Mediblink M340 User manual

EN
Mediblink Non-Contact Infrared Body Thermometer M340
INSTRUCTIONS FOR USE
Please read the instructions for use carefully before using the product
SLO
 Mediblinkbrezkontaktniinfrardečitermometerza
merjenje osebne temperature M340
NAVODILA ZA UPORABO
Prosimo, da pred uporabo izdelka v celoti preberete navodila za uporabo
HR
Mediblink bezkontaktni infracrveni termometar za
mjerenje tjelesne temperature M340
UPUTE ZA UPOTREBU
Pažljivo pročitajte upute prije upotrebe uređaja

2
EN
TABLE OF CONTENTS
Safety Information 6
1. Overview 9
2. Operation 15
3. Troubleshooting 20
4. Replacing the Battery 21
5. Cleaning, Care and Storage 22
6. Disposal 23
7. Warranty 24
8. EMC Declaration 26
9. Body Temperature 30

3
SLO
KAZALO
Varnostne informacije 33
1. Pregled 36
2. Uporaba 42
3. Odpravljanje napak 48
4. Zamenjava baterij 49
5. Čiščenje,vzdrževanjeinshranjevanje 50
6. Odstranjevanje 51
7. Garancija 52
8. Izjavavzvezizelektromagnetnozdružljivostjo 54
9. Telesna temperatura 59

4
CRO
SADRŽAJ
Sigurnosne informacije 61
1. Pregled 64
2. Korištenje 70
3. Otklanjanjepoteškoća 75
4. Zamjena baterije 76
5. Čišćenje,održavanjeiskladištenje 77
6. Odlaganje 78
7. Jamstvo 79
8. EMC deklaracija 81
9. Tjelesna temperatura 85

5
EN
Foreword
The Non-Contact Infrared Body Thermometer operating In-
structions intend to provide the necessary information for prop-
er operation of M340, thermometer model HTD8816C.
Only body mode was reviewed and certied by notied body.
General knowledge of infrared thermometer and an under-
standing of the features and functions of the HTD8816C ther-
mometer model are prerequisites for proper use.
The Non-Contact Infrared Body Thermometer is a medical de-
vice, and can be used repeatedly, which using life is 5 years.
Please read the manual rst before using it, if not fully under-
stand the usages, please stop using the thermometer.
Do not operate any of HTD8816C (REF: M340) thermom-
eter without completely reading and understanding these
instructions.
Notice
Purchase or possession of this device does not carry any ex-
press or implied license to use with replacement parts which
would, alone or in combination with this device, fall within the
scope of one of the relating patents.

6
EN
Safety Information
This device may only be used for the purposes described in
these instructions. The manufacturer cannot be held liable for
damage caused by incorrect application.
The Non-Contact Infrared Body Thermometer is designed to
minimize the possibility of hazards from errors in the software
program by following sound and light engineering design pro-
cesses, Risk Analysis and Software Validation.
Warning
WarningsareidentiedbytheWARNINGsymbolshown
above.
• The Non-Contact Infrared Body Thermometer is to be oper-
ated by consumers in the home setting and primary care set-
ting as screening tool. This manual, accessories, Directions
for Use, all precautionary information, and specications
should be read before use.
• This product is designed to measure human body tempera-
ture on the forehead. Do not use it for any other purpose.
• This product is intended in the home setting and primary care
setting as screening tool.
• Do not use the thermometer if it malfunctions or has been
damaged in any matter.
• When the ambient temperature of the thermometer changes
too much, such as moving the thermometer from one place
of lower temperature to another place of higher temperature,

7
EN
allow the thermometer to remain in a room for 30 minutes
where the temperature is between 15℃ to 40℃ (59–104℉).
• Remove primary batteries if equipment is not likely to be
used for long time.
• This product is not waterproof, do not be immersed in water
or other liquid; If cleaning and disinfection, please follow the
“Care and Storage” section requirements.
• Do not touch the sensor of infrared detection with your ngers.
• If a cold compress on the forehead with patients with fever is
used, or other measures to cool down the temperature are
taken, measuring data will be lower as expected, and meas-
uring body temperature with this method should be avoided.
• If measuring human forehead temperature, please select
“body” mode; for measure other objects, liquids, food and
other temperature please select “surface” mode.
• This product must be operated in a stable environment. If the
ambient environment is not stable, please check whether there
is fog on the sensor. If there is any fog, remove it in accordance
with “Care and Storage” section of this instructions for use.
• To avoid the impact on the accuracy of the measurement
data, do not use the thermometer near strong electrostatic
eld or strong magnetic elds.
• Do not mix the old and new batteries to avoid damage to the
product.
• It may a󰀨ect the accuracy of measurements when the fore-
head is covered by hair, perspiration, cap or scarf.
• The measuring result of this product is only for your refer-
ence. If you have any doubt, please measure the tempera-
ture using other methods.

