Philips NightBalance User manual

Instructions for use
Sleep position therapy
NightBalance

2
Introduction ............................................... 3
Intended use...............................................4
Intended use
Indications for use
Contraindications for use
Warnings and cautions .............................5
Getting started .......................................... 7
Check packing contents
NightBalance components .......................8
Install the app and register
Login and pair your Sensor Device
Setting up the Docking Station
Getting to sleep ....................................... 14
Placing the Chest Strap
Placing the Sensor Device
Understand the adaptation program
Sleeping with the Sensor Device
Removing the Sensor Device
Charging the Sensor Device
View therapy data ...................................26
Background information on Bluetooth use
Manually synchronizing the Sensor Device
View therapy data in the app
Care and maintenance ........................... 29
Charging the Sensor Device
Cleaning NightBalance products
Traveling with NightBalance
Disposal
Maintenance
Troubleshooting....................................... 31
Technical specications..........................34
Symbols.....................................................36
Environmental conditions ...................... 37
Regulatory information ..........................38
Data privacy & Security
Electromagnetic compatibility
Contact information................................43
Accessories...............................................43
Warranty...................................................44
Content
Content

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Read all instructions for use before using NightBalance. Contact your physician if you
have any questions as to whether NightBalance is right for you. You may also contact
customer service if you have any questions about NightBalance, see page 43.
Introduction
Obstructive sleep apnea (OSA) is a potentially serious sleep disorder. It causes breathing
to repeatedly stop and start during sleep. OSA occurs when the throat muscles relax and
block the airway during sleep. When sleep apnea occurs mainly when people sleep on
their back (supine position), it is called positional obstructive sleep apnea.
The Sensor Device is worn in a Chest Strap on your body. It monitors you while you are
asleep and gently vibrates to remind you to not sleep on your back, while preserving
your natural sleep. Several clinical studies have demonstrated its ecacy and positive
impact on the quality of life.
Sleep well!
Introduction

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Intended Use
Intended use
NightBalance is intended as a therapy for mild to moderate Positional Obstructive Sleep
Apnea (POSA) in adults with a non-supine AHI<10. NightBalance is intended to be used
by patients during sleep in their home environment. The device is to be used only on the
instruction of a licensed physician.
Indications for use
The following are the Indications for Use for NightBalance.
• You are at least 18 years of age.
• You have a supine AHI which is at least twice as high as the non-supine AHI.
• You have been diagnosed with mild or moderate OSAS (5 ≤AHI ≤30).
• You have an AHI in non-supine position below 10.
• You sleep at between 10-90% in supine position.
• You should be able to switch sleeping positions independently.
Contraindications for use
• NightBalance should not be used by a patient using another medical aid that can be
aected by mild vibrational stimuli - on the chest.
• NightBalance is not recommended for the treatment of patients who are supposed to
sleep in a supine position because of a medical condition (e.g. because of shoulder of
back surgery or osteoarthritis).
• NightBalance cannot be used by patients who sleep in an upright position or require
more than 2 pillows during sleep.
Intended Use

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NOTE
• Do not exchange NightBalance with someone else. Use NightBalance only for your own therapy.
• Note all warnings and cautions throughout these Instructions for Use and on labels on the
components.
Warnings & Cautions
Warnings
• NightBalance is only to be used for the purpose as specied in the ‘Intended Use’.
• NEVER wear or use the Sensor Device or Docking Station in a wet environment such as the
shower or bath. This may result in injury and may damage the device.
• Always CONSULT your physician if you are using another electronic medical device (e.g. pace-
maker) prior to using NightBalance. NightBalance vibrations may interfere with the operation of
another electronic medical device.
• CHECK for any damage to the Sensor Device, Docking Station and Power Adapter when you
receive the device, and whenever you charge the Sensor Device. DO NOT use the device if any
part is damaged. Respironics cannot ensure continued safe use of a damaged device.
• DO NOT attempt to open or modify NightBalance components for any reason. The device does
not contain any parts that you can service. Opening or modifying NightBalance components can
aect your right on warranty and might result in short-circuiting and/or an electrical shock.
• DO NOT replace the lithium battery of the Sensor Device. Replacement of lithium batteries or fuel
cells by inadequately trained personnel could result in a hazard.
• DO NOT keep NightBalance near young children and pets. Strangulation by long parts and swal-
lowing small parts are hazards.
Warnings & Cautions

