AB5000 Circulatory Support System

Transcription

1 At the Heart of Circulation SM TM AB5000 Circulatory Support System Operator s Manual

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3 ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEMS Operator's Manual For use only by personnel trained in accordance with the ABIOMED Training Program. Read all warnings, precautions, and instructions carefully prior to use. Rx Only. Manufactured by: ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA USA 24-Hour, Emergency Hotline to ABIOMED: , USA & Canada , European Community European Representative: ABIOMED Europe GmbH Neuenhofer Weg Aachen, Germany +49 (241) (voice) +49 (241) (fax) (EU 24 Hour, Emergency Hotline) +49 (0) europe@abiomed.com ( ) AB5000 Console: 93/42/EEC Class IIb EN Class 1 UL Class 1 IPX Rev L ABIOMED, Inc.

4 March 2009ABIOMED, Inc. and our authorized representatives and distributors are responsible for the effect of safety, reliability, and performance of the equipment only if: All service, repairs, and periodic maintenance are carried out by ABIOMED, Inc. or its authorized representative or distributor using ABIOMED-approved replacement parts only. The electrical environment and installation of the User s site complies with all VDE requirements (if applicable). The AB5000 Console is used only in accordance with this Operator s Manual. ABIOMED, the ABIOMED logo and BVS are trademarks of ABIOMED, Inc. and are registered in the USA. AB5000 and ANGIOFLEX are trademarks of ABIOMED, Inc. At the Heart of Circulation is a service mark of ABIOMED, Inc. U.S. Patent 4,826, , 2006 ABIOMED, Inc. All rights reserved. ABIOMED, Inc. page 2

5 Table of Contents Section 1: Introduction System Overview Blood Pumps BVS Cannula (Refer to Instructions For Use) AB5000 Console For BVS Blood Pump ONLY Accessories For BVS Blood Pumps and AB5000 Ventricles Aircraft Mounting Plate Console Accessory7 Section 2: Indications for Use... 8 Section 3: Contraindications for Use... 8 Section 4: Specifications Console Blood Pump Specifications Console Safety Specifications Section 5: Installation & Operation Installation Console Power-Up and Self-Test Blood Pump Preparation Recommended Cannulation Method Interconnection Procedure Pumping Battery Operation and Transport Weaning For AB5000 Ventricle ONLY Adjusting the Vacuum Level (optional feature) For BVS Blood Pumps and AB5000 Ventricles Adjustable Low Flow Alarm Level (optional feature) Remote Alarm Output (optional feature) Section 6: Alarms And Status Indicators Introduction Flow, Pressure, and Vacuum Alarms Pump Detection Alarms Alarm Mute Battery Status Emergency System Section 7: Console Failure AB5000 Hand Pump Removing and Operating the Hand Pump Stowing Hand Pump Section 8: Routine Maintenance and Shipment Routine Check of Backup Systems Hand Pump Test Self-Test Routine Emergency System Test Packing for Shipment For BVS Blood Pumps and AB5000 Ventricles Cleaning Scheduled Maintenance Replacement Parts Service Ordering Information AB5000 Console Display Messages For BVS Blood Pumps and AB5000 Ventricles Operating Instructions AB5000 Console Domestic Limited Service Warranty Symbol Definitions Patient Transport with the AB5000 Circulatory Support System ABIOMED, Inc. page 3

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7 SECTION 1: INTRODUCTION 1.1 System Overview The ABIOMED AB5000 Circulatory Support System (AB5000 System) is an automated biventricular support device intended to provide complete short-term support of the left and/or right sides of the heart. The AB5000 System uses a microprocessor-based drive Console to supply pneumatic power to a disposable blood pump. Beat rates and systolic/diastolic intervals are determined automatically by sensing driveline airflow at the Console. The Console drives and adjusts the left and right blood pumps independently. 1.2 Blood Pumps The AB5000 Console can be used to operate either BVS Blood Pumps or AB5000 Ventricles BVS Blood Pump (Refer to Instructions for Use) The disposable BVS Blood Pump (Figure 1.1) is a pneumatically driven two-chambered device that supports one side of the heart. The BVS Blood Pump is placed external to the patient. Blood inflow from the left atrium or ventricle is returned to the thoracic aorta. Inflow from the right atrium returns to the pulmonary artery. Connection of the BVS Blood Pump to the patient uses transthoracic cannulation techniques. Figure 1.1 BVS Blood Pump ABIOMED, Inc. page 5

8 1.2.2 AB5000 Ventricle (Refer to Instructions for Use) The disposable AB5000 Ventricle (Figure 1.2) is a pneumatically driven one-chambered device that supports one side of the heart. The AB5000 Ventricle is placed external to the patient. Blood inflow from the left atrium or ventricle is returned to the thoracic aorta. Inflow from the right atrium returns to the pulmonary artery. Connection of the AB5000 Ventricle to the patient uses transthoracic cannulation techniques. Figure 1.2 AB5000 Ventricle 1.3 BVS Cannula (Refer to Instructions For Use) There are two cannulae supplied with each Blood Pump and Ventricle; one for left and right atrial connections, and one for the aortic or PA connection. The atrial and arterial cannulae are both supplied with tie wraps, a tunneling bullet for tunneling the cannula through the skin, and a cannula restraint for the cannula connector junction. The arterial cannula is manufactured with a coated woven graft Hemashield bonded to one end. This graft permits end-to-side anastomosis of the cannula to the PA or aorta. The elastomeric coating on the graft eliminates the need for preclotting and provides a graft porosity < 1cc/min/cm AB5000 Console The AB5000 Console (Figure 1.3 & Figure 1.4) is a microprocessor-controlled pneumatic drive system that can operate one or two disposable Blood Pumps. The Console automatically adjusts the beat rate and systolic/diastolic ratio based on air flow into and out of the Blood Pump. Blood pump flow and rate are displayed on the control panel. The Console incorporates several systems to ensure safe operation. Automatic self-testing upon power-up alerts the operator about potential problems. Battery backup is provided for one hour (when fully charged) of portable or power fail operation. An alphanumeric display and message indicators show AB5000 System status. Alarms alert the operator to abnormal flow or pressure conditions. ABIOMED, Inc. page 6

