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PM-2020-01-07/2020
List of Harmonized EN Standards
The device is classified as a medical device, Class IIa (MDD Article 9
Annex IX Rule 10)
Applicable Directives: Medical Device Directive (MDD) 93/42/EEC
Radio Equipment Directive 2014/53/EU
RoHS Directive 2011/65/EU
Applicable standards:
EN 1041:2008+A1:2013
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-1:2006+Al:2013
EN 60601-1-2:2015
EN 60601-1-11:2015
EN 60601-1-6:201O+A1:2015
EN 60601-2-47:2015
EN 62304:2006+A1:2015
EN 62366-1:2015
EN 80601-2-30:2010+A1:2015
EN ISO 10993-1:2009/AC:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 13485:2016
EN ISO 14971:2012
EN ISO 15223-1:2016
EN ISO 81060-2:2019+A1:2020
EN 300 328 V2.2.2
EN 301 489-1 V2.2.3
EN 301 489-17 V3.1.1
EN 62479:2010
EN 62368-1:2014+A11:2017
EN 50581:2012
Cleaning of the device
• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral)
detergent to clean your monitor and the arm cuff and then wipe them
with a dry cloth.
• When electrodes are dirty, use a soft cloth or cotton swab moistened
with alcohol-based sanitizer to clean the electrodes.
• Do not use alcohol to clean any other parts, and use it only to clean
electrodes.
• Do not wash or immerse your monitor and arm cuff or other
components in water.
• Do not use gasoline, thinners or similar solvents to clean your monitor
and arm cuff or other components.
