CVS Health DET-5000 User manual

Contents Introduction
1 2
Introduction ..................................................02
Wa r n i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 3
Product Description ....................................... 04
LCD Display Introduction ..................................... 05
Basic F u n c t i o n s ....................................... . . . 0 6
Ear Ther m om e t er Ad va n ta g e s . . . .. . .. . . .. . .. . . .. . . 0 7
Bod y Te mp e r a tur e . ... . . . ... . . . ... . . ... . . . ... . . . ... . . ... . . 0 9
Rea l Ti m e Clock Se t ting ... . . . . . . . . .............. . . . . . 1 0
I l l u s t r a t i o n Fo r U s e .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2
Te m p e r a t u r e Ta k i n g H i n t s . . . . . . . . . . . . . . . . . . . . . . . . . 1 6
M e m o r y M o d e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8
C a r e A n d C l e a n i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9
Ba t t e r y R e p l a c e m e n t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1
Sp e c i f i c a t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . 2 2
Tr o u b l e s h o o t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3
Calibration ......................................................25
Symbol Explanation
Service ......................................................27
Warranty .... .... ..................... .... .... .... .... .... .... ...2 8
Electromagnetic Compatibility Information ...........31
..
FC C Info rmat ion
..................................................26
.. .... .... .... .... .... ... . ... . ... . ... . ... . ... . 29
Please read all instructions carefully and thoroughly
before using this product.
Indication for Use: The infrared ear thermometer is intended for
the intermittent measurement of human body temperature by people
of all ages. This thermometer can be reused by many people.
The DET- thermometer is specifically designed for safe use
in the eardrum. The Infrared Ear Thermometer is a device capable
of measuring people's body temperature by detecting the intensity
of infrared light emitted from the eardrum of human. It converts
the measured heat into a temperature reading displayed on the LCD.
When properly used, it will quickly assess your temperature in an
accurate manner.
5000
Document No.:
Article No.:
Version: Z
Date of Issue:
JDET-2504-002
001
2020.08
Telephone: [phone]
Fax: [phone]
JOYTECH Healthcare Co., Ltd.
No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou , Zhejiang 311100 China
Made in China
This appliance conforms to the following standards:
ASTM E1965-98 Standard Specification for Infrared Thermometers
for Intermittent Determination of Patient Temperature,
ISO 80601-2-56 Medical electrical equipment —Part 2-56:
Particular requirements for basic safety and essential performance
of clinical thermometers for body temperature measurement,
IEC 60601-1-11 Medical electrical equipment —Part 1-11: General
requirements for basic safety and essential performance –Collateral
Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
and complies with the requirements of IEC 60601-1-2(EMC) ,
AAMI ANSI ES60601-1(Safety) standards. And the manufacturer
is ISO 13485 certified.
Model DET-103

Product Description
1. Probe
2. Test Button
3. Memory Button
4.
5.
Setting Button
Battery Door
3
6
Basic Functions
LCD Display Introduction
4
5
1
2
5
3
4
Warning
This thermometer is intended for home use only.
It's not meant to replace a visit to the doctor. Please
consult with doctor if you have health concerns.
2. There is no gender or age limitation for using infrared
ear thermometer.
3. Do not expose the thermometer to temperature extremes
(below -25℃/-13℉ or over 55℃/131℉) nor excessive
humidity (>95%RH).
4. Keep the battery away from children.
ME equipment should not be cleaned and disinfected while in
use.
1.
5. Remove battery from the device when not in operation for
a long time.
6. Do not put the thermometer in direct sunlight or with cotton
wool, otherwise the accuracy will be affected.
7. Portable and mobile RF communications can affect the devise.
The device needs special precaution regarding EMC according
to the EMC information provided in the accompany documents.
8.
Real Time Clock
Ear Mode
Object Mode
Memory Mode
/ Switch℃ ℉
The machine can store up to 30 sets of measurements. Each memory also records
the measurement results date/time/mode. When the data exceeds 30 sets,
the coverage starts from the earliest data.
Beep Hint When the testing is done, it will sound one short beep.
The real time clock will be recorded with the memory function and help
you to recognize each measurement result.
→ Please see the Real time clock setting section to learn how to setup the
time in the first use.
The thermometer has been designed for practical use. It's not meant to
replace a visit to the doctor. Please also remember to compare the
measurement result to your regular body temperature.
→Please see the Illustration For Use section to learn how to measure
the body temperature.
The object mode shows the actual, unadjusted surface temperatures,
which is different from the body temperature. It can help you to monitor
if the object temperature is suitable for the baby or patient, for example
the baby's milk.
→ Please see the Illustration For Use section to learn how to measure the
object temperature.
Please see the section to learn how to
change between Celsius and Fahrenheit.
Illustration For Use
AM and PM
Low voltage sign
Ear temperature mode Unit sign: ℃ or ℉
Temperature result
Time and date sign in Time mode
Memory mode
Object temperature mode