9 The Console has two levels of operational redundancy. Should the microprocessor-based system fail, a hardware-based backup system continues pumping at a fixed rate. In case of complete Console failure, a hand-operated pump allows continued support. Figure 1.3 AB5000 Console shown on Standard Cart Figure 1.4 AB5000 Console shown on ipulse Cart 1.5 For BVS Blood Pump ONLY Accessories BVS I.V. Pole Mount: (Refer to Instructions For Use) The BVS I.V. Pole Mount is provided as a mounting bracket for the BVS Blood Pump while in use. It attaches to an I.V. pole and can accommodate two Blood Pumps. The BVS I.V. Pole Mount can be stowed on the console cart, shown on AB5000 Cart and on ipulse Cart (Figures 1.3 and 1.4 respectively) BVS Bed Mount: (Refer to Instructions For Use) The BVS Bed Mount is also an accessory that can be used to secure the Blood Pump during patient transport. It slides between the mattress and bed and can accommodate two pumps. This eliminates the need for transporting the pumps on an I.V. pole next to the patient. BVS Blood Pump Sling: (See instructions for Use in the Patient Transport Section) This accessory allows for horizontal positioning of the Blood Pump attached to the stretcher or bed. BVS Pump Mount Set: Includes pole and bed mounts, as described above. 1.6 For BVS Blood Pumps and AB5000 Ventricles Aircraft Mounting Plate Console Accessory Provides a secure method for mounting the Console in helicopters and fixed-wing aircraft. ABIOMED, Inc. page 7

10 SECTION 2: INDICATIONS FOR USE The AB5000 System is a mechanical circulatory support system for use in patients suffering from reversible ventricular dysfunction. It can also be used to facilitate patient transport. Typical patients have undergone successful cardiac surgery and subsequently developed low cardiac output, or suffer from acute cardiac disorders leading to hemodynamic instability. The intent of therapy is to provide circulatory support, restore normal hemodynamics, reduce ventricular work, and allow the heart time to recover adequate mechanical function. The Console is external to the patient and is intended for short-term use. Appropriate patient groups include those that are likely to recover cardiac function after the myocardium is permitted to rest on ventricular support. Examples include, but are not limited to: Patients who fail to wean from cardiopulmonary bypass (CPB) following heart surgery. Failed transplant patients who require ventricular assist following heart transplantation. Patients who require right ventricular assist device (RVAD) support while on implantable left ventricular assist devices (LVADs). Patients suffering from acute cardiac disorders such as viral myocarditis. A patient is a candidate for mechanical assistance with the AB5000 System if he/she meets all of the following criteria: a) Patient has a body surface area > 1.3 m 2 and is 75 years of age. b) Patient is in relatively good health other than the cardiovascular problem for which surgery was undertaken. c) All appropriate measures have been attempted to correct low arterial ph, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, arrhythmia, and residual hypothermia. d) Cardiac resuscitation employing pharmacologic agents has been attempted. While the use of the Intra-Aortic Balloon Pump (IABP) is recommended prior to AB5000 assistance, its use may not always be appropriate (e.g., fibrillating heart, peripheral atherosclerosis). e) Patient is unable to be weaned from CPB or is unable to maintain acceptable hemodynamics in the immediate postoperative period (< 6 hours after the first attempt to wean from CPB) or Patient is unable to maintain acceptable hemodynamics following a significant cardiac event despite the measures cited above. SECTION 3: CONTRAINDICATIONS FOR USE 1) Major cardiac or extracardiac catastrophes occurring during operation or in the postoperative period that preclude survival such as uncontrolled hemorrhage, massive air embolization, interstitial pulmonary hemorrhage with inability to maintain adequate ventilation, pump oxygenator or perfusion difficulties, or massive transfusion reaction, hemolysis during bypass, or inadequate cannulation. 2) Central nervous system damage resulting in fixed and dilated pupils. ABIOMED, Inc. page 8

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12 SECTION 4: SPECIFICATIONS 4.1 Console Physical Width: Depth: Height: 23 inches (58.4 cm) without cart 28 inches (71.1 cm) with cart 12 inches (30.5 cm) without cart 18 inches (45.7 cm) with cart 29 inches (73.7 cm) without cart 38 inches (96.5 cm) with cart Weight: Operating Temperature Range: 10 C to 40 C 96 lbs. (43.5 kg) without cart 155 lbs. (70.3 kg) with cart Operating Humidity Range: Operating Atmospheric Pressure Range: Storage and Transport Temperature Range: Storage and Transport Humidity Range: Storage and Transport Pressure Range: 30% to 75% (non-condensing) 7,500 ft (767 hpa) to ft (1051 hpa) -15 C to +50 C 10% to 95% (non-condensing) 18,000 ft (506 hpa) to ft (1051 hpa) CAUTION: If the Console has been stored in an environment exceeding the Operating Ranges, let the Console stabilize at the operating ambient conditions prior to use to ensure specified performance Electrical Mains voltage: Mains frequency: Mains current: Maximum power consumption: Line leakage current: Power cable: Battery: VAC Hz 2.5 A maximum at any input voltage. 250 W <300 µa at any input voltage. 11 ft. (3.4 m) of #16 AWG Type SJT; hospitalgrade plug (N.A.). Internal 24 V battery provides 1 hour operating time when fully charged. Charging time is 16 hours to full charge after 1 hour of use. ABIOMED, Inc. page 10

13 4.1.3 Mechanical System Drive medium: Drive technology: Compressed air Compressor system drives independent pressureregulated systems. Switching from a pressurized to a non-pressurized state in the BVS Blood Pump and the AB5000 Ventricle is via independent 3-way solenoid valves. Return air is allowed to vent to atmosphere or vacuum. For the BVS Blood Pump, left line pressure is regulated to 320 mmhg, right line pressure is regulated to 200 mmhg, and left and right line vacuum are regulated to 35 mmhg. For the AB5000 Ventricle, left line pressure is regulated to 420 mmhg, right line pressure is regulated to 300 mmhg, and left and right line vacuum are regulated to 100 mmhg (standard) or is user adjustable to between 35 mmhg and 100 mmhg (adjustable vacuum option) Operator Controls Pump controls: Pressing Left or Right ON button initiates pumping. Pressing Left or Right OFF button twice within 13 seconds (typical) ceases pumping. Weaning controls: Priming controls: Alarm mute: Alarm volume: Help: Operator display: While pumping, the up or down arrow is pressed while pressing the ACTIVATE button. The desired flow is selected and the ACTIVATE button is released to engage weaning at the selected flow rate. With pumping OFF, press ACTIVATE button and press LEFT STROKE or RIGHT STROKE button each time a single stroke of the Blood Pump or Ventricle is desired. Silences audible alarm for one minute (except for complete Console failure, which has separate alarm). Cycles alarm volume through 3 levels. Provides additional information on current operating conditions. 320 X 240-pixel color LCD with backlighting. ABIOMED, Inc. page 11

