SleepRes V̇-Com™

Indications for use:

This device is intended for single patient use in noninvasive breathing circuits to provide comfort to patients struggling with peak inspiratory flow from CPAP and NIV therapy, particularly with nasal pillow type interfaces.

Directions for use:

1) Make sure flow-generating device is turned off.
2) Remove V̇-Com™ device from package and place in noninvasive breathing circuit between the hose from the flow-generating device and the patient interface (mask).
2) Verify all fittings are secure before turning on flow-generating device.
4) Clean (or replace) V̇-Com™ device after each use or 24-hour period per instructions below
5) Once the patient develops tolerance to CPAP or NIV therapy, the V̇-Com™ device may be removed from the breathing circuit.

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

Resistance to flow:
0.26 cm H2O @ 20 Lpm
0.60 cm H2O @ 30 Lpm
1.1 cm H2O @ 40 Lpm
1.6 cm H2O @ 50 Lpm
2.3 cm H2O @ 60 Lpm
3.0 cm H2O @ 70 Lpm

Cautions:

Single patient use. Do not attempt to sterilize. Use cleaning instructions below. Before each use visually inspect the V̇-Com™ device to ensure airflow path is not obstructed.

Warnings:

V̇-Com™ device may affect algorithms for auto-titration and respiratory event detection. To minimize this possibility, do not place the V̇-Com™ device in an active breathing circuit. First, turn flow-generating device off, place V̇-Com™ device in the breathing circuit, and then turn flow-generating device on. V̇-Com™ has not been tested in adaptive servo ventilation breathing circuits.

Cleaning Instructions:

Wash with soap (e.g., Liquid dish soap) and water inserting a small, bristled brush in both ends of the V̇-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 or residue. If seen, reclean or replace.