Arthrex AR-3200-0022, AR-3200-0021, AR-3210-0023, AR-3210-0022, AR-3210-0026 Instructions For Use Manual

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950-0047-04, Rev. A English

1-(800) 391-8599

AR-3200-0020 AR-3200-0021 AR-3200-0022 AR-3200-0023

Synergy

UHD4

System

Instructions for Use Manual

The Arthrex Synergy Camera Head User’s Guide provides important information

for the safe operation of all components of the Synergy Camera System, including accessories. Read this User’s Guide thoroughly prior to using this system and keep it in an easily accessible place for use by all operating personnel. Read and follow all safety warnings, cautions and precautions.

UHD4

System Camera Control Unit and

UHD4

AR-3210-0018 AR-3210-0021 AR-3210-0022 AR-3210-0023 AR-3210-0025 AR-3210-0026 AR-3210-0028 AR-3210-0029 AR-3210-0030 AR-3210-0031

Arthrex, Inc.

1370 Creekside Blvd. Naples, FL 34108, USA +1 (800) 934-4404

Technical Support

EC REP

Arthrex GmbH

Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0

AR-3210-0032

950-0047-04A Page 1 of 69

This is not a warranty document. For all warranty information, including disclaimers, exclusi o ns, terms, conditions, and related provis ions, 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.

950-0047-04A Page 2 of 69

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

950-0047-04A Page 3 of 69

1.0 Introduction

WARNING: The safety and/or health

PRECAUTION: This contains

It is recommended that personnel study this manual before attempting to operate, clean, and/or sterilize the Arthrex Synergy

Synergy 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 Synergy comprised of:

NOTE: AR-3200-0020/AR-3200-0022 Synergy

UHD4

• AR-3200-0020 [Synergy with Matrix]

• AR-3200-0021 [Synergy 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 C- Mount Camera Head, autoclavable]

• AR-3210-0026 [4K SynergyUHD4 C- Mount Camera Head, 0 Degree, autoclavable]

• AR-3210-0028 [4K SynergyUHD4 C- Mount w/20 foot cable, autoclavable]

• AR-3210-0029 [4K SynergyUHD4 Broadband Camera Head, autoclavable]

• AR-3210-0030 [4K SynergyUHD4 C- Mount Broadband Camera Head, autoclavable]

• AR-3210-0031 [4K SynergyUHD4 Ultra Camera Head, autoclavable]

• AR-3210-0032 [4K S ynerg yUHD 4 Ultra C-Mount Camera Head, autoclavable]

UHD4

Consoles or Camera Control Units

System and accessories. The

UHD4

System is

UHD4

Console

UHD4

(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.

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.

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 com plet el y familiar with the required techniques and instructions for use of the equipment. Prior to using the device,

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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 pati ent

• 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 Synergy 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 q ual if icatio ns .

7. This device shall only be used with original and manufacturer’s accessories and replacement parts. Use of

UHD4

video system be

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 protrusi ons whic h 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.

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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 re-

UHD4

orienting or relocating the Synergy 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.

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.

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 Li ght Eng ine 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

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 instrum ents m ay interfer e 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 Arthr ex 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

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 acces s ories . See “Maintenance” section of this manual.

8. Ensure that the available mains voltage matches the mains voltag e 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 intende d 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 i nput 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 dou bt, contact a qual ified 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.

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

Physician.

components.

Safety Sign

Follow Operating

Instructions

Power Standby/On

ON-OFF

Push-Push

Attention, Consult

Accompanying

Documents

Caution: Federal

Law Restricts this device to

sale by or on the

order of a

Not for use in the

Presence of

Flammable

Anesthetics.

USB Tablet

Computer

Connection

Fragile

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

This Side Up

Keep Dry

Temperature

Limits for

Storage and

Transport

950-0047-04A Page 9 of 69

Alternating Current

Equipment] Symbol.

Pressure Limits for Storage and

Transport

Protective Earth

[Ground]

Equipotential

[Equipment

Potential]

WEEE [Waste

Electronics and

Electrical

Regarding European

Union End-of-Life of

Product.

White Balance

Symbol

Humidity Limits for Storage and

Transport

Universal Serial

Bus

RF Symbol. Non-

ionizing

Electromagnetic

Radiation

Color Video

Camera

950-0047-04A Page 10 of 69

LED Light

MFi

Made for iPad

Catalog Number

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/Perchlorate

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 m ust 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 Synergy 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.

UHD4

1.8 Returning the Device

If it becomes necessary to return the device, always use the original pack aging. T he 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. The CCU shall be cleaned per section Cleaning and Sterilization prior to returning for service.

2. The Camera Head shall be cleaned and Sterilized per Cleaning and Sterilization p rior to returning for service. Camera Head shall be clearly labeled as “Sterile.”

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

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Figure 1- Synergy

UHD4

1.9 System Indicators

UHD4

1.9.1 Synergy

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

Front Panel

• 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.

Front Panel [AR-3200-002x]

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 rec eptacle are sp ecially keyed to prevent the camera head from being improperly connect ed. Ensure that the “U P” 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 a nd cooled 15 minutes prior to insertion.

7. LED Light Engine On/Standby Switch-The Light S ource On/Standb y Switch to ggles the Light Source between ON [Operational Mode] and STANDB Y.

