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PM-1769-E-01-03/2018
List of Harmonized EN Standards
The device is classified as a medical device, Class IIa (MDD Annex IX Rule 10)
Applicable Medical Device Directive (93/42/EEC) standards:
EN ISO 15223-1:2016
EN 1041:2008
EN 1060ꞏ1:1995+A2:2009
EN 1060ꞏ3:1997+A2:2009
EN 60601-1:2006+A1:2013
EN 60601-1-2:2015
EN 60601-1-6:2010+A1:2015
EN 60601-1-11:2015
EN 80601-2-30:2010+A1:2015
EN 62304:2006+A1:2015
EN 62366:2008+A1:2015
EN ISO 10993-1:20091AC:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
EN ISO 14971:2012
EN ISO 81060-2:2014
Operation and care
Cleaning of the device
The device should be cleaned with a soft dry cloth, or a soft cloth moistened with
neutral soap to clean on the monitor and the wrist cuff.
Warnings
Please read the Important Safety Information in this instruction manual before using
this monitor.
Please follow this instruction manual thoroughly for your safety.
Please keep for future reference. For specific information about your own blood
pressure, CONSULT WITH YOUR PHYSICIAN.
Warning: Indicates a potentially hazardous situation which, if not avoided, could
result in serious injury.
• DO NOT use this monitor on infants, toddlers, children or persons who cannot
express themselves.
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