SynergyHD3 System AR-3200-xxxx Instructions for Use Manual Rev B

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 Arthrex expressly warrants to customer that all Arthrex Products purchased by customer shall be free from defects in materials and workmanship for 1 year from date of purchase. Arthrex’s liability shall include replacing or repairing those Products shown to be defective either in materials or workmanship. Claim of defect in materials or workmanship in any Product shall be considered when it is submitted to Arthrex in writing within thirty (30) days after discovery. 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 Use of Sterilants or Chemicals other than those listed in the “Cleaning and Sterilization” section shall void the product’s warranty. 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.

950-0027-01B

2 of 55

Table of Contents 1.0

Introduction ... 4

1.1

Intended Use ...4

1.2

Contraindications ...4

1.3

Warnings and Precautions ...4

1.4

Symbol Definitions ...9

1.5

End of Life, Environmental Directives ... 11

1.6

Initial Use of the Device ... 11

1.7

Unpacking and Inspecting the Device ... 12

1.8

Returning the Device ... 13

1.9

System Indicators ... 14

2.0

System Installation and Operation with Data Input Device ... 18

2.1

Installation... 18

2.2

Accessories for Intended Use ... 19

2.3

System Setup Facility and Surgeon Settings ... 20

2.4

Scheduling and Starting Cases... 29

2.5

System Operation without Tablet Data Input Device ... 35

2.6

Picture in Picture Operation ... 37

3.0

Maintenance ... 39

3.1

Life Expectancy ... 39

3.2

Periodic Maintenance... 39

3.3

Cleaning and Sterilizing ... 39

3.4

Troubleshooting ... 42

3.5

Recommended Annual Camera Control Unit Maintenance Requirements ... 44

3.6

Replacement of the Lithium Battery ... 44

4.0

Technical Information ... 45

5.0

APPENDIX [Detailed EMC Information] ... 48

6.0

APPENDIX [SW Version access] ... 53

950-0027-01B

3 of 55

1.0 Introduction It is recommended that personnel study this manual before attempting to operate, clean, and/or sterilize the Arthrex SynergyHD3 System and accessories. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual.

1.1

1.3

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

The Arthrex SynergyHD3 System is comprised of: 

AR-3200-0001T Camera Control Unit.



AR-3210-0001 Camera Head with Integrated Optics



AR-3210-0003 Camera Head, CMount.



AR-3210-0004 Camera Head, CMount 20 foot.



AR-3210-0007 Camera Head, CMount, Zero Degree

This system is designed for use by physicians and surgeons and is intended for endoscopic camera use in a variety of endoscopic surgical procedures, including but not limited to, orthopedic, laparoscopic, urologic, sinuscopic and plastic surgical procedures. It is also intended to be used as an accessory for microscopic surgery.

1.2

NOTE: A note is added to provide additional, focused, information. 1.3.1 

This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Prior to using the device, read and follow all warning and precautionary notices and instructions marked on the product and included in this manual. Become familiar with the operation and function of this device and associated accessories. Failure to follow these instructions can lead to:



Life-threatening injuries to the patient



Severe injuries to the surgical team, nursing or service personnel, or



Damage or malfunction of the device or accessories.

Contraindications

Do not use the device if endoscopic surgery is contraindicated. Do not use the device if the environmental conditions for use do not meet the standards or regulations defined in the accompanying documents.

950-0027-01B

WARNINGS

1. Do not open or attempt to service this system, as this may void your warranty. There are no userserviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerous high voltages or other risks. If the system malfunctions, return it for service immediately.

