HOMEDICS HTD8216C Infrared Body Thermometer Instructions

HOMEDICS HTD8216C Infrared Body Thermometer

FOREWORD

The Infrared Body Thermometer operating Instructions intend to provide the necessary information for proper operation of the thermometer model. Only body mode was reviewed and certified by notified body. General knowledge of Infrared thermometer and an understanding of the features and functions of the thermometer model are prerequisites for proper use. The Infrared Body Thermometer is a medical device, and can be used repeatedly for the product’s recommended lifetime of 5 years. Please read the manual first before using it, if not fully understand the usages, please stop using the thermometer. Do not operate the thermometer without completely reading and understanding these instructions.
Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.
For further information contact:
FKA Brands Ltd, Somerhill Business Park, Five Oak Green Road,
Tonbridge, Kent TN11 0GP.
Customer Service: service@homedics.co.uk

SAFETY INFORMATION

This device may only be used for the purposes described in these instructions. The manufacturer cannot be held liable for damage caused by incorrect application. The Infrared Body Thermometer is designed to minimize the possibility of hazards from errors in the software program by following sound and light engineering design processes, Risk Analysis and Software Validation.
WARNING: Warnings are identified by the WARNING symbol shown above.

• The Infrared Body Thermometer is to be operated by consumers in the home setting and primary care setting as screening tool. This manual, accessories, Directions for Use, all precautionary information, and specifications should be read before use.
• This product is designed to measure human body temperature on the forehead and ear. Do not use it for any other purpose.
• This product is intended for use in the home setting and primary care setting as screening tool.
• Do not use the thermometer if it malfunctions or has been damaged in any matter.
• When the ambient temperature of the thermometer changes too much, such as moving the Thermometer from one place of lower temperature to another place of higher temperature, allow the thermometer to remain in a room for 30 minutes where the temperature is between 15°C to 35°C (59°F- 95°F).
• Remove primary batteries if equipment is not likely to be used for long time.
• This product is not waterproof, do not immerse in water or other liquid; If cleaning and disinfecting, please follow the “Care and Storage” section requirements.
• Do not touch the sensor of infrared detection with your fingers.
• Avoid using the thermometer to take a body temperature reading while using a cold compress or other measure to reduce fever.
• If measuring human temperature, please select “body” mode or“ear” mode.
• This product must be operated in a stable environment. If the ambient environment is unstable, please check whether there is fog on the sensor and remove this before using in accordance with the “Care and Storage” section.
• Do not near strong electrostatic field or strong magnetic fields, thus avoiding the impact on the accuracy of the measurement data.
• Do not mix the old and new batteries to avoid damage to the product.
• It may affect the accuracy of measurements when the forehead is covered by hair, perspiration, cap or scarf.
• The measuring result of this product is only for your reference. If you have any doubt, please measure the temperature in other methods. Also the ear wax will lower down the temperature. So please be sure use correct way in case of accuracy of measurements.
• Some people are not suitable to use ear mode properly for oily ears or for other reasons.
• The device should be kept out of the reach of children/pets. When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the thermometer body.
• Do not throw batteries into fire.
• Only use recommended batteries. Do not use rechargeable batteries.
• This thermometer does not replace a hospital diagnosis.
• Do not drop, disassemble or modify the device.
• Do not use this device if you think it is damaged or notice anything unusual.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the ‘Technical Specifications’ section.
• Not servicing/maintenance while the thermometer is in use. When using, do not touch battery and the patient simultaneously.
• Do not use the device if it is damaged/ degraded/loosened in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger. Based on the current science and technology, other potential allergic reactions are unknown. This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS.

OVERVIEW

Intended Use
The HoMedics Infrared Body Thermometer is designed to be used for intermittent measurement and monitoring of human body temperature by consumers in the home setting and primary care setting as screening tool.

Description of Infrared Body Thermometer
Device principle and introduction

• The Infrared Body Thermometer is a hand-held, reusable, battery operated device, which can measure human body temperature on forehead, the skin temperature on one’s forehead.
• The operation principle is based on Infrared Sensor technology. The IR sensor can output different signal when measuring different object temperatures or in different ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital value and display it on the LCD.

