TE-101 - Thermometer HOMEDICS - Free user manual and instructions

Product type	Infrared ear thermometer
Brand	Homedics
Model	TE-101
Dimensions (L × W × H)	112.8 mm × 34.4 mm × 44.5 mm
Weight (battery included)	Approx. 49 g
Power supply	3V CR2032 lithium battery
Measurement range	34 °C to 43 °C (93.2 °F to 109.4 °F)
Accuracy (laboratory)	±0.2 °C (between 35 °C and 42 °C)
Display resolution	0.1 °C / °F
Measurement time	Approx. 1 second
Measurement site	Ear
Display	LCD with backlight
Fever indicator	Smiling face (< 38 °C) or unhappy face (≥ 38 °C)
Memory	Last 10 readings
Auto-off	After 1 minute of inactivity
Unit selection	°C / °F (button switch)
Low battery indicator	Yes, symbol on display
Cleaning and disinfection	70% isopropyl alcohol or ethanol; do not use water
Water protection	IP22 (water drops, 15° tilt)
Operating environment	Temperature 15 °C to 35 °C, humidity ≤ 95%
Service life	3 years
Warranty	2 years
Spare parts	Not available (except replaceable battery)

Frequently Asked Questions - TE-101 HOMEDICS

How to use the TE-101 thermometer?

Press the power button for 1 second to turn on the device. Wait for the beep, then gently insert the probe into the ear canal while pulling the ear up and back. Press the same button again for 1 second. A beep indicates the end of the measurement. Read the result on the display.

The thermometer displays 'Lo' or 'Hi', what to do?

'Lo' means the measured temperature is below 34 °C (93.2°F) or the probe is not in proper contact. Make sure the probe is correctly positioned in the ear canal. 'Hi' means a temperature above 43 °C (109.4°F). Check the usage conditions and clean the probe.

How to clean the thermometer?

Clean the lens and probe with a cotton swab or soft cloth soaked in 70% isopropyl alcohol. Never use water or abrasive products. Disinfect after each use.

Which battery to use and how to change it?

Use a 3V CR2032 lithium battery. To change it, unscrew the battery compartment cover with a Phillips screwdriver, remove the old battery, insert the new one with the + pole facing up, then screw the cover back on.

How to switch from °C to °F?

Make sure the device is on. Simultaneously press the power and measurement button and the memory button to toggle between °C and °F.

How long should I wait between two measurements?

It is recommended to wait at least 1 minute between consecutive readings to ensure accuracy. After cleaning the probe, wait 10 minutes.

Is the thermometer suitable for newborns?

Yes, from 6 months. In infants under 6 months, the ear canal is very narrow, which may give too low readings. For children, gently pull the ear back.

What does the smiling or unhappy face mean?

The smiling face appears if the temperature is below 38 °C (100.4°F), indicating no fever. The unhappy face appears if the temperature is equal to or above 38 °C, indicating a fever.

How to view the measurements in memory?

Press the memory button. The display shows the last recorded measurement. Hold the button to scroll through the previous 10 readings.

What to do if the display shows the low battery symbol?

The low battery symbol (empty battery) warns you that the battery needs to be replaced. You can still take a few measurements, but it is recommended to change the battery quickly to avoid automatic shutdown.

USER MANUAL TE-101 HOMEDICS

INFRARED EAR THERMOMETER

This equipment needs to be installed and put into service in accordance with the information provided in this manual

TE-101-EU

2 YEAR GUARANTEE

INTRODUCTION

This Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages in the home environment.

Utilizing infrared technology, this thermometer takes temperatures in seconds by measuring heat generated by the ear. This product conforms to the provisions of the EC directive MDD(93/42/EEC). Its advantages include:

1. Ear measurement
2. Probe cover not required
3. Waterproof probe design
4. One-second reading
5. Auto power off for power saving
6. Low-battery Indicator
7. Warning indication - indications for battery condition and measuring range.
8. Jumbo LCD Display
9. Memory function

IMPORTANT INFORMATION BEFORE USE

When using this product, please be sure to follow all the notes listed below. Any action against these notices may cause injury or affect the accuracy.

