NPB-290 Service Manual Nov 2011

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588 USA Telephone Toll Free 1.800.NELLCOR Mallinckrodt Europe BV Hambakenwetering 1 5231 DD”s-Hertogenbosch The Netherlands Telephone +31.73.648.5200

Nellcor Puritan Bennett is a wholly owned subsidiary of Mallinckrodt Inc. Nellcor, Nellcor Puritan Bennett, Oxinet II, Oxisensor II, and Durasensor are trademarks of Mallinckrodt Inc. To obtain information about a warranty, if any, for this product, contact Mallinckrodt Technical Services Department, or your local Mallinckrodt representative. Notice: 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. 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; 5,368,026; 5,533,507; and 5,662,106.

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-290 Pulse Oximeter Description ... 1.3 Related Documents ... Section 2: Routine Maintenance ... 2.1 Cleaning... 2.2 Periodic Safety and Functional Checks... 2.3 Battery... Section 3: Performance Verification ... 3.1 Introduction ... 3.2 Equipment Needed ... 3.3 Performance Tests ... 3.4 Safety Tests... Section 4: Audible Alarm Settings and Service Menu ... 4.1 Introduction ... 4.2 Audible Alarm Settings ... 4.3 Operator's Menu Options... 4.4 Service Menu Options ... 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/Replacement ... 6.8 Power Supply Removal/Replacement... 6.9 Cooling Fan Removal/Replacement... 6.10 Display PCB Removal/Replacement... 6.11 User Interface PCB Removal/Replacement ... 6.12 Alarm Speaker Removal/Replacement ... Section 7: Spare Parts... 7.1 Introduction ...

iii v vi 2-1 2-1 2-1 2-2 2-1 2-1 2-1 2-1 3-1 3-1 3-1 3-1 3-10 4-1 4-1 4-1 4-2 4-4 5-1 5-1 5-1 5-1 5-1 5-1 5-2 5-8 6-1 6-1 6-1 6-2 6-3 6-4 6-5 6-6 6-7 6-9 6-10 6-11 6-12 7-1 7-1

iii

Table of Contents 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 ... Section 10: Data Port Interface Protocol ... 10.1 Introduction ... 10.2 Enabling the Data Port ... 10.3 Connecting to the Data Port ... 10.4 Real-Time Printout... 10.5 Nurse Call ... 10.6 Analog Output... 10.7 Interactive Mode ... Section 11: Technical Supplement ... 11.1 Introduction ... 11.2 Oximetry Overview ... 11.3 Circuit Analysis ... 11.4 Functional Overview ... 11.5 AC Input... 11.6 Power Supply PCB Theory Of Operation ... 11.7 Battery... 11.8 User Interface PCB... 11.9 Front Panel Display PCB and Controls ... 11.10 Schematic Diagrams ... Section 12: Index ...

iv

8-1 8-1 8-1 8-3 9-1 9-1 9-1 9-1 9-1 9-2 9-2 9-2 10-1 10-1 10-1 10-2 10-3 10-6 10-7 10-7 11-1 11-1 11-1 11-2 11-2 11-3 11-3 11-4 11-5 11-8 11-9 12-1

