TRULY TET-351 Clinical Infrared Thermometers User Manual

Clinical Infrared Thermometers
TET-351

Statement

If replacing the original parts with parts not provided by the manufacturer may cause measurement errors. When the unit or accessories in the and of the service life, it should be handled in accordance with local regulations or returned to the manufacturer, and cannot be discarded at will.

Intended use

The TRULY infrared Thermometer TET-351 is an electronic clinical thermometer using an infrared sensor to detect human body temperature from the auditory canal and from the forehead in the neonatal, pediatric, and adult population used in the home setting.

| Authorized Representative in the European Community
---|---
| CE Mark conforms to essential requirements of the Medical Device Directive 93/42/EEC.
| IP is short for Ingress Protection which means that Protection’s level.
| Date of manufacture.
| Manufacturer

SN

| Species serial number
| Type BF applied part
| Direct current
| The device should not be used after the end of the shown or the day
| DISPOSAL: Do not dispose of this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
| Caution
| Follow instructions for use
FCC ID:2ABG7 -TET-351

Thank you for purchasing the electronic thermometer. Please read through this manual before using the product.

Cautions

1. Please handle the unit with care. Do not drop or shock the unit.
2. Do not expose the unit under the sunlight. Do not immerse the unit in water.
3. Keep the device out of reach of infants, children, or pets, since inhalation or swallowing of small parts (e.g. carpet feet, batteries) can be dangerous or even fatal.
4. Avoid touching the lens with bare hands.
5. Do not use in areas with strong electromagnetic interference.
6. When the measurement data exceeds the normal temperature of the human body, please consult your doctor.
7. If the unit is not working properly, please contact customer service.
8. Do not disassemble the unit. Open the battery cover only when replacing batteries. Dispose of the replaced battery in accordance with local waste battery recycling requirements.
9. If the unit needs to be scrapped after the expiration date, please dispose of it properly according to local regulations.
10. Please contact the manufacturer if the unit enters calibration mode.
11. Use the thermometer at room temperature, or within10-40°C.
12. Do not store the unit long period of time under -25°C or above 70°C, or relative humidity above 90%.
13. For other precautions, please follow “Cleaning and Care” in this manual.
14. The device is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide.
15. The operator shall not touch the battery compartment and the patient simultaneously.
16. The manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to SERVICE PERSONNEL in parts repair.

Warning:

1. When the body has a fever or the ambient temperature is low, the exposed forehead is affected by the low temperature of the environment. The human body will have a high body temperature and a low forehead temperature. If the digital thermometer tests the forehead with low value, please test the temples, ear roots, or other parts of the human skin covered with clothing with higher temperature.
2. The detector may not be directly pointed to the eardrum due to the small earholes of children, the curved earholes of adults, or affected by earwax and ear hair. If the digital thermometer ests the ear temperature with low value, please test the temples or other parts of the human skin covered with clothing with higher temperature.
3. The human body is a very complex biological integrated system. Affected by the environment and human body, the electronic thermometer may sometimes display abnormal body temperature (such as when body fever but forehead temperature or ear temperature show low value). Test the armpit temperature by mercury thermometer and consult a doctor in time.
4. Please do not test children’s ear temperature continuously. Inserting the probe into a child in the ear canal, can lead to infrared sensor temperature rise and cause each measurement data inconsistency, Wait a while after each measured test, which can guarantee the accuracy of temperature measurement.

Correct use is the key to the accuracy of measurement, otherwise, it may cause measurement error. Since infrared measurement has higher requirements on the surrounding environment, please follow the instructions below

1. When measuring ear temperature, it’s best to try to aim at the eardrum. It helps measure the temperature more accurately.
2. When the person to be measured comes from a place with a large temperature difference from the measurement environment, it should stay in the test environment for at least 5 minutes, and then measure after the temperature is consistent with the environment, otherwise, it will affect the measurement result.
3. When the instrument is taken from a place with a large temperature difference from being measured and used, the instrument should be placed in the user environment for 20 minutes before use.
4. The surrounding environment of the person to be tested must be stable, and it cannot be tested in places with large arrows such as fans and air outlets of air conditioners.
5. Do not use the instrument in strong sunlight.
6. When measuring, it is recommended to measure about 3 times each time, the most displayed set of data shall prevail.

