Nellcor NPB-190 User manual
SERVICE MANUAL
NPB-190 Pulse Oximeter
Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
To contact Mallinckrodt’s representative: In the United States, call 1.800.635.5267 or 314.654.2000; outside of the United
States, call your local Mallinckrodt representative.
1999 Mallinckrodt Inc. All rights reserved. 033925E-0599
0123
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 ....................................................................................... iii
List Of Figures......................................................................................... v
List Of Tables .......................................................................................... vi
Section 1: Introduction............................................................................... 1-1
1.1 Manual Overview.......................................................................... 1-1
1.2 NPB-190 Pulse Oximeter Description.......................................... 1-1
1.3 Power-On Self Test...................................................................... 1-2
1.4 Related Documents...................................................................... 1-3
Section 2: Routine Maintenance................................................................ 2-1
2.1 Cleaning ....................................................................................... 2-1
2.2 Periodic Safety and Functional Checks ....................................... 2-1
2.3 Battery.......................................................................................... 2-1
Section 3: Performance Verification ......................................................... 3-1
3.1 Introduction .................................................................................. 3-1
3.2 Equipment Needed ...................................................................... 3-1
3.3 Performance Tests....................................................................... 3-1
3.4 Safety Tests ................................................................................. 3-9
Section 4: Audible Alarm Settings & Service Menu................................. 4-1
4.1 Introduction .................................................................................. 4-1
4.2 Audible Alarm Settings ................................................................. 4-1
4.3 Service Menu ............................................................................... 4-2
Section 5: Troubleshooting ....................................................................... 5-1
5.1 Introduction .................................................................................. 5-1
5.2 How To Use This Section............................................................. 5-1
5.3 Who Should Perform Repairs ...................................................... 5-1
5.4 Replacement Level Supported ..................................................... 5-1
5.5 Obtaining Replacement Parts ...................................................... 5-1
5.6 Troubleshooting Guide ................................................................. 5-2
5.7 Error Codes.................................................................................. 5-7
Section 6: Disassembly Guide................................................................... 6-1
6.1 Introduction .................................................................................. 6-1
6.2 Prior to Disassembly .................................................................... 6-1
6.3 Fuse Replacement ....................................................................... 6-2
6.4 Monitor Disassembly .................................................................... 6-3
6.5 Monitor Reassembly .................................................................... 6-4
6.6 Battery Replacement.................................................................... 6-5
6.7 Power Entry Module (PEM) Removal/Installation ........................ 6-6
6.8 Power Supply Removal/Installation.............................................. 6-7
6.9 Display PCB Removal/Installation................................................ 6-9
6.10 UIF PCB Removal/Installation...................................................... 6-10
6.11 Alarm Speaker Removal/Installation............................................ 6-11
Section 7: Spare Parts ................................................................................ 7-1
7.1 Introduction .................................................................................. 7-1
Section 8: Packing For Shipment .............................................................. 8-1
8.1 General Instructions ..................................................................... 8-1
iii
Table of Contents
8.2 Repacking in Original Carton ....................................................... 8-1
8.3 Repacking in a Different Carton................................................... 8-3
Section 9: Specifications............................................................................ 9-1
9.1 General ........................................................................................ 9-1
9.2 Electrical....................................................................................... 9-1
9.3 Physical Characteristics ............................................................... 9-2
9.4 Environmental .............................................................................. 9-2
9.5 Alarms .......................................................................................... 9-2
9.6 Factory Default Settings ............................................................... 9-2
9.7 Performance ................................................................................ 9-3
Appendix (Serial Port Interface Protocol)................................................. A-1
A1 Introduction .................................................................................. A-1
A2 Enabling the Serial Port................................................................ A-1
A3 Connecting to the Serial Port ....................................................... A-1
A4 Real-Time Printout ....................................................................... A-2
A5 Nurse Call .................................................................................... A-5
Technical Supplement................................................................................ S-1
S1 Introduction .................................................................................. S-1
S2 Oximetry Overview....................................................................... S-1
