EDAN SA-20 Holter ECG and ABP 2-in-1 System

The EDAN SA-20 is a 2-in-1 ambulatory recorder that combines Holter ECG and ambulatory blood pressure monitoring (ABPM) in a single device—a configuration that allows clinicians to review arrhythmia events and blood pressure trends in parallel, rather than correlating data from two separate recorders after the fact.

The SA-20 received FDA 510(k) clearance under K230184 (September 25, 2023) , classified as Class II, Product Code DSH, 21 CFR 870.2800 (Medical Magnetic Tape Recorder). The cleared intended use states the device acquires, stores, and displays ambulatory ECG signals from adult and pediatric patients, and is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (>12 years) over a preprogrammed period of time. It is intended to be used by trained personnel under the direction of doctors.

The recorder is built around 3/12-lead digital ECG recording with pacemaker detection, a blood pressure measurement range of 10–290 mmHg, overtime and overpressure protection, and up to 48 hours of recording on two AA batteries—all in an enclosure weighing approximately 200 g with an IP22 rating when used with the carrying pouch. ECG sampling is 25.6 ksps with 24-bit A/D conversion, and the device stores ECG waveforms and BP measurements on an internal SD card.

The 2-in-1 analysis software supports ECG review (QRS template classification, Lorenz plots, automatic ST evaluation, automatic AFib segment detection) alongside BP analysis (AASI, day/night BP profile, morning surge and BP variability, pie and histogram charts), with a combined Holter ECG and BP view that places cardiac events and blood pressure trends on the same timeline. The SA-20 can also be used as an independent Holter ECG or ABPM recorder depending on clinical need.

The SA-20 is built for clinicians who need cardiac rhythm and blood pressure data from the same wear period, reviewed in a single software environment—without coordinating two devices, two wear schedules, and two data exports.

Key Features & Benefits

True 2-in-1 Recording: ECG and Blood Pressure in One Device

The SA-20 records ambulatory ECG and non-invasive blood pressure simultaneously or independently, depending on the clinical question. The FDA-cleared device description notes that the SA-20 Series combines ambulatory ECG Holter and BP monitor, acquiring ECG via surface electrodes and blood pressure via the oscillometric method. This allows a single wear period to generate both datasets, rather than requiring the patient to wear separate Holter and ABPM devices on different days.

FDA-Cleared Intended Use with Explicit Patient Boundaries

The K230184 clearance defines the SA-20’s use for adult and pediatric patients requiring ambulatory ECG and/or non-invasive blood pressure monitoring, with BP measurement cleared for patients over 12 years of age. The clearance also specifies contraindications: patients with erratic, accelerated, or mechanically controlled irregular heart rhythms; unsupervised children or patients with limited cognitive abilities (strangulation risk); and intensive care or surgical settings. ABP is not for pregnant or pre-eclamptic patients. These boundaries are presented here exactly as cleared, so buyers can confirm clinical suitability before purchase.

3/12-Lead ECG with Pacemaker Detection

The SA-20 supports 3-lead and 12-lead digital ECG recording, with pacemaker detection included. ECG is sampled at 25.6 ksps with 24-bit A/D conversion, and the device records and stores ECG waveforms on an internal SD card. The recorder ships with a 7-electrode HolterABP ECG cable as standard, with 10-electrode and 5-electrode cables available separately for different lead configurations.

Up to 48 Hours of Recording on Two AA Batteries

The SA-20 records for up to 48 hours on two AA alkaline batteries, supporting extended ambulatory monitoring without recharging or battery swaps mid-study. At approximately 200 g, the recorder is designed for patient comfort during multi-day wear, with rounded edges and an IP22 rating when used with the carrying pouch.

10–290 mmHg BP Range with Overtime and Overpressure Protection

The SA-20’s blood pressure measurement range extends from 10 mmHg to 290 mmHg, with overtime and overpressure protection intended to support patient safety during extended monitoring sessions. Systolic measurement is specified as 25–290 mmHg and diastolic as 10–250 mmHg, with 1 mmHg resolution.

2-in-1 Software: ECG Events and BP Trends on One Timeline

The analysis software places ECG arrhythmia events and ST segment changes alongside blood pressure trends in a combined view, reducing the need for time-matching or screen switching between separate ECG and BP reports. ECG analysis tools include QRS template classification, Lorenz plots, automatic ST evaluation and reanalysis, automatic AFib segment detection, and atrial tachycardia identification via the SVE function; BP analysis tools include AASI (Ambulatory Arterial Stiffness Index), day/night BP profile, morning surge and BP variability analysis, BP histograms and pie charts, and a data table that supports linked review of ECG waveforms at specific BP measurement times.

Flexible Configuration and Upgrade Path

The SA-20 can be configured with optional Vector ECG, Ventricular Late Potentials, T-wave Alternans, and Waterfall Plot analysis functions. Optional 10-electrode and 5-electrode ECG cables and multiple cuff sizes (XS, S, M, L) allow the recorder to adapt to different lead protocols and patient arm circumferences. A Holter ABP 2-in-1 Analysis Software Kit is available as a separate line item, with an FDA-specific kit shipped separately to meet regulatory requirements.

Technical Specifications

Why Choose the EDAN SA-20?