NPB-190 Service Manual May 1999

Mallinckrodt, Inc. 675 McDonnell Boulevard P.O. Box 5840 St. Louis, MO 63134 Tel 314.654.2000 Toll Free 1.800.635.5267 Nellcor Puritan Bennett 4280 Hacienda Drive Pleasanton, CA 94588 USA Mallinckrodt Europe BV Hambakenwetering 1 5231 DD’s-Hertogenbosch The Netherlands Tel +31.73.6485200

Nellcor Puritan Bennett is a wholly owned subsidiary of Mallinckrodt Inc. Nellcor and Nellcor Puritan Bennett are trademarks of Mallinckrodt Inc. To obtain information about a warranty, if any, for this product, contact Mallinckrodt Technical Services or your local Mallinckrodt representative. Purchase of this instrument confers no express or implied license under any Mallinckrodt patent to use the instrument with any sensor that is not manufactured or licensed by Mallinckrodt. Durasensor, and Oxisensor II, are trademarks of Mallinckrodt Inc. 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; Re.35.122; 4,928,692; 4,934,372; 5,078,136; and 5,368.224.

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 NPB-190 Pulse Oximeter Description... 1.3 Power-On Self Test... 1.4 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: Audible Alarm Settings & Service Menu... 4.1 Introduction ... 4.2 Audible Alarm Settings... 4.3 Service Menu ... 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... 5.7 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 Reassembly ... 6.6 Battery Replacement... 6.7 Power Entry Module (PEM) Removal/Installation ... 6.8 Power Supply Removal/Installation... 6.9 Display PCB Removal/Installation... 6.10 UIF PCB Removal/Installation... 6.11 Alarm Speaker Removal/Installation... Section 7: Spare Parts ... 7.1 Introduction ... Section 8: Packing For Shipment ... 8.1 General Instructions ...

iii v vi 1-1 1-1 1-1 1-2 1-3 2-1 2-1 2-1 2-1 3-1 3-1 3-1 3-1 3-9 4-1 4-1 4-1 4-2 5-1 5-1 5-1 5-1 5-1 5-1 5-2 5-7 6-1 6-1 6-1 6-2 6-3 6-4 6-5 6-6 6-7 6-9 6-10 6-11 7-1 7-1 8-1 8-1

iii

Table of Contents

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 ... Appendix (Serial Port Interface Protocol)... A1 Introduction ... A2 Enabling the Serial Port... A3 Connecting to the Serial Port ... A4 Real-Time Printout ... A5 Nurse Call ... Technical Supplement ... S1 Introduction ... S2 Oximetry Overview... S3 Circuit Analysis... S4 Functional Overview... S5 AC Input ... S6 Power Supply PCB Theory of Operation... S7 Battery... S8 User Interface PCB (UIF) ... S9 Front Panel Display PCB and Controls ... S10 Schematic Diagrams...

iv

8-1 8-3 9-1 9-1 9-1 9-2 9-2 9-2 9-2 9-3 A-1 A-1 A-1 A-1 A-2 A-5 S-1 S-1 S-1 S-3 S-3 S-3 S-4 S-5 S-5 S-8 S-9

Table of Contents

LIST OF FIGURES Figure 1-1: NPB-190 Front Panel... Figure 1-2: NPB-190 Rear Panel ... Figure 3-1: NPB-190 Controls... Figure 3-2: Self-Test Display... Figure 3-3: Adjusting High %SpO2 Alarm Limit ... Figure 3-4: Adjusting Low %SpO2 Alarm Limit ... Figure 3-5: Adjusting High Heart Rate Alarm Limit ... Figure 3-6: Adjusting Low Heart Rate Alarm Limit ... Figure 3-7: Alarm Silence Duration ... Figure 3-8: Alarm Volume Display ... Figure 4-1: NPB-190 Controls... Figure 6-1: Fuse Removal... Figure 6-2: NPB-190 Corner Screws ... Figure 6-3: Separating Case Halves ... Figure 6-4: Battery Removal ... Figure 6-5: Power Entry Module... Figure 6-6: Power Supply Leads Connections ... Figure 6-7: Power Supply... Figure 6-8: Display PCB... Figure 6-9: UIF PCB... Figure 6-10: Alarm Speaker ... Figure 7-1: NPB-190 Exploded View... Figure 8-1: Repacking the NPB-190 ... Figure A-1: Serial Port Pin Layout... Figure A-2: Real-Time Printout ... Figure S-1: Oxyhemoglobin Dissociation Curve ... Figure S-2: NPB-190 Functional Block Diagram... Figure S-3 Front End Red/IR Schematic Diagram ... Figure S-4 Front End LED Drive Schematic Diagram... Figure S-5 Front End Output Schematic Diagram ... Figure S-6 Front End Power Supply Schematic Diagram ... Figure S-7 Isolation Barrier EIA-232 Port Schematic Diagram ... Figure S-8 CPU Core Schematic Diagram ... Figure S-9 PIC and Speaker Schematic Diagram ... Figure S-10 Indicator Drive Schematic Diagram... Figure S-11 Core Power Supply Schematic Diagram ... Figure S-12 Parts Locator Diagram for UIF PCB... Figure S-13 Display PCB Schematic Diagram... Figure S-14 Parts Locator Diagram for Display PCB ... Figure S-15 Power Supply Schematic Diagram ... Figure S-16 Parts Locator Diagram for Power Supply PCB...

