Service Manual
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SERVICE MANUAL NPB-4000/4000C Patient Monitor
To contact Mallinckrodt, Inc. representative: in the United States, call 1-800-635-5267: outside of the United States, call your local Mallinckrodt representative. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
©2000 Mallinckrodt Inc. All rights reserved
062643A-0700
Mallinckrodt Inc. 675 McDonnell Boulevard P.O. Box 5980 St. Louis, MO 63134 Telephone 314.654.2000 Toll Free 1.800.635.5267 Mallinckrodt Europe BV Hambakenwettering 1 5231 DD’s-Hertogenbosch The Netherlands Telephone +31.73.6485200 Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588
To obtain information about a warranty, if any, for this product, contact Mallinckrodt Technical Services or your local Mallinckrodt representative. Nellcor Puritan Bennett Inc. is a wholly owned subsidiary of Mallinckrodt Inc. Nellcor, Nellcor Puritan Bennett, Durasensor,and Oxisensor II are trademarks of Mallinckrodt Inc. Purchase of this instrument confers no expressed or implied license under any Mallinckrodt patent to use the instrument with any sensor that is not manufactured or licensed by Mallinckrodt. 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.
www.mallinckrodt.com
TABLE OF CONTENTS List of Figures List of Tables
List of Figures... vi List of Tables ... viii Section 1: Introduction ... 1-1 1.1 Manual Overview... 1-1 1.2 Warnings, Cautions, and Notes ... 1-1 1.3 NPB-4000/C Patient Monitor Description ... 1-1 1.4 Related Documents... 1-2 Section 2: Routine Maintenance... 2-1 2.1 Cleaning ... 2-1 2.2 Periodic Safety and Functional Checks... 2-1 2.3 Batteries ... 2-2 2.4 Environmental Protection ... 2-2 Section 3: Performance Verification... 3-1 3.1 Introduction... 3-1 3.2 Equipment Needed... 3-1 3.3 Performance Tests... 3-2 3.4 Safety Tests ... 3-17 Section 4: Power-Up Defaults Menu and Diagnostic Mode ... 4-1 4.1 Introduction... 4-1 4.2 Power-Up Defaults Menu ... 4-1 4.3 Diagnostic Mode... 4-3 Section 5: Troubleshooting... 5-1 5.1 Introduction... 5-1 5.2 How to Use This Section ... 5-1 5.3 Who Should Perform Repairs ... 5-1 5.4 Replacement Level Supported ... 5-1 5.5 Obtaining Replacement Parts ... 5-1 5.6 Troubleshooting Guide ... 5-2 Section 6: Disassembly Guide ... 6-1 6.1 Introduction... 6-1 6.2 How to Use This Section ... 6-1 6.3 Disassembly Sequence Flow Charts... 6-3 6.4 Closed Case Disassembly Procedures... 6-4 6.5 Front Case Disassembly Procedures... 6-6 6.6 Rear Case Disassembly Procedures ... 6-10 Section 7: Spare Parts ... 7-1 7.1 Introduction... 7-1 Section 8: Packing For Shipment ... 8-1 8.1 General Instructions ... 8-1 8.2 Repacking In Original Carton ... 8-1 8.3 Repacking In a Different Carton... 8-1 Section 9: Specifications... 9-1 9.1 Scope ... 9-1 9.2 General... 9-1 9.3 Electrical... 9-2 9.4 Environmental ... 9-2 9.5 Measuring Parameters... 9-3 9.6 Trends ... 9-6
iii
Contents
