Intended Use - Miele PG 8581 Operating Instructions Manual

Intended use

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This Miele washer-disinfector is a Class IIb medical device (Directive
93/42/EEC).
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,
transmission instruments etc. can be reprocessed in this washer-
disinfector.
UK only: This washer-disinfector is NOT intended for reprocessing
transmission instruments such as turbines, hand-pieces and
contra-angles.
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 programme, e.g. the Vario TD programme should
be selected.
According to the A
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disinfection occurs at 90°C (+ 5 °C, - 0 °C) with 5 min holding time
(A 3000), depending on the disinfection result required. The efficacy
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standard A 3000 is suitable for deactivating the HBV virus.
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Regional and/or other official directives may apply (CFPP, HTM or
relevant technical memorandums in the UK). Refer to your country's
local and national health and safety regulations and guidelines.
The cleaning programme must be chosen according to the type of
soiling and load being processed.
The agents 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 sterilisation can be carried out and that the
items can be used again safely.
Medical devices are best processed using the Vario TD programme
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 machine 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, fully demineralised water or demineralised water).
This machine complies with EN ISO 15883 for validation purposes.
concept described in EN ISO 15883-1, thermal