Kinetik Wellbeing ET-100D User manual

ET-100D
Infra-red Ear Thermometer

Support
Introduction
Specification
Parts
Warning and safety notices
How to use (°C displays for example)
Changing from Celsius to Fahrenheit
Explanation of symbols on unit
Product disposal
Cleaning and Storage
Replacing the batteries
Quality warranty
EMC Table
2
3
4 - 5
6
7 - 8
9 - 10
10
11
12
12
13
13
14 - 18
Content

Support
Our manual should provide you with all the information you need to set up and use this product.
For further assistance, why not contact our Customer Care team directly? We’re here to help!
Our Customer Care team are available from 9am-5pm, Monday to Friday (excluding bank holidays).
We promise to respond to all queries and will ensure to resolve any issue you may be having.
You can reach us by…
Phone:
[phone]
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
[email protected]
Post:
Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ
2

Please read the instructions carefully before using.
The ear thermometer is a device capable of achieving infra-red temperature measurement when
placed in the auditory canal of a user. It is a safe means of measuring human body temperature
through the ear.
3
Introduction

The standard we adopted is EN12470-5:2003 Clinical thermometers -- Part 5: Performance of infrared
ear thermometers (with maximum device).
This device complies with the requirements of IEC 60601-1,IEC 60601-1-11 and IEC 60601-1-2.
Range of displayed temperature : 34°C - 44°C (93.2°F - 111.2F)
Display L°C (L°F) when the temperature is under 34°C (93.2°F)
Display H°C (H°F) when the temperature is over 44°C (111.2°F)
Operating ambient:
Temperature: 16°C - 35°C (60.8°F - 95.0°F) Atmospheric pressure: 700 - 1060hPa
Humidity: ≤85%rh Altitude: <2000m
Storage and transport condition:
Temperature: -25°C to 55°C (-13°F to 131°F)
Humidity: ≤85%rh
Display resolution temperature range: 0.1°C (0.1°F)
Accuracy: ±0.2°C (from 35.5°C to 42.0°C)
±0.4°F (from 95.9°F to 107.6°F)
Display: liquid crystal display, 3½ digits
temperature value: display the maximum temperature in measuring process
4
Specification

5
Specification
temperature unit: centigrade or fahrenheit
display of memory: last ten memories
low voltage warning: the LCD display and then a beep sound is heard
Power consumption: ≤30 mW
Battery: two 1.5V alkalescence batteries (AAA)
Battery life: 4000 uses
Shelf life: 3 years
Dimension: 146mm by 32mm by 37mm
Net weight: Approx. 74g
Beeper sign: on/off, measuring finish and low voltage warning, etc.
Self-testing sequence:
Press the ‘on/recall’ button to turn on the thermometer and all symbols
should be displayed on the LCD within a second (See Fig A on page 9).
Calibration frequency: If used privately no calibration is needed. For professional use it is recommend
to check once a year.
Manufacturing and Calibration date: See the label in the battery compartment.

6
Battery cover
Scan button
Probe membrane
LCD
On/recall button
Cap
Disposable probe cover

Cautions
7
Warning and safety notices
Before measuring, please condition the thermometer for at least 30 mins under operating conditions.
New Disposable probe cover required for each measurement, otherwise inaccurate readings will occur.
Please keep your ear canal clear, if not, the measuring result shall be inaccurate.
The symbol ' ' on the LCD shows you can measure in the ear;
Please don’t scratch the probe membrane, otherwise the thermometer shall lose efficacy;
If the LCD does not turn on or respond after pressing a button, please remove the batteries and
reinsert;
Please don’t use the thermometer if your ear canal is inflamed.
Do not expose this thermometer to electric shock.
Do not expose the thermometer to sunlight or to water.
Do not use near strong electromagnetic fields, i.e. Keep it away from any radio systems and mobile
phones.
Do not modify this device without authorization of the manufacturer.
This device must always be kept in a clean, dry area.
If the temperature is not in the normal range, please consult your doctor
Do not impact the thermometer, otherwise it may affect the accuracy of the measurement
This device include small parts, don't inhale or swallow it.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

