GIMA M26530EN Non Surgical Instruments Instructions
- July 6, 2024
- GIMA
Table of Contents
GIMA M26530EN Non-Surgical
Product Information
Specifications
- Manufacturer: IT Fabbricante / GB Manufacturer / FR Fabricant / ES Fabricante / PT Fabricante / DE Hersteller / GR SA
- Product Code: IT Codice prodotto / GB Product code / FR Code produit
- Batch Number: DE Chargennummer
- Medical Product : DE Medizinprodukt
- EU Regulation : 2017/745 DE Medizinprodukt im Sinne der Verordnung (EU) 2017/745
- Revision: M26544-M-Rev.8-06.24
Product Usage Instructions
- Ensure that all serious accidents involving the medical device are reported to the manufacturer and the competent authority in your member state.
- Refer to the specific symbols provided in the manual for understanding different aspects of the product.
- Use the product code for identification and tracking purposes.
- Take note of the batch number for quality control and traceability.
- Handle the medical product according to the EU Regulation 2017/745 for compliance.
- Check the revision details for any updates or changes to the product.
USER MANUAL FOR NON-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 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 exitsthe blind holes several
times. Use completely demineralized water in the final rinse phase.
Instruments that are not dried could suffer damage by corrosion. Always drythe
instruments. Also make sure that the product does not come into contact with
acids or other aggressive disinfectants that could corrode it. Instruments
that show signs of corrosion mustbe 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. Whilst the instruments areunder warranty, repairs
and/or replacement of all defective parts, for reasons that are accepted by
the manufacturer, are free, with the exception of costs for labour, travel,
transport, packing, etc. Damage caused by improper use of the product is not
covered by the warranty.
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
Gima S.p.A.
- Via Marconi, 1 – 20060 Gessate (MI) Italy
- gima@gimaitaly.com
- export@gimaitaly.com
- www.gimaitaly.com
Made in Pakistan
FAQ
-
Q: What should I do if I encounter a serious accident with the product?
A: Report the accident to the manufacturer and the relevant authority in your country as soon as possible. -
Q: How can I identify the product correctly?
A: Use the provided product code and batch number for accurate identification. -
Q: Is this product compliant with EU regulations?
A: Yes, this product complies with EU Regulation 2017/745 for medical devices.
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