AB5000TM Circulatory Support System Operator’s Manual Rev L

Operator’s Manual

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At the Heart of Circulation

AB5000 Circulatory Support System TM

Operator’s Manual

AB5000TM Circulatory Support System ◊ Operator’s Manual

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 01923 USA 24-Hour, Emergency Hotline to ABIOMED: 1-800-422-8666, USA & Canada 01-978-777-5410, European Community

European Representative:

ABIOMED Europe GmbH Neuenhofer Weg 3 52074 Aachen, Germany +49 (241) 8860-0 (voice) +49 (241) 8860-111 (fax) (EU 24 Hour, Emergency Hotline) +49 (0)1805 2246633 [email protected].com (email)

AB5000 Console: 93/42/EEC Class IIb EN60601-1 Class 1 UL 2601-1 Class 1 IPX 1

0015-9000 Rev L

ABIOMED, Inc.

AB5000TM Circulatory Support System ◊ Operator’s Manual

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 4,826,477. © 2005, 2006 ABIOMED, Inc. All rights reserved.

ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Table of Contents Section 1: Introduction .................................................................................................................................. 5 1.1 System Overview ............................................................................................................................ 5 1.2 Blood Pumps .................................................................................................................................. 5 ® 1.3 BVS Cannula (Refer to Instructions For Use) .............................................................................. 6 ™ 1.4 AB5000 Console .......................................................................................................................... 6 ® 1.5 – For BVS Blood Pump ONLY – Accessories .............................................................................. 7 ® ™ 1.6 – 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 ............................................................................................................................ 10 4.1 Console ......................................................................................................................................... 10 4.2 Blood Pump Specifications ........................................................................................................... 14 4.3 Console Safety Specifications ...................................................................................................... 17 Section 5: Installation & Operation .............................................................................................................. 18 5.1 Installation ..................................................................................................................................... 18 5.2 Console Power-Up and Self-Test ................................................................................................. 18 5.3 Blood Pump Preparation .............................................................................................................. 21 5.4 Recommended Cannulation Method ............................................................................................ 21 5.5 Interconnection Procedure ........................................................................................................... 21 5.6 Pumping ........................................................................................................................................ 22 5.7 Battery Operation and Transport .................................................................................................. 23 5.8 Weaning ........................................................................................................................................ 27 ™ 5.9 – For AB5000 Ventricle ONLY – Adjusting the Vacuum Level (optional feature) ...................... 28 ® ™ 5.10 – For BVS Blood Pumps and AB5000 Ventricles – Adjustable Low Flow Alarm Level (optional feature) .................................................................................................................................................... 32 5.11 Remote Alarm Output (optional feature)....................................................................................... 33 Section 6: Alarms And Status Indicators .................................................................................................... 34 6.1 Introduction ................................................................................................................................... 34 6.2 Flow, Pressure, and Vacuum Alarms ........................................................................................... 34 6.3 Pump Detection Alarms ................................................................................................................ 35 6.4 Alarm Mute ................................................................................................................................... 35 6.5 Battery Status ............................................................................................................................... 35 6.6 Emergency System....................................................................................................................... 37 Section 7: Console Failure .......................................................................................................................... 38 ™ 7.1 AB5000 Hand Pump................................................................................................................... 38 7.2 Removing and Operating the Hand Pump ................................................................................... 38 7.3 Stowing Hand Pump ..................................................................................................................... 40 Section 8: Routine Maintenance and Shipment .......................................................................................... 42 8.1 Routine Check of Backup Systems .............................................................................................. 42 8.2 Hand Pump Test ........................................................................................................................... 42 8.3 Self-Test Routine .......................................................................................................................... 42 8.4 Emergency System Test .............................................................................................................. 42 8.5 Packing for Shipment.................................................................................................................... 42 ® ™ 8.6 – For BVS Blood Pumps and AB5000 Ventricles – Cleaning .................................................. 42 8.7 Scheduled Maintenance ............................................................................................................... 43 8.8 Replacement Parts ....................................................................................................................... 43 8.9 Service .......................................................................................................................................... 43 8.10 Ordering Information ..................................................................................................................... 44 ™ AB5000 Console Display Messages ........................................................................................................ 46 ® ™ – For BVS Blood Pumps and AB5000 Ventricles – Operating Instructions ........................................... 50 ™ AB5000 Console Domestic Limited Service Warranty ............................................................................. 51 Symbol Definitions ...................................................................................................................................... 52 ™ Patient Transport with the AB5000 Circulatory Support System .............................................................. 53

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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. 1.2.1

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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/cm2.

