Service Manual
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Pulse Oximeter Service Manual
N-395 Pulse Oximeter
N-395
| Service Manual N-395 064750B-1202
To obtain information about a warranty, if any, for this product, contact Nellcor Technical Services (1.800.NELLCOR) or your local Nellcor representative. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Nellcor Puritan Bennett, Durasensor, and Oxisensor II are trademarks of Nellcor Puritan Bennett Inc. 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. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; 5,078,136; 5,351,685; and 5,368,026.
TABLE OF CONTENTS List of Figures List of Tables TABLE OF Contents ... List of Figures ... List of Tables ... SECTION 1: Introduction... 1.1 Manual Overview... 1.2 Description of N-395 Pulse Oximeter... 1.3 Related Documents... SECTION 2: Routine Maintenance ... 2.1 Cleaning ... 2.2 Periodic Safety and Functional Checks ... 2.3 Battery ... SECTION 3: Performance Verification ... 3.1 Introduction... 3.2 Equipment Needed... 3.3 Performance Tests ... 3.4 Safety Tests... SECTION 4: Power-On Settings and Service Functions... 4.1 Introduction... 4.2 Power-On Settings ... 4.3 Factory Default Settings ... 4.4 Service Functions... 4.5 Setting Institutional Defaults (Sample) ... SECTION 5: Troubleshooting ... 5.1 Introduction... 5.2 How to Use this Section ... 5.3 Who Should Perform Repairs ... 5.4 Replacement Level Supported ... 5.5 Returning the N-395 ... 5.6 Obtaining Replacement Parts ... 5.7 Troubleshooting Guide ... 5.8 Error Codes ... SECTION 6: Disassembly Guide... 6.1 Introduction... 6.2 Prior to Disassembly ... 6.3 Fuse Replacement ... 6.4 Monitor Disassembly ... 6.5 Monitor Assembly... 6.6 Battery Replacement... 6.7 Power Entry Module (PEM) Removal/Replacement ... 6.8 Power Supply Removal/Replacement... 6.9 Cooling Fan Removal/Replacement ... 6.10 Display PCB Removal/Replacement... 6.11 User Interface PCB Removal/Replacement... 6.12 Alarm Speaker Removal/Replacement ... SECTION 7: Spare Parts... 7.1 Introduction... SECTION 8: Packing For Shipment... 8.1 Introduction...
i iii iii 1-1 1-1 1-1 1-5 2-1 2-1 2-1 2-1 3-1 3-1 3-1 3-1 3-10 4-1 4-1 4-1 4-1 4-1 4-8 5-1 5-1 5-1 5-1 5-1 5-1 5-2 5-2 5-6 6-1 6-1 6-1 6-2 6-3 6-4 6-5 6-6 6-7 6-9 6-10 6-11 6-13 7-1 7-1 8-1 8-1
i
Table of Contents
8.2 General Instructions... 8-1 8.3 Repacking in Original Carton... 8-2 8.4 Repacking in a Different Carton... 8-3 SECTION 9: Specifications... 9-1 9.1 General ... 9-1 9.2 Electrical... 9-1 9.3 Physical Characteristics... 9-2 9.4 Environmental ... 9-2 9.5 Alarms ... 9-2 9.6 Factory Default Settings... 9-2 9.7 Performance ... 9-3 SECTION 10: Data Port Interface Protocol ... 10-1 10.1 Introduction ... 10-1 10.2 Configuring the Data Port ... 10-1 10.3 Connecting to the Data Port ... 10-5 10.4 Communications with a PC... 10-7 10.5 Using Data on ohe PC ... 10-8 10.6 Real-Time Printout ... 10-8 10.7 Trend Data Printout (ASCII Mode)... 10-11 10.8 Trend Printout (Graph Mode)... 10-12 10.9 Nurse Call ... 10-12 10.10 Analog Output ... 10-13 SECTION 11: Technical Supplement ... 11-1 11.1 Introduction ... 11-1 11.2 Oximetry Overview... 11-1 11.3 Satseconds Alarm Management... 11-2 11.4 Reads Through Motion ... 11-3 11.5 Circuit Analysis ... 11-3 11.6 Functional Overview ... 11-3 11.7 AC Input ... 11-3 11.8 Power Supply PCB ... 11-4 11.9 Battery... 11-5 11.10 User Interface PCB ... 11-5 11.11 Front Panel Display PCB And Controls ... 11-8 11.12 Schematic Diagrams... 11-9 SECTION 12: Index ... 12-1
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Table of Contents
