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Asset Type
Electrocardiograph (EKG) Machine
Manufacturer
Model
Manual Reference
MAC 5 A4 / MAC 5 A5 / MAC 5 Lite Resting ECG Analysis System Service Manual, 5864335-002-6
Manufacturer Recommendation / AEM Status
Manufacturer-Listed PM Frequency
Regular yearly maintenance, irrespective of usage, is listed as essential to ensure the equipment is functional when required.
Manufacturer-Listed PM / Checkout Items
The service manual lists visual inspection per IEC 62353:2014 subsection 5.2, electrical safety checks, functional checkout, operational checks using simulated ECG data, and diagnostic checks through device service diagnostics. Cleaning procedures are referenced to the MAC 5 Operator’s Manual and are not fully listed in the provided service manual.
Calibration: The service manual states the system does not require calibration procedures.
Manufacturer-Listed Electrical Safety Limits
Protective earth resistance: ≤ 100 mΩ.
Equipment leakage current: normal condition ≤ 500 µA; single fault condition ≤ 1000 µA.
Touch current, not mandatory for IEC 62353: normal condition ≤ 100 µA; single fault condition ≤ 500 µA.
Patient leakage current, not mandatory for IEC 62353: normal condition ≤ 10 µA; single fault condition ≤ 50 µA.
Applied part leakage current per IEC 62353: ≤ 50 µA.
Manufacturer-Listed Part Numbers Found in the Manual
Battery: 2062895-001.
A4 paper: 2104772-001.
Letter paper: 2104771-001.
A5 paper: 5684683.
AC/DC adapter: 2205621-001-S.
External barcode scanner kits: 2106084-025, 2106084-028, 5844816-001-S.
Intervals and Applicability
Battery replacement interval: Not specified in the provided manual.
Filter replacement interval: Not applicable / not listed.
Calibration interval: No calibration procedures required per the provided service manual.
Post-Repair Safety Inspection Requirements
The manual separates checkout requirements by FRU or non-FRU repair. Electrical safety checks are listed for several FRU repairs and for annual electrical safety checkout. For non-FRU repairs, electrical safety is listed as required if the device is opened.
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 annual visual inspection, battery inspection, patient cable inspection, power cord inspection, connector inspection, trolley inspection if equipped, label inspection, functional ECG checkout using simulated ECG, printer checks, barcode checks, LAN/WLAN checks, USB checks, display checks, audio checks, touchscreen checks, battery diagnostics, electrical safety testing, and CMMS documentation.
Required Tools and Equipment
Electrical safety analyzer capable of IEC 62353 testing.
ECG simulator.
Known-good patient cable and leadwire set, if needed for verification.
USB flash drive, if exporting diagnostics or logs.
Barcode reader, if barcode function is installed or used.
ECG paper for MAC 5 A4 or MAC 5 A5 printer models.
Network access or test destination, if LAN/WLAN/DCP/MUSE/Gateway transmission is part of the facility PM.
Facility-approved cleaning supplies, per Operator’s Manual and facility policy.
Step-by-Step PM Procedure
1. Identify the Device
Action: Confirm asset tag, serial number, MAC 5 configuration, and whether the unit is MAC 5 A4, MAC 5 A5, or MAC 5 Lite.
Expected outcome: Device identity and configuration match the CMMS record.
2. Remove From Clinical Use
Action: Confirm the ECG is not in active patient use. Power the unit down before inspection or cleaning. Disconnect AC power and remove the battery before internal visual inspection or cleaning.
Expected outcome: Device is safe to inspect.
3. Visual Inspection - Exterior
Action: Inspect the device surface for cracks, dust collection, deformation, damaged plastic, loose hardware, missing screws, damaged labels, or illegible safety markings.
Expected outcome: Housing, labels, and safety markings are intact and legible.
4. Patient Cable, Leadwire, and Electrode Inspection
Action: Inspect the patient cable, leadwires, and electrodes for defects, damage, metal corrosion, discoloration, brittle wires, damaged connectors, or expiration.
Expected outcome: Patient connection accessories are safe and usable.
Remove from service if patient cable or leadwires are cracked, corroded, brittle, damaged, expired, or unreliable.
5. Keyboard and Touchscreen Inspection
Action: Inspect the keyboard membrane for cuts, cracks, or illegible labels. Inspect the touchscreen/display for scratches, cracks, viewing impairment, or opaque display filter issues.
Expected outcome: User input and display are readable and physically intact.
6. Power System Inspection
Action: Inspect the AC power cord, AC/DC adapter, DC inlet, AC outlet used for charging, and power connectors for fraying, bent pins, cracked housings, loose screws, or damage.
Expected outcome: Power components are intact and safe.
Remove from service if power cord, adapter, inlet, or connector damage is found.
