Chapter 9: Annex
127
Guidance and manufacturer’s declaration - electromagnetic immunity
Immunity tests
IEC 60601 test level Compliance level
Electromagnetic envi-
ronment - guidance
Rapid transient dis-
turbances/bursts as
per
IEC 61000-4-4
± 2 kV for power
cables
± 1 kV for input and
output cables
± 2 kV for power
cables
± 1 kV for input and
output cables
The quality of the supply
voltage should corre-
spond to one of the typ-
ical business or hospital
environments.
Surges
as per
IEC 61000-4-5
± 1 kV voltage
Outer conduc-
tor-outer conductor
± 2 kV voltage outer
conductor-earth
± 1 kV voltage outer
conductor-outer
conductor
± 2 kV voltage outer
conductor-earth
The quality of the supply
voltage should corre-
spond to one of the typ-
ical business or hospital
environments.
Conducted
HF disturbances as
per
IEC 61000-4-6
3 V
Effective value
150 kHz – 80 MHz
6 V
Effective value
in ISM
and amateur radio
bands between
150 kHz – 80 MHz
3 V
6 V
Portable and mobile radio
devices should be used
spaced at least at the sug-
gested safety distance to
the
TREND III
respiratory
therapy device, including
wires, which is calculated
using the equation for
transmission frequency.
Suggested safety dis-
tance: 0.3 m
Magnetic fields at
supply frequency
(50/60 Hz) as per IEC
61000-4-8
30 A/m
30 A/m
Magnetic fields at supply
frequency should corre-
spond to typical values
for business and hospi-
tal environments.
Summary of Contents for 5CPD10
Page 2: ......
Page 10: ...10 List of figures ...
Page 11: ...Chapter 1 Introduction 11 Chapter 1 Introduction ...
Page 21: ...Chapter 2 Safety Information 21 Chapter 2 Safety Information ...
Page 28: ...28 Chapter 2 Safety Information ...
Page 29: ...Chapter 3 Description of Device 29 Chapter 3 Description of Device ...
Page 36: ...36 Chapter 3 Description of Device ...
Page 37: ...Chapter 4 Commissioning 37 Chapter 4 Commissioning ...
Page 56: ...56 Chapter 4 Commissioning ...
Page 57: ...Chapter 5 Therapy Modes 57 Chapter 5 Therapy Modes ...
Page 65: ...Chapter 6 Operating the Device 65 Chapter 6 Operating the Device ...
Page 91: ...Chapter 7 Notifications Messages 91 Chapter 7 Notifications Messages ...
Page 95: ...Chapter 8 Cleaning and Disinfection 95 Chapter 8 Cleaning and Disinfection ...
Page 104: ...104 Chapter 8 Cleaning and Disinfection ...