Real Time Clock Setting
Ear Thermometer Advantages
78
Clinical studies have shown that the ear is an excellent site for
temperature measurement because temperatures taken in the ear
,
reflect the body s core temperature. Body temperature is regulated
by the hypothalamus, which shares the same blood supply as the
tympanic membrane. Changes in core body temperature are usually
seen sooner at the tympanic membrane than at other sites, such as
the rectum, mouth or under the arm.
Advantages of taking temperatures at the ear versus other sites:
● Axillary temperature readings only reflect skin temperature
which may not indicate the internal body temperature.
● Rectal temperatures often lag significantly behind internal body
temperature changes, especially at times of rapidly changing
temperatures.
● Oral temperatures are often influenced by eating, drinking,
thermometer placement, breathing through the mouth, or the
inability of the person to close their mouth completely.
Body Temperature
910
Set the time format
The device can display the time in either
an AM/PM (12-hour) or a 24:00
(24-hour) format. Press and release
Test button to select the format.
With the preferred time format on the
display, press Setting Button, the Hour
figure is flashing automatically.
①
Set the hour
Press and release the Test to advance
one hour until the correct hour appears.
After the hour is set, press Setting Button, the Minute
figure is flashing automatically.
②
Button
Vital Organs
Ear Thermometer Advantages
Infrared Ear Thermometer measures core body temperature,
which is the temperature of a body's vital organs. (See Figure 1)
Ear temperatures accurately reflect core body temperatures since
the eardrum is in the cranial cavity and is not affected by the
environment. The eardrum shares blood supply with the
hypothalamus (part of the brain.) Therefore, body temperature
changes are reflected sooner in the ear than they are in other
parts of the body.
Figure 1
When using thermometer for the first time, please set the parameters
of the thermometer. With the thermometer off, press and hold
Setting BUTTON to enter into setting mode.
Set the minute
Press and release the Test to advance
one minute until the correct minute appears.
After the minute is set, press Setting Button, the Year
figure is flashing automatically.
③
Button

Illustration For Use
Illustration For Use
14
Illustration For Use
Figure 3
X
√
3. The thermometer is ready for testing again once an ear mark
displays on the LCD. A waiting period of 20 seconds between
testing is recommended to avoid excessive cooling of the skin.
4. The thermometer will shut off automatically after 60 seconds
of inactivity. To prolong battery life, press and hold
to turn the unit off.
Memory
Button
13
12
11
To measure object temperature:
1. Aim the thermometer at the center of the object you want to
measure with a distance less than 5cm.
2. Press the Test Button to turn on the thermometer,
you can take
the object temperature after hearing two beep sounds.(see figure 4)
Remarks:
This mode shows the actual, unadjusted surface temperatures,
which is different from the body temperature.
then press and
hold Setting Button to switch to object mode,
If error messages appears, it means the thermometer is not ready for
measurement.
Figure 4
How to change the ear mode and object mode:
You can press and hold Setting Button to switch the mode between
ear mode and object mode.
1. Press the Test , the display is activated to show all
segments.
Button
After self-checking Figure 2 appears on the display
screen with beeps, so you can start a new measurement. If error
messages appears, it means the thermometer is not ready for
measurement.
2. Insert the probe along the ear canal as deep as possible into the
ear as depicted in Figure 3. Then press the Test BUTTON once
to start the measurement. A long beep will sound approximately
1 second after the Test BUTTON is activated. This signals the
end of the process as results are displayed on the LCD screen.
To measure ear temperature:
Figure 2
Real Time Clock Setting
Set the year
Press and release the Test to advance
one year until the correct year appears.
After the year is set, press Setting Button, the Month
figure will appear.
④
Button
Set the month
Press and release the Test to advance
one month until the correct month appears.
After the month is set, press Setting Button, the Date
figure is flashing automatically.
⑤
Button
Set the date
Press and release the Test to advance
one day until the correct month appears.
After the day is set, press Setting Button to exit the
setting mode.
⑥
Button
How to change temperature unit :
You can press Setting Button to change the unit between ℃ and ℉.

