Zhejiang IFU-MIET User manual

Instruction for Use
(File No.: IFU-MIET)
Version: 01
Mobile Infra-red Ear Thermometer
Zhejiang Medzone Medical Equipment Co.,Ltd

1 Preface
Dear Customers, thank you for purchasing the Mobile Infra-red Ear Thermometer.
This instruction for use describes the characteristics and technical requirements of the
device, main structure, performance, specifications, transportation, usage, operation,
maintenance and storage methods, safety measures are also included, please see
specific chapters.
Please read this instruction for use carefully before you using this device, and follows this
instruction. This instruction will tell you how to use the device, operations which may
cause to abnormal conditions, risks to causes damages to the device and human body.
Any abnormal condition or damages to the device and human body which caused by
without following this instruction for use, the company will not assume responsibility for
safety, reliability and performance, and will not be free of charge for such failure.
This product is a medical device that can be reused.
Please keep the instruction for use well, and refer it at any time.
2Safety
2.1 Safety information
Danger
To remind urge dangers or unsafe operations, if not avoided, may result in
death or serious personal injury or property damage.
Warning
To remind potential dangers or unsafe operations, if not avoided, may result in
death or serious personal injury or property damage.
Caution
To remind potential dangers or unsafe operations, if not avoided, will lead to
minor personal injury, product failure, damage or loss of property.
Attention
To emphasize important attentions, provide a description or explanation to
better use this device.
2.1.1 Danger
Forbidden to use the Mobile Infra-red Ear Thermometer during charging the
mobile phone, preventing from electric shock.
2.1.2 Warnings
For patients, it is danger to self-judge and self-treat according to measured
results, please follow doctors guidance, self-judge may cause disease
deterioration.
If you use this product near the microwave oven, TV, X-ray equipment or other
strong electromagnetic field, the measuring results may make mistakes; in order
to avoid electromagnetic field effect, please stay away from the electrical
measurement facilities, or to switch off the appliance before use.
The user shall disinfect the probe before using the device to prevent from cross
infection.
2.1.3 Cautions
Place the device from where children can touch, if the children use the device,
may hurt their ears. If carelessly eat the battery or probe protective cover, please
contact the doctor immediately.

2.1.4 Attentions
Don’t touch the infra-red sensor by hand or blow it with mouth. Damaged or dirty
infra-red sensor may cause incorrect measure results.
When the infra-red sensor is dirty, it is advised to wipe softly with soft dry cloth,
using sanitary paper or paper towel to wipe will hurt the infra-red sensor, which
will produce incorrect measure results.
When the ear temperature is lower than the operation temperature requirement
of the device, please warm the ear firstly and then measure. Using the water
pillow or water bag and just entering household in winter, the measure value may
be lower than real value.
Please DO NOT put the probe shield into the ears, and it shall immediately stop
to use when feel pain and other abnormal feeling, otherwise, the ear membranes
may be hurt.
Person who suffers from otitis diseases shall not use the device, otherwise, the
affected area may be deteriorated.
Please DO NOT use when your ear is wet after such as swimming, bathing,
otherwise, the ear hole may be hurt.
If the device storage environment is different from use environment, please put
the device firstly in the room temperature which is the use environment for 30
minutes, and then use to measure, otherwise, wrong measurement results may
be caused.
The device is suitable for ear temperature measurement of infants, children and
adults.
Please get out the battery when not use the device in long time (more than 3
months)
Please pay attention to the polarity of the battery, they shall be installed correctly,
otherwise it may cause damage to the product.
The disposal of the device and its components such as battery, plastic
membranes, plastic box and paper box, shall follow local regulations and laws.
The shelf life of the device is advised 5 years, once use beyond this period, the
measurement result may be inaccurate.
2.2 Symbols instruction
BF type application part
Serial number
Recycling according to local
laws
Date of manufacture
See the Instruction
Manufacturer
Cautions
European union
representative
Standby
IPX0
IP degree

Temperature range
Avoid sunlight
Humidity range
Up toward
Keep dry
3Product brief
3.1 Product characteristics
The Mobile Infra-red Ear Thermometer has a small size, low power consumption, easy to
use and carry. During measurement, insert the hardware into the mobile audio port, and
direct the infra-red probe facing the ear canal, the mobile screen will immediately display
the measured temperature value, the device has high accuracy and repeatability.
3.2 Scope
The Mobile Infra-red Ear Thermometer is intended to measure the human temperature by
measuring the human ear cavity infrared radiation.
3.3 Contraindications
Who has Ear deformity, external otitis, Otitis media, can not use the device.
4Prepare before use
4.1 Structure of the product
The Mobile Infra-red Ear Thermometer consists of the management software and
measurement hardware which is composed of the infra-red temperature sensor, the micro
controller (MCU), the audio port and the shell.
Diagram 1 Measurement hardware structure
4.2 How to install and change the battery
4.2.1 To press the battery cover groove, slip outward and open the battery cover;

