Test equipment

- Our basis

Our test equipment is of the highest quality and is
used worldwide by leading test institutions, ECG
manufacturers and notified bodies.

ECG simulator

phantom 320

The phantom 320 is a versatile simulator that allows you to test the functioning of your ECG equipment.

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ECG simulator

MS 410

MS410 is a new generation ECG simulator – small, handy and digital (signals according to IEC 60601-2-25).

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Defibrillation simulator

Zeus

Zeus is the first test device with which medical technology systems can be tested for defibrillation protection.

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Safety socket

medical protector

Medical protector instead of isolating transformer – our simple solution for medical electrical systems

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Test equipment –

Service

Regular calibration is a prerequisite and guarantee for your quality assurance.
Test equipment monitoring is an essential part of your quality assurance system. We offer regular calibration of our instruments in order to ensure our test and measuring instruments are used as test equipment in accordance with standards. This ensures that the test equipment relating to product quality always provides "correct" measurements.

Calibration of our instruments includes:

  • confirmation of traceability of measurement results to national standards
  • a calibration certificate
  • a measurement report (with indication of the measurement uncertainties according to DAKKs-DKD-3)

Important notes:

We perform a factory calibration. The frequency of calibration depends on your requirements. Please observe the calibration recommendations for the individual devices. Since our instruments are calibrated during production, the date on the calibration certificate applies to the calibration intervals. It is therefore possible to reduce the interval by up to 6 months (Zeus DEFIBRILLATION simulator) or 12 months (phantom 320 ECG simulator and MS410 ECG simulator). This reduction cannot be contested. Please contact us for further information.


Sample calibration certificates:

Test equipment certificates for our calibrations

The corresponding test equipment is indicated on the certificates:

Zeus defibrillation simulator

Why is the amplitude of the output voltage at Zeus 2 (25/400) only about 4 kV, despite the capacitor is charged to 5 kV?

An inductor is nothing but a resistance for an alternating current. In our case, the capacitor first is charged to 5 kV DC, but then the discharging switch is closed! In this moment, because of the rising Voltage the resistance of the inductor is also pretty rising! You have now a big resistor for the current, what results in a big voltage drop over the inductor and a smaller voltage drop over the following resistor (voltage divider of L1 and R1, R4 is the ohmic resistance of the inductor L1). This is the reason for missing of at least 1 kV! 

Please have a look at the attached papers, which show a Spice-Simulation of the discharging circuit. This should help you to understand what is going on. On page four you can see the max. reachable output Voltage with all tolerances included. 

Is it possible to test the functionality of the device?

You can check the output voltage using an oscilloscope with a high-voltage probe.
CAUTION! Please observe the corresponding safety regulations regarding measurement at high voltage!
The capacitor’s discharge curve shown on the oscilloscope can be compared with the values in the calibration report.

When must the instrument be returned for calibration?

We recommend a calibration after approx. 5000 discharges or after 24 months.

What max. energy does the device deliver at the test output?

The max. energy is calculated according to the formula:

Which instrument versions can be used to meet which standards requirements?

Depending on the version (Zeus or Zeus 25/400), Zeus enables defibrillation protection to be tested according to standards such as IEC 60601-1, IEC IEC 60601-2-25, IEC 60601-2-26, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49. (IEC 45502-1 is not testable).

Is there a version for 120 V supply voltage?

No, for other supply voltages they require a voltage transformer.

Can the instrument also be calibrated in the USA/other countries?

No, the instrument must be returned to us for calibration.

When measuring with the oscilloscope at the measuring output of the Zeus, voltages of up to 8 Vpp are produced, although there are no disruptive discharges.

The time base of the oscilloscope is set incorrectly (less than 1 ms). In the IEC 60601-1 standard: 2013-12 for tests in accordance with item 8.5.5.1, the RC member for recording discharges is shown in Figure 9 or 10. R2 = 100 kOhm and C1 or C2 = 1 uF gives a time constant of 100 ms. All signals recorded with a lower time base than the one stated above are to be considered pure high-frequency interfering signals.

