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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.
The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking and cleaning operations.
Metal parts exposed to external agents undergo surface treatments and/or coating in order to obtain better resistance. Clean the exposed
parts with water and delicate soap.
Never use solvents or stain removers.
Do not use cleaning agents containing sodium hypochlorite as corrosion of components may occur.
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.
If disinfecting , use products that do not have a solvent or corrosive action on materials constituting the device. Be sure to take all
precautions to ensure that there is no risk of cross-infection or contamination of patients and operators.
12.2
ROUTINE
MAINTENANCE
Establish a maintenance program and periodic checks, identifying a designated reference person. The person entrusted with device
maintenance must ensure the basic requirements envisaged by the manufacturer in the following paragraphs.
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.
To ensure the traceability of the products and protect maintenance and service procedures on your devices, Spencer has made the SPENCER
SERVICE SPENCER SERVICE
service.spencer.it available to you. From this site, you can view the data of the products in your possession or
placed on the market, monitor and update schedules for periodic checks and view and manage special maintenance.
Routine device maintenance must be carried out by operators with specific qualifications, training and instruction in the use and
maintenance of the device.
The operator must wear suitable personal protective equipment, such as gloves, goggles, etc. during all checking, maintenance and cleaning
operations.
Checks to be carried out before and after each use and at deadline indicated above, are as follows:
•
General functionality of the device
•
Cleanliness of the device (remember that the failure of cleaning may cause the risk of cross infections)
•
Correct tightening of all nuts, bolts and screws
•
Absence of cuts, holes, tears on the structure, including the straps
•
None of the tubes or metal sheets present bends or cracks
•
Welded areas are intact, without any cracks or breaks
•
Moving parts, wheels, levers, handles are intact and work properly
•
Lubrication of moving parts
•
Conditions of use of wheels and brake system
•
The wheels are correctly fixed, are stable and turn properly
•
The wheels are free of debris
•
The device opens and locks properly
•
The device opens and closes properly
•
Functioning of springs
•
The stretcher easily enters the ambulance
•
The medical vehicle is equipped with a Spencer fixing system intended for the stretcher
•
The coupling between the fixing system and the stretcher is suitable to guarantee the safety of the fixing
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.
Please note that cleaning must be carried out as described in this manual and that functionality must be verified before and after each use.
Spencer Italia S.r.l. declines any responsibility for improper functioning or damages caused to the patient or user by the use of devices not
subject to routine maintenance and will void the warranty and compliance to Medical Device Directive 2017/745/EU.
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 Regulation 2017/745/EU
Medical Devices.
12.3 PERIODIC OVERHAUL
The device must be overhauled every year by the Manufacturer, who uses internal and external technicians specialised and authorized by
the Manufacturer itself.
In the absence of an above-mentioned overhaul, the device must be DECOMMISSIONED
, as compliance with Regulation 2017/745/EU will
cease and, despite the CE marking, the device will no longer meet the safety requirements guaranteed by the Manufacturer at the time of
supply.