1-2 1-2 3-2 3-3 3-3 3-4 3-4 3-4 3-6 3-7 4-1 6-2 6-3 6-4 6-5 6-6 6-7 6-8 6-9 6-10 6-12 7-2 8-2 A-2 A-2 S-2 S-3 S-11 S-13 S-15 S-17 S-19 S-21 S-23 S-25 S-27 S-29 S-31 S-33 S-35 S-37

v

Table of Contents

LIST OF TABLES Table 3-1: Dynamic Operating Range... Table 3-2: Earth Leakage Current Limits ... Table 3-3: Enclosure Leakage Current Limits... Table 3-4: Patient Leakage Current Limits ... Table 3-5: Patient Leakage Current Test Configurations - Mains Voltage on the Applied Part ... Table 4-1: Factory Default Settings... Table 5-1: Problem Categories ... Table 5-2: Power Problems... Table 5-3: Button Problems ... Table 5-4: Display/Alarms Problems... Table 5-5: Operational Performance Problems ... Table 5-6: Serial Port Problems ... Table 5-7: Error Codes... Table A-1: Serial Port Pin Outs ... Table A-2: Status Codes ...

vi

3-8 3-10 3-11 3-12 3-12 4-3 5-2 5-3 5-4 5-4 5-5 5-6 5-7 A-1 A-4

SECTION 1: INTRODUCTION 1.1 1.2 1.3 1.4 1.1

Manual Overview NPB-190 Pulse Oximeter Description Power-On Self Test Related Documents

MANUAL OVERVIEW This manual contains information for servicing the Nellcor model NPB-190 Pulse Oximeter. Only qualified service personnel should service this product. Before servicing the NPB-190, read the operator’s manual carefully for a thorough understanding of operation. Warning: Explosion hazard. Do not use the NPB-190 pulse oximeter in the presence of flammable anesthetics.

1.2

NPB-190 PULSE OXIMETER DESCRIPTION The Nellcor NPB-190 portable pulse oximeter is intended for continuous, noninvasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor). The monitor is intended for use on adult, pediatric, and neonatal patients in all hospital-type facilities and in the home environment. It may be used during intrahospital transport when powered by its internal battery. Digital displays are provided for oxygen saturation and pulse rate, and a 10segment LED bar indicates pulse amplitude. High and low alarm limits for saturation and pulse rate can be adjusted by the operator. The NPB-190 can operate on AC or a rechargeable internal battery power. The controls and indicators for the NPB-190 are illustrated in Figures 1-1 and 1-2.

1-1

Section 1: Introduction

1

2

3 4

5

6

7

8

9

11

10

NPB190

15

14

13

12

Figure 1-1: NPB-190 Front Panel 1. SpO2 Sensor Port 2. Power On/Standby Button 3. AC/Battery Charging Indicator 4. Low Battery Indicator 5. %SpO2 Display 6. Pulse Amplitude Indicator 7. Pulse Beats per Minute Display 8. Alarm Silence Indicator

9. Alarm Silence Button 10. Adjust Up Button 11. Adjust Down Button 12. Pulse Search Indicator 13. Upper Alarm Limit Button 14. Lower Alarm Limit Button 15. Speaker

2

1

3

TM

NELLCOR PURITAN BENNETT, INC. PLEASANTON, CA 94588, U.S.A.

