Ihealth PT3 User Manual

Infrared No-Touch Forehead Thermometer
l'infrarouge Pas de contact forhead thermomètre
Infrarrojos Termómetro sin contacto frente
User’s Manual
Mode d'emploi
Manual de usuario
Version 1.0
EN
Contents
Product introduction
Safety Precautions
Caution
Overall Description
Product performance
Expected use and scope of applications
Contraindications
Instruction For Use
Product errors and troubleshooting
Body temperature
Care and Cleaning
Maintenance
Disposal
Operating, shipping, and storage conditions
Accessories
Standard icons
Calibration
Storage
Electromagnetic Compatibility (EMC) Tables
WARRANTY
Product introduction
Thank you for choosing our product. This product is a high-tech infra-red (IR) thermometer designed to take human body temperature by measuring the
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energy of IR emitted from the forehead. The product helps you to assess you and your family members’ health conditions easily and quickly. Product Name: Infrared No-Touch Forehead Thermometer Product Model: PT3
Safety Precautions
Warning Use of this thermometer is not intended as a substitute for consultation with your physician. Please consult your doctor if you have any doubt about the temperature reading. For consumer use only, not for professional use. Keep the thermometer out of reach of children. For accidental swallowing of the battery or other components, please contact emergency services immediately. Batteries must not be thrown into an open re or short circuited.
(1) Measurements
1. Thermometer readings should be regarded as a reference. Do not attempt self-diagnostics or self-treatment using the temperature readings. Please seek professional medical advice when necessary.
2. There is no absolute standard for human body temperature. Knowing your own normal body temperature range is important to accurately determine if you have a fever.
3. Make sure that the forehead of the subject is free from sweat, cosmetics, dirt, or grease before measuring.
4. Patients should not drink, eat, or be physically active before/while taking a reading. Wait 30 minutes before taking a measurement. Temperature readings taken when a body is in a state of stable equilibrium is more accurate and useful as a reference.
5. Do not take temperature measurement over scar tissue, open sores or abrasions.
6. Do not measure body temperature from scar tissues on the forehead as such tissues will aect temperature conduction of the body.
7. If there is a temperature dierence between the thermometer storage area and the new ambient environment around the subject, please let the thermometer sit within the new environment for 30 minutes before taking the measurement.
8. Do not measure body temperature immediately after consuming a drug that raises body temperature. Temperature readings taken at this time will not be accurate.
9. It is normal for readings taken from continuous measurements to uctuate within a small range. During continuous measurements, the subject’s body temperature may be transmitted to the thermometer, aecting
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measurement accuracy. We recommend taking only up to
3 continuous readings within a short period.
10. Do not directly face the sun or an air outlet of an air conditioning or radiator device during the measurement
as this will cause changes to the forehead temperature. Measurements should be taken in a stable environment where possible.
11. Do not measure body temperature in an environment with strong EM interference (examples include places close to a working microwave, induction cooker, or cellphone in-use) as EM interference may cause errors in the reading or even device failure.
12. This product should be considered a personal device. Clean and sanitize the product properly to prevent cross contamination.
13. To clean a dirty thermometer probe, gently swipe the probe using a cotton swab dipped in 75% alcohol. Let the cleaned thermometer sit for at least 15 minutes before taking more measurements.
14. This infrared thermometer meets requirements established in ASTM Standard (E1965-98) Except of clause
5.2.2. It displays subject’s temperature over a range of 89.6 ~109.2. Full responsibility for the conformance of this product to the standard is assumed by (manufacturer: Famidoc Technology Co., Ltd. Add: No. 212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town, Dongguan 523853, Guangdong Province, China.)
(2) About the product
1. This product is a precision device. Return the product to its
original packaging for proper storage after use. To ensure accurate measurements, avoid the device or probe contacting any liquid or droplets. Avoid tiny particles (such as dust or powder) falling into the probe.
2. Avoid dropping or subjecting the product to external
forces. Do not disassemble or re-assemble the product on your own.
3. Do not directly touch the probe with your ngers or blow
on it. Measurements taken using a damaged or dirty IR probe may be inaccurate.
4. Keep the product at a place inaccessible to children to
prevent children from swallowing the batteries or small parts.
5. Do not throw the thermometer or batteries into re to
prevent explosions.
6. Remove the batteries from the thermometer if the device
will not be used for more than one month.
7.If you are allergic to plastic/rubber, please don’t use this
device.
8.The materials (ABS, TPU, metal) of expect contact with
patient had passed the ISO 10993-5 and ISO 10993-10 standards test, no toxicity, allergy and irritation reaction. They are in compliance with the MDD requirements. Based on the current science and technology, other potential allergic reactions are unknown.
Overall Description
The thermometer is mainly comprised of a plastic casing, IR
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temperature sensor, MCU, vibration motor, LED display screen and batteries.
