SOMNICS iNAP One User manual

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

Table of Contents
1 INTRODUCTION 3
1.1 Description of iNAP One Sleep Therapy System 3
1.2 Indications for Use 3
1.3 Contraindications 4
1.4 iNAP One Sleep Therapy System Components 4
1.4.1 Console 5
1.4.2 Saliva Container 6
1.4.3 Oral Interface 6
1.4.4 Tubing Set 6
1.5 iNAP One Sleep Therapy System Console Icons 7
2 BEFORE USING THE INAP ONE SLEEP THERAPY SYSTEM 9
2.1 Important Safety Notes 9
2.1.1 Warnings (Possible Health Risks) 9
2.1.2 Warnings 11
2.1.3 Cautions 13
2.1.4 Precautions 14
3 PREPARING FOR USE INAP ONE SLEEP THERAPY SYSTEM 15
3.1 Check the Battery Status 15
3.2 Charge the System 15
3.3 Installation of DryPad 16
3.4 Connect the Oral Interface 19
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3.5 Wearing the Oral Interface 20
3.6 iNAP Muffler 22
4 OPERATING INSTRUCTIONS 23
4.1 Starting the Treatment of the iNAP One Sleep Therapy System 23
4.2 Getting Used to the Treatment of the iNAP One Sleep Therapy System 25
4.3 Stop the Treatment of the iNAP One Sleep Therapy System 26
4.4 Bluetooth and App Setup Procedures 27
5 CLEANING, MAINTENANCE AND STORAGE 28
5.1 Cleaning 28
5.1.1 Disconnect the Tubing Set and the Container 28
5.1.2 Discard the DryPad 28
5.1.3 Clean the Container, the Oral interface and the Tubing 29
5.1.4 Clean the Console 31
5.2 Weekly Cleaning 31
5.3 Maintenance 33
5.4 Disposal 33
6 TROUBLESHOOTING 34
7 SYSTEM SPECIFICATIONS 39
8 GUIDANCE AND MANUFACTURER’S DECLARATION REGARDING 41
ELECTROMAGNETIC COMPATIBILITY
9 CLINICAL DATA 53
10 SYMBOL 55
11 LIMITED WARRANTY 57 2

1.1 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. By moving the tongue and the soft palate in a forward
direction, the patency of the upper airway near the pharynx is maintained to prevent sleep-disordered breathing. This reduces
or eliminates the upper airway obstruction that causes OSA and allows each patient with OSA to enjoy deep, refreshing and
uninterrupted sleep.
More importantly, OSA patients will get rest and oxygen that they need to prevent some of the health risks associated with
OSA. Furthermore, the iNAP One Sleep Therapy System® is designed to provide quiet and comfortable treatment so that each
user can sleep through the night without distraction. The iNAP One Sleep Therapy System continuously detects air pressure
within the oral cavity and automatically adjusts the pressure gradient applied to the airway. The pressure in the oral cavity is
continuously and stably maintained which prevents respiratory obstructive events that may disturb the user's sleep. In the
absence of respiratory events, the user will have a good night’s sleep to maximize his or her quality of life. Clinical studies
conducted over a period of 28 days have demonstrated the effectiveness of the iNAP System.
1.2 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.
INTRODUCTION1
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1.3 Contraindications
The iNAP One Sleep Therapy System shall not be used
by anyone who:
• Has Central Sleep Apnea (CSA)
• Is under the age of 21.
For use only by order of a physician.
Note Use only the power adapter supplied with the device to
charge your iNAP One Sleep Therapy System.
Please check that all item listed are included in the package.
Contact local dealer or Somnics Customer Service if any items
are missing.
1.4 iNAP One Sleep Therapy System Components
iNAP One Sleep Therapy System is a portable system designed
to deliver a pressure gradient to the oral cavity to prevent sleep-
disordered breathing.
Console Container Oral Interface Tubing Set DryPad Power Adapter Muffler
(Optional) 4

