Thoratec Centrimag Blood Pump

CentriMag® Blood Pump

INSTRUCTIONS FOR USE (IFU)

READ ENTIRE CONTENTS PRIOR TO USING THE BLOOD PUMP

Thoratec Clinical & Technical Support Phone number(s)

Emergency HeartLine™ USA: Tel: +1-800-456-1477 United States Thoratec Corporation Tel: +1-925-847-8600 Main Switchboard: Fax: +1-925-847-8574

Emergencies outside USA: Tel: +1-925-847-8600 Outside United Urgent/24-Hour Europe: Tel: +44 (0) 7659 877901 States Thoratec Switzerland Tel: +41 (0) 44 275 7171 Main Switchboard: Fax +41 (0) 44 275 7172

Manufacturer: US Headquarters: Thoratec Switzerland GmbH Thoratec Corporation Technoparkstrasse 1 6035 Stoneridge Drive CH-8005 Zürich Pleasanton, CA 94588 Switzerland USA www.thoratec.com www.thoratec.com

PL-0070 Rev 04 January 2013 DCO No 13-080

SUPPLIED STERILE AND READY FOR USE – INTENDED USE/INDICATIONS DO NOT USE IF PACKAGING IS DAMAGED OR ANY STERILE SEALS ARE BROKEN. The Thoratec CentriMag Blood Pump is indicated for use only with the Thoratec Console to pump WARNING (Definition) blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods Warnings are used if there is a potential for appropriate to cardiopulmonary bypass (up to six a serious hazard with misuse of the device, hours). It is also indicated for use in when special attention is required for extracorporeal support systems (for periods up to safety of the patient, or when special care six hours) not requiring complete should be exercised to prevent improper cardiopulmonary bypass (e.g. valvuloplasty, operation of the device that may cause circulatory support during mitral valve damage. reoperation, surgery of the vena cava or aorta, liver transplants etc.) This device is not designed, sold, or intended for use except as indicated. CAUTION (Definition) CONTRAINDICATIONS Cautions are used to alert the user to exercise special care for the safe use of This Thoratec CentriMag Blood Pumping System the device. is contraindicated for use as a cardiotomy suction device. It is also contraindicated for patients who are unable or unwilling to be treated DESCRIPTION with heparin.

The Thoratec CentriMag Blood Pump has a WARNINGS spinning impeller that imparts rotary motion to the incoming blood, directing it through the 1. The Pump has not been qualified through in outflow port. The CentriMag Blood Pump is vitro, in vivo, or clinical studies for long-term intended for use in extracorporeal circulation use (longer than six hours) as a bridge-to- procedures and is designed to move blood by transplant or for pending recovery of the centrifugal force created by the rotating impeller. natural heart. The system is designed to allow improved blood handling and to decrease trauma, which may be 2. Instructions for Use and Manuals for all associated with extracorporeal circulatory related Thoratec extracorporeal devices support during cardiopulmonary bypass, by should be read prior to use. magnetically levitating the impeller and by eliminating seals and bearings. All pumps are 3. Possible side effects include, but are not sterilized before shipment. limited to: Infection, mechanical failure, hemolysis and thromboembolic phenomena. These are potential side effects with all extracorporeal blood systems.

4. Ensure that the Pump and circuit have been debubbled and primed properly prior to beginning bypass to minimize the risk of air reaching the patient. The use of an arterial filter is recommended.

5. Massive air entry into the Pump will cause the Pump to deprime and blood flow to stop. Stop the Pump and remove air prior to resuming circulation. Figure 1 – CentriMag Blood Pump 6. Do not expose to chemical agents as they may affect the integrity of this device. The CentriMag Blood Pump couples to a Anesthesia solutions such as forane are magnetic drive motor and console. The Blood known to degrade polycarbonate plastics. Pump, magnetic drive motor and console Avoid contact with these solutions with the comprise the Thoratec CentriMag Extracorporeal CentriMag Blood Pump. Blood Pumping System. 7. To prevent backflow of the patient’s blood This device is not designed or intended for use when the pump outlet tubing is open, except as indicated. establish and maintain a minimum pump Thoratec CentriMag® Blood Pump IFU Page 2 of 7 © 2013 Thoratec Switzerland GmbH – Document No PL-0070, Rev 04 (October 2013) speed that overcomes line and patient with attendant risk of death or severe bodily resistance. Failure to do this could allow injury. A massive air embolus will deprime retrograde flow and exsanguinate the patient. the Pump, halting outflow.

