CentriMag Blood Pump Instructions for Use Rev 09

SUPPLIED STERILE AND READY FOR USE – DO NOT USE IF PACKAGING IS DAMAGED OR ANY STERILE SEALS ARE BROKEN. This product is not made with natural rubber latex. For U.S. – California Only: Proposition 65, a State of California voter initiative, requires the following notice: WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.

WARNING (Definition) Warnings are used if there is a potential for a serious hazard with misuse of the device, when special attention is required for safety of the patient, or when special care should be exercised to prevent improper operation of the device that may cause damage. CAUTION (Definition) Cautions are used to alert the user to exercise special care for the safe use of the device. DESCRIPTION The CentriMag Blood Pump (Pump) is designed to allow improved blood handling and to decrease trauma by magnetically levitating and rotating the impeller and by eliminating seals and bearings. The Pump has a spinning impeller that imparts rotary motion to the incoming blood, directing it through the outlet port. TM

Figure 1 – CentriMag™ Blood Pump The Pump couples to a magnetic drive motor which is connected to a console. The CentriMag Pump, Motor, Console, Mag Monitor, Flow Probe, and cannulas

CentriMag™ Blood Pump IFU

comprise the core components of the CentriMag Circulatory Support System (System). INDICATIONS FOR USE The CentriMag Blood Pump is indicated for use as: • Part of a cardiopulmonary or other extracorporeal bypass circuit for periods up to 6 hours [510kcleared Device]. • Temporary circulatory support for up to 30 days for one or both sides of the heart to treat postcardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy [PMA Approved Device]. • Right ventricular assist device [Humanitarian Device]. The CentriMag Circulatory Support System, when used as a right ventricular assist device, is also authorized by Federal law to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. The effectiveness of this device for this use has not been demonstrated. The Pump is indicated for use only with the CentriMag System. This device is not designed, sold, or intended for use except as indicated. CONTRAINDICATIONS The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. It is also contraindicated for patients who are unable or unwilling to be treated with Heparin or an appropriate alternative anticoagulant. ADVERSE EVENTS Adverse events are a known risk of mechanical circulatory support. The adverse events that may be associated with the CentriMag Circulatory Support System are listed below. Adverse events are listed in decreasing order of frequency, except for death, because it is a non-reversible complication. For complete information on all adverse events observed during these studies, please refer to the CentriMag Circulatory Support System Clinical Reference Manual. • Death • Bleeding • Respiratory Failure • Infection • Cardiac Arrhythmias • Right Heart Failure • Renal Failure/Dysfunction • Neurologic Dysfunction • Hemolysis • Hepatic Dysfunction • Hypotension • Hypertension • Venous Thromboembolism

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• • • • • • • • •

Cardiac Tamponade Pericardial Fluid Collection Wound Dehiscence Psychiatric Episode Device Malfunction Arterial Non-CNS Thromboembolism Limb Ischemia Aneurysm Myocardial Infarction

WARNINGS 1. Read all individual Centrimag Circulatory Support System component Instructions For Use, the CentriMag Circulatory Support System Operation Manual, and the Clinical Reference Manual before use. Failure to read and follow all instruction, or failure to observe all stated warnings, could cause serious injury or death to the patient. 2. Ensure that the Pump and circuit have been debubbled and primed properly prior to use to minimize the risk of air entry to the patient. 3. Massive air entry into the Pump will cause the Pump to deprime and blood flow to stop. Clamp the outlet tubing, stop the Pump, and remove air prior to resuming circulation. 4. Do not expose the Pump to chemical agents as they may affect the integrity of this device. Anesthesia solutions such as forane are known to degrade polycarbonate plastics. 5. To prevent backflow of the patient’s blood when the Pump outlet tubing is open, establish and maintain a minimum pump speed that overcomes line and patient resistance. Failure to do this could allow retrograde flow and limit arterial pressure. 6. A Pump stoppage will create a reverse flow shunt through the Pump, as well as limit the body’s ability to maintain adequate arterial pressure. If the Pump is stopped, clamp the outlet tubing from the Pump to prevent a low flow, low pressure, and reverse flow condition. The tubing clamp must be removed before returning to normal pumping activity. 7. It is intended that systemic anticoagulation be utilized while this device is in use. Anticoagulation levels should be determined by the physician based on risks and benefits to the patient. 8. The Pump is designed to be operated only with the Console. There are no safety or performance data known to Abbott Medical which establishes compatibility of any other manufacturer’s devices or components to the CentriMag Circulatory Support System. 9. Potential risk to the patient should be evaluated prior to changing a Pump. CentriMag™ Blood Pump IFU

