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1 Line Leakage Measurements - This test is performed in order to determine the leakage current through the isolation barriers which could flow through the user/patient during operation of a product - The current through the earth conductor is measured (which is known as earth leakage current) - The touch current is measured by using a Measuring Device (also known as a MD). This simulates the impedance of the body if a patient would come contact with teh product being tested. - The test is made in normal condition and also under single fault conditions - Normal condition means with normal polarity and reverse polarity (possible with Schuko) - Single errors: open neutral condition/ interrupted ground connection - All combinations of reverse polarity and single fault conditions are tested (a full sequence of 8 tests) 2 AC source Requirements: - Some standards (e.g. IEC 60601-1 - Medical) require testing with higher (e.g. 110 %) mains voltage For example in Europe, you would need to test the product at 253 or 264V instead of the mains voltage - Testing at maximum specified power frequency - Typically an isolated galvanic source is needed Solution approach: - Electronically programmable AC sources allow voltages and frequences independent from supply network - Associated Research stand alone Line Leakage Testers and combined Instruments are able to control the power sources that are offered by their sister comapny named Associated Power Technologies. The product range goes from 400VA-18KVA 3 Phase - Omnia II 8207/8257 have a 500W/630VA internal programmable AC source 3 Chart showing the 3 Different Types of Line Leakage Tests. 4 Here are two Diagrams taken from the front panel of the OMNIA II showing the Set up of an Earth Leakage Test. Here you are changing the Fault Condition. This example showing opening and closing the Neutral Condition. 5 Here is a chart showing the 8 different Failure Combinations that need to be performed per Line Leakage test on a product. 6 This picture shows the DUT connection - AR Omnia II tester have internal relays for performing all of the different tests - AC supply comes from an external or internal AC power source 7 Earth Leakage Test Diagram with no fault conditions 8 Earth Leakage Test Diagram showing a Reverse Polarity Condition 9 Earth Leakage Test Diagram showing Neutral Open Condition 10 Touch Current Test - Leakage current flowing through the user when touching the product - The protective Earth is interrupted during the measurement - If exposed metal parts on a prodcut are not grounded, it is required to measure all metal parts against ground - Diagram shows how a touch current test would be performed 11 Patient leakage current and leakage current via applied parts - Testing of the leakage current flowing via the patient when connected to an application part - Leakage current flowing between different application parts - The MD is connected by external connections as you can see in the diagram. You would use the Probe Hi & Probe Lo measurement to perform the testing. 12 Here is an example of how to perform applied part testing with the use of a SC6540 Scanner. 13 Mains on applied part leakage test - The DUT is powered via an AC Source - The applied part are powered by a secondary power source, the current flowing through the MD is measured 14 SC6540 High voltage and high current switching unit - Master Scanner with integrated Automated interface such as GPIB/Ethernet/USB - RS232 - Slave Scanner controlled by safety compliance analyzer - Provided below are typical connections between Omnia II instrument and SC640 scanner 15 Diagram shows how you can perform an automated ground bond test 16 Diagram shows how you can perform an automated hipot mains DUT supply test 17 Diagram shows how you can perform an automated hipot test on applied parts or patient connections 18 Diagram shows how you can perform an automated earth leakage current test 19 Diagram shows how you can perform an automated patient leakage test on Applied Part 1 20 Diagram shows how you can perform an automated patient leakage test on Applied Part 2 21 Diagram shows how you can perform an automated mains on applied part leakage test on Applied Part 1 We are using a 8207 OMNIA II with a built in power source which powers the device and we are also using a secondary power source. The reason why we are connecting the External Power Source to perform the Mains on Applied Part test to two different scanners is because it is to account for polarity reversal on Switch S9 within the 60601 Standard Figure 16 Section 8.7.4 The second reason you are doing a polarity reversal is because you need to isolate your measurement circuit from the power source. Your measurements would not be accurate if you don’t use two scanners. 22 Diagram shows how you can perform an automated mains on applied part leakage test on Applied Part 2 23 The Entire System would be controlled by the Autoware II software to provide a full Medical Test Solution. 24