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If the instructions belong to another device and not the device received, inform the
Manufacturer immediately and avoid use of the device.
In the case of any doubts as to the correct interpretation of the instructions, please contact
Spencer Italia S.r.l. for any necessary clarifications.
Do not allow untrained persons to help during the use of the device, because they could cause
damage to the patient or to themselves.
Regularly check the appliance, carry out the prescribed maintenance and respect the average
life span, as indicated by the manufacturer in this user’s manual.
Before each use of device the perfect operating state of the device must be checked as specified
in the Instruction manual. If any damage or abnormalities which could in any way influence the
correct functioning and the safety of the device, of the patient and or of the user are detected,
the device must be immediately removed from service and the Manufacturer must be contacted.
If any failure or incorrect functioning of the device is detected, it must be immediately
substituted with a similar item so that the rescue procedures are guaranteed without any
interruption.
Use of the device in anyway other than described in this manual is forbidden.
Do not alter or modify in any way the appliance; any such interference could cause malfunctions
and injury to the patient and/or rescuer.
The appliance must not in any way be tampered with (modification, adjustment, addition,
replacement). In such cases all responsibility will be denied for any malfunctions or injuries
caused by the appliance itself; moreover CE certification and product warranty will be considered
void.
Those who modify or have modified, prepare or have prepared medical appliances in such a way
that they no longer serve the purpose for which they were intended, or no longer supply the
intended service, must satisfy the valid conditions for the introduction onto the market.
Handle with care.
Ensure that all the necessary precautions are taken in order to avoid the hazards that can arise
as the result of contact with blood or body fluids.
Register and store with these instructions: lot number, place and date of purchase, first date of
use, date of checks, name of users, any comments.
When the device is being used, the assistance of qualified staff must be guaranteed.
Do not store the device underneath any heavy objects which could cause structural damage.
Store in a cool, dry, dark place and do not expose to direct sun.
Store and transport device in its original packaging.
The device not be exposed to or come into contact with any source of combustion or
inflammable agents.
Position and adjust the device taking care not to cause any obstruction to rescuers and or any
other rescue equipment.
Attention: laboratory testing, post production tests, instruction manuals cannot always consider
every possible scenario for use. This means that in some cases the performance of the product
could be notable different from results to date obtained. Instructions are continually being
updated and are under tight surveillance of fully qualified staffs with adequate technical
formation.
With reference to the D. Lgs. 24th February 1997, n. 46 emended by D. Lgs. 25/01/2010, n. 37
– Acknowledgement of Directive 93/42/CEE and 2007/47/CE, we remind both public and private
operators that they are obliged to report any accident that involves any medical device to the
Ministry of Health and to the Manufacture as specified and within time given by the European
regulations.
In addition, both public and private operators are obliged to inform the Manufacturer of any
measures that should be adopted to make the steps necessary to guarantee the safety and the
health of the patients and the users o any medical device.
As a Distributor or End Users of products manufactured and/or marketed by Spencer Italia S.r.l.,
you are strictly required to have a basic knowledge of any legal requirements applying to the
devices contained in this supply that are in power in the goods final destination Country
(including laws and norms regarding technical specifications and/or safety requirements) and
therefore you are also strictly required to have the necessary knowledge to guarantee all
aspects regarding the total conformity of the products to the regulations in the relevant
territory.
Promptly notify Spencer Italia S.r.l. regarding any revisions to be made by Manufacturer in order
to guarantee the conformity of the product to the territory’s legal specifications (including those
resulting from rules and/or norms of other nature).