S3 Circuit Analysis............................................................................. S-3
S4 Functional Overview..................................................................... S-3
S5 AC Input ....................................................................................... S-3
S6 Power Supply PCB Theory of Operation...................................... S-4
S7 Battery.......................................................................................... S-5
S8 User Interface PCB (UIF) ............................................................. S-5
S9 Front Panel Display PCB and Controls ........................................ S-8
S10 Schematic Diagrams .................................................................... S-9
iv
LIST OF FIGURES
Table of Contents
Figure 1-1: NPB-190 Front Panel.................................................................. 1-2
Figure 1-2: NPB-190 Rear Panel .................................................................. 1-2
Figure 3-1: NPB-190 Controls....................................................................... 3-2
Figure 3-2: Self-Test Display......................................................................... 3-3
Figure 3-3: Adjusting High %SpO2 Alarm Limit ............................................ 3-3
Figure 3-4: Adjusting Low %SpO2 Alarm Limit ............................................. 3-4
Figure 3-5: Adjusting High Heart Rate Alarm Limit ....................................... 3-4
Figure 3-6: Adjusting Low Heart 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-190 Controls....................................................................... 4-1
Figure 6-1: Fuse Removal............................................................................. 6-2
Figure 6-2: NPB-190 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 Leads Connections .............................................. 6-7
Figure 6-7: Power Supply.............................................................................. 6-8
Figure 6-8: Display PCB................................................................................ 6-9
Figure 6-9: UIF PCB...................................................................................... 6-10
Figure 6-10: Alarm Speaker .......................................................................... 6-12
Figure 7-1: NPB-190 Exploded View............................................................. 7-2
Figure 8-1: Repacking the NPB-190 ............................................................. 8-2
Figure A-1: Serial Port Pin Layout................................................................. A-2
Figure A-2: Real-Time Printout ..................................................................... A-2
Figure S-1: Oxyhemoglobin Dissociation Curve ........................................... S-2
Figure S-2: NPB-190 Functional Block Diagram ........................................... S-3
Figure S-3 Front End Red/IR Schematic Diagram ....................................... S-11
Figure S-4 Front End LED Drive Schematic Diagram.................................. S-13
Figure S-5 Front End Output Schematic Diagram ....................................... S-15
Figure S-6 Front End Power Supply Schematic Diagram ............................ S-17
Figure S-7 Isolation Barrier EIA-232 Port Schematic Diagram .................... S-19
Figure S-8 CPU Core Schematic Diagram .................................................. S-21
Figure S-9 PIC and Speaker Schematic Diagram ....................................... S-23
Figure S-10 Indicator Drive Schematic Diagram.......................................... S-25
Figure S-11 Core Power Supply Schematic Diagram .................................. S-27
Figure S-12 Parts Locator Diagram for UIF PCB ......................................... S-29
Figure S-13 Display PCB Schematic Diagram............................................. S-31
Figure S-14 Parts Locator Diagram for Display PCB ................................... S-33
Figure S-15 Power Supply Schematic Diagram ........................................... S-35
Figure S-16 Parts Locator Diagram for Power Supply PCB......................... S-37
v
Table of Contents
LIST OF TABLES
Table 3-1: Dynamic Operating Range.......................................................... 3-8
Table 3-2: Earth Leakage Current Limits ..................................................... 3-10
Table 3-3: Enclosure Leakage Current Limits.............................................. 3-11
Table 3-4: Patient Leakage Current Limits .................................................. 3-12
Table 3-5: Patient Leakage Current Test Configurations - Mains
Voltage on the Applied Part ........................................................ 3-12
Table 4-1: Factory Default Settings.............................................................. 4-3
Table 5-1: Problem Categories .................................................................... 5-2
Table 5-2: Power Problems.......................................................................... 5-3
Table 5-3: Button Problems ......................................................................... 5-4
Table 5-4: Display/Alarms Problems............................................................ 5-4
Table 5-5: Operational Performance Problems ........................................... 5-5
Table 5-6: Serial Port Problems ................................................................... 5-6
Table 5-7: Error Codes................................................................................. 5-7
Table A-1: Serial Port Pin Outs .................................................................... A-1
Table A-2: Status Codes .............................................................................. A-4
vi
SECTION 1: INTRODUCTION
1.1 Manual Overview
1.2 NPB-190 Pulse Oximeter Description
1.3 Power-On Self Test
1.4 Related Documents
1.1 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
(SpO
2), 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
NPB190
101112131415
Figure 1-1: NPB-190 Front Panel
1. SpO2 Sensor Port 9. Alarm Silence Button
2. Power On/Standby Button 10. Adjust Up Button
3. AC/Battery Charging Indicator 11. Adjust Down Button
4. Low Battery Indicator 12. Pulse Search Indicator
5. %SpO2 Display 13. Upper Alarm Limit Button
6. Pulse Amplitude Indicator 14. Lower Alarm Limit Button
7. Pulse Beats per Minute Display 15. Speaker
8. Alarm Silence Indicator
1. Equipotential Terminal 4. Fuse Drawer
2. AC Connector 5. Voltage Selector Switch
3. Serial Port
1.3 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:
0123
1
2X
T 0.50A 250V
IPX1
5
CISPR 11
Group 1
Class B
NRTL/C
R
100-120 V~ 200-240 V~
50/60Hz
2
20 VA
4
SN
NELLCOR PURITAN BENNETT, INC.