7. Battery Inspection
Action: Remove and inspect the battery pack for cracked, swollen, or leaking enclosure and debris on battery electrical contacts.
Expected outcome: Battery is physically intact and contacts are clean.
Remove from service if the battery is swollen, leaking, cracked, or has damaged contacts.
8. Connector and Accessory Inspection
Action: Inspect USB ports, LAN port, ECG patient cable connector, KISS pump connector if equipped, barcode reader, and other external connectors for damage, bent pins, loose fit, or contamination.
Expected outcome: Connectors are intact and accessories seat securely.
9. Trolley and Caster Inspection, If Equipped
Action: Inspect trolley, mounting hardware, and casters. Lock the trolley casters and verify the wheels do not move.
Expected outcome: Trolley is stable and caster locks hold.
10. ECG Functional Checkout
Action: Connect an ECG simulator. Record a rhythm strip of simulated ECG data and verify it records successfully. Record a 12-lead ECG using a simulator set to normal sinus rhythm with known heart rate and gain, such as NSR at 80 bpm with 1 mV R-wave.
Expected outcome: Rhythm strip and 12-lead ECG acquire and record successfully.
11. Printer Check, If MAC 5 A4 or MAC 5 A5
Action: Confirm correct paper type is loaded. Print an ECG or printer test as applicable.
Expected outcome: Paper feeds correctly, print is readable, and printer door closes securely.
MAC 5 Lite does not support paper printing.
12. Storage / Report Handling Check
Action: Store a simulated ECG and verify it stored successfully. If facility workflow requires it, verify save, print, delete, transmit, and export functions.
Expected outcome: Report handling functions work according to the site workflow.
13. Barcode Reader Check, If Equipped
Action: Scan a barcode using the connected barcode reader. Run Barcode Reader Diagnostics if available.
Expected outcome: Barcode reader communicates successfully with the device and diagnostic result passes.
14. Network / Transmission Check, If Used by Facility
Action: If the device is networked, verify LAN or WLAN connection. If the facility uses MUSE, Gateway, shared folder, SFTP, USB export, or order download, verify the applicable workflow.
Expected outcome: Network connection and configured transmission/order workflow succeed.
15. Device Diagnostics
Action: Run applicable service diagnostics based on facility PM scope and device configuration:
Touchscreen Diagnostics.
Quick Battery Charge and Discharge Test.
Barcode Diagnostics, if equipped.
Display Diagnostics.
Audio Diagnostics.
Writer Diagnostics, if printer model.
LAN Diagnostics, if used.
WLAN Diagnostics, if used.
Brightness Diagnostics.
USB Port Diagnostics.
KISS Pump Diagnostics, if equipped.
Keyboard LED Diagnostics.
Expected outcome: Applicable diagnostics pass.
16. Final Functional Review
Action: Confirm the unit powers on, displays normally, responds to user input, charges on AC power, operates on battery, and completes an ECG acquisition workflow.
Expected outcome: Device is ready for clinical use.
Electrical Safety Testing if applicable
Perform electrical safety testing per the facility’s test method and the manufacturer-listed IEC 62353 checklist.
Ground resistance measured in ohms, manufacturer-listed expected ≤ 100 mΩ:
Result =
If your facility documents using the broader NFPA 99 style field, document both as applicable:
Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different:
Result =
Equipment leakage current measured in microamps:
Facility/manufacturer limit used =
Result =
Pass / Fail =
Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =
Patient leakage current measured in microamps, if tested:
Facility/manufacturer limit used =
Result =
Pass / Fail =
Applied part leakage current measured in microamps:
Facility/manufacturer limit used =
Result =
Pass / Fail =
Pass / Fail Criteria
Pass Criteria
Device housing, labels, cables, connectors, power supply, and battery pass visual inspection.
No cracked, swollen, leaking, corroded, brittle, expired, or unsafe patient-contact accessories are found.
ECG simulator rhythm strip and 12-lead ECG acquire successfully.
Printer works on MAC 5 A4 / A5 models.
Battery and charging checks pass.
Applicable diagnostics pass.
Electrical safety results meet manufacturer-listed or facility-approved limits.
Device completes the site-required save / print / transmit / export workflow.
Remove From Service Criteria
Failed electrical safety test.
Damaged power cord, AC/DC adapter, DC inlet, or exposed wiring.
Swollen, leaking, cracked, or damaged battery.
Damaged patient cable, leadwires, or patient connector.
Failed ECG acquisition from simulator.
Failed required diagnostic check.
Unreadable display or unreliable touchscreen / controls.
Printer failure on models requiring print function.
Network/transmission failure if required for clinical workflow and no approved downtime process exists.
Copy/Paste CMMS Work Order Procedure
Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.