WHALETEQ DFS360 User manual

DFS360 / DFS400 |User Manual
WHALETEQ
DFS360 / DFS400
User Manual
PC Software Version 1.0.2.7
Revision 2023-08-10

DFS360/ DFS400 |User Manual
1
Copyright © 2013-2023, All Rights Reserved.
WhaleTeq Co. LTD
No part of this publication may be reproduced, transmitted, transcribed,
stored in a retrieval system, or translated into any language or computer
language, in any form, or by any means, electronic, mechanical, magnetic,
optical, chemical, manual or otherwise, without the prior written
permission of WhaleTeq Co. LTD.
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:
is a registered trademark of WhaleTeq Co. LTD
All other trademarks or trade names are property of their respective
holders.

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Contents
1 Introduction........................................................................6
1.1 Concept.....................................................................................................6
1.2 Applications..............................................................................................6
2 Specification .......................................................................7
2.1 General Specifications ............................................................................7
2.2 Compliance Specifications......................................................................7
2.3 Energy Measurement Specifications ....................................................8
2.4 ECG Signal Specifications........................................................................9
3 Instrument Familiarization..................................................9
3.1 Top View...................................................................................................9
3.2 Front View ..............................................................................................10
3.3 Rear View................................................................................................10
3.4 Side View ................................................................................................11
3.5 Wiring Diagram.......................................................................................12
3.5.1 Connection Diagram and Precautions ............................................................................13
4 Getting Started .................................................................14
4.1 PC System Requirements .....................................................................14
4.2 Software Installation.............................................................................14
4.3 USB Driver Installation..........................................................................15
4.4 Microsoft .Net Framework Installation..............................................16
4.5 PC Software and Firmware Update ....................................................16
5 PC Software Operation .....................................................17
5.1 Software Function Introduction..........................................................17
5.1.1 ECG Settings.................................................................................................... 19
5.1.2 Performance Waveform ................................................................................. 25
5.1.3 Auto Sequence................................................................................................ 26
5.1.4 Settings ........................................................................................................... 27
5.1.5 Function Buttons............................................................................................. 28
5.1.6 R & R Analysis (Repeatability and Reproducibility Analysis, optional function)
30

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5.2 PC Software Operation Instructions ...................................................33
5.3 Over Heat Warning and Function Protection....................................36
5.3.1 AP Display Status ............................................................................................ 36
5.3.2 DFS Status LED ................................................................................................ 37
5.3.3 Fan Behavior ................................................................................................... 37
5.3.4 Over Heat Protection...................................................................................... 37
5.4 Optional Software Development Kit (SDK) ........................................38
5.4.1 Command Function......................................................................................... 38
6 Standalone Operation.......................................................39
7 Calibration and Validation ................................................40
8 Troubleshooting................................................................40
9 Cautions............................................................................40
10 Ordering Information........................................................42
11 Package Contents..............................................................46
12 Revision History................................................................47
13 Contact WhaleTeq ............................................................48

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List of Tables
Table 1: General Specifications ......................................................... 7
Table 2: Compliance Specifications ................................................... 7
Table 3: Energy Measurement Specifications ................................... 8
Table 4: ECG Signal Specifications..................................................... 9
Table 5: Status LED Description....................................................... 11
Table 6: AP Interface Function Introduction ................................... 17
Table 7: Customized ECG Waveform Function Introduction .......... 21
Table 8: Auto Sequence Function Introduction .............................. 26
Table 9: Setting List Introduction .................................................... 27
Table 10: Shock Result Introduction................................................ 35
Table 11: Command Function.......................................................... 38
Table 12: DFS360 Standard Test System ......................................... 42
Table 13: DFS400 Standard Test System ......................................... 43
Table 14: Optional Paddle Box Set .................................................. 44
Table 15: Optional Software Add-On Pack...................................... 44
Table 16: Optional Tool ................................................................... 44
Table 17: Optional Calibration Service and Warranty Extension.... 45
Table 18: Package Contents for DFS360 Standard Test System...... 46
Table 19: Package Contents for DFS400 Standard Test System...... 46
Table 20: Revision History ............................................................... 47

