NPB-195 Service Manual Jan 2000

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

Nellcor Puritan Bennett Inc. is a wholly owned subsidiary of Mallinckrodt Inc. Nellcor, Nellcor Puritan Bennett, Durasensor, and Oxisensor II are trademarks of Mallinckrodt Inc. To obtain information about a warranty, if any, for this product, contact Mallinckrodt's 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. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; 5,078,136; 5,351,685; and 5,368,026.

TABLE OF CONTENTS List of Figures List of Tables Table of Contents ... List of Figures... List of Tables ... Section 1: Introduction ... 1.1 Manual Overview... 1.2 NPB-195 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: Power-On Settings and Service Functions ... 4.1 Introduction ... 4.2 Power-On Settings ... 4.3 Service Functions... 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 Cooling Fan Removal/Installation ... 6.10 Display PCB Removal/Installation... 6.11 UIF PCB Removal/Installation... 6.12 Alarm Speaker Removal/Installation... 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...

iii v vi 1-1 1-1 1-1 1-4 1-4 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 6-7 6-8 6-9 6-10 6-11 6-13 7-1 7-1 8-1 8-1 8-2 8-3

iii

Table of Contents 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: Serial Port Interface Protocol... 10.1 Introduction ... 10.2 Enabling the Serial Port... 10.3 Connecting to the Serial Port ... 10.4 Real-Time Printout ... 10.5 Trend Data Printout... 10.6 Nurse Call ... 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 (UIF) ... 11.9 Front Panel Display PCB and Controls ... 11.10 Schematic Diagrams... Section 12: Index ...

iv

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

Table of Contents

LIST OF FIGURES Figure 1-1: NPB-195 Front Panel ... Figure 1-2: User Softkey Map... Figure 1-3: NPB-195 Rear Panel... Figure 3-1: NPB-195 Controls ... Figure 3-2: Self-Test Display ... Figure 3-3: Adjusting %SpO2 Upper Alarm Limit ... Figure 3-4: Adjusting % SpO2 Lower Alarm Limit ... Figure 3-5: Adjusting High Pulse Rate Alarm ... Figure 3-6: Adjusting Low Pulse Rate Alarm... Figure 4-1: Service Function Softkeys... Figure 4-2: Service Function Softkey Map ... Figure 4-3: Param Softkeys... Figure 4-4: Print Softkeys ... Figure 4-5: Trend Printout ... Figure 4-6: Errlog Printout ... Figure 4-7: Instat Printout ... Figure 4-8: Next Softkeys ... Figure 4-9: Alarms Softkeys ... Figure 6-1: Fuse Removal ... Figure 6-2: NPB-195 Corner Screws... Figure 6-3: Separating Case Halves ... Figure 6-4: NPB-195 Battery ... Figure 6-5: Internal Power Connections ... Figure 6-6: Power Entry Module ... Figure 6-7: Power Supply ... Figure 6-8: Cooling Fan... Figure 6-9: Display PCB ... Figure 6-10: UIF PCB ... Figure 6-11: Alarm Speaker ... Figure 7-1: NPB-195 Expanded View... Figure 8-1: Repacking the NPB-195... Figure 10-1: Serial Port Pin Layout... Figure 10-2: Real-Time Printout ... Figure 10-3: Trend Data Printout... Figure 11-1: Oxyhemoglobin Dissociation Curve ... Figure 11-2: NPB-195 Functional Block Diagram ... Figure 11-3: UIF PCB Front End Red/IR Schematic Diagram ... Figure 11-4: Front End LED Drive Schematic Diagram ... Figure 11-5: Front End Output Schematic Diagram ... Figure 11-6: Front End Power Supply Schematic Diagram... Figure 11-7: Isolation Barrier EIA-232 Port Schematic Diagram... Figure 11-8: CPU Core Schematic Diagram A... Figure 11-9: CPU Core Schematic Diagram B... Figure 11-10: MC331 CPU Core Schematic Diagram A ... Figure 11-11: MC331 CPU Core Schematic Diagram B ... Figure 11-12: Display Driver Schematic Diagram ... Figure 11-13: Speaker Driver Schematic Diagram... Figure 11-14: Core Power Supply Schematic Diagram... Figure 11-15: Power On/Off Circuit Schematic Diagram ... Figure 11-16: UIF PCB Parts Locator Diagram ... Figure 11-17: Power Supply Schematic Diagram... Figure 11-18: Power Supply Parts Locator Diagram ...

