Technical Update TAA.TU.11093 Rev. 1

http://www.gambro.com/en/usa_tech/ 800-525-2623 303-222-6500 Technical Update TAA.TU.11093 Rev. 1 Effective: 05 APR 2013 CO# 13084 Product: Subject: From: Phoenix Dialysis System Required Electrical Safety Inspections: VI, PET, ELT, PLT Gary Willis Abstract: This update provides a detailed description of and frequency for, the Electrical Safety Inspections (ESI) that the manufacturer requires to be performed on the Phoenix Dialysis System. The ESI procedures include the Visual Inspection (VI), the Protective Earth Test (PET), the Earth Leakage Test (ELT), and the Patient Leakage Test (PLT). NOTE: TO AVOID ELECTRICAL SHOCK HAZARD, ALL ESI TESTING MUST BE PERFORMED BY A TRAINED AND QUALIFIED TECHNICIAN USING PROPER ELECTROSTATIC SAFETY DEVICES (i.e. wrist grounding strap). NOTE: Please read and understand this entire document before performing the ESI procedures. ELECTRICAL SAFETY INSPECTION TEST DESCRIPTIONS 1. VI Visual Inspection detects potential faults or conditions that could be related to the electrical safety of the machine. 2. PET Protective Earth Test verifies that three grounded parts of the machine have a safe low resistance electrical path to earth ground in case of insulation failure. 3. ELT Earth Leakage Test verifies, with four test conditions, that the AC leakage current in the ground wire of the main power cord of the Phoenix machine is within safe limits, using normal and reverse AC polarity, and with neutral closed (Normal Condition - NC) and open (Single Fault Condition SFC). 4. PLT Patient Leakage Test verifies, with eight test conditions, that the AC and DC leakage current in the hydraulic fluid path of the Phoenix machine is within safe limits, using normal and reverse AC polarity, and with earth ground intact (Normal Condition - NC) and open (Single Fault Condition SFC). ELECTRICAL SAFETY INSPECTION TEST STANDARDS 1. The ESI tests described in this update are in accordance with the following standards: 1.1. IEC 60601-1: Medical Electrical Equipment - Part 1: General requirements for safety. 1.2. IEC 62353: Medical Electrical Equipment - Recurrent test and test after repair of medical electrical equipment. 2. Recognizing their enhanced patient safety features, Gambro has adopted these international standards, as have other biomedical equipment manufacturers worldwide. All ESI testing performed by Gambro Technical Services (GTS) employees on any Gambro equipment will be conducted in accordance with these standards. Page 1 of 11

ELECTRICAL SAFETY INSPECTION TEST FREQUENCY ESI testing should be performed: 1. After first installation. (VI, PET, ELT, PLT) 2. After repair / replacement of components that are connected to ground. * 3. After repair / replacement of components with a direct or indirect electrical contact with the dialysis fluid. * 4. After repair / replacement of components connected to AC power parts. * 5. After a component has been replaced that has been identified in its Instructions Sheet as requiring an ESI test following installation. * 6. After unexpected electrical events affecting the AC line voltage. 7. After accidental leakage of fluid onto internal components from external or internal sources. 8. After transportation (other than what is normal within the clinical environment). 9. During a Preventive Maintenance (PM). (VI, PET, ELT, PLT) 10. After an ESI test fails, and subsequent machine repairs are made, then the failed ESI test must be performed again to verify the success of the repair. * Due to the nature of the part that is replaced, ESI testing may include: 1. VI and PET 2. VI and PLT 3. VI, PET, ELT, and PLT Refer to the instruction sheet provided with the spare part for the ESI testing requirements, or contact Gambro Technical Assistance Services (TAS) at 800-525-2623 for further information. EQUIPMENT REQUIRED 1. Fluke ESA612 Electrical Safety Analyzer (ESA) and accessories Gambro Technical Services has standardized the ESI testing procedures described below around this analyzer. ESA devices from other manufacturers may be used, as long as they are able to meet the test requirements of the IEC standards described above. 2. 515037000 Patient Leakage Test (PLT) Fixture 3. 6041370 Hexagon Wrench 4. 6960942 P2 Pump Calibration Tool 5. 515019000 A/V Test Cartridge 6. Condo/Temp Calibration Tool (included in 6041610 Calibration Tool Kit) 7. Graduated Cylinder 8. Approx. 10 length of blood cartridge tubing filled with water ELECTRICAL SAFETY INSPECTION TEST PROCEDURES 1. VISUAL INSPECTION (VI) The VI procedure involves verifying and correcting any hardware condition of the Phoenix machine that does not conform to specifications in the following areas: 1.1. Verify exterior parts, panels, and covers for damage, cracks, etc. 1.2. Verify placement and condition of safety related markings and labeling. 1.3. Verify integrity of mechanical parts (damage, obstructions, misalignments, contamination, etc.). 1.4. Verify electrical components and cabling (cuts, incorrect or loose connections and fuses, etc.). Page 2 of 11