1. Do not disassemble, repair, or remodel the thermometer.
2. Be sure to clean the thermometer lens each time after usage.
3. Avoid direct finger contact with the lens.
4. No modification of this equipment is allowed.
5. It is recommended that user may take 3 temperatures. If they are different, use the highest reading.
6. Do not expose the thermometer to extreme temperature, very high humidity, or direct sunlight.
7. Avoid extreme shock or dropping the device.
8. Before the measurement, users and thermometer should stay in steady state room condition for at least 30 minutes.

9. Avoid measuring temperature for 30 minutes after exercise, bathing, or returning from outdoors.

10. To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations.

11. It is ill-advised to disassemble the thermometer.
12. Please use the thermometer solely for its intended purpose.
13. Carefully hold the device when in use to avoid dropping the device.
14. Allow one minute between successive measurements as slight variations may occur if measurements are taken over a short period of time. Use average temperatures instead.
15. There are no absolute body temperature standards. Keep reliable records of your personal temperature to serve as a reference for judging a fever.
16. Under any circumstances, the temperature taking result is ONLY for reference. Before taking any medical action, please consult your doctor.
17. It is recommended calibrate the device every 1 year.

PRODUCT IDENTIFICATION

DESCRIPTION OF LCD DISPLAY

TIPS FOR MEASURING HUMAN TEMPERATURE

Bear in mind that the thermometer needs to have been in the room in which the measurement is taken for at least 30 minutes before use.

NOTE:

• Some people produce different readings in their left and right ear. In order to record temperature changes, always measure a person's temperature in the same ear.
• The ear thermometer may be used by children only under adult supervision. Measurement is usually possible over the age of 6 months. In infants under 6 months, the ear canal is still very narrow so the temperature of the eardrum often cannot be recorded and the result displayed is often too low.
• The measurement must not be taken in an ear affected by inflammatory diseases (e.g. discharging pus or secretion), after possible ear injuries (e.g. eardrum damage) or in the healing period after operative procedures. In all of these cases, please consult your doctor.
• Use of the thermometer on different persons can be inappropriate in the event of certain acute infectious diseases because of the possible spread of germs despite cleaning and disinfection. If you have any doubts, please consult your doctor.
• This thermometer may only be used without a disposable protective cover.
• If you have been lying on one ear for some time, the temperature is slightly raised. Wait 60 seconds or measure in the other ear.
• As ear wax can affect the measurement, you should clean the ear before measuring if necessary.

MEASURING BODY TEMPERATURE IN THE EAR

1. Press the Power & Measure Button for 1 second to switch the thermometer on. All screen data will display on screen. Then wait for beep sound to let you know the appliance is ready and followed by last temperature reading.

1. Make sure that the sensor tip and also the ear canal are clean. As the ear canal is slightly curved, you have to pull the ear slightly up and backwards before inserting the sensor tip. This is important so that the sensor tip can be pointed directly at the eardrum.

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Under 1 year

Have child lay flat with the head sideways, so that the ear is facing upwards. Gently pull the ear straight back.

1 year +

Stand behind and slightly to the side of the child/adult. Gently pull the ear up and back to straighten the ear canal.

1. Insert the probe into the ear canal (the probe must insert well to ensure an accurate temperature measurement), then press the Power & Measure Button for about 1 second, release the button and you will hear 1 short beep sound means complete the measurement.
2. You may take out the device to read the measurement result.
3. The backlight display will remain light for approximately 5 seconds each time the Power & Measure Button is pressed, after each reading is completed, and each time the Memory button is pressed to recall a previous reading.
4. The thermometer will automatically shut off after one minute without use.

Note:

1. To ensure accuracy, please wait at least 1 minute between successive readings.
2. Clean the thermometer lens again after use. After cleaning, wait at least 10 minutes between readings, to ensure accuracy.

The readings

If the temperature measurement is below 38^ C ( 100.4^ C), a smiling face will be appear next to the reading.

If the reading is 38^ C ( 100.4^ C) or above, a frowning face will be displayed.

