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Idiomas disponibles
Idiomas disponibles
AUTOMATED CLEANING AND DISINFECTION –
When selecting the disinfector, ensure the following
• that the disinfector has validated efficacy (e.g. DGHM or FDA approval or CE Mark according to DIN EN ISO 15883),
• that, if possible, a validated thermal disinfection program (A0 value > 3000 or, or, in older devices, at least 5 min
at 90°C) is used
• that the used program is suitable for the instruments and has sufficient rinsing cycles,
• that only sterile or germ-reduced, (max. 10 germs / ml) as well as, endotoxine reduced (max. 0.25 endotoxine units / ml)
water (e.g. purified / highly purified water) is used for rinsing.
• that the air used for drying is filtered
• that the disinfector is maintained and inspected regularly.
Caution: Chemical disinfection poses the hazard of disinfectant residues on the instruments.
When selecting the applied cleaning system, ensure
• that it is suitable for cleaning metal and plastic instruments,
• that – unless thermal disinfection is used – a suitable disinfectant with validated efficacy (e.g. VAH / DGHM or FDA
approved or with a CE Mark) is used and that this is compatible with the applied cleanser and
• that the applied chemicals are compatible with the instruments (refer to chapter 12 on „Material durability").
Caution: The concentration provided by the manufacturer of the cleaning resp. disinfection agent must be
followed.
Procedure:
1. Disassemble the medical devices completely.
2. Place the disassembled medical devices into the disinfector, ensure that the instruments do not touch each other. Insert
the cable loose, they may not be kinked or crushed.
If applicable: Connect all instrument luminas to the rinsing connection by using the Luer-Lock connection on the product
or by applying a suitable rinsing hose to the rinsing adapter of the disinfector. Otherwise, rinse all lumens of the instru-
ments five times using a disposable syringe (minimum volume 10-50 ml, depending on the instrument's size) slipped over
the Luer connector or by a tube- at inlet and outlet of the lumen.
3. Start the program.
4. When the program is finished, remove the medical devices from the disinfector
5. Inspect and pack the medical devices preferably immediately after removal after additional drying in a clean place.
joimax
recommendation regarding cleaning and disinfection: Proof of fundamental instrument suitability for effective
®
mechanical cleaning and disinfection was provided by an independent accredited testing laboratory with the use of the
disinfector G 7836 CD (thermal disinfection, Miele & Cie. GmbH & Co., Gütersloh) and the cleaning agent Neodisher medi-
clean forte (Dr. Weigert GmbH & Co. KG, Hamburg), whereby the procedure described above was used.
PACKING
Sort the cleaned and disinfected instruments into the provided sterilization tray. Then pack the sterilization tray into
disposable dual packaging and / or sterilization containers complying with the following requirements:
• DIN EN ISO / ANSI AAMI ISO 11607-1; 11607-2
• suitable for steam sterilization (heat resistant minimum 141° C / 286° F, sufficient vapor permeability)
• regularly maintained
• cleared by the FDA (No. K803293, K953776 and K973827)
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NOT FDA CLEARED, FOR OUTSIDE US MARKETS ONLY
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