Cleaning Method 2

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Product Care Instructions

Devices: All Ocular MaxField® Glass and MaxLight® CR-39 Indirect Diagnostic/Laser Lenses

Note: See Cleaning Method 3 for the following:
OI-20A, MaxAC® 20D Indirect, OI-28D; MaxAC® 28D Indirect

Warnings

• Read all instructions before use.
• Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used.
• Wherever possible avoid the use of abrasive materials for cleaning and drying.
• Incorrect handling and care or misuse can lead to premature wear of these devices.
• Inspect these devices carefully for damage, cracks or malfunctions before each use.
• Do not use damaged devices.
• Use only approved disinfectant solutions (e.g., FDA, DGHM, CE Mark…).
• Each device requires cleaning and disinfection before its first use and any subsequent use.
• Ensure cleaning and disinfection solutions fully contact all device surfaces and lumens.
• Store devices in a cleaned, disinfected and dry state.
• Sterilize all devices before surgery.
• Never Steam Autoclave or Boil listed lenses.
• Never soak in Acetone or Other Solvents.

Limitations on Reprocessing

Repeated processing has minimal effect on these devices. Rapid cooling may damage devices.

Instructions

Point of Use

Clean with alcohol wipe.

Preparation for decontamination:

Reprocess all devices as soon as reasonably practical following use.

Cleaning: Automated

Not recommended.

Cleaning: Manual

Wipe: Clean with Alcohol wipe.

Then: Proceed with either disinfection or sterilization instructions.

Caution: If fluid/gas exchange has occurred, wipe lens with alcohol to remove any trace of oil present. If lens is not promptly and properly cleaned, permanent damage may result.

Disinfection

Disinfectant solutions (e.g., Approved by FDA, DGHM, CE Mark…) may be used in accordance with label instructions of the disinfectant manufacturer. Pay strict attention to disinfectant manufactures recommended concentrations and contact durations. Ensure that disinfectant solution makes complete contact with all device surfaces and lumens.

After manual high level disinfection, soak and rinse lens in large volume of cool or tepid sterile water for 1 minute and thoroughly flush lumens. Repeat this procedure 2 times with fresh rinse water to ensure removal of disinfection solution.

Caution: To avoid damage to the lens, do not exceed recommended exposure time.

Drying

Dry devices carefully with lint free tissues or hospital grade compressed air and place in a dry storage case.

Maintenance, Inspection and Testing

Inspect these devices carefully for damage, cracks or malfunctions before each use. Do not use damaged devices.

Packaging

Standard biological peel packs (wrapped) may be used. The pack should be large enough to contain the device without stressing the seals. Biological peel packs ensure sterility after the sterilization process.

Sterilization

EO

• Minimum Time: 1 hour
• Temperature: 130°F (54°C)
• Aerations Time: 12 Hours

STEAM AUTOCLAVE

• NO

STERRAD

• STERRAD 100NX System (Standard Cycle) ^{1, 2}
• STERRAD NX: Standard Cycle ^{1, 2}
• STERRAD 100S, 200: Short Cycle ^{1, 2}
• STERRAD 50 ^{1, 2}

Process product in STERRAD approved tray or container and wrap when applicable.

Follow STERRAD instructions.

Not compatible with: MaxLight CR-39 Indirects.

Steris SYSTEM 1E

Follow Steris Instructions

Not compatible with MaxLight CR-39 Indirects

3M™ Optreoz™ 125-Z Low Temperature Sterilization System – Cycle 1¹

Follow 3M™ Optreoz™ 125-Z Low Temperature Sterilization System instructions.

Notes:

1. Colored aluminum will fade to a natural aluminum color within 25 cycles.
2. Polyacetal components (black or white plastic) may have limited life after repeated sterilization with this method.

For information on compatibility with alternative product care methods, contact Customer Service.

Storage

Ensure devices are cleaned, disinfected and dry before storage. Store in a clean and dry room temperature environment.

Additional Information

Other forms of cleaning and sterilization equipment are available. Please consult instructions of the processing equipment or the manufacturer for compatibility claims. All cleaning and sterilization processes require validation at the point of use.

Note: These lenses are known to be compatible with Glutaraldehyde (2% or 3.4%), BLEACH (10% solution mixed at: 1 part bleach to 9 parts cool or tepid water, recommended exposure time = 10 minutes), Medical disinfectant wipes (Asepti-Wipe II, Cavicide, DisCide Ultra, Envirocide, and Opti-Cide-3) and Medical disinfectant solutions such as Cidex and Cidex OPA.

Manufacturer contact

See brochure for telephone number and address of local representative.

Notes

The instructions contained herein have been validated as being CAPABLE of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually performed using equipment, material and personnel in the reprocessing facility achieve the desired result. This normally requires validation and routine monitoring of the process.