4 of 55

2. For the protection of the patient it is recommended that a back-up camera system for the Arthrex SynergyHD3 video system be maintained, sterilized, and ready to be implemented. 3. For the protection of the patient it is essential that the endoscopic video system interconnection is complete and produces a viable color picture on the surgical monitor PRIOR to administration of patient anesthesia. 4. Disconnect camera head from patient prior to applying cardiac defibrillation to patient. 5. Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect. 6. This device and its accessories are to be used only by physicians and medical assistants under the direction of a physician with appropriate technical qualifications. 7. This device shall only be used with original and manufacturer’s accessories and replacement parts. Use of other parts or materials may degrade safety. 8. Do not use in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 9. Equipment grounding is vital for safe operation. Plug the power cord into a properly earthed mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices defeat the safety ground and could cause injury. 10. This equipment should not share an electrical outlet or grounding with life supporting or life sustaining equipment. 11. If one or more mains powered units are connected simultaneously to one socket by the means of a distribution box, the sum of the individual leakage currents may exceed the tolerated limits. 12. The scope light guide tip can get extremely hot as result of high intensity light, giving 950-0027-01B

rise to high temperatures in front of the light emission window which may cause severe burns. Always keep the light source in the STANDBY mode when not in use. 13. Before each use, the outer surface of the portions of the Endoscope and any Endoscopically Used Accessory, which are intended to be inserted into the patient, should be checked to ensure there are no unintended rough edges, sharp edges or protrusions which may cause a safety hazard. 14. Safety hazards to patients may result from gas embolism caused by, for example, overinsufflation of air or inert gas prior to high frequency surgery or laser assist gas 15. The leakage current through the patient could increase using endoscopes with powered accessories. 16. When Endoscopes are used with Energized Endoscopically Used Accessories, the Patient Leakage Currents may be additive. This is particularly true if a CF Applied Part is used, in which case a Type CF Endoscopically Used Accessory should be used to minimize total Patient Leakage Current. 17. Explosive gas concentrations inside the patient can cause hazards while using HighFrequency Endoscopically Used Accessories. 18. For the protection of service personnel, and for safety during transportation, all devices and accessories that are returned for repair must be prepared for shipment as described in “Returning the Device” of this manual. The manufacturer has the right to refuse to carry out repairs if the product is contaminated. 19. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the SynergyHD3 Video System or shielding the location. 20. NOT for use in an Oxygen Rich Environment. 21. Applied Parts of other ME Equipment used within the configuration for Endoscopic

5 of 55

Application shall be type BF or CF Applied Parts. 22. NO Modifications of this equipment is allowed. 23. Connecting any equipment that has not been supplied as part of this ME System to Multiple Socket Outlets may result in increased leakage currents. Use an IEC Approved Isolation Transformer to isolate any such interconnections from the ME System. 24. Before each use or after changing viewing modes/settings the Operator should check to ensure that the view observed through the Endoscope provides a live image (rather than a stored one) and has the correct image orientation. 25. Risk of burns! Light sources emit large amounts of light energy and thermal energy. As a result:  Surface temperatures of the insertion portion of the endoscope as well as light guide connectors on the CCU and the endoscope rise during use. This can cause the temperature of the body tissue to rise in excess of 106 °F (41°C).  Potential Thermal injury to the patient’s tissue (e.g. from prolonged exposure to the intense illumination in small cavities, or if the endoscope’s distal end is placed in close proximity with the tissue) may result, as well as burns to the patient’s or user’s skin. Burns or thermal damage to surgical equipment may also result.  Avoid prolonged exposure to intense illumination.  Use the minimum level of illumination necessary to satisfactorily illuminate the target area.  Do not place the endoscope’s distal end or light guide connector on the patient’s skin, on flammable materials or on heat sensitive materials.  Turn the light source off when detaching the endoscope from the light guide cable.  Allow the endoscope and light guide cable to cool down after use. 950-0027-01B

26. High Frequency [HF] electrical surgical instruments may lead to severe patient injuries and/or damage to the endoscope. Please take caution to insure that the working element is kept within field of view to prevent accidental burns. A sufficient distance from the tip of the endoscope to other conductive accessories and instruments should be maintained (10 mm) before activating the HF output to prevent burns and damage to the endoscope. Refer to the HF Surgical Device Instructions for proper and safe use. 27. HF surgical Instruments may interfere with video images. To prevent such interference, HF equipment and video imaging equipment should be connected to different power supply circuits. 28. Use of Lasers in surgery may result in Eye Damage or damage to the endoscope from reflected laser energy. Refer to the Laser Device Instructions for proper and safe use.

