AR-3210 Synergy Insert Manual Rev F

AR-3210-0001 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 - 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. Cleaning the AR-3210-0001 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 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.

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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 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

NA

Drying

06:00

90oC

NA

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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.

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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.

Sterilization of the AR-3210 Camera Heads

Sterilization Protocols Validated

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.

Sterilization Protocol Steris Systems

Sterrad System 100S

Details

AR-3210-XXXX Camera Heads are validated for Sterilization Assurance using the Steris systems listed below, and following the manufacturer’s instructions. 

V-PRO 1 Plus [Non-Lumen Cycle]



V-PRO maX [Non-Lumen Cycle]



V-PRO 1

AR-3210 Camera Heads are validated for Sterilization Assurance using the Sterrad System 100S, System NX and System 100NX. Follow the Sterrad Instructions for use.

Sterrad System NX Sterrad System 100NX

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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

3.3.4 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

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

All rights reserved. Printed in USA

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