8
EN
Warning
• The device should be kept out of the reach of children/pets.
When not in use, store the device in a dry room and protect it
against extreme moisture, heat, lint, dust and direct sunlight.
Never place any heavy objects on the storage case.
• Do not throw batteries into re.
• Use only recommended batteries. Do not use rechargeable
batteries.
• This thermometer is not irreplaceable for diagnostic in hospi-
tals.
• Do not fall, disassemble or modify the device.
• Do not use this device if you think it is damaged or if you
notice anything unusual.
• This device comprises sensitive components and must be
treated with caution. Observe the storage and operating con-
ditions described in the ‘Technical Specications’ section.
• Do not perform service/ maintenance while the thermometer
is in use.
• When the thermometer is in use, the patient and batteries
must not be touched simultaneously.
• Do not use the device if it is damaged/ degraded/ loosened in
any way. The continuous use of a damaged unit may cause
injury, improper results, or serious danger.
• Based on the current science and technology, other potential
allergic reactions are unknown.
• This equipment needs to be installed and put into service in
accordance with the information provided in the ACCOMPA-
NYING DOCUMENTS.

9
EN
1. Overview
Intended Use
The Mediblink Non-Contact Infrared Body Thermometers are
designed to be used for intermittent measurement and moni-
toring of human body temperature by consumers in the home
setting and primary care setting as screening tool.
Description of Non-Contact Infrared
Body Thermometer
• Device principle and introduction
The Mediblink Non-Contact Infrared Body Thermometers are
hand-held, reusable, battery operated devices, which can
measure human body temperature on forehead, the skin tem-
perature on one’s forehead.
The operation principle is based on Infrared Sensor technolo-
gy. The IR sensor can output different signal when measuring
different object temperature or in different ambient tempera-
ture, and the ASIC can turn the signal from IR Sensor to a
digital value and display it on the LCD.

10
EN
Description on Controls, Indicators, and Symbols
6
4
3
2
7
8
9
10 11 12
13
1514
16
1
5
Figure 1: Forehead thermometer M340
1. Liquid crystal display (LCD)
2. Battery Cover
3. On/Scan button
4. MODE button
5. MEMO button
6. IR sensor
7. Surface mode
8. Body mode
9. Data indicator
10. Indicator of measurement
result
11. Low Battery indicator
12. Voice on /o󰀨 indicator
13. Fahrenheit
14. Memory number
15. Celsius
16. Memory indicator

11
EN
Thermometer Applications
Thermometer
Model Number Thermometer
Style
Adult Pediatric
Ear Forehead Ear Forehead
REF: M340
Model: HTD8816C
Non-Contact
Infrared Body
Thermometer
Remark
Warning Restriction of Hazardous
Substances
Non sterile packaging Batch code
Refer to operating instructions
e-IFU: http://www.mediblink.com/
f/m340.pdf
Compliance with WEEE
Standard
-20 °C
55 °C
Transport and Storage
Temperature DO NOT THROW AWAY Intended for multiple use
93 %
10 %
Transport and Storage
Humidity Operating atmospheric pressure
This device compiles with
Part 15 of FCC (Federal
Communications
Commission) Rules.
0598
Indicates this device is in
compliance with MDD
93/42/EEC. 0598 is the
Notied Body Number
Manufacturer Authorized Representative in
the European Community
Recyclable Serial number
Number of products in one
packaging Class IIa medical device
IP22
IP22: The rst number 2: Protected against solid foreign objects of
Ф 12.5 mm and greater. The second number: Protected against vertically
falling water drops when enclosure titled up to 15˚.

