Warnings
♦ Instruments must be used for their specified purpose and incorrect use could damage the instrument.
♦ Our instruments are designed for use by surgeons, who have a good knowledge of their features and how they should be used. Any other use can compromise the safety of the user and the patient. It is the responsibility of the surgeon to choose the most suitable instrument for the surgical technique being performed, based on his experience and expertise.
♦ Before using Ophthalmic, examine the instruments with special lenses. Do not use instruments that show problems or defects.
♦ Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used. Wherever possible avoid use of mineral acids and harsh, abrasive agents.
♦ No part of the process shall exceed 140°C.
♦ Some sensitive materials (e.g. Aluminium) are damaged by high alkaline solutions (pH>10).
♦ Devices with long, narrow cannula, hinges and blind holes require particular attention during cleaning.
♦ Do not use hydrogen peroxide on TITANIUM instruments or on anodised surfaces in order to avoid decolourisation.
Note: When reprocessing medical devices, always handle with care, wearing protective clothing, gloves and eyewear in accordance with local Health & Safety procedures.
Sterilisation
Instruments can be sterilised using the following methods: -
100% ETO Cycles
Concentration ETO: 850 ± 50mg/l
Temperature: 37°C - 47°C
Exposure time: 3-4 hours
Humidity: 70% RH minimum
Stream autoclaving
Sterilizer type Gravity displacement Pre-vacuum
Sample config.: wrapped wrapped
Temperature: 121°C to 123°C 132°C to 135°C
Exposure time: 15 to 30 minutes 3 to 4 minutes
Flash' autoclaving
Sterilizer type: Gravity displacement Prevacuum
Sample config.: unwrapped unwrapped
Temperature: 132°C 132°C
Exposure time: 3 minutes 3 minute
Above-mentioned sterilization cycles represent industry standards and should be capable of producing a sterile device. Due to variations in sterilization equipment and device bio-burden in clinical use, we are not able to produce specific cycle parameters. It is the responsibility of each user to perform a validation and verification of the sterilisation cycle to ensure an adequate sterility assurance level for our products.
Storage
Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.
Maintenance
Apply surgical grade lubricants to hinges, joints and moving parts as per the lubricant manufacturer's instructions.