TIVATO 700 Instructions for Use Ver 1.0 Sept 2020

Copyright © 2020, Carl Zeiss Meditec AG, Jena Brands TIVATO® 700 from ZEISS is a brand or registered trademark belonging to Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany and/or other countries. All other brands mentioned in this document are the property of their respective owners.

Instructions for Use ZEISS TIVATO 700

Table of Contents

Table of Contents 1

Notes on the instructions for use ... 11

1.1

Device name ... 11

1.2

Area of application ... 11

1.3

Purpose and storage of the documentation ... 11

1.4

Questions and comments ... 11

1.5 1.5.1 1.5.2

Conventions in this document ... 11 Conventions in all text areas... 11 Conventions in a course of action... 12

1.6

Other applicable documents ... 13

2

Safety notes ... 15

2.1

Target group ... 15

2.2

Area of use ... 15

2.2.1 2.2.2 2.2.3 2.2.4

Intended use ... Indications... Normal use... Risk of burn injuries caused by high illumination intensity ...

2.3

Responsibilities and duties of the operator ... 20

2.3.1 2.3.2

Requirements for the network connection... 22 Messages to manufacturer and authorities ... 23

2.4

Measures and duties of the operator... 24

2.5

Electromagnetic compatibility ... 25

3

Description of the device... 27

3.1

Marking on the device... 27

3.2

Labeling on packaging ... 31

3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6

Structure of the device ... 33 Device overview ... 33 Surgical microscope overview... 34 14-function foot control panel ... 36 Stand base ... 37 Overview of connector panel... 37 Overview of video connector panel ... 38

3.4 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6 3.4.7 3.4.8 3.4.9

Control elements and displays ... 40 Screen keyboard... 40 Display: Editing... 40 Online help... 41 Surgical microscope control elements... 42 Foldable tube control elements ... 43 Tiltable tube control elements ... 44 Controls for widefield eyepieces ... 45 Controls of handgrips... 46 14-function foot control panel ... 47

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Instructions for Use ZEISS TIVATO 700

3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 3.5.10 3.5.11 3.5.12 3.5.13 3.5.14 3.5.15 3.5.16 3.5.17 3.5.18 3.5.19 3.5.20 3.5.21 3.5.22 3.5.23 3.5.24 3.5.25 3.5.26 3.5.27 3.5.28 3.5.29 3.5.30 3.5.31

Software description ... 47 General ... 47 Interactive buttons ... 48 User interface ... 50 Status information... 53 Patient data... 54 Import patient data from the DICOM Worklist... 55 Video recording playback ... 57 SmartLinks... 58 Light... 59 Tube... 60 Focus ... 61 Zoom ... 62 Handgrips... 63 Foot control panel ... 65 Stand ... 66 Displays... 67 Audio ... 68 Photo ... 69 Video camera ... 70 Video recording... 71 Fluorescence ... 72 Storage ... 73 Navigation... 74 Computer name ... 75 Ping IP Address ... 75 LAN... 76 Web interface... 77 ZEISS Smart Services ... 77 Info ... 78 Extras ... 79 Password-protected settings and configurations... 80

3.6

Data management ... 96

4

Installation ... 97

4.1

Requirements ... 97

4.2

Connecting the device to the power supply and switching it on... 97

4.3

Initial device login ... 98

4.4

Connecting the wired foot control panel ...100

4.5

Pairing the wireless foot control panel with the device...101

4.6 4.6.1 4.6.2

Connecting external video devices and monitors...103 Connecting the 4K monitor ... 105 Connecting the HD monitor ... 107

4.7

Connecting USB storage media ...109

4.8

Connecting an iPad to the charging station (option) ...110

4.9 4.9.1 4.9.2 4.9.3

Configuring the network ...111 Activating IT admin system rights ... 111 Activating the network connection via LAN adapter ... 112 Activate network connection via wireless LAN (option)... 112

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4.9.4 4.9.5 4.9.6

Creating and activating the device as a hotspot... 114 Network drive (option) ... 115 Configuring the network connection for DICOM (option) ... 115

4.10

Changing the computer name of the device ...116

4.11 4.11.1 4.11.2 4.11.3

Configuring the Service PC ...117 Service ... 117 Settings ... 118 Log Files ... 119

4.12

Connecting the navigation system to the device ...119

4.13

Mounting the laser micromanipulators...120

5

Daily startup...123

5.1

Safety during preparation...123

5.2

Setting the position of the handgrips ...124

5.3 5.3.1 5.3.2 5.3.3

Positioning the device in the OR...125 Cranial procedures and ENT... 125 Face-to-face procedures ... 126 Moving the device... 126

