Synergy UHD4 System

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 ............................................................................................................. 41 2.7 System Operation without Tablet Data Input Device ................................................................. 44 3.0 Maintenance................................................................................................................................... 46 3.1 Life Expectancy............................................................................................................................ 46 3.2 Periodic Maintenance ................................................................................................................. 46 3.3 Cleaning, Disinfecting, and Sterilizing ......................................................................................... 47 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 CMount Camera Head, autoclavable] • AR-3210-0022 [HD SynergyUHD4 CMount 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 (CCU) are identical to AR-3200-0021/AR-3200-

0023 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, read and follow all warning and

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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. • Caution: Federal law restricts this device to sale by or on the order of a physician. • This device is intended to be used by a trained medical professional. • Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. • Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred. • In CE Accepting Countries: Procedures carried out using these devices may be used on the general population. • In CE Accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. • In CE Accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices. 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. 4. Disconnect camera head and endoscope from the 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. 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

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

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other conductive accessories and instruments should be maintained (10 mm (0.39 in.)) 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. • 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 (7.9 in.) 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 (7.9 in.) 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. • Surgeons are advised to review the product-specific surgical technique prior to performing any surgery. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique information and demonstrations. Or, contact your Arthrex representative for an onsite demonstration. 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. 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

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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 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 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, Disinfecting, 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 All of the symbols used on the labeling along with the title, description and standard designation number may be found on our website at www.arthrex.com/symbolsglossary.

Safety Sign Follow Operating Instructions Power Standby/On

Caution: Federal Law Restricts this device to sale by or on the order of a Physician. Not for use in the Presence of Flammable Anesthetics.

ON-OFF Push-Push

USB Tablet Computer Connection

Attention, Consult Accompanying Documents Precaution of Warning Notice Defibrillation Proof Type CF Equipment

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.

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Fragile This Side Up Keep Dry Temperature Limits for Storage and Transport

Alternating Current Protective Earth [Ground] Equipotential [Equipment Potential] WEEE [Waste Electronics and Electrical Equipment] Symbol. Regarding European Union End-of-Life of Product. White Balance Symbol LED Light MFi Made for iPad Catalog Number

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Pressure Limits for Storage and Transport Humidity Limits for Storage and Transport Universal Serial Bus RF Symbol. Nonionizing Electromagnetic Radiation Color Video Camera Do Not Use if Damaged EC Rep Serial Number

1.5 End of Life, Environmental Directives 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. 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/Perchlora te In the US a list of recyclers in your area can be found at www.eiae.org/

1.6 Initial Use of the Device WARNINGS: 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. • IEC 60601-2-18 for endoscopic devices. • IEC 60601-1 for medical electrical equipment. 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, Disinfecting, and Sterilizing prior to returning for service. The Camera Head shall be cleaned and Sterilized per Cleaning, Disinfecting, and Sterilizing 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.

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.

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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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 AR-3210-0029 AR-3210-0030 AR-3210-0031 AR-3210-0032 All other camera head models mentioned in this IFU

Compatible SynergyUHD4 Firmware Version 850-0026-01-A or higher 850-0026-01-A or higher 850-0026-02-B or higher 850-0026-02-B or higher 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 950-0047-06r0_fmt_en-US

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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 12. 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

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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Figure 12- SynergyUHD4 Typical Interconnect Diagram with OPTIONAL Digital Documentation Tablet [Integrated Optics Heads]

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Figure 13- SynergyUHD4 Typical Interconnect Diagram [C-MT Heads]

2.2 Accessories for Intended Use

Arthrex SynergyUHD4 System Accessories

Part Number

Description

AR-3250-XXXX

Arthrex Monitors

SONY UP-PR80MD

Medical Grade Printers

SONY UP-PR80MD with UPDR80MD/NKIT

AR-3350-XXXX

Arthrex Arthroscopes

AR-3351-XXXX

Arthrex Laparoscopes

AR-3352-XXXX

Arthrex Hi Mag Laparoscopes

AR-3355-XXXX

Arthrex C-Mount Arthroscopes

AR-3200-1007

SynergyUHD4 Synergy Documentation Tablet

AR-3200-1013

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Arthrex SynergyUHD4 System Accessories

Part Number

Description

(AR-3200-1013 must be used with SynergyUHD4 CCU having software version v.4.13.1 or newer.)

