9
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 o any medical
device.
As a distributor or end user 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’s 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.
The distributor or final user is 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 Spencer Italia S.r.l. expressly disclaims any
responsibility and/or liability for your non-compliance with the present regulatory provisions.
2.2
Specific warnings
The resuscitation masks must only be used by personnel trained in cardio-pulmonary resuscitation techniques (CPR or ACLS).
The mask should not be exposed to combustion heat sources and inflammable agents.
The use of oxygen in the presence of hydrocarbons creates explosive mixes.
Do not use the mask in a polluted environment.
When opening its box and before every use, check the general condition of the device.
Spencer Mask resuscitation masks should be sterilized after each use. Their re-use without proper cleaning can cause cross-
infections. Do not use the device over the life time established in this manual.
2.3
Contraindications and side effects
The use of the device, if used by personnel, trained in cardio-pulmonary resuscitation techniques (CPR or ACLS), does not present
any contraindications and side effects.