Intended Use; Defintition: "Responsible Authority" In Relation To The Device - Smeg WD3060 User Manual

3 INTENDED USE

Instrument washers for use in hospitals, class IIb medical devices (in accordance with the classification criteria
established by Directive 93/42 and subsequent additions and amendments, extended and amended by EC Directive
2007/47).
INTENDED USE: treatment, through washing and thermal disinfection, of instruments inside hospitals and dental
centers to prevent, thanks to thermal disinfection, the spread of infectious agents that could potentially harm dental
personnel and final patients.
This product is designed exclusively for the applications described in the manual, especially for CSSD (Central
Sterilisation Supply Departments), substerilisation, hospitals, clinics and laboratories. Any other use is considered
improper use.
The appliance is built to provide the following function:

Washing with Thermal Disinfection of surgical or dental instruments;

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 the manufacturer 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. The authorized installation engineer 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 IEC61010-2-040:2005
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 IEC61010-2-040:2005.
3.1

DEFINTITION: "RESPONSIBLE AUTHORITY" IN RELATION TO THE DEVICE

Responsible authority: "Person or group responsible for the use and ordinary maintenance of the unit and for operator
training." Definition taken from point 3.5.13 of the IEC61010-1:2001 standard.
WD3060 - WD5090 USER MANUAL 6