WITHINGS WSM02 Sleep Analyzer and Apnea Detector User Guide

: October 30, 2023
: Withings

WITHINGS WSM02 Sleep Analyzer and Apnea Detector

Product Information

The Sleep Analyzer is a home-use connected smart device developed by Withings to measure several sleep parameters at home and provide them to individuals of 18 years and older. The Sleep Analyzer can measure, record and transfer the following features without medical purposes:
- Sleep Apnea Detector (for Non-US regions) is a medical device software available on the Sleep Analyzer, used in the management of sleep apnea syndrome at home, that needs to be activated via the Withings app.
The product requires an iOS (14.0 or higher) or Android (8.0 and higher) mobile device to install it. Thereafter, the product can be used without your mobile device on you, thanks to the Wi-Fi. You will need to be connected to your wifi on your phone to synchronise your results to see them in the Withings app.

Product Usage Instructions

To use the Sleep Analyzer and take a measurement, follow these steps:

Install the Sleep Analyzer on your iOS or Android device.
Place the sensor below your mattress at heart level. If you’re sleeping alone in a double bed, make sure the sensor is centered below the mattress.
Make sure that your Sleep Analyzer is assigned to the correct user in the Devices tab under the device name.
Go to bed and sleep as you normally would.
In the morning, open the Withings app and synchronize your results by connecting to your wifi on your phone.

Troubleshooting

If you encounter any issues with your Sleep Analyzer, please try the following troubleshooting steps:

If the sleep time of your device is incorrect or you have no sleep data in the Withings app, open your Withings app, tap on Devices and look for your Sleep Analyzer, tap on All Settings, in Advanced Settings, tap on the Location of your device, enter your device’s location and click on OK.
If Withings app can’t find your Sleep Analyzer via Bluetooth, turn off the Bluetooth of your mobile device then turn it back on, unplug your Sleep Analyzer and plug it back in, uninstall the Withings app and then reinstall it. If the issue persists, press the reset button.
If the setup process fails, make sure you have access to the internet on your mobile device, keep the Withings app open during the installation process, and remain on the Withings app during the installation process.
If your data seems inaccurate, make sure the sensor is properly positioned, and if your bed has a slatted frame, you may need to place a thin, flat object (such as a piece of cardboard, for example) between the frame and the sensor.

Technical Specifications

Type BF applied part
Wireless Information: 802.11 b/g/n
Mode: BT-LE BT EDR
Frequency Band (MHz): 2400-2483.5 2402-2480 2402-2480
Maximum Output Power (dBm): 24.38 7.99 -6.47
Note: Specifications are subject to change without prior notice or any obligation on the parts of the manufacturer.

Important Notice

Before using the Sleep Analyzer and Sleep Apnea Detector, review the information in this guide. You may also find this guide online at: https://www. withings.com/guides
Retain this documentation for future reference. Installation instructions are available within the Quick Start Guide provided with this user guide. Please contact Withings when in need of assistance, for setting up, using the device, or to report unexpected operations/events.
Any serious incident that has occurred in relation to the Sleep Apnea Detector should be reported to Withings and the competent authorities in your country of residence.

Getting Started

Sleep Analyzer is a home-use connected smart device developed by Withings in order to measure several sleep parameters at home and provide them to individuals of 18 years and older. The Sleep Analyzer can measure, record and transfer the following features without medical purposes:

Sleep duration
Sleep stages (Light, Deep, REM)
Sleep interruptions
Time to fall asleep
Heart rate
Snoring

Sleep Apnea Detector (for Non-US regions) is a medical device software available on the Sleep Analyzer, used in the management of sleep apnea syndrome at home, that needs to be activated via the Withings app.

Sleep Apnea Detector Intended Use:

The Sleep Apnea Detector may be used:
- as a diagnostic test for the risk of sleep apnea syndrome
- as a monitoring tool for patients treated by alternative treatments to CPAP,
- as an educational tool for patients treated with CPAP,
- and by health-conscious individuals
The Sleep Apnea Detector is intended for use by an adult population (18 years or older).

