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This section provides technical information on specific requirements in standards, based on the work that WhaleTeq and MEDTEQ have been involved in.


These articles including the general knowledge of test equipment and also particular standards covering ECG, IBP, NIBP, Temperature, HF surgery, patient monitoring and the like. Refer to the navigation on the right side or the list below for links.

Recently, WhaleTeq has been also sharing newsletters regarding new product functions. We hope customers can benefit from WhaleTeq tools continuously with the improvement made.

In addition, users can also refer to below Frequently Asked Questions we constantly update.

 


Standards and Technology

Subject Brief overview
IEC 60601-2-25:2011 changes IEC 60601-2-25 (changes from IEC 60601-2-25:1993/A1:1999 + IEC 60601-2-51:2003)
IEC 60601-2-27:2011 changes IEC 60601-2-27 (change from the 2005 edition)
IEC 60601-2-25:2011 CSE database testing notes Provides some practical explanation for the CSE database tests

Application Notes

Subject Brief overview
ECG Leads Explanation ECG LEADS and LEAD ELECTRODES
ECG Filters Introduce how the filters design affect ECG tests
High Frequency Dielectric Strength Tests For IEC 60601-2-2 & IEC60601-2-18 dielectric strength test
MECG Range Why NST Noise waveforms are not embeded in MECG.

WhaleTeq News

Subject Brief overview
SECG 4.0 New Function: Load ECG File With two formats the SECG software supports- Text and Binary files, you can easily import your own ECG waveform in analogue method.
MECG 2.0 Command Replay: Edit and Generate Database Waveforms by Command Scripts "Command Replay" is a new tool that allows you to generate a sequence of test waveform by command to increase test efficiency.
Importance of System Validation Introduce how to use MECG 2.0 to conduct system validation for an ECG.
Your SECG 4.0 Can Do More: SDK helps you design your own automation test tool WhaleTeq provide free Software Development Kit(SDK) with two examples. SECG 4.0 can be controlled by your software and it helps you speed up your test. These two examples include (1) UI Demo (2) Sequence Demo.
Your SECG 4.0 Can Do More: New Features to the updated SECG 4.0 software 1. Support Hot Plugging 2. Support “Backward” and “Forward” in Auto Pacing Assistant 3. SECG Assistant Software E27 Function Update for IEC 60601-2-27: 201.12.1.101.11 Baseline reset
WhaleTeq Brings the Integrated CMRR Tester to the Market First CMRR Tester Combines Accuracy, Convenience and Flexibility All Together

Frequently Asked Questions

Subject Brief overview
Has the ECG Set proved by any authorized party? The ECG set has been employed by many offices of major agencies such as UL, TUV SUD, TUV Rhienland, SGS, ITS and CSA, and has often been used to support IECEE CB scheme accreditation for ECG standards. Several agencies have performed thier 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 the ECG Set? 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 recieving laboraties, 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 seperate 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 the ECG Set 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 CMRR 3.0 DC offset 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 the ECG Set in production line as well? Yes, the ECG Set can be used in production line as well according to customer's test needs. WhaleTeq also provide the Software Development Kit(SDK) for the SECG 4.0 that allow customers to design their own test procedures and user interfaces in different testing environment or for different design/quality/ production phases.
How does the ECG Set function? The ECG Set 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 and converted to analogue voltages. Detailed introduction please check the answers provided.
What is the test set up of ECG Set? For SECG 4.0 and MECG 2.0, install the USB driver and PC software. Connect the USB module (test unit) to any USB socket of the PC and run the WhaleTeq Single Channel ECG 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, there is a detailed video prepared to demonstrate the test operation.
How is the ECG Set 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 is used for all SECG, all MECG, baseline noise test and the CMRR test for some standards. A special breakout box is used for CMRR only for selected standards.
Does the ECG Set 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 and CMRR are required.
I am going to do test for IEC60601-2-27, what devices do I need? SECG and CMRR 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 recommanded for system validation in analog method.
Why do I need to connect another function generator and a digital meter to conduct the CMRR test? The CMRR test is a single test. Due to special noise conerns the CMRR module was considered best implemented as a separate 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 the ECG Set? The ECG set provides the required signals and circuits, but the operator must record, measure and interpret the results on the equipment under test. WhaleTeq software is provdied to assist in determining compliance.
Why are there two different breakout boxes with ECG Set? The current CMRR test box 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 accuratly? 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 can not be played by MECG 2.0? How can I have it tested instea 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 your ECG Set? Yes, in general EC57 can be tested with the MECG, 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.
Dose the system support 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 software is also designed to interface directly with the Physionet databases which include many test waveforms.
How can the HFIT be calibrated? Calibration of this device is complex due to both high frequency and high voltages involved. Formal, accredited traceability for 7200Vp/400kHz is unlikely to be available anywhere on the planet. While oscilloscopes and HV probes may be "calibrated", a careful inspection of the records will usually find traceability exists only for DC and low frequency. Most importantly, these devices often use different operating modes and various compensation schemes to achieve a wide bandwidth, making the low frequency calibration irrelevant to the high frequency measurements. Real measurement errors in the 5-10% region are normal in practice.
For HFIT, does WhaleTeq provide also accessories for testing to this standard (like low inductance l WhaleTeq can recommend resistors to purchase from retailers such as RS components and Digikey that are known to be useful for ESU testing.
Does the HFIT comes with CE DoC and safety/EMC compliance certificates or ISO 17025 calibration cert The power supply used with the HFIT is CE marked and has various agency approvals. The HFIT is low volume production, hand made to order and customized to the client's request such as peak voltage and output load. The supply voltage is 48Vdc (below SELV limits) and the high voltage output is at 400kHz region which there is no risk of electric shock (fibrillation), although HF burns are possible. During the test very high frequency noise from ionization is expected and may cause EMC noise (as with HF surgery). While idle no significant noise is expected due to the nature of the design.

HRS Software

Subject Brief overview
HRS SDK Software Development Kit for HRS. It includes: C SDK header, C# SDK header, 3 demo application and demo source code.

SEEG100

Subject Brief overview
SEEG100 SEEG100 Application Software

SECG 4.0P

Subject Brief overview
SECG 4.0P Software This is the application for SECG 4.0P.

MT2511 Production Line Test Software

Subject Brief overview
MT2511 Production Line Tester Software Production line tester software for wearable equipped with Mediatek AFE IC MT2511