ENGINEERING TEST REPORT

Device: Electrocardiograph Date: 04/20/2021

Manufacturer: GE/Marquette Tech: Harnish
Model: MAC 1200
Test Equipment: TE00150
S/N: 550046127

A] Machine Configuration
Software Revision: 6.11
MEAS: 376326715536 ☒
DIAG: 331314254425 ☒
MEMO: 275561117732 ☒

B] Visual Visual/Physical Integrity Inspection

Pass Fail Pass Fail
Housings/Covers ☒ ☐ Printer Door ☒ ☐
Ports/Pins ☒ ☐ Print head ☒ ☐
Carrying Handle ☒ ☐ Recorder Rollers/Gears ☒ ☐
LCD Screen ☒ ☐ Patient Cable ☒ ☐
Keypad ☒ ☐ AC Power Cord ☒ ☐
Resting Electrode Tips/Banana Tips ☒ ☐ Rubber Feet ☒ ☐

C] Operational Testing

Initial checks
Pass Fail Pass Fail
Boot Up Sequence ☒ ☐ Printer Roller Cleaning ☒ ☐
Self-Test ☒ ☐ Printer ECG Quality ☒ ☐
Photo Sensor Cleaning ☒ ☐ Sinus Rhythm Displayed ☒ ☐
Printer Functionality ☒ ☐ Correct Heart Rate Displayed ☒ ☐
Paper Out Sensing ☒ ☐ 12-Lead Analysis Displayed ☒ ☐
Patient Simulator Connection ☒ ☐ ☒ ☐

Hardware Functions/System Setup/Storage Program

Pass Fail Pass Fail
Display Test ☒ ☐ Current Time and Date ☒ ☐
Keyboard Test ☒ ☐ Motor/Speed Test ☒ ☐
Test Results (See Below) ☒ ☐ Recording Test (Signal Gain) ☒ ☐
Delete All Storage Program ECGs ☒ ☐ System Setup to Default Settings ☒ ☐

Battery Tests: Measured (Digital Multi-meter)

Charging Discharging
Initial Charge (1-2 hours)
Voltage (V)
Normal Current Rate (mA)
Printing Current Rate (mA)
Measured (Voltage) Pass Fail
Coin Cell Replacement ☒ ☐

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D] Functional Testing
Writer HR/Speed (Accuracy) Measured: at 25 mm/s Gain Analysis - Measured
Heart Rate: 30 60 120 180 240 5 mm/mV 5
Display 30 60 120 180 240 10 mm/mV 10
Measured 29 59 119 179 239 20 mm/mV 20
Print Head Resistance (Ω): 40 mm/mV 40
Pass Fail
Speed Change (mm/s): 50/25/5 ☒ ☐

12SL Interpretation
Pass Fail Pass Fail Pass Fail
Sinus Bradycardia ☒ ☐ Sinus Tachycardia ☒ ☐ Normal Sinus rhythm ☒ ☐

Test Results (Main Parameters) – Attach Printed Page to Test Report

Pass Fail Pass Fail
Memory stores free from errors? ☒ ☐ Battery Voltage > 18V? ☒ ☐
ASIC test O.K.? ☒ ☐ Printed clearly and legible? ☒ ☐
Sample rate 1000Hz? ☒ ☐ Verify serial number ☒ ☐

E] Electrical Safety Test: ☐ not applicable

AC Supply: ☒110V, 50Hz ☐110V, 60Hz ☐220V, 50Hz ☐ 220V, 60Hz ☐other (specify)
AC Power cord integrity: ☒Pass ☐Fail
Ground to Chassis resistance:
Patient device: ≤ 0.15Ω, Non-Patient device: ≤ 0.50Ω)

Leakage Current (≤ 100µA)

Normal Polarity Reverse Polarity
Grounded Ungrounded Grounded Ungrounded
Power ON
Power OFF

Electrode Leakage Current (≤ 10µA)

Normal Polarity Reverse Polarity
Ungrounded
RA LA LL RL V1 – V6 RA LA LL RL V1 – V6
Power ON
Power OFF

Note/Comments:

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