12
EN
TechnicalSpecications
Measurement
Unit
°C / °F
Operating mode Adjusted mode (Body mode)
Direct mode (Surface mode)
Reference Body
Site
Axillary
Measuring site Forehead
Rated output
range
Body mode: 34.0–43.0°C / 93.2–109.4°F
Surface mode: 0–100.0°C / 32–212°F
Output Range Body mode: 34.0–43.0°C / 93.2–109.4°F
Surface mode: 0–100.0°C / 32–212 °F
Laboratory
Accuracy
Body mode:
34.0–34.9°C: ±0.3°C / 93.2–94.8°F: ±0.5°F;
35.0–42.0°C: ±0.2°C / 95.0–107.6°F: ±0.4°F;
42.1–43.0°C: ±0.3°C / 107.8–109.4°F: ±0.5°F
Surface mode: ±2°C / ±3.6°F
Display
Resolution
0.1°C / 0.1°F
Three-color
Backlight
(Color Alarm)
35.5–37.3°C / 95.9–99.1°F: Green (Normal Temperature);
37.4–38.0°C (Alarm point) / 99.3–100.4°F: Yellow
(Slight Fever)
38.1–43.0°C / 100.6–109.4°F: Red (High Fever)
Note:
1. Surface mode is always with Green backlight.
2. In body mode 34.0–35.4°C is with green backlight
AutoPowerO󰀨
Time
≤18s
Measuring Time ≤2s
Measuring
Distance
1–5cm (0,4–2,0in)
Memories 50

13
EN
Power Supply Requirements
Batteries 1.5V (AAA) Alkaline battery X 2 (IEC Type LR03)
Adaptable Range 2.6–3.6V
Environmental
Operating
Condition
Operating Temperature: 15°C–40°C (59°F–104°F),
Relative Humidity ≤85%, atmospheric pressure:
70Kpa–106Kpa
Transport and
Storage Condition
Storage Temperature: –20°C–55°C / –4°F–131°F,
Relative Humidity ≤93%, atmospheric pressure:
70Kpa–106Kpa
Dimension and Weighting
Weight (without
batteries)
80g
Size L:122mm × W:96 mm × H:42mm
Compliance
Item Compliant with
Equipment
classication
Safety Standards: EN 60601-1: 2006+A1:2013,
EN 60601-1-2: 2015
Type of protection Internally powered equipment (on battery power)
Degree of
protection
Non Applied part
Front panel and
case labeling
EN ISO15223-1:2016
Temperature EN ISO80601-2-56:2017
Home healthcare
environment
EN 60601-1-11:2015

14
EN
Calculated values of the indicators
according to ISO 80601-2-56
Forehead mode:
Group A1 Group A2 Group B Group C
Bias 0.015 0.000 -0.042 -0.040
Standard Deviation 0.123 0.121 0.121 0.137
Limits of Agreement 0.245 0.243 0.243 0.274
Clinical Repeatability
(for All Group) 0.071
Note: the above value is calculated from clinical data of HTD8818A.
SafetyclassicationofMEequipment
Protection against electric shock Internally powered ME equipment
Applied part Non Applied part
Protection against harmful ingress of
water or particulate matter
IP22
Mode of operation Continuous operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH
ENVIRONMENT

15
EN
2. Operation
2.1 Battery installation
Caution: The Non-Contact Infrared Body Thermometer does
not operate with dead batteries and does not input outer power.
Install new batteries.
1) Pull the battery cover downward, toward the bottom of the
Non-Contact Infrared Body Thermometer, and remove the
battery through access door;
2) Insert two pieces AAA size batteries according to the “+”
and “–”;
3) Close the battery cover.
2.2 How to Operate
Before Applying the thermometer
Be sure to read and understand all warnings listed of the in-
structions before use.
• Align the thermometer with the middle of the forehead to
measure body temperature (between the eyebrows) and
keep the thermometer in vertical position, at a distance of
1–5 cm from the forehead, then press the On/Scan button,
and body temperature will be displayed in less then 2 sec-
onds (figure 2).

16
EN
1–5cm
Figure 2: Measuring position and distance
• When the ambient temperature of the thermometer changes
too much, such as when moving the thermometer from one
place of lower temperature to another place of higher tem-
perature, allow the thermometer to remain in a room for 30
minutes where the temperature is between 15℃to 40℃.
• The ambient temperature around the test person should be
stable. Thermometer should be kept away from the larger
ow fan, air-conditioning vents and so on.
• When people are moving from one place of lower temper-
ature to another place of higher temperature, they should
remain in the test environment more than 5 minutes, to be
consistent with the ambient temperature after the re-meas-
urement.
• Wait at least 1 second for the next measurement. If ve con-
tinuous measurements are performed it is recommended to
wait at least 30 seconds before a new measurement is made.
• You cannot use the thermometer in place where the sun is
strong.
• If for some reason the low forehead temperature measure-
ment does not work, try to align the thermometer behind the
ears. See gure 3.

