HS JOHN WEISS
IOL Cutter Care, Maintenance and Reprocessing Guidelines
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Care, Maintenance & Reprocessing Guidelines for IOL Cutter Symbols Caution consult document for important safety related information Manufacturer This product complies with medical device directive (93/42/ EEC) Batch code
Devices
New reusable surgical instruments are not delivered sterile, and consequently it is necessary to clean and sterilise them properly before use.
Warnings
Protective caps provided with instruments are not suitable for high temperatures and must be removed before sterilisation. Please note that silver products such as some Cannula and Lacrimal Probes are subject to tarnishing and discolouration. This will in no way affect the performance of the instrument Devices with long, narrow cannula, hinges, blind holes and lumens require particular attention during cleaning. Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used. Wherever possible avoid mineral acids and harsh, abrasive agents. Instruments must be used for their specified purpose. Incorrect use could damage the instrument Our instruments are designed for use by surgeons, who have a full understanding 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 suitable instrument for the surgical technique being performed, based on their experience and expertise. Note: When reprocessing medical devices, always handle with care, wearing protective clothing, gloves and eyewear in accordance with Health & Safety Procedures.
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10 December 2015
Limitations on Reprocessing
Repeated processing has minimal effect on these instruments End of life is normally determined by wear and damage in use.
Conditions of Use
To be used only for foldable IOL’s. This product is NOT designed to be used on PMMA IOL’s and any attempts to use it on such materials may damage the instrument and case harm to the patient. The Instrument must be cleaned and sterilised before the first and all subsequent uses. Thorough Cleaning of the IOL Cutter Immediately after use is Essential.
Cleaning & Decontamination Procedure 1. Clean the exterior of the instrument with a moistened John Weiss Instrument Wipe (#1701010). 2. Pull the plunger back to the limit of its travel.
3. Remove cap from handle.
4. Fill a 20cc syringe with distilled water, attach to handle and flush through.
5. Do not flush through with any liquid that will leave a residue e.g. saline. 6. Remove water by flushing through with 100% alcohol. 7. To remove the majority of alcohol blow through with one or two syringes of air. 8. Operate the mechanism a number of times to ensure no liquid remains inside the instrument. Repeat step 8 if required. 9. Replace cap on handle. JW2015/597 Issue 1
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10. The instrument must then be cleaned using a HSSD washer disinfector with a ref 4 disinfection cycle and then decontaminated using a HSSD Autoclave at a minimum of 134°C ± 5°C for 3.5 minutes.
Maintenance
Apply a small amount of surgical grade lubrication oil to hinges, joints and moving parts to prevent build up, staining, corrosion and wear.
Inspection
All instruments in the tray should be checked for damage or malfunction after each procedure, whether or not they were used. Use of an appropriate microscope is recommended due to the delicate and precise nature of the instruments. Any damaged or worn instruments must be removed from the tray at this stage and returned to John Weiss for repair.
Packaging
Instruments should be secured in recommended John Weiss Ophthalmic Trays with silicone matting of holders to prevent movement. Ensure that cutting edges are protected, and do not exceed the recommended number of instruments, as specified for the type of instrument tray being utilised. Wrap trays using appropriate method.
Sterilisation
Only sterilise a clean instrument. Follow the guidelines in CFPP 01 01 Part C or the equivalent guidance document in your region. For effective steam penetration, use perforated Ophthalmic Trays and open all ratchets and locks on the instruments. Steam at pH 7 is ideal for sterilisation, as referred to in HTM 2031 or the equivalent guidance document in your region.Instruments should not be taken from the Sterile Services Department until properly cooled down, as rapid lowering of temperature will cause condensation and may cause corrosionInstruments must be completely free of moisture before storage.
Storage
Ensure Instruments are dry before storage, and stored in a dry clean condition.
Additional Information
These guidelines should be read in conjunction with:
CFPP 01 01 on sterilisation* CFPP 01 01 Part D on washer disinfectors* HTM 2031 on steam pH levels*
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*Consult the equivalent guidance documentation for your region.
New Instruments
The care of delicate surgical instruments starts on delivery. John Weiss makes every effort to supply you with perfect instruments. Carefully remove them from their boxes and examine them under magnification to be assured they are in perfect condition. If a problem is found, notify John Weiss immediately (see additional information for contact details). Once the instrument has been examined and accepted it should be cleaned before placing it in the sterilising tray.
Cleaning Inspection After cleaning visually inspect all surfaces, cannulations, ratchets, joints, holes and lumens for complete removal of soil and fluids. If any soil or fluids is still visible, return the instruments for repeat decontamination.
General
Please contact John Weiss on +44 (0)1908 340000 for further advice concerning the care of your microsurgical instruments and our expert repair service. To protect your valuable investment, ask us about our full range of instrument trays. Please note that all John Weiss products are latex free.
The instructions provided above 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 processing is performed using the equipment, materials and personnel in the processing facility to achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. John Weiss & Son Ltd 23 Shenley Pavilions, Chalkdell Drive Shenley Wood, Milton Keynes MK5 6LB, UK Tel: 01908 340000 Fax: 01908 340014 Email: [email protected]
JW2015/597 Issue 1
10 December 2015