Kinsa KET-005 Instructions For Use Manual

ENGLISH
KET-005 Kinsa Smart Ear
ThermometerTM Instructions For
Use
Thank you for purchasing the KET-005 Kinsa Smart Ear
Thermometer™, a professionally accurate instrument for
fast and easy temperature taking in the ear. Please read
these instructions carefully to ensure accurate
temperatures and safe operation.
Your Kinsa Smart Ear Thermometer is optimized for use
with the free Kinsa app, but can be used alone as well. For
the full experience including features such as symptom
tracking and fever guidance, download the app on the
App Store or Google Play store and connect your
thermometer to your mobile device. For the full list of
supported devices, see kinsahealth.com/phones.
Feel Better.
1
Product Description
C
B
F
A
D
E
G
2
A
Power/Start button
B Probe
C Probe tip
D Display
E Battery door
F Protective ca p
Kinsa mobile app
G
ENGLISH
Intended Use
The Kinsa Smart Ear Thermometer is intended to measure the human body temperature
in the ear. This device is reusable for clinical or home use on both adults and children.
Warnings And Precautions
• This thermometer functions with most Apple and Android mobile devices. Please see
kinsahealth.com/phones for the full list of supported
•
devices. Clean the probe before and after use.
• Never use the thermometer for purposes other than body temperature measurement.
• Please follow the safety precautions when using on children.
• The operating ambient temperature range for this thermometer is 59° - 104 °F (15- 40 °C).
• Do not expose the thermometer to temperature extremes:
(below -13 °F / -25 °C or over 131 °F / 55 °C) or excessive humidity (>95% RH).
• Use of this thermometer is not intended as a substitute for consultation with your physician.
• High, prolonged fever requires medical attention. Be sure to contact your physician.
• The thermometer is water resistant, not waterproof. Never dip the thermometer into
water or other liquids. Do not boil the probe. For cleaning and disinfecting, please see
Cleaning and Storage.
• Keep out of reach of unattended children. Do not allow children to walk or run while
taking a temperature.
• Kinsa recommends using a password on your smartphone to protect your information.
• The patient is an intended operator.
• Do not perform maintenance and checks during operation.
The ear thermometer with installed probe cover is considered an applied part and has
• been tested and evaluated accordingly.
Features of your Kinsa Smart Ear Thermometer
• Fast 1 second reading.
• Meets ASTM & ISO standards for professional accuracy.
• Gentle and easy to use in the ear.
• No probe covers needed.
• Conveniently displays in °F or °C.
• Water resistant, for safe cleaning.
• Use with or without your mobile device. Connects via Bluetooth Low Energy.
• Additional Smart functionality available through Kinsa app.
3
Body Temperature
Temperature readings vary from person to person, by age, time of day, and by site of
measurement. For example, core body temperature often decreases with age. The
best method to determine your own normal temperature is to use the thermometer
when you are feeling well. Record your temperature twice a day (early morning and late
afternoon) using the Kinsa app. Take the average of the two temperatures. This is
considered your normal body temperature. Any variation from it may indicate some
sort of illness and you should consult your physician.
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.
Why Measure in the Ear?
Ear temperatures accurately reflect core body temperature, since the eardrum shares
a blood supply with the temperature control center in the brain: the hypothalamus.1
The Kinsa Smart Ear Thermometer monitors the infrared heat radiated from the
eardrum and surrounding tissue and detects once an accurate temperature
measurement has been taken.
4
To Set Up Your Thermometer For First Time Use
E
1. Open the battery door E.
2. Insert two AAA batteries (included), making sure the poles are in the right
direction, into the thermometer. Snap battery door into place.
3. Enable Bluetooth on your mobile device.
4. Download the Kinsa app from the App Store or Google Play. The app can also
be downloaded by going directly to kinsahealth.com/download. Please see
kinsahealth.com/phones for the full list of supported devices.
5. Launch the Kinsa app. (The app will be on your Home screen or in your Apps
folder depending on type of mobile device.)
6. Turn the thermometer on and follow the prompts to install.
7. Your thermometer is now successfully connected to your mobile device. For
future temperature readings, open the Kinsa app to automatically sync
readings to your mobile device and assign to individual family members, add
notes or symptoms/medications, and see guidance.
To Set Up Your Thermometer with Additional Mobile Devices
1. If you have the original phone, open Kinsa, go to “More,” select the
thermometer to remove and choose “Forget Thermometer.”
