126
Chapter 9: Annex
Guidance and manufacturer’s declaration - electromagnetic immunity
The TREND III respiratory therapy device is intended for operation in environments as described
below. The user of the Trend III respiratory therapy device must ensure it is operated in such an
environment.
Immunity tests
IEC 60601 test level Compliance level
Electromagnetic envi-
ronment - guidance
Discharge of static
electricity as per IEC
61000-4-2
± 8 kV contact dis-
charge
± 2, 4, 8, 15 kV air
discharge
± 8 kV contact dis-
charge
± 2, 4, 8, 15 kV air dis-
charge
± 2, 4, 8, 15 kV air dis-
charge display
Floors should be made of
wood or concrete, or be
lined with ceramic tiles.
If the floor is lined with
a synthetic material, the
relative humidity must be
at least 30%.
Emitted HF distur-
bances as per IEC
61000-4-3
10 V/m
80 MHz – 2.7 GHz
80% AM at 1 kHz
10 V/m
Portable and mobile HF
communication devices
(including wires and
antenna) should be
used at least 0.3 m (sug-
gested safety distance) to
the
TREND III
respiratory
therapy device.
27 V/m
385 MHz PM: 18 Hz
27 V/m
28 V/m
450 MHz
FM ± 5 Hz: 1kHz sine
28 V/m
9 V/m
710, 745, 780 MHz
PM:217Hz
9 V/m
28 V/m
810, 870, 930 MHz PM:
18 Hz
28 V/m
28 V/m
1720, 1845, 1970 MHz
PM: 217 Hz
28 V/m
28 V/m
2450 MHz PM:217Hz
28 V/m
9 V/m
5240, 5500, 5785
PM:217Hz
9 V/m
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 ...