Cleaning Method 4
Download this information as a pdf
Product Care Instructions
Devices: All Ocular Tonometers
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 soak in Acetone or Other Solvents.
- Allow devices to air cool to room temperature before use. Rapid cooling may damage devices.
Limitations on Reprocessing
Tonometers have a lifetime of 5 years. After a period of 2 years of purchase, check for the following:
- Any visual damage
- Easy gliding and turning without any resistance
- No complete rip of the white ‘O’ type joint ring
- Scratches on applanation (contact surface)
- Complete visibility of engraved white ring on the applanation (contact) surface
Contact customer service for any such concern.
Instructions
Point of Use
Rinse: Immediately upon removal from patient's eye, thoroughly rinse in cool or tepid water.
Preparation for decontamination:
Reprocess all devices as soon as reasonably practical following use.
Cleaning: Automated
Not recommended.
Cleaning: Manual
Wash: Disassemble lens and place a few drops of low foaming mild soap (neutral pH (7.0) detergent formulated for medical instruments) on a moistened cotton ball. Gently clean with a circular motion.
Rinse: Thoroughly rinse lens and flush lumens in cool or tepid high purity water, then dry carefully with a non-linting tissue or hospital grade compressed air.
Visually inspect all surfaces, crevices, joints, holes and lumens for complete removal of soil and fluid. If any soil or fluid is visible, then repeat cleaning.
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.
Caution: If used on an ulcerated cornea, lens must be STERILIZED before next procedure.
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
Flash Autoclave Only
Prep: Rinse devices with sterile water. Place product in sterilization case.
Gravity Cycle (unwrapped)
- Temperature: 270°F (132°C) min.
- Time: 4 minutes min.
- No Dry Time
Pre-Vacuum Cycle (unwrapped)
- Temperature: 270°F (132°C) min.
- Time: 4 minutes min.
- No Dry Time
or
- Temperature: 273°F (134°C) min.
- Time: 3 minutes min.
- No Dry Time
Warning: REMOVE PROMPTLY, longer exposures will damage lens.
The intense heat for an extended time will cause the plastic to cloud. Reassemble before use. In the absence of the ring, a false reading will occur.
Note: Use of distilled water in steam sterilizer is recommended. If not distilled, mineral deposits from hard water (steam) could leave a cloudy film on the lens. The deposits can only be removed by regrinding and re-polishing the lens and repair costs approximate that of a new lens.
Caution: Reassemble before use. In the absence of the ring, a false reading will occur.
Sterrad
STERRAD 100NX System (Standard Cycle)1, 2 | STERRAD NX: Standard Cycle1, 2 | STERRAD 100S, 200: Short Cycle1, 2 | STERRAD 501,2
Process product in STERRAD approved tray or container and wrap when applicable. Follow STERRAD instructions.
Steris SYSTEM 1E
Follow Steris instructions.
3M™ Optreoz™ 125-Z Low Temperature Sterilization System – Cycle 11
Follow 3M™ Optreoz™ 125-Z Low Temperature Sterilization System instructions.
Note:
- Colored aluminum will fade to a natural aluminum color within 25 cycles.
- 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. Also compatible with H2O2-3%.
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.
