WHALETEQ UM RDCA EN 200908 Rhythm Database Compliance Analyzer User Manual

WHALETEQ
Rhythm Database Compliance Analyzer
Database Comparison Software
USER MANUAL

Revision Date: 2020-09-08
Software Version 1.8.8.3

UM RDCA EN 200908 Rhythm Database Compliance Analyzer

Copyright (c) 2013-2020, All Rights Reserved.
WhaleTeq Co. LTD

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without the prior written permission of Whale Teq Co. LTD.

Disclaimer
Whale Teq Co. LTD. provides this document and the programs “as is” without warranty of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability or fitness for a particular purpose.
This document could contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be incorporated in future revisions of this document. Whale Teq Co. LTD.
**** is under no obligation to notify any person of the changes.
The following trademarks are used in this document: is a registered trademark of WhaleTeq Co. LTD
All other trademarks or trade names are property of their respective holders.

Introduction

This product is designed for analyzing and comparing the differences between the outcome of ECG algorithms and databases required by IEC60601-2-47, EC57 and YY0885. In other words, this is the software that analyzes and compares Test Annotation File (TAF) of a diagnostic ECG with standard-required databases.
In addition to analysis and comparison functions, RDCA software also serves as a useful tool for algorithm engineers to adjust and fix errors in analog tests.

1.1 Who Needs RDCA Database Comparison Software

1. Single-lead ECG manufacturer: RDCA software is the database analysis software for database tests of IEC60601-2-47, EC57 and YY0885. These medical standards are specifically written for verifying single-lead ECGs.
2. Diagnostic ECG manufacturer: IEC60601-2-47 and EC57 are ECG standards with requirements of disease diagnosis function for heart rhythm disorders. If ECG is declared to have disease diagnosis function, it would need RDCA software or equivalent tool to verify the compliance.
3. Heart Rhythm Disorder Algorithm provider: RDCA software can manage to analyze the gross and average rate between diagnostic ECG algorithm and standard requirements.
4. Certification Laboratory: RDCA software can generate required test reports of IEC60601-2-47, EC57 and YY0885.
5. Engineers who want to improve diagnostic algorithm: After analyzing the gross and average rate between algorithms and databases, RDCA software further displays sections that are different from the databases, so that algorithm engineers can easily  modify and improve algorithms.

1.2 Product Specification

· VEB Se、VEB +P、VEB FPR
· VEB COU Se、VEB COU +P、VEB S_Run Se、VEB S_Run +P、VEB L_Run Se、VEB L_Run +P
· RMS heart rate error
· % beats missed、% N and S missed 、% V missed、% F missed、Total SHUTDOWN time
· SVEB Se、SVEB +P、SVEB FPR
· SVEB COU Se、SVEB COU +P、SVEB S_Run Se、SVEB S_Run +P、SVEB L_Run Se、SVEB L_Run +P
· VF EP Se、VF EP +P、VF DU Se、VF DU +P、VF FPR、VF Time
· AF EP Se、AF EP +P、AF DU Se、AF DU +P、AF FPR、AF Time
· ST EP Se、ST EP +P、ST DU Se、ST DU +P
TAF Format| · Binary-MIT annotation (.atr)
· Text-MIT Label (.txt)
· Text-AHA Label (.txt)
· Text-AAMI Label (.txt)
· Text -AHA 2 fields (.txt)
· Text -AAMI 2 fields (.txt)
Supported Time Unit| ·  Sample Index (100Hz ~ 1500Hz)
·  Absolute Time
Supported Report Export Format| **** TXT, CSV, Excel, Word

• For details of Test Annotation File (TAF) format, please refer to section 4.

1.2.1 Database Description

Below table is based on IEC60601-2-47:2012 and databases of AHA, MIT-BIH, NST and CU, it also indicates waveforms which are needed to test or waveforms which can be excluded.