Description on Controls, Indicators, and Symbols

fig: 1

1. Passive infrared probe
2. Cap
3. Start button
4. Liquid crystal display (LCD)
5. Battery cover (MODE button is behind the battery cover)

fig: 2

1. Forehead mode
2. Ear mode
3. Surface mode
4. Measurement unit
5. Data indicator
6. Low Battery indicator
7. Indicator of the measurement result
8. Volume on/off indicator
9. Memory indicator

THERMOMETER APPLICATIONS

Thermometer Model Number|

Thermometer Style

| Adult| Pediatric
---|---|---|---
Ear| Forehead| Ear| Forehead
Model: HTD8216C TE-300-EU 1| Infrared Body Thermometer| | | |

EQUIPMENT SYMBOLS

TECHNICAL SPECIFICATIONS

Surface mode: 0°C – 100.0°C / 32°F -212°F

Laboratory Accuracy| Body mode:

34.0 – 34.9°C: ± 0.3°C / 93.2 – 94.8°F: ± 0.5°F

35.0 – 42.0°C: ± 0.2°C / 95.0 – 107.6°F: ± 0.4°F

42.1 – 42.9°C: ± 0.3°C / 107.8 – 109.2°F: ± 0.5°F

Surface mode:

± 2°C / ± 3.6°F

Display Resolution| 0.1°C/0.1°F
Three-colour Backlight (Colour Alarm)| 34 – 37.3°C / 93.2 – 99.1°F: Green (Normal Temperature)

37.4 – 38.0°C (Alarm point) / 99.3 – 100.4°F: Yellow (Slight Fever) 38.1 – 42.9°C / 100.6 – 109.2°F: Red (High Fever)

Note: Colour Alarm is only for Body mode, Surface mode is always with Green backlight.

Auto Power Off Time| ≤35s
Measuring Time| ≤ 5s (under ear mode)

≤2S(under Forehead mode)

3-10s (under Forehead scan mode)

Memories| 1
Power Supply Requirements

Batteries| 2 x 1.5V (AAA) Alkaline battery (IEC Type LR03)
Environmental
Operating Condition| Operating Temperature: 15 – 35°C (59 – 95°F)| Relative Humidity:

≤ 85%

| Atmospheric pressure: 70-106Kpa
Transport and Storage Condition| Storage Temperature:

-20 – 55°C (-4 – 131°F)

| Relative Humidity:

≤ 93%

| Atmospheric pressure: 70-106Kpa
Dimension and Weighting

Weight (without batteries)| 66g
Size| L:154mm X W:34mm X H:52mm
Compliance
Item| Compliant with
Equipment classification| Safety Standards:

EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015

Type of protection| Internally powered equipment (on battery power)
Front panel and case labelling| EN ISO 15223-1:2016
Temperature| EN ISO80601-2-56:2012
Home healthcare environment| EN 60601-1-11:2015
Accessory name| number
AAA battery| 2
User manual| 1

Calculated values of the indicators according to ISO80601-2-56-2012 Ear mode:

| Group A1| Group A2| Group B| Group C
---|---|---|---|---
Bias| 0.000| -0.097| -0.046| -0.060
Standard deviation| 0.175| 0.154| 0.116| 0.125
Limits of agreement| 0.349| 0.308| 0.233| 0.249
Clinical repeatability (for all groups)| 0.057

Forehead mode:

| Group A1| Group A2| Group B| Group C
---|---|---|---|---
Bias| -0.060| -0.083| -0.032| 0.000
Standard deviation| 0.170| 0.144| 0.139| 0.120
Limits of agreement| 0.340| 0.288| 0.278| 0.239
Clinical repeatability (for all groups)| 0.108

Forehead scan mode:

| Group A1| Group A2| Group B| Group C
---|---|---|---|---
Bias| -0.015| -0.063| -0.068| -0.090
Standard deviation| 0.173| 0.167| 0.135| 0.125
Limits of agreement| 0.345| 0.334| 0.269| 0.250
Clinical repeatability (for all groups)| 0.064

Safety classification of ME EQUIPMENT

OPERATION

Battery installation
Caution: The Infrared Body Thermometer does not operate with dead batteries or external power sources. Install new batteries.