T 0.50A 250V

R

IPX1 NRTL/C

5

MADE IN IRELAND

NELLCOR PURITAN BENNETT EUROPE BV, 's-HERTOGENBOSCH, THE NETHERLANDS

CISPR 11 Group 1 Class B

012 3

NPB-190

SN

2X

100-120 V~ 200-240 V~ 50/60Hz 20 VA

036400-1098

U.S. PATENTS: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; Re. 35,122; 4,928,692; 4,934,372; 5,078,136

4

Figure 1-2: NPB-190 Rear Panel 1. Equipotential Terminal 2. AC Connector 3. Serial Port

1.3

4. Fuse Drawer 5. Voltage Selector Switch

POWER-ON SELF TEST When the NPB-190 is turned on it will perform a POST (Power On Self Test). During POST the following sequence should occur: • • •

1-2

All indicator lights illuminate All segments of the numeric digits light All segments of the Pulse Amplitude Display light

Section 1: Introduction

Upon completion of the POST display test, the software versions will be displayed for approximately 2 seconds. Two versions are displayed: •

The first version is indicated by the numeral “1” in the leftmost segment of the %SpO2 display. The series of digits and decimal points displayed to the right of the “1” represent the main processor software version.

•

The second version is indicated by the numeral “2” in the leftmost segment of the %SpO2 display. The number(s) appearing to the right of the “2” represent the subprocessor software version.

The software version numbers are often needed when calling Mallinckrodt’s Technical Services Department or your local Mallinckrodt representative for technical assistance. Record the numbers and have them available prior to requesting technical assistance. Upon successful completion of POST, the NPB-190 sounds a 1-second tone indicating that the monitor has passed the test. If the start-up sequence is not completed as described above do not use the monitor. 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-190 operator’s manual. To understand the various Nellcor sensors that work with the monitor, refer to the individual sensor directions for use.

1-3

SECTION 2: ROUTINE MAINTENANCE 2.1 Cleaning 2.2 Periodic Safety and Functional Checks 2.3 Battery 2.1

CLEANING Caution: Do not immerse the NPB-190 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-190, 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 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 NPB-190 for damage.

2.

Inspect safety labels for legibility. If the labels are not legible, contact Mallinckrodt’s 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.

5.

Inspect the fuses in the Power Entry Module for proper value and rating. The fuses are slow blow, 0.5 amp, and 250 volt.

BATTERY Mallinckrodt recommends replacing the instrument battery every 2 years. When the NPB-190 is going to be stored for 3 months or more remove the battery. To replace or remove the battery, refer to Section 6, Disassembly Guide. If the NPB-190 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 to receive a full charge. The battery is being charged anytime the instrument is plugged into AC.

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 NPB-190 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 NPB-190 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 Digital multimeter (DMM) Durasensor

oxygen transducer

Oxisensor II oxygen transducer Pulse oximeter tester Safety analyzer Sensor extension cable Serial interface cable Stopwatch

3.3

Description Fluke Model 87 or equivalent DS-100A D-25 SRC-2 Must meet current AAMI specifications EC-4 or EC-8 EIA-232 cable (optional) 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). Note:

This section is written using Mallinckrodt factory-set defaults. If your institution has preconfigured custom defaults, those values will be displayed. Factory defaults can be reset using the configuration procedure described in paragraph 4.3.3.

3.3.1 Battery Charge

Perform the following procedure to fully charge the battery. 1.

Connect the monitor to an AC power source.

3-1

Section 3: Performance Verification

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.

3.3.2 Performance Tests

The power-up performance tests (3.3.2.1 and 3.3.2.2) verify the following monitor functions: • •

Power-On Self-Test Factory Power-On Defaults and Alarm Limit Ranges On/Standby

Alarm Silence

NPB-190

Lower Alarm Upper Alarm Limit Limit

Adjust Down

Adjust Up

Figure 3-1: NPB-190 Controls Note: 3.3.2.1

3-2

Refer to Figure 3-1, NPB-190 Controls, when following the instructions listed below.

Power-On Self-Test

1.

Connect the monitor to an AC power source. 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/Standby button. Verify that the monitor performs the following sequence:

Section 3: Performance Verification

a.

All indicators light for a few seconds as illustrated in Figure 3-2. LEDs illuminated

888 displayed

LED illuminated

NPB190

10 segments LED illuminated illuminated

Figure 3-2: Self-Test Display b.