LIST OF FIGURES Figure 1-1: N-395 Front Panel ... 1-2 Figure 1-2: N-395 Rear Panel... 1-2 Figure 1-3: Limits Softkey Map ... 1-3 Figure 1-4: Trend Softkey Map ... 1-3 Figure 1-5: Setup Softkey Map ... 1-4 Figure 3-1: N-395 Controls ... 3-2 Figure 3-2: Self-Test Display ... 3-2 Figure 3-3: Blip (Magnified) View... 3-3 Figure 3-4: Adjusting %SpO2 Upper Alarm Limit ... 3-3 Figure 3-5: Adjusting % SpO2 Lower Alarm Limit ... 3-4 Figure 3-6: Adjusting High Pulse Rate Alarm ... 3-4 Figure 3-7: Adjusting Low Pulse Rate Alarm ... 3-4 Figure 3-8: SatSeconds Alarm... 3-5 Figure 3-9: Data Port Pinouts ... 3-8 Figure 4-1: Service Function Softkeys... 4-2 Figure 4-2: Service Function Softkey Map... 4-2 Figure 4-3: PARAM Softkeys ... 4-3 Figure 4-4: PRINT Softkeys ... 4-4 Figure 4-5: Trend Printout... 4-4 Figure 4-6: Errlog Printout... 4-5 Figure 4-7: Instat Printout ... 4-5 Figure 4-8: INFO Printout... 4-6 Figure 4-9: NEXT Softkeys ... 4-6 Figure 4-10: ALARMS Softkeys ... 4-6 Figure 4-11: Service Function Softkeys... 4-7 Figure 4-12: Service Function NEXT Softkey ... 4-7 Figure 4-13: Service Function ALARMS Softkey... 4-7 Figure 4-14: Service Function Softkeys... 4-8 Figure 4-15: PARAM Softkeys ... 4-9 Figure 4-16: SAVE Softkeys ... 4-9 Figure 6-1: Fuse Removal ... 6-2 Figure 6-2: N-395 Corner Screws... 6-3 Figure 6-3: Separating Case Halves... 6-4 Figure 6-4: N-395 Battery ... 6-5 Figure 6-5: Power Entry Module ... 6-6 Figure 6-6: Power Supply ... 6-7 Figure 6-7: Cooling Fan ... 6-9 Figure 6-8: Display PCB ... 6-10 Figure 6-9: User Interface PCB ... 6-12 Figure 6-10: Alarm Speaker... 6-13 Figure 7-1: N-395 Expanded View... 7-2 Figure 8-1: Repacking the N-395... 8-2 Figure 10-1: Data Port Softkeys ... 10-1 Figure 10-2: SpaceLabs Connection ... 10-3 Figure 10-3: Data Port Pin Layout ... 10-6 Figure 10-4: Real-Time Printout ... 10-9 Figure 10-5: Trend Data Printout (ASCII Mode) ... 10-11 Figure 10-6: Trend Data Printout (GRAPH MODE)... 10-12 Figure 11-1: Oxyhemoglobin Dissociation Curve ... 11-2 Figure 11-2: N-395 Functional Block Diagram ... 11-3 Figure 11-3: Linear Power Supply Schematic ... 11-9
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Table of Contents
Figure 11-4: 404 Analog Front End Schematic ... 11-9 Figure 11-5: 404 Analog Front End and Pre-Amp Schematic... 11-9 Figure 11-6: 404 Analog and Digital Schematic... 11-9 Figure 11-7: 404 DSP Core and Communication Schematic... 11-9 Figure 11-8: 404 Front End to 331 Core Communication Schematic ... 11-9 Figure 11-9: 404 Front End Power Supplies Schematic ... 11-9 Figure 11-10: SIP/SOP Interface Schematic... 11-9 Figure 11-11: SIP/SOP Interface Schematic... 11-9 Figure 11-12: MC331 CPU Core Schematic ... 11-9 Figure 11-13: MC331 Memory Schematic ... 11-9 Figure 11-14: Contrast and Sound Schematic ... 11-9 Figure 11-15: Power Supply Schematic... 11-9 Figure 11-16: Display Interface and Drivers Schematic... 11-9
LIST OF TABLES Table 3-1: Dynamic Operating Range... 3-8 Table 5-1: Problem Categories ... 5-2 Table 5-2: Power Problems... 5-3 Table 5-3: Button Problems... 5-4 Table 5-4: Display/Alarms Problems ... 5-4 Table 5-5: Operational Performance Problems... 5-5 Table 5-6: Data Port Problems... 5-6 Table 5-7: Error Codes... 5-6 Table 6-1: Power Supply Lead Connections... 6-8 Table 7-1: Parts List ... 7-1 Table 9-1: Factory Default Settings (Adult) ... 9-2 Table 9-2: Factory Default Settings (Neonate)... 9-3 Table 10-1: Data Port Pin Outs ...10-6 Table 10-2: Printout Codes ...10-11 Table 10-3: Nurse Call Relay Pin States...10-12 Table 10-4: Rating of Nurse Call Relay...10-13
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SECTION 1: INTRODUCTION 1.1 1.2 1.3
1.1
Manual Overview Description of N-395 Pulse Oximeter Related Documents
MANUAL OVERVIEW The latest version of this manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html This manual contains information for servicing the Nellcor model N-395 pulse oximeter. Only qualified service personnel should service this product. Before servicing the N-395, read the operator’s manual carefully for a thorough understanding of operation. WARNING: Explosion hazard. Do not use the N-395 pulse oximeter in the presence of flammable anesthetics.
