Warning and Safety instructions
17
Quality assurance
The following points should be observed to assist in maintaining
quality standards when processing medical devices, in order to
protect patients, and to avoid damage to the loads being
cleaned.
If it is necessary to interrupt a programme in exceptional
circumstances, this may only be done by authorised personnel.
The standard of cleaning and disinfection in the disinfection
programmes must be routinely confirmed by the user. The process
must be thermo-electrically validated on a regular basis, and checked
against documented control results.
Chemical disinfection procedures should also be validated using bio
indicators.
For thermal disinfection, use temperatures and temperature holding
times to achieve the required infection prophylaxis in accordance with
current health and safety regulations.
Make sure items being washed are suitable for machine
reprocessing and are in good condition. Plastic items must be
thermally stable. Nickel plated items and aluminium items can be
machine processed using special procedures only.
Items containing iron, and soiling containing residual rust must not be
placed in the cabinet.
Medical products are processed by means of thermal disinfection.
Disinfection of heat-sensitive items, e.g. theatre shoes, can be carried
out using a chemical disinfecting agent. Miele Service will set up a
special programme for this purpose. The range of effective
disinfection is based on claims made by the producer of the
disinfecting agent. Their instructions on handling, use and
effectiveness must be observed. The use of chemical disinfection
procedures is the responsibility of the operator.
Chemical disinfection processes are not suitable for the reprocessing
of medical products.
Chemical agents can, in certain circumstances, cause damage to
the machine. Always follow the recommendations of the chemical
agent manufacturer.
In case of damage or doubt about compatibility, please contact
Miele.
Instrument care products based on paraffin oils (white oils) can
damage the elastomers and plastic in the machine. Such care
products must not be dispensed as chemical agents in this machine
even if they are recommended for machine use by the care product
manufacturer.