2201, 2203-2210
3201-3210
4201-4210
5201-5210
6201-6210
7201-7210
8201-8204, 8206-8210
AHA records in complete test| No VEBs
Isolated uniform vEBs
Isolated multiform VEBS
Bigeminy
R-on-T vEBs
Ventricular couplets
Ventricular tachycardia
Ventricular fibrillation| 10
9
10
10
10
10
10
9
78
(excluded)| 2202. 8205| Paced beats| 2
MIT-131H database| 100, 101,103, 105, 106, 108, 109, 111-119, 121-124
200-203, 205, 207-210, 212- 215. 219-223. 228. 230-234
MIT-BIN records in complete test| Records include no or common arrhythmias
Records include less common but clinically important arrhythmia| 20
24
44
(excluded)| 102, 104, 107, 217| Paced beats| 4
NST database| 118e00, 119e00, 118e06,
119e06, 118e12, 119e12,
118e18, 119e18, 118e24,
119e24, 118e_6, 119e_6,| Noise Stress Test Database| 12
CU database| cu01-cu35| Ventricular Tachyarrhythmia Database| 35
NOTE: The AHA record ID numbers given refer to the 35 min version of the AHA database. The second digit from left in the ID numbers is “0” (rather than ’21 for the corresponding 3 h records. Only the last 35 min of the 3 h records (equivalent to the 35 min records) may be presented to the algorithm as part of a complete test if the 3 h records are used.

For ECG declares to have diagnostic function of “ST-segment”, it is a must to test ESC database in accordance with ANSI/AAMI EC57:2007. For details about ESC database, please refer to: https://physionet.org/physiobank/database/edb/

1.3 Installation and Environment Setup
The latest version of RDCA software can be downloaded on Whale Teq’s website. Please follow the below instructions to complete the installation.

• Click [Download] link to download the file to your computer
• Select to the download location
• Extract to the target folder
• Open the selected folder and ensure all the documents are extracted to the same folder
• Click and run the software

Hardware Minimum Requirement

1.4 Cautions

• After the purchase of RDCA software, Whale Teq server will send out a notification email to the assigned email address with the account name, password and activation link.
• The software availability period counts from the time you click on “activation link”.
• Make sure to secure the account info and password carefully. If they are lost, please contact service@whaleteq.com

Software Interface Instruction

This section describes software interface of major functions.
2.1 Main Interface

1. Load: Used for loading test annotation file (TAF). Available options are [Select Files] and [Whole Folder].
2. Project: Available options are [Load], [Save] and [New].
3.  Run: Starts comparison and provides options for timing and test clause setup before comparison.
4. Error: Lists all the timing and waveform incorrectly determined by the algorithm in the compared record. This is designed for debugging algorithm.
5. Report: Get example reports in medical standards
6. Other DB: Imports other databases into RDCA and calculates for results using standard algorithm.
7. Utility: Provides utilities such as “TAF Factory”, “Error Browser” etc.
8. About: Provides RDCA product information, including purchased features, expires days, etc.
9. Test Annotation File: List all TAFs to be calculated and those have been calculated.
10. Format: Displays format of imported TAF. Once TAF is imported, RDCA software will automatically analyze and determines its format. However, it is recommended to check whether the result is correct.
11. Settings of compared record: Configures database type and record number of Reference Annotation File (RAF).
12. Results: After clicking “Run”, this area displays the result for selected compared items. If there is no corresponding disorder in the compared TAF, it shows “-”.

2.2 Analyze Configuration

1. TAF time unit: Choose whether the comparison standard of TAF uses [Sample Index] or [Absolute Time]. Select [Sample Index] requires to input sample rate of TAF file.

2. Detailed Sync.: This button connects to a utility for synchronizing timing. Please see 2.3 for the detailed interface and 3.3 for the user guide.

3. Standard Set: Choose which standard to be based on. “Test clause selection” differs when changing to different standards set

4. Essential Test clause selection: Choose test clauses which are needed to test to meet the standard.

5. Optional Test clause selection: Choose test clauses that are required when declared to support specific disease disorder.

6. Comparison Parameter: Time period that is actually counted into comparison. Typically this is to set the learning period time.1

7. Database Set: After clicking the set of a database, RDCA software assists to select test clauses based on whether the standard requires that database to be tested.

8. Start: Starts comparing TAF with RAF using the calculation method documented in the standard.
   1 IEC60601-2-47: “The first 5 min of each record are designated as a learning period. The remainder of each record is the test period. Device performance is measured only during the test period of each record.” Therefore, learning period should not be count into the actual comparison record.

9. Cancel: Cancels comparison and go back to main interface.

2.3 Detailed Timing Synchronize before Analyze

Please see section 3.3 for detailed operation of this function.

