OxiMax N-600 Service Manual

Contents

Contents Contents... i Figures...v Tables... vii Introduction... 1 Warnings ... 1 Cautions ... 2 Notes ... 3 Manual Overview ... 3 Description of N-600 ... 4 Front Panel ... 5 Rear Panel ... 5 Softkey Menu ... 6 Related Documents ... 9

Routine Maintenance...11 Cleaning ... 11 Periodic Safety Checks ... 11 Functional Checks ...12 Battery ... 12

Performance Verification... 13 Introduction ... 13 Equipment Needed ... 13 Performance Tests ... 13 Battery Charge ... 14 Power-Up Performance ... 14 Power-On Self-Test ... 14 Power-On Defaults and Alarm Range Limits ... 16 Operational Setup ... 19 Alarms and Alarm Silence ... 20 Alarm Volume Control ... 22 Pulse Tone Volume Control ... 23 Nurse Call ... 23 Analog Output ... 24 Operation on Battery Power ... 26 General Operation ... 26 LED Excitation Test ... 27 Operation with a Live Subject ... 28 Pulse Oximetry Functional Tests ... 29 Introduction ... 29 Initial Setup ... 30 Test #1: BPM ... 31 Test #2: SpO2 ... 32 Test #3: Modulation Level ... 33 Test #4: Light ... 35 Safety Tests ... 36 OxiMax N-600

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Contents

Power-On Settings and Service Functions... 37 Introduction ... 37 Power-On Settings ...37 Factory Default Settings ... 37 Neonate Default Settings ... 38 Adult Default Settings ... 39 Service Functions ... 39 Accessing the Service Functions ... 40 Exit Softkey ...41 Next Softkey ... 41 Param Softkey Menu ... 42 Reset Softkey ... 42 Save Softkey ... 42 Sensor Softkey ... 42 Print Softkey Menu ... 43 Trend Softkey ... 44 ERRLOG Softkey ... 45 INSTAT Softkey ... 45 INFO Softkey ... 46 Next Softkey Menu ... 47 DOWNLD Softkey ... 47 ALARMS Softkey ... 47 SELECT Softkey ... 47 Setting Institutional Defaults (Sample) ... 49

Troubleshooting... 53 Introduction ... 53 How To Use This Section ... 53 Who Should Perform Repairs ... 53 Troubleshooting Guide ... 53 Power ... 55 Buttons ... 56 Display/Alarms ... 57 Operational Performance ... 58 Data Port ... 59 Error Codes ... 59 Other Messages ... 63 Adjust Contrast Up, Down ... 63 Clock Settings Lost ... 63 Data In OxiMax Sensor ... 63 Data Type: SpO2 ... 63 Data Type: Event/SpO2+BPM ... 63 Defaults Lost ... 63 Delete Trend? ... 63 Invalid Blip Vol ... 64 Invalid Silence Duration ... 64 Invalid SpO2 Limit ... 64 Low Battery ... 64 Reading Trends ... 64 Reset Defaults? ... 64 Save Defaults? ... 65 Sensor Disconnected ... 65

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Contents Settings Lost ... 65

Disassembly Guide... 67 Introduction ... 67 Replacement Level Supported ... 68 Prior to Disassembly ... 68 Fuse Replacement ...69 Monitor Disassembly ... 70 Monitor Assembly ... 71 Battery Replacement ... 72 Removal ... 72 Replacement ... 73 Power Entry Module (PEM) Removal/Replacement ... 73 Removal ... 73 Replacement ... 74 Power Supply Removal/Replacement ... 75 Removal ... 75 Replacement ... 76 Cooling Fan Removal/Replacement ... 77 Removal ... 77 Replacement ... 78 Display PCB Removal/Replacement ... 79 Removal ... 79 Replacement ... 81 User Interface PCB Removal/Replacement ... 81 Removal ... 81 Replacement ... 83 Alarm Speaker Removal/Replacement ... 83 Removal ... 83 Replacement ... 84 Top Case Assembly Removal/Replacement ... 85 Removal ... 85 Replacement ... 85

