Manufacturerʼs declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment
The WH-001 is intended for use in the electromagnetic environment (for profe-
ssional healthcare) specified below.
The customer or the user of the WH-001 should assure that it is used in such an
environment.
Test
Frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modula-
tion
b)
Maximum
Power
(W)
Dis-
tance
(m)
Immunity
Test
Level
(V/m)
Compliance
Level
(V/m)
(for
professional
healthcare)
385
380-390 TETRA 400
Pulse
modula-
tion
b)
18 Hz
1.8
0.3
27
27
450
430-470
GMRS 460,
FRS 460
FM
c)
±
5 kHz
deviation
1 kHz sine
2
0.3
28
28
704-787 LTE Band
13, 17
Pulse
modula-
tion
b)
217 Hz
0.2
0.3
9
9
710
745
780
800-960
GSM 800/
900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modula-
tion
b)
18 Hz
2
0.3
28
28
810
870
930
1700-
1990
GSM 1800,
CDMA 1900,
GSM 1900,
DECT,
LTE Band
1, 3, 4, 25,
UMTS
Pulse
modula-
tion
b)
217 Hz
2
0.3
28
28
1720
1845
1970
2450
2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n,
RFID 2450,
LTE Band 7
Pulse
modula-
tion
b)
217 Hz
2
0.3
28
28
5100-
5800
WLAN
802.11
a/n
Pulse
modula-
tion
b)
217 Hz
0.2
0.3
9
9
5240
5500
5785
NOTE
If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the trans-
mitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1
m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used
because while it does not represent actual modulation, it would be worst case.
IFU-1801
EN 2020-09 rev.5.7
-7-
-8-
-9-
N.【Symbols Description】
Symbol
Definition
SN
The warning signs or patterns marked on the label of this manual or the
outer box are intended to maintain the safety of its use and to prevent the
user or others from being injured or property damage in advance.
Serial number
Remark: Please check the warnings and precautions
Single-use only and used it for sterilization bag of cassette
(Do not reuse it)
Contact with electric shock protection
(Do not contact with the heart)
Double insulation
Non-general household waste
Manufacturer name and address
Date of manufacture (year/month/day)
Do not use if the package is damaged
Maximum and minimum temperature
Please read the instructions before use
Manufacturing batch number
Catalogue number
REF
LOT
European Authorized Representative
REP
Recommended separation distance between portable and mobile RF
communications equipment and the WH-001
The WH-001 is intended for use in an electromagnetic environment (for profe-
ssional healthcare) in which radiated RF disturbances are controlled. The cus-
tomer or the user of the WH-001 can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF commu-
nications equipment (transmitters) and the WH-001 as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of
transmitter
m
150 kHz to 80 MHz
= 1.2√
80 MHz to 800 MHz
= 1.2√
800 MHz to 2.7 GHz
= 2.3√
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance
in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where
is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
Winnoz Technology, Inc.
5F.-1 No.238, Liancheng Rd., Zhonghe Dist., New Taipei City
235, Taiwan
Telephone: +886 2 2221 7879
Website: www.winnoz.com
Email: [email protected]
Winnoz Technology, Inc. has entrusted Gigatek Inc. for manufacturing.
Made in Taiwan
R.O.C. (Taiwan) Patent： I652463
U.S. Patent：10,136,848
European Patent：EP3445311
MedNet EC-REP GmbH
Borkstrasse 10,
48163 Muenster, Germany
EC REP
IVD
®
