Nellcor OxiMax N-550B Service Manual
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Nellcor OxiMax N-550B Service Manual

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Summary of Contents for Nellcor OxiMax N-550B

  • Page 2 To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett.

  • Page 3: Table Of Contents

    C o n t e n t s Contents ........... . i Figures .
  • Page 4 Contents Accessing Menu Items ................33 Menu Item 1 (Trend Print) ..............33 Menu Item 2 (Trend Clear) ..............34 Menu Item 3 (Language Selection) ............34 Menu Item 4 (Baud Rate) ..............34 Menu Item 5 (EPP Mode) ..............34 Service Menu Options ..................
  • Page 5 Contents Repacking in a Different Carton ................77 Specifications ..........79 Performance .......................
  • Page 6 Contents Storage of Patient Data ...............114 Front Panel PCB and Controls .................115 Front Panel Display ................115 Button Interface ...................115 Index ........... 143...
  • Page 7 Contents F i g u r e s Figure 1: N-550B Front Panel ................3 Figure 2: N-550B Rear Panel ................3 Figure 3: N-550B Controls ................9 Figure 4: Adjusting High %SpO2 Alarm Limit ..........12 Figure 5: Adjusting Low %SpO2 Alarm Limit ..........13 Figure 6: Adjusting High Pulse Rate Alarm Limit ..........
  • Page 8 Contents Figure 49: Main PCB Battery Charger Schematic Diagram ......117 Figure 50: Main PCB Isolation for MP-506 Schematic Diagram .....119 Figure 51: Main PCB Isolation for External Interface Schematic Diagram ..121 Figure 52: Main PCB DC Battery Input and DC/DC Converter Schematic Diagram Figure 53: Main PCB Interface and Speaker Control Schematic Diagram ..125 Figure 54: Main PCB MCU and Storage Control Schematic Diagram ....127 Figure 55: Main PCB Parts Locator Diagram ..........129...
  • Page 9 Contents T a b l e s Table 1: Equipment Needed ................7 Table 2: N-550B Menu Selections ..............30 Table 3: Institutional Default Values ............... 37 Table 4: Factory Default Settings ..............38 Table 5: Problem Categories ................44 Table 6: Power Problems ................
  • Page 10 Blank Page...

  • Page 11: Introduction

    I n t r o d u c t i o n Warnings Warnings are identified by the WARNING symbol shown above and a line above and below the warning text. The word WARNING and all warning text are boldfaced. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user.

  • Page 12: Manual Overview

    Introduction Manual Overview ® This manual contains information for servicing the Nellcor model N-550B pulse oximeter. Only qualified service personnel should service this product. Before servicing the N-550B, read the operator's manual carefully for a thorough understanding of operation. WARNING: Explosion hazard. Do not use the N-550B pulse oximeter in the presence of flammable anesthetics.

  • Page 13: Figure 1: N-550B Front Panel

    Introduction 1 — SpO Sensor Port 12 — SatSeconds Alarm Limit Button Power On/Off Alarm Limit 2 — Button 13 — Button % SpO Motion 3 — Display 14 — Indicator 4 — Pulse Amplitude Indicator 15 — Sensor Off Indicator Pulse Rate Sensor Message...

  • Page 14: Related Documents

    N-550B. Refer to the N-550B operator's manual. To understand the various Nellcor sensors that work with the N-550B, refer to the individual sensor's directions for use.

  • Page 15: Routine Maintenance

    1. Inspect the equipment for mechanical and functional damage. 2. Inspect safety labels for legibility. If the labels are damaged, contact Nellcor’s Technical Services Department, 1.800.635.5267, or your local Nellcor representative. Functional Checks 1. If the N-550B has been visibly damaged or subjected to mechanical shock (for example, if dropped), perform the performance tests.

  • Page 16: Battery

    250 volts). Battery Nellcor recommends replacing the N-550B's battery every two years. When the N-550B is going to be stored for two months or more, remove the battery prior to storage. To replace or remove the battery, refer to Disassembly Guide on page 53.

  • Page 17: Performance Verification

    P e r f o r m a n c e V e r i f i c a t i o n Introduction This section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without removing the N-550B cover.

  • Page 18: Performance Tests

    Performance Verification Performance Tests Note: This section is written using Nellcor factory-set defaults. If your institution has preconfigured custom defaults, those values will be displayed. Factory defaults can be restored. See Menu Item 10 (Restore Factory Default Settings as Power-On Default) on page 38.

  • Page 19: Power-On Self-Test (Post)

    Power-On Self-Test (POST) CAUTION: If any indicator or display element does not light, or the speaker does not sound, do not use the N-550B. Instead, contact qualified service personnel, your local Nellcor representative, or Nellcor's Technical Services Department, 1.800.635.5267. Note: The N-550B should complete the POST function within 12 seconds.
  • Page 20 Performance Verification 3. The N-550B automatically starts the Power-On Self-Test (POST), which tests N-550B circuitry and functions. CAUTION: During POST (immediately after power-up), confirm that all display segments and indicators light, and the speaker sounds a one-second pass tone. 4. While performing POST, the self-test display appears for approximately five seconds.

  • Page 21: Power-On Defaults And Alarm Limit Ranges

    Note: The version above is only a sample. Check your N-550B for the current version installed. The version number is needed when calling Nellcor's Technical Services Department, 1.800.635.5267, or your local Nellcor representative for technical assistance. Write down the number and have it available prior to requesting technical assistance.

  • Page 22: Figure 4: Adjusting High %Spo2 Alarm Limit

    Performance Verification 1. Turn the N-550B on by pressing the Power On/Off button. 2. Wait for POST to be completed. 3. Press and release the SpO Alarm Limit button. 4. Verify that the N-550B emits a single beep and the %SpO display indicates an upper alarm limit of “100”...

