OxiMax N-600x Service Manual Rev A

Service Manual

188 Pages

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File Name: oximax_n-600x_service_manual_rev_a.pdf

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Service Manual

Nellcor

OxiMax N-600x Pulse Oximeter

OxiMax TM Technology

COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2011 Covidien. U.S. Patents 5,485,847; 5,676,141; 5,743,263; 6,035,223; 6,226,539; 6,411,833; 6,463,310; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774; 7,212,847; 7,400,919. To obtain information about a warranty, if any, contact Covidien Technical Services at 1.800.635.5267 or your local representative. Purchase of this instrument confers no express or implied license under any Covidien patent to use the instrument with any pulse oximeter that is not manufactured or licensed by Covidien.

Contents

Contents Introduction... 1 Warnings ...1 Cautions ...3 Overview ...4 Monitor Description ...4 Front Panel ...5 Rear Panel ...6 Softkey Menu ...6 Related Documents ...10

Routine Maintenance... 11 Cleaning the Monitor ...11 Periodic Safety Checks ...12 Functional Checks ...12 Battery Operation ...13

Performance Verification... 15 Overview ...15 Required Equipment ...15 Performance Tests ...16 Battery Charge ...16 Power-Up Performance ...16 Operational Setup ...22 General Operation ...29 Pulse Oximetry Functional Tests ...32 Safety Tests ...46

Power-On Settings and Service Functions... 47 Overview ...47 Adjusting the Power-On Settings ...47 Factory Default Settings ...48 Neonate Default Settings ...48 Adult Default Settings ...50 Service Functions ...51 Accessing the Service Functions ...51 Exit Softkey ...52 Next Softkey ...52 Param Softkey Menu ...53 Print Softkey Menu ...54 Next Softkey Menu ...58 Setting Institutional Defaults (Sample) ...61

Troubleshooting... 63 Overview ...63 Performing Repairs ...63 Problem Resolution ...63 Power ...65 Buttons ...66 Display/Alarms ...67 N-600x Service Manual

Contents Operational Performance ...68 Data Port ...69 On-Screen Help ...70 Accessing Multiple Topics ...70 Accessing Single Topics ...72 Error Codes ...74 Additional Messages ...80 Primary Speaker Failure ...81

Disassembling the Monitor... 83 Overview ...83 Replacement Level ...84 Replacing the Fuse ...84 Disassembling the Monitor ...85 Assembling the Monitor ...88 Battery Replacement ...88 Removing the Old Battery ...88 Replacing the Battery ...89 Power Entry Module (PEM) Replacement ...90 Removing the Power Entry Module ...90 Replacing the Power Entry Module ...91 Power Supply Replacement ...91 Removing the Power Supply ...91 Replacing the Power Supply ...92 Cooling Fan Replacement ...93 Removing the Cooling Fan ...93 Replacing the Cooling Fan ...94 Display PCB Replacement ...95 Removing the Display PCB ...95 Replacing the Display PCB ...96 Main Board PCB Replacement ...97 Removing the Main Board PCB ...97 Replacing the Main Board PCB ...98 Alarm Speaker Replacement ...99 Removing the Alarm Speaker ...99 Replacing the Alarm Speaker ...101 Top Case Assembly Replacement ...102 Removing the Top Case Assembly ...102 Replacing the Top Case Assembly ...102

Spare Parts... 103 Overview ...103 Ordering Replacement Parts ...103 Spare Parts List ...104

Packing for Shipment... 107 Overview ...107 Returning the Monitor ...107 Repacking the Monitor Using the Original Carton ...108 Repacking the Monitor Using a Generic Carton ...109

Specifications... 111 Performance ...111 Electrical Requirements ...112 N-600x Service Manual

Contents Environmental Conditions ...114 Physical Characteristics ...115 Compliance ...115 Manufacturer’s Declaration ...117 Safety Tests ...124 Ground Integrity ...124 Earth Leakage Current ...124 Enclosure Leakage Current ...124 Patient Applied Risk Current ...125 Patient Isolation Risk Current ...125