1-2 1-3 1-4 3-2 3-3 3-3 3-4 3-4 3-4 4-2 4-3 4-4 4-4 4-5 4-6 4-6 4-7 4-7 6-2 6-3 6-4 6-5 6-6 6-7 6-8 6-9 6-10 6-12 6-13 7-2 8-2 10-2 10-2 10-5 11-2 11-3 11-8 11-8 11-8 11-8 11-8 11-9 11-9 11-9 11-9 11-9 11-9 11-9 11-9 11-9 11-9 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: 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 7-1: Parts List ... Table 9-1: Default Settings ... Table 10-1: Serial Port Pin-Outs... Table 10-2: Status Codes...

vi

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

SECTION 1: INTRODUCTION 1.1 1.2 1.3 1.4

1.1

Manual Overview NPB-195 Pulse Oximeter Description Power-On Self Test Related Documents

MANUAL OVERVIEW This manual contains information for servicing the Nellcor model NPB-195 pulse oximeter. Only qualified service personnel should service this product. Before servicing the NPB-195, read the operator’s manual carefully for a thorough understanding of operation. WARNING: Explosion hazard. Do not use the NPB-195 pulse oximeter in the presence of flammable anesthetics.

1.2

NPB-195 PULSE OXIMETER DESCRIPTION The NPB-195 is a portable pulse oximeter intended for use as a continuous noninvasive monitor of arterial oxygen saturation (SpO2) and pulse rate. It can be used on adult, pediatric and neonatal patients. Oxygen saturation and pulse rate are displayed digitally along with a plethysmographic waveform or a tensegment blip bar which indicates pulse intensity. Through the use of the four softkeys, the operator can access trend information, select an alarm limit to be changed, choose the language to be used, adjust the internal time clock, and change communications protocol. The NPB-195 can operate on AC power or on an internal battery. This monitor is intended for use in hospital, hospital-type facilities, during intra-hospital transport, and in home environments. The controls and indicators for the NPB-195 are illustrated in Figure 1-1 through Figure 1-3. Figure 1-2 illustrates the various functions available, and how to access them, through the use of the softkeys. A complete explanation of the keys is provided in the NPB-195 operator’s manual.

1-1

Section 1: Introduction

1

2 3

4

5

6

8

9

11

10

7

NPB-195

%SP02 BPM LIMITS

15 14

16

TREND

SETUP

100 110

LIGHT

13

12

1. SpO2 Sensor Port

9. Alarm Silence Button

2. Low Battery Indicator

10. Adjust Up Button

3. Power On/Standby Button

11. Adjust Down Button

4. AC/Battery Charging Indicator

12. Contrast Button

5. Waveform Display

13. Softkeys

6. %SpO2 Indicator

14. Menu Bar

7. Pulse Beats Per Minute display

15. Pulse Search Indicator

8. Alarm Silence Indicator

16. Speaker

Figure 1-1: NPB-195 Front Panel

1-2

Section 1: Introduction %SPO2 BPM

Limits

Trend

Normal Display Mode

95 65

Setup

Light LCD Display Light ON/OFF

Sel

Exit

Select alarm limit to be adjusted High/Low %SpO2 or Pulse

View

View

Next

Clock

Exit Return to Display Mode

Return to Display Mode

Pleth

Exit

Next

Zoom

Exit

Blip

Return to Display Mode

Selects trend data from last 24, 12, 8, 4, 2 or 1 hours 30min or 15min

Set

Exit

Sel

Exit

Dual

SpO2

Pulse

Hist

Comm

Lang

Trend for SpO2 and Pulse

SpO2 trend only

Pulse trend only

Histogram for SpO2 and Pulse

Select 2400 9600 or 19200

English Francais Deutsch Italiano Espanol Dutch Portug

Clear

Print

Next

Print out of screen

Yes

No

Clears all trend info

Returns to prior trend display

Cycles between (Clear, Print, Exit, Next) screen and (View, Zoom, Exit, Next) screen

