Famidoc FDTH3400 Instruction sheet

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Product instructions
FDTH3400
PN:6004213F001-03A
Description Version: V3.0
Revision date: April 2021
The production date is shown on the outer package.
For American please refer to "℉",
For European please refer to "℃".
Before using your device, please read these instructions and warnings completely.
FCC ID :PONFDTHB34

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CONTENT
1. Product Description .......................................................................................................................................3
2. Product structure and components .............................................................................................................. 4
3. Product specifications ...................................................................................................................................5
4. Intended use and scope of application .........................................................................................................6
5. Contraindications .......................................................................................................................................... 7
6. Notes ............................................................................................................................................................. 8
7. Installation and use .....................................................................................................................................10
8. Body Temperature .......................................................................................................................................14
9. Troubleshooting instructions .......................................................................................................................15
10. Maintenance and maintenance ................................................................................................................ 16
11. List of accessories .....................................................................................................................................17
12. Final disposal ............................................................................................................................................ 18
13. Information on critical parts ...................................................................................................................... 19
14. Explanation of standardized symbol ........................................................................................................ 20
15. Electromagnetic compatibility information ................................................................................................21
16. Standard List .............................................................................................................................................26
17. Warranty ....................................................................................................................................................27

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1. Product Description
Thank you very much for choosing our products!
This product is a high-tech electronic thermometer which is used to measure the temperature of human
body by collecting the change of the temperature and energy of human body heat source.
This product has 8 seconds rapid measurement mode and direct measurement mode, so that you can
easily and quickly know the health status of yourself and your family anytime and anywhere.
Product name:Digital Clinical Thermometer
Product model: FDTH3400

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2. Product structure and components
The thermometer mainly consists of plastic shell, thermistor, PCBA, buzzer chip, LCD display,and battery.
Main appearance structure diagram description:
Display Description:

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3. Product specifications
Product name
Digital Clinical Thermometer
Product model
FDTH3400
Power supply voltage
d.c. 3.0V, one CR1632 battery
Measurement type
Adjusted mode / Direct mode
Measuring part
Axillary / Oral / Rectal
Reference site
Oral cavity
Measuring range
32.00℃~ 42.90℃(89.60℉~109.22℉)
Measuring accuracy
±0.10℃: between 35.00℃~42.00℃
(±0.18℉between 95.00℉~107.60℉)
±0.20℃(or±0.36℉): outside this ranges
Display resolution
0.01℃(0.01℉)
Repeatability error
≤0.20℃(±0.36℉)
Measurement time
Adjusted mode：Less than 8s (for water bath)
Direct mode：Less than 50s (for water bath)
High body temperature hint
≥37.60℃(99.68℉)
Operation environment
Temperature:5℃~40℃(41℉~104℉)
Relative humidity:15%~95%RH，No condensing
Atmospheric pressure:70 kPa~106 kPa
Transportation and storage
Temperature:-25℃~55℃(-13℉~131℉)
environment
Relative humidity:15%~95%RH，No condensing
Atmospheric pressure:70 kPa~106 kPa
Temperature unit
°C/°F
Memory group
Last time memory display
Battery life
1 year/1000 measurement
Product size
28mm×13mm×131mm
Net Product
17g（Battery free）
Period of validity
5 years (excluding vulnerable parts)
Software version
V1.0
Grade of waterproof
IP22
Electric shock
Internally powered ME equipment
Operational mode
Continuous operation
Applied part
Type BF applied part,including the whole unit.
*Statement: If stored or used outside the temperature, humidity or atmospheric pressure range specified by
the manufacturer, the product may not achieve the claimed performance.

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4. Intended use and scope of application
4.1 This product is used to measure the temperature of human body by collecting the change of the
temperature and energy of Axillary,Oral,Rectal heat source.
4.2 Expected patients：and can be used for body temperature measurement in infants, children and adults.
4.3 Intended user ：Doctor, nurse or regular user.（We recommend adults to operate the thermometer
instead of babies and children.）
4.4 Expected Operating environment：Hospitals, clinics and home Settings

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5. Contraindications
5.1 Do not use local lesions such as inflammation, trauma and postoperative.
5.2 It is forbidden for those who are allergic to stainless steel and ABS plastic.