If 'Lo' is displayed, you may need to check that the thermometer is in direct contact with the ear canal

CHANGING THE MEASUREMENT UNIT (°C/°F)

Changing °C/°F, please make sure the device is in power on condition. Press the Power & Measure and Memory Recall buttons together to toggle between °C and °F.

MEMORY FUNCTION

You can recall up to 10 stored measurements in memory to share with your doctor or trained healthcare professional.

1. Press the Memory Recall button. The first reading displayed is the latest measurement stored in memory.
2. Continue to press the Memory Recall button button to view the next previously stored measurement.
3. Any new measurement will be recorded and the oldest memory deleted without you having to do anything.

CLEANING AND DISINFECTING

For home use device disinfection, 70% Ethanol or Isopropyl alcohol (available in the pharmacy) can be used.

Clean the measuring sensor after each use.

Use a clean cloth or cotton bud that can be moistened with 70 % alcohol.

Lens/ Measurement Sensor

Gently clean with an alcohol swab.

Do not use water to wash the thermometer lens directly.

Thermometer

Clean with a soft, dry cloth.

Do not use water to rinse the device.

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APPLIED STANDARDS

This product conforms to the provisions of the EC directive MDD(93/ 42/ EEC).

The following standards apply to design and/or manufacture of the products:

ISO 80601-2-56

Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

IEC/EN 60601-1

Medical electrical equipment- Part 1: General requirement for safety

IEC/EN 60601-1-2

Medical electrical equipment- Part 2: Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC/EN 60601-1-11

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

BATTERY INSTALLATION

Low battery warning

When the batteries get weak, the battery warning symbol appears . It is still possible to measure temperature.

The batteries must be replaced. When the battery symbol

flashes □ and Lo appears in the display, the batteries must be replaced. If the batteries are too flat, then the thermometer will switch off automatically.

NOTE:

• It is recommended to remove the batteries if the unit will not be used for an extended period of time.
• Please store batteries away from small children and heat.
• Do not use rechargeable batteries.
• Dispose of used batteries in accordance with the applicable legal regulations. Never dispose of batteries in the normal household waste.

Replacing the Battery

1. Use a Phillips head screwdriver to loosen battery cover screw. Remove the battery cover.
2. Remove used battery.
3. Replace with a lithium 3V CR2032 battery in designated area. The + sign on the battery should be facing upwards.
4. Place the battery cover on the thermometer and tighten the screw to secure it in place.

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CLINICAL ACCURACY VALIDATION METHOD

This device is an adjusted mode clinical thermometer

the validated information for clinical accuracy in each adjusted mode are:

GroupA1: cb = -0.01^, L A = 0.18, r = ± 0.08^

GroupA2: cb = 0.06^, L ≠0.22, r = ± 0.08^

GroupB: cb = -0.01^, L A = 0.20, r = ± 0.07^

GroupC: cb = -0.01^, L A=0.18, r = ± 0.07^

Δcb: CLINICAL BIAS

LA: LIMITS OF AGREEMENT

δr: CLINICAL REPEATABILITY

ERROR CODES

When a malfunction or incorrect temperature measurement occurs, an error message will appear as described below.

LCD Display Cause $ Solution
	It may be the thermometer probe is not in direct contact with the ear canal	Check that the thermometer is in direct contact with the ear canal
	The temperature measured is lower than 34°C (93.2°F)	Operate the thermometer only between the specified temperature ranges. If necessary, clean the sensor tip. In the event of a repeated error message, contact your retailer or Customer Services.
	The temperature measured is higher than 43°C (109.4°F)
	The operating temperature is not in the range 15°C~35°C (59°F~95°F)	Operate the thermometer only between the specified temperature ranges.

