Sentinel III - Medical System

Sentinel III – Medical System

- 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
- Device Stays Powered-On During Scanning
- Control AC Line Voltage & Frequency
- 19032 Tests: AC, DC, IR, GB, LC & Open/Short measurements from a single test connection
- LC Tests: Earth, Enclosure, Patient & Patient Auxiliary
- 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
  - 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 III System provides complete Electrical Safety Testing to IEC60601-1 and IEC 60601-2-49 (Multifunctional Patient Monitoring Equipment) in a fully automated fashion. The Sentinel III saves time by scanning patient connections for leakage current without powering down the device. The Sentinel III System comes in two basic configurations:

- - Sentinel III can be upgraded to a 2000VA or 4000VA AC Source and can support 2-16 patient connections.

Sentinel III systems save time by scanning patient connections for leakage current without powering down the medical device. They also have soft start/stop capability, which permits PC-based medical devices to boot up/shut down before starting leakage tests and removing mains power.

CaptivATE provides the Sentinel III 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 Multipoint
  - Mains to AP Dielectric Withstand
  - DC Hipot up to 6kVdc-Multipoint
  - Patient Leakage up to 16 points
  - Earth Leakage – 1 point
  - Enclosure Leakage – 4 points
  - Patient Auxiliary Leakage – up to 16 points
  - F-Type Leakage (100% Mains Applied Part) – up to 16 points
  - 110% Mains on SIP/SOP’s
  - Programmable AC Source

- - IEC/EN/UL/CSA 60601-1 Testing and IEC 60601-2-XX Testing
  - Patient Monitor Testing
  - Defibrillator Testing
  - Electro Surgical Device Testing
  - Devices with Multiple Patient Connections
  - Testing Main Powered & Internally Powered Devices
  - Testing Medical Devices with B,BF & CF Applied Parts

Description:

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; save all data to a database.

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

No Changing Cables during the Test: Perform F-Type leakage tests and Mains to Patient connection hipot testing without the need for operator interaction. The system can also be configured for multipoint hipot, ground bond, and leakage current measurements. The operator does not have to connect/disconnect cables at any other point during the test other than at the beginning and end.

Need More Patient Connections: Add 1, 2 or 3 General modules to the standard configuration for an additional 4, 8 or 12 points. The maximum number of patient (applied part) connections is 16 (4 General modules).

Engage Medical Device Functions: Use the Sentinel III 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.

Sentinel III System
IEC 60601-1 & 60601-2-49 Testing with 1500VA AC Source and 4-16 Patient connections.

Sentinel III-04
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
61603 1500VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(1) General Module
(3) Blank Modules
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters
Cables, Adapters required for DUT

Sentinel III-08
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
61603 1500VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(2) General Modules
(2) Blank Modules
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters
Cables, Adapters req’d for DUT

Sentinel III-12
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
61603 1500VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(3) General Modules
(1) Blank Module
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters
Cables, Adapters req’d for DUT

Sentinel III-16
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
61603 1500VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(4) General Modules
(0) Blank Modules
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters

Sentinel IIIa System
IEC 60601-1 & 60601-2-49 Testing with 1500VA AC Source and 4-16 Patient Connections

Sentinel IIIa-04
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
6408-1 800VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(1) General Module
(3) Blank Modules
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters
Cables, Adapters req’d for DUT

Sentinel IIIa-08
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
6408-1 800VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(2) General Modules
(2) Blank Modules
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters
Cables, Adapters req’d for DUT

Sentinel IIIa-12
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
6408-1 800VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(3) General Modules
(1) Blank Modules
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters
Cables, Adapters req’d for DUT

Sentinel IIIa-16
Chroma 19032
Chroma 190308 Leakage Scanner
CaptivATE Software
6408-1 800VA AC Source
Matrix 8000 Scanning System
(1) AC Line Module
(1) GBF-2 Module
(1) Earth Module
(1) AC Line 2 Module
(4) General Modules
(0) Blank Modules
(2) G32 Isolation Transformers
(1) G42 Barcode Scanner
(3) RS-232 Cables
(2) USB – RS-232 Adapters
Cables, Adapters req’d for DUT

Sentinel III System Medical Device Electrical Safety Test System

Sentinel III System with 1500VA programmable AC Source

- - Sentinel III-04 4 Patient Connections
  - Sentinel III-08 8 Patient Connections
  - Sentinel III-12 12 Patient Connections
  - Sentinel III-16 16 Patient Connections

Sentinel IIIa System with 800VA programmable AC Source

- - Sentinel IIIa-04 4 Patient Connections
  - Sentinel IIIa-08 8 Patient Connections
  - Sentinel IIIa-12 12 Patient Connections
  - Sentinel IIIa-16 16 Patient Connections

Options:

- - 21U 19” Rack Mount Enclosure
  - PC, Monitor & Keyboard

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Sentinel III – Medical System

Test Capabilities

Description:

Sentinel III System Medical Device Electrical Safety Test System

AppNotes

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