2. PROTECTIVE EARTH TEST (PET) 2.1. NOTE: The PET procedure is performed with the PHOENIX MACHINE POWERED OFF and DISCONNECTED FROM MAIN AC POWER. 2.2. Turn on the ESA612 main power switch. 2.3. The ESA612 will display the message: Select a test or SETUP 2.4. Press the SETUP key. 2.5. Press the More (F4) key. 2.6. Press the Instrument (F2) key. 2.7. The Standard (F1) on the display should indicate 60601. (If not, press the Standard [F1] key and scroll to 60601 using the and arrow keys and then press the Standard [F1] key again.) 2.8. The GFCI Limit should indicate 10 ma. (If not, press the GFCI Limit [F2] key and scroll to 10 ma and press the GFCI Limit [F2] key again.) 2.9. The Polarity Delay should indicate 5 s. (If not, press the Polarity Delay [F3] key and scroll to 5 s and press the Polarity Delay [F3] key again.) 2.10. The ESA612 display should appear as shown in FIGURE 1. FIGURE 1 2.11. Press the Done (F4) key. 2.12. Connect the Phoenix AC power cord into the Equipment Outlet on the right side of the ESA612. 2.13. Connect one end of the red test lead to the red V/Ω/A jack of the ESA612 and the other end to the red alligator clip. 2.14. Insert the 3 cm long silver Null Post Adapter into the green Ø / NULL jack of the ESA612. 2.15. Connect the red alligator clip to the Null Post Adapter. See FIGURE 2. 2.16. Press the Ω key and press the Zero Leads (F4) key to zero out the resistance of the test lead. 2.17. Remove the red alligator clip from the adapter post and remove and store the Null Post Adapter. 2.18. NOTE: To avoid electrical shock, remove the Null Post Adapter from the Ø / NULL jack after zeroing the test lead. The adapter is grounded and could become potentially hazardous during some of the later ESI test conditions. Page 3 of 11

2.19. PET Test Point #1 (Left Door Hinge ) 2.19.1. Remove the top cover and open the Phoenix machine using the Hexagonal Wrench or equivalent. 2.19.2. Connect the red alligator clip to the ground connections near the left door hinge of the Phoenix machine, as shown in FIGURE 3. 2.19.3. NOTE: During the measurement, the power cord shall be flexed along its length in order to detect possible variations of resistance due to deterioration. 2.19.4. Verify that the indicated resistance is < 0.279 Ω (or < 0.181 Ω if during installation or if the power cord has just been replaced). If not, find and correct the problem before 2.19.5. NOTE: All requirements for maximum measured values indicated in these ESI procedures have been reduced to allow for the operating characteristics of the EAS612. 2.19.6. NOTE: The test lead connection to the door hinge is subject to the contact resistance of the alligator clip. Wiggle the alligator clip on the hinge to obtain the lowest resistance indication on the ESA612 display. Use this same technique on the other two test locations to minimize the contact resistance. 2.19.7. RECORD the maximum observed resistance for the Left Door Hinge. 2.19.8. Remove the red alligator clip from the hinge. FIGURE 2 FIGURE 3 2.20. PET Test Point #2 (Bracket Ethernet Board) 2.20.1. Connect the red alligator clip to the Bracket of the Ethernet Board of the Phoenix machine, as shown in FIGURE 4A. If the Ethernet Board and bracket are not installed, connect the red alligator clip to the External Interface Plate grounding stud, as shown in FIGURE 4B. 2.20.2. Verify that the indicated resistance is < 0.279 Ω (or < 0.181 Ω if during installation or if the power cord has just been replaced). If not, find and correct the problem before 2.20.3. RECORD the maximum observed resistance for the Bracket Ethernet Board. 2.20.4. Remove the red alligator clip from the test point. Page 4 of 11

