wheezo WZO01 WheezeRate Detector/Breath Sensor User Guide

WZO01 WheezeRate Detector/Breath Sensor
User Guide

INTENDED USE

wheezo® is intended to detect and record abnormal breath sounds (continuous adventitiousbreath sounds/CABS) at the windpipe (trachea), reported as WheezeRate in adults and children (2 years and older).
A licensed health care professional’s advice is required to understand the meaning and importance of the wheezo® readings.

WHAT’S IN THE BOX

wheezo® Breath Sensor
USB-A to USB-C charging cable
Quick Start Guide

SMART DEVICE COMPATIBILITY

Owner supplied smart device
Made for iPhone 6s and up running iOS 13 or later
Select Android devices

SETTING UP wheezo® FOR THE FIRST TIME

wheezo® STEP-BY-STEP SET-UP

1. wheezo® breath sensor is powered by a built-in rechargeable battery. Before using it for the first time, plug one end of the USB charging cable supplied into the end of the device and the other end into a compliant AC adaptor. Charge it for up to three hours before first use. A fully charged the battery typically lasts up to 20 recordings.
2. While charging, the breath sensor’s LED indicator will flash green. When it is fully charged, the LED will display solid green.
3. Download the respiri™ app from the App Store or Google Play and launch it to connect the breath sensor to the app.
4. Enable Bluetooth® on your mobile device. Allow the app to access and use Bluetooth® and follow the instructions on the screen. Note: Android requires Location Services to be enabled for the initial Bluetooth® pairing.
5. Remove the wheezo® breath sensor’s protective cap and turn it on by holding the power button down until the LED indicator flashes blue, indicating it is ready to pair with your smart device.
6. When the wheezo® breath sensor and your smart device are paired, the LED indicator will display solid blue.
7. If you require assistance to set up your wheezo®, please contact support@respiri.co.

LIMITATIONS AND CONTRAINDICATIONS

wheezo® is not intended for diagnostic use.
wheezo® is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate in adults and children (2 years and older).
A licensed health care professional’s advice is required to understand the meaning and importance of the wheezo® readings.

OPERATING ENVIRONMENT

wheezo® has been designed for use in a quiet environment e.g. home, school or office. It is not designed to be used in direct air currents (e.g. wind), sources of heat or cold, direct sun rays or another source of light or energy, dust, sand, or any other chemical substances or performance will be affected.

WARNINGS

If the user is feeling breathless, or experiencing other symptoms, it is important to prioritize treatment overtaking a wheeze rate. Do not delay treatment.
Regardless of the wheeze rate, if the user has signs and symptoms such as chest tightness, shortness of breath, coughing, or wheezing, they should always follow their healthcare professional’s advice.
Electromagnetic interference (EMI) can occur in the home health care environment as control over other equipment cannot be guaranteed.
Interference from other equipment can be recognized by an interruption during recording. If this occurs, one of the following error messages will appear on the application screen:
Something went wrong. (Error code: 266) – Try again
Couldn’t find my breath sensor.
Make sure it is switched on and within range – Try again
There is no essential performance for the wheezo® device for the purpose of wheezerecording. The basic safety of the device is not affected if the recording is interrupted.
Continuous transmission of breath sounds and background sounds to the respiri™ app over Bluetooth demonstrates an immunity to sources of electromagnetic interference.
This has been demonstrated by complying with the standard IEC60601-1-2.
Moving away from the source of interference will usually allow the device to operate normally. Sources of interference may include communication equipment, wireless communication devices, household appliances, and industrial equipment. Examples are radio frequency identification systems (RFID), FM radio, television, a cellular network of
mobile phones, security systems, and microwave ovens.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of wheezo® including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

