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Exploring Sentinel I – Medical System

Sentinel I - Medical System

Chroma Sentinel I

  • Chroma 19032 Electrical Safety Analyzer & CaptivATE
  • 19032 Plus Tests: AC, DC, IR, GB, LC & Open/Short measurements from a single test connection
  • LC Tests: Earth, Enclosure, Patient & Patient Auxiliary

The Sentinel I System provides fully automated Electrical Safety Testing to IEC/EN/UL/CSA 60601-1. This system is ideal for testing medical products with one or no patient connections or low volume production where operators can manually change leads between different patient connections. This is a 5 in one Hipot test system that can test Hipot, Ground Bond, Insulation Resistance, Patient Leakage, Earth Line Leakage, Enclosure Leakage and Patient Auxiliary Leakage.

This system combined with our CaptivATE Software allows for data logging all your electrical tests and provides an easy to use Customizable/Programmable software interface.

  • Chroma 19032 Electrical Safety Analyzer & CaptivATE
  • 19032 Plus Tests: AC, DC, IR, GB, LC & Open/Short measurements from a single test connection
  • LC Tests: Earth, Enclosure, Patient & Patient Auxiliary
  • 1 Patient Connection
  • Manual Multi-Point Hipot, GB and LC Testing using Pause Function
  • LC Scanner: 20A Input Current Capability
  • The Sentinel I will prove Ground Bond, AC Hipot up to 5KVac and DC Hipot up to 6kVdc.
  • 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
    • 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

Sentinel I System

  • IEC 60601-1 Testing
  • Chroma 19032 Safety Analyzer with A190308 Leakage Scanner
  • CaptivATE Software
  • (1) G32 Isolation Transformer
  • (1) G42 Barcode Scanner
  • (1) RS-232 Cable
  • (1) USB - RS-232 Adapter

Optional Equipment
  • External Scanner: 8HV, 4GB Channels
  • 19 inch Rack Mount Enclosure
  • PC, Monitor and Keyboard

The Sentinel I will provide Ground Bond, AC Hipot up to 5KVac and DC Hipot up to 6kVdc. The Sentinel I System accommodates Class I, Class II and internally powered medical devices with the following specifications:


  • Mains Power up to 4400VA, 0-300Vac
  • 1 B-Type Patient Connection

CaptivATE provides the Sentinel I System the capability to: create test sequences, capture data, bar code scanning of device model and serial number, and automatic recall of test setup 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

Engage Medical Device Functions: Use the Sentinel I System to create 'worst case' leakage current conditions before making measurements. Allows PC systems to power up prior to making the leakage current measurement.


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


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.


The Sentinel I System Testing Capability: Using CaptivATE software and a Chroma 19032 Series Analyzer, 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. Chroma 19032 has an internal leakage current scanner with 20A input current capability.


Central Database & Historical Search Capability: Information updated in real time makes electronic record searches easier allowing for faster analysis of data for Corrective & Preventative Action and Statistical Process Control.

  • 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
  • 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 the 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
  • Built-In Operator Prompted Software Calibration Routine
  • Front and Rear Panel Output Connections
  • 40A Ground Bond Testing with Optional Transformer
  • * GB: Standard 30A output, Optional 40A output

More Features

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Media

Sentinel Series: IEC60601 Medical Device Automated Test Systems with IQ/OQ Test Protocol Documents

Chroma Sentinel Systems are automated test systems with software designed specifically for Medical device compliance testing of multi-functional patient monitoring equipment to IEC60601-1 and IEC60601-2-49 Standards.

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Chroma C8900

  • Open architecture software
  • Expandable hardware
  • Editable test library

Sentinel I – Medical System

Chroma Sentinel I

  • Chroma 19032 Electrical Safety Analyzer & CaptivATE
  • 19032 Plus Tests: AC, DC, IR, GB, LC & Open/Short measurements from a single test connection
  • LC Tests: Earth, Enclosure, Patient & Patient Auxiliary

Sentinel II – Medical System

Chroma Sentinel II

  • 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

Sentinel III – Medical System

Chroma Sentinel III

  • Chroma 19032, CaptivATE, 1500VA or 800VA AC Source, Matrix 8000 Scanning System
  • Testing to IEC 60601-1 & IEC 60601-2-49
  • F-Type LC (Mains-on-Applied-Part)
  • Multi-Point Hipot, GB and LC Testing
  • Up to 16 Patient (Applied Part) Connections
  • Power-Up Computerized Devices