10. Frequent patient and device monitoring is recommended. 11. Do not use the Pump if the “Use Before” Date on the package has expired. 12. Do not operate the Pump in the absence of forward flow. The temperature within the Pump will rise and increased cellular damage and clotting may result. 13. The Pump must be handled in an aseptic manner until primed and connected to a closed tubing circuit. 14. Do not operate the Pump with its inlet tubing clamped as a negative pressure will be generated in the Pump and air bubbles may be formed in the priming fluid or blood. 15. Monitor the patient’s hemodynamics and the Console Flow display to ensure adequate blood volume for the inlet cannula position, Pump RPM, and desired flow. Increase the Pump RPM in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation. 16. As with all continuous flow pumps, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, outgassing, cavitation and increased risk of embolism. Always operate the system at the lowest speed consistent with the volume of blood available to be pumped and clinically acceptable circulatory support. 17. The Pump contains a magnet. To avoid injury, keep all sharp metal objects and instruments at least six inches away from the Pump. Do not remove the Pump from its inner tray until ready to assemble within the circuit and insert pump into the motor receptacle. 18. If the Pump’s operation is ever halted or flow reduced, consideration should be given to monitoring and adjustment of the patient’s anticoagulation status. 19. Do not restart the Pump if the Pump has been stopped for more than 5 minutes without adequate anticoagulation, as the risk of thromboembolism is increased after blood has remained stagnant in the Pump, extracorporeal circuit, connectors, and cannulae. 20. Monitor the Pump and tubing for air because the Pump, similar to other centrifugal pumps, will pump air immediately. Clamp the Pump outlet tubing if air enters the Pump as gaseous emboli may be introduced into the patient, with attendant risk of death or severe bodily injury. A massive air embolus will deprime the Pump, halting blood flow.

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21. Use of the Pump for periods longer than 30 days may result in Pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli. 22. The safety and effectiveness of use of the CentriMag System in an ECMO circuit (i.e. cardiopulmonary support > 6 hours) has not been demonstrated. 23. The safety and effectiveness of use of the CentriMag System for use > 30 days has not been demonstrated. CAUTIONS 1. Use of this device should only be by or on the order of a physician. 2. This device should only be used by persons thoroughly trained in extracorporeal circulation procedures. 3. Do not hit or strike the Pump with hands, objects, or instruments. Do not strike the Pump against any surface or object. Shock may cause damage to the device, which may cause device malfunction. 4. The Pump is provided sterile in an unopened and undamaged unit package. Inspect the device and package carefully prior to use. Do not use if the unit package or the product has been dropped, damaged or soiled. 5. Each Pump is intended for single use only. Safely dispose of the Pump after single use to avoid risk of infection. 6. Attach tubing to the Pump in such a manner as to prevent kinks or restrictions that may alter flow or cause regions of stasis or turbulence. Attach in a manner that does not bend or fracture the tubing connectors or ports. Advance the tubing beyond the second barb point of the Pump connectors. 7. The inlet and outlet tubing and cannulae connections must be secured with two small (approximately 3.94 in (10 cm length)) cable-ties or tie bands on each connector. The locking mechanisms of the two ties should be oriented 180 degrees from each other to insure a tight seal of the tubing to the connector. 8. Ensure the Pump is properly locked into the Motor per the Instructions for Use supplied with the Motor. 9. Monitor carefully for any signs of occlusion throughout the circuit. CentriMag™ Blood Pump IFU

