liftup RAIZER - EU Declaration of conformity

Liftup Inc. | 3630 Peachtree Road NE | Suite 920 | Atlanta GA-30326 | T: +1 404-835-9421 | M: info@liftup.us | www.liftup.us
USER MANUAL – RAIZER – US VERSION 1.6
9
2.2 EU Declaration of conformity
Manufacturer: Liftup A/S
Address: Hagensvej 21, DK-9530 Støvring tel. +45 9686 3020
Reg. no. 523867 - Danish Medicines Agency
Hereby declares that: RAIZER® Battery operated mobile lifting chair
is in compliance with
Medical Device Directive MDD 93/42/EEC. Medical devices under class 1 (according to rule
1of annex IX of the Council Directive MDD 93/42/EEC).
Conformity assessment was performed according to Annex VII.
EMC Directive 2014/30/EU.
ROHS-Directive: 2011/65/EU. substances in electronic equipment
RED 2014/53/EU, Radio Equipment Directive.
FCC (USA) CFR 47 Part 15 FCC ID: 2AK8H-RAIZER1
ISED (Industry Canada) RSS-210 IC-ID: 22516-RAIZER1
MIC (Japan) ARIB STD-T66 Low power systems. MIC no. [R] 202-LSF033
Raizer meets the relevant requirements notably in following standards:
EN/ISO 10535:2006 Hoist for the transfer of disabled persons
Confirmed by Danish Technological Institute, certificate no. 222
EN 12182:2012 Technical aids for disabled general requirements and test methods
EN 60601-1:2006+Corr-1,-2:2008 +AC, A1:2013 Safety of Medical Electrical Equipment
EN 60601-1-2: 2015 EMC of Medical Electrical Equipment
EN 60601-1-11:2015 Home Care
CISPR 11, Class B Emission
EN 61000-4-2:2009 ESD Electrostatic Discharges
EN 61000-4-3:2006+A1:2008+
IS1:2009+A2:2010 Radiated RF Immunity
EN 61000-4-8:2010 Magnetic Field
EN 62479:2010 Human exposure
EN 300 440, v2.1.1 Electromagnetic compatibility + Radio spectrum Matters
Draft EN 301489-1, v2.2.0 Electromagnetic compatibility + Radio spectrum Matters
Draft EN301489-17, v3.2.0 Electromagnetic compatibility + Radio spectrum Matters
AS/NZS 4268 Radio Equipment and Systems – Short Range devices
AS/NZS 2772.2 Radio Frequency Fields (mean power < 1 mW)
Testing and conformity assessment performed by Danish Technological Institute, Jens-EMC and Liftup A/S
The above products are manufactured under the following management system:
EN ISO 9001: 2008 Quality management, Certificate No. 44 100 117583
EN 14971: 2012 Application of risk management to medical devices
Director Søren Elisiussen
Title Name
Liftup A/S, Hagensvej 21, DK-9530 Støvring
Company
2016-09-15 _____________________________
Date Signature