8. Arterial lines must be clamped when the 20. Do not restart the Pump if the Pump has Pump is at rest to prevent retrograde flow. been stopped for more than five minutes. The pump should also not be restarted after 9. It is intended that systemic anticoagulation it has stopped due to motor overheating. be utilized while this device is in use. Anticoagulation levels should be determined 21. Use of this Pump for periods longer than by the physician based on risks and benefits durations appropriate to cardiopulmonary to the patient. bypass procedures may result in pump failure, reduced pumping capacity, excessive 10. The Thoratec CentriMag Blood Pump is blood trauma, degradation of blood contact designed to be operated only with the materials with possibility of particles passing Thoratec drive console. There are no safety through the blood circuit to the patient, leaks, or performance data known to Thoratec and increased potential for gaseous emboli. which establishes compatibility of any other manufacturer’s devices or components to the CAUTIONS CentriMag Blood Pumping System. 1. Federal (U.S.A.) law restricts this device to 11. Potential risk to the patient should be sale, distribution and use by or on the order evaluated prior to changing the Pump. of a physician.

12. Frequent patient and device monitoring is 2. This device should only be used by persons recommended; do not leave the device thoroughly trained in extracorporeal unattended while in use. circulation procedures.

13. Do not use the CentriMag Blood Pump if the 3. Do not hit or strike the Pump with hands or Use By Date on the package has expired. instruments. Shock may cause damage to the device, which may cause device 14. Do not operate the Pump for more than 30 malfunction. seconds in the absence of flow. The temperature within the Pump will rise and 4. The CentriMag Blood Pump is sterile in an increased cellular damage and clotting may unopened and undamaged unit package. result. Inspect device and package carefully prior to use. Do not use if the unit package or the 15. The Pump must be handled and used in an product has been damaged or soiled. aseptic manner. 5. Each Pump is intended for single use only. 16. Do not operate the Pump with its inlet Do not resterilize. Resterilization by any clamped as a negative pressure would be means may cause severe damage to the generated in the Pump and air bubbles may device or its components. Dispose of safely be formed in the blood. after single use to avoid risk of infection.

17. The Pump contains a magnet. To avoid 6. Attach tubing in such a manner as to prevent injury, keep all sharp metal objects and kinks or any restrictions that may alter flow. instruments at least six inches away for the Pump. Do not remove the Pump from its 7. All tubing connections must be secured with inner tray until ready to insert into the motor standard sta-straps or tie wraps. receptacle. 8. Ensure the Pump is properly locked into the 18. If the Pump stops, clamp the venous and motor per the Directions for Use supplied arterial lines and check for air in the arterial with the Motor. line due to retrograde flow: remove air, attain a Pump speed adequate to overcome the 9. Monitor carefully for any signs of occlusion circuit resistance and then unclamp the lines. throughout the circuit.

19. Monitor the arterial line for air because the 10. Do not operate this Pump when unprimed as Thoratec CentriMag Blood Pump, similar to it may damage the impeller. other centrifugal pumps, will pump air. Stop infusion if air enters the Pump as gaseous 11. Run the Pump only on a properly maintained emboli may be introduced into the patient, Thoratec drive console and motor. Thoratec CentriMag® Blood Pump IFU Page 3 of 7 © 2013 Thoratec Switzerland GmbH – Document No. PL-0070, Rev. 04 (January 2013) 12. Do not use the Pump if dropped. Dropping or the fittings on the motor receptacle. Rotate other severe shock may cause damage counterclockwise until the Pump locks which could lead to device malfunction. securely into place. Thread the retaining screw clockwise to secure in place. The 13. Do not use excessive force to install tubing Pump must be fully seated into the on Pump as damage to Pump may occur. receptacle to function properly. To remove, unthread the retaining screw 14. Take care to prevent damage to connectors counterclockwise. Rotate the pump when repositioning prior to attaching tubing. clockwise until the grooves are matched. Lift and remove the pump. 15. Always have a spare CentriMag Blood Pump, back-up Console and equipment 3. Assemble the extracorporeal circuit; be sure available for change out. to connect the inlet and outlet tubing to the correct pump inlet and outlet. Connect 3/8 16. Do not place Pump near items adversely inch (9,5mm) Inner Diameter (ID) x minimum affected by magnetic fields. 3/32 inch (2,4mm) wall tubing from the reservoir outlet to the pump inlet. Attach 3/8 17. Monitor the Pump and replace it if there are inch (9,5mm) ID tubing to the pump outlet. fluid leaks or noisy operation. Band all connections.

