3
• 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 of 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).
• Act, with all due care and diligence, and contribute to ensure conformity to general safety requirements of
all devices marketed in the territory, by providing final users with all necessary information for carrying out
periodical checks on their devices, as specified in the relevant user manual.
• Actively contribute to product safety checks on products sold, by communicating any relevant risk analysis
information both to the manufacturer and to any competent authorities so that the necessary action can be
promptly taken.
• You are aware that in the event of any failure to conform to the above mentioned requirements you will be
deemed fully responsible for all damages that might occur. Therefore we expressly disclaim any
responsibility and/or liability for your non-compliance with the present “Regulatory provisions”.
2.2 Specific warnings
• Establish a maintenance program and periodic testing, identifying a reference employee. The person to
whom the ordinary maintenance of the device is entrusted must ensure the basic requirements foreseen by
the manufacturer in the user’s manual.
• 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.
• Use only accessories/spare parts that are original or approved by Spencer Italia S.r.l., in order to carry out
any operation without causing any alteration or modification to the device, otherwise we assume no
responsibility for the proper functioning or damage resulting from device to the patient or the operator and
warranty and will be considered void according to the compliance to the Medical Device Directive 93/42/CEE.
• Always respect the maximum capacity of the device, as indicated in this user's manual. Maximum load
capacity means the total weight distributed according to the human anatomy. In determining the load of the
total weight on the product, the operator must consider the weight of the patient, the equipment and the
accessories. Moreover, the operator must consider that the overall dimensions of the patient do not
reduce the functionality of the device.