14 4.1.5 Outputs and Inputs LEFT and RIGHT device output: LEFT and RIGHT Blood Pump identification input: SERVICE PORT input/output: Blood Pump interface 1/4 inch (6mm) I.D. rotating driveline connectors. Fischer connector. DB15 connector for ABIOMED Diagnostic Terminal Assembly. Used for troubleshooting by ABIOMED authorized service personnel only Pumping System Control General: Flow rate: Filling and emptying is controlled by computer examination of air flow and volume into and out of the Blood Pump. Calculated by the computer system integrating the area under the air flow curve and performing a four-beat weighted average of the results. Displayed Flow Accuracy: With pump height as specified in Section 5.6: Left side: +/- 15% over the following ranges: Inflow Pressure: Outflow Pressure: 5 to 25 mmhg 60 to 90 mmhg Right side: +/- 15% over the following ranges: Inflow Pressure: Outflow Pressure: 5 to 15 mmhg 30 to 40 mmhg As elevation increases from sea level, flow rates displayed on the Console may under-report flows while actual flow delivered to the patient is maintained. At elevations of 5000 ft and higher, flow rates displayed on the Console may underreport flows by as much as 1.0 L/min for the BVS Blood Pump and by as much as 1.7 L/min for the AB5000 Ventricle. AB5000 Ventricle only: For flow rates <3 L/min (when flow into pump is restricted), flow rates displayed on the Console may over-report flows by as much as 0.7 L/min. Resolution of Displayed Flow: +/- 0.1 L/min Flow: With pump height as specified in Section 5.6: Left Side BVS Blood Pump or AB5000 Ventricle: Flow >4.8 L/min at outflow pressure of 90 mmhg and inflow pressure >10 mmhg for 42 Fr. Atrial ABIOMED, Inc. page 12

15 Cannula used with 12 mm or 10 mm Arterial Cannula. Right Side BVS Blood Pump or AB5000 Ventricle: Flow >4.8 L/min at outflow pressure of 40 mmhg and inflow pressure >10 mmhg for 42 Fr. Atrial Cannula used with 12 mm or 10 mm Arterial Cannula. Left Side BVS Blood Pump or AB5000 Ventricle: Flow >4.0 L/min at outflow pressure of 90 mmhg and inflow pressure >10 mmhg for 32 Fr. and 36 Fr. Atrial Cannula used with 12 mm or 10 mm Arterial Cannula. Right Side BVS Blood Pump or AB5000 Ventricle: Flow >4.0 L/min at outflow pressure of 40 mmhg and inflow pressure >10 mmhg for 32 Fr. and 36 Fr. Atrial Cannula used with 12 mm or 10 mm Arterial Cannula. Under most normal operating conditions, BVS Blood Pump flow rates and AB5000 Ventricle flow rates are equivalent. Under conditions using a 32 Fr. or 36 Fr. atrial cannula for left side support, AB5000 Ventricle flow rates may be up to 0.8 L/min lower than BVS Blood Pump flow rates at the same conditions. Weaning method: Weaning range: Rate reduction via computer control. 2.0 L/min to full available flow Alarm Limits LOW FLOW: <1.8 L/min flow (AB5000 Ventricle and BVS Blood Pump) during normal operation. <1.5 L/min flow (AB5000 Ventricle and BVS Blood Pump) during weaning operation. LOW PRESSURE: Left side barb pressure <80 mmhg during systole (AB5000 Ventricle and BVS Blood Pump). Right side barb pressure <50 mmhg during systole (AB5000 Ventricle and BVS Blood Pump). Left side plenum pressure <248 mmhg (BVS Blood Pump), <256 mmhg (AB5000 Ventricle). Right side plenum pressure <136 mmhg (BVS Blood Pump), <142 mmhg (AB5000 Ventricle). HIGH PRESSURE: Left side barb pressure >300 mmhg during systole (BVS Blood Pump), >280 mmhg (AB5000 Ventricle). ABIOMED, Inc. page 13

16 Right side barb pressure >190 mmhg during systole (BVS Blood Pump and AB5000 Ventricle). Right and left side barb pressure >50 mmhg during diastole (BVS Blood Pump and AB5000 Ventricle). Left side plenum pressure >360 mmhg (BVS Blood Pump), >460 mmhg (AB5000 Ventricle). Right side plenum pressure >240 mmhg (BVS Blood Pump), >340 mmhg (AB5000 Ventricle). LOW VACUUM: HIGH VACUUM: BATTERY (red LED): CHARGING (yellow LED): Left and right side plenum pressure > 25 mmhg (BVS Blood Pump), > 90 mmhg (AB5000 Ventricle and standard AB5000 Console) or > vacuum set by user +10 mmhg (AB5000 Ventricle and AB5000 Console with adjustable vacuum option). Left and right side plenum pressure < 75 mmhg (BVS Blood Pump), < 140 mmhg (AB5000 Ventricle and standard AB5000 Console) or < vacuum set by user -40 mmhg (AB5000 Ventricle and AB5000 Console with adjustable vacuum option). <30 minutes of battery time remaining. (This is the minimum time remaining when BATTERY LED goes from yellow to red.) Displayed when battery is below 80% capacity Hardware Backup System Indication: Allowable low limit: Allowable high limit: Backup pumping rate: EMERGENCY SYSTEM ON indicator. Backup engages if system pumping <6 BPM. Backup engages if system pumping >144 BPM (typical). 75 BPM, open loop control. Hand Pump: See Section Blood Pump Specifications BVS Blood Pump Parameters Number of bladders Specifications Two: filling and pumping Number/type of valves Two: inflow and outflow, ABIOMED Trileaflet Angioflex Polyurethane Bladder/valve material Angioflex Polyurethane ABIOMED, Inc. page 14

17 Volume of pumping bladder Volume of filling bladder Extracorporeal volume (system) 100 cc 100 cc <660 cc Operating pressures on bladder Left side: 320 mmhg Right side: 200 mmhg Maximum operating vacuums on bladder: Left side: 35 mmhg Right side: 35 mmhg Bladder burst pressure Valve prolapse pressure >325 mmhg >410 mmhg Valve forward flow P <6.5 mmhg at 10L/min. Drive medium applied to bladder Housing material Compressed air Class VI medical grade polycarbonate Patient connections: Blood Pump inflow 48 inches (1.2 m) of 1/2 inch (12.7 mm) I.D., 3/32 inch (2.4 mm) wall thickness Class VI surgical grade PVC tubing with 1/2 inch (12.7 mm) to 1/2 inch (12.7 mm) Class VI polycarbonate tubing connector attached. Blood Pump outflow Atrial ventricular cannula (supplied with Cannula restraint, tunneling bullet, and tie wraps) Arterial cannula (supplied with Cannula restraint and tunneling bullet) Driveline connection Sterilization Weight 72 inches (2 m) of 1/2 I.D., 3/32 inch (2.4 mm) wall thickness Class VI surgical grade PVC tubing with 1/2 inch (12.7 mm) to 1/2 inch (12.7 mm) tubing connector attached. 32 French (10.7 mm) Cannula 36 French (12 mm) reinforced malleable backbone 42 French (14 mm) reinforced 10 mm Hemashield Gold graft Arterial (outflow) cannula 12mm pre-coated Dacron Arterial (outflow) cannula 72 inches (2 m) of PVC Class VI tubing 1/4 inch (6.4 mm) I.D., attached to the Blood Pump for Console interface. It should be connected to appropriate (left, right) driveline connector on the Console. The disposables are ethylene-oxide gas sterilized, the Blood Pump is packaged in a Tyvek /PETG tray, and the cannulae in a Tyvek /Mylar pouch. * 3.5 lbs (1.6 kg) ABIOMED, Inc. page 15

