KINEVO 900 Instructions for Use sw rev 4.0 March 2020

Copyright © 2020, Carl Zeiss Meditec AG, Jena Brand names KINEVO 900 and the fluorescence application INFRARED 800 with FLOW 800 Option are trademarks or registered trademarks of Carl Zeiss Meditec AG or another company 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 INFRARED 800 with FLOW 800 Option

Table of contents

Table of contents 1

Notes on the instructions for use ...

5

1.1

Product name ...

5

1.2

Area of application ...

5

1.3

Purpose and storage of the documentation ...

6

1.4

Questions and comments ...

6

1.5 1.5.1 1.5.2

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

6 6 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 ... Normal use...

9 9

3

Product description ... 11

3.1

Labeling on KINEVO 900 ... 11

3.2

Functional description ... 12

3.3

Licenses ... 15

3.4 3.4.1 3.4.2 3.4.3

Software description ... 16 KINEVO 900 user interface ... 16 “INFRARED 800” menu ... 18 “FLOW 800” menu... 20

4

Configuring INFRARED 800 ... 27

4.1

Configuring the [Fluorescence] button on the handgrip and (optionally) on the foot control panel ... 27

4.2

Adjusting the screen display ... 28

4.3

Setting the fluorescence parameters ... 28

4.4

Showing INFRARED 800 with FLOW 800 (option) in the eyepieces ... 31

5

Prior to each use ... 33

5.1

Performing a function test... 33

5.2

Preparing patients ... 34

6

Operation ... 35

6.1

Operating INFRARED 800 with FLOW 800 Option via handgrip or foot control panel... 37

6.2

Operating INFRARED 800 with FLOW 800 Option via the monitor... 39

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Table of contents

Instructions for Use INFRARED 800 with FLOW 800 Option

6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7

Analyzing and editing FLOW 800 data ... 42 Calling FLOW 800 data... 42 Observing different characteristics of the FLOW 800 display... 43 Setting markers (ROIs) ... 45 Interpreting and editing the diagram ... 47 Optimize View... 50 Comparing FLOW 800 displays ... 52 Transferring markers (ROIs)... 54

7

Technical Data KINEVO 900 ... 55

7.1

Integrated HD camera ... 55

7.2

Digital video outputs ... 55

7.3

4K video outputs ... 55

7.4

Digital video inputs... 55

7.5

Ambient requirements for operation ... 56

7.6

Ambient requirements for transport and storage ... 56

7.7

Operation with intraoperative MRT systems ... 56

8

Order data... 57

8.1

Fluorescence target ... 57

8.2

Licenses ... 57

Glossary ... 59 Keyword index ... 61

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Instructions for Use INFRARED 800 with FLOW 800 Option

1 Notes on the instructions for use 1.1 Product name

1 Notes on the instructions for use 1.1 Product name INFRARED 800 is an application for KINEVO 900. FLOW 800 is an optional upgrade for the application INFRARED 800. All applications and upgrades are activated by their respective licenses on the KINEVO 900. Display and operation Only activated applications can be displayed and operated on the KINEVO 900 monitor.

1.2 Area of application These instructions for use apply to INFRARED 800 with FLOW 800 Option and the following identification label: • reference number: 7012 These instructions for use describe only the INFRARED 800 with FLOW 800 Option fluorescence application. Read and follow the applicable instructions for use for KINEVO 900. The INFRARED 800 with FLOW 800 Option fluorescence technologies are fully integrated in the KINEVO 900 and are available for sale in the United States. They are also available in other markets. Depending on the national regulations of the respective country where the system is operated, an additional approval may be required for the system and its application. Please contact your local ZEISS contact person to obtain more information regarding the registration status of INFRARED 800 with FLOW 800 Option in your country.

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1 Notes on the instructions for use 1.3 Purpose and storage of the documentation

Instructions for Use INFRARED 800 with FLOW 800 Option

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.

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 a 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 with FLOW 800 Option

1 Notes on the 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 Please observe the applicable instructions for use for KINEVO 900 in the software version used.