AR-3200-1026, -1027

BioOptico Licenses

AR-3200-1020

DICOM Licenses

AR-3200-1030, -1034, -1036, -1042, -1043, Synergy.net Licenses

-1044, -1045, -1046, -1047, -1049

AR-3210-XXXX

Arthrex C-mount couplers

AR-3200-1010, -1012

Arthrex encrypted USB sticks

AR-3200-1040

Arthrex Synergy System Integration Cable Kit

AR-3370-0006

Arthrex Starfish™

AR-3370-0008

Arthrex C-Mount Starfish

AR-3201-1005

Video Input-Output 1080P Converter

AR-3240-XXXX

Arthrex Light Guides

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2.3

System Setup Facility and Surgeon Settings

NOTE: Facility, surgeon, and procedural settings are made from the SynergyUHD4’s Tablet Data Input Device. Screens may appear slightly different than those shown in this document depending on the particular features enabled on SynergyUHD4.

Figure 14-System Maintenance

2.3.1

System Set-Up can be accessed by pressing the Maintenance Icon

on the

SynergyUHD4 Tablet Data Input Device and then selecting “Advanced Settings”.

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Figure 15-System Maintenance Screen

2.3.2

Selecting “System” enables several facility preferences to be setup; • User can input the facility name associated with that specific SynergyUHD4. • User can select the language used with SynergyUHD4. • User can select number of cases saved to system before data is automatically purged. • Other configuration options are also available to users.

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Figure 16-Date & Time Screen

2.3.3

Selecting “Date & Time” enables adjustment of the SynergyUHD4 date and time settings. • User can use a network time server or user can select the date and time options manually.

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2.3.4

Figure 17-Print Settings Screen Selecting “Print Settings” enables adjustment of the SynergyUHD4 print settings. • User can enable the use of a local printer and select the paper size for that printer.

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2.3.5

Figure 18-System Maintenance Network Selecting “Network” allows for connecting the SynergyUHD4 system to a facility network. Fields are: • Ethernet IP Mode • Host Name • Ethernet IP Address • Ethernet Subnet Mask • Ethernet Default Gateway

Note: If DHCP option is selected, then the Ethernet address is acquired automatically and no fields need to be completed.

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2.3.6 2.3.7 2.3.8

Figure 19-Surgeon Management List

Surgeons can be added to the SynergyUHD4 with their own system preferences.

To add surgeons and their preferences, press the maintenance icon

on the

SynergyUHD4 Tablet Data Input Device and then select Surgeon Management. A list of

surgeons will appear.

To add a surgeon, press the “+ Add New Surgeon” button, enter the first and last name of a surgeon, then press the “Preferences” button. Note: When a new surgeon is created it will automatically inherit all of the procedures and preferences associated with the default Surgeon account.

Figure 20-Surgeon Management Preferences

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2.3.9

Figure 21-Surgeon Preferences Settings Surgeon preferences can be defined for the following: • Camera Button Settings • Printer Settings • Print Settings • Multimedia • Web Server Access • Display • BioOptico (Note: BioOptico is optional functionality for SynergyUHD4.)

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Figure 22-Surgeon Management Procedures Select 2.3.10 Procedure preferences can be added to individual surgeon preferences. On the surgeon management list, select a surgeon, and a list of procedures will appear 2.3.11 Select the appropriate Procedure for the Surgeon. If the procedure is not currently in the list, select the “Create New Procedure” from the Procedures drop down list, and enter the name of the new procedure.

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Figure 23-Surgeon Procedure Settings 2.3.12 Once a Procedure has been added select the “Procedure Settings” next to the Procedure name to configure camera, pump, and shaver settings associated with the Procedure.

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2.4 Icon Guide 2.4.1 Figure 24 shows what is displayed on a surgical monitor when a SynergyUHD4 is first powered on.

Figure 24-Connectivity Icons 2.4.2 In the lower left corner of the screen are icons that represent connectivity with SynergyUHD4. The icons shown below represent tablet, network, and Synergy.net connectivity.

