Service Manual
136 Pages
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SERVICE MANUAL Nellcor Symphony ® N-3000 Patient Monitor SpO2, ECG, and Respiration Capabilities
To contact Nellcor Puritan Bennett’s representative: In the United States, call 1-800-NELLCOR or 510 463-4000; outside the United States, call your local Nellcor Puritan Bennett representative. Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
© 1996 Nellcor Puritan Bennett Incorporated. All rights reserved.
035071A-1096
Corporate Headquarters
Regional/Local Offices
Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, California 94588 U.S.A. Tel. 510 463-4000 or 1-800-NELLCOR Fax 510 463-4420
Nellcor Puritan Bennett UK Ltd. 10, Talisman Business Centre London Road Bicester Oxfordshire OX6 0JX United Kingdom Tel. +44.1869.322700
U.S. Service Repair Center Nellcor Puritan Bennett Inc. 2391 Fenton Street Chula Vista, California 91914 U.S.A. Tel. 619 482-5000 European Office Nellcor Puritan Bennett Europe BV Hambakenwetering 1 5231 DD ’s-Hertogenbosch The Netherlands Tel. +31.73.6485200 Asia/Pacific Office Nellcor Puritan Bennett HK Ltd. Room 1602 Evergo House 38 Gloucester Road Wanchai Hong Kong Tel. +852.2529.0363
Nellcor Puritan Bennett Belgium NV/SA Interleuvenlaan 62/8, Zone 2 B-3001 Heverlee Belgium Tel. +32.16.400467 Nellcor Puritan Bennett France 21 rue Albert Calmette 78353 Jouy-en-Josas Cedex France Tel. +33.1.34.63.06.00 Nellcor Puritan Bennett Germany GmbH Black-&-Decker-Strasse 28 65510 Idstein Germany Tel. +49.6126.5930 Nellcor Puritan Bennett Italia Srl Via dei Tulipani, 3 20090 Pieve Emanuele (MI) Italy Tel. +39.2.90786404
To obtain information about a warranty, if any, for this product, contact Nellcor Puritan Bennett Technical Services or your local Nellcor Puritan Bennett representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Nellcor Puritan Bennett, Durasensor, Nellcor Symphony, Oxisensor II, and the Nellcor Puritan Bennett knob configuration are trademarks of Nellcor Puritan Bennett Incorporated. 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
Section 1: Introduction... 1.1 Manual Overview ... 1.2 N-3000 Patient Monitor Description ... 1.3 Related Documents ... Section 2: Routine Maintenance ... 2.1 Cleaning... 2.2 Periodic Safety and Functional Checks... 2.3 Batteries... Section 3: Performance Verification ... 3.1 Introduction ... 3.2 Equipment Needed... 3.3 Performance Tests ... 3.3.1 Battery Charge ... 3.3.2 Battery Performance Test ... 3.3.3 Power-up Performance... 3.3.3.1 Power-On Self-Test... 3.3.3.2 Adult Power-On Defaults and Alarm Limit Ranges... 3.3.3.3 Neonate Power-On Defaults and Alarm Limit Ranges 3.3.4 Hardware and Software Tests... 3.3.4.1 Operation with a Pulse Oximeter Tester ... 3.3.4.2 Operation with an ECG Simulator... 3.3.4.3 Operation with a Respiration Simulator ... 3.3.4.4 General Operation... 3.3.4.5 ECG Cable Test ... 3.4 Safety Tests ... 3.4.1 Ground Integrity ... 3.4.2 Electrical Leakage... 3.4.2.1 Chassis Source Current... 3.4.2.2 Patient Source Current... 3.4.2.3 Patient Sink Current ... Section 4: Configuration Mode, Service Mode, and Alarm Active Function... 4.1 Introduction ... 4.2 Configuration Mode ... 4.2.1 Adult/Neonatal Mode Default... 4.2.2 Default SpO2 Upper Alarm Limit ... 4.2.3 Default SpO2 Lower Alarm Limit... 4.2.4 Default Heart/Pulse Rate Upper Alarm Limit ... 4.2.5 Default Heart/Pulse Rate Lower Alarm Limit... 4.2.6 Default Respiration Rate Upper Alarm Limit ... 4.2.7 Default Respiration Rate Lower Alarm Limit ... 4.2.8 Default Alarm Volume ... 4.2.9 Default Alarm Silence Duration ... 4.2.10 Configuration Menu... 4.2.10.1 Pulse Tone Volume ... 4.2.10.2 UIF Software Version Report ... 4.2.10.3 SpO2 Software Version Report ... 4.2.10.4 Serial Port Baud Rate... 4.2.10.5 Trend Type...
