AR-3200-1026 Synergy BioOptico Spectral Mode Instructions for Use Rev C

Proprietary Information This manual contains information deemed proprietary to Arthrex. The information contained herein, including all of the designs and related materials, is the sole property of Arthrex, and/or its licensors. Arthrex and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of Arthrex. Arthrex reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law. Product Warranties; Limitation of Liability Product Warranty HD3

See the Synergy

IFU for system warranties.

No claim shall be allowed on Products that have been altered, neglected, damaged or stored improperly. Arthrex shall promptly replace or repair any Product which malfunctions, fails to operate, fails to meet specifications, or which is otherwise defective This warranty shall not apply to any Product which has been misused, adulterated or modified by the customer. Arthrex’s repair or replacement of defective Product shall be customer’s exclusive remedy under this express warranty. THE PROVISIONS OF THE FOREGOING WARRANTIES ARE IN LIEU OF ANY OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). IN NO EVENT SHALL ARTHREX, INC. BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR CONTINGENT DAMAGES, WHETHER OR NOT ARTHREX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

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Table of Contents 1.0

Introduction ... 4

1.1

Intended Use ...4

1.2

Contraindications ...4

Not intended as a diagnostic tool...4 1.3

Licensing ...4

1.4

Warnings and Precautions ...4

1.4.1

WARNINGS

...4

1.4.2

PRECAUTIONS ...4

1.5

Symbol Definitions ...5

1.5

Initial Use of the Device ...5

1.6

Unpacking and Inspecting the Device ...5

1.7

Returning the Device ...5 HD3

2.0

Arthrex Synergy

3.0

Synergy

4.0

Arthrex Synergy

5.0

Maintenance ... 14

HD3

BioOptico Spectral Mode Function Equipment List ... 6

BioOptico Spectral Mode License Key Installation ... 7 HD3

BioOptico Spectral Mode Operation Instructions... 9

5.1

Cleaning ... 14

5.2

Troubleshooting ... 15

Appendix 1.0 Synergy HD3 BioOptico Spectral Mode LICENSE Label ... 16

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1.0 Introduction It is recommended that personnel study this HD3 manual before utilizing Synergy BioOptico Spectral Mode functions. The safe and effective use of this system requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual.

1.1

1.4

The words WARNING, PRECAUTION, and NOTE carry special meanings and they should be read carefully. WARNING: The safety and/or health of the patient, user, or a third party is at risk. Comply with this warning to avoid injury to the patient, user, or third party. PRECAUTION: This contains information concerning the intended use of the device or accessory. Damage to the equipment is possible if these instructions are not followed.

Intended Use HD3

The Synergy BioOptico Spectral Mode function is intended to provide overlays to the video image which represent the image’s spectral content, as an alternate visualization tool.

1.2

1.3

Contraindications Not intended as a diagnostic tool.

NOTE: A note is added to provide additional, focused, information.

1.4.1

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WARNINGS



Prior to use, read the entire Arthrex, HD3 Inc. Synergy System [950-0027-00] video instruction manual before use during surgical procedures.



Follow all warnings and cautions in these manuals.

Licensing

BioOptico Spectral Mode is an optional feature HD3 on the Synergy and requires the purchase and activation of a BioOptico Spectral Mode license (part number AR-3200-1026). When a site purchases a BioOptico Spectral Mode license they will be provided with a license key HD3 that is unique to each individual Synergy (i.e., this license cannot be used on another HD3 Synergy unit). Licenses are issued on a per HD3 Synergy basis and are not transferrable to another device. In the event that a BioOptico HD3 Spectral Mode -licensed Synergy is replaced HD3 by another Synergy due to a failure covered HD3 under warranty, the new Synergy would be also be licensed for BioOptico Spectral Mode.

Warnings and Precautions

1.4.2

PRECAUTIONS



Prior to use, read the entire Arthrex, HD3 Inc. Synergy System [950-0027-00] video instruction manual before use during surgical procedures.



Follow all warnings and cautions in these manuals.

NOTES: 1. Observe all national waste management regulations. 2. Do not dispose of Waste Electrical and Electronic Equipment [WEEE] as unsorted municipal waste.

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1.5

Symbol Definitions HD3

See the Synergy System [950-002700] video instruction manual for symbols used.

1.5 Initial Use of the Device WARNINGS: 1. Read each the Instructions for Use prior to use. 2. The electrical installation of the operating room where the device is used must comply with applicable national requirements. 3. The system is not intended for use in areas of explosion hazards. If explosive nitrous gases are used the system may not be operated in the danger zone. 4. Do not simultaneously touch the System Equipment and the patient. The System Equipment is intended to be used outside the Patient Vicinity. 5. Additional peripheral equipment connected as part of the Endoscopic Video System must meet the requirements of the following specifications: 

1.6 Unpacking and Inspecting the Device Upon receipt, carefully unpack the System and accessories. Ensure contents are complete and are free from damage. If any damage is noted contact your Arthrex Customer Service. Contact the Manufacturer for Return Authorization PRIOR to shipping your device for service. Save ALL packaging materials; they may be needed to verify any claims of damage by the shipper.

