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62288090010 (EN) Rev. D (August 2020) © 2012, 2020 Zimmer Surgical, Inc.
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Zimmer Surgical, Inc. 200 West Ohio Avenue Dover, Ohio 44622 USA (800) 830-0970 www.ZimmerBiomet.com BIOMET GSCC B.V. Hazeldonk 6530 4836 LD Breda The Netherlands
ZIMMER® A.T.S.® CYLINDRICAL TOURNIQUET CUFF
IMPORTANT! READ THIS INFORMATION BEFORE USING CUFF AND SAVE FOR FUTURE REFERENCE
WARNING! Do not use tourniquet cuffs to control the distal flow of CO2 or any other gases used as a distention media. Tourniquet cuffs have not been evaluated for safety or effectiveness in controlling gas flow. The effects of using a tourniquet cuff in this manner include serious subcutaneous emphysema proximal to the cuff. PRECAUTlONS When using a tourniquet on patients with sickle-cell disease or trait, severe post-operative pain may result in the operative limb from sickling of cells.
PRODUCT DESCRIPTION Tourniquet cuff consisting of a sealed black envelope (brushed nylon on the patient side), contact closure material running the full outside length of the tourniquet cuff and extending sufficiently beyond to provide a primary securing means, a secondary contact closure to provide positioning mechanism, positive CPC hose connectors and a flexible plastic liner.
Test for hemoglobin type and level before using a tourniquet on patients with sickle-cell disease or trait. Carefully exsanguinate the limb and closely monitor the patient’s PO2 and pH, since sickling is dependent on oxygen tension and pH.
The cuff is inflated by connecting it, via a hose assembly, to a tourniquet system. Refer to your tourniquet operator’s manual for proper use of your system. Dual bladder tourniquet cuffs require two hose assemblies to connect the bladders to the tourniquet system.
During exsanguination with an elastic bandage, maintain a safe zone of uncovered skin about 1 in. (2.5 cm) wide between cuff and bandage. This is necessary to prevent the cuff from slipping distally. Cuff effectiveness is also reduced if the bandage is wound up to the cuff.
The cuffs are available in a selection of lengths to facilitate proper size selection. INDICATIONS AND USAGE Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single cuff tourniquets are generally used for operations lasting less than 90 minutes.
Careful and complete exsanguination reportedly prolongs pain-free tourniquet time. However, partial exsanguination may be desirable in certain cases where residual blood flow will aid in visualization and identification of vascular structures.
Tourniquets are useful in surgical procedures involving the extremities, such as: Reduction of certain fractures Bone grafts Kirschner wire removal Amputations Tumor and cyst excision Subcutaneous fasciotomy Knee joint replacements Nerve injuries Arthroscopy of certain joints Tendon repair Replacement of joints of the fingers Total wrist joint replacement
In the presence of infection and painful fractures, after the patient has been in a cast, or in amputations because of malignant tumors, exsanguination before tourniquet application must be done without an elastic bandage by elevating the limb for 3 to 5 minutes.
CONTRAINDICATIONS The medical literature lists the following as possible contraindications:
Do not allow preoperative skin preparations to flow and collect under the cuff where they may cause chemical burns. A distal seal to prevent fluids form flowing beneath the cuff is recommended.
Do not use an elastic bandage for exsanguination in cases where bacteria, exotoxin, or malignant cells could be spread to the general circulation, or where it could dislodge thrombi that may have formed in the vessels.
Open fractures of the leg
Inflation must be done as rapidly as possible to occlude arteries and veins simultaneously, and to avoid return of blood into the limb. Quick deflation aids in preventing engorgement.
Post-traumatic lengthy hand reconstruction Severe crushing injuries
Heat generated by surgical lights or powered instruments is not dissipated in limbs under tourniquet control, and tissue may be subject to drying or trauma. Frequent irrigation, special draping, and low-power surgical lights are recommended to reduce the risk of thermal damage.
Elbow surgery (where there is concomitant excess swelling) Severe hypertension Skin grafts in which all bleeding points must be readily distinguished Comprised vascular circulation, e.g., peripheral artery disease
Prolonged ischemia may lead to temporary or permanent damage to tissues, blood vessels, and nerves. Tourniquet paralysis may result from either excessive or insufficient pressure. The latter is considered more dangerous, resulting in passive congestion with possible irreversible functional loss. Prolonged tourniquet time can also produce changes in the coagulability of the blood with an increase in clotting time. In severe cases, pooling of blood in the edemic limb may cause cardiac arrest and death.
