iHealth PT3 Forehead Thermometer User Manual

PT3
Infrared No-Touch Forehead Thermometer
User’s Manual
Version 4.5

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 infra-red (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.
Product Name: Infrared No-Touch Forehead Thermometer
Product Model: PT3

Safety Precautions

A 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.

A Caution
(1) Measurements 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 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 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).

(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 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. 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

1. 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.
   

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

3. 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

1. 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.
2. Under this mode, press the measurement button to switch to Fahrenheit or Celsius. The corresponding symbol of the selected unit after switching will flash.
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 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

1. Press down and hold the battery cover with the finger and apply some force to slide the cover backward 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 for more than one month.
• When using, shall not touch the battery, and the patient
• Do not throw batteries into fire.
• The typical service life of the new and unused batteries is 3000 measurements for the operation time is 60s.

Product errors and troubleshooting

them correctly.
| • Unable to carry out measurement as the current battery capacity is too low.| Replace the batteries
| • Measurement distance too long. The target temperature is beyond the range of measurements 89.6°F-109.2°F(32°C-42.9°C) • Environment temperature either exceeds the design range 59°F-104°F(15°C-40°C) or is unstable| Follow the instruction manual and repeat the measurements
| • Current state: All symbols are flashing on the screen. The product is not usable.| Please contact customer services.
| • Current battery capacity is too low.| Replace the battery as soon as possible.

Body temperature

• Body temperature varies from person to person and fluctuates 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°C-37.8°C). 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 1.8°F/1°C or more is generally an indication of fever.
• Different measurement sites(rectal, axillary, oral, frontal, auricular) will give different readings. Therefore it is wrong to compare the measurement taken from different sites.
• The following are typical temperatures for adults, based on different measurement sites:

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 point 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

Accessories
Use only accessories provided by the original manufacturer, and check for any missing accessories.

Standard icons

| The symbol for “THE OPERATION GUIDE MUST BE READ” 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.
| The symbol for “MANUFACTURER”
| The symbol for “WARNING”
| The symbol for “Type BF Applied Parts”
| The symbol for “SERIAL NUMBER”
| The symbol for”EUROPEAN REPRESENTATIVE”
| 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 finger); the grade of waterproof is dripping (15° tilted).

Calibration

The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the user’s instruction, periodic re- adjustment is not required. If any time your question the accuracy of measurement, please contact the distributor or manufacturer, the contact information is on the last page.

Storage

1. Do not put the thermometer under direct sunlight, high temperature, or moist environments. Do not allow it to come into contact with fire or harsh vibrations.
2. Take out the battery if the device is not used for a long period of time.

OTHER STANDARDS AND COMPLIANCES

The Infrared No-Touch Forehead Thermometer corresponds to the following standards: IEC 60601-1: 2005 +A1:

2012(E)/EN 60601-1: 2006/A1: 2013 (Medical electrical equipment — Part 1: General requirements for basic safety and essential performance), IEC 60601-1-2: 2014 (Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and Tests), ISO 80601-2-56: 2017/AC: 2018 ( Medical Electrical Equipment—Part 2-56: Particular Requirements For The Basic Safety And Essential Performance Of clinical thermometers for body temperature measurement), ASTM E1965-98: 2016( Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature).

ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1 – Emission limits per environment

environment.
Harmonic
distortion| IEC 61000-3-2 NA| The device is powered by a battery.
Voltage fluctuations and Bicker| IEC 61000-3-3 NA| The device is powered by a battery.

Table 2 – Enclosure Port

Home Healthcare Environment

Electrostatic Discharge| IEC 61000-4-2| +–8 kV contact

±2kV, ±4kV, ±8kV, ±15kV air

Radiated RF EM field| IEC 61000-4-3| 10V/m

80MHz-2.7GHz 80% AM at kHz

Proximity fields from RF wireless communications equipment| IEC 61000-4-3| Refer to table 3
Rated power frequency

magnetic fields

| IEC 61000-4-8|

30A/m

50Hz or 60Hz

Table 3 – Proximity fields from RF wireless communications equipment

Professional healthcare facility environment
385| 380-390| Pulse modulation 18Hz, 27V/m
450| 430-470| FM, t5kfiz deviation, kHz sine, 2f3V/m
710| 704-787| Pulse modulation 217Hz, 9V/m
745
780
810| 800-960| Pulse modulation 18Hz, 28V/m
870
930
1720| 1700-1990| Pulse modulation 217Hz, 28V/m
1845
1970
2450| 2400-2570| Pulse modulation 217Hz, 28V/m
5240| 5100-5800| Pulse modulation 217Hz, 9V/m
5500
5785

WARRANTY

Please contact your dealer or the device center in case of a claim under the warranty. If you have to send in the unit, enclose a copy of your receipt with a clear statement of defect description.

The warranty terms are as below:

1. The warranty period for the device is one year from the date of delivery. In the case of a warranty claim, the date of delivery has to be proven by means of the sales receipt or invoice.
2. Repairs under warranty do not extend the warranty period.
3. The following cases are excluded under the warranty

• All damage that has arisen due to improper treatment, e.g. nonobservance of the user instruction.
• All damage is due to repairs or tampering by the customer or unauthorized third parties.
• Damage has arisen during transport from the manufacturer to the consumer or during transport to the service center.
• Accessories that are subject to normal wear and tear.

4. Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim.

Manufactured for iHealth Labs Inc.
120 San Lucar Ct., Sunnyvale, CA 94086, USA
+1-855-816-7705

www.ihealthlabs.com

health labs Europe SAS www.health labs.eu 36 rue de Ponthieu, 75008, Paris, France

Andon Health Co., LTD.
No. 3 Jin Ping Street, Ya An Road, Nankai District, Tianjin 300190, China.

Factory: ANDON MEDICAL CO., LTD.
Address: No.26 Hongyu Road, Pilot Free Trade Zone, Tianjin, China

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