MANUAL THERMOCOAGULATION - EVRF
Date
26/06/2018
Page 9 of 34
Revision N° : 18
1.8.1.1 Apparatus
You can clean the external face of the apparatus with a soft, dry rag or a damp rag.
Don't use aggressive products because they can damage the parts inside the device.
In case of streaks or smears, use non aggressive soapy water.
No liquid may penetrate into the apparatus - dry the device carefully after cleaning.
1.8.1.2 Hygiene
The needles, catheters and probes are sterile and for single use.
Never use the same
needle, catheter or probe for more than one patient and wear gloves during the
treatment.
Reusing or re-sterilizing the needles, catheters or probes can result in
transmission of blood borne pathogens (including HIV and Hepatitis) and
endanger patients and operators.
1.8.1.3 Waste handling
Please, throw the single use products in the appropriate bio-medical waste bins,
according to national regulations.
1.8.1.4 End of life considerations:
At the end of its life, the product is taken out of service. European legislation and
sometimes national laws arrange the basic principles on how to treat the product.
Different rules apply depending on possible contamination risks. For electrical and
electronic equipment, the EU Directive on WEEE deals with recovery and treatment
of waste at European level.
Recommendations:
The user must contact the MANUFACTURER if he is unsure what to do with the
product when it is taken out of service.
1.8.1.5 Fuses
The replacement of the fuses, accessible through the fuse holder of the mains power
supply, must be realised with a flat screwdriver. The two fuses are type F2A/250V in
glass 5 mm per 20 mm.
Maintenance
The EVRF device must be controlled annually by F care systems or a company
authorised by F care systems after the warranty has expired.
Transport and storage
The apparatus can be transported and stored in the following environment conditions:
Room temperature between – 40°C and + 70°C.
Relative dampness between 10% and 100%.
Atmospheric pressure comprised between 500 hPa and 1060 hPa.
After 15 weeks the device must pass the procedure test again.