PRECAUTION: Use only FUSED Light Guides to ensure

proper operation of LED Light Engine.

950-0047-04A Page 13 of 69

Figure 2- Synergy

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 Synergy

UHD4

to the primary surgical monitor via multiple output types (e.g., display port and DVI, Synergy Matrix a nd 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 Contr ol.

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 CC U 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.

UHD4

Rear Panel

10. Synergy Ma tr ix [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 diff erent met al 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 oper ation between th e bodies of the Medical Electrical devices and conduct ive 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.

950-0047-04A Page 14 of 69

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

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

950-0047-04A Page 15 of 69

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

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 T abl et Dat a Inp ut Device” for programming information.

2. Button 2-A programmable button that can activate various functions of the camera. See “Optional Tablet Data Input

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.

Device” for programming information.

950-0047-04A Page 16 of 69

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

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

950-0047-04A Page 17 of 69

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

AR-3210-0022 HD SynergyUHD 4 C-Mount Camera Head, 0 Degree, autoclavable

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.

950-0047-04A Page 18 of 69

950-0047-04, Rev. A English

AR-3210-XXXX Camera Head SynergyUHD4 Firmware Compatibility CAUTION:

• Som e 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 firmwar e may fail to produce an acceptable quality vide o 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

Determining the Firmware Version of the Sy nergyUHD4 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.

All versions

Figure 11- SynergyUHD4 Firmware Version

950-0047-01A Page 19 of 69

2.0 System Installation

and Operation with Data Input Device

2.1 Installation

1. Your Synergy indicate which software configuration is enabled at boot up on the Vid eo Mon itor ’s Splash screen.

2.1.1 Typical System Installation

NOTE: See Typical Interconnect Diagram, Figure.

NOTE: Synergy tower or on an equipment boom.

1. Place Synergy (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 Synergy secondary tower arm or equipment boom. Connect the cable from the Data Input Device to the connector labeled “tablet” on

the back of the Synergy

4. Connect a Display Port cable to a Display Port output on the rear panel of the

Synergy of the Displa y Port cab le to the D ispl a y Port input of the display monitor. (3G-SDI or D VI cables may be used instead of Display Port cables.) Note: Arthrex recommends connecting Synergy

UHD4

Camera Control Unit will

UHD4

may be installed in a

UHD4

Camera Control Unit

UHD4

Data Input Device to

UHD4

CCU.

UHD4

CCU. Connect the other end

UHD4

to the primary

surgical monitor via multiple output types (e.g., Display Port and DVI, Displa y 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

UHD4

Synergy

CCU. Connect the other end

of printer cable to the printer.

6. Plug the AC power cord into the

UHD4

Synergy

power inlet module and a standard grounded AC Mains outlet (100240 V˜, 50-60Hz).

7. Insert the card edge connector of the

UHD4

Synergy

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

UHD4

Synergy

CCU. Attach the other end of

the Light Guide cable to the endoscope.

9. Insert the endoscope into the Synergy

UHD4

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 Synergy

UHD4

CCU, pressing the On/Standby Switch will no t activate the LED light engine until one is connected.

950-0047-04A Page 20 of 69

950-0047-04, Rev. A English

Figure 12- Synergy

Documentation Tablet [Integrated Optics Heads]

UHD4

Typical Interconnect Diagram With OPTIONAL Digital

950-0047-01A Page 21 of 69

Arthrex Synergy

System Accessories

Part Number

Description

AR-3250-XXXX

Arthrex Monitors

DR80MD/NKIT

AR-3355-XXXX

Arthrex C-Mount Arthrosc o pes

AR-3200-1013

Figure 13- Synergy

UHD4

2.2 Accessories for Intended Use

SONY UP-PR80MD SONY UP-PR80MD with UP-

AR-3350-XXXX AR-3351-XXXX AR-3352-XXXX

AR-3200-1007

Typical Interconnect Diagram [C-MT Heads]

UHD4

Medical Grade Printers

Arthrex Arthroscopes Arthrex Laparoscopes Arthrex Hi Mag Laparoscopes

SynergyUHD4 Synergy Documentation Tablet

950-0047-04A Page 22 of 69

Arthrex Synergy

UHD4

System Accessories

Part Number

Description

CCU having software version v.4.13.1 or newer.)

1043,

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

AR-3370-0008

Arthrex C-Mount Starf ish

AR-3201-1005

Video Input-Output 1080P Converter

AR-3240-XXXX

Arthrex Light Guides

(AR-3200-1013 must be used with SynergyUHD4

AR-3200-1026, -1027 AR-3200-1020 AR-3200-1030, -1034, -1036, -1042, -

AR-3210-XXXX AR-3200-1010, -1012 AR-3200-1040 AR-3370-0006

BioOptico Licenses DICOM Licenses Synergy.net Licenses

Arthrex C-mount couplers Arthrex encrypted USB sticks Arthrex Synergy System Integration Cable Kit Arthrex Starfish

950-0047-04A Page 23 of 69

2.3 System Setup Facility and Surgeon Settings

NOTE: Facility, surgeon, and procedural settings are made from the Synergy

Device. Screens may appear slightly different than those shown in this document depending on the particular features enab led on Syner gy

UHD4

’s Tablet Data Input

Figure 14-System Maintenance

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

UHD4

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

950-0047-04A Page 24 of 69

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 Synergy

UHD4

• User can select the language used with Synergy

• User can select number of cases saved to system before data is automatically purged.

