Vitalograph ALPHA Touch - 15 FDA Notice

32Page of 36
ENG
DT_0006 Issue 15
A Global Leader in Respiratory Solutions
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5%100V(>95% dip
in100V) for 0,5 cycle
40 %100V(60% dip in100V)
for 5 cycles
70 %100V(30% dip in100V)
for 25 cycles
<5%100V(>95% dip
in100V) for 5 sec
Performance A
Performance A
Performance A
Performance A
Conducted RF
IEC61000-4-6
3 Vrms
150kHz to 80 MHz in ISM
bands
3 Vrms
150kHz to 80 MHz in ISM
bands
Radiated RF
EN 61000-4-3
3 V/m
80MHz to 2700MHz
3 V/m
80MHz to 2700 MHz
Warning: In the unlikely event of an electrostatic discharge causing the
ALPHA Touch to switch off, the device should be turned off and then on
again using the power switch.
Medical Devices may be affected by mobile RF communications equipment
including cellular telephones and other personal or household devices not
intended for medical facilities. It is recommended that all equipment used near
the Vitalograph product comply with the medical electromagnetic compatibility
standard and to check before use that no interference is evident or possible. If
interference is suspected or possible, switching off the offending device is the
normal solution, as is required in aircraft and medical facilities.
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided.
15. FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order of a
physician.