SERVICE MANUAL. NPB-295 Pulse Oximeter

Transcription

1 SERVICE MANUAL NPB9 Pulse Oximeter Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician. To contact Mallinckrodt, Inc. representative: In the United States, call 00; outside the United States, call your local Mallinckrodt representative Mallinckrodt Incorporated. All rights reserved. 009C0

2 Nellcor Puritan Bennett Inc. 0 Hacienda Drive Pleasanton, CA 9 USA Telephone Toll Free.00.NELLCOR Mallinckrodt Europe BV Hambakenwetering DD shertogenbosch The Netherlands Telephone...00 Nellcor Puritan Bennett Inc. is a wholly owned subsidiary of Mallinckrodt, Inc. To obtain information about a warranty, if any, for this product, contact Mallinckrodt Technical Services or your local Mallinckrodt representative. Purchase of this instrument confers no express or implied license under any Mallinckrodt patent to use the instrument with any sensor that is not manufactured or licensed by Mallinckrodt. Nellcor Puritan Bennett, Nellcor, Durasensor, and Oxisensor II, are trademarks of Mallinckrodt Incorporated. Covered by one or more of the following U.S. Patents and foreign equivalents:,,;,,9;,00,0;,0,9;,9,;,,9;,0,;,,;,,0;,,0; and,,0.

3 TABLE OF CONTENTS List of Figures List of Tables Table Of Contents... iii List Of Figures... v List Of Tables... vi Section : Introduction.... Manual Overview.... Npb9 Pulse Oximeter Description.... Related Documents... Section : Routine Maintenance.... Cleaning.... Periodic Safety And Functional Checks.... Battery... Section : Performance Verification.... Introduction.... Equipment Needed.... Performance Tests.... Safety Tests... 9 Section : PowerOn Settings And Service Functions.... Introduction.... PowerOn Settings.... Service Functions... Section : Troubleshooting.... Introduction.... How To Use This Section.... Who Should Perform Repairs.... Replacement Level Supported.... Obtaining Replacement Parts.... Troubleshooting Guide.... Error Codes... Section : Disassembly Guide.... Introduction.... Prior To Disassembly.... Fuse Replacement.... Monitor Disassembly.... Monitor Reassembly.... Battery Replacement.... Power Entry Module (Pem) Removal/Installation.... Power Supply Removal/Installation....9 Cooling Fan Removal/Installation Display Pcb Removal/Installation Uif Pcb Removal/Installation.... Alarm Speaker Removal/Installation... Section : Spare Parts.... Introduction... Section : Packing For Shipment... iii

4 Table of Contents. General Instructions.... Repacking In Original Carton.... Repacking In A Different Carton... Section 9: Specifications General Electrical Physical Characteristics Environmental Alarms Factory Default Settings Performance... 9 Section 0: Serial Port Interface Protocol Introduction Configuring The Data Port Connecting To The Data Port RealTime Printout Trend Data Printout Nurse Call Analog Output... 0 Section : Technical Supplement.... Introduction.... Oximetry Overview.... Circuit Analysis.... Functional Overview.... Ac Input.... Power Supply Pcb Theory Of Operation.... Battery.... User Interface Pcb (Uif)....9 Front Panel Display Pcb And Controls....0 Schematic Diagrams... 9 iv

5 Table of Contents LIST OF FIGURES Figure : NPB9 Front Panel... Figure : User Softkey Map... Figure : NPB9 Rear Panel... Figure : NPB9 Controls... Figure : SelfTest Display... Figure : Adjusting %SpO Upper Alarm Limit... Figure : Adjusting % SpO Lower Alarm Limit... Figure : Adjusting High Pulse Rate Alarm... Figure : Adjusting Low Pulse Rate Alarm... Figure : Service Function Softkeys... Figure : Service Function Softkey Map... Figure : Param Softkeys... Figure : Print Softkeys... Figure : Trend Printout... Figure : Errlog Printout... Figure : Instat Printout... Figure : INFO Printout... Figure 9: Next Softkeys... Figure 0: Alarms Softkeys... Figure : Fuse Removal... Figure : NPB9 Corner Screws... Figure : Separating Case Halves... Figure : NPB9 Battery... Figure : Power Entry Module... Figure : Power Supply... Figure : Cooling Fan... 9 Figure : Display PCB... 0 Figure 9: UIF PCB... Figure 0: Alarm Speaker... Figure : NPB9 Expanded View... Figure : Repacking the NPB9... Figure 0: Data Port Softkeys... 0 Figure 0: Data Port Pin Layout... 0 Figure 0: RealTime Printout... 0 Figure 0: Trend Data Printout... 0 Figure : Oxyhemoglobin Dissociation Curve... Figure : NPB9 Functional Block Diagram... Figure : UIF PCB Front End Red/IR Schematic Diagram... Figure : Analog Front End Schematic Diagram... Figure : Front End Power Supply Schematic Diagram... Figure : SIP/SOP Interface Schematic Diagram... Figure : Data Port Drivers Schematic Diagram... 9 Figure : CPU Core Schematic Diagram A... Figure 9: CPU Memory Schematic Diagram B... Figure 0: Contrast and Sound Schematic Diagram A... Figure : UIF PCB Power Supply Schematic Diagram B... Figure : Display Interface Schematic Diagram... 9 Figure : UIF PCB Parts Locator Diagram... Figure : Power Supply Schematic Diagram... v

6 Table of Contents LIST OF TABLES Figure : Power Supply Parts Locator Diagram... Table : Dynamic Operating Range... Table : Earth Leakage Current Limits...0 Table : Enclosure Leakage Current Limits... Table : Patient Leakage Current Limits... Table : Patient Leakage Current Test Configurations Mains Voltage on the Applied Part... Table : Factory Default Settings... Table : Problem Categories... Table : Power Problems... Table : Button Problems... Table : Display/Alarms Problems... Table : Operational Performance Problems... Table : Serial Port Problems... Table : Error Codes... Table : Power Supply Leads Connections... Table : Parts List... Table 9: Default Settings...9 Table 0: Data Port Pin Outs...0 Table 0: Status Codes...0 Table 0: Nurse Call Relay Pin States...0 Table 0: Rating of Nurse Call Relay...0 vi