1. TAF: This area displays the file path of test annotation file (TAF), file format, time unit, database to be compared and database number.
2. Syncing parameters: This area includes parameters such as [Begin Offset] and [End Delta]. [Begin Offset] is used to sync the beginning of TAF and RAF; [End Delta] is used to eliminate accumulative errors caused by different hardware clock.
3. Syncing matches: To take action to synchronize matches. Options include manual [Match] and [Al Sync.] Al sync allows RDCA software to automatically looks for [Begin Offset] and [End Delta] parameters that are most suitable.
4. Matching ratio: After performing synchronizing operation, RDCA displays the matching ratio of the TAF.
5. Time Period Selector: Use for switching to the different time period. Buttons from left to right are: resume to the beginning time period, previous time period, next time period and final time period.
6. Waveform Viewer: Displays detailed matching status and waveform of test annotation file (TAF) and reference annotation file (RAF). Capital letter indicates the label of RAF while lower-case letter indicates the label of TAF. Label in grey color indicates the matching is within ±150ms while label in red color indicates the matching is not within ±150ms.
7. Export TAF: Exports test annotation file that has been debugged based on Begin Offset and End Delta (TAF), and sets location and postfix of TAF.
8. Return: If you entered this interface via [Run] window, clicking this button returns parameters back. Then, you can continue the comparison.
9. Close: Closes this window.

2.4 Error Browser
Error Brower function is designed to browse all the error information after the comparison, including beat-by-beat (bxb), run-by-run (rxr), VF, AF (epic), and shutdown periods.
Error information can be saved as a single file as well.

1. TAF information: Describes the corresponding TAF information for “Waveform display”.
2. Error list: Lists name and time frame of all TAFs with errors
3. Waveform display: Displays waveform intervals with errors and marks annotation labels.
4. Save/Load: Saves the current list or loads a list that is previously saved.
5. Close: Closes [Error Browser] window.

Using RDCA Software

This section walks you through the operation of RDCA software.

3.1 Initial Use of RDCA Software
Step 1: Get notification mail with “account and password”
After purchasing RDCA software, you will get your account and password along with a link for activating RDCA software.

Step 2: Click “Activation Link”
Before using RDCA software, please click “activation link”. Login will fail if you launch the software without clicking “activation link”.
Please note that availability period of RDCA software counts from the time you click on the link.

Step 3: Launch and Log in RDCA
Why not start using RDCA since you have bought it!
After launching, the login window appears. Please key in your account and password information from the notification mail.

3.2 Start Comparison and Generate Report
Step 1: Load Test Annotation File (TAF)
Click “Load” button and choose the file or folder to be tested.

Select Files: Load one or more TAF(s). You can choose multiple files by pressing “ctrl” or “shift” key.

– Whole Folder: Load all TAFs in a folder.
Step 2: Check and select [Format], [Database] and [Record]

RDCA software automatically determines possible File Format, Database and Record by identifying the file name of TAF. You can also click on the column to modify the configuration manually. For description of each Format, please click “?” and “Help” at the bottom.

Step 3: Adjust begin offset and sample rate

A window appears once you click [Run] button.
i) TAF and RAF initialize at the same time position: Choose between sample index and absolute time as the time unit.
ii) TAF does not initiate at the same location as RAF: Click [Detailed Sync.] for further adjustment.
Please refer to 3.3 for details of [Detailed Sync].
Step 4: Choose test standards and clauses

• Test Standard: RDCA software supports three standards. Test clauses and database to be tested differ among standards. Click “?” next to the standard for information of clauses and database required by the standard.
•  Basic Test Clauses: Required to test for complying with the standard
•  Optional Test Clauses: For DUT that is declared to have diagnostic function for specific disease disorders. Not available for basic license.

Step 5: Start testing
The test starts once you click [start]. Test results will directly show on the page.

Step 6: Reporting
Click [Report] button to select the report type to view on main screen. Click [Export All] option indicates exporting a report for all selected test clauses to a text file.

