Omron WheezeScan HWZ-1000T-E User manual

Wheeze Detector
WheezeScan
(HWZ-1000T-E) NO WHEEZE
WHEEZE
EN
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ES
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Instruction Manual
Mode d’emploi
Gebrauchsanweisung
Manuale di istruzioni
Manual de instrucciones
Gebruiksaanwijzing
Руководство по эксплуатации
Kullanım Kılavuzu
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19M2882

EN1
Table of Contents
Introduction..........................................................................EN2
Safety Instructions......................................................................................................EN2
Intended Use ................................................................................................................EN2
Receiving and Inspection ........................................................................................EN2
Important Safety Information................................................................................EN3
1. Know Your Device .............................................................EN7
1.1 Contents ..................................................................................................................EN7
1.2 Part Names .............................................................................................................EN8
2. Installing Batteries ...........................................................EN9
3. Detecting Wheeze ............................................................EN10
3.1 Taking a Measurement.......................................................................................EN10
3.2 Checking Result....................................................................................................EN14
4. Managing Results with Your Smart Device.....................EN15
5. Maintenance .....................................................................EN16
5.1 Maintenance ..........................................................................................................EN16
5.2 Storage ....................................................................................................................EN16
5.3 Cleaning ..................................................................................................................EN16
6. Troubleshooting ...............................................................EN17
7. Specifications ....................................................................EN19
8. Limited Warranty..............................................................EN21
9. Guidance and Manufacturer’s Declaration.....................EN22
10. How the Device Works....................................................EN24

EN
EN2
Introduction
Thank you for purchasing the OMRON WheezeScan. WheezeScan uses innovative listening
technology to identify “wheeze” or “no wheeze” quickly and accurately. WheezeScan is a
convenient tool to help parents to manage their children’s asthmatic symptoms at home.
The cause of these symptoms can be bronchitis, bronchiolitis or bronchial asthma.
Safety Instructions
This instruction manual provides you with important information about WheezeScan.
To ensure safe and proper use of this device, READ and UNDERSTAND all of these
instructions. If you do not understand these instructions or have any questions,
contact your OMRON retail outlet or distributor before attempting to use this
device.
Intended Use
The OMRON WheezeScan is intended to detect the presence of wheezing in infants,
toddlers and children from 4 months to 7 years of age.
The WheezeScan shows “Wheeze” or “No Wheeze” as the result of measurement. The
obtained results should be discussed with your physician.
Environment of use: home, clinic
Receiving and Inspection
Remove this device and other items from the packaging and inspect for damage. If this
device or any other items are damaged, DO NOT USE and consult with your OMRON
retail outlet or distributor.

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Important Safety Information
Read the Important Safety Information in this instruction manual before
using this device.
Follow this instruction manual thoroughly for your safety. Keep for future reference. For
specific information about patient’s symptoms, CONSULT WITH A PHYSICIAN.
WARNING Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
• NEVER diagnose or treat a patient based only on the result from this device. ONLY a
physician is qualified to diagnose and treat patient’s respiratory disease.
• This device is intended for use on a patient whose illness was diagnosed as bronchitis,
bronchiolitis or bronchial asthma.
• Consult with a physician to discuss the results of the measurement with this device.
• If a patient is having signs and symptoms of chest tightness, shortness of breath,
coughing or wheezing, a wheeze may not be detected because:
- the breathing sound is too loud or too soft;
- the wheeze is at extremely small amplitude, extremely short duration, extremely
high frequency or extremely low frequency;
- an asthma attack occurs without wheezing.
Always take action as prescribed by a physician, no matter what the result from this
device is.
This device also may incorrectly detect any noise as a wheeze because various sounds
are occurring in patient’s body such as:
- voice or cry of a patient;
- nasal obstruction sound;
- sputum sound etc.
• DO NOT use in case of severe asthma attack or respiratory failure. Consult with a
physician immediately.
• Take a measurement again if you are concerned about the result. This device can detect
wheeze only while taking a measurement. Wheeze can occur after taking a measurement.
If you are still concerned after taking a measurement again, consult with a physician.
• DO NOT use this device on a chest that is injured or that is under medical treatment.

