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GENERAL INFORMATION
GENERAL INFORMATION
APPLICATION SPECIFICATION
The application specifi cation for the
A.T.S.
4000TS including characteristics related to the use of the device, intended
use, intended patient population, intended part of the body, intended user profi le, intended conditions of use and
operating principles is contained in this manual.
INTENDED USE
The
A.T.S.
4000TS Tourniquet System is intended to be used by qualifi ed medical professionals to temporarily occlude
blood fl ow in a patient’s extremities during surgical procedures on those extremities. Tourniquets have been found
useful in producing a bloodless operation fi eld in surgical procedures involving the extremities including:
•
Reduction of certain fractures.
•
Kirschner wire removal.
•
Subcutaneous fasciotomy.
•
Nerve injuries.
•
Bone grafts.
•
Total wrist joint replacement.
•
Knee joint replacements.
•
Amputations.
•
Tumor and cyst excisions.
•
Tendon repair.
•
Replacement of joints in the fi ngers.
•
Replantations.
WARNING:
Do not use Tourniquet cuffs to control the distal fl ow of CO
2
or any other gases used as a
distention media. Tourniquet cuffs have not been evaluated for safety or effectiveness in controlling gas
fl ow beyond the surgical site during arthroscopic insuffl ation procedures. Possible effects of using a
Tourniquet cuff in this manner include serious subcutaneous emphysema proximal to the cuff.
CONTRAINDICATIONS
The medical literature lists the following as possible contraindications:
•
Open fractures of the leg.
•
Post-traumatic lengthy hand reconstruction.
•
Severe crushing injuries.
•
Elbow surgery (where there is excess swelling).
•
Severe Hypertension.
•
Diabetes mellitus.
•
Skin grafts in which all bleeding points must be
readily distinguished.
•
Compromised vascular circulation, e.g., peripheral
artery disease.
•
The presence of sickle cell disease is a relative
contraindication (See PRECAUTIONS IN USE).
CAUTION:
•
In every case, the fi nal decision whether to use a Tourniquet rests with the attending physician.
•
A Tourniquet should also be avoided in patients who are undergoing secondary or delayed procedures
after immobilization.
•
Certain physiologic or anatomical conditions, including small fi ngers and toes of infants and children, may
prevent the A.T.S. 4000TS from making a determination of LOP, in which case the instrument will display an
appropriate message and will terminate the attempt to measure LOP. In that event, the physician’s judgment
should be used to set Tourniquet pressure in the absence of the LOP feature.