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Philips NightBalance, Инструкция по эксплуатации

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39

Electromagnetic compatibility 

(

EMC

)

NightBalance is intended for use in the electromagnetic environment specified in the 
coming sections. The customer or the user of NightBalance should assure that it is used in 
such an environment. NightBalance needs special precautions regarding EMC according to 
the EMC information provided in this chapter. 

NOTE  

Representative to the function of the device EMC testing has been performed 

per 60601-1-2 and 60601-1-11.

 

WARNING

Portable and mobile RF communications equipment including antennas can affect 
NightBalance’s operations. 

DO NOT

 use portable and mobile RF communications 

equipment closer than 30 cm (12 inches) to any part of NightBalance, including 
cables specified by the manufacturer. Other equipment, even if that other equipment 
complies with CISPR emission requirements, may interfere with NightBalance. 

WARNING

The use of accessories, transducers and cables other than those specified, with the 
exception of transducers and cables sold by NightBalance as replacement parts for 
internal components, may result in increased emissions or decreased immunity of 
NightBalance.

Regulatory Information

Содержание NightBalance

Страница 1: ...Instructions for use Sleep position therapy NightBalance ...

Страница 2: ...m 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 specifications 34 Sym...

Страница 3: ...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 ...

Страница 4: ... 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 affected by mild vibrational stimuli on the chest NightBalance is not ...

Страница 5: ...lectronic 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 ...

Страница 6: ...ance of sensors and electronics can degrade DO NOT attach other accessories or components than specified 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 t...

Страница 7: ...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 different Getting Started ...

Страница 8: ...8 Sensor Device Navigation buttons ON OFF switch LED light Display Docking Station Contact pins Power port NightBalance Components NightBalance Components ...

Страница 9: ...r 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 different Chest Strap Buckle Device pocket NightBalance Components ...

Страница 10: ...t 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 13 86 1 07 42 13 Create new account Install the Ap...

Страница 11: ...nsor 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 first use For daily synchronization of your therapy data see page 27 Step 3 Login and Pair your Sensor Device Pressdown SwitchON 2 1 Login and Pair your Sensor...

Страница 12: ...e 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 difficult 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 ...

Страница 13: ...ds 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 ...

Страница 14: ...y 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 ...

Страница 15: ...d loop position of the Chest Strap The Chest Strap should fit 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 ...

Страница 16: ...efore using it during sleep 2 Confirm 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 ...

Страница 17: ...est 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 ...

Страница 18: ...s 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 Night...

Страница 19: ...tes 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 first two nights of the adaptation program See page 18 Step 3 Sleeping with the Sensor Device 2 Sleeping with the Sensor Device ...

Страница 20: ...tions 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 1x 1x Activating Activating pause mode pause mode Activating Activating pause mode pause mode Sleeping with the Sensor Device ...

Страница 21: ...Device out of the Chest Strap 3 View last night s sleep data on the Sensor Device s display if desired NOTE Sleep data from short naps 2 hours is excluded from any data calculations and visualizations Step 4 Removing the Sensor Device 1 2 Removing the Sensor Device ...

Страница 22: ...OFF position 5 Confirm that the white LED light on the Sensor Device stops blinking This indicates it is switched OFF NOTE It might take some time before the LED is switched OFF in case the Sensor Device is transmitting data ON 3 5 Switch OFF Removing the Sensor Device 4 ...

Страница 23: ...ove it from the Docking Station to disconnect the power WARNING DO NOT touch the contact pins on the Docking Station This may result in an electrical shock and may damage the device NOTE To disconnect power from the Docking Station unplug the power adapter cable from the back of the Docking Station Step 5 Charging the Sensor Device 1 Charging the Sensor Device ...

Страница 24: ...he display shows a battery icon and the white LED blinks After some time the icon will disappear and the white LED blinking will stop 2 Upon correct placement onto the Docking Station the Sensor Device display becomes active and the LED starts to blink i 2 ...