18 Mounting methods Blood Pump mounting height BVS Blood Pump can be mounted to an I.V. pole or vertical pole mount or to the bed with the appropriate selection of accessories. 42 Fr. (14 mm) 0-10 inches (0-25 cm) below the level of the patient's atrium. 36 Fr. (12 mm) and 32 Fr. (10.7 mm) 4-14 inches (10-35 cm) below the level of the patient's atrium. Storage conditions 10 C to 40 C, relative humidity 30% to 75% * The 10 mm Hemashield graft arterial cannula is Gamma-sterilized AB5000 Ventricle Parameters Number of bladders Specifications One Number/type of valves Two: inflow and outflow/ ABIOMED Trileaflet Angioflex Polyurethane Bladder/valve material Volume of bladder Extracorporeal volume (system) Angioflex Polyurethane 100 cc <200 cc Operating pressures on bladder Left side: 420 mmhg Right side: 300 mmhg Maximum operating vacuums on bladder: Left side: 100 mmhg Right side: 100 mmhg Valve prolapse pressure >600 mmhg Valve forward flow P <30 mmhg at 10L/min. Drive medium applied to bladder Housing materials Compressed air Epoxy, anodized aluminum, Class VI medical grade polycarbonate, titanium Patient connections: Ventricle inflow Ventricle outflow inch (12.0 mm) Class VI polycarbonate tubing connector inch (12.0 mm) Class VI polycarbonate tubing connector. ABIOMED, Inc. page 16

19 Atrial ventricular cannula (supplied with Cannula restraint, tunneling bullet, and tie wraps) Arterial cannula, (supplied with Cannula restraint and tunneling bullet) Electronic Key Driveline connection Sterilization Weight Ventricle height 32 French (10.7 mm) Cannula 36 French (12 mm) reinforced malleable backbone 42 French (14 mm) reinforced 10 mm Hemashield Gold graft Arterial (outflow) cannula 12mm pre-coated Dacron Arterial (outflow) cannula Fischer connector integrated with electrical/pneumatic connector. 72 inches (2 m) of PVC Class VI tubing 1/4 inch (6.4 mm) I.D., attached to the Ventricle and to the electrical/pneumatic connector, which should be connected to appropriate (left, right) driveline connector on the Console. The disposables are ethylene-oxide gas sterilized, the Ventricle is packaged in a Tyvek /PETG tray, and the cannulae in a Tyvek /Mylar pouch. * 0.66 lbs (0.30 kg) 0-12 inches (0-30 cm) below the level of the patient's atrium. Storage conditions 10 C to 40 C, relative humidity 30% to 75% * The 10 mm Hemashield graft arterial cannula is Gamma-sterilized. 4.3 Console Safety Specifications Type of protection against electric shock Degree of protection against type of applied part Class I equipment Type B Applied Part Not sterile Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Mode of operation Degree of protection against ingress of water Continuous IPX1 ABIOMED, Inc. page 17

20 SECTION 5: INSTALLATION & OPERATION 5.1 Installation Prior to clinical use, on-site installation and testing of this Console shall be performed by an authorized ABIOMED Service Representative. CAUTION: Device must be plugged into AC outlet to maintain battery charge when not in use. CAUTION: To remove all AC power from the Console, unplug the unit from the line cord. 5.2 Console Power-Up and Self-Test DANGER: Explosion risk if used with flammable anesthetics. CAUTION: If the Console has been stored in an environment exceeding the Operating Ranges, let the Console stabilize at the operating ambient prior to use to ensure specified performance. CAUTION: Do not lean on or place any objects on the control panel. CAUTION: Minimize the exposure of the Console to sources of electromagnetic, magnetic, optical, and thermal radiation. Exposure to sources of electromagnetic radiation, such as cell phones and walkie-talkies, or other types of radiation may cause operational interference. To clear symptoms of interference, turn off the interfering device. The Console should resume normal operation. CAUTION: Minimize the exposure of the Console to vibration and mechanical shocks during transport. See section "Patient Transport with the AB5000 Circulatory Support System." Lift the device by side handles only over steps or obstructions. CAUTION: Avoid activities that may build up static charges on the Console or on personnel contacting the Console. Avoid brushing bed sheets across the Console or touching the Console immediately after performing activities likely to build static charge. If electrostatic discharge interrupts operation of the Console, cycle the POWER ON/OFF switch. CAUTION: Operation of the Console may interfere with the operation of other devices. If this is suspected, maximize the distance between the Console and the device. WARNING: Patient physiological pressure must be monitored continuously. Do not rely solely on the AB5000 Alarm System. ABIOMED, Inc. page 18

21 If possible, the Console should be powered up one hour before use; however, there is no minimum warm-up time required. A self-test procedure automatically runs after power-up, and requires about ten seconds to complete. During self-test, the Console flashes all indicators, sounds the alarm tone, and pumps air through the driveline connectors. It also checks the processor system integrity. The operator should observe the control panel during the selftest to detect abnormalities. Figure 5.1 AB5000 Console Side Panel Figure 5.2 AB5000 Console Control Panel a) Unwrap line cord from cord wrap and plug into an outlet. (Check that the AC POWER indicator is lighted on the top panel. CHARGING may also be lighted.) Activate the Console with the power switch on the side panel (Figure 5.1). The system will automatically begin to run its self-test. Where the integrity of the external protective conductor in the installation or its arrangement is in doubt, the Console shall be operated from its internal battery. b) Check visible and audible machine functions: watch for the flashing of all alarm and status lamps (Figure 5.2). The BATTERY indicator will not be lighted. Listen for the alarm tone. It first sounds soft, then sounds loud. Listen for valve actuation and the sound of air venting from the top panel driveline connectors. ABIOMED, Inc. page 19

22 c) The display should read LEFT (RIGHT) SYSTEM READY FOR USE after self-test (Figure 5.3). LEFT SYSTEM READY FOR USE RIGHT SYSTEM READY FOR USE Amb. FULL Amb. Pump Pump CHARGE Figure 5.3 Display, System Ready for Use Help -> If any message other than READY FOR USE appears on the display, or if the display is blank and the Console reverts to hardware backup operation (Figure 5.4), call qualified service personnel immediately. EMERGENCY SYSTEM OPERATION Figure 5.4 Hardware Backup Operation Message d) Check the condition of the batteries. If the CHARGING indicator is illuminated, the batteries are not capable of providing a full hour s operation of the Console. Allow more charging time before portable use. The Console is now ready for operation. CAUTION: Do not lean on or place any objects on the control panel. ABIOMED, Inc. page 20