7 SECTION : INTRODUCTION. Manual Overview. NPB9 Pulse Oximeter Description. Related Documents. MANUAL OVERVIEW This manual contains information for servicing the Nellcor model NPB9 pulse oximeter. Only qualified service personnel should service this product. Before servicing the NPB9, read the operator s manual carefully for a thorough understanding of operation. Warning: Explosion hazard. Do not use the NPB9 pulse oximeter in the presence of flammable anesthetics.. NPB9 PULSE OXIMETER DESCRIPTION The NPB9 is a portable pulse oximeter intended for use as a continuous noninvasive monitor of arterial oxygen saturation (SpO) and pulse rate. It can be used on adult, pediatric and neonatal patients. Oxygen saturation and pulse rate are displayed digitally along with a plethysmographic waveform or a 0segment blip bar that indicates pulse intensity. This monitor is intended for use in hospital and hospitaltype facilities, during intrahospital transport, and in home environments. Through the use of the four softkeys, the operator can access trend information, select an alarm limit to be changed, choose the language to be used, adjust the internal time clock, and change communications protocol. The NPB9 can operate on AC power or on an internal battery. The controls and indicators for the NPB9 are illustrated in Figures through. 9 LIMITS TREND SETUP %SP0 BPM LIGHT NPB SpO Sensor Port. Low Battery Indicator. Power On/Off Button. AC/Battery Charging Indicator. Waveform Display. %SpO Indicator. Pulse Beats Per Minute display. Alarm Silence Indicator 9. Alarm Silence Button Figure : NPB9 Front Panel 0 0. Adjust Up Button. Adjust Down Button. Contrast Button. Softkeys. Menu Bar. Motion Indicator. Pulse Search Indicator. Speaker

8 Section : Introduction Figure illustrates the various functions that are available through the use of the softkeys, and how to access them. A complete explanation of the keys is provided in the NPB9 operator's manual. %SPO BPM LIMITS TREND SETUP LIGHT 9 LCD display backlight ON or OFF Normal Display Mode SELECT Select alarm limit to be adjusted EXIT Return to main display VIEW CLOCK NEXT EXIT PLETH BLIP EXIT COMM LANG NEXT EXIT Adjust baud rate and protocol Select Language VIEW ZOOM NEXT EXIT Select data from last /0 min. or last,,,,, or hrs. Return to main display NCALL Norm or Norm SET ANALOG 0 Volt, Volt, or Step EXIT NEXT EXIT DUAL SPO PULSE HIST Display both SpO and pulse trend data Display SpO Data Display pulse trend data SELECT EXIT VIEW NEXT EXIT Return to main display DELETE PRINT NEXT EXIT Print trends Returns to prior menu Return to main display YES Deletes all trend info NO Return to prior trend menu Figure : User Softkey Map

9 R TM Section : Introduction X T 0.0A 0V CISPR Group Class B IPX 0 NRTL/C 000 V 000 V 0/0 Hz 0VA NPB9 SN NELLCOR PURITAN BENNETT, INC. MADE IN U.S.A. PLEASANTON, CA 9, U.S.A. NELLCOR PURITAN BENNETT EUROPE BV, 'shertogenbosch, THE NETHERLANDS U.S. PATENTS:,,;,,9;,00,0;,0,9;,9,; Re.,;,9,9;,9,;,0,. RELATED DOCUMENTS. Equipotential (ground) Terminal. AC Inlet. DB Interface Connector (Data Port) Figure : NPB9 Rear Panel. Fuse Receptacle. Voltage Selection Switch To perform test and troubleshooting procedures, and to understand the principles of operation and circuit analysis sections of this manual, you must know how to operate the monitor. Refer to the NPB9 operator s manual. To understand the various Nellcor sensors that work with the monitor, refer to the individual sensor s directions for use.

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11 SECTION : ROUTINE MAINTENANCE. Cleaning. Periodic Safety and Functional Checks. Battery. CLEANING Caution: Do not immerse the NPB9 or its accessories in liquid or clean with caustic or abrasive cleaners. Do not spray or pour any liquid on the monitor or its accessories. To clean the NPB9, dampen a cloth with a commercial, nonabrasive cleaner and wipe the exterior surfaces lightly. Do not allow any liquids to come in contact with the power connector, fuse holder, or switches. Do not allow any liquids to penetrate connectors or openings in the instrument cover. Wipe sensor cables with a damp cloth. For sensors, follow each sensor's directions for use.. PERIODIC SAFETY AND FUNCTIONAL CHECKS. BATTERY The NPB9 requires no calibration. The battery should be replaced every years. See Battery Replacement on. The following checks should be performed at least every years by a qualified service technician.. Inspect the exterior of the NPB9 for damage.. Inspect safety labels for legibility. If the labels are not legible, contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative.. Verify the unit performs properly as described in paragraph... Perform the electrical safety tests detailed in paragraph.. If the unit fails these electrical safety tests, do not attempt to repair the NPB9. Contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative.. Inspect the fuses for proper value and rating (F & F = 0. amp slow blow). Mallinckrodt recommends replacing the instrument's battery every years. When the NPB9 is going to be stored for months or more, remove the battery prior to storage. To replace or remove the battery, refer to Section, Disassembly Guide. If the NPB9 has been stored for more than 0 days, charge the battery as described in paragraph... A fully discharged battery requires hours with the monitor in standby, or hours if it is in use, to receive a full charge. The battery is being charged whenever the instrument is plugged into AC.