10. Do not operate the Pump when unprimed as it may damage the Pump impeller. 11. Run the Pump only on a properly maintained Console and Motor. 12. Do not use the Pump if it has been dropped. Dropping or other severe shock may cause damage which could lead to device malfunction. 13. Do not use excessive force to install tubing on the Pump as damage to the Pump and 3/8” pump ports may occur. 14. Take care to prevent damage to Pump connectors when setting up and de-airing the Pump. 15. Always have a backup CentriMag Pump, Console, Motor, and accessories available for use. 16. Do not place the Pump near items adversely affected by magnetic fields. 17. Only use flow probes supplied by Abbott Medical with the CentriMag Circulatory Support System. PACKAGE CONTENTS The sterile Pump package contains: • One CentriMag Blood Pump • Product documentation INSPECTION PRIOR TO USE 1. The package containing the Pump should be inspected prior to use for any damage to the sterile barrier. The package seals should be intact to ensure sterility. Do not use the Pump if the associated package is damaged. Contact Abbott Medical regarding return of any damaged product. 2. The Pump should be inspected prior to use for any damage or particulate matter contamination. Do not use the Pump if damaged or if any particulate matter is found on or inside the Pump. Contact Abbott Medical regarding return of any suspect Pump. ACCESSORIES The following accessories are required to use the Pump: • One drainage cannula • One return cannula • Tubing (drainage and return sections) Abbott Medical recommends use of the CentriMag Drainage and Return Cannula Kits, but equivalent commercially available venous and arterial cannula can be used at the preference of the clinician. Any commercially available medical grade 3/8 inch (9.5 mm)

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inner diameter PVC tubing and barbed tubing connectors can be used. PRE-PUMPING CHECKLIST

3. Fill a sterile basin with sterile heparinized saline. Use 10,000 units of Heparin per liter saline. Remove from packaging and submerge into the heparinized saline the following four components:

1. Connect the Motor to the Console.

•

2. Check that all electrical connections are secure including the flow probe and AC power cord.

• • •

3. Test the Console by powering it up; verify that there are no self-test errors upon boot-up. 4. Check the date and integrity of the sterile Pump package, sterile cannulae, sterile tubing and connectors. 5. Check that a flow probe is included with the Console and is clean and ready for use. PUMP SETUP AND OPERATION The CentriMagTM Circulatory Support System is designed to be operated safely during use of ESU’s (electrosurgery or electrocautery units). An ESU, a frequently used RF technology, is used to cut, cauterize, fulgurate or desiccate tissue. Note: ESUs have the potential for interfering with other medical devices found in the operating and ICU room environment. If the Console is used concurrently with an Electrosurgery unit, Abbott Medical recommends the user to read and follow the electrocautery manufacturer’s instructions for prevention of interference with other electronic devices. Follow the system preparation directions in the CentriMag Circulatory Support System Operation Manual. Inspect the complete system; do not use a malfunctioning or damaged system. 1. To mount the Pump on the Motor, remove the Pump from the inner tray and insert the Pump into the motor receptacle. Place the bottom of the Pump into the motor receptacle with the outlet port positioned in the large groove. Match the grooves on the periphery of the Pump with the fittings on the motor receptacle. Rotate the Pump counterclockwise until the Pump locks securely into place. Thread the retaining screw clockwise to secure in place. The Pump must be fully seated into the receptacle to function properly. Note: If the Pump is not properly seated, a “Pump Not Inserted” alarm will be displayed on the Console display. 2. To remove the Pump from the Motor, unthread the retaining screw counterclockwise, and then rotate the Pump clockwise until the grooves are matched. Lift and remove the Pump. CentriMag™ Blood Pump IFU

Two 3/8 X 3/32 inch (9.5 X 2.4 mm) (4’) sterile tubing sets, One inlet drainage (venous) cannula, One outlet return (arterial) cannula, and One tubing interconnector 3/8 X 3/8 inch (9.5 X 9.5 mm) Sterile Straight Barbed Connector without Luer Lock .