• Other configuration options are also available to users.

UHD4

950-0047-04A Page 25 of 69

Figure 16-Date & Time Screen

2.3.3 Selecting “Date & Time” enables adjustment of the Synergy

• User can use a network time server or user can select the date and time options manually.

UHD4

date and time settings.

950-0047-04A Page 26 of 69

Figure 17-Print Settings Screen

2.3.4 Selecting “Print Se ttings” enables adjustment of the Synergy

• User can enable the use of a local printer and select the paper size for that printer.

UHD4

print settings.

950-0047-04A Page 27 of 69

Figure 18-System Maintenance Network

2.3.5 Selecting “Network” allows for connecting the Synergy

UHD4

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.

950-0047-04A Page 28 of 69

Figure 19-Surgeon Management List

UHD4

2.3.6 Surgeons can be added to the Synerg y

with their own system preferences.

2.3.7 To add surgeons and their preferences, press the maintenance icon on the

UHD4

Synergy

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

surgeons will appear.

2.3.8 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

950-0047-04A Page 29 of 69

Figure 21-Surgeon Preferences Settings

2.3.9 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 Synergy

UHD4

950-0047-04A Page 30 of 69

Figure 22-Surgeon Management Procedures Select

2.3.10 Procedure preferences can be added to individual surgeon preferences. On the surgeon

management list, sel ect a su rgeon , 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.

950-0047-04A Page 31 of 69

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.

950-0047-04A Page 32 of 69

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

950-0047-04A Page 33 of 69

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.

950-0047-04A Page 34 of 69

2.5 Scheduling and Starting Cases

Figure 25-Scheduling a case

2.5.1 To schedule a case, press the “+ Add New Case” ic o n

950-0047-04A Page 35 of 69

Figure 26-Scheduling a Case

2.5.2 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. #

2.5.3 Input any of the other optional data elements in the appropriate fields.

2.5.4 Press the “Save” icon.

950-0047-04A Page 36 of 69

Figure 27-Starting a Case

2.5.5 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.

950-0047-04A Page 37 of 69

Figure 28-Confirming a Case

2.5.6 A “Case Confirmation” window will appear showing the patient and case demographics. If the

information is correct press the “Start” icon.

950-0047-04A Page 38 of 69

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

950-0047-04A Page 39 of 69

Figure 30-Print Changes During Case

950-0047-04A Page 40 of 69

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

UHD4

and the Synergy

Tablet Data Input Device will transition to the case review screen.

950-0047-04A Page 41 of 69

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.

950-0047-04A Page 42 of 69

Figure 33-Export Status

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

950-0047-04A Page 43 of 69

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 b y 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

950-0047-04A Page 44 of 69

2.7 System Operation without Tablet

Data Input Device

1. Connect the Synergy “Typical System Installation”, Figures 12 and 13.

UHD4

System per

Figure 35-Synergy

UHD4

Initial Screen

2. The camera will take approximately 60 seconds to fully load its boot software. When the software has fully loaded, you

UHD4

will see the Synergy

Initial Screen

shown below in Figure 35.

UHD4

3. The Synergy

Initial Scr ee n wil l in d ic at e 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 Bright n es s .

• 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 th e LEFT Button will DECREASE ZOOM.

UHD4

7. The Synergy

Initial Screen will also indicate that the Printer is Active and that it is set to 8 prints per page.

UHD4

8. The center screen of the Synergy

Initial Screen shows that both Buttons are now set to White Balance, and that a White Balance Operation is required to initialize the

UHD4

Synergy

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 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.

950-0047-04A Page 45 of 69

Figure 36-White Balance OK

• When the White Balance has not been completed successfully, a Red X with WHITE BALANCE below will b e 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 m ust m ove the T ip of the Endoscope cl oser or farther from the White Gauze unti l the operation can be completed successfully.

15. Once the White Balance Operation has been successfully completed, the Camera Head buttons will function as

UHD4

defined on the Synergy

Initial Screen

Figure 35.

950-0047-04A Page 46 of 69

3.0 Maintenance

Regular and proper maintenance of your Synergy

are the best ways to protect your investment and avoid non-warranty repairs.

Recommended care and handling of the Synergy

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 warra nt y 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.

UHD4

and/or AR-3210 Camera Heads

UHD4

Camera Control Unit (CCU) and

950-0047-04A Page 47 of 69

3.3 Cleaning 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 the Camera Control Unit (CCU)

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 clean, soft cloth dampened with a mild, pH- balanced detergent.

4. Wipe the CCU again with a clean, soft cloth dampened with Tap or sterilized water.

5. Dry the CCU with a clean, soft cloth.

3.3.3 Cleaning the Tablet

1. Disconnect the Tablet from power.

2. Wipe the Tablet Touchscreen with a clean, soft cloth dampened with a mild pH-balanced detergent.

CAUTION: Do not sterilize the CCU/Tablet or immerse in liquid or disinfectant solution.