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6. Notes
6.1 Measurement
1. This product is only for monitoring and self-testing body temperature, can not be used for disease
diagnosis, patients only through the results of self-judgment and treatment is very dangerous, so please
follow the guidance of the doctor.
2. To ensure the accuracy of the measurement, please set the thermometer in the normal working
environment for more than 30 minutes, so that it reaches the equilibrium state before measuring.
3. Please do not measure under strong electromagnetic interference environment (working microwave
oven, induction cooker, mobile phone nearby, etc.), this may cause measurement is not correct or can not
be measured.
4. Participants were measured after taking medications that change their body temperature (e.g. aspirin,
acetaminophen, ibuprofen), which may cause measurement bias.
5. The subjects may cause temperature fluctuations after intense exercise, crying, eating, etc. It is
recommended to keep quiet for 30 minutes before measurement.
6. When measuring, please keep the subject quiet and steady, according to the measurement method
shown in the specification, so as not to cause the measurement deviation caused by improper operation.
7. Continuous measurement, the measurement results may have a small error, which is a normal
phenomenon, it is recommended that the maximum continuous measurement in a unit of time 3 times.
8. The human body temperature fluctuates from time to time, and the body temperature collected from
different parts will also vary. When observing the changes in body temperature, it is recommended to
measure and observe the body temperature in the same part multiple times.
9. Different types and brands of temperature measuring products do not have comparative value. It is
recommended to use the same temperature measuring product to observe temperature changes in order to
better grasp the temperature changes.

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6.2 About Products
1.Except for measurement of Axillary, oral and rectal temperature, don ’t use this product for other
purposes.
2.Please do not force collision, fall, stampede or shake this product, may cause product failure or cause
measurement deviation.
3. Do not disassemble, repair or modify the product.
4. Do not use in electromagnetic interference environment, which may affect the measurement results.
5. Please keep this product out of reach of children to prevent children from swallowing batteries or small
parts. If swallowed, please contact the doctor immediately.
6. Please keep the product in accordance with the product transportation / storage conditions to avoid
use problems or measurement deviations.
7. Do not put in direct sunlight, high temperature and humidity, dust, near the fire, vulnerable to vibration
shock place custody.
8. The thermometer is not used for a long time, the battery should be removed to prevent battery
leakage.
9. Do not place this product in a place with electric shocks.
10. Do not insert the metal probe end of the thermometer into the power socket. This may cause electric
shock.
11. Do not throw the thermometer and its accessory batteries into the fire, which may cause an
explosion.
12. Please dispose of waste or residue at the end of the product's service life in accordance with local
laws and regulations.
13. The normal use of this product is the human body temperature measurement mode, if you need to
enter the correction mode must contact the company's after-sales service agencies.

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7. Installation and use
7.1 Installation of batteries
1.This product uses One CR1632 button battery and has been built into the thermometer body when it
leaves the factory.(Note: The built-in battery in the thermometer is a trial battery. This battery may not
provide the same life as the new battery.)
2.To replace the battery, turn the phillips screwdriver counterclockwise to remove the screw on the battery
cover.
3.gently remove the battery cover, then take out the old battery.
4.Follow the battery polarity mark in the battery compartment and put the new battery into the battery
compartment. When installing, pay attention to the positive and negative polarity.
5.Reinstall the battery cover as is, and use a Phillips screwdriver to turn clockwise to tighten the fixing
screws.
7.2 Measurement process
7.2.1 Adjusted mode / Direct mode
1. Tap the “power key”, the thermometer will display in full screen, and then display the effective memory
temperature value measured last time.
2. If adjusted mode was used last time, then this measurement is also adjusted mode.
If direct mode was used last time, this measurement will also be in direct mode.
Note: In direct mode, the screen displays the " " direct mode icon.
3.When the icon "℃" or"℉" on the screen begins to blink, place the temperature sensor of the thermometer
in the following test parts:
Measuring
part
Measuring method
Graphic
Automatic
conversio
Automatic
conversion

