Sentinel II – Medical System | Chroma Systems Solutions, Inc.

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

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Sentinel II – Medical System

Test Capabilities

Description:

Equipment for Sentinel II Medical Device Electrical Safety Test System

AppNotes

Related Products

Guardian Electrical Safety Analyzer – 19032

Programmable AC Power Source – 6400

Sentinel I – Medical System

Sentinel III – Medical System

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