INFRARED 800 for TIVATO 700 Instructions for Use sw rel 3.0 Mar 2019

Copyright © 2019, Carl Zeiss Meditec AG, Jena Brands The ZEISS TIVATO® 700 with the INFRARED 800 fluorescence application are trademarks or registered trademarks of Carl Zeiss Meditec AG or other companies belonging to 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 INFRARED 800

Table of contents

Table of contents 1

Notes on Instructions for Use... 5

1.1

Product name ... 5

1.2

Area of application ... 5

1.3

Purpose and storage of the documentation ... 5

1.4

Questions and comments ... 6

1.5 1.5.1 1.5.2

Conventions in this document ... 6 Conventions in all text areas... 6 Conventions in a course of action... 7

1.6

Other applicable documents ... 7

2

Safety notes ... 9

2.1

Target group ... 9

2.2

Area of use ... 9

2.2.1 2.2.2

Intended use ... 9 Normal use... 9

3

Product description ... 11

3.1

Marking on the device... 11

3.2

Functional description ... 15

3.3

Licenses ... 16

3.4 3.4.1 3.4.2 3.4.3

Software description ... 17 User interface ... 17 INFRARED 800... 20 Fluorescence ... 22

4

Configuring INFRARED 800 ... 23

4.1

Configuring the [Fluorescence] button on the handgrip ... 23

4.2

Configuring the [Fluorescence] button on the foot control panel (optional) ... 24

5

Prior to each use ... 25

5.1

Making settings for INFRARED 800 ... 26

5.2

Procedure for functional test... 27

5.3

Preparing patients ... 27

6

Operation ... 29

6.1

Operating INFRARED 800 via handgrip or foot control panel... 30

6.2

Operating INFRARED 800 via the user interface on the monitor ... 32

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Table of contents

Instructions for Use INFRARED 800

7

Technical specifications... 35

7.1

Conformity ... 35

7.2 7.2.1 7.2.2 7.2.3 7.2.4 7.2.5 7.2.6 7.2.7

Technical data of the surgical microscope ... 35 Xenon light source ... 35 Integrated 3-chip HD camera ... 35 Integrated 4K camera... 36 Digital video outputs ... 36 Digital video inputs... 36 Ambient requirements for operation ... 37 Ambient requirements for transport and storage ... 37

8

Order data... 39

8.1

Fluorescence target ... 39

8.2

Licenses ... 39

Glossary ... 41 Keyword index ... 43

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Instructions for Use INFRARED 800

1 Notes on Instructions for Use 1.1 Product name

1 Notes on Instructions for Use 1.1 Product name INFRARED 800 is an application for the ZEISS TIVATO 700. All applications are activated on the ZEISS TIVATO 700 via a license. Display and operation Only activated applications can be displayed and operated on the ZEISS TIVATO 700 monitor.

1.2 Area of application These Instructions For Use apply to the INFRARED 800 with the following marking: • Reference number: 7012 These instructions for use describe only the INFRARED 800 fluorescence application. The INFRARED 800 fluorescence technologies are fully integrated in the ZEISS TIVATO 700. Read and follow the Instructions for Use for the ZEISS TIVATO 700 (G-30-2032). Please use the fluorescent agent in accordance with its approval status for use in your country.

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.

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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.

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1 Notes on Instructions for Use 1.4 Questions and comments

Instructions for Use INFRARED 800

1.4 Questions and comments u

If you have questions or comments regarding these instructions for use or about the device, 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: Questions and comments [} 6]. 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

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Instructions for Use INFRARED 800

1 Notes on Instructions for Use 1.6 Other applicable documents

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.

1.6 Other applicable documents

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Document type

Document title

Document number

Instructions For Use

ZEISS TIVATO 700

G-30-2032

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Empty page, for your notes

Instructions for Use INFRARED 800

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. The intended usage site for the product is operating rooms in clinics and hospitals.

2.2 Area of use 2.2.1 Intended use INFRARED 800 with FLOW 800 option used during fluorescence guided surgery aids in viewing the visual assessment of intraoperative blood flow as well as vessel patency in surgical procedures in neurosurgery, plastic and reconstructive procedures and coronary artery bypass graft surgery.

2.2.2 Normal use INFRARED 800 is an accessory product for a surgical microscope that is used to observe and visually assess the intraoperative blood flow in the region of the cerebral blood vessels. Its applications include i.a. the assessment of cerebral aneurysms and vascular occlusions as well as the permeability of very small perforator vessels. In addition, it supports real-time visualization of the blood flow and visual assessment of vessel types before and after surgical procedures for arteriovenous malformations (AVM). The use of INFRARED 800 in fluorescence-guided surgery also supports the observation and visual assessment of the intraoperative blood flow as well as the vascular permeability during surgical bypass procedures in neurosurgery, plastic and reconstructive surgery and coronary artery bypass graft operations. When using INFRARED 800 in conjunction with a fluorescent agent, the medical contraindications which must be considered when using suitable fluorescent agents and state-of-the-art examination techniques apply. It must be ensured that the fluorescent agent can be excited in the wavelength range from 700 to 780 nm and that it emits fluorescent light of sufficient intensity in the wavelength range from 820 to 900 nm. As in almost all procedures, false-positive and false-negative results can occur. Evaluation based on other methods is necessary.

