User's Manual

Transport and storage
Suggestion
Normal body temperature range for different
measurement body part
Symbols information
1. The device transport and storage should be under
temperature control：Humidity -20°C-55°C，relative
humidity≤93%, no condensation environment.
2. Must do package transport simulation test after device
package, will allow to use ordinary transport but must avoid
rain, moist, extrusion and collision.
3. The device must not be stored or used at an excessively
high or low temperature or humidity (see technical data), in
sunlight, in association with an electrical current or in dusty
locations. Otherwise inaccuracies can occur.
Type BF applied part
Attention and read before use
Indicates the medical device manufacturer
Indicates the authorized representative in the European community
The device against ingress of solid foreign objects≥12.5mm
diameter and water (15 titled)
Refer to instruction manual
Please dispose of the device / battery / packing in accordance with
the legal obligation in your area.
Serial number
o
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P 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.
Guidance and manufacturer’s declaration–electromagnetic emission
The E127B Infrared Thermometer 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.
Electromagnetic environment - guidance
The E127B Infrared Thermometer uses RF
energy only for its internal function.
Therefore, its RF emissions are very low and
are not likely to cause any interference in
nearby electronic equipment.
The E127B Infrared Thermometer is suitable
for use in all establishments, including
domestic establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
Emission test
RF emissions
CISPR 11
RF emission
CISPR 11
Harmonic emissions
IEC/EN61000-3-2
Voltage fluctuations
/flicker emissions
IEC/EN61000-3-3
Compliance
Group 1
Class B
Not applicable
Not applicable
Guidance and manufacture’s declaration–electromagnetic immunity
The E127B Infrared Thermometer 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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical Fast
Transient/Burst
IEC/EN61000-4-4
IEC 60601
test level
±8kV contact
±15kV air
±2kV for power
supply lines
±1kV for input/
output lines
Compliance level
±8 kV contact
±15 kV air
Not applicable
Electromagnetic
environment-guidance
Floors should be
wood, concrete or
ceramic tile. If floor are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Not applicable
Surge
IEC/EN61000-4-5
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC/EN61000-4-11
Power frequency
(50Hz/60Hz)
magnetic field
IEC61000-4-8
±1kV line(s) to
line(s)
±2kV line(s) to earth
<5%UT(>95% dip
in UT) for 0.5cycle
40%UT(60%dip in
UT) for 5 cycles
70%UT(30%dip in
UT) for 25 cycles
<5%UT(>95% dip
in UT) for 5s
30 A/m
Not applicable
Not applicable
30 A/m
Not applicable
Not applicable
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Guidance and manufacture’s declaration–electromagnetic immunity
The E127B Infrared Thermometer 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
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
IEC 60601
test level
3 Vrms
150kHz~80MHz
6Vrmsc)in ISM
bands between
0,15MHz and
80MHz
10V/m
80MHz~2.7GHz
Compliance level
3 Vrms
150kHz~80MHz
6Vrmsc)in ISM
bands between
0,15MHz and
80MHz
10V/m
80MHz~2.7GHz
Electromagnetic
environment-guidance
Portable and mobile RF
communications
equipment should be used
no closer to any part of the
E127B Infrared
Thermometer, including
cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the
transmitter.
Recommended separation
distance:
d=1.2 P
150kHz to 80MHz
d=1.2 P
80MHz to 800MHz
d=2.3 P
800MHz to 2.7GHz
d=6 /E at RF wireless
communications
equipment bands
(Portable RF
communications
equipment (including
peripherals such as
antenna cables and
external antennas) should
be used no closer than
30cm (12 inches) to any
part of the E127B
Infrared Thermometer,
including cables specified
by the manufacturer).
