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1.6 Labelling
Each device has got an identifying label, positioned on the device itself and/or on the box. This label
includes information about the Manufacturer, the product, CE mark, lot number (LOT). It must never
be removed or covered.
2. WARNINGS
2.1 General warnings
The product must be used by trained personnel only, having attended specific training for this
device and not for similar products.
Training routines must be registered on a special register in which the names of those trained, of
the trainers, date and place are indicated. This register which will certify the eligibility of the
operators to use the Spencer device has to be kept for a period of 10 years after the disposal of
the device itself. This register will be made available to the Competent Authorities and/or
Manufacturer if requested.
Spencer Italia S.r.l. is always available for conducting training courses.
Before carrying out any kind of operation on the appliance (training, installation, use), the
operator must carefully read the enclosed instructions, paying particular attention to the correct
safety precautions and to the procedures to be followed for installation and for correct use.
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 personnel to help when using the device as they may cause injury to the
patient or themselves.
Perform the required maintenance and to respect the life span of the device, as indicated by the
Manufacturer in the 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.
Never leave an unassisted patient. The presence of at least one operator is essential at all times
when the medical device is in use.
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