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13 SECTION : PERFORMANCE VERIFICATION. Introduction. Equipment Needed. Performance Tests. Safety Tests. INTRODUCTION. EQUIPMENT NEEDED This section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without removing the NPB9 cover. All tests except the battery charge and battery performance tests must be performed as the last operation before the monitor is returned to the user. If the NPB9 fails to perform as specified in any test, repairs must be made to correct the problem before the monitor is returned to the user. Equipment Digital multimeter (DMM) Durasensor oxygen transducer Oxisensor II oxygen transducer Pulse oximeter tester Safety analyzer Sensor extension cable Serial interface cable Stopwatch Description Fluke Model or equivalent DS00A D SRC Must meet current AAMI ES/99 & IEC 0/99 specifications SCP0 or MC0 EIA cable (optional) Manual or electronic. PERFORMANCE TESTS The battery charge procedure should be performed before monitor repairs whenever possible. Note: This section is written using Mallinckrodt factoryset defaults. If your institution has preconfigured custom defaults, those values will be displayed. Factory defaults can be restored using the configuration mode procedure described in paragraph..... Battery Charge Perform the following procedure to fully charge the battery.. Connect the monitor to an AC power source.. Verify the monitor is off and that the AC Power/Battery Charging indicator is lit.

14 Section : Performance Verification.. Powerup Performance. Charge the battery for at least hours in standby. The powerup performance tests (... through...) verify the following monitor functions: PowerOn SelfTest PowerOn Defaults and Alarm Limit Ranges Power On/Off Alarm Silence LIMITS TREND SETUP %SP0 BPM LIGHT NPB Softkeys Contrast Adjust Down Adjust Up Figure : NPB9 Controls... PowerOn SelfTest. Connect the monitor to an AC power source and verify the AC Power/Battery Charging indicator is lit.. Do not connect any input cables to the monitor.. Observe the monitor front panel. With the monitor off, press the Power On/Off button. The monitor must perform the following sequence. a. Within seconds all LEDs are illuminated, then all pixels on the LCD display are illuminated, after which the backlight comes on. b. The indicators remain lighted. c. The LCD display shows the Nellcor Puritan Bennett logo and the software version of the NPB9 (Figure ). NPB9 Nellcor Puritan Bennett NPB9 Version..0. Figure : SelfTest Display

15 Section : Performance Verification d. A second beep sound indicating proper operation of the speaker, and all indicators turn off except the AC Power/Battery Charging indicators. e. The NPB9 begins normal operation.... PowerOn Defaults and Alarm Limit Ranges Note: Note: When observing or changing default limits, a 0second timeout is in effect. If no action is taken within 0 seconds, the monitor automatically returns to the monitoring display. The descriptions that follow are based on the assumption that Pleth is the view that has been selected. The steps to change an alarm limit are the same if the view being used is Blip.. Ensure that the monitor is on. Press and release the Limits softkey. Verify the monitor emits a single beep and the plethysmograph waveform is replaced with a display of the alarm limits. The high alarm limit for %SpO will indicate an alarm limit of 00 inside a box (Figure.). ALARM LIMITS SPO BPM UPPER 00 0 LOWER 0 SELECT %SP0 BPM EXIT NPB Figure : Adjusting %SpO Upper Alarm Limit. Press the Limits softkey. Press and hold the Down Arrow button. Verify the boxed number for %SpO upper alarm limit reduces to a minimum of. Note: A decimal point in the display indicates that the alarm limits have been changed from factory default values.. Press the SELECT softkey. Verify the monitor emits a single beep and the box moves to the %SpO lower alarm limit of. ALARM LIMITS SPO BPM UPPER 00 0 LOWER 0 SEL %SP0 BPM EXIT NPB Figure : Adjusting % SpO Lower Alarm Limit. Press and hold the Down Arrow button and verify the %SpO lower alarm limit display reduces to a minimum of 0.. Press and hold the Up Arrow button and verify the %SpO lower alarm limit display cannot be raised past the upper alarm limit setting of.. Press the Exit button.

16 Section : Performance Verification. Press the Limits softkey then press the SELECT softkey two times Verify the monitor emits a beep after each keystroke. The Pulse upper alarm limit should be 0 and should be boxed. ALARM LIMITS SPO BPM UPPER 00 0 LOWER 0 SEL %SP0 BPM EXIT NPB Figure : Adjusting High Pulse Rate Alarm. Press and hold the Down Arrow button. Verify the minimum displayed value is 0 for the Pulse upper alarm limit. 9. Press the exit button. 0. Press the Limits softkey then press the SELECT softkey three times. Verify the Pulse lower alarm limit display indicates an alarm limit of 0 and is boxed. ALARM LIMITS SPO BPM UPPER 00 0 LOWER 0 SEL %SP0 BPM EXIT NPB Figure : Adjusting Low Pulse Rate Alarm. Press and hold the Down Arrow button. Verify the boxed Pulse lower alarm limit display reduces to a minimum of 0.. Press and hold the Up Arrow button and verify the boxed Pulse lower alarm limit display cannot be adjusted above the Pulse high limit of 0.. Press the Power On/Off button to turn the monitor off.. Press the Power On/Off button to turn the NPB9 back on.. Press and release the Limits softkey. Verify the %SpO upper alarm limit display is boxed and indicates an alarm limit of 00.. Press the SELECT softkey. Verify the %SpO lower alarm limit display is boxed and indicates an alarm limit of.. Press the SELECT softkey a second time. Verify the Pulse upper alarm limit display is boxed and indicates an alarm limit of 0.. Press the SELECT softkey a third time. Verify the Pulse lower alarm limit display is boxed and indicates an alarm limit of Press the Power On/Off button to turn the monitor off.