Diabetes mellitus The presence of sickle cell disease is a relative contraindication (See PRECAUTIONS). WARNINGS Maximum cuff pressure must not exceed 600 mmHg.
In case of incomplete or improper inflation, the tourniquet cuff must be fully deflated and the limb exsanguinated again before cuff reinflation. Reinflation over blood-filled vasculature may lead to intravascular thrombosis.
This product is subject to wear and deteriorates with use. It is essential to inspect this device before each use (See UTILIZATION for instructions on inspection). If the cuff fails to pass inspection, it is no longer usable and must be discarded. Use of a damaged cuff could result in one or more of the following events: loss of cuff pressure; release of the cuff from around the patient’s limb; movement of the cuff on the patient’s limb; excessive leakage of cuff pressure; or pinching of tissue under the cuff. Some of these failures could cause catastrophic injury, including death, to the patient by releasing blood into the surgical site or anesthetic into other parts of the body.
Whenever the tourniquet cuff pressure is released, the wound must be protected from blood resurgence by applying pressure dressings and, if necessary, elevating 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. Completely remove the deflated cuff and any underlying padding immediately following final cuff deflation. Even the slightest impedance of venous return may lead to congestion and pooling of blood in the operative field.
Zimmer does not recommend applying the cuff to the skin without limb protection. Zimmer strongly recommends the use of a limb protection sleeve.
Tourniquet users must be familiar with the inflation-deflation sequence when using a dual bladder cuff or using two single bladder cuffs together (see UTILIZATION), so that the wrong bladder or cuff will not be released accidentally, which could cause severe injury to the patient or death.
The cuff should only be connected to a tourniquet controller known to be in operable condition. Refer to your tourniquet controller operator’s manual for information on testing and maintenance. The tourniquet cuff must be applied at the proper location on the limb for an appropriate time, and within the appropriate pressure range (See UTILIZATION). Application of the tourniquet cuff over the peroneal nerve (the knee or ankle), or the ulnar nerve (the elbow) may produce nerve/bone impingement resulting in nerve damage or paralysis.
Whenever infiltration anesthesia is used, it has been suggested in published literature that the tourniquet remain inflated for a minimum of 15 minutes from the time of injection to ensure that most of the anesthetic agent has been absorbed into the limb tissue. For a procedure requiring only a few minutes, too rapid a release of the anesthetic agent can be prevented by quickly deflating and reinflating the tourniquet several times.
Do not readjust an already positioned tourniquet cuff by rotation. Rotation produces shearing forces which may damage the underlying tissues. Never puncture the cuff. Towel clips used near the cuff must by handled with care. Excessive compression by a leg holder may damage the cuff.
ADVERSE EFFECTS A dull, aching pain (tourniquet pain) may develop throughout the limb following use. Stiffness, weakness, reactive hyperemia, and skin discoloration may also occur to some degree in all patients after tourniquet use.
Application of the cuff in a smooth, wrinkle-free manner helps reduce the chances of mechanical injury to the skin, including blistering.
Pathophysiological changes due to pressure, hypoxia, hypercarbia, and acidosis of the tissue occur and become significant after about 1-1/2 hours of tourniquet use. Symptoms of tourniquet paralysis are: motor paralysis and loss of the sense of touch, pressure, and proprioceptive responses. Page 1/2
Intraoperative bleeding may be caused: 1. By the slight impeding effect exerted by an underpressurized cuff (and 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 flow to enter while preventing venous return (See UTILIZATION). 4. By blood entering through the nutrient vessels of the long bones (such as the humerus).
Pressure Settings: For each patient, the tourniquet pressure should be set to the minimum effective pressure. The minimum effective pressure should be determined by taking into account factors such as: 1. Whether the cuff is to be applied to an upper or lower limb 2. Whether the limb is normal, hypertrophied or obese 3. The patient’s preoperative systolic pressure 4. The maximum anticipated rise in systolic pressure during the surgical procedure 5. The presence of hypertension
UTILlZATION Inspection Before Use: This product is subject to wear and deteriorates with use. It is essential to inspect the cuff before each use.
