Belter Health Measurement and Analysis Technology ETE-68B4 Infra-red Ear Thermometer User Manual

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Document ID	3928858
Application ID	+owY+eHffGUK/7B0m9jqFA==
Document Description	User manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	49.47kB (618335 bits)
Date Submitted	2018-07-18 00:00:00
Date Available	2018-07-18 00:00:00
Creation Date	2018-04-08 12:19:40
Producing Software	Microsoft® Word 2010
Document Lastmod	2018-04-08 12:19:40
Document Title	医疗设备用户说明书 应按照如下顺序及包含以下内容：
Document Creator	Microsoft® Word 2010
Document Author:	微软用户

ETE-68B4
Infra-red Ear Thermometer
Edition：A0
Thank you for choosing Belter Infrared ear thermometer. The product combined the
newest technology and had passed related certification test.With its unique technology ,it
can get stable and accurate measurement result every time.This product will self test and
display the current room temperature when starting up to ensure the accuracy of the
measurement.
This product is suitable for home or hospital to measure and monitor human body
temperature，and suitable for people of all ages.
Measurement site of this product :auditory meatus
Key of symbols
Description
symbol
WARNING
WARNING indicates a hazardous situation which, if not
avoided, could Result in death or serious injury
CAUTION
CAUTION indicates a hazardous situation which, if not
avoided, may result in minor or moderate injury
NOTICE
NOTICE addresses practices not related to personal
injury, such as product and/or property damage
Type BF
Do not dispose this product as unsorted municipal
waste. Collection of such waste separately for special
treatment is necessary
This item is compliant with Medical Device Directive
93/42/EEC of June 14,1993, a directive of the European
Economic community
Refer to instruction manual / booklet
IP22
Degree of protection against harmful ingress of
particulate matter and water.
Manufacturer
Authorized representative in the European Community
Date of manufacture
Serial number
WARNING
Do not judge you own body state according to if you have fever or not. If you worry
about your health , please consult a physician
Do not dispose of electrical appliances as unsorted municipal waste, use separate
collection facilities. Contact you local government for information regarding the
collection systems available. If electrical appliances are disposed of in landfills or
dumps, hazardous substances can leak into the groundwater and get into the food
chain, damaging your health and well-being.
The device is not suitable for use in the presence of flammable anesthetic mixtures
with air or with oxygen or nitrous oxide.
The device requires no calibration.
The device is not repairable and contains no user serviceable parts.
No modification of this equipment is allowed.
Remove batteries if equipment is not likely to be used for some time.
The user must check that the equipment functions safely and see that it is in proper
working condition before being used.
The manufacturer does not require such preventive inspections by other persons.
The ear thermometer is used only for testing, it cannot replace a doctor.
Please do not use the thermometer in other ways except measure body temperature,
if it is used for children please observe the general safety precautions.
Please do not dismantle, re-assemble or drop the ear thermometer.
The ear thermometer temperature sensing head protective cover or other
components should keep away from children.
Incorrect usage of battery may cause damage, please do not re-charge, dismantle
the battery or throw the battery into fire, please deal with the battery according to
local related regulations .
Please don't operate the product out of operating conditions or out of the operating
temperature range .It may cause measurement value anomaly or malfunction
Please don’t bite, throw, folding ,pull and strong impact the device .Or it may cause a
failure
Please don’t measuret if have auricle inflammation or otitis media .Or it may
aggravate inflammation
CAUTION
Please do not dip the device into water or other liquid Cleaning and disinfecting
please follow(cleaning and storage) section in the manual
Keep the device from sunshine, and store in dust free, dry, store temperature of
-20℃-+55℃（-4℉-+131℉）areas .
If the sensor or product is broken, please do not use. If the device is broken, please
do not repair it by yourself, contact with your nearest customer service.
Left ear wax can cause measurement of low temperature phenomenon ,so please
make sure the ear is clean to ensure accurate measurement result.
Before measurement please make sure the sensor mirror is clean .If there’s any
dirt,please clean it with alcohol cotton swab before use.
The device is made of precision parts. Do not drop it,and protect it from strong
impact .Please don’t twist the device or sensor.
Please clean the thermometer sensor after use , to ensure the measurement
accurancy and avoid cross-infection.
Please don't add any protective sleeve to the sensor, or the measurement result will be
incorrect
please make sure the device appearance is not damaged and the sensing head is not dirty
before use.If there is any breakage ,please don’t use .Damage and smudginess may cause
incorrect measurement result.
CAUTION
Please read the manual carefully before use, and keep it in safe place.
To make sure the measurement result is accurate, please wait at least 30 seconds
after measuring every time, then you can measure again.
After cleaning the inductive head with alcohol, the device should be kept for a few
minutes till the alcohol volatilize,and the inductive head back to natural
temperature.Usually the suggested time is 5 minutes, otherwise the result may be
incorrect.
Because baby's temperature adjustment ability has not been perfect, if the
environment temperature changed sharply, do not use the device test baby's
temperature, the result may be incorrect. Wait a few minutes in the same
environment till the baby's temperature become stable.
When testing ,suggest test in the same ear, because the temperature of left and right
ear is different.
The following situations should test three times, and use the highest one:
1） baby who born in 100 days.
2） Baby under 3 years, the baby whose immune system has defects,
User who use the device in the first time,
get the stable temperature reading.
before he is familiar with the device and
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 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.
Any Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
RF Exposure
The equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment. This device should be installed and operated with
minimum distance 0mm between the radiator & your body.
SPECIFICATIONS
Item NO.
TE-68B4
Test site
ear
test range
34.0℃-43.0℃
measurement accuracy
±0.2℃ (36℃≤t<39) ;
Use environment
16℃ ~ 40℃
temperature division
0.1℃/0.1℉
indicator or fever alarm
buzzer“bi-bi”
information storage
store the latest 10 group test data before
turn off
unit shift
℃/℉
Automatic off
approx. 60's after use
storage and transport condition
-20℃ - +55℃（-4℉-+131℉）
storage environment humility
15%RH-90%RH
power supply
2 x AAA
battery life time
5000 times
low battery indicator
Below DC2.5V±0.1V
clinical allow maximum error margin
This product pass clinical verification, the
clinical maximum allowable error is 0.3
Bluetooth 4.0 transmission, android and
apple 4.0.
bluetooth function
±0.3℃other range
<95%RH
Body temperature
A person’s normal temperature range tends to decrease with age. The following table
shows normal ThermoScan ranges by age.
Normal ThermoScan ranges by age :
0–
2 years
97.5 – 100.4 °F
36.4 – 38.0 °C
3–
10 years
97.0 – 100.0 °F
36.1 – 37.8 °C
11 – 65 years
96.6 – 99.7 °F
35.9 – 37.6 °C
65 years 96.4 – 99.5 °F
35.8 – 37.5 °C
The normal temperature range will change between different people and different time in a
day.So make sure you and your family member's normal temperature is very important .you
can use this product to observe you and your family normal temperature range easily.
Operating Information:
1．Protect a set
2．Probe membrane
3．battery cover
4．Scan/M button
5．LCD
6．ON/OFF button