Spare Parts... 87 Introduction ... 87 Obtaining Replacement Parts ... 87 Parts List ... 88

Packing for Shipment... 91 Introduction ... 91 Returning the N-600 ... 91 General Instructions ... 91 Repacking in Original Carton ... 91 Repacking in a Different Carton ... 93

Specifications... 95 Performance ... 95 Electrical ... 96 Environmental Conditions ... 97 Physical Characteristics ... 98 Compliance ... 99 Manufacturer’s Declaration ... 99 Safety Tests ...103

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Contents Ground Integrity ...103 Earth Leakage Current ...103 Enclosure Leakage Current ...104 Patient Applied Risk Current ...104 Patient Isolation Risk Current ...105

Data Port Interface Protocol... 107 Introduction ...107 Configuring the Data Port ...107 Communication Baud Rate ...108 Communication Protocol ...109 Language Selection ...111 Nurse Call Setup ...111 Analog Calibration Setup ...112 Agilent (HP) Communications ...113 SpaceLabs Communications ...114 Marquette Communications ...114 Datex-Ohmeda Communications ...115 Connecting to the Data Port ...116 Communication With a PC ...117 Dump Instrument Info (Option 1) ...117 Set Date and Time (Option 2) ...118 Dump Trend (Option 3) ...118 Dump Error Log (Option 4) ...118 Exit Interactive Mode (Option 5) ...118 Using Data on the PC ...119 Real-Time Printout ...119 Column Heading ...121 Data Source ...121 Software Revision Level ...121 Alarm Limits ...122 Monitor Status ...122 Column Headings ...122 Patient Data and Operating Status ...122 Time ...122 Patient Data ...123 Operating Status ...123 Trend Data Printout (ASCII Mode) ...124 Trend Printout (Graph Mode) ...125 Nurse Call ...125 Analog Output ...126

Technical Discussion... 127 Oximetry Overview ...127 Functional versus Fractional Saturation ...128 Measured versus Calculated Saturation ...128 SatSeconds Alarm Management ...129 Signal Processing ...129 OxiMax Technology ...129 Block Diagram Theory ...130

Index... 167

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Contents

Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: Figure 11: Figure 12: Figure 13: Figure 14: Figure 15: Figure 16: Figure 17: Figure 18: Figure 19: Figure 20: Figure 21: Figure 22: Figure 23: Figure 24: Figure 25: Figure 26: Figure 27: Figure 28: Figure 29: Figure 30: Figure 31: Figure 32: Figure 33: Figure 34: Figure 35: Figure 36: Figure 37: Figure 38: Figure 39:

OxiMax N-600

N-600 Front Panel ...5 N-600 Rear Panel ...5 SRC-MAX OxiMax Oximetry Tester ...29 Fuse Removal ...69 Corner Screws ...70 Separating Case Halves ...71 Removing the Battery ...72 Power Entry Module ...74 Power Supply ...76 Cooling Fan ...78 Display PCB ...80 User Interface PCB ...82 Alarm Speaker ...84 Exploded View ...89 Packing ...92 Data Port Pin Layout ...116 Real-Time Printout ...120 Trend Data Printout (ASCII Mode) ...124 Monitor Trend Data Printout (Graph Mode) ...125 Sensor Event Record Printout (Graph Mode) ...125 Oxyhemoglobin Dissociation Curve ...128 Block Diagram ...130 Main PCB Schematic Diagram (Sheet 1 of 13) ...133 Main PCB Schematic Diagram (Sheet 2 of 13) ...135 Main PCB Schematic Diagram (Sheet 3 of 13) ...137 Main PCB Schematic Diagram (Sheet 4 of 13) ...139 Main PCB Schematic Diagram (Sheet 5 of 13) ...141 Main PCB Schematic Diagram (Sheet 6 of 13) ...143 Main PCB Schematic Diagram (Sheet 7 of 13) ...145 Main PCB Schematic Diagram (Sheet 8 of 13) ...147 Main PCB Schematic Diagram (Sheet 9 of 13) ...149 Main PCB Schematic Diagram (Sheet 10 of 13) ...151 Main PCB Schematic Diagram (Sheet 11 of 13) ...153 Main PCB Schematic Diagram (Sheet 12 of 13) ...155 Main PCB Schematic Diagram (Sheet 13 of 13) ...157 Main PCB Assembly Drawing (Front View) ...159 Main PCB Assembly Drawing (Rear View) ...161 Linear Power Supply Schematic Diagram ...163 Linear Power Supply Assembly Drawing ...165

