Frontiermedical Toto Manual De Instrucciones página 13

Drying
To avoid shrinkage, line dry in a clean indoor environment. Thoroughly dry before re-fitting to the
Toto® platform.
Do not mangle or iron.
Platform, Cabling, Control Unit and Air Hoses
Before cleaning, disconnect from the mains power supply.
The platform, cabling, control
derivative. Take care when wiping the control unit not
End of Life Disposal
Cared for correctly the Toto® system is long lasting and durable. The control unit has a life expectancy of up
to 5 years.
To minimise hazards to health and the environment, and to ensure the device is recycled, dispose of at a
separate collection facility for electrical and electronic equipment in accordance with the Waste Electrical
and Electronic Equipment Directive, and as denoted by the wheelie bin symbol marked on the product.
At the end of its life, clean and disinfect the platform according to the instructions and dispose of with non-
hazardous clinical waste.
Storage
When not in use, the Toto® lateral turning system should be stored in a secure location away from the public
using the transport bag supplied.
• Do not drag.
• Never store other items on top of the Toto® platform.
• Do not store next to radiators or other heating devices.
• Do not store in damp conditions.
Warranty
The Toto® system warranty is valid for two years from the time of shipping. In the event of a defect or fault,
please contact Frontier Therapeutics Customer Services on Tel: +44 (0) 330 460 6030 or email: info@
frontier-group.co.uk immediately.
Frontier Therapeutics Limited guarantees the equipment is free from defects in material and workmanship,
under regular use and service.
During the warranty period, any product that has become defective due to faulty workmanship or material
will be replaced as deemed appropriate by Frontier Therapeutics Limited, without charge for parts or labour.
During this time, a loaned control unit will be made available if required.
If the product is damaged due to an accident, negligence or misuse, the product warranty will be forfeited.
No unauthorised alterations are permitted. Both warranty and fire retardancy certification will be null and
void if non-Frontier Therapeutics Limited spares or replacement parts are used.
Frontier Therapeutics Limited will not accept responsibility for damage caused by misuse, negligence,
accidental damage nor non-observance of the instruction set out in this document.
This warranty does not affect your statutory rights.
Fire Testing
The Toto® platform meets the requirements of BS 7175:1989 Section 2 Methods of test for the ignitability of
bedcovers and pillows by smouldering and flaming ignition sources.
BS EN 597-1:2015. Furniture. Assessment of the ignitability of mattresses and upholstered bed frames.
Ignition source smouldering cigarette. BS EN 597-2:2015. Furniture. Assessment of the ignitability of
mattresses and upholstered bed frames. Ignition source: match flame equivalent.
Compliance
The Toto System conforms to MDD 93/42/EEC and MDR 2017/745 and the following standards: BS EN
ISO 9001:2015 Quality Management Systems. BS EN 13485:2016 Medical Devices. Quality Management
Systems. Requirements for Regulatory Purposes. BS EN 14971:2019 Medical Devices. Application of Risk
Management to Medical Devices. BS EN ISO 15223-1:2021 Medical Devices. Symbols to be Used with
Medical Device Labels, Labelling and Information to be Supplied. General Requirements. BS EN ISO
10993-5:2009 Biological Evaluation of Medical Devices. Tests for In Vitro Cytotoxicity. BS EN 10993-10:2013
Biological Evaluation of Medical Devices. Tests for Irritation and Skin Sensitization.
The control unit is tested to EU Directive 2014/30/EU and BS EN 62353:2014 Medical Electrical Equipment –
Recurrent Test and Test After Repair of Medical Electrical Equipment.
Manufactured to comply with EN 60601-1 (Safety) and EN 60601-1-2 (EMC);
IEC/EN 60601-1; IEC /EN 60601-1-11; IEC/EN 60601-1-8.
Restriction of the use of certain hazardous substances (RoHS) Directive. 2011/65/EU.
Toto DOES NOT incorporate as an integral part. A substance, which used separately may be considered to be
a medicinal product as defined by European Communities medicinal products Directive (Directive 2001/83/
EC, as amended) and Human Medicines Regulation 2012 (SI 2012/1916).
unit and air hoses can be wiped clean with alcohol wipes and a chlorine
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to allow liquids to enter through any openings.