ulrich medical uCentrum Instructions For Use Manual page 15

CLEANING, DISINFECTION AND STERILIZATION - IMPLANTS
Basic principles
The implants are supplied non-sterile and must be thoroughly cleaned, disinfected and sterilized before use (clean and disinfect after
removing the transport packaging and sterilize after removing the primary packaging). Implants that have already come into contact with a
patient or have become contaminated must not be used again under any circumstances; these must be discarded. Clean/disinfect implants
which you have touched, return them to the implant storage tray and sterilize the implant storage tray when it is fully loaded. Please also
follow the legal regulations which apply in your country as well as the hygiene regulations of the medical practice and/or hospital.
Cleaning and disinfection
For cleaning and disinfection of the implants, a mechanized process (disinfector) should be used whenever possible. A manual method – even
when using an ultrasound cleaning bath – is considerably less effective and should only be used when a mechanical procedure is not available.
The implants must be removed from the sterilization tray during cleaning/disinfection!
Manual
When choosing the cleaning agent and disinfectant to be used, care must be taken that
ƒ it is thoroughly suitable for cleaning and disinfection the implants,
ƒ the cleaning agent is suitable for ultrasonic cleaning (no generation of lather)
ƒ the disinfectant possesses approved effectiveness (e.g., FDA clearance) and is compatible with the cleaning agent used, and
ƒ the chemicals used are compatible with the implants (see section "material stability").
ƒ A combined cleaning/disinfectant should not be used if at all possible.
ƒ Manual brushing is not permitted due to risk of damaging the implant surface.
The concentrations of the cleaning agent and disinfectant and application times stipulated by the manufacturer of must be adhered to without
fail. When rinsing, only use freshly produced solutions, sterile or nearly sterile (maximum 10 bacteria/ml) and endotoxin free (maximum 0.25
endotoxin units/ml) water is used (e.g., purified water/ highly purified water). When drying, use only filtered air.
Pre-cleaning
Disassemble movable parts or joints prior to pre-treatment. Rinse the products under running water. Remove superficial impurities with a soft
plastic brush; products containing lumen rinse appropriately (at least 5 times) with water and using a syringe.
ƒ Cleaning:
Immerse the products for 5 min into the 104°F warm freshly prepared cleaning solution (e.g. Cidezyme LF) and intensively clean them
with a soft plastic brush. Thoroughly rinse (at least 5 times) products containing lumen at the beginning and end of the brush cleaning
with cleaning solution. Then carefully rinse (at least 3 times for one minute) those products with sterile, deionized water using a syringe.
ƒ Disinfection:
Soak the products for 12 min in a disinfection solution. (e.g. Cidex OPA). Thoroughly rinse (at least 5 times) products containing lumen at
the beginning and end of the brush cleaning with disinfection solution. Then rinse the products sufficiently (at least 3 times) with sterile,
deionized water. Flush lumen using a sufficient amount of sterile, deinoized water (at least 100 ml) and a syringe.
Automated cleaning and disinfection
When choosing the disinfector, care must be taken that
ƒ the disinfector possesses approved effectiveness (e.g., FDA clearance),
ƒ if possible, an approved program for thermal disinfection is used (10 minutes minimum at 93°C (199.4°F) or A
disinfection involves the risk of disinfectant residues on the implants,
ƒ the program used for the implants is suitable and includes sufficient rinsing cycles,
ƒ during rinsing, only water which is sterile or nearly sterile (maximum 10 bacteria/ml) and endotoxin free (maximum 0.25 endotoxin units/
ml) is used (e.g., purified water/ highly purified water),
ƒ the air used for drying is filtered and
ƒ the disinfector is regularly maintained and checked.
When choosing the cleaning system to be used, care must be taken that
ƒ it is thoroughly suitable for cleaning the implants,
ƒ if thermal disinfection is not used, a suitable disinfectant with approved effectiveness (e.g., FDA clearance) is used and that this is compat-
ible with the cleaning agent used
ƒ the chemicals used are compatible with the implants (see section "material stability").
ƒ The concentrations of the cleaning agent and disinfectant stipulated by the manufacturer of must be adhered to without fail.
ƒ Procedure:
ƒ Place the implants onto the disinfector. Take care to ensure that the implants remain untouched.
ƒ Start the program
ƒ Remove the implants from the disinfector once the program has ended.
ƒ Inspect and pack the implants immediately after removal from the disinfector or if necessary, after additional drying has take place at
a clean location (see section "inspection" and "packaging").
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.
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value > 3000). Chemical
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2019-05-06