Section 10: Introduction and System Description ... 10-1 10.1 System Overview ... 10-1 10.2 System Block Diagram... 10-1 10.3 ECG Processing... 10-5 10.4 Respiration Processing ... 10-6 10.5 NIBP Processing ... 10-6 10.6 SpO2 Processing... 10-6 10.7 Temperature Processing... 10-6 Section 11: Isolated Front End Functions - Theory of Operation ... 11-1 11.1 Block Diagram... 11-1 11.2 Overview ... 11-2 11.3 Interface Circuit ... 11-4 11.4 ECG... 11-5 11.5 Respiratory Circuit... 11-7 11.6 Temperature Circuit ... 11-7 11.7 Optocouplers ... 11-8 11.8 Controls ... 11-9 11.9 A/D Converter... 11-10 11.10 Isolated Power Supply... 11-12 11.11 SpO2 Board ... 11-12 11.12 Isolation ... 11-12 Section 12: NIBP - Theory of Operation... 12-1 12.1 NIBP System Overview ... 12-1 12.2 The Pneumatic Assembly ... 12-3 12.3 NIBP Hardware ... 12-3 Section 13: Microprocessor Computer and Control –Theory of Operation... 13- 1 13.1 General... 13-1 13.2 Power Supply Connections ... 13-2 13.3 NIBP Processing ... 13-4 13.4 Recorder Operation... 13-5 13.5 Isolated Front End Interface ... 13-7 13.6 RS-232 Serial Port Interface ... 13-8 13.7 CPU Connections... 13-9 13.8 DRAM Control ... 13-12 13.9 FLASH Control ... 13-14 13.10 LCD Display... 13-16 13.11 Real-Time Clock (RTC)... 13-18 13.12 DUART Control ... 13-19 13.13 Knob Interface Control ... 13-19 13.14 Switch Control ... 13-20 13.15 Miscellaneous Control - CS5#... 13-20 13.16 Digital Schematic Figure 17-5 Through Figure 17-7 ... 13-23 13.17 Current Drain Of Digital Electronics ... 13-25 Section 14: Main Color Board Digital Theory of Operation ... 14-1 14.1 General... 14-1 14.2 Power Supply Connections ... 14-3 14.3 CPU Connections... 14-5 14.4 LNA 386EX Connections... 14-7 14.5 CPU Timing Signals ... 14-7 14.6 DRAM Control ... 14-8 14.7 FLASH Control ... 14-10 14.8 LCD Display... 14-12 14.9 Real Time Clock (RTC) ... 14-15 14.10 DUART Control ... 14-16
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Contents
14.11 Knob Interface Control ... 14-17 14.12 Push Button Control ... 14-17 14.13 Miscellaneous Control - CS5#... 14-17 14.14 Speaker ... 14-20 14.15 NIBP (Non Invasive Blood Pressure) Control... 14-20 14.16 Front End Interface... 14-24 14.17 Digital Schematic... 14-26 14.18 Block Diagram... 14-37 14.19 Current Drain of Digital Electronics ... 14-39 Section 15: Power Supply - Theory of Operation... 15-1 15.1 Overview ... 15-1 15.2 AC Mains Flyback Power Supply ... 15-3 15.3 Battery Charger ... 15-5 15.4 Buck Converter Operation... 15-5 15.5 Power Devices ... 15-6 15.6 Miscellaneous Control ... 15-7 15.7 System Power Supply ... 15-7 15.8 Mains (AC) Led Operation... 15-8 15.9 Power Supply Control Logic ... 15-9 15.10 Alarm Section ... 15-10 15.11 NIBP Pump Control ... 15-10 15.12 Safety Devices ... 15-10 Section 16: MP-205 Service Manual (Npb P/N: 044540A-0296)... 16-1 16.1 Overview ... 16-1 16.2 Module Descripton ... 16-1 16.3 Circuit Description ... 16-2 16.4 Interconnections ... 16-2 16.5 Sensor Interconnect ... 16-2 16.6 Oxichip Circuit ... 16-2 16.7 Preamp... 16-3 16.8 Programmable Gain Amplifier (PGA), Demodulator and Demultiplexer ... 16-3 16.9 Filters and Level Shifter... 16-3 16.10 LED Driver... 16-4 16.11 Reset Schmitt Trigger ... 16-4 16.12 High Resolution A/D Converter ... 16-4 16.13 Input Filter ... 16-4 16.14 Power Decoupling ... 16-5 16.15 Status and Timing ... 16-5 16.16 Analog Power Regulation ... 16-5 16.17 Microcontroller... 16-5 16.18 Troubleshooting The MP-205... 16-7 16.19 Packing for Shipment ... 16-13 16.20 MP205 Specifications... 16-14 Section 17: Drawings ... 17-1 17.1 Overview ... 17-1 17.2 List of Figures... 17-1
