ulrich medical uCentrum, Instructions For Use Manual

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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
The implants were determined to be thoroughly suitable for effective mechanical cleaning and disinfection (disinfector G7836 CD, Miele
Professional, Princeton NJ) by an independent testing laboratory using the following parameters for the cleaning and disinfection phase.
Process step Description Parameters
Pretreatment (rinsing) Rinsing temperature 10 +/-2°C
Treatment time 1 min.
Solution cold water
Cleaning Cleaning temperature 40 +/-2°C
Treatment time 5 min.
Cleaning solution Sekumatic FR
Concentration 0.3% (3ml/l)
Neutralization Neutralization temperature 10 +/-2°C
Treatment time 2 min.
Neutralizer Sekumatic FNZ
Concentration 0.1% (1ml/l)
Follow-up treatment (rinsing) Rinsing temperature 10 +/-2°C
Treatment time 2 min.
Solution deionized water
Thermal disinfection Disinfection temperature 93 +/-2°C
Treatment time 10 min.
Solution deionized water
Inspection
Inspect all implants for damage and contamination and reject any implants that are damaged and contaminated.
Packaging
Sort and put away all cleaned and disinfected implants into the implant storage tray provided and pack these into suitable sterilization
packaging (FDA cleared, disposable sterilized packaging with single or double wrap and/or sterilization containers) having the following
requirements:
ƒ Correspond to ANSI AAMI 11607
ƒ Are suitable for steam sterilization (minimum temperature of 141 °C (286°F), permitting sufficient steam penetration
ƒ Provides sufficient protection of the implants and sterilized packaging from mechanical damage
ƒ For the sterilization containers, has regular maintenance in accordance with manufacturer’s guidelines
CLEANING, DISINFECTION AND STERILIZATION – INSTRUMENTS
ulrich instrument processing instructions
ulrich GmbH & Co. KG ulrich medical USA
Buchbrunnenweg 12 l 89081 Ulm l Germany 18221 Edison Avenue
Telefon/Phone +49 (0)731 9654-225 Chesterfield, MO 63005 USA
Phone: 636.519.0268, Fax: 636.519.0271
VALID IN THE FOLLOWING COUNTRY: USA
PROCESSING
Basic principles
All instruments, including the sterilization layers and trays, must be thoroughly cleaned, disinfected and sterilized before each use; this applies
especially to the first-time use after delivery because all instruments are shipped in non-sterile condition (clean and disinfect after removing
the transport packaging and sterilize after packaging). Effective cleaning and disinfection is an indispensable prerequisite for effective
sterilization. When using instruments, please make sure to keep dirty instruments separate and do not place them back into the instrument
tray in order to prevent serious contamination of the equipped instrument tray. Clean/disinfect the dirty instruments, sort them and place
them back in the instrument tray, then sterilize the entire equipped instrument tray. Within the scope of your responsibility for instrument
sterility, please ensure that only cleaning/disinfection and sterilization processes which have been appropriately validated in a device-
specific and product-specific manner are used, that the employed devices (disinfecting machine, sterilizer) undergo regular maintenance
and inspections and that the validated parameters are complied with during each cycle. In addition, please follow all applicable laws in your
country as well as the hygiene regulations of the medical practice or hospital in question. This applies especially to the various requirements
regarding effective prion inactivation.
2019-05-06