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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.

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. Calibration is a separate issue to validation and should be performed periodically or on a before use basis, following the procedures outlined in the operation manual.

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

For each item, a calibration procedure is outlined in the operation manual. For the SECG 4.0, a software assisted calibration mode is provided due to the complexity of the process. The recommended calibration interval is the standard 12 months. Due to the use of an internal battery, the DC offset of CMRR 2.0 and 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.

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 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.

How does WhaleTeq ECG test system work?

The WhaleTeq ECG test system uses a normal PC to interface and control the USB modules. Test waveforms are streamed real time from the PC to the USB module and converted to analogue voltages.

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

For SECG 4.0, MECG 2.0 and CMRR 3.0, install the USB driver and PC software. 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 the breakout box. Follow grounding procedures to minimize noise if required; For CMRR 2.0 and CMRR 3.0, there is a detailed video prepared to demonstrate the test operation.

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

A breakout box is provided which has terminals compatible with most ECG systems. A general purpose breakout box BB-C1 is used for SECG 4.0, MECG 2.0, baseline noise test and the CMRR test for some standards. A special breakout box BB-C2 is used for CMRR 2.0 only for selected standards.

Does WhaleTeq test system bear a CE mark?

Yes, it does.

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

As a minimum, SECG 4.0 and CMRR 3.0 are required.

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

SECG 4.0 and CMRR 3.0 are required if the patient monitor does not claim a diagnostic function.

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

As a minimum, SECG and CMRR are required; for database testing, MECG 2.0 would be recommended for system validation in analog method.

Why do I need to connect another function generator and a digital meter to conduct the CMRR test with CMRR 2.0?

The CMRR test is a single test. Due to special noise concerns, the CMRR 2.0 was considered proper implemented as a separate and passive test unit. As a single test, it was also considered more efficient to make use of support equipment typically available in most laboratories.

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.

Why are there two different breakout boxes of BB-C1 and BB-C2 in WhaleTeq ECG test systems?

CMRR 2.0 uses a special construction to eliminate the need for many switches. Due to this simplification, two types of breakout boxes are used to access two different configurations found the various IEC and AAMI standards.

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

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

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

Currently the NST database is recommended to be tested by digital means. The current MECG is designed with 12 bit resolution making it difficult to cover the precise voltages in small ST segments while at the same time covering the large voltages in the NST database.

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.

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.

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

Yes, any waveform can be streamed from both the SECG and the MECG. The MECG 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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