immediately to treat patients as soon as possible, control the situation, and improve the treatment’s success rate. 2. In case of an adverse surgical event, the concerned person or the person on duty should immediately report the adverse event orally to the head nurse, director of the department, or the anesthesiologist. If it is a major adverse event (such as surgically related error, intraoperative patient emergency, accidental injury, and wrong count of items), it should be immediately reported to the duty room of the medical department, and directly reported to the department leader in charge (e.g., director of the medical department) or the hospital leader in charge. In addition, the surgical nurse should protect all equipment, items, and the scene, to ensure there is no further adverse event. Nonessential personnel should not

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be allowed to enter, so as not to interfere with the investigation and handling of the matters. 3. After receiving the notice, the head nurse should immediately arrive at the scene, coordinate with human resources, coordinate and organize human resources, issue orders, quickly find out the situation, track the progress of the situation, and cooperate with doctors or relevant departments to handle the event. Also, the head nurse should learn about the cause of the event from the concerned person, estimate possible adverse consequences, and report to the director of the nursing department or the leader of the competent department. When the situation involves many departments, the head nurse should remain calm and cool-headed, be responsible and decisive, and maintain unified command in an orderly manner. 4. Prepare rescue records. Rescue records should be filled according to the medical document writing specifications. Rescue records must be filled within 6 h after rescue. The content, time, and disposal of the record sheet for medical treatment and nursing rescue should be objective, true, and accurate. Medical records should be consistent and not contradictory. At the same time, the circulating nurse should record the process, treatment, and result of adverse events in the intraoperative nursing record book or the Risk Event Record Book. Within 24 h, the head nurse should review and sign the nursing rescue records and intraoperative nursing records, and such review and signing of records should be done immediately if the patient dies. 5. The concerned person should finish the Report Form of Adverse Surgical Events, enter the detailed process, causes, main problems, severity, and treatment results of the events as required by the standard form, and submit them to the head nurse for review. After reviewing the signature, the head nurse should report it to the nursing department or competent department within 24  h through the electronic system. In case of sharp instrument injury, the relevant form provided by the infection control department should also be completed. 6. Within 1 week (no more than 1 month) of the event, the nursing department or the competent department should determine the nature of such event according to its cause, nature, damage degree, impact, compensation amount and other relevant factors, and propose treatment suggestions, which should be reported back to the department in the form of written reports. 7. The department should hold the nursing safety analysis meeting or special issue seminar within 1 month. First of all, it is necessary to find out the problem, make a comprehensive and truthful analysis of the event, find out the

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problems and causes as per the system standards, management procedures, and operation implementation, and determine what went wrong, what the problem was, what was unclear, or who was negligent. Second, it is necessary to analyze the causes, as well as the correlation, inevitability and harmfulness among the causes of the problems, and find the breakthrough point and effective methods to solve the problems. Third, the responsibility should be clarified, and handling suggestions should be proposed. Finally, according to the weak links in the work and the guidance given by the nursing department, relevant comprehensive improvement measures should be formulated. 8. The department should learn from the adverse events, draw inferences from one example, and take preventive measures. The existing rules and regulations, operating standards, measure requirements, equipment maintenance, etc., of the department should be comprehensively sorted out, reviewed, and revised. In particular, it should be compared with the new standards and requirements to find out where there are mistakes and omissions, deficiencies, or hidden dangers, so as to manage carefully and move the risk prevention window forward. 9. Perfect and improve nursing measures. The department should organize general nurses to hold symposiums or safety analysis meetings on unexpected events. First, the causes and problems of the event itself should be analyzed, especially if it is necessary to find the problems from the management level. Second, it is necessary to comprehensively sort out the existing system, process, and requirements of the department through this event, to draw inferences and find hidden dangers. Only when the issues are identified accurately and completely can preventive measures be effective. Third, corrective measures should be formulated according to the cause analysis of the department and the guidance of the nursing department. Fourth, everyone should learn lessons from events, enhance risk awareness, strengthen the sense of responsibility, and learn new measures and implementation requirements. Fifth, rewards and punishments should be implemented according to the handling opinions of the nursing department and performance management measures of the department. Sixth, corrective measures formulated by the safety analysis committee and the opinions on the final handling of events should be reported to the nursing department. 10. Monitor and check the nursing effect dynamically. First, the content and implementation requirements of the measures should be repeatedly emphasized through the morning shift meeting and weekly (monthly) quality

