JOYTECH HEALTHCARE 0003 DIGITAL THERMOMETER User Manual JDMT 7904 008 Z DMT4752 FDA

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Document Description	User Manual
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Date Submitted	2018-12-14 00:00:00
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Document Title	JDMT-7904-008 Z DMT4752说明书FDA
Document Creator	CorelDRAW
Document Author:	Administrator

124mm
DIGITAL THERMOMETER
OWNER’
S M ANUAL
Model:DMT-4752
Warning :
Read instructions thoroughly before using digital thermometer.
Choking Hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow children
to use this device without parental supervision.
Do not use thermometer in ear. Designed use is for oral and vaginal readings only.
Do not place thermometer battery near extreme heat as it may explode.
Note: Use of the probe cover may result in a 0.01℃(0.02℉) discrepancy from actual temperature.
Remove battery from the device when not in operation for a long time.
The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for the
interpretation of results. Self-diagnosis may lead to the worsening of existing disease conditions.
Do not attempt measurements when the thermometer is wet as inaccurate readings may result.
Do not bite the thermometer. Doing so may lead to breakage and/or injury.
Do not attempt to disassemble or repair the thermometer. Doing so may result in inaccurate readings.
After each use, disinfect the thermometer especially in case the device is used by more than one person.
Do not force the thermometer into the rectum. Stop insertion and abort the measurement when pain is
present. Failure to do so may lead to injury.
For children who are two years old or younger, please do not use the devices orally.
If the unit has been stored at temperatures over 5℃～40℃(41℉～104℉), leave it in 5℃～40℃
(41℉～104℉) ambient temperature for about 15 minutes before using it.
PLEASE READ CAREFULLY BEFORE USING
This digital thermometer provides a quick and highly accurate reading of an individual's body
temperature. The digital thermometer is intended to measure the human body’s temperature in
regular mode orally, or vagina , and the device is reusable for clinical or home use on people of all
ages. To better understand its functions and to provide years of dependable results, please read all
instructions first.
This appliance conforms to the following standards:
EN 12470-3 Clinical thermometers —Part 3: Performance of compact electrical thermometers
(non-predictive and predictive) with maximum device,
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,
EN 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 EN 60601-1-2(EMC), IEC/EN60601-1(Safety) standards. And the manufacturer
is ISO 13485 certified.
332.96
CONTENTS
1 Thermometer, 1 Owner’
s Manual, 1 Storage Case
PRODUCT ILLUSTRATION
LED digital display
HOW TO USE THIS PRODUCT
1、Please download and install APP before using this product.
2、Turn on the phone bluetooth through APP and press the on/off button next to
LED digital tube display to turn on the device.The display will briefly shows
full segment at current unit mode. Show the last stored temperature. When the
LED digital tube display “Lo ℃”or "Lo ℉" , it means that the thermometer is
waiting for measurement.
3、Placing thermometer in desired position
a） Oral Use: Place thermometer under tongue as indicated by“√”position
shown in Figure 2. Close your mouth and breathe evenly through the nose to
prevent the measurement from being influenced by inhaled/exhaled air.
Normal temperature between 35.70℃ and 37.30℃(96.26℉and 99.14℉)
b）Vaginal:Place probe tip approximately 1cm (less than 1/2 ") into vaginal.
Normal temperature between 36.20℃ and 37.70℃ (97.16℉ and 99.86℉).
4、The thermometer will finish measurement with one short beep
after 3 minutes. To make sure the accuracy, do not move the
thermometer during the measurement. After finishing the
measurements, user can connect bluetooth through APP and
upload the data.
Figure 2
Remark:When using the thermometer at the first time, pls enter the passkey to
connect the bluetooth and APP.
5、To prolong battery life, press the On/Off Button to turn unit off after testing is
complete. If no action is taken, the unit will automatically shut off after
around 30s.
*Note:
①. So that in order to achieve better body temperature measurement result,
recommend to at least 30 seconds measurement interval should be maintained.
②.When connecting the APP via bluetooth, please enter the correct key.
③.When the OLED display “--.--℃” or “--.--℉”,it means that the thermomenter
has no memory.
④.When bluetooth connects to APP, the LED will light up, and when bluetooth
disconnects from APP, the LED will go out.