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Empty page, for your notes

Instructions for Use INFRARED 800 with FLOW 800 Option

2 Safety notes 2.1 Target group

2 Safety notes 2.1 Target group The present Instructions for Use are intended for physicians, medical and technical staff and nurses who prepare and operate the product after receiving appropriate instruction. 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 with FLOW 800 Option 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 with FLOW 800 Option during fluorescence-supported surgery also assists in the viewing and assessment of the interoperative blood flow and of the vessel patency for surgical bypass procedures in neurosurgery, plastic and reconstructive surgery, and coronary artery bypass graft surgery. 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.

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2 Safety notes 2.2 Area of use

Instructions for Use INFRARED 800 with FLOW 800 Option

u

Check whether the fluorescent agent can be excited in the wavelength range from 700 to 780 nm and whether it emits fluorescent light of sufficient intensity in the wavelength range from 820 to 900 nm.

The automatic detection (AD) and the FLOW 800 display require a correspondingly high fluorescence signal. If the fluorescence signal is too low, this can lead to an inaccurate AD calculation and FLOW 800 display. As in almost all procedures, false-positive and false-negative results may occur. Evaluation using other methods is necessary.

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Instructions for Use INFRARED 800 with FLOW 800 Option

3 Product description 3.1 Labeling on KINEVO 900

3 Product description 3.1 Labeling on KINEVO 900 The labeling for INFRARED 800 with FLOW 800 Option is attached to the KINEVO 900.

1

Figure 1: Labeling for INFRARED 800 with FLOW 800 Option on the KINEVO 900 Pos. Symbol 1

Designation

Explanation

Identification label INFRARED 800

Provides information on: • Product designation • Manufacturer • Item and serial number • Date of manufacture • UDI labeling • CE label

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Serial No.

-

Catalog number

Reference number:

Date of manufacture

Contains the product’s date of manufacture.

UDI

UDI labeling

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3 Product description 3.2 Functional description

Instructions for Use INFRARED 800 with FLOW 800 Option

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 with the FLOW 800 module. The FLOW 800 module summarizes the video data recorded by the INFRARED 800 fluorescence application. This summary of the video data supports fast and objective interpretation of the blood flow. Markers (ROIs) can be set at important and/or interesting locations in the tissue. This allows the different characteristics of the influx and flow properties of the blood at these marked locations to be conveniently interpreted. Another important function is the Compare Mode of the FLOW 800 module. In the Compare Mode, the currently recorded video data can be compared with a patient’s previously recorded video data. The Compare Mode can be used, for example, during an AVM procedure to visually assess vessel types and their blood flow and compare them at the beginning of and after surgery.

Composition of the application The application INFRARED 800 with FLOW 800 Option comprises two modules: • INFRARED 800 provides the hardware and software for the video recording of the infrared fluorescence during the operation. • The optional module FLOW 800 provides an easy-to-use interface that enables comfortable visualization of the fluorescence video data recorded by the INFRARED 800 module. It compiles the INFRARED 800 video data in color coded overviews in which the sequence in which the fluorescence appears (“Delay” characteristic), the intensity of the fluorescence (“Intensity” characteristic) and the speed of the fluorescence rise (“Speed” characteristic) are displayed in a convenient and comprehensible manner. Both modules are integrated in the KINEVO 900. You can open and operate both modules via the handgrips, the foot control panel or the main monitor of the KINEVO 900. First, you record video data during the infrared fluorescence with the INFRARED 800 module. If necessary, you can use the “Replay” function for further assessment of the blood flow and, optionally, FLOW 800 for further interpretation.

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Instructions for Use INFRARED 800 with FLOW 800 Option

3 Product description 3.2 Functional description

Main functions Designation

Functional description

INFRARED 800

Records video data of the fluorescing tissue in the surgical field during the operation. The video recording process is divided into three phases: • Setup - Preparation phase; here you can set the focus and zoom parameters (provided that the “Skip Setup” function has been deactivated) and select the image section; then the recording phase starts. • Record - Recording phase; starts the detection and display of the fluorescence signals and saves this as a video file. • Replay - Playback phase; plays the recorded video files on the screen: "Short replay" plays a short sequence at the beginning of the video (duration adjustable) on repeat (repetition rate adjustable). "Long replay" plays the entire video on repeat (repetition rate adjustable). If the KINEVO 900 is equipped with the 3D option, you can simultaneously record a white light video with the INFRARED 800 module and record a INFRARED 800 video and display both recordings on the screen as an overlay or picture-in-picture.

