Aircast VenaFlow 30A, VenaFlow 30AXL, VenaFlow 30AXXL User manual

VenaFlow
®
system 30A, 30AXL, 30AXXL
Operator’s Manual
prophylaxis for DVT and associated PE
VenaFlow system with Calf Cuff
VenaFlow
®
Contents
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Design Philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Cuff Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Pump Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–10
Ambulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Single Cuff Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Top Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Top Panel Displays/Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Pressure Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Optional Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Components and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Latex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Ordering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1
2
VenaFlow
®
system

Introduction

Aircast® pioneered graduated, pneumatic compression for the functional management of orthopedic injuries. The VenaFlow system evolved from this unique experience, and from performance principles established by earlier researchers in pneumatic compression. VenaFlow provides intermittent pneumatic compression as a prophylaxis for deep vein thrombosis. This graduated, sequential, compression accelerates blood velocity and en­hances fibrinolysis.
4,9,12,13

Design Philosophy

The VenaFlow system is designed to move blood faster and be more com­fortable than any other known device.
Studies show that the Aircast VenaFlow system increases venous velocity significantly more than other intermittent pneumatic compression (IPC) sys­tems. This is because the compression is extremely rapid, graduated and sequential — principles for optimal DVT prophylaxis demonstrated by Kamm, et al, at MIT. and Foot Cuffs, reduces the risk of pooling of blood between compartments that is seen with conventional segmented cuffs.13 In addition, the VenaFlow system’s compression is asymmetric for more effective emptying of the veins. The unique cuffs are designed to enhance patient compliance and comfort, and are available in three designs (Calf, Foot, and Thigh) to suit individual physician preferences.
6,7,10
The patented Duplex™ aircell design, employed in the Calf
VenaFlow system’s rapid, graduated compression causes a three to four fold increase in femoral vein velocity (Calf Cuff). In a typical Doppler trace, precompression velocity is .19 meters per second, the peak during compression, .92 m/s — an increase of 384%. This compares with the 80% to 140% increase found with conventional systems.
3,9
VenaFlow
®
3

Function

The cuffs are applied, pump and tube assembly connected, and pump turned on. Compression is rapid, graduated and sequential for maximum effectiveness. The distal aircell inflates rapidly, then settles to 52 mmHg ±10%, and the proximal aircell follows in .3 sec­onds to settle at 45 mmHg ±10%. After 6 seconds of compression, the cuffs deflate. This cycle re­peats every minute.
When the pump is activated, the peak pressures gradually rise through the first five minutes of op­eration. This allows the patient to gradually adjust to the treatment.
The VenaFlow system pump automatically adjusts compres­sion for each style of cuff. While peak pressures vary with each cuff style, the settle pressures remain consistent for all cuffs.
Compression Curve Using Calf Cuff
150 140 130 120 110 100
90 80 70 60
Calf Compression mmHg
50
Proximal
40
30 20 10
0
0
2
Distal
46
Seconds
8
Compression Curve Using Foot Cuff
150 140 130 120 110 100
90 80 70 60 50
Foot Compression mmHg
40 30 20 10
0
0246810
Distal
Proximal
Seconds
10
4
VenaFlow
®
system

Indications

The N.I.H., Consensus Development Conference Panel on Prevention of Venous Thrombosis and Pulmonary Embolism (Volume 6, Number 2) that DVT is a marker for PE, and that risk of DVT is high following major high risk surgery: general, orthopedic, urological, neurological, gyneco­logical, and trauma. The Panel found external pneumatic compression an effective and safe modality in these surgical categories.
8
found

Contraindications

The VenaFlow system should not be used by persons with known or sus­pected deep vein thrombosis, 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 system where increased venous or lymphatic return is undesirable.
VenaFlow
®

Cuff Features

Comfort All cuffs are made from lightweight, hypoallergenic fabric. This
material is very breathable and encourages evaporation to keep the pa­tient cool and comfortable.
• Asymmetric Compression All cuff designs ap-
ply focused pressure, maximizing blood velocity and total flow.
• Seamless Duplex™ Aircell design
In both the Calf and Foot Cuff de­signs, the proximal aircell overlaps the distal, providing consistent, un­interrupted compression.
(see Evaporation Rate Chart below)
Breathable Fabric
.
Aircell
5
14
12
10
8
Hours
6
4
2
0
Evaporation Rate for Calf Cuff
Sock Only
VenaFlow Brand X Brand Y
Duplex Aircell Design
In tests to compare evaporation, a wet sock with 50 cc’s of moisture was placed on an artificial leg. With nothing covering the sock, it took 6.4 hours to lose half its moisture. The test was repeated on each of the three products.
6

Pump Features

VenaFlow
®
system
Top View
Top Panel
Front View
with gray face
{
or
with black face
Proximal Output
Distal Output
COUNTER
COUNTER
VenaFlow
COUNTER
VenaFlow
PRESSURE-mmHg/ALARM
®
system
PRESSURE-mmHg / ALARM
®
system
COUNTER
RESET
RESET
ON / OFF
ALARM RESET
ON
ALARM RESET
OFF
Power Cord
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