Table of Contents

LIST OF FIGURES Figure 1-1: NPB-290 Front Panel ... 2-1 Figure 1-2: NPB-290 Rear Panel... 2-2 Figure 3-1: NPB-290 Controls ... 3-2 Figure 3-2: Power-On Self-Test Display ... 3-3 Figure 3-3: Adjusting High %SpO2 Alarm Limit... 3-4 Figure 3-4: Adjusting Low %SpO2 Alarm Limit ... 3-4 Figure 3-5: Adjusting High Pulse Rate Alarm Limit ... 3-4 Figure 3-6: Adjusting Low Pulse Rate Alarm Limit ... 3-4 Figure 3-7: Alarm Silence Duration... 3-6 Figure 3-8: Alarm Volume Display ... 3-7 Figure 4-1: NPB-290 Controls ... 4-1 Figure 6-1: Fuse Removal ... 6-2 Figure 6-2: NPB-290 Corner Screws ... 6-3 Figure 6-3: Separating Case Halves... 6-4 Figure 6-4: Battery Removal ... 6-5 Figure 6-5: Power Entry Module ... 6-6 Figure 6-6: Power Supply ... 6-7 Figure 6-7: Cooling Fan ... 6-9 Figure 6-8: Display PCB ... 6-10 Figure 6-9: User Interface PCB ... 6-11 Figure 6-10: Alarm Speaker... 6-13 Figure 7-1: NPB-290 Exploded View ... 7-2 Figure 8-1: Repacking the NPB-290... 8-2 Figure 10-1: Data Port Pin Layout ... 10-2 Figure 10-2: Real-Time Printout ... 10-3 Figure 10-3: Instrument Info Printout ... 10-9 Figure 10-4: Trend Printout... 10-10 Figure 10-5: Error Log Printout ... 10-10 Figure 11-1: Oxyhemoglobin Dissociation Curve ... 11-2 Figure 11-2: NPB-290 Functional Block Diagram... 11-3 Figure 11-3: User Interface PCB Front End Red/IR Schematic Diagram ... 11-9 Figure 11-4: Front End LED Drive Schematic Diagram... 11-9 Figure 11-5: Front End Power Supply Schematic Diagram... 11-9 Figure 11-6: SIP/SOP Isolation Barrier Schematic Diagram ... 11-9 Figure 11-7: Data Port Drivers and Analog Output Schematic Diagram ... 11-9 Figure 11-8: User Interface PCB MC331 Core Schematic Diagram ... 11-9 Figure 11-9: User Interface PCB MC331 Memory Schematic Diagram B ... 11-9 Figure 11-10: Speaker Driver Schematic Diagram A ... 11-9 Figure 11-11: User Interface PCB Power Supply Schematic Diagram B ... 11-9 Figure 11-12: Display Interface Schematic Diagram ... 11-9 Figure 11-13: Parts Locator Diagram for USER INTERFACE PCB ... 11-9 Figure 11-14: Power Supply Schematic Diagram... 11-9 Figure 11-15: Power Supply Parts Locator Diagram ... 11-9 Figure 11-16: Display PCB Schematic Diagram... 11-9 Figure 11-17: Display PCB Parts Locator Diagram ... 11-9

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: Language Selection... Table 4-2: 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: Data Port Problems ... Table 5-7: Error Codes ... Table 6-1: Power Supply Leads Connections ... Table 7-1: Parts List... Table 9-1: Default Settings ... Table 10-1 Data Port Pin Outs... Table 10-2: Status Codes ... Table 10-3: Nurse Call Relay Pin States ... Table 10-4: Rating of Nurse Call Relay ...

vi

3-8 3-11 3-11 3-12 3-13 4-3 4-5 5-2 5-3 5-4 5-5 5-6 5-7 5-8 6-8 7-1 9-2 10-2 10-6 10-7 10-7

SECTION 1: INTRODUCTION 1.1 1.2 1.3

1.1

Manual Overview NPB-290 Pulse Oximeter Description Related Documents

MANUAL OVERVIEW This manual contains information for servicing the NPB-290 pulse oximeter. Only qualified service personnel should service this product. Before servicing the NPB-290, read the operator's manual carefully for a thorough understanding of how to operate the NPB-290. Warning: Explosion hazard. Do not use the NPB-290 pulse oximeter in the presence of flammable anesthetics.

1.2

NPB-290 PULSE OXIMETER DESCRIPTION The Nellcor NPB-290 pulse oximeter is intended for continuous, noninvasive monitoring 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 areas, hospital-type facilities, and in the home environment. It may be used during intra-hospital transport when powered by its internal battery. Digital displays are provided for oxygen saturation and pulse rate, and a 10segment light-emitting diode (LED) bar indicates pulse amplitude. The NPB-290 can operate on AC or rechargeable internal battery power. The controls and indicators for the NPB-290 are illustrated in Figure 1-1 and Figure 1-2. 

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NPB-290

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1. SpO2 Sensor Port

9. Alarm Silence Button

2. Power On/Off Button

10. Adjust Up Button

3. Low Battery Indicator

11. Adjust Down Button

4. AC Power Indicator

12. Pulse Search Indicator

5. %SpO2 Display

13. Motion Indicator

6. Pulse Amplitude Indicator

14. Lower Alarm Limit Button

7. Pulse Rate Display

15. Upper Alarm Limit Button

8. Alarm Silence Indicator

16. Speaker

Figure 1-1: NPB-290 Front Panel

1-1

Section 1: Introduction 

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NPB-290 SN

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

T 0.50A 250V

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

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IPX1 012 3

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

MADE IN U.S.A.