  • Page 23: Figure 5: Adjusting Low %Spo2 Alarm Limit

    Performance Verification Figure 5: Adjusting Low %SpO Alarm Limit 8. Press the SpO Alarm Limit button two times rapidly. Within three seconds, press and hold the Adjust Down button and verify that the display reduces to a minimum of “20.” Press and hold the Adjust %SpO Up button and verify that the %SpO display cannot be raised past the...

  • Page 24: Figure 7: Adjusting Low Pulse Rate Alarm Limit

    Performance Verification 14. Press the Pulse Rate Alarm Limit button two times (twice within 3 seconds). Verify that the N-550B emits two beeps and that the Pulse Rate display indicates an alarm limit of “40” for 3 seconds. Verify that “LO”...

  • Page 25: Figure 8: Adjusting Satseconds Alarm Limit

    Performance Verification Figure 8: Adjusting SatSeconds Alarm Limit 21. Press the SatSeconds Alarm Limit button. Within three seconds press the Adjust Up button or the Adjust Down button. Verify that the Pulse Rate display changes between 10, 25, 50, 100, and OFF. 22.

  • Page 26: General Operation

    Operation with a Live Subject on page 17. LED Excitation Test This procedure uses normal system components to test circuit operation. A Nellcor O oxygen transducer (sensor), model MAX-A, is used to examine LED intensity control. The red LED is used to verify intensity modulation caused by the LED intensity control circuit.

  • Page 27: Operation With A Live Subject

    1. Ensure that the N-550B is connected to an AC power source. 2. Connect a DOC-10 pulse oximetry cable to the N-550B sensor port (1). 3. Connect a Nellcor Durasensor oxygen transducer (sensor), model DS-100A, to the sensor cable. 4. Clip the DS-100A to the subject as recommended in the sensor's directions for use.

  • Page 28: Alarm Volume Control

    Performance Verification 6. The N-550B should stabilize on the subject's physiological signal in about 15 to 30 seconds. Verify that the oxygen saturation and pulse rate values are reasonable for the subject. Alarm Volume Control 1. Press and hold the Alarm Silence button for more than three seconds. Verify the following: •...

  • Page 29: Pulse Tone Volume Control

    Performance Verification Pulse Tone Volume Control 1. When a valid pulse is acquired, press the Adjust Up button and verify that the sound level of the beeping pulse tone increases. 2. Press the Adjust Down button and verify that the beeping pulse tone decreases until it is no longer audible.

  • Page 30: Introduction

    10 — Infrared LED Drive Indicator Introduction The SRC-MAX functional tester allows qualified technicians to functionally test Nellcor O technology-based pulse oximeters and OEM O technology-based monitors. The technician must perform the test setup procedure before performing tests 1 through 4. The following is a brief description of each test: •...

  • Page 31: Test #1: Bpm

    Performance Verification 1. With the N-550B turned off, connect the DOC-10 pulse oximetry cable to the sensor port. 2. Connect the SRC-MAX tester to the other end of the DOC-10 cable. 3. Turn on the N-550B by pressing the Power On/Off button. 4.

  • Page 32: Test #2: Spo2

    Performance Verification Pulse Amplitude indicator - low level modulation • 4. Press the SRC-MAX Pulse Rate select button. The SRC-MAX Pulse Rate 60 LED will light. 5. The N-550B pulse rate will decrease to 60 and stabilize at 60 bpm. The test pass criteria is 57 to 63 bpm.

  • Page 33: Test #3: Modulation Level

    Performance Verification Pulse Amplitude indicator - low level modulation • 4. Press the SRC-MAX %SpO select button. The SRC-MAX %SpO LED will light. 5. The N-550B will display three dashes until the SRC-MAX stabilizes at 75 %SpO . The test pass criteria is 73 to 77 %SpO 6.
  • Page 34 Performance Verification 3. The N-550B will display: • 75 %SpO2 (test pass criteria is 73 to 77 %SpO • 60 bpm (test pass criteria is 57 to 63 bpm) • alarm Pulse Amplitude indicator - high level modulation • 4. Perform Test #1: BPM on page 21. The Pulse Amplitude indicator should indicate high level modulation.

  • Page 35: Test #4: Light

    Performance Verification 9. Perform Test #1: BPM on page 21. The Pulse Amplitude indicator should indicate low level modulation. 10. Perform Test #2: SpO2 on page 22. The Pulse Amplitude indicator should indicate low level modulation. Test #4: Light 1. Press the SRC-MAX Light Level selection button. The SRC-MAX Light Level LED will light.

  • Page 36: Safety Tests

    Performance Verification 6. Press the SRC-MAX Light Level selection button. The SRC-MAX Light Level LED will light. 7. The N-550B Pulse Amplitude indicator will stabilize and illuminate 4 bars with each pulse beat. 8. The N-550B will display: • 75 %SpO2 •...
  • Page 37 Performance Verification • Patient Applied Risk Current, see page 93 for test values. • Patient Isolation Risk Current, see page 93 for test values. Note: Patient Applied Risk Current and Patient Isolation Risk Current. The leakage test lead from the test equipment must be connected to the N-550B SpO Sensor Port using a male 9-pin “D”...
  • Page 38 Blank Page...

  • Page 39: Audible Alarm Settings And Service Functions

    A u d i b l e A l a r m S e t t i n g s a n d S e r v i c e F u n c t i o n s Introduction This section discusses use of the service menu to reconfigure power-on default values, and how to control the behavior of the audible alarm.