Data Port Interface Protocol... 127 Overview ...127 Configuring the Data Port ...127 Communication Baud Rate ...128 Communication Protocol ...129 Language Selection ...131 Nurse Call Setup ...132 Analog Calibration Setup ...133 Philips Communications ...133 GE Marquette Communications ...134 Datex-Ohmeda AS/3 Communications ...135 Connecting to the Data Port ...136 Communicating with a Computer ...137 Dump Instrument Info (Option 1) ...137 Set Date and Time (Option 2) ...138 Dump Trend (Option 3) ...138 Dump Error Log (Option 4) ...138 Exit Interactive Mode (Option 5) ...138 Using Data on the Computer ...139 Real-Time Printout ...139 Column Heading ...141 Patient Data and Operating Status ...142 Trend Data Printout (ASCII Mode) ...144 Trend Printout (Graph Mode) ...145 Nurse Call ...145 Analog Output ...146

Technical Discussion... 147 Oximetry Overview ...147 Functional versus Fractional Saturation ...148 Measured versus Calculated Saturation ...148 SatSeconds Alarm Management ...149 Signal Processing ...149 OXIMAX Technology ...149 Block Diagram Theory ...150

Index... 177

N-600x Service Manual

iii

Contents

N-600x Service Manual

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-600x when recording the sensor event record to the sensor. The accuracy of the date and time is the responsibility of the N-600x. It is recommended that the N-600x user set the date and time to the correct value before a sensor event record-enabled sensor is connected, and that this date and 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 and time between monitors and the sensor event record data 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.

OXIMAX N-600x Service Manual

Introduction

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

WARNING: Do not spray, pour, or spill any liquid on the N-600x, its accessories, connectors, switches, or openings in the chassis as this may damage the pulse oximeter.

WARNING: Before attempting to open or disassemble the N-600x, disconnect the power cord to avoid possible injury.

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

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

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

WARNING: Pressing ALARM SILENCE will keep ALL alarms from sounding for the alarm silence duration period.

WARNING: When installing the monitor’s AC power cord, ensure the cord is carefully positioned to prevent tripping and entanglement.

Introduction

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-600x 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-600x and when handling any of the components of the N-600x. Caution: When reassembling the N-600x, tighten the screws that hold the cases together (10-in lbs. maximum). Overtightening could strip out the screw holes in the top case, rendering it unusable. Caution: When installing the power supply or the Main Board PCB, tighten the seven screws (4-in lbs. maximum). Overtightening could strip out the screw holes in the bottom case, rendering it unusable.

OXIMAX N-600x Service Manual

Introduction

Overview This manual contains information for servicing the Nellcor OXIMAX N-600xTM pulse oximeter. Only qualified service personnel should service this product. Before servicing the monitor, please read the OXIMAX N-600xTM Operator's Manual carefully for safe operation.

Monitor Description The N-600x monitor is intended for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The N-600x 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. Homecare 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 OXIMAX N-600x Operator's Manual. Through the use of the four softkeys, users 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 monitor can operate on AC power or on an internal battery. The controls and indicators for the N-600x are illustrated and identified in Figure 1 and Figure 2.

Introduction

Front Panel

1. SpO2 OXIMAX Sensor Port 2. Low Battery Indicator 3. AC Power Indicator 4. ON/STANDBY Button 5. Battery Fuel Gauge Indicator 6. Waveform Display 7. SatSecondsTM Indicator 8. %SpO2 Display 9. Pulse Rate Display 10. Alarm Silence Indicator 11. ALARM SILENCE Button

12. ADJUST UP Button 13. ADJUST DOWN Button 14. Neonate Mode Indicator 15. HELP/CONTRAST Button 16. Fast Response Mode Indicator 17. Softkeys 18. Menu Bar 19. Data In-Sensor Indicator 20. Interference Indicator 21. Pulse Search Indicator 22. Monitor Speaker

