V̇-Com^™ Specifications

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 sur.e 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 ar.e secure before turning on flow-generating device.
4) Clean (or replace) V-Com™ device after each use or 24-hour period per
instru.ctions 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 i.nspect 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 (e.g., Liqu.id 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.

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