The software version is displayed and the AC Power/Battery Charging indicators remain on.

c.

When a sensor is connected a zero is displayed in each window, a 1second Power-On Self-Test (POST) beep sounds and the Pulse Search LED is illuminated. If no sensor is connected a 1 second POST beep sounds, 3 dashes are displayed in each window and the Pulse Search LED is off.

d.

3.3.2.2

The NPB-190 begins normal operation if a sensor is connected. Without a sensor the monitor will be in the idle mode (3 dashes in each window).

Factory 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.

Turn the monitor on by pressing the Power On/Standby button. Wait for POST to be completed. Press and release the Upper Alarm Limit button. Verify that the monitor emits a single beep and the %SpO2 display indicates a high alarm limit of “100” for about 3 seconds. Verify that three dashes are displayed at the top of the pulse rate display window.

Note:

The location of the three dashes indicates the type of alarm limit that is being adjusted. Three dashes in the top of the display window indicate a high alarm limit and three dashes in the bottom of the display window indicate a low alarm limit.

Figure 3-3: Adjusting High %SpO2 Alarm Limit Normal monitoring is resumed after 3 seconds.

3-3

Section 3: Performance Verification

2.

Press the Upper Alarm Limit button. Press and hold the Adjust Down button. Verify that the %SpO2 display reduces to a minimum of “85”.

Note: 3.

A decimal point to the right of the value in either display indicates that the alarm limits are not power-on default values.

Press the Lower Alarm Limit button. Verify that the monitor emits a single beep and that the %SpO2 display indicates an alarm limit of “85” for 3 seconds. Verify that three dashes are displayed at the bottom of the pulse rate display window.

Figure 3-4: Adjusting Low %SpO2 Alarm Limit 4.

Press the Lower Alarm Limit button. Press and hold the Adjust Down button and verify that the %SpO2 display reduces to a minimum of “20”. Press and hold the Adjust Up button 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, the pulse rate display indicates an alarm limit of “170”, and that the %SpO2 display window shows three dashes at the top for about 3 seconds.

Figure 3-5: Adjusting High Heart Rate Alarm Limit 6.

Press the Upper Alarm Limit button two times rapidly. Press and hold the Adjust Down button. Verify that the pulse rate display reduces to a minimum of “40”.

7.

Press the Lower Alarm Limit button two times rapidly. Verify that the pulse rate display indicates an alarm limit of “40” and that the %SpO2 display window shows three dashes at the bottom for 3 seconds.

Figure 3-6: Adjusting Low Heart Rate Alarm Limit

3-4

8.

Press the Lower Alarm Limit button two times rapidly. Press and hold the Adjust Down button. Verify that the pulse rate display reduces to a minimum of “30”.

9.

Press the Lower Alarm Limit button two times rapidly. Press and hold the Adjust Up button and verify that the pulse rate display cannot be adjusted above “40”.

Section 3: Performance Verification

10. Press the Power On/Standby button to turn the unit off. Turn the unit back on. 11. Press and release the Upper Alarm Limit button. Verify that the %SpO2 display indicates an alarm limit of “100”. 12. Press and release the Lower Alarm Limit button. Verify that the %SpO2 display indicates an alarm limit of “85”. 13. Press the Upper Alarm Limit button two times rapidly. Verify that the pulse rate display indicates an alarm limit of “170”. 14. Press the Lower Alarm Limit button two times rapidly. Verify that the pulse rate display indicates an alarm limit of “40”. 15. Press the Power On/Standby button to turn the monitor off. 3.3.3 Hardware and Software Tests

Hardware and software testing include the following tests: • • 3.3.3.1

Operation with a Pulse Oximeter Tester General Operation

Operation with a Pulse Oximeter Tester

Operation with an SRC-2 pulse oximeter tester includes the following tests: • • • • • 3.3.3.1.1

Alarms and Alarm Silence Alarm Volume Control Pulse Tone Volume Control Dynamic Operating Range Nurse Call

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 RATE LIGHT MODULATION RCAL/MODE

2.

POSITION 38 HIGH OFF RCAL 63/LOCAL

Press the Power On/Standby button to turn the monitor on. After the normal power-up sequence, verify that the pulse rate initially indicates zeroes. Note:

The pulse bar may occasionally indicate a step change as the monitor is in the pulse search mode.