1.2
DESCRIPTION OF N-395 PULSE OXIMETER The N-395 pulse oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-395 is intended for use with neonatal, pediatric, and adult patients during both no-motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only. Note:
“Hospital type” environments include surgicenters (including physician office based facilities, sleep labs, and skilled nursing facilities). Use with any particular patient requires the selection of an appropriate oxygen transducer as described in the operator’s manual. Motion performance claims are applicable to Nellcor models D-25, N-25, I-20, D-20, and D-25L oximetry sensors.
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-395 can operate on AC power or on an internal battery. The controls and indicators for the N-395 are illustrated in Figure 1-1 and Figure 1-2.
1-1
Section 1: Introduction
1. SpO2 Sensor Port 2. AC/Battery Charging Indicator 3. Power On/Off Button 4. Low Battery Indicator 5. Waveform Display Area 6. SatSeconds™ Indicator 7. %SpO2 Indicator 8. Pulse Rate Display 9. Alarm Silence Indicator 10. Alarm Silence Button
11. Adjust Up Button 12. Adjust Down Button 13. Neonate Indicator 14. Contrast Button 15. Softkeys 16. Menu Bar 17. Motion Indicator 18. Pulse Search Indicator 19. Speaker
Figure 1-1: N-395 Front Panel
1. Equipotential (ground) Terminal 2. AC Inlet 3. DB-15 Interface Connector (Data Port)
4. Fuse Receptacle 5. Voltage Selection Switch
Figure 1-2: N-395 Rear Panel Figures 1-3, 1-4, and 1-5 illustrate 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 N-395 operator's manual.
1-2
Section 1: Introduction
Figure 1-3: Limits Softkey Map
Figure 1-4: Trend Softkey Map
1-3
Section 1: Introduction
Figure 1-5: Setup Softkey Map
1-4
Section 1: Introduction
1.3
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 monitor. Refer to the N-395 operator’s manual. To understand the various Nellcor sensors that work with the monitor, refer to the individual sensor’s directions for use. The latest version of this manual and Nellcor Sensor’s directions for use are available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html
1-5
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SECTION 2: ROUTINE MAINTENANCE 2.1 2.2 2.3
2.1
Cleaning Periodic Safety and Functional Checks Battery
CLEANING Caution: Do not immerse the N-395 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 N-395, 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.
2.2
PERIODIC SAFETY AND FUNCTIONAL CHECKS The following checks should be performed at least every 2 years by qualified service technicians.
2.3
1.
Inspect the exterior of the N-395 equipment for damage.
2.
Inspect the safety labels for legibility. If the labels are not legible, contact Nellcor Technical Services Department or your local Nellcor representative.
3.
Verify that the unit performs properly as described in paragraph 3.3.
4.
Perform the electrical safety tests detailed in paragraph 3.4. If the unit fails these electrical safety tests, repair the unit or contact Nellcor Technical Services Department or your local Nellcor representative for assistance.
5.
Inspect the fuses for proper value and rating (F1 & F2 = 0.5 amp slow blow).
BATTERY Nellcor recommends replacing the instrument's battery every 2 years. When the N395 is going to be stored for 3 months or more, remove the battery prior to storage. To replace or remove the battery, refer to Section 6, Disassembly Guide. If the N-395 has been stored for more than 30 days, charge the battery as described in paragraph 3.3.1. A fully discharged battery requires 14 hours with the monitor in standby, or 18 hours if it is in use, to receive a full charge. The battery is being charged whenever the instrument is plugged into AC. Note:
If power stored in the battery is too low, the unit will not operate even when plugged into AC. If this occurs, leave the unit plugged in to allow the battery to charge as described in paragraph 3.3.1. After approximately 10 minutes, the battery should have enough charge to allow the unit to operate on AC.
