TIVATO 700 Instructions for Use Ver 2.0 Oct 2018

Copyright © 2018, Carl Zeiss Meditec AG, Jena Brand names/Trademarks TIVATO 700 is a trademark or registered trademark of Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany and/or other countries. All other trademarks mentioned in this document are the property of their respective owners.

Instructions for Use TIVATO 700

Table of contents

Table of contents 1

Notes on Instructions for Use... 9

1.1

Device name ... 9

1.2

Area of application ... 9

1.3

Purpose and storage of the documentation ... 9

1.4

Questions and comments ... 9

1.5 1.5.1 1.5.2

Conventions in this document ... 9 Conventions in all text areas... 10 Conventions in a course of action... 10

1.6

Other applicable documents ... 11

2

Safety notes ... 13

2.1

Target group ... 13

2.2

Area of use ... 13

2.2.1 2.2.2 2.2.3

Intended use ... 13 Normal use... 13 Risk of burn injuries caused by high illumination intensity ... 14

2.3 2.3.1 2.3.2

Responsibilities and duties of the operator ... 16 Requirements for the network connection... 19 Messages to manufacturer and authorities ... 20

2.4

Measures and duties of the operator... 20

2.5

Electromagnetic compatibility ... 22

3

Description of the device... 23

3.1

Marking on the device... 23

3.2

Labeling on packaging ... 27

3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6

Structure of the device ... 29 Device overview ... 29 Surgical microscope overview... 30 14-function foot control panel ... 33 Stand base ... 33 Overview of connector panel... 34 Overview of video connector panel ... 35

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 ... 37 Screen keyboard... 37 Display: Editing... 37 Online help... 38 Surgical microscope control elements... 39 Foldable tube control elements ... 40 Tiltable tube control elements ... 41 Controls for widefield eyepieces ... 42 Controls of handgrips... 43 14-function foot control panel ... 44

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Instructions for Use 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

Software description ... 45 General ... 45 Interactive buttons ... 45 User interface ... 47 Status information... 50 Patient data... 51 Import patient data from the DICOM Worklist... 53 Video recording playback ... 55 SmartLinks... 56 Light... 57 Tube... 58 Focus ... 59 Zoom ... 60 Handgrips... 61 Foot control panel ... 63 Stand ... 64 Displays... 65 Audio ... 66 Photo ... 67 Video camera ... 68 Video recording... 70 Fluorescence ... 71 Storage ... 72 Navigation... 73 Info ... 74 Extras ... 75 Password-protected settings and configurations... 76

4

Installation ... 89

4.1

Requirements ... 89

4.2

Connecting the device to the power supply and switching it on... 89

4.3

Initial device login ... 90

4.4

Connecting the wired foot control panel ... 91

4.5

Pairing the wireless foot control panel with the device... 92

4.6

Connecting external video devices and monitors... 94

4.7

Connecting USB storage media ... 95

4.8 4.8.1 4.8.2 4.8.3 4.8.4

Configuring the network ... 96 Activating IT admin system rights ... 96 Activating the network connection via LAN adapter ... 97 Network drive (option) ... 97 Configuring the network connection for DICOM (option) ... 98

4.9

Changing the computer name of the device ... 99

4.10 4.10.1 4.10.2 4.10.3

Configuring the Service PC ... 100 Service ... 100 Settings ... 101 Log Files ... 102

4.11

Connecting the navigation system to the device ... 103

4.12

Mounting the laser micromanipulators... 104

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Table of contents

5

Daily startup... 105

5.1

Safety during preparation... 105

5.2

Setting the position of the handgrips ... 106

5.3 5.3.1 5.3.2 5.3.3

Positioning the device in the OR... 107 Cranial procedures and ENT... 107 Face-to-face procedures ... 108 Moving the device... 109

5.4

Checking the movement freedom of the device ... 110

5.5

Configuring the device for applications ... 110

5.6 5.6.1 5.6.2 5.6.3

Attaching tubes and eyepieces ... 111 Attaching tubes to the microscope body ... 112 Attaching tubes and stereo bridge to microscope... 112 Attaching the documentation/co-observation equipment ... 113