1.3.2



When using a laser always wear protective glasses designed for the laser’s wavelength.



Cover the patient’s eyes, or use protective glasses designed for the laser’s wavelength.



To prevent damage to the Endoscope, the Laser should be activated only after the tip of the laser can be seen thought the endoscope. PRECAUTIONS

1. United States Federal law restricts sale of this device to or on the order of a physician. 2. Do not use the camera with incompatible equipment or accessories that are not authorized by Arthrex. Doing so may void certifications and/or warranties. 3. The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: 

The device or the accessories are improperly used, prepared or maintained;



The instructions in the manual are not adhered to;

6 of 55



Non-authorized persons perform repairs, adjustments or alterations to the device



Non-authorized persons open the device.

NOTE: Receipt of technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations to the device or accessories. Only authorized service personnel may perform repairs, adjustments or alterations on the device and accessories. Any violation will void the manufacturer’s warranty. Authorized service technicians are trained and certified only by the manufacturer. The Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions and other information required for service to any Arthrex Authorized Service Center. 4. This device should only be used in compliance with its intended use. 5. Prior to each use, the CCU and all associated equipment must be inspected for proper operation. Visually inspect lenses to assure there are no scratches, chips or cracks. 6. To carry out safe operation, it is absolutely necessary to carry out proper care and maintenance of the device and accessories. See “Maintenance” section of this manual. 7. Ensure that the available mains voltage matches the mains voltage data on the rear of the device which is located near the appliance inlet module. 8. This device may only be connected to endoscopes which, in their intended use and technical specifications, are appropriate for use with the device for the intended medical procedure. The endoscopes must comply with the latest version of DIN EN 60601-2-18 and ISO 8600. 9.

This equipment has been tested and found to comply with Class A limits of IEC 606011-2:. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, if interference does occur with

950-0027-01B

other equipment, it may be corrected by one or more of the following measures; 

Reorient or relocate this equipment, the other equipment, or both;



Increase the distance between the different pieces of equipment;



Consult a biomedical engineer.

10. Do not expose the Camera Control Unit [CCU] to moisture, or operate it in a wet area, or store liquids above the CCU. 11. Do not excessively bend or kink instrument power cord or camera head cable. 12. Handle all equipment carefully. If the CCU or camera head is dropped or damaged in any way, return it immediately for service. 13. If the camera head or camera head cable are damaged in any way, or cable or connector jacket are cut, do not autoclave camera head, or immerse camera head in liquid (water, chemical disinfectants or sterilants, etc.). Notify your Arthrex Sales Representative. If it is necessary to return the camera head to Arthrex for service, disinfect the camera head before shipping and reference “Returning the Device”. 14. Store camera head and all accessories in a protective container to prevent damage during storage. Do not store CCU where it will be exposed to temperatures in excess of 140°F (+ 60°C). 15. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1 ). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative, or the technical department.

7 of 55

16. Any person who connects external equipment to signal input and signal output ports or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601-1. If in doubt, contact a qualified Biomedical technician or your local representative. 17. This equipment has been tested and found to comply with the Class A limits for medical devices to the IEC 60601-1-2 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other device(s) in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: (a) Reorient or relocate the receiving device. (b) Increase the separation between the equipment.

950-0027-01B

(c) Connect the equipment into an outlet on a circuit different from that to which the other devices are connected. (d) Consult the manufacturer or field service technician for help. This unit was not evaluated for use with electrosurgical devices which access the site via the same endoscope as the light source and camera. The unit must be reevaluated prior to use with electrosurgical devices when they will operate through the same endoscope as the light source and camera. 18. After each use, thoroughly clean unit and accessories (See “Cleaning and Sterilizing”). NOTES: 1. Observe all national waste management regulations. 2. Do not dispose of WEEE as unsorted municipal waste.