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List of Figures
Figure 1: Top View of DFS360/DFS400.............................................. 9
Figure 2: Front View of DFS360/DFS400 ......................................... 10
Figure 3: Rear View of DFS360/DFS400........................................... 10
Figure 4: Side View of DFS360......................................................... 11
Figure 5: Side View of DFS400......................................................... 12
Figure 6: Wiring Diagram................................................................. 12
Figure 7: Correct Wiring Diagram of the AED Cable........................ 13
Figure 8: Correct Wiring Diagram of the USB Cable........................ 13
Figure 9: AP Interface ...................................................................... 17
Figure 10: Provided ECG Waveforms .............................................. 20
Figure 11: The Load Waveform Mode and ECG Waveform Window
................................................................................................. 20
Figure 12: Customized ECG Waveforms for Selection .................... 21
Figure 13: Performance Waveforms with Adjustable BPM,
Frequency, and Amplitude ...................................................... 25
Figure 14: Auto Sequence Tab......................................................... 26
Figure 15: Setting List ...................................................................... 27
Figure 16: Recall Window................................................................ 28
Figure 17: Documents in the Folder................................................ 28
Figure 18: Waveform Details........................................................... 29
Figure 19: Error Report Window ..................................................... 29
Figure 20: Pass Criteria Window and Sync Configuration Function 30
Figure 21: Set a Designated Range of Time..................................... 31
Figure 22: Check Desired Test Results for Analysis ......................... 31
Figure 23: Repeatability and Reproducibility Analysis (Top: The
Consistency of Shock Waveforms of Multiple DUTs; Bottom:
The Reliability of a Single DUT)................................................ 32
Figure 24: Select Test Items............................................................. 33
Figure 25: Shock Result.................................................................... 34
Figure 26: Shock Waveform Details ................................................ 34
Figure 27: High-Temperature Alert ................................................. 36
Figure 28: DFS360/DFS400 Return to Normal Temperature .......... 37

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1 Introduction
1.1 Concept
The WhaleTeq DFS360/DFS400 is a multifunction testing device,
functioning as an ECG signal simulator and energy measurement
equipment for the AED and defibrillator manufacturers.
For ECG signal simulation, the DFS360/DFS400 simulates NSR as well
as various arrhythmias that may or may not need AED defibrillation.
Arrhythmia convert combination (ECG waveform before vs. after
defibrillation) is also available.
For energy measurement calculation, the DFS360/DFS400
distinguishes multiple kinds of biphasic waveforms and monophasic
waveforms, which are what the majority of current AEDs and
defibrillators deliver. Capturing the characteristic points of each kind
of waveform, the DFS360/DFS400 is also capable of displaying the real
defibrillation waveforms.
These features can be consolidated into the computer software of
AED or defibrillator manufacturers. What’s more, the DFS400 is
designed to withstand more intense defibrillation shocks over longer
stretches; it takes shocks at 15-second intervals, meaning a boost of
testing capacity. All in all, the DFS360/DFS400 is a durable tester to
speed up AED or defibrillator development and verification process.
1.2 Applications
The WhaleTeq DFS360/DFS400 is suitable for AED or defibrillator
manufacturers. With the raw data play function, users can customize
their test items and enhance AED/defibrillator algorithms through
clinical data. Besides, ensuring consistent AED/defibrillator quality and
reliability could be easier by adopting the Repeatability and
Reproducibility Analysis to compare shock waveforms of multiple test
records.