TROUBLESHOOTING
Error message
Probe
On/Off Button
Figure 1
PRECAUTION
* The performance of the device may be degraded should one or more of the following occur:
- Operation outside the manufacturer’s stated temperature and humidity range.
- Storage outside the manufacturer’s stated temperature and humidity range.
- Mechanical shock (for example, drop test) or degraded sensor..
- Patient temperature is below ambient temperature.
* Portable and mobile RF communications can affect the device. The device needs special pre-cautions
regarding EMC according to the EMC information provided in the accompany documents.
SYMBOL EXPLANATION
Batch Code
Direct Current
Type BF Applied Part
55℃
Consult Accompanying Documents
-20℃
EC
REP
Problem
Solution
Turn off, wait 10 minute and take a new temperature
Temperature taken is
lower than 32.00°C(89.60°F) via close contact and sufficient rest.
Manufacturer
Storage and Transportation
Temperature Limit: -20℃~55℃
(-4℉ ～131℉)
Temperature taken is higher
than 43.99°C(111.18°F)
Turn off, wait 10 minute and take a new temperature
via close contact and sufficient rest.
The system is not
functioning properly.
Unload the battery, wait for 1 minute and repower
it. If the message reappears, contact the retailer
for service.
Dead battery: Battery icon is
flashing, can’t be measurable. Suggest to charge immediately.
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 recommend checking calibration
every two years or whenever clinical accuracy of the thermometer is in question. Turn on the thermometer
and insert into the water bath and then check the laboratory accuracy of thermometer. 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.
European Authorized Representative
CLEANING AND DISINFECTION
SPECIFICATIONS
Type:
Digital Thermometer (Not Predictive)
Measure Range:
32.00℃－43.99℃(89.60℉-111.18℉)(℃ /℉ chosen by user)
±0.05℃(±0.1℉) during 35.00℃~38.00℃(95.00℉~100.40℉) at
18.00℃～28.00℃(64.40℉～82.40℉) temperature range
±0.1℃(±0.2℉) for other measuring and ambient operating range
Accuracy:
Operating mode:
Display:
Memory:
Battery:
LED digital tube display , 4 ½ digits.
For storing the last 30 measurements.
One rechargeable 3.7V lithium battery
Battery life:
3 measurements per day about 60 times
Dimension:
Weight:
Expected service life:
133mm×30mm×22mm(L x W x H)
Approx. 48 grams
Ambient operating range:
Storage and transportation
condition:
Direct Mode
Three years
Temperature: 5℃～40℃(41℉～104℉)
Relative humidity: 15%~95%RH
Atmospheric Pressure : 700hPa ~ 1060hPa
Temperature: -20℃~55℃(-4℉～131℉)
Relative humidity: 15%~95%RH
Atmospheric Pressure : 700hPa ~ 1060hPa
Ingress Protection Rating:
IP 64
Classification:
Type BF
Warning: The battery cannot be replaced. In order to extend battery life, the batteries should be
stored at room temperature, charged to about 30% to 50% of capacity for long time storage.
We recommend that batteries be charged about once per half a year to prevent over discharge.
The device cannot be used when in charging. When the device need to charge, you must
use a class II adapter or class II computer that complies with IEC 60601-1.
The charging specification is 5V
, 1A. If you use a computer, adapter or other power
supply that does not meet the required specifications, it may cause electric shock hazard.
Do not open the USB cover when not charging, it may cause electric shock hazard.
℃/℉ SWITCHABLE
When finishing measurement or entering into the memory mode, user can change the unit though APP
after connecting bluetooth.
PRODUCT FUNCTIONS & FEATURES
This product has two parts functions : the first function can be used to measure the temperature of the vagina,
this function should be used by women to measure basal body temperature. the second function can be used as
a normal thermometer ,used to measure and record body temperature data, this function suitable for most
people to use .
Wipe the thermometer with a soft clean cloth.For stubborn stains, wipe the thermometer with
a cloth that has been dampened with water or a neutral detergent solution and then wring
thoroughly. Finish by wiping with a soft dry cloth.For disinfection, 75% Ethanol or Isopropyl
alcohol can be used.Observe the following to prevent damage to the thermometer.
