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11.3 USING THE FASTENING SYSTEM
Positioning the chair on the fastening system
• Close the chair and all its folding parts (footrests, handles, headrests, slides if present).
• Lift the chair and position the lower part inside the base of the fastening system, placing the bushings coaxial to the wheels inside the appropriate seats of the fastening
system.
• Tilt the chair until it comes into contact with the wall.
• Fasten the seatbelt, adjusting the tension so that the chair is perfectly integral with the fastening system.
Removing the chair from the fastening
• Hold the top of the chair firmly.
• Release the quick-release buckle on the belt.
• Tilt the chair towards you and lift it up, thus removing it from the fastening system.
12. CLEANING AND MAINTENANCE
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.
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 this can lead to the risk of corrosion of 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 ASSTEC portal
it/asstec/login.aspx, 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 commissioning, or every 3 months if the device is not in use, 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 or abrasions on the entire structure
• No elements present bends or cracks
• The device locks the chair correctly
• Check the functionality of the quick-release buckle. The buckle must close ensuring the correct coupling between the male and female parts.
• The coupling between the fastener and the chair is correct and secure.
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 instructions for use 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 EU Regulation 2017/745.
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
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 EU Regulation 2017/745 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.
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