IMPORTANT SAFETY INSTRUCTIONS

Once removed from its packaging, check that there is no visible damage on the wheezo® breath sensor. In the case of damage, do not use it and return it to the seller.
Use only with iOS and select Android devices
Use only an AC adaptor that complies with IEC 60950-1 or IEC 60601-1 for charging
The USB-C port on the bottom of the breath sensor is only for charging the internal battery To prevent entanglement and strangulation, do not place the USB charging cable provided in reach of children Use only in environments specified in this Owner’s Manual Do not expose to liquids Do not tamper with the blue sensor diaphragm Do not expose the device to extreme temperatures – very hot or very cold, high humidity, dust or direct sunlight. wheezo® should be used in temperatures 0° – 40° C.
Do not drop the device or treat it roughly in any way Never attempt to repair the device yourself. Opening of wheezo® invalidates all guarantee claims Degraded sensors and microphones can affect performance
The normal function of the product may be disturbed by strong Electro-Magnetic Interference. If so, simply reset the product to resume normal operation by following the instruction manual. In case the function cannot resume, please use the product in a different location
The distance between the wheezo® device and smartphone must not exceed 1.3 meters.
In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2012/19/EU, do not dispose of this product as unsorted municipal waste. Follow local, state, and national governing ordinances and recycling instructions reading disposal or recycling of the device IEC 60950-1 is the reference standard for power supplies under Information Technology Equipment. IEC60601-1 is the international basic safety and essential performance standard for electrical medical equipment and medical electrical systems.

LIMITED WARRANTY AND RETURNS POLICY

wheezo® LIMITED WARRANTY AND RETURNS POLICY

This Limited Warranty and Returns Policy (“Limited Warranty”) applies to the wheezo® product, including accessories (the “Product”) and is given by Respiri Limited to the individual or entity (the “Owner”) who uses the Product which has been obtained from Respiri or a Respiri authorized dealer. This Limited Warranty applies only within countries where the respiri™ app is available for customers to download and for customers located in such countries and is not transferable.

30-DAY RETURN POLICY
If you purchased the Product directly from Respiri, then you may return the Product within 30 days of receiving it. In order for a refund under this Returns Policy to be granted, you must request a Return Merchandise Authorization (RMA) number from Respiri during the 30-day period following the date you received the Product from Respiri. You may request an RMA number by submitting a request to support@respiri.co. The Product must be received by Respiri within 3 weeks from the date on which the RMA was issued in order for you to receive a refund.
If the Product is returned to Respiri in accordance with this Returns Policy, Respiri will credit the account you used to make the original purchase with the full purchase price you paid for the Product and any applicable taxes minus any shipping and handling charges you paid when you purchased the Product. You are responsible for and must prepay all return shipping charges and you assume all risk of loss or damage to the Product while in transit back to Respiri.
The time to credit your account may vary, depending on processing time. Please allow up to seven business days for Respiri to credit the account used to make the original purchase. If you received a damaged Product directly from Respiri, please contact support@respiri.co.
Purchases through an Authorized Dealer: If you purchased the Product from a Respiri authorized retailer or distributor, please contact that retailer or distributor. You must follow the return policy of that authorized retailer or distributor.

MANUFACTURER’S LIMITED WARRANTY
Respiri warrants to the Owner that the Product will materially conform to its published specifications and be free from defects in materials and workmanship under normal use for a period of the greater of 1 year or the amount of time required by applicable consumer regulations in the country of purchase and commencing on the date of delivery (the “Warranty Period”).
If the Product proves defective during the Warranty Period, you must follow the instructions set out below for returning the Product, or part thereof, and Respiri will replace the Product with a product that is the same or equivalent to the Product you purchased.
A replacement product assumes the remaining warranty of the original Product, or 30 days from the date of replacement, whichever is longer. Respiri reserves the right to replace any discontinued product with a new product of comparable value and function.

