Models; Intended Use; Intended Use And Clinical Benefits; Target Patients - Spencer ROCK PIN Manual De Uso Y Mantenimiento

1.

MODELS

The following basic models may be subject to implementation or change without notice.
• ROCK PIN • ROCK PIN MAX
2.

INTENDED USE

2.1 INTENDED USE AND CLINICAL BENEFITS

Spine boards are devices designed to lift and immobilize patients with suspected spinal injuries. 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.

2.3 PATIENT SELECTION CRITERIA

The expected patients are typically subjects for whom it is necessary to immobilize the spine in order to avoid aggravating suspected trauma to the spine itself.
It is common practice to use a head restraint with the device to prevent any aggravation of neck injuries.
Operators must also be trained to perform device application manoeuvres so as to prevent aggravation of spinal injuries or possibly compromised organs or fractures.
The device is known to have consequences for patients related to prolonged laying on a rigid, non-anatomical surface.
The actual need for use of this type of device must therefore be carefully assessed by the rescuer in accordance with local guidelines.

2.4 CONTRAINDICATIONS AND SIDE EFFECTS

Known contraindications for spine boards are:
• Pain
• Compromised breathing caused by immobilization
• Pressure sores
• Need for additional radiological tests

2.5 USERS AND INSTALLERS

The intended users are rescue workers with in-depth knowledge related to the immobilisation and handling of people suffering from road traffic injuries, spinal injuries
and fractures.
• Personnel trained for use of the device must also have training in managing lifting and handling suspended loads with people.
These devices are not intended for lay people.
Spine boards 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 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
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 have the appropriate skills and qualifications to ensure correct attachment of any ambulance restraints. The device in itself does not require installation.
3.

REFERENCE STANDARDS

REFERENCE
EU Regulation 2017/745
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.
4.

INTRODUCTION

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,
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 2017/745 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).
• B-BAK PIN • B-BAK PIN MAX
DOCUMENT TITLE
EU Regulation on Medical Devices
http://support.spencer.it or by contacting the Manufacturer. Exceptions are those items whose essentiality
• TANGO • BABY GO • PEDI LOC
IT
EN
DE
FR
ES
PT
EL
CS
13