Exit Returns to display mode

Next

Exit Return to Display Mode

Figure 1-2: User Softkey Map

1-3

Section 1: Introduction 1

2

3

TM

2X T 0.50A 250V

R

IPX1 NRTL/C

MADE IN IRELAND

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

CISPR 11 Group 1 Class B

012 3

NPB-195

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

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

5

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

1. Equipotential (ground) Terminal

4. Fuse Receptacle

2. AC Inlet

5. Voltage Selection Switch

3. DB-15 Interface Connector

Figure 1-3: NPB-195 Rear Panel 1.3

POWER-ON SELF TEST When the NPB-195 is turned on it will perform a POST (Power-On Self Test). During POST the following sequence should occur: •

All indicator lights illuminate

•

All pixels in the LCD display illuminate

•

The backlight turns on and the Nellcor Puritan Bennett logo and software version are displayed

Upon successful completion of POST, the NPB-195 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. The software version is often needed when calling Mallinckrodt's Technical Services Department or your local Mallinckrodt representative for technical assistance. Record the software version and have it available prior to requesting technical assistance. 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-195 operator’s manual. To understand the various Nellcor sensors that work with the monitor, refer to the individual sensor’s directions for use.

1-4

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-195 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-195, dampen a cloth with a commercial, nonabrasive cleaner and wipe the exterior surfaces lightly. Do not allow any liquids to come in contact with the power connector, fuse holder, or switches. Do not allow any liquids to penetrate connectors or openings in the instrument cover. Wipe sensor cables with a damp cloth. For sensors, follow each sensor’s directions for use.

2.2

PERIODIC SAFETY AND FUNCTIONAL CHECKS The following checks should be performed at least every 2 years by a qualified service technician.

2.3

1.

Inspect the exterior of the NPB-195 for damage.

2.

Inspect safety labels for legibility. If the labels are not legible, contact Mallinckrodt's Technical Services Department or your 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 the NPB-195. Contact Mallinckrodt's Technical Services Department or your local Mallinckrodt representative.

5.

Inspect the fuses for proper value and rating (F1 & F2 = 0.5 amp slow blow).

BATTERY Mallinckrodt recommends replacing the instrument battery every 2 years. When the NPB-195 is going to be stored for 3 months or more, remove the battery prior to storage. To replace or remove the battery, refer to Section 6, Disassembly Guide. If the NPB-195 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 in standby, or 18 hours if in use, 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-195 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-195 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

EC-4 or EC-8

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 returning the instrument to use. 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 restored using the configuration mode procedure described in paragraph 4.2.1 below.

3-1

Section 3: Performance Verification 3.3.1 Battery Charge

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

Connect the monitor to an AC power source.

2.

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

3.

Charge the battery for at least 14 hours in standby.

3.3.2 Power-up Performance

The power-up performance tests (3.3.3.1 through 3.3.3.3) verify the following monitor functions: •

3.3.2.1

Power-On Self-Test

•

3.3.2.2

Power-On Defaults and Alarm Limit Ranges Power On/Standby

Alarm silence

NPB-195

%SP02 BPM LIMITS

TREND

SETUP

Soft keys

100 110

LIGHT

Contrast Adjust Down

Adjust Up

Figure 3-1: NPB-195 Controls 3.3.2.1

3-2

Power-On Self-Test

1.

Connect the monitor to an AC power source and verify that the AC Power/Battery Charging indicator is lit.

2.

Do not connect any input cables to the monitor.

Section 3: Performance Verification

3.

Observe the monitor front panel. With the monitor off, press the Power On/Standby button. See Figure 3-1. The monitor must perform the following sequence. a.

Within 2 seconds all LEDs are illuminated, then all pixels on the LCD display are illuminated, after which, the backlight comes on.

b.

The indicators remain lighted.

c.