v
Contents
LIST OF FIGURES Figure 6-1: NPB-4000/C Disassembly Sequence Flow Chart, Sheet 1 ...6-3 Figure 6-2: NPB-4000/C Disassembly Sequence Flow Chart, Sheet 2 ...6-4 Figure 7-1: NPB-4000/C Top Assembly Drawing...7-2 Figure 7-2: NPB-4000/C Front Case Assembly Diagram (Sheet 1 of 2)...7-4 Figure 7-3: NPB-4000/C Front Case Assembly Diagram (Sheet 2 of 2)...7-6 Figure 7-4: NPB-4000/C Rear Case Assembly Diagram (Sheet 1 of 2) ...7-8 Figure 7-5: NPB-4000/C Rear Case Assembly Diagram (Sheet 2 of 2) ...7-10 Figure 7-6: NPB-4000/C Power Supply/Heat Sink Assembly Diagram...7-12 Figure 10-1: NPB-4000/C System Block Diagram ...10-2 Figure 11-1: NPB-4000/C Simplified Block Diagram...11-1 Figure 11-2: Isolated Front End Block Diagram ...11-2 Figure 11-3: Front End Block Diagram, Expanded ...11-3 Figure 11-4: Interface Circuit Block Diagram ...11-4 Figure 11-5: ECG Circuit Block Diagram ...11-5 Figure 11-6: Respiratory Circuit Block Diagram ...11-7 Figure 11-7: Optocouplers Block Diagram ...11-8 Figure 11-8: Controls Block Diagram ...11-9 Figure 12-1: NPB-4000/C System Block Diagram ...12-1 Figure 12-2: NIBP System Block Diagram ...12-2 Figure 12-3: Oxcillatory Characteristics Diagram...12-2 Figure 12-4: Pneumatic Assembly Block Diagram...12-3 Figure 12-5: NIBP Hardware Block Diagram ...12-3 Figure 13-1: Power Supply Interface ...13-2 Figure 13-2: NIBP Processing Circuitry Block Diagram ...13-4 Figure 13-3: Recorder System Block Diagram...13-6 Figure 13-4: Isolated Front End Block Diagram ...13-7 Figure: 13-5: 16 Bit Word ...13-8 Figure 13-6: Watch Dog Timer Block Diagram ...13-11 Figure 13-7: CPU Signals...13-12 Figure 13-8: DRAM Timing...13-13 Figure 13-9: RAS# and CAS# Requirements...13-14 Figure 13-10: Flash Cycle ...13-15 Figure 13-11: Write Pulse ...13-15 Figure 13-12: DS1693 Timing ...13-18 Figure 13-13: Interface Timing ...13-19 Figure 13-14: DUART Control ...13-19 Figure 13-15: Digital Section Block Diagram...13-24 Figure 14-1: Power Supply Connections ...14-3 Figure 14-2: LNA 386EX CONNECTIONS ...14-7 Figure 14-3: CPU Timing Diagram...14-8 Figure 14-4: DRAM Timing...14-9 Figure 14-5: RAS# and CAS# Timing ...14-9 Figure 14-6: Flash Read Timing...14-11 Figure 14-7: Flash Write Timing...14-11 Figure 14-8: DS1693 Timing ...14-15 Figure 14-9: Interface Timing ...14-16 Figure 14-10: DUART Read/Write Timing ...14-16 Figure 14-11: Oscillatory Characteristics Diagram...14-21 Figure 14-12: Pneumatic Assembly Block Diagram...14-22 Figure 14-13: NIBP Hardware Block Diagram ...14-23 Figure 14-14: NPB-4000C Color Motherboard Block Diagram ...14-38 Figure 15-1: Power Supply Block Diagram ...15-2 Figure 15-2: Power Supply Detail Diagram ...15-2 Figure 15-3: General Flyback Circuit Concept ...15-3 Figure 15-4: AC Power Supply Block Diagram ...15-3 Figure 15-5: Buck Converter Circuit ...15-5 Figure 15-6: Float Voltage vs. Temperature ...15-6
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Contents