PLEASANTON, CA 94588, U.S.A.
NELLCOR PURITAN BENNETT EUROPE BV,
's-HERTOGENBOSCH, THE NETHERLANDS
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
TM
3
NPB-190
MADE IN IRELAND
Figure 1-2: NPB-190 Rear Panel
036400-1098
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 %SpO
2 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 %SpO
2 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 BATTERY
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.
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 Introduction
3.2 Equipment Needed
3.3 Performance Tests
3.4 Safety Tests
3.1 INTRODUCTION
This section discusses the tests used to verify performance following repairs or
during routine maintenance. All tests can be performed without removing the
NPB-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 Description
Digital multimeter (DMM) Fluke Model 87 or equivalent
Durasensor oxygen transducer
Oxisensor II oxygen transducer
Pulse oximeter tester SRC-2
Safety analyzer Must meet current AAMI specifications
Sensor extension cable EC-4 or EC-8
Serial interface cable EIA-232 cable (optional)
Stopwatch Manual or electronic
DS-100A
D-25
3.3 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
Note: Refer to Figure 3-1, NPB-190 Controls, when following the instructions
3.3.2.1 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:
Lower Alarm
listed below.
Limit
Upper Alarm
Limit
Figure 3-1: NPB-190 Controls
Adjust
Down
Adjust
Up
3-2
Section 3: Performance Verification
a. All indicators light for a few seconds as illustrated in Figure 3-2.
LEDs
illuminated
888 displayed
10 segments
illuminated
NPB190
LED
illuminated
LED
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 1-
second 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. 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).
3.3.2.2 Factory 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.
1. 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 %SpO
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.
2 display indicates
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 %SpO
Note: A decimal point to the right of the value in either display indicates that
3. Press the Lower Alarm Limit button. Verify that the monitor emits a single
beep and that the %SpO
seconds. Verify that three dashes are displayed at the bottom of the pulse
rate display window.
4. Press the Lower Alarm Limit button. Press and hold the Adjust Down
button and verify that the %SpO
Press and hold the Adjust Up button and verify that the %SpO
cannot be raised past the upper alarm limit setting of “85”.
2 display reduces to a minimum of “85”.
the alarm limits are not power-on default values.
2 display indicates an alarm limit of “85” for 3
Figure 3-4: Adjusting Low %SpO2 Alarm Limit
2 display reduces to a minimum of “20”.
2 display
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 %SpO
2 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 %SpO
2 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 %SpO
display indicates an alarm limit of “100”.
12. Press and release the Lower Alarm Limit button. Verify that the %SpO
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:
• Operation with a Pulse Oximeter Tester
• General Operation
3.3.3.1 Operation with a Pulse Oximeter Tester
Operation with an SRC-2 pulse oximeter tester includes the following tests:
• Alarms and Alarm Silence
• Alarm Volume Control
• Pulse Tone Volume Control
• Dynamic Operating Range
• Nurse Call
2
2
3.3.3.1.1 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 POSITION
RATE 38
LIGHT HIGH
MODULATION OFF
RCAL/MODE RCAL 63/LOCAL
2. 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
b. The pulse tone is heard.