8 of 55

1.4

Symbol Definitions

Safety Sign Follow Operating Instructions

950-0027-01B

Caution: Federal Law Restricts this device to sale by or on the order of a Physician.

Power Standby/On

Not for use in the Presence of Flammable Anesthetics.

Attention, Consult Accompanying Documents

Fragile

Precaution of Warning Notice

This Side Up

Type BF Equipment

Keep Dry

Electrical Hazard, Dangerous Voltages are Present. Never attempt to repair the equipment. Only Trained Service Personnel may remove the cover, or obtain access to system components.

Temperature Limits for Storage and Transport

Alternating Current

Pressure Limits for Storage and Transport

Protective Earth [Ground]

Humidity Limits for Storage and Transport

9 of 55

Equipotential [Equipment Potential]

Universal Serial Bus

WEEE [Waste Electronics and Electrical Equipment] Symbol. Regarding European Union End-of-Life of Product.

RF Symbol. Nonionizing Electromagnetic Radiation

White Balance Symbol

Color Video Camera

Catalog Number

Serial Number

Manufacturer

Authorized Representative in the European Community

Do Not Use if Package is Damaged

950-0027-01B

10 of 55

1.5

End of Life, Environmental Directives

1.6

Initial Use of the Device WARNINGS:

WEEE Directive [2012/19/EU] on Waste Electrical and Electronic Equipment The Directive on Waste Electrical and Electronic Equipment obliges manufacturers, importers, and/or distributors of electronic equipment to provide for recycling of the electronic equipment at the end of its useful life. Do not dispose of WEEE in unsorted municipal waste. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical endoscopic video equipment at the end of its useful life for recycling, please contact Arthrex Customer Service Department. The Camera Controller contains a Lithium Coin BATTERY. The BATTERY must be recycled or disposed of properly. NOTE for State of California, USA: State of California Requirement: Lithium Batteries contain Perchlorate Material -special handling may apply. See www.dtsc.ca.gov/HazardousWaste/Perchlorate

In the US a list of recyclers in your area can be found at www.eiae.org/

950-0027-01B

1. The device is only completely isolated from the mains if the power plug is disconnected from the device’s power inlet module. 2. The electrical installation of the operating room where the device is used must comply with applicable national requirements. 3. Loss of the Mains Voltage may result in an unacceptable risk due to loss of Essential Performance. An Uninterruptable Power Supply [UPS] is recommended to mitigate this risk. 4. The device is not intended for use in areas of explosion hazards. If explosive nitrous gases are used the Camera Control Unit may not be operated in the danger zone. 4. Do not simultaneously touch the Camera Control Unit and the patient. Camera Control Unit is intended to be used outside the Patient Vicinity. 6. 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.



EN 60601-2-18 for endoscopic devices.



EN 60601-1 for electro medical devices.

7. All final Endoscopic Video Systems must meet the requirements of EN 60601-1-1. 8. Whoever connects additional equipment to signal input or signal output is obligated to meet the requirements of the EN 60601-1-1 standard.

11 of 55

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.

950-0027-01B

1.7

Unpacking and Inspecting the Device

Upon receipt, carefully unpack the SynergyHD3 Controller Unit (CCU) 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.

12 of 55

1.8

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.

950-0027-01B

NOTE: 1.

2.

The CCU shall be cleaned per section Cleaning and Sterilization prior to returning for service. The Camera Head shall be cleaned and Sterilized per Cleaning and Sterilization prior to returning for service. Camera Head shall be clearly labeled as “Sterile.”