Figure 16-1: Preamplifier and PGA Outputs ...16-9 Figure 16-2: Filter Outputs and ADC Input...16-10 Figure 16-3: MP-205 with an SRC-2 Filter Output ...16-11 Figure 16-4: MP-205 with an SRC-2 LED Drive Current Test at TP7 ...16-12 Figure 16-5: MP-205 with SRC-2 Serial Port TXD Signal, U4 Pin 25 ...16-13 Figure 17-1: MP-205 PCB Schematic (Sheet 1 of 2) ...17-3 Figure 17-2: MP-205 PCB Schematic (Sheet 2 of 2) ...17-5 Figure 17-3: NPB-4000/C Power Supply PCB Schematic (Sheet 1 of 2)...17-7 Figure 17-4: NPB-4000/C Power Supply PCB Schematic (Sheet 2 of 2)...17-9 Figure 17-5: NPB-4000/C Main PCB Schematic (Sheet 1 of 3)...17-11 Figure 17-6: NPB-4000/C Main PCB Schematic (Sheet 2 of 3)...17-13 Figure 17-7: NPB-4000/C Main PCB Schematic (Sheet 3 of 3)...17-15 Figure 17-8: NPB-4000/C Interconnect Diagram ...17-17 Figure 17-9: NPB-4000C Color Motherboard Schematic...17-19
vii
Contents
LIST OF TABLES Table 3-1: Required Test Equipment…………………………………. 3-1 Table 3-2: Dynamic Operating Range………………………………… 3-7 Table 3-3: Serial Port Voltage…………………………………………. 3-16 Table 3-4: Earth Leakage Current Values……………………………. 3-18 Table 3-5: Enclosure Leakage Current……………………………….. 3-19 Table 3-6: Patient Leakage Current Values………………………….. 3-20 Table 3-7: Patient Leakage Current Values – Mains Voltage on Applied Part…………………………………………….. 3-21 Table 3-8: Test Lead Combinations…………………………………… 3-21 Table 3-9: Allowable Leakage Current………………………………... 3-22 Table 4-1: Power-up Defaults Menu…………………………………… 4-2 Table 4-2: A/D Channel Designators………………………………….. 4-5 Table 5-1: Problem Categories………………………………………… 5-2 Table 5-2: Power Problems…………………………………………….. 5-3 Table 5-3: Serviceable Hardware Error Codes………………………. 5-4 Table 5-4: Error Code Categories……………………………………… 5-6 Table 5-5: Switches/Knob Problems…………………………………… 5-7 Table 5-6: Display/Audible Tones Problems………………………….. 5-8 Table 5-7: Operational Performance Problems………………………. 5-9 Table 7-1: Top Assembly (Figure 7-1)………………………………… 7-3 Table 7-2: Front Case Assembly (Figure 7-2)………………………… 7-5 Table 7-3: Front Case Assembly (Figure 7-3)………………………… 7-7 Table 7-4: Rear Case Assembly (Figure 7-4)………………………… 7-9 Table 7-5: Rear Case Assembly (figure 7-5)…………………………. 7-11 Table 7-6: Power Supply Assembly (Figure 7-6)…………………….. 7-13 Table 7-7: NPB-4000/C Accessories………………………………….. 7-13 Table 16-1: Oxichip Circuit Pin Descriptions…………………………. 16-5 Table 16-2: Fault Evaluation…………………………………………… 16-7 Table 16-3: Reported Errors…………………………………………… 16-8
viii
SECTION 1: INTRODUCTION 1.1 1.2 1.3 1.4
Manual Overview Warnings, Cautions, and Notes NPB-4000/C Patient Monitor Description Related Documents
1. INTRODUCTION 1.1 MANUAL OVERVIEW
This manual contains information for servicing the model NPB-4000 and NPB-4000C patient monitor, subsequently referred to as NPB-4000/C throughout this manual. Only qualified service personnel should service this product. Before servicing the NPB-4000/C, read the operator’s manual carefully for a thorough understanding of operation. 1.2 WARNINGS, CAUTIONS, AND NOTES
This manual uses three terms that are important for proper operation of the monitor: Warning, Caution, and Note. 1.2.1 Warning
