Models; Intended Use; Reference Standards; Introduction - Spencer CARRERA INCUBATOR Instructions D'utilisation

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• CARRERA INCUBATOR
The main models shown above can be produced in chrome as well as in colour variations.
2.

INTENDED USE

Incubator stretchers are trolleys for transporting incubators in ambulances. Certified 10g when used with the dedicated fixing systems in relation to the coupling between the
fixing system and the trolley. Compliance with the requirements of EN 1789 for fixing between the incubator and trolley is the responsibility of the outfitter.
TARGET PATIENTS
There are no particular indications related to the patient group.
PATIENT SELECTION CRITERIA
The intended patients are those for whom transport with an incubator is necessary.
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
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.
Possible users also include emergency vehicle outfitters who may use the product before commissioning or during maintenance of the vehicle on which the stretcher is used,
as well as installers who are responsible for installing the incubator and its interfaces on the trolley.
These devices are not intended for lay people.
User training
Note: 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.
The device is intended for professional use only. All operators must be trained to transport patients safely and efficiently. Do not allow untrained persons to help while using
the product, as they may cause injury to themselves or others.
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 for lifting and holding and be
able to grasp the device firmly with both hands.
Operators must be able to provide the necessary patient care.
Users must be able to safely lift and handle the weight of the trolley, the incubator and any other equipment used with the device.
The ability of each operator must be assessed before the definition of rescuer roles in use of the device
• 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.
Document user training using appropriate forms.
Installer training
Device installation must be carried out by qualified personnel who have been trained and certified by Spencer Italia S.r.l.
The installer must strictly adhere to these instructions as well as to the state of the art for vehicle installations.
IT
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.
EN
REFERENCE
EU Regulation 2017/745
UNI EN ISO 1865-1
DE
UNI EN 1789
4.

INTRODUCTION

FR

4.1 USING THEINSTRUCTIONS 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
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
EL
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 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.
Regulation 2017/745/EU 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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• CARRERA PRO INCUBATOR PRO
http://support.spencer.it
• CARRERA XL INCUBATOR
DOCUMENT TITLE
EU Regulation on Medical Devices
Patient handling equipment used in road ambulances - Part 1: General stretcher
systems and patient handling equipment
Medical vehicles and their equipment - Road ambulances
or by contacting the Manufacturer. Exceptions are those items whose essentiality