  • Page 40: Alarm Silence Duration

    Audible Alarm Settings and Service Functions Alarm Silence Duration 1. Press and hold the Alarm Silence button. 2. Press the Adjust Up or Adjust Down button to change the duration of the alarm silence. The alarm duration can be set to 30, 60, 90, or 120 seconds, or the alarm can be turned to Off.
  • Page 41 Audible Alarm Settings and Service Functions Table 2: N-550B Menu Selections (Continued) Menu Sub-Menu Function Number Number EPP Mode Real Time ASCII External equipment communications In-sensor Trend Mode Event SpO Event SpO + Pulse Rate Not use in-sensor trend function RS-232 and RS-422 Nurse Call polarity (negative - low, positive - high) Positive on alarm, normally negative...

  • Page 42: Operator's Menu Options

    Silence alarms (No alarm condition, both audio and visual alarms) N-550B display turned on Alarm sound selection Nellcor style Alarms sound IAW IEC 60601-1-8 Alarms sound IAW EN 475 Operator's Menu Options The menu items listed below are options that are available to the operator.
  • Page 43 Audible Alarm Settings and Service Functions default values that have been stored. Factory-set power-on default values are listed in Table 4 on page 38. Accessing Menu Items 1. Menu items can be accessed at any time by pressing the SpO Alarm Limit and Pulse Rate Alarm Limit buttons simultaneously until the option 1 screen is displayed.
  • Page 44 Audible Alarm Settings and Service Functions displayed. For more information about trend printouts, refer to the N-550B Operator’s manual. Menu Item 2 (Trend Clear) When menu item 2 is selected, trend data that is available through the use of menu item 1 will be deleted when the SatSeconds Alarm Limit button is pressed and held until three beeps are heard.
  • Page 45 Audible Alarm Settings and Service Functions When the desired option is indicated in the %SpO display, press the SatSeconds Alarm Limit button to initiate the current selection. Note: Menu items greater than 5 cannot be accessed when a valid sensor is connected to the N-550B.

  • Page 46: Figure 10: Year Month Display

    Audible Alarm Settings and Service Functions • Option 0 = positive on alarm, normally negative • Option 1 = negative on alarm, normally positive • Option 2 = do not use When the desired option is indicated in the %SpO display, press the SatSeconds Alarm Limit button to initiate the current selection.

  • Page 47: Figure 12: Minute Second Display

    Audible Alarm Settings and Service Functions Press the SatSeconds Alarm Limit button to select Hour and the next press of the SatSeconds Alarm Limit button will select the Minute Second display. See Figure 12. Figure 12: Minute Second Display Press the SatSeconds Alarm Limit button to select Second and the next press of the SatSeconds Alarm Limit button enters the selected date and time into the N-550B.

  • Page 48: Table 4: Factory Default Settings

    Audible Alarm Settings and Service Functions Table 3: Institutional Default Values (Continued) Parameter Range Alarm silence restrictions None, sound reminder, do not allow alarms off Blip volume 0 to 10 Language English Serial port baud rate 2400, 9600, 19200 Serial port mode ASCII, external equipment communications Event in-sensor trend format , SpO...
  • Page 49 Audible Alarm Settings and Service Functions Table 4: Factory Default Settings (Continued) Factory Parameter Range Default Setting Pulse Rate Lower 30 bpm to Upper Alarm Limit 40 bpm Alarm Limit minus 1 Alarm Silence On or Off Reminder Alarm Silence Off, 30, 60, 90, 120 seconds 60 seconds Duration...
  • Page 50 This menu item is used to select the alarm sound style. With menu item 14 selected, press the SatSeconds Alarm Limit button, then use the Adjust Up or Adjust Down button to scroll to the desired option. • Option 1 = Nellcor style • Option 2 = sound in accordance with IEC 60601-1-8 •...
  • Page 51 Audible Alarm Settings and Service Functions When the desired option is indicated in the %SpO display, press the SatSeconds Alarm Limit button to set the current selection. The N-550B sounds a confirmation tone. Setting Institutional Defaults (Sample) Set alarm limits to the values established by your facility. After all alarm limits are set, you will access menu Item 9 to set the alarm limit values to institutional defaults.
  • Page 52 Audible Alarm Settings and Service Functions 5. Simultaneously press SpO Alarm Limit button and Pulse Rate Alarm Limit button for over three seconds. Menu Item 1 screen appears. 6. Press the Adjust Up button until menu Item 9 is displayed. 7.
  • Page 53 Who Should Perform Repairs Only qualified service personnel should open the N-550B housing, remove and replace components, or make adjustments. If your medical facility does not have qualified service personnel, contact Nellcor’s Technical Services or your local Nellcor representative. Troubleshooting Guide Problems with the N-550B are categorized in Table 5 on page 44.

  • Page 54: Table 5: Problem Categories

    Troubleshooting Table 5: Problem Categories Problem Area Refer To 1. Power Power on page 44 • No power-up on AC and/or DC • Fails power-on self-test • Powers down without apparent cause 2. Buttons Buttons on page 46 • N-550B does not respond properly to buttons being pressed 3.

  • Page 55: Table 6: Power Problems

    Troubleshooting Table 6: Power Problems Condition Recommended Action Battery Low indicator Ensure that the N-550B is plugged into an operational lights steadily while AC outlet and the AC indicator is on. 550B is connected to Check the fuses. The fuses are located in the Power AC and battery is fully Supply PCB as indicated in Separating Top and Bottom charged.