A warning precedes an action that may result in injury or death to the patient or user. Warnings are boxed and highlighted in boldface type. 1.2.2 Caution
A caution precedes an action that may result in damage to, or malfunction of, the monitor. Cautions are highlighted in boldface type. 1.2.3 Note
A note gives information that requires special attention. 1.3 NPB-4000/C PATIENT MONITOR DESCRIPTION
The purpose and function of the NPB-4000/C patient monitor is to monitor: ECG; heart rate; noninvasive blood pressure (systolic, diastolic, and mean arterial pressures); functional arterial oxygen saturation; respiration rate; and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances. The physical and operational characteristics of the monitor are described in the operator’s manual and in the Specifications section of this manual.
1-1
Section 1: Introduction
1.4 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 NPB-4000/C operator’s manual. To understand the various Nellcor sensors, ECG leads, blood pressure cuffs, and temperature probes that work with the monitor, refer to the individual directions for use that accompany these accessories.
1-2
SECTION 2: ROUTINE MAINTENANCE 2.1 2.2 2.3 2.4
Cleaning Periodic Safety and Functional Checks Batteries Environmental Protection
2. ROUTINE MAINTENANCE 2.1 CLEANING
WARNING: Do not immerse the NPB-4000/C 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 NPB-4000/C, 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 or switches. Do not allow any liquids to penetrate connectors or openings in the instrument. For cables, sensors and cuffs, follow the cleaning instructions in the directions for use that accompany these accessories. 2.2 PERIODIC SAFETY AND FUNCTIONAL CHECKS
The NPB-4000/C requires no routine service or calibration other than cleaning and battery maintenance. The following performance verification tests may be used following repair or during routine maintenance (if required by your local institution). 1.
Inspect the exterior of the NPB-4000/C for damage.
2.
Inspect labels for legibility. If the labels are not legible, contact Mallinckrodt Technical Services Department or your local Mallinckrodt 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, do not attempt to repair. Contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative.
2-1
Section 2: Routine Maintenance
2.3 BATTERIES
If the NPB-4000/C has not been used for a long period of time, the battery will need charging. To charge the battery, connect the NPB-4000/C to an AC outlet or external DC supply as described in Paragraph 3.3.1 in this service manual or the Setup and Use section of the operator’s manual. Note: Storing the NBP-4000/C for a long period without charging the battery may degrade the battery capacity. A complete battery recharge requires 8 hours. The battery may require a full charge/discharge cycle to restore normal capacity. Mallinckrodt recommends that the NPB-4000/C’s sealed, lead-acid batteries be replaced at 2-year intervals. Refer to Section 6, Disassembly Guide. 2.4 ENVIRONMENTAL PROTECTION
Follow local governing ordinances and recycling plans regarding disposal or recycling batteries and other device components.