3.3 Adjusting TAF Timing (TAF Factory / Detailed Sync.)
Step 1: Enter [TAF Factory / Detailed Sync.]
There are two ways to use [TAF Factory / Detailed Sync.] function:

1. Choose [TAF Factory] under [Utility]
2. Click [Run] button, then choose [Detailed Sync.]

Step 2: Import TAF and check compared data
Click [TAF] button to import the designated TAF file. Check and adjust data including TAF format, time unit, database and record.

Step 3: Click [Match] to see the comparison status
Click [Match] to allow RDCA software to show status and matching ratio of TAF- to RAF label.
Step 4: Click [AI Sync.] to proceed automatic configuration
If the result of TAF-to-RAF label did not come out as expected, you can use [AI Sync.] to let RDCA software find the appropriate “Begin Offset” and ”End Delta” value automatically.
Step 5: Adjust Begin Offset value manually
If the result still did not go as expected after “AI Sync.”, you can manually adjust “Begin Offset” value using the pane for label status to sync the beginning label of TAF and RAF.

Step 6: Adjust End Delta value manually

Click **** button to go to the end of status pane. Then, adjust “End Delta” value manually to sync the ending label of TAF and RAF 2。

Step 7: Export file
Finally, click [Export] button to export the adjusted file (TAF). The name of exported file consists of “original file name” and “content of [Postfix] field”.
Exported file can be found under the path in [Folder] field.

2 As specified in standards, if labels of TAF and RAF have a difference over 150ms, they cannot be treated as the same label set. But in analog tests, there is time difference between ECG and simulator because they use different clocks as operation base. The difference can exceed 150ms as accumulated over time and affect the comparison result. The parameter “End Delta” is used to distribute the difference between TAF and RAF to TAF’ evenly.

Test Annotation File (TAF) Format

RDCA currently supports six import formats:

1. Binary-MIT annotation (*.atr)
2. Text-AAMI Label (*.txt)
3. Text-MIT Label (*.txt)
4. Text-AHA Label (*.txt)
5. Text-AHA 2 fields (*.txt)
6. Text-AAMI 2 fields (*.txt)

If not familiar with these formats, it’s recommended to use “Text-AAMI Label (.txt)” and “Text-AAMI 2 fields (.txt)”, whose heart beat labels are the least and same as the standards.
For more details about formats, click [Format] field in RDCA software, then select “?” or “Help”.

*4.1 Binary-MIT annotation (.atr)**

File Format Characteristics:
✓ A binary document
✓ Used by reference annotation file (RAF)
✓ Similar with Text-MIT Label. Both of them have fields “Annotation”, “Num”, “Sub”, “Chan”, “Aux”, etc.

Details:
Each annotation occupies even bytes. The leading byte in each pair is the least significant bit.

The six most significant bits of each byte (A) are the code of annotation type, and
the other ten bits (I) specify time period of annotation and sample interval of
previous annotation (or the first annotation from the beginning of annotation).

If 0 <A = ACMAX [49.], it uses those from MIT annotation code. Other possibilities are:
✓ A = SKIP [59.] ◼ I = 0; the following four bytes are the interval of long integer format of PDP-11 (high 16 bits followed by low 16 bits, with least significant bytes first).
✓ A = NUM [60.] ◼ I =Num character of current and following annotations; otherwise, assume the previous annotation num (initially 0).
✓ A = SUB [61.] ◼ I = Annotation subtype character of current annotation only; otherwise, assume subtype = 0.
✓ A = CHN [62.] ◼ I =Annotation chan character of current and following annotations; otherwise, assume the previous chan (initially 0).
✓ A = AUX [63.] ◼ I =Number of bytes in auxiliary messages (included in the next I byte); if this is an odd, append an additional empty value that is not included in number of bytes.
✓ A = I = 0: End of document.

MIT annotation code – annotations for beats:

nodal)
[5.]| V| [PVC]| Premature ventricular contraction
[41.]| V| [RONT]| R-on-T premature ventricular contraction
[6.]| F| [FUSION]| Fusion of ventricular and normal beat
[34.]| S| [AESC]| Atrial escape beat
[11]| S| [NESC]| Nodal (junctional) escape beat
[35]| S| [SVESC]| Supraventricular escape beat (atrial or nodal)
[10.]| V| [VESC]| Ventricular escape beat
[12.]| Q| [PACE]| Paced beat
[38]| Q| [PFUS]| Fusion of paced and normal beat
---|---|---|---
[13.]| Q| [UNKNOWN]| Unclassifiable beat
[30]| Q| [LEARN]| Beat not classified during learning

MIT annotation code – annotations without beats:

*4.2 Text-AAMI Label (.txt)**

File Format Characteristics:
✓ A text file with annotations that are the same as standards.
✓ Six rows in total. Major information is in the first three rows: 1st row is time, nd2 row is sample index and 3 rd row is annotation.
✓ Similar with “Text-MIT Label” and “Text-AHA Label”. The major difference is in annotation and represented disorders.

