PROBLEM CAUSE ACTION:

1. The system fails to work. A vacuum lock may exist in the reservoir. Press and hold the lever or disconnect the luer connector to release the vacuum.

The system is damaged. If necessary, replace the system. See To Remove/Replace the System.

2. The vacuum indicator The vacuum control dial may not be turned on. Turn the vacuum control dial to the prescribed setting.fails to invert. The system may have an air leak. Inspect all connections. Make all connections air tight. If air leak is suspected,

contact a physician. Reinfusion is contraindicated.

The system air filter may be saturated or the system is damaged. If necessary, replace the system. See To Remove/Replace the System.*

3. Minimal or no blood is Wound drain tubing or evacuator tubing may be blocked. Knead the tubing to stimulate flow. Turn the vacuum control dial to a higher vacuum setting.collected by the system. Clots may be in the Y-connector. Knead the clots through the Y-connector.

The system reservoir is located Relocate the system at or below the wound site. Turn the vacuum control above the wound site. dial to a higher vacuum setting.

The system may have an air leak. Inspect all connections. Make all connections air tight. If air leak is suspected, contact a physician. Reinfusion is contraindicated.

The wound drain may not be placed correctly. Contact physician to relocate wound drain.

The system pre-filter may be saturated If necessary, replace the system. See To Remove/Replace the System.or the system is damaged.

4. Blood clots appear in the A tourniquet was applied at the wound site and the vacuum control Replace the system. See To Remove/Replace the System.*system reservoir. dial was turned on too soon after the tourniquet was removed.

5. Blood fails to transfer from the A vacuum lock may exist in the reservoir. Pump the drain lever or hold down drain lever and knead the tubing to stimulate flow.system reservoir to the blood bag.

The blood bag is located above the system reservoir. Relocate the blood bag below the system reservoir.

The system air filter may be saturated or the system is damaged. Insert a needle into the vacuum indicator and press the drain lever to transfer the bloodfrom the reservoir. Replace the system. See To Remove/Replace the System.*

6. Blood fails to transfer from the blood The administration kit filter may not be primed or is air locked. Manually squeeze the blood bag until the blood begins to flow to the kit.bag to the administration kit.

7. Sporadic electrical Electrical noise is present. Turn off all electrical equipment not in use in the operating room.interference is experienced.

Relocate electrical equipment; increase spatial distance.

Plug operating room equipment into different operating room outlets.

RECOVERY

NOTE: Leave the blood bag banded until ready to transfer blood.

1. Secure unit to foot board or side rail of bed. Depress the mounting clamp to adjust its fit. Secure unit with thesecurity strap as shown.

WARNING: Unit must remain upright at all times.

2. Set vacuum to LOW ( I ) for the first 10 minutes.

3. Turn the vacuum adjustment knoblocated on top of the unit clockwise to set the vacuum level.

Approximate Vacuum Levels:

LOW ( I ) 0.5 psi (25mmHg)MEDIUM ( I I ) 1.0 psi (50mmHg)HIGH ( I I I ) <1.9 psi (<100mmHg)

4. Note that the vacuum indicator has inverted. This indicates vacuum within the reservoir.

5. Record start time and volume output on reservoir label.

BLOOD REINFUSION

1. Unband the blood bag and tubing. Hold the blood bag tubing so that it forms half of a loop at the base of the reservoir.

2. Fully depress and hold down the lever on top of the unit to transfer blood intothe blood bag. Once blood starts to flow, blood bag tubing can hang freely.

NOTE: An amount of fluid will remain in reservoir after transfer. This fluid maycontain fats which have risen to the top of the collected fluid and should not be reinfused.

3. When transfer is complete, release the lever and use the slideclamp to clamp off the blood bag tubing as close to the blood bag as possible.

4. Reinfuse with standard blood administration set. Use 20 or 40microaggregate filter as directed by hospital protocol.

NOTE: Saline is not required with the infusion of whole blood; however, it is useful in the initial venting and priming of the administration set and filter.

5. Repeat process for additional reinfusions.

4100 East Milham AvenueKalamazoo, MI 49001 USAt: 269 323 7700 f: 269 353 3026toll free: 800 253 3210

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CBCII ConstaVacTM

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or userinstructions before using any Stryker product. Products may notbe available in all markets. Product availability is subject to theregulatory or medical practices that govern individual markets.Please contact your Stryker representative if you have questionsabout the availability of Stryker products in your area.

