KLS Martin NON-STICK red Instrucciones De Uso página 28

NOTICE
Risk of damage to the bipolar forceps!
Do not sterilize with hot air.
•
Do not use the "Sterrad" plasma sterilization method (STERRAD
•
Johnson & Johnson Inc.).
Do not use "flash" autoclaving.
•
Do not use dry heat sterilization, radiation sterilization, formaldehyde and ethylene oxide
•
sterilization, or plasma sterilization.
Use certified sterile packing (e. g. according to EN 68, ISO 1607) or sterile containers for
•
the sterilization. We recommend the KLS Martin screen basket system, see section 3.1.1
"Screen Basket System", page 22.
Sterilization at high temperature or a long sterilization time reduces the lifespan of the
•
instruments.
Ensure sufficient drying.
•
As regards sterilizer handling, loading and parameter setting, please follow the
•
recommendations of the manufacturer of your machine.
The operator must ensure that the sterility is maintained after the sterilization process.
•
Only use the sterilization methods listed below. Do not use other sterilization procedures.
Method
Fractionated vacuum
(dynamic air removal)
Gravity2
2
The less efficient gravitation procedure may only be applied if the fractionated vacuum
procedure is not available
— Steam sterilizer according to EN 13060 and EN 285
— Validation according to EN SO 7665 (previously EN 54 / ANSI AMI SO 11134), valid
IQ / OQ (commissioning) and product specific performance qualification [PQ])
— Make sure not to exceed a sterilization temperature of 138 °C (280 °F); plus tolerance
according to EN ISO 17665 [previously EN 554 / ANSI AAMI ISO 11134])
NOTICE: The fundamental suitability of the instruments for effective steam sterilization by
the fractionated vacuum procedure and the gravity procedure was demonstrated by an
independent accredited test laboratory (Test report 111739-10). Typical conditions of use
in hospitals and doctor's practices as well as the specified procedure were considered.
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Exposure Temperature
min. 132 °C (270 °F)
max. 138 °C (280 °F)
min. 132 °C (270 °F)
Bipolar Forceps NON-STICK
©
Exposure Time
min. 3 min
max. 20 min
min. 40 min
Instructions for Use
is a trademark of
Drying Time
min. 30 min
min. 30 min
Revision 3
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