Synergy Camera Head Insert AR-3210 Manual

AR-3210 Camera Head Page Left Intentionally Blank 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 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.

Cleaning Instructions CAUTION: Wear protective gloves, clothing and face mask for cleaning of contaminated equipment. REF: 950-0032-00 A [IFU, English, Head Insert]

Page 2 of 8

REF: 950-0032-00 A [IFU, English, Head Insert]

Page 7 of 8

Camera Head Assembly Page Left Intentionally Blank

REF: 950-0032-00 A [IFU, English, Head Insert]

1. Thoroughly rinse the camera head to remove all gross debris. Tap water is recommended for cleaning and rinsing of the camera head. 2. Complete immerse the camera head assembly and camera cable in a neutral pH enzymatic cleaning solution (e.g. Enzol, Metrizyme or equivalent diluted to proper concentrations per manufacturer’s instructions) and Tap water. Arthrex does not recommend the use of detergents alone, as they contain high levels of surfactants which can leave a film on the equipment. 3. Remove any residual debris and contaminants from the camera head assembly with a soft brush. Cleaning accessories are available from Arthrex. 4. Be sure that the card edge connector is thoroughly clean. 5. Cleaning brushes should be cleaned and high level disinfected or sterilized daily. 6. Triple-rinse the camera head assembly with Tap water, for a minimum of one minute for each rinse. The rinse water should be discarded at the end of each rinse, as it will be contaminated with the cleaning solution. Thoroughly rinsing of the camera head assembly is necessary for removing any debris or detergent which could interfere with sterilization. 7. Dry the equipment with a lint-free soft cloth. Wipe the card edge connector with 70% isopropyl alcohol to remove any residual detergent. 8. 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. 9. After cleaning, inspect the camera head assembly and camera head cable for cleanliness and damage. 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. Page 6 of 8

REF: 950-0032-00 A [IFU, English, Head Insert]

Page 3 of 8

10. Before sterilization and/or disinfection, coil the camera head cable into loops at least six Sterilizing the AR-3210 Camera Head

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.

Sterilization Protocols Validated

PRECAUTION:: After sterilization, set the AR-3210 Camera Head aside for 15 minutes to allow equipment to cool before connecting to the CCU or attaching to a scope.

Sterilization Protocol Steris System V-Pro 1 Plus

Details

AR-3210 Camera Heads are validated for Sterilization Assurance using the Steris System V-Pro 1 Plus and following the Steris System V-Pro 1 Plus Instructions.

STERILIZATION PARAMETERS Method

Cycle

Minimum Exposure Temperature

Exposure Time

Steam (Wrapped)

Prevacuum

132° C (270° F)

4 Minutes

30 Minutes

Steam (Wrapped)

Gravity

132° C (270° F)

15 Minutes

30 Minutes

Gravity

132° C (270° F)

10 Minutes

NA

Steam (UnWrapped)

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.

REF: 950-0032-00 A [IFU, English, Head Insert]

Dry Time

Page 4 of 8

Arthrex California Technology, Inc 460 Ward Drive Santa Barbara, CA 93111, USA 1 (800) 934-4404

Distributed by: Arthrex Inc. Naples, FL 34108, USA 1 (800) 934-4404 Technical Support 1-888-420-9393

REF: 950-0032-00 A [IFU, English, Head Insert]

Page 5 of 8