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Developing Sleep Solutions

Nasal Pillow DeviceDeltaWave

Users Guide(English)Version 1.0

Rx onlyFEDERAL LAW (UNITED STATES) RESTRICTS THIS DEVICE TO

SALE BY OR ON THE ORDER OF A PHYSICIAN

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Welcome to DeltaWAVE

Thank you for choosing DeltaWAVE—a new, revolutionary interface for people with sleep apnea.The DeltaWAVE is a new CPAP interface that represents a quantum leap forward in airflow dynam-ics. The DeltaWave may look like other interfaces but that’s where the similarity ends. After years of research, development and refinement we have created a new standard for the industry.

The DeltaWave separates itself from the competition by addressing the major concerns of users:

• Virtually Zero Work Of Breathing• Less CO2 Retention• Eliminates Claustrophobic Effects• Minimizes or Eliminates Drying of the Sinuses• Minimizes Need For a Humidifier• Uses Less Drive Pressure

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Contents

DeltaWAVE Components 4

DeltaWAVE Parts Description 6

DeltaWAVE Intended Use 6

Symbols on Packaging: 6

DeltaWAVE Interface Step-By-Step Assembly 7

DeltaWAVE Interface “How to wear” 11

DeltaWAVE Interface Removal Options 11

Technical Specifications 12

Environmental conditions 12

Troubleshooting 13

DeltaWAVE Warnings 13

Cleaning 14

Storage 14

Disposal 14

Limited Warranty 14

Symbols on Packaging: 15

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1) Retainer Bar (qty 2) 4) Exhalation Port (qty1 )2) Head Strap (qty 2) 5) Short Tubing (qty 1)3) Nasal Pillows : XSM, SM, MD, LG (qty 4) 6) Swivel Connector (qty 1)

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DeltaWAVE ComponentsYour DeltaWAVE package will contain the mask components below. Continue to read and fol-low step-by-step assembly instructions.

DeltaWAVE Nasal Pillow SystemP/N 8000

DIAGRAM A

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Exhalation port with Swivel connector and Short tubing

(P/N 8006)

Replacement parts can be ordered in assemblies as follows:

Headgear Assembly(P/N 8005)

Nasal PillowP/N:8001 XSM8002 SM8003 MD8004 LG

DIAGRAM B

DIAGRAM C

DIAGRAM D

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DeltaWAVE Parts Description

DeltaWAVE Item Description Part Number

Nasal Pillow System (See Diagram A) 8000

Exhalation Port with Tubiing and Swivel connector (See Diagram B) 8006 Headgear Assembly(Iincludes two straps and two retainers) (See Diagram C) 8005

Nasal Pillows (See Diagram D) 8001 XSM 8002 SM 8003 MED 8004 LARGE

DeltaWAVE Intended UseRX Only

The DeltaWAVE channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.

The DeltaWAVE is:

• To be used by adult patients (>66 lb/30 kg) for whom positive airway pressure has been prescribed.

• Intended for single patient use in the home environment and multi-patient re-use in the hos-pital/institutional environment.

Notes:

• The DeltaWAVE is not compatible for use with AutoSet™ and VPAP™devices.

• SmartStop™ may not operate effectively when using this mask with some CPAP or bi-level devices that have this feature.

• If you experience nasal dryness or irritation, use of a humidifier is recommended.

DeltaWAVE Item Description Part Number

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STEP 1

Select appropriate pillow insert size. There are four available sizes: XSM, SM, MD and LG. Select the size that feels the most comfortable and creates a seal inside your nostrils.

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DeltaWAVE Interface Step-By-Step Assembly

Please make sure you read and understand all instructions before you begin using.

A) Using a mirror take a nasal pillow and gently push the tip of the pillow into your na-sal cavity. When you place the pillows in your nose, make sure you have them facing you as per the diagram shown here.

NOTE: Each pillow has its size marked on it. Make sure the size letters are “right side up”. This will ensure you have them oriented cor-rectly B) You have a good fit (4 sizes to choose from) when you can push the cannula in and they do not fall out of your nose. If they are not comfortable, try a different size.