1.4

™

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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 1.5

Figure 1.4 AB5000™ Console shown on iPulse™ Cart

– 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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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 and is ≤ 75 years of age. 2

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.

Central nervous system damage resulting in fixed and dilated pupils.

ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

SECTION 4: SPECIFICATIONS 4.1

Console 4.1.1

Physical Width:

23 inches (58.4 cm) without cart 28 inches (71.1 cm) with cart

Depth:

12 inches (30.5 cm) without cart 18 inches (45.7 cm) with cart

Height:

29 inches (73.7 cm) without cart 38 inches (96.5 cm) with cart

Weight:

96 lbs. (43.5 kg) without cart 155 lbs. (70.3 kg) with cart

Operating Temperature Range:

10°C to 40°C

Operating Humidity Range:

30% to 75% (non-condensing)

Operating Atmospheric Pressure Range:

7,500 ft (767 hpa) to -1000 ft (1051 hpa)

Storage and Transport Temperature Range:

-15°C to +50°C

Storage and Transport Humidity Range:

10% to 95% (non-condensing)

Storage and Transport Pressure Range:

18,000 ft (506 hpa) to -1000 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. 4.1.2

ABIOMED, Inc.

Electrical Mains voltage:

100 - 230 VAC

Mains frequency:

50 - 60 Hz

Mains current:

2.5 A maximum at any input voltage.

Maximum power consumption:

250 W

Line leakage current:

<300 µA at any input voltage.

Power cable:

11 ft. (3.4 m) of #16 AWG Type SJT; hospitalgrade plug (N.A.).

Battery:

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

4.1.3

Mechanical System Drive medium:

Compressed air

Drive technology:

Compressor system drives independent pressureregulated systems. Switching from a pressurized ® to a non-pressurized state in the BVS Blood ™ Ventricle is via Pump and the AB5000 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). 4.1.4

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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:

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.

Priming controls:

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.

Alarm mute:

Silences audible alarm for one minute (except for complete Console failure, which has separate alarm).

Alarm volume:

Cycles alarm volume through 3 levels.

Help:

Provides additional information on current operating conditions.

Operator display:

320 X 240-pixel color LCD with backlighting.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

4.1.5

Outputs and Inputs LEFT and RIGHT device output:

LEFT and RIGHT Blood Pump identification input: SERVICE PORT input/output:

4.1.6

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:

Filling and emptying is controlled by computer examination of air flow and volume into and out of the Blood Pump.

Flow rate:

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:

5 to 25 mmHg

Outflow Pressure:

60 to 90 mmHg

Right side: +/- 15% over the following ranges: Inflow Pressure:

5 to 15 mmHg

Outflow Pressure:

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 under® report 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.

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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 page 12

AB5000TM Circulatory Support System ◊ Operator’s Manual 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.

4.1.7

Weaning method:

Rate reduction via computer control.

Weaning range:

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:

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Left side barb pressure >300 mmHg during systole (BVS Blood Pump), >280 mmHg (AB5000 Ventricle).

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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).

4.1.8

4.2

LOW VACUUM:

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).

HIGH VACUUM:

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).

BATTERY (red LED):

<30 minutes of battery time remaining. (This is the minimum time remaining when BATTERY LED goes from yellow to red.)

CHARGING (yellow LED):

Displayed when battery is below 80% capacity.

Hardware Backup System Indication:

EMERGENCY SYSTEM ON indicator.

Allowable low limit:

Backup engages if system pumping <6 BPM.

Allowable high limit:

Backup engages if system pumping >144 BPM (typical).

Backup pumping rate:

75 BPM, open loop control.

Hand Pump:

See Section 7.

Blood Pump Specifications 4.2.1

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BVS Blood Pump Parameters

Specifications

Number of bladders

Two: filling and pumping

Number/type of valves

Two: inflow and outflow, ABIOMED Angioflex® Polyurethane

Bladder/valve material

Angioflex Polyurethane

Trileaflet

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Volume of pumping bladder

100 cc

Volume of filling bladder

100 cc

Extracorporeal volume (system)

<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

>325 mmHg

Valve prolapse pressure

>410 mmHg

Valve forward flow

<6.5 mmHg at 10L/min.

