Philips NightBalance User manual

Instructions for use
English (EU)
Sleep position therapy
NightBalance
EN

2
Introduction ............................................... 3
Intended use...............................................4
Intended use
Indications for use
Contraindications for use
Warnings and precautions........................5
NightBalance components .......................8
Getting started ........................................ 10
Check pack contents
Install the app and register
Login and pair your Sensor Device
Setting up the Docking Station
Understand the adaptation program
How to use NightBalance daily .............. 16
Placing the Chest Strap
Placing the Sensor Device
Sleeping with the Sensor Device
Removing the Sensor Device
Charging the Sensor Device
View therapy data ...................................26
Manually synchronizing the Sensor
Device with your smartphone
View therapy data in the app and Portal
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
Warranty...................................................43
Contact information................................43
Content
Content

3
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. A noticeable sign of OSA is snoring. When sleep apnea
occurs mainly when people sleep on their back (supine position), it is called positional
obstructive sleep apnea (POSA).
The Sensor Device 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

4
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 without the need for instructions
from a 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
Intended use

5
more than 2 pillows during sleep.
⚠Always inform your physician if you are using another electronic medical device
(e.g. pacemaker) prior to using NightBalance.
⚠Do not exchange NightBalance with someone else. Use NightBalance only for your
own therapy.
Warnings & Precautions
Warnings
⚠NightBalance is only to be used for the purpose as specied in the ‘Intended Use’.
Note all warnings and cautions throughout this user guide and on labels on the
components.
⚠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.
⚠NightBalance vibrations may interfere with the operation of another electronic
medical device. Always CONSULT a physician when using NightBalance with
another 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. NightBalance cannot ensure continued safe
use of a damaged device.
Warnings & Precautions

6
⚠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 attach other pieces than specied in these instructions to NightBalance
components. This may damage the device. Continued safe use cannot be ensured
of a damaged device.
⚠Only use accessories, detachable parts and materials described in the Instructions
for Use. 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. NightBalance cannot ensure continued safe use of a damaged
device.
⚠DO NOT keep NightBalance near young children and pets. Strangulation by long
parts and swallowing small parts are hazards.
⚠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.
Warnings & Precautions

7
Precautions
⚠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.
⚠USE, and CHARGE NightBalance in temperatures between -5ºC and 40ºC (23ºF and
104ºF). STORE NightBalance in temperatures between -25ºC and 70ºC (-13ºF and
158ºF).
⚠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 34 and 35) has passed. After the service life has passed, performance of
sensors and electronics can degrade.
Warnings & Precautions

8
Docking Station
5. Contact pins
6. Power port
Sensor Device
1. Navigation buttons
2. LED light
3. ON/OFF switch
4. Display
0344
3.1.0/1
SN
FXXSDYYYYYYY
L2SEDE01
REF
NightBalance B.V.
Benoordenhoutseweg 46-13,
2596BC, Den Haag
The Netherlands
(01) 08719689344214
(11) YYMMDD
(10) XXXXXXXX
(21) LXXSDYYYYYYY
FCC ID:
XPYNINAB1
NightBalance
Sensor Device
NightBalance components
Front
Back
Front
Back
1
2
3
5
6
4
NightBalance components

9
Chest Strap
7. Buckle
8. Device pocket
Power Adapter
Cable length: 1.5m (4’11”)
LThe Power Adapter and wall outlet as visualized in the instructions are an example
only, they might look dierent.
7
8
NightBalance components

10
Getting started
Step 1: Check packaging contents
Upon receiving, make sure your packaging
contains:
1. Travel case
2. Instructions for Use
3. Chest Strap
4. Docking Station
5. Sensor Device
6. Power Adapter
LIf any of these items are missing upon
receiving, contact your distributor or
customer service (see page 43).
1
2
3
4
5
6
Getting started

11
LDon’t have a smartphone? You can
also create an account in the Portal to
register your Sensor Device.
Go to the online Portal at
eu.mynightbalance.com and follow the
instructions on the Portal.
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
(Europe).
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
13
86
3
07:42
13
86
Create new account
Getting started

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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.
LPairing ensures a secure connection
between your Sensor Device and your
smartphone and is to be performed
once.
⚠Only activate the pairing mode of the
Sensor Device on rst use. For daily
synchronization of your therapy data,
see page 26.
Step 3: Login and pair your Sensor Device
i
2
Getting started

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1. Insert the Power Adapter cable into
the back of the Docking Station.
2. Connect the Power Adapter into a
standard wall outlet (100-240V AC).
Step 4: Setting up the Docking Station
1 2
Getting started

14
3. Place the Sensor Device on the
Docking Station with the buttons on
top and display towards you.
LOn the Docking Station, the Sensor
Device charges itself automatically.
4. The display and LED of the Sensor
Device should become active. This
indicates the right placement.
NightBalance is now ready for use.
3 4
Getting started

15
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.
It is recommended to use NightBalance
every night, or as agreed with your
physician for best therapy results.
Step 5: Understand the Adaptation Period
Getting started
Night
Vibrations
1) Analysis phase 2) Build-up phase
1 2 3 4 5 6 7 8 9

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1. Wrap the Chest Strap around your
chest
LIn case the Chest Strap is too short,
adjust the tightness (see next page).
2. Hook the buckle through the opening
How to use NightBalance daily
Step 1: Placing the Chest Strap
1 2
How to use NightBalance daily

17
3. Adjust the tightness if needed by
adjusting the velcro 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.
3 4
How to use NightBalance daily

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1. Power on the Sensor Device by sliding
the ON/OFF switch to the ON position.
2. Conrm that the white LED light on
the Sensor Device starts blinking. This
indicates it is switched on.
Step 2: Placing the Sensor Device
1 2
OFF
ON
How to use NightBalance daily

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3. Place the Sensor Device inside the
Device pocket of the Chest Strap.
Check that the Device pocket is placed
on the middle of your chest.
4. Make sure the Sensor Device buttons
are on the top and the display is
facing away from your body.
Now you can go to sleep.
Display is not facing
away from your body
Buttons are not on
top
4
How to use NightBalance daily

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1. Fall asleep in any position you desire.
LNightBalance 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.
LNightBalance regulates the intensity of
the vibrations based on your sleeping
behavior.
Step 3: Sleeping with the Sensor Device
2
How to use NightBalance daily