4. Insert the outlet cannula into a systemic (LVAD) or pulmonary (RVAD) artery by standard technique with the supplied introducer and Trocar from the outlet cannula kit. Clamp the outlet cannula approximately 25 mm (1 inch) from the 3/8” connector as the Trocar is removed to prevent blood loss. Secure the outlet cannula in place with double purse string suture. Carefully bleed the outlet cannula by gently unclamping restriction and letting any air bubbles out. WARNING Do not over tighten sutures when securing cannulae to tissues and vessels. Over tightened sutures may result in obstruction and interruption of blood flow through the cannulae. Suturing used to secure cannula must be made with sufficient tension to hold the cannula in place over the full range of patient activity. Failure to effectively secure cannulae in place poses risk of decannulation, bleeding, or air embolus. 5. After the outlet cannula has been surgically inserted and externalized, connect one of the prewetted, filled and debubbled extension tubes to the barbed connector of the outlet cannula. Debubble and clamp the tubing at a length beyond the anticipated final tubing length. 6. Fill the inlet cannula with sterile heparinized saline. Clamp at approximately 25 mm from the distal end of the inlet cannula where there is no reinforcing spring. Place the inlet cannula directly into the left (LVAD) or right (RVAD) ventricle (or respective atrium) by means of a surgical incision, and then secure it in place with a pledgeted purse-string suture to the ventricular apex. Ensure that the cannula tip does not compromise the valves of the Ventricle. 7. Allow blood to displace any air within the inlet cannula by holding the distal end vertically, and partially unclamp to gently let any air escape. 8. After the inlet cannula has been surgically inserted and externalized, take the pre-wetted 3/8 X 3/8 inch

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(9.5 X 9.5 mm) barbed connector and insert into the inlet cannula.

CAUTION

9. Take the remaining pre-wetted, filled and debubbled extension tubing set and connect to the barbed connector on the inlet cannula. Debubble and clamp at a length beyond the expected final tubing length.

Do not hit or strike the CentriMagTM Pump with hands, objects, or instruments. Do not strike the CentriMag Pump against any surface or object. Shock may cause damage to the device, which may cause device malfunction.

10. Prime and debubble the Pump by flushing through the outlet port while debubbling through the inlet port. Eliminate air from the device by “walking” the air out of the inlet.

WARNING

11. Cut the outlet extension tubing to a length based on the desired final location of the Pump. 12. Connect the outlet tubing to the outlet port of the Pump taking care to clear the flow path of bubbles. This can be accomplished by continuously irrigating the connection with sterile heparinized saline solution while mating. 13. Position the inlet tubing immediately adjacent to the inlet of the Pump and determine the correct length for the extension tubing. Clamp the extension tubing between the cannula and the Pump inlet port. Cut the extension tubing to length. Fully fill both the inlet tubing and Pump with the sterile heparinized saline solution. While continuously irrigating, make the connection. 14. With the inlet tubing unclamped, and the outlet tubing clamped, turn the Console ON. 15. Connect the flow probe to the outlet tubing according to the instructions provided in the CentriMag Circulatory Support System Operation Manual. WARNING Do not reverse the inlet and outlet cannulae connections. Reversal of inlet and outlet cannulae will limit circulatory support. Always use care in determining the direction of flow when connecting the CentriMag Pump to the cannulae to avoid physical harm to the patient.

Ensure that the CentriMag Pump and circuit have been debubbled and primed properly to minimize the risk of air reaching the patient. WARNING Massive air entry into the Pump will cause the Pump to deprime and blood flow to stop. Clamp the outlet tubing, stop the Pump, and remove air prior to resuming circulation. WARNING Do not operate the Pump in the absence of forward flow. The temperature within the Pump may rise and increased cellular damage may result. WARNING Do not operate the Pump with the inlet tubing or cannula clamped as a negative pressure will be generated in the Pump and bubbles may be form in the Pump. 16. Remove all remaining tubing clamps, bring the Pump’s RPM up to a sufficient speed to achieve a positive flow, inspect the integrity of the Pump, the tubing, and the connections. If any anomalies are noted, immediately stop the Pump, clamp the outlet tubing and correct the anomaly before unclamping and restarting. CAUTION Placing a tubing clamp on the tubing near a tubing connection point can damage the connector, resulting in thrombus formation at the area of the damage.