3.

Set the modulation switch on the SRC-2 to HIGH.

4.

Verify the following monitor reactions:

3-5

Section 3: Performance Verification

a.

The pulse blip 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 and pulse rate displays.

d.

After about 10 to 20 seconds, the monitor displays oxygen 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

e.

5.

The audible alarm sounds and both the %SpO2 and pulse rate displays flash. This is an indication that both parameters have violated the default alarm limits.

Press and hold the Alarm Silence button on the front of the monitor for less than 3 seconds. Verify that the pulse rate display indicates “SEC” and the %SpO2 display indicates “60” while the Alarm Silence button is pressed. The alarm is silenced when the button is released.

Figure 3-7: Alarm Silence Duration 6.

3-6

Release the Alarm Silence button. Verify the following: a.

The alarm remains silenced.

b.

The Alarm Silence indicator lights.

c.

The %SpO2 and pulse rate displays resume flashing.

d.

The pulse tone is still audible.

e.

The audible alarm returns after approximately 60 seconds.

7.

While pressing the Alarm Silence button, press the Adjust Down button until the %SpO2 display indicates “30”. Press the Adjust Up button and verify that the displays indicate 60 SEC, 90 SEC, 120 SEC, and OFF. Release the button when the display indicates “OFF”. Press the Alarm Silence button again and verify that the Alarm Silence indicator flashes.

8.

Wait approximately 3 minutes. Verify that the alarm does not return. After 3 minutes ± 10 seconds, the alarm silence reminder beeps three times, and continues to do so at 3-minute intervals.

Section 3: Performance Verification

3.3.3.1.2

Alarm Volume Control

After completing the procedure in paragraph 3.3.3.1.1: 1.

Press and hold the Alarm Silence button for more than 3 seconds. 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 %SpO2 display indicates “VOL”, and the pulse rate display indicates the default setting of 5.

Figure 3-8: Alarm Volume Display

3.3.3.1.3

3.3.3.1.4

2.

Press the Adjust Down button until an alarm volume setting of 1 is displayed. Verify that the volume of the alarm has decreased but is still audible.

3.

Press the Adjust Up button to increase the alarm volume setting to a maximum value of 10. Verify that the volume increases. Press the Adjust Down button until a comfortable audio level is attained.

4.

Release the Alarm Silence button. The tone stops.

Pulse Tone Volume Control

1.

When a valid pulse has been acquired, press the Adjust Up button and verify that the beeping pulse tone sound level increases.

2.

Press the Adjust Down button and verify that the beeping pulse tone decreases until it is no longer audible. Press the Adjust Up button to return the beep volume to a comfortable level.

Dynamic Operating Range

The following test sequence verifies proper monitor operation over a range of input signals: 1.

Connect the SRC-2 to the NPB-190 and turn the NPB-190 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 NPB-190 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 Alarm Silence button to silence the alarm.

3-7

Section 3: Performance Verification

Table 3-1: Dynamic Operating Range RATE 38 112 201 201 3.3.3.1.5

The Nurse Call tests must be performed with the instrument operating on AC power.

1.

Connect the negative lead of a voltmeter to pin 10 and positive to pin 11 of the serial port on the back of the instrument (Figure A-1 in appendix). Ensure that the audible alarm is not silenced or turned off.

2.

Set the SRC-2 to create an alarm condition. Verify an output voltage at pins 10 and 11 between +5 to +12 VDC.

3.

Press the Alarm Silence button. With no active audible alarm, the output voltage at pins 10 and 11 must be between -5 to -12 VDC.

4.

Turn the instrument off. Disconnect the voltmeter and the SRC-2.

Operation on Battery Power

1.

Turn the instrument on using AC Power.

2.

Disconnect the instrument from AC and verify that the AC Power Indicator turns off.

3.

Verify that the instrument continues monitoring normally and that the Low Battery Indicator is not lit.

Note: 4. 3.3.3.2

NPB-190 Indications SpO2 Pulse Rate 79 - 83* 37 - 39* 79 - 83* 110 - 114 79 - 83* 198 - 204* 79 - 83* 198 - 204*

Nurse Call

Note:

3.3.3.1.6

SRC-2 Settings LIGHT MODULATION HIGH2 LOW HIGH1 HIGH LOW LOW LOW HIGH

If the Low Batter Indicator is illuminated, perform the procedure outlined in step 3.3.1.