1-1 1-1 1-1 1-2 2-1 2-1 2-1 2-1 3-1 3-1 3-1 3-2 3-2 3-2 3-3 3-3 3-4 3-6 3-7 3-7 3-11 3-13 3-13 3-19 3-19 3-19 3-19 3-20 3-21 3-22 4-1 4-1 4-1 4-2 4-2 4-3 4-3 4-3 4-4 4-4 4-4 4-4 4-5 4-6 4-6 4-6 4-6 4-7
iii
Table of Contents
4.3
iv
4.2.10.6 Reset to Factory Defaults ... 4.2.10.7 Primary Heart/Pulse Rate Source ... 4.2.10.8 Primary Pulse Tone Source... 4.2.10.9 ECG Lead Selection ... 4.2.10.10 ECG Pacer Filter Status ... 4.2.10.11 ECG Low Frequency Filter Status... 4.2.10.12 ECG Software Version Report ... 4.2.10.13 Respiration Noise Timeout... 4.2.10.14 Respiration Sensitivity Selection... Service Mode ... 4.3.1 Menu Item 1: Software Version Report ... 4.3.2 Menu Item 2: Knob and Lamp Test... 4.3.3 Menu Item 3: Button Test ... 4.3.4 Menu Item 4: Speaker Test ... 4.3.5 Menu Item 5: Internal Configuration Code (ICC) Report ... 4.3.6 Menu Item 6: Total Operating Hours Report ... 4.3.7 Menu Items 7-16: Error Log Record Report ... 4.3.8 Menu Item 17: Instrument Identification (IID) Report .. 4.3.9 Menu Item 18: Power Status ... 4.3.10 Menu Item 19: Persistent Time Sense Report ... 4.3.11 Menu Item 20: Reset to Factory Defaults... 4.3.12 Menu Item 21: Initial Cluster Instrument Number Report ... 4.3.13 Menu Item 22: Latching Alarms... 4.3.14 Menu Item 23: Enable/Disable Alarm Silence Reminder ... 4.3.15 Menu Item 25: Dump EEPROM Data ... 4.3.16 Menu Item 28: Enable/Disable Battery Charge Circuit ... 4.3.17 Menu Item 29: Instrument Compatibility Report... 4.3.18 Menu Item 30: SpO2 RCAL Report... 4.3.19 Menu Item 31: SpO2 IR and Red Offset Report ... 4.3.20 Menu Item 32: SpO2 Corrected IR and Red Signals Report ... 4.3.21 Menu Item 33: SpO2 IR LED Drive Test ... 4.3.22 Menu Item 34: SpO2 Red LED Drive Test ... 4.3.23 Menu Item 35: SpO2 DM-Gain Test... 4.3.24 Menu Item 36: SpO2 P-Gain Test... 4.3.25 Menu Item 37: Set SpO2 Analog Test Mode ... 4.3.26 Menu Item 38: SpO2 A/D-Cal Line Test... 4.3.27 Menu Item 39: SpO2 Enable Automatic Operation... 4.3.28 Menu Item 40: Set ECG Lead ... 4.3.29 Menu Item 41: Set ECG Pacer Filter ... 4.3.30 Menu Item 42: Set ECG Low Frequency Filter... 4.3.31 Menu Item 43: Set ECG Baseline Reset... 4.3.32 Menu Item 44: ECG POST Test Signal ... 4.3.33 Menu Item 45: Check ECG Cable Off Detection... 4.3.34 Menu Item 46: Check ECG Lead Off Detection ... 4.3.35 Menu Item 47: Display ECG Output Value... 4.3.36 Menu Item 49: ECG Enable Automatic Operation... 4.3.37 Menu Item 51: Set Respiration Baseline Reset... 4.3.38 Menu Item 53: Display Respiration Output Value... 4.3.39 Menu Item 54: Enable/Disable Respiration Monitoring ...