950-0047-04A Page 48 of 69

3.3.4 Cleaning the Camera Head

Automatic Washer Cycle Definition

(Minutes)

Concentration

Pre-Wash 1

02:00

COLD TAP WATER

Enzyme Wash

03:00

HOT TAP WATER

Enzol® 1oz/gallon

[140OF]

Drying

06:00

90oC [194OF]

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/sterilizer.

Preparation for Cleaning and Sterilization

Immediately after use, place the camera head assembly in a container and soak with neutral pH (PH 6.0 –

8.0) enzymatic cleaning solution (e.g. Enzol, Metrizyme or equivalent diluted to proper concentrations per manufacturer’s instructions), in order to prevent blood, protein and other contaminants from drying onto the camera head.

3.3.4.1 Automated Cleaning

• Use only washers according to the International Standard ISO 15883.

• Refer to the washer’s instruction manual.

1. Transfer the camera head into the washer for processing.

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.

3. Do not overload the washer.

4. Remove the camera heads immediately after the automatic procedure has stopped.

5. Set up and run washer for the wash cycle listed below.

Phase Recirculation Time

Rinse 1 00:15 HOT TAP WATER 60OC

6. Dry the equipment with a lint-free soft cloth. Wipe the card edge c on nec tor with 7 0% isopr opyl 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.

7. After cleaning, inspect the camera head assembly and camera head cable for cleanliness and damage.

8. 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.

9. 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.

Temperature Detergent Type and

950-0047-04A Page 49 of 69

Minimum

Temperature

Steam (Wrapped)

30 Minutes

Steam (Wrapped)

30 Minutes

Steam (Un-Wrapped)

3.3.4.2 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 tap water to remove the 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 enzymatic detergent, such as Enzol®, using tap water at 1 oz/gallon.

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 tap 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 tap water each time. b. Rinse under running tap 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 and remove if required.

7. Dry the equipment with a lint-free soft cloth. 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.

8. After cleaning, inspect the camera head assembly and camera head cable for cleanliness and 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.

3.3.5 Sterilization of the AR-3210-xx Camera Heads

connecting to the CCU or attaching to a scope.

950-0047-04A Page 50 of 69

PRECAUTION: After sterilization, set the AR-3210 Camera Heads aside for 15 minutes to allow equipment to cool before

STEAM STERILIZATION PARAMETERS

Method Cycle

Pre-vacuum

Gravity Gravity

Exposure

Exposure Time

132° C (270° F) 4 Minutes 132° C (270° F) 15 Minutes 132° C (270° F) 10 Minutes

Dry Time

assurance level (SAL) of 10-6.

• V-PRO® 60 Low Temperature Sterilization System [Lumen and Non-lumen Cycles]

DEVICE STERILIZATION METHO DS

The following cycles have been validated for AR-3210-XXXX Camera Heads to provide a sterility

System Cycles

Steris® Systems

Sterrad® Systems

• V-PRO® 1 Low Temperature Sterilization System [Standard Cycle]

• V-PRO® 1 Plus Low Temperature Sterilization System [Lumen and Non-lumen Cycles]

• V-PRO® maX Low Temperature Sterilization System [Lumen, Non-lumen and Flexible

Cycles]

• Sterrad® System 100S [Short Cycle]

• Sterrad® System NX [Short Cycle]

• Sterrad® System 100NX [Standard Cycle]

3.3.6 Material Compatibility In addition to the Sterilization chem icals listed abo ve, the AR -3210-XXXX camera heads are Material

Compatible with Cidex OPA. No SAL claims are made with Cidex OPA.

WARNING: Use of Sterilants or Chemicals other than those listed in the Cleaning and Sterilization section may result in the compromise of the device’s safety and effectiveness. Use of Sterilants or Chemicals other than those listed in the “Cleaning and Sterilization” section shall void the product’s warranty.

950-0047-04A Page 51 of 69

3.4 Troubleshooting

Symptom

Possible Cause

Corrective Action

Camera does not power up. Standby LED does not illuminate.

Intermittent picture.

Camera will not white balance.

• Power cord is unplugged.

• Suspect power cord.

• Verify camera head connector

card edge is fully inserted into the CCU camera receptacle.

• Suspect video and/or power cables.

• Suspect camera head or cable.

• Too much light.

• Too little light.

• Wrong Color Temperature

light.

• Plug power cord into CCU and/or a properly grounded receptacle.

• Replace power cord.

• Reinsert camera head connector card

edge.

• Flex video and power cables. If picture is affected, inspect cables and replace as necessary.

• Flex camera cable. If picture is affected, return to factory for repair or replacement.

• If monitor indicates “White Balance Fail”, move the scope further away from the white gauze when you white balance, or turn down the LED Light Engine brightness.

• If monitor indicates “White Balance Fail”, move the scope closer to the white gauze when you white balance, or turn up the LED Light Engine brightness.

Camera head buttons do not function as programmed.

• Incorrect camera head button programming.

• Reprogram camera head buttons. NOTE: Tablet Data Input device option only.

950-0047-04A Page 52 of 69

Symptom

Possible Cause

Corrective Action

No video image on monitor.

• CCU and/or monitor are not ON and/or plugged in.

• Equipment is not connected properly or cable(s) damaged.

• Suspect camera head and/or cable.

