GE Vivid 7 Service Manual
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GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL Chapter 10 - Care & Maintenance 10 - 13 10-7-2GEHC Leakage Current Limits The following limits are summarized for NFPA 99/UL2601-1/UL60601-1 (for USA) and IEC 60601-1 Medical Equipment Safety Standards. These limits are GEHC standards and in some cases are lower than the above standards listed. NOTE: *Mains Applied refers to the sink leakage test where mains (supply) voltage is applied to the part to determine the am ount of current that will pass (or sink ) to ground if a patient contacted mains voltage. The following tests are performed at the factory and sh ould be performed at the site. These tests are: grounding continuity, chassis leakage current, probe leakage current, and ECG leakage current. All measurements are made with an el ectrical safety analyzer. Table 10-12 Chassis Leakage Curre nt Limits—Accessible Metal Surfaces CountryNormal ConditionOpen GroundReverse PolarityOpen Neutral USAN/A 0.3 mA 0.3 mA N/A Other 0.1 mA 0.5 mA 0.5 mA 0.5 mA Table 10-13 Type BF Patient Leakage Limits - Non-Conductive (Floating) Surface and Cavity Probes Country Normal Condition Open GroundReverse PolarityOpen Neutral*Mains Applied USA 0.1 mA 0.5 mA 0.5 mA 0.5 mA 5.0 mA Other 0.1 mA 0.5 mA 0.5 mA 0.5 mA 5.0 mA Table 10-14 Type CF Patient Leakage Limits - Surgical Probes and ECG Connections Country Normal Condition Open GroundReverse PolarityOpen Neutral*Mains Applied USA 0.01 mA 0.05mA 0.05 mA N/A 0.05 mA Other 0.01 mA 0.05 mA 0.05 mA 0.05 mA 0.05 mA
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL 10 - 14 Section 10-6 - Using a Phantom 10-7-3 Outlet Test - Wiring Arrangement - USA & Canada Test all outlets in the area for proper grounding and wiring arrangement by plugging in the neon outlet tester and noting the combination of lights that are illuminated. Any problems found should be reported to the hospital immediately and the receptacle should not be used. NOTE: No outlet tester can detect the condition where the Neutral (grounded supply) conductor and the Grounding (protective earth) conductor are reversed. If later tests indicate high leakage currents, this should be suspected as a possible cause and the outlet wiring should be visually inspected. 10-7-4 Grounding Continuity Measure the resistance from the thir d pin of the attachment plug to the exposed metal parts of the case. The ground wire resistance should be less than 0.2 ohms. Reference the proc edure in the IEC 601-1.1. Figure 10-1 Typical Alternate Outlet Tester CAUTIONElectric Shock Hazard. The patient must not be contacted to the equipment during this test Figure 10-2 Ground Continuity Test
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL Chapter 10 - Care & Maintenance 10 - 15 10-7-4-1 Meter Procedure Follow these steps to test the ground wire resistance. 1.) Turn the Vivid 7 unit OFF. 2.) Plug the unit into the meter, and the meter into the tested AC wall outlet. 3.) Plug the black chassis cable in to the meters “CHASSIS” connecto r and attach the black chassis cable clamp to an exposed metal part of the Vivid 7 unit. 4.) Set the meters “FUNCTION” swit ch to the RESISTANCE position. 5.) Set the meters “POLARITY” swit ch to the OFF (center) position. 6.) Measure and record the ground wire resistance.