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EN4
Important Safety Information
• DO NOT disassemble or attempt to repair this device. This may cause an inaccurate
result. This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers or children.
Data Transmission
• This product emits radio frequencies (RF) in the 2.4 GHz band. Turn off the Bluetooth®
feature in this device and remove batteries when in RF restricted areas.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or children.
CAUTION
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user or
patient, or cause damage to the equipment or other property.
• ONLY apply this device on a patient who is between 4 months old and 7 years old.
• ONLY parents who are advised by a physician, caregivers, school nurses and physicians
are allowed to use this device. DO NOT let patient use this device on his/her own.
• An inaccurate result may happen when:
- clothes touch the device (ALWAYS place the sound sensor on the patient’s skin directly);
- the device is used on crying, speaking or moving patients;
- the sound sensor is placed on an incorrect place on the body;
- the sound sensor is placed on the body too strongly or too lightly;
- the sound sensor is not adhered to the body;
- the patient’s chest has too much muscle or fat.
• Stop using this device and consult with a physician if you or the patient experience
skin irritation or discomfort.
• DO NOT use this device for any purpose other than detecting wheeze.
• DO NOT use in a location where there is moisture or a risk of water splashing on this
device. This may damage this device.
• DO NOT wash or immerse the device in water.
• DO NOT use chemicals other than alcohol to clean the sound sensor.
• DO NOT drop or subject this device to strong shocks or vibrations.
• DO NOT use this device in places with high or low humidity or high or low
temperatures. Refer to “Operating conditions” in section 7.
• This device may not work when the sound sensor is damaged. If it happens, contact
your OMRON retail outlet or distributor.

EN5
Important Safety Information
• This device does not have a waterproof structure. Contact customer support
immediately if the device is exposed to or submerged in water.
• Contact customer support if the device receives a strong shock such as being dropped.
• During operation, make sure that no mobile device or any other electrical device that
emits electromagnetic fields is within 30 cm of this device. This may result in incorrect
operation of the device and/or cause an inaccurate indication.
• DO NOT use this device with other medical electrical (ME) equipment simultaneously.
This may result in incorrect operation of the device and/or cause an inaccurate indication.
• Ensure that this device has acclimated to room temperature before taking a
measurement. Taking a measurement after an extreme temperature change could
lead to an inaccurate indication. OMRON recommends waiting for approximately
2 hours for the monitor to warm up or cool down when the device is used in an
environment within the temperature specified as operating conditions after it is
stored either at the maximum or at the minimum storage temperature. For additional
information on operating and storage/transport temperatures, refer to section 7.
• Read and follow the “Correct Disposal of This Product (Waste Electrical & Electronic
Equipment)” in section 9 when disposing of the device and any used accessories.
• DO NOT keep touching the sound sensor for more than 1 minute.
Unusable Environment
• This device cannot be used in an environment with noise at 60 dB or above, such as:
- near working vacuum cleaners, hair dryers or washing machines
- in moving vehicles
- in noisy public or private areas
In any of these places, an error may occur while taking a measurement.
Data Transmission
• DO NOT replace batteries while readings are being transferred to your smart device.
This may result in incorrect operation of this device and failure to transfer readings.
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 2 “AAA” alkaline batteries with this device. DO NOT use other types of
batteries. DO NOT use new and used batteries together.
• Remove batteries if this device will not be used for a long period of time.

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EN6
• If battery fluid should get in patient’s or your eyes, immediately rinse with plenty of
clean water. Consult with a physician immediately.
• If battery fluid should get on patient’s or your skin, wash the skin immediately with
plenty of clean, lukewarm water. If irritation, injury or pain persists, consult with a
physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working condition.
• ONLY use batteries specified for this device. Use of unsupported batteries may
damage and/or may be hazardous to this device.
Important Safety Information

EN7
1.1 Contents
1. Know Your Device
Device
NO WHEEZE
WHEEZE
Storage case
2 “AAA” alkaline
batteries Instruction manual
Quick reference guide

EN
EN8
1.2 Part Names
NO WHEEZE
WHEEZE
A
B
D
C
E
F
G
I
H
ASound sensor HConnection indicator
BDisplay I[Connection] button
CError symbol
DBattery symbol
Low: flashes / Depleted: lights
EPower indicator
F[Power] button
GBattery compartment