Details:
This format has one annotation in each column. Each column includes the following characters (from left to right) separated with SPACE or TAB:
＃1. Annotation time in hour, minute, second and ms.
＃2. Annotation time that takes annotation-point-based index as unit.
＃3. Annotation label of AAMI collection. Please see the following table for description of labels.
＃4. SUB field: Annotation subtype field of current annotation only; otherwise, assume subtype = 0.
＃5. CHN field: Chan field of current and following annotations; otherwise, assume the previous chan (initially 0).
＃6. NUM field: Annotation number field of current and following annotations; otherwise, assume the previous annotation num (initially 0).

AAMI annotation label – labels for beats:

fall into the S, V, F, or Q categories described below
S| A supraventricular ectopic beat (SVEB)| An atrial or nodal (junctional) premature or escape beat, or an aberrated atrial premature beat.
V| A ventricular ectopic beat (VEB)| A ventricular premature beat, an R-on-T ventricular premature beat, or a ventricular escape beat.
F| A fusion of a ventricular and a normal beat| Fusion of a ventricular and a normal beat
Q| A paced beat| A fusion of a paced and a normal beat, or a beat that cannot be classified.
U| A label that marks a segment of unreadable data| Beats cannot be located because of excessive noise or signal loss in the signals.

AAMI annotation label – labels for rhythm:

Examples:

4.3 Text-MIT Label (*.txt)

File Format Characteristics:
✓ A text file
✓ Similar annotation as Binary-MIT annotation
✓ Seven rows in total. Major information is in the first three rows: 1st row is time, 2nd  row is sample index, 3rd row is annotation and 7th row is auxiliary annotation
✓ Similar with “Text-MIT Label” and “Text-AHA Label”. The major difference is in annotation and represented disorders.

Details:
This format has one annotation in each column. Each column includes the following characters (from left to right) separated with SPACE or TAB:
＃1. Annotation time in hour, minute, second and ms.
＃2. Annotation time that takes annotation-point-based index as unit.
＃3. Annotation label of MIT collection. Please see the following table for description of labels.
＃4. SUB field: Annotation subtype field of current annotation only; otherwise, assume subtype = 0.
＃5. CHN field: Chan field of current and following annotations; otherwise, assume the previous chan (initially 0).
＃6. NUM field: Annotation number field of current and following annotation; otherwise, assume the previous annotation num (initially 0).
＃7. Auxiliary field: Auxiliary message string (if available) (assumed as an ASCII string with null terminator).

MIT annotation code – annotations for beats:

nodal)
V| V| [PVC]| Premature ventricular contraction
r| V| [RONT]| R-on-T premature ventricular contraction
F| F| [FUSION]| Fusion of ventricular and normal beat
e| S| [AESC]| Atrial escape beat
j| S| [NESC]| Nodal (junctional) escape beat
n| S| [SVESC]| Supraventricular escape beat (atrial or nodal)
E| V| [VESC]| Ventricular escape beat
/| Q| [PACE]| Paced beat
f| Q| [PFUS]| Fusion of paced and normal beat
Q| Q| [UNKNOWN]| Unclassifiable beat
?| Q| [LEARN]| Beat not classified during learning

MIT annotation code – annotations without beats:

Examples:

4.4 Text-AHA Label (*.txt)

File Format Characteristics:
✓ A text file
✓ Six rows in total. Major information is in the first three rows: 1st row is time,2nd row is sample index and 3rd row is annotation.
✓ Similar with “Text-MIT Label” and “Text-AHA Label”. The major difference is in annotation and represented disorders.

