B - 2
BeneVision N1 Patient Monitor Operator’s Manual
•
When the inputted signal is below the minimum amplitude provided in technical specifications,
erroneous measurements could result.
•
The EMISSIONS characteristics of this device make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required) this device might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating or re-orienting the
device.
•
If the essential performance is lost or degraded, it may be necessary to take mitigation measures,
such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM or shielding the location or
stopping using the monitor and contact the service personnel.
If the device is operated within the electromagnetic environment listed in Table
Guidance and Declaration —
Electromagnetic Immunity
, the system will remain safe and provide the following essential performance:
■
Operating mode
■
Accuracy
■
Function
■
Accessories identification
■
Data stored
■
Alarm
■
Detect for connection
Guidance and Declaration - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device
should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15kV air
±8 kV contact
±15kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
(length greater than 3
m)
±2 kV for power
supply lines
±1 kV for input/
output lines
(length greater than 3
m)
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Voltage dips and
Voltage interruptions
IEC 61000-4-11
0 % U
T
for 0,5 cycle
0 % U
T
for 1 cycle and
70 % U
T
for 25/30
cycles
0 % U
T
for 250/300
cycle
0 % U
T
for 0,5 cycle
0 % U
T
for 1 cycle and
70 % U
T
for 25/30
cycles
0 % U
T
for 250/300
cycle
Mains power quality should be that of a
typical commercial or hospital environment. If
the user of our product requires continued
operation during power mains interruptions,
it is recommended that our product be
powered from an uninterruptible power
supply or a battery.
RATED power
frequency
magnetic fields
IEC 61000-4-8
30 A/m
50 Hz / 60 Hz
30 A/m
50 Hz / 60 Hz
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Note: U
T
is the AC mains voltage prior to application of the test level.
