Romed-Holland THERM-IR User manual

Thank you for purchasing the Romed Infrared Forehead Thermometer.
Be sure to read this Instruction Manual before using the unit in order to use it safely it safely and
correctly. The instruction manual should be well kept for your reference at any time.
H O L L A N D
H O L L A N D
USER MANUAL
INFRARED FOREHEAD THERMOMETER
: THERM-IR
www.biomark.lv

 There are no contraindications
 You should stop using the device and should consult with your physicians if you experience
adverse reactions caused by the device the device.
 This device can be applied to all people. No special training is needed, but the user shoul
read the manual carefully before use.
1. Foreword
2. Device Description
3. Instructions for Use
4. Specifications
5. Cleaning and Disinfection
6. Maintenance
7. Trouble Shooting
8. Disposal
9. Electromagnetic Compatibility
INDEX
1
2
4
7
8
8
8
9
9
www.biomark.lv

1 FOREWORD
WARNINGS
● This unit is used for temperature measurement and not for disease diagnosis; it cannot be
used for emergency and continuous measurement in surgery. The patients cannot diagnose
the disease and get treatment by themselves on the basis of the measurement results, they
must follow the instruction of doctors. Please ask medical professionals to explain the
measured value of the body temperature.
● The main material of the enclosure is plastic. Be careful to the potential allergic reactions to
these materials.
● Please do not use with infectious wound.
● Please do not touch or blow on the infrared sensor.
● No mobile phones are allowed to be used around this product. Please do not use equipment
that generates electromagnetic fields near the product.
● The use of heat and cold producing devices (such as electric heating blankets, heating pads
or ice packs) may impair the performance of the device and increase the risk of injury to the
patient.
● Do not store the unit under sunlight, at a high temperature, in high humidity or dust.
Performance may be degraded.
● Please do not disassemble or repair this device by yourself including modifying the device.
● Please do not clean or perform maintenance on the device while in use.
● Please wait for 30 minutes before use if the environment has a sudden change (e.g. from
under sunlight to an air-conditioned room), or the accuracy may be influenced.
● Degraded sensors and electrodes, or loosened electrodes, can degrade performance or
cause other problems.
● DO NOT open the battery cover around any source of ignition which has the potential to ignite
the batteries and cause a fire.
● Please keep the device out of reach of infants, children or pets, inhalation or swallowing of
small parts is dangerous or even fatal.
PRECAUTIONS
● This product is intended to be used by lay users. It is not intended to be used by children
under 12 years. The user can take measurements and change the battery under normal
circumstances and can maintain the device and its accessories according to the user manual.
● Please do not bend, or stretch, hit, drop this device or expose this device to heavy shock.
● Performance of the device may be degraded if: operated or stored outside stated temperature
and humidity ranges or if the patient's temperature is below the room temperature. If the
thermometer has been stored at below freezing temperatures, please warm it naturally to
roomtemperature before use.
● Clean the thermosensor (probe) before storage.
1
www.biomark.lv

2 DEVICE DESCRIPTION
PRODUCT INSTRUCTION
The Romed Infrared Forehead Thermometer is intended to measure human body temperature by
measuring at the forehead. It is suitable for displaying the body temperature by measuring the
heat radiation fromthe forehead.
Probe: Type BF Applied part
Serial number
Batch code
Catalogue number.
CE Mark
Date of manufacture
Manufacturer
Keep dry
Keep away from sunlight
Temperature limit
Collect separately from other household waste
IP classification
Refer to user manual
Consult instructions for use
Caution
2
www.biomark.lv

COMPONENTS/ACCESSORIES
1. LCD Display
2. Temperature / Memory Button
3. Power / Mode Button
4. Thermosensor
5. Distance Sensor
6. Battery Cover
7. Body Mode Indicator
8. Object Mode Indicator
9. Temperature reading / distance indicator
10. °C / °F / CM
11. Memory Indicator
12. Memory Times / Remaining time
13. Battery Charge
14. Measure Distance
15. Batteries
3
www.biomark.lv