TECHNICAL SPECIFICATION

• Measuring range: Human Body: 34°C \~43°C (93.2°F \~ 109.4°F)
• Laboratory Accuracy: 34^ 43^ ± 0.2^ (93.2°F \~ 109.4°F ±0.4°F)
• Measuring site: Ear
  • Reference body site: Oral
• Calibration Accuracy: ±0.2°C(±0.4°F): from 35°C \~42°C (95°F \~ 107.6°F) ±0.3°C(±0.5°F): out of range
  • Display resolution: 0.1°C/°F
• Operating environment: 15°C\~35°C (59°F \~ 95°F) with relative humidity up to 95% (non condensing)
• Storage/transportation environment: -25 to 55 °C(-13 to 131 °F) with relative humidity up to 95% (non condensing)
  • Power supply: A lithium 3V CR2032 battery
• Memory: 10 sets
  • Weight: approx. 49g (with battery)
• Dimensions: approx. 112.8mm×34.4mm×44.5mm (L×W×H)
• Shelf life: 3 years

EMC TABLES

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information.

1. Electromagnetic/Radio Frequency Interference (EMC/RFI): Readings may be affected if the unit is operated within a radio frequency electromagnetic field strength of approximately 3 volts per metre, but the performance of the instrument will not be permanently affected. Care should be taken to keep the thermometer at least 15cm/6 inches away from R/C transmitters to avoid radio frequency interference.
2. Avoid keeping the thermometer too close to objects that continuously generate high heat (like a hot plate) for long periods of time, which can cause overheating of the thermometer.

Table 1 For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer's declaration-electromagnetic emissions
The Ear Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Ear Thermometer should assure that it is used in such an environment.
Emissions test Compliance		Electromagnetic environment guidance
RF emissions CISPR 11 CISPR 11	11	The Ear Thermometer uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class	B	The Ear Thermometer is suitable for use in all establishments other that domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissionsIEC 61000-3-2	Not applicable
Voltage fluctuationsFlicker emissionsIEC 61000-3-3	Not applicable

Table 2 For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer's declaration-electromagnetic immunity
The Ear Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Ear Thermometer should assure that it is used in such an environment.
Immunity test IEC 60601 test level		Compliance level	Electromagnetic environment-guidance
Electrostatic discharge (ESD)IEC 61000-4-2	±6kV contact±8kV air	±6kV contact±8kV air	Floor should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burstIEC 61000-4-4	±2 kV for power supply lines±1 kV air for input/output lines	Not applicable	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC61000-4-5	±1kV differential mode±2kV common mode	Not applicable	Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11	<5% UT (>95% dip in UT for 0.5 cycle40% UT (60% dip in UT for 5 cycles70% UT (30% dip in UT for 25 cycles5% UT (>95% dip in UT for 5 sec	Not applicable	Mains power quality should be that of a typical commercial or hospital environment. If the use of the Ear Thermometer requires continued operation during power mains interruptions, it is recommended that the Ear Thermometer be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz)magnetic fieldIEC 61000-4-8	3 A/m 3A/m		Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3 For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer's declaration-electromagnetic immunity
The Ear Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Ear Thermometer should assure that it is used in such an environment.
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment-guidance
Conducted RF IEC 61000-4-6	3Vrms150kHz to80 MHz	3 Vrms	Portable and mobile RF communications equipment should be used no closer to any part of the Ear Thermometer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance.d=1.2 √Pd=1.2 √80 MHz to 800 MHZd=2.3 √800 MHz to 2.5 Ghzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,"should be less than the compliance level in each frequency range." Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3	3V/m80MHz to2.5 GHz	3 V/m
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.
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 Ear Thermometer is used exceeds the applicable RF compliance level above, the Ear Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Ear Thermometer. Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.

Table 4 For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the Ear Thermometer
The Ear Thermometer is intended for use in an electromagnetic environment in which radiated RF distances are controlled. The customer or the user of the Ear Thermometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ear Thermometer as recommended below according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter / W	Separation distance according to frequency of transmitter / m
	150 kHz to 80 MHZ d=1.2 √P	80 MHz to 800 MHZ d=1.2 √P	800 MHz to 2.5 GHz d=2.3 √P
0.01 0.12 0.12	0.23
0.1 0.38 0.38	0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

2 YEAR GUARANTEE

FKA Brands Ltd guarantees this product from defect in material and workmanship for a period of 2 years from the date of purchase, except as noted below. This FKA Brands Ltd product guarantee does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorised accessory; alteration to the product; or any other conditions whatsoever that are beyond the control of FKA Brands Ltd. This guarantee is effective only if the product is purchased and operated in the UK / EU. A product that requires modification or adaptation to enable it to operate in any country other than the country for which it was designed, manufactured, approved and / or authorised, or repair of products damaged by these modifications is not covered under this guarantee. FKA Brands Ltd shall not be responsible for any type of incidental, consequential or special damages. To obtain guarantee service on your product, return the product post-paid to your local service centre along with your dated sales receipt (as proof of purchase).