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evaluation meeting. Secondly, the head nurse of the department and the nursing department should carry out scheduled or unscheduled inspections and spot checks to check the implementation and effect of corrective measures and improve the corresponding measures in time, to achieve continuous quality improvement. 11. The nursing quality team of the department and nursing department should conduct dynamic quality tracking, inspection and monitoring of the corrective measures, and review the implementation and improvement effect, to achieve the purpose of continuous improvement.

7.4.3 B  asic Requirements for Risk Management in Robotic Surgery Rooms 1. A first-level management organization for nursing quality and safety in the robotic surgery room should be established, which shall be responsible for formulating the annual risk management plan and the reporting system for risk events, improving work procedures and process improvement or reform, preparing surgical safety protection plan and continuous improvement measures, and specifying objectives, responsibilities, and division of labor, so as to define each person’s responsibility. The team members should be composed of the head nurses, cochief superintendent nurses, and senior nurses, who should be proficient in their respective fields, have mastered the standards and evaluation rules of specialty nursing quality, and are familiar with risk management organizational processes, and can carry out regular nursing work. 2. The zero-defect consciousness of medical personnel should be strengthened. When medical personnel undertakes surgical treatment of the patient, they have assumed the responsibility for safety protection of the patient’s life and health. People only have one life, and no “defect” is allowed. Therefore, the fundamental way to prevent accidents and errors is to prevent them in advance rather than deal with them afterward. Based on learning new regulations, new norms, and new theories, the existing system, standards, and measures should be compared, revised, and improved on time. By analyzing the cases of adverse events regularly and learning lessons, the reasons behind the adverse event should be found out from the perspective of the system, management process and personnel

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quality, and management methods and training contents should be adjusted accordingly. Nurses should be educated to complete tasks on time and in accordance with standards, and completed tasks should be checked and determined to be completely correct before the shift is handed over, so as to eliminate hidden dangers at the source. 3. Risks should be measured and evaluated regularly, and risk ranking and data summarization should be conducted according to the severity, degree of harm, economic loss, and occurrence frequency of defects or adverse events on their own or within the industry, so as to determine the focus, order and rectification intensity in solving problems, once a month. 4. A nonpunitive reporting system for adverse events during robotic surgery should be established, and the report should include the type of event, patient data, data of persons involved, event history, cause analysis, processing results, and summary. 5. Nurses should develop the capacity for lifelong learning. Only by combining the knowledge acquired in the classroom and continuing education after graduation can nurses become experts in their domain. Therefore, it is necessary to closely link the development of surgery, rules and regulations, and surgery requirements, to conduct self-study and level-based training, constantly update the knowledge structure, and improve professional quality so that everyone strives to do things right every time. This is also the core and requirement of refined management.

7.5

 reatment of Emergencies in Robotic T Surgery Room

An emergency is a sudden and unpredictable event that endangers the health or life of the patient, such as fire, power failure, water shortage, and earthquake. In the event of an emergency in the operating room, the instruments or equipment may be damaged or malfunction, leading to the failure of the operation, and seriously endanger the patient’s life. Therefore, the principle of putting prevention first and being constantly prepared should be followed with respect to emergencies. Emergency plans need to be developed and all staff trained on their roles and responsibilities during emergency situations.

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7.5.1 E  mergency Plan for Fire in Operating Room (Fig. 7.2) Found the fire

1. The cause of the fire, the scope of the fire, the personnel, the injury, and the available safe passage. 2. Rescue items for fire protection and firefighting.

