Care and Cleaning of Vitreoretinal & Microincision Instruments

Instruction for Initial Use

It is essential that the instrument be cleaned and sterilized before initial use following the procedures as outlined in this instruction brochure.

Care and Handling

Intraocular tips have a delicate precision mechanism inside. Intraocular fluids will enter this mechanism during surgery. If these fluids are not promptly and properly cleaned out, it will lead to corrosion or clogs and the possibility of instrument malfunction. Proteins may also accumulate inside of the mechanism.

Cleaning

1. Unscrew the tip from the handle and attach the flushing adapter.
2. Ultrasonically clean both parts, if possible.
3. Flush the tip with distilled or deionized water using a syringe.
4. Flush the tip with alcohol to remove water and facilitate drying.
5. Dry the tip with pressurized air.
6. Use thermoresistant instrument milk to maintain function.
7. Dry again the tip with pressurized air.
8. Handle should be soaked in distilled or deionized water for two minutes.
9. Dry with a surgical sponge.
10. Lubricate joints in the handle with instrument milk and work the mechanism.

Instrument Detergents and Cleaners

Only detergents and cleaners specially designed for use on surgical stainless steel or titanium instruments are acceptable for use in the cleaning process. The cleaning guidelines of the solution manufacturer and your institution should be observed.

Ultrasonic Cleaning Equipment

An ultrasonic cleaner may be used but should not be the sole cleaning method. The instrument should be flushed with distilled water before being placed in the ultrasonic cleaner. A 5-10 minute cycle should be sufficient. The instrument must be secured on a silicone finger mat to prevent damage.

Lubrication

Moving parts and working mechanisms should be lubricated occasionally with a medical-grade instrument lubricant to ensure smooth operation.

Storage and Sterilization

Instruments should be stored in sterilizing trays lined with soft silicone mats. Stainless steel and titanium instruments can be sterilized using steam autoclaving, chemical disinfectants, ethylene oxide gas, or dry hot air.

Sterilization Cycles

• 100% ETO cycles: Concentration ETO: 850±50mg/l, Temperature: 37°C - 47°C, Exposure time: 3-4 hours, Humidity: 70% RH minimum.
• Steam Autoclaving: Temperature: 121°C to 135°C, Exposure time: 15 to 30 minutes.
• Flash Autoclaving: Temperature: 132°C, Exposure time: 3 minutes.

Inspection

Inspect every microsurgical instrument at the end of each surgical day under a microscope or magnification lens. If a damaged instrument is detected, repair or replace it.

Warranty

Warranty period: 2 years from the date of sale. Manufacturer assumes obligation to repair or replace defective instruments if the defect developed under normal use.

Claims

Claims should be sent to the manufacturer at the address provided.

Statement of Compliance

This instrument complies with technical documentation and is fit for regular use.

Recycling

Instruments are non-toxic, apyrogenic, and recyclable after disinfection.

Contact Information

BIS MASTERMED, s.r.o.
Južná trieda 119, 04001 Košice, Slovakia, EU
Phone/Fax: +421 55 230 31 74