GE Healthcare CARESCAPE B450

Asset Type

Patient Monitor

Manufacturer

GE Healthcare

Model

CARESCAPE B450

Manual Reference

CARESCAPE Monitor B450 Technical Manual, Software Version 2, Hardware Version B450-01, 2062973-003, September 19, 2016.

Manufacturer Recommendation / AEM Status

The manual lists planned maintenance for the CARESCAPE Monitor B450 main unit. Parameter module preventive maintenance is not fully covered by this manual; the manual points to the Module Frames and Modules Technical Manual for planned and corrective maintenance of parameter modules.

Manufacturer-Listed PM Frequency

Every 12 months after installation.

Manufacturer-Listed Planned Maintenance Items

Manufacturer-listed planned maintenance includes visual inspection, electrical safety tests, functional check, all steps, and battery maintenance.

Manufacturer-Listed Replacement Interval

CPU timekeeper battery: Replace every 5 years, or whenever Service Monitor Error Code 0xHOST1100 is shown.

Manufacturer-Listed Part Numbers Found

Safety Test Body Kit: M1155870 or equivalent.

CPU Battery FRU: 2069650-001, FRU CPU Battery, B450, CR2032, 5 pcs.

Monitor Battery: 2062895-001, Monitor Battery, B450, type FLEX-3S2P.

Post-Repair / Corrective Maintenance Note

The manual lists checkout requirements after corrective maintenance before returning the monitor to clinical use. Depending on the service activity, required checkout may include visual inspection, electrical safety testing, and functional check steps. After replacing any service part, the manual points back to the specified checkout procedure in Chapter 10.

AEM Note

If a facility performs this PM at a different interval or changes the listed activities, that should be handled under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

This procedure covers visual inspection of the monitor and connected peripherals, electrical safety testing, functional checkout, battery maintenance review, CPU timekeeper battery interval review, and CMMS documentation for scheduled PM.

Required Tools and Equipment

Electrical safety analyzer / leakage current tester equivalent to the circuits shown in the manual.

Safety Test Body Kit, P/N M1155870, or equivalent, when patient leakage testing is performed.

Calibrated test equipment with calibration due dates documented.

PSM, PDM, and/or E-modules as applicable to the installed configuration.

Keyboard, mouse, barcode reader, network, printer, recorder, or iPanel test setup only if those options are installed and facility policy includes those checks.

Step-by-Step PM Procedure

1. Confirm Device and Configuration

Verify the asset tag, serial number, monitor type, software version, installed modules, and connected peripherals.

The PM should be performed on the correct CARESCAPE B450 configuration. The main unit PM is covered by this manual, but parameter module PM may require the Module Frames and Modules Technical Manual.

2. Visual Inspection

Inspect the monitor, connected peripheral devices, mounting hardware, cables, connectors, and modules.

Check that the monitor and connected peripherals are undamaged, properly mounted with specified mounting solutions, and connected with intact, secured cables. Confirm that modules are properly connected and locked.

No physical damage, loose mounting, damaged cabling, incorrect connections, or loose modules should remain.

3. Electrical Safety Testing

Perform electrical safety testing according to the manual and facility policy.

Manufacturer-listed electrical safety checks include test setup, power outlet, power cord and plug, ground / earth integrity, earth leakage current, enclosure leakage current / touch current, patient source leakage current if applicable, patient sink leakage current if applicable, and test completion.

Electrical safety results should meet the manual-listed acceptance criteria or facility-approved criteria.

4. Functional Check

Perform functional check steps applicable to the installed configuration.

Manufacturer-listed functional check items include start-up, display, PSM / PDM identification, E-module identification, keypad and remote, mouse, alphanumeric keyboard, barcode reader, MC Network and S/5 Network, Wireless LAN, IX printers, iPanel connection, InSite with ExC, recorder, synchronization connector test, and test completion.

Installed features should operate correctly. Non-installed features should be documented as N/A.

5. Battery Maintenance

Review monitor battery condition, charge status, battery diagnostics, and replacement need. Replace the monitor battery if it fails facility criteria, shows battery failure, or does not support expected operation.

The manual lists monitor battery maintenance as part of annual planned maintenance. PDM battery maintenance is covered in the Module Frames and Modules Technical Manual, not this B450 main unit manual.

6. CPU Timekeeper Battery Review

Check whether the CPU timekeeper battery is due by age or error condition.

The CPU timekeeper battery should be replaced every 5 years or when Service Monitor Error Code 0xHOST1100 is shown.

Electrical Safety Testing

Perform electrical safety testing with a calibrated electrical safety analyzer. The manual says to record electrical safety test results, for example using the installation / maintenance check forms included in the manual.

Ground / Earth Integrity

Manual-listed acceptance criteria:

Without power cord: ≤ 0.1 Ω.

With power cord: ≤ 0.2 Ω.

Ground resistance measured in ohms, expected ≤ 0.2 Ω with power cord or facility/NFPA 99 criteria if different.

Earth Leakage Current

Manual-listed acceptance criteria:

Normal Condition: ≤ 300 µA UL 60601-1 or ≤ 500 µA EN/IEC 60601-1.

Single Fault Condition: ≤ 1 mA.

Earth leakage measured in microamps:

Facility / standard used =

NC result =

SFC result =

Pass / Fail =

Touch / Enclosure Leakage Current

Manual-listed acceptance criteria:

Normal Condition: ≤ 100 µA.

Single Fault Condition: ≤ 300 µA UL 60601-1 or ≤ 500 µA EN/IEC 60601-1.

Touch/chassis leakage measured in microamps:

Facility limit used =

NC result =

SFC result =

Pass / Fail =

Patient Leakage Current, If Applicable

Patient leakage testing applies to connected parameter modules and patient connectors listed in the manual. The manual lists the Safety Test Body Kit P/N M1155870 or equivalent for patient leakage testing.

Manual-listed patient source leakage criteria:

Normal Condition: ≤ 10 µA.

Single Fault Condition: ≤ 50 µA.

Manual-listed patient sink leakage criteria:

Normal polarity: ≤ 50 µA.

Reverse polarity: ≤ 50 µA.

Patient leakage measured in microamps, if applicable:

Module / connector tested =

Source leakage NC result =

Source leakage SFC result =

Sink leakage result =

Pass / Fail =

Pass / Fail Criteria

PM passes when visual inspection passes, electrical safety testing passes using the manual-listed or facility-approved criteria, functional check passes for the installed configuration, battery condition is acceptable, required CPU timekeeper battery replacement is not due or has been completed, and no active service error, physical damage, failed safety test, or failed functional check remains.

Remove from service if electrical safety testing fails, monitor startup or functional checkout fails, display, touchscreen, alarms, recorder, modules, or network functions required for clinical use fail, battery failure affects intended use, CPU timekeeper battery replacement is due because of error code and cannot be completed, or physical damage, loose mounting, damaged power cord, or damaged connectors create a safety risk.

Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.