FIGURE 4A FIGURE 4B FIGURE 5 2.21. PET Test Point #3 (Hydraulic Metal Rack) 2.21.1. Connect the red alligator clip to the hydraulic metal rack of the Phoenix machine, as shown in FIGURE 5. 2.21.2. Verify that the indicated resistance is < 0.279 Ω (or < 0.181 Ω if during installation or if the power cord has just been replaced). If not, find and correct the problem before 2.21.3. RECORD the maximum observed resistance for the Hydraulic Metal Rack. 2.21.4. Remove the red alligator clip from the metal rack. 2.21.5. Remove the red test lead from the V/Ω/A jack of the ESA612. 2.21.6. Remove the Phoenix power cord from the Equipment Outlet of the ESA612. 3. EARTH LEAKAGE TEST (ELT) 3.1. NOTE: Do not attempt the ELT unless the above PET has been completed successfully. 3.2. Install the BJ2ECG Input Jack Adapter accessory on the top of the ESA612, as shown in FIGURE 6. FIGURE 6 FIGURE 7 3.3. Install a red alligator clip at one end of a red test lead and a black alligator clip at the other end of the lead. Page 5 of 11

3.4. Connect the black alligator clip to the RL terminal of the Input Jack Adapter mounted on the ESA612, as shown in Figure 6. 3.5. Gather the supplies needed to setup the Phoenix for a simulated patient treatment. 3.6. Plug the Phoenix machine into the wall receptacle, turn it ON, and put the machine into a simulated treatment, with blood detection, and increase the Blood Pump speed until it reaches maximum. 3.7. NOTE: During ESI testing, the simulated patient treatment should utilize mid-range dialysate conductivities and temperature. Suggested values are: Acid = 15 ms/cm, Bicarb = 3.2 ms/cm and Temperature = 37 ºC. The leakage test results are not overly sensitive to conductivity variations, as long as, the conductivity is in the normal range for patient treatments. 3.8. Attach the PLT Test Fixture in-line with the blue dialyzer line and the blue connector of the P2 Pump Test Tool using the Condo/Temp Test Tool. Connect the red alligator clip from the ESA612 to the metal terminal of the PLT Fixture. See FIGURE 7. 3.9. NOTE: The PLT Fixture will not be used during the ELT procedures, but should be connected now to facilitate the PLT procedures later. The presence of the connection between the ESA612 and the PLT Fixture will not alter the ELT results since the ESA612 is configured internally based upon the selected test. 3.10. The general configuration of equipment when beginning the ELT (and PLT) measurements is represented in the diagram in FIGURE 8. 3.11. NOTE: The AC power cable connection between the Phoenix machine and the ESA612, indicated in FIGURE 8, will be accomplished later in this procedure. 3.12. NOTE: During ELT and PLT measurements, insure that the drain tube is not connected to an earth grounded drain system, which might affect leakage current readings. If unsure, allow the Phoenix machine to drain into an insulated container (plastic bucket, etc.) while taking measurements. 3.13. ELT Test Condition #1 (AC, Normal Polarity, Closed Neutral) 3.13.1. Press the μa key on the ESA612. 3.13.2. Press the Earth (F1) key. 3.13.3. Press the or arrow keys until the ESA612 display indicates AC only. 3.13.4. There will be no AC power applied to the ESA612 Equipment Outlet since the ESA612 display indicates OFF for POLARITY on the right side of the display. 3.13.5. Press the POLARITY key and the ESA612 display should indicate NORMAL POLARITY and CLOSED NEUTRAL. The EARTH key will have no options displayed. Power will be applied to the ESA612 receptacle at this time. 3.13.6. When the Phoenix is in full dialysis mode, unplug the Phoenix from the wall and plug it into the ESA612 Equipment Outlet. Page 6 of 11

