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+886-2-2517-6255

CONTACT US

+886-2-2517-6255

SUPPORT

-FREQUENTLY ASKED QUESTION

ECG/EKG Tester

ECG/EKG Tester

AECG100

Q1
Have WhaleTeq ECG test systems proved by any authorized party?

The WhaleTeq ECG test systems have been employed by many offices of major agencies such as UL, TUV SUD, TUV Rheinland, SGS, ITS and CSA, and have often been used to support IECEE CB scheme accreditation for ECG standards. Several agencies have performed their own verification of the system in addition to our own validation. There is no formal accreditation or approval required for this kind of device.

Q2
How do I validate the quality of WhaleTeq ECG test systems?

As with any test and measurement system, validation is generally considered the responsibility of manufacturer. A report for validation can be provided on request. Due to the complexity of the system, it is not recommended that complete validation is attempted by receiving laboratories. Although it is understood some users may wish to re-confirm certain aspects of the system, in which case the WhaleTeq validation report can be used as a template. 

Q3
How do I calibrate WhaleTeq ECG test systems and how often should I do calibration?

The recommended calibration interval is the standard 12 months. WhaleTeq had developed the calibration assistant software considering the complexity of the process.  If you have any requirements for calibration, please contact WhaleTeq (service@whaleteq.com | +886225960701) for detailed information.

 

Due to the use of an internal battery, the DC offset of CMRR 3.0+ is recommended to be checked before use. Otherwise, there are no parts or components with any concerns for drift in accuracy or performance. For equipment used infrequently, calibration before use may be considered.

Q4
Can I use WhaleTeq ECG test systems in production line as well?

Yes, WhaleTeq ECG test systems can be used in production line as well according to customer's test needs. WhaleTeq also provides the Software Development Kit(SDK) for SECG 5.0 AIO, SECG 4.0, MECG 2.0 and CMRR 3.0+. This allows customers to design their own test procedures and user interfaces in different testing environment or for different design/quality/production phases.

Q5
How does WhaleTeq ECG test system work?

SECG 4.0, MECG 2.0 and CMRR 3.0+ can be controlled by PC software via USB connection. Test waveforms are streamed real time from the PC to the USB module and converted to analogue voltages. In addition, SECG 5.0 AIO and CMRR 3.0+ offers stand-alone operation mode. User can easily conduct the test via the touch panel.

 

Meanwhile, WhaleTeq ECG test systems can be controlled by SDK (Software Development Kit). User can develop customized or automated software for improving the test efficiency. 

Q6
What is the test set up of WhaleTeq ECG test system?

Before use the PC software operation mode of SECG 4.0, SECG 5.0 AIO, MECG 2.0 and CMRR 3.0+, please download PC software from WhaleTeq website and complete the installation. Connect the USB module of the test system to any USB socket of the PC and run the WhaleTeq software. Connect the ECG under test to the terminals provided on WhaleTeq tester. Follow grounding procedures to minimize noise if required.

Q7
How is WhaleTeq ECG test system connected to the DUT (device under test)?

WhaleTeq tester is equipped with terminal sockets compatible with most ECG systems. By using the standard accessory named compound terminals, user can easily connect the lead wires of DUT to WhaleTeq tester.

 

Q8
Does WhaleTeq test system bear a CE mark?

Yes, it does.

Q9
I am going to do test for IEC60601-2-25, what devices do I need?

As a minimum, SECG 5.0 AIO and CMRR 3.0+ are required.

Q10
I am going to do test for IEC60601-2-27, what devices do I need?

SECG 5.0 AIO and CMRR 3.0+ are required if the patient monitor does not claim a diagnostic function.

Q11
I am going to do test for IEC60601-2-47, what devices do I need?

As a minimum, SECG 5.0 AIO and CMRR 3.0+ are required; for database testing, MECG 2.0 and RDCA database comparison software would be recommended for system validation in analog method.

Q12
Can I get the test result using WhaleTeq ECG test systems?

The WhaleTeq ECG test systems provide the required signals and circuits, but the operator must record, measure and interpret the results on the equipment under test. WhaleTeq also provides Assistant software is to help user to determine compliance in an effective way.

Q13
What are the sample rate of the equipment? Are they sufficient to play our signals accurately?

The sample rate of SECG 5.0 AIO is 10kHz ± 0.05% while SECG 4.0 is 5kHz ± 0.1%. MECG 2.0 provides a variable sample rate depending on the source, with a maximum of 1kHz.

Q14
The NST database large noise signal cannot be played by MECG 2.0? How can I have it tested instead?

MECG 2.0 (2020) is designed with 16 bit resolution making it capable to cover the precise voltages in small ST segments while at the same time covering the large voltages in the NST database.

Q15
Can I also test EC57 with WhaleTeq ECG test systems?

Yes, in general EC57 can be tested with the MECG 2.0, provided that the database remains within +/-5mV range.

Q16
Do I still need to buy CSE Database/AHA Database if I already buy your equipment?

Yes, the CSE and AHA databases are protected data and need to be purchased directly from the owners.

Q17
Does the system support to test ST segment, Ventricular fibrillation, Arterial Fibrillation ?

Yes, any waveform can be streamed from both the SECG 5.0 AIO and the MECG 2.0. The MECG 2.0 is designed for multichannel simulation, and also high accuracy at the very low voltage region associated with ST segments. The MECG 2.0 software is also designed to interface directly with the PhysioNet databases which include many test waveforms. After downloading the databases, MECG 2.0 software can also select the source labels and assign to MECG leads to output analog database signals.

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