Products referenced with TM designation are trademarks of Stryker.Products referenced with ® designation are registered trademarks of Stryker.

Literature Number: 1000-192-000 Rev. E UnDe/PS

Copyright © 2011 StrykerPrinted in USA

OPERATING INSTRUCTIONS

INDICATIONS FOR USE:

The CBCII is a closed blood recovery system used to post-operatively collect, filter, and allow for reinfusion of autologous blood.

CONTRAINDICATIONS

• Abnormal renal and/or hepatic function • Malignant lesions • Contamination/sepsis • Fluids unsuitable for reinfusion • Hemostatic agents • Excessive hemolysis • Coagulation disorders • Potential for air embolism, microembolism, fat embolism

WARNING: Reinfusion of topical hemostatic agents such as thrombin or AviteneTM is not recommended as they may initiate coagulation. Blood containing BetadineTM and similar wound irrigants, methyl methacrylate, and antibiotics not licensed for parenteral use should not be reinfused. If these substances are employed, the wound should be well irrigated with normal saline prior to closing the wound.

WARNING: Unit must remain upright at all times.Saturation of reservoir air filter (located on inner side of reservoir lid) may cause the filter to occlude and inhibit or prevent transfer of blood to reinfusion bag.

OPERATING ROOM

1. Remove contents from package using aseptic technique. NOTE: The blue cover should remain wrapped around the unit to reduce the chance of transfer of blood from the surgical field to the outer surface.

2. Slide evacuator tube (tube with Y-connector) from blue cover.

3. Pull needle through tissue and clip, leaving perforated tubing in wound site.

4. Trim Y-connector at proper level to accept wound drain outer diameter. Secure wound drain(s) to evacuator tube. NOTE: Ensure all connections are airtight.

5. DO NOT turn unit on until Y-connector is attached to the patient drain tube and tourniquet has been released for 15 minutes.

6. The unit may remain in the sterile field or be passed back to the circulating nurse. The circulating nurse can remove and discard the blue cover.

7. The unit may be hung on the bed rail and secured with the security strap for transport.

WOUND DRAINAGE

1. Discontinue use for reinfusion per hospital protocol orphysician’s discretion. Unit then functions as a wounddrainage receptacle.

The blood bag and associated tubing may be cut (or disconnected if using quick disconnect) approximately2” away from the reservoir and discarded. Cap the end of the tube remaining on the reservoir using the red cap.

2. Wound drainage output is measured directly from the reservoir.

NOTE: In the event that the reservoir requires emptying,the red cap is removed, the lever on the lid is depressed,and the blood is transferred into a separate container.

3. The unit may be ambulated in an upright position along with the patient .

NOTE: Emptying the reservoir is recommended prior topatient ambulation. This reduces the weight of the reservoirand risk of occluding the air filter.

4. The unit is discontinued for wound drainage per hospitalprotocol or physician’s discretion.

5. The drains are removed from the patient and, along with the unit disposed of properly.

UNIT REPLACEMENT

1. Using aseptic technique, clamp evacuator tube on each side of the quick-connect.

2. Twist quick-connect to separate evacuator tube.

3. Discard Y-connector portion of evacuator tube from new unit.

4. Attach quick-connect of new unit to quick-connect of evacuator tube attached to patient.

5. Set vacuum level at prescribed setting.

6. Unclamp evacuator tube.

For instructions on the following situations refer to “Directions For Use” packaged with each CBCII unit.

• Air leak• High drainage • No or low drainage

TROUBLESHOOTING GUIDE

For more information contact your local Stryker Sales Representative or call 1-800-253-3210

For quick and easy reference. In no way should this replace “Directions for Use” packaged with each CBCII unit.

WARNING: Adherence to “Universal Blood and Body Fluid Precautions” is highly recommended when handling the CBCII reservoir or any blood related product.

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Blood Conservation System

*For more information, see “Directions For Use” or call your Stryker Instruments Sales Representative orStryker Customer Service at 1-800-253-3210. (Outside U.S.A., contact your nearest Stryker Subsidiary)