Special Features

1. Measurement Range: Body: 32~43°C.
2. Accuracy ±0.2°C. (Outside 35~42°C measurement range, accuracy ±0.3°C).
3. 1 second measurement time.
4. LCD display.
5. Red, orange, and green backlight reminder
6. Ear temperature and forehead temperature can store 30 latest measured values each.
7. Automatic power of when the thermometer is not in use after 1 minute.
8. Unit of Measurement: °C/°F.

Measurement Principle

All objects, solids, liquids, and gases radiate infrared energy to the surrounding environment. The energy that the human body radiates to the outside world is basically based on infrared radiation. The electronic thermometer can accurately measure the body temperature by accurately measuring the weak infrared energy released by the human body, and then through complex calculation processing and various compensation corrections. The product is composed of a built-in infrared probe head and related hardware and software can sense, analyze and record the temperature of the measured object and the environment.
The infrared radiation sensor is activated when the user places the thermometer near certain parts of the body and space presses the Power/Measure button. The thermal energy generated by the arterial blood flow is quickly detected by the infrared sensor so that the body temperature is accurately measured.

Product scope

For measurement of body temperature through eardrum and forehead.
Normal body temperature range according to World Health BODY TEMPERATURE:

The component of the product

Temperature measurement

1. Press” ” to turn on the device, it will appear successively following: –> “bee” sound and the display is on; –> backlight display shows red, orange, green –> “°C” symbol is flashing (measurement waiting).
2. Measure ear temperature
   Gently pull the auricle to straighten the ear canal, fix the head, insert the detector into the ear hole and align with the eardrum. Press the” MEAS” button, when you hear the” beep” sound and finish the measurement.
   How to pull the ear * For babies below
   12 months: Pull the ear
   smoothly backward.

• For children above
  12 months old and
  adults: Pull the ear
  smoothly upward.

  3. Measurement result.
     Measurement complete, the device will show the test result, and with white backlight display.
     Green: 35.8°C~37.3°C
     Orange: 37.4°C~38.0°C
     Red: 38.1°C~43°C, high temperature, please consult your doctor.
     No backlight:32°C~35.7°C

  4. Interval Between Measurements
     If you need to take another measurement, allow an interval of 8 seconds until the signal “°C / °F” flashes. If you press the measurement button within 8 seconds, the beep signal will be sounded. And there is no measurement result displayed.

  5. The temperature is automatically recorded.

• Push the Power/memory button until The “OFF” signal is displayed.

• the thermometer will turn off Automatically without use for 1 minute.

Forehead measurement

1. Turn on the thermometer.
2. Press the button to select the forehead mode.
3. Place the detector at the position of the eyebrow, press the measurement button, and the measurement is completed after hearing the sound “bee”.
4. While taking the temperature, the screen indicates an audible beeps sound.
5. Release the measurement button, wait for the validation sound to beep before removing the thermometer.
6. Read the temperature on the screen.
7. The temperature is automatically recorded.
8. Interval time is the same as the ear mode.

Note:
When the ambient temperature is low, the skin temperature of the forehead is quite different, and the detector is not aligned with the eyebrow, which will cause the forehead temperature measurement temperature to be below.
This temperature reading must be considered as an estimation. The temperature reading of the forehead can be influenced by environmental conditions because the probe is more sensitive to perspiration, sebum, physical activity, and environmental temperature. It is recommended that you wipe the forehead before taking a reading, In case of important differences or in any doubt, the ear measurement must be pointed out, we remind you that there is a significant difference between an ear temperature reading and a forehead temperature reading.

When the Measurement Result is Abnormal

1. Possible causes for high temperature:

• After exercise, meal, or crying.

• Prolong is staying in a high-temperature environment.

• Thermometer is taken out from the low-temperature environment.
  Keep the thermometer at room temperature for at least 30 minutes before using it.

  2. Possible causes for low temperature:

• The probe is dirty.

• Just be exposed to a cold temperature environment before taking measurements.

• Forehead: The probe is not facing forehead in straight.

• The thermometer is pulled out from the ear before the measurement is complete.

