IHealth PT3V1 No Touch Forehead Thermometer User Manual

IHealth PT3V1 No Touch Forehead Thermometer

Indications for Use

The Infrared No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

Product Introduction

Thank you for choosing our product. This product is a high-tech infrared (IR) thermometer designed to take human body temperature by measuring the energy of IR emitted from the forehead. The product will help you to assess your and your family members’ health conditions easily and quickly.

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 doubts about the temperature reading.
• 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 fire or short-circuited.

Caution : Measurements Thermometer readings should be regarded as a reference.

1. 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 are more accurate and useful as a reference.

5. Do not take temperature measurements over scar tissue, open sores, or abrasions.

6. Do not measure body temperature from scar tissues on the forehead as such tissues will affect temperature conduction of the body.

7. If there is a temperature difference 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 fluctuate within a small range. During continuous measurements, the subject’s body temperature may be transmitted to the thermometer, affecting 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 70% Isopropyl. Let the cleaned thermometer sit for at least 15 minutes before taking more measurements.

14. This infrared thermometer meets the requirements established in ISO 80601-2-56: 2017/AC: 2018. It displays the subject’s temperature over a range of 89.6°F —109.2°F (32°C-42.9°C). Full responsibility for the conformance of this product to the standard is assumed by (manufacturer: ANDON HEALTH CO., LTD. Add: No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China).

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 from 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 fingers 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 the fire 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 expecting contact with the 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.
9. 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.

Overall Description

The thermometer is mainly comprised of a plastic casing, IR temperature sensor, MCU, vibration motor, LED display screen, and batteries.

LED Screen Instructions

• 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

Product Performance

1. Measurement position: Centre of the forehead surface
2. Measurement distance: <I.18in(3 cm)
3. Power source: 2 x 1.5V = SIZE AAA batteries
4. Measurement range: 89.6°F-109.2°F(32°C-42.9°C)
5. Measurement precision: ±0.4°F/0.2°C within 95°F-107.6°F (35°C-42°C), and±0.5°F/0.3°C for other temperature ranges.
6. Resolution: 0.1 °F/0.1 °C
7. Clinical reproducibility: Within ±0.5°F/0.3°C
8. Operating conditions:
   • Temperature: 59°F-104°F(15°C-40°C)
   • Humidity: 15-95%RH, non-condensing
   • Atmospheric Pressure: 70-106kPa
9. Operation mode:
   • Adjusted model: forehead
10. The expected lifetime of the product: 5 years
11. Reference Body Site: Oral
12. Software version: V1.0

Expected use and scope of applications

This product mainly uses infrared sensors to measure the temperature of the human forehead. It can be used for babies, children, and adults. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement.
Reminder: Temperature readings may differ according to skin tone and measurement distance.

Contraindications

It is not recommended for people whose measuring part has local lesions, such as inflammation, trauma, postoperative, etc.

Instruction For Use

The patient is an intended operator. The patient can measure, transmit data and charge the battery.

1. Installing the product
   Insert two batteries into the battery compartment on the back of the device. The product will initiate a self-check and then enter the 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 forehead and keep the probe 1.18in (3cm) away from the forehead (the optimal distance is about the width of an adult’s index finger). Do not touch the forehead with the probe.
     The infrared thermometer measurement window should be held perpendicular to the forehead and the subject should remain steady.
     

   • Gently press the measurement button [ ] to start the measurement.

   • The device will vibrate once a reading is obtained. Once the measurement is successful, the reading will be displayed on the screen. The whole time is about 1s. If the measurement is failed, the device will not vibrate the screen but display [ – – – °F ] instead.

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 difference;
  * C. Target temperature exceeds measurement range.

3. Power off
   If no more measuring is required, simply let the device sit idle for 8 seconds to power off automatically.

4. Unit switching

   • When the device is powered OFF, press and hold the measurement button for 8 seconds to enter unit switching Under this model, both °C and °F should flash at the same time.
   • Under this mode, press the measurement button to switch to Fahrenheit or Celsius. The corresponding symbol of the selected unit after switching will flash.
   • 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 confirm the unit selected before the screen switches off, the system will consider the switch as a failure and retain the original unit for temperature measurements.

5. Installing and replacing batteries
   Each time the thermometer is started, the battery will be automatically detected. If the 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, flashing [ ] icon and automatically switch OFF after 8 seconds. To continue using the device, old batteries must be replaced.

6. Replacing batteries

• * Press down and hold the battery cover with your finger and apply some force to slide the cover backward to open the battery compartment.

