Models; Intended Use And Clinical Benefits; Target Patients; Patient Selection Criteria - Spencer Res Q Matt Instructions D'utilisation

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• COMBIMATT • NEXUS
2. INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

Vacuum mattresses are devices primarily intended to ensure immobilization of the whole body during patient transport.
It is not foreseen that the patient be able to intervene on the 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 immobilization 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 and requiring immobilization.

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.
Vacuum mattresses 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.
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
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.
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

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
EU Regulation 2017/745
4.

INTRODUCTION

4.1 USING THEINSTRUCTIONS FOR USE

The purpose of these instructions 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
ownership. If any instructions for use for products other than the one received are present, please contact the Manufacturer immediately before use.
Spencer product instructions for use can be downloaded from the site
lity 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 these instructions before 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.
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).

4.3 SYMBOLS

Symbol Meaning
Device in compliance with EU Regulation 2017/745
Medical device
• RES-QMATT • CDK
DOCUMENT TITLE
EU Regulation on Medical Devices
http://support.spencer.it or by contacting the Manufacturer. Exceptions are those items whose essentia-
Symbol Meaning
See the instructions for use
Lot number
• RES-Q-MATT PLUS • MINI MATT
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