• The probe is not fit snugly into the ear canal.

• The probe is not facing the eardrum or is not placed in a corrective position in the canal. See “Correct Measurement Method”.

• Excess ear wax build-up. 3. Temperatures measured from left and right ears are different:
  There could be a slight difference in temperatures when taken from both ears. Therefore, always take the temperature from the same ear.

°C /°F unit conversion formula

°F=1.8x°C+32

Unit( °C / °F) Switch

When the product is in of state, press and holds “power/memory”
Button for 10 seconds until the display shows ” °C” or ” °F” alternately.
Release the button when the display is showing your desired unit.
Correct Measurement Method

1. Ensure the probe is facing the eardrum In a straight line. Otherwise, the measured temperature will be lower than the actual body temperature.
2. For accurate results, clean the probe with a cotton bud before measuring.

Memory function

This thermometer stores the last 30 temperature readings.

• When power on, press the power/memory button to recall the first reading.
• Repeat pressing the power/memory button to recall the next reading.
• Delete memory:
  Press both power/memory and measurement buttons and hold for 3 seconds. The signal “Clr” is displayed and the memory will be deleted.

Replacing the Batteries

This thermometer is powered by 2 AAA batteries. When the power is low, a low battery signal is displayed. To replace batteries:

1. Press and push the battery cover to open it.

2. Remove the old batteries and replace them with new ones.
   Make sure the batteries are in the right polarity direction.

3. Close the battery cover.

Note:
To protect the environment, dispose of empty batteries at your retail store or at appropriate collection sites according to national or local regulations.

Disposal

This product includes removable parts and accessories, and cannot be disposed of with household waste. All users must return electrical and electronic equipment to a separate waste collection and collection center that specializes in electrical and electronic equipment for disposal in order to comply with 2002/96 / EC. Otherwise, you can recycle it for the retailer you purchased. Violations of this rule will result in severe penalties.
Do not dispose of electrical appliances as unsorted municipal waste, use separate collection facilities. Contact your local government for information regarding the collection systems available. If electrical appliances are disposed of in land_lls or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being.

Cleaning and Maintenance

When using the product, please follow the prompts when you find the following conditions.

1. External dirt: Wipe the dirt with a clean soft cloth with water, or use a cotton swab with medical alcohol. Wiping with medical alcohol can also have sterilization purposes. Take care not to add too much water or alcohol to prevent damage to the inside of the instrument.
2. Internal dirt: The black glass lens of the internal probe is an important device. Do not touch or press with your fingers or other objects, otherwise, it will affect the accuracy of the measurement. When the glass lens surface is dirty, please wipe the lens surface with 95% anhydrous alcohol with a cotton swab.
3. Storage: Keep in a dry, dark place out of direct sunlight.

Note:
Do not wipe the lenses with 75% sterile alcohol (residual watermarks).
Do not use other chemical agents to wipe the lens (damage the lens).

Display Message

temperature (10-40°C) for 30 minutes.
| The temperature measured is higher than normal human temperature (above 43°C)| Check the measured object and take a new measurement.
| The temperature measured is lower than a normal human temperature (below 32°C;)| Check the measured object and take a new measurement.
| Low battery| Replace batteries.

Product specification

Relative humidity:15% to 90% ；
Atmospheric pressure : 70kPa ~ 106kPa
Storage temperature| Ambient temperature:-25°C~70°C ；
Relative humidity: ≤90% ；
Atmospheric pressure : 70kPa ~ 106kPa
Automatic shutdown| 1 minute after not being used
Memory| 30 groups memory
Battery| 2 x AAA
Used Life Span of Battery| 1000 times
Service life| 5 Year
Software version| A01
Contents of the packaging| batteries. manual
Size| I 52x52x36 mm
Weight| About 66g (Not including batteries)

Note: Subject to modification without prior notice.

Normative references

1. TET-351 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS;
2. Portable and mobile RF communications equipment can affect TET-351.

