Model note · ECG
GE HealthCare MAC 5500 HD Resting ECG Analysis System
The MAC 5500 HD is a cart or desktop resting electrocardiograph that acquires, analyses, displays and prints 3, 6, 12 or 15 lead ECGs for adult and paediatric patients, running GE's Marquette 12SL interpretation. Its distinguishing hardware feature is the external CAM HD acquisition module, which digitises the signal close to the patient before it reaches the main unit. It has a thermal writer, NiMH battery, SD card storage and optional wired or wireless transfer to the MUSE cardiology information system.
The model
Maker, model and type.
- Maker
- GE Medical Systems Information Technologies, Inc. (GE HealthCare)
- Model
- MAC 5500 HD Resting ECG Analysis System
- Device type
- ECG
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Leads and channels | 15 lead (14 channel) automatic electrocardiograph; 3, 6, 12 or 15 lead reports | Source |
| Sampling | 4000 samples/s per channel digital sampling; analysis at 500 samples/s | Source |
| Frequency response | -3 dB at 0.01 to 150 Hz (0.01 to 250 Hz for Hi-Res and PHi-Res signal averaged input) | Source |
| Dynamic range and resolution | AC differential plus or minus 5 mV, DC offset plus or minus 320 mV; 4.88 uV/LSB at 250 sps, 1.22 uV/LSB at 500 sps | Source |
| Common mode rejection and input impedance | Above 140 dB (123 dB with AC filter off); input impedance above 10 Mohm at 10 Hz, defibrillator protected | Source |
| Pace detection | 750 uV at 50 us duration, orthogonal LA, LL and V6 | Source |
| Writer | Thermal dot array; 5, 12.5, 25 or 50 mm/s; speed accuracy plus or minus 2%, amplitude accuracy plus or minus 5%; A or A4 z-fold paper | Source |
| Storage and display | Up to 200 ECG records in internal memory plus SD card archive; 10.4 in (264 mm) 640 x 480 LCD | Source |
| Power and battery | 100 to 240 VAC, 50 to 60 Hz; user replaceable 18 V 3.5 Ah NiMH pack, about 100 single page reports or 6 hours without printing, about 4.5 h recharge | Source |
| Size, weight and electrical safety class | 38.1 x 35.1 x 9.4 cm, 6.8 kg without paper; Class I, internally powered; Type BF defibrillation proof patient cable; patient leakage below 10 uA | Source |
| FDA clearance | K110266 (MAC 5500 HD and MAC 3500), product code DPS, Class II, decided 29 April 2011; predicate MAC 5500 K073625 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- A qualified physician must overread every computer generated interpretation; it is only meaningful alongside clinical findings. Source
- Where defibrillation is possible, use non-polarising silver or silver chloride electrodes, since polarising electrodes can hold a residual charge that blocks the ECG. Source
- This is Class I equipment; if the protective earth is in doubt, run the unit from its battery. Source
- Do not use near flammable anaesthetic vapours, and keep nearby equipment EMC compliant because X-ray and MRI systems can interfere. Source
- Never immerse, autoclave or steam clean the unit, cables or leadwires, and avoid ammonium chloride, alcohol based and abrasive cleaners. Source
Sources
Where this note comes from.
- GE HealthCare MAC 5500 HD product page (India)
- FDA 510(k) K110266 summary, MAC 5500 HD and MAC 3500 ECG Analysis Systems
- GE MAC 5500/MAC 5500 HD Service Manual, software version 10, 2046275-017G (copy of the original PDF on a reseller CDN)
- openFDA recall search, GE electrocardiographs (product code DPS)
Not covered: No FDA recall record names the MAC 5500 or MAC 5500 HD; the GE electrocardiograph recalls in openFDA cover the MAC VU360 and MAC 800, so the recalls list is empty. The service manual is a third party hosted copy of GE's version 10 document (2046275-017G) rather than a GE download, and revisions may differ. The manual has no numeric error code list, only symptom messages, so the error entries are on screen messages. MAUDE has only single figure problem counts for this brand, too few to show a trend. Part numbers were left out on purpose.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
ECG