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Manual Reference
Cardiosave Hybrid / Rescue Operating Instructions applicable to the installed hardware and software; Cardiosave Battery Operation Quick Reference Guide; Cardiosave Hybrid / Rescue Operating Instructions Addendum MCA000000751, Revision B, ©2025 Datascope Corp.; and the current controlled Cardiosave service manual. Verify Hybrid or Rescue configuration, software revision, battery revision, transport accessories, and regional documentation before service.
Manufacturer Recommendation / AEM Status
Getinge separates maintenance into Schedule A and Schedule B. Schedule A items require no tools and may be completed by the clinical user or a Getinge-trained/certified BMET. Schedule B work requires a Getinge factory-trained and certified technician, special tools, and in some cases removal of instrument covers. Never perform PM while the IABP is attached to a patient.
Schedule A calls for checking the battery system and charge indicator before or after each use, and checking battery runtime every 12 months. Schedule B requires checking battery rated voltage and runtime every 12 months or 2,500 hours. Replace a battery when runtime is less than 60 minutes per fully charged battery at 120 BPM and 22 ±5°C, or after four years. Use only Cardiosave battery pack P/N 0146-00-0097.
The 2025 addendum adds replacement of the quick-disconnect fitting O-ring and lubrication of the console release latch every 12 months or 2,500 hours, whichever comes first. Replace the Real Time Clock NVRAM IC on the Executive Processor Board every 8 years. The full Schedule B also contains configuration-specific cycle-, assist-hour-, operating-hour-, and four-year activities; complete those only from the current service manual after reviewing the recorded counters.
If a facility changes these activities or intervals, that decision should be managed through its approved AEM program, documented risk assessment, maintenance history, and applicable regulatory requirements. Restricted Schedule B work and manufacturer training qualifications should not be bypassed through a local checklist.
What This PM Procedure Covers
- Hybrid/Rescue identity, software, configuration, service history, and counters
- Console, cart, transport accessories, controls, connectors, cables, labels, and cooling airflow
- Battery inspection, charging, transfer, voltage, and annual runtime testing
- Startup/self-test, user interface, alarms, signal inputs, helium/pneumatic operation, and assist function
- Annual/2,500-hour O-ring and console-latch service
- Applicable cycle-, hour-, four-year, and eight-year Schedule B actions
- Electrical safety, final readiness, and CMMS documentation
Required Tools and Equipment
- Configuration- and software-specific Cardiosave Operating Instructions, current addenda, and controlled service manual
- Getinge-specified Schedule B service tools, fixtures, software, and test instrumentation
- Approved IABP test load/simulator and test accessories specified by the current service procedure
- Cardiosave-compatible ECG and arterial-pressure test capability
- Approved helium supply and manufacturer-specified pneumatic test equipment
- Battery runtime test setup capable of the specified 120 BPM test condition
- Calibrated multimeter and electrical safety analyzer when required by the controlled procedure
- Cardiosave batteries P/N 0146-00-0097 and other configuration-specific scheduled parts when due
- Approved cleaning/disinfection supplies and facility-required personal protective equipment
Step-by-Step PM Procedure
1. Remove the IABP From Patient Use
Action: Confirm the Cardiosave is not connected to a patient or catheter and has been released for maintenance. Provide equivalent backup IABP capability according to facility policy and label the unit unavailable.
Expected outcome: No patient depends on the system during inspection or testing.
2. Verify Identity, Software, and Configuration
Action: Record asset tag, console serial number, Hybrid cart or Rescue configuration, software revision, installed options, batteries and revisions, charging accessories, helium configuration, cables, transport accessories, and regional labeling. Confirm the controlled manuals apply.
Expected outcome: The exact system configuration and applicable service procedure are identified.
3. Review Service History and Counters
Action: Review prior PM and repairs, operating hours, assist hours, inflate/deflate cycle counts, battery dates and test results, NVRAM date, O-ring/latch service, alarms, gas-loss complaints, shutdowns, transport problems, fluid ingress, recalls, and current Getinge field actions.