1.4.1 Console
Bottom of console
Caution Blocking the air outlet of the device while in
operation might lead to insufficient negative pressure.
Ejection Button
Power Button
Ejection Button USB Port Cover USB port
Air outlet
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1.4.2 Saliva Container 1.4.3 Oral Interface
1.4.4 Tubing Set
Lip shield
Flexible tube with vacuum port
Tongue shield
Oral interface connector
Device connector
Container Cover
Container Body
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1.5 iNAP One Sleep Therapy System Console Icons
Icon Light Status Status Indicator
Battery power status
Flash Low battery
On Enough battery
Flash Charging
On Fully charged
(with charging cable plugged in)
Vacuum status
Flash Pump to target vacuum
Off Target vacuum achieved
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Container
Flash Not installed, or
Improper installation
Off Properly installed
On Container full
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BEFORE USING THE INAP ONE SLEEP THERAPY SYSTEM2
2.1 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
- Aspiration Pneumonia
- Infection of teeth/gingiva
- Oral tissue irritation
- Hematoma / Bleeding
- Gingival or dental soreness
- Blood in mucus
- Excessive salivation
- Headache
- Soft Palate pain
- Nasal congestion
- Obstruction of oral breathing
- Chest tightness
- Soreness of the wrist
- Dental discomfort
- Tooth movement or changes in dental occlusion
- Pain or soreness to the temporomandibular joint
- Higher risk in elderly-Dementia, Parkinson’s disease
and those with movement disorders affecting the tongue
- Possible Bronchial infections/Upper respiratory
infections/Pneumonia due to contamination in the
tubing system
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• 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.
• 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
ensure adequate treatment.
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2.1.2 Warnings
• Universal precautions should be observed whenever working with potentially contaminated components or equipment of the
iNAP One Sleep Therapy System. When transporting, operating, repairing or disposing of the iNAP One Sleep Therapy System
and its accessories, the risk of infectious liquids being aspirated or contamination of the device through incorrect use cannot
be eliminated.
• The iNAP One Sleep Therapy System is not computed tomography (CT) or Magnetic resonance imaging (MRI) compatible. DO
NOT put the console into the scanner range or MRI suite.
• The iNAP One Sleep Therapy System is not suitable for use in the presence of flammable anesthetic mixtures with air or
with oxygen or nitrous oxide.
• The iNAP One Sleep Therapy System is not suitable for use in areas where there is danger of explosion (e.g., hyperbaric
oxygen unit).
• 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. Always follow the instructions enclosed with the accessories.
• This system has been evaluated by biocompatibility testing. In the case of oral tissue discomfort, stop using it immediately
and consult with physician.
• DO NOT leave long length of tubing around the top of your bed. It could twist around your head or neck to cause suffocation
while you sleep. Leave some slack in the tubing when you might turn over or move around.
• 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
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water or other liquids. Always unplug the device before cleaning and make sure it is dry before reconnecting.
• 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.
• 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.
• Keep the iNAP One Sleep Therapy System away from hot or flammable surfaces, gases or materials.
• iNAP One Sleep Therapy System is not intended for life support.
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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.
• In the event of a power failure or console malfunction, remove the oral interface. The system will not provide effective therapy
if the console is not powered on or functioning properly.
• Patients should have documented obstructive sleep apnea.
• Adequacy of nasal patency should be assessed.
• 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.
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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.
• DO NOT expose the system and its accessories to open flames, or other sources of ignition, such as cigarettes, etc.
• DO NOT store the system in direct sunlight.
• Make sure the system is clean and dry prior to storage.
• This system is for SINGLE PERSON USE only. Use of the oral interface or saliva container for more than one patient may result
in cross contamination that may lead to infection.
• If you put the system on the floor, make sure that the area is free from dust and clear of bedding, clothes or other objects that
could block the air outlet.
• Make sure the area around the system is dry and clean.
• Please keep small parts and accessories away from children and pets at all time to avoid any risk of the parts been
swallowed.
• Contact Somnics Customer Service if there are any questions during setup, use or maintenance.
• DO NOT use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps, scented oils, or
phenol-based solutions to clean the system. These solutions may create a shock hazard, cause damage and reduce the life of
these items.
• Retain the original product literature for future reference.
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.
• DO NOT expose the system and its accessories to open flames, or other sources of ignition, such as cigarettes, etc.
• DO NOT store the system in direct sunlight.
• Make sure the system is clean and dry prior to storage.
• This system is for SINGLE PERSON USE only. Use of the oral interface or saliva container for more than one patient may result
in cross contamination that may lead to infection.
• If you put the system on the floor, make sure that the area is free from dust and clear of bedding, clothes or other objects that
could block the air outlet.
• Make sure the area around the system is dry and clean.
• Please keep small parts and accessories away from children and pets at all time to avoid any risk of the parts been
swallowed.
• Contact Somnics Customer Service if there are any questions during setup, use or maintenance.
• DO NOT use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps, scented oils, or
phenol-based solutions to clean the system. These solutions may create a shock hazard, cause damage and reduce the life of
these items.
• Retain the original product literature for future reference.
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3.1 Check the Battery Status
Press the power button to check the battery status.
Battery status Status Indicator Suggestion
On Enough battery
Flash Low battery Please charge!
3.2 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).
Note 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 when charging.
Use ONLY Authentic Somnics accessory to charge the
console.
PREPARING FOR USE INAP ONE SLEEP THERAPY SYSTEM3
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3.3 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.
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3. Squeeze the sides of DryPad then insert the center tube of the container cover
into the opened iNAP DryPad.
4. Put the cover on the body of the
container and make sure there is
no gap between the container cover
and the container body.
Make the position of marking
line under the container body
Squeeze the side of DryPadTear (if applicable) the
dotted line of DryPad and
squeeze to open it
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“Click”sound
Note If the container icon is
flashing, please reconfirm the
connection condition of the
container and the console.
Please refer to section1.5
Caution Wrong container cover position
Caution Wrong DryPad position
Caution DO NOT contact the filter
5. Connect the console and
container make sure that you
hear the click sound
Filter
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3.4 Connect the Oral Interface
1. Connect the oral interface
with the tubing.
2. Connect the tubing to the
console.
3. Ready to use.
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