CentriMag™ Blood Pump IFU

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WARNING

CLEANUP AFTER USE

If leaks or other anomalies are found in the circuit, remove the Pump and replace with a new, sterile Pump, repeating the above steps to prime.

1. Turn OFF power to the main and backup Consoles. 2. Properly discard disposable components according to hospital procedure for contaminated materials.

17. Increase RPM to produce desired flow.

3. Clean the Console and Motor according to established hospital procedure.

18. Set the Console’s low flow alarm to the desired minimum flow point.

4. Clean the flow probe according to established hospital procedure.

19. Secure the motor in order to maintain its location in relation to the patient.

5. Reconnect the Consoles to AC power to maintain charge on batteries.

WARNING

EMERGENCY PUMP REPLACEMENT

The Motor must be immobilized near the patient. Failure to immobilize the Motor could lead to unanticipated movement of the Motor resulting in stress on the cannulae.

In some instances when the Pump has been OFF for more than five minutes, or if there has been a Motor overheating condition, it will be necessary to either terminate pumping or replace the Pump.

WARNING As with any continuous flow pump, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, out gassing, cavitation and increased risk of embolism. Always operate the system at the lowest speed consistent with the volume of blood available to be pumped, cannulae placement, and clinically acceptable circulatory support.

To replace the Pump, disconnect the Pump from the Motor and any affected tubing. Attach the replacement Pump per the standard procedures described above, prime and debubble. Operate the Console as described in the CentriMag Circulatory Support System Operation Manual. PRESSURE VS FLOW GRAPH The Pump output is pressure responsive. In the graph below, the Pump flow rate (LPM) versus the outlet pressure (mmHg) is plotted at a variety of pump speeds. This graph is for informational purposes only and does not necessarily reflect the rates to be achieved under clinical conditions.

CAUTION Any time the Pump is stopped, the pump outlet should be clamped to prevent retrograde flow. The clamp used should be a smooth jawed tubing clamp.

EMERGENCY BACKUP EQUIPMENT 1. A backup Console must be plugged in with the motor and flow probe connected (if designed to accommodate a flow probe), and kept near the patient ready for use. 2. A backup sterile Pump and supplies to prime must be available. 3. Backup power must be available. 4. Two smooth jawed tubing clamps.

CentriMag™ Blood Pump IFU

Note: Actual obtainable flow is dependent on the difference between the preload and afterload of the Pump (pump pressure differential), the resistance to flow through the extracorporeal circuit components (cannulas, tubing, etc.) and the patient hemodynamics (intravascular pressures, cardiac output, and available volume).

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PUMP SPECIFICATIONS

Symbol

Blood contact materials: Polycarbonate Pump priming volume: 31 ml Pump rotational range: 0-5,500 RPM Outflow capacity: (see graph) 0-10.0 LPM Outflow pressure: (see graph) 0-600 mmHg Connects to 3/8 inch (9. 5 mm) I.D. tubing

Description

Manufacture Date

Temperature limitation

STORAGE CONDITIONS Temperature: 0 – 40°C (32 – 104°F) OPERATING CONDITIONS Temperature: 15 – 40°C (59 – 104°F) PRODUCT RETURNS

Contents of Package Caution: Federal U.S. law restricts this device to sale by or on the order of a physician.

Prior to returning any product, contact your Abbott Medical Customer Service Representative for a return authorization and instructions. SYMBOLS ON THE PRODUCT PACKAGE The following table describes the symbols used on the Pump package: Symbol

Description

Catalog Number Lot Number Use By Date

See Instructions for Use

Single Use Only

Sterilized By Ethylene Oxide

Pyrogen free

Manufacturer

CentriMag™ Blood Pump IFU

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CentriMagTM Circulatory Support System Operation Manual READ ALL INDIVIDUAL CENTRIMAG CIRCULATORY SUPPORT SYSTEM COMPONENT INSTRUCTIONS FOR USE (IFU), THE CENTRIMAG CLINICAL REFERENCE MANUAL, AND THE ENTIRE CONTENTS OF THIS MANUAL BEFORE USE.

