SecuLife ST HV Testing of Electrical Medical Appliance

Test Instrument with Test Sequences per EN 62353, EN 60601, EN 61010, EN 60335, EN 60950, VDE 0701-0702

As a multifunctional test instrument, the SECULIFE ST is ideally suited for performing and documenting measurements at medical devices. It allows for precision testing of portable medical devices, and can also be used for large devices such as X-ray equipment and MRI scanners.

The SECULIFE ST is the only measuring instrument available on the market which has been designed to test medical devices operated with 3-phase electrical current. The three-phase current adapters AT3-IIIE and AT3-IIS 3-phase current adapters can be furnished to this end as optional accessories.

Applications

Testing for the Electrical Safety of Electrical Equipment in Accordance with BGV A3

The test instrument can be utilized for quick and safe testing of repaired or modified electrical devices and as well as for periodic testing in accordance with DIN VDE 0701-0702:2008.
The following are measured in accordance with the standards:

• Protective conductor resistance
• Insulation resistance
• Protective conductor current for SC1 devices
• Contact current for SC2 devices
• Absence of voltage at exposed conductive parts (= contact current)

Measuring methods for leakage current measurements:

- Direct measurement
- Equivalent leakage current
- Residual current

Testing for the Electrical Safety of Electrical Medical Devices in Accordance with the German Medical Product Law (MPG) and the associated Operator’s Regulations

The test instrument with feature KA01 is used for quick and safe testing and measurement of repaired or modified electrical medical devices or their components (e.g. patient ports) in accordance with IEC 62353/DIN EN 62353 (VDE 0751) and EN 60601. Observance of technical safety requirements allows the user of the test instrument to operate electrical medical devices in a hazard-free fashion. The safety of the patient is also assured through the use of tested electrical medical devices.

The following are measured in accordance with IEC 62353 (VDE 0751-1) regulations:

• Protective conductor resistance
• Insulation resistance
• Equivalent device leakage current
• Equivalent patient leakage current
• Device leakage current
• Patient leakage current (AC/DC portions are measured separately)

Measuring methods for leakage current measurements: 
– Direct measurement
– Equivalent leakage current
– Residual current

A software upgrade (optional) allows for measurement in accordance with EN 60601 regulations, see features on page 6 (with the following single-fault conditions: voltage at application part, interrupted neutral and interrupted protective conductor, with automatic polarity reversal L-N)

• Protective conductor resistance
• Insulation resistance
  • – L and N connected to protective conductor
  • – Application parts connected to protective conductor
• Earth leakage current, housing leakage current, patient leakage current, patient auxiliary current

The following additional test conditions can be selected:

• Interrupted operational earth and equipotential bonding
• Housing to ground, application parts to ground

Function Test with Power Analysis
(also suitable for high power devices under test up to 16 A)

The device under test can be subjected to a function test with mains voltage via the integrated test socket. The following are measured or automatically calculated during the function test:

• Line voltage
• Residual current
• Power consumption
• Active and apparent power
• Power factor
• Electrical energy
• On-time

Multimeter Functions

Extensive multimeter functions including temperature measurement expand measuring options for the user in a sensible fashion.

The following individual measurements can be performed:

• Direct and alternating voltage (momentary and min/max values)
• Resistance
• Voltage against PE, e.g. phase detection
• Current and protective conductor resistance with clip-on meter (accessory)
• Temperature with Pt100 or Pt1000 (accessory)

High-Voltage Test with Direct Voltage (SECULIFE ST HV)

The mains plug of the device under test (safety class I and II devices) is connected to the test socket at the test instrument. The test instrument monitors the mains connection. Incorrect or dangerous mains connection is indicated, and measurement is disabled in the event of danger.

Use of the test instrument for high-voltage testing is trouble-free because DIN VDE 0104 does not apply. The high-voltage test is performed with direct voltage. In order to comply with requirements for alternating voltage, testing is performed with 1.5-fold direct voltage. This multiplying factor is applied automatically during testing.

This DC high-voltage test complies with EN 60601 3rd edition/ EN 50106 (VDE 0700 part 500), as well as with other standards.

Report Functions

All values required for electrical device approval reports or device log books (e.g. for ZVEH) can be measured with the test instrument.

All measured data can be documented and archived with the measurement and test report, which can be saved to memory and printed out from a PC.

The measurement and test report substantiates regular maintenance and testing for users of electrical devices. The SECUTEST SI+ module (accessory equipment), a memory with integrated interface and keypad which can be mounted inside the lid of the test instrument, expands the applications range of the test instrument.