Arthrex shall not implement repairs on equipment which is not returned cleaned and sterile

13 of 55

Figure 1- SynergyHD3 Front Panel [AR-3200-0001T]

1.9 1.9.1

System Indicators HD3

Synergy

Front Panel

1. On/Standby Switch - The On/Standby switch toggles the (CCU) between ON [operational mode], and STANDBY. The Green LED will illuminate when the CCU is in the ON mode. Press and HOLD the switch to toggle between ON and STANDBY. 2. Light Guide Turret - Turret for Light Guide input 3. USB Ports [2x] - Connect USB devices here. 4. “WHITE BALANCE” Button - Press to initiate camera white balance. 5. “CAMERA” Input Connection - Insert the camera head connector here. The camera head connector and receptacle are specially keyed to prevent the camera head from being improperly connected. Ensure that the “UP” label on the camera head connector is facing upwards when the camera head connector is inserted. PRECAUTION: Ensure camera head contacts are clean and dry and cool 15 minutes prior to insertion. 950-0027-01B

6. Light Source On/Standby Switch - The Light Source On/Standby Switch toggles the Light Source between ON [Operational Mode], and STANDBY.

PRECAUTION: 1. Use Only FUSED Light Guides to ensure proper operation of LED Engine. 2. LED Engine Cleaning Requirements.  Allow LED Engine to cool for ½ hour before cleaning.  Dampen one end of a cotton swab with isopropyl alcohol.  Clean any residue from optic using circular motion.  Use the DRY END of the cotton swab to dry the face of the optics.  Inspect the optics for residue or cotton fibers and clean as required.  Allow to AIR DRY for 5 minutes prior to use.

14 of 55

Figure 2- SynergyHD3 Rear Panel

1.9.2

Rear Panel

1. “DVI” Video Output Connectors - Supplies a digital video signal output in DVID format. 2. Accessory Ports (Inputs/Outputs - 2X mini Stereo-Phone Connectors) - Accessory ports allow for control of the Camera Control Unit (CCU) with a footswitch, or for the CCU to control external devices through the camera head buttons. 3. Reset Button - Resets CCU to factory Defaults. 4. Audio Out- Line Level audio output to Medical Grade devices. 5. Audio IN-Line Level audio input for Microphone

potentials between different metal parts of the various Medical Electrical [ME] equipment which make up a Medical Electrical system, or to reduce differences of potential which can occur during operation between the bodies of the Medical Electrical devices and conductive parts of other objects. The Potential Equalization Connector may be connected directly between any ME Devices, or to a common busbar of the electrical installation. Reference IEC 60601-1 for ME Systems. 10. IEC 320 Power Inlet Module (100-240V~, 50/60 Hz) - The CCU is equipped with a switching power supply that automatically adjusts to the line voltage being used. Accepts the supplied hospital grade power cord. 11. HDSDI- 3G Serial Video Output

6. Ethernet Connector- Isolated-10/100 MB/Sec.

12. DVI Input – 1080P/60 input from other medical devices

7. USB Connector - Connect USB devices here.

13. AUX-Ethernet connection

8. RS-232 Connector-Isolated-connection to devices requiring Serial Control.

14. USB – USB Connection

9. Potential Equalization Connector (POAG) - Potential Equalization Connector per DIN 42801.

15. USB TABLET CONNECTION– Connect Tablet Data Input device here. Provides for data interchange and tablet charging.

NOTE: The purpose of the Potential Equalization Connector is to equalize the

950-0027-01B

15 of 55

Figure 3-AR-3210-0001 3 CCD Camera Head with Integrated Optics

1.9.3

AR-3210-0001 Camera Head with Integrated Optics

1. Button 1 - A programmable button that can activate various functions of the camera. See “Optional Tablet Data Input Device” for programming information. 2. Button 2 - A programmable button that can activate various functions of the camera. See “Optional Tablet Data Input Device” for programming information.

950-0027-01B

3. Focus Ring - Used to sharpen, or bring into focus, the image detail. 4. Grasping Mechanism - Accepts and locks into place the compatible scope. DIN 58105 compliant endoscope interface.

16 of 55

Figure 4-AR-3210-0003 [C-MT], AR-3210-0004 [C-MT, 20 Foot]

Figure 5-AR-3210-0007 [C-MT, Zero Angle] 1.9.4

C-Mount Camera Heads

1. Button 1 - A programmable button that can activate various functions of the camera. See “Optional Tablet Data Input Device” for programming information.