Drive medium applied to bladder

Compressed air

Housing material

Class VI medical grade polycarbonate

Patient connections:

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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

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.

Atrial ventricular cannula (supplied with Cannula restraint, tunneling bullet, and tie wraps)

• 32 French (10.7 mm) Cannula • 36 French (12 mm) reinforced malleable backbone • 42 French (14 mm) reinforced

Arterial cannula (supplied with Cannula restraint and tunneling bullet)

• 10 mm Hemashield Gold graft Arterial (outflow) cannula ® • 12mm pre-coated Dacron Arterial (outflow) cannula

Driveline connection

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.

Sterilization

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. *

Weight

3.5 lbs (1.6 kg)

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Mounting methods

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.

Blood Pump mounting height

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. 4.2.2

™

AB5000 Ventricle Parameters

Specifications

Number of bladders

One

Number/type of valves

Two: inflow and outflow/ ABIOMED Angioflex® Polyurethane

Bladder/valve material

Angioflex Polyurethane

Volume of bladder

100 cc

Extracorporeal volume (system)

<200 cc

Operating pressures on bladder

Left side: 420 mmHg

Right side: 300 mmHg

on bladder:

Left side: –100 mmHg

Right side: –100 mmHg

Valve prolapse pressure

>600 mmHg

Valve forward flow

<30 mmHg at 10L/min.

Trileaflet

Maximum operating vacuums

Drive medium applied to bladder

Compressed air

Housing materials

Epoxy, anodized aluminum, Class VI medical grade polycarbonate, titanium

Patient connections:

ABIOMED, Inc.

Ventricle inflow

0.475 inch (12.0 mm) Class VI polycarbonate tubing connector.

Ventricle outflow

0.475 inch (12.0 mm) Class VI polycarbonate tubing connector.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Atrial ventricular cannula (supplied with Cannula restraint, tunneling bullet, and tie wraps)

• 32 French (10.7 mm) Cannula • 36 French (12 mm) reinforced malleable backbone • 42 French (14 mm) reinforced

Arterial cannula, (supplied with Cannula restraint and tunneling bullet)

• 10 mm Hemashield Gold graft Arterial (outflow) cannula ® • 12mm pre-coated Dacron Arterial (outflow) cannula

Electronic Key

Fischer connector integrated with electrical/pneumatic connector.

Driveline connection

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.

Sterilization

The disposables are ethylene-oxide gas sterilized, ® the Ventricle is packaged in a Tyvek /PETG tray, ® ® and the cannulae in a Tyvek /Mylar pouch. *

Weight

0.66 lbs (0.30 kg)

Ventricle height

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

Class I equipment

Degree of protection against type of applied part

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.

ABIOMED, Inc.

Mode of operation

Continuous

Degree of protection against ingress of water

IPX1

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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

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.

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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

FULL

Amb. Pump

CHARGE

Help ->

Figure 5.3 Display, System Ready for Use 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

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

5.3

Blood Pump Preparation ®

Prior to operation, see BVS Blood Pump Instructions for Use 0505-9000 or AB5000 Instructions for Use 0055-9001. 5.4

™

Ventricle

Recommended Cannulation Method Prior to operation, see Cannulae Instructions for Use 0506-9110.

5.5

Interconnection Procedure Prior to operation, see BVS Blood Pump Instructions for Use 0505-9000 or AB5000 Ventricle Instructions for Use 0055-9001. ®

– 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

BVS

RIGHT SYSTEM READY FOR USE

FULL

BVS

Pump

CHARGE

Help ->

Figure 5.5 Display, System Showing BVS Pump Default

™

– 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

Amb.

RIGHT SYSTEM READY FOR USE

FULL

Amb.

Pump

CHARGE

Help ->

™

Figure 5.6 Display, System Showing AB5000 Ventricle Detected on Left and Right ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

™

– 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. 5.6.1

– 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 0506-9110).

FLOW: RATE:

X.X XX

BVS

LPM BPM

FULL

Pump

RIGHT SYSTEM READY FOR USE

BVS Pump

CHARGE

Help ->

Figure 5.7 Display, Normal Pumping

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. 5.6.2

– 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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual 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. 5.6.3

™

– 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.