Thermometer
LED display area
Measurement button
probe Distance
probe
Battery cover
LED screen instructions
Temperature display area
Low power reminder
Device dimensions: 5.39 in x 1.34 in x 1.54 in Screen dimensions: 1.01 in x 0.75 in Product weight: 90 g
Celsius
Fahrenheit
Product performance
1. Measurement position: Centre of the forehead surface
2. Measurement distance: ≤1.18in(3 cm)
3. Power source: DC 3V; 2 x 1.5V AAA batteries
4. Measurement range: 89.6-109.2(32-42.9)
5. Measurement precision: ±0.4 within 95-107.6, and±0.5 for other temperature ranges.
6. Resolution: 0.1
7. Clinical reproducibility: Within ±0.5
8. Operating conditions: Temperature: 59-104(15-40) Humidity: 15-85%RH, non-condensing Atmospheric Pressure: 70~106kPa
9. Operation mode: Adjusted mode: forehead Direct mode: surface mode
10. Expected service life: 2 years
11. Reference Body Site: Oral
12. Software version: V1.0
ASTM laboratory accuracy requirements in the display range of 98°F to 102°F(37) for IR thermometers is ±0.4°F(±0.2), whereas for mercury in-glass and electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is ±0.2°F(±0.1).
Expected use and scope of applications
This product mainly uses IR temperature sensing of the forehead to measure human body temperature. Can be used for babies, children, and adults. Babies and children should not operate the thermometer on their own. Body temperature readings for babies and children should be taken by an adult. Reminder: Temperature readings may dier according to skin tone and measurement distance.
Contraindications
It is not recommended for people whose measuring part has local lesions, such as inammation, trauma, postoperative, etc.
Instruction For Use
The patient is an intended operator. The patient can measure, transmit data and change battery.
(1) Installing the product
Insert the 2 battery cells from the packaging box into the battery compartment at the back of the device. The product will start automatic inspection and a standby mode (if the device indicates low battery power, then replace the batteries to ensure ample power supply).
(2) Measurement process
Aim the thermometer probe at the center of the
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forehead and keep the probe 1.18in (3cm) away from the forehead (the optimal distance is about the width of an adult’s index nger). Do not touch the forehead with the probe.
≤1.18in(3cm)
Gently press the
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measurement button [ ] to start the measurement.
The device will vibrate
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once a reading is obtained. The reading will be displayed on the screen. If the measurement is failed, the device will not vibrate the screen but display [ ] instead.
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Possible reasons for measurement errors include:
A. Measurement distance is greater than
1.18in (3cm);
B. Environment temperature does not
meet measurement requirements or there is an excessively large temperature dierence;
C. Target temperature exceeds
measurement range.
(3) Power o
If no more measuring is required, simply let the device sit idle for 8 seconds to power o automatically.
(4) Unit switching
1. When the device is powered OFF, press and hold the measurement button for 8 seconds to enter unit switching mode. Under this mode, both and °F should ash at the same time.
2. Under this mode, press the measurement button to switch to Fahrenheit or Celsius. The corresponding symbol of the selected unit after switching will ash.
3. After selecting the unit, press and hold the measurement button for 8 seconds to leave the unit switching mode.
Reminder: If you do not press and hold the measurement button for 8 seconds to conrm the unit selected before the screen switches o, the system will consider the switch as a failure and retain the original unit for temperature measurements.
(5) Installing and replacing batteries
When switched ON for use, the thermometer will automatically detect remaining battery capacity. If battery capacity is low but adequate for measurements, the low power symbol [ ] will be displayed with the measurement results. However, if the battery capacity is too low for measurements, the screen will display a single, ashing [ ] icon and automatically switch OFF after 8 seconds. To continue using the device, old batteries must be replaced.
(6) Replacing batteries
1. Press down and hold the battery cover with the nger and apply some force to slide the cover backwards to open the battery compartment.
2. Remove the old batteries and install the new batteries.
3. Refer to the battery polarity symbols to orient the batteries properly during installation. Make sure that the new batteries are tightly inserted into the battery compartment and make sure that the polarity is not reversed during installation.
4. Return the battery cover to close the battery compartment.
Comply with relevant national laws and regulations when disposing of the used batteries. Do not dispose of batteries directly into the trash bag. Remove the batteries if the device will not be used more than one month.
When using, shall not touch battery and the patient simultaneously. Do not throw batteries into re. The typical service life of the new and unused batteries is 300 measurements for the operation time is 60s.
Product errors and troubleshooting
Item to detect SolutionProblem
Replace old
Battery depleted
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· Batteries have been installed with the wrong polarity
· Batteries are not installed properly
Unable to carry out
· measurement as current battery capacity is too low.
· Measurement distance too long
Target temperature is
· beyond range of
measurements 89.6-
109.2(32-42.9)
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Environment temperature either exceeds the design range 59-104(15­40) or is unstable
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Current state: All symbols are ashing on the screen. The product is not usable.
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Current battery capacity is too low.
batteries with new ones
Take out the batteries and re-install them correctly.
Replace the batteries
Follow the instruction manual and repeat the measurements
Please contact customer services.
Replace the battery as soon as possible.
