7
Checks to be carried out before and after each use, and at least every 3 months, are as follows:
General functionality of the device
Cleanliness of the device (remember that failure of the cleaning operation may cause the risk of cross infections)
Absence of cuts, holes, tears on the structure, including the straps.
Do the straps fold in the correct way?
Correct grasp of the straps
Status of wear of the components (straps, buckles)
Proper working of buckles
Absence of oxidation on buckles
That the movement of any adjustment system slides properly and its fixation is safe
Visual inspection of the seams between the straps and carabiners (check that there are no pulled or damaged wires)
Verify opening and closing of each carabiner
Only on STX 519 test the functionality of the adjustment system
Check the presence and legibility of the label containing warning, data, life span and loading capacity.
Is necessary to formalize the above mentioned controls at least every six months, recording them on the appropriate form
of ANNEX B
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 improper 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.
5.2.2
Periodic maintenance
In addition to cleaning and maintenance described in paragraphs “Cleaning” and “Maintenance”, it is necessary to submit the
device to the following tests every year:
Visual inspection of the seams between the straps and carabiners (check that there are no pulled or damaged wires)
Verify opening and closing of each carabiner
Only on STX 519 test the functionality of the adjustment system
Check the presence and legibility of the label containing warning, data, life span and loading capacity.
Depending on the intensity of use, the device must undergo revision procedures to certify its suitability for use, during
the permitted life span of the product according to par. 5.2.4. Such revisions shall be formalized and documented in a
report with certain date which shall be sent to the manufacturer. The report form to be filled can be find in Annex C of
this user manual.
A copy of the report must be sent to the manufacturer through PEC or registered post (with return
receipt)
.
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.
5.2.4
Life span
The device, if used as indicated in the instruction manual, has an average life span (ALS) from the purchase date depending
on the intensity of use:
Intense (daily use) – ALS 1 year without servicing
Normal (once a week) – ALS 3 years with annual servicing
Occasional (once a month) – ALS 5 years with annual servicing
At the end of this period, the device must be disposed according to the procedures described in paragraph 1.5 and this
event must be notified to the manufacturer.
The validity of the average life span is bound by the successful outcome of controls provided in this manual.
In any case, the maximum life span in every condition of use is 5 years starting from the purchase date subject to
compliance with the above conditions.
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 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.
