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EDAN SE-1200 Express Electrocardiograph
EDAN SE-1200 Express Electrocardiograph
The EDAN SE-1200 Express is a 12-channel resting electrocardiograph designed for hospitals, clinics, and diagnostic centers that need simultaneous 12-lead acquisition, integrated thermal printing, and network-ready data management in a single portable device. It pairs an 8-inch high-resolution color touchscreen (800 × 600 dots) with a full alphanumeric keyboard, giving clinicians both touch and physical input options during acquisition and review.
The SE-1200 Express is FDA-cleared as part of the SE-12 Series under 510(k) K102830 (December 2, 2010) , Class II, 21 CFR 870.2340, Product Code DPS. The SE-12 Series includes four models: SE-12, SE-1200, SE-12 Express, and SE-1200 Express, sharing the same ECG board, power supply board, and main control board. The cleared intended use covers acquisition of ECG signals from adult and pediatric patients through body surface ECG electrodes, for use in hospitals or healthcare facilities by doctors and trained healthcare professionals. Critically, the cleared labeling states that the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only—it is intended to help users analyze and diagnose heart disease, but does not replace professional judgment. The FDA summary states “No clinical data provided”; substantial equivalence was supported by software testing, risk analysis, safety testing, and environmental testing.
The signal chain includes a 24-bit A/D converter, sampling rate up to 64,000/sec/channel, CMRR ≥ 140 dB (AC on) / ≥ 123 dB (AC off) , and a frequency response referenced as 0.05–150 Hz in distributor documentation. The device acquires all 12 leads simultaneously and prints 12-channel reports on a 216 mm-wide thermal printer, with paper speeds of 5, 6.25, 10, 12.5, 25, or 50 mm/s. SEMIP software provides automatic measurements and interpretation, with Glasgow interpretation referenced as built-in in EDAN product literature, and signal quality indication for at-a-glance electrode confidence.
The SE-1200 Express stores up to 800 ECG records internally, expandable via USB flash disk. Connectivity covers LAN, built-in Wi-Fi (optional), and RS-232, with PDF, SCP, FDA-XML, and DICOM report export where configured. The optional SE-1515 Data Management System supports bi-directional communication with hospital systems via DICOM Worklist, HL7, and GDT protocols. The 14.8 V lithium-ion battery is available in 2500 mAh or 5000 mAh configurations, supporting approximately 1.5 or 2.5 hours of continuous printing, or 300 or 450 ECG reports respectively. The device weighs approximately 5 kg (excluding paper and battery) and measures 420 × 330 × 105 mm.
The SE-1200 Express carries CE marking as a Class IIa medical device under EU MDR 2017/745, with the SE-12 Series covered under TÜV SÜD CE 0123. It is classified as Class I with internal power supply, Type CF, defibrillation-proof, and is designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards.
The SE-1200 Express is built for facilities that need a proven, FDA-cleared 12-channel ECG platform with a large touchscreen, simultaneous 12-lead acquisition, 12-channel printing, and flexible network connectivity—without the footprint of a larger workstation, and with a Basic version available for budget-conscious departments.
Key Features & Benefits
8-Inch Color Touchscreen with Full Keyboard
The 8-inch high-resolution color touchscreen (800 × 600 dots) displays all 12 waveforms simultaneously and supports touch interaction with one-touch operation and age/gender shortcuts for faster workflow. The full alphanumeric keyboard remains available for efficient patient information entry and direct commands, reducing reliance on on-screen menus during high-throughput ECG sessions.
Simultaneous 12-Lead Acquisition with 24-Bit Signal Chain
The SE-1200 Express acquires all 12 leads simultaneously through body surface electrodes. The signal chain includes a 24-bit A/D converter, sampling rate up to 64,000/sec/channel, CMRR ≥ 140 dB (AC on) / ≥ 123 dB (AC off) , and a frequency response referenced as 0.05–150 Hz. Comprehensive digital filters address baseline drift, AC interference, and EMG noise, with ECG signal quality indication supporting electrode confidence before recording.
Built-In 12-Channel Thermal Printer with A4 Support
The integrated high-resolution thermal recorder prints 12-channel reports on normal thermal paper or A4-size fax paper, with paper speeds of 5, 6.25, 10, 12.5, 25, or 50 mm/s. External USB printer support is also available for standard office printing when required.
SEMIP and Glasgow Interpretation, Advisory Only
The SE-1200 Express includes automatic ECG measurements and interpretation, processed by the SEMIP algorithm, with Glasgow interpretation referenced as built-in in EDAN product literature. Per the cleared labeling under K102830, the ECG with measurements and interpretive statements is offered on an advisory basis only—it supports, but does not replace, clinician analysis and diagnosis. EDAN documentation also notes that interpretation has been tested with CSE/AHA/MIT databases.
120-Second Waveform Freezing and Review
The device supports 120 seconds of real-time waveform freezing and review, allowing the clinician to pause and examine a captured segment before printing or storing. Extended printing is triggered when arrhythmia is detected, supporting further rhythm analysis without manual intervention.
800 ECG Internal Storage with LAN/Wi-Fi and DICOM/HL7
The SE-1200 Express stores up to 800 ECG records internally, with USB flash disk expansion. Data can be transmitted to a PC via LAN, built-in Wi-Fi (optional), or RS-232, and reports can be exported in PDF, SCP, FDA-XML, and DICOM formats. The optional SE-1515 Data Management System supports bi-directional communication and access to EMR/HIS/PACS/GDT-based systems via DICOM Worklist, HL7, and GDT.
