Disposal: The product must not be disposed of along with other domestic waste. The users must
dispose of this equipment by bringing it to a specific recycling point for electric and electronic equip-
ment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Recommended minimum separation distances
Nowadays, many RF wireless equipments have being used in various healthcare locations where med-
ical equipment and/or systems are used. When they are used in close proximity to medical equipment
and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be
affected. This device has been tested with the immunity test level in the below table and meet the related
requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance
between RF wireless communications equipment and this device as recommended below.
Test
frequency
(MHz)
Band
(MHz)
Service
Modulation
Maximum
power W)
Distance
(m)
Immunity
test level
(V/m)
385
380-390
TETRA400
Pulse modulation
18Hz
1,8
0,3
27
450
430-470
GMRS 460
FRS 460
FM ± 5 kHz
deviation
1 kHz sine
2
0,3
28
710
745
780
707-787
LTE Band
13, 17
Pulse modulation
217Hz
0,2
0,3
9
810
870
930
800-960
GSM 800/900
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse modulation
18Hz
2
0,3
28
1720
1845
1970
1700-1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse modulation
217Hz
2
0,3
28
2450
2400-2750
Bluetooth,
WLAN, 802.11
b/g/n, RFID
2450,
LTE Band 7
Pulse modulation
217Hz
2
0,3
28
5240
5500
5785
5100-5800
WLAN 802.11
a/n
Pulse modulation
217Hz
0,2
0,3
9
Guidance and manufacture’s declaration – electromagnetic immunity
The device is suitable for use in the specified electromagnetic environment and it has meets the follow-
ing immunity test levels. Higher immunity levels may cause the device’s essential performance lost or
degraded.
Phenomenon
Basic EMC standard
or test method
Professional
healthcare facility
environment
Home healthcare
facility environment
Electrostatic discharge
IEC 61000-4-2
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air
Radiated RF EM fields
IEC 61000-4-3
3V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
10V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
1kHz or 2Hz can be specified by the manufacturer
Proximity fields from RF
wireless communica-
tions equipment
IEC 61000-4-3
See the RF wireless communication equipment
table in “Recommended minimum separation dis-
tances
Rated power
frequency
magnetic fields
IEC 61000-4-8
30A/m; 50 Hz or 60Hz
Electric fast
transients bursts
IEC 61000-4-4
N/A
For input a.c. power port
d.c. power lines or signal input/output lines whose length exceeding 3m
Surges
IEC 61000-4-5
N/A
Conducted
disturbances
induced by
RF fields
IEC 61000-4-6
N/A
For 1. input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. all patient-coupled cables
4. SIP/SOP whose maximum cable length ≥ 3m
Voltage dips
IEC 61000-4-11
N/A
Voltage interruptions
IEC 61000-4-11
N/A
UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz
