DeltaWave Nasal Pillow Device Rx only. Developing Sleep Solutions. Users Guide (English) Version 1.0. Page 1

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1 Users Guide (English) Version 1.0 Developing Sleep Solutions Page 1 DeltaWave Nasal Pillow Device Rx only FEDERAL LAW (UNITED STATES) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

2 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 dynamics. 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 Page 2

3 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 Page 3

DeltaWAVE Components Your DeltaWAVE package will contain the mask components below. Continue to read and follow step-by-step assembly instructions.

4 DeltaWAVE Components Your DeltaWAVE package will contain the mask components below. Continue to read and follow step-by-step assembly instructions. DIAGRAM A DeltaWAVE Nasal Pillow System P/N ) 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) Page 4

5 Replacement parts can be ordered in assemblies as follows: DIAGRAM B Exhalation port with Swivel connector and Short tubing (P/N 8006) DIAGRAM C DIAGRAM D Headgear Assembly (P/N 8005) Nasal Pillow P/N: 8001 XSM 8002 SM 8003 MD 8004 LG Page 5

6 DeltaWAVE Parts Description DeltaWAVE Item Description Part Number 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 Use RX 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: Notes: 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 hospital/institutional environment. 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. Page 6

DeltaWAVE Interface Step-By-Step Assembly Please make sure you read and understand all instructions before you begin using. STEP 1 Select appropriate pillow insert size.

???? A) Using a mirror take a nasal pillow and gently push the tip of the pillow into your nasal cavity.

7 DeltaWAVE Interface Step-By-Step Assembly Please make sure you read and understand all instructions before you begin using. 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.???? A) Using a mirror take a nasal pillow and gently push the tip of the pillow into your nasal 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 correctly 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 cannula, you will need a larger size. Page 7

Exhaust ports Push the first support band into Cannula STEP 2 Insert the selected pillows into the Exhalation Port. Make sure the exhaust ports (small holes) are facing up.

Push the first support bands into the cannula till they seat as shown. STEP 3 Now we will place the retainer bars onto the cannula.

8 Exhaust ports Push the first support band into Cannula 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. 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. Head gear slots Page 8

9 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 Exhalation Port STEP 6 At this point, the assembly should look like the picture shown here. Page 9

STEP 7 We will now attach the Short Tubing to the Exhalation Port.

while gently pushing the Short Tubing approximately one half inch onto the

10 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 approximately 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 Connector is the standard 22mm size and will be used to connect your new Short Tubing to the flexible hose provided with your CPAP machine. Page 10

STEP 9 The final step is to attach the two neoprene head straps to the DeltaWAVE assembly. Simply insert the black velcro tabs through the corresponding slots in the retainer bar ends.

11 STEP 9 The final step is to attach the two neoprene 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 cannula 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 nostrils B) 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 device D) 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. Page 11

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.

12 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 information Physical 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 Page 12

13 Troubleshooting Problem Nasal Pillows won t seal properly. Nasal Pillows are uncomfortable. Interface is noisy. Solution 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. The headgear is tightened to much loosen it up slightly. Check to see if Pillows are oriented correctly. The only sound you should hear is when you are breathing 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, alcohol 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. Page 13

14 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- Page 14

15 nation due to cigarette, pipe, cigar or other smoke. Warranty is void on product sold, or resold, outside 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 Page 15

English. Fealite Nasal Pillows System. User Manual

English. Fealite Nasal Pillows System. User Manual Fealite Nasal Pillows System User Manual 0123 Table of Contents Fealite Nasal Pillows System 1 Intended Use 1 Medical Information 1 Parts of the Fealite 3 Fitting the Fealite 5 Using Tube Retainer (Optional)