C) To test for airtight seal, block off ends of cannula with thumbs and exhale with your mouth closed. If air is leaking around the can-nula, you will need a larger size.

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STEP 2

Insert the selected pillows into the Exhalation Port. Make sure the exhaust ports (small holes) are facing up. Now insert the silicone pillows into the Exhalation Port making sure the insert size (XSM, SM, MD, LG) which is located on the tab connecting the two inserts, is right side up. Push the first support bands into the cannula till they seat as shown.

Exhaust ports

STEP 3

Now we will place the retainer bars onto the cannula.Keeping the upper surface of the cannula (the one with the exhaust ports) pointing up, select one of the side retainer bars and orient it as shown. Pay attention to the orientation of the head gear slots.

Push the first support band into Cannula

Head gear slots

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STEP 4

Slip the slot in the retainer bar over the protruding tab on the side of the Exhalation Port. This will require a little force to stretch the silicone over the tab until it seats, as shown in the picture on the right.

STEP 5

Repeat the same operation using the remaining retainer bar on the other side of the Exha-lation Port

STEP 6

At this point, the assembly should look like the picture shown here.

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STEP 7

We will now attach the Short Tubing to the Exhalation Port. Simply place either end of the hose onto the Exhalation Port port and rotate while gently pushing the Short Tubing ap-proximately one half inch onto the port.

STEP 8

We will now attach the swivel Connector to the other end of the Short Tubing. This Swivel Con-nector is the standard 22mm size and will be used to connect your new Short Tubing to the flex-ible hose provided with your CPAP machine.

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STEP 9

The final step is to attach the two neo-prene head straps to the DeltaWAVE assembly. Simply insert the black velcro tabs through the corresponding slots in the retainer bar ends. One is for the strap on top of your head and the other is for the strap that goes around the back of your head. Make sure the light gray side is facing outward as you insert the velcro through the slot from the “inside” side of the retainer as shown in the picture.

Congratulations. Your DeltaWave device is now ready for fitting.

DeltaWAVE Interface “How to wear”

Remove all packaging before using the interface.CAUTION

• If any visible deterioration of a system component is apparent (cracking, crazing, tears or can-nula damage), the component should be discarded and replaced.• Avoid connecting flexible PVC products (e.g. PVC tubing) directly to any part of the mask. Flexible PVC contains elements that can be detrimental to the materials of the system, and may cause the components to crack or break.

A) Insert nasal pillows into your nostrilsB) Pull the headgear over your head and situate it so that it feels comfortable and that the straps are not twisted.C) Adjust the headgear straps. Do not overtighten. If straps are too tight the Nasal Pillows will be uncomfortable in your nose. Once the headstraps have been properly tightened, you should not need to readjust them as you subsequently put on and remove the deviceD) Plug the end of the Swivel Connector into the hose from your CPAP device.

DeltaWAVE Interface Removal Options

To remove the DeltaWAVE, reverse the order of placing on your head.

A) Unplug the hose from the connector (probably not required)B) Pull the headstraps over your head towards yor face.C) Gently pull the Nasal Pillow from your nose and lift entire assembly from you head.

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Technical Specifications

Pressure–flow curve

The interface contains passive venting to protect against re-breathing. As a result of manufacturing variations, the vent flow rate may vary.

Dead space informationPhysical dead space is the empty volume of the nasal pillows to the end of the Exhalation Port.

Therapy pressure 4 to 20 cm H2O

Resistance Drop in pressure measured (nominal) at 50 L/min at 100 L/min

Environmental conditions

Operating temperature: +41°F to 104°F (+5°C to +40°C)

Operating humidity: 15% to 95% relative humidity non-condensing

Storage and transport temperature: -4°F to 140°F ( -20°C to +60°C)

Storage and transport humidity: up to 95% relative humidity non-condensing

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Troubleshooting

Problem SolutionNasal Pillows won’t seal properly. Refer to Step 1 on page 4. You may need to try a larger

size pillow. Make sure the pillows are oriented correctly with the Exhalation Ports pointing up and the insert size label in the “readable” orientation,i.e. not upside down.

