Intended Use; General Description; How It Works; Medical Use - Miele PG 8582 CD Operating Instructions Manual

Intended use

General description

This Miele washer-disinfector is a medical device as defined in the
Medical Device Regulation MDR (EU) 2017/745.
Washer-disinfectors are used to wash and thermally disinfect
reprocessable medical devices.

How it works

Medical devices are cleaned and disinfected using programmes
validated by the user in which the water quality and temperature as
well as the process chemicals and system components used are
selected based on the nature of the soiling and the types of medical
device being reprocessed.
Thermal disinfection usually takes place during the final rinse.
Thermolabile medical shoes are an exception in this case and
undergo thermochemical disinfection.
According to the A concept described in EN ISO 15883-1, thermal
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disinfection occurs at 80 °C (+5 °C, -0 °C) with 10 min holding time
(A 600), or at 90 °C (+5 °C, -0 °C) with 5 min holding time (A 3000),
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depending on the disinfection result required.
The use of suitable load carriers (mobile units, modules, inserts, etc.)
is important to ensure adequate reprocessing of the medical devices.

Medical use

The cleaning result, achieved by means of the Vario TD procedure, for
example, must ensure that reprocessable medical devices can be
disinfected correctly, that subsequent sterilisation can be carried out
and that items can be used again safely.
To ensure standardisation, medical devices should ideally be
reprocessed using machine-based cleaning processes.

Purpose

This Miele washer-disinfector can be used to clean, rinse, disinfect
and, depending on the type of device, dry reprocessable medical
devices in healthcare institutions such as dental/medical practices,
hospitals, outpatient clinics or veterinary practices. It is also essential
to heed the information issued by the manufacturers of the medical
devices (EN ISO 17664), as well as the information issued by the
process chemical manufacturers.
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