WHALETEQ TRF Generator Software User Guide

: August 16, 2024
: WHALETEQ

Table of Contents

WHALETEQ TRF Generator Software
Introduction
Operation Mode
Import Database Comparison Results
Troubleshooting
Ordering Information
Read User Manual Online (PDF format)
Download This Manual (PDF format)

WHALETEQ TRF Generator Software

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Disclaimer
WhaleTeq 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. WhaleTeq Co. LTD. is under no obligation to notify any person of the changes.

The following trademarks are used in this document:
WHALETEQ is a registered trademark of WhaleTeq Co. LTD
All other trademarks or trade names are property of their respective holders.

Introduction

Basics
WhaleTeq Universal Medical Standard TRF Generator (“TRF Generator”) is designed to improve the efficiency of performance tests for medical devices. Both DUT testing and report generation can be done in TRF Generator with control over test equipment, medical standards assistant, and IEC Test Report Form unified.
Note: For now, the TRF Generator cannot receive data returned from the DUT. Therefore, the test operator will need to observe the results and fill them in the report record of TRF Generator manually.

System Requirements
A PC with CPU frequency at 1.5GHz or higher and 4G RAM or higher. Recommended OS is Windows 10, with Microsoft Word 2016 or higher installed.

Software Setup
Visit WhaleTeq’s website to download and install TRF Generator on PC.

Software Auto Updates
When TRF Generator launches, it automatically checks whether there’re any updates for TRF generator software or medical standard project files via internet access. Update if needed.

Operation Mode

Login
After purchasing TRF Generator, you will receive an activation mail with a link from WhaleTeq. Click the link to activate the account.

Once activation is done, you will receive another email with login details.

Launch TRF and click any test item. When [Activate TRF License] window shows, enter the Account email from the login information email and click [Login].

Then [Authentication] window shows. Enter the Password from the login information email and you will be able to access the full functionality of TRF Generator.
If you have any questions or need help with account activation, feel free to contact WhaleTeq for assistance.

Download Project File for Different Medical Standards

Click [Cloud Library] then [Management].
In [Cloud TRF], select the Standard TRF profile or Standard Assistant profile to be used. Once selected, click [Download] to download it to the PC.

Standard TRF contains Questionnaire, IEC Test Report Form, and Standard Assistant. Standard Assistant contains test projects and the control capability for WhaleTeq test equipment.
We will update the profiles once there are any IEC Test Report Form updates available. If you have any questions, email us at service@whaleteq.com. We will get back to you as soon as possible.

3. When the download completes, the profiles will show in [Local TRF].
If an item in [Cloud TRF] is in RED, it indicates that the versions are not matching between Local TRF and Cloud RTF. Please update if needed.

Getting Started
Select the preferred medical standard. The instruction below uses IEC 60601-2-47 as an example.

Click [IEC60601-2-47:2012]. You will see the details that consist of 4 parts:

A. Questionnaire: As we know, there are some questions in the body of the standards that need to be answered beforehand. Please answer these questions based on the attributes and the usage of the DUT. Some test projects will determine whether the tests need execution or parameter adjustment.
B. Test Item: It consists of all the test clauses for the standards. Choose the test clause that you want to test.
C. Test Record: Displays Report, Description, Procedure, Pass Criterion, and Diagram based on your selection for the test clause.
D. Test Report Form: IEC Test Report Form with the test results and lets you see how the results display in the report form in real-time.

Select to start a test and fill in the records.
By selecting one of the test clauses, you shall see:

Select any fields in the report. Right-click to see [Start Test] and [Edit Result].

Select [Start Test]. A window for controlling the test equipment and filling test results shows.
The window for controlling the test equipment

A. Test Parameter: Shows test parameters required by the test clause.
B. Executed SDK Routines: Controls the test equipment based on the selected test clause and outputs the corresponding waveform.
C. Prompt Message: Prompts if manual intervention in the process is needed based on the requirements of the test clause. During the test, please pay attention to the messages and act on them accordingly.
D. Waveform: Displays the waveform based on the test clause.

