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1. MODELS
The following basic models may be subject to implementation or change without notice.
MODEL
BELT TYPE
HOOK
STX 597
1 PIECE
PLASTIC
STX 598
2 PIECES
PLASTIC
STX 591
1 PIECE
METAL
STX 494
2 PIECES
SPRING CATCH
STX 592
2 PIECES
METAL
STX 526
2 PIECES
METAL
STX 701
1 PIECE
METAL
STX 702
2 PIECES
METAL
STX 580
2 PIECES
ALUMINIUM
STX 499
4-PIECE THORAX BELT
METAL
DNA STRAP
2 PIECES WITH RE-WINDING SYSTEM
METAL
DNA STRAP THORAX BELT
4 PIECES WITH RE-WINDING SYSTEM
METAL
2. INTENDED USE
2.1 INTENDED USE AND CLINICAL BENEFITS
Restraint belts are aids used to obtain a degree of restraint that allows patients to be transported safely when used in accordance with the product in use.
2.2 TARGET PATIENTS
There are no particular indications related to the patient group.
Further limitations of use may be related to the device with which the belt is used. For this purpose, please refer to the user manual of the transport device in use.
2.3 PATIENT SELECTION CRITERIA
The expected patient selection criteria are those applicable to the device with which the belt is used.
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 and experts in patient handling, immobilisation and transport.
These devices are not intended for lay people.
Restraint belts are devices 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.
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. Operators’ ability must be assessed before the definition of roles
in use of the stretcher.
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.
•
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 docu-
mentation 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.
•
Do not allow untrained persons to help while using the product, as they may cause injury to themselves or others.
Note: Spencer Italia S.r.l. is always available for training courses.
2.5.2 INSTALLER TRAINING
DNA belt installers must be able to carefully read and understand the contents of this manual and must ensure that installation of this device has been carried out up to
standard, as described in par. 11.6.
Installation is not required for the other devices described in this manual.
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,
therefore, to understand the requirements necessary to ensure compliance of the products themselves with all legal requirements of the territory.
REFERENCE
DOCUMENT TITLE
EU Regulation 2017/745
EU Regulation on Medical Devices
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.
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.
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