17 Section : Performance Verification.. Hardware and Software Tests Hardware and software testing includes the following tests: Operation with a Pulse Oximeter Tester General Operation... Operation with a Pulse Oximeter Tester Operation with an SRC pulse oximeter tester includes the following tests: Alarms and Alarm Silence Alarm Volume Control Pulse Tone Volume Control Dynamic Operating Range Nurse Call Analog Output... Alarms and Alarm Silence Operation on Battery. Connect the SRC pulse oximeter tester to the sensorinput cable and connect the cable to the monitor. Set the SRC as follows: SWITCH RATE LIGHT MODULATION RCAL/MODE POSITION LOW OFF RCAL /LOCAL. Press the Power On/Off button to turn the monitor on. After the normal powerup sequence, press the following softkeys; Setup, View, and Pleth. Verify the %SpO and Pulse initially indicates zeroes.. Move the modulation switch on the SRC to LOW.. Verify the following monitor reactions: a. The plethysmograph waveform begins to track the artificial pulse signal from the SRC. b. The pulse tone is heard. c. Zeroes are displayed in the %SpO and Pulse displays. d. After about 0 to 0 seconds, the monitor displays saturation and pulse rate as specified by the tester. Verify the values are within the following tolerances: Oxygen Saturation Range = 9% to % Pulse Rate Range = to 9 bpm e. The audible alarm sounds and both the %SpO and Pulse displays flash, indicating that both parameters have violated the default alarm limits.. Press and hold the Alarm Silence button on the front of the monitor for less than seconds.

18 Section : Performance Verification... Alarm Volume Control. Verify the %SpO display indicates 0 and the Pulse display indicates SEC while the Alarm Silence button is pressed.. When the button is released the alarm is silenced.. With the alarm silenced, verify the following: a. The alarm remains silenced. b. The Audible Silence indicator lights. c. The %SpO and Pulse displays continue to flash. d. The pulse tone is still audible. e. The audible alarm returns in approximately 0 seconds. 9. While pressing the Alarm Silence button, press the Down Arrow button until the Pulse display indicates Press the Up Arrow button and verify the displays indicate 0 SEC, 90 SEC, 0 SEC, and OFF. Release the button when the display indicates OFF.. Press and release the Alarm Silence button. Verify the Alarm Silence Indicator flashes.. Wait approximately minutes. Verify the alarm does not return.. After minutes, the alarm silence reminder beeps three times, and will continue to do so at approximately minute intervals. After completing the procedure in paragraph...:. Press and hold the Alarm Silence button and verify the following: a. OFF is displayed for approximately seconds. b. After seconds: a steady tone is heard at the default alarm volume setting the %SpO display indicates VOL the Pulse display indicates the default setting of.. While still pressing the Alarm Silence button, press the Down Arrow button until an alarm volume setting of is displayed.. Verify the volume of the alarm has decreased but is still audible.. Continue pressing the Alarm Silence button and press the Up Arrow button to increase the alarm volume setting to a maximum value of 0.. Verify the volume increases. Press the Down Arrow button until a comfortable audio level is attained.. Release the Alarm Silence button. The tone stops.

19 Section : Performance Verification... Pulse Tone Volume Control... Dynamic Operating Range. Press the Up Arrow button and verify the beeping pulse tone sound level increases.. Press the Down Arrow button and verify the beeping pulse tone decreases until it is no longer audible.. Press the Up Arrow button to return the beep volume to a comfortable level. The following test sequence verifies proper monitor operation over a range of input signals.. Connect the SRC to the SCP0 or MC0, which is connected to the NPB 9, and turn the NPB9 on.. Place the SRC in the RCAL /LOCAL mode.. Set the SRC as indicated in Table. Note: An * indicates values that produce an alarm. Press the Alarm Silence button to silence the alarm. Table : Dynamic Operating Range SRC Settings NPB9 Indications RATE LIGHT MODULATION SpO Pulse Rate HIGH LOW 9 * * HIGH HIGH 9 * 09 0 LOW LOW 9 * 9 0* 0 LOW HIGH 9 * 9 0* Note: Allow the monitor several seconds to stabilize the readings.. Verify the NPB9 readings are within the indicated tolerances.... Nurse Call Note: The Nurse Call tests must be performed with the instrument operating on AC power.. Connect the negative lead of a voltmeter to pin and positive to pin of the data port on the back of the instrument (Figure A in Appendix). Ensure that the audible alarm is not silenced or turned off.. Set the SRC to create an alarm condition.. Verify an output voltage at pins and between and volts DC.. Press the Alarm Silence button. With no active audible alarm, the output voltage at pins and must be between and volts DC.. With the instrument in an alarm condition, use a DVM to verify there is no continuity between pins and and that there is continuity between pins and.

20 Section : Performance Verification... Analog Output. Adjust the alarm limits so that there is no alarm condition. Use a DVM to verify there is continuity between pins and and that there is no continuity between pins and. Note: The Analog Output tests must be performed with the instrument operating on AC power.. Connect the negative lead of a voltmeter to pin 0 and positive to pin of the data port on the back of the instrument (Figure A in Appendix).. Press the following softkeys: Setup, Next, Next, and Analog. Press the volt softkey.. Verify the output voltage is.0 ± 0.0 volts DC.. Leave the negative lead connected to pin 0 and verify.0 ± 0.0 volts DC on pins and. Note: If step takes more than minutes to complete, the analog output will time out. Repeat step to initiate the analog output.. Move the positive lead back to pin.. Press the following softkeys; Setup, Next, Next, and Analog. Press the 0volt softkey.. Verify the output voltage is 0.0 ± 0.0 volts DC.. Leave the negative lead connected to pin 0 and verify 0.0 ± 0.0 volts DC on pins and. Note:... Operation on Battery Power If step takes more than minutes to complete, the analog output will time out. Repeat step to initiate the analog output. 9. Disconnect the voltmeter from the instrument.. With the instrument operating on AC, turn on the backlight.. Disconnect the instrument from AC and verify the AC/Battery Charging indicator and the backlight turn off.. Verify the instrument continues monitoring normally and that the low battery indicator is not lit. Note:... General Operation If the low battery indicator is illuminated, perform the procedure outlined in step.... Connect the instrument to AC and verify the backlight and AC/Battery Charging indicator turn on and that the instrument is monitoring normally. The following tests are an overall performance check of the system:... LED Excitation Test... Operation with a Live Subject

