SOMNICS iNAP One Instructions For Use Manual
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SOMNICS iNAP One Instructions For Use Manual

Sleep therapy system
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®
iNAP
One
Sleep Therapy System
INSTRUCTIONS FOR USE
®
This user guide contains instructions for using the iNAP
One Sleep Therapy System.
Read all Instructions for Use before using the system.

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Summary of Contents for SOMNICS iNAP One

  • Page 1 ® iNAP Sleep Therapy System INSTRUCTIONS FOR USE ® This user guide contains instructions for using the iNAP One Sleep Therapy System. Read all Instructions for Use before using the system.

  • Page 2: Table Of Contents

    1.4.1 Console 1.4.2 Saliva Container 1.4.3 Oral Interface 1.4.4 Tubing Set iNAP One Sleep Therapy System Console Icons BEFORE USING THE INAP ONE SLEEP THERAPY SYSTEM Important Safety Notes 2.1.1 Warnings (Possible Health Risks) 2.1.2 Warnings 2.1.3 Cautions 2.1.4 Precautions...
  • Page 3 Muffler OPERATING INSTRUCTIONS Starting the Treatment of the iNAP One Sleep Therapy System Getting Used to the Treatment of the iNAP One Sleep Therapy System Stop the Treatment of the iNAP One Sleep Therapy System Bluetooth and App Setup Procedures...

  • Page 4: Introduction

    28 days have demonstrated the effectiveness of the iNAP System. Indications for Use The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.

  • Page 5: Contraindications

    Contraindications iNAP One Sleep Therapy System Components The iNAP One Sleep Therapy System shall not be used iNAP One Sleep Therapy System is a portable system designed by anyone who: to deliver a pressure gradient to the oral cavity to prevent sleep- •...

  • Page 6: Console

    1.4.1 Console Bottom of console Ejection Button Ejection Button USB Port Cover USB port Power Button Air outlet Caution Blocking the air outlet of the device while in operation might lead to insufficient negative pressure.

  • Page 7: Saliva Container

    1.4.2 Saliva Container 1.4.3 Oral Interface Lip shield Flexible tube with vacuum port Container Cover Tongue shield 1.4.4 Tubing Set Oral interface connector Container Body Device connector...

  • Page 8: Inap One Sleep Therapy System Console Icons

    One Sleep Therapy System Console Icons Icon Light Status Status Indicator Battery power status Flash Low battery Enough battery Flash Charging Fully charged (with charging cable plugged in) Vacuum status Flash Pump to target vacuum Target vacuum achieved...
  • Page 9 Container Flash Not installed, or Improper installation Properly installed Container full...

  • Page 10: Before Using The Inap One Sleep Therapy System

    BEFORE USING THE INAP ONE SLEEP THERAPY SYSTEM Important Safety Notes 2.1.1 Warning (Possible health risks) • Use of the iNAP One Sleep Therapy System may cause: - Drying of the nose, mouth, or throat - Obstruction of oral breathing...
  • Page 11 • The long term effectiveness and safety of the iNAP One Sleep Therapy System has not been determined. Assessment of effectiveness and safety of long term use of the iNAP One Sleep Therapy System should be conducted by your physician to...

  • Page 12: Warnings

    • Make sure the power adapter and plug are in good condition and the equipment is not damaged. • Beware of electric shock. Keep the iNAP One Sleep Therapy System away from all sources of liquids and DO NOT immerse in...
  • Page 13 • DO NOT operate the iNAP One Sleep Therapy System in an area which may cause overheating. • DO NOT cover the iNAP One Sleep Therapy System with any object or material which would cause them to overheat. • DO NOT leave the system on prolonged charge when not in use.

  • Page 14: Cautions

    • Patients who have obstructed nasal passages, as evidenced by the inability to breathe through the nose with the mouth closed, should not use iNAP One Sleep Therapy System. • iNAP One Sleep Therapy System effectiveness has not been assessed in patients with nighttime mouth breathing.

  • Page 15: Precautions

    • Check the system regularly when in use, for pump operation, battery status, interface integrity and type/amount of exudates. • Keep the iNAP One Sleep Therapy System away from all sources of liquids and DO NOT immerse in water or other liquids.

