GIMA M26703EN Reusable Surgical Instruments User Manual
- June 6, 2024
- GIMA
Table of Contents
GIMA M26703EN Reusable Surgical Instruments
USER MANUAL FOR REUSABLE SURGICAL INSTRUMENTS
These instruments are intended to be used by medical practitioners who are specially trained on how to use and care of them. The incorrect use, poor or inappropriate maintenance can rapidly lead to deterioration of the instruments. The first time, and after every use it is recommended to clean, dry and sterilise the instruments. The instruments must always be cleaned prior to sterilisation. For automated cleaning use only washing equipment with approved and certified detergents. For manual cleaning use approved and certified detergents, brush and running water. Always follow instructions on how to use the detergent; clean the instruments both when open and closed; rinse for 3 minutes and check that water also enters and exits the blind holes several times. Use completely demineralised water in the final r inse p hase. I nstruments t hat a re n ot dried could suffer damage by corrosion. Always dry the instruments. After cleaning, and before sterilisation it is recommended that you treat the instruments with physiologically safe oil, especially the tips, connectors, terminals and all moving parts. Also make sure that the product does not come into contact with acids or other aggressive disinfectants that could corrode it. The recommended method of sterilisation is that of autoclave steam, the temperature of the cycle must not exceed 135°C (275°F) for a maximum of 15 minutes, to avoid damage to the product. The process of steam sterilisation must take place in accordance with EN ISO 17664. In the context of validating the sterilisation process, check the suitability of the specific measures for drying. The humidity in the container can cause the instruments to rust. Often bad, and insufficient drying, is due to the incorrect positioning of the load and the use of unsuitable types of cloths for drying. For hot air sterilisation, it is recommended to have a temperature ranging between 180° and 200°C. The instruments can also be disinfected in washer disinfectors up to a temperature of 121°C. There is no advice about maximum number of sterilisation cycles, this depends largely on the state of the product. Instruments that show signs of corrosion must be discarded immediately. Always perform a visual inspection for damage or signs of wear: sharp edges must be free of dents and with continuous edges; there should be no distortion of instruments with long parts; the instruments that are part of a larger assembly, must be checked together with other assembly components; always check the rotating movement of hinges, which must not have excessive play; always check that the locking systems are working.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
WARNINGS
All serious accidents concerning the medical device supplied by us must be
reported to the manufacturer and competent authority of the member state where
your registered office is located.
Symbols
| Manufacturer
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| Date of manufacture
| Non-sterile
| Caution: read instructions (warnings) carefully
| Consult instructions for use
| Keep away from sunlight
| Keep in a cool, dry place
| Product code
| Lot number
| Medical Device
| Medical Device complies with Directive 93/42/EEC; in accordance with MDCG
2020-2, they shall be made compliant with Regulation (EU) 2017/745, for change
of class, by May 2024.
Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com –
export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
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