12
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. 24
th
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.
Never leave the patient unassisted on the device, because he may be injured.
The device and all its components, after washing, should be allowed to dry completely before storing.
Avoid contact with sharp objects.
Do not use the device if it is pierced, torn or frayed.
Make sure, before lifting, that the operators have a firm grip on the device.
Avoid pulling the device on rough surfaces.
The device is a stretcher for patients transport and cannot be used as a stationing device.
First practice with an empty stretcher in order to get used to the way in which the stretcher manoeuvres.
For the use of the device, at least two operators in suitable physical conditions are needed; they must therefore
have strength, balance, coordination, and common sense and must be trained on the correct functioning of the
device Spencer stretcher.
For techniques for loading particularly heavy patients, for rescue operations on steep ground or in unusual circumstances,
it is recommended the presence of more operators (not just two as required under standard conditions).
The maximum weight sustained by each rescuer must comply with requirements prescribed by the law of the
Country, concerning Health and Safety at Work.
Before each use, check the integrity of the belts and their hooks, as specified in the User’s Manual. In case of malfunction
or damage that may compromise the function and safety of the device, patient or operator, it is necessary to replace the
belts.
Make sure the belts are properly fastened to the frame/patient board of a stretcher.
Always immobilize the patient, using the straps supplied by the Manufacturer; lack of immobilization may cause serious
damage.
To optimize the immobilization of the patient, it is required the use a thorax belt, in addition to the belts provided.
Do not operate in case the weight has not been distributed correctly.
Always grasp the structure to lift and carry the stretcher and not the sidebars or polyethylene boards.
Keep the stretcher firmly if the patient is sitting.
Use the stretcher only as described in this user's manual.
Do not alter or modify the stretcher arbitrarily to make it fit into the ambulance: the modification may cause
unforeseeable functioning and damages to the patient and operators. In any case the warranty will be lost.