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Empty page, for your notes

Instructions for Use INFRARED 800

3 Product description 3.1 Marking on the device

3 Product description 3.1 Marking on the device Symbol

Name

Explanation

Warning label

General warning sign!

Warning label

Warning: risk of hand injuries!

Warning label

Hot surface warning!

Warning label

Maximum load capacity 7 kg!

Warning label

Warning label, LED radiation, Risk group 2 • Warning of (visible) optical radiation emitted by this device. • Do not look into the source of the operating light.

Mandatory label

Observe the instructions for use and the accompanying documents.

Approval label with performance data

Provides information on: • Manufacturer • Device data • Performance data • Device compliance • CSA label

Manufacturer

Carl Zeiss Meditec AG Goeschwitzer Strasse 51 - 52, 07745 Jena, Germany

WEEE label

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Do not dispose of electrical and electronic devices along with normal domestic waste.

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3 Product description 3.1 Marking on the device

Instructions for Use INFRARED 800

Symbol

Name

Explanation

Item number

-

Serial Number

-

Manufacture Date

-

UDI data matrix

UDI label • Machine-readable label (barcode) • UDI Device Identifier (UDI-DI) • UDI Production Identifier (UDI-PI)

Serial number

-

Service Identification Program (SIP label)

Provides information on: • Manufacturer • Manufacturer's contact information • SIP number of the device

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Identification label, device options

Identifies installed device options.

Foot control panel, wireless

-

Indicator

Pairs the device with the wireless foot control panel (FCP WL).

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Instructions for Use INFRARED 800

3 Product description 3.1 Marking on the device

Symbol

Name

Explanation

Transport position

Transport position: • Observe the instructions for use and the accompanying documents. • Pushing position • General Warning

ZEISS TIVATO 700

Varioskop

Drape position

Identifies the seal for the drape vacuum system

Brand / Logo

ZEISS logo

Device name

-

Open

Open, right/left co-observation port

Zoom

Adjust zoom magnification manually

Focus

Focus / Working distance

Illumination diameter

Illumination diameter / Luminous field diaphragm

Brand name

-

Non-ionizing electromagnetic radiation & Rx Only

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Non-ionizing electromagnetic radiation

-

Rx Only

Only for USA: "Prescription use only"

RFID symbol

RFID scanning or reading device

Standby / ON

-

USB-C port

-

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3 Product description 3.1 Marking on the device

Instructions for Use INFRARED 800

Symbol

Name

Explanation

USB-A port

-

Video output (optional)

Number 1: HD-SDI / 3G-SDI output Number 2, 3: HD-SDI / 3G-SDI output Number 4: HDMI output

4K

Video output (4K option)

Number 11-14: 4K 3G-SDI output Number 4: 4K HDMI output

LAN

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Video input (optional)

Number 5: HDMI input

Video output (optional)

Number 1: HD-SDI / 3G-SDI output

Video output (optional and 4K option)

Number 11-14: 4K 3G-SDI output

Video output (optional)

Number 2, 3: HD-SDI / 3G-SDI output

Video output (4K option)

Number 4: HDMI output

Video input (optional)

Number 5: HDMI input

Navigation (optional)

Port for navigation system (ODUMAC)

Network connection (LAN)

-

Foot control panel, 14 functions

-

Remote connector

-

Fuse display F1

-

Potential equalization

-

Number 4: 4K HDMI output

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Instructions for Use INFRARED 800

3 Product description 3.2 Functional description

Symbol

Name

Explanation

Lamp cover

Manual lamp replacement (removal of light source cover)

Lamp exchange

Manual lamp replacement (replacement of lamp container)

Light 1

-

Light 2

-

Identification label, HLQ 300 Future

-

Identification label, lamp 300 W+ xenon

-

Identification label, ITOS FO 180 RGB MODULE

-

SGS: NRTL classification Approval label for INFRARED 800

-

3.2 Functional description The INFRARED 800 fluorescence application supports the observation and visual assessment of the intraoperative blood flow as well as the vascular permeability during surgical procedures. This process records and saves video data which can be played back during or after the surgical procedure and forms the basis for a detailed analysis of the fluorescence application. INFRARED 800 provides the hardware and software for the video recording of the infrared fluorescence during the operation. INFRARED 800 is integrated in the ZEISS TIVATO 700 and can be accessed and operated via the hand grips, the foot control panel or the main monitor of the ZEISS TIVATO 700. You record the video data during the infrared fluorescence with the INFRARED 800 module and, if necessary, use the "Long Replay" function for further assessment of the blood flow.

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3 Product description 3.3 Licenses

Instructions for Use INFRARED 800

Main function INFRARED 800 records video data of the fluorescing tissue in the surgical field during the operation. The video recording is subdivided into the following phases: • The "IR Record" recording phase starts the detection and display of the fluorescence signals and saves this as a video file. • "Long Replay" playback phase: the recorded video data are played back on the screen. The entire video can be played back repeatedly and successively. It also is possible to skip the "Long Replay" playback phase. The video files are saved to the patient data.