21 Section : Performance Verification... LED Excitation Test This procedure uses normal system components to test circuit operation. A Nellcor Oxisensor II oxygen transducer, model D, is used to examine LED intensity control. The red LED is used to verify intensity modulation caused by the LED intensity control circuit.. Connect the monitor to an AC power source.. Connect an SCP0 or MC0 sensor input cable to the monitor.. Connect a D sensor to the sensorinput cable.. Press the Power On/Off button to turn the monitor on.. Leave the sensor open with the LEDs and photodetector visible.. After the monitor completes its normal powerup sequence, verify the sensor LED is brightly lit.. Slowly move the sensor LED in proximity to the photodetector element of the sensor. Verify as the LED approaches the optical sensor, that the LED intensity decreases.. Open the sensor and notice that the LED intensity increases. 9. Repeat step and the intensity will again decrease. This variation is an indication that the microprocessor is in proper control of LED intensity. 0. Turn the NPB9 off.... Operation with a Live Subject. SAFETY TESTS Patient monitoring involves connecting the monitor to a live subject for a qualitative test.. Ensure that the monitor is connected to an AC power source.. Connect an SCP0 or MC0 sensor input cable to the monitor.. Connect a Nellcor Durasensor oxygen transducer, model DS00A, to the sensor input cable.. Clip the DS00A to the subject as recommended in the sensor's directions for use.. Press the Power On/Off button to turn the monitor on and verify the monitor is operating.. The monitor should stabilize on the subject's physiological signal in about to 0 seconds.. Verify the oxygen saturation and pulse rate values are reasonable for the subject. NPB9 safety tests meet the standards of, and are performed in accordance with, IEC 0 (EN 00, Second Edition, 9; Amendment, 99, Amendment 9

22 Section : Performance Verification.. Ground Integrity.. Electrical Leakage, 990) and UL 0 (August, 99), for instruments classified as Class and TYPE BF and AAMI Standard ES (ANSI/AAMI ES 99). Ground Integrity Electrical Leakage This test checks the integrity of the power cord ground wire from the AC plug to the instrument chassis ground. The current used for this test is < volts RMS, 0 or 0 Hz, and A.. Connect the monitor AC mains plug to the analyzer as recommended by the analyzer operating instructions.. Connect the analyzer resistance input lead to the equipotential terminal (grounding lug) on the rear panel of the instrument.. Verify the analyzer indicates 00 milliohms or less. The following tests verify the electrical leakage of the monitor: Note:... Earth Leakage Current Earth Leakage Current Enclosure Leakage Current Patient Leakage Current Patient Source Current (Mains on Applied Part) For the following tests, ensure that the AC switch on the rear of the instrument is configured for the AC voltage being supplied. This test is in compliance with IEC 0 (earth leakage current) and AAMI Standard ES (earth risk current). The applied voltage for AAMI ES is 0 volts AC 0 Hz, for IEC 0 the voltage is volts AC, 0 to 0 Hz. All measurements shall be made with the power switch in both the On and Off positions.. Connect the monitor AC plug to the electrical safety analyzer as recommended by the analyzer operating instructions.. The equipotential terminal is not connected to ground. AC POLARITY Table : Earth Leakage Current Limits LINE CORD NEUTRAL CORD LEAKAGE CURRENT Normal Closed Closed 00 µa Reversed Closed Closed 00 µa Normal Open Closed 000 µa Normal Closed Open 000 µa 0

23 Section : Performance Verification... Enclosure Leakage Current This test is in compliance with IEC 0 (enclosure leakage current) and AAMI Standard ES (enclosure risk current). This test is for ungrounded enclosure current, measured between enclosure parts and earth. The applied voltage for AAMI/ANSI is 0 volts AC, 0 Hz, and for IEC 0 the applied voltage is volts AC, 0 to 0 Hz.. Connect the monitor AC plug to the electrical safety analyzer as recommended by the analyzer operating instructions.. Place a piece of 00 cm foil in contact with the instrument case making sure the foil is not in contact with any metal parts of the enclosure that may be grounded.. Measure the leakage current between the foil and earth. Note: The analyzer leakage indication must not exceed values listed in Table. AC LINE CORD... Patient Applied Risk Current Table : Enclosure Leakage Current Limits NEUTRAL LINE CORD POWER LINE GROUND CABLE IEC 0 AAMI/ANSI ES STANDARD Closed Closed Closed 00 µa 00 µa Closed Closed Open 00 µa 00 µa Closed Open Closed 00 µa 00 µa Open Closed Closed 00 µa 00 µa Open Open Closed 00 µa 00 µa Open Closed Open 00 µa 00 µa This test is in compliance with AAMI Standard ES (patient applied risk current), and IEC 0 (patient auxiliary current). The leakage current is measured between any individual patient connection and power (earth) ground. The applied voltage for AAMI/ANSI is 0 volts AC, 0 Hz, and for IEC 0 the applied voltage is volts AC, 0 to 0 Hz.. Configure the electrical safety analyzer as follows: Function: Patient Leakage Range: µa. Connect the monitor AC plug to the electrical safety analyzer as recommended by the analyzer operating instructions for Patient Leakage Current.. Connect the electrical safety analyzer patient leakage input lead to all pins of the monitor's patient cable at the end of the cable.. The equipotential terminal is not connected to ground.. All functional earth terminals are not connected to ground.. Measure the leakage current between the patient connector and earth.

