Mortara ELI 250 / ELI 210

Asset Type

Electrocardiograph (EKG) Machine

Manufacturer

Mortara

Model

ELI 250 / ELI 210

Manual Reference

ELI 250 / ELI 210 Service Manual, REF 9516-163-50-ENG, Revision B1

Model scope: The provided service manual specifically covers the ELI 250 and ELI 210. Do not automatically apply every step in this procedure to other Mortara ELI Series models without confirming compatibility with the model-specific service documentation.

Manufacturer Recommendation / AEM Status

Manufacturer-Listed PM Frequency

Clean and inspect the unit every 6 months.

Increase cleaning and inspection to every 3 months when the unit is in heavy use.

Clean the printhead every 80 operating hours. The manual also recommends monthly printhead cleaning.

Perform leakage testing according to facility or regulatory requirements.

Periodically inspect the power cord and transmission cables for fraying or damage. The manual does not assign a specific interval to this cable inspection.

The customer is responsible for establishing and implementing a satisfactory maintenance schedule.

Post-Repair Safety Testing

Perform leakage testing after removal or replacement of the following assemblies:

• Printed circuit board assembly
• AC connector assembly
• Writer assembly

The manual also requires leakage testing when these assemblies are removed or replaced during normal maintenance or repair.

Parts Relevant to Maintenance

• Rechargeable battery: Mortara P/N 4800-006, 12 V, 2.2 Ah
• AC fuse: Mortara P/N 4021-001, Type T, 250 V, 1 A, 5 × 20 mm slow-blow
• Battery fuse: Mortara P/N 4021-006, Type T, 5 A, 250 V slow-blow

The manual does not provide a scheduled battery-replacement interval.

AEM Status

If the facility performs this PM at a different interval or changes the manufacturer-listed activities, document the change under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

• Exterior cleaning and physical inspection
• Power cord, communication cable, connector, patient cable, and lead-wire inspection
• Keyboard, display, speaker, date, and time checks
• Writer, paper path, and printhead inspection
• ECG acquisition and printing verification
• Lead-fail verification
• Battery and AC operation checks
• Electrical safety testing and documentation

Required Tools and Equipment

• Clean, lint-free cloth
• Cloth dampened with water for exterior cleaning
• Isopropyl alcohol for printhead cleaning
• ECG patient simulator
• Metric ruler
• Electrical safety analyzer
• Facility-approved leakage-current test equipment
• Replacement ECG paper as needed
• Digital multimeter when performing internal power-supply or battery testing
• Mortara-style shorting plug for the optional noise test; the manual states that Mortara does not supply this plug

Do not use alcohol, solvents, or cleaning solutions on the exterior covers.

Step-by-Step PM Procedure

1. Confirm Device Identification and PM Interval

Action: Record the model, serial number, asset number, software version when required by facility policy, and operating environment.

Confirm whether the device is maintained at a six-month interval, a three-month interval because of heavy use, or another interval approved under the facility’s AEM program.

Expected outcome: Equipment identification is legible and the applicable PM interval is documented.

2. Remove the Device From Clinical Use

Action: Confirm that no patient is connected. Disconnect accessories that are not required for testing and inspect the unit before applying power.

Do not disassemble the unit while AC power is connected. Remove the battery fuse before internal disassembly.

Expected outcome: The unit is safely prepared for inspection and testing.

3. Clean the Exterior

Action: Wipe the exterior covers and line cord with a cloth dampened with water. Dry all surfaces before applying power.

Do not submerge, autoclave, or steam-clean the device or patient cables. Do not use alcohol, solvents, or cleaning solutions on the exterior plastic surfaces. Do not use abrasive materials on labels or nameplates.

Expected outcome: Exterior surfaces are clean, dry, and free from residue or damage.

4. Perform Exterior Inspection

Action: Inspect the complete unit for:

• Cracks, deformation, or signs of impact
• Corrosion, deterioration, or excessive wear
• Loose or missing hardware
• Damaged paper tray, writer cover, hinges, or latches
• Damaged or illegible labels
• Liquid intrusion or contamination
• Blocked openings
• Damage to the AC inlet, fuse holder, patient input, serial port, LAN, modem, or other installed connectors

Expected outcome: The enclosure and accessible components are secure and free from damage that could affect safety or operation.

5. Inspect the Power Cord and Communication Cables

Action: Inspect the hospital-grade power cord and installed transmission cables for cuts, fraying, crushed insulation, bent or loose contacts, discoloration, overheating, or damage at the connector and strain relief.