035285X-1296

U.S. PATENTS: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; 4,911,167; 4,928,692; 4,934,372; 5,078,136

"

1. Equipotential Terminal

4. Fuse Drawer

2. AC Connector

5. Supply Voltage Selector Switch

3. Data Port

Figure 1-2: NPB-290 Rear Panel 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 NPB-290 operator's manual. To understand the various Nellcor sensors that work with the monitor, refer to directions for use for individual sensors.

1-2

SECTION 2: ROUTINE MAINTENANCE 2.1 2.2 2.3

2.1

Cleaning Periodic Safety and Functional Checks Battery

CLEANING Caution: Do not immerse the NPB-290 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-290, 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 NBP-290 requires no calibration. The battery should be replaced at least every 24 months (paragraph 6.6). The following checks should be performed at least every 24 months by a qualified service technician.

2.2.1

2.2.2

Periodic Safety Checks

1.

Inspect the equipment for mechanical and functional damage.

2.

Inspect safety labels for legibility. If the labels are not legible, contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative.

Functional Checks

If the monitor has been visibly damaged or subjected to mechanical shock (for example, if dropped), perform the performance tests, refer to paragraph 3.3. The following checks should be performed at least every 2 years by a qualified service technician.

2.3

1.

Perform the electrical safety tests detailed in paragraph 3.4. If the unit fails these electrical safety tests, refer to Section 6, Troubleshooting.

2.

Inspect the fuses for proper value and rating (F1 & F2 = 0.5 amp, 250 volts).

BATTERY Mallinckrodt recommends replacing the instrument battery every 2 years. When the NPB-290 is going to be stored for 2 months or more, remove the battery. To replace or remove the battery, refer to Section 6, Disassembly Guide.

2-1

Section 2: Routine Maintenance

If the NPB-290 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 when the NPB-290 is in the standby mode and 18 hours if the NPB-290 is in use. The battery is being charged anytime that the instrument is plugged into AC power.

2-2

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 NPB-290 performance following repairs or during routine maintenance. All tests can be performed without removing the NPB-290 cover. If the NPB-290 fails to perform as specified in any test, repairs must be made to correct the problem before the monitor is returned to the user.

3.2

EQUIPMENT NEEDED Equipment

3.3

Description

Digital multimeter (DMM)

Fluke Model 87 or equivalent

Durasensor® oxygen transducer

DS-100A

Oxisensor® II oxygen transducer

D-25

Pulse oximeter tester

SRC-2

Safety analyzer

Must meet current AAMI ES1/1993 & IEC 601-1/1998 specifications

Sensor extension cable

SCP-10 or MC-10

Serial interface cable

Refer to paragraph 10.3

Stopwatch

Manual or electronic

PERFORMANCE TESTS The battery should be charged before the monitor is repaired whenever possible. Note:

3.3.1

This section is written using Mallinckrodt factory-set defaults. If your institution has pre-configured custom defaults, those values will be displayed. Factory defaults can be reset using the configuration procedure described in paragraph 4.4.5.

Battery Charge

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

Connect the monitor to an AC power source.

2.

Verify that the monitor is off and that the AC Power/Battery Charging indicator is lit.

3.

Charge the battery for at least 14 hours.

3-1

Section 3: Performance Verification 3.3.2

Performance Tests

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

3.3.2.1 Power-On Self-Test

•

3.3.2.2 Factory Power-On Defaults and Alarm Limit Ranges
 



 



NPB-290


  


  


  



  


Figure 3-1: NPB-290 Controls 3.3.2.1

Power-On Self-Test (POST)

Note:

See Figure 3-1 for the location of the NPB-290 controls.

1. Connect the monitor to an AC power source. Verify the AC Power/Battery Charging indicator is lit.

2. Do not connect any input cables to the monitor. 3. Observe the front panel of the monitor. With the monitor off, press the Power On/Off button. Verify that the monitor performs the following sequence: a. Red "8.8.8." is displayed in both windows for a few seconds and the 10segment blip bar is completely illuminated in green. Only the AC Power Indicator is illuminated.