  • Page 56: Table 7: Button Problems

    Troubleshooting Table 6: Power Problems (Continued) Condition Recommended Action Battery does not Replace battery if it is more than 2 years old. charge. Replace the battery as indicated in Battery Removal on page 66. Open the N-550B as described in Separating Top and Bottom Cases on page 54.

  • Page 57: Table 8: Display/Alarms Problems

    Troubleshooting Display/Alarms Table 8 lists symptoms of problems relating to non-functioning displays and audible tones or alarms and recommended actions. If the action requires replacement of a PCB or module, refer to Disassembly Guide on page 53. Table 8: Display/Alarms Problems Symptom Recommended Action Display values are...

  • Page 58: Table 9: Operational Performance Problems

    Troubleshooting Table 8: Display/Alarms Problems (Continued) Symptom Recommended Action An alarm condition Replace the Front Panel PCB. Refer to Front Case exists but no alarm Disassembly on page 57. (audible or visual) is indicated. Operational Performance Table 9 lists symptoms of problems relating to operational performance (no error codes displayed) and recommended actions.

  • Page 59: Table 10: Data Port Problems

    Troubleshooting Data Port Table 10 lists a symptom for data port problems and recommended actions. If the action requires replacement of the User Interface PCB, refer to Disassembly Guide on page 53. Table 10: Data Port Problems Symptom Recommended Action No printout is being The N-550B is running on battery power.

  • Page 60: Table 11: Error Codes

    Troubleshooting • displays a red “EEE” in the left numeric display area • displays a red error code in the left numeric display Note: Cycling the power clears the displayed error code Table 11: Error Codes Error Meaning Code front end RAM error front end ROM/code integrity error.
  • Page 61 Troubleshooting Table 11: Error Codes (Continued) Error Meaning Code SpO2 back end reports packet length error SpO2 back end reports message length error SpO2 back end reports packet contains unsupported Key SpO2 back end reports packet CRC error SpO2 back end reports end of packet missing SpO2 back end reports packet contains undefined key SpO2 back end reports corrupted variable SpO2 back end reports memory overflow...
  • Page 62 Troubleshooting Table 11: Error Codes (Continued) Error Meaning Code Application program is corrupt Invalid FE102 version Error in the start up sequence OS multitasking service failure A state machine has received an unknown state transition The operation just attempted was not completed successfully example, Institutional Defaults could not be reset An unexpected value was received for example, an out...
  • Page 63 D i s a s s e m b l y G u i d e Introduction WARNING: Do not operate the N-550B after repair or maintenance has been performed until the N-550B’s performance can be verified. Refer to the Performance Verification on page 7, for performance tests and safety tests.
  • Page 64 Disassembly Guide WARNING: Before attempting to open or disassemble the N-550B, disconnect the power cord from the N-550B. CAUTION: Observe ESD (electrostatic discharge) precautions when working within the N-550B. Note: Some spare parts have a business reply card attached. When you receive these spare parts, please fill out and return the card.

  • Page 65: Figure 13: N-550B Rear Panel Screws

    Disassembly Guide 2. Remove the two rear panel screws. See Figure 13. Figure 13: N-550B Rear Panel Screws 3. Place the N-550B up-side down and remove the five screws holding the cases together. See Figure 14. Figure 14: N-550B Case Screws 4.

  • Page 66: Figure 15: Top Case Removal

    Disassembly Guide Figure 15: Top Case Removal 6. Carefully disconnect the two cables from the main PCB. See Figure 16 items 1 and 2. Figure 16: Separated Cases...

  • Page 67: Figure 17: Front Case Wiring

    Disassembly Guide Front Case Disassembly 1. Perform the procedure Prior to Disassembly on page 54. 2. Perform the procedure Separating Top and Bottom Cases on page 54. 3. Disconnect the SpO cable connector from the MP-506 PCB. See Figure 17 item 1. Figure 17: Front case Wiring 4.

  • Page 68: Figure 18: Front Case Mounting Screws

    Disassembly Guide Figure 18: Front Case Mounting Screws 7. Remove the bracket screw, item 2, connected to the front PCB. 8. Remove the front panel assembly from the top case assembly. 9. Remove the bracket and screw connected to the front PCB. See Figure 19 item 1.

  • Page 69: Figure 20: Speaker Removal

    Disassembly Guide Figure 20: Speaker Removal 11. Carefully lift the front PCB out of the front case. See Figure 21. Figure 21: Front PCB Removed MP-506 Removal 1. Perform the procedure Prior to Disassembly on page 54. 2. Perform the procedure Separating Top and Bottom Cases on page 54. 3.

  • Page 70: Figure 22: Mp-506 Cable Connections

    Disassembly Guide Figure 22: MP-506 Cable Connections 4. Disconnect the main PCB cable connector from the MP-506 PCB connector, item 2. 5. Carefully lift the MP-506 PCB out of the top case. See Figure 23. Figure 23: MP-506 Removal Main PCB Removal 1.

  • Page 71: Figure 24: Front Case Wiring

    Disassembly Guide 3. Disconnect the SpO cable connector from the MP-506 PCB. See Figure 17 item 1. Figure 24: Front case Wiring 4. Disconnect the speaker wire connector, item 2, from the main PCB. 5. Disconnect the ribbon cable connector, item 3, from the front case PCB. 6.

  • Page 72: Figure 26: Main Pcb Removal

    Disassembly Guide 8. Remove the front panel assembly from the top case assembly. 9. Disconnect the MP-506 to main PCB cable from the main PCB connector. See Figure 26 item 1. Figure 26: Main PCB Removal 10. Disconnect the main PCB to front PCB cable from the main PCB connector item 2.