Expected outcome: Every applicable calendar-, operating-hour-, assist-hour-, cycle-, and condition-based activity is identified.
4. Clean and Decontaminate
Action: Power down, disconnect AC, remove batteries, and separate the console from the cart when required by the applicable cleaning instructions. Clean/disinfect the console, cart, cables, transport accessories, controls, seams, and vent grates using only Getinge-approved products and contact times. Do not spray liquid directly into the device.
Expected outcome: The system is visibly clean, dry, and safe to handle, with cooling airflow unobstructed.
5. Inspect the Console and Accessories
Action: Inspect the enclosure, display, touchscreen, encoder, keys, handles, covers, vents, speaker openings, printer, connectors, labels, power inlet/cord, equipotential connection, helium connection, patient cable ports, and accessory cables. Look for cracks, looseness, contamination, corrosion, heat, liquid entry, or unauthorized modification.
Expected outcome: The console and accessories are complete, legible, secure, and free of damage.
6. Inspect Hybrid Cart or Rescue Transport Hardware
Action: Inspect console docking, release latch, cart frame, casters, brakes, handles, storage areas, cylinder restraint, transfer connections, Rescue transport case/mounting, and all installed transport accessories. Verify secure engagement and controlled release.
Expected outcome: The system is mechanically stable, mobile as intended, and safely retained during use and transport.
7. Check the Battery System
Action: Inspect both battery bays and each P/N 0146-00-0097 battery for damage, swelling, contamination, terminal damage, age, and correct seating. Verify the battery charge indicator, charging LEDs, recognition of each battery, AC operation, and uninterrupted transfer to battery power. Maintain batteries charged while the system is not in use.
Expected outcome: Both battery positions, indicators, charging, and power transfer function normally.
8. Perform the Annual Battery Runtime Test
Action: Fully charge and test each battery separately using the current Getinge procedure at 120 BPM and 22 ±5°C. Record battery serial/revision, age, rated voltage, measured voltage, runtime, alarms, and cutoff behavior. Replace any battery below 60 minutes per pack or at four years, whichever requires replacement first.
Expected outcome: Each installed battery provides at least 60 minutes under the specified test condition and is within its age limit.
9. Power Up and Verify Self-Test
Action: Reassemble the approved configuration, connect AC and helium as directed, and start the system. Verify startup/self-test completion, display, touchscreen, encoder, keys, indicators, speaker, printer, date/time, configuration recognition, and absence of unresolved fault messages.
Expected outcome: Startup completes normally and the Cardiosave reaches a ready state.
10. Verify ECG and Pressure Signal Paths
Action: With the approved simulator/test setup, verify ECG input and lead selection, arterial-pressure input and zeroing, waveform quality, trigger recognition, displayed rate/pressure, and switching among applicable trigger sources. Inspect all patient cables and connectors.
Expected outcome: Signal inputs are stable, accurate within the current service criteria, and reliably trigger assist operation.
11. Verify Pneumatic and Assist Operation
Action: Using the controlled service procedure and approved test load, verify helium supply indication, autofill, pneumatic connections, inflation/deflation, assist-ratio selection, timing controls, standby, and manual/automatic operation as applicable. Check for leakage, abnormal noise, delayed cycling, or repeated refill conditions.
Expected outcome: Pneumatic operation and assist timing meet all configuration-specific service criteria without leakage or faults.
12. Verify Alarms and Indicators
Action: Test required audible and visual alarms under controlled conditions, including power loss, low/depleted or removed battery, helium/gas condition, trigger/signal loss, catheter/pneumatic fault, system fault, and other service-manual alarm checks. Verify alarm volume, priority, messages, silence/reset behavior, and visibility during transport.
Expected outcome: Every required alarm activates, sounds, displays, prioritizes, and resets correctly.