Confirm that the power cord is the correct three-wire grounded type.

Expected outcome: Cords and connectors are intact, properly grounded, and suitable for continued service.

Remove from service when: A conductor is exposed, the ground pin is missing, the strain relief is damaged, or a connector is loose or shows evidence of overheating.

6. Inspect the Patient Cable and Lead Wires

Action: Inspect the patient cable and lead wires for:

• Cracks, cuts, or stretched sections
• Bent, recessed, corroded, or contaminated contacts
• Damaged lead-wire connectors
• Loose strain relief
• Evidence of improper repair
• Intermittent connections during gentle cable movement

The manual states that compatible patient cables include at least 10 kΩ series resistance in each lead for defibrillation protection. Do not substitute an unapproved cable.

Expected outcome: The patient cable and lead wires are intact and produce stable connections.

7. Inspect and Clean the Printhead

Action: Open the writer cover and inspect the paper path, platen, cue-sensor area, and printhead.

Apply isopropyl alcohol to a clean cloth. Wipe the printhead until foreign material is removed, allow it to dry completely, and load the correct thermal paper.

Expected outcome: The printhead is clean and dry, and paper feeds without obstruction.

Manufacturer-listed interval: Every 80 operating hours, with monthly cleaning also recommended.

8. Verify AC and Battery Operation

Action: Connect the unit to an appropriate hospital-grade grounded outlet. Verify that the AC or charging indicator illuminates. Power the unit on and confirm normal startup.

Disconnect AC power and confirm that the device continues operating from its internal battery. Reconnect AC power after testing so the battery can recharge.

Expected outcome: The unit powers up from AC, transfers to battery operation, and indicates charging when AC power is restored.

The manual does not provide a specific minimum battery runtime for PM acceptance. Use facility policy or an approved battery-capacity procedure when runtime testing is required.

9. Test Keyboard Operation

Action: Enter a test-patient screen and exercise the alphanumeric keys, function keys, Enter, Backspace, Auto, Rhythm, Stop, and other controls used during normal operation.

Expected outcome: Each selected character or function is recognized without sticking, double-entry, or missed input.

10. Test the Display

Action: Apply an ECG simulator signal. Inspect the display for missing segments, gaps, black areas, flickering, distortion, or intermittent operation.

Adjust contrast through its normal range when accessible, then return it to a usable setting.

Expected outcome: The display is readable and presents complete waveforms and menu information.

11. Test the Speaker

Action: Access the configured volume setting and verify that the speaker produces an audible tone. Change the volume through multiple settings and confirm that the tone changes appropriately from setting 0 through setting 8.

Expected outcome: The speaker operates and responds correctly to volume changes.

12. Verify Date and Time

Action: Open the Date/Time screen and confirm that the displayed date and time are correct. Correct them according to facility policy when necessary.

Restart the unit and verify that the date and time are retained.

Expected outcome: The device displays and retains the correct date and time.

13. Perform the Writer Test

Action: With AC power connected, initiate the writer test using the applicable service key sequence:

ALT + SHIFT + RHY

Inspect the test printout for:

• Complete printable characters
• A 200 mm reference line
• Complete zigzag patterns without missing dots
• A reasonable cue-sensor trace
• Diagonal lines without missing dots or stepping
• A circle without breaks or unexplained gaps
• Proper paper advancement and cueing

Measure the 200 mm reference line with a metric ruler.

Expected outcome:

• Reference line measures 200 mm ±2 mm
• No missing printhead dots
• No abnormal stepping, gaps, or paper-feed distortion
• Paper advances and cues correctly

The manual notes that the printed circle may show a gap when the configured filter is below 300 Hz. This condition alone should not be treated as a writer failure.

14. Verify Calibration Pulse and Paper Speed

Action: Print an ECG at the paper speeds used by the facility. Measure the calibration pulse with a metric ruler rather than relying on the printed paper grid.

Expected calibration-pulse width:

• 5 mm/s: 1 mm
• 10 mm/s: 2 mm
• 25 mm/s: 5 mm
• 50 mm/s: 10 mm

Expected calibration-pulse amplitude:

• 5 mm/mV gain: 5 mm
• 10 mm/mV gain: 10 mm
• 20 mm/mV gain: 20 mm

Expected outcome: Measured pulse width and amplitude correspond to the selected speed and gain.

15. Perform ECG Acquisition Test

Action: Connect the ECG simulator to the patient cable and apply a known 12-lead ECG signal.

