Omron WheezeScan User manual

Wheeze Detector
WheezeScan
(HWZ-1000T)
Instruction Manual
NO WHEEZE
WHEEZE
Rx ONLY

1
Table of Contents
Introduction....................................................................................................... 2
Safety Instructions..................................................................................................................................................... 2
Intended Use ............................................................................................................................................................... 2
Receiving and Inspection ....................................................................................................................................... 2
Important Safety Information............................................................................................................................... 3
1. Know Your Device.......................................................................................... 7
1.1 Contents.................................................................................................................................................................. 7
1.2 Part Names ............................................................................................................................................................ 8
2. Installing Batteries ........................................................................................ 9
3. Detecting Wheeze ....................................................................................... 10
3.1 Taking a Measurement.................................................................................................................................... 10
3.2 Checking Result................................................................................................................................................. 14
4. Managing Results with Your Smart Device ............................................... 15
5. Maintenance ................................................................................................ 16
5.1 Maintenance .......................................................................................................................................................16
5.2 Storage.................................................................................................................................................................. 16
5.3 Cleaning ............................................................................................................................................................... 16
5.4 Disposal ................................................................................................................................................................ 16
6. Troubleshooting.......................................................................................... 17
7. Specifications............................................................................................... 19
8. FCC Statement ............................................................................................. 21
9. Limited Warranty......................................................................................... 22
10. Guidance and Manufacturer’s Declaration ............................................. 23
11. How the Device Works............................................................................... 25

2
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 1-800- 634-4350 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 contact 1-800-634-4350.

3
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.
Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
WARNING
• 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.
• ONLY apply this device on a patient whose illness was diagnosed as bronchitis, bronchiolitis or
bronchial asthma.
• Consult with a physician before using this device. This device is intended to be used under the
direction of a physician or licensed healthcare professional.
• 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.
• 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.

4
Important Safety Information
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.
CAUTION
• 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 customer
service.
Data Transmission
• This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in
locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth®
feature in this device and remove batteries when in RF restricted areas. For further information on
potential restrictions refer to documentation on the Bluetooth usage by the FCC.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers or children.

5
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.
• 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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• 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

7
1.1 Contents
1. Know Your Device
Device
NO WHEEZE
WHEEZE
Storage case
2 "AAA" alkaline
batteries Instruction manual
Quick reference guide

8
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

9
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 correctly aligned.
3Close the battery cover.
Turn the battery cover clockwise to close.
2. Installing Batteries

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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.

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3.1 Taking a Measurement
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.

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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.
………
………

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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 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.

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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.
• 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.
CAUTION
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.
5.4 Disposal
Dispose of the device , battery and accessories in accordance with local regulations. Unlawful
disposal may cause environmental pollution.

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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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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 customer service. Refer to
section 9.
flashes
Batteries are low. Replacing all batteries with 2 new
batteries is recommended. Refer to
section 2.
lights
Batteries are depleted or
battery polarities are not
properly aligned.
• Immediately replace all batteries
with 2 new batteries. Refer to
section 2.
• Confirm the batteries are properly
inserted with polarities correctly
aligned. Refer to section 2.
No power.
Nothing appears.
Results change when
taking measurements
repeatedly.
The patient’s condition is
always changing.
NEVER diagnose or treat yourself
based on the result of measurement.
Consult with a physician if you are
concerned.
If you are not able to solve your problem, contact customer service. Refer to section 9.

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Product name WheezeScan
Model XXXXXXX HWZ-1000T-Z
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 +41 °F to +104 °F (+5 °C to +40 °C ) / 15 to 90 % RH (non-condensing) /
700 to 1060 hPa
Storage /
transportation conditions
-4 °F to +140 °F (-20 °C to +60 °C) / 10 to 90 % RH (non-condensing)
Weight Approx. 2 oz. (55 g) (not including batteries)
Dimension Approx. 1.3” (w) x 1.1” (d) x 4.7” (l) (33 x 27 x 121 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 +118.4 °F (+48 °C)
7. Specifications