AR-3200-00xx SynergyUHD4 System Instructions for Use Manual Rev 04A

This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions, and related provisions, refer to the “Arthrex U.S. Product Warranty” section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

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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 ... 12

1.9

System Indicators ... 13

2.0

System Installation and Operation with Data Input Device ... 20

2.1

Installation ... 20

2.2

Accessories for Intended Use... 22

2.3

System Setup Facility and Surgeon Settings ... 24

2.4

Icon Guide ... 33

2.5

Scheduling and Starting Cases ... 35

2.6

Status Notification Icons ... 42

2.7

System Operation without Tablet Data Input Device ... 45

3.0

Maintenance ... 47

3.1

Life Expectancy... 47

3.2

Periodic Maintenance ... 47

3.3

Cleaning and Sterilizing ... 48

3.4

Troubleshooting ... 52

3.5

Resolving Error Messages ... 55

3.6

Recommended Annual Camera Control Unit Maintenance Requirements ... 55

4.0

Technical Information ... 56

5.0

APPENDIX [Radio Module Information]... 61

6.0

APPENDIX [Detailed EMC Information]... 62

7.0

APPENDIX [SW Version access]... 67

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1.0 Introduction It is recommended that personnel study this manual before attempting to operate, clean, and/or sterilize the Arthrex Synergy SynergyUHD4 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. The Arthrex SynergyUHD4 System is comprised of: • AR-3200-0020 [SynergyUHD4 Console with Matrix] • AR-3200-0021 [SynergyUHD4 Console] • AR-3200-0022 [SynergyUHD4 Console with Matrix, HCRI] • AR-3200-0023 [SynergyUHD4 Console, HCRI] • AR-3210-0018 [HD, SynergyUHD4 Camera Head, autoclavable] • AR-3210-0021 [HD SynergyUHD4 C-Mount Camera Head, autoclavable] • AR-3210-0022 [HD SynergyUHD4 C-Mount Camera Head, 0 Degree, autoclavable] • AR-3210-0023 [4K SynergyUHD4 Camera Head, autoclavable] • AR-3210-0025 [4K SynergyUHD4 CMount Camera Head, autoclavable] • AR-3210-0026 [4K SynergyUHD4 CMount Camera Head, 0 Degree, autoclavable] • AR-3210-0028 [4K SynergyUHD4 CMount w/20 foot cable, autoclavable] • AR-3210-0029 [4K SynergyUHD4 Broadband Camera Head, autoclavable] • AR-3210-0030 [4K SynergyUHD4 CMount Broadband Camera Head, autoclavable] • AR-3210-0031 [4K SynergyUHD4 Ultra Camera Head, autoclavable] • AR-3210-0032 [4K SynergyUHD4 Ultra C-Mount Camera Head, autoclavable]

NOTE: AR-3200-0020/AR-3200-0022 SynergyUHD4 Consoles or Camera Control Units 950-0047-04A

(CCU) are identical to AR-3200-0021/AR-32000023 CCUs except that AR-3200-0020/AR3200-0022 incorporate the Matrix PWA for transmission of UHD4 data by fiber optic.

1.1

Intended Use

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

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.

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

WARNINGS 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, Page 4 of 69

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.

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. 2. For the protection of the patient it is recommended that a back-up camera system for the Arthrex SynergyUHD4 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.

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. 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. 13. Refer to Insufflation Device Instructions regarding safety hazards to patients resulting from gas emboli.

4. Disconnect camera head and endoscope from the patient prior to applying cardiac defibrillation to patient.

14. The leakage current through the patient could increase when using endoscopes with powered accessories.

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.

15. 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.

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

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16. Applied Parts of other ME Equipment used within the configuration for Endoscopic Application shall be type BF or CF Applied Parts. 17. Explosive gas concentrations inside the patient can cause hazards while using HighFrequency Endoscopically Used Accessories. Page 5 of 69

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 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 SynergyUHD4 Video System or shielding the location.

• •

•

20. NOT for use in an Oxygen Rich Environment. 21. NO Modifications of this equipment are allowed. 22. 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. 23. 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. 24. Risk of burns! LED Light Engines emit large amounts of light and thermal energy. As a result: •

•

•

Always keep the LED Light Engine in the STANDBY mode when not in use. The endoscope light guide connection can get extremely hot as result of high intensity light, giving rise to high temperatures in front of the light emission window which may cause severe burns. Surface temperatures of the insertion portion of the endoscope as well as light guide connectors on the Camera Control Unit (CCU) and the endoscope rise during use. Potential thermal injury to the patient’s tissue and skin may result from prolonged exposure to the intense

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•

•

illumination in small cavities, or if the endoscope’s distal end is placed in close proximity with the tissue. This can cause the temperature of the body tissue to rise in excess of 106 °F (41°C). 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 before reprocessing.

25. High Frequency [HF] electrical surgical instruments may lead to severe patient injuries and/or damage to the endoscope. Care should be taken to ensure 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. 26. 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. 27. 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. •

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

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•

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 through the endoscope.

