ABIOMED® BVS 5000i®

Transcription

ABIOMED® BVS 5000i®

At the Heart of Circulation
SM
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] (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.
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.
page 2
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
ABIOMED, Inc.
page 3
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ABIOMED, Inc.
page 4
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.
page 5
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.
page 6
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.
page 7
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.
ABIOMED, Inc.
page 8
ABIOMED, Inc.
page 9
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:
Height:
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.
page 10
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
ABIOMED, Inc.
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.
page 11
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.
ABIOMED, Inc.
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
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:
and inflow pressure >10 mmHg for 32 Fr. and 36
Arterial Cannula.
Right Side BVS Blood Pump or AB5000 Ventricle:
and inflow pressure >10 mmHg for 32 Fr. and 36
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:
ABIOMED, Inc.
Left side barb pressure >300 mmHg during systole
(BVS Blood Pump), >280 mmHg (AB5000
Ventricle).
page 13
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
ABIOMED, Inc.
®
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
page 14
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:
ABIOMED, Inc.
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
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)
®
page 15
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)
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
P
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.
page 16
Atrial ventricular 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,
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
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
page 17
SECTION 5: INSTALLATION & OPERATION
5.1
Installation
Prior to clinical use, on-site installation and testing of this Console shall be performed by an
®
authorized ABIOMED Service Representative.
CAUTION: Device must be plugged into AC outlet to maintain battery charge when not in
use.
CAUTION: To remove all AC power from the Console, unplug the unit from the line cord.
5.2
Console Power-Up and Self-Test
DANGER:
Explosion risk if used with flammable anesthetics.
CAUTION: If the Console has been stored in an environment exceeding the Operating
Ranges, let the Console stabilize at the operating ambient prior to use to
ensure specified performance.
CAUTION: Do not lean on or place any objects on the control panel.
CAUTION: Minimize the exposure of the Console to sources of electromagnetic,
magnetic, optical, and thermal radiation. Exposure to sources of
electromagnetic radiation, such as cell phones and walkie-talkies, or other
types of radiation may cause operational interference. To clear symptoms of
interference, turn off the interfering device. The Console should resume
normal operation.
CAUTION: Minimize the exposure of the Console to vibration and mechanical shocks
™
during transport. See section "Patient Transport with the AB5000 Circulatory
Support System." Lift the device by side handles only over steps or
obstructions.
CAUTION: Avoid activities that may build up static charges on the Console or on
personnel contacting the Console. Avoid brushing bed sheets across the
Console or touching the Console immediately after performing activities likely
to build static charge. If electrostatic discharge interrupts operation of the
Console, cycle the POWER ON/OFF switch.
CAUTION: Operation of the Console may interfere with the operation of other devices. If
this is suspected, maximize the distance between the Console and the device.
WARNING: Patient physiological pressure must be monitored continuously. Do not rely
™
solely on the AB5000 Alarm System.
ABIOMED, Inc.
page 18
If possible, the Console should be powered up one hour before use; however, there is no
minimum warm-up time required. A self-test procedure automatically runs after power-up, and
requires about ten seconds to complete. During self-test, the Console flashes all indicators,
sounds the alarm tone, and pumps air through the driveline connectors. It also checks the
processor system integrity. The operator should observe the control panel during the selftest to detect abnormalities.
™
Figure 5.1 AB5000 Console Side Panel
™
Figure 5.2 AB5000 Console Control Panel
a)
Unwrap line cord from cord wrap and plug into an outlet. (Check that the AC POWER
indicator is lighted on the top panel. CHARGING may also be lighted.) Activate the
Console with the power switch on the side panel (Figure 5.1). The system will
automatically begin to run its self-test. Where the integrity of the external protective
conductor in the installation or its arrangement is in doubt, the Console shall be operated
from its internal battery.
b)
Check visible and audible machine functions: watch for the flashing of all alarm and status
lamps (Figure 5.2). The BATTERY indicator will not be lighted.
Listen for the alarm tone. It first sounds soft, then sounds loud.
Listen for valve actuation and the sound of air venting from the top panel driveline
connectors.
ABIOMED, Inc.
page 19
c)
The display should read LEFT (RIGHT) SYSTEM READY FOR USE after self-test (Figure
5.3).