2-2
SECTION 3: PERFORMANCE VERIFICATION 3.1 3.2 3.3 3.4
Introduction Equipment Needed Performance Tests Safety Tests
3. PERFORMANCE VERIFICATION 3.1 INTRODUCTION
This section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without removing the NPB-4000/C covers. If the NPB-4000/C fails to perform as specified in any test, repairs must correct the problem before the monitor is returned to the user. 3.2 EQUIPMENT NEEDED
Table 3-1 lists the equipment required for performance verification. Table 3-1: Required Test Equipment Equipment
Description
Digital multimeter (DMM)
Fluke Model 87 or equivalent
Sensor extension cable
EC-8
Durasensor ® oxygen transducer
DS-100A
Oxisensor® II oxygen transducer
D-25
ECG cable
CE-10
ECG electrodes
standard
ECG leads
LE series
NIBP hose
SHBP-10
NIBP cuff
SCBP series
Pulse oximeter tester
Nellcor SRC-2
ECG simulator
medSim 300 or equivalent
NIBP simulator
Bio-Tek “BP Pump” or equivalent
Respiration simulator
medSim 300 or equivalent
Temperature simulator
medSim 300 or equivalent
Safety analyzer
Bio-Tek 601 Pro or equivalent
Stopwatch
Manual or electronic
3-1
Section 3: Performance Verification
3.3 PERFORMANCE TESTS
The battery charge and battery performance test should be performed before monitor repairs whenever the battery is suspected as being a source of the problems. All other tests may be used following repairs or during routine maintenance (if required by your local institution. Before performing the battery performance test, ensure that the battery is fully charged (Paragraph 3.3.1). This section is written using Nellcor factory-set power-up defaults. If your institution has preconfigured custom defaults, those values will be displayed.
3.3.1 Battery Charge
Perform the following procedure to fully charge the battery. 1. Connect monitor to AC power source using proper power cord. 2. Verify BATTERY CHARGING/AC SOURCE indicator is lit.
3. Charge battery for at least 8 hours. Note: The battery may require a complete charge/discharge cycle to restore its normal capacity, depending on its previous usage. 4.
The only way to check for a full charge is to perform the procedure in paragraph 3.3.2 “Battery Performance Test.”
3.3.2 Battery Performance Test
1. The NPB-4000 monitor is specified to typically operate on battery power a minimum of 4 hours, at 25° C, with no printing, and one NIBP measurement every 15 minutes. The NPB-4000/C monitor is specified to typically operate on battery power a minimum of 3 hours, at 25° C, with no printing, and one NIBP measurement every 15 minutes. Before performing this test, ensure that the battery is fully charged (paragraph 3.3.1). 2. Connect Nellcor SRC-2 pulse oximeter tester to monitor viaEC-8 sensor cable.
3. Connect NIBP simulator to monitor via SHBP-10 hose. 4. Set SRC-2 switches as follows: SWITCH RATE LIGHT MODULATION RCAL/MODE
3-2
POSITION 38 LOW LOW RCAL 63/LOC
Section 3: Performance Verification
5. Set NIBP simulator to simulate pressure setting of 120/80 mmHg and heart rate of 80 bpm. 6. Ensure monitor is not connected to AC power. 7. With NPB-4000/C turned off, press On/Standby switch and verify battery icon appears at bottom of display after power-on self-test is completed. Boxes in battery icon should all be filled, indicating battery is charged. 8. Verify monitor is responding to SpO2 simulator signal and audible alarm is sounding. Use knob to select SpO2 Menu and permanently silence SpO 2 audible alarm. 9. Use knob to select NIBP Menu and set Automatic Measurement Interval to 15 minutes. Exit menu and press front panel NIBP Start/Stop switch to manually initiate first NIBP measurement. Subsequent NIBP measurements will be taken automatically every 15 minutes. 10. NPB-4000 monitor must operate for at least 4 hours before monitor automatically powers down due to low battery condition. NPB-4000/C monitor must operate for at least 3 hours before monitor automatically powers down due to low battery condition. 11. Verify low battery alarm occurs 15-30 minutes before battery fully discharges. 12. Allow monitor to operate until it automatically powers down due to low battery condition. Verify audible alarm sounds when monitor automatically shuts down. Press Alarm Silence switch to terminate this audible alarm. 13. If monitor passes this test, immediately recharge battery (paragraph 3.3.1, steps 1–3). 3.3.3 Power-On Self-Test
1.