Automatic Gain Control

Automatic camera gain increase during the recording phase. You can switch this function on or off.

AutoDetection

The system determines the point of time in the video data when the fluorescence agent flows into the tissue. If this function is switched on, the playback phase automatically starts at this point of time. Video data which precede this point of time are not displayed. You can switch this function on or off.

AutoZoom

The system starts the recording phase at the magnification previously set in the setup menu. You can switch this function on or off.

Analytical characteristics of the FLOW 800 module

The FLOW 800 module processes the video data of the fluorescing tissue according to the following characteristics: • Delay of the fluorescence influx into the tissue • Maximum intensity achieved by the fluorescence signal in the tissue • Speed at which the fluorescence signal increases (supports the assessment of the speed of blood flow)

ROI (region of interest)

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During the playback of the video data, you can set markers (ROIs: regions of interest) at locations which are of interest to you. The intensity of the fluorescence in the tissue is processed and displayed as a curve in a diagram for each marker set. With the help of this diagram, you can conveniently and quickly evaluate and compare the time course of the fluorescence intensity in the tissue.

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3 Product description 3.2 Functional description

Instructions for Use INFRARED 800 with FLOW 800 Option

Designation

Functional description

Diagram display

The diagram displays the time course of the fluorescence intensity for the previously set markers (ROIs). You can observe the change of intensity of the fluorescence brightness (in %) over time (in sec.) in the diagram. Each marker (ROI) is displayed as a separate curve in the diagram. In addition, the following values are displayed: • “Delay” characteristic • "Speed of fluorescence increase" characteristic • Time to Peak (TTP) (Period of time the contrast medium requires to reach its maximum concentration in the tissue (time until maximum hyperintensity)) • Rise Time (RT) (Period of time the contrast medium requires until an increase from a preset start value to a preset maximum value occurs)

Auto-correction

This function compensates for small movements of the KINEVO 900 (e.g. vibrations) and, if necessary, for poor illumination towards the edges of the image (vignetting).

Optimize View

Using this function, you can select a partial sequence of the INFRARED 800 video recording that is to be summarized in the FLOW 800 module. In this way you can e.g. exclude artifacts which occurred at the beginning or at the end of the INFRARED 800 video recording from the summary, thus optimizing the display. You then can save the optimized display; the entire video recording also will be preserved.

Compare FLOW 800 displays

Using this function, you can compare two FLOW 800 displays of the same patient recorded at different times. Thus, for example, you can record and save FLOW 800 displays of your patient before and after surgery to enable a before/ after comparison of the fluorescence intensity in the tissue. In the compare view, you can display the fluorescence intensity based on the Delay, Intensity and Speed characteristics. You can compare different diagrams only if you have saved a display of each of the diagrams to be compared.

Transfer markers (ROIs)

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Using this function, you can transfer the markers of a previously recorded FLOW 800 display to your currently recorded FLOW 800 display. This enables you to conveniently compare the fluorescence intensity of the previous FLOW 800 display with that of the current one based on the Delay, Intensity and Speed characteristics. For example, you can compare the fluorescence influx into the tissue before and after surgery side-by-side.

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Instructions for Use INFRARED 800 with FLOW 800 Option

3 Product description 3.3 Licenses

3.3 Licenses Each module requires a license which is managed by KINEVO 900. You can open the modules and operate them only if you have valid licenses for this purpose: Designation

Symbol

Scope of operation

INFRARED 800 Compact

Recording of video data during the operation without the main functions AutoGain and AutoDetection, i.e. the camera gain and recording time point must be set manually. The "Replay" playback phase is not available.

INFRARED 800

Recording and saving of video data during the operation with the main functions AutoGain and AutoDetection [} 12].

INFRARED 800 with FLOW 800

Playback, analysis and editing of the recorded video data.

To determine which licenses are activated on your KINEVO 900, check the identification label for applications [} 11] on the KINEVO 900 or open the “Fluorescence” function on the user interface .