2.4.3 The icons on the lower right of the monitor represent local and external peripheral connectivity (e.g., printer, USB, iPad, DICOM, network export) as shown in the figures below.

Printer

USB

iPad

DICOM

Network

Synergy.net

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2.4.4

Beneath each of the icons is a status bar. The color of the bar indicates the status of the connection. A status bar that is green means that there is active connectivity between that device and SynergyUHD4 and no issues are detected. A status bar that is blue means that there is active connectivity between that device and SynergyUHD4, no issues are detected, and an active data transfer is taking place (e.g., images are exporting to a USB device or a DICOM export is ongoing). At the end of a data transfer, the blue status icon will change back to green. A status bar that is yellow means that connectivity should be present but there is an issue with the connection. A status bar that is gray means that the device is not connected to SynergyUHD4.

2.4.5

A yellow status bar event should be investigated prior to the start of a case as data transfers may not occur to any device where connectivity with SynergyUHD4 has not been established or has been lost.

2.4.6

Once a case is started, a smaller subset of connectivity icons will appear in the lower right corner of the surgical monitor. These status icons represent connectivity status based on the individual surgeon’s preferences (e.g., if a surgeon has autoprinting enabled but the printer is powered off it will show a yellow status). The colors of the status bars match those described above. Again, any items with a yellow status should be investigated for issues prior to the start of a case.

2.4.7

The onscreen status icons are intended to only provide a status of connectivity of various devices to SynergyUHD4. A surgeon can always begin and perform a case regardless of the status of any of the device connections.

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2.5 Scheduling and Starting Cases Figure 25-Scheduling a Case 2.5.1 To schedule a case, press the “+ Add New Case” icon.

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Figure 26-Scheduling a Case

2.5.2 2.5.3 2.5.4

Select the “Room” (if present, optional field depending on how system is configured), “Surgeon” and/or “Procedure,” and enter data in the following required fields. • Patient First Name • Patient Last Name • Patient I.D. # Input any of the other optional data elements in the appropriate fields. Press the “Save” icon.

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2.5.5

Figure 27-Starting a Case To start a case, select the case/patient from the Case List and press the “Start” icon. NOTE: Cases may also be started from the “Add Case” screen by entering the required fields and pressing the “Start” icon.

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2.5.6

Figure 28 -Confirming a Case A “Case Confirmation” window will appear showing the patient and case demographics. If the information is correct press the “Start” icon.

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Figure 29 -Camera Head Button Change During Case

2.5.7

Changes to SETTINGS may be made during the procedure by pressing the “Maintenance Icon”. Changes may be made to the following: • Camera Head Button Functions • Print Settings

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Figure 30 -Print Changes During Case

Figure 31 -Ending a Case 2.5.8 Ending a Case; to end a case, press the “End Case” Icon. NOTE: An “End the Case?” confirmation message will appear. If confirmed, the case will end, and the SynergyUHD4 Tablet Data Input Device will transition to the case review screen.

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2.6 Status Notification Icons

Figure 32 -Status Notification Icons

2.6.1

When a manual export/print is performed, the status notification for the action will appear on the tablet. The blue progression bar will indicate that the export is in progress. Once the export is complete the status bar will turn green. Green arrows for each image indicate a successful export.

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Figure 33 -Export Status 2.6.2 The system in Figure 33 displays a successful USB export and an iPad export in progress.

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Figure 34 -Export and Print Status During a Case

2.6.3

Export and print statuses will also display during surgery if auto export or auto print is enabled for the surgeon using the system. A successful export will display a green checkmark for the images completed. A failure will be displayed by a yellow caution triangle. (Note: Print statuses are not reflected in the individual image status icons.) The external devices statuses and connectivity status will also be displayed during the case in the lower right corner of the tablet.

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2.7 System Operation without Tablet Data Input Device 1. Connect the SynergyUHD4 System per “Typical System Installation”, Figure 12 and Figure 13.

2. The camera will take approximately 60 seconds to fully load its boot software. When the software has fully loaded, you will see the SynergyUHD4 Initial Screen shown below in Figure 35.