FIGURE 8 3.13.7. NOTE: ALTERNATELY, the Phoenix setup can be accomplished after plugging the machine into the ESA612 that has been configured as in steps 13.13.1 to 3.13.5. 3.13.8. A Phoenix power failure alarm should be displayed (unless equipped with a second 12V Backup Battery). Press the Override key to clear it, and any other alarm caused by the power interruption. When the treatment has resumed proceed to the next step. 3.13.9. NOTE: All ELT / PLT leakage measurements must be made when the Phoenix machine is in hydraulic Phase 19. Failure to observe this condition could result in leakage currents that are lower than the correct values. 3.13.10. Verify that the Phoenix machine is in hydraulic Phase 19. Verify that the displayed current on the ESA612 is < 296 μa. If not, find and correct the problem before 3.13.11. NOTE: All requirements for maximum measured values indicated in these ESI procedures have been reduced to allow for the operating characteristics of the EAS612. 3.13.12. NOTE: During each of the four ELT test conditions, note the maximum leakage current observed. Record only one leakage current value when all four ELT tests are complete, which is the maximum value measured during any of the four ELT Test Conditions. 3.14. ELT Test Condition #2 (AC, Reverse Polarity, Closed Neutral) 3.14.1. Press the POLARITY key and the ESA612 display should indicate OFF POLARITY. The NEUTRAL and EARTH keys will have no options displayed. The Phoenix machine will shut down, since power to the machine has been removed. 3.14.2. Wait a minimum of 5 seconds before proceeding. 3.14.3. Press the POLARITY key again and the ESA612 display should indicate REVERSE POLARITY and CLOSED NEUTRAL. The EARTH key will have no option displayed. Page 7 of 11

3.14.4. Power should now be applied to the Phoenix machine. 3.14.5. Resume the simulated patient treatment and clear any alarms until the Phoenix machine is again in hydraulic Phase 19. 3.14.6. Verify that the indicated current is < 296 μa. If not, find and correct the problem before 3.15. ELT Test Condition #3 (AC, Reverse Polarity, Open Neutral) 3.15.1. Press the NEUTRAL key and the EAS612 display should indicate REVERSE POLARITY and OPEN NEUTRAL. The EARTH key will have no options displayed. 3.15.2. The Phoenix machine will shut down, since power to the machine has been removed. 3.15.3. Verify that the indicated current is < 296 μa. If not, find and correct the problem before 3.16. ELT Test Condition #4 (AC, Normal Polarity, Open Neutral) 3.16.1. Press the POLARITY key and the ESA612 display should indicate OFF POLARITY. The NEUTRAL and the EARTH keys will have no options displayed. 3.16.2. Wait a minimum of 5 seconds. 3.16.3. Press the POLARITY key again and the EAS612 display should indicate NORMAL POLARITY and OPEN NEUTRAL. The EARTH key will have no options displayed. 3.16.4. The Phoenix machine will remain shut down, since power has not yet been restored. 3.16.5. Verify that the indicated current is < 296 μa. If not, find and correct the problem before 3.16.6. NOTE: RECORD only one current value for the ELT, which is the maximum value measured at any of the ELT Test Conditions #1 through #4 in the field marked for ELT 115V: NC; SFC. 3.16.7. Press the NEUTRAL key and the EAS612 display should indicate NORMAL POLARITY and CLOSED NEUTRAL. The EARTH key will have no options displayed. 3.16.8. Power should now be applied to the Phoenix machine. Resume the simulated patient treatment and clear any alarms until the machine is again in hydraulic Phase 19. 4. PATIENT LEAKAGE TEST (PLT) 4.1. NOTE: Do not attempt the PLT unless the VI has been completed successfully. 4.2. NOTE: If the PET and ELT are required, they must be completed successfully before proceeding with the PLT. 4.3. Configure the ESA612 and setup the Phoenix machine as indicated in steps 3.2 through 3.12 above. (Skip this step if you have just completed the ELT procedure.) 4.4. NOTE: Ensure that all the air is removed from the fluid path of the PLT Fixture by holding the fixture so the blue dialysate connector from the Phoenix is at the bottom allowing dialysate to flow up through the fixture and remove any trapped air. Air remaining in the fixture will cause inaccurate leakage current measurements. 4.5. Turn the ESA612 ON and press the μa key. 4.6. Press the More (F4) key. 4.7. Press the Select (F1) key. 4.8. Verify the EAS612 display indicates AC only. Use the or keys if necessary to change. 4.9. Press the POLARITY key and the ESA612 display should indicate: AC only, NORMAL POLARITY, CLOSED NEUTRAL, CLOSED EARTH. 4.10. When the Phoenix is in full dialysis mode, unplug the Phoenix from the wall and plug it into the ESA612 Equipment Outlet. 4.11. A Phoenix power failure alarm should be displayed (unless equipped with a second 12V Backup Battery). Press the Override key to clear it, and any other alarm caused by the power interruption. When the treatment has resumed proceed to the next step. Page 8 of 11