23 5.3 Blood Pump Preparation Prior to operation, see BVS Blood Pump Instructions for Use or AB5000 Ventricle Instructions for Use Recommended Cannulation Method Prior to operation, see Cannulae Instructions for Use Interconnection Procedure Prior to operation, see BVS Blood Pump Instructions for Use or AB5000 Ventricle Instructions for Use For BVS Blood Pump ONLY The default blood pump type selection is BVS Blood Pump. Verify that left and right pump types displayed are BVS PUMP (Figure 5.5). LEFT SYSTEM READY FOR USE RIGHT SYSTEM READY FOR USE BVS Pump FULL CHARGE BVS Pump Help -> Figure 5.5 Display, System Showing BVS Pump Default a) For AB5000 Ventricle ONLY Plug the electrical/pneumatic connector into the receptacle on the rotating driveline turret. Verify that the corresponding pump type displayed is AMB. PUMP (Figure 5.6). LEFT SYSTEM READY FOR USE RIGHT SYSTEM READY FOR USE Amb. Pump FULL CHARGE Amb. Pump Help -> Figure 5.6 Display, System Showing AB5000 Ventricle Detected on Left and Right ABIOMED, Inc. page 21

24 b) For AB5000 Ventricle ONLY Pump type selection will be latched once the pump ON button is pressed. Removing the electrical/pneumatic connector while pumping is on will trigger an alarm. If the electrical/pneumatic connector is not attached prior to pressing pump ON, attach the connector and turn the pump OFF, then ON again. The new pump type will then be latched. WARNING: The pump type displayed on the Console must match the pump type in use. 5.6 Pumping Connect the pneumatic line(s) from the disposable to the rotating driveline connectors. To start pumping, depress the appropriate ON button. If bi-ventricular support is required, start pumping on the left side before starting pumping on the right. If pumping is started prior to connecting the disposable, the system will require additional time before reaching full flow. Full flow can be achieved faster in this situation by stopping pumping and then immediately restarting pumping For BVS Blood Pump ONLY Expected Beat and Flow Rates Observe the beat rate (Figure 5.7). Any gross instability of beat rate (double beats, etc.) indicates a possible problem with the placement of the BVS Blood Pump relative to the patient (refer to Section 5.6.2) or a problem with cannulation (refer to Cannulae Instructions for Use ). FLOW: X.X LPM RATE: XX BPM RIGHT SYSTEM READY FOR USE BVS FULL BVS Pump Pump CHARGE Figure 5.7 Display, Normal Pumping Help -> A step change in rate is normal, especially during the first two minutes. During this period, the Console adjusts itself to determine the optimal pumping rate. A brief extension of one beat every two minutes is normal as the Console routinely recalibrates For BVS Blood Pump ONLY Adjustment of Blood Pump Filling Proper filling of the BVS Blood Pump can easily be assessed through an examination of Blood Pump flow and the behavior of the upper bladder. When operating in the normal (full flow) mode, flow should be > 2 liters per minute (L/min or LPM), and typically ranges from 3 L/min. to 6 L/min. To optimize blood flow, first make certain that the patient is appropriately hydrated, with filling pressures within their normal ranges. If the patient is hypovolemic, administer fluids according to standard procedures. Second, observe the filling and emptying of the ABIOMED, Inc. page 22

25 upper bladder. The bladder should just barely fill the plastic chamber during pump systole, and just empty during pump diastole. If the bladder is too full, move the Blood Pump higher to reduce inflow pressure. If the bladder is too empty and the patient is sufficiently hydrated, lower the pump to increase inflow pressure. The top of the upper bladder chamber should be positioned between 0 and 14 inches (35 cm) below the patient s atria. If the pump is raised above the level of the patient s atria or is lowered more than 14 inches (35 cm) below the patient s atria, a decrease in pump flow may result. After adjusting Blood Pump height, observe bladder filling for two minutes before adjusting again. This will allow the system to reach steady state before further adjustment For AB5000 Ventricle ONLY Optimizing Blood Pump Filling When operating in the normal (full flow) mode, flow should be > 2 L/min, and typically ranges from 3 L/min to 6 L/min. To optimize blood flow, make certain the patient is appropriately hydrated, with filling pressures within their normal ranges. If the patient is hypovolemic, administer fluids according to standard procedures. The AB5000 Ventricle is filled via vacuum assist. However, avoid raising the Ventricle above the heart to view it, because this could result in lower flow For BVS Blood Pumps and AB5000 Ventricles To Stop Pumping To stop pumping, press the appropriate OFF button twice within 13 seconds (typical). The button must be pressed twice to stop the pump (Figure 5.8). This is a safety feature to prevent accidental operation. A single press of the OFF button will be ignored after 13 seconds (typical). TO STOP PUMPING PRESS OFF AGAIN RIGHT SYSTEM READY FOR USE Amb. Pump FULL CHARGE BVS Pump Help -> Figure 5.8 Display, After Pressing OFF Button Once 5.7 Battery Operation and Transport The internal battery, when fully charged, will automatically power the Console for one hour. The battery requires approximately 16 hours to charge after one hour of use. Before preparing the Console for transport, ensure that the hand pump is stored on the side of the Console (refer to Section 7.1) and make sure the battery is fully charged (refer to Sections and 6.5). When the patient is transported from the operating room to intensive care, the BVS Blood Pump can be mounted to the bed. The Console is unplugged and rolled alongside of the patient. ABIOMED, Inc. page 23

26 5.7.1 For BVS Blood Pump ONLY Mounting the Blood Pump to the Accessory Mounts Three types of accessory mounts are available to mount the Blood Pump for transport (Figures 5.9 and 5.10). BVS I.V. Pole pole mount Mount BVS Bed Mount Figure 5.9 BVS Blood Pump Accessory Mounting Brackets Figure 5.10 BVS Blood Pump Sling The BVS I.V. Pole Mount attaches to a standard I.V. pole. The BVS Bed Mount slips under the patient s mattress and accepts a BVS I.V. Pole Mount. The BVS Blood Pump Sling allows the Blood Pump to be mounted horizontally for transport To attach the BVS I.V. Pole Mount to the I.V. pole 1) Unscrew the screw clamp enough to fit the clamp around the I.V. pole. 2) Tighten the screw clamp onto the I.V. pole by turning the black knob clockwise. 3) Adjust the height of the Pole Mount by turning the central adjustment lever counter clockwise one half turn to loosen it, while holding the handle (the adjustment lever will now be pointing up towards 12 o clock). 4) Move the Pole Mount up or down with the handle to the desired position. 5) Turn the central adjustment lever clockwise, back to its original position, to secure the Pole Mount in place. ABIOMED, Inc. page 24

