Delfi Portable Tourniquet System (P.t.s.) General Information; Intended Use; Contraindications; Precautions In Use - Delfi P.T.S. Operator And Maintenance Manual

SECTION 1.0:
GENERAL INFORMATION
NOTE: Use this tourniquet system according to the policies in your practice setting. The following
information on intended use, precautions, contraindications, and adverse effects are offered as a
guide to assist in this process.
1.1

INTENDED USE

The Delfi Portable Tourniquet System (P.T.S.) is intended to be used by qualified medical professionals to
temporarily occlude blood flow in a patient's extremity during surgical procedures on that extremity.
Tourniquets are generally used for operations lasting less than 90 minutes. Tourniquets have been found
useful in producing a bloodless operation field in surgical procedures involving the extremities including:
- Reduction of certain fractures
- Tumor and cyst excisions
- Arthroscopy of certain joints
- Bone grafts
- Subcutaneous fasciotomy
- Tendon repair
WARNING: Do not use tourniquet cuffs to control the distal flow of CO
distention 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.
1.2

CONTRAINDICATIONS

Refer to the medical literature for possible contraindications to tourniquet use. A partial list is provided below,
however in every case the final decision to use a tourniquet rests with the attending physician.
- Open fractures of the leg
- Severe crushing injuries
- Severe hypertension
- Elbow surgery (where there is concomitant excess swelling)
- Skin grafts in which all bleeding points must be readily distinguished
- Compromised vascular circulation, e.g., peripheral artery disease
- Sickle cell disease or trait (relative contraindication, see PRECAUTIONS IN USE).
- Secondary or delayed procedures after immobilization.
1.3

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. Tourniquet pressure and the
time the tourniquet is inflated on the limb should both be minimized. There is additional potential risk
to superficial nerves in unprotected areas; never apply a tourniquet over an area where major nerves
may be directly compressed against bone (eg. peroneal nerve near the proximal head of the fibula).
Never apply a tourniquet over the joints of the limb. 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.
DELFI PORTABLE TOURNIQUET SYSTEM (P.T.S.)
- Kirschner wire removal
- Knee joint replacements
- Replacement of finger joints
- Amputations
- Nerve injuries
- Total wrist joint replacement
- Post-traumatic lengthy hand reconstruction
- Diabetes mellitus
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