2. On the additional mobile device, repeat Steps 3 through 7 above.
3. Your thermometer is now successfully connected to an additional
mobile device.
5
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.
• 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
a little while or measure in the other ear.
• As ear wax can affect the measurement, you should clean the ear before measuring if
necessary.
6
ENGLISH
Taking a Temperature
1. Tap the Power/Start button A to turn on the thermometer. You will hear a
beep when the thermometer is ready to take a temperature.
During an internal self-check, the display shows all segments. The
thermometer will be ready for temperature taking when the screen
shows three dashes.
2. First, gently tug the ear straight up and back. Next, fit the probe snuggly
into the ear canal. Be sure to position the probe so that it is pointing
toward the center of the head. Once in position, push and release the
Power/Start button.
3. A beep will indicate when the temperature measurement is successfully
completed. Temperature readings typically take 1 second.
4. The temperature reading will be shown on the illuminated display. A smiling
face icon indicates that the temperature is normal while a neutral or
frowning face indicates a mild or high fever, respectively.
5. The thermometer will automatically turn off after 30 seconds of inactivity.
The display will briefly flash OFF and it will go blank. You can also hold down
the button to power off.
NOTE: Always take measurements in the same ear since temperature readings may
differ from the right and left ear.
7
8
Understanding Your Thermometer Display
DISPLAY
SITUATION
SOLUTION
Battery icon,
empty, blinking
Battery is critically low
and may not operate
correctly
Insert new batteries.
Battery levels:
2 bars = 40% battery
1 bar = 20% battery
0 bars = 5% battery
HI
Temperature taken is not
within typical human
temperature range (93.2108 °F or 34-42.2 °C) HI =
too high
LO = too low
Make sure the probe tip and lens are
clean. Make sure the thermometer is
properly inserted. Then, take a new
temperature.
If you continue to encounter an error,
contact Kinsa Customer Support.
APP
Connect to Kinsa app. Please refer to the set up process.
ERR
The operating
temperature is not
in the range 15°C–40°C
Operate the thermometer only
between the specified temperature
ranges.
Kinsa App Set Up Process
Download the Kinsa app from the App Store or Google Play. The app can also be downloaded
by going directly to kinsahealth.com/download. Please see kinsahealth.com/phones for the
full list of supported devices.
Changing The Temperature Scale
If you wish to change the temperature scale of your thermometer, turn your
thermometer on and then press the big white button two more times in rapid
succession.
NOTE: temperature scale in app can be changed within app settings.
ENGLISH
Cleaning And Storage
To ensure your Smart Ear thermometer is recording accurate
temperatures, it is very important to keep the probe sensor tip clean.
To clean the probe tip, gently wipe it with a cotton swab or soft cloth
moistened with alcohol. Gently circle the alcohol wipe around the
inner sensor area at the tip of the Smart Ear. Be sure to clean the inner
flat surface of the sensor - not just the rim. Never submerge your
Kinsa or put it in boiling water or a dishwasher.
Keep the protective cap snapped onto the top of the thermometer when not in use to
protect the tip from damage.
Replacing the Battery
E
The Kinsa Smart Ear thermometer is powered by 2 AAA
batteries. The low battery icon displays when power is low.
To replace the batteries:
Open the back battery cover E by pressing on the Kinsa logo and applying
downward pressure to slide it off. Remove the old batteries and replace with new
ones. Make sure the the batteries are in the correct polarity direction.
Close the battery cover.
To protect the environment, dispose of the product and empty batteries at your retail
store or at appropriate collection sites according to national or local regulations.
Note: For long durations of non-operation, please remove all batteries from the device.
Batteries should be disposed of in accordance with local environmental and institutional
policies.
Calibration
This thermometer is initially calibrated at the time of manufacture. If this thermometer is used
according to the use instructions, periodic re-adjustment is not required. If at any time you
question the accuracy of temperature measurements, please contact Customer Support.
