GE Cardiocap 5 Service Manual
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Functional Check Form NeuroMuscular Transmission (NMT) test OK N.A. Fail 29. Recognition 30. Communication and memory 31. ElectroSensor recognition 32. Stimulus current test 33. TOF measurement with NMT simulator T1% 950-1059 Supramax. current < 70 mA T2% 950-1059 TOF% 95-105 T3% 950-1059 Count 4 T4% 950-1059 T1% 95-105 Ratio% 950-1059 Noise < 50 34. Stimulus pulse width 100 µs 300 µs Allowed range TOF% 95-105 Count 4 T1% 95-105 OK N.A. Fail 35. No response to stimulus 36. DBS measurement with NMT simulator T1% 950-1059 DBS% 95-105 T2% 950-1059 Count 2 Ratio% 950-1059 T1% 95-105 37. ST measurement with NMT simulator T1% 950-1059 Count 1 T1% 95-105 OK N.A. Fail 38. Automatic measurement off 39. MechanoSensor recognition Appendix A 3
Functional Check Form Performance Checks General OK N.A. Fail 1. Screen setup 2. Waveforms InvBP measurement 3. Test with patient simulator SpO2 measurement 4. SpO2 sensor detection 5. Test measurement 6. “Probe off” detection NIBP measurement 7. Test measurement and cuff identification Gas measurement 8. D-fend check 9. CO2 waveform Notes Signature Date Appendix A 4
EMC Guidance EMC GUIDANCE Table 1. Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Cardiocap/5 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardiocap/5 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The Cardiocap/5 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class A Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies The Cardiocap/5 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Appendix B 1
Functional Check Form Table 2. Guidance and manufacturer’s declaration – electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Cardiocap/5 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardiocap/5 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transients/bursts IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines(1 ±1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode ±1 kV differential mode ±2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11 95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles 95 % dip in UT) for 5 sec 95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles 95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If user of the Cardiocap/5 requires continued operation during power mains interruptions, it is recommended that the Cardiocap/5 be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. (1 ±1 kV for ECG and RESP measurement and K-CREMCO. Appendix B 2
EMC Guidance Table 3. Guidance and manufacturer’s declaration – electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Cardiocap/5 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardiocap/5 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Cardiocap/5, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms d = 1.2 P 3 Vrms 150 kHz to 80 MHz 1 Vrms (2 d = 3.5 P Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Cardiocap/5 is used exceeds the applicable RF compliance level above, the Cardiocap/5 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Cardiocap/5. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. (2 For N-XOSAT SpO2 measurement. Appendix B 3
Functional Check Form Table 4. Recommended separation distances between portable and mobile RF communications equipment and the Cardiocap/5. Recommended separation distances between portable and mobile RF communications equipment and the Cardiocap/5. The Cardiocap/5 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Cardiocap/5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Cardiocap/5 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz d = 1.2 P d = 3.5 P (2 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5 GHz d = 2.3 P 0.01 0.12 0.35 (2 0.12 0.23 0.1 0.38 1.1 (2 0.38 0.73 1 1.2 3.5 (2 1.2 2.3 10 3.8 11 (2 3.8 7.3 100 12 35 (2 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (2 For N-XOSAT SpO2 measurement. Appendix B 4
Contents Chapter 3. Planned Maintenance 3.1 Introduction ........................................................................\ . 3-1 3.1.1 Using the Planned Maintenance Form .......................................................... 3-1 3.1.2 Recommended parts........................................................................\ ........... 3-1 3.1.3 Recommended tools and accessories .......................................................... 3-2 3.2 Planned maintenance checks................................................ 3-3 1. Visual inspection ........................................................................\ .......... 3-3 2. Parts replacement ........................................................................\ ........ 3-3 3. Functional inspection ........................................................................\ ... 3-4 4. ECG measurement test ........................................................................\ . 3-5 5. Temperature measurement test ............................................................. 3-5 6. Non-invasive blood pressure (NIBP) measurement test............................ 3-6 7. SpO2 measurement test ........................................................................\ 3-6 8. Invasive blood pressure measurement test ............................................. 3-7 9. Gas measurement test........................................................................\ .. 3-7 10. Anesthetic agent identification test ........................................................ 3-7 11. Spirometry test........................................................................\ ............. 3-8 12. Gas sampling line and D-fend check ...................................................... 3-8 13. Trend test ........................................................................\ .................... 3-8 14. Watchdog test........................................................................\ .............. 3-8 15. Recorder test ........................................................................\ ............... 3-8 16. Network test........................................................................\ ................. 3-9 17. Data card test ........................................................................\ ............ 3-10 18. Service log check ........................................................................\ ....... 3-10 19. Electrical safety check ........................................................................\ 3-10 Planned Maintenance Form ..........................................End of this chapter Table of Figures Figure 3-1. Nafion tube and fi lters to replace in gas unit .................................................... 3-3
Planned Maintenance 3. PLANNED MAINTENANCE 3.1 Introduction These instructions include procedures for planned maintenance (PM) of the Datex-Ohmeda Cardiocap/5 monitor. Performance of planned maintenance procedures is recommended once each year after installation of the monitor. These instructions are for the maximum functional configuration of the monitor. Perform the procedures in order and skip items that do not correspond with the configuration of your monitor. Complete instructions on how to perform complex procedures are included in the Service Procedures chapter later in this manual. 3.1.1 Using the Planned Maintenance Form A Planned Maintenance Form is included at the end of this chapter. Complete this “checklist” as you perform the maintenance procedures. NOTE: means to sign the form after performing the procedure. 3.1.2 Recommended parts Part Order Number Nafion™ tube 733382 Filter (2 pieces) 886136 OM reference filter 86901 Zero absorber 895933 D-fend O-ring (2 pieces) 65312 D-fend (black) 876446 D-fend+ (green) 881319 Sampling line 3.0 m 73319 Fan filter 896113 Recorder paper (if N-XREC option is installed) 74205 Planned Maintenance Kit, Anesthesia 8001760 Planned Maintenance Kit, Critical Care 8001761 NOTE: The contents of the Planned Maintenance Kits are listed in the Spare Parts chapter. 3-1
Cardiocap/5 Technical Reference Manual 3.1.3 Recommended tools and accessories Tool Order Number Patient simulator for ECG, Impedance Respiration, and BP Obtain locally Pressure manometer Obtain locally Temperature test set 884515 5-lead ECG cable Obtain locally SpO2 finger sensor (compatible with the installed pulse oximetry) Obtain locally InvBP transducer Obtain locally Adult NIBP cuff 572435 Adult NIBP hose 877235 Infant NIBP cuff 877407 Infant NIBP hose 877514 Flowmeter Obtain locally Flow cassette 50/1.1 873812 Extra silicon tubing Obtain locally Calibration gas (CO2, N2O, O2, Des) North America (must use with regulator 75553-01) 755571 Outside North America (must use with regulator 755533) 755583 Sampling line 3.0 m 73319 Spirometry tester 884202 Spirometry tube 884101 D-lite 733950 Screwdriver, pozidrive type Obtain locally Hexagon wrench, M3 Obtain locally Troubleshooting extension cable 884298 3-2