New Study: V̇-Com™ Reducing Inspiratory Positive Airway Pressure

KPAP Efficacy and Comfort Trial

   provides inspiratory comfort for patients using Continuous Positive Airway Pressure (CPAP & APAP) and bi-level PAP therapy.

Read The White Paper

V̇-Com™ Increases Comfort and May Decrease Adverse Effects with Positive Airway Pressure Therapy

Suggesting a Diminished Role for Inspiratory Pressure in Treating Uncomplicated Obstructive Sleep Apnea

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V̇-Com™ Specifications

 provides inspiratory comfort for patients using Continuous Positive Airway Pressure (CPAP & APAP) and bi-level PAP therapy.

UNDERSTANDING THE V-COM™ DEVICE

CPAP comfort that doesn’t compromise therapy.

Developed by leading sleep scientist Dr. William Noah, V-Com™ was designed to attenuate or soften the peak inspiratory airflow for sleep apnea patients using CPAP, APAP, or bi-level PAP machines.

During inspiration, when the PAP device generates both exhaust flow and patient flow, many new and existing CPAP therapy patients report uncomfortably high pressure levels – Dr. Noah’s game-changing device softens the impact to patients without compromising the quality and effectiveness of care.

During expiration, when respiratory cycle flow from the PAP machine is at its lowest, the flow-dependent V-Com™ device has minimal impact on expiratory positive airway pressure (EPAP). In the breaths preceding a hypopnea or apnea resulting in inspiratory pharyngeal instability,

expiratory upper airway resistance increases while end-expiratory pharyngeal cross-sectional area decreases. EPAP offsets this both directly (by maintaining pharyngeal patency from “splinting” of the airway) and indirectly (from the increased functional residual capacity). This process is principally responsible for many of CPAP therapy’s positive results.

Before the development of V-Com™, the only way a clinician could reduce discomfort was by decreasing the pressure settings – this would also decrease EPAP and compromise the efficacy of treatment. V-Com™ enables CPAP therapy patients to soften the airflow intake without negatively impacting EPAP. In other words, V-Com™ does not prevent the PAP machine from delivering its core benefits to patients, but it does reduce discomfort and noise.

V-Com™ is classified as a comfort device by the FDA. It is not therapy, but rather a PAP circuit accessory that provides users with initial comfort and tolerance of their treatment – this has been shown to promote long-term adherence of CPAP therapy.

Installing V-Com™

Indications for use:

This device is intended for single patient use in noninvasive breathing circuits to provide comfort to patients on CPAP, APAP, and bi-level PAP therapy.

Directions for use:

1) Make sure flow-generating device is turned off.

2) Remove V-Com™ device from package and place in noninvasive breathing circuit between the hose from the flow-generating device and the patient interface (mask).

3) Verify all fittings are secure before turning on flow-generating device.

4) Clean (or replace) V-Com™ device after each use or 24-hour period per instructions below.

5) If V-Com™ is to be used long term, it should be replaced every 3 months (similar to hoses, masks, etc.).

22MM OD / 22MM ID   Volume: 18 mL    Weight: 9 grams

Resistance to flow:

0.3 cmH2O @ 20 Lpm

0.6 cmH2O @ 30 Lpm

1.1 cmH2O @ 40 Lpm

1.7 cmH2O @ 50 Lpm

Cautions:

Single patient use. Do not attempt to sterilize. Use cleaning instructions below. Before each use visually inspect the V-Com™ device to ensure airflow path is not obstructed. Replace V-Com™ if signs of wear are present.

Warnings:

Do not place the V-Com™ device in an active breathing circuit as this could possibly affect algorithms for auto-titration and respiratory event detection. Always turn flow-generating device off first, place V-Com™ device in the breathing circuit, and then turn flow-generating device back on.

V-Com™ affects inspiratory PAP more than expiratory PAP which may decrease pressure support and tidal volume during NIV therapy. V-Com™ has not been tested in adaptive servo ventilation and average volume-adjusted pressure support breathing circuits.

Cleaning Instructions:

Wash with soap (eg., Liquid dish soap) and water inserting a small, bristled brush in both ends of the V-Com™ device to penetrate and clean the complete airflow path. Twist the brush several times. Rinse with clean water and let air dry. Inspect for any damage orresidue. If seen, reclean or replace.

Contains No BPA

Manufactured in USA by: SleepRes, LLC

1508 Carl Adams Drive, Ste 200

Murfreesboro, TN 37129 1-615-921-2406

V-Com™ is an accessory to a prescription therapy (CPAP, APAP, or bi-level PAP) and does not require a separate prescription.