17
1. The right ear reading may differ from the reading taken at the
left ear. Therefore, always take the temperature in the same ear.
2. The ear must be free from obstructions or excess earwax buildup
to take an accurate reading.
3. External factors may influence ear temperatures such as:
● lying on one ear or the other
● their ears covered
● exposed to very hot or very cold temperatures
● recently swimming or bathing
In these cases, remove the individual from the situation and wait
20 minutes prior to taking a temperature.
4. For persons wearing hearing aids or ear plugs, remove the device
and wait 20 minutes prior to taking a temperature.
5. When using the thermometer on infants under age 1, pull the
ear up making sure the sensor faces the eardrum.
(See Figure 5)
6. When using the thermometer on individuals over the age of 1,
pull the ear back making sure the sensor faces the eardrum.
(See Figure 6)
7. Do not touch the probe window. A cotton swab and rubbing
alcohol may be used to clean the sensor window.
8. If the thermometer is stored in a significantly different
environment than testing location, place it in the testing
location for approximately 30 minutes prior to use.
9. It is not intended for use in the oxygen rich environment and
presence of flammable anesthetic mixture with air, oxygen or
nitrous oxide.
15 16
Temperature Taking Hints
18
Temperature Taking Hints
Figure 5 Figure 6
Figure 8
Figure 7
Memory Mode
3.
The user can press the Test Button to take new measurements.
In the memory mode, mark or mark will not change.
1. The Memory Mode can be accessed either in ear mode or object
mode:
When the thermometer has been turned on and followed by
Figure 2/4 or finished testing, press the . The
letter MEM will appear at the of the display.
(See Figure )
Memory Button
top right corner
7
2. The thermometer will automatically memorize the last 30
temperature readings.
Each time the Button
is pressed, the screen displays past readings that correspond
with a number 1-30. The number 1 reflects the most recent
reading, while the number 30 reveals the oldest reading stored
in memory.(See Figure )
Each memory also records the
measurement date/time/mode icon. Memory
8
After measurement:
1. Power off: Device will automatically shut off if left idle for
more than 1 minute to extend battery life.
2. Clean the probe after each use to ensure an accurate reading and
avoid cross contamination.
(See the section of Care and Cleaning for details.)
BackLight:
In Ear mode:
1. The display will be lighted GREEN for 3 seconds when the unit
is ready for measurement and a measurement is completed with
a reading less than 37.3 (99.1 ).
2. The display will be lighted YELLOW for 3 seconds when a
measurement is completed with a reading less than
3. The display will be lighted RED for 3 seconds when a measurement
is completed with a reading equal to or higher than
In Object mode:
The display will only be lighted GREEN for 3 seconds when the
unit is ready for measurement and a measurement is completed.
℃℉
38.0℃(100.4 ).
38.0℃(100.4℉).
℉
Illustration For Use

