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private health care professionals are required to notify the Manufacturer of any other incident that may allow the adoption of measures to ensure the protection and health
of patients and users.
General warnings for medical devices
The user must carefully read the following in addition to the general warnings.
•
It is not foreseen that application of the device lasts longer than the time required for first aid operations and subsequent transport to the nearest rescue point.
•
Qualified personnel and at least two operators must be present during use of the device.
•
Do not use if the device or parts of it are punctured, torn, frayed, or excessively worn.
•
Follow the internal procedures and protocols approved by your organisation.
•
Do not alter or modify the device arbitrarily, as doing so could result in unpredictable operation and damage to the patient or rescuers and shall void the manufactu-
rer’s warranty and release the manufacturer from all liability.
•
Do not use drying machines to dry the device.
•
In case of exposed and/or injured skin, cover the surfaces in contact with the patient with a surgical sheet that respects bio-compatibility regulations to protect the patient’s
health.
6. SPECIFIC WARNINGS
To use the restraint belts, you must also have read, understood and carefully follow all the instructions in the user manual.
•
Always comply with the positioning specifications defined by the device with which the belts are used. In addition, the operator should assess whether the overall size
of the patient reduces the functionality of the product.
•
Always apply the number of belts provided by the transport equipment in use.
•
Perform rescue simulations with the belts applied to the product with which it is intended to be used and a patient simulating load and accessories before putting
the device into service.
•
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.
•
Avoid contact with sharp objects.
•
Follow approved Emergency Medical Service procedures for patient immobilization and transportation.
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Follow approved Emergency Medical Service procedures for patient positioning and transportation.
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Before each use, always check the conditions of the device and its components, as specified in the user manual. 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.
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Do not arbitrarily 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 and shall void the manufacturer’s warranty and release the manufacturer from all liability.
•
To preserve the life of the device, protect it as much as possible from UV rays and adverse weather conditions.
•
Make sure that the buckles are properly anchored to the strap and that they are intact and functional.
7. RESIDUAL RISK
No residual risks, or rather risks that could arise despite compliance with all warnings in this user manual, have been identified.
8. TECHNICAL DATA AND COMPONENTS
Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without notice.
ID
DESCRIPTION
4
8
6
7
3
5
9
2
1
10
1
Female metal buckle
2
Thorax hook
3
Male metal hook
4
Re-winding system
5
Thorax strap
6
Spring catches
7
Female plastic hook
8
Male plastic hook
9
Male aluminium hook
10
Female aluminium hook
BELT COMPONENT
MATERIAL
Metal buckle
Chrome-plated steel and plastic
Plastic buckle
Nylon
Aluminium buckle
Aluminium
Strap
Nylon
MODEL
L max (mm)
L min (mm)
MODEL
L max (mm)
L min (mm)