LEFT SYSTEM
READY FOR USE
RIGHT SYSTEM
READY FOR USE
FULL
Amb.
Pump
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
d)
Check the condition of the batteries. If the CHARGING indicator is illuminated, the
batteries are not capable of providing a full hour’s operation of the Console. Allow more
charging time before portable use.
The Console is now ready for operation.
CAUTION: Do not lean on or place any objects on the control panel.
ABIOMED, Inc.
page 20
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
Pump
CHARGE
Help
->
®
Figure 5.5 Display, System Showing BVS Pump Default
a)
™
– For AB5000 Ventricle ONLY – Plug the electrical/pneumatic connector into the
receptacle on the rotating driveline turret. Verify that the corresponding pump type
displayed is “AMB. PUMP” (Figure 5.6).
LEFT SYSTEM
READY FOR USE
Amb.
RIGHT SYSTEM
READY FOR USE
FULL
Amb.
Pump
Pump
CHARGE
Help
->
™
Figure 5.6 Display, System Showing AB5000 Ventricle Detected on Left and Right
ABIOMED, Inc.
page 21
b)
™
– For AB5000 Ventricle ONLY – Pump type selection will be latched once the pump ON
button is pressed. Removing the electrical/pneumatic connector while pumping is on will
trigger an alarm. If the electrical/pneumatic connector is not attached prior to pressing
pump ON, attach the connector and turn the pump OFF, then ON again. The new pump
type will then be latched.
WARNING: The pump type displayed on the Console must match the pump type in use.
5.6
Pumping
Connect the pneumatic line(s) from the disposable to the rotating driveline connectors. To start
pumping, depress the appropriate ON button. If bi-ventricular support is required, start pumping
on the left side before starting pumping on the right.
If pumping is started prior to connecting the disposable, the system will require additional time
before reaching full flow. Full flow can be achieved faster in this situation by stopping pumping
and then immediately restarting pumping.
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.
page 22
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.
page 23
®
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.
ABIOMED, Inc.
page 24
®
®
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.
ABIOMED, Inc.
page 25
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.
ABIOMED, Inc.
page 26
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
ABIOMED, Inc.
page 27
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.
ABIOMED, Inc.
page 28
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.
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."
ABIOMED, Inc.
page 29
Press and hold the ACTIVATE button for the desired side (left or right). The default level of 100
mmHg is displayed. While holding the ACTIVATE button, press the down ▼
( ) arrow to reach the
desired vacuum level.
Release the ACTIVATE button. The desired vacuum level is now displayed.
In the following example, the vacuum level has been set to 50 mmHg:
LEFT SYSTEM
READY FOR USE
VACUUM:
50
Amb.
Func
<-
RIGHT SYSTEM
READY FOR USE
mmHg
VACUUM:
FULL
---
mmHg
Amb.
Pump
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.
ABIOMED, Inc.
page 30
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
To set Amb. Pump
vacuum level:
- Hold ACTIVATE.
- Press UP/DN.
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)
Press and hold the ACTIVATE button for the desired side (left or right). While holding the
ACTIVATE button, press the down (▼) arrow or the up (▲) arrow to reach the desired vacuum
level.
Release the ACTIVATE button. The desired vacuum level is now displayed.
ABIOMED, Inc.
page 31
™
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.
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.
Set Flow Alarm target.
To set low flow alarm:
- Hold ACTIVATE.
- Press UP/DN.
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.
page 32
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
ABIOMED, Inc.
page 33
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:
HIGH VACUUM or LOW VACUUM
Internal vacuum problem:
Table 6.1 Flow, Pressure, and Vacuum Alarms
CAUTION: Obtain a backup Console if all of the above have been checked and these
alarms continue to occur with pump rates at 20 to 30 BPM in the “normal”
operation mode.
ABIOMED, Inc.
page 34
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.
ABIOMED, Inc.
page 35
Indicators
Cause
AC POWER
LED (green)
Console is plugged into AC power
receptacle.
No action required.
AC POWER LED
(green) AND
CHARGING LED
(amber)
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)
receptacle.
No action required.
BATTERY
CHARGING
(battery bar amber)
receptacle AND charge is < 80%
capacity.