4.12. NOTE: All ELT / PLT leakage measurements must be made when the Phoenix machine is in hydraulic Phase 19. Failure to observe this condition could result in leakage currents that are lower than the correct values. 4.13. The PLT procedure will test for leakage current in the dialysate under eight test conditions. 4.14. PLT Test Condition #1 (AC, Normal Polarity, Closed Neutral, Closed Earth) 4.14.1. Before beginning the PLT measurements, verify the ESA612 display indicates: AC only, NORMAL POLARITY, CLOSED NEUTRAL, CLOSED EARTH. See FIGURE 9. (NOTE: the measured μa value may differ from the example shown in FIGURE 9.) FIGURE 9 4.14.2. Verify the Phoenix machine is in a simulated treatment and in hydraulic Phase 19. 4.14.3. Verify that the indicated current is < 8.9 μa. If not, find and correct the problem before 4.14.4. NOTE: All requirements for maximum measured values indicated in these ESI procedures have been reduced to allow for the operating characteristics of the EAS612. 4.15. PLT Test Condition #2 (DC, Normal Polarity, Closed Neutral, Closed Earth) 4.15.1. Press the or arrow keys until the Analyzer display indicates DC only. 4.15.2. Verify that the ESA612 display indicates: DC only, NORMAL POLARITY, CLOSED NEUTRAL, CLOSED EARTH. 4.15.3. Verify the Phoenix is in hydraulic Phase 19. 4.15.4. Verify that the indicated current is < 8.9 μa. If not, find and correct the problem before 4.16. PLT Test Condition #3 (DC, Reverse Polarity, Closed Neutral, Closed Earth) 4.16.1. Press the POLARITY key and the ESA612 display should indicate OFF POLARITY and CLOSED EARTH. The NEUTRAL will have no options displayed. 4.16.2. The Phoenix machine will shut down, since power to the machine has been removed. 4.16.3. Wait a minimum of 5 seconds. 4.16.4. Press the POLARITY key again and the ESA612 display should indicate: DC only, REVERSE POLARITY, CLOSED NEUTRAL, CLOSED EARTH. 4.16.5. Power should now be applied to the Phoenix machine. Page 9 of 11

4.16.6. Resume the simulated patient treatment and clear any alarms until the machine is again in hydraulic Phase 19. 4.16.7. Verify that the indicated current is < 8.9 μa. If not, find and correct the problem before 4.17. PLT Test Condition #4 (AC, Reverse Polarity, Closed Neutral, Closed Earth) 4.17.1. Press the or arrow keys until the ESA612 display indicates AC only. 4.17.2. Verify that the ESA612 display indicates: AC only, REVERSE POLARITY, CLOSED NEUTRAL, CLOSED EARTH. 4.17.3. Verify the Phoenix machine is in hydraulic Phase 19. 4.17.4. Verify that the indicated current is < 8.9 μa. If not, find and correct the problem before 4.17.5. NOTE: RECORD the maximum value measured at either of PLT Test Conditions #1 & #4 in the field marked for the PLT NC 10 μa AC. 4.17.6. NOTE: RECORD the maximum value measured at either of PLT Test Conditions #2 & #3 in the field marked for the PLT NC 10 μa DC. 4.18. PLT Test Condition #5 (AC, Reverse Polarity, Closed Neutral, Open Earth) 4.18.1. Press the EARTH key and the ESA612 display should indicate: AC only, REVERSE POLARITY, CLOSED NEUTRAL, OPEN EARTH. 4.18.2. Verify the Phoenix machine is in hydraulic Phase 19. 4.18.3. Verify that the indicated current is < 395 μa. If not, find and correct the problem before 4.19. PLT Test Condition #6 (DC, Reverse Polarity, Closed Neutral, Open Earth) 4.19.1. Press the or arrow keys until the ESA612 display indicates DC only. 4.19.2. Verify that the ESA612 display indicates: DC only, REVERSE POLARITY, CLOSED NEUTRAL, OPEN EARTH. 4.19.3. Verify the Phoenix machine is in hydraulic Phase 19. 4.19.4. Verify that the indicated current is < 38.6 μa. If not, find and correct the problem before 4.20. PLT Test Condition #7 (DC, Normal Polarity, Closed Neutral, Open Earth) 4.20.1. Press the POLARITY key and the ESA612 display should indicate: DC only, OFF POLARITY, OPEN EARTH. The NEUTRAL key will have no options displayed. 4.20.2. The Phoenix machine will shut down, since power to the machine has been removed. 4.20.3. Wait a minimum of 5 seconds. 4.20.4. Press the POLARITY key again and the ESA612 display should indicate: DC only, NORMAL POLARITY, CLOSED NEUTRAL, OPEN EARTH. 4.20.5. Resume the simulated patient treatment and clear any alarms until the Phoenix machine is again in hydraulic Phase 19. 4.20.6. Verify that the indicated current is < 38.6 μa. If not, find and correct the problem before 4.21. PLT Test Condition #8 (AC, Normal Polarity, Closed Neutral, Open Earth) 4.21.1. Press the or arrow keys until the ESA612 display indicates AC only. 4.21.2. Verify that the ESA612 display indicates: AC only, NORMAL POLARITY, CLOSED NEUTRAL, OPEN EARTH. 4.21.3. Verify the Phoenix machine is in hydraulic Phase 19. 4.21.4. Verify that the indicated current is < 395 μa. If not, find and correct the problem before 4.21.5. NOTE: RECORD the maximum value measured at either of PLT Test Conditions #5 & #8 in the field marked for the PLT SFC 400 μa AC. Page 10 of 11

4.21.6. NOTE: RECORD the maximum value measured at either of PLT Test Conditions #6 & #7 in the field marked for the PLT SFC 40 μa DC. 5. This completes the ESI testing procedures. The simulated patient treatment may be continued for the length of time necessary to complete any other required testing or terminated at the Phoenix technician s discretion. 6. Power OFF the Phoenix machine and remove the ESI test equipment. 7. Power OFF the ESA612. 8. Remove the Phoenix machine AC power cord from the ESA612 Equipment Outlet. 9. Remove the PLT Fixture from the dialysate flow path. 10. Rinse the PLT Fixture internal flow path with RO water to flush out any remaining dialysate. NOTE: Questions regarding these ESI procedures should be directed to Gambro Technical Assistance Services (TAS) at (800) 525-2623. Page 11 of 11