-Do not use benzene, thinner, gasoline or other strong solvents to clean the thermometer.
-Do not attempt to disinfect the sensing section (tip) of the thermometer by immersing in
alcohol or in hot water (water over 50℃(122℉)).
-Do not use ultrasonic washing to clean the thermometer.
FCC INFORMATION
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.
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.
*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.
LIMITED WARRANTY
The thermometer is guaranteed for one year from the date of purchase. If the thermometer does not
function properly due to defective components or poor workmanship, we will repair or replace it free of
charge. All components are covered by this warranty excluding the battery. The warranty does not cover
damages to your thermometer due to improper handling. To obtain warranty service, an original or copy
of the sales receipt from the original retailer is required.
Document No. JDMT-7904-008
Disposal of this product and used batteries should be carried out
Article No.: 001
in accordance with the national regulations forthe disposal of
Version: Z
electronic products.
Date of Issue: 2018.11
JOYTECH HEALTHCARE CO.LTD.
No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city, 311100 Zhejiang,China
Tel:+86-571-81957767
Made in China
124mm
Table 3
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.
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
IMMUNITY test
IEC 60601
test level
Compliance
level
Electromagnetic environmentguidance
Conducted
RF IEC
61000-4-6
3 Vrms 150
kHz to 80
Mhz
N/A
Portable and mobile RF communications equipment
should be used no closer to any part of the device,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Radiated RF
IEC 610004-3
10 V/m 80
MHz to 2.7
Ghz
10 V/m
Table 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Recommended seperation distance
80 MHz to 800 MHz
800 MHz to 2.7 Ghz
Emissions test
Compliance
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
254mm
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Electromagnetic environment-guidance
The device uses RF energy only for its internal function.
Therefore, its emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
380MHz, 27V
/m
380MHz, 27V
/m
RF Wireless
Communication
Equipment
450MHz, 28V 450MHz, 28V
/m
IEC 61000/m
4-3
710MHz,745 710MHz,745
MHZ,780MHz MHZ,780MHz
9V/m
9V/m
N/A
810MHz,870 810MHz,870
MHZ,930MHz MHZ,930MHz
28V/m
28V/m
N/A
1720MHz,1845 1720MHz,1845
MHZ,1970MHz MHZ,1970MHz
28V/m
28V/m
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
2450MHz, 28V 2450MHz, 28V
/m
/m
Table 2
5240MHz,5500 5240MHz,5500
MHZ,5785MHz MHZ,5785MHz
9V/m
9V/m
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
IMMUNITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrostatic
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
IEC 60601 test level
± 8 kV
contact
±2 kV,±4 kV,
±8 kV,
±15 kV air
± 2 kV for
power supply
lines
± 1 kV for
input/output
lines
± 1 kV
differential
mode
± 2 kV
common
mode
Compliance
level
± 8 kV
contact
±2 kV,±4 kV,
±8 kV,
±15 kV air
Electromagnetic environm
entguidance
Table 4
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
N/A
N/A
IEC 61000-4-8
Rated maximum output power
of transmitter
Separation distance according to frequency of transmitter
800 MHz to 2.7 GHz
80 MHz to 800 MHz
0.01
0.12
0.23
0.1
0.38
0.73
1.2
2.3
10
3.8
100
N/A
12
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
<5% UT (>95% dip in UT)
for 5 secretary
Power frequency
(50/60 Hz)
magnetic field
The device is intended for use in an electromagnetic environment in which radiated therefore
disturbances are controlled. The customer or the user of the device can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the device as recommended below, according to the maximum output
power of the communications equipment.
< 5% UT (>95% dip in UT)
for 0.5 cycle
Voltage dips,
short interrupti- 40% UT (60% dip in UT)
ons and voltage for 5 cycle
variations on power supply in70% UT (30% dip in UT)
put lines
for 25 cycle
IEC 61000-4-11
Recommended separation distances between portable and mobile RF communications equipment and
the device
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higer frequency range applies.
30 A/m; 50Hz
or 60Hz
Power frequency magnetic fields
30 A/m; 50Hz should be at levels charactertic of a
or 60Hz
typical location in a typical commercial or hospital environment.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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Title                           : JDMT-7904-008 Z DMT4752说明书FDA

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