Box Content

Sleep Analyzer
USB Power Adapter
Quick Start Guide
Product Guide
In order to use your Sleep Analyzer, you need an iOS (14.0 or higher) or Android (8.0 and higher) mobile device to install it. Thereafter, the product can be used without your mobile device on you, thanks to the Wi-Fi. You will need to be connected to your wifi on your phone to synchronise your results to see them in the Withings app.

Cautions

The Sleep Apnea Detector cannot provide information for sleep breathing disorders other than sleep apnea.
DO NOT change your medication or treatment without talking to your doctor. This device is not intended for use by individuals under the age of 18. You should talk to your doctor if you experience symptoms or concerns. Interpretations made by this software are potential findings, not a complete diagnosis of neither sleep apnea, nor other sleep breathing disorders. The user is not intended to interpret or take clinical action based on the Sleep Apnea Detector output without consultation of a qualified healthcare professional.
If you believe you’re having a medical emergency, call emergency services.
Sleep Apnea Detector is not indicated for use on patients with arrhythmia, cardiac insufficiency, asthma, or chronic obstructive pulmonary disease.
DO NOT take into consideration results from data tracked when another person than the main user lays on the top of the Sleep Analyzer.
DO NOT use with waterbeds, air beds, or mechanically articulated mattresses.
DO NOT use the Sleep Apnea Detector when the Sleep Analyzer is in close vicinity to strong electromagnetic fields (e.g. electromagnetic anti-theft systems, metal detectors).
DO NOT take into account recordings performed outside of the operational temperature range (-20°C – 35°C), humidity range of 15% to 85% rela-tive humidity and atmospheric pressure range 700-1060hPa.
DO NOT use accessories, detachable parts, or materials not described in the product guide.
Use of parts and components other than those specified or provided by Withings could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
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 the Sleep Analyzer, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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.
DO NOT interconnect this equipment with other equipment not described in the instructions for use.

How to to use the Sleep Analyzer and take a measurement

Set-Up
- Sleep Analyzer is a sleep tracking mat, distributed without the Sleep Apnea detection function
- Sleep Apnea Detector is a medical device software activated during the installation of the Sleep Analyzer by the user
- Sleep Apnea Detector is only available on the Sleep Analyzer, installed with a smartphone with iOS 14.0 or later, or Android 8.0 or later.
On-boarding
- Open Withings app.
- In the Device tab, select your Sleep Analyzer, then select “Understand sleep apnea detection”
- Follow the instructions.
- You may exit the on-boarding at any time by pressing the return button.
Track Sleep Apnea
- Check that the placement of your Sleep Analyzer is optimal for Sleep Apnea detection It should be:
- Placed under the mattress
- With the maximal contact surface between the Sleep Analyzer and the bed, and between Withings Sleep and the bed box. If needed, a cardboard sheet can be used to maximise contact
- Placed at heart level
- Covering as much as possible your sleeping zone in the bed.
- Make sure your Sleep Analyzer is plugged to the power outlet using the provided adapter. If not, plug it in and wait for 10 minutes before anyone enters the bed. Don’t leave heavy objects on the bed when you are not using it.
- Go to sleep for at least 5 hours
- Sleep Analyzer will synchronise the data to your Withings app account once you get out of bed
- Results are readable in the Withings app

Troubleshooting

If you cannot fix the problem using the following troubleshooting instructions, please contact Withings or visit: withings.com/support

The sleep time of my device is incorrect.

1. Open your Withings app
2. Tap on Devices and look for your Sleep Analyzer
3. Tap on All Settings
4. In Advanced Settings, tap on Location of your device
5.  Enter your device’s location and click on OK

You have no sleep data in the Withings app

1. Make sure that your Sleep Analyzer is plugged in.
2. Make sure that your Sleep Analyzer appears in Devices in the Withings app.

If not, you need to install it.

3.  Make sure that your Sleep Analyzer has been assigned to the correct user when installing your device. You can check in the Devices tab which profile the device is assigned to by checking the user name directly under the device name.
4. Make sure your Wi-Fi network works properly. If it doesn’t, your Sleep Analyzer won’t be able to communicate with the Withings app.
5. Log in to the web dashboard to see if your sleep data is there. If it is, simply log out from the Withings app and then log back in. If that still doesn’t fix the issue, try uninstalling the Withings app and installing it again.
6. Make sure the sensor is properly positioned.

It should be below your mattress, at heart level.