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL 10 - 16 Section 10-6 - Using a Phantom 10-7-5 Chassis Leakage Current Test 10-7-5-1 Definition This test measures the current t hat would flow in a grounded person who touched accessible metal parts of the bedside station if the ground wire shoul d break. The test verifies the isolation of the power line from the chassis. The meter is connected from accessible metal parts of the case to ground. Measurements should be made wi th the unit On and Off, with the power line polarity Normal and Reversed. Record the highest reading. 10-7-5-2 Generic Procedure The test verifies the isolation of the power line from the chassis. The testing meter is connected from accessible metal parts of the case to ground. Meas urements should be made with the unit ON and OFF, with the power line polarity Normal and Reversed. Record the highest reading of current. When using the Microguard or a similar test instru ment, its power plug may be inserted into the wall outlet and the equipment under test is plugged into t he receptacle on the panel of the meter. This places the meter in the grounding conductor and the cu rrent flowing from the case to ground will be indicated in any of the current ranges. The maximum allowable limit for chassis source leakage is shown in Table 10-12 Chassis Leakage Current Limits—Acc essible Metal Surfaces on page 10-13. 7.) Follow the test conditio ns described for respective test points shown in Table 10-15 Chassis Leakage Current Test Condition on page 10-17 . CAUTIONElectric Shock Hazard. When the meters ground switch is OPEN, dont touch the unit! CAUTIONEquipment damage possibility. Never switch the Polarity and the status of Neutral when the unit is powered ON. Be sure to turn the unit power OFF before switching them using the POLARITY switch and/or the NEUTRAL switch. Otherwise, the unit may be damaged. Figure 10-3 Set Up for Chassis Source Leakage Current, IEC 601-1 Clause 19 - Continuos Leakage Currents and Patient, Auxiliary Currents
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL Chapter 10 - Care & Maintenance 10 - 17 10-7-5-2 Generic Procedure (cont’d) . 8.) Keep a record of the results with other hard copies of PM data kept on site. 10-7-5-3 Data Sheet for Chassis Source Leakage Current The test passes when all readings measure less than the value shown in Table 10-12. Record all data on the PM Inspection Certificate. 10-7-6Isolated Patient Lead (Source) Leakage–Lead to Ground 10-7-6-1 Definition This test measures the current which would flow to ground from any of the isolated ECG leads. The meter simulates a patient who is connected to the monitoring equipment and is grounded by touching some other grounded surface. Measurements should be made with the ground open and closed, with power line polarity normal and reversed, and wit h the ultrasound console Off and On. For each combination the operating controls, such as the lead switch, should be operated to find the worst case condition. Table 10-15 Chassis Leakage Current Test Condition TESTCONDITION 1 Mounting screw for probe receptacle 2 Wheel support 3 Mounting screw for CRT housing 4Mounting screw for peripheral plugged into unit 5Mounting screw for other peripheral powered by unit Table 10-16 Typical Data Sheet for Chassis Source Leakage Current Unit Power Tester Polarity Switch Tester Neutral or Ground SwitchTest 1 Probe Connector Test 2 WheelTest 3 CRTOptional Test 4 Optional Test 5 Enter Name of tested peripheral here: ON NORM OPEN ON NORM CLOSED ONREVOPEN ONREVCLOSED OFFNORMOPEN OFF NORM CLOSED OFF REV OPEN OFF REV CLOSED CAUTIONEquipment damage possibility. Never switch the Polarity when the unit is powered ON. Be sure to turn the unit power OFF before switching the polarity using the POLARITY switch. Otherwise, the unit may be damaged.
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL 10 - 18 Section 10-6 - Using a Phantom 10-7-6-2 Generic Procedure Measurements should be made with the ground open and closed, with power line polarity normal and reversed, and with the unit Off and On. For each combination, the operating controls such as the lead switch should be operated to find the worst case condition. 10-7-7 Isolated Patient Lead (Source) Leakage–Lead to Lead Reference the procedure in the IEC 60601-1. When using the Dale 600, switch the meter’s function selector to the LEAD-LEAD position. Select and test each of the five ECG lead positions (except ALL) on the LEAD selector, testing each to the power cond ition combinations found in the table. Record the highest leakage current measured. Figure 10-4 Test Circuit for Measuring Non-Isolated Patient Leads Table 10-17 Testing Power Conditions ECG PowerMeter’s Polarity SwitchMeter’s Neutral Switch ON NORM CLOSED ON NORM OPEN ON REVERSE CLOSED ONREVERSEOPEN OFFNORMCLOSED OFFNORMOPEN OFF REVERSE CLOSED OFF REVERSE OPEN POWER OUTLET H (Black) N (White) G (Green)Internal circuitry Insulating surface Polarity reversing switch (use both positions) Appliance power switch (use both off and on positions) Patient connected leads The connection is at service entrance or on the supply side of a separately derived system Building ground Grounding contact switch (use in both open and closed positions) Current meter H = Hot N = Neutral (grounded) G = Grounding conductor H N G Patient lead selector switch (if any) (activated as required) Appliance Between each patient lead and ground
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL Chapter 10 - Care & Maintenance 10 - 19 10-7-8 Isolated Patient Lead (S ink) Leakage-Isolation Test Reference the procedure in the IEC 60601-1. When using the Dale 600, switch the meter’s function selector to the LEAD-ISO. Select the ALL position on the lead selector. Depress the rocker switch to ISO TEST to test lead isolation. NOTE: It is not necessary to test each lead individua lly or power condition combinations as required in previous tests. CAUTIONLine voltage is applied to the ECG leads duri ng this test. To avoid possible electric shock hazard, the system being tested must not be touched by patients, users or anyone while the ISO TEST switch is depressed.