What can you do with the “Measuring In” input?

This input is used to measure any voltages that may occur on the touchable housing parts of the sample (see Fig. 9 and 10 in IEC 60601-1: 2013-12).

Is the patient in Zeus simulated?

The patient is simulated with R1 and R3 as indicated in the corresponding standards
(see block diagram in the Zeus user manual and corresponding pictures in the standards).

What must be taken into account when converting the output voltage to 20 Vpp?

After changing the output voltage of the sinusoidal generator to 20 Vpp (results in 5 mVpp on the ECG trace) in the latest editions of the IEC 60601-1, IEC 60601-2-25, IEC 60601-2-27 and IEC 60601-2-49 standards, the 5 Vpp version of the Zeus is no longer available.

If required, you can convert your Zeus with 5 Vpp generator voltage to 20 Vpp.
We would be happy to prepare a quotation for you.

MS410 ECG simulator

What can I do if I perform the immunity test – as required by IEC 60601-2-25 – and there is distortion of the ECG signal?

Try shielding the MS410 as suggested in the standard.

Which languages is the MS410 available in?

You can choose between German and English in the “Settings” menu.

Does the MS410 contain all test ECGs of the IEC 60601-2-25 standard?

No, the MS410 contains the signals of the CTS Atlas (Appendix GG, IEC 60601-2-25:2011), as well as artificial forms of signals adapted to the human ECG.

When must the instrument be returned for calibration?

We recommend calibration after 60 months.

The operating instructions for the MS410 describe 24 types of ECG signals. Can these signals be used for tests according to IEC 60601-2-51 point 50.102.3?

These ECG signals are artificially generated, despite their “natural” appearance. They have been designed to allow quick and easy testing of an electrocardiograph. Unfortunately, they are not suitable for testing according to IEC 60601-2-51: 2004-02, point 50.102.3. The signal curves described in the standard must be used for this purpose.

Are the amplitudes of the MS410 infinitely variable?

No, the amplitudes are fixed in the respective programs.

The display is dark and difficult to read.

Change the position of the MS410.

You can read and adjust the menu:

  • In the main menu select Settings menu (arrow keys under “Main menu”).
  • Press the submenu button until Contrast is displayed (arrow keys under “Submenu”, twice in quick succession).
  • Press the up arrow key until the contrast is set to optimum.

The device (display) no longer switches on.

Possible causes:

  • You have tried to switch the device on several times while the batteries are empty
  • Short-term power supply failure (e.g. dropped on the floor)
  • Batteries have been removed from the device while it was switched on

Remedy:

Please remove the batteries, wait at least 10 seconds and then insert new batteries. Switch the instrument on again and, if necessary, continue with the FAQ at “The display is dark and difficult to read”.

phantom 320 ECG simulator

Is the phantom 320 also available in US version with the corresponding AHA colours?

There are two versions as specified in the standards IEC 60601-2-51: 2004-02 point 101 and IEC 60601-2-27: 2004-03 point 1:
Version I according to Code 1 (Europe) Product no.: 59.009
Version II according to Code 2 (America) Product no.: 59.010

Why are pathological heartbeats detected during ECG analysis by ECG recorders at normal sinus rhythm?

Despite the name “normal sinus rhythm”, the phantom 320 is an artificial ECG curve. An adaptation to physiological signals was deliberately omitted for reasons of cost effectiveness. Some analysis algorithms therefore also display pathological events during normal beats. If physiological signals are required, we recommend our MS410 model.

When must the instrument be returned for calibration?

We recommend calibration after 60 months.

General / Calibration

Are there distributors of the products abroad?

No. Please send your order directly to us.

Do you sell and ship to the USA or only to Europe?

We sell and ship all over the world.

Who can perform the calibration?

Please send the device to us. There are no companies authorised by us for calibration.

Are the instruments delivered with a calibration certificate?

The MS410 and Zeus devices are always supplied with a calibration certificate. For the phantom 320 the certificate has to be ordered for a fee.

How much time is required for calibration?

We need approx. 4-5 days to calibrate the instrument, plus shipping time.