4-7 4-7 4-8 4-8 4-8 4-9 4-9 4-9 4-10 4-10 4-13 4-14 4-14 4-15 4-15 4-16 4-16 4-16 4-17 4-17 4-18 4-18 4-18 4-19 4-19 4-20 4-20 4-20 4-21 4-21 4-21 4-22 4-23 4-23 4-24 4-24 4-25 4-25 4-25 4-26 4-26 4-26 4-27 4-27 4-28 4-28 4-29 4-29 4-30
Table of Contents
4.3.40 4.3.41
Menu Item 55: Enable/Disable Breath Pulses ... Menu Item 56: Respiration Enable Automatic Operation ... 4.3.42 Menu Item 60: Set Serial Port Baud Rate... 4.3.43 Menu Item 61: Serial Port Loop Back Test ... 4.3.44 Menu Item 62: Serial Port Transmit Test ... 4.4 Alarm Active Function ... 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 Obtaining Replacement Parts ... 5.6 Troubleshooting guide ... 5.6.1 Power... 5.6.2 Error Codes... 5.6.2.1 User-Correctable Error Codes ... 5.6.2.2 Failure Error Codes ... 5.6.3 Buttons/Knob... 5.6.4 Display/Alarms ... 5.6.5 Operational Performance ... 5.6.6 Stacked Operation ... 5.6.7 Serial Port ... Section 6: Disassembly Guide ... 6.1 Introduction ... 6.2 Removing the Battery... 6.3 Battery Replacement ... 6.4 Fuse Replacement ... 6.5 Monitor Disassembly ... 6.5.1 Communications Board Switch Settings ... 6.6 Removing the Alarm Speaker... 6.7 Removing the SpO2 PCB and SpO2 Controller PCB... 6.8 Removing the Communications PCB... 6.9 Removing the ECG PCB and ECG Controller PCB ... 6.10 Removing the UIF PCB and Display PCB... 6.10.1 Installing a Replacement UIF PCB ... 6.11 Control Knob Assembly Replacement... 6.12 Lithium Battery Replacement... 6.13 Reassembly... Section 7: Spare Parts ... 7.1 Introduction ... Section 8: Packing for Shipment ... 8.1 General Instructions ... 8.2 Repacking in Original Carton... 8.3 Repacking in a Different Carton... Section 9: Specifications... 9.1 General ... 9.2 Electrical ... 9.3 Physical Characteristics... 9.4 Environmental ... 9.5 Alarms... 9.6 Factory Default Settings ... 9.7 Performance...
4-30 4-31 4-31 4-31 4-32 4-32 5-1 5-1 5-1 5-1 5-1 5-1 5-2 5-3 5-4 5-4 5-4 5-7 5-8 5-9 5-10 5-12 6-1 6-1 6-2 6-3 6-4 6-4 6-5 6-6 6-6 6-7 6-8 6-8 6-9 6-10 6-11 6-11 7-1 7-1 8-1 8-1 8-1 8-2 9-1 9-1 9-1 9-2 9-2 9-2 9-2 9-3
v
Table of Contents
Appendix ... A1 Error Types ... A2 User-Correctable Error Codes... A3 Failure Error Codes ... A4 Internally Corrected Error Codes ... Technical Supplement... S1 Introduction ... S2 Oximetry Overview... S2.1 Automatic Calibration ... S2.2 Functional Versus Fractional Saturation ... S2.3 Measured Versus Calculated Saturation ... S3 Stackbus Interconnect ... S4 Circuit Analysis... S4.1 Functional Overview ... S4.2 Circuit Description ... S4.2.1 SpO2 Module ... S4.2.2 ECG/Respiration Module... S4.2.3 UIF Module ... S4.2.4 SpO2 Controller... S4.2.5 ECG Controller... S4.2.6 Communications Submodule... S4.2.7 Display Board... S.5 Schematic Diagrams ...
vi
A-1 A-1 A-2 A-2 A-3 S-1 S-1 S-1 S-1 S-2 S-2 S-2 S-3 S-3 S-4 S-4 S-6 S-9 S-16 S-18 S-19 S-21 S-22
Table of Contents
LIST OF FIGURES 1-1 3-1 3-2 3-3 3-4 3-5 3-6 4-1 6-1 6-2 6-3 6-4 6-5 6-6 6-7 6-8 6-9 6-10 6-11 7-1 8-1 S2-1 S4-1 S4-2 S4-3 S4-4 S4-5
N-3000 Front Panel ... Self-Test Display ... Serial Port Interface... Serial Port Connector - External Pin Locations ... Battery Cover Removal ... Speaker Test ... ECG Cable Pin Locations ... Serial Port Pin Locations ... Battery Replacement ... Removing the Battery ... N-3000 Fuses ... N-3000 Corner Screws... Opening the N-3000 Monitor... Handle, Left Side Panel, and Speaker Disassembly... Rear Panel and SpO2 Module Disassembly ... Communications PCB Removal... Display PCB and UIF PCB Disassembly ... Knob Encoder Disassembly ... Knob Disassembly ... N-3000 Expanded View ... Repacking the N-3000 ... Oxyhemoglobin Dissociation Curve ... N-3000 Functional Block Diagram ... Timing Diagram... Internal/External Stackbus Connections... Communications Sub module Block Diagram ... Display Board Block Diagram ...
1-2 3-3 3-15 3-16 3-17 3-18 3-19 4-33 6-2 6-3 6-4 6-4 6-5 6-6 6-7 6-8 6-9 6-10 6-10 7-2 8-1 S-2 S-4 S-5 S-13 S-20 S-21
3-1 3-2 3-3 4-1 4-2 4-3 5-1 5-2 5-3 5-4 5-5 5-6 5-7 5-8 A-1 A-2 A-3 A-4 S4-1 S4-2 S4-3 S4-4 S4-5 S4-6
Dynamic Operating Ranges... Serial Port Voltages... ECG Cable Resistances ... Configuration Mode Menu ... Configuration Menu ... Service Mode Steady State - Main Menu... Problem Categories... Power Problems ... N-3000 Failure Error Codes... Buttons/Knob Problems... Display/Alarms Problems ... Operational Performance Problems... Stack Problems ... Serial Port Problems ... Error Types ... N-3000 User-Correctable Error Codes ... N-3000 Failure Error Codes... N-3000 Internally Corrected Error Codes ... J13 Inter Stack Connector ... J8 Connector... J12, J22 Inter Module Connector... J5 Display Connector ... J2 Speaker Connector... J3 Knob Connector...
3-9 3-16 3-20 4-2 4-5 4-12 5-2 5-3 5-5 5-7 5-8 5-9 5-10 5-12 A-1 A-2 A-2 A-3 S-9 S-14 S-15 S-16 S-16 S-16
LIST OF TABLES
vii
SECTION 1: INTRODUCTION 1.1 1.2 1.3
1.1
Manual Overview N-3000 Patient Monitor Description Related Documents
MANUAL OVERVIEW This manual contains information for servicing the Nellcor Symphony model N-3000 patient monitor. Only qualified service personnel should service this product. Before servicing the N-3000, read the operator’s manual carefully for a thorough understanding of operation.
1.2
N-3000 PATIENT MONITOR DESCRIPTION The purpose and function of the Nellcor Symphony N-3000 patient monitor is to noninvasively and continuously monitor functional arterial oxygen saturation, ECG, pulse rate, heart rate, and respiration rate for adult, pediatric, and neonatal patients in all hospital areas and hospital-type facilities. It may be used for hospital transport when powered by its internal battery. The N-3000 can operate as a standalone monitor or it can be connected to (stacked with) other Nellcor Symphony instruments, such as the N-3100 blood pressure monitor and N-3200 display/printer. When used with the N-3200 display/printer, the instruments can display and print out ECG, respiration, and plethysmographic waveforms and SpO2, pulse rate, heart rate, and respiration rate tabular data. The physical and operational characteristics of the monitor are described in the operator’s manual and Section 9, Specifications, of this manual. Figure 1-1 depicts the front panel of the N-3000 and the names of its displays and controls.
1-1
Section 1: Introduction
Figure 1-1: N-3000 Front Panel 1. SpO2% display 2. PULSE AMPLITUDE indicator indicator 3. ECG HEART RATE indicator 4. HEART/PULSE RATE display 5. RESPIRATION RATE display 6. NEONATAL MODE indicator 7. AUDIBLE ALARM OFF indicator 8. ON/STANDBY button 9. POWER ON indicator 10. STACKED indicator
11. 12.
PRINT button BATTERY IN USE/BATTERY LOW
13. 14. 15. 16. 17. 18. 19. 20.
BATTERY CHARGING indicator LINKED indicator* RF LOCKED indicator* LOWER ALARM LIMIT button UPPER ALARM LIMIT button LEADS OFF indicator PULSE SEARCH indicator PATIENT MOTION indicator
* Not used on this model
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-3000 operator’s manual. To understand the various Nellcor Puritan Bennett sensors and ECG leads that work with the monitor, refer to the individual sensor or leads directions for use.
1-2
SECTION 2: ROUTINE MAINTENANCE 2.1 2.2 2.3
2.1
Cleaning Periodic Safety and Functional Checks Batteries
CLEANING Caution: Do not immerse the N-3000 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-3000, 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 and ECG lead extension cables with a damp cloth. For sensors and ECG leads, follow the individual directions for use.
2.2
PERIODIC SAFETY AND FUNCTIONAL CHECKS The following checks should be performed at least every 2 years by a qualified service technician.
2.3
1.
Inspect the exterior of the N-3000 for damage.
2.
Inspect safety labels for legibility. If the labels are not legible, contact Nellcor Puritan Bennett’s Technical Services Department or your local Nellcor Puritan Bennett 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 Nellcor Puritan Bennett’s Technical Services Department or your local Nellcor Puritan Bennett representative.
5.
Inspect the fuses for proper value and rating (F1: 1.0 Amp, 250 Volt, SloBlow and F2: 2.5 Amp, 250 Volt, Slo-Blow) as discussed in paragraph 6.4.
BATTERIES Nellcor Puritan Bennett recommends replacing instrument batteries at least every 2 years. To replace the batteries, refer to Section 6, Disassembly Guide. If the N-3000 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 of charging time for a full charge. A 6-hour charge is required for 1 hour of operating time.
2-1
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 N3000 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-3000 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 Equipment
Description
AC power adapter
Use an appropriate Nellcor Symphony SPS-N1 or PSS-1 power supply.
Connector adapter
6-pin, “D”
Digital multimeter (DMM)
Fluke Model 87 or equivalent
®
3.3
Durasensor oxygen transducer
DS-100A
ECG cable
SCE-10
ECG electrodes
standard
ECG leads
SLE series
ECG simulator
Dynatech Nevada, medSim 300 or equivalent
Oxisensor® II oxygen transducer
D-25
Pulse oximeter tester
SRC-2
Respiration simulator
Dynatech Nevada, medSim 300 or equivalent
Safety analyzer
Must meet current AAMI specifications
Sensor cable
SCP-10
Serial interface cable
EIA-232 cable (optional)
Stopwatch
Manual or electronic
PERFORMANCE TESTS The battery charge procedure should be performed before monitor repairs whenever possible. It should also be performed before and after performing the battery performance test (paragraph 3.3.2).
3-1
Section 3: Performance Verification
This section is written using Nellcor Puritan Bennett factory-set defaults. If your institution has preconfigured custom defaults, those values will be displayed. Factory defaults can be reset using the configuration mode procedure described in paragraph 4.2.10.6. 3.3.1 Battery Charge Perform the following procedure to fully charge the battery. 1.
Connect the monitor to an AC power source using an external power supply.
2.
Verify that the monitor is off and that the BATTERY CHARGING indicator is lit.
3.
Charge the battery for at least 14 hours. Note:
The BATTERY CHARGING indicator is programmed to go out when the N-3000 has been connected to AC power for approximately 14 hours with no power interruptions. If there are any power interruptions, the 14-hour charging period begins again when power is restored. An illuminated BATTERY CHARGING indicator is not necessarily an indication that the battery contains less than a full charge. It is merely used as a timer to indicate that the battery has been continuously charging for less than 14 hours.
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 The monitor is specified to operate on battery power a minimum of 4 hours. (This time may decrease if the N-3000 is operating in the stacked configuration with an N-3100 or N-3200.) Before performing this test, ensure that the battery is fully charged (paragraph 3.3.1). 1.
Connect the Nellcor Puritan Bennett SRC-2 pulse oximeter tester to the monitor via the SCP-10 sensor cable.
2.
Set the SRC-2 switches as follows:
3.
3-2
SWITCH
POSITION
RATE LIGHT MODULATION RCAL/MODE
38 LOW LOW RCAL 63/LOC
Ensure that the monitor is not connected to AC power.
Section 3: Performance Verification
4.
With the N-3000 turned off, press the ON/STANDBY button and verify that the BATTERY IN USE/BATTERY LOW indicator lights after the power-on self-test is completed. Verify that the monitor is responding to the simulator signal and the audible alarm is sounding. Do not silence the alarm during this test.
5.
The monitor must operate for at least 4 hours.
6.
Verify that the BATTERY IN USE/BATTERY LOW indicator will start to flash after about 3.5 to 3.75 hours (15-30 minutes before the battery fully discharges).
7.
Allow the monitor to operate until it automatically powers down due to the low battery.
8.
If the monitor passes this test, immediately recharge the battery (paragraph 3.3.1, steps 1 - 3).
3.3.3 Power-up Performance The power-up performance tests (3.3.3.1 through 3.3.3.3) verify the following monitor functions: • • •
3.3.3.1 3.3.3.2 3.3.3.3
Power-On Self-Test Adult Defaults and Alarm Limit Ranges Neonate Defaults and Alarm Limit Ranges
3.3.3.1 Power-On Self-Test 1.
Connect the monitor to an AC power source and verify that the 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 ON/STANDBY button. The monitor must perform the following sequence. a.
The monitor emits three consecutively higher pitched beeps.
b.
All indicators light for a few seconds as illustrated in Figure 3-1. Verify that the SpO2% (left-most display), HEART/PULSE RATE (middle), and RESPIRATION RATE (right) displays all indicate “8.8.8.”.
Figure 3-1: Self-Test Display c.
All displays turn off momentarily.
3-3
Section 3: Performance Verification
d.
Digital displays individually light in a scanning test pattern.
e.
A 1-second beep sounds and all displays again illuminate momentarily.
f.
All displays turn off except the POWER ON and BATTERY CHARGING indicators. The SpO2% and HEART/PULSE RATE displays are blank. The RESPIRATION RATE display indicates “0”for about 15 seconds, then is blank. The monitor is in the “normal mode steady state.”
g.
Press and hold the NEW PATIENT/NEONATAL button (located on the rear panel) for 3 seconds until you hear three beeps, indicating that stored patient data is cleared.
3.3.3.2 Adult Power-On Defaults and Alarm Limit Ranges Note:
1.
When observing or changing default limits, a 3-second timeout is in effect, that is, if no action is taken within 3 seconds, the monitor automatically returns to the normal mode steady state.
Ensure that the monitor is on. Press and release the UPPER ALARM LIMIT button. Verify that the monitor emits a single beep and the SpO2% display indicates an alarm limit of “100”for about 3 seconds. Verify that the other displays indicate a single bar at the top of each window while the “100”is displayed.
At the end of the 3 seconds, the displays are blank (normal mode steady state). 2.
Press and release the UPPER ALARM LIMIT button. Begin rotating the control knob counterclockwise (CCW) within 3 seconds. Verify that the SpO2% display reduces to a minimum of “85.”. Note:
3-4
A decimal point in the display indicates that the alarm limits have changed.
3.
Press and release the LOWER ALARM LIMIT button. Verify that the monitor emits a single beep and the SpO2% display indicates an alarm limit of “85”for 3 seconds. Verify that the other displays indicate a single bar at the bottom of each window.
4.
Press and hold the LOWER ALARM LIMIT button. Rotate the control knob CCW and verify that the SpO2% display reduces to a minimum of “20”. Rotate the control knob clockwise (CW) and verify that the SpO2% display cannot be raised past the upper alarm limit setting of “85”.
5.
Press the UPPER ALARM LIMIT button two times rapidly (twice within 3 seconds). Verify that the monitor emits two beeps and the HEART/PULSE RATE display indicates an alarm limit of “170”for about 3 seconds.
Section 3: Performance Verification
6.
From the normal mode steady state, press the UPPER ALARM LIMIT button two times rapidly. Begin rotating the control knob CCW within 3 seconds. Verify that the HEART/PULSE RATE display reduces to a minimum of “40”.
7.
Press the LOWER ALARM LIMIT button two times rapidly. Verify that the HEART/PULSE RATE display indicates an alarm limit of “40”for 3 seconds.
8.
From the normal mode steady state, press the LOWER ALARM LIMIT button two times rapidly. Rotate the control knob CCW. Verify that the HEART/PULSE RATE display reduces to a minimum of “30”.
9.
Press the LOWER ALARM LIMIT button three times rapidly. Verify that the RESPIRATION RATE display indicates an alarm limit of “4”for 3 seconds.
10. From the normal mode steady state, press the LOWER ALARM LIMIT button three times rapidly. Begin rotating the control knob CW within 3 seconds. Verify the RESPIRATION RATE display increases to a maximum of “40”. 11. Press the UPPER ALARM LIMIT button three times rapidly. Verify the RESPIRATION RATE display indicates an alarm limit of “40”for 3 seconds. 12. Press the UPPER ALARM LIMIT button three times rapidly. Begin rotating the control knob CW within 3 seconds. Verify that the RESPIRATION RATE display increases to a maximum of “150”. 13. Press the ON/STANDBY button to turn the monitor off. Verify that the monitor emits three decreasing pitch beeps. 14. Press the ON/STANDBY button to turn the N-3000 back on. 15. Press and release the UPPER ALARM LIMIT button. Verify that the SpO2% display indicates an alarm limit of “100”. 16. Press and release the LOWER ALARM LIMIT button. Verify that the SpO2% display indicates an alarm limit of “85”. 17. Press the UPPER ALARM LIMIT button two times rapidly. Verify that the HEART/PULSE RATE display indicates an alarm limit of “170”. 18. Press the LOWER ALARM LIMIT button two times rapidly. Verify that the HEART/PULSE RATE display indicates an alarm limit of “40”. 19. Press the UPPER ALARM LIMIT button three times rapidly. Verify that the RESPIRATION RATE display indicates an alarm limit of “40”. 20. Press the LOWER ALARM LIMIT button three times rapidly. Verify that the RESPIRATION RATE display indicates an alarm limit of “4”. 21. Press the ON/STANDBY button to turn the monitor off.
3-5
Section 3: Performance Verification
3.3.3.3 Neonate Power-On Defaults and Alarm Limit Ranges Note:
When observing or changing default limits, a 3-second timeout is in effect, that is, if no action is taken within 3 seconds, the monitor automatically returns to the normal mode steady state.
1.
Turn the monitor on.
2.
Press the NEW PATIENT/NEONATAL button on the rear panel twice within 2 seconds. Verify that there is an audible beep each time the button is pressed.
3.
Verify that the NEONATAL MODE indicator on the front panel is lit.
4.
Press and release the UPPER ALARM LIMIT button. Verify that the SpO2% display indicates an alarm limit of “95”for 3 seconds. Verify that the other displays indicate a single bar at the top of each window while the “95”is displayed.