Note:
• In order to avoid the spreading germs, please use a new disposable probe cover for each measurement.
• Check to ensure probe cover is fitted on firmly before use (please see the diagrams below).
If the probe cover is broken, discard and apply a new one immediately.
8
Warning and safety notices
Incorrect Correct

Fig A
Newborn-1 year 1 year - adult
Fig B
9
How to use (°C displays for example)
Measuring human body temperature in the Ear Canal
1. Press the 'on/recall' button to turn on the thermometer, a beep
sound is heard and the LCD displays as Fig A in one second.
When the LCD displays as Fig B, now ready to measure.
2. Straighten the ear canal by pulling the outer ear up and back to
give a clear view of the eardrum.
• For children under 1 year, Pull the ear straight back.
• For children ages 1 year to adult, Pull the ear up and back.
(Caution: Many pediatricians suggest use of ear thermometers for children older than 6 months.)
3. While pulling the outer ear, insert the probe snugly into the ear canal (as deep as is comfortable),
press the 'scan' button and then immediately release it. You will hear a beep seconds after, this
means that the measurement is complete. Remove the thermometer from the ear, the display
will show the measured temperature.
4. Measuring again: If measuring again, please wait for the ' ' symbol to be displayed on screen.
Then press the 'scan' button to measure.

Fig C Fig D
Fig E
Fig F
5. Memory search: Turn the device on, then press the 'on/recall' button.
The last ten memories (No.9-No.0) will take turns to display on the LCD
as Fig C and Fig D.
6. The LCD will displays 'Er 1' as Fig E and cannot displays temperature
when the ambient temperature is out of the range of 10°C to 35°C.
Note: Before measuring, the thermometer shall be stabilized at the operating
ambient condition for a minimum of 30 min.
7. Shut off: The thermometer shall automatically shut off without manipulating in one minute.
How to use (°C displays for example)
Changing from Celsius to Fahrenheit
To switch the display between °C and °F, turn the unit on. Press and hold the on/recall
button for 3 seconds, the display will show as Fig. F , the unit will prepare for a
measurement.
10

11
L O T
battery is empty
Product disposal instructions for electronic devices
The battery in this product complies with the requirements stated in
European Directives 006/66/EEC
Model Reference
Memory
Type BF equipment
CE conformity marking
subject temperature is under 34°C
subject temperature is above 44°C
Read IFU carefully
Authorised representative in the european community
Manufactured by
Classification according to the degree of protection against ingress of water
as detailed in IEC 60529
Lot Number
L°C or L°F
H°C or H°F
or
IP22

Please ensure environmental protection. Batteries do not belong in the domestic waste. Please
hand them in at collection point or the municipal recycle material centre as special waste.
This symbol on products and/or accompanying documents means that consumed electronic
products must not be mixed with conventional domestic waste. Take these products to the
corresponding collection points for correct treatment and reycling, where they will be accepted
free of charge. For more information on the closeset collection point, Please enquire with your
local authorities.
Product disposal
1. Store thermometer and the Disposable probe covers in a dry location free from dust
and contamination and away from direct sunlight. The ambient temperature at the
storage location should remain fairly constant and within the range of -25°C to 55°C.
2. Use an alcohol swab or cotton swab moistened with alcohol (70% lsopropy) to clean the
thermometer casing and the measuring probe. Ensure that no liquid enters the interior of the
thermometer.
3. Never use abrasive cleaning agents, thinners or gasoline for cleaning and never immerse the
instrument in water or other cleaning liquids. Take care not to scratch the surface of the probe
membrance or display.
Cleaning and Storage
12

Replacing the batteries
Quality warranty
1. When voltage of the batteries are low, the LCD will display ' ' symbol, please replace two new
batteries in unit. The thermometer cannot work accurately under the condition of low voltage.
2. The thermometer is supplied with two 1.5V ALKALESCENCE BATTERIES (AAA). Insert new batteries
when the low battery symbol appears on the LCD.
3. Remove the battery cover and take out the old batteries.
4. Place two new batteries according to the '+' or '-'
5. Please take out the batteries to avoid battery leaking if unit not used for over six months.
6. The disposal of the battery and the device shall comply with the local environment requirements.
The lithium battery or fuel cell may lead to excessive temperatures, fire or explosion.
13
This thermometer is guaranteed for one year under proper use according the operating manual from
the date that the product is sent out the factory. The manufacturer will make available on request
circuit diagrams, component part lists, descriptions, calibration instructions, or other information
that will assist service personnel to repair those parts of device.

