IEC/EN 60601-1-11 : General requirements for basic safety and essential performance –Collateral Standard:
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare
environment
IEC 80601-2-30: 2009 (First Edition) for use in conjunction with IEC 60601-1:2005
EN 80601-2-30: 2010/ ANSI/AAMI 80601-2-30: 2009 : Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
EN300328 V1.7.1 :2006 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband
transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band
modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
EN301489-1-3 V1.9.2 :2011 Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
EN301489-1-17 V2.2.1 :2012 Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
EN60601-1-2: 2007 /AC 2010: Medical electrical equipment: Part 1‐2: General requirements for basic safety and
essential performance-collateral standard electromagnetic compatibility
EN 55011Group 1 Class B: 2009+A1:2010 : Industrial, scientific and medical equipment - Radio-frequency
disturbance characteristics - Limits and methods of measurement
FCC part B 15B: 2013 Electromagnetic Compatibility
FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC Rule Part: 15.247 Cat: DTS (BT4.0)
EN ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk
management process (ISO 10993-1:2009)
ANSI/AAMI SP10: 2002/A1 2003(R) 2008: Manual, electronic or automated sphygmomanometers
ANSI/AAMI/ISO 81060‐2:2009 Non‐invasive sphygmomanometers Part 2: Clinical validation of automated
measurement type
FCC statement
Federal Communications Commission (FCC) Statement 15.21
You are cautioned that changes or modifications not expressly approved by the part responsible for
compliance could void the user’s authority to operate the equipment.
15.105(b)
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that interference will not occur
in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
-Consult the dealer or an experienced radio/TV technician for help.
