User's Manual

EMC Guidance
1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in
the ACCOMPANYING DOCUMENTS.
2. Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this
equipment and should be kept at least a distance d = 3,3 m away from the equipment.
(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell
phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of
3 V/m)
Health Tips - About Calorie
The device uses your age, height, gender and an activity level setting to calculate
the estimated number of calories you can consume a day to maintain your present weight.
This estimation may gradually help you with a weight loss, gain or maintenance plan.
Appendix Appendix
24
25
Table 1 – Guidance and MANUF ACTURER ’ S declaration – ELECTROMAGNETIC EMISSIONS
for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration
– electromagnetic emissions
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.
Emissions test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Not applicable
Not applicable
The device must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment may be
affected.
Not applicable
Not applicable
Not applicable
Table 2 – Guidance and MANUFACTURER ’ S declaration – electromagnetic IMMUNITY –
for all
ME EQUIPMENT and ME SYSTEMS
Compliance level
Electromagnetic environment
–
guidance
± 6 kV contact
± 8 kV air
ro etercnoc ,doow eb dluohs sroolF
ceramic tile. If fl
oors are covered with
synthetic material, the relative humidity
should be at least 30 %.
a fo taht eb dluohs ytilauq rewop sniaM
typical commercial or hospital
environment.
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
a fo taht eb dluohs ytilauq rewop sniaM
typical commercial or hospital
environment.
<5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 s
sdleif citengam ycneu
qerf rewoP
m/A 3 m/A 3
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
device requires continued operation
during power mains interruptions, it
is recommended that the device be
powered from an uninterruptible
power supply or a battery.
Guidance and manufacturer’s 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.
IMMU NITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
lines