5.4

Checking the movement freedom of the device ...127

5.5

Configuring the device for applications ...127

5.6

Attaching tubes and eyepieces ...128

5.6.1 5.6.2 5.6.3

Attaching tubes to the microscope body ... 129 Attaching tubes and stereo bridge to microscope... 129 Attaching the documentation/co-observation equipment ... 130

5.7

Attaching a ZEISS SMARTDRAPE...131

5.8

Balancing the device...133

5.9

Adjusting the microscope ...134

5.10

Activating a connection to the navigation system ...135

5.11

Preparing the device for use of laser micromanipulators...136

6

Operation ...139

6.1

Safety during operation...139

6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6 6.2.7 6.2.8 6.2.9 6.2.10 6.2.11

Software configuration...142 Configure microscope ... 142 Configuring the button assignment of the handgrips and foot control panel ... 147 Configuring the stand... 150 Configuring displays ... 150 Configuring Audio ... 151 Configuring Photo ... 151 Configuring the video camera ... 151 Configuring the video recording ... 153 Configuring fluorescence... 154 Configuring storage... 154 Configuring navigation ... 155

6.3

Managing users ...155

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6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7

Adding users ... 155 Configuration of users ... 156 Exporting user settings to a USB storage device... 156 Importing user settings from a USB storage device ... 157 Change of user... 157 Copy a user ... 157 Delete User ... 158

6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 6.4.9

Managing patients ...158 Adding a patient ... 158 Changing patients ... 159 Editing patient data ... 159 Searching for a patient ... 160 Sorting patients... 160 Exporting patient data... 161 Importing patient data from the USB port or network ... 162 Importing patient data from the DICOM Worklist ... 163 Deleting patients ... 164

6.5

Video recording (option)...165

6.6

Creating photos with the integrated video camera ...166

6.7 6.7.1 6.7.2 6.7.3 6.7.4

Patient data, photos and videos ...166 Opening the patient directory... 167 Display of media objects (files)... 167 Viewing patient images ... 167 Viewing patient videos ... 168

6.8

DICOM (option)...168

6.8.1 6.8.2

Importing patient data from the DICOM Worklist ... 169 Exporting patient data to DICOM ... 170

6.9

YELLOW 560 (option) ...171

6.9.1 6.9.2 6.9.3

Configuring YELLOW 560... 172 Procedure for YELLOW 560 function test... 173 Starting the YELLOW 560 fluorescence application... 174

6.10

Using the device as a hotspot...175

6.11 6.11.1 6.11.2 6.11.3

Using ZEISS Smart Services...176 Activating ZEISS Smart Services ... 176 Send Diagnostic Package... 176 Allow Remote Service Access ... 176

6.12

Switching the device off ...177

7

Cleaning and disinfection ...179

7.1

Safety during cleaning and disinfection...179

7.2

Contamination of the system...179

7.3 7.3.1

Cleaning and disinfecting agent ...180 Cleaning agents... 180

7.4 7.4.1 7.4.2 7.4.3

Cleaning ...180 Cleaning optical surfaces ... 180 Cleaning the monitor (touchscreen)... 180 Cleaning mechanical surfaces ... 181

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7.4.4

Fogging of optical surfaces... 181

7.5 7.5.1

Disinfection ...181 Disinfecting the mechanical surfaces ... 181

8

Maintenance ...183

8.1

Safety during maintenance...183

8.2

User maintenance intervals...183

8.3 8.3.1 8.3.2

Maintenance schedule for the authorized service...184 Service maintenance intervals ... 184 Performance of safety inspections ... 184

8.4

Remote service ...185

9

Troubleshooting...187

9.1

Localize faults...187

9.1.1 9.1.2 9.1.3

Fixing faults with messages ... 187 Export Log Files ... 187 Service information ... 188

9.2

Faults without messages ...188

9.3

Basic functions following failure of the system control (Basic Function Mode)...190

9.4

Device in the de-energized state...191

9.5

Activating the backup xenon lamp via the monitor ...191

9.6

Activating the backup xenon lamp via the light source ...192

9.7

Changing the lamp container of the xenon light source ...194

10

Technical specifications...197

10.1

Regulatory information ...197

10.2 10.2.1 10.2.2

Radio frequency approval...197 Displaying radio frequency approvals on the monitor ... 197 Radio frequency approval labeling ... 198

10.3 10.3.1 10.3.2 10.3.3

Radio modules...198 FCP WL, FCP Gateway WL and FCP Interface... 198 WLAN module... 198 RFID ... 199