Figure 35 -SynergyUHD4 Initial Screen

3. The SynergyUHD4 Initial Screen will indicate the Factory Default settings for the Camera Head Button programming. 4. SHORT presses on both buttons will capture Still Images. 5. Long Press on the LEFT BUTTON will control Brightness. • After a LONG press on the LEFT BUTTON, pressing the Right Button will INCREASE Brightness. • After a LONG press on the LEFT BUTTON, pressing the Left Button will DECREASE Brightness. 6. Long Press on the RIGHT BUTTON will control Digital Zoom. • After a LONG PRESS on the RIGHT BUTTON, pressing the RIGHT Button will INCREASE ZOOM. • After a LONG PRESS on the RIGHT BUTTON, pressing the LEFT Button will DECREASE ZOOM.

7. The SynergyUHD4 Initial Screen will also indicate that the Printer is Active and that it is set to 8 prints per page. 8. The center screen of the SynergyUHD4 Initial Screen shows that both Buttons are now set to White Balance, and that a White Balance Operation is required to initialize the SynergyUHD4 use. 9. Turn on the LED Light Engine. 10. Using a stack of 4 x 4 white gauze, hold the tip of the Endoscope approximately 1 inch (2.5 cm) away from the gauze until the gauze image fills the screen completely. 11. Press either of the Camera Head buttons to start the White Balance Operation. 12. The Surgical monitor will display one of the following. • When the White Balance has been completed successfully, a Green Check Mark with WHITE BALANCE below will be shown on screen.

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Figure 36 -White Balance OK • When the White Balance has not been completed successfully, a Red X with WHITE BALANCE below will be shown on screen.

Figure 37 -White Balance Fail 13. If the White Balance Operation has been successful, the camera will enter the Surgical Ready Mode and be ready for surgical operation. 14. If the White Balance Operation has not been successful, you must move the Tip of the Endoscope closer or farther from the White Gauze until the operation can be completed successfully. 15. Once the White Balance Operation has been successfully completed, the Camera Head buttons will function as defined on the SynergyUHD4 Initial Screen Figure 35.

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3.0 Maintenance Regular and proper maintenance of your SynergyUHD4 and/or AR-3210 Camera Heads are the best ways to protect your investment and avoid non-warranty repairs. Recommended care and handling of the SynergyUHD4 Camera Control Unit (CCU) and camera head includes proper day-to-day operation, cleaning, and sterilization which are extremely important to ensure safe and efficient operation. It is important to visually inspect the camera head, cable and card edge before each use. 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. 3.1 Life Expectancy Life expectancy for the product is expected to meet and exceed the warranty period for approximately 5 years under normal use and standard of care. 3.2 Periodic Maintenance The product should be inspected prior to and after each use to ensure that the camera head, cable, strain relief, overmold, or connector contacts are not damaged or worn. If it becomes necessary to return the camera head to Arthrex for service, please sterilize the camera head before shipping.

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3.3 Cleaning, Disinfecting, and Sterilizing

Follow universal precautions for protective apparel when handling and cleaning contaminated instruments.

3.3.1

Cleaning the LED Light Engine

1. Allow LED Light Engine to cool for ½ hour before cleaning. 2. Dampen one end of a cotton swab with isopropyl alcohol. 3. Clean any residue from optic using circular motion. 4. Use the DRY END of the cotton swab to dry the face of the optics. 5. Inspect the optics for residue or cotton fibers and clean as required. 6. Allow to AIR DRY for 5 minutes prior to use.

3.3.2 Cleaning and Disinfecting the Camera Control Unit (CCU) and Tablet

1. Turn the CCU power off. Disconnect the power cord from the electrical power source and from the rear of the CCU. 2. Remove the camera head from the CCU. 3. Wipe the CCU with a disinfecting towelette or clean, low-linting cloth dampened with disinfectant solution. 4. Using a second (fresh) towelette or cloth, thoroughly wet the surface and ensure it remains visibly wet for the contact time recommended by the disinfectant manufacturer. The use of additional towelettes or cloths may be used to ensure the surface remains visibly wet for the entire contact time. 5. If required by the disinfectant manufacturer, rinse per instructions; otherwise, allow to air dry.