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• DO NOT place the Chest Strap on damaged skin.
• DO NOT touch the contact pins on the Docking Station. This may result in an electrical shock and
may damage the device.
Cautions
• USE, and CHARGE NightBalance in temperatures between 10ºC and 40ºC (50ºF and 104ºF).
STORE NightBalance in temperatures between -20ºC and 45ºC (-4ºF and 113ºF).
• CHECK that the wall outlets you use to plug in the Power Adapter are providing the right voltage
(100-240V). You may damage the device if these voltages do not match.
• REPLACE NightBalance components after their service life (equivalent to in-use life on page 33
and 34) has passed. After the service life has passed, performance of sensors and electronics can
degrade.
• DO NOT attach other accessories or components than specied in these instructions to
NightBalance components. This may damage the device. Respironics cannot ensure continued
safe use of a damaged device.
• Only use the Power Adapter provided by NightBalance (100-240 V, 50-60 Hz) included in your
NightBalance pack. Use of other parts and/ or materials may damage the device. Respironics
cannot ensure continued safe use of a damaged device.
NOTE
Any serious incident that has occurred in relation to this device should be reported to Philips and
the competent authority of the Member State in which the user and/or patient is established.
NOTE
CHARGE the Sensor Device at least once every other day for optimal performance. There is no
harm in charging the Sensor Device every morning after use.
Warnings & Cautions

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Getting Started
Step 1: Check packaging contents
Upon receiving, make sure your packaging
contains:
Travel case
Instructions for Use
Chest Strap
Docking Station
Sensor Device
Power Adapter
WARNING
Upon receipt, if any of these items
are missing or damaged, contact your
distributor or customer service (see
page 43).
NOTE
The Power Adapter as visualized here
is an example only, yours might look
dierent.
Getting Started

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Sensor Device
Navigation buttons ON/OFF switch
LED light Display
Docking Station
Contact pins
Power port
NightBalance Components
NightBalance Components

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Power Adapter
Cable length: 1.5m (4’11”)
NOTE
The Power Adapter and wall outlet as visualized in the instructions are an example
only, they might look dierent.
Chest Strap
Buckle
Device pocket
NightBalance Components

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1. Download the Philips NightBalance
app on your smartphone from the Play
Store (for Android) or App Store (for
iPhone).
2. Open the Philips NightBalance
app. Select and conrm your region
(Country of residence).
NOTE
It is important to select your region of
residence so that the data can upload
to the correct region.
App images displayed here may vary
per version
3. Next, choose “Create new account”
and follow the instructions in the app.
Complete the registration process by
activating your account with the link in
your email.
Step 2: Install the App and Register
07:42
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07:42
13
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Create new account
Install the App and Register

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1. Login to the Philips NightBalance app
after activating your account. Follow
the instructions in the app to complete
your account.
2. Once indicated by the app, activate the
pairing mode by switching the Sensor
Device ON while pressing one of the
navigation buttons.
NOTE
Pairing ensures a secure connection
between your Sensor Device and your
smartphone and is to be performed
once. Therefore, only activate the
pairing mode of the Sensor Device on
rst use. For daily synchronization of
your therapy data, see page 27.
Step 3: Login and Pair your Sensor Device
Press down
Switch ON
2
1
Login and Pair your Sensor Device

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1. Insert the Power Adapter cable
completely into the back of the Docking
Station.
CAUTION
Only use the Power Adapter
provided with NightBalance (100-
240 V, 50-60 Hz).
CAUTION
Do NOT position the Docking Station
in such a way that it is dicult to
reach the power adapter.
2. Connect the Power Adapter into a
standard wall outlet.
Step 4: Setting up the Docking Station
1 2
Setting up the Docking Station

