Zimmer A.T.S. 2000, Operators & Service Manual

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CONTROLS:
On/Standby Switch:
Applies power to unit / sets unit to
STANDBY
Pressure Touch-Switches:
Increase or decrease pressure set points.
Time Touch-Switches:
Increase or decrease the time alarm set points.
Cuff Touch-Switches:
Control inflation or deflation of the main cuff and/or sec-
ond cuff.
Alarm Silence Switch:
Allows operator to manually silence certain alarms for
30 seconds.
DISPLAYS:
Pressure:
Red 14 segment light emitting diodes (LED)
Time:
Red 14 segment light emitting diodes (LED)
AC Indicator Light:
Green LED
UL 60601-1 Classification:
Class I and Internally Powered, Type B, continuous opera-
tion. Use ordinary protection against ingression of liquids.
Not for use with flammable anesthetic or gases.
The
A.T.S. 2000 Tourniquet System complies with EMC
criteria set forth in IEC 60601-1-2.
1.3 INTENDED USE
The A.T.S. 2000 Tourniquet System is intended to be used
by qualified medical professionals to temporarily occlude
blood flow in a patient’s extremities during surgical proce-
dures 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 of the fingers
• Knee joint replacements
• Amputations
• Replantations
WARNING: Do not use tourniquet cuffs to control the distal
flow of CO
2
or any other gases used as distention media.
Tourniquet cuffs have not been evaluated for safety or ef-
fectiveness 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.
1.4 CONTRAINDICATIONS
The medical literature lists the following as possible con-
traindications. However, in every case, the final decision
whether to use a tourniquet rests with the attending physi-
cian.
•
Open fractures of the leg
• Post-traumatic lengthy hand reconstruction
• Severe crushing injuries
• Elbow surgery (where there is concomitant 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 contra-
indication. (See PRECAUTIONS IN USE.)
A tourniquet should also be avoided in patients who are
undergoing secondary or delayed procedures after immobi-
lization.
1.5 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 should never be punctured. There-
fore, 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 manu-
facturer should be followed carefully.
•
Do not use an elastic bandage for exsanguination in
cases where this will cause bacteria, exotoxins, or ma-
lignant 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 loca-
tion on the limb, for a “safe” period of time, and within
an appropriate pressure range. Never apply a tourni-
quet 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 perma-
nent damage to tissues, blood vessels, and nerves.
Tourniquet paralysis may result from excessive pres-
sure. Insufficient pressure may result in passive con-
gestion 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 pro-
longs pain free tourniquet time and improves the quality
of IVRA (Bier Block anesthesia). In the presence of in-
fection 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.