Models; Intended Use; Intended Use And Clinical Benefits; Target Patients - Spencer Fixo Kid Gebrauchsanweisung

1.

MODELS

Only one Fixo Kid model is available.
The device may be subject to implementation or modification without prior notice.
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

Fixo Kid is a restraint system for paediatric patients to be used to obtain a level of restraint that allows the patient to be transported safely when used in accordance with the
product in use.

2.2 TARGET PATIENTS

The target patients are paediatric patients weighing between 4 and 20 kg.
Further limitations of use may be related to the device with which the belt is used. For this purpose, please refer to the instructions of the transport device in use.

2.3 PATIENT SELECTION CRITERIA

The target patient selection criteria are those applicable to the device with which the paediatric restraint system 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 instructions for use.

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.
Fixo Kid is a device intended exclusively for professional use. 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 FORMAZIONE UTILIZZATORI

• 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

Installation is not required for this device.
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,
IT
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
EN
4.

INTRODUCTION

4.1 USING THE INSTRUCTIONS FOR USE

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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
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
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.
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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 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
ES
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
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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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DOCUMENT TITLE
EU Regulation on Medical Devices
http://support.spencer.it or by contacting the Manufacturer. Exceptions are those items whose essentiality