Intended Use; Models; Intended Use And Clinical Benefits; Target Patients - Spencer NEC UP Manuel D'utilisation Et D'entretien

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• NEC UP • SPECTAR
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

Cervical collars are devices to be used to help maintain neutral alignment of the cervical spine.
Depending on the model, they may or may not be equipped with a tracheotomy hole and be mono- or bi-valve.

2.2 TARGET PATIENTS

There are no particular indications related to the patient group.
The range of sizes for each model allows it to be utilised by an extensive group of patients, as long as the chosen size achieves the intended purpose of the device.

2.3 PATIENT SELECTION CRITERIA

The expected patients are typically those for whom cervical spine immobilisation is necessary.
The use of the cervical collar is contraindicated 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 neck trauma. The user must be able to evaluate
the most suitable type of device for use on the specific patient.
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
EU Regulation 2017/745
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).

4.2 SIMBOLI

Simbolo Significato
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 service@spencer.it.
Warranty and service conditions are available on the website
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 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
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.
• DALLAS
DOCUMENT TITLE
EU Regulation on Medical Devices
Simbolo Significato
Danger – Indicates a hazardous situation that may result in a situation
directly related to serious injury or death.
See the instructions for use
Lot number
Product code
Disposable
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