3.3 Licenses Each module requires a license which is managed by the ZEISS TIVATO 700. You can call up and operate the modules only if you have valid licenses for this purpose: Designation INFRARED 800

Symbol

Function Recording video data during an operation. The camera sensitivity gain ("Gain" function) and the brightness of the light source ("Light Intensity" function) must be set manually. The "Long Replay" playback phase is available.

To determine which licenses are activated on your ZEISS TIVATO 700, check the identification label for applications on the ZEISS TIVATO 700 or open the “Fluorescence” function on the user interface.

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Instructions for Use INFRARED 800

3 Product description 3.4 Software description

3.4 Software description 3.4.1 User interface 1

2

3

4

5

6

7

8

9

10 11 12 13

18

14 15 16 17 30 29 28 27 20 21 22

19 26

23 24 25

Figure 1: User interface layout Pos.

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Name

Explanation

1

Main menu (Home)

Opens the main menu with live image, status bar and main menu bar.

2

Edit Patient icon

Opens the window for editing the patient data.

3

Patient

Displays the current patient name. Tapping on the button opens the patient directory.

4

Edit User icon

Opens the window for editing the user data.

5

User

Displays the current user name. Tapping on the button opens the user directory.

6

Status Information

Displays current status information. Tapping on the button opens an overview.

7

Date, time

Displays the date and time.

8

Settings menu icon

Opens the configuration menu.

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3 Product description 3.4 Software description

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Instructions for Use INFRARED 800

Pos.

Name

Explanation

9

Help

Opens the help window on the right-hand edge of the screen.

10

Light

Switches the illumination on and off.

11

Focus Light Link

Limits the maximum light intensity for the selected working distance.

12

DOF

Activates the depth of field (DOF) Increased DOF on: High depth of field – less light – lower image resolution. Increased DOF off: Low depth of field – more light – high image resolution.

13

Light intensity

Displays the light intensity. The light intensity can be adjusted by tapping the button.

14

Focus speed

Displays the configured value for the working distance. The button can be tapped to adjust the speed of the motorized fine focus.

15

Zoom speed

Displays the configured start value for the zoom factor. The button can be tapped to adjust the speed of the zoom.

16

Movement mode XY adjustment (OPMI)

The button can be tapped to adjust the XY speed.

17

Fluorescence setting

The button can be tapped to select the activated fluorescence module, YELLOW 560 or IR 800 (INFRARED 800).

18

Arrow button

Opens and closes the additional menu.

19

Additional menu

Displays additional adjustment options for the device.

20

AutoBalance

The [System] button can be tapped to balance the device. Fine balancing with a drape can be performed by tapping the [Drape] button.

21

White balance

Starts the white balance.

22

Image Rotation

The camera image is rotated 180° per click.

23

AutoDrape

Starts the drape suction automatically if the RFID label of the SMARTDRAPE has been read in.

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Instructions for Use INFRARED 800

3 Product description 3.4 Software description

Pos.

Name

Explanation

24

Wired foot control panel icon

Tapping the button displays the button assignments for the foot control panel; the button assignments can be configured.

25

Ocular Settings

Displays the user-specific eyepiece settings.

26

Hand Grips icon

Tapping the button displays the button assignments for the hand grips; the button assignments can be configured.

27

Number of photos

Displays the number of captured photos.

28

Image capture

Takes a photograph.

29

Number of videos

Displays the number of videos taken.

30

Video Recording

Starts and stops the video recording.

All control elements, the status bar and the main menu bar can be hidden by tapping on the live image (full screen mode). Only the video runtime is displayed during a recording in full screen mode. The values displayed (SI units) are rounded. They serve to enhance the display and do not represent a measurement function. If you tap on the monitor again, all control elements, the status bar and the main menu bar will reappear.

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3 Product description 3.4 Software description

Instructions for Use INFRARED 800

3.4.2 INFRARED 800 When the INFRARED 800 application is started, the “INFRARED 800” menu opens. The top edge of the screen shows the different phases of the INFRARED 800 application. The blue bar marks the phase currently in progress. 1

2

3 4 6

5

Figure 2: "INFRARED 800" menu Posi Name tion 1

"IR Record" recording phase

Explanation During the "IR Record" recording phase, the fluorescence signal is detected, displayed and recorded as a video file. During the recording phase, the current values for the light intensity and camera sensitivity (Gain) are displayed.

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2

"Long Replay" playback phase

In the "Long Replay" playback phase, the recorded video data are played back on the screen. The entire video can be played back repeatedly and successively (adjustable repetition rates, 0 to 10 repetitions possible). Note: The "Long Replay" playback phase also can be skipped. To do this, you must set "IR 800 Retries" to "0" in the default settings of the "Fluorescence" menu before starting IR 800.

3

Light Intensity

Light Intensity - regulates the brightness and saturation of the light source. The desired value is continuously variable. The value selected for "Light Intensity" in the default settings should be 50%. Note: Always adjust the value for "Gain" before adjusting the value for "Light Intensity".

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