EN9
When the “ ” symbol flashes, it is recommended that you replace the
batteries. To replace batteries, turn the device off and remove batteries. Then
replace with 2 new alkaline batteries.
Note
• Replacing batteries does not delete previous results recorded in the device.
• The supplied batteries may have a shorter life span than new batteries.
• Disposal of used batteries should be carried out in accordance with local regulations.
1Open the battery cover.
Turn the battery cover anticlockwise to
open.
DO NOT pull the battery cover strongly. The
rubber may be torn off.
2Insert 2 ”AAA” alkaline batteries
as indicated in the battery
compartment.
Confirm the polarities are correctly aligned.
3Close the battery cover.
Turn the battery cover clockwise to close.
2. Installing Batteries

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EN10
3. Detecting Wheeze
3.1 Taking a Measurement
Do not use the device in locations exposed to extreme temperatures, humidity,
direct sunlight, dust or corrosive vapors such as bleach.
CAUTION
This device cannot be used in an environment with noise at 60 dB or above, such as:
- near working vacuum cleaners, hair dryers or washing machines;
- in moving vehicles;
- in noisy public or private areas
In any of these places, an error may occur while taking a measurement.
1
Remove phlegm and nasal mucus, if any,
before taking a measurement.
2Let the patient sit down or lay face up.

EN11
3Remove clothes to expose patient’s chest.
Being naked from the waist up is recommended.
WARNING
DO NOT place the sound sensor on clothes and DO NOT let clothes touch the device.
This may cause an inaccurate result. ALWAYS place the sound sensor directly on
the patient’s skin.
4Check where to place the sound sensor.
The sound sensor should be placed on the right chest under the right collarbone.
For appropriate location on the body, see the illustration shown below.
To avoid damage to the sound sensor, wipe off baby oil or any chemical products
from the patient’s skin before taking a measurement.
WARNING
DO NOT use this device on a chest that is injured or that is under medical
treatment.
Rib
Right collarbone
Place the sound sensor here.
3.1 Taking a Measurement

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3.1 Taking a Measurement
5Press the button.
The device will beep and the power indicator will
light green.
Note
• When the power is turned on, all indicators
will light up for 2 seconds. Then, the previous
measurement result (refer to section 3.2) will be
displayed for 2 seconds.
• If you do not start a measurement within 30seconds
after turning the power on, “ “ symbol will
appear. To restart the device, press and hold the
button to turn the power off and press it again to
turn the power on.
Beep
NO WHEEZE
WHEEZE
Power indicato
r
• Ensure that both the parent and the patient DO
NOT talk while the measurement is being taken.
………
………

EN13
3.1 Taking a Measurement
6Apply the sound sensor to the patient’s skin.
Place and adhere the sound sensor firmly.
Not adhering
Place and adhere firmly
7
The device will beep twice and begin measuring.
When the sound sensor is correctly placed on the
body, the device gives twice the sound “beep” and
the measurement starts automatically.
After the sound sensor is applied to the skin, the
sensor will flash white while taking the measurement.
Beep, Beep
Note
• Ensure that the patient DOES NOT talk, cry or move while the measurement is
being taken.
• Ensure that the patient continues to breathe normally.
8Wait until the measurement is completed.
When the measurement is completed, the device beeps 3 times.
The maximum measurement time is 30 seconds.
Note
KEEP the sensor in close contact and DO NOT move the device until the device
beeps 3 times. Otherwise the result may be inaccurate.

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3.2 Checking Result
After the measurement, the result will be shown as pictured below.
If wheezing is not detected, “No Wheeze” will light white.
If wheezing is detected, “Wheeze” will light orange.
Wheezing is NOT detected Wheezing is detected
NO WHEEZE
WHEEZE WHEEZE
NO WHEEZE
Note
• The device automatically turns off within a maximum of 3 minutes after completing
a measurement. You can turn the power off manually by pressing and holding the
button.
• If you want to check the last result, press the button to turn the power on. You will
see the last result displayed.
• If the device can not detect the sound correctly, it gives 2 longer beeps, “ “ symbol
appears and the sound sensor flashes or lights orange. Refer to section 6 for more
information.

EN15
4. Managing Results with Your Smart Device
This device can pair with your smart device and you can manage the
measurement results with your smart device using the “OMRON Asthma Diary”
app. Review the list of compatible smart devices at:
www.omron-healthcare.com/asthma-diary-compatibility
Follow the steps below to pair the device with your smart device.
Note
If you do not pair the device, measurements you take will not be stored in the
WheezeScan’s memory.
1Enable Bluetooth on your smart device.
Bluetooth ON
2Download and install the “OMRON Asthma
Diary” app onto your smart device.
asthma diary
3Open the app on your smart device and follow the instructions.
For more information about the app, refer to “Help“ section of the app.

