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Regardless of your level of experience with similar devices in the past, it is advisable to carefully read and understand the contents of this manual before installing,
operating, or servicing this product.
4.2 DEVICE LABELLING AND TRACEABILITY
Each device is provided with a label, placed on the device itself and/or on the packaging, which contains the Manufacturer’s identification data, product, CE marking, serial
number (SN) or lot number (LOT). This must never be removed or covered.
In the event of damage or removal, request a duplicate from the Manufacturer, or else the warranty will be void as the device can no longer be traced.
Regulation 2017/745/EU requires manufacturers and distributors of medical devices to keep track of their location. If the device is in a location other than the address to which
it was shipped or sold, or if it was donated, lost, stolen, exported or destroyed, permanently removed from use, or if the device was not delivered directly from Spencer Italia
S.r.l., please register the device at
http://service.spencer.it
, or inform Customer Service (see § 4.4).
4.3 SYMBOLS
Symbol
Meaning
Symbol
Meaning
Symbol
Meaning
Device in compliance with EU Regulation 2017/745
See the user manual
Product code
Medical device
SN
Serial Number
Lot number
Manufacturer
Danger – Indicates a hazardous situation that may result in a situation directly related to
serious injury or death.
Date of manufacture
Caution: Federal Law restricts this device to sale by or on the order of a licensed
practitioner (only for USA Market)
Unique Device Identifier
Production identification
Alphanumeric code that identifies the production units of the device, composed of:
(01)08057711230006(11)200626(21)1234567890
(01)0805771123 company prefix
000 progressive GS1
6 control number
(11)200626 date of production (YYMMDD)
(21) 1234567890 SN
(10) 1234567890 Lot number
4.4 WARRANTY AND SERVICE
Spencer Italia S.r.l. guarantees that products are free from defects for a period of one year from the date of purchase.
For information regarding correct interpretation of the instructions for use, maintenance, installation or return, please contact Spencer Customer Service tel. +39 0521 541111,
fax +39 0521 541222, e-mail
.
To facilitate service, always indicate the lot number (LOT) or serial number (SN) on the label attached to the package or device itself.
Warranty and service conditions are available at
http://support.spencer.it
.
Note: Record and keep with these instructions: lot (LOT) or serial number (SN), if present, place and date of purchase, date of first use, date of checks, user name and comments.
To ensure the traceability of the products and protect maintenance and service procedures on your devices, Spencer has made the SPENCER SERVICE portal (
http://service.
spencer.it/
) available to you. From this site, you can view the data of the products in your possession or placed on the market, monitor and update schedules for periodic
checks and view and manage special maintenance.
5. WARNINGS
Warnings, notes, and other important safety information are provided in this section and are clearly visible throughout the manual.
At least every 6 months, it is important to check for updated instructions and any changes involving your product. This information is freely available on the website
www.spencer.it
on the specific product page.
Product features
Use of the product for any purpose other than that described in the User Manual is prohibited.
•
Before each use, always check the conditions of the product, as specified in the User Manual. In the event of faults/damage that could compromise its functionality/safety,
immediately remove it from service and contact the Manufacturer.
•
If the product is found to be malfunctioning, immediately use a similar device to ensure continuity of ongoing operations. Non-compliant devices must be taken out of
service.
•
The product must not be tampered with or modified without the manufacturer’s authorisation (modification, tweaking, additions, repair, use of non-approved accessories),
as they may constitute imminent danger of injury to persons and material damage. Should these operations be performed, we decline any responsibility for incorrect ope-
ration or any damage caused by the product itself; moreover, the CE marking and the product warranty shall be null and void.
•
Anyone who modifies or causes products manufactured by Spencer Italia S.r.l. to be modified or re-processed in such a way that they no longer serve the intended purpose
or no longer provide the intended performance shall comply with the conditions valid for the first placing on the market.
•
When using the devices, position and adjust them in such a way that they do not hinder operator works or the use of any other equipment.
•
Be sure to take every precaution to avoid hazards from contact with blood or body secretions, if applicable.
•
Avoid contact with sharp objects.
•
Device installation must be carried out by qualified personnel trained and enabled by Spencer Italia S.r.l. The times and methods of such shall be agreed upon between the
customer and our Sales Offices.
•
Operating temperature: from -10°C to + 50°C.
Storage
•
The product must not be exposed or come into contact with thermal sources of combustion or flammable agents, but must instead be stored in a dry, cool place, away
from light and sun.
•
Do not store the product under other more or less heavy materials that may damage the structure of the product.
•
Store and transport the product with its original packaging, otherwise the warranty shall be invalidated.
•
Storage temperature: -20°C to +60°C.
Regulatory requirements:
As Distributor or End-User of the products manufactured and/or marketed by Spencer Italia S.r.l., users are strictly required to be familiar with the legal provisions in force in
the country of destination of the goods, applicable to the devices to be supplied (including regulations relating to technical specifications and/or safety requirements) and,
therefore, to understand the requirements necessary to ensure compliance of the products themselves with all legal requirements of the territory.
•
Promptly and in detail notify Spencer Italia S.r.l. (already in the quotation request phase) about possible fulfilments by the Manufacturer necessary for the compliance of
products with specific legal requirements of the territory (including those deriving from regulations and/or regulatory provisions of another nature).