Models; Intended Use; Intended Use And Clinical Benefits; Target Patients - Spencer HIRVIN 6 POIGNEES Instructions D'utilisation

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• HIRVIN 6 HANDLES
• HIRVIN PLUS
The above models are produced in different colour variations.
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

Injury transportation sheets are devices to be used to move and transport patients in a lying or seated position. It is not foreseen that patients be able to intervene on devices.

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. If paediatric
subjects must be transported, it will be in the role of the rescuer to determine whether the devices are suitable for their transport or if it will be necessary to use another device.

2.3 PATIENT SELECTION CRITERIA

The patients foreseen are those with injuries that prevent them from walking in a given rescue situation.

2.4 CONTRAINDICATIONS AND 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 instructions for use.

2.5 USERS AND INSTALLERS

The intended users are persons trained in first aid procedures and in use of medical equipment in an emergency medical service (EMS) environment.
These devices are not intended for lay people.
Injury transportation sheets 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, 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.
Operators must be able to provide the necessary patient care.
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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 these instructions for use 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
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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.
• 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.
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2.5.2 INSTALLER TRAINING

The installer must be able to ensure safe storage inside the ambulance. The device in itself does not require installation.
3.

REFERENCE STANDARDS

FR
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
ES
EU Regulation 2017/745
UNI EN 1865-1
PT
4.

INTRODUCTION

4.1 USING THE INSTRUCTIONS FOR USE

The purpose of these instructions for use is to provide healthcare professionals with the information necessary for safe and appropriate use and maintenance of the device.
Note: The Instructions for use are an integral part of the device and therefore must be kept for the entire life of the device and must accompany it in any changes of use or
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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 read and understand the contents of these instructions for use before installing,
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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 or lot
number (LOT). This must never be removed or covered.
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EU Regulation 2017/745 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).
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• HIRVIN 8 HANDLES • HIRVIN 10 HANDLES
• WOW • WOW WITH FOOTREST
DOCUMENT TITLE
EU Regulation on Medical Devices
Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment