Leading Manufacturer Chooses Chroma’s Sentinel III Systems for IEC/EN/UL/CSA 60601 Compliance Testing

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A leading medical device manufacturer will be using Chroma’s Sentinel III automated test system for IEC/EN/UL/CSA 60601 compliance testing of their ultra sound products.

A leading manufacturer of medical devices has chosen Chroma’s Sentinel III automated test system for final testing of their latest ultra sound product. This ultrasound system is a pioneering cardiac ultrasound platform that combines an ultra-high data rate echo engine with a suite of advanced applications to simplify echo for the user. This version allows for higher resolution and more data throughput enabling faster and more consistent image quality for greater confidence in the analysis.

Products under evaluation must comply with the IEC/EN/UL/CSA 60601 standard for medical devices. Each unit produced must be tested for Hipot, Leakage (F Type Leakage due to patient contact), Ground Bond (GB), and Insulation Resistance (IR).

Each Sentinel III System built for this customer consists of a Guardian 19032, a programmable AC Source, 2 Isolation Transformers (required if F type leakage is needed), and includes a 19200 Matrix with the AC module, a General Module, Earth Module, and the GBF2-Module. The systems are also integrated with Chroma’s latest version of CaptivATE™ automation and data logging software for Medical testing. Many country’s standards like to see full recorded data from test sequences to demonstrate compliance. As an example, in South America, INMETRO requires that all test results must be electronically recorded in order to pass certification. CaptivATE™ provides this data automatically.

In the process of developing the systems for this customer, Chroma Systems Solutions imported over 3600 test points from a past version of CaptivATE™. This saved weeks of programming test parameters for the testing team.

Chroma’s Sentinel III systems will be utilized by the QA and manufacturing teams and reside on the production floor to meet the manufacturers required tests on 100% of the units produced. With the pre-programmed test suite, the user inputs the unit serial number, connects the unit to the system and starts the test program. The system then automatically runs the hipot, GB, and leakage tests in sequence, and records all data associated with that serial number. These systems are custom designed and configured to comply with IEC/EN/UL/CSA 60601 standards and save production testing time by reducing the number of hard wire connections to the device under test.

About Chroma Systems Solutions

Chroma Systems Solutions, Inc. is a leader in providing power electronics and electrical safety testing instrumentation and systems. Chroma’s programmable power supplies, electronic loads, meters, hipot testers and automated testing systems provide solutions for applications in Aerospace, Military, Commercial, Medical, Battery, Marine, and Regulatory Testing as well as green energy markets including Solar, Electric Vehicle and LED. With offices and manufacturing facilities located around the globe, Chroma is dedicated to providing the highest quality equipment for compliance and R&D test engineers as well as unparalleled service and support. Chroma Systems Solutions corporate office is located in Foothill Ranch, CA. For more information please visit http://www.chromausa.com or call us at (949) 600-6400.

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Steve Grodt
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Chroma Systems Solutions, Inc. - Power Electronics Testing Solutions
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