  • Page 73: Figure 28: Power Supply Wiring

    Disassembly Guide Power Supply Removal 1. Perform the procedure Prior to Disassembly on page 54. 2. Perform the procedure Separating Top and Bottom Cases on page 54. Figure 28: Power Supply Wiring 3. Unplug the wiring harness connector from the power supply, item 1. 4.

  • Page 74: Figure 29: Power Supply Screws

    Disassembly Guide Figure 29: Power Supply Screws 6. Lift the power supply out of the bottom case. See Figure 30. Figure 30: Power Supply Removed Fan Removal 1. Perform the procedure Prior to Disassembly on page 54. 2. Perform the procedure Separating Top and Bottom Cases on page 54.

  • Page 75: Figure 31: Fan Wires

    Disassembly Guide Figure 31: Fan Wires 3. Unwrap the two fan wires, Figure 31 item 1, from the wiring harness. 4. Unplug the fan wires connector. 5. Remove the two screws holding the fan bracket to the bottom case. See Figure 32.

  • Page 76: Figure 33: Fan And Bracket Removal

    Disassembly Guide Figure 33: Fan and Bracket Removal 7. Remove the 4 screws attaching the fan to the fan bracket. See Figure 34. Figure 34: Fan Screws Battery Removal 1. Perform the procedure Prior to Disassembly on page 54. 2. Perform the procedure Separating Top and Bottom Cases on page 54. 3.

  • Page 77: Figure 35: Battery Screws

    Disassembly Guide Figure 35: Battery Screws Note: Hold onto the battery cover when turning the bottom case over. See Figure 37. Figure 36: Battery Cover 4. Disconnect the battery wiring connector. See Figure 37 item 1. Figure 37: Battery Connector N-550B...

  • Page 78: Figure 38: Battery Removal

    Disassembly Guide 5. Lift the battery cover out of the bottom case. See Figure 38 item 1. Figure 38: Battery Removal 6. Lift the battery out of the case. See Figure 38, item 2. Equipotential Terminal Removal 1. Perform the procedure Prior to Disassembly on page 54. 2.

  • Page 79: Figure 39: Ground Wire

    Disassembly Guide Figure 39: Ground Wire 4. Remove the remaining nut and washer from the equipotential ground terminal. See Figure 40. Figure 40: Equipotential Ground Terminal 5. Remove the equipotential ground terminal from the bottom case. See Figure 41. N-550B...

  • Page 80: Figure 41: Equipotential Ground Terminal Removed

    Disassembly Guide Figure 41: Equipotential Ground Terminal Removed...

  • Page 81: Table 12: Spare Parts And Accessories

    Nellcor's Technical Services provides technical assistance information and replacement parts. To obtain replacement parts, contact Nellcor's Technical Services (1.800.635.5267) or your local Nellcor representative. Refer to parts by the part names and part numbers. Spare parts and accessories, with part numbers, for the N-550B are listed on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/Apartweb/main/PartAcceMenu.html...
  • Page 82 Home Use Guide Main PCB to front PCB cable, 44 pin, bus cable Main PCB, 55M MP-506 data cable, 14 pin, bus cable Nellcor SpO2 module, MP-506, version 1.8.1.0 Operator's manual PI cable, 9 pin, flexible PCB cable Pole mount screw clamp Power cable, medical grade, 110 V, U.S.A.

  • Page 83: Figure 42: Exploded View

    Spare Parts Figure 42: Exploded View N-550B...
  • Page 84 Blank Page...
  • Page 85 General Instructions Pack the N-550B carefully. Failure to follow the instructions in this section may result in loss or damage not covered by any applicable Nellcor warranty. If the original shipping carton is not available, use another suitable carton. Prior to shipping the N-550B, contact your supplier or local Nellcor office (Technical Services Department) for a RGA number.

  • Page 86: Figure 43: Packing

    Packing for Shipment 1. Place the N-550B and, if necessary, accessory items in the original packaging. Figure 43: Packing 2. Place the N-550B into the shipping carton and seal the carton with packing tape. 3. Label the carton with the shipping address, return address, and RGA number.
  • Page 87 Packing for Shipment Repacking in a Different Carton If the original carton is not available, use the following procedure to pack the N-550B: 1. Place the N-550B in a plastic bag. 2. Locate a corrugated cardboard shipping carton with a bursting strength of at least 200 pounds per square inch (psi).
  • Page 88 Blank Page...
  • Page 89 S p e c i f i c a t i o n s Performance Measurement Range SpO2 1% to 100% Pulse Rate 0 and 20 beats per minute (bpm) to 250 bpm 0.03% to 20% Perfusion Range Accuracy and Motion Tolerance Saturation 70 to 100% ±2 digits Without Motion...