5.7

Attaching SMARTDRAPE ... 114

5.8

AutoBalance ... 116

5.9

Adjusting the microscope ... 118

5.10

Activating a connection to the navigation system ... 119

5.11

Preparing the device for use of laser micromanipulators... 120

6

Operation ... 123

6.1

Safety during operation... 123

6.2

Software configuration... 126

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

Configuring the microscope ... 126 Configuring the button assignment of the handgrips and foot control panel ... 131 Configuring the stand... 134 Configuring displays ... 134 Configuring Audio ... 135 Configuring Photo ... 135 Configuring the video camera ... 135 Configuring the video recording ... 138 Configuring fluorescence... 138 Configuring storage... 139 Configuring navigation ... 139

6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7

Managing users ... 139 Adding users ... 139 Configuring users ... 140 Exporting user settings to a USB storage device... 140 Importing user settings from a USB storage device ... 141 Change of user... 141 Copy User ... 141 Delete User ... 142

6.4 6.4.1 6.4.2 6.4.3 6.4.4

Managing patients ... 142 Adding a patient ... 142 Changing patients ... 143 Editing patient data ... 143 Searching for a patient ... 144

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6.4.5 6.4.6 6.4.7 6.4.8

Sorting patients... 144 Exporting patient data to DICOM ... 145 Importing patient data from the DICOM Worklist ... 146 Deleting patients ... 147

6.5

Video recording (option)... 148

6.6

Creating photos with the integrated video camera ... 149

6.7 6.7.1 6.7.2 6.7.3 6.7.4

Patient data, photos and videos ... 150 Opening the patient directory... 150 Display of media objects (files)... 150 Viewing patient images ... 151 Viewing patient videos ... 151

6.8 6.8.1 6.8.2

DICOM (option)... 153 Importing patient data from the DICOM Worklist ... 153 Exporting patient data to DICOM ... 154

6.9 6.9.1 6.9.2

YELLOW 560 (option) ... 155 Configuring YELLOW 560... 156 Starting the YELLOW 560 fluorescence application... 157

6.10

Using the device as a hotspot... 158

6.11

Switching the device off ... 159

7

Cleaning and disinfection ... 161

7.1

Safety during cleaning and disinfection... 161

7.2

Contamination of the device... 161

7.3

Cleaning ... 161

7.3.1 7.3.2 7.3.3 7.3.4 7.3.5

Cleaning agents... 161 Cleaning optical surfaces ... 162 Cleaning the monitor (touchscreen)... 162 Cleaning mechanical surfaces ... 162 Fogging of optical surfaces... 163

7.4 7.4.1

Disinfection ... 164 Disinfection of surfaces ... 164

8

Maintenance ... 165

8.1

Safety during maintenance... 165

8.2

User maintenance intervals... 166

8.3 8.3.1 8.3.2

Maintenance schedule for the authorized service... 167 Service maintenance intervals ... 167 Performance of safety inspections ... 167

9

Troubleshooting... 169

9.1 9.1.1 9.1.2 9.1.3

Locating faults... 169 Fixing faults with messages ... 169 Exporting log files... 170 Service information ... 170

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Table of contents

9.2

Faults without messages ... 170

9.3

Basic functions following failure of the system control (Basic Function Mode)... 172

9.4

Device in the de-energized state... 173

9.5

Activating the backup xenon lamp via the monitor ... 173

9.6

Activating the backup xenon lamp via the light source ... 174

9.7

Changing the lamp container of the xenon light source ... 176

10

Technical specifications... 179

10.1

Compliance... 179

10.2 10.2.1 10.2.2

Radio frequency approval... 179 Displaying radio frequency approvals on the monitor ... 179 Radio frequency approval labeling ... 180

10.3 10.3.1 10.3.2 10.3.3

Radio modules... 181 FCP WL, FCP Gateway WL and FCP Interface... 181 WLAN module... 181 RFID ... 182

10.4

Essential performance features ... 182

10.5

Electrical data... 182

10.6

Xenon light source ... 183

10.6.1

Additional information ... 183

10.7

LED light source... 183

10.8

Integrated 1-chip HD camera... 183

10.9

Integrated 3-chip HD camera... 183

10.10

Integrated 4K camera... 184

10.11

Digital video outputs ... 184

10.12

Digital video inputs... 184

10.13 Mechanical data ... 185 10.13.1 Device data ... 185 10.13.2 Weights of accessories ... 185 10.14 10.14.1 10.14.2 10.14.3