Operating instructions:
Open the battery cover, place two AAA batteries according to the indication sign in the
battery case, and take off the protection cover on the head.
CAUTION
Protective cover is used only when storing ,you must take down protective cover when
measuring.
2、Press the "ON/OFF" button and the device start self calibration,all symbols (picture A)
will display on the LCD with buzzing about one second.Picture B is detecting the measuring
head temperature,when it displays "0000"(picture C), the device is ready for testing.
3、pull the ear, and keep the ear straight.
A, Baby under 1 year should pull the ear back-forward.
adult should pull
B, baby older than 1 year and
up-back forward.
5、Insert the temperature sensing head into the ear canal,and combine closely to make
sure to measure accurate ear temperature.
6、Move out the device, and the temperature will display on LCD.
7、Wait 30 second, and then start next test.
8、If no operation in 60 second, the device will shut off automatically.
CAUTION
Please donn’t touch the heat detection , also don't let’s impact .otherwise it will cause
measurement value anomaly or malfunction
. The left ear canal and the right ear readings may be different ，so please measure in the
same ear canal.
.Accurate temperature can be measured only if there is no obstruction and no excessive
accumulation of ear wax in the ear
.The ear temperature may be high if you lie on the side and one ear is compressed,so after
going to bed please do not measure in the ear which is compressed on the side
.If you want to measure after eating ,doing sports and going out ,please have a rest for
thirty minutes to avoid inaccurate measurement result
.Repeated measure:If want to measure again you should wait for a minute.
.The ear thermometer is appropriate in measuring the temperature of human body ear
canal, compared with the common clinical thermometer, it measures principle and diagraph
part all different, as a result is not likely to acquire same measured value.
.The ear thermometer is a kind of high –tech and high sensitive thermometer. So it’s very
high request for operating environment and measuring a method when using. And easy
to cause the measurement not correct due to human operate not the ear thermometer
problem , please read the instructions carefully before use
The correct method
to insert in the ear canal
Inaccuracy
Exactitude
Before measuring ,please confirm the direction of the ear canal.
Human ear canal is not straight will bend with increased age
Opposite the ear tympanic membrane, gently pull back, it is easy to tympanic membrane
direction
The correct measurement method to measuring others
When measuring the ear temperature for adults or children, please clearly see the ear
canal, then deep into as much as possible
When measuring the ear temperature for active child, please put one hand on the other
side to make sure the head is not rotation,after you clearly see the ear canal, then deep
into as much as possible
When measuring the ear temperature for sleeping baby.Please make sure the ear up (let
face in a horizontal position), with one hand holds the head to avoid head rotation
When the ear is small cann’t insert , the tympanic direction just plug into the ear canal
Check the memory and delete the memory data.
1、The latest test data will be saved before shut off, and 10 memories can be kept mostly.
2、Press "Scan/M" button when the device is off,
the latest test data will display.
3、Press"Scan/M" button continuously can check all the saved data.
4、If the saved data more than 10 groups, the first one will be deleted.
Unit shift
1、Press "Scan/M" and "ON/OFF" buttons the same time when the device is off to enter Unit
10
shift mode.
2、Press "Scan/M" button can change the unit.
3、press "ON/OFF" to finish unit shift.
4.After completing the measurement , please pack the protective cover and store it in
required environment.
Cleaning instructions:
1、
Sensitive head is the most important part of the device, and the front mirror is
fragile. The sensitive dead can be cleaned with cotton swab or soft cloth with
alcohol / warm water
2、
Clean LCD and cover with clean soft cloth, do not use solvent, do not dip into
water or other liquid.
3、Please cover protective cover if don't use, avoid dust pollution and direct
sunlight .storage the thermometer environmental conditions should maintain relative
stability, had better be in 16-35, humidity is not more than 90% RH environment, so it is
easy to use at any time

