AB5000TM Circulatory Support System Operator’s Manual Rev L

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] (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.

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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 ™

®

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The AB5000 Console can be used to operate either BVS Blood Pumps or AB5000 Ventricles. 1.2.1

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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.

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Figure 1.1 BVS Blood Pump

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AB5000TM Circulatory Support System ◊ Operator’s Manual

1.2.2

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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.

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Figure 1.2 AB5000 Ventricle

1.3

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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

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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

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– 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.

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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.

2)

Central nervous system damage resulting in fixed and dilated pupils.

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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

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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

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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.

P

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

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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

P

Drive medium applied to bladder

Compressed air

Housing materials

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

Patient connections:

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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%

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®

®

* 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.

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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.

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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.

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Figure 5.1 AB5000 Console Side Panel

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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.

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