Connect monitor to AC power source and verify BATTERY CHARGING/AC SOURCE indicator is lit.
2.
Do not connect any input cables to monitor.
3.
Observe monitor front panel. With monitor off, press On/Standby switch. Monitor must perform the following sequence. a.
Monitor emits three consecutively higher pitched beeps.
b.
A few seconds later, display backlight illuminates, but display is blank.
c.
Nellcor logo then appears for a few seconds, with version numbers of boot and operational software displayed in lower left corner of display.
3-3
Section 3: Performance Verification
Note: The upper version number corresponds to the boot software, the lower version number corresponds to the operational software. Note: Power-on self-test takes approximately 10 seconds to complete. d.
A beep signals end of power-on self-test
e.
Upon successful completion of power-on self-test, display will be in normal monitoring screen configuration.
Note: No vital signs numeric values or waveforms will be displayed. 3.3.4 Hardware and Software Tests
Hardware and software testing include the following tests. •
3.3.4.1
SpO2 Testing
•
3.3.4.2
Operation with an ECG Simulator
•
3.3.4.3
Operation with a Respiration Simulator
•
3.3.4.4
Verification of Pneumatic System
•
3.3.4.5
Operation with a Temperature Simulator
•
3.3.4.6
General Operation
3.3.4.1 SpO2 Testing
SpO2 testing includes the following tests. •
3.3.4.1.1 Alarms and Alarm Silence
•
3.3.4.1.2 Heart Rate Tone Volume Control
•
3.3.4.1.3 Dynamic Operating Range
•
3.3.4.1.4 LED Excitation Test
3.3.4.1.1 Alarms and Alarm Silence
1.
3-4
Connect SRC-2 pulse oximeter tester to sensor input cable and connect cable to monitor.
Section 3: Performance Verification
2.
Set SRC-2 as follows: SWITCH RATE LIGHT MODULATION RCAL/MODE
POSITION 38 LOW OFF RCAL 63/LOCAL
3.
Press monitor On/Standby switch to turn monitor on.
4.
After normal power-up sequence, verify SpO2% display initially indicates zero.
Note: The pulse bar may occasionally indicate a step change as the monitor is in the pulse search mode. 5.
Move modulation switch on SRC-2 to LOW.
6.
Verify following monitor reaction: a.
Pulse bar begins to track artificial pulse signal from SRC-2.
b.
Initially, zero is displayed in SpO2 frame.
c.
After about 10 to 20 seconds, monitor displays saturation and heart rate as specified by tester. Verify values are within following tolerances: Oxygen Saturation Range 79% to 83% Heart Rate Range 35 to 41 bpm
d.
Audible alarm sounds and both SpO2% and HEART RATE displays will flash, indicating both parameters have violated default alarm limits.
Note: Heart rate tone source, found in the Heart Rate Menu, should be set to “SpO2”. e. 5.
Heart rate tone is heard.
Press Alarm Silence switch on monitor front panel. Audible alarm is temporarily silenced.
3-5
Section 3: Performance Verification
6.
Verify the following: a.
An audible alarm remains silenced.
b.
“Slashed bell” icon appears in each numeric frame on display.
c.
SpO2% and HEART RATE displays continue flashing.
d.
Heart rate tone is audible.
e.
Audible alarm returns in approximately 60 seconds.
3.3.4.1.2 Heart Rate Tone Volume Control
1.
Set up NPB-4000/C monitor and SRC-2 pulse oximeter tester as indicated in paragraph 3.3.4.1.1.
2.
Apply power to monitor and verify SpO2 and heart rate values are correctly displayed.
3.
Press Alarm Silence switch on front panel of the monitor to temporarily silence audible alarm.
4.
Verify heart rate tone source, found in Heart Rate Menu, is set to “SpO 2”.
5.
Press Heart Rate Tone Volume switch on front panel of monitor.
6.
Within 3 seconds of having pressed Heart Rate Tone Volume switch, rotate knob CW and verify beeping heart rate tone sound level increases.