Страница 25: ...k last session Total time you used the Sensor Device the session before Your daily response to the vibrations of the Sensor Device NOTE Press the navigation buttons on top of the Sensor Device to switch from one screen to the next 3 Charging the Sensor Device ...

Страница 26: ...e will take place automatically if the Philips NightBalance app is opened on your phone and you turn the Sensor Device ON or OFF during daily use If the app is not opened synchronization will not occur automatically For synchronization progress and information see the Philips NightBalance app NOTE The Sensor Device is designed to be used with Bluetooth version 4 2 or 5 0 Compatibility with other B...

Страница 27: ...ensor Device and smartphone are within reach max 5m 16ft of each other NOTE The Philips NightBalance app indicates when the last successful data transfer took place Go to Profile and click Sensor Device 2 Turn the Sensor Device ON wait a few seconds and turn the Sensor Device OFF again Synchronizing should start automatically Step 1 Manually synchronizing the Sensor Device with your smartphone 2 0...

Страница 28: ...st 7 days NOTE Sleep data from short naps 2 hours is excluded from any data calculations and visualizations in the app 1 After synchronizing your therapy data with your smartphone you can view your therapy data in the Night view and Week view tabs Tip Discuss therapy progress with your physician if desired Your physician can review your data if you grant them access Step 2 View therapy data in the...

Страница 29: ...ry do not dry in a clothes dryer Ensure strap is completely dry before use CAUTION DO NOT use chlorine bleach or fabric softener DO NOT place the Sensor Device in a wet Chest Strap DO NOT dry the strap in a dryer DO NOT iron the Chest Strap It is the user s responsibility to keep NightBalance equipment dust free Turn the Sensor Device off and unplug the power adapter from the Docking Station and w...

Страница 30: ... visit www philips com recycling This device contains a lithium ion battery that cannot be recycled Please contact customer service at 1 724 387 4000 or send an e mail to service respironics com for safe disposal instructions of this part Please note that the Sensor Device can contain data that has not been transferred by synchronizing with your smartphone This data is encrypted Maintenance The Se...

Страница 31: ...e app is not ready to pair Follow the instructions in the app Initiate pairing on the Sensor Device only if the app indicates to do so See page 11 The smartphone and Sensor Device are not within reach Keep the smartphone and Sensor Device within reach 1m of eachother The Sensor Device is not turning ON or shows the following screen The battery is empty Place the Sensor Device on the powered Dockin...

Страница 32: ...evice has not yet synchronized with the Philips NightBalance app Synchronize the Sensor Device with your smartphone Follow the instructions on page 27 The app does not show data from the Analysis Phase day 1 2 of therapy Sleep for a few days with the Sensor Device synchronize the sleep data see pages 27 28 and come back to the app Short naps 2 hours are excluded from any data calculations and visu...

Страница 33: ...t to do My sleep data is not visible in the Philips NightBalance app You used the device prior to pairing it with the app Only data recorded after pairing will appear Ensure that you have paired with your smartphone Troubleshooting ...

Страница 34: ...istics Bluetooth version 4 2 5 0 Band support 2 4GHz Effective radiated power 6 dBm Bluetooth encryption AES CCM encrypted channel Docking Station Dimensions 10 2 x 8 3 x 3 2 cm 4 0 x 3 3 x 1 3 inch Weight 85 gr 3 0 oz Material ABS PC In use life 3 years Power Adapter Input 100 240V AC 50 60 Hz 0 27 0 15A Output 5 0V DC 2 0A 10W MAX Travel Case Accessory of NightBalance Dimensions 20 0 x 17 0 x 6 ...

Страница 35: ...ets the requirements of IEC EN 60601 1 IEC EN 60601 1 2 IEC EN 60601 1 11 The Sensor Device is IP22 rated for normal use when placed in the Chest Strap This means that the device is protected against solid foreign objects of 12 5 mm diameter and greater and against vertically falling water drops when enclosure tilted up to 15 The Docking Station is IP21 rated for normal use This means that the dev...

