Medtronic MOSAIC ULTRA SUPRA-X Instrucciones De Uso página 7

UltraSupra_EN_ch.fm 7/29/05 1:15 pm
4.375 x 7.0 inches
The following cleaning/disinfection and sterilization procedures have been tested by
Medtronic and found to be effective. A hospital may choose the procedure tested by
Medtronic or another procedure, which should be qualified. In either case, the procedure's
effectiveness should be established. Medtronic utilized biological indicators to establish the
procedure's effectiveness. Other methods can be found in ISO 11134 Standard,
"Sterilization of Health Care Products – Requirements for Validation and Routine Control –
Industrial Moist Heat Sterilization" or, in Europe, EN 554 Standard, "Sterilization of Medical
Devices – Validation and Routine Control of Sterilization by Moist Heat." Contact a sterilizer
manufacturer for additional information regarding sterilization procedures.
Cleaning/Disinfection
Warning: Supra-X™ and OD Sizers are supplied NONSTERILE and MUST be sterilized
prior to each use. Prior to sterilization, the accessories MUST be thoroughly cleaned.
Note: Contaminated sizers must not be allowed to dry prior to implementing any cleaning/
disinfection procedures.
Medtronic has established that the following manual cleaning and disinfection procedure is
compatible with these sizers:
1. Prepare a 470-ppm active quaternary solution and detergent containing alkyl dimethyl
benzyl ammonium chloride as the active ingredient (eg, Mikro-Quat
water.
2. Completely immerse the sizer in solution for a minimum of 15 minutes.
3. Rinse each sizer in a minimum of 3 liters of purified water.
4. Continue to rinse the sizer until it is thoroughly cleaned.
5. Gentle wiping of the sizer during rinsing may be necessary to remove all adherent,
visible soil.
Sterilization/Resterilization
Prior to sterilization, package the sizers in a steam sterilizable pouch, autoclavable drape,
or other container suitable for sterilization.
Medtronic has established that the following methods are compatible with the sizers:
1. Normal Autoclavable Cycle:
121°C (250°F) for 30 minutes
2. Flash Autoclave Cycle:
132°C (270°F) for 5 minutes
Sterilization was performed in an AMSCO Medallion general purpose, gravity, single-door
steam sterilizer with a fully loaded container. The sterilizer has the following specifications:
Size: 51 cm x 51 cm x 96.5 cm (20 in x 20 in x 38 in)
■
Temperature Range: 66°C to 138°C (150°F to 280°F)
■
Chamber Pressure Rating: 248 kPa (36 psig)
■
Reuse
Medtronic performed a minimum of 20 cycles of flash autoclave sterilization of the sizer
without noting any damage. Prior to any reuse, each sizer should be examined for signs of
excessive cracking or other damage and replaced if any signs are observed.
1 ®
Mikro-Quat is a registered trademark of Ecolab, Inc.
A12506001
Medtronic Confidential
CS006
®1
English Instructions for Use 5
Rev 1.0
) using purified