2 SERVICE LIFE
Service life (or “lifetime”) of the device: 10 years or 50000 cycles (whichever limit is reached first), in
conditions of normal use and regular maintenance, following the intervals and controls recommended in
this manual, carried out by technical staff authorized by the manufacturer.
“Service life” is considered the period of time when the device characteristics and performances are not
affected to such a degree that nor the efficacy of the treatment neither the safety of
the operators are compromised.
3 INTENDED USE AND CLASSIFICATION
3.1 INTENDED USE
PRODUCT DESCRIPTION: Thermal disinfectors designed to wash and sanitize medical devices that can be
reused, as well as other items used in medical, dental, pharmaceutical, veterinary and laboratory sectors.
Large instrument washer with forced-air drying system and hinged door, available in both
single-door and double-door ("pass-through") versions.
Door opening type: hinged. Washing capacity: up to 12 DIN baskets.
Max. power 13.0 kW.
Large instrument washer with forced-air drying system and sliding door, available in both
single-door and double-door ("pass-through") versions. Door opening type: sliding
(vertical). Washing capacity: up to 12 DIN baskets.
Max. power 13.0 kW.
Large instrument washer with forced-air drying system and sliding door, available in both
single-door and double-door ("pass-through") versions. Door opening type: sliding
(vertical). Washing capacity: up to 18 DIN baskets.
Max. power 20.0 kW.
WD 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 personnel and final patients.
The treatment of the device is necessary for the subsequent correct sterilization of the load.
. The device has been validated according to ISO 15883-1, 15883-2, 15883-5 standards
. Instruments used for the test: in compliance with paragraphs 15883-2 and 6.3.2.2 “Solid
devices,” the following elements have been used to simulate the actual loading of surgical
instruments: M12 x 100 EN 10088-2 screws and solid surgical instruments (Examples of
“Solid devices”: surgical scissors, dissecting forceps, tissue forceps, retractors).
. Validation is carried out using the chemical products recommended in this manual.
Using other chemical products is not specified by the manufacturer and may impair the
intended use of the device.
The appliance does not sterilize the load.
Sterilization is carried out by other devices (e.g. steam sterilizers); this procedure follows the
washing and thermal disinfection phase.
The washing cart functions in support of the load and determines the typology of
instruments that can be processed in a cycle. (The base device is supplied without washing
To Next Page
Loading...