Test Result window
The window shows the Pass Criterion of the test clause. The text will be in Blue if the test results are within the scope of the criterion; Red if they are out of the range.

Fill in the test report with the results according to the criterion of IEC Test Report Form to preview. The text will be in Green if the test results are within the scope of the criterion; Red if they are out of the scope.

Test Progress: Current test progress is marked at the end of each item name for both the whole reports and single test items.

Actions in [User Data]

Clean Questionnaire: Clean all the content in the questionnaire.
Clean All Tables: Clean all the data in test table.
Export User Data: Stores the test results in the selected folder.
Import User Data: Imports the results from the last run to continue testing.
Clean Result Table: Clean the test results of the selected test item.
Export Table in Word: Exports the results of the selected test table to Word.

Generate Test Report
Select [TRF] and click [Generate Word TRF] to export the test report as a Word document to the folder you select. You can still edit the test report after it is generated.

Supported Test Equipment

Table 1: Supported Test Equipment

Item| Equipment Name| Manufacturer| Medical Standards| IEC TRF Form
---|---|---|---|---
1| ****

SECG 5.0 AIO

SECG 4.0

| WhaleTeq| IEC 60601-2-25

IEC 60601-2-27

IEC 60601-2-47 YY0782-2010 YY0885-2013 YY1079-2008

YY1139-2013

| IEC 60601-2-25

IEC 60601-2-27

IEC 60601-2-47

2| CMRR 3.0+

CMRR 3.0

| WhaleTeq| IEC 60601-2-25

IEC 60601-2-27

IEC 60601-2-47 YY0782-2010 YY0885-2013 YY1079-2008 YY1139-2013

| IEC 60601-2-25

IEC 60601-2-27

IEC 60601-2-47

Import Database Comparison Results

Import Database Comparison Results from WhaleTeq RDCA
When using WhaleTeq RDCA for IEC60601-2-47 database compliance analysis, please import the test files of the 5 ECG databases to WhaleTeq RDCA by databases. It is recommended to name the folders with the name of the ECG databases, as shown in the image below.

Select to export the reports of 5 ECG databases to 5 folders respectively, as shown in the image below.

Under [RDCA Reports] below the questionnaire of TRF Generator, click the database name and select the folder with database comparison results to import. Once imported, the reports of relevant test items will display, as shown in the image below.

Import Database Comparison Results from WhaleTeq CDCA
Use WhaleTeq CDCA for IEC 60601-2-25 database comparison and generates 3 different kinds of comparison results. Select [Export Result Report] to export them to the local storage, as shown in the image below.

Export the 3 reports to 3 RTF files individually, as shown in the image below.

Import the 3 RTF files into TRF Generator. Once imported, the reports of relevant test items shall display, as shown in the image below.

Troubleshooting

Q1: What if the test equipment cannot be controlled and output test signals?
A: Please use the test equipment supported by TRF Generator. In case the equipment cannot output signals as expected, reconnect the equipment. Close and reopen TRF Generator software. Do not worry, the data you filled in will be retained when you open it next time. If you would like to save it to local storage, click [User Data] and select [Export User Data].

Q2: The test is completed, but I cannot export the report to Word.
A: Please check if Microsoft Word 2016 or higher is correctly installed on the PC. If yes, close any Word instances and try to generate the report again.

Q3: What to do when a message shows that the license is invalid?
A: It means your account has expired and become invalid. Please contact us if you want to keep using it.

Q4: The version of IEC Test Report Form is found not to be the latest one.
A: Please let WhaleTeq know your software version and the environment under which it runs. We will help you with the issue as soon as possible.

Ordering Information

Table 2: Ordering Information

Part No.	Description
HB0-TR00001	TRF Report Generator for IEC 60601-2-25:2011
HB0-TR00002	TRF Report Generator for IEC 60601-2-27:2011
HB0-TR00003	TRF Report Generator for IEC 60601-2-47:2012