• Camera head cable connector not inserted correctly or completely.

• Plug CCU and/or monitor in and/or turn power ON.

• Confirm cable connections and reroute video cables, if necessary per interconnect diagram. Check video cables for damage, replace as necessary.

• Replace the camera head with a working unit and verify image on monitor. If image is now viewed, the original camera head and/or cable were faulty, return them to Arthrex for repair.

• Insert camera head cable connector completely into the CCU’s camera head receptacle on the front panel.

• Check monitor using color bars from the CCU.

• Try the CCU on a different monitor.

Poor color reproduction.

System does not boot up correction./Banners do not display or do not display properly.

AR-3200-1013 Tablet will not connect to CCU.

• White Balance Issues.

• Improper shut down of CCU.

• Software Incompatibility

• White Balance camera head.

• Check monitor settings using

color bars from the CCU.

• Try the CCU on a different monitor.

• Power down device, wait 3 minutes, and restart system.

• SynergyUHD4 Software must be updated to v4.13.1 or newer.

950-0047-04A Page 53 of 69

Symptom

Possible Cause

Corrective Action

Tablet continually restarts or will not progress beyond the Samsung startup screen.

• Damage to Tablet

• Improper Charger Used

• Improper USB Charger

extension cable used.

• Verify Tablet cable and connector are not damaged. If damaged, contact Arthre x Technical Support for further assistance.

• Ensure charger is a Samsung mode EPTA10JWE that has a minimum of 2.0A of charge current. Replace charger if it is not. Contact Arthrex Technical Support if problem persists.

• Ensure USB charger cable is a USB 3.0 cable (both connectors) with a length that does not exceed 6 ft. (1.83 meters). Replace charger cable if it is not. Contact Arthrex Technical Support if problem persists.

950-0047-04A Page 54 of 69

3.5 Resolving Error Messages

Error Message

Corrective Action

If not resolved, contact Arthrex Technical Support for further assistance.

The software update performed was not

Technical Support for further assistance.

Camera head is not compatible and should not be system

Unfortunately, we were una ble to restore the their default values.

Contact Arthrex Technical Support for further assistance.

Cannot connect to Synergy. Touch to try again. User account is locked. Contact site administrator for assistance.

User not assigned to valid network group. Contact site administrator for assistance.

The software update to <new version> f ailed and was automatically rolled back to <original version>.

used in any surgical procedures with the current

following items and they have been reset back to

An error occurred while fetching version info: The Synergy console cannot be reached. Failed to install updated controller.

successful. The device has automatically rolled back to the software version before the attempted upgrade. Contact Arthrex

Refer to Instructions for Use for list of compatible Camera Heads.

Contact Arthrex Technical Support for further assistance.

3.6 Recommended Annual Camera Control Unit Maintenance Requirements

Recommended Annual Camera Control Unit Maintenance Requirements

Test Type Test Value

Ground Impedance

Test Chassis Leakage Currents

Test Earth Leakage Currents

Test Dielectric Withstand Test Line and Neutral to Ground @ V = 1500 V~, no breakdown *

* See IEC 60601-1 for test methods.

950-0047-04A Page 55 of 69

ZG < 100 mOhm from the ground pin on the power inlet module to the Camera Control Unit’s exposed metal parts. *

IL < 100 µA in NORMAL Condition. IL < 500 µA in Single Fault Conditi ons [300 µA US deviation] *

IL < 5 mA NORMAL Condition IL < 10 mA Single Fault Condition *

Group 1 [RF internally generated for the

4.0 Technical In formation

NOTE: Technical data is subject to modification, revision and improvement without notice.

Safety, EMC and Regulatory Requirements

Parameter Parameter Value

FDA Class Class II

System Classification

Safety Certifications

EU Class Class I Health Canada Class Class II

Domestic Certification

Canadian Certification

EU Certification

CISPR 11 EMC Class Class A

• ANSI/AAMI ES60601-1/A1:2012

• CAN/CSA-C22.2 No. 601.1-M90

• CAN/CSA-C22.2 No. 60601-1:2014

• ANSI/AAMI ES60601-1/A1:2012

• IEC 60601-1:2005 + Corrigendum

1:2006 + Corrigendum 2:2007 + AM1:2012 [IEC 60601-1:2012]

EMC Certifications

Safety Certification Marking

CE Marking

950-0047-04A Page 56 of 69

CISPR 11 EMC Group

EMC Certification Certification to IEC 60601-1-2:2014 Class A

CE Marking for MDD 93/42/EEC, RoHS 2011/65/EU, and (RED)(2014/53/EU)

operation of the device]

Safety, Classification s

Classification of Equipment

Parameter Value

According to protection against electric shock. Class I [Grounded] According to degree of protection against

electric shock.

According to Degree of protection against harmful ingress of water.

According to the degree of safety in the presence of Flammable Anesthetics

According to the mode of operation. Continuous

Specifications

Parameter Parameter Value

Rated Voltage: 100 – 240 VAC

Power Requirements

Supply Frequency: 50-60 Hz Power Input: 160 VA Fuses: No user serviceable fuses

Video Output Description

Display Port (2x) 3840 x 2160 pixels [4K/UHD], 10-bit color

Applied part is Type CF Defibrillation Proof

Camera Control Units are Ordinary [IPX-0] no protection.

