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The carrying handle is securely attached to the device
The seat belts for the immobilization of the patient are intact and functioning
The lifting handles stretch and block
The lifting handles open and close
The front wheels are stable, turn, rotate and self-position around the pin (if equipped)
The control handle extends and locks in any position (if equipped)
The optional accessories are intact and functioning properly
State of wear of the wheels and braking system
State of wear of the slides and the sliding system with belt
Presence of all labelling for proper use
Integrity of components
Integrity of handles (Are they torn or show signs of tearing? The seams are intact?)
Lubrication of moving parts
State of wear of the wheels and braking system
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 paragraph 5.1 and verify functionality before and after each use.
Spencer Italia S.r.l. declines any responsibility for the proper functioning or damages caused to the patient or user by the use
of devices not subject to routine maintenance warranty and will void the compliance to the Medical Device Directive
93/42/CEE.
The person responsible for every day maintenance can substitute the spare parts indicated on paragraph “Spare Parts”, only
if authorized by the manufacturer or by a centre authorised by Spencer.
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/CEE.
5.2.2
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 it will no longer be compliant
with the 93/42/CEE Directive for Medical Devices and therefore there is the possibility that 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.
5.2.3
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 device, if used as indicated in the following instruction manual, has an average life span of 5 years. The life span can be
expanded only following a general revision of the product that must be carried out by the manufacturer or by a centre
authorised by the manufacturer. Straps and seat and backrest sheets have an average life span of 2 years.
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 repaired, or certified on expiry date by the manufacturer or by one of the manufacturer's Authorised
Service centres, making void the guarantee and the conformity to the Medical Devices Directive 93/42/CEE.
Summary of Contents for EVA
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