Exploring Sentinel II – Medical System
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
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
Key Features
- 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
- 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
Model Options
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 required for DUT
Options:
- 5000-04 External Scanner: 8HV, 4GB Channels
- 19” Rack Mount Enclosure
- PC, Monitor & Keyboard
Test Capabilities
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
Uses
- 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 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 A190308, 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.
Specifications
Sentinel II System
IEC 60601-1 Testing with 1500VA AC Source and 1 Patient Connection
Chroma 19032 with A190308 Leakage Scanner
CaptivATE Software
61603 1500VA AC Source
IEC 60601-1 Testing with 1500VA AC Source and 1 Patient Connection
Chroma 19032 with A190308 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 A190308 Leakage Scanner
CaptivATE Software
6415 AC Source
Chroma 19032 with A190308 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
- 6415
- 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
More Features
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Watch
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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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