5.6.4

™

– 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

Amb.

RIGHT SYSTEM READY FOR USE

FULL

Pump

BVS Pump

CHARGE

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 5.7.2 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.

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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. ®

5.7.1.1 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.

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5.7.1.2 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 5.6.2. 8) 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. ®

5.7.1.3 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 5.6.2. ®

5.7.1.4 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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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 5.6.2. 5.7.2

™

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. 5.7.3

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 5.7.2 and 6.5). Unplugging the line cord automatically activates battery operation. transport, unplug the line cord, and wind it around the cord wrap.

When ready for

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.

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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. 5.8.1 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

RIGHT SYSTEM READY FOR USE

Set Weaning target. To set Wean Target: - Hold ACTIVATE. - Press UP/DN.

BVS

FULL

Pump

BVS Pump

CHARGE

Help ->

Figure 5.13 Display, Weaning Activation

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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: RATE:

X.X XX

BVS

LPM BPM

FULL

Pump

RIGHT SYSTEM READY FOR USE

BVS Pump

CHARGE

Help ->

Figure 5.14 Display, Weaning Operation

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) 5.9.1 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 4.1.7. 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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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. 5.9.2 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

VACUUM:

FULL

Amb. Func <-

RIGHT SYSTEM READY FOR USE

Pump

---

mmHg

Amb. Help ->

Pump

CHARGE

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

VACUUM LEVEL:

---

mmHg

Set Vac. Level target.

To set Amb. Pump vacuum level: - Hold ACTIVATE. - Press UP/DN.

Amb. Func <-

FULL

Pump

Amb. Pump

CHARGE

Help ->

Figure 5.16 Display, Adjustable Vacuum Option (Pumping Off)

Open the panel marked "Weaning and Priming Controls."

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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:

Amb. Func <-

RIGHT SYSTEM READY FOR USE

mmHg

VACUUM:

FULL

---

mmHg

Amb.

Pump

CHARGE

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. 5.9.3 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.

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In the following example, an AB5000 Ventricle is pumping on the left side. The vacuum setting is at the default 100 mmHg level.

FLOW: RATE:

X.X XX

VACUUM:

LPM BPM

100 mmHg

VACUUM:

FULL

Amb. Func <-

RIGHT SYSTEM READY FOR USE ---

mmHg

Amb.

Pump

Help ->

Pump

CHARGE

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

VACUUM LEVEL:

---

mmHg

Set Vac. Level target.

To set Amb. Pump vacuum level: - Hold ACTIVATE. - Press UP/DN.

Amb. Func <-

FULL

Pump

Amb. Pump

CHARGE

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

™

In the following example, an AB5000 Ventricle is pumping on the left side with the vacuum level set to 35 mmHg:

FLOW: RATE:

X.X XX

LPM BPM

VACUUM:

35 mmHg

VACUUM:

FULL

Amb. Func <-

RIGHT SYSTEM READY FOR USE

Pump

---

mmHg

Amb. Pump

CHARGE

Help ->

Figure 5.20 Display, Vacuum Level Adjusted by User (Pumping On)

5.10

– For BVS Blood Pumps and AB5000 (optional feature)

™

Ventricles – 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

LOW FLOW ALARM:

1.8

LPM

Set Flow Alarm target.

To set low flow alarm: - Hold ACTIVATE. - Press UP/DN.

Amb. Func <-

FULL

Pump

BVS Pump

CHARGE

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.

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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

Specification

Switch contacts

Closed - alarm active Open - no alarm present or alarm muted

Connector

1/4" phone jack

Maximum input

100 VAC / 100 VDC

Maximum switch current

2 amps

Switch contact resistance

< 1 ohm

Table 5.1: Remote Alarm Output Specifications

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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.

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6.3

Pump Detection Alarms

Message

Cause ™

Action

New Pump ID detected

AB5000 Ventricle connected after Pump ON was pressed.

Turn Pump OFF, then ON again (to change Pump ID).

Pump ID Unplugged

Accidental dislodgement or intentional removal of AB5000 Ventricle connection.

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Indicators

Cause

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 activated by disconnecting line plug.

Expect an operating time of approximately one hour.

Battery low, < 30 minutes of battery power remaining.

Plug Console into AC power receptacle or obtain backup Console.

Possible battery fault.

Do not unplug the Console. Obtain a backup Console.