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2 Specification
2.1 General Specifications
Table 1: General Specifications
Items
Specifications
Temperature
Operating: 0 °C ~ + 50 °C (+ 32 °F ~ + 122 °F)
Storage: -20 °C ~ + 60 °C (-4 °F ~ + 140 °F)
Humidity
10 % ~ 90 % non-condensing
Communications
USB Type-C connector
Operation Modes
Remote (PC Software via API and SDK)
Power
DFS400: DC12V Power Adaptor
DFS360: USB 3.0 Bus Power
Mechanical
Housing: ABS Plastic
• DFS400
Size (L x W x H): 24.0 x 24.0 x 6.0cm
Weight: 1.6kg
• DFS360
Size (L x W x H): 19.0 x 12.5 x 6.0cm
Weight: 665g
2.2 Compliance Specifications
Table 2: Compliance Specifications
Items
Specifications
Safety Standards
CE: IEC/EN61010-1:2010 + A1:2016; Pollution
degree 2
61010-2-030:2017
Electromagnetic
Compatibility
Standards (EMC)
CE: EN61326-1
FCC: EMC P15B

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2.3 Energy Measurement Specifications
Table 3: Energy Measurement Specifications
Items
Specifications
Maximum Energy
Range: Up to 600J
Accuracy:
±1% of reading ±1J for up to 360J;
±1% of reading ±1J, typical for 360J ~ 600J
Voltage
Range: Up to 3000V
Accuracy:
±(1% of reading + 1V) for 450V ~ 3000V & -450V ~
-3000V;
± (1% of reading + 2V) for -450V ~ 450V
Current
Range: 1.2 ~ 100.0A
Accuracy: ± (1% of reading + 0.1A)
Load Resistance
DFS400 Resistance: 25, 50, 75, 100, 125, 150, 175,
200Ω
DFS360 Resistance: 50Ω
Energy Accuracy
For 50Ω:
±1% of reading ±0.1J for up to 360J;
±1% of reading ±0.1J, typical for 360J ~ 600J
For other resistance:
±2% of reading ±0.1J for up to 360J;
±2% of reading ±0.1J, typical for 360J ~ 600J
Note: Maximum energy of monophasic defibrillation
may not reach 360J.
Pulse Width
Range: 1.0 ~ 48.0ms
Accuracy: ±0.05ms
Sample Rate
250kHz (4μs sample)
Maximum Average
Power
DFS400: 24W, equivalent to 1 defibrillation pulse of
360J every 15 seconds
DFS360: 12W, equivalent to 1 defibrillation pulse of
360J every 30 seconds

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2.4 ECG Signal Specifications
Table 4: ECG Signal Specifications
Items
Specifications
Ventricular Fibrillation - Coarse
Vp-p = 3mV
Ventricular Fibrillation - Fine
Vp-p = 0.5mV
Ventricular Tachycardia (≒180BPM)
Vp-p = 3mV
Ventricular Tachycardia Plus (≒234BPM)
Vp-p = 3mV
Atrial Fibrillation
Vp-p = 1.2mV
Asystole
Vp-p = 0.03mV
Normal Sinus Rhythm (NSR)
(30 ~ 240BPM by 1BPM per step)
Vp-p 0.5 ~ 5.0mV, step
0.5mV
User-defined Pattern (Max. 5K Sample Rate)
A total capacity of up to
1000 seconds of raw data
files with variable duration
for each file
Note: Specifications are subject to change without prior notice.
3 Instrument Familiarization
3.1 Top View
Figure 1: Top View of DFS360/DFS400
A. Load LEDs: Indicate the selected load for testing.
A

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3.2 Front View
Figure 2: Front View of DFS360/DFS400
B. AED Input Ports: Use AED cables provided to connect device under test
(an AED or a defibrillator) to the DFS360/DFS400.
3.3 Rear View
Figure 3: Rear View of DFS360/DFS400
B
B
C
D
D
C
E

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C. USB Port: Use to supply power. Also, it can be used to connect to the
computer for sending commands and transferring data.
D. Status LED: Indicate the working state of DFS360/DFS400.
E. Power Jack: Connect the provided power adapter to this power jack and a
power source to power on the DFS400.
Table 5: Status LED Description
Mode
Normal
Heat Alert
Standalone Operation
Green light flashes
every 2 seconds.
Red light flashes
every 2 seconds.
AP Connected
(ECG Playing)
AP Connected
(ECG NOT Playing)
Green light always on.
Red light always on.
3.4 Side View
Figure 4: Side View of DFS360
F
G