24 Section : Performance Verification AC LINE POLARITY Table : Patient Leakage Current Limits NEUTRAL LINE POWER LINE GROUND CABLE IEC 0 AAMI/ANSI ES STANDARD Normal Closed Closed 00 µa 0 µa Normal Open Closed 00 µa 0 µa Normal Closed Open 00 µa 0 µa Reverse Closed Closed 00 µa 0 µa Reverse Open Closed 00 µa 0 µa Reverse Closed Open 00 µa 0 µa... Patient Isolation Risk Current (Mains Voltage on the Applied Part) This test is in compliance with AAMI Standard ES (patient isolation risk current [sink current]), and IEC 0 (patient leakage current). Patient Leakage Current is the measured value in a patient connection if mains voltage is connected to that patient connection. The applied voltage for AAMI/ANSI is 0 volts AC, 0 Hz, and for IEC 0 the applied voltage is volts AC, 0 to 0 Hz. Warning: AC mains voltage will be present on the patient cable terminals during this test. Exercise caution to avoid electrical shock hazard.. Configure the electrical safety analyzer as follows: Function: Patient Leakage (Mains on Applied Part) Range: µa. Connect the monitor AC plug to the electrical safety analyzer as recommended by the operating instructions for patient sink (leakage) current.. Connect the electrical safety analyzer patient leakage input lead to all connectors in the patient cable at the patient end of the cable.. The equipotential terminal is not connected to ground.. All functional earth terminals are not connected to ground.. The analyzer leakage current must not exceed the values shown in Table. AC LINE POLARITY Table : Patient Leakage Current Test Configurations Mains Voltage on the Applied Part NEUTRAL LINE POWER LINE GROUND CABLE IEC 0 AAMI/ANSI ES STANDARD Normal Closed Closed ma 0 µa Reverse Closed Closed ma 0 µa

25 SECTION : POWERON SETTINGS AND SERVICE FUNCTIONS. Introduction. Poweron Settings. Service Functions. INTRODUCTION. POWERON SETTINGS.. Factory Default Settings This section discusses how to reconfigure poweron default values, and access the service functions. The following paragraphs describe how to change poweron default settings. Through the use of softkeys shown in Figure, the user can change: alarm limits type of display baud rate time and date trends to view A decimal point is added to the right of a display when the alarm limit for that display has been changed to a value that is not a poweron default value. If the new value is saved as a power on default value, the decimal point will be removed. By using the service functions, changes can be saved as poweron default values. Some values cannot be saved as poweron default values. A SpO Low limit less than 0 will not be saved as a poweron default. Audible Alarm Off will not be accepted as a poweron default. An attempt to save either of these values as default will result in an invalid tone. Both values can be selected for the current patient, but they will be lost when the instrument is turned off. Factory poweron default settings for the NPB9 are listed in Table. Following the procedures listed in the paragraphs that follow can change these settings.

26 Section : PowerOn Settings and Service Functions. SERVICE FUNCTIONS.. Introduction Table : Factory Default Settings Parameter SpO High 00% SpO Low % Pulse Rate High Pulse Rate Low Default Value 0 bpm 0 bpm Alarm Volume Level Alarm Silence Duration Alarm Silence Restriction 0 seconds Pulse Beep Volume Level Data Port Mode Sound Reminder ASCII Baud Rate 900 Display Trend Contrast Language.. Accessing the Service Functions Nurse Call Polarity Pleth Saturation Midrange English Positive (NCALL) These functions can be used to select institutional defaults, and to access information about the patient or instrument. A Mallinckrodt Customer Service Engineer should only access some of the items available through the service functions. These functions will be noted in the text. The sensor cable must be disconnected from the instrument to access service functions. Simultaneously press the th softkey from the left and the contrast button for more than seconds. The menu bar will change to the headings listed in Figure. Note: Note: If a Sensor Disconnected prompt appears on the screen, press the Alarm Silence button and repeat the above procedure. If the above steps are performed with a sensor cable connected, only the Param and Exit softkeys appear on the screen. %SP0 PARAM PRINT NEXT EXIT NPB9 BPM Figure : Service Function Softkeys

27 Section : PowerOn Settings and Service Functions Figure can be used as a quick reference showing how to reach different softkey functions. Items reached through the Param softkey can be accessed during normal operation. Functions provided by the Print and Next softkeys cannot be accessed when a sensor cable is connected to the instrument. Each of the various functions is described in the text to follow. Param Print Next Paragraph... Paragraph... Paragraph... and... Exit Paragraph... Contrast Reset Save Exit Trend Errlog Instat Info Yes No Yes No Downld Alarms Next Exit SELECT Exit Figure : Service Function Softkey Map... Exit & Next Softkeys... Param NEXT There are not enough buttons to display all of the options that are available at some levels of the menu. Pressing the Next button allows you to view additional options available at a given menu level. EXIT To back up one menu level, press the Exit button. The service functions can be exited by repeatedly pressing the Exit button. When the Param softkey is pressed, the function of the softkeys changes as shown in figure. These options can be accessed without disconnecting the sensor cable from the instrument. %SP0 RESET SAVE EXIT NPB9 BPM Figure : Param Softkeys

28 Section : PowerOn Settings and Service Functions RESET The Reset button is used to return to the factory default settings. If Yes is pressed, the instrument sounds three tones and the settings return to factory default values. When No is pressed, there are no changes made to the settings stored in memory. SAVE When adjustable values are changed from factory default, the Save button can be used to preserve the settings as institutional poweron default values. Pressing Yes stores the current settings in memory. The instrument sounds three tones indicating that the changes have been saved as poweron default values. The new saved values will continue to be used through poweron and off cycles until they are changed and saved again, or until they are reset. If No is pressed, the changed values will not be saved. Note: An invalid tone indicates a parameter value cannot be saved as a power on default (refer to paragraph.). Along with the invalid tone, a message will be displayed indicating which parameter could not be saved as a poweron default.... Print PRINT Accessing the Print softkey makes four printouts available. Refer to the Appendix for information about how to make connections to the data port and how data is presented in a printout. The appropriate printout can be selected by pressing the corresponding softkey. Figure represents the softkey configuration after the Print softkey has been selected. Up to hours of trend data can be viewed on the printouts described below. When the instrument is turned on, trend data is recorded every seconds. As an example, an instrument that is used hours a week would take approximately weeks to fill its memory.. The hours of stored trend data is available for downloading to Score software for days. There are no limitations for displaying or printing data. Note: The twoletter codes and the symbols that occur in the printout are described in Table 0. TREND ERRLOG INSTAT %SP0 INFO NPB9 BPM Figure : Print Softkeys