Evaluation

3. Number of fire fighters required. 4. Rescue items; the number, property, and location of the fire-fighting equipment. 1. Notify the security department on duty of the hospital immediately if there is a fire.

Report to relevant departments

2. Call 119 (911) immediately if difficult to control the fire, and tell the exact address. 3. Inform all operating rooms to prepare for firefighting. 1. Organize existing personnel, gather all firefighting equipment to actively fight and control the fire

Organize fire fighting

2. Immediately cut off the power supply and gas supply to the fire scene, and remove the inflammable and explosive items. 3. Close the doors and windows of adjacent rooms to prevent the fire from spreading 4. Lower the fire gate to isolate the fire area 1. Assist the surgeon to stop the bleeding, bandage the patients on the operating

Evacuate and evacuate surgical patients and staff

table, and put them on the stretcher as soon as possible. 2. For patients needing assisted breathing, the anesthesiologist should attach the breathing sac to maintain artificial respiration. 3. Evacuate patients and staff, leave the fire scene and go to a safe area, and do not use elevators.

Rescue valuable equipment and data

When the safety of life is not threatened and the fire is under control, save as much valuable equipment and information as possible and transfer them to a safe place.

Fig. 7.2  Fire emergency protocol in the operation room

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Find out reason and Inform maintenance department, electricians

Enable the backup power

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Observe patent

Turn off the instrument

Adjust instrument parameters after power back on

document and report the power failure and condition of patient

Fig. 7.3  Emergency protocol for forecasting and sudden power failure in operating room

7.5.2 E  mergency Plan for Planned and Sudden Power Failure in Operating Room (Fig. 7.3) Found a power outage 1. The reasons and scope of power outage. Ask for reasons

2. Whether instruments are damaged or not. 3. Whether there are casualties or not. 1. Report to the head nurse, director of anesthesiology department, and the personnel on duty in time after receiving the notice of power failure.

General power outage

2. Indicate the time of the outage in the special case log book. 3. Organize personnel to prepare for power outage, having hand lanterns and flashlights ready. 4. If there is no backup power supply to the operating rooms during power outage, in principle, elective surgery cannot be arranged. 1. Turn on the emergency hand lanterns immediately, and inform the water and

Sudden power outage

electricity shift and chief duty. 2. Turn off all instruments in use and electrical switches. 3. Start the backup power supply for the devices.

Strengthen peram bulations and observations of the disease

1. Strengthen perambulations of the operating rooms and observations of the disease for surgical patients. 2. Prevent falls or bruises. 3. Be aware of accidents and other incidents.

Restore power and check instruments

Charge the backup power sources

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7.5.3 E  mergency Plan for Planned and Sudden Water Shutdown in Operating Room Found the water outage

Ask for reasons

1. The reasons and scope of water outage. 2. Check existing water reserves. 1. Report to the head nurse and the personnel on duty in time after receiving the notice of water outage.

Genal water outage

2. Understand the reason of water outage and water intake way, then record and indicate the time of water outage in the special record book. 3. Organize personnel to prepare for water outage, storing as much water as possbile.

Sudden water outage

1. Inform the head nurse, the water and electricity shift, and chief duty. 2. Use reserve water or convert to alternative water sources.

7.5.4 E  mergency Plan for Sudden Cessation of Central Oxygen Supply in Operating Room 1. The reasons, scope and time of the sudden cessation of central oxygen supply. Ask for reasons

2. Whether there is operation, patient needs oxygen supply. 3. Available non-central emergency oxygen supply devices and their location. 1. If it is a fault that the nurse cannot remove, shut off the central oxygen supply, notify the worker of central oxygen supply immediately to maintenance and

Report to relevant departments

find out the reasons. 2. Report to the anesthesiologist, surgeon, and head nurse for decision on alternative oxygen supply devices. 3. If the fault is not temporary, notify the head nurse and the chief duty immediately to eliminate the cause as soon as possible. 1. Push the spare oxygen cylinders from the treatment room into the operating

Take other oxygen supply devices

room timely and connect it to the anesthesia machine for direct oxygen supply. 2. When there is no oxygen cylinder, the patient who needs assisted breathing

Strengthen peram bulations and observations of the disease

shall be given artificial respiration by respiratory sac.