Connect the instrument to AC and verify that the AC Power Indicator turns on and that the instrument is monitoring normally.

General Operation

The following tests are an overall performance check of the system: • • 3.3.3.2.1

LED Excitation Test Monitor Operation with a Live Subject

LED Excitation Test

This procedure uses normal system components to test circuit operation. A Nellcor Oxisensor IIâ 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. 3-8

Section 3: Performance Verification

1.

Connect the monitor to an AC power source.

2.

Connect an EC-4 or EC-8 sensor input cable to the monitor.

3.

Connect a D-25 sensor to the sensor input cable.

4.

Press the Power On/Standby button to turn the monitor on.

5.

Leave the sensor open with the LEDs and photodetector visible.

6.

After the monitor completes its normal power-up sequence, verify that the sensor LED is brightly lit.

7.

Slowly move the sensor LED in proximity to the photodetector element of the sensor. Verify, as the LED approaches the photodetector, that the LED intensity decreases.

8.

Open the sensor and notice that the LED intensity increases.

9.

Repeat step 7 and the intensity will again decrease. This variation is an indication that the microprocessor is in proper control of LED intensity.

10. Turn the NPB-190 off. 3.3.3.2.2

Monitor Operation with a Live Subject

Pulse oximetry involves connecting the monitor to a live subject for a qualitative test.

3.4

1.

Ensure that the monitor is connected to an AC power source.

2.

Connect an EC-4 or EC-8 sensor input cable to the monitor.

3.

Connect a Nellcor Durasensorâ oxygen transducer, model DS-100A, to the sensor input cable.

4.

Clip the DS-100A to an adult subject as recommended in the sensor directions for use.

5.

Press the Power On/Standby button to turn the monitor on and verify that the monitor is operating.

6.

The monitor should stabilize on the subject’s physiological signal in about 15 to 30 seconds. Verify that the saturation and heart rates are reasonable for the subject.

SAFETY TESTS NPB-190 safety tests meet the standards of, and are performed in accordance with, IEC 601-1 (EN 60601-1, Second Edition, 1988; Amendment 1, 1991-11, Amendment 2, 1995-03) and UL 2601-1 (August 18, 1994), for instruments classified as Class 1 and TYPE BF and AAMI Standard ES1 (ANSI/AAMI ES1 1993). 3-9

Section 3: Performance Verification

• •

Ground Integrity Electrical Leakage

3.4.1 Ground Integrity

This test checks the integrity of the power cord ground wire from the AC plug to the instrument chassis ground. The current used for this test is < 6V RMS 50 or 60 Hz and 25 A. 1.

Connect the monitor AC mains plug to the analyzer as recommended by the analyzer operating instructions.

2.

Connect the analyzer resistance input lead to the equipotential terminal (grounding lug) on the rear panel of the instrument. Verify that the analyzer indicates 100 milliohms or less.

3.4.2 Electrical Leakage

The following tests verify the electrical leakage of the monitor: • • • •

Earth Leakage Current Enclosure Leakage Current Patient Leakage Current Patient Source Current (Mains on Applied Part)

Note: 3.4.2.1

For the following tests, ensure that the AC switch on the rear of the instrument is configured for the AC voltage being supplied.

Earth Leakage Current

This test is in compliance with IEC 601-1 (earth leakage current) and AAMI Standard ES1 (earth risk current). The applied voltage for AAMI ES1 is 120 VAC 60 Hz, for IEC 601-1 the voltage is 264 VAC 50 to 60 Hz. All measurements shall be made with the power switch in both the “On” and “Off” positions. 1.

Connect the monitor AC plug to the electrical safety analyzer as recommended by the analyzer operating instructions.

2.

The equipotential terminal is not connected to ground. Table 3-2: Earth Leakage Current Limits

AC POLARITY Normal Reversed Normal Normal 3.4.2.2

LINE CORD Closed Closed Open Closed

NEUTRAL CORD Closed Closed Closed Open

LEAKAGE CURRENT 500 µA 500 µA 1000 µA 1000 µA

Enclosure Leakage Current

This test is in compliance with IEC 601-1 (enclosure leakage current) and AAMI Standard ES1 (enclosure risk current). This test is for ungrounded enclosure current, measured between enclosure parts and earth. The applied voltage for

3-10