Cleaning; Routine Maintenance; Periodic Overhaul; Special Maintenance - Spencer COMBIMATT Instrucciones De Uso

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.
• 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 instructions for use in order to avoid the risk of
cross-infection 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.

11.1 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.
The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking and cleaning operations.
Clean the exposed parts with water and delicate soap. Never use solvents or stain removers.
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, as it penetrates the joints and removes lubricant, creating the risk of corrosion on components. 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.
After complete drying, proceed with lubrication as described below.
If 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.
Carefully follow the instructions of the manufacturer of the product used with regards to the application method and contact time.
Be sure to take all precautions to ensure that there is no risk of cross-infection or contamination of patients and operators.

11.2 ROUTINE MAINTENANCE

You must establish a maintenance program and periodic checks, identifying a designated reference person. The person entrusted with device maintenance must ensure
the basic requirements envisaged within the instructions for use.
All routine and special maintenance activities and all general overhauls must be recorded and documented with the relevant technical intervention 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.
The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking, maintenance and cleaning operations.
The maintenance schedule must comply with the following table:
Minimum maintenance intervals
Disinfection
Cleaning
Inspection
Check vacuum tightness
The inspection to be carried out after each use involves:
• Check that all components are present
• Check device conditions – There must be no cracks, holes or cuts
IT
• Check conditions of wear – There must not be any level of abrasion that would compromise the safety of the product
• Check that the moving parts slide properly
• General check of the state of wear of each component
• Check that all the accessories provided are present, functional and intact.
Vacuum tightness test consists of bringing the mattress to a vacuum and then simulating application. The mattress must remain rigid enough to allow immobilization for at
EN
least 30 minutes.
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.
DE

11.3 PERIODIC OVERHAUL

No periodic overhaul is foreseen for the device.

11.4 SPECIAL MAINTENANCE

Special maintenance can only be carried out by the Manufacturer, who uses internal and external technicians specialised and authorised by the Manufacturer itself.
FR
Only maintenance activities carried out by specialised technicians authorised by the Manufacturer are considered valid by Spencer Italia S.r.l..

11.5 LIFE SPAN

The device, if used as described in the following instructions, has an average life span of 5 years from the date of purchase, beyond which it must be disposed of.
ES
Spencer Italia S.r.l. will accept no responsibility for incorrect operation or damage caused by the use of devices that have exceeded the maximum allowable life span.

12. TROUBLESHOOTING TABLE

PROBLEM
PT
The device stiffens during a drop in altitude
The device tends to lose the set vacuum
and regenerate a pressure level equal to the
EL
ambient value inside it.
No vacuum in the device
Device does not adapt to the patient's shape
Damage (holes, cuts and abrasions) to the
external containment structure
If a problem or fault is detected that does not correspond to the above, please contact Spencer Italia srl customer care service.
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At each use
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CAUSE
Change in relative pressure
Valve deteriorated.
Possible holes in the internal chamber
Inefficiency of the pump or wear/breakage of
the connection system between the valve and
the surface of the device
Non-conforming device material Limited
flexibility
Improper use.
Incorrect storage.
If necessary
●
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REMEDY
Check the actual pressure status of the device by opening the valve or
depressurising the pump. If the problem persists, remove the device
from service and contact customer service.
Immediately remove the device from service and contact customer
service.
Immediately remove the device from service and contact customer
service.
Immediately remove the device from service and contact customer
service.
Immediately remove the device from service and contact customer
service.
Monthly
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