It has been suggested in published literature that for normal patients, effective tourniquet operation may be achieved at pressure settings of 75–100 mmHg above the preoperative systolic pressure for upper limbs, and two times the preoperative systolic pressure for lower limbs when using single bladder cuffs.
The following is a list of items to check. 1. Is there any physical damage (rips, tears, holes, etc.) to the cuff? 2. Is (are) the CPC connector(s) bent, broken or worn? 3. Is the ribbon torn or the ribbon stitching broken? 4. Is the hook and loop strapping torn or is any of the strap stitching broken? 5. After cleaning, is more than 25% of the contact closure embedded with fibers that cannot be removed? 6. Connect the cuff to a tourniquet regulator, wrap the cuff onto itself, and inflate the cuff. Are there any leaks in the cuff or connectors? 7. Is there any other physical change or damage to the cuff which would compromise the cuff’s ability to maintain occlusion during a surgical procedure?
Because the bladders on dual bladder cuffs are narrower, higher pressures will be required to achieve and maintain occlusion. It has been suggested in some literature that for an upper limb, 300 mmHg is a minimum pressure setting when using a dual bladder cuff.
If any of the above conditions is present, the cuff is no longer usable and must be discarded. (See WARNINGS for a description of the possible consequences of using a damaged cuff.) These consequences include the possibility of catastrophic injury, including death, to the patient due to the release of blood into the surgical site or anesthetic into other parts of the body.
There is also general agreement that, for reasonable healthy adults, two hours should not be exceeded without releasing the tourniquet to allow blood circulation to the limb for about 15 to 20 minutes. During this time, the limb should be elevated about 60 degrees with steady pressure applied to the incision with sterile dressing.
Inflation time: Tourniquet inflation time depends greatly on the patient’s anatomy, age, and absence of vascular disease. A physician needs to determine when the tourniquet is to be inflated, to what pressure, for what time duration, and at what point in the operation the tourniquet should be released. In many operating rooms, it is customary to prominently note the time of inflation and to warn the physician after a certain elapsed time period so that the need for further tourniquet time can be assessed.
Cuff Removal: Whenever the tourniquet pressure is released, the wound must be protected from blood surging back by applying pressure dressings and, if necessary, elevating the limb. Transient pain upon tourniquet 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.
Proper Size Selection: Prior to cuff application, measure the circumference of the patient’s limb at the point where the proximate edge of the cuff will be. The following chart shows the proper size of single bladder cuffs. Limb Circumference 4.0 – 5.0 in. (10.0 – 13.0 cm) 6.0 – 9.0 in. (15.0 – 23.0 cm) 12.0 – 15.0 in. (31.0 – 38.0 cm) 18.0 – 21.0 in. (46.0 – 53.0 cm) 24.0 – 27.0 in. (61.0 – 69.0 cm) 28.0 – 31.0 in. (71.0 – 79.0 cm) 36.0 – 39.0 in. (91.0 – 99.0 cm)
Recommended Cuff Size 8 in. (20 cm) 12 in. (30 cm) 18 in. (46 cm) 24 in. (61 cm) 30 in. (76 cm) 34 in. (86 cm) 42 in. (107 cm)
It is best to remove the tourniquet cuff and any underlying padding immediately following final deflation to prevent venous congestion. The time of tourniquet removal should be noted, and the circulation of the limb should be checked. DUAL BLADDER CUFFS The selection of the proper dual bladder cuff size is similar to that for single bladder cuffs. Measure the patient’s limb at the point where the proximal edge of the cuff will be. The following chart shows the proper sizing of dual bladder cuffs.
Selection of a cuff that is too small may result in the ends of the bladder not overlapping and the cuff’s inability to sustain occlusion, possibly resulting in venous engorgement. Selection of a cuff that is too large results in excessive bladder overlap which reduces the effectiveness of the cuff and may cause the cuff to move distally (“walk”) on the patient’s limb, possibly resulting in loss of full occlusion.
Limb Circumference 6.0 – 9.0 in. (15.0 – 23.0 cm) 12.0 – 15.0 in. (31.0 – 38.0 cm) 18.0 – 21.0 in. (46.0 – 53.0 cm)
The 8 in. (20 cm) tourniquet cuff is intended for thin or small limbs. Generally, it is used with lower inflation pressures than the other size cuffs.
