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.

6
• 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