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3 Product description 3.4 Software description

Instructions for Use INFRARED 800 with FLOW 800 Option

3.4 Software description 3.4.1 KINEVO 900 user interface The INFRARED 800 with FLOW 800 Option application can be opened, controlled and configured by using the following control elements on the KINEVO 900: • Main monitor (touchscreen): Open, control and configure INFRARED 800 with FLOW 800 Option application • Handgrips: Open and control INFRARED 800 with FLOW 800 Option application • Foot control panel: Open and control INFRARED 800 with FLOW 800 Option application The user interface is subdivided into different areas with different controls. 3 4

5

18

17 16 15

6

7

8

9 10 11

2

1

14 13

12

Figure 2: Overview of user interface and status bar

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1

Live video camera image

2

Status bar

3

Home (Navigation for video camera live image)

4

Edit patient data

5

Display of patient name, opens patient archive

6

Edit user data

7

Display of user name, opens user archive

8

Status information (opens corresponding menu)

9

Date, time

10

Setup menu

11

Help

12

Extended operation (open)

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Instructions for Use INFRARED 800 with FLOW 800 Option

3 Product description 3.4 Software description

13

Main menu bar

14

Start INFRARED 800 with FLOW 800 Option application

15

Number of images taken

16

Capture still image (photo)

17

Number of videos recorded

18

Video recording Start/Stop

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. If you tap on the monitor again, all control elements, the status bar and the main menu bar will reappear. The displayed values are rounded. They serve only to enhance the display and do not represent a measurement function. Detailed information on the user interface is provided in the instructions for use of KINEVO 900 in the software version used.

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3 Product description 3.4 Software description

Instructions for Use INFRARED 800 with FLOW 800 Option

3.4.2 “INFRARED 800” menu 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

10 9 8

7

6

5

Figure 3: “INFRARED 800” menu Pos. Name

Explanation

1

“Setup” preparation phase

In the “Setup” preparation phase you can set the focus and zoom parameters and select the image section.

2

“IR Record” recording phase

During the 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 gain are displayed.

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3

“Short Replay” playback phase

The “Short Replay” playback mode repeatedly and successively plays back a short sequence at the beginning of the video (adjustable duration and adjustable repetition rates).

4

“Long Replay” playback phase

The “Long Replay” playback mode repeatedly and successively plays back the complete video (adjustable repetition rates).

5

Marking of the recording area

The two vertical white broken lines mark the area of the INFRARED 800 video in which summaries are created for the FLOW 800.

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Instructions for Use INFRARED 800 with FLOW 800 Option

3 Product description 3.4 Software description

Pos. Name

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Explanation

6

Take photo of current display

Creates and saves documentation for the current display. You can view these images in the “Patient” menu.

7

Video recording Start/Stop

You can optionally start or stop the INFRARED 800 video recording by tapping this button.

8

Notification window

This window displays notifications concerning recommended settings that may help improve the INFRARED 800 recordings.

9

Zoom

Information indicator for the “Zoom” function. If the indicator line is colored white, the zoom is currently within the recommended zoom range.

10

Focus

Information indicator for the “Focus” function. If the indicator line is colored white, the focus is currently within the recommended focus range.

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3 Product description 3.4 Software description

Instructions for Use INFRARED 800 with FLOW 800 Option

3.4.3 “FLOW 800” menu Once a patient's video data have been recorded with INFRARED 800, you can display them in the FLOW 800 menu. 2

3

4

5

6 7

1 8 9 10

11 Figure 4: Structure of the “FLOW 800” menu Pos. Name

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Explanation

1

Scale with slide control

Slider for individual adjustment of the color coding. The slider can be adjusted continuously.

2

Delay characteristic

Displays the time course (in sec.) of the fluorescence influx into the tissue. The red colored areas are perfused first; the blue colored areas are perfused later (delayed).

3

Intensity characteristic

Displays the maximum fluorescence achieved in the tissue. Values are shown as % of maximum value (100%). The fluorescence intensity is high in the red colored areas and low in the blue colored areas.

4

Speed characteristic

Displays the speed (AI/sec.) of the brightness rise in the tissue. The rise rate is high in red colored areas and low in blue colored areas.

5

Diagram

The diagram displays the time course of the fluorescence intensity for the previously set markers (ROIs). You can observe the change of intensity of the fluorescence brightness (in %) over time (in sec.) in the diagram. Each marker (ROI) is displayed as a separate curve in the diagram.

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