Design Philosophy; Function; Intended Use/Indications; Contraindications - Aircast Venaflow Elite Operator's Manual

Design Philosophy

Pneumatic compression is a clinically proven modality for minimizing the risks
associated with deep vein thrombosis .¹ The Aircast VenaFlow Elite System leverages
the same clinically proven technology as the existing VenaFlow offering, but is
presented in a low profile, light-weight design . VenaFlow Elite combines two proven
technologies, rapid inflation and graduated sequential compression, to accelerate
venous velocity and enhance fibrinolysis . This unique combination makes VenaFlow
the only technology platform on the market that mimics ambulation .² Additionally,
VenaFlow Elite incorporates asymmetric compression for the superior emptying
of veins .³ The breathable and comfortable VenaFlow Elite calf, foot and thigh cuffs
enhance the patient experience, assist in increasing compliance and are compatible
with one universal pump .

Function

Standard Operation (rapid inflation): The VenaFlow Elite system defaults to a
rapid inflation mode . Once powered on, the system begins the compression cycle
and inflates the cuffs one leg at a time, alternating between the two legs every 30
seconds . First the distal aircell inflates rapidly within less than 0 .5 seconds, then the
proximal aircell follows . The distal pressure peaks at approximately 73 mmhg ±15%
and the proximal pressure peaks at approximately 63 mmhg ±15% . These pressures
then settle at 45mmhg ±10% and after 6 seconds, the cuff deflates . In 54 seconds, the
inflation cycle begins again . An icon will appear on the graphical display signalling
when the inflation cycle is in progress . (See 'Pump Features' section) Pressure and the
inflate/deflate cycle are automatic and an alarm will be activated if the system is not
functioning properly . (See 'System Alarms' section) .
S Mode Operation (slow inflation): The user has an option to select the S mode
button to switch to a slower inflation mode . After selection, both cuffs begin to inflate
simultaneously once every 60 seconds . The inflation cycle is approximately 10 seconds
long . The aircells inflate to a peak pressure of 45mmhg ±10% . In 50 seconds, the
inflation cycle begins again . In S mode, pressures are automatic and alarms function
normally .
1. Labropoulos N, OH D.S, Golts, E, et al: Improved Venous Return By Elliptical, Sequential and Seamless
Air-cell Compression. Loyola University Medical Center, January 2003.
2. Whitelaw G, Oladipo O, Shah BP, et al: Evaluation of Pneumatic Compression Devices. Boston Orthopedics,
March 2001.
3. Kamm R: Unsteady Venous Blood Flow Resulting From Different Modes of External Compression Cambridge,
MIT, 1996
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Intended Use/Indications

The VenaFlow Elite System is an intermittent pneumatic compression device that
is intended as a prophylaxis for deep vein thrombosis (DVT) in a clinical setting or
in the home . The VenaFlow Elite System is designed to be used only with VenaFlow
Elite cuffs .

Contraindications

The VenaFlow Elite System should not be used by persons with known or
suspected deep vein thrombosis, severe congestive heart failure, pulmonary
edema, thrombophlebitis, severe arteriosclerosis, or active infection . Do not
use on extremities which are not sensitive to pain, where cuff will interfere
with gangrene, on patients with vein ligation or recent skin grafts, or extreme
deformity of the leg . Do not use the VenaFlow Elite System where increased
venous or lymphatic return is undesirable .
Warning and Precautions
• The VenaFlow Elite cuffs are designed for single patient use only.
• Risk of explosion if used in the presence of flammable anaesthetics.
• The equipment or system should not be used adjacent to or stacked with other
equipment and, if adjacent or stacked use is necessary, the equipment or system
should be observed to verify normal operation in the configuration in which it will
be used .
• Medical Electrical Equipment needs special precautions regarding EMC. Portable
and Mobile RF Communications Equipment can be affected by other Medical
Electrical Devices .
• Cuffs used in combination with warming devices may cause skin irritation.
Regularly check for patient comfort, compliance and skin irritation .
• Special attention should be given to those patients with neuropathies or tissue
viability problems (i .e . diabetes, arterial or venous insufficiencies) .
• To prevent extremity compartment syndrome, special attention should be given
to patients who are positioned in the supine lithotomy position for extended
lengths of time . This includes patients with or without compression cuffs .
• If you experience pain, swelling, sensation changes or any unusual reactions while
using this device, consult your medical professional immediately .
• Foot cuffs are only for use in standard rapid inflation mode.
• Ingress of water or liquids could result in unpredictable failures.
• Inspect equipment for obvious damage prior to use.
• Do not walk with tubing connected to cuffs.
• The device should never be opened by anyone other than a trained technician.
• Use of device outside of all recommended specifications could result in unpredictable
failures .

Latex Information

All components of the VenaFlow Elite System are latex-free . All VenaFlow Elite
cuffs are latex free and may be placed directly against the skin or over a light
compression dressing .
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