Details:
This format has one annotation in each column. Each column includes the following characters (from left to right) separated with SPACE or TAB:
＃1. Annotation time in hour, minute, second and ms.
＃2. Annotation time that takes annotation-point-based index as unit.
＃3. Annotation label of MIT collection. Please see the following table for description of labels.
＃4. SUB field: Annotation subtype field of current annotation only; otherwise, assume subtype = 0.
＃5. CHN field: Chan field of current and following annotations; otherwise, assume the previous chan (initially 0).
＃6. NUM field: Annotation number field of current and following annotations; otherwise, assume the previous annotation num (initially 0).

AHA annotation code – annotations for beats:

AHA annotation code – labels for rhythm:

Examples:

*4.5 Text-AHA 2 fields (.txt)
File Format Characteristics:**
✓ A text file
✓ A simplified version of “Text-AHA Label”.
Two rows in total. 1st row is sample index and 2nd row is annotation.
✓ Similar with “Text-AAMI 2 fields”. The major difference is in annotation and represented disorders.

Details:
This format is a refined version of AHA annotation format. There are only 2 characters in each column, which are separated with SPACE or TAB:
＃1. Annotation time that takes annotation-point-based index as unit.
＃2. Annotation label of AHA collection. Please refer to the following table for description of labels.

AHA annotation code – annotations for beats:

AHA annotation code – labels for rhythm:

Examples:

*4.6 Text-AAMI 2 fields (.txt)**

File Format Characteristics:
✓ A text file with annotations that are the same as standards
✓ A simplified version of “Text-AAMI Label”.
Two rows in total. 1st row is sample index and 2nd row is annotation.
✓ Similar with “Text-AHA 2 fields”. The major difference is in annotation and represented disorders.

Details:
This format is a refined version of AAMI annotation format. There are only 2 characters in each column, which are separated with SPACE or TAB:

＃1. Annotation time that takes annotation-point-based index as unit.
＃2. Annotation label of AAMI collection. Please refer to the following table for description of labels.

AAMI annotation code – annotations for beats:

fall into the S, V, F, or Q categories described below
S| A supraventricular ectopic beat (SVEB)| An atrial or nodal (junctional) premature or escape beat, or an aberrated atrial premature beat.
V| A ventricular ectopic beat (VEB)| A ventricular premature beat, an R-on-T ventricular premature beat, or a ventricular escape beat.
F| A fusion of a ventricular and a normal beat| Fusion of a ventricular and a normal beat
Q| A paced beat| A fusion of a paced and a normal beat, or a beat that cannot be classified.
U| A label that marks a segment of unreadable data| Beats cannot be located because of excessive noise or signal loss in the signals.

AAMI annotation code – labels for rhythm:

Examples:

FAQ

This section introduces frequently asked questions. If none of them describes your situation, please feel free to contact Whale Teq.

5.1 Forgot password

When this happens, please send your login account to service@whaleteq.com vial email and confirm that you need to reset the password. Whale Teq will soon handle and send a new password to your email.

5.2 Poor Comparison Result

Please use “TAF Factory/Detailed sync.” Function first to identify why the comparison result is not as expected. “TAF Factory” operation can be found in section 3.3. Check if TAF information is correctly input, then click [Match] or [AI Sync.] button to check the matching ratio.

If the result is still not as expected, you can look into the content of TAF-to-RAF pane to see if there are lots of exceeded beats in TAF. If so, it is possible that the test environment was not ideal and ECG DUT mistakenly identifies noises as heart beats. The other possible root cause is that the algorithms need to be improved.

If there is no anomaly in TAF-to-RAF pane, you can check out bxb matrix and other corresponding matrix, error browser, etc. Below shows an unexpected result of VEB Predictivity in which many N were determined as V.

5.3 No Waveforms Shown in Waveform Browser
Waveforms can be incomplete if they are downloaded via poor network connectivity. Please go to
C:\RDCA\DB_Analyzer\DB\$(DatabaseName)\$(RecordID).dat to delete the file and select to browse the waveform again.

In addition, a feature that “downloads all waveforms at once and detects any incomplete downloads at the same time” is available in [DB Downloader] under “Utility” button.

Contact us

WHALETEQ Co., LTD
service@whaleteq.com | (O)+886 2 2517 6255
8F., No. 125, Songjiang Rd., Zhongshan Dist., Taipei City 104474, Taiwan

References

• European ST-T Database v1.0.0

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