Description

1.2 INTENDED USE

The A.T.S. 3000 Tourniquet System is intended to be used by

qualified medical professionals to temporarily occlude blood

flow in a patient’s extremities during surgical procedures

on those extremities. Tourniquets have been found useful in

producing a bloodless operation field in surgical procedures

involving the extremities including:

Reduction of certain fractures

Kirschner wire removal

Tumor and cyst excisions

Subcutaneous fasciotomy

Nerve injuries

Tendon repair

Bone grafts

Total wrist joint replacement

Replacement of joints in the fingers

Knee joint replacements

Amputations

Replantations

WARNING: Do not use tourniquet cuffs to control the

distal flow of CO

or any other gases used as a distention

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media. Tourniquet cuffs have not been evaluated for safety or

effectiveness in controlling gas flow beyond the surgical site

during arthroscopic insufflation procedures. Possible effects

of using a tourniquet cuff in this manner include serious

subcutaneous emphysema proximal to the cuff.

1.3 CONTRAINDICATIONS

The medical literature lists the following as possible

contraindications. However, in every case, the final

decision whether to use a tourniquet rests with the

attending physician.

Open fractures of the leg

Post-traumatic lengthy hand reconstruction

Severe crushing injuries

Elbow surgery (where there is excess swelling)

Severe hypertension

Skin grafts in which all bleeding points must be

readily distinguished

Compromised vascular circulation, e.g., peripheral

artery disease

Diabetes mellitus

The presence of sickle cell disease is a relative

contraindication. (See PRECAUTIONS IN USE.)

A tourniquet should also be avoided in patients who

are undergoing secondary or delayed procedures

after immobilization.

1.4 PRECAUTIONS IN USE

◆ The tourniquet system must be kept well calibrated

and in operable condition. Accessories should be checked

regularly for leaks and other defects.

◆ The tourniquet cuff must never be punctured; therefore

towel clips used near the system must be handled with

special care. Cuffs with inner rubber bladders must be

completely enclosed by the outer envelope to preclude

ballooning and possible rupture of the bladder. Cleaning and

assembly instructions of the cuff manufacturer should be

followed carefully.

◆ Do not use an elastic bandage for exsanguination in

cases where this will cause bacteria, exotoxins, or malignant

cells to spread to the general circulation, or where it could

dislodge thromboemboli that may have formed in the vessels.

◆ The tourniquet cuff must be applied in the proper

location on the limb, for a “safe” period of time, and within

an appropriate pressure range. Never apply a tourniquet

over the area of the peroneal nerve or over the knee or

ankle. Do not readjust an already inflated cuff by rotating it

because this produces shearing forces which may damage the

underlying tissue.

◆ Prolonged ischemia may lead to temporary or permanent

damage to tissues, blood vessels, and nerves. Tourniquet

paralysis may result from excessive pressure. Insufficient

pressure may result in passive congestion of the limb with

possible irreversible functional loss. Prolonged tourniquet

time can also produce changes in the coagulability of the

blood with increased clotting time.

◆ Inflation should be done rapidly to occlude arteries and

veins as near simultaneously as possible.

◆ Careful and complete exsanguination reportedly

prolongs pain free tourniquet time and improves the quality

of Intravenous Regional Anesthesia, (Bier Block anesthesia).

In the presence of infection and painful fractures, after

the patient has been in a cast, and in amputations because

of malignant tumors, exsanguination before tourniquet

application may be done without the use of an elastic

bandage by elevating the limb for 3 to 5 minutes.

◆ In case of failure, the tourniquet cuff must be fully

deflated and the limb exsanguinated again before reinflation.

Reinflation over blood-filled vasculature may lead to

intravascular thrombosis.

◆ Tourniquet users must be familiar with the inflation-

deflation sequence when using a dual-cuff tourniquet or two

tourniquet cuffs together for IVRA (Bier Block anesthesia),

so that the wrong tourniquet will not be released accidentally.

◆ Test for hemoglobin type and level before using a

tourniquet on patients with sickle-cell anemia. When the

tourniquet is used for these patients, the limb should be

carefully exsanguinated and the PO2 and pH should be

closely monitored.

◆ Select the proper cuff size to allow for an overlap of

about 3 to 6 in. (7.6–15 cm). Too much overlap may cause

cuff rolling and telescoping, and may lead to undesired

pressure distribution on the limb. The skin under the

tourniquet cuff must be protected from mechanical injury by

smooth, wrinkle-free application of the cuff.

If the tourniquet cuff is applied over any material that

may shed loose fibers (such as Webril) the fibers may

become embedded in the contact closures and reduce their

effectiveness. As an under padding, a section of stockinette

may be used. The deflated cuff and any underlying

bandage or protective sleeve should be completely

removed as soon as tourniquet pressure is released.

After the cuff has been fully deflated and removed from

the patient, the unit can be set to STANDBY. Even the

slightest impedance of venous return may lead to congestion

and pooling of blood in the operative field.

◆ If skin preparations are used preoperatively, they should

not be allowed to flow and collect under the cuff where they

may cause chemical burns.

◆ Whenever the tourniquet cuff pressure is released, the

wound should be protected from blood surging back by

applying pressure dressings and, if necessary, elevating the

limb. Transient pain upon tourniquet pressure release can be

lessened by elevation of the limb. If full color does not return

within 3 to 4 minutes after release, the limb should be placed

in a position slightly below body level.

◆ Whenever IVRA, Bier Block anesthesia, is used, it is

recommended that the tourniquet remain inflated for at least

20 minutes from the time of injection.

◆ WARNING: Cuffs will not deflate in STANDBY

mode. Ensure cuffs are fully deflated before setting the

unit to STANDBY.

1.5 ADVERSE EFFECTS

A dull aching pain (tourniquet pain) may develop throughout

the limb following use.

hypercarbia, and acidosis of the tissues occur and become

significant after about 1 1/2 hours of tourniquet use.

Symptoms of tourniquet paralysis are motor paralysis

and loss of sense of touch, pressure, and proprioceptive

responses.

Intraoperative bleeding may be caused:

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Pathophysiologic changes due to pressure, hypoxia,

1.

By the slight impeding effect exerted by an

unpressurized cuff (and its padding, if used),

which prevents venous return at the beginning of

the operation.

2.

By blood remaining in the limb because of

insufficient exsanguination.

3.

By inadequate tourniquet pressure (between systolic

and diastolic blood pressure of the patient), or slow

inflation and deflation, all of which allow arterial

blood to enter while preventing venous return.

4.

By blood entering through the nutrient vessels of the

long bones, such as the humerous.