7.
Rotate knob CCW and verify beeping heart rate tone decreases until it is no longer audible.
8.
Rotate knob CW to return beep volume to a comfortable level.
Note: Three seconds after the last switch-press or rotation of the knob, function of the knob reverts to moving the highlight on the display screen. 3.3.4.1.3 Dynamic Operating Range
The following test sequence verifies proper monitor operation over a range of input signals.
3-6
1.
Connect SRC-2 to NPB-4000/C and turn NPB-4000/C on.
2.
Place SRC-2 in RCAL 63/LOCAL mode.
3.
Set SRC-2 as indicated in Table 3-2. Verify NPB-4000/C readings are within indicated tolerances. Allow monitor several seconds to stabilize readings.
Section 3: Performance Verification
Note: A “*” indicates values that produce an alarm. Press the Alarm Silence switch to temporarily silence the audible alarm. Table 3-2: Dynamic Operating Range SRC-2 Settings
NPB-4000/C Indications
RATE
LIGHT
MODULATION
SpO2
Pulse Rate
38 112 201 201
HIGH2 HIGH1 LOW LOW
LOW HIGH LOW HIGH
79 - 83* 79 - 83* 79 - 83* 79 - 83*
35 - 41* 109 - 115 195 - 207* 195 - 207*
Note: For the pulse rate setting of 201 BPM, the pulse rate tolerance of 195 to 207 BPM is greater than the ±3 BPM accuracy specification of the monitor, due to the performance characteristics of the SRC-2 tester. 4.
Turn monitor off.
3.3.4.1.4 LED Excitation Test
This procedure uses normal system components to test circuit operation. A Nellcor Oxisensor II oxygen transducer, model D-25, is used to examine LED intensity control. The red LED is used to verify intensity modulation caused by the LED intensity control circuit. 1.
Connect EC-8 sensor extension cable to monitor.
2.
Connect D-25 sensor to sensor extension cable.
3.
Press On/Standby switch to turn monitor on.
4.
Leave sensor open with LEDs and photodetector visible.
5.
After monitor completes normal power-up sequence, verify sensor LED is brightly lit.
6.
Slowly move sensor LED in proximity of photodetector element of sensor. Verify; as LED approaches optical sensor, LED intensity decreases.
7.
Open sensor and notice LED intensity increases.
8.
Repeat step 6 and intensity will again decrease. This variation is an indication that microprocessor is in proper control of LED intensity.
9.
Turn NPB-4000/C off.
3-7
Section 3: Performance Verification
3.3.4.2 Operation with an ECG Simulator
1.
With monitor off, connect ECG leads to appropriate jacks on ECG tester.
2.
Connect leads to CE-10 ECG cable.
3.
Connect CE-10 to ECG input port on NPB-4000/C.
4.
Set ECG tester as follows: Heart rate:
30 bpm
Amplitude:
1 millivolt
Lead select:
II
Normal sinus rhythm Adult mode Note: The accuracy of NPB-4000/C ECG measurements is ±5 bpm. In the procedure below, add the tolerance of the simulator to the acceptable range of readings. 5.
Press On/Standby switch to turn monitor on.
6.
After normal power-up sequence, verify the following monitor reactions: a.
After at least five heartbeats, monitor displays a heart rate of 30 ±5 bpm.
b.
Audible alarm will sound and HEART RATE display will flash, indicating heart rate is below default lower alarm limit.
7.
Press Alarm Silence switch. Verify audible alarm is silenced.
8.
Increase heart rate setting on ECG simulator to 240 bpm.
9.
After at least five heartbeats, verify monitor displays heart rate of 240 ±5 bpm.
10. Verify audible alarm sounds and HEART RATE display flashes, indicating heart rate is above default upper alarm limit. 11. Press Alarm Silence switch to silence alarm. 12. Decrease heart rate setting on ECG simulator to 120 bpm. 13. After at least five heartbeats, verify monitor displays heart rate of 120 ±5 bpm.
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