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7.5.5 E  mergency Plan for Sudden Cessation of Central Attraction in Operating Room 1. The reasons, scope, and time of the sudden cessation of central vacuum aspiration. Ask for reasons

2. Available mobile electric aspirators and their location. 1. If it is a fault that the nurse cannot remove, shut off the central vacuum aspiration,

Report to relevant departments

then notify the worker of central vacuum aspiration immediately to maintenance and find out the reasons. 2. Report to the anesthesiologist, surgeon, and head nurse. 3.If the fault is not temporary, notify the head nurse and the equipment department or the hospital chief duty immediately to eliminate the cause as soon as possible.

Employ other suction devices

1. Start mobile electric aspirators. 2. No mobile electric aspirators and patients with respiratory secretions, syringe can be used for sputum suction.

Strengthen perambulations and observations of the disease

7.5.6 E  mergency Plan for Wrong Count of Surgical Items Found error in the counting of surgical items

Seek immediately

1. Reconfirm the number of surgical items. 2. Review the entire operation process and search lost items within the scope of the operating table and the operating room, and ask relevant personnel. 1. If there is an error in the counting of surgical items, report to the head nurse, surgeon, and anesthesiologist timely.

Dispose in time

2. Arrange bedside radiograph when necessary. If the objects are found, record it in the book that register foreign matters left in the operating room. 3. If the item is not found, ask for the head nurse. The head nurse shall report to

Patient leaves the operating room

the surgeon, medical department, and other relevant departments step by step to discuss the treatment plan, take relevant measures, and record them.

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7.5.7 P  reventive Measures for Patient Falling from Bed, Tumbling, or Collision in Operating Room and Emergency

Plan for Patient Falling from Bed, Tumbling, or Collision

1. Check the performance of the operation transport vehicle. Pay attention to the patient's hands and feet not exceeding the edge of the transport vehicle, and escort the person on the side of the patient's head. Before the operation

2. Assess patient condition: when transporting children, comatose, or agitated patients, bedside rail restraint should be pulled well, the restraint bands should be tied well, and patient should be escorted. 3. Conduct safety education for awake patients to guide them to move correctly and do well in protection work. 1. During the operation: patients during general anesthesia induction phase

Intraoperative

and before being fully awake should be monitored closely. Special attention should be paid to patients’ limbs. Use drapes when necessary. 2. Use pads and drapes to properly secure the patient during the surgery. 1. In cases of accidental falling bed, fall or bump, inform the doctor immediately to make a preliminary assessment of the injury, and rescue if necessary. 2.The minor injury can be lifted back to the operating bed. And then comfort patient, measure vital signs, and do necessary examinations and treatments. 3. If fracture or ligament injury is suspected, appropriate handling methods

During the operation

should be adopted according to the injured site and condition. X-ray examination and corresponding treatments should be done. 4. When the consciousness obstacle of head injury endangers life, gently lift the patient to the operating bed immediately, observe the changes of the condition closely, and take measures in time. 5. Report to the head nurse and the managing doctor immediately, assist the doctor to inform the patient's family, and report to the medical department or chief duty in time. 6. Check the patient's condition at the end of the operation, record the process

After the operation

of falling bed, falling or bumping accurately and timely, and rescue on the surgical nursing record sheet. 7. Hand over the patient's condition to the ward nurses carefully. Follow up the prognosis frequently after the operation.

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7.5.8 P  reventive Measures for Pressure Sores in Operating Room and Emergency

Plan in Case of Occurrence of Pressure Sores

1. Patients were visited on the first day before the operation to evaluate the risk factors of intraoperative pressure sores. Preoperative

2. On the day of operation, check the skin condition of the patient's whole body. If there are pressure sores or broken skin, carefully understand with the nurse in the ward. 3. For the elderly, patients with poor general condition, thin or obese body shape, poor skin elasticity and long operation time, they should report to the specialist group leader and the head nurse for evaluation, fill in the "Registration Form of Unavoidable Pressure Sores" and inform their families.