9
10
Product Specifications
Displayed temperature range:
Operating ambient temperature range:
Operating relative humidity:
Display resolution:
93.9 °F – 108 °F (34.4 °C – 42.2 °C)
59°F – 104 °F
(15 °C – 40 °C)
0-95%RH
(non-condensing)
0.1 °F or °C
ACCURACY FOR PATIENT TEMPERATURE RANGE
95.0 °F – 107.6 °F (36 °C – 39 °C):
Outside this range:
MAXIMUM LABORATORY ERROR
±0.4 °F
(±0.2 °C)
±0.6 °F
(±0.3 °C)
Typical Service Life : 3 years
Temperature of Storage and
Transporation Range:
Humidity of Storage and
Transporation Range:
–4 °F to 122 °F (–20 °C to 50 °C)
Battery type:
Battery life:
Bluetooth:
Two AAA batteries
Approx 2 years
Bluetooth 5
Operating、
Transport &
Storage
Atmospheric
Pressure:
Guarantee of Quality:
0 – 95 % RH (non-condensing)
700hPa~1060hPa
Complies with ASTM E 1965-98,
IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-11
FCC Rules - This device complies with part 15 of FCC rules. Operation is subject to the following two
conditions; (1) This device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
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.
This equipment is suitable for use in domestic establishments and is tested to CISPR emissions Class B
Group 1 as well a home healthcare immunity criteria found in IEC 60601-1-2 Table 4, 6, and Table 9.
During the IEC 60601-1-2 immunity tests performed the thermometer will accurately measure
temperature or display an error. Smart Ear utilizes Bluetooth Low Energy (BLE), which uses the 2.4 GHz
ISM band. BLE operates between 2.402 and 2.480 GHz. Smart Ear transmits less than -2 dBm
effective radiated power. To protect the environment, dispose of empty batteries at appropriate
collection sites according to national or local regulations. Keep out of reach of young children, elderly
and pets. FCC WARNING: Changes or modifications not expressly approved by the party responsible
for compliance could void the user’s authority to operate the equipment.
FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced radio/ TV technician for help.
RF exposure warning
The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment.
The equipment must not be co-located or operating in conjunction with any other antenna or transmitter.
Manufactured By:
Kinsa, Inc
535 Mission Street, 18th Fl
San Francisco, CA 94105
www.kinsahealth.com
Customer Support: [email protected]
Limited Warranty:
Kinsa, Inc warrants this product against any defects that are due to faulty material or
workmanship for a period of one year from the original date of consumer purchase or
receipt as a gift. This warranty applies when used for normal household use in
accordance with the Instructions for Use and excludes the battery and damage to the
product resulting from accident or misuse. This product is not warrantied when used in
a professional environment.
In no event shall Kinsa, Inc be liable for any special, incidental, indirect, or consequential
damages in connection with the purchase or use of this product or costs over the
original cost of the product.
If the product should not perform to specifications within the warranty period, please
contact Customer Support.
11
Explanation of Symbols
Consult instructions for use
Manufacturer batch code
Product contains no latex
Temperature limitation
Catalogue number Non-
Type BF applied part
Humidity limitation
sterile
Do not use if product is
broken, damaged, or open
FCC ID:2AFEOSE3
Dust and water rating
L-10252 Rev A
© Copyright 2017 Kinsa, Inc.
For patents: kinsahealth.com/patents
12
Manufacturer’s declaration-electromagnetic emissions
The Kinsa Smart Ear Thermometer is intended for use in the electromagnetic
environment (for home healthcare) specified below.
The customer or the user of the Kinsa Smart Ear Thermometer should assure
that it is used in such an environment.
Emission test
Compliance
Electromagnetic
environment-guidance
(for home healthcare environment)
RF emissions
CISPR 11
Group 1
The Kinsa Smart 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
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
fluctuations
/flicker emissions
IEC 61000-3-3
Not applicable
The Kinsa Smart Ear Thermometer is
suitable for use in all establishments,
including domestic establishments and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Manufacturer’s declaration-electromagnetic immunity
The Kinsa Smart Ear Thermometer is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the Kinsa Smart Ear Thermometer should assure that it is used in such an environment.
IEC 60601
Immunity test
Compliance level
test level
Electromagnetic
environment-guidance
(for home healthcare environment)
Electrostatic
Contact:±8 kV
Contact:±8 kV
Floors should be wood, concrete or
discharge(ESD)
Air±2 kV,±4 kV,±8 kV,±15 kV
Air±2 kV,±4 kV,±8 kV,±15 kV
ceramic tile. If floors are covered with
synthetic material, the relative humidity
IEC 61000-4-2
should be at least 30%
Electrical fast
+ 2kV for power supply lines
Not applicable
Mains power quality should be that of a
transient/burst
+ 1kV for input/output lines
Not applicable
typical home healthcare environment.
