User's Guide

108 109
* Declaration of EMC compatibility
The Diabecare DANA-i insulin pump is intended for use in the electromagnetic environment
and comply with the United States Federal Communications Commission and international
standards for electromagnetic compatibility.
Phenomenon Basic EMC standard
or test method
Operating
mode
Port
tested
Test
Voltage
Electro
Radiated
disturbance
EN 55011:2016+A1: 2017
CISPR11: 2015
Injection
mode
Enclosure DC 1.5V Group1, Class B
Electrostatic
Discharge
Immunity
EN 61000-4-2: 2009
IEC 61000-4-2: 2008
Injection
mode
Enclosure DC 1.5V ±8Kv/ Contact
±2, ±4, ±8, ±15Kv/Air
Radiated RF
Electromagnetic
Field Immunity
EN 61000-4-3:
2016+ A2:2010
IEC 61000-4-3:
2006+A1:2007+A2:2010
Injection
mode
Enclosure DC 1.5V 10V/m
80MHz – 2.7GHz
80% AM at 1kHz
Immunity to
Proximity Fields
from RF wireless
Communications
Equipment
EN 61000-4-8: 2010
IEC 61000-4-8: 2009
Injection
mode
Enclosure DC 1.5V Table 9 in IEC
60601-1-2:2014
Power
Frequency
Magnetic Field
Immunity
EN61000-4-8: 2010
IEC 61000-4-8: 2009
Injection
mode
Enclosure DC 1.5V 30A/m
50Hz & 60Hz
7. Wireless communication
* DATA Security
The Diabecare DANA-i system ensure data security via proprietary means and ensure data
integrity using error checking processes, such as cyclic redundancy checks.