The LCD display shows the Nellcor Puritan Bennett logo and the software version of the NPB-195 (Figure 3-2).

NPB-195

Nellcor Puritan Bennett NPB-195 Version 1.1.0.5

Figure 3-2: Self-Test Display

3.3.2.2

d.

A 1-second beep sounds indicating proper operation of the speaker, and all indicators turn off except the AC Power/Battery Charging indicators.

e.

The NPB-195 begins normal operation.

Power-On Defaults and Alarm Limit Ranges

Note:

When observing or changing default limits, a 10-second timeout is in effect. If no action is taken within 10 seconds, the monitor automatically returns to the monitoring display.

Note:

The descriptions that follow are based on the assumption that Pleth is the view that has been selected. The steps to changing an alarm limit are the same if the view being used is Blip.

1.

Ensure that the monitor is on. Press and release the Limits softkey. Verify that the monitor emits a single beep and the plethysmograph waveform is replaced with a display of the alarm limits. The high alarm limit for %SpO2 will indicate an alarm limit of “100” inside a box (Figure 3-3). NPB-195

ALARM LIMITS %SP02 PULSE SPO2 170 100 BPM 85 40 EXIT

UPPER LOWER SEL

100 110

Figure 3-3: Adjusting %SpO2 Upper Alarm Limit At the end of 10 seconds, with no activity, normal monitoring is resumed.

3-3

Section 3: Performance Verification

2.

Press the Limits softkey. Press and hold the Down Arrow button. Verify that the boxed number for %SpO2 upper alarm limit reduces to a minimum of “85.” Note:

3.

A decimal point in the display indicates that the alarm limits have been changed from factory default values.

Press the SEL softkey. Verify that the monitor emits a single beep and the box moves to the %SpO2 lower alarm limit of “85.” See Figure 3-4. NPB-195

ALARM LIMITS %SP02 PULSE SPO2 170 100 UPPER BPM 85 LOWER 40 SEL EXIT

100 110

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

Press and hold the Down Arrow button and verify that the %SpO2 lower alarm limit display reduces to a minimum of “20.” Press and hold the Up Arrow button and verify that the %SpO2 lower alarm limit display cannot be raised past the upper alarm limit setting of “85.” Press the Exit button.

5.

Press the Limits softkey and then press the SEL softkey two times. Verify that the monitor emits a beep after each keystroke. The Pulse upper alarm limit should be “170” and should be boxed. See Figure 3-5. NPB-195

ALARM LIMITS %SP02 PULSE SPO2 170 100 UPPER BPM 85 LOWER 40 SEL EXIT

100 110

Figure 3-5: Adjusting High Pulse Rate Alarm 6.

Press and hold the Down Arrow button. Verify that the Pulse upper alarm limit display reduces to a minimum of “40” and is displayed. Press the Exit button.

7.

Press the Limits softkey and then press the SEL softkey three times. Verify that the Pulse lower alarm limit display indicates an alarm limit of “40” and is boxed. See Figure 3-6. NPB-195

ALARM LIMITS %SP02 PULSE SPO2 170 100 UPPER BPM 85 LOWER 40 SEL EXIT

100 110

Figure 3-6: Adjusting Low Pulse Rate Alarm

3-4

Section 3: Performance Verification

8.

Press and hold the Down Arrow button. Verify that the boxed Pulse lower alarm limit display reduces to a minimum of “30.”

9.

Press and hold the Up Arrow button and verify that the boxed Pulse lower alarm limit display cannot be adjusted above the Pulse high limit of “40.”

10. Press the Power On/Standby button to turn the monitor off. 11. Press the Power On/Standby button to turn the NPB-195 back on. 12. Press and release the Limits softkey. Verify that the %SpO2 upper alarm limit display is boxed and indicates an alarm limit of “100.” 13. Press the SEL softkey. Verify that the %SpO2 lower alarm limit display is boxed and indicates an alarm limit of “85.” 14. Press the SEL softkey a second time. Verify that the Pulse upper alarm limit display is boxed and indicates an alarm limit of “170.” 15. Press the SEL softkey a third time. Verify that the Pulse lower alarm limit display is boxed and indicates an alarm limit of “40.” 16. 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

•

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

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

2.