Страница 36: ...cates that relevant information for use of the product is available in electronic form Do not bleach Authorized rep in the European Community SN Serial Number Do not iron Country of Manufacture Indicates the country of manufacture of the product Note When applied to the label CC is replaced by the country code Do not dry clean Keep dry Type BF medical equipment Do not tumble dry Batch code Separat...

Страница 37: ...pressure between 700 and 1060 hPa Operating conditions NightBalance components can be safely used at temperatures between 10o C 50o F and 40o C 104o F a relative humidity between 15 and 90 and an atmospheric pressure between 700 and 1060 hPa 1060hPa 700hPa 90 20o C 10o C 45o C 40o C NOTE The device is ready for use when within the operating conditions Environmental Conditions 10 90 15 1060hPa 700h...

Страница 38: ...cess to your recorded data only you can access and with your permission your physician Respironics seeks to use reasonable organizational technical and administrative measures to protect Personal Data within our organization Unfortunately no data transmission or storage system can be guaranteed to be 100 secure The best technical security can be defeated particularly if you do not protect your use...

Страница 39: ...able and mobile RF communications equipment including antennas can affect NightBalance s operations DO NOT use portable and mobile RF communications equipment closer than 30 cm 12 inches to any part of NightBalance including cables specified by the manufacturer Other equipment even if that other equipment complies with CISPR emission requirements may interfere with NightBalance WARNING The use of ...

Страница 40: ...stablishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC61000 3 3 Complies Regulatory Information WARNING NightBalance should not be used adjacent to or stacked with other equipment If adjacent or s...

Страница 41: ...burst IEC 61000 4 4 2 kV for power supply lines 2 kV for power supply lines Surge IEC 61000 4 5 0 5 kV 1 kV line s to line s 0 5 kV 1 kV line s to line s RF Common mode Conducted usceptibility IEC 61000 4 6 3 Vrms 6V in amateur radio bands 150 kHz to 80 MHz 3 Vrms 6V in amateur radio bands Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Voltage dips IEC 61000 4 11 0 UT 1 cycle ...

Страница 42: ...4 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 1720 1845 1970 1700 1900 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 2450 2400 2570 Bluetooth WLAN 80211 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28 5240 5500 5785 5100 5800 WLAN 80...

Страница 43: ...isit https www philips com c cs support country selector html NOTE Store NightBalance components inside the Travel Case when sending it for repairs or returns Accessories The following accessories are available for use with this device Contact Philips or your healthcare provider for additional information Part Number Description RPL2CHST01 NightBalance Chest Strap RPL2TRCA01 NightBalance Travel Ca...

Страница 44: ...by purchaser for the end user What this Warranty does not cover This warranty does not apply to any software included with the Product as the software warranty is included in the software license This warranty does not cover damage or injury whether to the Products personal property or persons caused by accident misuse abuse Acts of God water ingress repair or alteration by anyone other than Phili...

Страница 45: ...LIPS RESPIRONICS SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE IN NO EVENT WILL PHILIPS RESPIRONICS MAXIMUM LIABILITY UNDER THESE WARRANTIES EXCEED THE ORIGINAL PURCHASE PRICE OR WILL PHILIPS RESPIRONICS BE LIABLE FOR ANY ECONOMIC LOSS LOSS OF PROFITS OVERHEAD OR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES Repair replace...

Страница 46: ...aler and collecting the product from the authorised Philips Respironics dealer after repair or replacement at its own cost Philips Respironics is responsible only for the freight cost of transporting the product between the authorised Philips Respironics dealer and Philips Respironics Philips Respironics reserves the right to charge an evaluation and postage fee for any returned Product where no p...

Страница 47: ...r refund for a major failure and for compensation for any other reasonably foreseeable loss or damage You are also entitled to have the good repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure 9 The following statement is provided to a Buyer who is a consumer under the Consumer Guarantees Act 1993 New Zealand Our goods come with gua...

Страница 48: ...48 Koninklijke Philips N V 2021 All rights reserved 1146045 R02 DLK 01 21 2021 ...

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