Recommended Size Cuff 12 in. (30 cm) 18 in. (46 cm) 24 in. (61 cm)
During cuff application, each bladder should be individually fitted to the shape and circumference of the patient’s limb. The dual bladder cuff is connected to the tourniquet controller via two hose assemblies. Consult the operator’s manual for your tourniquet regulator for more information on this connection and any adapters that may be required. The general procedure for the use of a dual bladder cuff is to fully exsanguinate the limb, inflate the proximal cuff, and after it reaches the pressure setpoint, to inject the regional anesthetic.
Cuff Application: In most cases, a cuff should be applied at the widest part of the limb to allow as much tissue as possible to lie between the cuff and any nerves or vascular structures susceptible to damage. The optimum positions are the upper arm and the proximal third of the thigh. The cuff should be applied so as to avoid being compressed by a leg holder. Excessive compression by a leg holder may damage the plastic liner of the cuff.
IMPORTANT! Before the anesthetic agent is injected, full occlusion should be verified by palpation of the radial artery and/or auscultation. This ensures the pressure setting and cuff application for that patient is correct and successful.
After the cuff is found to be leak-free, apply it smoothly, without wrinkles. Place the valve stem(s) and tube connection(s) so that the tubing will not be kinked when the limb is positioned for surgery.
When the patient becomes uncomfortable from tourniquet pain, the distal cuff (which is over an anesthetized area) is inflated. When the distal cuff is fully inflated, the proximal cuff is then deflated. This procedure is only a general guideline and may differ in your institution.
Apply the cuff snugly. A cuff that is applied too loosely will reduce the effectiveness of the selected pressure. The hook strap must be pressed firmly against the loop material on the cuff surface along the entire length of the strap.
Whenever intravenous regional anesthesia is used, it has been suggested in published literature that the tourniquet remain inflated for a minimum of 15 minutes from the time of injection to ensure that most of the anesthetic agent has been absorbed into the limb tissue. For a procedure requiring only a few minutes, too rapid a release of the anesthetic agent can be prevented by quickly deflating and reinflating the cuff several times or by decreasing cuff pressure.
Loose fibers in the strap must be removed prior to cuff application since these fibers will reduce the effectiveness of the strap; if more than 25% of the hook is embedded with fibers that cannot be removed, the cuff is no longer usable and must be discarded. After application of the cuff, the ribbon is tied to prevent strap or cuff movement during the procedure.
CLEANING The tourniquet cuff may be cleaned in lukewarm water and an alkaline detergent (formulated to possess good blood dissolving characteristics) and rinsed thoroughly. A soft hand brush may be used to remove encrusted material. The cuff may also be wiped with isopropyl alcohol. The cuff should not be immersed. Presence of fluid in the bladder may damage the tourniquet controller.
Connect the cuff to the tourniquet controller using a hose assembly. Note that the hose assembly has CPC connectors on one end to match the cuff port(s), and connector(s) on the other end to match the tourniquet controller. For procedures that require a dual bladder cuff or two single bladder cuffs, use two hose assemblies.
The cleaned cuff should be allowed to drip dry at room temperature. If loose fibers are present in the contact closure straps, the fibers may be removed using a non-metallic brush or comb in a side to side manner.
The limb is then prepared and draped for surgery. Establish the viability of the skin and deeper tissues prior to exsanguination of the limb and tourniquet inflation. Exsanguinate the limb by elevating it for a minimum of 2 minutes and wrapping it, starting from the distal and progressing to the proximal part, using an Esmarch, Martin, or other elastic bandage. The bandage should come up approximately to 1 in. (2.5 cm) from the edge of the tourniquet cuff. The elastic bandage is removed following rapid inflation of the cuff.
The cuff cannot be sterilized by gas or steam methods. STORAGE Store the tourniquet cuff in a clean, dry area. Do not store the cuff wet. Store the cuff laying flat or in a loose roll. Do not roll the cuff tighter than a 5 in. (12.7 cm) diameter. Protect the internal stiffener from bending, folding, or buckling during storage.
Refer to your tourniquet controller operator’s manual for information on the proper use of your system. If skin preparations are used preoperatively, do not allow them to flow and collect under the cuff where they may cause chemical burns. In addition, soaking of the contact closure straps by fluids may reduce their effective strength. The cuff may be draped to prevent contact with preoperative solutions.
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