Abbott Medical Clinical & Technical Support Phone number(s) Emergency HeartLine™ Support:

Tel: +1-800-456-1477

Abbott Medical

Tel: +1-925-847-8600

Main Switchboard:

Fax: +1-925-847-8574

Manufacturer: Thoratec Switzerland GmbH Technoparkstrasse 1 CH-8005 Zürich Switzerland

US Headquarters: Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 USA www.abbott.com

PL-0047, Rev 11 November 2019 DCO No 19-038

CentriMag Circulatory Support System Operation Manual (US) © 2019 Abbott Medical – Document No PL-0047, Rev 11 (November 2019)

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TABLE OF CONTENTS 1

MANUAL OVERVIEW ...5

2

INDICATIONS AND CONTRAINDICATIONS ...6

3

2.1

Indications for Use ... 6

2.2

Contraindications for Use ... 9

GENERAL CONVENTIONS ...10 3.1

Warnings and Cautions... 10

3.2

Patents and Trademarks ... 10

3.3

Conventions Used in This Manual ... 10

4

WARNINGS AND PRECAUTIONS ...11

5

DESCRIPTION ...13

6

7

5.1

General Overview ... 13

5.2

Required User Supplied Items ... 32

SPECIFICATIONS AND GENERAL DESCRIPTION ...33 6.1

Classification ... 33

6.2

Specifications ... 34

6.3

Environmental Conditions ... 34

6.4

Essential Performance ... 35

6.5

EMI Considerations... 35

6.6

Permanent Magnet Considerations ... 35

6.7

Operator Controls ... 35

6.8

Digital Display Information ... 49

6.9

Power Assembly ... 49

6.10

Requirements for Connecting Additional Equipment ... 49

SETTING UP THE SYSTEM ...50

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8

7.1

Unpacking ... 50

7.2

Console Mounting ... 52

7.3

Monitor Mounting ... 53

7.4

Motor Mounting ... 57

7.5

Powering Up the Console ... 59

7.6

Self-Test Initiation ... 62

7.7

Configuring the Console ... 63

7.8

Console BIOS ... 65

7.9

Setting the Console Max Flow Alert ... 66

7.10

Setting the Console Min Flow Alert ... 67

7.11

Entering the Pressure Menu ... 68

7.12

Setting the Max or Min Pressure Alert Settings for the P1 Transducer ... 68

7.13

Setting the Max or Min Pressure Alert Settings for the P2 Transducer ... 69

7.14

Activating the Pressure Monitoring System (Pressure Display) ... 69

7.15

Stopwatches ... 72

7.16

Flow range ... 73

7.17

Changing the flow recorder speed ... 74

7.18

Setting the Console Speed Step Resolution ... 75

7.19

Selecting Displayed Language ... 76

7.20

Setting the Console flow limit sensitivity ... 77

7.21

Setting the Application Mode ... 78

7.22

The System Data Logger ... 79

7.23

Copy Logger Data to a USB Memory Stick ... 82

7.24

Monitor Connection ... 83

7.25

Accessing the Monitor Management Application ... 84

7.26

Pump Set-up ... 85

SYSTEM OPERATION ...86 8.1

Operation of the Pump ... 86

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8.2

Console Alarm/Alert Strategy... 89

8.3

Alarms ... 91

8.4

Battery Operation ... 97

8.5

Operation of the CentriMagTM Circulatory Support System On Internal Console Battery Power ... 99

