iHealth PT3 Infrared No-Touch Forehead Thermometer

Product Introduction and Indications

The iHealth PT3 Infrared No-Touch Forehead Thermometer is designed for the intermittent measurement of body temperature from the forehead. It is suitable for people of all ages and can be used by consumers in a household environment and by healthcare providers.

This product is a high-tech infra-red (IR) thermometer that measures body temperature by detecting the infrared energy emitted from the forehead, helping users quickly assess their health conditions.

Product Name: Infrared No-Touch Forehead Thermometer

Product Model: PT3

Manufacturer: ANDON HEALTH CO., LTD.

Safety Precautions

Warning:

• This thermometer is not a substitute for professional medical advice. Consult a doctor if you have any doubts about temperature readings.
• Keep the thermometer out of reach of children. For accidental swallowing of batteries or components, contact emergency services immediately.
• Batteries must not be thrown into fire or short-circuited.

Caution - Measurements:

1. Readings are for reference only. Do not attempt self-diagnosis or self-treatment. Seek professional medical advice when necessary.
2. There is no absolute standard for human body temperature. Knowing your normal body temperature range is important for accurate fever determination.
3. Ensure the forehead 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 after such activities before measurement for stability.
5. Do not measure over scar tissue, open sores, or abrasions, as these affect temperature conduction.
6. If there is a significant temperature difference between the storage area and the ambient environment, allow the thermometer to acclimate for 30 minutes before use.
7. Do not measure immediately after taking medication that raises body temperature, as readings will be inaccurate.
8. It is normal for readings to fluctuate slightly during continuous measurements. Limit continuous readings to a short period (e.g., up to 3).
9. Avoid direct sunlight, air conditioning outlets, or radiators during measurement, as these affect forehead temperature. Measurements should be taken in a stable environment.
10. Do not measure in environments with strong electromagnetic interference (e.g., near microwaves, induction cookers, or active cell phones), as this can cause errors or device failure.
11. This is a personal device. Clean and sanitize properly to prevent cross-contamination.
12. To clean a dirty probe, gently wipe with a cotton swab dipped in 70% isopropyl alcohol. Allow the thermometer to sit for at least 15 minutes before the next measurement.
13. This infrared thermometer meets ISO 80601-2-56:2017/AC:2018 requirements and displays temperatures from 89.6°F to 109.2°F (32°C to 42.9°C).

About the Product:

• This is a precision device. Store it in its original packaging. Avoid probe contact with liquids or particles.
• Avoid dropping or subjecting the product to external forces. Do not disassemble or modify the device.
• Do not touch the probe with fingers or blow on it. Measurements may be inaccurate with a damaged or dirty probe.
• Keep out of reach of children to prevent swallowing of small parts or batteries.
• Do not throw the thermometer or batteries into fire.
• Remove batteries if the device will not be used for over one month.
• If you are allergic to plastic/rubber, do not use this device.
• Materials (ABS, TPU, metal) have passed ISO 10993-5 and ISO 10993-10 standards tests for toxicity, allergy, and irritation.
• This device complies with part 15 of the FCC Rules, subject to two conditions: it must not cause harmful interference, and it must accept any interference received.

Overall Description and Product Performance

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

Device Components:

• LED display area
• Measurement button
• iHealth logo
• Thermometer probe
• Distance probe
• Battery cover

LED Screen Instructions: The screen displays the measured temperature in Celsius (°C) or Fahrenheit (°F) and may show a low power reminder.

Dimensions: Device: 5.39 in x 1.34 in x 1.54 in. Screen: 1.01 in x 0.75 in. Weight: 90 g.

Product Performance Specifications:

• Measurement Position: Center of the forehead surface.
• Measurement Distance: ≤1.18 inches (3 cm).
• Power Source: 2 x 1.5V AAA batteries.
• Measurement Range: 89.6°F - 109.2°F (32°C - 42.9°C).
• Measurement Precision: ±0.4°F/±0.2°C within 95°F-107.6°F (35°C-42°C); ±0.5°F/±0.3°C for other ranges.
• Resolution: 0.1°F/0.1°C.
• Clinical Reproducibility: Within ±0.5°F/±0.3°C.
• Operating Conditions: Temperature: 59°F-104°F (15°C-40°C); Humidity: 15-95% RH (non-condensing); Atmospheric Pressure: 70-106kPa.
• Operation Mode: Adjusted mode for forehead measurement.
• Expected Lifetime: 5 years.
• Reference Body Site: Oral.
• Software Version: V1.0.

Instructions for Use

The patient can measure, transmit data, and change batteries.

1. Installing the Product: Insert two batteries into the compartment on the back of the device. The product will perform a self-check and enter standby mode.

2. Measurement Process:

• Aim the thermometer probe at the center of the forehead, keeping it 1.18 inches (3 cm) away (approximately the width of an adult's index finger). Do not touch the forehead with the probe. The measurement window should be 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. A successful measurement displays the reading on the screen within approximately 1 second. If the measurement fails, the device will not vibrate and will display [---°F] instead.

Possible Reasons for Measurement Errors:

• Measurement distance is greater than 1.18 inches (3 cm).
• Environment temperature does not meet requirements or has a large difference.
• Target temperature exceeds the measurement range.

3. Power Off: The device will automatically power off after 8 seconds of inactivity.

4. Unit Switching:

• With the device powered OFF, press and hold the measurement button for 8 seconds to enter unit switching mode. Both °C and °F symbols will flash.
• Press the measurement button to switch between Fahrenheit and Celsius. The selected unit's symbol will flash.
• Press and hold the measurement button for another 8 seconds to exit unit switching mode.
• Reminder: If the unit is not confirmed by holding the button for 8 seconds before the screen turns off, the system will retain the original unit.

