Intended Use - Miele PG 8581 Operating Instructions Manual

Intended use

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This Miele washer-disinfector is a Class II medical device in
accordance with Health Canada.
This Miele washer-disinfector can be used to clean, rinse, and
thermally disinfect a wide range of reprocessable medical devices for
dental use. Information issued by the manufacturers of medical
devices (EN ISO 17664) must be heeded.
Instruments such as dental instruments, suction instruments,
handpieces etc. can be reprocessed in this washer-disinfector.
Reprocessing items by machine achieves reproducible results and
should be used in preference to processing them by hand. Where
disinfection is required for the protection of staff and/or patients, a
thermal disinfection program, e.g. the Vario TD program should be
selected.
According to the A
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CSA-Z15883), thermal disinfection occurs at 90°C (+ 5 °C, - 0 °C)
with 5 min holding time (A
result required. The efficacy standard A
deactivating the HBV virus (Hepatitis virus).
Regional and/or other official directives may apply (e.g. CSA Z314.8
Decontamination of reusable Medical Devices in Canada). Refer to
your country's local and national health and safety regulations and
guidelines.
The cleaning program must be chosen according to the type of
soiling and load being processed. The processing chemicals used for
reprocessing the products should be selected to suit the level of
cleaning required.
The cleaning result must ensure that items can be disinfected
correctly, that subsequent sterilization can be carried out and that the
items can be used again safely.
Reusable medical devices are best processed using the Vario TD
program where applicable.
The use of a suitable carrier (basket, module, insert, etc.) is important
to ensure the adequate cleaning of the load. Examples are given in
the section "Areas of application".
This washer-disinfector is programmed to carry out the final rinse with
mains water or with processed water of a quality to suit the
application (e.g. purified water, reverse osmosis water or
demineralized water).
This washer-disinfector complies with EN ISO 15883 (CAN/CSA-
Z15883).
concept described in EN ISO 15883-1 (CAN/
3000), depending on the disinfection
0
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3000 is suitable for