19
22
20
21
6.
7. Periodic cleaning and disinfection of the device following use to
prevent patient cross infection.
-Use a soft cloth slightly moistened with a 75% isopropyl alcohol
solution to disinfect the thermometer and probe. Do not use
abrasive cleaners.
8. Ensure that children do not use the instrument unsupervised;
some parts are small enough to be swallowed.
9. Do not remove or modify the equipment without permission.
10. Put the thermometer back to the original packaging after using.
Store the thermometer in a dry location, free from dust and
contamination and away from direct sunlight.
Specifications
Ear/Object mode:
10℃~40℃(50℉~104℉), 15%~95%RH, non-condensing
0kPa ~ 106kPaAtmospheric Pressure : 7
152.7*38.1*59.0mm
Approx.117grams(with batteries)
DC3V(2× battery)AAA
Measuring range
Laboratory accuracy
Display resolution 0.1℃ or 0.1℉
Measure time Approximately one second
Operating temperature
range:
Storage and transport
temperature range
-25℃~ 55℃ (-13℉~131℉), 15%~95%RH, non-condensing
Atmospheric Pressure : 70kPa ~ 106kPa
Clinical accuracy
Dimension
Weight
Battery
Battery life Approx. 1 year/6000 readings
Measuring site Ear canal(Ear Mode)
Oral (This thermometer converts the ear temperature to
display its “oral equivalent.”)
Reference body site
Operation mode Ear mode(Adjust mode)
Ingress protecting rating
IP22
Clinical bias：0.08℃(0.14℉)
Clinical repeatability：0.13℃(0.23℉)
Limits of agreement:0.73℃(1.31℉)
Shock withstands drop of 3 feet
Expected service life Three years
Ear mode: 32.0℃~43.0℃(89.6℉~109.4℉)
Object mode: 0℃~100℃(32℉~212℉)
Ear mode:
±0.2℃ (0.4℉) during 35.5℃~42.0℃ (95.9℉~107.6℉)
at 15℃~35℃ (59.0℉~95.0℉) operating temperature range
±0.3℃ (0.5℉) for other measuring and operating
temperature range
Object mode: ±4% or ±2℃(4℉) whichever is greater
Battery Replacement
1. Replace battery when " appears in the
of LCD
"
display. (See Figure )
top right corner
9
2. Slide battery cover down as shown in Figure .10
3. Remove battery and install 2 new alkaline batteries AAA
as shown . in Figure 11
4. Slide battery cover back on.
Figure9
Figure10
Contraindication
No contraindication
Care And CleaningCare And Cleaning
1. The probe window must be kept clean, dry, and undamaged at all
times to ensure accurate readings. The accuracy of temperature
readings can be affected by damage to the probe window, or the
presence of dirt and ear wax on the probe window.
2. Fingerprints, earwax, dust and other soiling compounds reduce
transparency of the window and result in lower temperature
readings.
3. The probe window is the most delicate part of the thermometer.
To safely clean the window, gently wipe its surface with a cotton
swab slightly moistened with isopropyl alcohol and immediately
wipe dry with a clean cotton swab. After cleaning, allow at least
5 minutes drying time before taking temperatures.
Note: Do not use any chemical other than isopropyl alcohol to
clean the probe window.
4. Use a soft, dry cloth to clean the thermometer display and
exterior.
5. Do not put the thermometer into water directly.
Please clean the window before each use.
Figure11

Calibration
The thermometer is initially calibrated at the time of manufacture.
If the thermometer is used according to the use instruction, periodic
readjustment is not required. However, We recommends checking
calibration every two years or whenever clinical accuracy of the
thermometer is in question. Please send the complete device to the
dealers or manufacturer.
The above recommendations do not supersede the legal requirements.
The user must always comply with legal requirements for the control
of the measurement, functionality, and accuracy of the device which
are required by the scope of relevant laws, directives or ordinances
where the device is used.
A clinical summary and procedures for checking calibration are
available upon request.(Turn on the thermometer and press the
Button long time until entering into calibrate mode, software version
will be displayed.)
Test
Troubleshooting
In Ear mode:
Temperature taken is
higher than 43.0 ℃
(109.4℉).
In Object mode:
Temperature taken is
higher than 100 ℃
(212℉).
Problem Solution
Read Temperature
Taking Hints thoroughly ,
then make sure the probe
cover and lens filter are
clean, then take a new
temperature measurement.
The thermometer could
not work due to low
battery.
Replace two new
alkaline batteries
size . AAA
Error message
Read Temperature Taking
Hints Thoroughly, then
check the integrity of the
probe cover and take a new
temperature measurement.
24
In Ear mode:
Temperature taken is
lower than 32.0 ℃
(89.6℉).
In Object mode:
Temperature taken is
lower than 0 ℃
(32℉).
23
2625
Symbol Explanation
Troubleshooting
Problem Solution
The ambient temperature
is not within the range
between 10℃ and 40℃
(50℉~104℉).
Place the
in a room for at least 30
minutes at room
temperature between
10℃ and 40℃
(50℉~104℉)
thermometer
The thermometer is
placed incorrectly
or unsteady.
The thermometer
showing a rapid ambient
temperature change.
The thermometer is not
functioning properly.
Read Illustration For
Use thoroughly and
take a new temperature
measurement.
Allow the thermometer
to rest in a room for at
least 30 minutes at
room temperature:
between 10℃ and 40℃
(50℉~104℉)
Unload the battery,
wait for 1 minute and
repower it. If the
message reappears,
contact the retailer
for service.
Error message
Take a measurement
until or appears
on the display.
Measurement before
thermometer is ready
Caution
95%
15%
131oF
-1 3oF
Manufacturer
Manufacturing Date
Direct Current
Batch Code
Storage and Transportation Temperature
Limit: -13℉~131℉(-25℃~55℃)
TYPE BF APPLIED PART
Refer to instruction manual/booklet
General symbol for
recovery/recyclable
Disposal of this product and used batteries should be
carried out in accordance with the national regulations
for the disposal of electronic products.
106kPa
70kPa
Atmospheric pressure limitation
Storage and Transportation
15%~95%RH
Humidity limitation:
The first num.2:Protected against solid foreign objects of 12,5
mm and greater.
The second num.2:Protection against vertically falling water
drops when ENCLOSUREtilted up to 15°.
IP22