3 INSTRUCTIONS FOR USE
1. Press the battery cover and it will bounce open
automatically. Prepare 2 pieces of 1.5V AAA batteries, install
them into the battery chamber according to correct positive
and negative poles and close the cover.
2. Press and release the power button once. Backlight will
come on and the start-up sequence will begin. When the
thermometer is ready and correctly positioned, a horizontal
line of dashes (“- - -”) will appear on the screen.
Remark: The environmental
temperature variation can significantly
affect the device measurement
accuracy. This device can detect the
environmental temperature. If the
fluctuation goes beyond the normal
range (e.g. the device is moved from the outside to a room winter or the other way round during
winter), or the environmental temperature goes beyond 10°C-40°C (50°F-104°F), the device
would display "Err". To avoid such "Err", leave the device for 30 minutes before operation if it is
moved from different environment and make sure the device always works in the correct range
temperature.
3. Position thermometer up to 3 cm away from the centre of the
forehead, just between the eyebrows. If the eyebrow area is
covered with hair, sweat or dirt, please clean the area beforehand to
improve the reading accuracy. It is important to hold the
thermometer and the forehead steady during measurement.
Movement will impact the temperature reading.
4. Press the temperature button. When the thermometer is placed correctly, the display shows the
temperature reading. The appropriate fever light colour is displayed on screen and the
confirmation beep is heard. If the thermometer is positioned too far away from the forehead, it will
prompt you to move the thermometer closer by displaying diagram and “0-3 cm”. Slowly move the
thermometer toward the forehead until
hear the beep sound and the
temperature reading is displayed.
Backlight will remain on 5 seconds
and auto turn off. 4
www.biomark.lv

5. Read the temperature. If the temperature
range is < 32°C or > 43°C, you can hear a single
short beep. For normal (green backlight) and low
fever (yellow backlight) temperature range, you
will hear a single long beep for 1 second. For
high fever (red backlight) temperature range, you
will hear 10 short beeps. Backlight will remain on
5 seconds and auto turn off.
To keep each measurement accurate, the
thermometer requires a 5-second interval
between measurements. The user can see the
countdown from 5 to 0 in screen. To repeat the
measurement go to step 3.
FEVER GUIDANCE FEATURE
Fever guidance helps you to better understand the meaning of the temperature with the colour
indicated on the display. The screen displays green is normal, yellow when the temperature is low
fever and a red alert for a possibly high fever. 10 audible beeps indicate temperatures above 38.5
°C (101.3 °F) to alert the user that the patient may have a fever.
Backlight ColourTemperatureMeaning
Green<37.5°C Normal
Yellow ≥37.5°C and ≤38.5°C Low fever
Red >38.5°C High fever
SWITCHING BETWEEN TEMPERATURE SCALES
In the battery chamber, press the °F / °C change
button to switch between Fahrenheit degree (°F)
and Celsius degree (°C) .
5
5 sec. interval
Normal
Green
Low fever
Yellow
High fever
Red
fever guidance
www.biomark.lv

VIEW MEMORY STORAGE
In OFF status, press the temperature button, the screen will display 30
groups of measurement in reverse order. Switch the display value by
pressing the temperature button. Thermometer stores body temperature
only, no object temperature. It will turn off automatically without operating for
approx. 30 seconds or press power button to turn off.
In the memory view interface, press and hold the measurement button for
approx. 5 seconds to display "CLR" and delete the all memories.
CHANGING MEASUREMENT MODE
In the ON status, press the power button to switch between the object
mode and the body temperature mode. Object mode is able to measure
the surrounding environment or object temperature.
To ensure the accuracy of measurement, please do not conduct
forehead measurement in object mode. No matter what mode it is before
turning off, its default is always body mode after power on.
6
www.biomark.lv

4 SPECIFICATIONS
Product Name Infrared Forehead Thermometer
Model THERM-IR
Power Consumption Max. 50 mW in measurement mode
Rating 2×1.5V AAA alkaline batteries
Battery Life More than 1000 Times of continuous operation
Auto Power-off Approx 30 seconds
Dimension 149(L) x 34(W) x 52(H) mm
Weight Approx 95g (excluding batteries)
Display Screen Green <37.5°C Normal
Yellow ≥37.5°C and ≤38.5°C Low fever
Red ＞38.5°C High fever
Measurement Range Body Mode 32°C ~ 43°C (89.6°F ~ 109.4°F)
Object Mode 0°C ~ 100°C (32°F ~212°F)
Measurement Mode Body Mode / Object Mode
Minimum Scale 0.1°C/0.1°F
Measurement
Accuracy
±0.2°C, for range 35.0°C ~ 42.0°C
±0.3°C, outside this temperature range at standard room temperature of
25°C (77.0°F)
Memory 30 recorded measurements
Button 3 buttons: Power/Model Button, Measurement/Memory Button, °C / °F
Button
Alarm Sound when peak temperature reached
Calibration No need for calibration before use. To ensure the measurement accuracy,
please use and store the device in appropriate environment described
below.
Working Environment Temperature: 15°C ~ 40°C (59°F ~ 104°F)
Relative humidity: 15%RH-93%RH
Pressure: 70KPa to 106KPa
Storage and
Transportation
Environment
Temperature: -25°C ~ 60°C (-13°F ~ 140°F)
Relative humidity: 0%RH-90%RH, non-condensing
Pressure: 70KPa to 106KPa
Expected Service Life 5 years
7
www.biomark.lv

