GIMA 37320 Silicone Mat Owner’s Manual
- June 10, 2024
- GIMA
Table of Contents
PROFESSIONAL MEDICAL PRODUCTS
TAPPETINO IN SILICONE SILICONE MAT
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.
Intended use/ function:
- Device shall be used in autoclave process.
- Silicone mat securely and gently holds instruments in place inside a sterilization tray. Can be used as is or cut to size to fit different trays. Perforations help with air circulation, aiding in the drying process.
Component Specification:
This device is manufactured from Silicone.
Cleaning I Sterilization:
AII Silicone Mat have to be stored in a dry and dust free environment.
Products supplied by GIMA S.p.A. are non-sterile when shipped.
Steam Sterilization:
- Steam sterilizer in accordance with DIN EN 13060 or DIN EN 285
- Maximum sterilization temperature 134°C/273°F; in accordance with relevant standards and regulations.
- Sterilization time (exposure time at the sterilization temperature) minimum 5 min at 134°C/273°F.
Cleaning Agent:
When choosing the cleaning agent and disinfectant ensure that they do not
contain the following components:
- Organic, mineral or oxidizing acids (maximum permitted Ph 9.5, a neutral/ enzymatic cleaner is recommended)
- Strong alkali
- Organic solvents
- Oxidation agents (e.g. hydrogen peroxide)
- Halogens (chlorine, iodine, bromine)
- Aromatic/ halogenated hydrocarbons
- Heavy metal salts
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
| Keep in a cool, dry place
---|---
| Product code
| Medical Device compliant with Regulation (EU) 2017/745
| Keep away from sunlight
| Medical Device
| Date of manufacture
| Lot number
| Caution: read instructions (warnings) carefully
| Manufacturer
| Consult instructions for use
| Non-sterile
37320 – 37321 – 37323
Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com –
export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan M37320-M-Rev.4-09.21
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