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Figure 5: Side View of DFS400
F. Air Inlet: Allow ventilation during long hours of operation.
G. Air Outlet: Allow ventilation during long hours of operation.
3.5 Wiring Diagram
Figure 6: Wiring Diagram
F
G

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3.5.1 Connection Diagram and Precautions
1. Connect the AED cable to the DFS360/DFS400.
•Do not put the AED cable on the DFS360/DFS400 main
console.
•The AED cable should not twist together.
Figure 7: Correct Wiring Diagram of the AED Cable
2. After connecting the AED cable, connect the DFS360/DFS400
and PC/laptop with a USB cable.
•The USB cable and PC/laptop should not be placed near the
AED cable.
•The USB cable should not twist with the AED cable.
•The USB cable should not be placed on the DFS360/DFS400
main console.
Figure 8: Correct Wiring Diagram of the USB Cable

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3. Make sure the output voltage of the USB cable is between
4.75V ~ 5.25V (The minimum input voltage that the
DFS360/DFS400 can work is 4.5V/12V respectively. To power
on the DFS400, please use the provided power adaptor to
connect a power source to it.).
4. Activate AP “WhaleTeq Defibrillator Test System” on PC/laptop.
4 Getting Started
4.1 PC System Requirements
The DFS360/DFS400 software uses a Windows PC to connect and
control the DFS360/DFS400 via USB module.
PC requirements:
- Windows PC (Windows 7 or later, suggest to use the genuine
version)
- Microsoft .NET 4.0 or higher
- Administrator access (essential for installing software, driver, and
Microsoft .Net Framework)
- 1.5 GHz CPU or higher
- 1GB RAM or higher
1
- USB port
4.2 Software Installation
Please follow the steps below to download and execute DFS software.
1
Relative to normal PC processing, there is no special use of PC speed. However, there has been
noted a slow increase in system RAM usage over long periods of time up to 30-40MB (related to MS
Windows “garbage collection”). PCs with only 512MB or less installed and are running several other
programs (in particular, Internet Explorer), may exceed the available RAM, requiring access to the
hard drive and dramatically impacting speed. In this case, streaming interruptions and other
problems may occur.

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1. Download the DFS360/DFS400 software from WhaleTeq’s
website.
2. Open the file explorer and select the download location.
3. Double click on WhaleTeqDFS400.exe to execute DFS360/DFS400
PC software.
Note: If DFS software can’t be executed properly, or this is the first
time using WhaleTeq’s product, please refer to the two sections
below (4.3 and 4.4) to confirm that the USB driver and Microsoft .Net
Framework 4.0 are both installed.
4.3 USB Driver Installation
If Windows Device Manager can’t recognize WhaleTeq’s product,
please follow the instructions below to install Microchip® USB Driver.
For Microsoft Windows 10
⚫As Windows 10 has built-in Microchip® USB Driver, there is no
need to install any drivers. It just takes a while for Windows
Device Manager to recognize and install the driver.
For Microsoft Windows 8 and Windows 8.1
⚫If Windows 8 and Windows 8.1 can’t recognize the
DFS360/DFS400 unit, please download “mchpcdc.inf” from
WhaleTeq’s website. This driver is provided by Microchip®, and is
intended to be used with PIC microprocessors which have built-in
USB functions.
⚫As mchpcdc.inf provided by Microchip® does not contain a digital
signature, please disable the driver signature enforcement in
Windows 8 and Windows 8.1. Please click here to watch the
tutorial video.
⚫When the USB module is connected for the first time, select
Manual Installation, and point to the folder containing the above
file. Then, continue to follow the instructions to finish the