  • Page 16: Preparing For Use Inap One Sleep Therapy System

    PREPARING FOR USE INAP ONE SLEEP THERAPY SYSTEM Check the Battery Status Press the power button to check the battery status. Battery status Status Indicator Suggestion Enough battery Flash Low battery Please charge! Charge the System Open the USB port cover and connect the micro USB plug of the power adapter into the port of the console, then plug the power adapter into a standard wall outlet (100-240 Vac).

  • Page 17: Installation Of Drypad

    Installation of DryPad 1. Disconnect the console and the container. 2. Open the Container Press the ejection button, then pull the saliva container upward to separate it from console.
  • Page 18 3. Squeeze the sides of DryPad then insert the center tube of the container cover 4. Put the cover on the body of the into the opened iNAP DryPad. container and make sure there is no gap between the container cover and the container body.
  • Page 19 5. Connect the console and container make sure that you hear the click sound Caution Wrong container cover position “Click”sound Note If the container icon is Caution Wrong DryPad position flashing, please reconfirm the connection condition of the Filter container and the console. Please refer to section1.5 Caution DO NOT contact the filter...

  • Page 20: Connect The Oral Interface

    Connect the Oral Interface 1. Connect the oral interface 2. Connect the tubing to the 3. Ready to use. with the tubing. console.

  • Page 21: Wearing The Oral Interface

    Wearing the Oral Interface If you find any possible defect that you think will impact the performance of the system, DO NOT use the oral interface. Contact Somnics Customer Service. Note Wash the oral interface with warm water before using it the first time.
  • Page 22 Caution DO NOT put the tongue shield on the tongue inside your mouth. Close your mouth and get ready to start the treatment of the iNAP One Sleep Therapy System. Note Caution DO NOT put lip shield outside the lips.

  • Page 23: Inap Muffler

    Muffler It is an accessory dedicated to use with iNAP One Sleep Therapy System. Please read this instruction thoroughly before use. Note The sponge inside is part of the muffler. Do not remove the sponge from the muffler. 1. Hold the muffler tight and put 2.

  • Page 24: Operating Instructions

    OPERATING INSTRUCTIONS Starting the Treatment of the iNAP One Sleep Therapy System • Press and hold the power button for over 2 seconds to turn on the console. The console runs a system check and all icons flash once. After system check battery icon...
  • Page 25 One Sleep Therapy System. If you have difficulty maintaining the target vacuum pressure during the treatment, please refer to the troubleshooting guide for potential causes and their solutions. If the problem can not be resolved, contact iNAP One Sleep Therapy System Customer Service.

  • Page 26: Getting Used To The Treatment Of The Inap One Sleep Therapy System

    Getting Used to the Treatment of the iNAP One Sleep Therapy System Anything new, including the iNAP One Sleep Therapy System, takes time to get used to. You may not feel comfortable with the oral interface in your mouth when you first start using the iNAP One Sleep Therapy System.

  • Page 27: Stop The Treatment Of The Inap One Sleep Therapy System

    Stop the Treatment of the iNAP One Sleep Therapy System Take out the oral interface from mouth, then press the power button on the console for at least 2 seconds to turn the device OFF. The oral interface and the container should be cleaned after each use.

  • Page 28: Bluetooth And App Setup Procedures

    Bluetooth and App Setup Procedures Somnics provides a mobile app for you to track your daily progress. You may download the app via Google Play (Android) or App Store (iOS). 1. Click iNAP App icon on the mobile device. 2. Turn on iNAP One Sleep Therapy System.

  • Page 29: Cleaning, Maintenance And Storage

    CLEANING, MAINTENANCE AND STORAGE Clean the oral interface and the container after each use. Cleaning 5.1.1 Disconnect the Tubing Set and the Container 5.1.2 Discard the DryPad Remove the used DryPad from the container and discard it. Remove the oral interface from your mouth and disconnect the device connector from the container cover.

  • Page 30: Clean The Container, The Oral Interface And The Tubing

    5.1.3 Clean the Container, the Oral interface and the Tubing • Oral Interface Cleaning • iNAP Tubing Set Cleaning • Container Cleaning Pull Let warm water flow through the tubing set for about 30 seconds. • Disconnect the oral interface Rinse and gently rub the oral from the connector.
  • Page 31 Note If the container body is not wetted by saliva, you can use a soft brush or a sponge to gently scrub the surface of the container. Note Rinse the container with warm water. DO NOT touch or brush the filter inside the Caution DO NOT wash, touch or brush the container body.