Optical data... 186 Surgical microscope... 186 Widefield eyepiece (magnification factor 10x) ... 186 Widefield eyepiece (magnification factor 12.5x) ... 186

10.15

Ambient requirements for operation ... 187

10.16

Ambient requirements for transport and storage ... 187

10.17

Dimensional drawing... 188

10.18 Guidelines and manufacturer’s declaration for electromagnetic compatibility ... 188 10.18.1 EMC - Electromagnetic compatibility as per IEC 60601-1-2:2007 (3rd Edition) ... 188 10.18.2 EMC - Electromagnetic compatibility as per IEC 60601-1-2: 2014 (4th Edition) ... 193

11

Accessories and spare parts ... 197

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Instructions for Use TIVATO 700

11.1 11.1.1 11.1.2 11.1.3 11.1.4 11.1.5 11.1.6 11.1.7 11.1.8 11.1.9 11.1.10 11.1.11 11.1.12 11.1.13

Accessories ... 197 Video accessories ... 197 Main tube with eyepieces... 197 Eyepieces ... 197 Left/right co-observation ... 198 Face-to-face co-observation ... 198 Tube and stereo bridge 50 covers... 198 Tube for posterior fossa... 198 Foot control panel ... 199 Fluorescence targets... 199 Sterile covers/drapes... 199 Sterile caps... 199 Magnification changer ... 200 Country-specific cables ... 200

11.2 11.2.1

Spare parts ... 200 Lamp container of the xenon light source... 200

12

Disposal ... 201 Glossary ... 203 Keyword index ... 205

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Instructions for Use TIVATO 700

1 Notes on Instructions for Use 1.1 Device name

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

1.2 Area of application The present Instructions for Use apply to TIVATO 700 with Software Release 1.0 and the following identification: • 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 function. 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, please 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.

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1 Notes on Instructions for Use 1.5 Conventions in this document

Instructions for Use TIVATO 700

1.5.1 Conventions in all text areas • This is a list. – This is a second level list. This is a cross-reference: Questions and comments [} 9]. This is bold type. This is software code or program text. 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 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

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

G-30-1706

Instructions for use

INFRARED 800

G-30-2034

Training record

Training record for newly installed systems.

G-30-1714

Conformance statement

DICOM Conformance Statement

EN_30_200 _0084I

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Empty page, for your notes

Instructions for Use 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. CAUTION! Federal law restricts this device to sale by or on the order of a physician.

2.2 Area of use 2.2.1 Intended use TIVATO 700 is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures. The device must not be used for ophthalmological procedures, as this may damage the patient's eye.

2.2.2 Normal use The overall 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. 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. TIVATO 700 is also ideally suited for multidisciplinary use in microsurgery. 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. 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 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.

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2 Safety notes 2.2 Area of use

Instructions for Use TIVATO 700

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)

2.2.3 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: Basics 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! Various factors contribute to the risk of burn injuries: System-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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Instructions for Use TIVATO 700

2 Safety notes 2.2 Area of use

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, local vasoconstrictive medications and incision drapes may also result in a higher risk of injury (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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2 Safety notes 2.3 Responsibilities and duties of the operator

Instructions for Use TIVATO 700

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.

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

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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 simplify access for all operating personnel, order additional copies of the Instructions for Use from ZEISS as required.

u

Specify the competencies for handling the device and state who is authorized for what tasks.

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Instructions for Use TIVATO 700

2 Safety notes 2.3 Responsibilities and duties of the operator

u

Determine the reporting obligations for faults and damage and make them known. Notification to manufacturers and authorities [} 20]

u

Provide the necessary protective clothing.

u

Regularly check that the legal regulations regarding accident prevention and health and safety at work generally applicable in your country are being complied with.

Technical safety tests u

To prevent a decrease in device safety due to aging and wear: Have a safety inspection in compliance with IEC 62353 performed on time and to the prescribed extent. Observe the respective prevailing national regulations.

The technical safety checks must only be performed by the manufacturer or qualified personnel. u

Comply with the specified time limits (see Maintenance [} 165]).

u

Carry out checks according to the extent specified.