1. The operation position should be placed reasonably, and the movements should be gentle and standard. It is strictly prohibited to drag, pull, push, pull, and other Intraoperative

actions that are easy to damage the skin. 2. Appropriate width and tightness of the restraint belt, reasonable placement of backing, support, force point, find the appropriate fixed point. 3. During the operation, inspect the skin color and temperature under pressure frequently, and strengthen the safety measures.

1. At the end of the operation should check the patient's whole skin condition, if pressure sores, should immediately report to the head nurse, take effective treatment Post operation

measures, record truthfully on the surgical care record list, and complete the "Registration Form of Unavoidable Pressure Sores". 2. Communicate with ward nurses carefully, take active treatment measures, follow-up after surgery, closely observe the pressure sores outcome, and record it timely and accurate.

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7.5.9 P  revention of Burns or Scalding in Operating Room and Emergency Plan for Burns or Scalding 1. Patient assessment: special attention will be paid to pediatric, coma, hypothermia, Preoperative

and paralysis patients. 2. Check the performance of the high-frequency electric knife. The patient's whole skin should not touch the metal part of the operating bed.

1. Strictly implement the high-frequency electric knife operation specifications, the negative plate flat paste on the muscular plump and no skin damage surface, contact area should be more than 70%. Intraoperative

2. Keep the operation sheet, cloth pad flat and dry, if soaked in disinfection should be replaced in time, especially to avoid burns children patients. 3. Attention should be paid to the concentration, dosage, and method of using chemicals to avoid burns. 4. When the patient is burned or scalded, should immediately take effective treatment measures, and timely report to the head nurse.

1. At the end of the operation, check the patient's skin condition, truthfully record on Post operation

the surgical care record sheet, and carefully communicate with the ward nurses. 2. Postoperative follow-up, take positive measures, closely observe the burn or scald the outcome, timely and accurate record.

7.5.10 Emergency Plan for Surgical Robot Failure 1. Start the machine 30min in advance and check the self-test of the machine. Preoperative

2. Observe the functional state of the robot operating system, pay special attention to the motion state of the robot arm and the light source system. 3. Prepare a set of HD laparoscopic system and corresponding laparoscopic instruments.

1. Strictly implement the operation specifications of robot system to avoid equipment failure caused by human factors during operation. 2. In the event of a failure, the system determines whether the failure is recoverable. If the fault can be recovered, you can touch the Recovery button to ignore; If the Intraoperative

failure is unrecoverable, the system must be restarted. The system displays the following information: Non-recoverable fault: XXXX; Restart System to continue . 3. Malfunction of the arm will display an error icon; the arm LED light turns yellow or red. Instead of an arm-specific malfunction, all arm LED light turns yellow or red (Picture.7.5.4). 4. If the malfunction cannot be eliminated after restart, the operation can be completed by changing the operation mode according to the patient's condition.

Post operation

1. Contact robot maintenance engineer for system overhaul and maintenance timely. 2. Patients' recovery should be followed up after operation.

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Infection Management in Robotic Surgery Room Gongxian Wang, Yu Zeng, and Xia Sheng

Nosocomial infection refers to an infection acquired by an inpatient in a hospital, and includes infections that occur during hospitalization and/or acquired after discharge, but does not include infections that begin before admission or are in the incubation period at the time of admission. Surgical site infection is a major form of nosocomial infection and is the most common nosocomial infection in surgical patients. Robotic surgery teams should follow the management standards for operating rooms against nosocomial infection, carefully implement relevant rules and regulations for nosocomial infection management, and prevent and control surgical site infection. This chapter elaborates the rules and regulations, infection control, disinfection, sterilization and storage of robot instruments, and self-protection, from risk factors related to the operating room, etc.