  • Page 32: Clean The Console

    The console does not require cleaning after each use, and it can be wiped when necessary with a damp towel. Note Keep the iNAP One Sleep Therapy System away from all sources of liquids and DO NOT immerse in water or other liquids. Weekly Cleaning 1 Clean the oral interface, tubing set, and container daily.
  • Page 33 Turn on the iNAP console 6 Lay down the container and turn on the iNAP console. At this time, the battery power light will be solid green , and the vacuum status light will be flash blue . The negative pressure will draw the water through the tubing and into saliva container.

  • Page 34: Maintenance

    When traveling, be aware of the voltage differences in different regions. The iNAP One Sleep Therapy System is ONLY compatible with electrical outlets from 100-240Vac (50~60Hz). Disposal At the end of the product life cycle, dispose the iNAP One Sleep Therapy System according to the local regulation of disposal of bio-contaminated electronic devices.

  • Page 35: Troubleshooting

    TROUBLESHOOTING Problem Possible Cause Light Status Solution Cannot feel Incorrect connection of oral Re-connect oral interface and tube and make vacuum in interface and tubing sure hear the “click sound”. Mouth Incorrect connection of Re-connect container connector and saliva saliva container and tubing container cover and make sure hear the “click sound”.
  • Page 36 1.Check if the inlet port on the console is free from obstructions. blocked 2.If blocked, remove the obstruction, or clean it with damp swab. Rest for 30 minutes before power on again. 3.If the problem persists, please contact Somnics Customer Service.
  • Page 37 Make sure a "click" is heard when assembling. Low battery Check battery status by pressing power button. If battery indicator flashes for 2 seconds, recharge the console using adapter comes with the package. Note: Use ONLY Somnics authentic adapter to charge.
  • Page 38 Customer Service for help. Charging Check if the charging plug is still connected to the console. Unplug it and try again. iNAP One Sleep Therapy System is designed not to be used during charging. Console is not The battery is fully...
  • Page 39 Problem Possible Cause Light Status Solution Pain, soreness Oral interface is improperly Stop using the system immediately. Contact or physically worn. your physician. change to your Prolonged use of oral teeth or gum interface Console is The console is close to ears Place the console farther from the head.

  • Page 40: System Specifications

    SYSTEM SPECIFICATIONS Product Name iNAP One Sleep Therapy System Dimensions (Console and Container) 5.98’’ x 3.14’’ x 1.41’’(152 x 80 x 36mm) Weight (Console and Container) 0.47 lbs (210g) Warranty/Life time (Console) 2 years Battery Run Life Approximately 4 nights (8 hours per night) Bluetooth Module Frequency Range: 2.402 GHz - 2.480 GHz...
  • Page 41 Product Name iNAP One Sleep Therapy System Operating Range 5°C ~ 40°C 15 ~ 93% (non condensing) Operation/Storage Atmospheric pressure: 700hPa ~ 1060hPa Operating Altitude Up to 8,858ft (2700m) Vacuum Setting / Accuracy 54 cmH2O / ±10% Ingress Protection IP22...