4.2.2 To refer the battery cover reed polarity direction, insert into one 3V button battery;
4.2.3 Close the battery cover.
Warnings: When the oxygen terminal appears low voltage, please change the battery in
time. If it is not used for a long time, remove the battery, so as to avoid battery leakage.
4.2 Installation and use of the Mobile Infra-red Ear Thermometer management
software, see “Rapid use manual of mobile Mobile Infra-red Ear Thermometer”
5Method of use
5.1 Correctly install the battery and the mobileAPP software.
5.2 Press the power switch of the infra-red ear thermometer hardware, the blue power
indicator lamp will be light.
5.3 Open the mobile APP software into the measurement interface.
5.4 Insert the hardware into the mobile audio port according to guidance in the software,
and then insert the probe into ear canal.
5.5 Click the mobile screen to start measurement, when hear the buzzer sound, the
measurement is finished, get out the probe, and the measurement results will be
displayed in the mobile screen.
5.6 The infra-red ear thermometer hardware will automatically shutdown in absence of
new order.
6Maintenance and repair
6.1 Don’t fall or strongly collide the device.
6.2 Avoid high temperature or exposure to the sun!
6.3 When clean the shell or rubber pad, firstly turn off the power, use soft cotton fabric
dipped in a little neutral detergent gently wipe the surface, and dry naturally, it is prohibited
high temperature baking! It is recommended to clean monthly.
6.4 This product is strictly forbidden water!
6.5 Please take out the battery if long term not to use, so as to avoid battery leakage!
6.6 Do not disassemble the product body!
6.7 It is forbidden to use this product for other purposes!
6.8 The shelf life of the product is 5 years. To ensure the service life of the device, please
pay attention to the device’s maintenance.
7Troubleshooting
Abnormal
phenomenon
Reason of analysis
Troubleshooting
Abnormal
measurement
values happen
The depth of the probe into the ear
was not enough, the membrane
temperature was not successful
measured.
Adjust the direction and depth
of the probe into the ear canal,
and then measure again.

Too low or high environment
temperature
Use the device on required
environment
Interference happen or wrong
operation
Leave the interference source,
use according to IFU
Earwax is too thick
Clean the ear canal, and
measure again.
The software can
not connect to
the hardware
Orange lamp flashing, Low battery
voltage
Change the battery
The hardware may enter
hibernation, or automatic shutdown
Press the power key and
reconnect
Mobile phone bluetooth function
does not open
Open the mobile phone
bluetooth function
No display after
pressing power
button
Battery energy is completely
consumed, or no battery
Change the battery
Orange lamp
flashing after
pressing power
button
Low battery voltage
Change the battery
8Specifications
Unit
℃
Temperature range
32.0~42.0℃
Accuracy
35.0℃～42.0℃
±0.2℃
35.0℃～42.0℃
±0.3℃
Power
Internal d.c rated value: 3±10% V
Battery
CR1632 3V button battery
Work
environment
Environment temperature
16℃～35℃
Relative humidity
≤85%
Air pressure
70KPa~106KPa
Storage and
transport
environment
Environment temperature
-5℃～50℃
Relative humidity
15%～85%RH, Non condensing
Air pressure
50KPa～107.4 KPa
No corrosive gas and well ventilated indoor.

Equipment
information
Classification of electric shock type: internal power supply
equipment
Classification of electric shock degree: BF type
Protection against liquid: IPX0
Running mode: continuous operation
Safety classification of using with flammable anesthetic gas or
flammable anesthetic gas mixed with oxygen or nitrous oxide: Non
AP/APG
9 Guidance and manufacturer’s declaration-electromagnetic emissions
9.1 Emission
Band width: 120kHz; Frequency range: 30MHz to 1000MHz
Result: Fulfilled

9.2 Immunity
Test frequency: 50Hz, 60Hz; Continuous field: 3 A/m; Test duration: 5m; Antenna factor:
0.917A/m;Axis: X, Y, Z.
Test results: No degradation of function, comply with EN 60601-1-2:2007+AC:2010, ISO
80601-2-56:2009 Clause 202, EN 60601-1-11:2010 Clause 12.