BATTERY LED (amber) is no
longer illuminated.
BATTERY IN USE
(battery bar amber)
Battery activated by
disconnecting line plug.
approximately one hour.
Battery low, < 30 minutes of
battery power remaining.
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.
page 36
6.6
Emergency System
If the microprocessor-based pump control system fails, a fixed-rate control system takes over.
This system will continue pumping at approximately 75 BPM and will light the emergency system
indicator (Table 6.5). A continuous audible alarm will be generated. The alarm can be silenced
by pressing the mute button.
When the emergency system is on, only the rate and battery LED indicators are valid. The ON
and OFF buttons function normally.
Indicator
Cause
Action
EMERGENCY
SYSTEM OPERATION
(LCD display will be
blank)
Microprocessor
system failure
Obtain backup system
as soon as possible.
Call Service personnel.
Table 6.5 Emergency System Message
ABIOMED, Inc.
page 37
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
b)
™
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.
page 38
Left
Left
Right
Right
™
AB5000 Ventricle Connection
®
BVS Blood Pump Connection
Figure 7.2b Connecting driveline(s) to hand pump
c)
Check the hand pump settings. Set the shuttle mechanism to the position appropriate for
the blood pump in use (Figure 7.3).
®
™
Left Side 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.
page 39
d)
The hand pump may be operated while mounted on the Console or may be removed and
held during operation as show in Figure 7.4
e)
Pull the handle from the hand pump until it stops. Press it to fully return it to its original
position. Repeat. This should result in a normal pumping rate of 30 to 60 times per
minute. Observe the Blood Pump / Ventricle for proper filling and emptying.
™
Figure 7.4 AB5000 Hand Pump Operation
7.3
f)
Obtain a backup Console. Power it up and allow the self-test to run. Transfer the
driveline(s) from the hand pump to the backup Console.
g)
Begin pumping by pressing the ON button.
h)
Call service personnel at the earliest opportunity to repair the failed Console.
Stowing Hand Pump
a)
Return hand pump to bracket on side of Console.
ABIOMED, Inc.
page 40
ABIOMED, Inc.
page 41
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.
page 42
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.
Danvers, Massachusetts 01923
(978) 777-5410
(800) 422-8666
ABIOMED, Inc.
International:
ABIOMED
Impella CardioSystems GmbH
Neuenhofer Weg 3
+49 (241) 8860-0
page 43
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
®
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.
page 44
ABIOMED, Inc.
page 45
AB5000™ CONSOLE DISPLAY MESSAGES
Emergency System Message
Action
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
Weaning Messages
Action
TARGET FLOW: X.X LPM
Set Weaning target.
To set Wean Target:
- Hold ACTIVATE.
- Press UP/DN.
FLOW: X.X LPM
RATE: XX BPM
NOT ENOUGH FLOW
TO BEGIN WEANING
Flow must be greater than
1.8 LPM to begin weaning
Release ACTIVATE button.
ABIOMED, Inc.
page 46
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:
LOW PRESSURE
Internal pressure problem if indicated
when not pumping:
HIGH VACUUM or LOW VACUUM
Internal vacuum problem:
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.
Microprocessor system failure:
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.
page 47
Battery Messages
Action
FULL CHARGE
(battery bar green)
No action required.
BATTERY IN USE
(battery bar amber)
approximately 1 hour.
BATTERY LOW
(battery bar red)
receptacle or obtain a backup
Console.
BATTERY CHARGING
(battery bar amber)
battery LED is no longer illuminated.
BATTERY FAULT
Do not unplug
Do not unplug the Console. Obtain a
backup Console.
ABIOMED, Inc.
page 48
ABIOMED, Inc.
page 49
– FOR BVS® BLOOD PUMPS AND AB5000™ VENTRICLES –
Operating Instructions
NORMAL OPERATION
1) Turn power “ON” (switch and line cord located at side).
2) Wait for display:
LEFT (RIGHT) SYSTEM READY FOR USE.
3) For BVS Blood Pump, connect pneumatic line(s) to driveline
connectors on top of Console.
For AB5000 Ventricle, attach electrical/pneumatic connector to
Console.
4) To start pumping, press appropriate “ON” button.
5) To stop pumping, press “OFF” button twice.