10.4

Essential performance features ...199

10.5

Electrical data...199

10.6 10.6.1

Xenon light source ...200 Additional information ... 200

10.7

LED light source...200

10.8

Integrated 1-chip HD camera...200

10.9

Integrated 3-chip HD camera...201

10.10

Integrated 4K camera...201

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10.11

Digital video outputs ...201

10.12

Digital video inputs...202

10.13 Mechanical data ...202 10.13.1 Device data ... 202 10.13.2 Weights of accessories ... 202 10.14 10.14.1 10.14.2 10.14.3

Optical data...203 Surgical microscope... 203 Widefield eyepiece (magnification factor 10x) ... 203 Widefield eyepiece (magnification factor 12.5x) ... 204

10.15

Ambient requirements for operation ...204

10.16

Ambient requirements for transport and storage ...204

10.17

Operation with intraoperative MRT systems ...204

10.18

Dimensional drawing...205

10.19 Guidelines and manufacturer’s declaration for electromagnetic compatibility ...206 10.19.1 EMC - Electromagnetic compatibility as per IEC 60601-1-2:2007 (3rd Edition) ... 206 10.19.2 EMC - Electromagnetic compatibility as per IEC 60601-1-2: 2014 (4th Edition) ... 210 10.20 10.20.1 10.20.2 10.20.3 10.20.4 10.20.5 10.20.6 10.20.7

Security Concept...213 Security Concept ... 213 System overview... 213 General principles... 213 Data protection ... 214 Functions relevant to cybersecurity ... 215 Sicherstellen einer vertrauenswürdigen Systemvorbereitung ... 220 Schutz kritischer Gerätefunktionen ... 221

11

Accessories and components ...223

11.1

Video options ...223

11.2

Main tube with eyepieces...223

11.3

Eyepieces...223

11.4

Left/right co-observation ...224

11.5

Face-to-face co-observation...224

11.6

Tube for posterior fossa ...224

11.7

Magnification changer...224

11.8

Tube and stereo bridge 50 covers ...224

11.9

Fluorescence...225

11.10

Foot control panel ...225

11.11

Sterile covers/drapes ...225

11.12

Sterilizable caps...225

11.13

Country-specific cables ...225

11.14

Lamp container of the xenon light source ...226

11.15

Connectivity and data management ...226

11.16

Navigation interface ...226

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11.17

Positioning functions ...226

11.18

Video accessories ...227

12

Disposal ...229 Glossary ...231 Index ...233

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Empty page, for your notes

Instructions for Use ZEISS TIVATO 700

1 Notes on the instructions for use 1.1 Device name

1 Notes on the instructions for use 1.1 Device name The ZEISS TIVATO 700 is referred to as "the device" in the present Instructions for Use.

1.2 Area of application These instructions for use apply to the ZEISS TIVATO 700 version 1.4 and the following identification label: • reference number: 6643

1.3 Purpose and storage of the documentation These instructions for use explain the safety features, functions and performance parameters of the device. They contain instructions on the safe use of the device and identify measures for its care and maintenance. Correct operation of the device is imperative for its safe and successful functioning. u

Read these instructions for use before setting up and using the device the first time.

u

Keep the instructions for use accessible for all users at all times.

u

Pass the instructions for use to future owners of the device.

1.4 Questions and comments u

If you have any questions or comments concerning these instructions for use or the device itself, contact ZEISS Service.

You can find the ZEISS contact partner for your country on the following website: www.zeiss.com/med

1.5 Conventions in this document Certain types of information are specially marked in this document for better recognition.

1.5.1 Conventions in all text areas • This is a list. – This is a second level list. This is a cross-reference: Conventions in this document [} 11]. This is highlighted text. This is software code or program text.

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1 Notes on the instructions for use 1.5 Conventions in this document

Instructions for Use ZEISS TIVATO 700

Names of software dialogs, fields or menus, and software messages are marked by quotation marks: • "View" menu. • "Do you want to save the settings?" The steps in menu and file paths are separated by slashes: • "File / Save as" • "My documents / Documents" Keys, buttons, knobs, levers, and other operating controls are marked by square brackets: • [START] key • [Next] button

1.5.2 Conventions in a course of action

WARNING!

This is warning information about hazards that can cause death or severe injuries if not avoided. The warning message names the possible consequences. u

CAUTION!

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause injuries if not avoided. The warning message names the possible consequences. u

NOTE

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause property damages if not avoided. The warning message names the possible consequences. u

This is a measure with which hazards can be prevented.

