SynergyUHD4 and SynergyID Camera Head Instructions for Use Manual Rev 0 June 2020

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Camera Head Overview

Figure 1- AR-3210-0023 [4K SynergyUHD4 Camera Head, autoclavable]

Figure 2-AR-3210-0018 [HD, SynergyUHD4 Camera Head, autoclavable]

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Figure 3-AR-3210-0025 [4K SynergyUHD4 C-Mount Camera Head, autoclavable], AR-3210-0028 [4K SynergyUHD4 C-Mount Camera Head w/20 foot cable, autoclavable] and Not Pictured AR-3210-0026 [4K SynergyUHD4 C-Mount Camera Head, 0 Degree, autoclavable]

Figure 4-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]

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Figure 5- AR-3210-0029 [4K SynergyUHD4 Broadband Camera Head, autoclavable]

Figure 6- AR-3210-0030 [4K SynergyUHD4 C-Mount Broadband Camera Head, autoclavable]

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2

1

3

4

Figure 7- AR-3210-0031 [4K Ultra SynergyUHD4 Camera Head, autoclavable]

1

2

Figure 8- AR-3210-0032 [4K Ultra SynergyUHD4 C-Mount Camera Head, autoclavable]

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Figure 9- AR-3210-0033 [4K SynergyID 4MOS Camera Head, autoclavable]

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AR-3210-XXXX Camera Head 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 [Integrated Optics Only]- Used to sharpen, or bring into focus, the image detail. 4. Grasping Mechanism [Integrated Optics Only] - Accepts and locks into place the compatible scope. DIN 58105 compliant endoscope interface. AR-3210-XXXX Camera Head SynergyUHD4/ID Firmware Compatibility

CAUTION: • Some AR-3210-XXXX camera heads are only compatible with specific SynergyUHD4/ID firmware versions as shown in the following table. Attempting to use these camera heads with incompatible SynergyUHD4/ID 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 AR-3210-0033 All other camera head models mentioned in this IFU

Compatible SynergyUHD4/ID 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 850-0026-03-A or higher All versions

Determining the Firmware Version of the SynergyUHD4/ID 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.

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Figure 9- SynergyUHD4/ID Firmware Version Cleaning the AR-3210-XXXX Camera Head

CAUTIONS: • If the camera head is dented or damaged, or if the connector 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. Automated Cleaning

• •

Use only washers according to the International Standard ISO 15883. Refer to the washer’s instruction manual.

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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. Automatic Washer Cycle Definition Phase

Recirculation Time (Minutes)

Temperature

Detergent Type and Concentration

Pre-Wash 1

02:00

COLD TAP WATER

NA

Enzyme Wash

03:00

HOT TAP WATER

Enzol®1oz/gallon

Rinse 1

00:15

HOT TAP WATER 60OC [140OF]

NA

Drying

06:00

90oC [194OF]

NA

6. 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. 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.

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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-to-clean 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.

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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

Sterilization of the AR-3210-XXXX Camera Heads PRECAUTION: After sterilization, set the AR-3210 Camera Heads aside for 15 minutes to allow equipment to cool before connecting to the CCU or attaching to a scope. STEAM STERILIZATION PARAMETERS Method

Cycle

Minimum Exposure Temperature

Exposure Time

Dry Time

Steam (Wrapped)

Prevacuum

132° C (270° F)

4 Minutes

30 Minutes

Steam (Wrapped)

Gravity

132° C (270° F)

15 Minutes

30 Minutes

Steam (UnWrapped)

Gravity

132° C (270° F)

10 Minutes

NA

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DEVICE STERILIZATION METHODS The following cycles have been validated for AR-3210-XXXX Camera Heads to provide a sterility assurance level (SAL) of 10-6. System

Cycles

STERIS® Systems

•

V-PRO® 1 Low Temperature Sterilization System [Standard Cycle] V-PRO® 1 Plus Low Temperature Sterilization System [Lumen and Nonlumen Cycles] V-PRO® maX Low Temperature Sterilization System [Lumen, Non-lumen and Flexible Cycles] V-PRO® 60 Low Temperature Sterilization System [Lumen and Non-lumen Cycles]

STERRAD® Systems

•

STERRAD® System 100S [Short Cycle] STERRAD® System NX [Short Cycle] STERRAD® System 100NX [Standard Cycle]

Material Compatibilities In addition to the Sterilization chemicals listed above, the AR-3210 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.

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Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108, USA Customer Service 866-267-9138 Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0 www.arthrex.de

Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108, USA +1 (800) 934-4404 www.arthrex.com Technical Support 1-888-420-9393

All rights reserved. Printed in USA

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