Triride 1776590, Руководство пользователя и обслуживание

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TRIRIDE s.r.l.
ManUso_TRIBIKE_eng_r01 01/06/2020 Pag. 8 di 49
USER MANUAL AND MAINTENANCE
3.3 Further General Recommendations
4. APPLICABLE LEGISLATION
For any problems with Tribike or for any regular and special maintenance, always contact your agents or
an Authorised Technical Service.
Only use accessories approved by TRIRIDE S.R.L.
Avoid proximity of Tribike with fires and open flames.
If Tribike is exposed to direct sunlight or high (> 41°C) or low (< 0°C) temperatures for extended periods, its
components may overheat or become excessively cold.
Tribike should not be used in the rain or on snow-covered, slippery or unstable surfaces.
Only use the battery charger provided to charge the Tribike battery.
If you do not use Tribike for an extended period, remove the battery from its housing and keep it charged,
recharging at least every two months to avoid possible damage due to complete discharging.
Store Tribike out of the reach of children, unless supervised by an adult.
No tampering or interference with the battery is permitted, as this may lead to a risk of explosion and/or
fire.
Remove the battery from Tribike and store it in a sheltered, safe place when transporting in any other form
of transport (car, bus, train, aeroplane, etc.).
Tribike is a medical device compliant with European Council Directive 93/42/CEE and meets the following
technical standards:
• EN 14971:2012 - Medical devices – Application of risk management to medical devices;
• EN ISO 15223-1:2012 – Medical devices – Symbols to be used with medical device labels, labelling and
information to be supplied – Part 1: General requirements;
• EN 1041:2013 – Information supplied by the manufacturer of medical devices;
• EN 10993-1:2010 – Biological and clinical evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process;
• EN 12182:2012 – Assistive products for persons with disability – General requirements and test methods;
• EN 12183:2014 – Manual wheelchairs – Requirements and test methods;
• EN 12184:2014 – Electrically powered wheelchairs, scooters and their chargers – Requirements and test methods;
• EN 60601-1:2015 – Medical electrical equipment Part 1: General requirements for basic safety and
essential performance;