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3. Place the Sensor Device on the Docking
Station with the buttons on top and
display towards you.
Once on the Docking Station, the
Sensor Device charges automatically.
4. The display and LED of the Sensor
Device should become active. This
indicates the correct placement.
The setup process is now complete. Please
ensure your device is charged before using.
3 4
Setting up the Docking Station

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1. Wrap the Chest Strap around your
chest.
NOTE
• If the Chest Strap is too loose, the
sensor may stop collecting data and
providing appropriate therapy.
• In case the Chest Strap is too loose,
adjust the tightness (see next page).
CAUTION
DO NOT place the Chest Strap on
damaged skin.
2. Hook the buckle through the opening.
Getting to sleep
Step 1: Placing the Chest Strap
1 2
Placing the Chest Strap

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3. Adjust the tightness if needed by
adjusting the hook and loop position
of the Chest Strap. The Chest Strap
should t tight enough to stay in place
and feel comfortable to wear at the
same time.
4. Make sure the Device pocket is placed
in the middle of your chest as shown in
the image below.
3 4
Placing the Chest Strap

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1. Power on the Sensor Device by sliding
the ON/OFF switch to the ON position.
NOTE
Ensure the Sensor Device is charged
before using it during sleep.
2. Conrm that the white LED light on
the Sensor Device starts blinking. This
indicates it is switched on.
If the white LED light does not start
blinking, it may mean the battery is
depleted. See the troubleshooting
section.
Step 2: Placing the Sensor Device
OFF
1 2
Switch ON
Placing the Sensor Device

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3. Place the Sensor Device into the Device
pocket of the Chest Strap with the
Sensor Device buttons on top and the
display facing away from your body.
4. Close the zipper of the pocket of the
Chest Strap.
5. Check that the Device pocket is placed
on the middle of your chest.
Now you can go to sleep.
3
Placing the Sensor Device

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If this is your rst time using your
NightBalance device, you will start your
therapy with a 10 day adaptation program.
The adaptation program of NightBalance is
designed to slowly train you to respond to
the Sensor Device’s vibrations during sleep.
You need to use NightBalance for nine nights
before the device will provide full position
therapy.
1) Analysis phase
No vibrations are given during the rst two
nights of the therapy. NightBalance gathers
baseline data on your sleep patterns during
night 1 and 2. This data is used to tailor the
therapy to your individual sleeping behavior
later on.
2) Build-up phase
NightBalance starts to deliver vibrations
during night 3 to 9. The vibrations will build
up gradually when laying on your back,
allowing you to get used to therapy.
NOTE
The recommendation is to use
NightBalance every night, or as agreed
with your physician for best therapy
results.
Understanding the Adaptation Period
Understanding the Adaptation Period
Night
Vibrations
1) Analysis phase 2) Build-up phase
1 2 3 4 5 6 7 8 9

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1. Now that you understand how the
adaptation program works, you can fall
asleep in any position you desire.
NOTE
NightBalance allows you to fall asleep
in any position. 15 minutes after
switching the Sensor Device ON, the
therapy starts.
2. Once the Sensor Device vibrates, turn
to your side.
NOTE
• NightBalance regulates the intensity
of the vibrations based on your
sleeping behavior.
• The Sensor Device will not vibrate
during the rst two nights of the
adaptation program. See page 18.
Step 3: Sleeping with the Sensor Device
2
Sleeping with the Sensor Device

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Tip: Activating Pause Mode
In pause mode, the Sensor Device
will not give vibrations for 5 minutes.
Pause mode can be activated if you
get up during the night , or if you
turn the Device pocket of the Chest
Strap vertical for a second .
1 2
1x1x
ActivatingActivating
pause modepause mode
ActivatingActivating
pause modepause mode
Sleeping with the Sensor Device