20 Additional Information Ibis PowerDrive
12 Additional Information
Note!
A notice to the user and/or patient that any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority of the Member State in which the
user and/or patient is established.
B4Me special adaptations
Sunrise Medical strongly recommends that in order to ensure that your B4Me product operates, and
performs as intended by the manufacturer; all the user information supplied with your B4Me product is
readandunderstood,beforetheproductisrstused.
Sunrise Medical also recommends that the user information is not discarded after reading it, but it is
kept safely stored for future reference.
Medical Device Combinations
It may be possible to combine this Medical device with one or more other Medical Device or other
product. Information on which combinations are possible can be found at www.Sunrisemedical.co.uk.
All combinations listed have been validated to meet the General Safety and Performance
Requirements, section 14.1 of the Medical Device Regulation 2017/745.
Guidance on the combination, such as mounting, can be found at www.SunriseMedical.co.uk
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