24
The inspection frequency is determined by factors such as legal requirements, the type of use, frequency of use, environmental conditions
during use and storage.
Please note that you must do the cleaning as described in this manual and verify functionality before and after each use. Spencer Italia S.r.l.
declines any responsibility for the improper functioning or damages caused to the patient or user by the use of devices not subject to routine
maintenance and will void the warranty and the compliance to the Medical Device Directive 93/42/CEE.
Use only accessories/original spare parts approved by Spencer Italia S.r.l., otherwise we will accept no responsibility for the incorrect
functioning and/or damage caused by the use of any device which has not been repaired, or certified on expiry date by the manufacturer or
by one of the manufacturer's authorised service centres. Warranty will be considered void in compliance with the Medical Device Directive
93/42/EEC.
12.3
Periodic maintenance
The device must be serviced by the manufacturer or by an authorised centre, every year.
If the correct revision is not carried out, the CE branding will no longer be considered valid as the product will no longer be compliant with
the 93/42/CE Directive for Medical Devices and consequently it is no longer compliant with the safety standards declared by the
manufacturer at time of purchase.
Spencer Italia S.r.l. will take no responsibility the incorrect functioning or any damage caused by a device that has not undergone regular
revision.
For any operations that are not carried out directly by the manufacturer but by an authorised centre, we have to underline that a report
regarding all operations carried out must be requested. This will permit both Spencer Italia S.r.l. and the end user to keep a log book
regarding the operations carried out on the device.
12.4
Special servicing
Only the manufacturer or centres with written authorisation are authorised to complete any special servicing operations.
For any operations that are not carried out directly by the manufacturer but by an authorised centre, we have to underline that a report
regarding all operations carried out must be requested. This will permit both Spencer Italia S.r.l. and the end user to keep a log book
regarding the operations carried out on the device.
The end user is authorised to replace only the spare parts indicated in the paragraph 15.
12.5
Life span
The device, if used as indicated in the following instruction manual, has an average life span of 5 years from the purchase date.
Such life span and can be extended for up to another 5 years following the annual revision.
General revisions must be carried out by the manufacturer or by a centre authorised by the manufacture. If such annual revisions are not
carried out, the device
MUST BE DISPOSED ACCORDING TO THE PROCEDURES SPECIFIED IN PARAGRAPH 16 AND THIS EVENT MUST BE
NOTIFIED TO THE MANUFACTURER
.
Spencer Italia S.r.l. will accept no responsibility for the incorrect functioning and/or damage caused by the use of any device which has not
been serviced by the manufacturer or authorised centre, or of any device for which the life span is expired.