CAUTION: Do not sterilize the CCU/Tablet or immerse in liquid or disinfectant solution. CAUTION: Do not clean the CCU/Tablet with abrasive cleaning or disinfectant compounds, solvent, or other materials that could scratch or damage the device. Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration, exposure times, temperature, and material compatibility.

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3.3.3

Cleaning the Camera Head

CAUTIONS: • If the camera head is dented or damaged, or if the cable silicone jacket is cut, DO NOT autoclave or immerse in liquid (water, chemical disinfectants or sterilants, etc.). Notify your Arthrex Sales Representative. • Do not place the camera head or accessories in an ultrasonic cleaner or ultrasonic washer-disinfector.

Devices must be adequately cleaned and sterilized prior to use or re-use. All devices are to be cleaned and sterilized prior to each application; this is required as well for the first use after delivery of the unsterile devices. Effective cleaning is an indispensable requirement for an effective sterilization of the devices. If possible, the Automated Cleaning procedure (Washer-Disinfector) should be used for cleaning. The Manual Cleaning procedure should only be used if an automated procedure is not available; in this case, the significantly lower efficiency and reproducibility of the manual procedure should be considered. Manual cleaning may require onsite validation by the healthcare facility and appropriate procedures should be in place to avoid human factor variability.

3.3.3.1

Point of Use Preparation, Containment, and Transportation

It is recommended that camera heads are reprocessed within a maximum of 2 hours of use. At point of use, soiled devices must be removed from trays and moistened to prevent debris from drying before transportation to the reprocessing area for cleaning procedures. Soaking in enzyme solutions facilitates cleaning, especially in devices with complex features and hard-to-reach areas (lumens, etc.). These enzyme solutions as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based materials from drying on devices. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. Devices should be contained and transported in a closed, puncture-proof device to ensure safety.

3.3.3.2

Detergent Selection

Consider the following points during selection of the cleaning detergent: 1. Suitability of the cleaning agent for cleaning (no foam development). 2. Compatibility of the cleaning agent with the devices. Arthrex recommends the use of neutral pH or enzymatic cleaning agents. Alkaline agents may be used to clean devices in countries where required by law or local ordinance, or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) or Creutzfeldt - Jakob disease (CJD) are a concern (applies only outside of the US). Arthrex does not recommend the use of a specific brand of cleaning agent. Enzol® and neodisher® MediClean forte were utilized during the validation of these instructions. Caution: Low acid or alkaline solutions are not recommended, as they corrode metal parts and compromise plastics. Follow the instructions of the detergent manufacturer regarding use concentration and temperature for either manual or automated cleaning. Please use only freshly prepared solutions as well as only purified (critical, e.g. RO or DI) water for final rinse.

3.3.3.3

Automated Cleaning

1. Load the devices in the washer-disinfector such that all design features of the device are accessible to cleaning. 2. Make sure that the camera head has been securely fixed to the unit’s trays or baskets. Make sure that the camera head does not touch other instruments.

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3. Run an automated wash cycle with fundamentally approved efficiency of the washer-disinfector (for example, CE marking according to ISO 15883 or FDA approval/clearance/registration).

Phase Pre-Wash 1 Detergent Wash Rinse 1 Drying

RECOMMENDED WASHING CYCLE PARAMETERS

Recirculation Time (Minutes)

Temperature

Detergent

02:00

COLD UTILITY WATER

NA

03:00

FOLLOW DETERGENT MANUFACTURER’S RECOMMENDATION

Enzymatic or Alkaline Detergent

00:15

HOT WATER

NA

06:00

90°C [194°F]

NA

4. Remove the camera heads immediately after the automated procedure has stopped. 5. Dry the equipment with a soft, low-linting cloth and/or filtered medical grade air. Wipe the card edge connector with 70% isopropyl alcohol to remove any residual detergent. a. Do not allow exposed glass windows to air dry. 70% isopropyl alcohol may be applied to glass surfaces with a soft cotton applicator to prevent streaks and spots. Dry the surfaces thoroughly with a cotton applicator after applying the alcohol. 6. After cleaning, inspect the camera head assembly and camera head cable for cleanliness and damage. Repeat cleaning if soil is visible and re-inspect; otherwise, proceed to Sterilization. 7. CAUTION: Inspect the camera head cable for breaks and cuts. Camera heads with damaged cables should not be sterilized or disinfected. Return camera heads with damaged cables to Arthrex for repair. 8. Before sterilization and/or disinfection, coil the camera head cable into loops at least six inches in diameter. Do not kink or twist the cable.