Nasal Pillows are uncomfortable. The headgear is tightened to much—loosen it up slightly. Check to see if Pillows are oriented correctly.

Interface is noisy. The only sound you should hear is when you are breath-ing out, through the exhalation port. If air is leaking around the Nasal Pillows, you may need to use a larger size. Make sure you have assembled the interface correctly. Check to see if any of the exhaust ports are blocked or occluded in any way. Use asoft bristle brush to clean.

DeltaWAVE Warnings

WARNING Do not use aromatic-based solutions or scented oils (e.g. eucalyptus or essential oils), bleach, alco-hol or products that smell strongly (e.g. citrus) to clean any of the mask components. Residual vapors from these solutions can be inhaled if not rinsed thoroughly. They may also damage the interface, causing cracks.

• The Exhalation Ports must be kept clear.

• The manufacturer reserves the right to change these specifications without notice.

• This system should be reprocessed when used between patients.

• The interface should not be used unless the CPAP system is turned on and operating properly.

• Follow all precautions when using supplemental oxygen.

• Oxygen flow must be turned off when the CPAP or bi-level device is not operating, so that unused oxygen does not accumulate within the CPAP or bi-level device enclosure and create a risk of fire.

• At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration varies, depend ing on the pressure settings, patient breathing pattern, Interface, point of application and leak rate.

• The technical specifications of the interface are provided for your clinician to check that they are compatible with the CPAP or bi-level device. If used outside specification or if used with incompatible devices, the seal and comfort of the interface may not be effective, optimum therapy may not be achieved, and leak, or variation in the rate of leak, may affect the CPAP or bi-level device function.

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• Discontinue using this interface if you have ANY adverse reaction to the use of the interface, and consult your physician or sleep therapist.

• As with all interfaces, some re-breathing may occur at low CPAP pressures.

• Refer to your CPAP or bi-level device manual for details on settings and operational informa tion.

NOTE: The DeltaWAVE system does not contain latex, PVC or DEHP materials.

Cleaning & Storage of Your DeltaWAVE Interface

Cleaning• Your nasal cannula and headgear should only be hand washed by gently rubbing in warm (ap proximately 86°F/30°C) water using mild soap.• All components should be rinsed well with drinking quality water and allowed to air dry out of direct sunlight.

Daily/After each use• Hand wash the Nasal Pillows.• If the ports on the Exhalation Port requires cleaning, use a soft bristle brush.

Weekly• Hand wash the headgear.

Storage

Ensure that the interface is thoroughly clean and dry before storing it for any length of time. Store the interface in a dry place out of direct sunlight.

Disposal

This interface does not contain any hazardous substances and may be disposed of with your normal household refuse.

Limited Warranty

RemSleep inc. warrants that your DeltaWAVE interface system shall be free from defects in material and workmanship from the date of purchase for the period of 90 days or in the case of disposable cannula the maximum use period.

This warranty is only available to the initial consumer. It is not transferable.If the product fails under conditions of normal use, RemSleep inc. will repair or replace, at its option, the defective product or any of its components.

This limited warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by RemSleep inc. to perform such repairs; and c) any damage or contami-

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nation due to cigarette, pipe, cigar or other smoke. Warranty is void on product sold, or resold, out-side the region of original purchase.

Warranty claims on defective product must be made by the initial consumer at the point of purchase.This warranty replaces all other expressed or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.

RemSleep inc. shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale, installation or use of any RemSleep inc. product. Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may also have other rights which vary from region to region.

Symbols on Packaging:

Caution, consult accompanying documents

LOT number

REF Part number

Temperature limitation

Humidity limitation

Does not contain latex

Manufacturer

Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device.

Keep away from rain

This way up

Fragile, handle with care