kENDALL SCD EXPRESS - Indications and Contraindications; Leg Compression Indications; Foot Compression Indications; Leg Compression Contraindications

EN-1
Indications
The SCD EXPRESS
TM
Compression System is designed to apply intermittent pneumatic compression to increase venous blood flow in
at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The System consists of the Controller, the Tubing Sets (provided
with the Controller) and single-patient use garments (purchased separately from this Controller). The garments, both leg sleeves and foot cuffs,
compress the limbs to enhance venous blood movement. After the compression, the Controller measures the time it takes for the limbs to refill with
blood and waits that period of time before the next compression is initiated.
Leg Compression
The use of the SCD EXPRESS Compression System with Leg Sleeves is indicated for:
1. Deep vein thrombosis and pulmonary embolism prophylaxis.
Foot
Compression
The use of the SCD EXPRESS Compression System with Foot Cuffs is indicated for:
1. Circulation enhancement. 5.
E
xtremity pain incident to trauma or surgery.
2.
Deep vein thrombosis prophylaxis.
6.
L
eg Ulcers.
3. Edema - Acute. 7.
V
enous stasis / venous insufficiency.
4. Edema - Chronic.
If you need further
information regarding the SC
D EXPRESS Compression System or its clinical benefits, please contact your
Contraindications
Leg Compression
The SCD EXPRESS Compression System
may not
be recommended for use with Leg Sleeve on patients with the following:
1. Any local leg condition in which the sleeves may interfere, such as: (a) dermatitis, (b) vein ligation [immediate postoperative], (c) gangrene, or
(d)
recent skin graft.
2. Severe arteriosclerosis or other ischemic vascular disease.
3. Massive edema of the legs or pulmonary edema from congestive heart failure.
4. Extreme deformity of the leg.
5. Suspected pre-existing deep venous thrombosis.
Foot Compression
The SCD EXPRESS Compression System
may not
be recommended for use with Foot Cuffs on patients with the following:
1. Conditions where an increase of fluid to the heart may be detrimental.
2. Congestive heart failure.
3. Pre-existing deep vein thrombosis, thrombophlebitis or pulmonary embolism.
Use with caution on the infected or insensitive extremity.
Cautions
1. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
2. Patients with diabetes or vascular disease require frequent skin assessment.
3. Explosion hazard. Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
WARNING:
Do not attempt to repair or replace broken tubing connect
ors as hazardou
s
inflation of
the sleeves may occur
.
K
endall’s SCD EXPRESS Compression System is protected by one or more of the following U.S. patents: 5,022,387; 5,031,604;
5,478,119; 5,876,359;
Des.363,988; Des.364,460; Des.369,664; Des.373,192. Other patents pendi
ng.
Tyco Healthcare
expressly states that no implied license with respect to
use of non-Tyco Healthcare components is grante
d by the sale or lease of this system.
The use of
an intermittent pneumatic compression controller with a compression garment to measure venous refill time in a limb, without permission
from Tyco H
ealthcare Group LP,
may constitute infring
ement
of Tyco Healthcare’s U.S. Patent No. 6,231,532.