  • Page 90: Table 13: Tone Definition

    High Priority Alarm Volume level Adjustable alarm volume Pitch (±30 Hz) 932 Hz Pulse width (±20 msec) Nellcor = 255 msec IAW IEC 60601- 1-8 = 120 msec IAW EN 475 = 150 msec Pulse repetition interval Nellcor = 320 (±20 msec) (double burst)
  • Page 91 Volume level Adjustable alarm Alarm volume Pitch (±30 Hz) 752 Hz Pulse width (±20 msec) Nellcor = N/A IAW IEC 60601- 1-8 = 160 msec IAW EN 475 = 200 msec Pulse repetition interval Nellcor = N/A (±20 msec) (double burst)
  • Page 92 Specifications Table 13: Tone Definition (Continued) Audible Indicator Parameter Value Valid Button Press Volume level Not changeable Pitch (±30 Hz) 784 Hz Pulse width (±20 msec) 30 msec Pulse repetition interval (±20 msec) (double burst) Repetitions Volume Setting Volume level Adjustable alarm volume Pitch (±30 Hz)
  • Page 93 Specifications Battery Complies 91/157/EEC With Sensors Wavelength The wavelength range of the light emitted are near 660 nm to 890 nm. Environmental Conditions Operation Temperature 50 ºF to 113 ºF (10 ºC to 45 ºC) Altitude/Barometric Pressure 390 m to 3,012 m 1,280 ft.
  • Page 94 Specifications Sensor Power Dissipation Sensor Dissipation 52.5 mW 52.5 mW 52.5 mW 52.5 mW 52.5 mW 52.5 mW 52.5 mW Oxiband OXI 52.5 mW Oxiband OXI 52.5 mW Durasensor DS 100A OxiCliq P 52.5 mW OxiCliq N 52.5 mW OxiCliq I 52.5 mW OxiCliq A 52.5 mW...
  • Page 95 Specifications Compliance Item Standard Description Quality System EN ISO 13485: 2000, Quality system — Medical ISO 13485: 1996 Devices, Particular Requirements for application of ISO 9001: 2000 EC Directive 93/42/EEC Medical Device Directive (Europe + Int.) FDA Guidance FDA RG (Nov. 1993) Reviewers Guide for Premarket Notification Submission Safety —...

  • Page 96: Table 14: Cable Compliance

    Specifications Item Standard Description Safety Alarms EN 60601-1-8: 2004 General Application of Alarms in Medical Electric Equipment Front panel and IEC 60878, EN 980, case labeling ISO 7000, EN 60417-1, EN 60417-2 Button spacing ISO 7250 Year of EN 980 manufacture symbol Operation during...
  • Page 97 Specifications Table 14: Cable Compliance (Continued) Cables Comply With: (Continued) • RF emissions, EN 55011, Class B/Group 1 • EN 60601-1-2; 2001 Cables and OxiMax Sensors (Continued) Maximum Length Oxinet II data cable 10 ft. (3 m) HP Agilent interface cable 3 ft.

  • Page 98: Table 15: Electromagnetic Emissions

    Specifications Table 15: Electromagnetic Emissions The N-550B is intended for use in the electromagnetic environment specified below. The customer or the user of the N-550B should assure that it is used in such an environment Electromagnetic Environment — Emission Test Compliance Guidance RF emissions...
  • Page 99 Specifications Table 16: Electromagnetic Immunity The N-550B is intended for use in the electromagnetic environment specified below. The customer or user of the N-550B should assure that it is used in such an environment. Electromagnetic IEC 60601 Compliance Immunity Test Environment —...

  • Page 100: Table 17: Electromagnetic Immunity

    Specifications Table 17: Electromagnetic Immunity The N-550B is intended for use in the electromagnetic environment specified below. The customer or user of the N-550B should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic Immunity Test Test Level Level Environment —...

  • Page 101: Table 18: Recommended Separation Distances Between Portable And Mobile Rf

    Specifications Table 18: Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the N-550B The N-550B is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the N-550B can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the N-550B as recommended below, according to the maximum output power of the...
  • Page 102 Specifications Safety Tests Ground Integrity 100 milliohms or less Earth Leakage Current IEC 60601 AC Line AC Line Neutral AAMI/ UL 2601 Polarity Cord Line Cord ANSI Normal Closed Closed µ 300 µA Reversed Closed Closed µ 300 µA Normal Open Closed µ...
  • Page 103 Specifications Patient Risk Applied Current Power Line IEC 60601 AAMI/ AC Line Neutral Line Ground Polarity Cord UL 2601 ANSI Cord Normal Closed Closed µ µ Normal Open Closed µ µ µ µ Normal Closed Open Reversed Closed Closed µ µ...
  • Page 104 Specifications...
  • Page 105 D a t a P o r t I n t e r f a c e P r o t o c o l Introduction The data port, located at the rear of the N-550B, provides interfacing capabilities for: •...
  • Page 106 Data Port Interface Protocol 4. Press the SatSeconds Alarm Limit button to select option 5. 5. Select protocol 1 or 2 by pressing Adjust Up or Adjust Down button. 6. Press the SatSeconds Alarm Limit button to set the selection. Baud Rate Menu item 4 is used to select baud rate.

  • Page 107: Table 19: Data Port Pinouts

    Data Port Interface Protocol 5. Select baud rate by pressing Adjust Up or Adjust Down button (2400, 9600, or 19200 [default]). 6. Press the SatSeconds Alarm Limit button to set the selection. Connecting To The Data Port Data is transmitted in the RS-232 and RS-422 formats. RS-232 data can be transmitted a maximum of 25 feet (7.62 meters).

  • Page 108: Figure 44: Data Port Pin Layout

    Data Port Interface Protocol Table 19: Data Port Pinouts (Continued) Signal Name Signal Ground Nurse Call (RS-232 level output) TXD- (RS-422 negative output) (-5 to -12 VDC with no audible alarm, 5 to 12 VDC with audible alarm) Nurse Call Common for Dry Contacts The pin layouts are illustrated in Figure 44.
  • Page 109 Data Port Interface Protocol Nurse Call Polarity Settings Voltage at pins Nurse Call Polarity Alarm State 10 to 11 Normally High No alarm or Alarms Silenced 5 to 12 VDC Audible Alarm -5 to -12 VDC Normally Low No alarm or Alarms Silenced -5 to -12 VDC Audible Alarm 5 to 12 VDC...

