Models; Intended Use; Intended Use And Clinical Benefits; Target Patients - Spencer NRT Benutzungs- Und Wartungshandbuch

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• NRT WHITE
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

Recovery stretches are devices to be used when the morphological characteristics of the intervention area require particularly compact equipment and adherence to the
patient.

2.2 TARGET PATIENTS

There are no particular indications related to the patient group.
The product configuration is able to accommodate any subject as long as he/she is within the maximum capacity and within the limits of the size of the device.

2.3 PATIENT SELECTION CRITERIA

The patients foreseen are those with injuries that prevent them from walking in a given rescue situation, or who are in a state of unconsciousness.

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, typically technical, carrying out operations related to the use of harnessing systems.
• Personnel trained for use of the device must also have training in managing lifting and handling suspended loads with people.
• Personnel who carry out interventions in situations classified as high risk or which are purely technical must be suitably trained and experienced in rescue.
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.
• Training in the use of the product must be recorded and supported by practical tests on use, the result of which must be documented and certified by a training officer. It is
advisable to repeat training annually. This documentation must be kept for at least 10 years after the end of the device's life. .
3.

REFERENCE STANDARDS

REFERENCE
EU Regulation 2017/745
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.
4.

INTRODUCTION

4.1 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.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.

4.2 SYMBOLS

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

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
Warranty and service conditions are available on the website
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

Product features
Use of the product for any purpose other than that described in the User Manual is prohibited.
• 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.
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.
• 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
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
service@spencer.it
http://support.spencer.it
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