SOMNICS iNAP R07-A Instructions For Use Manual
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SOMNICS iNAP R07-A Instructions For Use Manual

One sleep therapy system
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®
iNAP
One
Sleep Therapy System
INSTRUCTIONS FOR USE
Model: R07-A
IFU-134 ver.01
Released: Aug. 28, 2023
This user guide contains instructions for using the iNAP
Read all Instructions for Use before using the system.
®
One Sleep Therapy System.

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  • Page 1 ® iNAP Sleep Therapy System INSTRUCTIONS FOR USE Model: R07-A IFU-134 ver.01 Released: Aug. 28, 2023 ® 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

    Table of Contents INTRODUCTION Description of iNAP One Sleep Therapy System Indications for Use Contraindications iNAP One Sleep Therapy System Components 1.4.1 Console 1.4.2 Saliva Container 1.4.3 Tubing Set 1.4.4 ral Interface 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)
  • Page 3 Wearing the Oral Interface iNAP 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 CLEANING, MAINTENANCE AND STORAGE Cleaning...

  • Page 4: Introduction

    INTRODUCTION Description of iNAP One Sleep Therapy System iNAP One Sleep Therapy System is designed to treat obstructive sleep apnea (OSA) in adults. When using iNAP One Sleep Therapy System during sleep, it provides a pressure gradient within the oral cavity, and the pressure gradient pulls the tongue toward the upper palate and also pulls the soft palate forward.

  • 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 Tubing Set T01(Only for I07 series) Oral Interface Connector Container Cover Device Connector Container Body...

  • Page 8: Ral Interface

    1.4.4 Oral Interface I02 Series I07 Series Tongue Shield Lip Shield Flexible Tube with Vacuum Port Flexible Tube with Vacuum Port Lip Shield Tongue Shield Device Connector...

  • Page 9: Inap One Sleep Therapy System Console Icons

    iNAP One Sleep Therapy System Console Icons Icon Light Status Status Indicator Battery Power Status Flash Low battery. Please charge! Enough battery Flash Charging Fully charged (with charging cable plugged in) Vacuum Status Flash Pump to target vacuum At target vacuum...
  • Page 10 Container Flash Incorrect installation Properly installed Container full or excessive suction detected...

  • Page 11: 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 - Aspiration Pneumonia - Chest tightness - Infection of teeth/gingiva...
  • Page 12 • Assessment of effectiveness of the iNAP One Sleep Therapy System should be conducted by your physician to ensure adequate treatment. • If the oral interface causes prolonged discomfort, remove it and contact your physician. • The oral interface, tubing set, saliva container, and DryPad are for your use only. DO NOT share your oral interface, saliva container and DryPad with others.

  • Page 13: Warnings

    • The iNAP One Sleep Therapy System and its accessories are provided nonsterile and should not be used in a sterile field. • Use only Authentic Somnics accessories (container, tubing set, oral interface and DryPad). A different type of the tubing and the oral interface may damage the system.
  • Page 14 • DO NOT leave the system on prolonged charge when not in use. • Please use the power adapter provided by Somnics, Inc., Use of an improper power adapter might cause electric shock or damage the iNAP One Sleep Therapy System.

  • Page 15: Cautions

    2.1.3 Cautions • Physician should consider the medical history and condition of the patient, including but not limited to, history of asthma, sinusitis, nasal obstruction, breathing, or respiratory disorders or other relevant health problems, and refer the patient to the appropriate health care provider before prescribing this system.

  • Page 16: Precautions

    2.1.4 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 17: Preparing For Use Inap One Sleep Therapy System

    A lithium-ion battery embedded in the console is not replaceable. Please charge more than 8 hours for the first time. Caution DO NOT use the system while charging. The device does not work while charging. Use ONLY Authentic Somnics accessory to charge the console.

  • Page 18: Installation Of Drypad

    Installation of DryPad Disconnect the console and the container. Open the Container. Press the ejection button, then pull the saliva container upward to separate it from console.
  • Page 19 Squeeze the sides of DryPad, match the opening of the DryPad with the center Ensure that you hear it "click" tube of the container cover, then place the container cover with the DryPad into place. You will see the into the container. gap between the lid and the container less than ¼".
  • Page 20 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 Section 1.5 Caution DO NOT contact the filter...

  • Page 21: Connect The Oral Interface

    Connect the Oral Interface I07 Series Connect the oral interface Connect the tubing Ready to use. with the tubing. to the console.
  • Page 22 I02 Series container cover. For the adjustable oral interface I02 series, connect its tubing with the...

  • Page 23: 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 iNAP Customer Service. Note Wash the oral interface with warm water before using it the first time. Insert the oral interface in your Be sure that the lip shield is Keep the lip shield and the flexible tube...
  • Page 24 Caution DO NOT put the tongue shield on the tongue inside your mouth. Keeping your lips closed, you are now ready to start using the iNAP One Sleep Therapy System. Note Please put the oral interface ONLY in your mouth. Note DO NOT chew on or swallow the oral interface.