7. If you’re sleeping alone in a double bed, make sure the sensor is centred below the mattress.
8. If your bed has a slatted frame, you may need to place a thin, flat object (such as a piece of cardboard, for example) between the frame and the sensor.

Withings app can’t find your Sleep Analyzer via Bluetooth

1. Turn off the Bluetooth of your mobile device then turn it back on
2. Unplug your Sleep Analyzer and plug it back in.
3.  Uninstall the Withings app and then reinstall it
4.  If the issue persists, press the reset button

The setup process fails

1. Make sure you have access to the internet on your mobile device.
2.  Make sure that you keep the Withings app open during the installation process.
3.  Make sure that you remain on the Withings app during the installation process.

Your data seems inaccurate

1. Make sure that your Sleep Analyzer is assigned to the correct user in the Devices tab under the device name.
2. Make sure the sensor is properly positioned. It should be below your mattress, at heart level.
3. If you’re sleeping alone in a double bed, make sure the sensor is centred below the mattress.
4.  If your bed has a slatted frame, you may need to place a thin, flat object (such as a piece of cardboard, for example) between the frame and the sensor.

LED Colors Meaning

The LED display on Sleep Analyzer can be:

Flashing blue: If the Sleep Analyzer hasn’t been installed or paired with a mobile device.
Solid blue: If the Sleep Analyzer has been paired with a mobile device and is in setup mode.
Flashing red: If the inflation process has been stopped or if the air bladder has a potential leak.
The LED can also flash red if you press and hold the reset button.
Solid red: If the Sleep Analyzer can’t connect to the Internet.
Solid green : If the factory reset has been completed.
The LED can also be green when the Sleep Analyzer is ready for Wi-Fi configuration or when you try to set up a device already installed. Flashing purple: The installation has timed out. Sleep Analyzer is no longer discoverable via Bluetooth. Restart the installation process.
Note that Sleep Analyzer can be installed during the first 30 minutes that it is plugged in. After that, the LED blinks purple which means that the setup time is over. In this case, you’ll need to unplug, then replug Sleep Analyzer using the provided adapter. You’ll then be able to install it. Flashing yellow: If the device has been dissociated from the user (no user associated).
Solid white: If the deflation process is ongoing.

Technical Specifications

Product description: Air inflated pad equipped with a pressure sensor and a sound sensor.
Model: WSM02
Pad Inflation: Automatic inflation with air pump of the pad at 100 mmHg (13 333 Pascal)
Pressure sensor: Digital air pressure sensor
Sound sensor: Micro-electromechanical systems microphone
Pressure sensor accuracy: +/- 0,01mmHg
Sound sensor tolerance: 1 dB
Measurement range (pressure): 0 to 200 mmHg
Measurement range (sound): Frequency Range from 60 Hz to 4 kHz
Operating conditions: 10°C to +35°C; Humidity range of 20% to 90% relative humidity; Atmospheric pressure range (700-1060 hPa).
Storage and transport conditions:
- Temperature : – 20°C to + 85°C ;
- Humidity range : 20% – 90% ,
- atmospheric (500-1060 hPa)
Power source: Sleep Analyzer has no battery and should be plugged into a power socket, using the provided adapter.
Weight: 350 grams
Accessories: Charging cable, Quick Start Guide, Product Guide, Power adapter
Expected product life: 3 years
Wireless transmission: Wi-Fi and BLE

Wireless Information

Safety and Performance

The Sleep Apnea Detector software’s ability to accurately classify a sleep recording into sleep apnea severity was studied in a multi-centric clinical investigation, on 118 subjects, against polysomnography scored according to AASM recommendations. The Sleep Apnea Detector demonstrated 88.0% sensitivity and 88.6% specificity on the AHI = 15 events/h threshold, and 86.0% sensitivity and 91.2% specificity on the AHI = 30 events/h threshold.
Declaration – Electromagnetic Emissions and Immunity for equipment and systems that are not life-supporting and are specified for use only in a shielded location.
RF Statement: Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the following. Portable and mobile RF communication equipment can affect Medical Electrical Equipment.

