HoMedics TE-101-EU Bedienungsanleitung
TE-101-EU
This equipment needs to
be installed and put into
service in accordance
with the information
provided in this manual 2 YEAR GUARANTEE
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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 o 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 aect 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 dierent, 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.
Probe tip
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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
Memory Recall button
Battery compartment
lid
Probe tip
Power & Measure
button
LCD display
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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 dierent 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 aected 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 dierent 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 aect the measurement, you should clean the ear before measuring
if necessary.
Temperature in degrees
Celcius scale
Fahrenheit scale
Scan in progressFrowning face
Measurement
≥38.0°C(≥ 100.4°F)
Fever
Smiling face
Measurement
<38.0°C(< 100.4°F)
No Fever
Low battery warning
Memory symbol and sets of records
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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.
2. 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.
Under 1 year
Have child lay flat with the head sideways, so that the ear is facing
upwards. Gently pull the ear straight back.
3. 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.
4. You may take out the device to read the measurement result.
5. 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.
6. The thermometer will automatically shut o after one minute without use.
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.
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Note:
7. To ensure accuracy, please wait at least 1 minute between successive readings.
8. Clean the thermometer lens again after use. After cleaning, wait at least
10 minutes between readings, to ensure accuracy.
CHANGING THE MEASUREMENT UNIT (ºC/ºF)
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.
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
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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.
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
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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 o 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°C, LA=0.18, δr = ±0.08°C
GroupA2: ∆cb= 0.06°C, LA=0.22, δr = ±0.08°C
GroupB : ∆cb=-0.01°C, LA=0.20, δr = ±0.07°C
GroupC : ∆cb=-0.01°C, LA=0.18, δr = ±0.07°C
∆cb: CLINICAL BIAS
LA: LlMITS 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.
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TECHNICAL SPECIFICATION
• Measuring range:
Human Body: 34°C ~43°C (93.2°F ~ 109.4°F)
• Laboratory Accuracy:
34°C ~43°C±0.2°C (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 3VCR2032 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
aected 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 aected. 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.
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