Specific Warnings - Spencer SHELL Manual De Uso Y Mantenimiento

mation necessary to carry out periodic revisions on the supplied devices, exactly as indicated in the User Manual.
• Participate in safety checks on products placed on the market, transmitting information regarding product risks to the Manufacturer as well as to the Competent Authorities
for their respective actions.
• Without prejudice to the above, the Distributor or End-User shall assume wider liability related to non-compliance with non-fulfilment of the above-mentioned obligations,
with consequent obligation to indemnify and/or hold Spencer Italia S.r.l. harmless from any possible injurious effect.
• With reference to EU Regulation 2017/745, please note that public or private operators who, when exercising their activity, detect an incident involving a medical product
are required to notify the Ministry of Health, within the terms and in the manner established by one or more ministerial decrees, and notify the Manufacturer. Public or
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.
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Qualified personnel and at least two operators must be present during use of the device.
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• 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-
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rer's warranty and release the manufacturer from all liability.
• Disinfection operations must be carried out in accordance with the validated cycle parameters, as stated in the specific technical standards.
• 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 basket stretchers, you must also have read, understood and carefully follow all the instructions in the user manual.
Always comply with the maximum capacity, if any, indicated in the User Manual. Maximum load capacity means the total weight distributed according to human ana-
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tomy. 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 User Manual.
• The maximum weight, which weighs on each operator, must comply with local health and safety requirements.
• The warranty seals, if present on the product, must not be removed; otherwise, the Manufacturer shall no longer recognise the product warranty and shall decline all
responsibility for incorrect operation or any damage caused by the product itself.
• 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.
• Use only original or Spencer Italia S.r.l. approved components/replacement parts and/or accessories to carry out any operation without causing alterations or modifications
to the device. Otherwise, we decline all responsibility regarding incorrect operation or any damage caused by the device to the patient or the operator, invalidating the
warranty and invalidating compliance with EU Regulation 2017/745.
• Never leave the patient on the device unsupervised, as they could get injured.
• If applicable, lubrication must be carried out after cleaning and complete drying.
• 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 supporting structure of the device.
The device is a patient transport stretcher and cannot be used as a stationing device.
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• Practice with an empty stretcher to make sure you are familiar with the manoeuvres.
At least two operators in suitable physical conditions are required for use of the device. They must be endowed with strength, balance, coordination, common sense
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and must be trained on the correct operation of the Spencer stretcher 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 two minimum operators.
• Before each use, always check the conditions of the device and its accessory 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 or replace the components that are not intact.
• Make sure that the belts are properly fastened to the stretcher frame.
• Always immobilize the patient, using at least the belts provided by the manufacturer. A failure to do so can cause serious damage to the patient.
• Do not move the stretcher if the weight is not properly distributed.
• Use the stretcher only as described in this user manual.
Do not alter or modify the stretcher to adapt it to unforeseen conditions of use: doing so could result in unpredictable operation and damage to the patient or
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rescuers and shall void the manufacturer's warranty and release the manufacturer from all liability.
• Pay the utmost attention to any obstacles (water, ice, debris, etc.) present on the route, as they may cause the operator to lose balance and compromise proper functioning
of the device. If you cannot clear the route, choose an alternative route.
• During hoisting, the stretcher must be kept horizontal with respect to the ground. Any abnormal inclination can cause serious damage to the patient, the device and the
operator.
• If it is necessary to use ropes, winches, ladders, lifting straps or other special equipment to move the stretcher or in the presence of a rescue that is classified as high risk or
of a purely technical nature, these interventions must be carried out solely by personnel adequately trained and experienced in rescue.
• For lifting with harness, use only the appropriate fixing points as indicated in the operating instructions.
• The stretcher can only be hoisted with Spencer harnesses and with hoisting systems given by a fixed position.
• Dragging the basket stretcher on any type of surface leads to premature deterioration of the stretcher, which reduces its useful life and initial safety conditions.
• To preserve the life of the device, protect it as much as possible from UV rays and adverse weather conditions.
• The Dakar, Dakota e Dakota Light basket stretchers cannot be used in water.
No fixing devices are envisaged for basket stretchers inside vehicles or other environments.
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• Spencer basket stretchers are not approved for use in aircraft.
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