Arthrex AR-3210-0018 Camera Head User Manual

AR-3210-0018 Camera Head
User Manual

Warnings/Cautions

WARNING: Prior to use, Read this Manual carefully and become familiar with the operation of the device and the accessories before use during surgical procedures.
WARNING: Prior to use, Read the entire Arthrex, Inc. SynergyUHD4 System [950-0047-00] Instructions for Use manual before use during surgical procedures.

Camera Head Overview

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

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

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]

Figure 5 -AR.-3210-0029 {4K SynergyUH04 Broadband Camera Head, autoclavable]

Figure 6- AR. -3210-0030 [4K SynergyuHD4 C-Mount Broadband Camera Head, autoclavable]

Figure 7- AR-3210-0031 4K Ultra SynergyuHD4 Camera Head, autoclavable]

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 Firmware Compatibility

CAUTION:

• Some AR-3210-XXXX camera heads are only compatible with specific SynergyUHD4 firmware versions as shown in the following table. Attempting to use this camera
  heads with incompatible SynergyUHD4 firmware may fail to produce an acceptable quality video output on the surgical display.

Determining the Firmware Version of the SynergyUH04 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. 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 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.

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 the washer for the wash cycle listed below.
   Automatic Washer Cycle Definition

   Phase| Recirculation
   Time
   (Minutes)| Temperature| Detergent Type
   and
   Concentration
   Pre-Wash 1| 2:00| COLD TAP WATER| NA
   Enzyme
   Wash| 3:00| HOT TAP WATER| Enzol®1ozigallon
   Rinse 1| 0:15| HOT TAP WATER
   60°C [140°F]| NA
   Drying| 6:00| 90°C [194°F]| 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. Ory 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.

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 activates 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 ii in a basin of warm tap water. Allow the camera head to sit in the water for a minimum of 1 minute while soaking activates 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

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)| Pre-
vacuum| 132° C (270° F)| 4 Minutes| 30
Minutes
Steam
(Wrapped)| Gravity| 132° C (270° F)| 15 Minutes| 30
Minutes
Steam (U n –
Wrapped)| Gravity| 132° C (270° F)| 10 Minutes| NA
DEVICE STERILIZATION METHODS
The following cycles have been validated for the AR-3210-XXXX Camera
Heads to provide a sterility assurance level (SAL) of 10°.

System| Cycles
STERIS® 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] • 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.

Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108, USA
Customer Service
866-267-9138 Arthrex GmbH
Erwin-Hielscher-Strasse g
81249 M~nchen, Germany
+49 89 909005-0 Arthrex, Inc.
1370 Creekside Blvd.
Naples, Fl 34108, USA
+1 800-934-4404
Technical Support
1-888-420-9393

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