Figure 1: N-600x Front Panel

OXIMAX N-600x Service Manual

Introduction

Rear Panel 1

Type BF

N-600x SN

MADE IN IRELAND

T 0.50A 250V

TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT INCORPORATED PLEASANTON, CA USA 94588 AUTHORIZED REPRESENTATIVE: TYCO HEALTHCARE UK LTD GOSPORT PO13 0AS, UK

CISPR 11 Group 1 Class B

0123

IPX1

100-120 200-240V 50/60 Hz 30VA

1. Equipotential Terminal (Ground) 2. AC Power Connector 3. Data Port Connector 4. Fuse Holder 5. Supply Voltage Selector Switch

Figure 2: N-600x Rear Panel

Softkey Menu The monitor’s softkey menu hierarchy is outlined below. Choose the type of trend data to view by selecting the Monitor or Sensor trend data in the Trend menu. Sensor sub-menu choices differ depending on what type of patient alarm event data is stored in the sensor chip, such as, event or loop. The menu structure includes BACK softkey options to return to the previous menu level without exiting the Trend menu entirely. Trend data must be compiled on entry or re-entry to the Trend menu. When the softkeys are available, both BACK and EXIT options are available. The BACK softkey returns to the previous level and the EXIT softkey returns to the Main menu. If only one space is available, the BACK softkey is included, this may require returning one or two levels to access an EXIT softkey. The BACK and EXIT softkeys are positioned on the right-most softkeys, respectively. The menu structure below identifies:

•

BOLDFACE TYPE - softkey title as displayed on the monitor

•

Underlined Text - description of the softkey menu item

•

Italicized Text - the destination of the BACK and EXIT softkeys

Introduction (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 BACK (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) ZOOM (Monitor Trend Zoom Menu) TIME (Cycle through 48h, 36h, 24h, 12h, 8h, 4h, 2h, 1h, 30m, 15m, 40s, 20s for current view) SCALE (Cycle through ±5, ±10, ±15, ±20, ±25, ±30, ±35, ±40 and ±50 (units of BPM or %SpO2, depending on the data displayed) of the max and min. values under the cursor, default to 10-100 for SAT trend graph and 5-250 for Pulse trend graph if there is no data point under the cursor for current view) 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 Graph menu, the screen remains 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)

OXIMAX N-600x Service Manual

Introduction -

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) BACK (back to Trend menu) EXIT (to Main menu) (Sensor/Loop Menu) (If continuous-Loop data is in the sensor, the following displays) 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) SETUP (Setup Monitor Menu) VIEW (Setup View Menu) PLETH BLIP TREND VIEW (RT Trend View Menu) DUAL SPO2 PULSE BACK ZOOM (RT Trend View Menu) TIME SCALE AUTO BACK BACK (back to Setup 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)

Introduction -

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) 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 (Light Menu) OFF (turns display backlight off) EXIT (to Main menu)

OXIMAX N-600x Service Manual

Introduction

Related Documents An understanding of the OXIMAX N-600x monitor is critical in order to perform the tests, troubleshoot procedures, use the principles of operation, and circuit analysis sections of this manual. Refer to the OXIMAX N-600x Operator's Manual. To utilize the various Nellcor approved OXIMAX sensors used with the monitor, refer to the individual OXIMAX Sensor's Directions for Use (DFU). The OXIMAX N-600x Operator’s and Service Manuals are posted on the Internet at: http://www.nellcor.com

A Spare Parts and Accessories list is also posted on the Internet at: http://www.nellcor.com

Routine Maintenance

Cleaning the Monitor WARNING: Do not spray, pour, or spill any liquid on the N-600x, its accessories, connectors, switches, or openings in the chassis as this may damage the pulse oximeter. For surface-cleaning and disinfecting follow your institution's procedures or use the steps outlined below: To surface clean the monitor: 1. Obtain a soft cloth. 2. Dampen the cloth with either a commercial, non-abrasive cleaner or a solution of 70% alcohol in water. 3. Lightly wipe each exterior surface using the dampened soft cloth. To disinfect the monitor: 1. Saturate a soft cloth with 10% solution of chlorine bleach in tap water. 2. Lightly wipe each exterior surface using the saturated soft cloth. Caution: Before attempting to clean an SpO2 OXIMAX sensor, read the directions for use enclosed with the OXIMAX sensor. Each sensor model has specific cleaning instructions.