Guidance and manufacturer’s declaration – electromagnetic emissions
The device Sleep Analyzer is intended for use in the electromagnetic environment specified below. The customer or the user of the device Sleep Analyzer should ensure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic emissions
The device Sleep Analyzer is intended for use in the electromagnetic environment specified below. The customer or the user of the device Sleep Analyzer should ensure that it is used in such an environment.

Note 1 : The EUT is not required to meet the limits as its power consumption is less than 75W.

Guidance and manufacturer’s declaration – electromagnetic immunity
The device Sleep Analyzer is intended for use in the electromagnetic environment specified below. The customer or the user of the device Sleep Analyzer should ensure that it is used in such an environment.

After Use

Cleaning and maintenance
To clean the textile cover of the sensor, gently remove the cover first. The cover can be machine washed, but do not tumble dry or iron it. Wait until the cover is completely dry before replacing it on the sensor.
Storage
Store the device and the components in a clean and safe location. If storage conditions are different from the usage conditions indicated in this doc- ument, please wait 30 minutes before installing the device.
Disposal
Actuation of European directive 2012/19/EU, for reduction in use of dangerous substances in the electric and electronic device and for garbage disposal. The symbol applied on the device or its packaging means that at the end of its useful life, the product must not be disposed of separately, not as unsorted municipal waste with domestic waste. At the end of the device’s useful life, the user must deliver it to a collection center for electric and electronic garbage, or return it to the retailer when purchasing a new device. Disposing of the product separately prevents possible negative environmental and health consequences deriving from inadequate disposal. It also allows the recovery of materials it is composed of to save en-ergy and resources and avoid negative effects to the environment and health. In case of abusive disposal of devices by the user, will be applied administrative endorsements in compliance with current standards. The device and its parts must be disposed of as appropriate, in accordance with national or regional regulations.

Warranty

Withings Two (2) Years Limited Warranty – Withings Sleep Analyzer

Withings, 2 rue Maurice Hartmann, 92130 Is-sy-les-Moulineaux, (“Withings”) warrants the Withings-branded product (“Withings Prod-uct”) against defects in materials and work-manship when used normally in accordance with Withings’ published guidelines for a pe-riod of TWO (2) YEARS from the date of orig-inal retail purchase by the end-user purchas-er (“Warranty Period”). Withings’ published guidelines include, but are not limited to, infor-mation contained in technical specifications, safety instructions or Quick Start Guide. With-ings does not warrant that the operation of the Withings Product will be uninterrupted or error-free. Withings is not responsible for dam-age arising from failure to follow instructions relating to the Withings Product’s use.
Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or re-fund for a major failure and compensation for any other reasonably foreseeable loss or dam-age. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.

Security

Withings recommends that you add a pass-code (personal identification number [PIN]), Face ID or Touch ID (fingerprint) to your phone to add a layer of security. It is important to se-cure your phone since you will be storing per-sonal health information. Users will also receive additional update notifications on the Withings app, and updates are delivered wirelessly, en-couraging rapid adoption of the latest secu-rity fixes. Users are able to see the currently installed software version in the Withings app, in Devices > Sleep Analyzer. This tab also indi-cates if an update is available or not.
Do not install the device on a smartphone that you do not own.
Do not use a public Wi-Fi network you don’t know. Use a trusted Wi-Fi network with your device. Withings also recommends upgrading your Withings app when an upgrade is avail-able.
The Withings app is not intended to be used on a computer. No indication of anti-virus soft-ware is needed.
Only use official app stores to download the Withings app. If in doubt, use the link go.with-ings.com.

European Union – Declaration of Conformity

Sleep Analyzer
Withings hereby declares that the Sleep Analyzer is in conformity with the essential and relevant require-ments of applicable EU Directives. The full text of the EU declaration of conformity is available at: withings. com/compliance
Sleep Apnea detector
Withings hereby declares that the Sleep Apnea Detector is in conformity with the essential and relevant re-quirements of the Directive 93/42/EEC. The full text of the EU declaration of conformity is available at: withings. com/compliance

Regulatory markings & Logos Explanation

Australian sponsor:
Emergo Australia Level 20, Tower II, Darling Park, 201 Sussex Street, Sydney NSW2000, Australia
UK Responsible Person:
Emergo Consulting (UK) Ltd c/o Cr360 – UL International Compass House, Vision Park Histon – Cambridge CB24 9BZ United Kingdom