Rehadapt Rehadapter Instructions For Use Manual page 30

A A 3 3 I I n n d d u u s s t t r r y y C C a a n n a a d d a a C C l l a a s s s s B B C C o o m m p p l l i i a a n n c c e e S S t t a a t t e e m m e e n n t t
This Class B digital apparatus complies with Canadian ICES-003.
Contains transmitter module IC: 23872-FSCBT1026
This device can be operated with a minimum distance of 0 cm between the equipment and the user's
body. As a precaution, keep 10 mm in the area of the kickstand/antenna.
A A v v i i s s d d e e c c o o n n f f o o r r m m i i t t é é à à l l a a r r é é g g l l e e m m e e n n t t a a t t i i o o n n d d ' ' I I n n d d u u s s t t r r i i e e C C a a n n a a d d a a
Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.
Contient le module émetteur IC: 23872-FSCBT1026
Ce dispositif peut être exploité en toute sécurité avec un 0 cm distance minimale entre le matériel et
les corps de l'utilisateur. Par précaution, respectez une distance de 10 mm au niveau du support de
pied/antenne.
A A 4 4 R R e e g g u u l l a a t t i i o o n n s s , , D D i i r r e e c c t t i i v v e e s s a a n n d d S S t t a a n n d d a a r r d d s s
The Rehadapter™ is a class I medical device and complies with the following regulations and directives:
•
Medical Device Regulation (MDR) (EU) 2017/745
•
Low Voltage Directive (LVD) 2014/35/EU
•
Electromagnetic Compatibility (EMC) Directive 2014/30/EU
•
Radio Equipment Directive (RED) 2014/53/EU
•
Restriction of Hazardous Substances 2 (RoHS 2) Directive 2011/65/EU, 2015/863/EU
•
Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU
•
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation
2006/121/EG, 1907/2006/EG Annex 17
•
Battery Directive 2013/56/EU
•
Federal Communications Commission (FCC), CFR Title 47, Part 15 Subpart B and C
•
Industry Canada Equipment Standard, ICES-003, Issue 7, Class B
Among other, the following standards have been used:
•
IEC 60601-1:2005 + AMD1:2012 (ed. 3.1)
•
IEC 60601-1-11:2015
•
EN ISO 13485:2016
•
EN ISO 14971:2019
•
IEC 62133-2:2017 + AMD1:2021
•
UN 38.3 (ST/SG/AC.10/11/Rev.7)
•
EN ISO 10993-5:2009
•
IEC 60601-1-2:2014
•
ETSI EN 301 489-1 V2.2.3
•
ETSI EN 301 489-17 V3.2.4
•
EN 55032:2015
•
EN 55035:2017
•
ETSI EN 300 328 V2.2.2
An extensive list of the standards used is included in the Declaration of Conformity for each intended
market.
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