17
EN
1–5cm
Figure 3: Alignment behind the ears
General Setup and Use
• Start measuring
1. Turn on the thermometer by pressing the On/Scan button.
The thermometer will perform self-test with all segments
displayed for 2 seconds.
2. Align the thermometer to the forehead to keep the dis-
tance 1–5 cm, and then press the On/Scan button to
start the measurement, read the data.
Note:
1) After all symbols on the LCD screen disappear, you will
hear a rattle or “beep beep beep” three times, which
means that the thermometer self-test has been complet-
ed, and the target value of the measured temperature will
be displayed on the LCD, while backlight will be displayed
according to the appropriate setting among one of the
three colors red, green, yellow. Green backlight means
ready for next measurement. When 37.4–38.0℃, backlight
is yellow, meaning slight fever warning. Please pay atten-
tion to body temperature. When the body temperature is
above 38.1℃, backlight is red, meaning high fever. Please
take action to cool down or go to see a doctor.

18
EN
2) To ensure the accuracy of the measurement, wait at least
30 seconds after 5 consecutive measurements.
• Mode conversion
When the device is ON press the MODE button to make con-
version between “body” mode and “surface” mode.
“Body” mode is used to measure human body temperature,
the “surface” mode is used to measure the surface tempera-
ture (the factory default is “body” mode).
• Recalling and Erasing Memory Data
The last temperature taken before the thermometer powers
o󰀨 is stored in memory, and up to 50 measurements are
stored in memory.
Steps:
1) In the boot or shutdown state, short press the MEMO but-
ton to view the history of measured values.
2) An empty memory cell shows “---℃” or “---℉”.
3) Temperature readings can be stored in memory. Up to 50
temperature readings can be stored into the memory cells
and new readings automatically overwrite historical data.
4) In boot mode, long-press the MEMO button until the LCD
displays “CLR”, which means that all stored data is erased
completely.
• Parameter settings
Steps:
1) Unit Set – F1
Under the boot mode, long press the MODE button to
enter F1, press the “MODE” or “MEMO” button to switch

19
EN
between Celsius and Fahrenheit temperature units, press
the On/Scan button to conrm the unit settings (factory
default is Celsius).
2) Fever alert Set – F2
Under F1 state, press On/Scan button to enter the F2,
press the “MODE” button to plus 0.1℃, press the “MEMO”
button decrease 0.1℃, long press to accelerate the speed
of temperature regulation, and nally press the On/Scan
button to save the settings (the factory default is 38.1℃).
3) Prompt sound settings – F3
Under F2 state, press On/Scan button to enter F3, press
MODE button or MEMO button to disable or enable the
voice, and press the On/Scan button to conrm the set-
tings (the factory default is enabled voice).
• Prompt sound settings ON/OFF function
Under the boot mode, short press power on/o󰀨 button, and at
the same time press the MODE button to take on or take o󰀨
the Prompt sound function.
• Restore to factory default settings function
Under the boot mode, short press power on/o󰀨 button, at the
same time press the MEMO button. Until LCD display “rst”.
Two seconds later, F1-F3 parameters will be back at factory
default settings.

20
EN
3. Troubleshooting
Message Situation Solution
Temperature taken is
not within typical human
temperature range
(34.0~43.0℃or
93.2~109.4℉).
Make sure that temperature
is measured in the forehead,
and not on other human
body site.
Measured over the distance:
1–5 cm (0.4–2 in).
Optimum measurement
distance is 1 cm.
Incorrect test position. See gure 2: Measuring
position and distance.
Subjects such as: forehead
hair, antipyretic stickers, head
with sweat, etc.
Subjects sit quietly 5–10
minutes before the test.
Some people’s body
temperature is lower than the
general population.
The main concern is fever –
high temperature.
Operating temperature
exceeds the range of
specied temperature.
Move to a room within the
operating range and wait
30 minutes before taking
temperature.
The screen ickers and
automatically turns o󰀨.
Replace the battery or the
product has been damaged,
and needs a repair.