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Contents

OxiMax N-600

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Contents

Ta b l e s Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Table 13: Table 14: Table 15: Table 16: Table 17: Table 18: Table 19: Table 20:

OxiMax Mx-600

Equipment Needed ... 13 Neonate Alarm Limit Factory Defaults ... 38 Adult Alarm Factory Defaults ... 39 Problem Categories ... 54 Power Problems ... 55 Button Problems ... 56 Display/Alarms Problems ... 57 Operational Performance Problems ... 58 Data Port Problems ... 59 Error Codes ... 60 Power Supply Lead Connections ... 76 Parts List ... 88 Electromagnetic Emissions ... 99 Electromagnetic Immunity, Portable RF Equipment ...100 Recommended Separation Distances ...101 Cable Compliance ...102 Data Port Pin Outs ...116 Operating Status Codes ...123 Nurse Call Relay Pin States ...126 Rating of Nurse Call Relay ...126

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Contents

OxiMax Mx-600

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Introduction

Warnings

Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user. WARNING: The sensor extrapolates from the date and time provided by the N-600 when recording the sensor event record to the sensor. The accuracy of the date/time is the responsibility of the N-600. It is recommended that the N-600 user set the time/date to the correct value before a sensor event record-enabled sensor is connected, and that this date/time not be changed while the sensor remains connected. Since a sensor with sensor event record data can be transported from one monitor to another, having discrepancies in the date/time between monitors and the sensor event record will affect the order the sensor event record data appears. To eliminate this possible problem, all monitors within an institution should be set to the same time.

WARNING: Explosion hazard. Do not use the N-600 pulse oximeter in the presence of flammable anesthetics.

WARNING: Do not spray, pour, or spill any liquid on the N-600, its accessories, connectors, switches, or openings in the chassis.

WARNING: Before attempting to open or disassemble the N-600, disconnect the power cord from the N-600.

WARNING: The LCD panel contains toxic chemicals. Do not ingest chemicals from a broken LCD panel.

OxiMax N-600

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Introduction

WARNING: The use of accessories, OXI-MAX sensors, and cables other than those specified may result in increased emission and/or decreased immunity of the N-600 pulse oximeter.

WARNING: Do not silence the N-600 audible alarm or decrease its volume if patient safety could be compromised.

Cautions

Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the N-600 pulse oximeter. Caution: Observe ESD (electrostatic discharge) precautions when working within the unit. Caution: Observe ESD (electrostatic discharge) precautions when disassembling and reassembling the N-600 and when handling any of the components of the N-600. Caution: When reassembling the N-600, tighten the screws that hold the cases together to a maximum of 10 inch-pounds. Over-tightening could strip out the screw holes in the top case, rendering it unusable. Caution: When installing the Power Supply or the User Interface PCB, tighten the seven screws to a maximum of 4 inch-pounds. Over-tightening could strip out the screw holes in the bottom case, rendering it unusable.

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Introduction

Notes

Notes are identified by the Note symbol shown above. Notes provide additional helpful information.

Manual Overview This manual contains information for servicing the Nellcor model N-600 pulse oximeter. Only qualified service personnel should service this product. Before servicing the N-600, read the operator's manual carefully for a thorough understanding of safe operation of the N-600. WARNING: Explosion hazard. Do not use the N-600 pulse oximeter in the presence of flammable anesthetics.

OxiMax N-600

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Introduction

Description of N-600 The OxiMax® N-600 pulse oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-600 is intended for use with neonatal, pediatric, and adult patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only. Note:

Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. Home Care use is defined as managed/used by a lay person (parent or other similar non-critical caregiver) in the home environment. Use with any particular patient requires the selection of an appropriate OxiMax oxygen sensor as described in the N-600 Operator's Manual.