8.6

Patient Transport ... 100

8.7

Shut Down by Operator ... 101

9

MAINTENANCE ...103 9.1

Changing Fuses ... 103

9.2

Maintenance Following Each Patient Use ... 103

9.3

Recommended Preventive Maintenance ... 104

9.4

Battery Maintenance ... 105

9.5

Motor Visual Inspection... 106

10

EMERGENCY / TROUBLESHOOTING ...109

10.1

Switching to Backup Hardware ... 109

10.2

Switching to another Pump ... 111

10.3

Defibrillation/ Cardioversion ... 111

10.4

Electrosurgical Units ... 111

11

DISPOSAL OF EQUIPMENT ...113

12

APPENDICES...114

12.1

Appendix I – Console Alarms and Alerts ... 114

12.2

Appendix II – Technical Specification ... 118

12.3

Appendix III – Electromagnetic Emissions ... 122

12.4

Appendix IV – Electromagnetic Immunity ... 123

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1 MANUAL OVERVIEW This manual provides technical information and use instructions for the CentriMagTM Circulatory Support System (System). The Clinical Reference Manual contains clinical use information on the System to help guide healthcare professionals. The user must understand and follow both manuals. The following summarizes the content of each section of this manual. Section 1:

Manual Overview describes the organization of this Manual.

Section 2:

Indications & Contraindications describes the intended use of the System.

Section 3:

General Conventions describes warnings, cautions, and conventions of expression used in this Manual. Also, this section describes the Patents and Trademarks involved.

Section 4:

Warnings & Precautions describes warnings and cautions to be considered when using the System.

Section 5:

Device Description describes the System and each element within the System.

Section 6:

Specifications and General Description describes the product specifications and physical attributes of the System.

Section 7:

Setting up the System describes the procedure for unpacking the System and configuring it for use.

Section 8:

System Operation describes how to operate the Console.

Section 9:

Maintenance describes procedures for maintaining and cleaning the System.

Section 10:

Emergency describes procedures for managing the Console during defibrillation and in the event of equipment malfunction.

Section 11:

Disposal of Equipment describes the procedure for proper disposal of used Console batteries and Consoles that have reached end of useful service life.

Section 12:

Appendices

Appendix I:

Alarm/Alert Table lists the Console’s audio/visual alarms and alerts and the expected System and operator response to each alarm or alert condition.

Appendix II:

Technical Specification lists the product specifications and physical attributes of the Console.

Appendix III:

Electromagnetic Emissions describes the electromagnetic environmental conditions under which the System may be operated.

Appendix IV

Electromagnetic Immunity describes the electromagnetic environmental conditions under which the System may be operated.

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2 INDICATIONS AND CONTRAINDICATIONS 2.1

Indications for Use

The CentriMagTM Circulatory Support System and its components may be used only for their intended purpose. The indications for use for the individual system components vary within the United States. Refer to the table below for specific Indications For Use by device product name. Indications for Use Chart Product Name and Market Application Number

Refer to Label Part No.

Required US Caution Statement(s)

Indications for Use

CentriMag Circulatory Support System

PL-0047, CentriMag Circulatory Support System Operation Manual

Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

The CentriMag Circulatory Support System is indicated for use as temporary circulatory support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy [PMA Approved Device].

PL-0085, CentriMag RVAS (Pump) IFU

Right ventricular assist device [Humanitarian Device]. The CentriMag Circulatory Support System, when used as a right ventricular assist device is also authorized by Federal law to provide temporary circulatory support

Right ventricular assist device [Humanitarian Device]. The CentriMag Circulatory Support System, when used as a right ventricular assist device is also authorized by Federal law to provide temporary circulatory support

PMA P170038

CentriMag Right Ventricular Assist System (RVAS) HDE H070004

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Indications for Use Chart Product Name and Market Application Number

CentriMag Extracorporeal Blood Pumping System

Refer to Label Part No.

Required US Caution Statement(s)

Indications for Use

for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. The effectiveness of this device for this use has not been demonstrated.

for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. The effectiveness of this device for this use has not been demonstrated.

PL-0070, CentriMag Blood Pump IFU

Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

The CentriMag Blood Pump is indicated for use with the 2nd Generation CentriMag Primary Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (CPB) for up to six hours. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete CPB (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.) This device is not designed, sold, or intended for use except as indicated.