27 To attach the BVS I.V. Pole Mount to the BVS Bed Mount: 1) Hold the Bed Mount so the metal post faces up. 2) Slide the Bed Mount under the head of the mattress (between mattress and bed) so that the metal post is facing up next to the mattress. 3) The weight of the mattress and the patient will hold the Bed Mount in place. 4) Hold the Pole Mount by the handle. 5) Unscrew the screw clamp enough to fit the clamp around the metal post. 6) Tighten the screw clamp onto the metal post by turning the black knob clockwise. 7) Adjust the height of the Pole Mount by turning the central adjustment lever counter clockwise, one half turn to loosen it, while holding the handle. See Section ) Instead of pointing down, the central adjustment lever will now be pointing up towards 12 o'clock. 9) Move the Pole Mount up or down with the handle to the desired position. 10) Turn the central adjustment lever clockwise, back to its original position, to secure the Pole Mount in place To attach the BVS Blood Pumps to the BVS I.V. Pole Mount 1) A long plastic plate is attached to the back of the Blood Pump. 2) At the top of this plate, slightly above the upper inflow bladder, is a square back plate designed to slide into the blood pump bracket. 3) Hold the Blood Pump securely so the inflow and outflow tubing is at the top of the blood pump and the driveline is at the bottom of the Blood Pump. 4) Slide the back plate into one of the blood pump brackets from the top down. 5) Make sure that both edges of the blood pump bracket fully engage the blood pump back plate to ensure that it is attached securely. 6) Adjust the pump height according to the instructions in To attach the BVS Blood Pumps to the BVS Blood Pump Sling 1) Always hold the pump below the patient s heart. 2) Lay the pump into the sling being careful not to kink or bend the blood or air tubing. 3) Close the sling around the pump by joining the 2 hook-and-loop fastening ends. ABIOMED, Inc. page 25

28 4) Attach the pump sling to the bed or stretcher using the mounting straps around the bed rail. 5) Adjust the pump height according to the instructions in AB5000 Console Battery Status As long as the Console line cord is plugged into an AC power source, the internal battery will be kept in a charged state. A column of labeled LED indicators to the right of the control panel (Figure 5.11) shows the status of the battery. AC POWER BATTERY CHARGING Figure 5.11 Battery Status Indicators AC POWER (LED green) appears when the Console is plugged in and line voltage is present at the receptacle. BATTERY (LED yellow) appears when the line cord is disconnected and the Console is operating on its battery. A periodic two-beep audible signal also indicates that the battery is on. BATTERY (LED red) appears when the line cord is disconnected and < 30 minutes (minimum) of battery operation remains. A periodic 3-beep audible signal is produced to advise the operator of low battery status. The operator should either plug in the Console line cord or obtain a backup Console. CHARGING (LED yellow) appears when the Console is plugged in and the battery charge is < 80% capacity Preparing the Console for Intrahospital Transport The internal battery, when fully charged, will automatically power the Console for one hour. The battery requires approximately 16 hours to charge after one hour of use. Before preparing the Console for intrahospital transport, ensure that the hand pump is stored on the side of the Console (refer to Section 7.1) and make sure the battery is fully charged (refer to Sections and 6.5). Unplugging the line cord automatically activates battery operation. When ready for transport, unplug the line cord, and wind it around the cord wrap. The Console can be transported on its cart or removed from its cart and transported separately. To remove the Console from the cart, first disengage the Console latch (located on the bottom rear of the cart) by lifting and then pulling the latch handle. Then lift the Console by its side handles clear of the cart. Place the Console on the floor. Roll the Console carefully to avoid kinking or disconnecting the driveline. To carry the Console over obstacles, grasp the handles at the sides and lift. ABIOMED, Inc. page 26

29 5.8 Weaning When the patient is to be weaned from the AB5000 System, the Blood Pump output may be set at any desired flow from 2.0 L/min to full flow (in 0.1 L/min. increments). The operator simply selects the desired flow rate and the Console reduces its pumping rate to achieve the desired flow Weaning Adjustment Figure 5.12 Weaning and Priming Controls To begin weaning, open the panel marked Weaning and Priming Controls. Press and hold the ACTIVATE button (figure 5.12) for the desired side (left or right). While holding the ACTIVATE button, press the down ( ) arrow or the up ( ) arrow to set the Weaning target flow (Figure 5.13). TARGET FLOW: X.X LPM Set Weaning target. RIGHT SYSTEM READY FOR USE To set Wean Target: - Hold ACTIVATE. - Press UP/DN. BVS FULL BVS Pump Pump CHARGE Figure 5.13 Display, Weaning Activation Help -> ABIOMED, Inc. page 27

30 Release the ACTIVATE button. The Console will begin to adjust itself toward the new weaning flow (Figure 5.14). This will generally take at least 8 beats. FLOW: X.X LPM RATE: XX BPM RIGHT SYSTEM READY FOR USE BVS FULL BVS Pump Pump CHARGE Figure 5.14 Display, Weaning Operation Help -> To return to normal operation, press and hold the ACTIVATE button and press the up arrow until the target flow setting stops increasing. Release the ACTIVATE button. The Console will automatically return to full available flow. During the Weaning operation, the Console s displayed flow may vary for several beats from the selected flow setting. This has occurred when patient conditions change and/or when the Console periodically adjusts Blood Pump ejection duration to optimize flow. However, actual Blood Pump flow will correspond to the selected flow setting. 5.9 For AB5000 Ventricle ONLY Adjusting the Vacuum Level (optional feature) Overview When the AB5000 Ventricle is used, the Console applies a default level of 100 mmhg of vacuum during diastole unless the vacuum level has been adjusted by the user. The vacuum level can be adjusted from 35 to 100mmHg (in 5 mmhg steps) whether pumping is ON or OFF. Reducing the vacuum level to 35 mmhg reduces the flow rate by up to 2 L/min from the level achieved at 100 mmhg. Reducing the vacuum level also changes the vacuum alarm limits listed in Section Flow rate reduction for weaning can be performed using the weaning controls alone, by reducing the vacuum level alone, or by using both means of flow reduction simultaneously. If an increase in flow rate is desired, increasing the vacuum level will increase the flow rate provided that there are no conditions limiting the flow through the device such as: Obstructions in the inflow cannula, outflow cannula, or driveline. Inadequate blood volume. Mispositioning of the AB5000 Ventricle. Disconnection or leak in the driveline. Increasing the vacuum level to increase the flow rate can be used in response to activation of the low flow alarm during normal operation, or during weaning operation when the target flow level cannot be maintained at a reduced level of vacuum. ABIOMED, Inc. page 28