Body temperature
Body temperature varies from person to person and uctuates during the course of the day. For this reason, it is suggested to know one's normal, healthy forehead temperature to correctly determine the temperature. Body temperature runs approximately from 95.9°F to100°F (35.5-37.8). To determine if one has a fever, compare the temperature detected with the person's normal temperature. A rise over the reference body temperature of 1°F(1) or more is generally an indication of fever. Dierent measurement sites(rectal, axillary, oral, frontal, auricular) will give dierent readings. Therefore it is wrong to compare the measurement taken from dierent sites.
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The following aretypical temperatures for adults, based on dierent measurement sites:
Rectal
Axillary
Oral
Auricular
97.9°F-99.1°F
94.5°F-99.1°F
95.9°F-99.5°F
96.4°F-100.4°F
36.6 to 38
34.7 to 37.3
35.5 to 37.5
35.8 to 38
Care and Cleaning
1. The probe (comprising a temperature sensor and a distance sensor) is the most intricate part of the thermometer, and should be kept clean and intact to acquire accurate readings. Use the following method to clean the probe: Gently swab the surface of the probe using a cotton bud soaked in > 75% medical alcohol.
2. If the probe (sensor) is broken, please contact customer services.
3. Use a piece of soft, dry cloth to clean the display screen and external surface of the thermometer. If the thermometer is very dirty, the cloth can be moistened with some medical alcohol to clean the device.
4. The product is not waterproof. Do not clean the device with detergents. Do not soak the thermometer in water or other liquids.
Maintenance
1. This company has not authorized any agency or individual to carry out product repairs or maintenance. Do not attempt to disassemble or modify the thermometer if you suspect functional issues with the device.
2. The IR thermometer is an extremely precise instrument. Any improper maintenance, disassembly, or modication may lead to inaccuracies of the product measurements.
3. If you suspect any product issues during the warranty period, please contact customer services for subsequent handling.
Disposal
Dispose of the battery in accordance with the regulation applicable at the place of operation. Dispose of at public collection point in the EU countries – 2002/96/EC WEEE Directive. If you have any queries, please refer to the local authorities responsible for waste disposal.
Notes
• Please act according to local laws for disposal of used batteries.
• Take out the battery if you are not going to use the unit for a long time.
To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations. Dispose of at public collection point in the EU countries – 2006/66/EC Directive.
Operating, shipping, and storage conditions
(1) Operating conditions
Range of operating environments Temperature: 59-104℉(15- 40) Humidity: 15-85%RHnon-condensing Atmospheric Pressure: 70kPa~106kPa
(2) Transportation / storage conditions
Main Unit: -4~131℉(-20~ 55℃) Humidity: 15-95%RH, non-condensing Atmospheric Pressure: 70kPa~106kPa
Accessories
Use only accessories provided by the original manufacturer, and check for any missing accessories.
1 IR Thermometer
1 Instruction manual
2 AAA batteries
1 Quick user guide
Standard icons
Attention: Follow instructions for use! (The sign background color: blue. The sign graphical symbol: white.)
The batteries and electronic instruments must be disposed of in accordance with the locally applicable regulation, not with domestic waste.
Manufacturer information
Symbol for "WARNING"
Serial number
Authorized representative in the European Community
IP code of the device: this device’s grade of against ingress of solid foreign objects -- ≥
12.5mm diameter (and the against access to hazardous parts with nger); the grade of waterproof is dripping (15° tilted).
Complies with MDD 93/42/eec Requirements
0120
Calibration
The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the use instruction, periodic re-adjustment is not required. If any time your question the accuracy of measurement, please contact distributor or manufacturer, the contact information is on the last page.
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Storage
1) Do not put the thermometer under direct sunlight, high temperature, or moist environments. Do not allow it to come into contact with re or harsh vibrations.
2) Take out the battery if the device is not used for a long period of time.
Electromagnetic Compatibility (EMC) Tables
Guidance and manufacturer’s declaration -
electromagnetic emissions
The PT3 device is intended for use in the electromagnetic
environment specied below.The customer or the user of the
PT3 should assure that it is used in such an environment.
Emissions test
RF emissions CISPR11
RF emissions CISPR11
Harmonic emissions lEC61000-3-2
Voltage uctuations/ ickeremissions lEC61000-3-3
environment specied below.The customer or the user of the
Immunity test IEC 60601 Test
Electrostatic discharge(ESD) lEC61000-4-2
environment specied below. The customer or the user of the
Compliance
Group 2 The PT3 device must emit
Class B
Not applicable
Not applicable
Guidance and manufacturer’s declaration —
electromagnetic immunity
The PT3 device is intended for use in the electromagnetic
PT3 should assure that it is used in such an environment.
level
±6kV contact ±8kV air
Guidance and - manufacturer’s declaration.
Electromagnetic immunity
The PT3 device is intended for use in the electromagnetic
PT3 should assure that it is used in such an environment.
Electromagnetic environment
-guidance
electromagnetic energy in order to perform its intended function. Nearby electronic equipment maybe aected.
The PT3 device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Compliance level
±6kV contact ±8kV air
Electromagnetic environment ­guidance
Floors should be wood , concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%.
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