Philips NightBalance Instructions For Use Manual

NightBalance
Sleep position therapy
Instructions for use
EN
English (US)
Content
Content
Introduction ...............................................3
Intended use ...............................................4
Intended use Indications for use Contraindications for use
Warnings and precautions........................5
NightBalance components .......................8
Getting started ........................................ 10
Check p ack contents Inst all the a pp and regist er Logi n and pai r your Sensor Dev ice Sett ing up t he Dock ing Station Understand the adaptation program
How to use NightBalance daily .............. 16
Placing the Chest Strap Plac ing the S ensor D evice Sleep ing with the Se nsor Device Remov ing the Sensor Device Charging th e Senso r Devi ce
View therapy data ...................................26
Background information on Bluetooth use Manually synchronizing t he Sens or Dev ice wit h your smartphone
2
View therapy d ata in the app an d Port al
Care and maintenance ............................30
Charging th e Senso r Devi ce Cleaning NightBalance products Traveling with NightBalance Disposal Maintenance
Troubleshooting .......................................32
Technical specications..........................34
Symbols .....................................................36
Environmental conditions ......................37
Regulatory information ..........................38
Data priva cy & Securit y Electromagnet ic compatibility
Warranty ...................................................43
Contact information ................................43
Read all instructions for use before using NightBalance. Contact your physician if you
Introduction
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 ser ious sleep disorder. It causes breathing to repeatedly stop and start dur ing 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 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!
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Intended use
Intended use
Intended use
NightBalance is indicated for prescript ion use for the treatment of adult patients with posit ional obstructive sleep apnea with a non-supine apnea-hypopnea index < 20. It records position and movement, so that positional changes in sleep quality can be assessed.
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.
⚠ 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.
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Warnings & Precautions
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 injur y 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, Dock ing 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 dev ice.
⚠ 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 r ight on warrant y and might result in short-circuiting and/or an electr ical 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 dev ice. Continued safe use cannot be ensured
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of a damaged device.
Warnings & Precautions
⚠ Only use accessor ies, detachable par ts 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. Respironics 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 Dock ing Station. This may result in an
electrical shock and may damage the device.
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Precautions
Warnings & 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 af ter use.
⚠ USE, and CHARGE NightBalance in temperatures between 50ºF and 104ºF (10ºC
and 40ºC). STORE NightBalance in temperatures between -4ºF and 113ºF (-20ºC and 45ºC).
⚠ 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 serv ice life has passed, performance of sensors and electronics can degrade.
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NightBalance components
NightBalance components
Sensor Device
1. Navigation buttons
2. LED light
3. ON/OFF switch
4. Display
1
2
3
Docking Station
5. Contact pins
6. Power port
5
4
Back
8
Front
Front
6
Back
Chest Strap
NightBalance components
7. Buckle
8. Device pocket
7
8
Power Adapter
Cable length: 4’ 11” (1.5m)
L The Power Adapter and wall outlet as visualized in the instructions are an example
only, they might look dierent.
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Getting started
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
L If any of these items are missing upon
receiv ing, contact your distributor or customer serv ice (see page 43).
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3
4
5
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Step 2: Install the app and register
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86
07:42
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Getting started
L Don’t have a smartphone? You can
also create an account in the Por tal to register your Sensor Device. Go to the online Portal at us.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 (United States).
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.
Create new account
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Step 3: Login and pair your Sensor Device
Getting started
1. Login to the Philips NightBalance app after act ivat ing your account. Follow the instructions in the app to complete your account.
2. Once indicated by the app, activate the pair ing mode by switching the Sensor Device ON while pressing one of the navigation buttons.
L Pair ing ensures a secure connect ion
between your Sensor Device and your smartphone and is to be per formed once.
⚠ Only activate the pair ing mode of the
Sensor Device on rst use. For daily synchronization of your therapy data, see page 26.
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2
i
Step 4: Setting up the Docking Station
Getting started
1. Insert the Power Adapter cable into the back of the Docking Stat ion.
⚠ Only use the Power Adapter prov ided
by NightBalance (100-240 V, 50-60 Hz) included in your NightBalance pack.
⚠ DO NOT position the Docking Station
on such way that it is dicult to operate the Power Adapter.
2. Connect the Power Adapter into a standard wall outlet (100-240V AC).
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3. Place the Sensor Device on the
Getting started
Docking Station with the buttons on top and display towards you.
4. The display and LED of the Sensor Device should become act ive. This indicates the right placement.
L On the Docking Station, the Sensor
Device charges itself automatically.
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NightBalance is now ready for use.
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