CDCA
Database Comparison Software

This software is designed to meet the test requirements of IEC 60601-2-25 and YY 0782 medical standards, specifically for comparing test results of CTS and CSE databases.
Engineers can import test results directly into the CDCA and perform comparisons between reference values and test values with a click to rapidly verify the compliance of the ECG algorithm.

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Origins

When conducting IEC 60601-2-25 and YY 0782 compliance tests, ECG device manufacturers must evaluate the algorithm performance in interpreting standard databases.
For example, in the IEC 60601-2-25 standard, the "CTS amplitude" test generates over 2,000 test values across 17 files, 11 test parameters*, and 12 leads. Manually comparing these test values with the reference values is time-consuming and prone to human error.

To address the comparison challenges and reduce human error, we developed the CTS and CSE database comparison software—CDCA (CTS/CSE Database Compliance Analyzer). Once the test results are listed in the required format, engineers can import the data into CDCA and perform comparisons with a click.
The comparison results are presented in a table, showing pass/fail status along with the reference and test values. Engineers can export the comparison results for recordkeeping without recording data manually, making it easier to track algorithm performance after modifications.

We understand that manufacturers focus heavily on product performance development. Through our software, we aim to assist manufacturers in smoothly completing compliance tests, allowing them to allocate more resources toward optimizing design.

*Note: Please refer to "201.12.1.101.2 Requirements for amplitude measurements" of IEC 60601-2-25 for detailed test parameter requirements.

Functions

Select

CTS and CSE Database Comparison
Supports Digital and Analog Data Input
Direct Import of Test Values
One-click Comparison of Test Values
Exports Comparison Results

Includes test items such as CTS amplitude, CTS interval & duration, and CSE interval, using required files like ANE20000, ANE20001, CAL05000, and CAL10000, in accordance with IEC 60601-2-25 and YY 0782.

Compatible with both digital and analog signal test results.

Users can directly import test values without manual input.

Simply click the "Compare" button to instantly compare test values with the reference values, and the comparison results are displayed on-screen.

The comparison results can be exported in Word format for archives and tracking.

Highlights

One-Stop Solution for CTS and CSE Database Test Result Comparison

Completes the CTS and CSE database comparison in just three steps: select the test item and type of data, import test values, and perform the comparison with a click; additionally, the comparison results can be exported for archives

Tabular Presentation of File from Database, Parameter, and Lead Comparison Results

Provides two types of comparison tables: a single file from the database or a single parameter, allowing cross-referencing test results across different leads

Comprehensive Compliance Testing Solution

Saves time studying the medical standard and training by completing performance and database testing required by IEC standards with WhaleTeq ECG testing products

👉IEC 60601-2-25 Testing Package

Category	Detail
Supported Standards	IEC 60601-2-25:2011, YY 0782-2010
Supported Databases	CTS, CSE
Supported Test Options – CTS Amplitude	• P1 amplitude • P2 amplitude • Q amplitude • R amplitude • S amplitude • J amplitude • ST20 amplitude • ST40 amplitude • ST60 amplitude • ST80 amplitude • T amplitude
Supported Test Options – CTS Interval & Duration Absolute	• P Duration • PR Interval • QRS Duration • QT Interval • Q Duration • R Duration • S Duration
Supported Test Options – CSE Global Intervals	• P Duration • PR Interval • QRS Duration • QT Interval
Supported Test Options – CSE Against NOISE (YY0782)	• P Duration • QRS Duration • QT Interval • 50 Hz noise • 60 Hz noise • High frequency noise • Baseline noise
Supported Report	• CTS Amplitude Analog Testing Report • CTS Amplitude Digital Testing Report • CTS Absolute Interval and Duration Analog Testing Report • CTS Absolute Interval and Duration Digital Testing Report • CSE Global Intervals Testing Report • CSE Against NOISE Analog Testing Report • CSE Against NOISE Digital Testing Report
Supported Report Export Format	RTF file (Compatible with MS Word)