Enter test-patient information, acquire an automatic ECG, print the ECG when printing is not automatic, and compare the displayed and printed ECG with the simulator settings.

Expected outcome:

• All expected leads are displayed
• Waveforms are stable and correctly labeled
• The printed ECG agrees with the simulator input
• No unexplained artifact, clipping, or missing leads are present

The manual does not state one universal amplitude, rate, or interval tolerance for this test. Use the simulator setting and facility-approved verification criteria.

16. Perform Lead-Fail Test

Action: With the patient cable attached to a simulator or approved shorting device, disconnect one lead at a time.

Verify the appropriate message:

• Right arm: LEAD RA OFF
• Left arm: LEAD LA OFF
• Left leg: LEAD LL OFF
• Chest leads: LEAD V1 OFF through LEAD V6 OFF
• All leads disconnected: LEADS OFF

Expected outcome: Only the appropriate lead-fail indication appears for each disconnected lead.

17. Optional Noise Test

Action: Perform this test only when the required shorting plug and an approved facility procedure are available.

Connect the specified shorting plug, set gain to 20 mm/mV, print a rhythm strip, allow at least 200 mm of paper to print, and inspect the baseline.

Expected outcome: No baseline peak exceeds 0.5 mm.

The manual states that Mortara does not supply the shorting plug.

18. Inspect Installed Communication Functions

Action: When communication features are part of the device’s clinical use, verify the applicable installed interface:

• RS-232
• Modem
• LAN
• WLAN

Confirm that configuration values have not been unintentionally changed. Perform a test transmission when included in the facility PM procedure.

Expected outcome: The installed communication method connects and transmits successfully, or the limitation is documented and referred to the appropriate IT or system-support group.

19. Optional Internal Inspection

Perform internal inspection only when included in facility policy and completed by qualified service personnel.

Action: Remove AC power and the battery fuse before opening the unit.

Inspect for:

• Loose, bent, or corroded contacts
• Worn wiring or harnesses
• Component leakage or deterioration
• Loose or damaged solder connections
• Charring, cracking, or brittle PCB areas
• Loose hardware
• Damaged chassis parts
• Incorrect cable routing

Expected outcome: Internal components are secure, clean, and free from damage.

After reinstalling the PCB assembly, AC connector assembly, or writer assembly, perform the manufacturer-listed leakage testing.

Electrical Safety Testing

The ELI 250 and ELI 210 are identified as Class I equipment with Type CF applied parts.

The service manual references ANSI/AAMI ES-1 and IEC 60601-1 and identifies the following safety tests:

• AC high-potential, patient to mains
• Earth leakage
• Chassis leakage
• Patient-source leakage
• Patient-sink leakage

The manual does not provide measured leakage-current limits. Use the current facility-approved standard and test configuration.

Protective-Earth Resistance

This acceptance value is based on facility policy rather than a numerical limit stated in the provided manual.

Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different:

Result =

Touch/Chassis Leakage

Touch/chassis leakage measured in microamps:

Facility limit used =

Result =

Pass / Fail =

Patient Leakage

Patient-source leakage measured in microamps =

Facility limit used =

Pass / Fail =

Patient-sink leakage measured in microamps =

Facility limit used =

Pass / Fail =

Post-Repair Requirement

Complete leakage testing after removal or replacement of the PCB assembly, AC connector assembly, or writer assembly.

Pass / Fail Criteria

Pass

The device may pass PM when:

• Cleaning and inspection are complete
• The enclosure, cords, cables, and connectors are intact
• The unit operates from AC and battery power
• The keyboard, display, speaker, date, and time functions operate correctly
• The writer reference line measures 200 mm ±2 mm
• Print quality is complete without missing dots or abnormal stepping
• Calibration-pulse measurements correspond to the selected speed and gain
• ECG acquisition agrees with the simulator input
• Lead-fail messages respond correctly
• Electrical safety results meet facility-approved limits
• No condition remains that could affect patient, operator, or data safety

Remove From Service

Remove the unit from service for:

• Exposed wiring, a damaged grounding pin, or an unsafe power cord
• A cracked enclosure or evidence of liquid intrusion
• Failed AC or battery operation
• Unresponsive controls, an unreadable display, or a failed speaker
• Incorrect or unstable ECG acquisition
• Missing or incorrect lead-fail detection
• A writer malfunction that affects clinical reports
• Electrical safety test failure
• A damaged patient cable or lead wires
• Any unresolved condition that may affect electrical safety, ECG accuracy, or reliable operation

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