The technical safety checks of the device should at least comprise the following points: • Availability of the Instructions for Use • Visual inspection of device and accessories for damage and legibility of labels • Leakage current test • Test of protective ground conductor • Function and wear test of the brakes • Function test of all switches, buttons, sockets and indicator LEDs of the device Maintenance and inspection u

To ensure safe operation of the device and reach the expected service life: Observe the maintenance and inspection intervals that are specified in these instructions for use (see: Maintenance [} 165]).

Changes to the product u

WARNING: This device must not be modified without the manufacturer’s permission. If the device is modified, suitable inspections and tests must be performed to ensure that the device can still be used safely.

Accessories and additional equipment u

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If you want to connect accessories or additional equipment to the device: Contact your ZEISS contact person [} 9].

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2 Safety notes 2.3 Responsibilities and duties of the operator

Instructions for Use TIVATO 700

Any additional equipment connected to medical electrical devices must demonstrably comply with the applicable IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, any configurations must comply with normative requirements for medical systems (within the European Union: see IEC 60601-1 Edition 3.1). Anyone connecting additional equipment to medical electrical devices is a system configurer and as such responsible for compliance of the system with the standards for systems. Local legislation has priority over the above normative requirements. Dangers arising from connection to a network Before connecting the device to a network, observe the following safety measures to prevent injury or damage: u

The user (or IT manager) is responsible for ensuring that no computer viruses are transmitted to the device via the network connection.

u

Make sure that there are no defects in the network which could lead to a hazardous voltage on the network connector.

u

Ensure a data transmission rate of 1 Gbit/s and the conformity of your network configuration with internet protocol IPv4 so that patient data can be exported to your network reliably, safely and error-free.

Changes to the network The following subsequent changes to the network may result in new risks: • Changes to the network configuration • Connecting additional devices to the network • Disconnecting devices from the network • Updates of devices connected to the network • Upgrades of devices connected to the network u

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Analyze and eliminate any risk factors newly incurred by such changes to the network.

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Instructions for Use TIVATO 700

2 Safety notes 2.3 Responsibilities and duties of the operator

2.3.1 Requirements for the network connection The following requirements apply to the network in which the TIVATO 700 is integrated: LAN Name

Value

Ethernet protocol IPv4

TCP/IP

Gigabit Ethernet

1000BASE-T, IEEE 802.3 Paragraph 40

Assignment of IP addresses

Static IP or DHCP (configurable within the device)

LAN connection to the navigation system Latency

< 3 ms

Data transmission rate

> 1 Mbit/s

Video recording for release in the network Data transmission rate

> 40 Mbit/s

Live streaming of camera image Data transmission rate

> 40 Mbit/s

WLAN Name

Value

Security standard

WPA2/PSK

WLAN standard

802.11a/b/g/n

Ethernet protocol IPv4

TCP/IP

Assignment of IP addresses

Static IP or DHCP (configurable within the device)

Video recording for release in the network Data transmission rate

> 40 Mbit/s

Live streaming of camera image Data transmission rate

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> 40 Mbit/s

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2 Safety notes 2.4 Measures and duties of the operator

Instructions for Use TIVATO 700

WLAN hotspot Name

Value

Security standard

WPA2/PSK

WLAN standard

802.11a/b/g/n

Ethernet protocol IPv4

TCP/IP

Assignment of IP addresses

DHCP

Live streaming of camera image Data transmission rate

> 40 Mbit/s

Network configuration Name

Value

Assignment of IP addresses

Static IP or DHCP (configurable within the device)

Shared network drive

SMB protocol (Server Message Block), also known as CIFS (Common Internet File System)

Streaming client (via LAN, WLAN, WLAN hotspot) Log

RTSP (RTP via UDP)

2D video codec:

• Video compression: H.264/MPEG-4 AVC / Baseline Profile / Level 4.2 • HD resolution: 1920x1080p25/30

2.3.2 Messages to manufacturer and authorities If a serious incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report this serious incidence to the manufacturer or seller of the medical product. In the European Union, the operator must report this serious incident to the responsible authorities in the applicable country.

2.4 Measures and duties of the operator Electrical safety

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u

Always switch off the device before connecting it to or disconnecting it from the power supply, for cleaning its surface, or if it will not be used for a prolonged period of time.

u

Only connect the device to a power supply that complies with the values specified on the rating plate.

u

Do not use any multioutlet power strips.

u

Do not use any extension cables.

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