5.
Press and release the UPPER ALARM LIMIT button. Begin rotating the control knob CCW within 3 seconds. Verify that the SpO2% display reduces to a minimum of “80”.
6.
Press and release the LOWER ALARM LIMIT button. Verify that the SpO2% display indicates an alarm limit of “80”. Verify that the other displays indicate a single bar at the bottom of each window.
7.
From the normal mode steady state, press and release the LOWER ALARM LIMIT button. Rotate the control knob CCW. Verify that the SpO2% display reduces to a minimum of “20”.
8.
Press the UPPER ALARM LIMIT button two times rapidly (twice within 3 seconds). Verify that the HEART/PULSE RATE display indicates an alarm limit of “190”.
9.
Press the LOWER ALARM LIMIT button twice rapidly. Verify that the HEART/PULSE RATE display indicates an alarm limit of “90”.
10. Press the UPPER ALARM LIMIT button three times rapidly. Verify that the RESPIRATION RATE display indicates an alarm limit of “80”. 11. Press the LOWER ALARM LIMIT button three times rapidly. Verify that the RESPIRATION RATE display indicates an alarm limit of “20”. 12. Press the ON/STANDBY button to turn the monitor off. 13. Press the ON/STANDBY button to turn the monitor on. The monitor performs the sequence described in 3.3.3.1. Verify that the “NEO”indicator is not lit. 14. Press and release the UPPER ALARM LIMIT button. Verify that the SpO2% display indicates an alarm limit of “100”. 15. Press and release the LOWER ALARM LIMIT button. Verify that the SpO2% display indicates an alarm limit of “85”. 16. Press the ON/STANDBY button to turn the monitor off.
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Section 3: Performance Verification
This completes the power-up performance tests. 3.3.4 Hardware and Software Tests Hardware and software testing include the following tests. • • • •
3.3.4.1 3.3.4.2 3.3.4.3 3.3.4.4
Operation with a Pulse Oximeter Tester Operation with an ECG Simulator Operation with a Respiration Simulator General Operation
3.3.4.1 Operation with a Pulse Oximeter Tester Operation with an SRC-2 pulse oximeter tester includes the following tests. • • • • • •
3.3.4.1.1 Alarms and Alarm Silence 3.3.4.1.2 Alarm Volume Control 3.3.4.1.3 Pulse Tone Volume Control 3.3.4.1.4 Dynamic Operating Range 3.3.4.1.5 RCAL Determination 3.3.4.1.6 LED Drive Test
3.3.4.1.1 1.
2.
Alarms and Alarm Silence
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
Press the ON/STANDBY button to turn the monitor on. After the normal power-up sequence, verify that the SpO2%, HEART/PULSE RATE and RESPIRATION RATE displays initially indicate zeroes. Note:
The pulse bar may occasionally indicate a step change as the monitor is in the pulse search mode.
3.
Move the modulation switch on the SRC-2 to LOW.
4.
Verify that the following monitor reaction: a.
The pulse bar begins to track the artificial pulse signal from the SRC-2.
b.
The pulse tone is heard.
c.
Zeroes are displayed in the SpO2%, HEART/PULSE RATE, and RESPIRATION RATE displays.
d.
After about 10 to 20 seconds, the monitor displays a 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
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Section 3: Performance Verification
e.
The audible alarm sounds and both the SpO2% and HEART/PULSE RATE displays will flash, indicating both parameters have violated the default alarm limits.
5.
Press and momentarily hold the AUDIBLE ALARM OFF button on the top of the monitor. Verify that the HEART/PULSE RATE display indicates “60”and the RESPIRATION RATE display indicates “SEC”while the AUDIBLE ALARM OFF button is pressed. The alarm is silenced.
6.
Release the AUDIBLE ALARM OFF button. Verify the following: a.
The alarm remains silenced.
b.
The AUDIBLE ALARM OFF indicator lights.
c.
The SpO2% and HEART/PULSE RATE displays resume flashing.
d.
The pulse tone is still audible.
e.
The audible alarm returns in approximately 60 seconds.
7.
Press and hold the AUDIBLE ALARM OFF button. Rotate the control knob CCW until the HEART/PULSE RATE display indicates “30”. Rotate the control knob CW and verify that the displays indicate 60 SEC, 90 SEC, 120 SEC, and OFF. Release the button when the display indicates “OFF”. Verify that the AUDIBLE ALARM OFF indicator flashes.
8.
Wait approximately 3 minutes. Verify that the alarm does not return. After 3 minutes, the alarm silence reminder beeps three times, and will continue to do so at 3-minute intervals.
3.3.4.1.2
Alarm Volume Control
After completing the procedure in paragraph 3.3.4.1.1: 1.
