AR-3200-1040 SynergyHD3 CABLE KIT Instructions for Use Rev D

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 individual components of the Synergy component warranties.

Cable Kit, Arthrex Shaver and Pump System for

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.

950-0052-00D

2 of 18

Table of Contents 1.0

Introduction ... 4

1.1

Intended Use ...4

1.5

Contraindications ...4

1.6

Warnings and Precautions ...4

1.7

Symbol Definitions ...5

1.8

Initial Use of the Device ...5

1.9

Unpacking and Inspecting the Device ...5

1.10

Returning the Device ...5

2.0

HD3

Cable Kit, Arthrex Pump and Shaver Equipment List ... 6

HD3

Cable Kit, Arthrex Pump and Shaver Equipment Interconnect Diagram ... 7

HD3

Cable Kit, Arthrex Pump and Shaver Operation Instructions ... 10

Synergy

3.0

Synergy

4.0

Synergy

5.0

Maintenance ... 16

5.1

Cleaning ... 16

5.2

Troubleshooting ... 17

950-0052-00D

3 of 18

1.0 Introduction It is recommended that personnel study this HD3 manual before utilizing Synergy Cable Kit, Arthrex Pump and Shaver. 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

1.6 Warnings and Precautions 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 Cable Kit, Arthrex Pump and Shaver is Intended to provide display of selected information from the AR-6480 [Pump] and AR-8305 [Shaver] on the periphery of the surgical monitor. Display of pump and shaver settings on the surgical monitor allows the surgeon to view these settings at any time in the procedure

1.5 Contraindications

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

1.6.1 



Not intended to Control any aspect of the Pump or the Shaver. .  1.6.2 





950-0052-00D

WARNINGS Prior to use, read the entire Arthrex, HD3 Inc. Synergy System [950-0027-00] video instruction manual before use during surgical procedures. Prior to use, read the entire AR-6480 [Dual/Wave Pump Console] and AR8305 [Shaver] instructions for use before use during surgical procedures. Follow all warnings and cautions in these manuals. PRECAUTIONS Prior to use, read the entire Arthrex, HD3 Inc. Synergy System [950-0027-00] video instruction manual before use during surgical procedures. Prior to use, read the entire AR-6480 [Dual/Wave Pump Console] and AR8305 [Shaver] instructions for use before use during surgical procedures. Follow all warnings and cautions in these manuals.

4 of 18

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

1.7 Symbol Definitions See System Component Manuals for Symbol Definitions.

1.8 Initial Use of the Device WARNINGS: 1. Read each of the Instructions for Use for each of the System Components 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.

1.9 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.

1.10

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.

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: 

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.

950-0052-00D

5 of 18

2.0 SynergyHD3 Cable Kit, Arthrex Pump and Shaver Equipment List Arthrex Synergy Part Number

HD3

System Accessories

Description

Comments

AR-3200-0001T

SynergyHD3

AR-6480

DualWave Arthroscopy Pump

AR-8305

Synergy Console

212-0052-00

Cable, HD3 Interface, ACB, 4 Either 4 foot interface cable or 8 foot interface cable may be used; foot

212-0053-00

Cable, Interface, ACB, 4 foot

212-0054-00

Cable, Interface, ACB, 8 foot

212-0055-00

Cable, HD3 Interface, ACB, 8 foot

950-0052-00

IFU, Arthrex HD3 Pump and Shaver Kit

950-0052-00D

Shaver

Resection

depending upon your equipment interconnection requirements.

6 of 18

3.0 SynergyHD3 Cable Kit, Arthrex Pump and Shaver Equipment Interconnect Diagram

Figure 1-Connection of the AR-6840 6480 DualWave Pump Console

950-0052-00D

7 of 18

Figure 2-Connection of the Shaver Console

950-0052-00D

8 of 18

Figure 3-Connection of the Pump and Shaver

950-0052-00D

9 of 18

4.0 SynergyHD3 Cable Kit, Arthrex Pump and Shaver Operation Instructions Pump and Shaver Setting Display

SynergyHD3 currently supports the ability to display pump and shaver settings from the current Arthrex pump [AR-6480] and shaver [AR-8305] on the surgical monitor. Display of pump and shaver settings on the surgical monitor allows the surgeon to view these settings at any time in the procedure even if the pump and shaver consoles are not visible to the surgeon. Requirements: To utilize the pump and shaver setting display a facility needs to:  Have the most recent hardware version of the Arthrex pump and shaver that supports SynergyHD3 integration  Have the Arthrex pump/shaver integration kit (part # AR-3200-1040)  Have SynergyHD3 Version x.6 or newer. Limitations: While pump and shaver settings are displayed on the surgical monitor, there is no control of the pump or shaver settings from SynergyHD3. Pump and shaver settings changes must be made directly on the pump and shaver consoles. Set Up/Configuration: To configure the SynergyHD3 for pump and shaver settings display, 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. Maintenance icon on SynergyHD3 tablet From the System tab (as shown in Figure 2) scroll down and locate the Enable Pump and Enable Shaver settings and turn these on for each device type connected to SynergyHD3. Once they are on touch the Save button in the lower right corner of the screen to save the settings.