  • Page 25: Inap Muffler

    iNAP Muffler It is an accessory dedicated to use with iNAP One Sleep Therapy System. Please read this instruction thoroughly before use. Note For patients experiencing noise from the device during treatment, a muffler can help reduce the device's noise level. Hold the muffler tight and put Make sure the connection between Place iNAP Console flat...

  • Page 26: Operating Instructions

    OPERATING INSTRUCTIONS Starting the Treatment of the iNAP One Sleep Therapy System • Hold the start button until all three lights illuminate, then release. The three icons will flash for a few seconds while warming up, and then the icon of battery power status will turn to solid green when the system is fully powered ON.
  • Page 27 • Wait for the vacuum level on the console to reach the target vacuum. Wait for the light of the vacuum icon turns from blue to OFF. If the light keeps flashing, it means the console is in the process of increasing vacuum pressure to its target level.

  • Page 28: 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. Here are some tips to help familiarize you with the system more quickly: •...

  • Page 29: Stop The Treatment Of The Inap One Sleep Therapy System

    Stop the Treatment of the iNAP One Sleep Therapy System Remove the oral interface, then press the power button on the console for 3 seconds to turn off iNAP. The oral interface and the container should be cleaned after each use. Note In case you need to leave bed during night sleep, press and hold the power button to turn OFF the console.

  • Page 30: Bluetooth And App Setup Procedures

    Bluetooth and App Setup Procedures iNAP supports a mobile app for you to track your daily progress. You can adjust the vacuum pressure according to the prescription. You may download the iNAP Lab+ app via Google Play (Android) or App Store (iOS). 1.

  • Page 31: Cleaning, Maintenance And Storage

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

  • Page 32: Clean The Container, The Oral Interface And The Tubing Set

    5.1.3 Clean the Container, the Oral Interface and the Tubing Set Disconnect the console from I07 Series the container and rinse the container with cool water. Pull Let warm water flow through both ends of the tubing for about 30 seconds. Separate the oral interface from Rinse and gently rub the oral the tubing by gently pulling it...
  • Page 33 I02 Series For cleaning of the adjustable oral interface, I02 series, clean the used oral interface and tubing. Rinse and gently rub the oral interface with cold water. Let cold water flow through the tubing set for about 30 seconds. Note You can use a soft brush or a sponge to gently scrub the surface of the oral interface.
  • Page 34 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 container body.

  • Page 35: Clean The Console

    5.1.4 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 36 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 37: Maintenance

    Maintenance • Console: iNAP One Sleep Therapy System is designed to provide accurate pressure without the need of additional calibration by the end user. No routine maintenance is required if the system is used in accordance with the user manual. •...

  • Page 38: 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 39 Problem Possible Cause Light Status Solution Saliva container cover In the situation of Clean the hole of saliva container cover or replace Cannot feel blocked blockage, Indicators a new saliva container. vacuum in might appear normal. Mouth Saliva container body 1.Check if the filter in saliva container is blocked.
  • Page 40 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 41 2.Turn on the console again. If the problem persists, please contact Somnics Customer Service for help. Charging Check if the charging plug is still connected to the console. Unplug it and try again. The console turns off with all lights off while unplugging the charger.
  • Page 42 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 43: 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 Transmit Power: Class 2 output power (0 dBm typical, +2 dBm maximum)
  • Page 44 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 -27~-122 cmH2O / ±6.8 cmH2O Ingress Protection IP22 Patient Protection Type BF...

  • Page 45: Guidance And Manufacturer's Declaration Regarding

    GUIDANCE AND MANUFACTURER’S DECLARATION REGARDING ELECTROMAGNETIC COMPATIBILITY 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 Compliance Electromagnetic environment-guidance...
  • Page 46 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 IEC 60601 test level Compliance level Electromagnetic environment-guidance...
  • Page 47 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 IEC 60601 test level Compliance level Electromagnetic environment-guidance...
  • Page 48 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 Compliance level Electromagnetic environment-guidance Conducted RF...
  • Page 49 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 50 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 51 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. EMC Information The iNAP Sleep Therapy System has been designed to meet EMC standards throughout its service life without additional maintenance.
  • Page 52 Manufacturer’s declaration-electromagnetic immunity 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 Band Service...
  • Page 53 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 54 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 55 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 -27~-122 cmH2O Tested with oral interface: ±6.8 cmH2O according to ISO 80601-2-70:...
  • Page 56 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 57 FCC Compliance Statement (FCC ID: A8TBM70ABCDEFGH) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 58: 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 59 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) 40-65 % 33-49 % P-value *...

  • Page 60: 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 61 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 62: 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 63 • 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 64 5F, No.22, Sec.2, Sheng Yi Rd, Hsinchu Science Park, 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.

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