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4. INTRODUCTION
4.1 USING THE MANUAL
The purpose of this manual is to provide healthcare professionals with the information necessary for safe and appropriate use and
maintenance of the device.
For correct reading of this manual, please refer to the pictures at the beginning of the manual.
Note: The Manual is an integral part of the device and therefore it must be kept for the entire life of the device and must accompany it in any
changes of use or ownership. If any instructions for use for products other than the one received are present, please contact the Manufacturer
immediately before use.
Spencer products User Manuals can be downloaded from the site http://support.spencer.it or by contacting the Manufacturer. Exceptions
are those items whose essentiality and reasonable and predictable use are such that it is not necessary to draw up instructions, in addition to
the following warnings and indications on the label.
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.
Image
P1 shows the positioning and main information contained on the label.
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.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.
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
Device in compliance with EU
Regulation 2017/745
See the user manual.
Medical device Serial Number
Manufacturer Product code
Date of manufacture
Danger – Indicates a hazardous situation that may result in a situation directly
related to serious injury or death.
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
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
service@spencer.it.
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 .