Camera Head is IXP-7 [Protected against temporary immersion in water]

Equipment is NOT suitable for use in the presence of flammable anesthetics.

DVI (2x) 1920 x 1080 pixels [1080p], 8-bit color

Video Outputs

Vertical Scanning Frequency

Signal to Noise Ratio

White Balance Range (using CCU Light Source)

CCU Dimensions

CCU Weight Approximately: 15 pounds/6.8 kg

3G-SDI (4x) 1920 x 1080 pixels [1080p], 8-bit color

3840 x 2160 pixels [4K/UHD], 8-bit color

Matrix Video (2x)

59.94 Hz > 52 dB [4K]

> 48 dB [HD] 2500 – 9000 K [4K]

2000 – 9000 K [HD] Approximately: 17” [W] x 3.5” [H] x 13.5” [D]

43.2 cm [W] x 8.9 cm [H] x 34.3 cm [D]

(AR-3200-0020 [CCU, Synergy UHD4, Matrix] and AR-3200-0022 [CC U, S ynergy UHD4, Matrix, HCRI ])

950-0047-04A Page 57 of 69

AR-3210-0018 Approximately

4” [L] x 1.8” [W], x 1.8” [H]

10.1 cm [L] x 4.5 cm [W] x 4.5 cm [H]

Camera Head Dimensions

AR-3210-0021

Approximately AR-3210-0022

Approximately

AR-3210-0023 Approximately:

AR-3210-0025 Approximately:

AR-3210-0026 Approximately:

AR-3210-0028 Approximately:

AR-3210-0029 Approximately:

AR-3210-0030 Approximately:

AR-3210-0031

Approximately:

2.7” [L] x 1.2” [W], x 1.3” [H]

6.9 cm [L] x 3.0 cm [W] x 3.3 cm [H]

2.7” [L] x 1.7” [W], x 1.7” [H]

6.9 cm [L] x 4.3 cm [W] x 4.3 cm [H]

4.1” [L] x 1.8” [W], x 1.8” [H]

9.9 cm [L] x 4.6 cm [W] x 4.6 cm [H]

2.8” [L] x 1.65” [W], x 1.7” [H]

7.1 cm [L] x 4.2 cm [W] x 4.3 cm [H]

2.9” [L] x 1.2” [W], x 1.3” [H]

7.3 cm [L] x 3.0 cm [W] x 3.3 cm [H]

2.8” [L] x 1.65” [W], x 1.7” [H]

7.1 cm [L] x 4.2 cm [W] x 4.3 cm [H]

4.1” [L] x 1.8” [W], x 1.8” [H]

9.9 cm [L] x 4.6 cm [W] x 4.6 cm [H]

2.8” [L] x 1.65” [W], x 1.7” [H]

7.1 cm [L] x 4.2 cm [W] x 4.3 cm [H]

4.5” [L] x 2.0” [W], x 2.0” [H]

11.4 cm [L] x 5.1 cm [W] x 5.1 cm [H]

AR-3210-0032

Approximately:

3.5” [L] x 2.0” [W], x 2.0” [H]

8.9 cm [L] x 5.1 cm [W] x 5.1 cm [H]

950-0047-04A Page 58 of 69

AR-3210-0018

Approximately

Approximately:

Atmospheric Pressure: 500 hPa to 1060 hPa

19.6 ounces [0.6 kg]

Camera Head Weight

AR-3210-0021

AR-3210-0022

Approximately

AR-3210-0023

AR-3210-0025

AR-3210-0026

AR-3210-0028

AR-3210-0029

AR-3210-0030 Approximately:

AR-3210-0031 Approximately:

AR-3210-0032

Approximately:

17.1 ounces [0.5 kg]

17.9 ounces [0.5 kg]

21.0 ounces [0.6 kg]

17.4 ounces [0.5 kg]

27.4 ounces [0.8 kg]

21.0 ounces [0.6 kg]

17.4 ounces [0.5 kg]

20.8 ounces [0.6 kg]

17.5 ounces [0.5 kg]

Transport & Storage Conditions

Operating Conditions

Ambient Temperature: -40°F to 122°F [-40°C to 50°C] Relative Humidity: 10% to 90%, non-condensing

Ambient Temperature: +50°F to 73°F [10°C to 23°C] Relative Humidity: 30% to 75%, non-condensing Atmospheric Pressure: Altitudes ≤ 3000 m

950-0047-04A Page 59 of 69

DICOM Specifications

DICOM Statement

DICOM Compatible with installation of AR-3200-1020 DICOM Key

LED Light Engine Specifications

Parameter Parameter Value

LED Light Engine Specifications

Standard

Light output

HCRI

Standard

Color Temp

HCRI

LED Life > 30,000 hours Light Guide Port

Turret

ACMI™ Standard, Storz™, Wolf™ and Olympus™

Minimum: 1600 Lumens Typical; 1800 Lumens

Minimum: 1000 Lumens Typical; 1125 Lumens

70 CRI Typical, 65 Minimum 5500-8500K

92 CRI Typical, 90 Minimum 5200-6700K

950-0047-04A Page 60 of 69

5.0 APPENDIX [Radio

Module Information]

FCC Information:

Contains FCC ID: PPD-AR5B225

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions; (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation

CAUTION: changes or modifications not expressly approved by Arthrex will void the user’s authority to operate this equipment.