Upon receipt, FKA Brands Ltd will repair or replace, as appropriate, your product and return it to you, post-paid. Guarantee is solely through HoMedics Service Centre. Service of this product by anyone other than the HoMedics Service Centre voids the guarantee.

This guarantee does not affect your statutory rights.

For your local HoMedics Service Centre, go to www.homedics.co.uk/servicecentres

EXPLANATION OF SYMBOLS

	The CE marking with the Registration Number of the Notified Body. This denotes the compliance of European Medical Device Directive 93/42/EEC
	Consult the instruction for use
	Disposal information: Should you wish to dispose of the article, do so in accordance with current regulations. Details are available from your local authority
	Type of protection of applied part against electric shock, body floating
	This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning test (protection against solid foreign objects of 12.5mm ∅ and greater and against vertically falling water drops when enclosure tilted up to 15°)
[CSAX]	Temperature limits
	European Authorized Representative
[DABC]	Manufacturer's name and address
[ZX27]	SN YYMWWWXXXXXSN: Product Serial NumberYY: year, MM: month, WWW: working sheet, XXXXX: serial no.
	The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
RoHS	This product fulfilling the requirements of the RoHS Directive 2011/65/EU.
REACH	This product fulfilling the requirements of the REACH Directive EC 1907/2006 and its amendments, do not contain Substances of Very High Concern in concentration above the limit of 0.1 %. No substance(s) is/are present in the parts of the product above the concentration of 0.1 % weight by weight.

PRÉSENTATION

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FONCTION DE MÉMOIRE

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NORMES APPLIQUÉES

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MÉTHODE DE VALIDATION DE LA PRÉCISION MÉDICALE

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Unter 1 Jahr

MEMORY FUNCTION

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GÜLTIGE NORMEN

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FUNCIÓN DE MEMORIA

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ESTÁNDARES APLICADOS

Diagram of a handheld electric shaver with internal components and a magnified inset showing a tool (no text or symbols)

Line drawing of a person receiving a medical injection from a bottle (no text or symbols)

Meno di 1 anno

FUNZIONE MEMORIA

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NORME APPLICATE

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Table 2 For all ME EQUIPMENT and ME SYSTEMS

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Jonger dan 1 jaar

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TOEGEPASTE NORMENS

Diagram of a handheld electric shaver with internal components and a magnified inset showing the tool (no text or symbols present)

VALIDATIEMETHODE VOOR KLINISCHE NAUWKEURIGHEID

The Ground Truth image displays a single, solid horizontal line. According to Rule 2 (UNDERSCORE & LINE RULES), this is a stylistic or background line, not a placeholder underscore. Therefore, the OCR result must ignore it. The provided OCR content is "____", which consists of four underscores. This is an incorrect interpretation of the line as a placeholder, violating the rule that stylistic lines must be ignored. The OCR has hallucinated underscores where none should exist in the GT. Therefore, the OCR result is inconsistent with the Ground Truth.

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[Non-Text]

Wellkang Ltd, 29 Harley Street, London W1G 9QR, UK

Manufactured by

AVITA Corporation 9F., No. 78, Sec.1, Sanchong Road, Sanchong District, New Taipei City, Taiwan, R.O.C.

Manufacturer site:

No.858, Jiao Tong Road, Wujiang Economic Development Zone Jiangsu Province, P.R.C. Postcode: 215200 Made in China

Distributed by

FKA Brands Ltd Somerhill Business Park Five Oak Green Road Tonbridge, Kent TN11 OGP, UK

Customer Service:

[e-mail]

IB-TE101EU-0320-01