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Asset Type
Electrocardiograph (EKG) Machine
Manufacturer
Model
Manual Reference
Midmark IQecg Operation Manual, document 48-78-0002 Rev. AB3, 2025, including the IQecg Service Manual section; applicable IQmanager documentation and patient-cable instructions.
Manufacturer Recommendation / AEM Status
Midmark requires a preventative inspection before each use. Inspect the ECG module and cables for cracks, cuts, discoloration, oxidation, or other deterioration. Replace damaged cables or accessories before use.
The digital acquisition module requires little maintenance, contains no user-adjustable or user-serviceable parts, and is designed to operate without adjustment for its lifetime. The reviewed manual does not specify a recurring calendar-based certification or PM interval. Certification policy and frequency are the end user's responsibility; Midmark offers factory certification and repair.
Use the facility-approved CMMS interval and AEM/risk process while continuing the before-each-use inspection. Verify separate requirements for legacy serial/RS-232 or battery-powered versions.
What This PM Procedure Covers
- Identification, configuration, and service-history review.
- Module, interface, patient cable, leads, clips, labels, and storage.
- Cleaning and patient-cable disinfection.
- Computer/software recognition and communication.
- 12-lead acquisition, lead-off response, signal stability, and report processing.
- Electrical-safety applicability and return-to-service review.
Required Tools and Equipment
- Compatible Windows computer with approved IQmanager/IQecg software and configured report destination.
- Known-good ECG patient simulator.
- Installed 10-lead resting ECG patient cable, lead wires, and clips.
- Soft cloth, mild detergent/water, and manufacturer-permitted cable disinfectant.
- Applicable Midmark manual and facility PM checklist.
- Electrical safety analyzer only when required by facility policy.
- Facility-required PPE.
Step-by-Step PM Procedure
1. Confirm Identification and Applicability
Action: Verify asset tag, serial number, module/interface version, software version, assigned PC, report destination, patient cable, accessories, and service history. Confirm this procedure applies to the configuration.
Expected outcome: The system matches its record and legacy configurations needing separate instructions are identified.
2. Remove the System From Clinical Use
Action: Confirm no patient is connected and no clinical ECG session is active. Close open ECG test instances.
Expected outcome: Work proceeds without interrupting care or corrupting a record.
3. Perform the Manufacturer's Preventative Inspection
Action: Inspect the module, housing, hanger, labels, interface, strain reliefs, patient cable, leads, clips, and connectors for cracks, cuts, discoloration, oxidation, contamination, bent contacts, looseness, exposed conductors, stretching, kinks, or tight coils. Confirm the patient-cable connection is tight. Do not repair a damaged cable or routinely unplug it from the module.
Expected outcome: Module and accessories are intact, secure, and free of damage that could cause malfunction.
4. Clean the ECG Module
Action: Wipe the module with a soft cloth and mild detergent/water; prevent fluid entry. A mild sterilizing detergent with low alcohol content may be used when necessary. Do not use aromatic hydrocarbons, rubbing alcohol, or chlorinated solvents on the module, and do not immerse it. Dry completely.
Expected outcome: The module is clean, dry, and undamaged.
5. Clean and Disinfect the Patient Cable
Action: Wipe cable parts toward the connectors/clips using lukewarm water and alcohol-free neutral soap. Avoid stretching, bending, or kinking. Remove cleaner with a water-moistened cloth and dry. Clean before wipe disinfection. Permitted active ingredients are 70-80% ethyl or isopropyl alcohol, 2% glutaraldehyde at pH 7.5-8, or a quaternary ammonium compound. After contact time, remove disinfectant with a water-moistened cloth.
Do not autoclave, UV-sterilize, immerse, or soak the cable. Avoid prolonged alcohol exposure, N-propyl alcohol, bleach, acetone, and toluene.
Expected outcome: Cable and leads are clean, dry, and free of chemical or mechanical damage.
6. Verify Storage and Cable Management
Action: Store the module in its case or by its built-in hanger, never by a cable. Arrange cables in large loops and keep the system away from heat, sunlight, extreme humidity, and liquids.
Expected outcome: Storage does not stress cables or expose the module to damaging conditions.
7. Verify Computer and Software Operation
Action: Start the approved PC and software. Confirm the application opens without error, versions are recorded, only one ECG test instance is open, the module is recognized through its intended interface, and required workflow screens are accessible.
Expected outcome: Software and module communicate normally.
8. Perform a 12-Lead Functional Acquisition Check
Action: Connect all leads to an ECG simulator and select a stable facility-approved rhythm/rate. Confirm all 12 leads are present and correctly identified; displayed rate meets facility criteria; waveforms are stable without unexplained noise, drift, flat lines, or interruption; gentle lead movement causes no intermittent loss; and lead-off appears when a selected lead is disconnected and clears when reconnected.
The reviewed manual provides no numerical field-certification tolerance. Do not represent this check as factory certification or calibration.
Expected outcome: Stable, correctly identified 12-lead data and lead-off response are verified.
9. Verify Report Processing
Action: Complete the simulated workflow. Confirm analysis, saving, and configured print/export. Verify legible fields, waveforms, lead labels, calibration marks, and page content. Remove or identify test data according to policy.
Expected outcome: The acquisition-to-report workflow passes.
10. Review Certification and Service Status
Action: Review complaints, drops, liquid exposure, signal history, and failures. Arrange Midmark certification if facility policy requires it. Refer a malfunctioning module to Midmark and obtain an RMA before return.
Expected outcome: Factory certification or repair needs are identified without unauthorized adjustment.
11. Complete Return-to-Service Review
Action: Confirm inspection, cleaning, storage, recognition, acquisition, lead-off, report processing, settings, and documentation pass. Restore the approved clinical configuration.
Expected outcome: The IQecg is ready for use.
Electrical Safety Testing
The manual identifies defibrillator-proof Type CF equipment and IEC 60601-1 compliance but does not prescribe recurring field electrical-safety testing or numerical PM limits. The current USB module is marked for 5 VDC, 80 mA operation.
Determine testing from the exact module/interface, associated computer/power equipment, facility risk classification, NFPA 99 policy, and applicable regulations. When required, ground resistance is measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different.
Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =
Document the analyzer, configuration, limits, and results. Do not import limits from another IQecg generation.
Pass / Fail Criteria
PM Pass Criteria
- Identity, configuration, software, and CMMS record agree.
- Module, cables, clips, connections, labels, and hanger have no unacceptable damage.
- Equipment is correctly cleaned, dry, and stored.
- Software recognizes the module with only one active test instance.
- All 12 simulator leads are stable/correctly identified and rate meets facility criteria.
- Lead-off response, analysis, saving, and configured print/export pass.
- Any facility-required electrical-safety test passes.
- No unresolved fault or factory action remains.
Remove From Service Criteria
- Module, cable, lead, clip, connector, or strain relief is damaged or cannot be safely cleaned.
- Fluid intrusion or prohibited cleaning may have affected equipment.
- Software communication is unreliable.
- A lead is missing, mislabeled, noisy, flat, intermittent, or does not recover.
- Simulator rate/waveform fails facility criteria.
- A required workflow or electrical-safety check fails.
- Factory certification is due or internal repair is required.
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.