Models; Intended Use; Intended Use And Clinical Benefits; Target Patients - Spencer STX 519 Betriebs- Und Wartungshandbuch

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• STX 519 – ADJUSTABLE HARNESS
• STX 540 – FIXED HARNESS
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

These harnesses are accessories for basket stretchers, to be used solely for lifting from a floor-mounted position (STX 519 and STX540) or for dragging (STX 519). It is not
foreseen that the patient be able to intervene on the devices.

2.2 TARGET PATIENTS

The target patients are those for whom use of the basket stretcher is foreseen.

2.3 PATIENT SELECTION CRITERIA

The selection criteria are those foreseen for use of the basket stretcher.

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 user manual.

2.5 USERS AND INSTALLERS

The intended users are rescue workers, typically technical,. carrying out operations related to the use of harnessing systems.
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• Personnel trained for use of the device must also have training in managing lifting and handling suspended loads with people.
• Personnel who carry out interventions in situations classified as high risk or which are purely technical must be suitably trained and experienced in rescue.
These devices are not intended for lay people.
Harnesses 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
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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 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 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.

2.5.2 INSTALLER TRAINING

Installation is not required.
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
EU Regulation 2017/745
4.

INTRODUCTION

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4.1 USING THE MANUAL

The purpose of this manual is to provide healthcare professionals with the information necessary for safe and appropriate use and maintenance of the device.
Note: The Manual is an integral part of the device and therefore it 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.
Regardless of your level of experience with similar devices in the past, it is advisable to carefully read and understand the contents of this manual 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, 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.
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 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