Other Standards And Compliances; Electromagnetic Compatibility Information - iHealth ECG3 Owner's Manual

compliance with safety and regulatory standards. Please note that the use of this
accessory with iPad may affect wireless performance.
iHealth is a trademark of iHealth Labs Inc.
Manufactured for iHealth Labs Inc.
120 Sun Lucar Ct., Sunnyvale, CA 94086, USA
+1-855-816-7705
www.ihealthlabs.com
iHealthLabs Europe SARL
EC REP 3 Rue Tronchet,75008,Paris,France
support@ihealthlabs.eu
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China
Tel: 86-22-60526161

OTHER STANDARDS AND COMPLIANCES

The Portable ECG monitor corresponds to the following standards: IEC 60601-1:2005
+A1:2012(E)/EN 60601-1:2006/A1: 2013 (Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance), IEC 60601-1-2:2014(Medical
electrical equipment -- Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and
Tests), ISO60601-2-47:2001 ( Medical Electrical Equipment -- Part 2-47: Particular
Requirements For The Basic Safety And Essential Performance Of Ambulatory
Electrocardiographic).

ELECTROMAGNETIC COMPATIBILITY INFORMATION

This product is applicable to the equipment and system requirements for the purpose of
receiving radio frequency energy for the purpose of the work, Bluetooth low energy receive
bandwidth 2M. This product can also be used to include RF transmitter equipment and
system requirements and emission frequency of 2.4GHz ISM band, BLE modulation types:
GFSK, effective radiated power: < 0dBm
Phenomenon
RF emissions
Harmonic
distortion
Voltage
fluctuations and
flicker
www.ihealthlabs.eu
Table 1 - Emission
Compliance
CISPR 11 Home healthcare environment
Group 1, Class
B
IEC 61000-3-2 Home healthcare environment
Class A
IEC 61000-3-3 Home healthcare environment
Compliance
Electromagnetic environment
12