Guidance and manufacturer's declaration - electromagnetic emissions
Phenomenon
Home healthcare
environment
Harmonic distortion
Voltage fluctuations
and flicker
Profession healthcare
facility environment
CISPR 11, Group 1, Class A or B
Home healthcare environment
NA
NA
EMC Table
14
This device is suitable for home healthcare environment and professional healthcare facility environment
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they
are operating normally.
The essential performance is the infra red ear thermometer can offer the temperature measurement
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic fields, near the
medical device. This may result in incorrect operation of the unit and create a potentially unsafe situation. Recommendation is
to keep a minimum distance of 30cm. Verify correct operation of the device in case the distance is shorter.
The device is suitable for use in the specified electromagnetic environment
and it has meets the following standard's emission requirements.
IEC 61000-3-3
or not applicable
CISPR 11, Group 1, Class B
IEC 61000-3-2,
Class A or not applicable

EMC Table
15
Guidance and manufacturer's declaration - electromagnetic emissions
Phenomenon
Electrostatic
discharge
Radiated RF
EM fields
Rated power
frequency
magnetic fields
Proximity fields
from RFwireless
communications
equipment
Basic EMC standard
or test method
IEC 61000-4-2
30A/m; 50 Hz or 60Hz
IEC 61000-4-3
IEC 61000-4-8
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV air
Professional healthcare
facility environment
3V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
Home healthcare
facility environment
10V/m
80MHz-2.7GHz
80%AM at 1kHz or 2Hz
1kHz or 2Hz can be specified by
the manufacturer
See the RF wireless communication equipment
table in "Recommended minimum
separation distances".
IEC 61000-4-3
The device is suitable for use in the specified electromagnetic environment and it has meets the following
immunity test levels. Higher immunity levels may cause the device's essential performance lost or degraded.

EMC Table
16
Electric fast
transients bursts
Surges
For 1.input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. output signal output lines connected directly to outdoor cables
NA
NA
NA
NA
For input a.c. power port
d.c. power lines or signal input/output lines whose length exceeding 3m
NA
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-11
IEC 61000-4-11
IEC 61000-4-6
UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz
Voltage
interruptions
Voltage dips
Conducted
disturbances
induced by
RF fields
For 1. input a.c. power port;
2. all d.c. power ports connected permanently to cables >3m
3. all patient-coupled cables
4. SIP/SOP whose maximum cable length ≥ 3m

EMC Table
17
Recommended minimum separation distances
Nowadays, many RF wireless equipments have being used in various healthcare locations where medical
equipment and/or systems are used. When they are used in close proximity to medical equipment and/or
systems, the medical equipment and/or systems' basic safety and essential performance may be affected.
This device has been tested with the immunity test level in the below table and meet the related
requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance
between RF wireless communications equipment and this device as recommended below.
Test
frequency
(MHz)
Band
(MHz) Service Modulation Maximum
power(W)
Distance
(m)
Immunity
test level
(Vim)
385
450
380-390 TETRA 400
Pulse
modulation
18Hz
1.8 0.3 27
430-470 GMRS 460
FRS 460
FM ± 5 kHz
deviation
1 kHz sine
20.3 28
710
745
780
704-787 LTE Band
13, 17
Pulse
modulation
217Hz
0.2 0.3 9

EMC Table
18
810
870 800-960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
18Hz
20.3 28
1700-1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
20.3 28
930
1720
1845
2400-2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE B and 7
Pulse
modulation
217Hz
Pulse
modulation
217Hz
Pulse
modulation
217Hz
20.3 28
1970
2450
5240
5500
5785
5100-5800 0.2 90.3
WLAN 802.11
a/n