WEANING AND PRIMING
Instructions and controls are provided under door labeled “Weaning and
Priming Controls.”
AC POWER (green LED)
Indicates Console is plugged into an AC power source.
BATTERY (yellow LED)
Battery, activated by disconnecting line plug, provides an operating time
of approximately one hour.
BATTERY (red LED)
Battery low, < 30 minutes of battery power remaining. Plug Console into
AC receptacle or obtain backup Console.
CHARGING (yellow LED)
This indicator is lighted ONLY if charge is < 80% capacity AND line cord
is plugged into AC line receptacle.
ABIOMED, Inc.
page 50
AB5000™ CONSOLE DOMESTIC LIMITED SERVICE WARRANTY
ABIOMED, Inc. warrants that, at the time of installation, all AB5000 Consoles (the “Goods”) sold
will be free from defects in material and workmanship and remain free from defects under normal
use and service for a period of one (1) year from the date of installation. Extended warranty and
service may, at ABIOMED's option, be offered for an additional charge, in which event separate
or additional terms and conditions may apply.
This warranty does not cover routine Preventative Maintenance or replacement parts that are
consumed per the console’s periodic maintenance schedule outlined in the Operator’s and
Service Manuals.
The express warranty set forth on this page is the only warranty given by ABIOMED with
respect to any goods furnished hereunder. ABIOMED makes no other warranty, express,
implied or arising by custom or trade usage, and specifically makes no warranty of
merchantability or of fitness for any particular purpose. Said express warranty shall not
be enlarged or otherwise affected by ABIOMED's rendering of technical or other advice or
service in connection with the Goods.
ABIOMED shall not be liable for incidental or consequential losses, damages or expenses,
directly or indirectly arising from the sale, handling or use of the Goods, or from any other cause
relating thereto, and ABIOMED’s sole responsibility under this warranty will be, at its option, to 1)
repair or replace the Goods or any components of the Goods found to be defective in
workmanship or material during the foregoing warranty period, or 2) to refund the purchase price
paid. All replaced components and Goods will become the property of ABIOMED. This warranty
shall not apply if the Goods have been: (a) repaired or altered in any way by other than
ABIOMED or ABIOMED authorized service personnel; (b) subjected to physical or electrical
abuse or misuse; or (c) operated in a manner inconsistent with ABIOMED's instructions for use of
the Goods. If ABIOMED determines that a claim was not caused by ABIOMED or ABIOMED's
authorized service personnel, then Buyer shall pay ABIOMED for all related costs incurred by
ABIOMED. This warranty is not transferrable without the express written consent of ABIOMED.
Under this warranty, ABIOMED will provide at no charge, updates or modifications which directly
affect the safe operation of the Goods. ABIOMED is not obligated to provide updates or
modifications which provide (a) product improvement or enhancement; (b) new product features,
or (c) options to the Goods.
ABIOMED has no obligation to provide a loaner system during service or maintenance of the
Goods. However, at ABIOMED's sole discretion, ABIOMED may provide such loaner systems.
This warranty applies to the AB5000 Console only and not to any disposable or other component
™
of the AB5000 System. Specific items excluded from this warranty include, but are not limited
to, Blood Pumps, cannula, and external tubing.
This warranty may not be amended without the express written consent of an authorized officer of
ABIOMED, Inc.
ABIOMED, Inc.
page 51
SYMBOL DEFINITIONS
Symbol
Description
"ON" (power)
Symbol
IPX1
Description
Protected against
dripping water
Protective earth
(ground)
Attention, consult
instructions
Equipotentiality
Year of Manufacture
Dangerous Voltage
SN
Variability in Steps
REF
Serial Number
Part Number
LOT
ABIOMED, Inc.
"OFF" for a part of
equipment
Lot number
Rechargeable Battery
Alternating Current
Type B applied part
Alarm inhibit
Fuse
Remote Alarm Output
(Optional)
page 52
PATIENT TRANSPORT WITH THE AB5000™ CIRCULATORY SUPPORT SYSTEM
In some instances, a patient on AB5000 System support may need to be transported to another
medical center. Examples of potential reasons for transport include moving patients to centers
with greater cardiac support experience and resources. If a patient needs to be transported to
another medical center, the following information should be considered. Planning ahead and
being prepared is important and makes any transport easier.