SRC-2.
c. Zeroes are displayed in the %SpO
2 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 %SpO
2 and pulse rate displays
flash. This is an indication that 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 3 seconds. Verify that the pulse rate display indicates “SEC” and the
%SpO
2 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. Release the Alarm Silence button. Verify the following:
a. The alarm remains silenced.
b. The Alarm Silence indicator lights.
c. The %SpO
2 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 %SpO
2 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.
3-6
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 %SpO
indicates the default setting of 5.
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.
Section 3: Performance Verification
2 display indicates “VOL”, and the pulse rate display
Figure 3-8: Alarm Volume Display
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.
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 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.
3.3.3.1.4 Dynamic Operating Range
The following test sequence verifies proper monitor operation over a range of
input signals:
1. Connect the SRC-2 to the 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
RATE LIGHT MODULATION SpO2 Pulse Rate
38 HIGH2 LOW 79 - 83* 37 - 39*
112 HIGH1 HIGH 79 - 83* 110 - 114
201 LOW LOW 79 - 83* 198 - 204*
201 LOW HIGH 79 - 83* 198 - 204*
3.3.3.1.5 Nurse Call
Note: The Nurse Call tests must be performed with the instrument operating
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.
Table 3-1: Dynamic Operating Range
SRC-2 Settings NPB-190 Indications
on AC power.
4. Turn the instrument off. Disconnect the voltmeter and the SRC-2.
3.3.3.1.6 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: If the Low Batter Indicator is illuminated, perform the procedure
outlined in step 3.3.1.
4. Connect the instrument to AC and verify that the AC Power Indicator turns
on and that the instrument is monitoring normally.
3.3.3.2 General Operation
The following tests are an overall performance check of the system:
• LED Excitation Test
• Monitor Operation with a Live Subject
3.3.3.2.1 LED Excitation Test
This procedure uses normal system components to test circuit operation. A
Nellcor Oxisensor II
intensity control. The red LED is used to verify intensity modulation caused by
the LED intensity control circuit.
3-8
â
oxygen transducer, model D-25, is used to examine LED
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.
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 Durasensor
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.
3.4 SAFETY TESTS
â
oxygen transducer, model DS-100A, to the
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: For the following tests, ensure that the AC switch on the rear of the
instrument is configured for the AC voltage being supplied.
3.4.2.1 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.
AC
POLARITY
Normal Closed Closed 500 µA
Reversed Closed Closed 500 µA
Normal Open Closed 1000 µA
Normal Closed Open 1000 µA
3.4.2.2 Enclosure Leakage Current
LINE CORD NEUTRAL
Table 3-2: Earth Leakage Current Limits
LEAKAGE
CORD
CURRENT
3-10
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
Section 3: Performance Verification
AAMI/ANSI is
120 VAC 60 Hz, and for IEC 601-1 the applied voltage is 264 VAC 50 to 60 Hz.
1. Connect the monitor AC plug to the electrical safety analyzer as
recommended by the analyzer operating instructions.
2. Place a 200 cm
is not in contact with any metal parts of the enclosure that may be grounded.
Measure the leakage current between the foil and earth.
The analyzer leakage indication must not exceed values listed in the table below:
Table 3-3: Enclosure Leakage Current Limits
AC LINE
CORD
Closed Closed Closed 100 µA 100 µA
Closed Closed Open 500 µA 300 µA
Closed Open Closed 500 µA 300 µA
Open Closed Closed 500 µA 100 µA
Open Open Closed 500 µA 300 µA
Open Closed Open 500 µA 300 µA
3.4.2.3 Patient Applied Risk Current
NEUTRAL
LINE CORD
This test is in compliance with AAMI Standard ES1 (patient applied risk
current), and IEC 601-1 (patient auxiliary current). The leakage current is
measured between any individual patient connection and power (earth) ground.