HOW TO OBTAIN WARRANTY SERVICE
To obtain warranty service on a Product purchased directly from Respiri, contact support@respiri.co.
If Respiri determines that a Product is eligible for warranty replacement, Respiri shall bear the costs associated with returning a Product under warranty. Respiri is not responsible for items damaged or lost in transit. Replaced Products are the property of Respiri. The time to credit your account may vary, depending on processing time.
Please allow up to seven business days for Respiri to credit the account used to make the original purchase. If you received a damaged Product directly from Respiri, please contact support@respiri.co.
Purchases through an Authorized Dealer: If you purchased the Product from a Respiri authorized retailer or distributor, please contact that retailer or distributor. You must follow the return policy of that authorized retailer or distributor.
A replacement Product provided under this Limited Warranty will only be dispatched to addresses within countries where the respiri™ app is available for customers to download and for customers located in such countries and is not transferable.
Purchases through an Authorized Dealer: To obtain warranty service on a Product purchased from a Respiri authorized distributor, please contact that authorized distributor.
Respiri covers the product for the Warranty Period as long as proof of purchase can be provided, please contact support@respiri.co.
WHAT IS NOT COVERED?
This Limited Warranty will be void if the Product: (a) is used in any manner that is inconsistent with the intended purpose or design of the Product as described in Respiri’s published documentation for the Product, (b) is altered in any way, (c) the Product is used or maintained in any manner that is inconsistent with Respiri’s instructions or warnings included with the Product or (d) the Product is subjected to any other misuse, abuse, neglect, accident, or external forces.
This Limited Warranty does not cover normal wear and tear.
Respiri does not warrant that the operation of The product will be uninterrupted or error-free.
WARRANTY DISCLAIMER: This Limited Warranty replaces all other Respiri warranties and liabilities whether oral, written, (non-mandatory) statutory, contractual, in tort or otherwise, including without limitation and where permitted by applicable law, any implied conditions, warranties, or other terms as to the satisfactory quality or fitness for purpose.
To the greatest extent permitted by applicable law, the warranties set forth in this limited warranty are exclusive and no other warranty, whether written or oral, expressed or implied, applies with respect to THE PRODUCT AND ANY SERVICES PROVIDED UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF DESIGN, MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE (EVEN IF ALIVECOR HAS BEEN INFORMED OF SUCH PURPOSE) OR AGAINST INFRINGEMENT.
IF ANY IMPLIED WARRANTY CAN NOT BE DISCLAIMED UNDER APPLICABLE LAW, THEN SUCH IMPLIED WARRANTY
SHALL BE LIMITED IN DURATION TO THE WARRANTY PERIOD set forth ABOVE.

LIMITATION OF REMEDIES
THE REMEDIES IN THIS LIMITED WARRANTY ARE YOUR SOLE AND EXCLUSIVE REMEDIES.
Resellers, agents, or employees of Respiri are not authorized to make any modification, extension, or addition to this Limited Warranty.
To the greatest extent permitted by applicable law, Respiri does not assume any liability for loss of or damage to or corruption of data, for any loss of profit, loss of use of  Products or functionality, loss of business, loss of contracts, loss of revenues or loss of anticipated savings, increased costs or expenses or for any indirect loss or damage, consequential loss or damage or special loss or damage.
To the greatest extent permitted by applicable law, Respiri’s liability shall be limited to the purchase value of the Product.
THE LIMITATIONS SET FORTH IN THIS LIMITED
WARRANTY IS INTENDED TO LIMIT THE LIABILITY OF RESPITE AND SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

OTHER IMPORTANT NOTICES
The rights provided to you under this Limited Warranty are provided in addition to all rights and remedies conveyed to you by applicable consumer protection laws and do not affect your legal (statutory) rights under your applicable national law.
The jurisdiction applicable to you may not allow the limitations of liability or damages set forth in this Limited Warranty, in which case such limitations shall only apply to you to the extent permitted in such jurisdiction.
This Limited Warranty is offered subject to Respiri’s Terms and Conditions, which may change from time to time. You can find the latest version on our website at:  www.respiri.co In the case of any inconsistencies between the Terms of Service and this Limited Warranty, this Limited Warranty will prevail.
This Limited Warranty does not apply to any mobile device or the cellular and/or other network or system on which the Product operates. Therefore, Respiri will not accept any responsibility under this Limited Warranty for the operation, availability, coverage, services or range of the cellular or other network or system.
Always completely follow safety, use, operation, and maintenance instructions for the Product or any other Respiri product.
This Limited Warranty is governed by the laws of Victoria, Australia.
wheezo® USER MANUAL
Please access the full user manual at www.respiri.co

Manufactured for
Respiri Limited
9/432 St Kilda Road, Melbourne, VIC, 3004, AustraliaDistributed by
Respiri USA Inc
850 New Burton Road, Suite 201, Dover, DE 19904
support@respiri.co 

Respiri Limited reserves the right to make changes and improvements to this manual and the products it describes at any time, without notice or obligation.
Download the full wheezo® Owner’s Manual via www.respiri.co

and wheezo® are registered trademarks of Respiri Limited
WZO01-0004 | Quick Start Guide | US Version 3 | En.

References

• Respiri makers of wheezo® and Respiri Limited AUS investor centre
• Respiri makers of wheezo® and Respiri Limited AUS investor centre

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