31 Note: If an inadvertent key stroke is made, allow the Console display to stabilize for about 5 seconds before proceeding. The display may take several seconds to update after an adjustment is made. The Console applies a fixed level of 35 mmhg of vacuum during diastole when operating the BVS Blood Pump. This vacuum level is not adjustable Adjusting the Vacuum Level with Pumping Off Upon power-up (after completing its self-test), the Console displays the following screen: LEFT SYSTEM READY FOR USE VACUUM: --- mmhg RIGHT SYSTEM READY FOR USE VACUUM: --- mmhg Func <- Amb. Pump FULL CHARGE Amb. Pump Help -> Figure 5.15 Display, Adjustable Vacuum Option Default (Pumping Off) The dashes ("---") indicate that the vacuum level is set to the default level of 100 mmhg. Press the pump ON button if no reduction in vacuum level is needed. To reduce the vacuum level, press the function (Func) key until the following screen is displayed: VACUUM LEVEL: --- mmhg Set Vac. Level target. To set Amb. Pump vacuum level: - Hold ACTIVATE. - Press UP/DN. VACUUM LEVEL: --- mmhg Set Vac. Level target. To set Amb. Pump vacuum level: - Hold ACTIVATE. - Press UP/DN. Func <- Amb. Pump FULL CHARGE Amb. Pump Help -> Figure 5.16 Display, Adjustable Vacuum Option (Pumping Off) Open the panel marked "Weaning and Priming Controls." ABIOMED, Inc. page 29

32 Press and hold the ACTIVATE button for the desired side (left or right). The default level of 100 mmhg is displayed. While holding the ACTIVATE button, press the down ( ) arrow to reach the desired vacuum level. Release the ACTIVATE button. The desired vacuum level is now displayed. In the following example, the vacuum level has been set to 50 mmhg: LEFT SYSTEM READY FOR USE VACUUM: 50 mmhg RIGHT SYSTEM READY FOR USE VACUUM: --- mmhg Func <- Amb. Pump FULL CHARGE Amb. Pump Help -> Figure 5.17 Display, Vacuum Level Adjusted by User (Pumping Off) Adjusting the vacuum level on one side does not affect the vacuum level on the other side. The user-set vacuum level is applied to the AB5000 Ventricle after its electrical/pneumatic connector is attached to the Console and the pump ON button is pressed. If pumping is inadvertently started before plugging in the Ventricle electrical/pneumatic connector, an alarm is generated instructing the user to "Turn Pumping OFF and then ON" to recognize that a Ventricle is attached. User-set vacuum levels are saved during these transitions and applied to operation of the Ventricle Adjusting the Vacuum Level with Pumping ON If no vacuum level is set by the user during startup, the default vacuum level of 100 mmhg is automatically selected after the Ventricle electrical/pneumatic connector is attached to the Console and the pump ON button is pressed. ABIOMED, Inc. page 30

33 In the following example, an AB5000 Ventricle is pumping on the left side. The vacuum setting is at the default 100 mmhg level. FLOW: X.X LPM RATE: XX BPM VACUUM: 100 mmhg RIGHT SYSTEM READY FOR USE VACUUM: --- mmhg Func <- Amb. Pump FULL CHARGE Amb. Pump Help -> Figure 5.18 Display, Vacuum Level at Default Value (Pumping On) To adjust the vacuum level, press the function (Func) key until the following screen is displayed: VACUUM LEVEL: --- mmhg Set Vac. Level target. To set Amb. Pump vacuum level: - Hold ACTIVATE. - Press UP/DN. VACUUM LEVEL: --- mmhg Set Vac. Level target. To set Amb. Pump vacuum level: - Hold ACTIVATE. - Press UP/DN. Func <- Amb. Pump FULL CHARGE Amb. Pump Help -> Figure 5.19 Display, Adjustable Vacuum Option (Pumping On) Open the panel marked "Weaning and Priming Controls." Press and hold the ACTIVATE button for the desired side (left or right). While holding the ACTIVATE button, press the down ( ) arrow or the up ( ) arrow to reach the desired vacuum level. Release the ACTIVATE button. The desired vacuum level is now displayed. ABIOMED, Inc. page 31

34 In the following example, an AB5000 Ventricle is pumping on the left side with the vacuum level set to 35 mmhg: FLOW: X.X LPM RATE: XX BPM VACUUM: 35 mmhg RIGHT SYSTEM READY FOR USE VACUUM: --- mmhg Func <- Amb. Pump FULL CHARGE Amb. Pump Help -> Figure 5.20 Display, Vacuum Level Adjusted by User (Pumping On) 5.10 For BVS Blood Pumps and AB5000 Ventricles (optional feature) Adjustable Low Flow Alarm Level The low flow alarm level can be adjusted when pumping is ON. It can be set to any level (in 0.1 L/min steps) between the current flow rate and 1.8 L/min during normal operation or 1.5 L/min in the weaning mode. Open the panel marked "Weaning and Priming Controls." To adjust the alarm level, press the function (Func) key until the following screen is displayed: LOW FLOW ALARM: 1.8 LPM Set Flow Alarm target. To set low flow alarm: - Hold ACTIVATE. - Press UP/DN. LOW FLOW ALARM: 1.8 LPM Set Flow Alarm target. To set low flow alarm: - Hold ACTIVATE. - Press UP/DN. Func <- Amb. Pump FULL CHARGE BVS Pump Help -> Figure 5.21 Display, Adjustable Low Flow Alarm Option Press and hold the ACTIVATE button for the desired side (left or right). While holding the ACTIVATE button, press the down ( ) arrow or the up ( ) arrow to reach the desired alarm level. Release the ACTIVATE button. The desired alarm level is now displayed. ABIOMED, Inc. page 32

35 5.11 Remote Alarm Output (optional feature) The remote alarm output allows the user to connect the Console to a remote call system. The remote alarm output jack is located on the right side of the Console below the service door (Figure 5.22) and accepts a standard phone plug. The switch is normally open, but closes when an alarm is generated. This switch closure can be used to trigger an alarm via the remote call system. Pressing the mute button on the Console silences the remote audible alarm. The alarm will sound again after the normal one-minute mute period. Remote Alarm Output Jack Figure 5.22 Remote Alarm Output Jack The specifications for the remote alarm output are provided in Table 5.1. Feature Switch contacts Connector Maximum input Maximum switch current Switch contact resistance Specification Closed - alarm active Open - no alarm present or alarm muted 1/4" phone jack 100 VAC / 100 VDC 2 amps < 1 ohm Table 5.1: Remote Alarm Output Specifications ABIOMED, Inc. page 33

