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Note:
Complete product codes, the manufacturer registration code (SRN), the UDI-DI code and any
references to used regulations are included in the EU declaration of conformity that Moretti S.p.A.
releases and makes available through its channels.
4.1 Applicable regulations and directives
The TIBODA front wheelchair drive is conforming and has been tested and approved pursuant to the
following directives and standards:
•
EN 14971:2012 – Medical devices – Application of risk management to medical devices
•
EN ISO 15223-1:2012 – Medical devices – Symbols for use in medical device labels, and in
obligatory labelling and information – Part 1: General requisites
•
EN 10993-1:2010 – Biological assessment of medical devices – Part 1: Assessment and testing as
part of the risk management process
•
EN 12182:2012 – Products for the assistance of disabled persons – General requisites and test
methods
•
EN 12183:2014 – Hand powered wheelchairs – Requisites and test methods
1
•
EN 12184:2014 – Electric wheelchairs, scooters and charging systems – Requisites and test
2
methods
•
EN 60601-1:2007 - Electric medical equipment, part 1: General safety and performance
prescriptions
•
EN 60601-1-2:2003 - Electric medical equipment, part 1: General safety prescriptions –
Collateral standard: Electromagnetic compatibility – Prescriptions and tests
•
EN 60601-1-11 - Electric medical equipment, part 1: General safety and performance prescriptions
for electric medical equipment
•
The "TIBODA" is also conforming with Directive EU2012/19/EC relating to the scrapping of waste
electrical and electronic equipment
EN 12183:2014 and
EN 12184:2014: the following standards have been used as guidelines; where
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possible, the tests specified in these standards have been applied
5. GENERAL WARNINGS
5.1 General warnings
Take great care when using the device the first few times. Every manoeuvre should be considered
potentially hazardous. It is essential that you familiarise yourself with every manoeuvre and gain
confidence in using the "TIBODA". Take special care when steering and accelerating. Choose a clear,
safe and level area to try out the "TIBODA" the first time, and have someone with you who has read
this manual and is able to help you if necessary.
Using the "TIBODA" in a way that poses no danger to yourself or other people takes training and
experience, and familiarity with the rules governing foot and road traffic in your country.
WARNING!
•
Do not use the product for any purpose other than that specified in this manual
•
Moretti s.p.a. declines all liability for damage or sanctions resulting from the use of the front
drive in violation of traffic regulations in the country/region in which Tiboda is used
•
The device may only be used by persons in possession of their full intellectual faculties
•
Keep the device away from children under the age of 12
•
Make sure the package is undamaged before you open it
•
Do not exceed a speed of 6 kph on irregular ground
•
Do not exceed a speed of 10 kph on cycle paths
•
Do not exceed a speed of 12 kph on private roads
•
Do not exceed a speed of 3 kph on bends. Failure to observe these limits is dangerous and may
cause the wheelchair to tip over
•
Do not use TIBODA on lengthy uphills. Doing so may overheat the battery
•
Do not use the battery charging cable as a tourniquet or rope, use it only as intended by the
manufacturer
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