13. Complete Annual/2,500-Hour Schedule B Work
Action: A Getinge factory-trained and certified technician must complete the full Schedule B procedure every 12 months or 2,500 hours, whichever comes first. Replace the quick-disconnect fitting O-ring and lubricate the console release latch as added by the current addendum. Perform all remaining inspections, adjustments, tests, and parts actions listed in the applicable service manual.
Expected outcome: The complete annual/2,500-hour Schedule B is documented, not merely the public addendum items.
14. Complete Cycle-, Hour-, and Age-Based Schedule B Work
Action: Compare the recorded counters with the full Schedule B thresholds, including 6,000,000 inflate/deflate cycles or four years; 12,000,000 cycles, 2,000 assist hours, or four years; and 5,000 operating hours as applicable. At eight years, replace the Real Time Clock NVRAM IC on the Executive Processor Board. Use only current service-manual procedures and qualified personnel.
Expected outcome: Every applicable threshold-controlled item is complete and traceable, or the unit remains out of service.
15. Perform Electrical Safety Testing
Action: Test the complete configured system according to the electrical-safety section below and the current Cardiosave service manual. Record analyzer identity, conditions, facility/manual limits, and actual readings.
Expected outcome: All required electrical-safety measurements pass.
16. Restore, Document, and Return to Service
Action: Remove test equipment, reinstall charged batteries, restore the approved helium and accessory configuration, confirm charging and ready indicators, repeat final startup/self-test and functional checks, and document parts, counters, readings, corrective work, and disposition.
Expected outcome: The Cardiosave is complete, charged, fully tested, and either returned to service with traceable records or clearly removed from service.
Electrical Safety Testing
Perform electrical safety only with the current configuration-specific Cardiosave service procedure and facility policy. The public battery guide and 2025 addendum do not publish the complete analyzer method or universal numeric leakage limits, so do not invent them. Test the console, AC cord, Hybrid cart and charging accessories in the required configuration.
Ground resistance measured in ohms, expected ≤0.5 Ω or facility/NFPA 99 criteria if different:
Result =
Touch/chassis leakage measured in microamps:
Facility or current service-manual limit used =
Result =
Pass / Fail =
Remove the system from service for a damaged power path, unreliable protective earth, excessive leakage, incomplete required test, or any electrically related shutdown or alarm that remains unresolved.
Pass / Fail Criteria
Pass
- Identity, software, counters, history, console, cart/transport hardware, labels, cables, connectors, and accessories pass inspection
- Cleaning is complete and cooling airflow is unobstructed
- Both battery positions, charging, AC/battery transfer, indicators, rated voltage, and annual runtime pass; each battery provides at least 60 minutes at 120 BPM and is within four years
- Startup/self-test, user interface, ECG/pressure inputs, trigger recognition, pneumatic assist, timing, alarms, and indicators meet the current service criteria
- The full annual/2,500-hour Schedule B and every applicable cycle-, hour-, four-year, and eight-year action are complete
- Electrical safety passes using documented current limits
- No unresolved alarm, field action, damage, leak, power, battery, signal, timing, or pneumatic fault remains
Remove From Service
- Startup/self-test, battery, signal path, trigger, pumping, timing, alarm, pneumatic, or electrical-safety testing fails
- A battery provides less than 60 minutes at the specified test condition, has reached four years, or shows damage/unreliable charging
- Physical damage, contamination, fluid entry, obstructed cooling, gas leakage, damaged electrical/patient connections, or unstable mounting is found
- A required Schedule B action, current field correction, special tool, service manual, part, or trained technician is unavailable
- Any condition remains that could interrupt or mistime IABP therapy
Copy/Paste CMMS Work Order Procedure
Cardiosave is life-support equipment. Never perform PM while it is attached to a patient, never bypass a failed test, and do not perform restricted Schedule B work without the current service manual, required tools, and Getinge factory training/certification.