1. Slide the battery door downward, toward the bottom of the Infrared Body Thermometer, and remove the battery access door;
2. Insert two pieces AAA size batteries according to the “+” and “-”;
3. Close the battery cover.
4. The product will not work without batteries installed.
5. Please obey the local laws and regulations to dispose of used batteries properly in order to avoid environmental pollution.
6. If the thermometer will not be used regularly, remove the battery to prevent possible damage due to chemical leakage.
7. Before using, check the appearance of the product for abnormalities, to ensure that the product has not been dropped or sustained any external damage that could affect its operation. If the product is damaged, do not use.

How to operate

• Forehead mode: Put on the probe cap and keep the thermometer aligned with
  the middle of the forehead to measure body temperature (between or above the eyebrows). Holding the product vertically, press the Start button – the temperature display will immediately appear.

• Forehead scan mode: Put on the probe cap, keep the thermometer close to the forehead and vertical, press and hold the Start button and move the thermometer from left to right or from right to left for approximately 3-10 seconds. The maximum temperature will be displayed on the screen.

• Please keep the forehead free of hair, perspiration, cap, scarf and etc during forehead temperature measurement.

• Ear mode: Remove the cap and insert ear thermometer probe slightly into the ear canal, then press the START button , measurement will be finished within 5 seconds.

• Please keep the ear canal and probe surface clean when taking ear temperature measurement.

• You should remain in the test environment for at least 5 minutes, and measure after the ambient temperature is in accordance with the environment.

• If using a cold compress or other physical cooling methods, the forehead temperature will be lower.

• The ambient temperature around the test person should be stable, should keep away from the larger flow fan, air-conditioning vents and so on.

• When people moving from one place of lower temperature to another place of higher temperature, should at least remain in the test environment more than 30 minutes, to be consistent with the ambient temperature after the re-measurement.

• You cannot use the thermometer in place where the sun is strong.

• It is recommended that you test at least 3 times and select the result that appears most often.

• When measuring body temperature, please select “ear “ mode or “forehead” mode; for measurement of other objects, liquid ,food temperature, please select surface mode.

• If for some reason the forehead temperature is low, try to take a measurement behind the ear or select ear mode to measure.

START MEASURING

Ear temperature measurement

1. Turn on the thermometer by pressing the Start button. The thermometer will perform self-test with all segments displayed for 2 seconds. See figure 3.
2. After full display over, you will hear “beep beep beep”, which means that the self-test is complete. The last measured temperature will be displayed. If no data is saved to memory, the display will indicate “—-”. See figure 4.
3. When initialisation is complete, the memory symbol disappears and the unit symbol starts flashing, which means the measurement can be started. See figure 5.
4. If the person being measured is more than one years old, please pull the ear up and back gently. If less than one year old, pull ear back gently.
5. Insert the thermometer probe slowly into the ear canal and press the START button. The device will start measuring with a short “beep” once at the start, then 2 – 5 seconds later. Finally 5 short “beeps” means measurement has been completed, and the target value of the measured temperature will display on the LCD. The LCD backlit colour will change to red, yellow or green. Green means the Normal Temperature and ready for measurement . Yellow means Slight Fever. Red indicates High Fever. Please kindly note that both yellow and red colour are a warning.
   Note: Colour Alarm is only for Body mode, Surface mode has a Green backlight

Forehead temperature measurement

1. Turn on the thermometer by pressing the Start button. The thermometer will perform self-test with all segments displayed for 2 seconds. See figure 6.
2. After full display over, you will hear “beep beep beep”, which means that the self-test is complete. The last measured temperature will be displayed. If no data is saved to memory, the display will indicate “—-”. See figure 7.
3. Please note, if the screen shows this symbol instead of , remove the battery cover and press the MODE button to switch to forehead mode. See figure 8.
4. After initialisation, the memory symbol “M” will disappear and the unit symbol °C (or symbol °F) will start flashing which means the device is ready to take a temperature measurement.
5. Temperature scan method: keep the thermometer vertical and close to the forehead. Press the Start button. The device will start measuring with a short “beep” once at the start, then 3 – 10 seconds later. Finally a long “beep” or 5 short “beeps” means measurement has been completed, and the target value of the measured temperature (maximum) will display on the LCD. The LCD backlit colour will change to red, yellow or green. Green means the Normal Temperature and ready for measurement . Yellow means Slight Fever. Red indicates High Fever. Please kindly note that both yellow and red colour are a warning.