950-0052-00D

10 of 18

Figure 2. System tab Once pump and shaver use has been enabled the preferences for each surgeon must be configured. Enter System Set-Up by pressing the Maintenance Icon located in the upper left corner of SynergyHD3 tablet (as shown in Figure 1 above) and then select Surgeon Management. On the Surgeons screen as show in Figure 3 touch the name of the surgeon that wants to use pump or shaver settings display and then select the “I” icon [ name once the name is highlighted.

] that appears to the right of the surgeon

Figure 3. Surgeons screen The Surgeon screen shown in Figure 4 will appear. Tap the Procedure Settings button next to each procedure where the pump and/or shaver will be used.

950-0052-00D

11 of 18

Figure 4. Surgeon screen The screen shown in Figure 5 will appear. Select the Pump tab (as shown in Figure 5) if the pump will be used with the procedure.

Figure 5. Pump tab

950-0052-00D

12 of 18

Adjust the Set Pressure slider to the surgeon’s desired value (note: as you adjust the slider the numerical value appears to the right of the slider). Finally, choose one of the three options for the surgical display. If “On” is selected the pump pressure appears on the surgical monitor at all times. If “Off” is selected the pump pressure is only displayed prior to the start of the case and never appears on the monitor during the case. If “On Change” is selected the pump change data appears on the surgical monitor only when the data changes. In this case it disappears from the monitor after displaying for several seconds. Touch Save after the changes have been made.

Figure 6. Shaver tab Select the Shaver tab (as shown in Figure 6) if the shaver will be used with the procedure. Adjust the Fwd/Rev Set Speed and Osc. Set Speed sliders to the surgeon’s desired value (note: as you adjust the slider the numerical value appears to the right of the slider). Next, choose the preferred Set Mode for the procedure using the drop down options. Finally, choose one of the three options for the surgical display. If “On” is selected the shaver speed appears on the surgical monitor at all times. If “Off” is selected the shaver speed is only displayed prior to the start of the case and never appears on the monitor during the case. If “On Change” is selected the shaver changed data appears on the surgical monitor only when the data changes. In this case it disappears from the monitor after displaying for several seconds. Touch Save after the changes have been made. After you have made the necessary pump and shaver configuration changes and have hit Save you will return to the Surgeon screen shown in Figure 4. Tap the Save button in the lower right corner of the Surgeon screen.

Use Instructions: Once this option is configured then the system will automatically display pump and/or shaver settings per the surgeon’s preferences during a case. There are no additional steps the user needs to take to utilize pump and shaver display settings.

950-0052-00D

13 of 18

The pump and shaver settings will appear on the left side of the surgical monitor as shown in Figure 10. Settings on the screen will update real time. The shaver text will turn from white to green during shaver activation.

Figure 10. Pump/shaver settings on surgical display If pump or shaver settings are not configured to automatically display on the monitor but the surgeon wants to see those settings during a procedure or if the settings display and on the screen and the surgeon wants them removed, then this can be done via the SynergyHD3 tablet. During a case tap the settings icon to the left of the tablet as shown in Figure 11.

950-0052-00D

14 of 18

Figure 11. Settings icon on tablet Tap either the pump or shaver icon to the left of the screen to open the pump or shaver settings menu. From these menus staff can choose to display pump or shaver settings on the surgical display or hide those settings. As shown in Figure 12 users have the option to turn the settings display on, off, or on only when the settings change.

Figure 12. Surgical display options for shaver 950-0052-00D

15 of 18

Any changes made to these settings are immediately applied and last for the remainder of the case or until they are changed again. If the surgeon wants those same settings applied for all future cases, then the surgeon preference should be modified as discussed in the previous section.

5.0 Maintenance HD3

Regular and proper maintenance of your Synergy Cable Kit, Arthrex Shaver and Pump System is the best ways to protect your investment and avoid non-warranty repairs. HD3

For Maintenance requirements, see the Equipment Manuals for the Synergy Shaver Display System.

, DualWave Pump and

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 , DualWave Pump and Shaver Display System components manuals for any recommended cleaning.

950-0052-00D

16 of 18

5.2 Troubleshooting Symptom Settings do not appear on surgical monitor

Possible Cause   

Settings appear as 0 on monitor

  

Settings disappear from surgical monitor

950-0052-00D



Pump/shaver not powered on Pump/shaver display not enabled Surgeon preferences set to not display settings Pump/shaver settings are set to 0 Integration cable is disconnected Pump/shaver not powered on

Surgeon preferences set to display on only settings changes

  

  



Corrective Action Ensure pump/shaver powered on Confirm pump/shaver enabled in settings Set surgeon preference to display settings Confirm pump/shaver settings are not 0 Confirm integration cables are connected Ensure pump/shaver powered on

Set surgeon preference to always display settings

17 of 18

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

All rights reserved. Printed in USA

950-0052-00D

18 of 18