2-1
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SECTION 3: PERFORMANCE VERIFICATION 3.1 3.2 3.3 3.4
3.1
Introduction Equipment Needed Performance Tests Safety Tests
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-395 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 N-395 fails to perform as specified in any test, repairs must be made to correct the problem before the monitor is returned to the user.
3.2
EQUIPMENT NEEDED Equipment
3.3
Description
Digital multimeter (DMM)
Fluke Model 87 or equivalent
Durasensor ® oxygen transducer
DS-100A
Oxisensor ® II oxygen transducer
D-25
Pulse oximeter tester
SRC-2
Safety analyzer
Must meet current AAMI ES1/1993 & IEC 601-1/1998 specifications
Sensor extension cable
SCP-10 or MC-10
Data interface cable
EIA-232 cable (optional)
Stopwatch
Manual or electronic
PERFORMANCE TESTS The battery charge procedure should be performed before monitor repairs whenever possible. Note:
3.3.1
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. Refer to paragraph 4.4.3, PARAM, subparagraph RESET.
Battery Charge
Perform the following procedure to fully charge the battery. 1.
Connect the monitor to an AC power source.
2.
Verify that the monitor is off and that the AC Power/Battery Charging indicator is lit.
3.
Charge the battery for at least 14 hours in standby.
3-1
Section 3: Performance Verification
3.3.2
Power-Up Performance
The power-up performance tests (3.3.2.1 through 3.3.2.2) verify the following monitor functions: • 3.3.2.1 Power-On Self-Test • 3.3.2.2 Power-On Defaults and Alarm Limit Ranges
Figure 3-1: N-395 Controls 3.3.2.1
Power-On Self-Test
1.
Connect the monitor to an AC power source and verify that the AC Power/Battery Charging indicator is lit.
2.
Do not connect any input cables to the monitor.
3.
Observe the monitor front panel. With the monitor off, press the POWER ON/OFF button (Figure 3-1). The monitor must perform the following sequence: a. Within 2 seconds, all LEDs are illuminated, all pixels on the LCD display are illuminated, and the backlight comes on. b. The indicators remain lighted. c. The LCD display shows NELLCOR and the software version of the N-395 (Figure 3-2). Note:
The software “Version” displayed in Figure 3-2 is X.X.X.X. The actual software version will be displayed on the monitor.
Figure 3-2: Self-Test Display
3-2
Section 3: Performance Verification
d. A 1-second beep sounds, indicating proper operation of the speaker, and all indicators turn off except the AC Power/Battery Charging indicator and the LCD screen. e. The N-395 begins normal operation. 3.3.2.2
Power-On Defaults and Alarm Limit Ranges
Note:
When observing or changing alarm limits, a 10-second timeout is in effect. If no action is taken within 10 seconds, the monitor automatically returns to the monitoring display.
Note:
The descriptions that follow are based on the assumption that Pleth view is the view that has been selected. The steps for changing an alarm limit are the same if the view being used is Blip (Magnified) view (Figure 3-3).
Figure 3-3: Blip (Magnified) View Note: 1.
Power-on defaults will be the factory-set defaults or the defaults set by your institution.
Ensure that the monitor is on. Press and release the LIMITS softkey. Verify that the monitor emits a single beep and the pleth view is replaced with a display of the alarm limits. The upper alarm limit for %SpO2 will indicate an alarm limit of "100" inside a box (Figure 3-4).
Figure 3-4: Adjusting %SpO2 Upper Alarm Limit Note: 2.
Press the LIMITS softkey. Press and hold the DOWN ARROW button. Verify that the boxed number for %SpO2 upper alarm limit reduces to a minimum of "85." See Figure 3-5.
Note: 3.
After 10 seconds with no activity, normal display is resumed.
A decimal point in the display indicates that the alarm limits have been changed from factory default values.
Press the SELECT softkey. Verify that the monitor emits a single beep and the box moves to the %SpO2 lower alarm limit of "85."
3-3
Section 3: Performance Verification
Figure 3-5: Adjusting % SpO2 Lower Alarm Limit 4.
Press and hold the DOWN ARROW button and verify that the %SpO2 lower alarm limit display reduces to a minimum of "20." Press and hold the UP ARROW button and verify that the %SpO2 lower alarm limit display cannot be raised past the upper alarm limit setting of "85." Press the EXIT softkey.
5.
Press the LIMITS softkey and then press the SELECT softkey three times. Verify that the monitor emits a beep after each keystroke. The Pulse upper alarm limit should be "170" and should be boxed. See Figure 3-6.