28. To ensure FCC RF Exposure limits for base station transmissions devices are met, a distance of 20 cm or more shall be maintained between the Camera Control Unit (which contains the antennas), and persons during operation. To ensure compliance, an operator closer than 20 cm to Camera Control Unit is not recommended. 1.3.2

PRECAUTIONS

1. United States Federal law restricts sale of this device to or on the order of a physician. 2. Only use the device with Arthrex compatible equipment listed in Section 2.2. 3. Inserting an incompatible Camera Head into the camera receptacle (see Figure 1) can result in damage to the CCU. 4. 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;

•

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 950-0047-04A

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. 5. This device should only be used in compliance with its intended use. 6. Prior to each use, the CCU and all associated equipment must be inspected for proper operation. Visually inspect lenses to ensure there are no scratches, chips or cracks. 7. 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. 8. 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. 9. 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. 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

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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. 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 IEC 60601-1-2:. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates 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

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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. (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 engine 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.

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1.4

Symbol Definitions

Safety Sign Follow Operating Instructions

Power Standby/On

Not for use in the Presence of Flammable Anesthetics.

ON-OFF

USB Tablet Computer Connection

Push-Push

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

Attention, Consult Accompanying Documents

Fragile

Precaution of Warning Notice

This Side Up

Defibrillation Proof Type CF 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

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Alternating Current

Pressure Limits for Storage and Transport

Protective Earth [Ground]

Humidity Limits for Storage and Transport

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

LED Light

Do Not Use if Damaged

MFi

EC Rep

Made for iPad

Catalog Number

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Serial Number

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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 Control Unit (CCU) contains a Lithium Coin BATTERY. The BATTERY must be recycled or disposed of properly.

1. The device is only completely isolated from the mains if the power plug is disconnected from the device’s power inlet module. Avoid positioning equipment such that removal of plug is difficult. 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 Clinical Function. 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. 5. 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: •

IEC 60950 for Information Technology Equipment.

NOTE for State of California, USA:

•

IEC 60601-2-18 for endoscopic devices.

State of California Requirement: Lithium Batteries contain Perchlorate Material -special handling may apply. See

•

IEC 60601-1 for medical electrical equipment.

www.dtsc.ca.gov/HazardousWaste/Perchlorate

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

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

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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.

1.7

Unpacking and Inspecting the Device

Upon receipt, carefully unpack the SynergyUHD4 Camera Control 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.

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 an 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. 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.”

Equipment will not be repaired unless decontaminated as stated above prior to return to the manufacturer.

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Figure 1- SynergyUHD4 Front Panel [AR-3200-002x]

1.9

System Indicators

1.9.1

SynergyUHD4 Front Panel

1. On/Standby Switch-The On/Standby switch toggles the Camera Control Unit (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

•

Wolf Input

•

Storz Input

•

ACMI Input

•

Olympus Input

NOTE: Rotate Light Guide Turret until the appropriate port is aligned with LED INDICATOR then Insert Light Guide.

3. USB Port-Connect USB devices here. 4. iPAD USB Port-Connect iPAD to this port. 5. “WHITE BALANCE” Button-Press to initiate camera white balance. 6. “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 cooled 15 minutes prior to insertion. 7. LED Light Engine On/Standby Switch-The Light Source On/Standby Switch toggles the Light Source between ON [Operational Mode] and STANDBY. PRECAUTION: Use only FUSED Light Guides to ensure proper operation of LED Light Engine.

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Figure 2- SynergyUHD4 Rear Panel

1.9.2

Rear Panel

1. “DVI” Video Output Connectors-Supplies a digital video signal output in DVI-D format. 2. Display Ports (2X)-Supplies UHD Video Signal output in either 1.1 [dual cable] or 1.2 [MST]. NOTE: Arthrex recommends connecting SynergyUHD4 to the primary surgical monitor via multiple output types (e.g., display port and DVI, Synergy Matrix and 3G-SDI) in the event that one type of connection is lost. 3. Audio In / Audio Out-Audio In: Line Level Audio input for Microphone. Audio Out: Line Level Audio output to Medical Grade Devices. 4. RS-232 Connector-Isolated connection to devices requiring Serial Control. 5. DVI Input-1080P/60 Input for Picture in Picture [PIP]. 6. USB 2.0 (2X)-USB 2.0 Connection. 7. USB 3.0 (2X)-USB 3.0 Connection. 8. Accessory Ports (Inputs/Outputs (2X) mini Stereo-Phone Connectors)-Accessory ports allow for control of the CCU with a footswitch or external device or for the CCU to control external devices via the camera head buttons. 9. Tablet Connection-Connection for Tablet Data Input device. Provides for data interchange and tablet charging.