1.7 Returning the Device If it becomes necessary to return the device, always use the original packaging. The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging. Please make sure that all required information has been supplied. Call Arthrex for a RMA Number for the device return for service.  Owner’s Name  Owner’s Address  Owner’s Daytime Telephone Number  Device type and model.  Serial Number  Detailed explanation of the damage.

EN 60950 for Information Technology Equipment.

6. CAUTION: Do not install the device in a location near heat sources such as air ducts or radiators and do not expose the device to direct sunlight, excessive dust, or mechanical vibration.

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2.0 Arthrex SynergyHD3 BioOptico Spectral Mode Function Equipment List Arthrex Synergy Part Number

Comments

HD3

Synergy

AR-3210-XXXX

Synergy

HD3

Camera Head

HD3

Synergy

Mode Key Kit

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System Accessories

Description

AR-3200-0001T

AR-3200-1026

HD3

BioOptico Spectral

Contains 

IFU 950-0053-00



BioOptico Key Label for enabling BioOptico on HD3 the Synergy

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3.0 SynergyHD3 BioOptico Spectral Mode License Key Installation Requirements: To utilize the BioOptico Spectral Mode a facility needs to:  Activate BioOptico Spectral Mode license Key [AR-3200-1026]. o The AR-3200-1026 [BioOptico Structure Mode Key] contents include 102-0289-00 [Label, Synergy HD3, BioOptico Spectral Mode Key]. o This label is designed to document your License Key Number, and your Camera Control Unit’s Serial Number; this data is used to activate BioOptico in the SynergyHD3 System. o To receive your activation key, contact your Arthrex Representative and provide them with the Serial Number of your Camera Controller. o Your Arthrex Representative will provide you with your BioOptico Key. o Write both the CCU Serial Number and the BioOptico Key on the 102-0289-00 [Label, Synergy HD3, BioOptico Spectral Mode Key], and secure it to your Camera Controller for future reference. See Appendix 1.  Have the latest SynergyHD3 firmware installed. All version 1.5 and 1.6 units have the necessary firmware. All 3.6 units shipped with version 3.6 installed (i.e., units that were not field upgraded to 3.6) also have the necessary firmware. All older SynergyHD3 devices will require a firmware upgrade to use BioOptico. If a facility is interested in utilizing BioOptico on an existing SynergyHD3 unit please contact SynergyHD3 support if you are unsure as to the firmware status of the device. Set Up/Configuration: To configure the SynergyHD3 for BioOptico use log in as an Administrator on the SynergyHD3 tablet. Enter System Set-Up by pressing the Maintenance Icon located in the upper left corner of SynergyHD3 tablet (as shown in Figure 1) and then select Advanced Settings.

Figure 1. SynergyHD3 Maintenance Menu

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Next select the BioOptico tab as shown in Figure 2.

Figure 2. BioOptico Tab If the facility has purchased a BioOptico Spectral Mode license, then the license key provided should be entered in the Spectral Mode field in the BioOptico tab. Once the key is entered tap the enable button next to the key. If the key is correct, then an Enable slider for the individual option will appear. Slide the slider to On and tap the Save button in the lower right corner of the screen to save the changes.

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4.0 Arthrex SynergyHD3 BioOptico Spectral Mode Operation Instructions BioOptico Spectral Mode

SynergyHD3 currently includes an optional BioOptico Spectral Mode algorithm. BioOptico’s Spectral Mode augmented reality algorithm enhances features in video signals. The BioOptico algorithm uses the standard SynergyHD3 camera and light source to generate overlays to the surgical image that may assist a surgeon to better visualize features in the surgical image. Limitations: There are no diagnostic claims made with the BioOptico Spectral Mode algorithm. This algorithm is provided “as is” for surgeon use. Once BioOptico is enabled it can be customized for individual surgeon preferences as follows. Enter System Set-Up by pressing the Maintenance Icon located in the upper left corner of SynergyHD3 tablet (as shown in Figure 1) and then select Surgeon Management. On the Surgeons screen (shown in Figure 3) touch the name of the surgeon that wants to customize BioOptico and select the i icon that appears to the right of the surgeon name once the name is highlighted.

Figure 3. Surgeons screen The Surgeon screen shown in Figure 4 will appear. Tap the Preferences button to the right of the surgeon name.