PUMP SETUP AND OPERATION 4. Note: If a roller Pump is used for standby equipment, leave sufficient tubing so that the The CentriMag System is designed to be Blood Pump line can be placed in the roller operated safely during use of ESU’s Pump. (electrosurgery or electrocautery units). An ESU, a frequently used RF technology, is used to cut, RECOMMENDED PUMPHEAD PRIMING cauterize, fulgurate or desiccate tissue. Note: PROCEDURE ESUs have the potential for interfering with other medical devices found in the operating and ICU 1. With accepted aseptic technique, attach the room environment. appropriate tubing to the inlet and outlet of the Pump. (Applying a sterile saline solution If the CentriMag Primary or Back-Up Consoles to the inlet/outlet connectors may aid tubing are used concurrently with an Electrosurgery attachment.) unit, Thoratec recommends the user to read and follow the electrocautery manufacturer’s 2. Where practical, flush the circuit and the instructions for prevention of interference with Pump with CO2 (from filter or reservoir bag.) other electronic devices. 3. Fill the Pump with prime, by gravity, to a Follow the system preparation directions in the point beyond the flow probe and clamp. Operating Manual for the Thoratec CentriMag Eliminate air from the device by “walking” the drive console being used; inspect the complete air out of the inlet. system, do not use a malfunctioning or damaged system, then install the Pump as follows: CAUTION 1. Determine the proper position for the Pump in the extracorporeal circuit. During use, the Do not hit or strike the Pump with hands or Pump fills by gravity from the reservoir and instruments. Shock may cause damage to the by the gentle suction generated by the device, which may cause device malfunction. spinning impeller. To reduce the potential for air embolism from inadvertent emptying of the reservoir and subsequent introduction of air into the Pump, the Pump is typically WARNING positioned near and just below the outlet of the reservoir from which the blood will be Ensure that the Pump and circuit have been pumped. debubbled and primed properly prior to beginning bypass to minimize the risk of air 2. Mount the Pump on the drive motor. To do reaching the patient. The use of an arterial so, remove the Pump from the inner tray and filter is recommended. insert the Pump into the motor receptacle. Place the bottom of the Pump into the drive motor receptacle with the outlet port positioned in the large groove. Match the grooves on the periphery of the Pump with Thoratec CentriMag® Blood Pump IFU Page 4 of 7 © 2013 Thoratec Switzerland GmbH – Document No. PL-0070, Rev. 04 (January 2013) WARNING WARNING

Massive air entry into the Pump will cause Do not operate the Pump with its inlet the Pump to deprime and blood flow to stop. clamped as a negative pressure would be Stop the Pump and remove air prior to generated in the Pump and air bubbles may resuming circulation. be formed in the blood.

4. With the outlet clamped, turn the Thoratec PRE-PUMP START CHECKLIST CentriMag Console ON. 1. EQUIPMENT ASSEMBLY 5. Zero (gain and balance) the flow probe according to the drive console Operating a. Mount drive motor correctly, relative to Manual. venous reservoir. b. Check that all electrical connections are 6. With the outlet still clamped, turn the RPM’s secure. of the console to a maximum RPM for 30 c. Test control module power and display. seconds. This delivers maximum pressure d. Check the date and integrity of sterile within the Pump which aids in assuring its centrifugal Blood Pump package. integrity. Observe the Pump for leakage or e. Check that flow transducer/sensor are other abnormalities. sized properly. f. Assemble perfusion circuit in sterile manner. WARNING g. Allow sufficient tubing length for standby pumping unit. Do not operate the Pump for more than 30 h. Connect flow transducer/sensor (and seconds in the absence of flow. The disposable probe) to circuit in correct temperature within the Pump will rise and location and flow direction. increased cellular damage may result. 2. PRIME, PUMP AND CIRCUIT

