Sentinel II – Medical System

Sentinel II - Medical System

 

  • Chroma 19032, CaptivATE & 500 VA AC Source (up to 4000VA, optional)
  • Control AC Line Voltage & Frequency
  • 19032 Tests: AC, DC, IR, GB & LC
  • LC Tests: Earth, Enclosure, Patient & Patient Auxiliary
  • 1 Patient Connection
  • Manual Multiple Patient Connections using Pause Function
  • LC Scanner: 20A Input Current Capability
  • Functional Run Testing
  • CaptivATE Automation Software
    • Print report capability for PASS/FAIL
    • Document Retrieval – Retrieve SOPs, Pictures and other documents during testing
    • IQ/OQ Test Protocol Document
    • User Name/Password Protection
    • 3 Levels of Administrator-Controlled Access to the System
    • User Name/Password Protection
    • 3 Levels of Administrator-Controlled Access to the System
    • Barcode Scan Model & Serial Numbers
    • Create, Edit and Store Unlimited Test Sequences
    • Association of Test Sequences to Unique UUT Models or ID Numbers
    • Historical Data Querying Tools
    • Capture, Archive & Print Test Parameters, Results & Reports
    • Electronic Test Records

The Sentinel II system provides fully automatic Electrical safety testing to IEC/EN/UL/CSA 60601-1. Sentinel II saves time by scanning patient connections for leakage current without powering down the medical device. The Sentinel II System can be configured to accommodate Class I, Class II, mains and Internally Powered medical devices with the following configurations:

  • Mains Power supply up to 4000VA, 0~300VAC @ 15~1kHZ
  • Up to 1 B-Type Patient Connection

500VA programmable AC Source: (can be upgraded to a 1000, 1500, 2000 or 4000VA AC Source) Automatically provides the capability to perform earth (line), enclosure or patient leakage current measurements at different mains voltages and frequencies.

CaptivATE provides the Sentinel II System with the capability to create test sequences, capture data, bar code scanning of device model and serial number, and automatically recall test setups based upon model number. All test data is saved into a database for trending and analysis.

Test Capabilities

  • Ground Bond
  • AC Hipot up to 5kVac
  • DC Hipot up to 6kVac
  • Patient Leakage
  • Earth Leakage
  • Enclosure Leakage
  • Patient Auxiliary Leakage
  • Programmable AC Source

  • IEC/EN/UL/CSA 60601-1 Testing
  • All Medical products can be supported
  • Testing Main Powered & Internally Powered Devices
  • Testing Medical Devices with B-Type Applied Parts

Description:

Engage Medical Device Functions: Use the Sentinell II System to create ‘worst case’ leakage current conditions before making measurements. Allows PC systems to power up prior to making the leakage current measurement.

AC Source: Automatically program and regulate mains voltage and frequency applied to the device under test.

CaptivATE Software: Create test sequences, capture data, provide bar code scanning of device model and serial number, automatic recall of test setup based upon model number and all data is saved into a database for trending and analysis.

CaptivATE software eliminates the need for the operator to make Pass/Fail judgment, record test results, make process deviation decisions, selection of the proper test, and interface with multiple types of test equipment.

The Sentinel II System Testing Capability: Using CaptivATE software, an AC Source and a Chroma 19032 Series Analyzer with the 190308, possible test functions include AC or DC Hipot, insulation resistance, ground bond, earth leakage, patient leakage, patient auxiliary leakage or enclosure current leakage, as well as a functional run test. The Guardian 6100 Plus has an internal leakage current scanner with 20A input current capability.

Sentinel II System
IEC 60601-1 Testing with 1500VA AC Source and 1 Patient Connection
Chroma 19032 with 190308 Leakage Scanner
CaptivATE Software
61603 1500VA AC Source

Sentinel IIa System
IEC 60601-1 Testing with 800VA AC Source and 1 Patient Connection
Chroma 19032 with 190308 Leakage Scanner
CaptivATE Software
6408-1 800VA AC Source

Chroma 19032 with 190308 Leakage Scanner

  • Programmable AC Hipot Voltage 50 to 5000VAC, Output Current to 40mA
  • Programmable DC Hipot Voltage 50 to 6000VDC, Output Current to 12mA
  • IR Measurements from 100kohm to 50Gohm, Test Voltage 50 to 1000VDC
  • Programmable Ground Bond Current from 1 to 40A*, Resistance Measurement to 510mohms
  • Twin Port – Simultaneous Hipot and Ground Bond
  • 20A Hipot/Line Leakage Scanner
  • Functional Run Testing: Voltage (to 300V), Current (to 20A) or Power (to 4400VA)
  • Earth, Enclosure, Patient & Patient Auxiliary Leakage Current Measurements
  • Open/Short Circuit Detection to ensure Device Under Test is connected
  • Pause Mode Allows the Operator to Change Device Connection and Continue
  • Programmable Hi/Lo Limits for Pass/Fail Testing
  • Programmable Ramp, Dwell and Test Times
  • Perform Multiple Tests in Sequence with Store/Recall of 100 Setups, 50 Steps Each
  • Front Panel Lockout Prevents Changes to Test Setup
  • Automatic Offset to Zero Out Residual Current
  • Fast High Voltage Cutoff and Quick Discharge of Device Under Test
  • RS-232 and I/O Interfaces Included Standard
  • IEEE-488 and Printer Interfaces Optional
  • Front and Rear Panel Output Connections
  • 40A Ground Bond Testing with Optional Transformer
  • GB: Standard 30A output, Optional 40A output