  • Page 110: Figure 45: Real-Time Printout

    Data Port Interface Protocol Real-Time Printout When a real-time printout is being transmitted, a new line of data is printed every two seconds. Every 25 line will be a Column Heading line. A Column Heading line will also be printed any time a value in the Column Heading line is changed.
  • Page 111 Data Port Interface Protocol Printout Source Data in the highlighted box above represents the source of the printout, in this case, the N-550B. Software Revision Level The next data field tells the user the software level (Version 1.0.0.0) and a software verification number (CRC XXXX).
  • Page 112 Data Port Interface Protocol Actual column headings are in the third row of the Column Heading line. Patient data, from left to right, are the time that the chart was printed, the current %SpO value being measured, the current pulse rate in beats per minute (bpm), the current Pulse Amplitude (PA), and the operating status of the N-550B.

  • Page 113: Table 20: Status Codes

    Data Port Interface Protocol The Status column indicates alarm conditions and operating status of the N-550B. The PH in this example indicates a Pulse Rate Upper alarm. The Status column can have as many as four codes displayed in one line of data. The status codes are listed in Table 20.
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  • Page 115 T e c h n i c a l D i s c u s s i o n Oximetry Overview The N-550B Pulse Oximeter measures functional oxygen saturation by measuring the light absorption of tissue, bone, and blood during the pulsatile cycle.
  • Page 116 Technical Discussion Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies, an oximeter must know the mean wavelength of the sensor's red LED to accurately measure SpO . During manufacturing, the mean wavelength of the red LED is encoded in a integrated circuit in the sensor.

  • Page 117: Figure 46: Oxyhemoglobin Dissociation Curve

    O advanced signal processing allows the N-550B to read through challenging motion conditions to deliver accurate saturation and pulse rate values. For a definition of motion, as applicable to the N-550B, contact Nellcor's Technical Services Department. N-550B...
  • Page 118 SpO . By having the calibration in the sensor, rather than the N-550B, Nellcor is able to improve the published accuracy of many sensors, because the calibration coefficients can be tailored to each sensor. Consult the accuracy card included with the N-550B for specific accuracy information for the N-550B with different Nellcor sensors.

  • Page 119: Figure 47: Mp-506 Interface

    Technical Discussion Figure 47: MP-506 Interface Table 21: MP-506 J1 Pinouts Signal DETECTOR (+) DIGICAL Ground DIGICAL 1 wire interface DETECTOR ( Inner Shield Ground No connection LED ( No connection LED (+) Outer Shield Ground N-550B...

  • Page 120: Table 22: Mp-506 J2 Pinouts

    Technical Discussion Table 22: MP-506 J2 Pinouts Signal LOCK Input Ground Ground Reset Input Ground +12 V Power Input Analog Output TX Transmit data output from MP RX Receive data input to MP +5 V Analog Power Input CTS (Clear to Send) input to MP Ground +5 V Digital Power input Ground...

