3
1.
MODELS
The following basic models may be subject to implementation or change without notice.
•
CARRERA TEC
•
CARRERA TEC TH
•
CARRERA XL
•
CARRERA PRO
•
CARRERA ACTIV
The models listed above are available with different coloured patient surfaces (yellow, black, red, white), in Trendelenburg or Trendelenburg
and Fowler versions and, depending on the model, may include accessories such as a mattress and/or IV carrier.
2.
INTENDED USE
Ambulance stretchers are the primary means of transporting sick and/or injured people in transit safely and comfortably in a lying position. It
is not foreseen that the patient be able to intervene on the device, nor is it intended for prolonged storage or use as a hospital bed. The
stretcher must be used with the dedicated fixing systems.
It is not foreseen that the patient be able to intervene on the device.
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 of the device. If paediatric
subjects must be transported, it will be in the role of the rescuer to determine whether the strap systems are suitable for immobilization or if
it will be necessary to use another device.
PATIENT SELECTION CRITERIA
The intended patients are those for whom ambulance transport 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 user
manual.
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.
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.
•
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 documentation 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 the form in Annex A of this manual or other 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.
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
UNI EN ISO 1865-1
Patient handling equipment used in road ambulances - Part 1: General stretcher systems and
patient handling equipment
UNI EN 1789
Medical vehicles and their equipment - Road ambulances