Tabla de contenido
Publicidad
Idiomas disponibles
Idiomas disponibles
4.3 SYMBOLS
Symbol
Meaning
Device in compliance with EU Regulation 2017/745
Medical device
Manufacturer
Date of manufacture
Unique Device Identifier
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 on correct interpretation of the use, maintenance, installation or return instructions, please contact the Spencer Customer Assistance at 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
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, 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.
• The times and methods of such shall be agreed upon between the customer and our Sales Offices.
• 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 structure of 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
User must carefully read the following in addition to the general warnings.
• The application of the device should not last longer than the time required for first aid operations and subsequent transport to the nearest rescue point.
• Qualified personnel and at least two operators must be present during use of the device.
• Do not use if the device or parts of it are punctured, torn, frayed, or excessively worn.
• Follow the internal procedures and protocols approved by your organisation.
• Do not alter or modify the device arbitrarily, as doing so could result in unpredictable operation and damage to the patient or rescuers and shall void the manufacturer's
warranty and release the manufacturer from all liability.
• Disinfection operations must be carried out in accordance with the validated cycle parameters, as stated in the specific technical standards.
• Do not use drying machines to dry the device.
Symbol
http://support.spencer.it
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
IT
EN
DE
FR
ES
PT
EL
BG
CS
11
Publicidad
Tabla de contenido