Figure 3-6: Adjusting High Pulse Rate Alarm 6.
Press and hold the DOWN ARROW button. Verify that the minimum displayed value is "40" for the Pulse upper alarm limit. Press the EXIT softkey.
7.
Press the LIMITS softkey and then press the SELECT softkey four times. Verify that the Pulse lower alarm limit display indicates an alarm limit of "40" and is boxed. See Figure 3-7.
Figure 3-7: Adjusting Low Pulse Rate Alarm 8.
Press and hold the DOWN ARROW button. Verify that the boxed Pulse lower alarm limit display reduces to a minimum of "30."
9.
Press and hold the UP ARROW button and verify that the boxed Pulse lower alarm limit display cannot be adjusted above the Pulse high limit of "40."
10. Press the LIMITS softkey and then press the SELECT softkey two times. Verify that SatSeconds SECS alarm is selected. See Figure 3-8.
3-4
Section 3: Performance Verification
Figure 3-8: SatSeconds Alarm 11. Press the UP ARROW button repeatedly and verify that the SatSeconds alarm display cycles from OFF through 10, 25, 50, 100, OFF. 12. Press the POWER ON/OFF button to turn the monitor off. 13. Press the POWER ON/OFF button to turn the N-395 back on. 14. Press and release the LIMITS softkey. Verify that the %SpO2 upper alarm limit display is boxed and indicates an alarm limit of "100." 15. Press the SELECT softkey. Verify that the %SpO2 lower alarm limit display is boxed and indicates an alarm limit of "85." 16. Press the SELECT softkey. Verify that the SatSeconds SECS alarm is set to OFF. 17. Press the SELECT softkey. Verify that the Pulse upper alarm limit display is boxed and indicates an alarm limit of "170." 18. Press the SELECT softkey. Verify that the Pulse lower alarm limit display is boxed and indicates an alarm limit of "40." 19. Press the POWER ON/OFF button to turn the monitor off. 3.3.3
Operation with a Pulse Oximeter Tester
Operation with an SRC-2 pulse oximeter tester includes the following tests: •
3.3.3.1 Alarms and Alarm Silence
•
3.3.3.2 Alarm Volume Control
•
3.3.3.3 Pulse Tone Volume Control
•
3.3.3.4 Dynamic Operating Range
•
3.3.3.5 Nurse Call
•
3.3.3.6 Analog Output
•
3.3.3.7 Operation on Battery Power
3-5
Section 3: Performance Verification
3.3.3.1
Alarms and Alarm Silence 1.
Connect the SRC-2 pulse oximeter tester to the sensor-input cable and connect the cable to the monitor. Set the SRC-2 as follows: SWITCH
POSITION
RATE LIGHT MODULATION RCAL/MODE
38 LOW OFF RCAL 63/LOCAL
2.
Press the POWER ON/OFF button to turn the monitor on. After the normal power-up sequence, press the following softkeys: SETUP, VIEW, and PLETH. Verify that the %SpO2 and Pulse initially indicate zeroes.
3.
Move the modulation switch on the SRC-2 to LOW.
4.
Verify the following monitor reactions: a. b. c. d.
e.
5.
Press and hold the ALARM SILENCE button on the front of the monitor for less than 3 seconds. Verify that the %SpO2 display indicates "60" and the Pulse display indicates "SEC" while the ALARM SILENCE button is pressed. When the button is released, the alarm is silenced.
6.
With the alarm silenced, verify the following: a. b. c. d. e.
3-6
The plethysmograph waveform begins to track the artificial pulse signal from the SRC-2. The pulse tone is heard. Zeroes are displayed in the %SpO2 and Pulse displays. Within 20 seconds, the monitor displays saturation and pulse rate as specified by the tester. Verify that the values are within the following tolerances: Oxygen Saturation Range 79% to 83% Pulse Rate Range 37 to 39 bpm The audible alarm sounds and both the %SpO2 and Pulse displays flash, indicating that both parameters have violated the default alarm limits.
The alarm remains silenced for 60 seconds. The Alarm Silence indicator lights. The %SpO2 and Pulse displays continue to flash. The pulse tone is still audible. The audible alarm returns in approximately 60 seconds.
7.
Press and hold the ALARM SILENCE button. Within 3 seconds, press the DOWN ARROW button until the Pulse Rate display indicates "30." Press the UP ARROW button and verify that the displays indicate 60 SEC, 90 SEC, 120 SEC, and OFF. Release the button when the display indicates "OFF."
8.
Press and release the ALARM SILENCE button. Verify that the Alarm Silence Indicator flashes.