3-2

Section 3: Performance Verification

Low Battery Indicator

Alarm Silence Indicator

AC Power 8.8.8. displayed Indicator NPB-290

10 segments illuminated

Motion Indicator

Pulse Search Indicator

Figure 3-2: Power-On Self-Test Display b. The "8.8.8." displayed in both windows turns green, the 10-segment blip bar is completely illuminated in green, and all LEDs are illuminated as shown in Figure 3-2. c. The software version is displayed and all LEDs are illuminated. d. A 1-second POST beep sounds, 3 dashes are displayed in each window, and all LEDs are off except the AC Power LED. Note:

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 along with the AC Power/Battery Charging LED. e. The NPB-290 begins normal operation if a sensor is connected. Without a sensor, the monitor will display 3 dashes in each window.

3.3.2.2

Factory Power-On Defaults and Alarm Limit Ranges

Note:

See Figure 3-1 for the location of the NPB-290 controls.

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.

1. Turn the monitor on by pressing the Power On/Off button. a. Wait for POST to be completed. b. Press and release the Upper Alarm Limit button. c. Verify that the monitor emits a single beep and the %SpO2 display indicates a high alarm limit of "100" for about 3 seconds. d. Verify that three dashes are displayed at the top of the pulse rate display. See Figure 3-3. 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.

3-3

Section 3: Performance Verification

Figure 3-3: Adjusting High %SpO2 Alarm Limit 2. Press the Upper Alarm Limit button. Within 3 seconds press and hold the Adjust Down button. Verify the %SpO2 display reduces to a minimum of "85." Note:

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

3. 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. See Figure 3-4.

Figure 3-4: Adjusting Low %SpO2 Alarm Limit 4. Press the Lower Alarm Limit button. Within 3 seconds 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. See Figure 3-5.

Figure 3-5: Adjusting High Pulse Rate Alarm Limit 6. Press the Upper Alarm Limit button two times rapidly. Within 3 seconds press and hold the Adjust Down button. Verify that the pulse rate display reduces to a minimum of "40." See Figure 3-6. 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 shows three dashes at the bottom for 3 seconds.

Figure 3-6: Adjusting Low Pulse Rate Alarm Limit

3-4

Section 3: Performance Verification

8. Press the Lower Alarm Limit button two times rapidly. Within 3 seconds 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. Within 3 seconds press and hold the Adjust Up button. Verify that the pulse rate display cannot be adjusted above "40." 10. Press the Power On/Off 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/Off button to turn the monitor off. 3.3.3

Hardware and Software Tests

Hardware and software testing includes the following tests:

3.3.3.1

•

3.3.3.1

Operation with a Pulse Oximeter Tester

•

3.3.3.2

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

•

3.3.3.1.1

Alarms and Alarm Silence

•

3.3.3.1.2

Alarm Volume Control

•

3.3.3.1.3

Pulse Tone Volume Control

•

3.3.3.1.4

Dynamic Operating Range

•

3.3.3.1.5

Nurse Call

•

3.3.3.1.6

Analog Output

•

3.3.3.1.7

Operation on Battery Power

Alarms and Alarm Silence

1. Connect the SRC-2 pulse oximeter tester to the sensor-input cable and connect the cable to the monitor. Refer to SRC-2 Operator's manual. Set the SRC-2 switches as follows: SWITCH

POSITION

RATE

38

LIGHT

HIGH 1

MODULATION

OFF

RCAL/MODE

RCAL 63/LOCAL

3-5

Section 3: Performance Verification

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

The pulse amplitude indicator 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 that the following monitor reactions: a. The pulse amplitude indicator 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. The audible alarm sounds and both the %SpO2 and pulse rate displays flash the values in red. This is an indication that both parameters have violated the default alarm limits. 5. Press and hold the Alarm Silence button located 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. See Figure 3-7.

Figure 3-7: Alarm Silence Duration 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." 8. 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." 9. Press the Alarm Silence button again and verify that the Alarm Silence indicator flashes. 3-6

Section 3: Performance Verification

10. Wait approximately 3 minutes. Verify that the alarm does not return. 11. After 3 minutes ± 10 seconds, the alarm silence reminder beeps three times, and continues to do so at 3-minute intervals. 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." See Figure 3-8.

•

the pulse rate display indicates the default setting of 5.