  • Page 42: Guidance And Manufacturer's Declaration Regarding

    Manufacturer’s declaration-electromagnetic emissions The iNAP One is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iNAP One should assure that it is used in such an environment. Emission test...
  • Page 43 Manufacturer’s declaration-electromagnetic immunity The iNAP One is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iNAP One should assure that it is used in such an environment. Immunity test...
  • Page 44 Manufacturer’s declaration-electromagnetic immunity The iNAP One is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iNAP One should assure that it is used in such an environment. Immunity test...
  • Page 45 Manufacturer’s declaration-electromagnetic immunity The iNAP One is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iNAP One should assure that is used in such and environment. Immunity test IEC 60601 test level...
  • Page 46 Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance Radiated RF 10 V/m 10 V/m Interference may occur in the vicinity of IEC 61000-4-3 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz equipment marked with the following symbol: 80 % AM at 1 kHz 80 % AM at 1 kHz NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
  • Page 47 Recommended separation distance between portable and mobile RF communications equipment and the iNAP One The iNAP One is intended for use in an electromagnetic environment (for home healthcare) in which radiated RF disturbances are controlled. The customer or the user of the iNAP One can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the iNAP One as recommended below, according to the maximum output power of the communications equipment.
  • Page 48 NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 49 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The iNAP One is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iNAP One should assure that it is used in such an environment. Test...
  • Page 50 Test Band Service Modulation Maximum Distance IMMUNITY TEST Compliance LEVEL frequency (MHz) power (W) LEVEL (V/m) (V/m) (for home (MHz) healthcare) GSM 800/900, TETRA 800, Pulse iDEN 820, 800 – 960 modulation CDMA 850, 18 Hz LTE Band 5 GSM 1800; CDMA 1900;...
  • Page 51 Test Band Service Modulation Maximum Distance IMMUNITY TEST Compliance LEVEL frequency (MHz) power (W) LEVEL (V/m) (V/m) (for home (MHz) healthcare) 5 240 Pulse WLAN 802.11 5 100 – 5 500 modulation 5 800 5 785 217 Hz NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
  • Page 52 Maximum single fault steady pressure Device will shut down in the presence of a single fault if the steady state pressure exceeds -204 cm H2O for more than 30 Note: -204 cmH2O = -150mmHg seconds. Pressure Accuracy Maximum static pressure variation at -54 cmH2O according Tested with oral interface: -54cmH2O ±10% to ISO 80601-2-70:...
  • Page 53 Measurement system uncertainties In accordance with ISO 80601-2-70:2015 the measurement uncertainty of the manufacturer’s test equipment is: For measurement of static pressure ±1 cmH2O Note: ISO 80601-2-70:2015 stated accuracies and test results provided in this manual for these items already includes the relevant measurement uncertainty from the table above Sound Declared dual-number noise emission values in accordance with ISO 4871:1996...

  • Page 54: Clinical Data

    CLINICAL DATA There are two pivotal studies for iNAP One. Clinical Pivotal Trial 1 Data from one clinical study showed a clinical response rate of 75% according to the Sher criteria comparing treatment PSG with baseline values. Clinical Pivotal Trial 2 Data from a second clinical study showed a 52% response to the treatment (see next page).
  • Page 55 Treatment Reponse Rate of iNAP One in Clinical Pivotal Trial 2 PE Cohort ITT Cohort Basline PSG Study vs Tx Basline PSG Study vs Tx PSG Study (n=63) PSG Study (n=130) Response Rate 52% (33/63) 40% (53/130) 95% CI (Wilson)

  • Page 56: Symbol

    SYMBOL Warning or caution Refer to instruction manual Product manufacturer Type BF, applied part Serial number Batch number 50ºC Storage/Transport temperature limits -20ºC Storage/Transport humidity limits 1060hPa Operation/Storage atmospheric pressure limits 700hPa...
  • Page 57 Prescription only medical device Protection against ingress of solids larger than 12.5 mm and drip water Do not use if package is damaged Keep dry The symbol of the crossed out wheeled bin indicates that the product (electrical and electronic equipment) should not be placed in municipal waste.

  • Page 58: Limited Warranty

    LIMITED WARRANTY Somnics, Inc. (“Somnics”) warrants that the iNAP One Sleep Therapy System (the “Product“ or “iNAP One”) shall be free from defects in materials and workmanship and will perform in accordance with the Product specifications set forth in the Product instructions for use, for a specified period below: •...
  • Page 59 • This is a limited warranty and does not cover: 1.Repairs carried out by any service organization that has not been expressly authorized by Somnics to perform such repairs; 2.Any nonconforming, missing or damage in the serial or lot number;...
  • Page 60 Zhubei City, Hsinchu County 30261, Taiwan +886-3-5509623 +886-3-5503633 Email info@somnics.com iNAP One is protected by one or more of the following patents. For detail information, see http://www.somnics.com/en/legal-and-ip.html Additional patents may be pending in the EU and elsewhere. P/N 405-099-XXX03 Revised: Sep. 24, 2021...

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