Mode conversion
The product will switch to ear mode if the cap is removed. When the cap is replaced, forehead mode and surface mode can be switched between using the MODE button. ”ear “ and “forehead” mode is used for measuring human body temperature, the “surface “ mode is used to measure the surface temperature. (The factory default is “body” mode).

TROUBLESHOOTING

REPLACING THE BATTERY

1. Open and release battery cover following indicator on the surface of battery cover. Before changing the battery be sure the thermometer is already turned off.
2. Press the battery holder lock to release the batteries and replace with 2 new type AAA batteries. Make sure to align properly as indicated inside the battery cover.
3. Slide the battery cover back in until it snaps in place. Do not dispose of used batteries in household waste. Take them to special local collection sites.
4. If the thermometer appears frozen after changing the batteries, remove batteries, wait 30 seconds and replace batteries again.

CLEANING, CARE AND STORAGE

• The lens is very delicate.
• It is very important to protect the lens from dirt and damage.
• The Infrared probe is very delicate. Do not touch or use tools on it. It must be carefully protected otherwise it will affect the accuracy of the measure.
• Use an alcohol cloth or 70%~75% alcohol wet cloth to clean the thermometer shell, surface of the device and LCD. When the thermometer probe is dirty or used by different people, please use alcohol swab or cotton swab moistened with 70%~75% alcohol to clean and disinfect the probe’s surface of thermometer gently. Do not use solvents or immerse the device into water or other liquids.
• Always keep the thermometer within the storage temperature range (- 20°C to 55°C or – 4°F to 131°F) and humidity range (≤93% non-condensing).
• The device requires at least 30 minutes to warm up from the minimum storage temperature between uses before it is ready for intended use.
• The device requires at least 30 minutes to cool down from the maximum storage temperature between uses before it is ready for intended use.
• It is recommended to store the thermometer in a dry location free from dust. Do not expose the thermometer to direct sunlight, high temperature/ humidity or any extreme environment, otherwise the function will be reduced.
• When the ambient temperature of the thermometer changes too much, such as moving the thermometer from one place of lower temperature to another place of higher temperature, allow the thermometer to remain in a room for 30 minutes where the temperature is between 15°C to 35°C.

DISPOSAL

• Used batteries should not be disposed of in the household rubbish. Used Batteries should be deposited at a collection point.
• At the end of its life, the appliance should not be disposed of in household rubbish.
• Enquire about the options for environment-friendly and appropriate disposal. Take local regulations into account.

WARRANTY

Our company warrants Infrared Body Thermometer at the time of its original purchase and for the subsequence time period of 2 years.
The warranty does not cover the followings:

• The device series number label is torn off or cannot be recognized.
• Damage to the device resulting from misconnection with other devices.
• Damage to the device resulting from accidents.
• Changes performed by users without the prior written authorization of the company.
• Batteries and packaging are not covered under warranty

When asked to provide warranty service, you must have a purchase date and purchase stamp dealers (including dealers name and address) of the warranty card. Be sure to ask the dealer to purchase this product signature on the warranty card. When asked to provide warranty service, please put the product to get our distribution points for repair. Products outside the warranty expires, will be charged accordingly.
Note:

1. If you have any problems with this device, such as setting up, maintaining or using, please contact with HoMedics Service Centre. Don’t open or repair the device by yourself.
2. Please report to HoMedics if any unexpected operation or events occur.
3. The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the user instructions, periodic re-adjustment is not required. If at any time you question the accuracy of temperature measurements, please contact us.
4. The patient is an intended operator. The patient can measure and change battery. Under normal circumstances and maintain the device and its accessories according to the user manual.

