ulrich medical ADDplus Instrucciones De Uso página 10

grease to implants. Please also follow the legal regulations which apply in your country as well as the hygiene regulations of the medical
practice or hospital concerned.
Cleaning and disinfection
Use a mechanical method (disinfector) to clean and disinfect the implants where possible. Because a manual method is considerably less
effective (even when using an ultrasound cleaning bath), it should only be used when a mechanical method is unavailable. To clean/disinfect,
the implants must be taken out of the sterilization tray.
Manual cleaning/disinfection
Please note the following when selecting the cleaning and disinfecting agents to be used:
ƒ The cleaning/disinfecting agents used must be fundamentally suitable for cleaning and/or disinfecting the implants.
ƒ If applicable, the cleaning agent should be suitable for ultrasonic cleaning of the implants (no foam formation).
ƒ Use a disinfecting agent that has been certified effective (e.g., VAH/DGHM-certified, FDA-approved or bearing the CE label). The disinfecting
agent used must also be compatible with the cleaning agent used.
ƒ The chemicals used must be compatible with the implants (see "Material stability" section).
ƒ Where possible, avoid using the cleanser and disinfectant in combination.
Cleaning/disinfection using a machine
When choosing a disinfector, make sure that:
ƒ The effectiveness of the disinfector has been thoroughly checked (e.g. VAH/DGHM or FDA approval or CE mark in compliance with DIN EN
ISO 15883).
ƒ A program for thermal disinfection which has been tested (A0 value > 3000 or for older devices at least 10 min. at 93°C (199.4°F)) is used
where possible (chemical disinfection involves the risk of disinfectant residues on the implants).
ƒ The program used for the implants is suitable and contains a sufficient number of rinsing cycles.
ƒ Only water which is sterile and free of germs (max. 10 germs/ml) and endotoxins (max. 0.25 endotoxin units/ml) is used for post-rinsing
(e.g. Aqua purificata/Aqua purificata valde).
ƒ The air used for drying is filtered.
ƒ The disinfector is regularly checked and maintained.
When choosing the cleaning system to be used, make sure that:
ƒ The cleaning system is generally suitable for cleaning implants.
ƒ Providing no thermal disinfection is used, a suitable disinfectant is used which has been checked for its effectiveness (e.g.VAH/DGHM or FDA
approval or CE mark) and that this is compatible with the cleaning agent used.
ƒ The concentrations stipulated by the manufacturer of the cleaning agent and, if necessary, disinfectant are maintained.
Inspection
Inspect all implants for damage and contamination and discard damaged and contaminated implants.
Packaging
Use the implant storage tray provided or a suitable sterilization packaging (EN ISO 11607 / EN 868-2f).
Sterilization
ƒ Flash sterilization is not permissible under any circumstances. Do not use hot-air sterilization or radiation sterilization procedures.
ƒ All implants, implant storage trays or sterilization containers may only be exposed to temperatures less than 141°C (285.8°F).
ƒ After sterilization, the implants must be stored in the sterilization packaging dry and free of dust.
ƒ Only the following sterilization methods may be used for the sterilization.
Steam sterilization
ƒ Validated according to DIN EN ISO/ANSI AAMI ISO 17665 (formerly: DIN EN 554/ ANSI AAMI ISO 11134) (valid commissioning (IQ/OQ) and
product-specific performance assessment (PQ))
ƒ Preferably fractionated vacuum procedure or gravitation procedure (with sufficient product drying)
ƒ Steam sterilizer according to DIN EN 13060 or DIN EN 285
ƒ Maximum sterilization temperature 138°C (280.4°F) plus tolerance as specified in DIN EN ISO/ ANSI AAMI ISO 17665 (formerly: DIN EN 554/
ANSI AAMI ISO 11134)
ƒ Duration of sterilization of the fractionated vacuum procedure: (treatment time at the sterilization temperature) at least 4 min. at 132-
134°C (269.6-273.2°F).
ƒ Duration of sterilization of the gravitation procedure: Treatment time 4 min. at temperature 132°C (269.6°F).
Material stability
When choosing the cleaning agent and disinfectant, make sure that they do not contain the following components:
ƒ Anticorrosives/corrosion inhibitors (triethanolamines are particularly problematic)
ƒ Strong organic, mineral and oxidizing acids
ƒ Stronger alkalis (pH > 12 is not permissible for implants, pH > 10.5 is not permissible for aluminum trays; neutral or weakly alkaline
cleaning agents are recommended)
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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2020-03-13