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 N-600 can operate on AC power or on an internal battery. The controls and indicators for the N-600 are illustrated and identified in Figure 1 and Figure 2.

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Introduction

Front Panel

1. 2. 3. 4. 5.

SpO2 Sensor Port AC Power Indicator On/Standby Button Low Battery Indicator Waveform Display

6. SatSecondsTM Timer 7. %SpO2 Display 8. Pulse Rate Display 9. Alarm Silence Display 10. Alarm Silence Button 11. Adjust Up Button

12. Adjust Down Button 13. Neonate Mode Indicator 14. Contrast Button 15. Fast Response Mode Indicator 16. Softkeys 17. Menu Bar 18. Data In-Sensor Indicator 19. Interference Indicator 20. Pulse Search Indicator 21. Speaker

Figure 1: N-600 Front Panel

Rear Panel

1. Equipotential Terminal (Ground) 2. AC Power Connector 3. Data Port Connector

4. Fuse Receptacle 5. Supply Voltage Selector Switch

Figure 2: N-600 Rear Panel

OxiMax N-600

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Introduction

Softkey Menu The N-600 hierarchy is outlined below. The user chooses the type of trend data to view by selecting either N-600 trend or Sensor trend data in the Trend menu. Sensor sub-menu choices differ depending on what type of in-sensor data is stored in the sensor chip, such as, event or loop. The menu structure includes BACK softkey options that allow the user to move back to the previous menu level without exiting the Trend menu entirely. Trend data must be compiled on entry/reentry to the Trends menu. When the softkeys are available, both BACK and EXIT options are available. The BACK softkey goes to the previous level and the EXIT softkey goes to the main menu. If only one space is available the BACK Softkey is included, this may require going back one or two levels to get to an EXIT softkey. The BACK and EXIT softkeys are positioned on the right-most softkeys, respectively. The below menu structure identifies: •

BOLDFACE TYPE - softkey title as displayed on the N-600

•

Underlined Text - description of the softkey menu item

•

Italicized Text - the destination of the BACK and EXIT softkeys

(Main Menu) LIMITS (Limits Menu) SELECT NEO ADULT EXIT (to Main menu) TREND (Trend Menu) MON (Monitor Menu) VIEW (Monitor Trend View Menu) DUAL SPO2 PULSE NEXT (History/Amplitude Menu) HIST (Delete/Print2 Menu) DELETE (delete Trends) “DELETE TRENDS” YES (return to Main menu) NO (back to Delete/Print menu) PRINT BACT (back to Hist/Amp menu) EXIT (to Main menu) AMP (Amplitude Menu) BACK (back to Hist/Amp menu) EXIT (to Main menu) BACK (back to Monitor Trend View menu) EXIT (to Main menu)

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Introduction -

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OxiMax N-600

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ZOOM (Monitor Trend Zoom Menu) TIME (for current view, cycle through 48h, 36h, 12h, 8h, 4h, 2h, 1h, 30m, 15m, 40s, 20s) SCALE (for current view, cycle through ±5, ±10, ±15, ±20, ±25, ±30, ±35, ±40 and ±50 of the max and min. values under the cursor, default to 10 to 100 if there is no data point under the cursor) AUTO (based on all of the graphed trend data: maximum value, rounded up to nearest multiple of 10, minimum value, rounded down to nearest multiple of 10 minus 10) BACK (back to Monitor menu) NEXT (Delete/Print1 Menu) DELETE “DELETE TRENDS?” YES (to Main menu) NO (back to Delete/Print1 menu) PRINT BACK (back to Monitor menu) EXIT (to Main menu) BACK (back to Trend menu) SENSOR (Sensor/Event Menu) (if Event data is in the sensor, the following menu, the Screen will remain in the appropriate state until the next menu selection is made) GRAPH (Graph Menu) (display events #1-N, in inverse chronological order; up/down also scroll through events in order) < (show previous graph, only available when there is a previous graph) > (show next graph, only available when there is a next graph) PRINT BACK (back to Sensor menu) TABLE (Table Menu) ^ (show previous table, only available when there is a previous graph; bottom/top line repeats in new table) v (show next table, only available when there is a next graph; bottom/top line repeats in new table) PRINT BACK (back to Sensor menu) EXIT (to Main menu) (Sensor/Loop Menu) (If continuous-Loop data is in the sensor, the following will be displayed) VIEW (Sensor Trend View Menu) DUAL (shows SPO2+BPM) SPO2 PULSE ZOOM (cycle through 2h. 1h, 30m, and 15m for current view) PRINT BACK (to Trend menu) EXIT (to Main menu)