  • Remove the old batteries and install the new batteries.
  • 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.
  • 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 for more than one month.
  • When using, shall not touch the battery, and the patient
  • Do not throw batteries into the fire.
  • The typical service life of the new and unused batteries is 3000 measurements for the operation time is the 60s.

Cleaning and Care

The thermometer is mainly for home use, if used for multiple patients, please clean the device in between uses with the following steps:

• Use an alcohol swab or cotton tissue moistened with alcohol (70% Isopropyl) to clean the thermometer casing thoroughly, The wiping process preferably lasts 15 seconds.
• Allow at least 5 minutes of drying time before taking a
• After cleaning, if the device is not visually clean when observed with magnification and adequate lighting, please repeat the clean steps above.

Note 1: The cleaning steps above have been validated according to the FDA Guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”.
Note 2: Ensure that no liquid enters the interior of the device. Never use abrasive cleaning agents, thinners, or benzene for cleaning, and never immerse the device in water or other cleaning liquids.

Care the Probe

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 70%
2. If the probe (sensor) is broken, please contact the customer
3. The product is not waterproof. Do not clean the device with 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 modification 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 the 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 points in the EU countries – 2006/66/EC Directive.

Operating, Shipping, and Storage Conditions

1. Operating conditions
   • Range of operating environments Temperature: 59°F-104°F (15°C- 40°C)
   • Humidity: 15-95%RH
   • Non-condensing Atmospheric Pressure: 70kPa-106kPa
2. Transportation/storage conditions
   • Temperature: -4°F-131°F(-20°C- 55°C)
   • Humidity: 15-95%RH
   • Non-condensing Atmospheric Pressure: 70kPa-106kPa

FAQs

How do I use the thermometer?****

1.      Remove the battery cover on the back of the thermometer.
2.      Insert one AA battery (not included).
3.      Close the battery cover.
4.      Press and hold the power button for 3 seconds to turn on the thermometer.
5.      The thermometer will beep until it has achieved a stable reading.
6.      Place the thermometer on your forehead, as shown in Figure A, and wait until it beeps again to indicate that it has taken a reading.
7.      The temperature reading will appear on the screen after a few seconds (Figure B). If you are not satisfied with the temperature reading, you can repeat steps 5-6 to take another reading.
8.      Remove the thermometer from your forehead and wait for it to shut off automatically after 30 seconds of inactivity or press the power button to turn off manually.

How accurate is this thermometer?****

This is a clinical-quality infrared thermometer that has been tested in accordance with international standards for accuracy and precision at temperatures between 32°F (0°C) and 104°F (40°C). It is accurate within ±0.2°F (-0.1°C) from 32°F (0°C) to 99°F (37°C), and within ±0.3°F (-0.1°C) from 100°F (37.7°C) to 104°F (40°C). It is designed for measuring body temperature, not ambient temperature or surface temperature, so please make sure you are using it correctly before taking any measurements or drawing any conclusions about your health conditions or those of others around you based on its readings alone. If you have any doubts about your health condition, please consult your doctor immediately.

Is Fahrenheit or Celsius the default setting on the thermometer?****

Celsius is the default.

Where is the best place to use a no-touch thermometer?****

The OUTPUT port of the source device (such a cable box) is connected to one end of an HDMI cable, which is connected to the INPUT port of the switch. Next, each OUTPUT port on the switch that connects to the TV receives an HDMI cable.

How accurate are no-touch thermometers?****

The non-contact thermometer has a sensitivity and specificity of 97%. The negative predictive value is 99%, which is particularly crucial to exclude fever and prevent pointless laboratory testing.

How many degrees do you add to a no-touch thermometer?****

If utilizing a fixed emissivity infrared thermometer, the oral equivalent might be calculated by measuring the temperature at the middle of the forehead and then adding 5 degrees Fahrenheit.

How do I make sure my forehead thermometer is accurate?****

One should follow the manufacturer’s instructions and make sure the measuring region on the forehead is clean and free of hair or headgear to acquire the most accurate reading.

Can you use a no-touch thermometer for water?****

No, if there is glass, a liquid, or any other transparent surface between the subject and the thermometer, it is impossible for the thermometer to measure the temperature properly.

What part of the forehead should you take the temperature?****

Put the sensor head so that it is touching the skin in the middle of the forehead. Move the thermometer slowly from the top of the ear across the forehead. Keep it in close proximity to your skin. When you get to the hairline, stop.

Do you add a degree to no touch forehead thermometer?****

You must add 0.5 to 1 degree to your temperature to get the reading it would have given if taken orally as a temporal thermometer would often read 0.5 to 1 degree lower than an oral thermometer. For instance, if the temperature on your forehead was 98.5°F, you could actually be suffering with a low-grade fever that is 99.5°F or higher.

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