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Operating temperature: from -10°C to +40°C
Atmospheric pressure: from 70 to 110 kPa
Relative humidity: 15% - 95%
Storage
The device should not be exposed or be in contact with any source of combustion or inflammable agents. It must be stored in a dry
and cool place, repaired from sun and light.
Do not store the product underneath any object, heavy or not, which could cause structural damage.
Store and transport the device in its original packaging. Failure to do so makes the warranty void.
Before the storage of the device it’s necessary to recharge the batteries, remove and storage them in a separate room with a
temperature between -20°C and 35°C.
Storage temperature: from -30°C to +70°C.
Transient operating conditions are the same as operating conditions
Maintenance/Cleaning
Spencer Italia S.r.l. declines any liability for any damage, direct or indirect, which is a result of an improper use of the device and
its replacement parts and/or of any repairs made by someone other than the Manufacturer, which employs authorized internal
and external trained technicians; in this case the warranty is void.
During all the operations of checking, maintenance and cleaning procedures, the operators must always wear adequate protection
devices, such as gloves, glasses, etc.
If required from the Manufacturer in the User Manual, it must be established a plan of maintenance, periodic testing and extension
of the average lifetime, identifying an employee responsible for overseeing. He must ensure the basic requirements foreseen by the
Manufacturer in the User’s Manual.
The frequency of inspections is determined by factors such as legal requirements, type of use, frequency of use, environmental
conditions during use and storage.
Repairs must necessarily be carried out by an authorized Spencer Italia S.r.l. service centre, which in using original spare parts will
provide a quality repair service in strict accordance with the technical specifications given by the manufacturer. Spencer Italia S.r.l.
declines any liability for any damage, direct or indirect, which is a result of an improper use of the replacement parts of the device
and/or of any repairs made by unauthorized subjects.
Use only original components/spare parts and/or original accessories or approved by Spencer Italia S.r.l., in order to carry out any
operations without causing alterations or modifications to the device.
All the maintenance and revision activities must be recorded and documented with the corresponding report of technical assistance.
The documentation must be maintained for at least 10 years from the end of life of the product, and must be made available to the
competent authorities and/or the Manufacturer if requested.
The cleaning, scheduled for reusable products, must be performed in accordance to the directions provided by the Manufacturer in
the User Manual, in order to avoid the risk of cross-infections due to the presence of secretions and/or residuals.
The device and all of its components, if washed, should be allowed to dry completely before storing.
Regulatory requirements
As Distributor or final User or the products manufactured or sold by Spencer Italia S.r.l., it is strictly required to have a basic
knowledge of any legal requirements applied in the country of destination of the goods, applicable to the devices contained in the
supply (including laws regarding technical specifications and/or safety requirements). It is also 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. (already during the first product enquiry) when requesting details regarding any revisions to be
made by the Manufacturer in order to guarantee the conformity of the products to the territory’s legal specifications (including those
required by different regulations and/or regulatory provisions).
Act, with all due care and diligence, and contribute to ensure the conformity to the general safety requirements of all the devices
marketed in the territory, providing to the final users all the necessary informations to carry out periodical checks on the devices,
exactly as written in the User Manual.
Actively contribute during safety check of the product sold,
by communicating any relevant information regarding the risks of the
product to the Manufacturer and to the competent authorities, so that necessary actions 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 will be
deemed fully responsible for any damage that might occur. Spencer Italia S.r.l. disclaims any responsibility and/or liability for your
non-compliance with the present regulatory provisions.
General warnings for medical devices
The user must read carefully not only the general warnings, but also those listed below.
It is not foreseen that the use of the device is prolonged beyond the time necessary for the first responders to complete their operations
and to complete the subsequent stages of transport to the nearest rescue point.
During the use of the device the assistance of qualified staff must be guaranteed, and at least one physician trained to the use of the
device must be present.
Follow the procedures and protocols approved by your internal organization.