EMC DECLARATION

1. This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS; This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
2.  Caution: Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
3. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
4.  Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.
5.  The infrared body thermometer is suitable for hospitals except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, were the intensity of EM DISTURBANCES is high.
6. Performance of the infrared body thermometer such as measure accuracy, information display would be lost or degraded due to EM DISTURBANCES.
7. Caution: the EMISSIIONS characteristics of this equipment make it suitable for use in hospitals and a residential environment (CISPR 11 Class B)

Guidance and manufacturer’s declaration-electromagnetic emissions

The Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Thermometer should assure that it is used in such an environment.
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

The Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Thermometer should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8kV contact

±2, ±4, ±8, ±15 kV air

| ±8kV contact

±2, ±4, ±8, ±15, kV air

Electrical fast transient/burst IEC 61000-4-4| The input a.c. power ports: ±2 KV The input d.c. power ports: ±2 KV Signal input/output ports: ±1 KV|

Not applicable

Surge IEC 61000-4-5| Input power ports: +0.5, +1.0 KV Signal input/output:+2.0 KV| Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0.5 cycles for > 95% (sync angle (degrees):0, 45, 90, 135, 180,225, 270, 315)

1 cycles for >95% UT (sync angle

(degrees):0)

25 (50Hz)/30 (60Hz) cycles for 30% U T (sync angle (degrees):0)

|

Not applicable

Voltage interruption IEC 61000-4-11| 250 (50Hz)/300 (60Hz) cycles for >95% UT (sync angle (degrees):0)
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8| 30 A/m| 30 A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration-electromagnetic immunity

The Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Thermometer should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level
Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

| 3Vrms

150kHz to 80 MHz

Professional healthcare environment: 3 V/m

Home healthcare environment 10 V/m 80MHz to 2.5 GHz

| Not applicable

Professional healthcare environment: 3 V/m

Home healthcare environment 10 V/m 80MHz – 2700 MHz

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a.Field strengths from fixed transmitters, such as base stations from radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast can not be predicted theoretic call with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Thermometer is used exceeds the applicable RF compliance level above, the Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Thermometer.

b.Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

Guidance and manufacturer’s declaration – RF wireless communication equipment immunity

Test frequency (Mhz)| Band a) (MHz)| Service a)| Modulation b)| Modulation

b) (W)

| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

385| 380-390| TETRA 400| Pulse modulation b) 18Hz| 1.8| 0.3| 27
450| 430-470| GMRS 460,

FRS 460

| FM c) ± 5kHz deviation 1kHz sine| 2| 0.3| 28
710| 704-787| LTE Band 13,17| Pulse modulation b) 217Hz| 0.2| 0.3| 9
745
780
810| 800-960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| Pulse modulation b) 18 Hz| 2| 0.3| 28
870
930
1720| 1700-

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3,

4,25; UMTS

| Pulse modulation b) 217 Hz| 2| 0.3| 28
1845
1970
2450| 2400-

2570

| Bluetooth, WLAN,

802.11 b/g/n, RFID 2450, LTE Band 7

| Pulse modulation 217 Hz| 2| 0.3| 28
5240| 5100-

5800

| WLAN 802.11

a/n

| Pulse modulation 217 Hz| 0.2| 0.3| 9
5500
5785
a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50% duty cycle square wave signal.

c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case

BODY TEMPERATURE

For consumer use only, not for professional use

• 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 35.5°C to 37.8°C (95.9°F-100°F). 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°C (1°F) or more is generally 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.
• Here below are typical temperatures for adults, based on different measurement sites:
  Rectal: 36.6°C to 38°C /97.9°F-100.4°F
  Axillary: 34.7°C to 37.3°C /94.5°F-99.1°F

ASTM laboratory accuracy requirements in the display range of 37°C (98°F to 102°F) for IR thermometers is ±0.2.(±0.4°F), whereas for mercury in-glass and electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is ±0.1.(±0.2°F).
Caution: 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 34.0°C ~42.9°C. Full responsibility for the conformance of this product to the standard is assumed by (Hetaida Technology Co., Ltd. Add: Room 801 ,802, 803, 804, 901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province, P.R.China).

References

• Service Centre

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