8.1

Regulations and Infection Control

Robotic surgery should be arranged in a relatively fixed clean operating room, in accordance with the Technical Specifications for Nosocomial Infection Prevention and Control in the Surgical Department and the Management Standards of the Hospital Surgical Department (Room). Prior to the operation, surfaces in the operating room should be routinely cleaned, and the number and flow of personnel minimized. Visitors should be as few as possible. A password lock should be set outside the door of the operating room. A password or fingerprint should be required for entering the operating room. During the operation, the door of the operating room G. Wang (*) Department of Urology, The first Affiliated Hospital of Nanchang University, Nanchang, China Y. Zeng Department of Operating Room, The first Affiliated Hospital of Nanchang University, Nanchang, China X. Sheng Robotic Urology Operating Theatre, Changhai Hospital, Shanghai, China

should be kept closed and positive pressure ventilation should be maintained as far as possible. If there is blood, bodily fluids, or secretion contamination on the ground or on any surface, it should be appropriately handled immediately. After each operation, any dirt should be immediately cleaned, and the effectiveness of self-purification time should be guaranteed for continuous operations. All cleaning utensils in the operation room should be replaced with disinfected ones after each use (Fig. 8.1). The operation notice of any quarantined patient should indicate the infection status, and strict quarantine measures should be implemented. Postoperative instruments and items should be handled in accordance with the requirements, and the operating room should be completely sterilized after the operation, and strictly monitored to ensure compliance before next use. All items, instruments, and the floor of the operating room should be cleaned and sterilized with effective chlorine disinfectant at the corresponding concentration every day after the operation. The operating room should be cleaned once a week on Friday. Specific persons should be placed in charge of such cleaning.

8.2

Disinfection, Sterilization, and Storage of Robot Equipment

Effective disinfection and sterilization methods should be selected according to the properties of the items and instruments. Items and instruments resistant to high pressure and moisture such as surgical instruments, robot arms, metal puncture tools, and calibrators should be sterilized with pressurized steam. Ethylene oxide or plasma-based low-­ temperature sterilization can be used for non-heat-resistant, non-moisture-resistant, and valuable items, such as laparoscopic instruments and robotic surgical lens. After usage, all instruments should be placed in a closed container and transported to the disinfection supply center (Fig. 8.2).

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 G. Wang et al. (eds.), Robotic Surgery and Nursing, https://doi.org/10.1007/978-981-16-0510-9_8

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Fig. 8.1  Cleaning tools should be replaced and disinfected after use

Sterilized items should be separated from unsterilized items. Prior to using sterile items, it is necessary to check the labels, item contents, and sterilization date, as well as the chemical indicator card for sterilization. Items can only be used if they meet the requirements. The specifications for autoclave sterilization should meet the requirements. Biological monitoring should be conducted every month, and the volume of the bag should be

(30 cm × 30 cm × 50 cm), the weight of the instrument bag should be 56 22.0% infection is increased. For patients who can improve peak expiratory flow with bronchodilators; bronchoof lesions similar to unidirectional flap in the lower dilators should be given preoperatively. The pulmoairway, which causes gas to be easily inhaled but difnary function grading of clinical severity of chronic ficult to exhale, nitrous oxide should be avoided in obstructive pulmonary disease (COPD) is shown in general anesthesia, so as not to increase the volume Table  12.3. The grading of dyspnea is shown in of the air cavity, and result in respiratory and circulaTable 12.4. tory dysfunction. (3) Preoperative examination includes blood biochemis(4) Preoperative medication: Short-acting benzodiaze try, electrocardiography, and blood gas analysis, as pines are generally given to relieve preoperative conwell as CT or MRI examination, if available. In case

12  Nursing Cooperation for Anesthesia in Robotic Surgery Table 12.3  Pulmonary function grading of chronic obstructive pulmonary disease (COPD) in clinical severity Grade I (mild) II (moderate) III (severe)

Function FEV1/FVC