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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.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.
EU Regulation 2017/754 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
Device in compliance with EU Regulation 2017/745
Danger – Indicates a hazardous situation that may result in a situation
directly related to serious injury or death.
Medical device
See the instructions for use
Manufacturer
Lot number
Date of manufacture
Product code
Unique Device Identifier
Caution: Federal law restricts the sale of this device by or on the order of a
licensed professional (US market only)
(01)8057711230006 (11) 200626 (10) 1234567890
Production identification
Alphanumeric code that identifies the production units of the device, composed of:
(01)805771123
company prefix
000
progressive GS1
6
control number
(11)200626
date of production (YYMMDD)
(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 541154,
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.
5. WARNINGS/DANGERS
Warnings, dangers, 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), as they may constitute
imminent danger of injury to persons and material damage. Should these operations be performed, we decline any responsibility for incorrect operation or any damage
caused by the product itself; moreover, the CE marking and the product warranty shall be null and void.
•
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 or abrasive objects.
•
Operating temperature: from -5°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 device.
•
Store and transport the product with its original packaging, otherwise the warranty shall be invalidated.
•
Storage temperature: -10°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).
•
Act with due care and diligence to help ensure compliance with the general safety requirements of the devices placed on the market, providing end-users with all the infor-
mation necessary to carry out periodic revisions on the supplied devices, exactly as indicated in the User Manual.
•
Participate in safety checks on products placed on the market, transmitting information regarding product risks to the Manufacturer as well as to the Competent Authorities
for their respective actions.
•
Without prejudice to the above, the Distributor or End-User shall assume wider liability related to non-compliance with non-fulfilment of the above-mentioned obligations,
with consequent obligation to indemnify and/or hold Spencer Italia S.r.l. harmless from any possible injurious effect.
•
With reference to EU Regulation 2017/745, please note that public or private operators who, when exercising their activity, detect an incident involving a medical product
are required to notify the Ministry of Health, within the terms and in the manner established by one or more ministerial decrees, and notify the Manufacturer. Public or