Description of maintenance and who should do it: Please hande it over to a
professional personnel to carry on maintaining

Storage instructions:
Please pack good protective sleeve in the collection bag if don’t use the thermometer.If it is
not installed protective sleeve state custody, it may cause a malfunction
Please make sure the thermometer , collection bag and protective sleeve out of the reach
of the baby, otherwise may cause failure
Please don’t put the thermometer into the collection bag storage when it’s wet.Or it may
cause a failure
. please do not place the device in too high/low temperature and humility environment, to
avoid sunshine, keep away from electric shock and dusty environment.
11
Please keep the device in dry environment, and the temperature should be -20℃- +55℃.
Please do not put this product in condition which exceeds above required storage and
transportation conditions.
. Take out the batteries if the device will not be used for long time, in case the battery may
destroy the device.
Replacing the batteries
1.When voltage of the batteries is low ,the lcd will display “ ”symbol,please place
two new batteries in unit .the Infra-red Ear Thermometer can not work accurately
under the condition of low voltage.
2.The Infra-red Ear Thermometer is supplied with “AAA”DC1.5V×2PCS
3.remove the battery cover and take out old batteries
4.place two new batteries according to the “+”or”-“
5.please take out the batteries to avoid battery leaking if the unit is not used for over six
months

Instructions on how to safely dispose of the device:

Batteries should be disposed of separately from household waste. Always dispose of
batteries as per your local regulations. Again, do not dispose of batteries with normal
household waste.
Observe the local regulations for material disposal. Dispose of the device in accordance
with local regulations. If you have any questions, please contact the local authorities
responsible for waste disposal.

Instructions on accessories:
. battery ：AAA×2PCS
Instruction manual
1 PCS
. Infrared ear thermometer 1PCS

Troubleshooting Information:
sign
Possible Reason
solution
when the temperature is
lower than 32.0℃, LCD
display "L"
check whether the sensitive
head mirror is broken or dirt
when the temperature is
higher than 42.9℃, the LCD
check whether the sensitive
head mirror broken or dirt
12
display "H"
when the environment
temperature is out of the
device working temperature
range
move the device into suitable
temperature environment,
keep about 30 minutes and
then test.
low power
change the battery
1）
the device shut off
1）
2）
the battery doesn't
install correctly
2）
3）
battery has no power
4）
no display on LCD
press "ON/OFF" turn
on
check whether the
battery is installed
correctly
no display
3）
change the battery
4）
contact with seller
CLASSIFICATION
1. Internally powered equipment;
2. Type BF applied part: Probe;
3. IP22;
4. Not category AP / APG equipment;
5. Mode of operation: continuous operation.
Additional Information:
non-toxic, No Stimulation, No sensitization adverse reaction for user during test.

Disease and self-care information:
The device has been calibrated before delivery, if you use it according to manual instruction,
there is no need to calibrate .If there's any question regarding to test, please contact with
professional person (our company)
Be subjected to vibration of the strong row such as the product, outside the dint function is
damaged or the measurement result have problem, please do not use, please contact with
my company.
If the product suffer strong vibration, damage or have query about the measurement results.Please do not use,
please contact with our company.

Warranty:
13
if you use the device according to the manual, replace it within 3 months and guarantee for
free a year.
The following situations are not included in warranty time:
1）
problem caused by self dismounting
2）
problem caused by shocking during use or delivery.
3）
problem caused by incorrect maintenance
4）
problem caused by incorrect operating, problems caused by unprofessional repair.
. supply the purchase prove when require warranty.
the repair will be charged if not in warranty period or range
. we keep the final explanation right for above warranty.
User Assistance Information:
ShenZhen Belter Health Measurement and Analysis Technology Co.,ltd
702/704, Block C, Tsinghua Unis Science Park, No.13 Langshan Rd, Hi-Tech Industrial
Park(north), Nanshan District, 518057 Shenzhen, People’s Republic of China
E-mail:belter@belterhealth.com
Postal code：518057
20XX-XX
14

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File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.5
Linearized                      : No
Page Count                      : 14
Language                        : zh-CN
Title                           : 医疗设备用户说明书 应按照如下顺序及包含以下内容：
Author                          : 微软用户
Creator                         : Microsoft® Word 2010
Create Date                     : 2018:04:08 12:19:40+08:00
Modify Date                     : 2018:04:08 12:19:40+08:00
Producer                        : Microsoft® Word 2010

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