þ This is a requirement that must be met before the start of a sequence of actions. 1. This is a command. 2. CAUTION! This is a warning message about hazards that can occur during a single action. This is a command. ð This is the result of a sequence of actions.

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1 Notes on the instructions for use 1.6 Other applicable documents

1.6 Other applicable documents

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Document type

Document title

Document number

Instructions for use

INFRARED 800 for the ZEISS TIVATO 700 (option)

G-30-2034

Instructions for use

14-function foot control panel, wired (FCP) or wireless (FCP WL) (option).

G-30-1706

Instructions for use

180° Tiltable Tubes with f=170 and f=200 (option)

G-30-1600

Instructions for use

Foldable Tube f170/f260 (option)

G-30-1776

Training record

Briefing report for newly installed systems

G-30-1714

Conformance statement

DICOM Declaration of Conformity

EN_30_200 _0084I

Release Notes

Release notes for ZEISS TIVATO 700

RN-30-9061

Product Overview

ZEISS Video Accessories

G-30-1888

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Instructions for Use ZEISS TIVATO 700

2 Safety notes 2.1 Target group

2 Safety notes 2.1 Target group These Instructions for Use are intended for physicians, medical and technical staff, and nurses who are responsible for preparing, operating or maintaining the device following training. It is the duty of the equipment owner/operator to train and instruct all operating personnel.

2.2 Area of use 2.2.1 Intended use The ZEISS TIVATO 700 is a surgical microscope intended to illuminate and magnify the surgical area and to support visualization in surgical procedures. Injury to the patient´s eye!

CAUTION!

The device must not be used for ophthalmological procedures. u

Make sure that no xenon light enters the patient's eyes.

2.2.2 Indications Information on the intended medical indications for use, contraindications and the target patient group has been set out in the following table. Intended medical indications for use Medical discipline:

• ENT surgery • Spine surgery • P&R surgery • Neurosurgery (cranial and spinal applications) • Microdentistry

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Indication:

The ZEISS TIVATO 700 is a surgical microscope intended to illuminate and magnify the surgical area and to support visualization in surgical procedures.

Contraindication:

Provided that the ZEISS TIVATO 700 is used within its indication of use, there are no known contraindications.

Patient target group:

No constraints

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2 Safety notes 2.2 Area of use

Instructions for Use ZEISS TIVATO 700

Intended medical indications for use Age:

No constraints

Gender:

All

2.2.3 Normal use The complete system comprises a surgical microscope with a floor stand containing the electronics, the light source, a graphic touchscreen and, optionally, a video display. The stand supports the operation of an optical microscope system. ZEISS TIVATO 700 is suited for cranial and spinal applications in neurosurgery as well as ENT applications in the area of the auditory nerve and the base of the skull. Further fields of application include P&R procedures and oral and maxillofacial surgery. ZEISS TIVATO 700 is also ideally suited for multidisciplinary use in microsurgery. ZEISS TIVATO 700 is equipped for the connection of navigation systems and for data communication with external network systems. Optional fluorescence modules enable enhanced visualization of tumors and healthy tissue and improved vascular visualization. ZEISS TIVATO 700 is intended for use in hospitals, clinics or other medical institutions. The user can trigger these functions using the keys on the hand grips and an optional foot control panel. These functions are set by default or are controlled by the optional central control unit in the stand and the interactive graphic touchscreen. The latter enables the user to configure all required settings. The ZEISS TIVATO 700 may be operated only by physicians, nurses and other medically trained OR staff who have received appropriate training and observe the instructions for use. The instructions for use also contain instructions for cleaning, disinfection, changing spare parts, maintenance and disposal. The installation conditions and the use of the system must meet microsurgical requirements: • Low vibration • Dust-free environment • Level, horizontal positioning • Avoidance of extreme mechanical stress • EMC-specific environment based on a professional healthcare facility (use of RF surgical devices in combination with the microscope)

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Instructions for Use ZEISS TIVATO 700

2 Safety notes 2.2 Area of use

2.2.4 Risk of burn injuries caused by high illumination intensity In case of misuse of the xenon or LED light source, an excessive illumination intensity may cause third-degree burns. A long surgical procedure increases the risk of injury, in particular if a standard procedure takes considerably longer than usual. Various factors contribute to the risk of burn injuries: General The device is equipped with a powerful xenon or LED light source. If used improperly, this light source can lead to an excessively high illumination intensity resulting in third-degree burns. Never leave a device unattended when its light source is switched on! Device-related factors: • If a high magnification is selected, the diameter of the field of view decreases and the light intensity at the surgeon's eye is reduced whereas the light intensity in the surgical field remains the same. This effect is increased by the use of certain accessories, e.g. eyepieces with higher magnification or the foldable tube f170/f260 with tube magnification (PROMAG function). When working at maximum magnification, you should therefore pay particular attention to the set light intensity to prevent burns, especially of the surrounding tissue. • If the stereo bridge is used, the light intensity at the surgeon's eye is reduced whereas the light intensity in the surgical field remains the same. When working with the stereo bridge, you should therefore pay particular attention to the set light intensity to prevent burns, especially of the surrounding tissue.