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions
CISPR 11| Group 1
RF emissions
CISPR 11| Class B
Harmonic emissions
IEC 61000-3-2| Not applicable
Voltage fluctuations/ flicker emissions
IEC 61000-3-3| Not applicable
Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2
Test level| Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2| ±8 kV contact
±2 kV, ±4 kV,±8 kV, ±15 kV air| ±8 kV contact
±2 kV, ±4 kV,±8 kV, ±15 kV air
Electrical fast transient/burst
IEC 61000-4-4| Not applicable| Not applicable
Surge
IEC 61000-4-5| Not applicable| Not applicable
Voltage dips, short interruptions, and voltage variations on the power supply input lines
IEC 61000-4-11| Not applicable| Not applicable
Power frequency magnetic field
IEC 61000-4-8| 30 A/m
50Hz/60Hz| 30 A/m
50Hz/6014z
Conducted RF
IEC61000-4-6| Not applicable| Not applicable
Radiated RF
IEC61000-4-3| 10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz| 10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF
IEC61000-4-3
(Test speci­cations
for ENCLOSURE
PORT IMMUNITY to
RF wireless
communications
equipment)|        Test
Frequency  (MHz)| Band (MHz)|  Service| Modulation| Modulation

(W)

| Distance

(m)

| IMMUNITY

TEST

LEVEL

(V/m)

385| 380

–390

| TETRA 400| Pulse modulation18 Hz| 1,8| 0.3| 27
450| 430

–470

| GMRS 460,
FRS 460| FM± 5 kHz deviation1 kHz sine| 2| 0.3| 28
745| 704 –

787

| LTE Band 13, 17| Pulse modulation217 Hz| 0,2| 0.3

| 9
710
780
810| 800 –

960

| GSM 800/900, TETRA
800,iDEN 820,CDMA850,LTE Band 5| Pulse modulation 18 Hz| 2

| 0.3

| 28

870
930
1720| 1 700 –1 990| GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE Band
1, 3, 4, 25;
UMTS| Pulse
modulation
217 Hz| 2

| 0.3

| 28

1845
1970
2450| 2 400 –2 570| Bluetooth, WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Pulse modulation
217 Hz| 2| 0.3| 28
5240| 5 100 –5 800| WLAN 802.11a/n| Pulse modulation
217 Hz| 0,2| 0.3| 9
5500
5785

1. Main safety features of the infrared electronic thermometer

1. Type of anti-shock: Internal power supply
2. Type of anti-shock:: BF type application
3. Degree of protection against ingress: Not applicable
4. degree of safety when used under flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide: Non-AP/APG type.
5. operating mode: Continue to operate
6. Rated voltage: d.c. 3V
7. Input power: Not applicable
8. The thermometer has no application part with protection against defibrillation discharge efects
9. The thermometer has no signal output section or input section
10. The thermometer is a portable device

2. The Temperature sensor is treated as the applied part.

Connect the device via Bluetooth

1. Installation
   Prior to first use, Download and install the “ TRULY Healthcare ” application on your device. (Bluetooth 4.0 capabilities,e.g.ios 11.0 ,or Android 7.0).
   download link
   IOS https://www.pgyer.com/1gi
   Android heps://www.pgyer.com/sp3J
   Login account: Moblie account
   Install password:123456

2. Open the “ TRULY Healthcare” application Pressure icon on the Measurement screen.
   

3. Turn on Bluetooth“Allow”,

4. Click“Thermometer”.

5. Press the “Start” button.

6. When the measurement is complete, the temperature will display on the Thermometer monitor & press “Save” Measurement data.

7. All the measurement data will be saved in the app.

FCC Statement

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.
This equipment should be installed and operated with a minimum distance of 0mm between the radiator and your body.

CONTACT INFORMATION
TET-351 is manufactured by: Truly Instrument Ltd.
Address ：2/F., Chung Shun Knitting Centre,1-3 Wing Yip St, Kwai Chung, N.T,
HONG KONG
TEL： （852）24879803
FAX： （852）21465756
Facility: Truly Instrument Ltd.
Truly Industrial Area, Shan Wei City,516600, Guang Dong Province, PEOPLE’S REPUBLIC OF CHINA
Authorized European Representative:
Wellkang Ltd t/a Wellkang Tech Consulting
Address： Suite B, 29 Harley Street, LONDON W1G 9QR, United Kingdom

Rev.03
2021/09/29

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>