Path medical Senti, User Manual

Page: 42 / 44

Page 42 / 44
Tests for immunity
to interference
IEC 60601 test level Concurrent level Electromagnetic environment
±2 kV voltage outer
conductor – earth ±2 kV voltage outer
conductor – earth (for
Sinpro MPU16C)
Voltage drop, short
interruption and
fluctuation of supply
voltage according to
IEC 61000-4-11 0 % U
T
(>95 % U
T
drop)
for ½ and 1 period
0 % U
T
for 300 periods
70 % U
T
(30 % U
T
drop)
for 30 periods
0 % U
T
(>95 % U
T
drop)
for ½ and 1 period
0 % U
T
for 300 periods
70 % U
T
(30 % U
T
drop)
for 30 periods
The quality of supply voltage shall
correspond to typical hospital or
commercial environment.
If the user of the medical electric
device also demands continued
proper functioning of the device
during an interruption of energy
supply, the connection of the
device to an uninterrupted power
supply (UPS) or battery is
recommended.
Magnetic field at
mains frequency
(50/60 Hz) according
to IEC 6000-4-8 30 A/m 30 A/m Magnetic fields at the mains
frequency shall correspond to
typical hospital or commercial
environment.
Note: U
T
is the mains AC voltage before applying the test level.
Table 6: Compliance with immunity to interference tests and resulting requirements for
electromagnetic environment
The user must take care, that the device is used in an environment with minimum distances
to potential radiators as described in
Table 7 .
Tests for immunity
to interference
IEC 60601 test level Concurrent level Electromagnetic environment
Conducted high-
frequency disturbance
according to IEC
61000-4-6 3 V
(150 kHz – 80 MHz)
6 V
(ISM frequencies)
3 V
6 V
Portable and mobile radio units
shall not be used closer than 30
cm (12‘’) to the device and its
components (i.e. connected
cables).
Radiated high-
frequency disturbance
according to IEC
61000-4-3 3 V/m
(80 MHz – 2.7 GHz)
9-28 V/m*
(wireless RF
communication)
3 V/m
9-28 V/m*
Portable and mobile radio units
shall not be used closer than 30
cm (12‘’) to the device and its
components (i.e. connected
cables).
* Wireless RF communication frequencies and levels:
28 V/m: 450 MHz, ±5 kHz FM, 1 kHz sine; 810 MHz, 50% PM at 18 Hz; 870 MHz, 50% PM at 18 Hz; 930 MHz,
50% PM at 18 Hz; 1720 MHz, 50% PM at 217 Hz; 1845 MHz, 50% PM at 217 Hz; 1970 MHz, 50% PM at 217 Hz;
2450 MHz, 50% PM at 217 Hz;
27 V/m: 385 MHz, 50% PM at 18 Hz;
9 V/m: 710 MHz, 50% PM at 217 Hz; 745 MHz, 50% PM at 217 Hz; 780 MHz, 50% PM at 217 Hz; 5240 MHz,
50% PM at 217 Hz; 5500 MHz, 50% PM at 217 Hz; 5785 MHz, 50% PM at 217 Hz;
Table 7: Minimum distance to potential radiators