Transport Vehicle qualification:
1. Planning adequate space is crucial. Console specifications include:
Weight = 96 lbs. (43.5 kg); height = 29 inches (73.7 cm); width = 23 inches (58.4 cm) and
depth = 12 inches (30.5 cm)
2. Satisfactory operation should be expected from a nominal 120 Vac. 60 Hz sine wave source
with at least 500 watt capacity or from a 120 Vac. 60 Hz quasi-sine wave source (i.e.,
®
Vanner Model 20-1000TUL). A square-wave source should not be used. Remember
that the hand pump is available for use if needed.
3. The transport vehicle’s inverter should be operating before the line cord is connected. All
power in the transport vehicle, including lights, should be ON before plugging in Console.
BVS® Blood Pump considerations:
1. The BVS Blood Pump is 18 inches long. The top of the Blood Pump should be level with or
below the patient’s ventricle to give good flows. Use of the AB5000 allows the Blood Pump to
be mounted in a horizontal orientation. Remember that pump filling is accomplished by
gravity and the patient’s preload.
2. Check the driveline(s) that connect the Blood Pump to the Console. Make sure there are no
kinks.
3. Carry ¼ inch tubing for any needed repairs or driveline extension. Driveline extension up to 6
feet (for a total maximum of 12 feet) has been done, with some decrease in actual flow, even
though displayed flow may be higher. However, this may not be appropriate for patients
already in low flow conditions. After repairing or extending the driveline, press “OFF” twice,
wait 3 seconds, and press “ON”. Again, make sure there are no kinks.
®
®
4. Use of a BVS Bed Mount or BVS Blood Pump Sling rather than an IV pole may make
maneuvering the Blood Pumps easier. Ensure that the Blood Pump is not damaged during
transport by providing adequate clearance.
™
AB5000 Ventricle considerations:
1. Check the driveline(s) that connect the Ventricle to the Console. Make sure there are no
kinks.
2. Carry ¼ inch tubing for any needed repairs. Driveline extensions are not recommended for
purposes of transport. After repairing the driveline, press “OFF” twice, wait 3 seconds, and
press “ON”. Again, make sure there are no kinks.
ABIOMED, Inc.
page 53
Console considerations:
1. Load all ancillary equipment (monitors, ventilators, etc.) into transport vehicle before bringing
patient from the hospital Intensive Care Unit (ICU) or Operating Room.
2. 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. Remove the Console from the cart.
3. Remove the hand pump from the Console prior to loading Console into transport vehicle so
that it will be readily accessible if it is needed.
4. Load the Console into the transport vehicle prior to loading the patient. If necessary, use the
6-foot tubing adapter to extend the tubing length during transport use. Try to situate the
Console in a position where the display is readily visible. Load patient into the vehicle feetfirst.
5. Console has a power consumption of 250 watts. Make sure that the vehicle is able to provide
the necessary power.
6. Make sure battery is fully charged prior to transport.
7. Unplug Console’s power cord prior to transport-vehicle shutdown.
8. Monitor battery runtime. Console has a maximum battery runtime of one hour when fully
charged. Much, if not all, of this can be consumed during the transfer back and forth from the
ambulance to the ICU. Remember that the hand pump is available for use if needed.
9. Fasten the Console to the ambulance/aircraft with appropriate straps or fixture to prevent
movement.
Examples of Additional Equipment to Consider:
1. Power strips for extra outlets (for use with equipment other than the system)
2. Monitors (EKG, BP and PA/CVP)
3. Extra oxygen tanks
®
4. Bed Mount or Blood Pump Sling (BVS Blood Pump only)
5. Sterile gloves, tubing clamps, irrigation bowl, irrigation syringe, and sterile sponges
6. Nylon straps to secure Console
ABIOMED, Inc.
page 54
ABIOMED, Inc.
Danvers, MA 01923
978-777-5410 (voice)
800-422-8666 (voice US only)
978-777-8411 (fax)
ABIOMED Europe GmbH
Neuenhofer Weg 3
+49 (241) 8860-0 (voice)
+49 (241) 8860-111 (fax)
www.abiomed.com

ABIOMED® BVS 5000i®

Transcription

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