Symbols; Warranty And Service; Warnings/Dangers; Product Features - Spencer STX 519 Betriebs- Und Wartungshandbuch

4.3 SYMBOLS

Symbol Meaning
Device in compliance with EU Regulation 2017/745
Medical device
Manufacturer
Date of manufacture
Production identification
Alphanumeric code that identifies the production units of the device, composed of:
UDI
(01)08057711230006 (11) 200626 (10) 1234567890

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 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.
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
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/DANGERS

Warnings, dangers, notes, and other important safety information are provided in this section and are clearly visible throughout the manual.

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.
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 product.
• 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
private health care professionals are required to notify the Manufacturer of any other incident that may allow the adoption of measures to ensure the protection and health
of patients and users.
General warnings for medical devices
The user must carefully read the following in addition to the general warnings.
It is not foreseen that application of the device lasts longer than the time required for first aid operations and subsequent transport to the nearest rescue point.
•
Symbol Meaning
Danger – Indicates a hazardous situation that may result in a situation
directly related to serious injury or death.
See the user manual.
Lot number
Product code
(01)0805771123 company prefix
000 progressive GS1
6 control number
(11)200626 date of production (YYMMDD)
(10)1234567890 lot/SN
IT
(http://service.
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