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Introduction SETUP (Setup Monitor Menu) VIEW (Setup View Menu) PLETH BLIP BACK (back to Setup menu) EXIT (to Main menu) SENSOR (Setup Sensor Menu) DATA (On-screen options for SENSOR-R (Write-once Sensor) sensor are: “SPO2, SPO2+BPM, DEFAULT.” On-screen options for SENSOR-RW (rewritable sensor) are: “SPO2, SPO2+BPM, DEFAULT.” SELECT toggles SENSOR-R or SENSOR-RW sensor type; up/down keys scroll through options in order.) The SENSOR-R feature supports all of the current OxiMax sensors. SELECT BACK (back to Setup Sensor menu) EXIT (to Main menu) MSG (Sensor Set Message Menu) BACK (back to Setup Sensor menu) EXIT (to Main menu) NEXT (Clock/Language Menu) CLOCK (Clock Menu) SET (Clock Set Menu) SELECT (press select to toggle through hours, minutes, seconds, month, day, year; use up/down buttons to set each selection) BACK (back to Clock/Language menu) EXIT (to Main menu) LANG (Language Setup Menu) (use up/down buttons to toggle though languages) BACK (back to Clock/Language menu) NEXT (Communication/Nurse Call Menu) COMM (Communication Port Configuration Menu) SELECT BACK (back to Communication/Language menu) EXIT (to Main menu) NCALL (Nurse Call Menu) NORM + NORM BACK (back to Communication/Nurse Call menu) EXIT (to Main menu) NEXT (Analog/Mode Menu) ANALOG (Analog Voltage Select Menu) 0 VOLT 1 VOLT STEP BACK (back to Analog/Mode menu) MODE (Mode Menu) BACK (back to Analog/Mode menu) EXIT (to Main menu) BACK (back to Communication/Nurse Call menu) EXIT (to Main menu) BACK (back to Clock/Language menu) BACK (back to Setup menu) EXIT (to Main menu) LIGHT (Turns the display backlight on or off)

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Introduction

Related Documents 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 N-600. Refer to the N-600 Operator's Manual. To understand the various Nellcor approved OxiMax sensors that work with the N-600, refer to the individual OxiMax sensor's directions for use. The latest version of the operator’s manual and the service manual are posted on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

Spare Parts and Accessories are posted on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/Apartweb/main/PartAcceMenu.html

OxiMax N-600

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Introduction

10

Routine Maintenance

Cleaning WARNING: Do not spray, pour, or spill any liquid on the N-600, its accessories, connectors, switches, or openings in the chassis. For surface-cleaning and disinfecting follow your institution's procedures or: •

The N-600 may be surface-cleaned by using a soft cloth dampened with either a commercial, nonabrasive cleaner or a solution of 70% alcohol in water, and lightly wiping the surfaces of the N-600.

•

The N-600 may be disinfected using a soft cloth saturated with a 10% solution of chlorine bleach in tap water.

Before attempting to clean an SpO2 OXI-MAX sensor, read the directions for use enclosed with the OXI-MAX sensor. Each sensor model has cleaning instructions specific to that sensor.

Periodic Safety Checks The N-600 requires no calibration. The battery should be replaced at least every 2 years. See Battery Replacement on page 72. The following checks should be performed at least every 24 months by a qualified service technician. 1. Inspect the equipment for mechanical and functional damage.

2. Inspect safety labels for legibility. If the labels are damaged, contact Nellcor’s Customer Services Customer Services Department, 1.800.635.5267, or your local Nellcor representative.

OxiMax N-600

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