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1.1
INTENDED USE
The appliance is built to provide the following function:
Washing with Thermal Disinfection
The appliance cannot be used to sterilize instruments or any other device.
The type of instrument which can be processed in a cycle depends on the washing trolley used. (The device is
supplied as standard without washing trolleys; contact your local dealer for advice about the trolleys best suited
to your needs ).
Any use other than that described in this manual constitutes misuse.
The manufacturer declines all liability for uses other than those stated above.
The manufacturer declines all liability for any damage caused by the use of the appliance to wash
glassware or instruments not approved by their manufacturers for automatic decontamination by
means of thermal disinfection.
The appliance may only be used by specifically trained staff. Authorised technician will train the
staff assigned to use the appliance at the time of installation.
The manufacturer declines all liability in the event of malfunctions or accidents caused by use of
the appliance by untrained staff.
The training of the staff responsible includes specific information on the possible risks involved in
the use of the appliance, and training in the safest possible way of carrying out the operating
procedures.
The installation engineer is also responsible for notifying the responsible authority of the USER and
SUPERUSER passwords for access to the setup parameters. The responsible authority must keep
these passwords in a safe place.
It is the duty of the appliance's RESPONSIBLE AUTHORITY to ensure that those using the
equipment have been suitably trained in its operation, its safe use and routine checks, and that
this training is suitably maintained.
Staff training should be checked regularly.
The installation engineer is responsible for ensuring that it operates correctly after commissioning.
Safety information supplied in compliance with 5.4.101.1 IEC61010-2-040:2015
Instrument manufacturers' instructions should always be followed when choosing the most
appropriate disinfection treatment.
In particular, it is important to check the compatibility of the load for treatment with the specific
washing cycle chosen, in terms of the maximum temperatures reached and the chemicals used.
Information supplied in compliance with point 5.4.4.r IEC61010-2-040:2015.
1.2
DEFINTITION: "RESPONSIBLE AUTHORITY" IN RELATION TO THE DEVICE
Responsible authority: "Person or group responsible for the use and ordinary maintenance of the unit"
Definition taken from point 3.5.12 of the IEC61010-1:2010 standard.
The responsible authority should be clearly identified within the facility where the appliance is used, (for example by
recording the relative names and responsibilities on corporate forms).
2
Treatment in an Instrument Washer is no substitute for sterilisation. Disinfection in an instrument washer is intended to reduce the risks for the
staff who handle laboratory instruments to prepare them for subsequent use.
User Manual
2
of surgical or dental instruments;
Tethys D60 - Tethys T60 - Tethys T45
Page 6 - 77
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