28
27
29 30
Caution: Changes or modifications to this unit not expressly
approved by the party responsible for compliance could void the
user authority to operate the equipment.
*Note:
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. 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 and correct the interference by
one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the distance between the equipment and the receiver.
- Connect the equipment to 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.
The device has been evaluated to meet general RF exposure
requirement. The device can be used in portable exposure
condition without restriction.
FCC Information
Warranty
Thermometer is warranted by manufacture to be free from defects in
material and workmanship under normal use and service for a period
of one year from the date of delivery to the first user who purchases
the instrument. This warranty does not cover batteries, damage to the
probe window, or damage to the instrument caused by misuse,
negligence or accident, and extends to only to the first purchaser of
the product. Additionally this warranty becomes void, if the
thermometer is operated with anything other than this brand
thermometer probe covers.
FCC Information
The thermometer has a limited one year warranty. Do not attempt
to disassemble or repair the thermometer by yourself. Should
service be required during or after the warranty period you must
contact the manufacturer. Repackage the thermometer carefully in
its original packaging or securely pack to avoid damage during
shipping. Include the original sales slip indicating the date of
purchase, a note describing the problem, and your return address.
Send the thermometer prepaid and insured.
The lay operator or lay responsible organization should contact the
manufacturer or the manufacturer's representative:
– for assistance, if needed, in setting up, using or maintaining the
thermometer; or
– to report unexpected operation or events.
Service
If the thermometer does not function properly call customer
service at 1-877-299-6700. Our representative will provide
instruction on how to correct the trouble or will ask you to
return the unit for repair or replacement.

32
31
34
33
Electromagnetic Compatibility Information
Electromagnetic Compatibility Information
Electromagnetic Compatibility Information
Electromagnetic Compatibility Information
The device satisfies the EMC requirements of the international
standard IEC 60601-1-2.The requirements are satisfied under the
conditions described in the table below.The device is an electrical
medical product and is subject to special precautionary measures
with regard to EMC which must be published in the instructions
for use.Portable and mobile HF communications equipment can
affect the device.Use of the unit in conjunction with non-approved
accessories can affect the device negatively and alter the
electromagnetic compatibility.The device should not be used
directly adjacent to or between other electrical equipment.

Electromagnetic Compatibility Information
Electromagnetic Compatibility Information
WARNINGS!
· This device should not be used in the vicinity or on the top of other
electronic equipment such as cell phone, transceiver or radio
control products. If you have to do so, the device should be
observed to verify normal operation.
· The use of accessories and power cord other than those specified,
with the exception of cables sold by the manufacturer of the
equipment or system as replacement parts for internal components,
may result in increased emissions or decreased immunity of the
equipment or system.
35 36
37
Electromagnetic Compatibility Information
38
Electromagnetic Compatibility Information
NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a The ISM(industrial, scientific and medical) bands between 0,15 MHz and 80 MHz
are 6,765 MHzto6,795 MHz;13,553 MHz to 13,567 MHZ;26,957 MHz to 27,283
MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz
and 80 MHz are 1,8 MHz to 2,0 MHz,3,5 MHz to 4,0 MHz,5,3 MHz to 5,4 MHz,7
MHz to 7,3 MHz,10,1 MHz to 10,15 MHz,14 MHz to 14,2 MHz,18,07 MHz to 18,17
MHz,21,0MHz to 21,4MHz,24,89 MHz to 24,99 MHz,28,0 MHz to 29,7 MHz and
50,0 MHz to 54,0 MHZ.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz
and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the
likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 has been incorporated into the formulae used in
calculating the recommended separation distance for transmitters in these
frequency ranges.
c Field strengths from fixed 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 device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
re-orienting or relocating the device.
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
Table 3 continued