SmartVest
SQL
Airway Clearance System
www.smartvest.com
5
Indications for Use
Electromed, Inc. has received clearance to market from the FDA for the
following indications: “The Electromed, Inc. SmartVest SQL Airway Clearance
System is designed to deliver High Frequency Chest Wall Oscillation (HFCWO)
to promote airway clearance and improve bronchial drainage. The SmartVest
is indicated when external chest manipulation is the physician’s treatment of
choice to enhance mucus transport.”
Indications for use of the SmartVest SQL Airway Clearance System follow the
published American Association Respiratory Care (AARC) Clinical Practice
Guidelines for Postural Drainage Therapy. For further information regarding
indications, contraindications, etc., refer to these Guidelines at:
http://www.rcjournal.com/cpgs/pdtcpg.html
Contraindications for Use
Absolute contraindications identified by the 1991 AARC Guidelines for external
manipulation of the thorax such as HFCWO include: (1) head and neck injury until
stabilized, and (2) active hemorrhage with hemodynamic instability.
The AARC has also identified relative contraindications which require an
individualized clinical assessment and careful consideration by the physician prior
to prescription including: hemoptysis; subcutaneous emphysema; recent epidural
spinal infusion or spinal anesthesia; recent skin grafts on the thorax; burns, open
wounds, and skin infections of the thorax; recently placed transvenous pacemaker
or subcutaneous pacemaker; suspected pulmonary tuberculosis; lung contusion;
bronchospasm; osteomyelitis of the ribs; osteoporosis; coagulopathy and complaint
of chest-wall pain.
Additional information regarding the effectiveness of HFCWO treatment on patients
with various conditions and diseases can be found at www.smartvest.com.
Safety
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