PL-0112, PediMag Blood Pump IFU

Federal (U.S.A.) law restricts this device to sale, distribution

The PediMag Blood Pump is indicated for use only with the

K020271 K051209 K053630 K081221 K083340 K090004 K102129 K131179

PediMag Blood Pump

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Indications for Use Chart Product Name and Market Application Number

Refer to Label Part No.

Required US Caution Statement(s)

Indications for Use

and use by or on the order of a physician.

2nd Generation CentriMag Primary Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (CPB) for up to six hours. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete CPB (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.) This device is not designed, sold, or intended for use except as indicated.

PL-0220, CentriMag Drainage (Venous) Cannula Kit IFU

Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

PL-0221, CentriMag Return (Arterial) Cannula Kit IFU

Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal

K090051

CentriMag Drainage (Venous) Cannula Kit K110983 K152190

CentriMag Return (Arterial) Cannula Kit K110980 K152161

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Indications for Use Chart Product Name and Market Application Number

Refer to Label Part No.

Required US Caution Statement(s)

Indications for Use

circulatory support for periods up to six hours.

2.2

Contraindications for Use

The CentriMagTM Circulatory Support System is contraindicated for use as a cardiotomy suction device. The System is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.

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3 GENERAL CONVENTIONS 3.1

Warnings and Cautions

Read and observe all WARNINGS and CAUTIONS listed in this Manual and observe relevant instructions and safety precautions throughout operation of the System.

WARNING (Definition) Warnings are used if there is a potential for a serious hazard with misuse of the device, when special attention is required for safety of the patient, or when special care should be exercised to prevent improper operation of the device that may cause damage.

CAUTION (Definition) Cautions are used to alert the user to exercise special care for the safe and effective use of the device. Warnings are located within the text of the subject matter to which the warning relates. For this reason, some of the warnings are included in more than one section.

3.2

Patents and Trademarks

Patents: One or more patents or published applications cover this product and its use. Trademarks: ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents © 2019 Abbott. All Rights Reserved.

3.3

Conventions Used in This Manual

Switches, keypads and connections on the Console and Monitor are indicated in NORMAL FACE TYPE IN UPPER CASE (e.g., POWER, STOP). The Console and Monitor displays are indicated in BOLD FACE TYPE IN UPPER CASE (e.g., SET SPEED, INCREASE, DECREASE, ON BATTERY). The first letter in the name of each System component is capitalized (e.g., Pump, Motor, Console and Monitor). The headers for warnings are in red and the headers for cautions are in yellow.

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4 WARNINGS AND PRECAUTIONS WARNING Read this entire manual before you use the CentriMag System. As with all prescription medical devices, clinical procedures should be conducted under the direction of the prescribing physician. The physician must be trained on the use of the System before using it. The professional staff at Abbott Medical regularly provide laboratory training and on-site, in-service programs. For information, please contact your local Abbott Medical Clinical Field representative.

WARNING The System is designed to be operated only with the CentriMag and PediMag Pumps. There are no safety or performance data that establish compatibility with any other manufacturer’s device or components.

WARNING One additional CentriMag Console, Motor and Flow Probe are required as backup components in the immediate vicinity of each patient whenever the CentriMag or PediMag Pump is used. The backup Console must be connected to the backup Motor and to the backup Flow Probe, have a battery charge sufficient for at least one hour of operation, be connected to AC power (except during transport) and be immediately available should the main Console, Motor or Flow Probe experience a malfunction.

WARNING The safety and effectiveness of use of the System in an ECMO circuit (i.e. cardiopulmonary support > 6 hours) has not been demonstrated.

WARNING The safety and effectiveness of use of the System for use > 30 days has not been demonstrated.

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WARNING Only use parts supplied by Abbott Medical. Do not modify the System in any way as there are no safety or performance data that establish compatibility with any other manufacturer’s device or components. Use of any other component may result in a sudden Motor stop.

WARNING Before use of the CentriMag System, always ensure that all components of the System are properly mounted with Abbott Medical elements. Improper mounting can cause malfunction of the System.

CAUTION The System is intended for use in all establishments, such as hospitals and medical centers, but not in domestic/residential buildings and environments.

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