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Thank you for choosing a Spencer product
1.
GENERAL INFORMATION
1.1
Aim and contents
The aim of this manual is to supply all the information necessary so that the client, will not only attain adequate use of the
appliance, he will also be capable of using the instrument in the most autonomous and secure way possible. This includes
information regarding technical aspects, functioning, maintenance, spare parts and safety.
1.2
Conservation of the instruction manual
The instruction and maintenance manual must be kept together with the product, for the whole life of the device, inside the
specially provided container and above all, away from any substances or liquids which could compromise perfect legibility.
1.3
Symbols used
Symbol
Meaning
General or specific warning
See instructions for use
Lot number
Product code
The product is compliant with the specifications of the Directive 93/42/CEE
1.4
Servicing requests
For any information regarding the use, maintenance and installation, please contact the Spencer Customer Care Service on
tel. 0039 0521 541111, fax 0039 0521 541222, e-mail [email protected] or write to Spencer Italia S.r.l. – Via Provinciale, 12 -
43038 Sala Baganza (Parma) - ITALY. In order to facilitate the assistance service, please always indicate or communicate the
serial number (SN) or lot number (LOT) shown on the label applied on the box or on the device.
1.5
Demolition
When the devices are no more suitable for being used, if they haven’t been contaminated by any particular agents, they can
be disposed of as normal solid waste, otherwise follow the current regulations about demolition.
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 at your disposal to plan trainings on products.
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 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.