2. Button 2 - A programmable button that can activate various functions of the camera. See “Optional Tablet Data Input Device” for programming information. 3. C-Mount Threads - Accepts standard C-Mount Optical Couplers.

950-0027-01B

17 of 55

2.0 System Installation and Operation with Data Input Device 2.1

Installation

NOTE: 1. Your SynergyHD3 Camera Control Unit will indicate which software configuration is enabled at boot up, on the Video Monitor’s Splash screen. 2.1.1

Typical System Installation

NOTE: See “Typical System Interconnect Diagram, Figure 6 1. Place SynergyHD3 console (CCU) on tower shelf. 2. Attach monitor to the tower and connect monitor DC power cable to the rear panel of the monitor as shown. 3. Attach SynergyHD3 Tablet docking station to secondary tower arm. Connect the cable from the docking cable to the connector labeled “tablet” on the back of the SynergyHD3 console. 4. Connect a DVI cable to the DVI output on the rear panel of the SynergyHD3 console. Connect the other end of the DVI cable to

950-0027-01B

the DVI input of the display monitor. (An HD-SDI cable may be used instead of DVI). 5. If using a printer, connect printer cable to USB connector on the rear panel of the SynergyHD3 console. Connect other end of printer cable to the printer. 6. Plug the AC power cord into the SynergyHD3 power inlet module and a standard grounded AC Mains outlet (100-240 V˜, 5060Hz). 7. Insert the card edge connector the SynergyHD3 camera head into the camera receptacle on the front of the console. NOTE: Ensure the camera head connector contacts are clean and dry prior to insertion. 8. Connect the Light Guide cable into the Light Guide receptacle on the front panel of the SynergyHD3 console. Attach the other end of the Light Guide cable to the endoscope. 9. Insert the endoscope into the SynergyHD3 camera head grasping mechanism. 10. Press the Light Source On/Standby Switch to activate LED light engine. NOTE: If there is no Light Guide cable connected to the SynergyHD3 console, pressing the On/Standby Switch will not activate the LED light engine until one is connected.

18 of 55

Figure 6- SynergyHD3 Typical Interconnect Diagram With OPTIONAL Tablet Data Input Device

2.2

Accessories for Intended Use Arthrex SynergyHD3 System Accessories Part Number

Description

AR-3200-1008

SynergyHD3 Digital Documentation Tablet,12"

AR-3200-1014

SynergyHD3 Digital Documentation Tablet

SONY UP-PR80MD

Medical Grade Printers

SONY UP-PR80MD with upDR80MD/NKIT AR-3250-2601

Medical Grade Surgical Monitor 26”

AR-3250-2602

Medical Grade Surgical Monitor 25”

AR-3250-2603

Medical Grade Surgical Monitor 26”

AR-3250-3201

Medical Grade Surgical Monitor 32”

AR-3250-3203

Medical Grade Surgical Monitor 32”

AR-3250-3204

Medical Grade Surgical Monitor 32”

950-0027-01B

19 of 55

Arthrex SynergyHD3 System Accessories Part Number

2.3

Description

AR-3240-3527

Light Guide 3.5mm x 274cm

AR-3240-5027

Light Guide 5.0mm x 274cm

AR-3240-5040

Light Guide 5.0mm x 400cm

AR-3200-1050

Bluetooth Wireless Microphone

AR-3210-0005

C-Mount Optical Zoom Coupler

AR-3210-1005

Video Input/Output Converter

System Setup Facility and Surgeon Settings

NOTE: Facility, surgeon, and procedural settings are made from the SynergyHD3’s tablet Data Input Device.

Figure 7-System Maintenance

2.3.1

System Set-Up can be accessed by pressing the Maintenance Icon on the SynergyHD3 Tablet Data Input Device and then selecting “Advanced Settings”

950-0027-01B

20 of 55