OXIMAX N-600x Service Manual

Routine Maintenance

Periodic Safety Checks The N-600x monitor requires no calibration. The battery should be replaced at least every two years. See Battery Replacement on page 88. The following safety checks should be performed at least every 24 months by a qualified service technician. To perform a periodic safety check: 1. Inspect the equipment for mechanical and functional damage. 2. Inspect safety labels for legibility. 3. Contact Nellcor’s Technical Services Department, 1.800.635.5267, or your local Nellcor representative if the labels are damaged.

Functional Checks If the monitor has been visibly damaged or subjected to mechanical shock (for example, if dropped), immediately perform the performance tests. See Performance Tests on page 16. The following checks should be performed at least every two years by a qualified service technician. To perform a functional check: 1. Perform the electrical safety tests detailed in Safety Tests on page 46. If the unit fails the tests, refer to Spare Parts on page 103. 2. Inspect the fuses for proper value and rating (F1 + F2 = 0.5 amp, 250 volts).

Routine Maintenance

Battery Operation The N-600x has an internal battery that can be used to power the monitor during transport or when AC power is not available. A new, fully-charged battery provides at least seven hours of monitoring time under the following conditions: •

No audible alarms sound

•

No analog or serial output devices are attached to the N-600x

•

Default display brightness setting

The monitor cannot be used when the battery is depleted unless the monitor is connected to an AC power source. A warning message displays and must be cleared by pressing the ALARM SILENCE button twice before the monitor can be used for patient monitoring. The pleth and blip displays include the Battery Fuel Gauge indicator that shows the remaining charge (operating hours). When the monitor is fully-charged, all four N-600x bars are lit on the indicator. Note: After three months of storage, the battery may lose its charge. The N-600x will not power up until the AC power is established. On AC power up, the battery fuel gauge shows empty. The N-600x operates on AC power while the battery is charging. Until the battery is recharged, the message, “UNIT WILL SHUT DOWN IF AC POWER IS LOST” appears. The monitor is now operational. Press the ALARM SILENCE button twice to remove the message from the screen. Caution: If the battery has been in storage for longer than six months, or if the battery does not fully recharge, the battery should be replaced. After the battery has been replaced and a new battery had been charged, an “EEE 575 Trends Lost” message appears when the N-600x is turned on. Turn the N-600x off and wait three seconds. Then turn the monitor on again. After the extended power-on self-test, the N-600x runs on AC or battery power. Caution: To fully recharge the monitor, it may take up to eight hours if the monitor is turned off or 12 hours if the monitor is turned on. Connect the monitor to an AC power outlet to charge a low or fully-depleted battery. Caution: The battery terminal clips may loosen after repeated insertions. After replacing the battery, check the battery terminal clips for secure fit and tighten if necessary (needle nose pliers may be used). WARNING: If the monitor is operating on an AC power source with a fullydepleted battery and the AC power is subsequently lost, the monitor will shut down immediately.

OXIMAX N-600x Service Manual

Routine Maintenance

When all of the following conditions are present for 15 minutes, the N-600x automatically shuts down: •

Monitor is running on battery power

•

No buttons have been pressed

•

No pulse has been detected (for example, when a patient is not connected to the OXIMAX sensor or the OXIMAX sensor is disconnected from the monitor)

•

No alarms are present (other than low battery or a non-correctable error)

Note: Whenever the monitor is connected to an AC power source, the battery is being charged. We recommend the monitor remain connected to an AC power source when not in use. This ensures full battery power when the monitor is needed. Caution: Repeated deep discharge reduces the life of the battery.

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