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5. Maintenance
5.1 Maintenance
To protect the device from damage, please follow the directions below:
• Store the device in a clean, safe location.
• Changes or modifications not approved by the manufacturer will void the user warranty.
WARNING
• DO NOT disassemble or attempt to repair this device. This may cause an inaccurate
result. This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers or children.
5.2 Storage
Put the device in the storage case, and store in a clean, safe location.
Do not store the device:
• If the device is wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight, dust or
corrosive vapors such as bleach.
• In locations exposed to vibrations or shocks.
5.3 Cleaning
• Use a soft cloth moistened with sanitizing alcohol to clean the sound sensor.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean
the device other than the sound sensor, and then wipe with a dry cloth.
• DO NOT use any abrasive or volatile cleaners.
• DO NOT use gasoline, thinners or similar solvents to clean the device.
CAUTION
• DO NOT wash or immerse the device in water.

EN17
6. Troubleshooting
If any of the below problems occur, check to make sure that no other electrical device is
within 30 cm. If the problem persists, refer to the table below.
Problem Possible cause Solution
The sound sensor
flashes orange and
“ ” symbol appears.
NO WHEEZE
WHEEZE
The measurement
did not start within
30seconds after the
power was turned on.
Place the sound sensor on the
patient’s body within 30 seconds
after the power is turned on.
The patient, parent or
anyone near the patient
was speaking.
• DO NOT speak while the
measurement.
• DO NOT use this device on a
crying, speaking or moving
patient.
The device was used
on clothes during the
measurement.
DO NOT put this device on
clothes. ALWAYS place this device
on the patient’s skin directly.
The sound sensor was
applied on an incorrect
location on the body.
Apply the sensor on appropriate
location (See sub-section 3.1 for
measurement location).
The sound sensor was
not placed and adhered
firmly on the skin.
KEEP the sensor in close contact
with the patient and DO NOT
move the device until you hear
3beep sounds.

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EN18
6. Troubleshooting
Problem Possible cause Solution
The sound sensor
lights orange and
“ ”
symbol appears.
NO WHEEZE
WHEEZE
There is an external noise
around the device.
• Take a measurement in a quiet
place.
• DO NOT talk while taking a
measurement.
• DO NOT apply this device on a
crying patient.
The sound sensor
does NOT flash or
light orange but “ ”
symbol appears.
An internal error
occurred.
Contact your OMRON retail outlet
or distributor.
flashes
Batteries are low. Replacing all batteries with 2 new
batteries is recommended. Refer
to sub-section 2.1.
lights
Batteries are depleted or
battery polarities are not
properly aligned.
• Immediately replace all
batteries with 2 new batteries.
Refer to sub-section 2.1.
• Confirm the batteries are properly
inserted with polarities correctly
aligned. Refer to sub-section 2.1.
No power.
Nothing appears.
Results change when
taking measurements
repeatedly.
The patient’s condition is
always changing.
NEVER diagnose or treat a patient
based only on the result. Consult with
a physician if you are concerned.
If you are not able to solve the problem, contact your OMRON retail outlet or distributor.

EN19
Product category Wheeze Detectors
Product description Wheeze Detector
Model (code) WheezeScan (HWZ-1000T-E)
Patient age range From 4 months to 7 years old
Power source 2 “AAA” alkaline batteries 3 V (2 x 1.5 V)
Battery life Approx. 450 measurements (using new alkaline batteries)
Durable period (service life) 5 years
Transmission method Bluetooth® Low Energy
Wireless communication Frequency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Effective radiated power: < 20 dBm
IP classification IP 22
Operating conditions +5 to +40 °C / 15 to 90 % RH (non-condensing) / 700 to 1060 hPa
Storage / transportation
conditions
-20 to +60 °C / 10 to 90 % RH (non-condensing)
Weight Approx. 55 g (not including batteries)
Dimension Approx. 33 (w) x 27 (d) x 121 (l) mm
Applied part Protection
against electric shock
Type BF (sound sensor)
Internally powered ME equipment
Operation Mode
Continuous operation
Memory Stores up to 150 readings
Maximum temperature of
the applied part
Lower than +48 °C
7. Specifications