29 Section : PowerOn Settings and Service Functions TREND A Trend printout will include all data recorded for up to hours of monitoring since the last Delete Trends was performed. A new trend point is recorded every seconds. Figure is an example of a Trend printout. NPB9 Version TREND SpO Limit: 000% PR Limit: 000 bpm TIME %SpO PR (bpm) PA 0Jul9 :00: Jul9 :00: Jul9 :00: Jul9 :00: Jul9 :00: 0Jul9 :00: NPB9 Version Trend SpO Limit: 000% PR Limit: 00 bpm Time %SpO PR (bpm) PA 0Jul9 :00: 0Jul9 :00: 0Jul9 :0: Jul9 :0:0 9 * 90 0Jul9 :0: 99 Output Complete Figure : Trend Printout The first two lines are the column heading lines. The first line includes information about the: type of instrument delivering the information software level, type of printout alarm parameters The second line is the headings for the columns. The first and second lines are printed out every lines, or when a change to an alarm limit is made. Patient data is represented with a date and time stamp for the data. In the example above, the means that a sensor was connected but no data was being received (patient disconnect). Patient data that is outside of an alarm limit is marked with an *. At the end of the printout Output Complete will be printed. This indicates that there was no corruption of data. If the Output Complete statement is not printed at the end of the printout, the data must be considered invalid. ERRLOG (Mallinckrodt Customer Service Engineer Only) A list of all the errors recorded in memory can be obtained by pressing the Errlog softkey. The first two lines are the column heading lines. The type of instrument producing the printout, software level, type of printout, and the time of the printout are listed in the first line. The second line of the printout is column headings. If nothing prints out, there have been no errors. An example of an Errlog printout is shown in Figure. NPB9 Version Error Log Time: 00:00:0 Op Time Error Task Addr Count 0::0 F ::0 A Output Complete Figure : Errlog Printout INSTAT (Mallinckrodt Customer Service Engineer Only)

30 Section : PowerOn Settings and Service Functions The Delete softkey, described in operator's manual, allows the user to delete the most recent trend data. The current trend data, along with the deleted trends, can be retrieved from the instrument through an Instat printout. The oldest deleted trend is Trend on the Instat printout. If a Trend already exists in memory from an earlier Delete, the next deleted trend will become Trend. Every time a Delete is performed from the User Softkeys the number of existing trends will increase by. The current trend will have the largest trend number. Figure illustrates an Instat printout. The first two lines are the column heading lines. Line one is for instrument type, software revision level, type of printout, and alarm parameter settings. The second line contains the column headings. A trend point is recorded for every seconds of instrument operation. Up to hours of instrument operation data can be recorded. The final line on the printout shows Output Complete. This indicates that data has been successfully transmitted with no corruption. If there is no Output Complete line printed, the data should be considered invalid. NPB9 Version Instrument SpO Limit: 000% PR Limit: 000 bpm TIME Trend 0 %SpO PR (bpm) PA SpO Status UIF Status Aud 0Jul9 :00:00 SD BU LB AO L 0Jul9 :00:0 PS BU LB AO 0Jul9 :00: BU LB 0Jul9 :00: BU LB NPB9 Version Instrument SpO Limit: 000% PR Limit: 00 bpm TIME Trend 0 %SpO PR (bpm) PA SpO Status UIF Status Aud 0Jul9 :: 9* * 0 PS SL PL BU LB M 0Jul9 ::9 9* * 0 PS SL PL BU LB AS M 0Jul9 ::9 0* 0* PS LP SL PL BU LB AS H NPB9 Version Instrument SpO Limit: 000% PR Limit: 00 bpm TIME Trend 0 %SpO PR (bpm) PA SpO Status UIF Status Aud Jul9 ::0 99 * 0 PH BU M Jul9 ::0 99 * 0 PH BU M Jul9 :: 99 * 0 PH BU M Jul9 :: 99 * 0 PH BU M Jul9 :: 99 * 0 PH BU M Jul9 :: 99 * 0 PH BU M Jul9 :: 99 * 0 PH BU M Output Complete Figure : Instat Printout INFO (Mallinckrodt Customer Service Engineer Only) Pressing the INFO softkey produces a printout of instrument information (Figure ). A single line will be printed. The data presented in the printout going from left to right is: instrument type (NPB9) Version is the software version level type of printout (INFO) CRC number (Cyclic Redundancy Check) time in seconds (current operating time/total operating time). NPB9 Version XXXXXX INFO CRC:XXXX SEC: 9/9 Figure : INFO Printout

31 Section : PowerOn Settings and Service Functions Next Additional options can be accessed from the main Service Functions menu by pressing the Next softkey. When Next is pressed, the softkeys change to the functions shown in Figure 9. NPB9 DOWNLD ALARMS NEXT %SP0 BPM EXIT Figure 9: Next Softkeys DOWNLD When Downld is selected, the instrument will display the revision of the Boot Code. To exit Downld, cycle power to the instrument by pressing the Power On/Off button. Consult the DFU provided with any downloads or upgrades to the FLASH firmware. ALARMS Pressing the Alarms softkey can change characteristics of the audible alarm. When the Alarms softkey is pressed, the softkey's functions change as shown in Figure 0. SEL ALARMS ALLOW OFF? OFF REMINDER? YES YES %SP0 EXIT NPB9 BPM Figure 0: Alarms Softkeys SELECT The Sel softkey is used to select what function of the audible alarm is going to be changed. A box can be cycled between two choices: Allow Off and Off Reminder. When Allow Off is selected, a choice is given between allowing an audible alarm Off or disabling the audible alarm Off. Pressing the Up or Down arrow key cycles between Yes and No. If Yes is selected, the operator has the option of selecting Audible Alarm Off. If No is selected, the operator is not given the option of selecting Audible Alarm Off as an alarm silence duration choice. If the audible alarm is set to Off, a reminder tone can be sounded every minutes to notify the user of this condition. The Up and Down arrow keys can be used to change the choice from Yes to No. Selecting Yes enables the Reminder. Selecting No disables the Reminder when the audible alarm is set to Off.