BATTERY LED (amber)

BATTERY LED (red)

AC POWER LED (green) and BATTERY LED (red)

Action

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

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, < 30 minutes of battery power remaining.

Plug Console into AC power receptacle or obtain backup Console.

Possible battery fault.

Do not unplug the Console. Obtain a backup Console.

BATTERY LOW (battery bar red)

BATTERY FAULT Do not unplug

Action

Table 6.4 Battery Status LCD Messages ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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

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.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Left Left

Right Right

™

AB5000 Ventricle Connection

BVS Blood Pump Connection

Figure 7.2b Connecting driveline(s) to hand pump

Check the hand pump settings. Set the shuttle mechanism to the position appropriate for the blood pump in use (Figure 7.3).

™

Left Side BVS Blood Pump (Top of Pump)

Left Side AB5000 Ventricle (Top of Pump)

Right Side BVS Blood Pump (Bottom of Pump)

™

Right Side AB5000 Ventricle (Bottom of Pump)

™

Figure 7.3 AB5000 Hand Pump Shuttle Mechanism Selection ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

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

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

7.3

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.

Begin pumping by pressing the ON button.

Call service personnel at the earliest opportunity to repair the failed Console.

Stowing Hand Pump a)

Return hand pump to bracket on side of Console.

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SECTION 8: ROUTINE MAINTENANCE AND SHIPMENT 8.1

Routine Check of Backup Systems ™

It is recommended that the AB5000 Console emergency systems be checked out regularly and prior to clinical use. The procedure is to test the hand pump, run the regular power-up self-test, and activate the emergency control system. 8.2

Hand Pump Test Operate the hand pump handle through its full range of motion and verify that air is exiting the driveline connectors.

8.3

Self-Test Routine Remove the line cord and plug into an outlet. Open the Weaning and Priming Controls door. Turn on the power switch. Check the flashing panel indicators. Assure that all indicator lights work and that the alarm tone sounds. Listen for valve actuation, and for the sound of air venting from the top panel driveline connectors. The display should read LEFT (RIGHT) SYSTEM READY FOR USE. If any display other than this appears, consider the unit inoperable. Obtain a backup unit and call qualified service personnel immediately. Refer to Section 5.2 for more details.

8.4

Emergency System Test Turn off the power switch on the side of the unit. Then turn on power. During the self-test period, while the indicator lights are flashing, press both of the ACTIVATE buttons for approximately 2 seconds. Wait for approximately 90 seconds from the end of self-test for the emergency system to activate. A continuous audible alarm will be generated. The alarm can be silenced by pressing the mute button. Press the pump ON button. The EMERGENCY SYSTEM OPERATION message and the RATE LEDs should blink as the Console pumps. The LCD display will be blank. Turn off the Console power switch to deactivate the emergency system.

8.5

Packing for Shipment If it becomes necessary to ship the Console a long distance by vehicle, it should be shipped only in its original shipping crate. If the original crate is not available, contact ABIOMED for a substitute crate and packing instructions.

8.6

™

– For BVS Blood Pumps and AB5000 Ventricles – Cleaning The Blood Pumps and Ventricles must be cleaned only with soap and water on all accessible parts (see note below). The Console display/control panel area should be cleaned with isopropyl alcohol and cotton. It is recommended that the display window only be cleaned this way or with soap and water to avoid scratching. Use of a mild detergent with a damp cloth is suggested for the Console enclosure. Cleaning must be conducted before and after each use and may be conducted as needed. The cleaning may be conducted by medical care personnel.

ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Note: Do not allow the following agents to come in contact with the BVS Blood Pumps or AB5000 Ventricles because they may attack the plastic and cause damage to the device: halogenated hydrocarbon-based anesthetic agents, other halogenated hydrocarbons such as chloroform, highly alkaline chemicals such as sodium hydroxide, and aromatic hydrocarbons such as ketones and acetone. 8.7

Scheduled Maintenance The Console must be installed and maintained by ABIOMED, Inc., an authorized service agent, or distributor only, using ABIOMED-approved replacement parts only. The periodic maintenance schedule calls for: Maintenance

Period

Perform cleaning, functional test, and calibration.

1 year

Replace batteries. *

2 years

Replace solenoid valves.

5,000 hours

Replace compressor.

5,000 hours

Replace proportional valves.