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed
RF transmitters, as
determined by an
electromagnetic site
survey, a should be less
than the compliance
level in each frequency
range. b Interference may
occur in the vicinity of
equipment marked with the
following symbol:
NOTE 1: At 80 MHz and 800 MHz, 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.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength
in the location in which the E127B Infrared Thermometer is used exceeds the
applicable RF compliance level above, the SD1Ultrasonic Doppler should be
observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the
E127B Infrared Thermometer.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than
3V/m.
c. The ISM (industrial, scientific and medical) bands between 0,15MHz and 80MHz
are 6,765MHz to 6,795MHz; 13,553MHz to 13,567MHz; 26,957MHz to 27,283MHz;
and 40,66MHz to 40,70MHz. The amateur radio bands between 0,15MHz and
80MHz are 1,8MHz to 2,0MHz, 3,5MHz to 4,0MHz, 5,3MHz to 5,4MHz, 7MHz to
7,3MHz, 10,1MHz to 10,15MHz, 14MHz to 14,2MHz, 18,07MHz to 18,17MHz,
21,0MHz to 21,4MHz, 24,89MHz to 24,99MHz, 28,0MHz to 29,7MHz and 50,0MHz
to 54,0MHz.
BIOLAND TECHNOLOGY LTD.
A6B7(Block G),Shangrong Industrial Zone,
No.5 Baolong Road,Baolong Community
Longgang District,518116 Shenzhen,Guangdong
PEOPLE'S REPUBLIC OF CHINA
Date of issue and Revision: 2018.12 /A1
EMC statement
FCC Requirement
Operation temperature limit
Date of manufacture
This device has been tested and homologated in accordance
with EN for EMC. This does not guarantee in any way that the
device will not be affected by electromagnetic interference.
Avoid using the device in high electromagnetic environment.
Recommended separation distances between portable and mobile RF
communications equipment and the E127B Infrared Thermometer.
The E127B Infrared Thermometer is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the
user of the E127B Infrared Thermometer can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the E127B Infrared Thermometer 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
d=1.2 P
80 MHz to 800 MHz
d=1.2 P
800 MHz to 2.5 GHz
d=2.3 P
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
35°C
16°C
a. When you tell the doctor about the measured temperature,
please indicate that you are measuring with an infrared
thermometer.
b. Do not force or fall or step on the thermometer.
c. Do not disassemble or repair the thermometer.
d. The product is not waterproof, please be careful not to let
liquid (alcohol, water droplets, hot water, etc.) enter inside.
e. The product must be kept clean and dry.
f. If you find any problems, you should contact the seller and
you cannot repair the product yourself.
g. Do not use in an electromagnetic interference environment.
h. Dispose of waste and residue at the end of its useful life in
accordance with local laws and regulations.
Body part
Anus
Oral cavity
Underarm
Ear
Normal temperature℃
36.6-38.0
35.5-37.5
34.7-37.3
35.8-38.0
Normal temperature℉
97.8-100.4
95.9-99.5
94.4-99.1
96.4-100.4
Age
0-2 years old
3-10 years old
11-65 years old
>65 years old
Normal temperature℃
36.4-38.0
36.1-37.8
35.9-37.8
35.8-37.5
Normal temperature℉
97.5-100.4
97-100.0
96.6-99.7
96.4-99.5
People's body temperature varies with different times of the
day, and is also affected by other external conditions, such as
age, gender, and skin color.
Normal body temperature range for different age
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to
operate the equipment.
This device complies with Part 15 of the FCC Rules. Operation
is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired operation.
Note: This equipment has been tested and found to comply
with the limits for a Class B digital device, pursuant to Part 15
of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and
can radiate radio frequency energy, and if not installed and
used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no
guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference
to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following
measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit different
from that to which the receiver is connected.
– Consult the dealer or an experienced radio/TV technician for
help.
This equipment complies with FCC radiation exposure limits
set forth for an uncontrolled environment. This equipment
should be installed and operated with a minimum distance of
20cm between the radiator & your body. This transmitter must
not be co-located or operating in conjunction with any other
antenna or transmitter.