0015-7309, RevH
AB5000™ System Installation / Preventative Maintenance Procedure
Page 1 of 8
ABIOMED, Inc. Proprietary and Confidential
SOP-QA1000-T2, Rev. B
AB5000™ System Console
S/N
AB5000™ AB Cart OR
iPulse Cart
S/N
Hand Pump
S/N
Time Meter
Hrs.
Date
Tested By
All service and maintenance, which involves disassembly of the AB5000
TM
Console, must be performed by factory
trained and certified service personnel. Replacement parts obtained from sources other than ABIOMED/IMPELLA
must not be used. Possible Electrostatic discharge precautions must be observed. Prior to servicing, check with
ABIOMED/IMPELLA technical support (USA 800-422-8666) (49-241 8860301) for available FCN
releases and Service Manual updates.
REQUIRED EQUIPMENT
Item
Specification (or ABIOMED P/N for Specialized
Tools)
Angled mirror
Miltex Mirror P/N 67-696/3 and Mirror Handle P/N 011-
26641 or equivalent
Lint free swab with 6“ plastic handle
Abiomed PN 7000-0030 (Lint free swab with 6” plastic
handle) or equivalent
Hydraulic Load Simulator
ABIOMED/IMPELLA P/N 0005-0070
Digital Voltmeter
Fluke 77 or Equivalent
Laptop Computer
Running Windows 2000 or Later, Serial Port
Diagnostic Download Cable
ABIOMED/IMPELLA P/N 0015-9612
Pump ID Connector
ABIOMED/IMPELLA P/N 0055-0737
Pressure/Vacuum Gauge
-200mmHg to +500mmHg min (Damping set to 1 sec.)
Safety Analyzer (EUROPE ONLY)
IEC601-1 Tester
[ ] 1. DECONTAMINATION
Prior to servicing, the AB5000
TM
Console must be decontaminated. Unless otherwise known, the Console
should be considered contaminated and universal safety precautions are to be taken. Gloves, masks, eye
protection, and protective garments are to be worn as required in the handling and decontamination of the
Console.
[ ] 2. UNCRATING
Uncrate the Console and Cart. Place the Hand Pump into the mounting bracket as required.
[ ] 3. EXTERNAL INSPECTION
Perform a thorough
exterior inspection of the Console and Cart. Inspect for:
[ ]
Turret rotation, panel damage, mechanical damage and any loose hardware.
[ ] 4. INTERNAL INSPECTION
Remove Console from Cart. Remove the Console panels. Perform a thorough
interior visual inspection.
(Inspect fittings, tubings, quick-connect tubing (insertion depth), cable connections, hardware).
[ ]
Perform a general inspection of the compressor subassemblies, including but not restricted to,
black debris in the rear bearing, tubing wear, mesh wear and electrical connections as per procedure
0015-7007.
[ ] 5. PERFORM REQUIRED FIELD CHANGES (FCNS) – CONTACT ABIOMED FOR CURRENT FCN
STATUS