POSITION

RATE

38

LIGHT

LOW

MODULATION

OFF

RCAL/MODE

RCAL 63/LOCAL

Press the Power On/Standby button to turn the monitor on. After the normal power-up sequence, press the following softkeys; Setup, View, and Pleth. Verify that the %SpO2 and Pulse initially indicate zeroes. 3-5

Section 3: Performance Verification

3.

Move the modulation switch on the SRC-2 to LOW.

4.

Verify the following monitor reactions: a.

The plethysmograph waveform 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 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

e.

3-6

The audible alarm sounds and both the %SpO2 and Pulse displays will flash, indicating both parameters have violated the default alarm limits.

5.

Press and hold the Alarm Silence button on the front of the monitor for less than 2 seconds. Verify that the %SpO2 display indicates “60” and the Pulse display indicates “SEC” while the Alarm Silence button is pressed. When the button is released the alarm is silenced.

6.

With the alarm silenced verify the following: a.

The alarm remains silenced.

b.

The Audible Silence indicator lights.

c.

The %SpO2 and Pulse displays continue to flash.

d.

The pulse tone is still audible.

e.

The audible alarm returns in approximately 60 seconds.

7.

Press and hold the Alarm Silence button. Press the Down Arrow button until the Pulse display indicates “30.” Press the Up Arrow button and verify that the displays indicate 60 SEC, 90 SEC, 120 SEC, and OFF. Release the button when the display indicates “OFF. "

8.

Press and release the Alarm Silence button. Verify that the Alarm Silence Indicator flashes.

9.

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 approximately 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 above: 1.

3.3.3.1.3

3.3.3.1.4

Press and hold the Alarm Silence button and verify the following: a.

“OFF” is displayed for approximately 2 seconds.

b.

After 2 seconds, a steady tone is heard at the default alarm volume setting, the %SpO2 display indicates “VOL,” and the Pulse display indicates the default setting of 5.

2.

While still pressing the Alarm Silence button, press the Down Arrow button until an alarm volume setting of 1 is displayed. Verify that the volume of the alarm has decreased but is still audible.

3.

Continue pressing the Alarm Silence button and press the Up Arrow button to increase the alarm volume setting to a maximum value of 10. Verify that the volume increases. Press the Down Arrow button until a comfortable audio level is attained.

4.

Release the Alarm Silence button. The tone will stop.

Pulse Tone Volume Control

1.

Press the Up Arrow button and verify that the beeping pulse tone sound level increases.

2.

Press the Down Arrow button and verify that the beeping pulse tone decreases until it is no longer audible. Press the Up Arrow 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-195 and turn the NPB-195 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-195 readings are within the indicated tolerances. Allow the monitor several seconds to stabilize the readings.

Note:

A 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

NPB-195 Indications

RATE

LIGHT

MODULATION

SpO2

Pulse Rate

38

HIGH2

LOW

79 - 83* 35 - 41*

112

HIGH1

HIGH

79 - 83* 109 - 115

201

LOW

LOW

79 - 83* 198 - 204*

201

LOW

HIGH

79 - 83* 198 - 204*

3-7

Section 3: Performance Verification 3.3.3.1.5

Nurse Call

Note:

3.3.3.1.6

1.

Connect the negative lead of a voltmeter to pin 10 and positive lead to pin 11 of the serial port on the back of the instrument (Figure 10-1). 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.

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

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

If the Low Battery 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

•

3.3.3.2.1

LED Excitation Test

•

3.3.3.2.2

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.

3-8

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.

Section 3: Performance Verification

7.

Slowly move the sensor LED in proximity to the photodetector element of the sensor. Verify, as the LED approaches the optical sensor, 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-195 off. 3.3.3.2.2

Operation with a Live Subject

Patient monitoring 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 extension 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 the subject as recommended in the sensor’s 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 oxygen saturation and pulse rate are reasonable for the subject.

SAFETY TESTS NPB-195 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). •

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.

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