Surge
+ 0.5kV, +1kV line(s) to line(s)
Not applicable
Mains power quality should be that of a
IEC 61000-4-5
+ 0.5kV, +1kV,+ 2kV line(s) to
Not applicable
typical home healthcare environment.
IEC 61000-4-4
earth
Voltage Dips, short
Voltage dips:
Voltage dips:
Mains power quality should be that of a
interruptions and voltage
0 % UT; 0,5 cycle
Not applicable
typical home healthcare environment.
variations on power supply
0 % UT; 1 cycle
Not applicable
If the user of the Kinsa Smart Ear
input lines
70 % U T; 25/30 cycles
Not applicable
Thermometer requires continued
operation during power mains
IEC 61000-4-11
Voltage interruptions:
Voltage interruptions:
interruptions, it is recommended that the
0 % UT; 250/300 cycle
Not applicable
Kinsa Smart Ear Thermometer be
powered from an uninterruptible power
supply or a battery.
Power frequency(50, 60
30 A/m
30 A/m
The Kinsa Smart Ear Thermometer
Hz) magnetic field
50 Hz or 60 Hz
50 Hz and 60 Hz
power frequency magnetic fields should
IEC 61000-4-8
be at levels characteristic of a typical
location in a typical home healthcare
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Manufacturer’s declaration-electromagnetic immunity
The Kinsa Smart Ear Thermometer is intended for use in the electromagnetic environment (for home healthcare) specified
below.
The customer or the user of the Kinsa Smart Ear Thermometer should assure that it is used in such and environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
(for home healthcare environment)
Conducted RF
3 Vrms:
IEC 61000-4-6
0,15 MHz – 80 MHz
6 Vrms:
Not applicable
Portable and mobile RF communications
equipment should be used no closer to any
Not applicable
part of the Kinsa Smart Ear Thermometer
in ISM and amateur
including cables, than the recommended
radio bands between
separation distance calculated from the
0,15 MHz and 80 MHz
equation applicable to the frequency of the
transmitter.
80 % AM at 1 kHz
Radiated RF
10 V/m
10 V/m
IEC 61000-4-3
80 MHz – 2,7 GHz
80 MHz – 2,7 GHz
Recommended separation distance:
80 % AM at 1 kHz
80 % AM at 1 kHz
d = 1,2
d = 1,2
d = 2,3
80MHz to 800 MHz
800MHz to 2,7 GHz
Where 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 metres
(m).
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
Recommended separation distance between
portable and mobile RF communications equipment and the Kinsa Smart Ear Thermometer
The Kinsa Smart Ear Thermometer is intended for use in an electromagnetic environment (for home healthcare) in
which radiated RF disturbances are controlled. The customer or the user of the Kinsa Smart Ear Thermometer can
help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Kinsa Smart Ear Thermometer as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter
power of transmitter
m
W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,7 GHz
d =1,2
d =1,2
d =2,3
0,01
N/A
0,12
0,23
0,1
N/A
0,38
0,73
1
N/A
1,2
2,3
10
N/A
3,8
7,3
100
N/A
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The Kinsa Smart Ear Thermometer is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the Kinsa Smart Ear Thermometer should assure that it is used in such an environment.
Maximum power
(W)
Distance
(m)
IMMUNITY TEST
LEVEL
(V/m)
Compliance LEVEL
(V/m)
(for home healthcare)
Pulse
modulation b)
18 Hz
1,8
0,3
27
27
GMRS 460,
FRS 460
FM c)
±5 kHz deviation
1 kHz sine
2
0,3
28
28
704 – 787
LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2
0,3
9
9
800 – 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
28
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2
0,3
28
28
2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2
0,3
28
28
5 100 –
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2
0,3
9
9
Test frequency
(MHz)
Band a)
(MHz)
385
380 –390
TETRA 400
450
430 – 470
Service
a)
710
745
780
810
870
930
1 720
1 845
1 970
2 450
5 240
5 500
5 785
NOTE
SYSTEM
a)
b)
c)
Modulation
b)
If necessary to achieve the IMMUNITY TEST LEVEL , the distance between the transmitting antenna and the ME EQUIPMENT or ME
may be reduced to 1 m. The 1 m test distanc e is permitted by IEC 61000-4-3.
For s ome services, only the uplink frequencies are included.
The carrier shall be modulated using a 50 % duty cycle square wave signal.
As an alternative to FM modulation, 50 % puls e modulation at 18 Hz may be us ed bec aus e while it does not repres ent actual
modulation, it would be worst case.