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

1.

MODELS

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

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

The extrication device is a first aid apparatus to be used for the extraction of a traumatised patient from a vehicle.
It must be used after the application of the cervical collar to maintain immobilisation and head-torso alignment.

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 expected are typically individuals who require extraction from the place where they are stuck.
The typical situation is car accidents.
Before extraction assisted by the use of the device, the patient must be immobilised with a cervical collar to prevent any aggravation of cervical injuries.

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 people suffering from road traffic injuries, spinal injuries and
crush injuries.
• Personnel trained for use of the device must also have training in managing lifting and handling suspended loads with people.
These devices are not intended for lay people.
The extrication device is an apparatus intended for professional use only. Do not allow untrained persons to help while using the product, as they may cause injury to
themselves or others.
IT
Despite all efforts, laboratory tests, trials, and instructions for use, standards do not always reproduce practice, so the results obtained under actual conditions of product
use in the natural environment may sometimes differ significantly.
The best instructions are the continuous practice of use under the supervision of competent and trained personnel.
Operators using the device should be physically able to use the device and have good muscle coordination, as well as strong back, arms, and legs, should it be necessary to lift
and/or support the device and the patient. Operators' ability must be assessed before the definition of roles in use of the stretcher.
EN
Operators must be able to provide the necessary patient care.

2.5.1 USER TRAINING

• Regardless of your level of experience with similar devices in the past, you should carefully read and understand the contents of this manual before installing, operating, or
servicing this product. In case of any questions, please contact Spencer Italia S.r.l. for the necessary clarifications.
DE
• Operators must also be trained to perform extrication manoeuvres so as to prevent aggravation of spinal injuries or possibly compromised organs.
• The product must be used only by personnel trained in the use of this product and not on other similar products.
• The suitability of the users for use of this product can be attested by the training registration, in which trained persons, trainers, date and place are specified. This documenta-
tion must be kept for at least 10 years after the end of the product's life and must be made available to the competent authorities and/or the Manufacturer when requested.
In the absence of such documentation, the relevant bodies will apply any foreseen sanctions.
FR
• The product must be put into use only by personnel trained in the use of this product and not on other similar products.
Note: Spencer Italia S.r.l. is always available for training courses.

2.5.2 FORMAZIONE INSTALLATORE

Installation is not required.
ES
3.

REFERENCE STANDARDS

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,
PT
therefore, to understand the requirements necessary to ensure compliance of the products themselves with all legal requirements of the territory.
REFERENCE
EU Regulation 2017/745
EL
4.

INTRODUCTION

4.1 USING THE MANUAL

The purpose of this manual is to provide healthcare professionals with the information necessary for safe and appropriate use and maintenance of the device.
BG
Note: The Manual is an integral part of the device and therefore it must be kept for the entire life of the device and must accompany it in any changes of use or ownership. If any
instructions for use for products other than the one received are present, please contact the Manufacturer immediately before use.
Spencer products User Manuals can be downloaded from the site http://support.spencer.it or by contacting the Manufacturer. Exceptions are those items whose essentiality
and reasonable and predictable use are such that it is not necessary to draw up instructions, in addition to the following warnings and indications on the label.
CS
Regardless of your level of experience with similar devices in the past, it is advisable to carefully read and understand the contents of this manual before installing,
operating, or servicing this product.

4.2 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.
In the event of damage or removal, request a duplicate from the Manufacturer, or else the warranty will be void as the device can no longer be traced.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.
EU Regulation 2017/754 requires manufacturers and distributors of medical devices to keep track of their location. If the device is in a location other than the address to which
it was shipped or sold, or if it was donated, lost, stolen, exported or destroyed, permanently removed from use, or if the device was not delivered directly from Spencer Italia
S.r.l., please register the device at http://service.spencer.it, or inform Customer Service (see § 4.4).
10
DOCUMENT TITLE
EU Regulation on Medical Devices