The applied voltage for AAMI/ANSI is 120 VAC 60 Hz, and for IEC 601-1 the
applied voltage is 264 VAC 50 to 60 Hz.
2
foil in contact with the instrument case making sure the foil
POWER LINE
GROUND CABLE
IEC 601-1 AAMI/ANSI ES1
STANDARD
1. Configure the electrical safety analyzer as follows:
Function: Patient Leakage
Range: µA
2. Connect the monitor AC plug to the electrical safety analyzer as
recommended by the analyzer operating instructions for Patient Leakage
Current.
3. Connect the electrical safety analyzer patient leakage input lead to all pins
of the monitor's patient cable at the end of the cable.
4. The equipotential terminal is not connected to ground.
5. All functional earth terminals are not connected to ground.
6. Measure the leakage current between the patient connector and earth.
3-11
Section 3: Performance Verification
Table 3-4: Patient Leakage Current Limits
AC LINE
POLARITY
Normal Closed Closed 100 µA 10 µA
Normal Open Closed 500 µA 50 µA
Normal Closed Open 500 µA 50 µA
Reverse Closed Closed 100 µA 10 µA
Reverse Open Closed 500 µA 50 µA
Reverse Closed Open 500 µA 50 µA
3.4.2.4 Patient Isolation Risk Current - (Mains Voltage on the Applied Part)
NEUTRAL
LINE
POWER LINE
GROUND
CABLE
IEC 601-1 AAMI/ANSI
This test is in compliance with AAMI Standard ES1 (patient isolation risk
current [sink current]), and IEC 601-1 (patient leakage current). Patient Leakage
Current is the measured value in a patient connection if mains voltage is
connected to that patient connection. The applied voltage for AAMI/ANSI is 120
VAC 60 Hz, and for IEC 601-1 the applied voltage is 264 VAC 50 to 60 Hz.
Warning: AC mains voltage will be present on the patient applied part
terminals during this test. Exercise caution to avoid electrical shock hazard.
1. Configure the electrical safety analyzer as follows:
Function: Patient Leakage (Mains On Applied Part)
Range: µA
ES1
STANDARD
2. Connect the monitor AC plug to the electrical safety analyzer as
recommended by the operating instructions for patient sink (leakage)
current.
3. Connect the electrical safety analyzer patient leakage input lead to all
connectors in the patient cable at the patient end of the cable.
4. The equipotential terminal is not connected to ground.
5. All functional earth terminals are not connected to ground.
6. The analyzer leakage current must not exceed the values shown in the table
below.
Table 3-5: Patient Leakage Current Test Configurations -
Mains Voltage on the Applied Part
AC LINE
POLARITY
Normal Closed Closed 5 mA 50 µA
Reverse Closed Closed 5 mA 50 µA
NEUTRAL
LINE
POWER
LINE
GROUND
CABLE
IEC 601-1 AAMI/ANSI
ES1
STANDARD
3-12
SECTION 4: AUDIBLE ALARM SETTINGS & SERVICE MENU
4.1 Introduction
4.2 Audible Alarm Settings
4.3 Service Menu
4.1 INTRODUCTION
This section discusses use of the service menu to reconfigure power-on default
values, and how to control the behavior of the audible alarm.
4.2 AUDIBLE ALARM SETTINGS
The following paragraphs describe how to change the behavior of the audible
alarm. Operators can select the volume of the alarm and the duration of alarm
silence. Controls for the NPB-190 are shown in Figure 4-1.
On/Standby Alarm silence
NPB190
4.2.1 Alarm Silence State
Press the Alarm Silence button to silence the alarm. Press the button a second
time to turn the alarm back on.
4.2.2 Alarm Silence Duration
1. Press and hold the Alarm Silence button for less than 3 seconds.
2. Before 3 seconds have passed the Adjust Up or Adjust Down button can be
used to change the duration of the alarm silence. The alarm’s duration can
be 30, 60, 90, 120 seconds, or the alarm can be turned off.