Press and hold the AUDIBLE ALARM OFF button on the top of the monitor. Verify the following: a.
“OFF”is displayed for approximately 3 seconds.
b.
After 3 seconds, a steady tone is heard at the default alarm volume setting, the HEART/PULSE RATE display indicates “VOL”, and the RESPIRATION RATE display indicates the default setting of 5.
2.
While continuing to hold the AUDIBLE ALARM OFF button, rotate the control knob CCW to decrease the alarm volume setting to a minimum value of 1. The alarm tone should decrease but still be audible.
3.
Rotate the control knob CW to increase the alarm volume setting to a maximum value of 10. Verify the volume increases. Rotate the knob CCW until a comfortable audio level is attained.
4.
Release the AUDIBLE ALARM OFF button. The tone will stop.
3.3.4.1.3 1.
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Pulse Tone Volume Control
Rotate the control knob CW and verify that the beeping pulse tone sound level increases.
Section 3: Performance Verification
2.
Rotate the control knob CCW and verify that the beeping pulse tone decreases until it is no longer audible. Rotate the knob CW to return the beep volume to a comfortable level.
3.3.4.1.4
Dynamic Operating Range
The following test sequence verifies proper monitor operation over a range of input signals. 1.
Connect the SRC-2 to the N-3000 and turn the N-3000 on.
2.
Place the SRC-2 in the RCAL 63/LOCAL mode.
3.
Set the SRC-2 as indicated in Table 3-1. Verify that the N-3000 readings are within the indicated tolerances. Allow the monitor several seconds to stabilize the readings.
Note:
A “*”indicates values that produce an alarm. Press the AUDIBLE ALARM OFF button to silence the alarm. Table 3-1: Dynamic Operating Range SRC-2 Settings
RATE 38 112 201 201 4.
LIGHT HIGH2 HIGH1 LOW LOW
N-3000 Indications
MODULATION LOW HIGH LOW HIGH
SpO2 79 - 83* 79 - 83* 79 - 83* 79 - 83*
Pulse Rate 37 - 39* 110 - 114 195 - 207* 195 - 207*
Turn the monitor off.
3.3.4.1.5
RCAL Determination
1.
Ensure that the N-3000 is turned off and connected to AC power via an external power supply.
2.
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:
3.
SWITCH
POSITION
RATE LIGHT MODULATION RCAL/MODE
38 LOW OFF RCAL 63/LOCAL
Enter the service mode as follows: a. While simultaneously holding down the UPPER and LOWER ALARM LIMIT buttons and the PRINT button, press and release the ON/STANDBY button. Continue to press and hold the UPPER and LOWER ALARM LIMIT and PRINT buttons while the monitor performs the power-on test. b. When “SEr”begins flashing in the AUXILIARY display, release the UPPER and LOWER ALARM LIMIT and PRINT buttons.
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Section 3: Performance Verification
c.
Press the PRINT button within 15 seconds or the monitor will turn off automatically. The number “1”appears in the SpO2% display. You are now in the service mode steady state.
4.
Select menu item 30 by rotating the knob until “30”appears in the SpO2% display.
5.
Press the UPPER ALARM LIMIT button.
6.
Verify the RCAL index number “63”is displayed in the HEART/PULSE RATE display.
7.
Set the SRC-2 RCAL/Mode switch to 64/LOCAL and verify that “64”is displayed in the HEART/PULSE RATE display.
8.
Press the ON/STANDBY button to turn the monitor off.
3.3.4.1.6
LED Drive Test
1.
Ensure that the N-3000 is turned off and connected to AC power via an external power supply.
2.
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:
3.
SWITCH
POSITION
RATE LIGHT MODULATION RCAL/MODE
38 LOW OFF RCAL 63/LOCAL
Enter the service mode as follows: a. While simultaneously holding down the UPPER and LOWER ALARM LIMIT buttons and the PRINT button, press and release the ON/STANDBY button. Continue to press and hold the UPPER and LOWER ALARM LIMIT and PRINT buttons while the monitor performs the power-on test. b. When “SEr”begins flashing in the AUXILIARY display, release the UPPER and LOWER ALARM LIMIT and PRINT buttons. c.
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Press the PRINT button within 15 seconds or the monitor will turn off automatically. The number “1”appears in the SpO2% display. You are now in the service mode.
4.
Select menu item 33 by rotating the knob until “33”appears in the SpO2% display.
5.
Press the UPPER ALARM LIMIT button.
6.
Verify that the SpO2 IR LED drive value “170”is displayed in the HEART/PULSE RATE display and the IR indicator on the SRC-2 is illuminated.
7.
Rotate the control knob to adjust the IR LED drive level indicated in the HEART/PULSE RATE display to “255”.