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aFor some sensitive people, nausea may occur when mouth temperature is measured;
bAfter measuring rectal temperature, there may be a slight feeling of distension in the anus.These are all
normal phenomena, and a rest may relieve them. If you are concerned that the measurement cannot be
done correctly, please consult a professional physician for the measurement.
cTo obtain more accurate measurement data, it is recommended to measure the oral and rectal
temperature in direct mode.
4.Under the direct mode,after the thermometer detects the temperature of the human body, the
measurement results will be displayed about 8s later with a prompt sound.
In direct mode, when the temperature value of human body is stable or the test time reaches 5min, the
thermometer will display the measurement result with prompt sound.
Axillary
• Raise your arm,Place the probe tip
under the armpit parallel to the arm,
pressing the arm against the body.
• Make sure the metal probe of the
thermometer is completely wrapped
around the armpit.
aOral
• Place the thermometer in one of the
two locations under the tongue, to the
left or right of the root of the tongue.
The measuring probe must be in good
contact with the tissue.
• Close your mouth and breathe
evenly through the nose to prevent
the measurement from being
influenced by inhaled/exhaled air.
bRectal
•This is the most reliable measuring
method, and is especially suitable for
infants and small children.
•Lay the baby on its back on a hard
surface and lift its legs to an angle of
approximately 90°. Hold them by the
ankles in order to prevent their body
from turning while taking the
temperature.
•Carefully insert the measuring
probe of the thermometer 2 to 3cm
into the anal aperture.Until the
thermometer's metal probe is
completely covered.
8 seconds

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5. Remove the battery of the thermometer and power it on again each time. The Adjusted mode is entered
by default for the next measurement.
7.2.2 The mode switch
1. In the off state, press and hold “power key”for 5 seconds and release it, then it will automatically enter the
measurement state different from that used last time.
2. If the adjusted mode was used last time, it will automatically change to direct mode and start temperature
measurement.
If the direct mode was used last time, it will automatically change to adjusted mode and start temperature
measurement.
7.3 Display and Sound Tips
After the measurement is completed, the following tips may appear in the thermometer:
7.4 Power off function
If the thermometer does not perform any operation within 30 seconds or press “power key” again, it will
enter the shutdown state directly.
Screen display
Sound Tips
Representation of information
Temperature :
32.00℃~37.59℃
（89.60℉~99.67℉）
"beep"~
Target temperature values for this
measurement
Temperature :
37.60℃~42.90℃
（99.68℉~109.22℉）
"beep beep beep"..."beep
beep beep"..."beep beep
beep"..."beep beep
beep"..."beep beep beep"
Target temperature values for this
measurement
Err
"beep "..."beep"..."beep "... "
beep"
Abnormal temperature rise rule
(e.g., measurement process shedding)
Hi
"beep "..."beep"..."beep "... "
beep"
The measurement temperature is higher than
the maximum value of the thermometer range
Lo
"beep "..."beep"..."beep "... "
beep"
The measured temperature is below the
minimum value of the thermometer range
Up to 5
minutes

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7.5 Temperature unit setting function
1. When the thermometer is off, hold down“power key” and do not release it. The product will start. Wait for
5 seconds after the screen turns off, and then enter the temperature unit setting interface.
2.Hold down the“power key” and do not release it. The unit of ℃or℉will be automatically switched,every 2s.
When the required unit is displayed, release the hand, that is, select the current unit, and the thermometer
immediately enters the state to be measured.
7.6 Low Voltage Prompt Function
1. The thermometer automatically detects the battery voltage every time it is turned on. When the battery
voltage is insufficient but can continue to use, the“ ” icon appears on the display screen, but does not
affect the operation.
2. When the battery voltage is too low to continue to use, the display screen appears separately “ ”icon
and flashes, about 8 s after forced shutdown, thermometer need to replace the new battery to continue to
use.
7.7 Initialization function
Remove the battery and repower the thermometer, and it will automatically restore to the factory setting.

