TDIM1_4_User Manual_1
35
Supported operating system
iOS 10.0 and later (as of 20.07.2020)
Download
App Store
If you still have further questions about your InnoMake and the range of
functions after reviewing the user manual, please contact your retailer or us
for support.
8. Legal information
CE
conformity
Thanks to the CE mark on your InnoMake, you can be assured that we meet
the requirements of
•
Directive 93/42/EEC
(Medical Device Directive)
•
Directive 2014/53/EU
(Radio Equipment Directive)
•
Directive 2011/65/EU
(Restriction of Hazardous Substances Directive)
InnoMake is a class 1 medical device.
We at Tec-Innovation GmbH have therefore drawn up the declaration of
conformity under our sole responsibility pursuant to Annex VII of the Medical
Device Directive.
Reporting of incidents
Due to legal requirements as it is a medical device, we must make you aware
that all any serious incidents that have occurred in connection with the
product must be reported to the manufacturer, i.e. us at Tec-Innovation
GmbH as well as the competent authority.
The term
“serious” includes:
▪
the death of a user,
▪
a life-threatening illness,
▪
permanent impairment to bodily function or permanent damage,
