Models; Intended Use; Intended Use And Clinical Benefits; Target Patients - Spencer BLUE SPLINT Manual De Uso Y Mantenimiento

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• BLUE SPLINT
• RES-Q-SPLINT
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

Splints are devices used to immobilise limbs in the event of suspected injuries or fractures of the limbs, to avoid additional strain during the pre-hospital phase.

2.2 TARGET PATIENTS

There are no particular indications related to the patient group.
The design of the product allows it to be applied to any subject as long as the chosen size achieves the intended purpose of the device.

2.3 PATIENT SELECTION CRITERIA

The intended patients are typically those for whom it is necessary to immobilise a fractured or injured limb.
The use of the splints is not recommended in cases of embedded/penetrating bodies.

2.4 CONTRAINDICATIONS AND UNWANTED SIDE EFFECTS

No particular contraindications or side effects are known with relation to use of the device, as long as it is used in accordance with the user manual.

2.5 USERS AND INSTALLERS

The intended users are rescue workers with in-depth knowledge related to the immobilisation and handling of individuals with fractures or suspected fractures.
These devices are not intended for lay people.
Operators must be able to provide the necessary patient care.
The product must be used only by personnel trained in the use of this product and not on other similar products.
3.

REFERENCE STANDARDS

REFERENCE
IT
EU Regulation 2017/745
4.

INTRODUCTION

4.1 DEVICE LABELLING AND TRACEABILITY

EN
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.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.

4.2 SIMBOLI

DE
Symbol Meaning
Device in compliance with EU Regulation 2017/745
FR
Medical device
Manufacturer
ES
Date of manufacture
Unique Device Identifier
PT

4.3 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.
Spencer Customer Service tel. +39 0521 541154, fax +39 0521 541222, e-mail [email protected].
Warranty and service conditions are available on the website http://support.spencer.it.
EL
5.

WARNINGS/DANGERS

Product features
Use of the product for any purpose other than that described in the User Manual is prohibited.
HU
• The product must not be tampered with or modified without the manufacturer's authorisation.
• Avoid contact with sharp or abrasive objects.
• Operating temperature: from -5°C to + 50°C.
• Storage temperature: -10°C to +60°C.
RO
General warnings for medical devices
• Do not use if the device or parts of it are punctured, torn, frayed, or excessively worn.
• 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.
SK
• 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.
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.
8
• FIXO SPLINT • URRA'
• RES-Q-SPLINT PLUS • EMSOFT
• AIR SPLINT
• EMSOFT PRO
DOCUMENT TITLE
EU Regulation on Medical Devices
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