Figure 3-8: Alarm Volume Display 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. 4. Press the Adjust Down button until a comfortable audio level is attained. 5. Release the Alarm Silence button. The tone stops. 3.3.3.1.3

Pulse Tone Volume Control

1. When a valid pulse has been acquired, press the Adjust Up button and verify that the sound level of the beeping pulse tone increases. 2. Press the Adjust Down button and verify that the beeping pulse tone decreases until it is no longer audible. 3. Press the Adjust Up button to return the beep volume to a comfortable level. 3.3.3.1.4

Dynamic Operating Range

The following test sequence verifies proper monitor operation over a range of input signals: 1. Turn the instrument off and connect the SRC-2 to the NPB-290. Turn the NPB-290 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-290 readings are within the indicated tolerances. Allow the monitor several seconds to stabilize the readings. 3-7

Section 3: Performance Verification

Note:

An asterisk (*) indicates values that produce an alarm. Press the Alarm Silence button to silence the alarm. Table 3-1: Dynamic Operating Range SRC-2 Settings Rate

3.3.3.1.5

Light

Modulation

NPB-290 Indications SpO2

Pulse Rate

38

HIGH2

LOW

79 - 83*

37 - 39*

112

HIGH1

HIGH

79 - 83*

110 - 114

201

LOW

LOW

79 - 83*

195 - 207*

201

LOW

HIGH

79 - 83*

195 - 207*

Nurse Call

Note:

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 the positive lead to pin 11 of the data port on the back of the instrument (Figure 10-1). Ensure that the audible alarm is not silenced or turned off. 2. Set the pulse rate switch of the SRC-2 to create an alarm condition. Refer to the SRC-2 Operator's manual. Verify that an output voltage at pins 10 and 11 between +5 and +12 volts DC. 3. Press the Alarm Silence button. With no active audible alarm, the output voltage at pins 10 and 11 must be between -5 and -12 volts DC. 4. With the instrument in an alarm condition, use an ohmmeter to verify that there is no continuity between pins 8 and 15 and that there is continuity between pins 7 and 15. 5. Adjust the alarm limits so that there is no alarm condition. Use an ohmmeter to verify that there is continuity between pins 8 and 15 and that there is no continuity between pins 7 and 15. 3.3.3.1.6

Analog Output

Note:

The Analog Output tests must be performed with the instrument operating on AC power.

1. Connect the negative lead of a voltmeter to pin 10 and the positive lead to pin 6 of the data port located on the back of the instrument (Figure 1-2). 2. Turn the instrument off, then turn it back on. 3. Verify that the output voltage is 0.000 ± 0.025 volts DC, then after about a minute verify that the voltage has increased to +1.000 ± 0.025 volts DC. 4. Move the positive lead to pin 13 and repeat steps 2 and 3. 5. Move the positive lead to pin 14 and repeat steps 2 and 3. 6. Disconnect the voltmeter from the instrument.

3-8

Section 3: Performance Verification 3.3.3.1.7

Operation on Battery Power

1. Turn the instrument on using AC power. 2. Disconnect the instrument from AC and verify the AC Power Indicator turns off. 3. Verify the instrument continues monitoring normally and that the Low Battery Indicator is not lit. Note:

If the Low Battery Indicator is lit, perform the procedure in paragraph 3.3.1.

4. Connect the instrument to AC and verify that the AC Power Indicator lights and that the instrument is monitoring normally. 3.3.3.2

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® 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 the monitor to an AC power source. 2. Connect an SCP-10 or MC-10 sensor input cable to the monitor. 3. Connect a D-25 sensor to the sensor-input cable. 4. Press the Power On/Off 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.

3.3.3.2.2

7.

Slowly move the sensor LED in close to the photodetector element of the sensor. As the LED approaches the photodetector, verify 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-290 off.

Monitor Operation with a Live Subject

Pulse oximetry involves connecting the monitor to a live subject for a qualitative test. 1. Ensure that the monitor is connected to an AC power source.

3-9

Section 3: Performance Verification

2. Connect an SCP-10 or MC-10 sensor input cable to the monitor. 3. Connect a Nellcor Durasensor® 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/Off 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. 3.4

SAFETY TESTS NPB-290 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).

3.4.1

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 < 6 volts RMS, 50 or 60 Hz, and 25 A. 1. Connect the monitor AC power cord 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. See Figure 1-2. Verify that the analyzer indicates 100 milliohms or less. 3.4.2

Electrical Leakage

The following tests verify the electrical leakage of the monitor:

3-10

•

Earth Leakage Current

•

Enclosure Leakage Current

•

Patient Applied Risk Current

•

Patient Isolation Risk Current (Mains Voltage on the Applied Part)

Note:

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