4.2.3 Alarm Volume
1. Press and hold the Alarm Silence button for more than 3 seconds.
Set lower
limit
Set upper
limit
Figure 4-1: NPB-190 Controls
Adjust
down
Adjust
up
4-1
Section 4: Audible Alarm Settings & Service Menu
2. After 3 seconds, while still pressing the Alarm Silence button, the Adjust
Up or Adjust Down button can be used to select alarm volumes from 1 to
10. Select a level that is suitable for the monitor’s location.
4.3 SERVICE MENU
The menu items listed below should be accessed only by a qualified service
technician. Power-on default values can be changed for the behavior of the
audible alarm, alarm limits, and for the serial port.
4.3.1 Accessing Menu Items
1. Menu items can be accessed at any time by pressing the Upper and Lower
Alarm Limit buttons simultaneously for at least 3 seconds. The service
menu has been accessed when a 1 appears in the pulse rate display.
2. Pressing the Adjust Up or Adjust Down button selects the menu item
number. Menu numbers 5 and 6, have items within them that can be selected
by first pressing the Upper Alarm Limit button, and then pressing the Adjust
Up or Adjust Down key.
Note: Service menu items greater than 2 cannot be accessed if a sensor is
connected to the monitor.
3. Once adjustments have been made within a menu item the, Upper Alarm
Limit button can be used to initiate the current selection. Three tones will
sound to indicate that the change has been accepted, and the monitor will
return to normal monitoring.
4. The service menu can be exited without making changes by pressing the
Lower Alarm Limit button. If a period of 10 seconds passes with no button
presses, the instrument will exit the service menu, go to normal monitoring,
and no changes will have been made.
4.3.2 Menu Item 1 (Save Current Values as Power-On Default)
1. If menu item 1 is selected, the current values for alarm limits, alarm volume,
pulse beep volume, audible alarm silence duration, alarm silence behavior,
and baud rate will be saved as the power-on default settings. Some values
are not allowed to be saved as power on default values, they are; an Alarm
Silence Duration of Off, and low %SpO
invalid tone is heard instead of the triple beep the current settings were not
changed.
Note: Current values will not be stored in memory as defaults, if power is
interrupted before exiting this menu option.
Note: When the operator changes an alarm limit to a value other than a power
on default value, a decimal point will appear to the right of the parameter
whose alarm limit was changed.
2 alarm limits less than 80%. If an
4-2
4.3.3 Menu Item 2 (Return to Default Settings)
Menu item 2 resets the monitor to factory default settings as shown in table 4-1.
Table 4-1: Factory Default Settings
Parameter Default Value
SpO2 High 100%
SpO2 Low 85%
Pulse rate High 170 bpm
Pulse rate Low 40 bpm
Pulse beep volume Level 4
Alarm Volume Level 5
Alarm Silence Duration 60 seconds
Alarm Silence Behavior 0 (Off with reminder)
Baud Rate 9600
Note: Menu items greater than 2 cannot be accessed when a valid sensor is
plugged into the unit.
Note: To reach menu item 5 two invalid tones will be heard when passing
through menu items 3 and 4.
Section 4: Audible Alarm Settings & Service Menu
4.3.4 Menu Item 3 (Not Displayed)
4.3.5 Menu Item 4 (Not Displayed)
4.3.6 Menu Item 5 (Alarm Silence Behavior)
1. This menu item is used to change alarm silence behavior. Three options; 0,
1, or 2 can be accessed by first pressing the Upper Alarm Limit button, then
using the Adjust Up or Down button to scroll to the desired number.
2. Option “0” will allow the operator to select Alarm Silence, but there will be
a reminder tone every 3 minutes.
3. Option “1” allows the operator to select Alarm Silence and there will be no
reminder tone.
4. Option “2” will not allow the operator to select Alarm Silence.
5. When the desired option is indicated in the display, press the Upper Alarm
Limit button to save the current selection. Three tones will sound to indicate
that the change has been accepted
Note: The low battery audible alarm cannot be disabled.
4.3.7 Menu Item 6 (Baud Rate)
1. Baud rates of 2400, 9600, and 19200 can be selected by first pressing the
Upper Alarm Limit button, then using the Adjust Up or Adjust Down button
to select the desired baud rate. The baud rates will be displayed in the
%SpO
2 window as 24, 96, or 192.
4-3
Loading...