CaptivATE Automation Software

  • Out of the Box Solution to Simplifying Electrical Safety Testing
  • Easy to use Interface for Operators
  • Barcode Scan Product, Test, Print and Save Data Seamlessly
  • Helps Reduce Operator Errors
  • Controls Quality Records
  • Central Database for all Test Data and Test Programs
  • Password Verification
  • 3 Levels of User Access
  • For Security, Automatically Logs Off Operator if Idle
  • CSV and XML Outputs Simplifies Integration to MES Systems
  • Eliminates Handwritten Data
  • Outputs Data directly to Microsoft Excel for SPC and Trending
  • Assists in 21CFR Part 11 Compliance
  • Software is validated based upon FDA’s Guidance on Principles of Software Validation
  • Developed based upon Chroma’s documented SDLC Process
  • IQOQ Test Protocol Document is Available
  • Based upon years of Input and Requirements from Leading Medical Device Manufacturers

AC Sources:

  • 61603
    • Output: 1500VA, 0-300V, 15-1kHz
    • Input: 90-250V, 22A max
  • 6408-1
    • Output: 800VA, 0-300V, 45-500Hz
    • Input: 90-132V, 12A max
  • 61604
    • Output: 2000VA, 0-300V, 15-1kHz
    • Input: 90-250V, 28A max
  • 80% Typical Efficiency
  • UVP, OVP, OCP, OPP, OTP & Short Protection
  • Built in Power Factor Converter
  • AC & DC Output Voltage Mode
  • 9 Measurement Parameters: V, Irms, Ipeak, Iin_rush, P, Q, S, PF, CF
  • Programmable Voltage & Current Limits
  • Store & Recall up to 9 Voltages & Frequencies
  • ON/OFF Phase Angle Control
  • Programmable Slew Rate (61603)
  • High Output Current Crest Factor for Inrush Current Test

Equipment for Sentinel II Medical Device Electrical Safety Test System

Sentinel II System
Chroma 19032 with 190308 Leakage Scanner
CaptivATE Software
1500VA programmable AC Source

Sentinel IIa System
Chroma 19032 with 190308 Leakage Scanner
800VA programmable AC Source

Included:
G32 Isolation Transformer
G42 Barcode Scanner
RS-232 Cables
USB – RS-232 Adapters
Cables, Adapters req’d for DUT

Options:
5000-04 External Scanner: 8HV, 4GB Channels
19” Rack Mount Enclosure
PC, Monitor & Keyboard

AppNotes

Why Product Safety Test Your Electrical Medical Products

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This application note provides information on why safety testing medical products is important. ...

Using Low Limits To Verify Hipot Connection

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This application note illustrates how to use low limits to verify hipot connection to the device being tested. ...

UL Standard

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This application note provides an overview of UL standards. ...

Using A Load Box To Verify A Tester Is Working

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This application note demonstrates how to use a load box to verify that the hipot tester is functioning properly. ...

Testing Filter Capacitors On Medical Devices

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This application note will show how the hipot tester can be used not just as a means to check the DC Leakage Current or the Insulation Resistance, but can also be used to verify the existence and the value...

Tutorial On Safety Testing

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This application note provides a tutorial on safety testing for UL certification of products. ...

Overview Of IEC 60601-1 Medical Electrical Equipment

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This application note provides an overview of the IEC 60601-1 Medical Electrical Equipment standard. ...

Resistive Load Boxes For Hipot

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This application note provides information on high voltage resistive load boxes and the manufacturers that make them. ...

Glossary Of Electrical Safety Terms

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A glossary of many standard terms used in discussing electrical safety concepts. ...

Line Leakage Measurement & Human Body Equivalent Circuits

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This note looks at the various line leakage tests and circuit models to determine possible patient/operator danger. ...

Leakage Current On Class I Medical Products

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This application note describes how IEC 60601-1 leakage current tests can be accomplished without the need to change the cable to a class 1 device during testing. ...

Leakage Current On Class II Medical Products

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This application note describes how IEC 60601-1 leakage current tests can be accomplished without the need to change the cable to a class 2 device during testing. ...

Leakage Current Part I

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Part 1 discusses the terms and definitions associated with leakage current and the two classes that electronic medical products are divided into per IEC60601-1. ...

Leakage Current Part II

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Part 2 builds on the basic principles of leakage current discussed in part 1 and details the IEC60601-1 measurement circuits for Earth, Touch/Chassis and Patient leakage current tests. ...

IEC60601-1 And Your Electrical Medical Products

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Beyond user safety and legal requirements, this note looks at two other reasons why a manufacturer would benefit from having its Electrical Medical Products tested. ...

Ensuring The Safety Of Medical Electronics

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Vital areas of electrical safety testing for medical products include leakage current, dielectric breakdown, insulation resistance and ground bond testing. To better understand the differences in these...

IEC60601-1 3rd Addition Leakage Current Differences

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This application note describes the differences between the 2nd and 3rd editions of the IEC60601-1 standard. ...

Hipot Testing Multi Conductor Feedthroughs

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This application note illustrates how to effectively perform electrical safety testing of IMD’s with feedthroughs. ...

Dielectric Strength Testing Of External Cardiac Defibrillator

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Explains testing procedures for cardiac defibrillators. ...

Testing to IEC60601 Standards

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Testing to IEC60601 Standards: Leakage Current, Dielectric Breakdown, Insulation Resistance, and Ground Bond. There are a number of areas of safety testing, which include leakage current, dielectric breakdown,...

Electrical Safety Testing 101

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This application note covers the basics of what electrical safety testing is, and the tests that can be performed. ...

Calculating Inrush Current Protection

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This application note looks at protecting devices from high inrush currents and provides a method and considerations necessary in specifying the inrush current protection needed for an example device. ...

Custom Design Your Own Shock Therapy

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This application note describes how to plan for product safety testing. ...

Advanced Technique For Dielectric Analysis

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This application note covers advanced techniques for dielectric analysis. ...

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