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL 10 - 20 Section 10-6 - Using a Phantom 10-7-8-1 Data Sheet for ECG Leakage Current The test passes when all readings measure less than the value shown in the table below. Record all data on the PM Inspection Certificate. Table 10-18 Maximum Allowance Limit for ECG Leakage Current AC Power Source Maximum Allowance Limit GROUND OPEN GROUND CLOSED Patient Lead to Ground Leakage Current Test and Patient Lead to Lead Leakage Current Test 115V 10uA 10uA 220/240V 500uA 10uA Table 10-19 Maximum Allowance Limit for ECG Leakage Current AC Power SourceMaximum Allowance Limit Patient Lead Isolation Current Test 115V 20uA 220/240V 5mA Table 10-20 Typical Data Sheet for ECG Leakage Current ECG Power Tester Polarity SwitchTester Ground SwitchTester Lead Selector RLRALALLC ON NORM CLOSED ON REVERSE CLOSED ON NORM OPEN ONREVERSEOPEN OFFNORMCLOSED OFFREVERSECLOSED OFF NORM OPEN OFF REVERSE OPEN
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL Chapter 10 - Care & Maintenance 10 - 21 10-7-9 Probe Leakage Current Test 10-7-9-1 Definition This test measures the current that would flow to ground from any of the probes through a patient who is being scanned and becomes grounded by touching some other grounded surface. 10-7-9-2 Generic Procedure Measurements should be made with the ground open and closed, with power line polarity normal and reversed, and with the unit Off and On. For each combin ation, the probe must be active to find the worst case condition. NOTE: Each probe will have some amount of leakage current, dependent on its design. Small variations in probe leakage curren ts are normal from probe to probe. Other variations will result from differences in line voltage and test lead placement. Figure 10-5 Set Up for Probe Leakage Current POWER OUTLETH (BLACK) POLARITY REVERSING SWITCH MOMENTARY SWITCH N (WHITE) G (GREEN)LEAKAGE TEST METER CONSOLE PROBE
GE HEALTHCARE DIRECTION FC091194, REVISION 11 VIVID 7 SERVICE MANUAL 10 - 22 Section 10-6 - Using a Phantom 10-7-9-3 No Meter Probe Adapter Procedure Follow these steps to test each transducer for leakage current. 1.) Turn the Vivid 7 unit OFF. 2.) Plug the unit into the test meter, and the meter into the tested AC wall outlet. 3.) Plug the external probe into the meters “EXTERNAL” connector. 4.) Set the meters “FUNCTION” switch to EXTERNAL position. 5.) Connect the probe for test with the connector of the console. 6.) Add the saline probe and the imaging area of the probe into the saline bath. 7.) Have unit power ON for the first par t; turn it OFF for the second half. 8.) Depress the ISO TEST rocker switch and record the highest current reading. 9.) Follow the test co nditions described in Table 10-21 Typical Data Sheet For Transducer Source Leakage Current on page 10-23 for every transducer. 10.) Keep a record of the results with other hand copies of PM data. Figure 10-6 No Meter Probe Adapter Procedure