Philips NightBalance Bedienungsanleitung

Instructions for use

English (EU)

Sleep position therapy

NightBalance

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

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

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

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

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

⚠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

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

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

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

NightBalance components

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.

NightBalance components

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).

Getting started

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