Industry Canada Information:

Contains IC: 4104A-AR5B225 IC Model; AR5B225

This device complies with Industry Canada licenseexempt RSS standard(s). Operation is subject to the following two conditions; (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation

European Union Information:

Compliant with (RED)(2014/53/EU)

950-0047-04A Page 61 of 69

6.0 APPENDIX [Detailed

EMC Information]

DETAILED EMC INFORMATION NOTE: CE marked equipment has been tested

and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC [EN 55011 Class A and IEC 60601-1-2]. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

The Equipment generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions , m a y cause harmful interference to other devices in the vicinity.

However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with 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:

• Reorient or relocate the receiving device.

• Increase the separation between the

equipment.

• Connect the equipment to an outlet on a circuit different from that to which the other device(s) is connected.

• Consult the manufacturer or a field service technician for assistance.

NOTE: The EMC tables and other guidelines that are included in the Instruction Manual provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electro-magnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without

disturbing other Equipment and Systems or non-medical electrical equipment.

NOTE: Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents.

WARNINGS:

1. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

2. Use of accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the equipment as replacement parts for internal components, may result in increased emissions and decreased immunity of the equipment or system.

3. The video equipment / system should not be used adjacent to or stacked with other equipment, and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it is intended to be used.

4. Under extreme conditions of primary power voltage sag [Primary voltage less than 60% of mains] the device may require operator intervention to recover lost image. Device may have to be restarted by pressing On/Standby Switch.

950-0047-04A Page 62 of 69

IEC 60601-1-2

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions Test

Compliance

Electromagnetic environment- guidance

likely to cause any interference in nearby equipment.

CISPR 11

IEC 61000-3-2

System Cables

Type

Use

Shielded?

Ferrite?

Maximum Length

the Box

Monitor

Video Monitor

Monitor

3 pin mini Stereo

Accessory Port

Yes

1.8 M

Ethernet

CCU to Computer

Yes

5 M

USB

CCU to Printer

Yes

1.8 M

The Arthrex customer or the user of the Arthrex

Harmonic Emissions

Voltage fluctuations /

UHD4

RE emissions

CISPR 11

RF emissions

flicker emissions

IEC 61000-3-3

Video System is intended for use in the electromagnetic environment specified below. The

UHD4

Video System should ensure that it is used in such an environment.

Group 1

Class A

Complies

The Arthrex internal function. Therefore its RF emissions are very low and not

The Arthrex in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the

Arthrex

UHD4

Video System uses RF energy only for its

UHD4

Video System is suitable for use

UHD4

Video System or shielding the location.

Power Cord Supply Line Power to

BNC to BNC Composite Video Out to

Display Port Display Port Output to

DVI DVI Video Out to

No No 2 M

Yes No 1.8 M

Yes Yes 2.0 M

950-0047-04A Page 63 of 69

IEC 60601-1-2

cycles

Guidance and manufacturer’s declaration – electromagnetic immunity

The Arthrex Arthrex

UHD4

Video System is intended for use in the electromagnetic environment specified below. The customer or user of the

Video System should ensure that it is used in such an environment.

Immunity Test IEC 60601 test level Compliance Level Electromagnetic environment - guidance

Electrostatic discharge [ESD] IEC 61000-4-2

Electrical fast transient / burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

± 8 kV contact ± 15 kV air

± 2 kV differential mode ± 1 kV for input / output

lines 100 khz Cycling

Frequency

± 1 kV differential mode.

± 2 kV common mode.

UT= 0%,0.5 cycle

(0, 45, 90,135, 180, 225, 270, and 315

)

= 0%;1 cycle

= 70%;25/30 cycles

(@0 degrees)

UT= 70%; 250/300

± 8 kV contact ± 15 kV air

± 2 kV differential mode ± 1 kV for input / output

lines 100 khz Cycling

Frequency

± 1 kV differential mode.

± 2 kV common mode.

UT= 0%,0.5 cycle

(0, 45, 90,135, 180, 225, 270, and 315

)

= 0%;1 cycle

= 70%;25/30 cycles

(@0 degrees)

UT= 70%; 250/300

Floors should be wood, concrete or ceramic tile. If floors are covered by synthetic material the relative humidity should be at least 30%.

Mains power should be that of a typical commercial or hospital environment.

Mains power should be that of a typical commercial or hospital environment. If the user of the

UHD4

Arthrex

Video System requires continued

operation during power mains interruptions, it is recommended that the Arthrex

UHD4

Video System

be powered from an uninterruptible power supply. If voltage dips or short interruptions do occur the

CCU will recover in < 5 seconds but the LED Light Source may be in stand-by. User will need to turn on the LED Light Engine with the front panel button.

Power Frequency [50/60 Hz] magnetic field.