  • Page 121: Figure 48: Block Diagram

    Technical Discussion Block Diagram Theory Figure 48: Block Diagram The N-550B functional block diagram is shown in Figure 48. Most of the functions of the N-550B are performed on the Main PCB. Functions on the Main PCB include the SpO module, MCU, and Memory.
  • Page 122 Technical Discussion Power Supply PCB Theory Of Operation The N-550B uses a switch mode power supply. This Power Supply provides the DC power needed to charge the battery and to power the Main PCB. Electromagnetic Static Discharge (ESD) protection is also provided by the power supply.
  • Page 123 Technical Discussion Regulated DC Power Supply The Main PCB receives the MAIN_DC unregulated voltage of 14 volts DC from the power supply, or 9.6 volts DC from the internal battery. The power supply on the Main PCB generates +5 and +12 volts DC. Controlling Hardware There is one microprocessor on the Main PCB, is a Microchips PIC17C756A.
  • Page 124 Technical Discussion pulse beep volume) are used by the N-550B until it is turned off. Default values will be restored when the N-550B is turned back on. Patient Data is stored by the N-550B and can be downloaded to a printer through the data port provided on the back of the N-550B.
  • Page 125 Technical Discussion Front Panel PCB and Controls Front Panel Display Visual patient data and N-550B status are provided by the Front Panel Display. At power up, all indicators are illuminated to allow verification of their proper operation. There are two sets of three, 7-segment displays. One set displays %SpO2 and the other displays pulse rate.
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  • Page 127 Technical Discussion TP28 TP31 T POINT M1 T POINT M1 04-05-18 CR11 BAT+ CR16 0_3216 MBRS340 22uF_35VEL 0.1uF BAT- TP59 T POINT M1 Alternative +5VC 100uH CR15 CR15-1 VOUT 0.33_2W_F 0.33_2W_F_SMD CR10 B772 CC10 Alternative MBRS340 330uF/16V TP58 Alternative CR12 T POINT M1 100K_F LM78L05A/SOIC...
  • Page 128 Technical Discussion +5VF2 +5VF2 TP57 TP56 T POINT M2 +5VF2 T POINT M2 +12VF 3.9K 120pF 120pF TP22 TP20 T POINT M2 T POINT M2 ANODE ENABLE TX2F CATHODE Vout 47pF CON14A 6N137 +5VF2 RX2F TX2F MP506 Connector 120pF TP23 TP21 10pF 10pF...
  • Page 129 Technical Discussion +5VF1 120pF JDP1 ANODE ENABLE TX1F CATHODE Vout RX1F TP24 TP26 6N137 T POINT M3 T POINT M3 TX1F TP15 +5VF1 ZJYS51R5-M4PA(T) TX1F_N T POINT M3 TP54 TP55 C118 T POINT M3 T POINT M3 10pF MAX232S 120pF C119 N.O.
  • Page 130 Technical Discussion PRR3 5.6K_F +5VB T POINT M4 PRU1 LM2675-ADJ PRR2 TP12 TP13 1.5K_F T POINT M4 T POINT M4 PRC4 PRL1 SB3040 INPUT_V PRD7 10nF BDS8040D-330M PRC2 PRR5 PRC1 PRC3 PRC6 47uF_16VEL 47uF_35VEL 0.47uF_3216 PRD1 0.1uF 2.7k_3216 MBRS340 PRC5 (1/4w) 100uF_16V_ TA_lowESR...
  • Page 131 Technical Discussion TP17 T POINT M5 0.47uF 47uF_16VEL 47uF_16VEL 0.1uF 5.1K 47uF_16VEL 47uF_16VEL TP18 C82 120pF GND1 T POINT M5 0.1uF B140 U17A LM324/SO CON2 820pF 100K_F 22nF TP16 TP19 GND2 5K_POT T POINT M5 T POINT M5 TDA7052A Alarm Sound Module Connector SEG a SEG b...
  • Page 132 Technical Discussion +5VA +5VA B140 2.2nF 2.2nF 2.2nF 2.2nF 10nF 10nF 10nF 10nF T POINT M6 T POINT M6 +5VA Power OUT VOUT B140 OSC2 1uF_3216 RA2/SS TP11 RA3/SDI/SDA T POINT M6 RA4/RX1/DT1 LM78L05A/SOIC RA5/TX1/CK1 2N2222A RB0/CAP1 RB1/CAP2 +5VB RB2/PWM1 T POINT M6 RB3/PWM2 RB4/TCLK12...
  • Page 133 Technical Discussion N-550+8 J3 2 MAIN_BD_XB 2004. 05. 21 C110 C109 C102 C117 43 TP12 TP18 TP10 XTAL2 TP17 C97 C96 C95 C94 C93 C92 C114 C115 TP16 14 13 R5 R4 TP13 BC10 TP57 R7 R6 J5 C50 TP24 R14 TP44 R29 LP1 RT1 TP56...
  • Page 134 Technical Discussion TP40 SpO2 Display Digits T POINT F1 FRF0 FRF1 FDIGIT 1 FDIGIT 2 FDIGIT 3 TP41 T POINT F1 FR18 FR19 FR20 FR21 FR22 FR17 FQ17 FQ21 FQ19 FQ18 FQ22 FQ20 2N2907A 2N2907A 2N2907A 2N2907A 2N2907A 2N2907A FSEG a FSEG b FSEG g FSEG c...
  • Page 135 Technical Discussion Function Button SatSecond Display Front Panel LEDs FSD1 FSEG a FR45 TP33 FR36 SpO2 FRC7 GLED T POINT F2 4.7K AC in (Green) Indicator 1N4148 FSW1 FSD2 FR31 FRB0 FSEG b ACLED 2.7K_3216(1/4w) GLED GLED Low Battery (Orange) Indicator FSD3 FSEG c FR32...
  • Page 136 Technical Discussion FSEG a 2N2907A FR10 FSEG b FRF1 FRF0 2N2907A FRF3 FRF2 FRE1 FRE0 FRC3 FRE2 FR11 FRC5 FRC4 FRC7 FRC6 FRB1 FRB0 FRB5 FRB4 FRB3 FSEG c FRC2 2N2907A FQ11 FQ15 FQ13 FR12 2N2222A 2N2222A 2N2222A 2N2222A DIN 44_AB-H ACLED FSEG d FRE3...
  • Page 137 Technical Description FSW9 FSW5 FSD1 N-550 FSW1 FSW3 FSW6 P1008-0 2001. 12. 02 FSW7 FSD5 Figure 59: Front Panel Parts Locator Diagram N-550B...
  • Page 138 Technical Discussion MDT15-20 1M/0.25W N.C. +14V/1.0A AC1 + B3R5-15.5T 10D-9 250V/2A S3L20U 120K 400V INPUT 47uF SXE100uF 1J104 85 VAC - 264 VAC LXV470uF LXV470uF 275V DWF-141C S1VB60 250V/2A UF4007 224LF-2023 TOP223Y 8.2K TLP621 47uF (H11A817) 4.7uF/50V IC21 TL431 1.2K 1J104 VR21 1SS133...
  • Page 139 Technical Discussion PB - MD15 - 14 Fine - Suntronix Made in Korea R24 IC21 VR21 INLET Figure 61: Power Supply Parts Locator Diagram N-550B...
  • Page 140 I n d e x Symbols data port interface protocol data port problems description of N-550 pulse oximeter disassembly guide display/alarms problems AC input theory accessing menu items accessories alarm limit ranges earth leakage current alarm off enabling the data port alarm parameter being violated enclosure leakage current alarm silence...
  • Page 141 Index measured versus calculated saturation POST menu item 1 (trend print) power problems menu item 10 (save factory default settings as pow- power supply PCB theory of operation er-on default) power supply removal menu item 11 (alarm silence behavior) power-on defaults and alarm limit ranges menu item 12 (silence) power-on self-test menu item 13 (all display off)
  • Page 142 Index spare parts specifications battery 82 compliance 86 electrical 82 electrical, instrument 82 environmental 83 ground integrity 92 patient isolation risk current 93 patient risk applied current 93 performance 79 physical 84 safety tests 92 specifications, performance SRC-MAX storage altitude 83 barometric pressure 83 relative humidity 83 temperature 83...
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  • Page 145 Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton, CA 94588 U.S.A. Telephone Toll Free 1.800.NELLCOR Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS, U.K. © 2004 Nellcor Puritan Bennett Inc. All rights reserved. Rx ONLY 069157B-1204...

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