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33 SECTION : TROUBLESHOOTING. Introduction. How to Use this Section. Who Should Perform Repairs. Replacement Level Supported. Obtaining Replacement Parts. Troubleshooting Guide. Error Codes. INTRODUCTION. HOW TO USE THIS SECTION This section explains how to troubleshoot the NPB9. Tables are supplied that list possible monitor difficulties, along with probable causes, and recommended actions to correct the difficulty. Use this section in conjunction with Section, Performance Verification, and Section, Spare Parts. To remove and replace a part you suspect is defective, follow the instructions in Section, Disassembly Guide. The circuit analysis section in the Technical Supplement offers information on how the monitor functions.. WHO SHOULD PERFORM REPAIRS Only qualified service personnel should open the monitor housing, remove and replace components, or make adjustments. If your medical facility does not have qualified service personnel, contact Mallinckrodt Technical Services or your local Mallinckrodt representative.. REPLACEMENT LEVEL SUPPORTED The replacement level supported for this product is to the printed circuit board (PCB) and major subassembly level. Once you isolate a suspected PCB, follow the procedures in Section, Disassembly Guide, to replace the PCB with a known good PCB. Check to see if the trouble symptom disappears and that the monitor passes all performance tests. If the trouble symptom persists, swap back the replacement PCB with the suspected malfunctioning PCB (the original PCB that was installed when you started troubleshooting) and continue troubleshooting as directed in this section.. OBTAINING REPLACEMENT PARTS Mallinckrodt Technical Services provides technical assistance information and replacement parts. To obtain replacement parts, contact Mallinckrodt Technical Services or your local Mallinckrodt representative. Refer to parts by the part names and part numbers listed in Section, Spare Parts.

34 Section : Troubleshooting Troubleshooting guide Problems with the NPB9 are separated into the categories indicated in Table. Refer to the paragraph indicated for further troubleshooting instructions. Note: Taking the recommended actions discussed in this section will correct the majority of problems you may encounter. However, problems not covered here can be resolved by calling Mallinckrodt Technical Services or your local Mallinckrodt representative. Table : Problem Categories. Power Problem Area No powerup on AC and/or DC Fails poweron selftest Powers down without apparent cause. Buttons Monitor does not respond properly to buttons. Display/Alarms Displays do not respond properly Alarms or other tones do not sound properly or are generated without apparent cause. Operational Performance Displays appear to be operational, but monitor shows no readings Suspect readings. Data Port NPB9 serial port not functioning properly Refer to Paragraph All of the categories in Table are discussed in the following paragraphs.

35 Section : Troubleshooting.. Power Power problems are related to AC and/or DC. Table lists recommended actions to power problems. Table : Power Problems Condition. Battery Low indicator lights steadily while NPB9 is connected to AC and battery is fully charged.. The NPB9 does not operate when disconnected from AC power.. Battery Low indicator on during DC operation and an alarm is sounding.. Battery does not charge. Recommended Action. Ensure that the NPB9 is plugged into an operational AC outlet and the AC indicator is on.. Check the fuses. The fuses are located in the Power Entry Module as indicated in paragraph. and Figure of the Disassembly Guide section. Replace if necessary.. Open the monitor as described in section. Verify the power supply s output to the battery while on AC. Disconnect the battery leads from the battery and connect a DVM to them. The voltage measured should be.0 ± 0. volts DC and the current should be 00 ± 0 ma. Replace power supply if above values are not met.. Check the ribbon connection from the bottom enclosure to the UIF PCB, as instructed in paragraph. of the Disassembly Guide section. If the connection is good, replace the UIF PCB.. The battery may be discharged. To recharge the battery, refer to paragraph.., Battery Charge. The monitor may be used with a less than fully charged battery but with a corresponding decrease in operating time from that charge.. If the battery fails to hold a charge, replace the battery as indicated in Section, Disassembly Guide. There are minutes or less of usable charge left on the NPB9 battery before the instrument shuts off. At this point, if possible, cease use of the NPB9 on battery power, connect it to an AC source and allow it to recharge (approximately hours). The NPB9 may continue to be used while it is recharging. (A full recharge of the battery while the monitor is being used takes hours.). Replace battery if more than years old.. Open the monitor as described in Section. Verify the power supply s output to the battery while on AC. Disconnect the battery leads from the power supply and connect a DVM to them. The voltage measured should be. ± 0. volts DC and the current should be 00 ± 0 ma. Replace power supply if above values are not met.

36 Section : Troubleshooting.. Buttons Table lists symptoms of problems relating to nonresponsive buttons and recommended actions. If the action requires replacement of a PCB, refer to Section, Disassembly Guide. Table : Button Problems Condition. The NPB9 responds to some, but not all buttons.. The NPB9 turns on but does not respond to any of the buttons. Recommended Action. Replace Top Housing assembly.. If the buttons still do not work, replace the UIF PCB.. Replace Top Housing assembly.. If the buttons still do not work, replace the UIF PCB... Display/Alarms Table lists symptoms of problems relating to nonfunctioning displays, audible tones or alarms, and recommended actions. If the action requires replacement of a PCB or module, refer to Section, Disassembly Guide. Condition. Display values are missing or erratic.. Display pixels do not light.. Alarm sounds for no apparent reason. Table : Display/Alarms Problems Recommended Action. If the sensor is connected, replace the sensor connector assembly.. If the condition persists, replace the sensor extension cable.. If the condition still persists, replace the UIF PCB.. Check the connection between the UIF PCB and the Display PCB.. If the condition does not change, replace the Display PCB.. If the condition still persists, replace the UIF PCB.. Moisture or spilled liquids can cause an alarm to sound. Allow the monitor to dry thoroughly before using.. If the condition persists, replace the UIF PCB.. Alarm does not sound.. Replace the speaker as described in Section, Disassembly Guide.. If the condition persists, replace the UIF PCB.