36 SECTION 6: ALARMS AND STATUS INDICATORS 6.1 Introduction The AB5000 Console provides alarms for high and low pumping pressure and pumping vacuum, and for low blood flow. These alarm messages appear on the display screen. Operation of the emergency pumping system is indicated on the keypad below the display screen. Status indicators for the battery system appear to the right of the pump controls. 6.2 Flow, Pressure, and Vacuum Alarms Alarm Message LOW FLOW Probable Causes Check Blood Pump: a. Obstruction of blood pump lines. b. Blood Pump placed too high relative to atrium. c. Inadequate blood volume. LOW FLOW LOW PRESSURE Check Blood Pump: a. Disconnection or leak in driveline. LOW FLOW HIGH PRESSURE Check Blood Pump: a. Driveline or blood pump lines kinked or occluded. HIGH PRESSURE Internal pressure problem: a. Obtain backup Console. LOW PRESSURE Internal pressure problem if indicated when not pumping: a. Obtain backup Console. HIGH VACUUM or LOW VACUUM Internal vacuum problem: a. Obtain backup Console. Table 6.1 Flow, Pressure, and Vacuum Alarms CAUTION: Obtain a backup Console if all of the above have been checked and these alarms continue to occur with pump rates at 20 to 30 BPM in the normal operation mode. ABIOMED, Inc. page 34

37 6.3 Pump Detection Alarms Message Cause Action New Pump ID detected Pump ID Unplugged AB5000 Ventricle connected after Pump ON was pressed. Accidental dislodgement or intentional removal of AB5000 Ventricle connection. Turn Pump OFF, then ON again (to change Pump ID). Re-attach Ventricle electrical/pneumatic connector. Table 6.2 Pump Detection Alarms 6.4 Alarm Mute Pressing the alarm mute switch silences the audible alarm for one minute but does not affect the visual display of the alarm conditions. A yellow light indicates that the alarm mute is activated. At the end of the minute, the audible alarm will be enabled again, without operator intervention. The mute interval is resettable, but not cumulative. This means that the operator can press the mute one or more times during the one-minute period, and the mute time will always be reset to one minute from the last activation of the button. It will not add one minute to the time remaining from the previous mute period. Continuous pressing of the alarm mute switch does not extend the mute duration. 6.5 Battery Status As long as the Console line cord is plugged into an AC power source, the internal battery will be kept in a charged state. A column of indicators to the right of the control panel shows the status of the battery (Table 6.3). The Console will periodically issue a 2-beep audible indication while operating on battery. If the battery system enters the BATTERY LED red condition, the indication becomes 3 beeps. ABIOMED, Inc. page 35

38 Indicators Cause Action AC POWER LED (green) Console is plugged into AC power receptacle. No action required. AC POWER LED (green) AND CHARGING LED (amber) Console is plugged into AC power receptacle AND charge is < 80% capacity. Leave Console plugged in until BATTERY LED (amber) is no longer illuminated. BATTERY LED (amber) Battery activated by disconnecting line plug. Expect an operating time of approximately one hour. BATTERY LED (red) Battery low, < 30 minutes of battery power remaining. Plug Console into AC power receptacle or obtain backup Console. AC POWER LED (green) and BATTERY LED (red) Possible battery fault. Do not unplug the Console. Obtain a backup Console. Table 6.3 Battery Status LED Indicators With the Console powered ON, the following messages show the battery status on the LCD display (Table 6.4): Message Cause Action FULL CHARGE (battery bar green) Console is plugged into AC power receptacle. No action required. BATTERY CHARGING (battery bar amber) Console is plugged into AC power receptacle AND charge is < 80% capacity. Leave Console plugged in until BATTERY LED (amber) is no longer illuminated. BATTERY IN USE (battery bar amber) Battery activated by disconnecting line plug. Expect an operating time of approximately one hour. BATTERY LOW (battery bar red) Battery low, < 30 minutes of battery power remaining. Plug Console into AC power receptacle or obtain backup Console. BATTERY FAULT Do not unplug Possible battery fault. Do not unplug the Console. Obtain a backup Console. Table 6.4 Battery Status LCD Messages ABIOMED, Inc. page 36

39 6.6 Emergency System If the microprocessor-based pump control system fails, a fixed-rate control system takes over. This system will continue pumping at approximately 75 BPM and will light the emergency system indicator (Table 6.5). A continuous audible alarm will be generated. The alarm can be silenced by pressing the mute button. When the emergency system is on, only the rate and battery LED indicators are valid. The ON and OFF buttons function normally. Indicator Cause Action EMERGENCY SYSTEM OPERATION (LCD display will be blank) Microprocessor system failure Obtain backup system as soon as possible. Call Service personnel. Table 6.5 Emergency System Message ABIOMED, Inc. page 37

40 SECTION 7: CONSOLE FAILURE 7.1 AB5000 Hand Pump In the case of AB5000 Console failure, the hand-operated pump allows manual operation of the Blood Pump / Ventricle. The hand pump is stored on the side of the Console (Figure 7.1b). A complete Console failure is indicated by no air being pumped regardless of how the controls are operated. 7.2 Removing and Operating the Hand Pump a) Turn off the Console and unplug. Remove hand pump from side of console Figure 7.1a Turn off Console Figure 7.1b AB5000 Hand Pump Removal b) Remove the driveline(s) (Figure 7.2a) from the connectors at the top of the Console and attach them to the hand pump, left pump to left connector and/or right pump to right connector. (Figure 7.2b) Figure 7.2a Blood pump driveline removal ABIOMED, Inc. page 38

41 Left Left Right Right AB5000 Ventricle Connection BVS Blood Pump Connection Figure 7.2b Connecting driveline(s) to hand pump c) Check the hand pump settings. Set the shuttle mechanism to the position appropriate for the blood pump in use (Figure 7.3). Left Side AB5000 Ventricle (Top of Pump) Left Side BVS Blood Pump (Top of Pump) Right Side AB5000 Ventricle (Bottom of Pump) Right Side BVS Blood Pump (Bottom of Pump) Figure 7.3 AB5000 Hand Pump Shuttle Mechanism Selection ABIOMED, Inc. page 39

42 d) The hand pump may be operated while mounted on the Console or may be removed and held during operation as show in Figure 7.4 e) Pull the handle from the hand pump until it stops. Press it to fully return it to its original position. Repeat. This should result in a normal pumping rate of 30 to 60 times per minute. Observe the Blood Pump / Ventricle for proper filling and emptying. Figure 7.4 AB5000 Hand Pump Operation f) Obtain a backup Console. Power it up and allow the self-test to run. Transfer the driveline(s) from the hand pump to the backup Console. g) Begin pumping by pressing the ON button. h) Call service personnel at the earliest opportunity to repair the failed Console. 7.3 Stowing Hand Pump a) Return hand pump to bracket on side of Console. ABIOMED, Inc. page 40