3
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. 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 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).
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 maintenance 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 an 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.