WARNING a. CO2 flush Pump and circuit. If indicated, turn OFF CO2. b. Gravity-prime and debubble Pump and Do not operate the Pump for more than 30 perfusion circuit. seconds in the absence of flow. The c. Check Pump for leaks, irregular motion, temperature within the Pump will rise and and noise. increased cellular damage may result. d. Check circuit for visible air. e. Check that all tubing connections are 7. Bring the RPM’s to zero and recheck the secure. integrity of the Pump. f. Check Pump outlet line completely. g. Clamp venous return line completely. 8. If no anomalies are noted, continue the priming of your circuit in the usual fashion. 3. OPERATING PARAMETERS

a. Calibrate transducers/sensors according WARNING to the manufacturer’s instructions. b. Set low flow alarm. If leaks or other anomalies are found, c. Verify low flow alarm. remove the Pump and replace with a new, sterile Pump, repeating the above steps to 4. EMERGENCY BACK-UP EQUIPMENT prime. a. Back-up power available b. Back-up motor and flow probe available 9. Verify all connections and the integrity and c. Back-up console must be available and flow of your circuit prior to use. ON with motor plugged IN. d. Back-up Pump available

Thoratec CentriMag® Blood Pump IFU Page 5 of 7 © 2013 Thoratec Switzerland GmbH – Document No. PL-0070, Rev. 04 (January 2013) PERFUSION Note: Actual obtainable flow is dependent on afterload of the Pump, which results from a. Achieve minimum Pump speed prior to extracorporeal circuit components and patient unclamping lines. arterial resistance. b. Monitor Control Console for message and alarms. SPECIFICATIONS c. Monitor perfusion circuit for visible air. d. Maintain minimum Pump speed prior to Blood contact materials: Polycarbonate clamping lines. Pump priming volume: 31 ml Pump rotational range: 0-5,500 RPM CLEANUP Outflow capacity: (see graph) 0-9.99 L/min Outflow pressure: (see graph) 0-600 mmHg Connects to 3/8 inch (9,5mm) I.D. tubing. a. Turn OFF power. b. Properly discard disposable components SYMBOLS ON THE PRODUCT PACKAGE according to hospital procedure for contaminated materials. The following table describes the symbols used c. Clean console and motor drive. on CentriMag Blood Pump package: d. Clean flow transducer/sensor.

CHECK EQUIPMENT Symbol Description

a. Inspect and verify that equipment is Catalog Number. operational. b. Maintain indicative preventative Lot Number. maintenance schedule. c. Recharge batteries to full capacity (if necessary). Use By Date.

EMERGECY PUMP REPLACEMENT Federal (USA) law restricts In some instances when the Pump has been this device to sale, OFF for more than five minutes, or if there distribution and use by or has been a Motor Overheating condition, it on the order of a physician. will be necessary to either terminate pumping due to thrombus in the circuit OR replace the Pump. To replace the Pump, disconnect the See Instructions for Use. Pump and any affected tubing. Attach the Pump per the standard procedure, prime and debubble. Operate the Console as described For single use only. Do not in the Console Operating Manual. reuse.

PRESSURE VERSUS FLOW GRAPH Sterilized with ethylene The Pump output is pressure responsive. In the oxide gas. graph below, the Pump flow rate (L/min) versus the outlet pressure (mmHg) is plotted at a variety of pump speeds. This graph is for informational The blood path of the purposes only and does not necessarily reflect device is PYROGEN free. the rates to be achieved under clinical conditions.

Symbol for manufacturer.

Manufacture Date.

Thoratec CentriMag® Blood Pump IFU Page 6 of 7 © 2013 Thoratec Switzerland GmbH – Document No. PL-0070, Rev. 04 (January 2013) Symbol Description Symbol for temperature limitation/temperature range. Both upper and lower limits are indicated adjacent to horizontal lines. Temp: 0-40 °C (32-104 °F)

PRODUCT RETURNS

Prior to returning any product, contact your Thoratec Customer Service Representative for a return authorization number and instructions.

Note: Thoratec® is a registered trademark and HeartLine™ is a trademark of Thoratec Corporation. CentriMag® is a registered trademark of Thoratec Corporation.