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2 Safety notes 2.2 Area of use

Instructions for Use ZEISS TIVATO 700

Surgery-related factors: • The size of the luminous field influences the risk of injury in the following respect: With a large luminous field diameter, areas of the skin are illuminated which are not monitored as strictly by the surgeon and which are not moistened sufficiently. These areas are particularly at risk of injury. These injuries can be prevented by adjusting the illuminated-field diameter to the smallest size required for the relevant operation. • If the luminous field is reduced in size, the intensity increases because the light is focused more. So, if possible, the intensity should be lowered as soon as the size of the illuminated field is reduced. • A long surgical procedure increases the risk of injury, in particular if a standard procedure takes considerably longer than usual. • Injuries in the peripheral area can be prevented by covering this area with moist, sterile gauze. The gauze must be moistened at regular intervals to prevent it from heating up or drying out. The risk is increased if dry drapes are used to cover such areas. • It should also be considered that some areas of the body may be more sensitive than others. • Certain preparations of the surgical field, the administration of vasoconstrictive medications and surgical incision drapes may also result in a higher risk of injury (surgical drapes may heat up to varying degrees depending on their color and moisture content). Patient-related factors: • The general condition of a patient's health may contribute to the risk of injury. • The skin type may also play a major role in this respect. • Certain medications also affect the sensitivity to light. • The interaction of heat and antimicrobial substances in incision foils may lead to an increase in the patient's reaction to these substances.

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Instructions for Use ZEISS TIVATO 700

2 Safety notes 2.2 Area of use

Recommendations • The initial illumination intensity should be preset to a low value. • If used, drapes should also be remoistened at regular intervals in order to prevent heat from accumulating underneath the drape. • The risk of burns can be reduced by constantly irrigating the illuminated surgical field and by keeping it moist. • Using the buttons on the hand grip or foot control panel, the surgeon can then set the illumination intensity to the value required for the procedure. Please note that the intensity increases with decreasing luminous field size if the spot function is used. For this reason, the intensity should be set only after the size of the illuminated field has been changed. • The device is equipped with "Automatic Light Field Limitation" (function: SmartLink Auto Brightness). This function should not be deactivated. • The magnification factor usually is increased during surgery. This darkens the image so that the illumination intensity must be increased. This loss in image brightness is automatically compensated if the zoom-dependent brightness control is activated (function: SmartLink Auto Brightness). • Never leave a device unattended when its light source is switched on. • Switch off the light when the microscope is not being used, and ensure it is not directed at unprotected bare skin.

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2 Safety notes 2.3 Responsibilities and duties of the operator

Instructions for Use ZEISS TIVATO 700

2.3 Responsibilities and duties of the operator Operating personnel Only personnel who have undergone training and instruction are allowed to use this instrument. u

Never leave the device unattended when it is located above the patient.

u

Make sure that the operating personnel are appropriately trained and instructed.

u

Make sure that the operating personnel have read and understood the Instructions for Use.

u

Keep the Instructions for Use available at all times for the operating personnel.

u

To facilitate access for the entire operating personnel: If necessary, request further copies of the instructions for use from ZEISS.

u

Define the required skills for handling the device and provide information on who is authorized for which activities.

u

Define rules for reporting errors and damage, and make sure that people are informed of these. Notification of the manufacturer and authorities [} 23]

u

Provide the necessary protective clothing.

u

Regularly check compliance with the national laws and regulations concerning accident prevention and occupational health.

Safety inspections u

To prevent a decrease in device safety due to aging and wear: ensure that safety inspections in compliance with IEC 62353 are performed on time and to the prescribed extent. Observe the applicable national regulations.

The safety inspections may only be performed by the manufacturer or qualified personnel. u

Comply with the specified time limits (see Maintenance).

u

Perform the inspections to the prescribed extent.

The device should, as a minimum, undergo the following checks and safety inspections: • Check the presence of the instructions for use • Visually inspect the device and its accessories for damage, as well as legibility of markings and labels • Leakage current test • PE conductor check

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