5. Installing and Replacing Batteries:

• The battery is automatically detected upon startup. A low power symbol [low battery indicator] will appear if capacity is low but adequate for measurements. If capacity is too low, a flashing [▶] icon will appear, and the device will power off after 8 seconds. Batteries must be replaced for continued use.
• Replacing Batteries:
• Press and slide the battery cover backward to open the compartment.
• Remove old batteries and install new ones, ensuring correct polarity.
• Close the battery compartment.
• Comply with national laws for disposing of used batteries. Do not dispose of batteries in household trash. Remove batteries if the device is unused for over a month.

Note: The typical service life of new batteries is 3000 measurements, providing approximately 60 seconds of operation time per measurement.

Product Errors and Troubleshooting

Body Temperature

Body temperature varies between individuals and fluctuates throughout the day. It is recommended to know your normal, healthy forehead temperature for accurate fever determination.

A rise of 1.8°F (1°C) or more above the reference body temperature is generally an indication of fever.

Different measurement sites (rectal, axillary, oral, frontal, auricular) yield different readings. Comparing measurements from different sites can be misleading.

Typical Temperatures for Adults (based on measurement site):

Cleaning, Care, and Maintenance

Cleaning and Care:

• For multi-patient use, clean the device between uses.
• Wipe the thermometer casing thoroughly with a cotton swab or tissue moistened with 70% isopropyl alcohol. Allow at least 5 minutes for drying before taking a temperature.
• If the device is not visually clean after wiping, repeat the cleaning steps.
• Note 1: Cleaning steps are validated according to FDA Guidance.
• Note 2: Ensure no liquid enters the device. Never use abrasive cleaners, thinners, benzene, or immerse the device in water or other cleaning liquids.

Care the Probe:

• The probe (temperature sensor and distance sensor) is intricate and must be kept clean and intact for accurate readings.
• Gently swab the probe surface with a cotton bud soaked in 70% isopropyl alcohol.
• If the probe is broken, contact customer services.
• The product is not waterproof. Do not clean with detergents or soak in liquids.

Maintenance:

• This company does not authorize any third party for product repairs or maintenance. Do not attempt to disassemble or modify the thermometer.
• The IR thermometer is a precise instrument; improper maintenance or modification can lead to inaccurate measurements.
• For product issues during the warranty period, contact customer services.

Disposal, Conditions, and Accessories

Disposal: Dispose of batteries according to applicable regulations and local laws. Dispose of at public collection points in EU countries (WEEE Directive, 2006/66/EC Directive). Consult local authorities for waste disposal queries.

Notes:

• Act according to local laws for disposal of used batteries.
• Remove batteries if the unit will not be used for a long time.
• Dispose of empty batteries at appropriate collection sites according to national or local regulations to protect the environment.

Operating, Shipping, and Storage Conditions:

• Operating Conditions: Temperature: 59°F-104°F (15°C-40°C); Humidity: 15-95% RH (non-condensing); Atmospheric Pressure: 70kPa-106kPa.
• 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.

• 1 IR Thermometer
• 2 AAA batteries
• 1 Instruction manual
• 1 Quick user guide

Standards, Compliance, and Icons

Standard Icons:

• [Read Operation Guide Symbol]: Symbol for "THE OPERATION GUIDE MUST BE READ". The sign background is blue, and the graphical symbol is white.
• [Disposal Symbol]: Indicates that batteries and electronic instruments must be disposed of in accordance with locally applicable regulations, not with domestic waste.
• [Manufacturer Symbol]: Symbol for "MANUFACTURER".
• [Warning Symbol]: Symbol for "WARNING".
• [Type BF Applied Parts Symbol]: Symbol for "Type BF Applied Parts".
• [Serial Number Symbol]: Symbol for "SERIAL NUMBER".
• [European Representative Symbol]: Symbol for "EUROPEAN REPRESENTATIVE".

IP Code: IP22 indicates the device's grade of protection against solid foreign objects (greater than 12.5mm diameter) and access to hazardous parts with finger, and its waterproof grade is dripping (when tilted 15°).

Calibration: The thermometer is initially calibrated at the time of manufacture. Periodic re-adjustment is not required if used according to instructions. Contact the distributor or manufacturer for accuracy concerns.

Storage: Do not expose to direct sunlight, high temperatures, or moist environments. Avoid contact with fire or harsh vibrations. Remove batteries if the device is not used for a long period.

Other Standards and Compliances: The iHealth PT3 corresponds to standards including IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56, and ASTM E1965-98.

Electromagnetic Compatibility (EMC) Information:

This device is intended for use in a home healthcare environment and is powered by battery.

Table 1 - Emission limits per environment

Table 2 - Enclosure Port Immunity test levels

Table 3 - Proximity fields from RF wireless communications equipment

Warranty Information

Contact your dealer or the device center for warranty claims. The warranty period is one year from the date of delivery, proven by sales receipt or invoice.

Warranty Exclusions:

• Damage due to improper treatment or non-observance of user instructions.
• Damage due to repairs or tampering by the customer or unauthorized third parties.
• Damage during transport from manufacturer to consumer or to service center.
• Accessories subject to normal wear and tear.

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

Manufactured for: iHealth Labs Inc., 120 San Lucar Ct., Sunnyvale, CA 94086, USA. Phone: +1-855-816-7705. Website: www.ihealthlabs.com

European Representative (EC REP): iHealthLabs Europe SAS, 36 rue de Ponthieu, 75008, Paris, France. Website: www.ihealthlabs.eu

Manufacturer/Factory: Andon Health Co., LTD., No. 3 Jin Ping Street, Ya An Road, Nankai District, Tianjin 300190, China. Factory: ANDON MEDICAL CO., LTD., No.26 HangYu Road, Pilot Free Trade Zone, Tianjin, China.