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installation. There may be a warning that the driver is not
recognized by Windows®, and this can be ignored. Please click
here to watch the tutorial video.
For Microsoft Windows 7
⚫If Windows 7 can’t recognize the DFS360/DFS400 unit, please
download “mchpcdc.inf” from WhaleTeq’s website. This driver is
provided by Microchip®, and is intended to be used with PIC
microprocessors which have built-in USB functions.
⚫When the USB module is connected for the first time, select
Manual Installation, and point to the folder containing the above
file. Then, continue to follow the instructions to finish the
installation. There may be a warning that the driver is not
recognized by Windows®, and this can be ignored. Please click
here to watch the tutorial video.
4.4 Microsoft .Net Framework Installation
WhaleTeq’s software is developed based on Microsoft .Net
Framework 4.0. If DFS software fails to execute properly, please check
whether Microsoft .Net Framework 4.0 or a higher version was
installed in the operating system.
If the PC hasn’t installed Microsoft .Net Framework 4.0 or a higher
version, please download it from Microsoft’s website. Please click
here to watch the tutorial video (from 2:17).
4.5 PC Software and Firmware Update
User can download the latest software from WhaleTeq’s website. If
User cannot update the DFS software, please contact WhaleTeq’s
service team ([email protected]).

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5 PC Software Operation
5.1 Software Function Introduction
After activating DFS360/DFS400 AP, users will see the figure below on
the screen.
Figure 9: AP Interface
Table 6: AP Interface Function Introduction
Item
Name
Description
A
ECG Settings
Select and set up the desired ECG
waveform or load raw data for testing.
Please refer to ‘’5.1.1 ECG Settings’’ for
more information.
B
Performance
Waveform
Provide Sine, Square, and Triangle
waveforms for essential performance
tests and calibration.
Please refer to ‘’5.1.2 Performance
Waveform’’ for more information.
G
H
K
B
A
C
D
E
I
F
J

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Item
Name
Description
C
Auto Sequence
Customize a test list with desired test
items that can be exported and
imported for quick testing.
Please refer to ‘’5.1.3 Auto Sequence’’
for more information.
D
Switchable Loads
Built-in loads ranging from 25Ω to
200Ω.
Note:
1. This function only applies to the
DFS400.
2. When the DFS400 is receiving a
shock, please refrain from switching
loads to prevent equipment damage
and potential impact on test results.
E
Start
Start the test with playing the
designated test item(s).
After the test starts, this button will
turn into ‘’Stop’’.
F
ECG Waveform
Display the playing ECG waveform.
G
Settings
Check for updates, choose naming
methods of test results, and select the
language, etc.
Please refer to ‘’5.1.4 Settings’’ for
more information.
H
Function Buttons
Top to bottom:
Recall: Recall history records for
review.
Browse: Open the folder storing test
results in the local computer.
Waveform Details: Display positions of
the parameters and characteristic
points on the defibrillation waveform.
Waveform Error Report: Allow users to
report issues to WhaleTeq in case of
software errors.
Pass Criteria: Set shock energy pass
criteria for each load on the Adult and
Child modes.

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Item
Name
Description
Please refer to ‘’5.1.5 Function
Buttons’’ for more information.
I
Shock Waveform
Display the shock waveform gave by
the DUT.
J
Shock Information
Display the energy (in Joules),
parameters, and characteristic points
of the shock.
K
R & R Analysis
The Repeatability and Reproducibility
Analysis for superimposing multiple
test waveforms to confirm the
consistency of quality on multiple DUTs
or the reliability of a single DUT.
Please refer to ‘’5.1.6 R &R Analysis’’
for more information’’
5.1.1 ECG Settings
There are two modes－Default and Load Waveform－in the ECG tab. In the
Default mode, users can select provided ECG waveforms with Adult (max.
3kV) mode and Child (max. 1.5kV) mode.
Note: Adjustable BPM, frequency, and amplitude are only available for NSR.
Provided ECG waveforms:
Ventricular Fibrillation –Coarse
Ventricular Fibrillation –Fine
Ventricular Tachycardia
Ventricular Tachycardia Plus (the faster VT)
Atrial Fibrillation
Asystole
NSR