Cleaning And Maintenance; Cleaning; Routine Maintenance; Periodic Overhaul - Spencer SED Manual De Uso Y Mantenimiento

12. CLEANING AND MAINTENANCE

Spencer Italia S.r.l. declines all responsibility for any direct or indirect damage which is the consequence of improper use of the product and spare parts and/or in any
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case of any repair carried out by a person other than the Manufacturer, who uses internal and external technicians authorised to do so; moreover, doing so will invalidate
the warranty.
• The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking, maintenance and cleaning operations.
• Establish a maintenance schedule, periodic inspections and extend the average life span, if foreseen by the Manufacturer in the User Manual, identifying a reference person
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who meets the basic requirements set forth in the User Manual.
• The frequency of inspections is determined by factors such as legal requirements, type of use, frequency of use, and environmental conditions during use and storage.
• Repairs of products manufactured by Spencer Italia S.r.l. must be carried out by the Manufacturer, who shall make use of specialised internal or external technicians
who, using original spare parts, shall provide quality repair service in strict compliance with the technical specifications indicated by the Manufacturer. Spencer Italia S.r.l.
declines any responsibility for any direct or indirect damage which is a consequence of improper use of spare parts and/or any repair work carried out by unauthorised
parties.
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• Where foreseen, use only original or Spencer Italia S.r.l. approved components/spare parts and/or accessories in order to carry out all operations without causing alterations
or modifications to the product.
• All maintenance and overhaul 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 product's life and must be made available to the competent authorities and/or the Manufacturer when requested.
• Cleaning, provided for reusable products, must be carried out in accordance with the Manufacturer's instructions in the User Manual in order to avoid the risk of cross-in-
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fection due to the presence of body fluids and/or residues.
• If required, the product and all its components must be washed and left to dry completely before storage.

12.1 CLEANING

Failure to carry out the correct cleaning operations could increase the risk of cross-infection due to presence of body fluids and/or residues.
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The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking and cleaning operations. .
Clean the device and its parts with soap and water using a brush with medium-hard bristles. Rinse thoroughly with lukewarm water, making sure you have removed all traces
of soap, which may deteriorate or compromise conditions and durability. Avoid using high-pressure water. Let dry completely before storing. Drying after washing or after use
in a wet environment must be natural and not forced. Do not use flames or other direct heat sources.
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When disinfecting, use products that do not have a solvent or corrosive action on materials constituting the device, in addition to being classified as medical-surgical devices.
Be sure to take all precautions to ensure that there is no risk of cross-infection or contamination of patients and operators.
After disinfection, rinse all parts with warm water and allow the device to dry completely before storage, as residual moisture may lead to the formation of mould. .

12.2 ROUTINE MAINTENANCE

The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking, maintenance and cleaning operations.
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The device does not require a routine maintenance program, but checks must be made to verify:
• All parts are present
• Integrity of the belts
• Integrity of the lifting handles
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• Integrity of the groin belts
• Integrity and operation of the buckles
• Integrity of internal slats
• Integrity of the chin and forehead bands
• General functionality of the device
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• Nape cushion conditions
• Cleanliness of the device (remember that the failure of cleaning may cause the risk of cross infections)
• Fulfilment of the requirements of the user manual in section 5 Warnings and 6 Specific Warnings.
• Fulfilment of the requirements of the manual in section 11 Proper use
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.

12.3 PERIODIC OVERHAUL

No periodic overhaul is foreseen for the device.
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Do not immobilise the head until checking the correct position of the extrication device in relation to the size of the patient. Take care
not to cause head and neck movements that could compromise the patient's condition. If there is a gap between the extrication device
and the patient's head, collar or shoulders, fill the nape space with the appropriate support cushion, making sure not to hyper extend or
flex the patient's neck.
While one operator holds the patient's head in position and positions the flaps, the other operator must secure the headband by tilting the
back slightly downwards. This reduces the risk of the headband slipping over the head.
Then apply the chin strap, taking care to support the cervical collar and tilt it towards the patient's ears. This avoids immobilising the jaw and
preventing the mouth from opening. Ensure that the straps are correctly secured and symmetrically positioned.
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When the stretcher or spine board has been brought to the extrication site, the final steps of the application can be carried out, i.e.
further tightening of the extrication straps, therefore:
1 – Tighten the upper belt (green)
2 – Check and tighten the lower belt (red)
3 – Check and tighten the groin belts.
After checking the correct application, the two operators can grasp the handles of the device to rotate the patient so that his or her back
faces the inside of the vehicle. Rotation must take place without twisting the spinal cord or the cervical spine.
The two operators can then grasp the nearest handle of the extrication device with one hand and the back of the patient's knees with the
other. After coordinating the operation correctly, they can lift the patient.
If needed, a third operator could apply a spine board.
The upper belt (green) must be loosened immediately after extrication to allow for proper expansion of the chest.