5
4.4
Warranty and support
Spencer Italia S.r.l. guarantees that the products are without defects for a period of
one year from the date of purchase
.
For any informations regarding the correct interpretation of the instruction manual, the use, maintenance, installation or restore of the
product, contact Spencer Customer Care ph. +39 0521 541111, fax +39 0521 541222, e-mail
. In order to facilitate the
assistance service, please always indicate the lot number (LOT) or serial number (SN) shown on the label applied on the box or on the device.
Conditions for warranty and assistance can be viewed on
Note:
Register and store with these instructions: lot (LOT) or serial number (SN) if any, date and place of purchase, date of first use, date of
servicing, name of the users and comments.
To guarantee the traceability of the products and to protect the procedures of maintenance and assistence of Yours devices,
Spencer has made available the ASSTEC portal
http://service.spencer.it/asstec/login.aspx
, which will allow you to view the data
of the products owned or on the market, to monitor and update the plans of periodic reviews, to view and manage
extraordinary maintenances.
5.
WARNINGS
Warnings, notes and other important safety information are indicated in this section and clearly visible throughout the
entire manual.
User training
Note:
despite all the effords, laboratory testing, post production tests and instruction manuals, the rules can’t always
reproduce the practical use, therefore the results obtained in the real conditions of use of the product could be notable
different.
The best instructions consist in the continuous practice under the supervision of trained and competent staff.
Regardless of the level of experience gained in the past with similar devices, it is recommended to read carefully this manual before
installation, use of the product or maintenance. If in doubt, contact Spencer Italia S.r.l. to obtain the necessary clarifications.
The device must be used only by a
trained physician
, having attended specific training for this device and not for similar products,
with appropriate clinical knowledge of artificial ventilation in order to correctly set the values available on the device according to
the patient’s clinical status.
The suitability of the user to use the product may be attested by the records of training, where the names of those trained, of the
trainers, dates and place are indicated.
The register which certifies the eligibility of the operators to use the Spencer device must
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. In the absence of such documentation, sanctions will be applied.
Do not allow any untrained person to help during the use of the product, because they could cause damage to themselves or to
others.
Note: Spencer Italia S.r.l. is always at your disposal to organise product training.
Installers training
The installer of the device must be able to ensure that all the equipments, systems, containers and connections are
compliant to the safety standards and regulations. This requires the knowledge of all the regulations and standards
applicable. In the particular case of connection to the main supply through a power adapter, this needs to be compliant with
IEC 60601-1, EN 60601-1-2 standards and periodic checks as prescribed by EN 62353 need to be established before the
installation of the device.
If these conditions are not met, the safety of the device and of the operators will be compromised.
Product functionality
The use of the product in any other way than the one described in the User Manual is forbidden.
Before each use of the device always check its integrity, as specified in the instruction manual. In case of damages/abnormalities that
could compromise its safety or functions, it is necessary to immediately remove the device from service and to contact the
manufacturer.
If any failure or malfunctioning of the device is detected, it must be immediately substituted with a similar item, so that the rescue
procedures are guaranteed without any interruption.
The product 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 product itself; moreover CE certification and product warranty will be
considered void.
Those who modified or have modified, prepare or have prepared the Spencer Italia S.r.l. medical appliances in such way that they no
longer serve the purpose for which they were intended, must satisfy the valid conditions for the first introduction into the market.
During the use of the devices you need to position and adjust them in such way that they won’t cause any obstructions to the
rescuers and/or any other rescue equipment.
Make sure that all the necessary precautions are taken in order to avoid the hazards that can arise from the contact with blood or
other body fluids, when applicable.
Ensure that the fixing system of the device is suitable to keep it fixed in the medical vehicle under all circumstances.
The warranty seaIs, if present on the product, must not be removed;
in such case, the manufacturer will no longer recognize the
warranty of the product and will accept no responsibility in case of malfunctioning or damage caused by the product itself
.
Avoid contact with sharp objects.