5,000 hours

Estimated useful Console life. **

10,000 hours

Please contact the authorized distributor if the hospital record does not show that this schedule has been maintained.

8.8

Warning: Sealed lead battery, must be recycled or disposed of properly.

At end of Console life, remove the battery and recycle or dispose of properly. Do not incinerate the battery as this could result in an explosion. Dispose of the Console in accordance with applicable local regulations or contact your authorized ABIOMED representative.

Replacement Parts Contact your authorized ABIOMED representative for a Spare Parts List.

8.9

Service For service, contact: North America: ABIOMED, Inc. 22 Cherry Hill Drive Danvers, Massachusetts 01923 (978) 777-5410 (800) 422-8666

ABIOMED, Inc.

International: ABIOMED Impella CardioSystems GmbH Neuenhofer Weg 3 52074 Aachen, Germany +49 (241) 8860-0

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AB5000TM Circulatory Support System ◊ Operator’s Manual

8.10

Ordering Information

Equipment Catalog No.

Language

Mains voltage

0015-0010-E1S

English

120 VAC

0015-0010-E2S

English

230 VAC

0015-0010-E3S

English

100 VAC

Accessories Catalog Number

Description

0015-0030

AB5000 Cart

1 per box

0015-0040

Aircraft Mounting Plate

1 per box

0050-3200

BVS Blood Pump Sling

0005-0090

BVS Pole Mount

0005-0080

BVS Bed Mount

0005-0060

BVS Pump Mounting Set

0015-9000

AB5000 System Operator's Manual

0015-9002

AB5000 Console Service Manual

™

Contents

1 per box

™

1 per box

™

1 per box

™

BVS and AB5000 Disposables Blood Pump and Ventricle Sets

ABIOMED, Inc.

Blood Pump and Ventricle sets (with selected Cannulae) and individual Cannula are available. Contact your representative or call 1-800-422-8666.

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ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

AB5000™ CONSOLE DISPLAY MESSAGES Emergency System Message

Action

EMERGENCY SYSTEM OPERATION

Get backup Console. Refer to Section 5.2 (c).

Normal Pumping Messages

Action

LEFT (RIGHT) SYSTEM READY FOR USE

Refer to Section 5.2 (c).

LEFT (RIGHT) FLOW X.X LPM RATE XX BPM

Refer to Section 5.6.1.

TO STOP PUMPING, PRESS "OFF" AGAIN

Refer to Section 5.6.4.

Weaning Messages

Action

TARGET FLOW: X.X LPM Set Weaning target. To set Wean Target: - Hold ACTIVATE. - Press UP/DN.

Refer to Section 5.8.1.

FLOW: X.X LPM RATE: XX BPM

Refer to Section 5.8.1.

NOT ENOUGH FLOW TO BEGIN WEANING Flow must be greater than 1.8 LPM to begin weaning

Release ACTIVATE button.

ABIOMED, Inc.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Alarm Messages

Action

LOW FLOW

Check Blood Pump: a. Obstruction of blood 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.

NEW PUMP ID DETECTED

Check AB5000 Ventricle electrical/pneumatic connector: a. Turn pump OFF and then ON again to change pump type selected by Console.

PUMP ID UNPLUGGED

a. Re-attach AB5000 Ventricle electrical/pneumatic connector to Console.

EMERGENCY SYSTEM OPERATION

Microprocessor system failure: a. Obtain backup Console.

Complete Console Failure [indicated by continuous audible alarm]

ABIOMED, Inc.

™

Action a. Connect driveline(s) to hand pump and continue pumping by hand while observing Blood Pump(s). b. Turn Console off and unplug. Obtain backup Console.

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AB5000TM Circulatory Support System ◊ Operator’s Manual

Battery Messages

Action

FULL CHARGE (battery bar green)

No action required.

BATTERY IN USE (battery bar amber)

Expect an operating time of approximately 1 hour.

BATTERY LOW (battery bar red)

Plug Console into AC power receptacle or obtain a backup Console.

BATTERY CHARGING (battery bar amber)

Leave Console plugged in until battery LED is no longer illuminated.

BATTERY FAULT Do not unplug

Do not unplug the Console. Obtain a backup Console.

ABIOMED, Inc.

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ABIOMED, Inc.

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Circulatory Support Systems

AB5000TM Circulatory Support System Operator’s Manual Rev L