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10. Synergy Matrix [Synergy Matrix Only]-Fiber Optic output to Matrix Monitor (point to point or managed) via Custom SFP+ Fiber Transceivers. Use Output 1 and 2 for 4K Video. Custom SFP+ Fiber Transceivers and Matrix License may be obtained from Arthrex Customer Service. 11. 3G-SDI Out-1080P/60 Output. 12. Ethernet Connector-Isolated 10/100 Mb/sec. 13. Potential Equalization Connector (POAG)Potential Equalization Connector per DIN 42801. NOTE: The purpose of the Potential Equalization Connector is to equalize the 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. 14. 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.

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Figure 3- AR-3210-0023 4K SynergyUHD4 Camera Head, autoclavable

Figure 4- AR-3210-0029 4K SynergyUHD4 Broadband Camera Head, autoclavable

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Figure 5-AR-3210-0018 HD, SynergyUHD4 Camera Head, autoclavable

2

1

3

4

Figure 6-AR-3210-0031 4K Ultra SynergyUHD4 Camera Head, autoclavable

1.9.3

Camera Heads 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.

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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.

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Figure 7-AR-3210-0025 4K SynergyUHD4 C-Mount Camera Head, autoclavable, AR-3210-0028 4K SynergyUHD4 C-Mount w/20 foot cable, autoclavable and Not Pictured AR-3210-0026 4K SynergyUHD4 C-Mount Camera Head, 0 Degree, autoclavable

1 2

3

Figure 8-AR-3210-0030 4K SynergyUHD4 C-Mount Broadband Camera Head, autoclavable

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Figure 9- AR-3210-0021 HD SynergyUHD4 C-Mount Camera Head, autoclavable, and Not Pictured AR-3210-0022 HD SynergyUHD4 C-Mount Camera Head, 0 Degree, autoclavable

1 2

Figure 10- AR-3210-0032 [4K Ultra SynergyUHD4 C-Mount Camera Head, autoclavable]

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 CMount Optical Couplers.

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950-0047-04, Rev. A English AR-3210-XXXX Camera Head SynergyUHD4 Firmware Compatibility CAUTION: • Some AR-3210-XXXX camera heads are only compatible with specific SynergyUHD4 firmware versions as shown in the following table. Attempting to use these camera heads with incompatible SynergyUHD4 firmware may fail to produce an acceptable quality video output on the surgical display. Camera Head

Compatible SynergyUHD4 Firmware Version

AR-3210-0029

850-0026-01-A or higher

AR-3210-0030

850-0026-01-A or higher

AR-3210-0031

850-0026-02-B or higher

AR-3210-0032

850-0026-02-B or higher

All other camera head models mentioned in this IFU

All versions

Determining the Firmware Version of the SynergyUHD4 System Firmware can be verified on the About screen, which is accessed by double tapping on the open blue area of the home login screen and tapping the About option. The firmware version is listed under Video FPGA as seen in the image below.

Figure 11- SynergyUHD4 Firmware Version

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2.0 System Installation and Operation with Data Input Device 2.1

Installation

1. Your SynergyUHD4 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 Interconnect Diagram, Figure. NOTE: SynergyUHD4 may be installed in a tower or on an equipment boom. 1. Place SynergyUHD4 Camera Control Unit (CCU) on tower shelf or installed on equipment boom. 2. Attach monitor to the tower or equipment boom and connect monitor DC power cable to the rear panel of the monitor as shown. 3. Attach SynergyUHD4 Data Input Device to secondary tower arm or equipment boom. Connect the cable from the Data Input Device to the connector labeled “tablet” on the back of the SynergyUHD4 CCU. 4. Connect a Display Port cable to a Display Port output on the rear panel of the SynergyUHD4 CCU. Connect the other end of the Display Port cable to the Display Port input of the display monitor. (3G-SDI or DVI cables may be used instead of Display Port cables.) Note: Arthrex recommends connecting SynergyUHD4 to the primary

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surgical monitor via multiple output types (e.g., Display Port and DVI, Display Port and 3G-SDI) in the event that one type of connection is lost. 5. If using a printer, connect the printer cable to the USB connector on the rear panel of the SynergyUHD4 CCU. Connect the other end of printer cable to the printer. 6. Plug the AC power cord into the SynergyUHD4 power inlet module and a standard grounded AC Mains outlet (100240 V˜, 50-60Hz). 7. Insert the card edge connector of the SynergyUHD4 camera head into the camera receptacle on the front of the CCU. Ensure the camera had connector contacts are clean and dry prior to insertion. WARNING: Inserting an incompatible Camera Head into the camera receptacle (see Figure 1) can result in damage to the CCU. 8. Connect the Light Guide cable into the Light Guide receptacle on the front panel of the SynergyUHD4 CCU. Attach the other end of the Light Guide cable to the endoscope. 9. Insert the endoscope into the SynergyUHD4 camera head grasping mechanism or into the C-Mount Coupler for C-Mount Heads. 10. Press the LED Light Engine On/Standby Switch to activate the LED light engine. NOTE: If there is no Light Guide cable connected to the SynergyUHD4 CCU, pressing the On/Standby Switch will not activate the LED light engine until one is connected.

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