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Figure 4. Surgeon screen The screen shown in Figure 5 will appear. Select the BioOptico tab.

Figure 5. BioOptico surgeon setting tab

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The first two settings apply to the BioOptico Spectral Mode. The third setting (Texture Color) is not relevant for the BioOptico Spectral Mode as it applies only to the BioOptico Texture Mode. The Refresh setting has three options (1, 2, 3) that determine how quickly the BioOptico Spectral Mode overlay is refreshed on the surgical monitor. The Spectral Opacity setting offers various opacity percentages ranging from 12.5% to 100% that determine the level of opacity of the BioOptico Spectral Mode overlay on the surgical monitor. Adjust these settings to optimize BioOptico for the individual surgeon. Surgeons will have different opinions on what settings look best. As a result these settings are left up to the judgment of the individual surgeon and no recommendations are made for setting these values. Once all the changes have been made tap the Back button in the upper left corner to return to the Surgeon screen shown in Figure 4 and tap the Save button in the lower right corner. If the surgeon wants to invoke BioOptico from a camera button tap the Preferences button on the Surgeon screen and choose the Button Settings tab as shown in Figure 6.

Figure 6. Button settings tab BioOptico can only be invoked via a long button press, so select either the left or right long press button dropdowns (the left is shown in Figure 6) and locate the BioOptico options. There are three different BioOptico options that can be assigned to the long press buttons. BioOptico Spectral or BioOptico Texture will invoke that individual BioOptico mode when the long press is used. When the same long press button is used a second time BioOptico overlays are removed from the surgical monitor. BioOptico Toggle offers both BioOptico modes via the same long button press. When the long press is used a menu appears on the monitor offering the options to select spectral, texture, or neither. The surgeon can select their preferred mode from the menu using the left and right camera buttons to move through the menu options. Once the buttons have been configured per surgeon preference tap the Back button in the upper left corner of the screen and tap the Save button on the lower right corner of the Surgeon screen (as shown in Figure 4) to save the changes. 950-0053-00C

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Use Instructions: Once this option is configured the BioOptico Spectral Mode algorithm can be invoked via the camera buttons as they were configured in the previous section. To use the BioOptico Spectral mode the surgeon will need to perform a calibration upon invoking the mode. When the mode is first selected a square target will appear on the screen as shown in Figure 7.

Figure 7. BioOptico Spectral Mode calibration target The surgeon should align this target on a white area within the patient and then press one of the camera buttons. If the calibration is successful, then a green checkmark will temporarily appear in the target and then the target will disappear. If the calibration is not successful, then a red X will appear in the target and the surgeon will need to repeat the calibration. If the second calibration attempt fails, then the system will use a default calibration and will allow the surgeon to start to use the feature. Figure 8 shows a sample BioOptico Spectral mode image. As the surgeon moves the camera the overlay follows the image on the surgical monitor. In this mode three colors may appear on the screen – yellow, orange, and red. These show relative differences compared to the calibrated source. Yellow most closely aligns with the calibrated source and red is the most different from that source.

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Figure 8. Sample BioOptico Spectral Mode image

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5.0 Maintenance HD3

Regular and proper maintenance of your Arthrex Synergy and avoid non-warranty repairs.

is the best ways to protect your investment HD3

For Maintenance requirements, see the Equipment Manual for the Synergy

System.

Your authorized Arthrex service department is the most knowledgeable about the Arthrex Medical Camera Systems and/or camera heads and will provide competent and efficient service. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure.

5.1

Cleaning HD3

Refer to the Synergy

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System components for any recommended cleaning.

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5.2 Troubleshooting Symptom BioOptico Spectral Mode isn’t invoked on button press

  

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Possible Cause Spectral Mode isn’t licensed Spectral Mode isn’t enabled Spectral Mode isn’t assigned to a camera button

  

Corrective Action Ensure Spectral Mode license key is activated Ensure Spectral Mode is enabled (On) Ensure Spectral Mode is assigned to a surgeon’s long press camera button

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Appendix 1.0 Synergy HD3 BioOptico Spectral Mode LICENSE Label

HD3

Figure 8-Synergy

BioOptico Spectral Mode License Label (SAMPLE) HD3

It is important to keep the License key number in a convenient place and Identify each Synergy HD3 Console that is enabled. Enter the License Key number and the Synergy console serial number with a “Sharpie” on this Label that is provided, shown above. Place the Label on the top cover of the Synergy HD3 HD3 console as shown in Figure 9-Synergy with BioOptico Spectral Mode License Label. .

HD3

Figure 9-Synergy

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with BioOptico Spectral Mode License Label

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Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108, USA Customer Service 866-267-9138

All rights reserved. Printed in USA

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