IEC 61000-4-8

3 A/m 3 A/m @50 & 60 Hz Power frequency magnetic fiel ds should be at levels

characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

950-0047-04A Page 64 of 69

IEC 60601-1-2

Guidance and manufacturer’s declaration – electromagnetic immunity

Test

level

Recommended separation distance

4-6

[ ]

PVd 1/5.3=

[ ]

PVd 1/5.3=

[

]

Ed 1

/7=

reflection by structures, objects and people.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

The Arthrex Arthrex

Immunity

Conducted

IEC 61000-

Radiated RF

IEC 61000-

UHD4

4-3

is intended for use in the electromagnetic environment specified below. The customer or user of the

should ensure that it is used in such an environment.

IEC 60601 test level Compliance

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

V1=3 Vrms

E1= 3 V/m

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Arthrex

including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

= 1.17

=1.17

= 2.33

Where P is the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer and d is the recommended separation in meters [m].

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

should be less that the

UHD4

Video System,

80 MHz to 800 MHz

800 MHz to 2.7 GHz

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

Field strengths from fixed transmitters, such as base stations for radio [cellular/cordless] telephones and land mobil e

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be

considered. If the measured field strength in the location in which the Arthrex applicable RF compliance level, above, the Arthrex

If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the

UHD4

Arthrex

Video System.

UHD4

Video System should be observed to verify normal operation.

UHD4

Video System is used exceeds the

950-0047-04A Page 65 of 69

IEC 60601-1-2

Arthrex

Video System

equipment.

[ ]

PEd 1/5.3=

[ ]

PEd 1/7=

0.01

0.12

0.23

0.1

0.37

0.74

1.17

1.14

2.33

3.70

7.37

100

11.70

23.3

reflection from structures, objects, and people.

[ ]

PVd 1/5.3=

Recommended separation distances between portable and mobile RF communications equipment and the

UHD4

The Arthrex are controlled. The customer or the user of the Arthrex

by maintaining a minimum distance between portable and mobile RF communications equipment [transmitters] and the Arthrex

Rated maximum output power of

transmitter [W]

For transmitters rated at a maximum output power not listed above, the recommended separation distance [d] in meters [m] can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output rating of the transmitter in watts [W] according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

UHD4

Video System is intended for use in an electromagnetic environment in which radiated RF disturbances

UHD4

Video System as recommended below, according to the maximum output power of the communications

Separation distance according to frequency of transmitter [m]

150 kHz to 80 MHz

UHD4

Video System can help prevent electromagnetic interference

80 MHz to 800 MHz

800 MHz to 2.7 GHz

950-0047-04A Page 66 of 69

7.0 APPENDIX [SW

Version access]

ACCESS to SW Version on Synergy

1. On POWER ON, the screen below appears.

2. Double click on screen to pull up SW Version.

3. Then Tap “About”

UHD4

Figure 34-Logging on to Android

Figure 35-About Screen

Figure 36-SW Version Screen

950-0047-04A Page 67 of 69

THIS PAGE INTENTIONALLY LEFT BLANK

950-0047-04A Page 68 of 69

Naples, FL 34108-1945, USA

Customer Servi ce

+1 (800) 934-4404

Arthrex, Inc.

Toll-Free Technical Support: 1-(800) 391-8599 Monday through Friday, 8:00 AM – 8:00 PM ET www.arthrex.com

Arthrex GmbH

Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0

950-0047-04A Page 69 of 69

Arthrex AR-3200-0022, AR-3200-0021, AR-3210-0023, AR-3210-0022, AR-3210-0026 Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1.0 Introduction

1.1 Intended Use

1.2 Contraindications

1.3 Warnings and Precautions

1.3.1 WARNINGS

1.3.2 PRECAUTIONS

1.4 Symbol Definitions

1.5 End of Life, Environmental Directives

1.6 Initial Use of the Device

1.7 Unpacking and Inspecting the Device

1.8 Returning the Device

1.9 System Indicators

1.9.2 Rear Panel

1.9.3 Camera Heads with Integrated Optics

1.9.4 C-Mount Camera Heads

2.1 Installation

2.1.1 Typical System Installation

2.2 Accessories for Intended Use

2.3 System Setup Facility and Surgeon Settings

2.3.2 Selecting “System” enables several facility preferences to be setup;

2.3.9 Surgeon preferences can be defined for the following:

2.4 Icon Guide

Figure 24-Connectivity Icons

2.5 Scheduling and Starting Cases

2.5.1 To schedule a case, press the “+ Add New Case” ic o n

2.5.3 Input any of the other optional data elements in the appropriate fields.

2.5.4 Press the “Save” icon.

2.5.5 To start a case, select the case/patient from the Case List and press the “Start” icon.

2.5.8 Ending a Case; to end a case, press the “End Case” Icon.

2.6 Status Notification Icons

3.0 Maintenance

3.1 Life Expectancy

3.2 Periodic Maintenance

3.3 Cleaning and Sterilizing

3.3.1 Cleaning the LED Light Engine

3.3.2 Cleaning the Camera Control Unit (CCU)

3.3.3 Cleaning the Tablet

3.3.4 Cleaning the Camera Head

3.3.4.1 Automated Cleaning

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

3.3.5 Sterilization of the AR-3210-xx Camera Heads

3.3.6 Material Compatibility In addition to the Sterilization chem icals listed abo ve, the AR -3210-XXXX camera heads are Material

3.4 Troubleshooting

3.5 Resolving Error Messages

3.6 Recommended Annual Camera Control Unit Maintenance Requirements

4.0 Technical In formation