5 CLEANING AND DISINFECTION
●For the thermosensor (probe): if there is dust or other dirt in the mirror or tunnel of the sensor,
clean the probe with a cotton swab dipped in anhydrous alcohol. Don't place the product
directly under the faucet to wash.
●For the product itself: please wipe the product with a soft and dry cloth to avoid scratching of
the product. Do not clean the product directly with water.
●Because infrared temperature adopts a highly sensitive technique to detect the temperature of
the target object, any dust layer not only may affect the measurement accuracy, but also may
cause a bacterial infection.
6 MAINTENANCE
●Before every use, check the device. Do not use the device if it is damaged in any way. The
continuous use of a damaged unit may cause injury, improper results, or serious danger.
●Store and use the device at a cool, dry and ventilated environment. Avoid approaching fire
and heat sources, or it will cause the battery to explode.
●If you have any problems with this device, such as setting up, maintaining or using, or in the
case of an unexpected operation or event, please contact Van Oostveen Medical B.V ( don’t
open or repair the device by yourself).
7. TROUBLESHOOTING
Problem Possible causesTry this Solution
If the steady battery icon is the
only symbol shown on the display,
the device cannot work. The
battery should be replaced
immediately.
Replace batteries
No display. Thermometer does not
have power.
Please check if the batteries have been
loaded correctly or are out of power.
Also check polarity (<+> and <–>) of
batteries. Contact customer service if
thermometer still does not function.
8
www.biomark.lv

This message displays when the
measured temperature is lower
than 32 °C (89.6 °F) in the body
mode.
Re-measure the temperature carefully
following the instructions in “Instructions
for use” section.
This message displays when the
measured temperature is higher
than 43 °C (109.4 °F) in the body
mode.
This message displays when the
room temperature is outside the
operating range of 10 °C – 40 °C
(50 °F – 104 °F).
Please wait for 30 minutes before use if
the fluctuation goes beyond the normal
range ( e.g. from outside to a room in
winter or from under sunlight to an air-
conditioned room), carefully following the
instructions about Working Environment
in the "Specifications" section.
8 DISPOSAL
DO NOT dispose the batteries in domestic waste. Dispose of the batteries
according to the local regulations dealing with the disposal of these special
materials (e. g. to the collecting points).
The device is made of a combination of plastic and stainless steel. Be sure to
dispose of it in accordance with local regulations as unsorted municipal waste. You
may recycle it at your local community or appliance recycling centre.
9 ELECTROMAGNETIC COMPATIBILITY
The Romed Infrared Forehead Thermometer has been tested and found to comply with the
electromagnetic compatibility (EMC) limits for medical devices. These limits are designed to
provide reasonable protection against harmful interference in a typical medical installation.
CAUTION:
Do not use this device simultaneously with devices having high EMI levels.
9
www.biomark.lv

MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS
The Romed Infrared Forehead Thermometer is intended for use in the electromagnetic environments specified
be
low. The customer or the user of the Romed Infrared Forehead Thermometer should assure that it is used in
such an environment.
Emission test
Compliance
Electromagnetic environment-guidance
R
F emissions
C
ISPR 11
G
roup 1
The Romed Infrared Forehead Thermometer uses RF energy
on
ly for its internal function. Therefore, its RF emissions are very
l
ow and are not likely to cause any interference in nearby
e
lectronic equipment.
RF emissions
CISPR 11
C
lass B
T
he Romed Infrared Forehead Thermometer is suitable for use
i
n all establishments, including domestic establishments and
t
hose directly connected to the public low-voltage power supply
ne
twork that supplies buildings used for domestic purposes.
H
armonic emissions
I
EC 61000-3-2
C
lass A
V
oltage fluctuations/flicker
e
missions
I
EC 61000-3-3
C
omplies
MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
The Romed Infrared Forehead Thermometer is intended for use in the electromagnetic environment specified
be
low. The customer or the user of The Romed Infrared Forehead Thermometer should assure that it is used
in such an environment.
I
mmunity test
I
EC 60601 test level
C
ompliance level
Electromagnetic environment -
guidance
E
lectrostatic
d
ischarge (ESD)
I
EC 61000-4-2
±
8 kV contact
±
2 kV, ± 4 kV,
±
8 kV, ± 15 kV air
±
8 kV contact
±
2 kV, ± 4 kV,
±
8 kV, ± 15 kV air
Floors should be wood, concrete
o
r ceramic tile. If floors are
c
overed with synthetic material,
t
he relative humidity should be at
least 30%.
E
lectrostatic
t
ransient / burst
I
EC 61000-4-4
±
2kV for power supply lines
±
1kV for input/output lines
N
ot applicable
N
ot applicable
S
urge
I
EC 61000-4-5
±
1kV differential mode
±
2kV common mode
N
ot applicable
N
ot applicable
Voltage dips, short
i
nterruptions and
v
oltage variations
on
power supply
i
nput lines
IEC 61000-4-11
<
5% UT (>95% dip
i
n UT) for 5 sec
N
ot applicable
N
ot applicable
P
ower frequency
(
50/60 Hz)
m
agnetic field
I
EC 61000-4-8
30
A/m
30
A/m
P
ower frequency magnetic fields
s
hould be at levels characteristic
o
f a typical location in a typical
c
ommercial or hospital
en
vironment.
N
OTE UT is the AC mains voltage prior to application of the test level.
10
www.biomark.lv

MANUFACTURER’S DECLARATION – ELECTROMAGNETIC
The Romed Infrared Forehead Thermometer is intended for use in the electromagnetic environment
specified below. The customer or the user of The Romed Infrared Forehead Thermometer should assure
that it is used in such an environment.
Immunity
test
IEC 60601
test level Compliance level Electromagnetic environment -guidance
Conducted
RF
IEC 61000-
4-6
Radiated
RF
IEC 61000-
4-3
3 Vrms 150kHz to
80MHz
6 Vrms in
ISM bands
3V/m 80MHz to
2.5GHz
385MHz-5786MHz
Test specification
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communication
equipment(refer
to table 9 IEC
60601-1-2:2
014)
Not applicable
Not applicable
3V/m
80MHz to 2.5GHz
385MHz-5786MHz
Test specification
for ENCLOSURE
PORT IMMUNITY
to RF
wireless
communication
equipment(refer to
table 9 IEC
60601-1-2:2014)
Portable and mobile RF communications
equipment should be used no closer to any
part of The Romed Infrared Forehead
Thermometer , including cables, than the
recommended
separation distance calculated from the
equation application to the frequency of the
transmitter.
Recommended separation distance
Where p is the maximum output power rating
of the transmitter in watts (W) according tothe
transmitter manufacturer and d is the
recommended separation distance in
metres(m).
Field strengths form 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 is affected by absorption and
reflection from structures, objects and people.
aField strengths from 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
Romed Infrared Forehead Thermometer is used exceeds the applicable RF compliance level above, The
Romed Infrared Forehead Thermometer should be observed to verify normal operation.If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating The
Romed Infrared Forehead Thermometer .
bOver the frequency range 150kHz to 80 MHz, filed strengths should be less than 3V/m.
11
www.biomark.lv

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE
RF communications equipment and the EQUIPMENT or SYSTEM
- For EQUIPMENT and SYSTMES that are not LIFE - SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and the
Romed Infrared Forehead Thermometer
The Romed Infrared Forehead Thermometer is intended for use in an electromagnetic environment in which
r
adiated RF disturbances are controlled. The customer or the user of the Romed Infrared Forehead
T
hermometer can help prevent electromagnetic interference by maintaining a minimum distance between
po
rtable and mobile RF communications equipment (transmitters) and the Romed Infrared Forehead
T
hermometer as recommended below, according to the maximum output power of the communications
equipment.
R
ated maximum
ou
tput of
t
ransmitter
(
W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0
.01
0
.12
0
.12
0
.23
0
.1
0
.38
0
.38
0
.73
1
1
.2
1
.2
2
.3
1
0
3
.8
3
.8
7
.3
10
0
1
2
1
2
2
3
For transmitters rated at a maximum output power not listed above the recommended separation distance d in
m
eters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
m
aximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
N
OTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
N
OTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
12
+15°C
+40°C
-25°C
+60°C
Working
Environment
Storage and
Transport
Environment
: THERM-IR
VAN OOSTVEEN MEDICAL B.V.
ROMED - HOLLAND
HERENWEG 269
3648 CH WILNIS
THE NETHERLANDS
WWW.ROMED.NL
V001,2020-10
www.biomark.lv