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QuadTech launches safety test solution for electronic medical devices
Maynard, Massachusetts | Monday, June 24, 2002, 08:00 Hrs  [IST]

QuadTech, Inc., announced the addition of its new Guardian 6100 instrument to its line of Electrical Safety Test (EST) products. The instrument is capable of performing all the electrical safety tests routinely required in the production of electronic medical products.

Without changing the connection to the device under test, the 6100 is able to perform up to 9 different critical electrical safety tests in sequence, and in accordance with UL, CSA, IEC standards, such as UL2601-1, UL1563, UL1950, UL544 and IEC60601.

The 6100 allows the stringent safety testing required on medical products to be performed quick and easy in a production environment, ensuring the shipment of electrically safe products from the manufacturing floor. The instrument can perform AC Hipot tests from 50 to 5000V, DC Hipot tests from 50 to 6000V, Insulation Resistance (IR) measurements over the range of 100k ohms to 50G ohms, and Ground Bond testing to 30A -- plus several leakage current measurements over a range of 0.1 micro A to 9.999 micro A.

Leakage current is the current that a patient or medical equipment operator could be subjected to in the event of product malfunction or breakdown of its electrical insulation. The leakage tests that are possible with the Model 6100 include: Earth Leakage, the current flowing back through the ground connection of the line cord; Enclosure Leakage, the current flowing from the product enclosure back to ground; Patient Leakage, the current flowing from a patient connected part back to ground; Patient Auxiliary Leakage, an unwanted current flowing between two or more separate patient connections.

Additionally, the unit is capable of monitoring Power Consumption (VA), including line voltage or current during normal operating conditions. All the leakage tests are measured with a simulated impedance of the human body, as specified by the various product standards. Likewise, tests performed under normal conditions, reverse power line or fault conditions, open ground and open neutral, are implemented automatically by the 6100, without operator intervention.

The Guardian 6100 is easily programmed from the front panel keypad or remotely via an IEEE-488 interface or optional RS-232. The unit's internal memory can store up to 99 test setups, with up to 99 steps each. The instrument's unique '"Pause Feature" allows testing to be temporarily halted, should any test leads or other operations need to be performed in the midst of a test sequence.

Test results are clearly indicated on the front panel display during the test, and an overall go/nogo indication is provided, based on programmed limits. The 6100 also offers password protected front panel lockout, to prevent an operator from inadvertently altering test conditions.

The price for the Model 6100 is $8,995, which includes test leads, adapter for connecting to 115V corded medical products, NIST traceable calibration certificate and 500VA Isolation Transformer. This isolation transformer is recommended by medical product standards, in order to establish a common reference point in the measuring circuit during the leakage tests.

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