Residual Risk; Technical Data And Components - Spencer COMBIMATT Instrucciones De Uso

Always comply with the maximum capacity, if any, indicated in the instructions for use. Maximum load capacity means the total weight distributed according to human
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anatomy. When determining the total weight load on the product, the operator should consider the weight of the patient, equipment and accessories. In addition, the
operator should assess whether the overall size of the patient reduces the functionality of the product.
• If foreseen for the device, make sure that operators are in good physical condition before lifting, as listed in the instructions for use.
• Establish a maintenance program and periodic checks, identifying a designated reference person. The person entrusted with routine maintenance of the device must ensure
the basic requirements envisaged by the manufacturer within these operating instructions.
• All maintenance activities must be recorded and documented with the relevant technical operation reports. This documentation must be kept for at least 10 years after the
end of the device's life and must be made available to the competent authorities and/or the manufacturer when requested.
• Never leave the patient on the device unsupervised, as they could get injured.
• Avoid contact with sharp objects.
• Follow approved Emergency Medical Service procedures for patient immobilization and transportation.
Follow approved Emergency Medical Service procedures for patient positioning and transportation.
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• Before lifting, make sure that operators have a secure grip on the device.
• Perform rescue simulations with a mattress and a patient simulating load and accessories before putting the device into service.
At least 4 operators in suitable physical conditions are required for use of the device. They must be endowed with strength, balance, coordination, common sense and
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must be trained on the correct operation of the device.
• For patient loading techniques for particularly heavy patients, for operations on steep terrain or in special and unusual circumstances, the presence of more than two ope-
rators is recommended in addition to the minimum foreseen operators.
• Before each use, always check the conditions of the device and its components, as specified in the instructions for use. In case of faults or damage that may compromise the
functionality and safety of the device, and therefore the patient and the operator, remove the device from service or replace the components that are not intact.
• Do not lift if the weight is not properly distributed.
• Use the devices only as described in these instructions for use.
Do not alter or modify the device to adapt it to unforeseen conditions of use: doing so could result in unpredictable operation and damage to the patient or rescuers
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and shall void the manufacturer's warranty and release the manufacturer from all liability.
• The device is expected to come into contact through the patient's clothing. In case of direct contact with the skin, place a protective surgical drape over it to avoid contami-
nation from substances that may have contaminated the device.
During lifting, the mattress must be kept horizontal with respect to the ground. Any abnormal inclination can cause serious damage to the patient, the device and
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the operator.
To preserve the life of the device, protect it as much as possible from UV rays and adverse weather conditions.
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• Always observe the maximum applicable static safety load indicated in these instructions for use. Maximum static load is intended as a mechanical force applied slowly, not
quickly, beyond which the device may not be safe. This value does not take into account the dynamic forces to be added to the static load, such as shocks, vibrations and
possible weather and climate conditions during use of the device.
• Never leave the patient unsupervised when the device is in use, as they could get injured.
• After washing, the device and all its components must be left to dry completely before storage away from sunlight and direct heat sources.
• Do not machine wash the device.
• Avoid contact with sharp objects.
• Never use solvents or stain removers.
• Do not use the device if cuts, burns, abrasions, open seams or fraying are present.
• Do not drag the device on rough surfaces.
• Always check the conditions of all parts of the straps and buckles before each use.
• Immediately replace devices with worn or damaged straps or buckles.
• Position and adjust the straps and buckles in such a way that they do not hinder rescuer operations or use of the use of rescue equipment.
• Keep the appropriate documentation for a period of ten years from the date of transfer to the final consumer and, therefore, show, where required, to trace the origin of
the products.
• Use of the device without proper patient immobilization can result in serious damage. Always make sure that the patient is properly immobilized before handling the device.
• The rescuer must assess the actual need for use of this type of device in accordance with local guidelines, ensuring that immobilization with vacuum devices is appropriate
in relation to the clinical condition of the patient.
7.

RESIDUAL RISK

No residual risks, or rather risks that could arise despite compliance with all warnings in these instructions for use, have been identified.
8.

TECHNICAL DATA AND COMPONENTS

Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without notice.
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2
Strap handles
1 Made of Nylon, allow lifting of the mattress and the patient.
PARTS
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6
3
7
4
8
DESCRIPTION AND MATERIALS
Mattress
6 Made of PVC with polystyrene filling, this is the part of the device subjected
to vacuum.
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