Rechargeable Li-Ion Battery with Two Capacity Options
The 14.8 V lithium-ion battery is available in 2500 mAh or 5000 mAh configurations. The 2500 mAh pack supports approximately 1.5 hours of continuous printing or 300 ECG reports; the 5000 mAh pack supports approximately 2.5 hours or 450 reports. The device can also operate on AC mains (100–240 V, 50/60 Hz).
Safety Classification: Class I, Type CF, Defibrillation-Proof
The SE-1200 Express is Class I with internal power supply, Type CF, and defibrillation-proof. The CF (Cardiac Floating) applied part indicates a high degree of patient isolation suitable for direct cardiac contact applications, and the device is designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards.
Regulatory Status: FDA-Cleared and CE IIa
The SE-1200 Express is FDA-cleared under K102830 (Class II, DPS) and CE-marked as a Class IIa medical device under EU MDR 2017/745, with the SE-12 Series covered under TÜV SÜD CE 0123. Availability and cleared claims vary by market; confirm local registration and labeling before purchase.
Technical Specifications
| Specification | Detail |
|---|---|
| Device Type | 12-channel resting electrocardiograph |
| FDA Clearance | K102830 (December 2, 2010); Class II, 21 CFR 870.2340, Product Code DPS |
| Acquisition | 12 leads simultaneous via body surface electrodes; 12-channel printing |
| Display | 8-inch color touchscreen, 800 × 600 dots; alphanumeric keyboard |
| A/D Converter | 24-bit |
| Sampling Rate | Up to 64,000/sec/channel |
| CMRR | ≥ 140 dB (AC On); ≥ 123 dB (AC Off) |
| Frequency Response | 0.05–150 Hz (distributor documentation); 0.01–300 Hz also referenced for the SE-12 Series platform |
| Filters | Comprehensive AC, DFT, EMG, and low-pass digital filters |
| Interpretation | SEMIP algorithm; Glasgow interpretation referenced as built-in; advisory basis only per cleared labeling |
| Waveform Review | 120-second real-time freezing and review; extended printing on arrhythmia detection |
| Internal Storage | Up to 800 ECG records; USB flash disk expansion |
| Recorder | Built-in thermal dot-matrix; 216 mm wide; 12-channel; 210 mm × 295 mm Z-fold or 210 mm × 30 m roll; 5–50 mm/s |
| External Printer | USB printer support |
| Data Transfer / Export | LAN; Wi-Fi (optional); RS-232; PDF, SCP, FDA-XML, DICOM where configured |
| Data Management | Optional SE-1515; bi-directional communication; DICOM Worklist/HL7/GDT |
| Battery | 14.8 V Li-ion; 2500 mAh (~1.5 h printing / 300 reports) or 5000 mAh (~2.5 h printing / 450 reports) |
| Power | AC 100–240 V, 50/60 Hz |
| Dimensions / Weight | 420 × 330 × 105 mm; approximately 5 kg (excluding paper and battery) |
| Safety Classification | Class I, internal power supply, Type CF, defibrillation-proof |
| Safety Standards | IEC 60601-1; IEC 60601-1-2; IEC 60601-2-25 |
| CE Marking | Class IIa, EU MDR 2017/745; TÜV SÜD CE 0123 (SE-12 Series platform) |
| Intended Patient Population | Adult and pediatric patients |
| Intended Use | Acquisition of ECG signals via body surface electrodes to help analyze and diagnose heart disease in hospitals or healthcare facilities by doctors and trained healthcare professionals; ECG with measurements and interpretive statements offered on an advisory basis only |
Why Choose the EDAN SE-1200 Express?
| Clinical or Operational Challenge | SE-1200 Express Solution |
|---|---|
| Need FDA-cleared 12-channel ECG with a large touchscreen and keyboard | SE-1200 Express covered under K102830; 8-inch color touchscreen (800 × 600) with full alphanumeric keyboard |
| Need simultaneous 12-lead acquisition with 12-channel printing | 12-lead simultaneous acquisition; 12-channel reports on 216 mm thermal paper; A4 fax paper support |
| Need high-resolution signal acquisition for routine and pediatric ECG | 24-bit A/D; up to 64,000/sec/channel; CMRR ≥ 140 dB; comprehensive digital filters |
| Need on-screen interpretation support with clear labeling | SEMIP and Glasgow interpretation referenced; advisory basis only per cleared labeling; CSE/AHA/MIT database testing referenced |
| Need extended waveform review and arrhythmia-triggered printing | 120-second waveform freezing; extended printing on arrhythmia detection |
| Need HIS/EMR/PACS integration and paperless workflow | LAN/Wi-Fi/RS-232; PDF/SCP/FDA-XML/DICOM export; optional SE-1515 for DICOM Worklist/HL7/GDT |
| Need substantial internal storage for daily ECG volume | Up to 800 ECG records; USB flash disk expansion |
| Need portable use with battery backup | 2500/5000 mAh battery options; 1.5/2.5 h continuous printing or 300/450 reports; ~5 kg |
| Need FDA and CE MDR regulatory coverage | FDA K102830; CE IIa (TÜV SÜD CE 0123) |