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8. Body Temperature
The normal body temperature of people is a range value, the normal body temperature of different people
will be different, and the personal body temperature will also change at different times.
The following are the reference values for the definition of fever in various parts of the human body:
*Data sources: ISO 80601-2-56：2017/AMD 1：2018, for information only.
It is dangerous to make self-diagnosis and treatment according to the measurement results. Please consult
a professional doctor with the measurement results.

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9. Troubleshooting instructions
Fault Description
Possible causes
Solution
The screen does not react when the power is
on or Equipped with batteries.
Battery runs out
Please replace the new
battery and re-open
Battery installation error
Please install the battery
correctly according to the
positive and negative pole
mark in the battery bin.
After reloading the battery,
the screen remains blank
Please contact after sale
All ICONS on the screen flicker
Hardware failure
Please contact after sale
The battery icon appears on the screen and
flashes
Too low battery voltage,
Causing failure to boot.
Please replace the new
battery and restart
Battery icon appears on the screen
Battery power is running
out
Please replace the new
battery as soon as possible
Abnormal temperature rise
rule
(e.g., measurement
process shedding)
Please restart the
measurement. The
thermometer should be
properly placed at the
measuring site according to
the instructions.
The measurement
temperature is higher than
the maximum value of the
thermometer range
Please check the
measurement target is
correct and re-measure
again.
The measured temperature
is below the minimum value
of the thermometer range
Please check the
measurement target is
correct and re-measure
again.

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10. Maintenance and maintenance
1. Please use a soft, dry cloth to gently wipe the dirt on the mainframe. If the surface is more serious dirty,
you can dip some alcohol to wipe.Cleaning is recommended every 1 month.
Caution: Do not wash with water or use cleaners, diluents or volatile oils containing abrasives.
2. After the thermometer measuring probe is soiled, please use a soft cloth dipped in more than 75%
concentration of medical alcohol to cover the measuring probe end and gently wipe it. If the wipe is still not
clean, please contact customer service.
3. If the thermometer measuring probe, button, display and other parts are damaged, please contact the
after-sales service.
4. Do not put in direct sunlight, high temperature and humidity, dust, near the fire, vulnerable to vibration
shock place custody.
5. When the thermometer is not used for a long time, the battery should be removed to prevent battery
leakage.
6. When the “ ” icon appears on the thermometer display screen, it indicates that the battery power is
about to run out. Please replace the battery as soon as possible.
7. We do not authorize any organization or individual to carry out maintenance, please do not disassemble
and adjust the thermometer.
8. The thermometer has been tested and calibrated at the time of manufacture. If you have any questions
about the function or measurement accuracy of the product, please contact the dealer or manufacturer.

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11. List of accessories
Use only original accessories to check whether the received accessories are complete.
Quantity
Components
1 pcs
FDTH3400 host
1 pcs
CR1632 batteries (Placed inside the mainframe）
1 pcs
User Manual
*The technical data should be combined with the user manual.
*In addition to specifying the use of CR1632 batteries, replacing existing components with
non-manufacturer supplied components may cause measurement errors and reduce safety.

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12. Final disposal
At the end of the product lifecycle, do not throw this product into the normal household garbage, but
bring it to a collection point for the recycling of electronic equipment.
Waste Electrical and Electronic Equipment can have potentially harmful effects on the environment.
Incorrect disposal can cause harmful toxins to build up in the air, water and soil and can be harmful
to human health.

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13. Information on critical parts
Name
Model
Supplier
Thermistor
XWTH002
A041
IC
XWIC036
A102
Thermometer casing
ABS
D004

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14. Explanation of standardized symbol
Complies with the European Medical Device
Directive (93/42/ EEC), Notified Body is SGS Belgium NV
Authorized representative in the European Community.
Attention: see Instructions for use!
Caution! Consult accompanying documents.
Type BF applied parts
Batch code
Serial number
Manufacturer information:
IP code of the device: this device's grade of against ingress of solid foreign objects .
Disposal in accordance with Directive 2002/96/EC (WEEE).
Medical Device
Catalogue number
Unique Device Identifier
Temperature limit
Humidity limitation
Date of manufacture