3.3.3.4

Manual Cleaning

CAUTION: Wear protective gloves, clothing and face mask for cleaning of contaminated equipment.

1. Immediately after use, rinse the camera head under cool running utility water to remove gross soil. Use a soft bristled brush to aid in the removal of soil paying particular attention to hard-toclean areas. 2. Prepare a neutral pH enzymatic detergent solution using utility water. 3. Fully immerse the camera head in the prepared solution and allow it to soak for a minimum of 10 minutes. Flush hard to reach areas to ensure all soil is removed. While soaking, activate movable parts. 4. After soaking, use a soft bristled nylon brush to remove all visible evidence of debris and soil. Pay close attention to the card edge connector. 5. Rinse the camera head by immersing it in a basin of warm utility water. Allow the camera head to sit in the water for a minimum of 1 minute. While soaking, activate movable parts. a. Repeat step 5 two additional times using fresh warm utility water each time. b. Rinse under running utility water to ensure water reaches hard to reach areas. Activate while rinsing until all visible evidence of detergent is removed. 6. Visually inspect the camera head for visible soil. Repeat cleaning if soil is visible and re-inspect. 7. Dry the equipment with a soft, low-linting cloth and/or filtered medical grade air. Wipe the card edge connector with 70% isopropyl alcohol to remove any residual detergent.

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a. Do not allow exposed glass windows to air dry. 70% isopropyl alcohol may be applied to glass surfaces with a soft cotton applicator to prevent streaks and spots. Dry the surfaces thoroughly with a cotton applicator after applying the alcohol. 8. After cleaning, inspect the camera head assembly and camera head cable for damage. 9. CAUTION: Inspect the camera head cable for breaks and cuts. Camera heads with damaged cables should not be sterilized or disinfected. Return camera heads with damaged cables to Arthrex for repair. 10. Before sterilization and/or disinfection, coil the camera head cable into loops at least six inches in diameter. Do not kink or twist the cable.

3.3.4

Sterilization of the AR-3210-XXXX Camera Heads

3.3.4.1

Sterile Packaging

Singly: Single devices should be packed as to ensure that the pack is large enough to contain the device without stressing the seals. Packaging should be completed utilizing a pouch or wrap which conforms to the recommended specifications for steam sterilization as outlined below. If a wrap is utilized, it should be completed following AAMI doublewrap or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body).

3.3.4.2

Sets: Where appropriate, cleaned and inspected devices should be placed into trays/cases as provided or in general-purpose sterilization trays. The total weight of trays/cases should not exceed 11.4 kg/25 lbs. (other local limits below 11.4 kg/25 lbs. may apply). Trays/cases should be double wrapped following AAMI or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Sterilization

Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table below. Sterilizers vary in design and performance characteristics. Cycle parameters and the load configuration should always be verified against the sterilizer manufacturer’s instructions.

PRECAUTION: After sterilization, ensure that the AR-3210 Camera Heads are allowed to adequately cool before connecting to the CCU or attaching to a scope.

Cycle

RECOMMENDED STEAM STERILIZATION PARAMETERS

Minimum Exposure Temperature

Minimum Exposure Time

Minimum Dry Time1

Minimum Cooling Time2

Pre-vacuum GravityDisplacement (Wrapped) GravityDisplacement (Un-Wrapped)

132°C (270°F) 132°C (270°F) 132°C (270°F)

4 Minutes 15 Minutes 10 Minutes

30 Minutes 30 Minutes NA

30 Minutes 30 Minutes NA

1Drying times vary according to load size and should be increased for larger loads. 2Cooling times vary according to the sterilizer used, device design, temperature and humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79.

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