Nellcor N295 Service manual
SERVICE MANUAL
NPB-295 Pulse Oximeter
Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
To contact Mallinckrodt, Inc. representative: In the United States, call 1-800-635-5267; outside the United States,
call your local Mallinckrodt representative.
© 2002 Mallinckrodt Incorporated. All rights reserved. 061097C-1202
0123
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 Inc. is a wholly owned subsidiary 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.
Nellcor Puritan Bennett, Nellcor, Durasensor, and Oxisensor II, are trademarks of Mallinckrodt Incorporated.
Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; 4,653,498;
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 .................................................................................... iii
List Of Figures.......................................................................................... v
List Of Tables ........................................................................................... vi
Section 1: Introduction ............................................................................ 1-1
1.1 Manual Overview......................................................................... 1-1
1.2 Npb-295 Pulse Oximeter Description .......................................... 1-1
1.3 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: Power-On Settings And Service Functions ........................... 4-1
4.1 Introduction .................................................................................. 4-1
4.2 Power-On Settings ...................................................................... 4-1
4.3 Service Functions ........................................................................ 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 Cooling Fan Removal/Installation................................................ 6-9
6.10 Display Pcb Removal/Installation ................................................ 6-10
6.11 Uif Pcb Removal/Installation........................................................ 6-11
6.12 Alarm Speaker Removal/Installation ........................................... 6-13
Section 7: Spare Parts ............................................................................ 7-1
7.1 Introduction .................................................................................. 7-1
Section 8: Packing For Shipment............................................................ 8-1
iii
Table of Contents
8.1 General Instructions..................................................................... 8-1
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............................................................... 9-1
9.4 Environmental .............................................................................. 9-1
9.5 Alarms .......................................................................................... 9-2
9.6 Factory Default Settings............................................................... 9-2
9.7 Performance................................................................................. 9-2
Section 10: Serial Port Interface Protocol ............................................... 10-1
10.1 Introduction .................................................................................. 10-1
10.2 Configuring The Data Port ........................................................... 10-1
10.3 Connecting To The Data Port ...................................................... 10-2
10.4 Real-Time Printout ....................................................................... 10-3
10.5 Trend Data Printout...................................................................... 10-6
10.6 Nurse Call .................................................................................... 10-6
10.7 Analog Output .............................................................................. 10-7
Section 11: Technical Supplement.......................................................... 11-1
11.1 Introduction .................................................................................. 11-1
11.2 Oximetry Overview....................................................................... 11-1
11.3 Circuit Analysis............................................................................. 11-2
11.4 Functional Overview .................................................................... 11-2
11.5 Ac Input ........................................................................................ 11-3
11.6 Power Supply Pcb Theory Of Operation...................................... 11-3
11.7 Battery.......................................................................................... 11-4
11.8 User Interface Pcb (Uif) ............................................................... 11-5
11.9 Front Panel Display Pcb And Controls ........................................ 11-8
11.10 Schematic Diagrams ..................................................................................... 11-9
iv
LIST OF FIGURES
Table of Contents
Figure 1-1: NPB-295 Front Panel ............................................................... 1-1
Figure 1-2: User Softkey Map ..................................................................... 1-2
Figure 1-3: NPB-295 Rear Panel................................................................ 1-3
Figure 3-1: NPB-295 Controls .................................................................... 3-2
Figure 3-2: Self-Test Display ...................................................................... 3-2
Figure 3-3: Adjusting %SpO2 Upper Alarm Limit ....................................... 3-3
Figure 3-4: Adjusting % SpO2 Lower Alarm Limit ...................................... 3-3
Figure 3-5: Adjusting High Pulse Rate Alarm ............................................. 3-4
Figure 3-6: Adjusting Low Pulse Rate Alarm .............................................. 3-4
Figure 4-1: Service Function Softkeys........................................................ 4-2
Figure 4-2: Service Function Softkey Map.................................................. 4-3
Figure 4-3: Param Softkeys ........................................................................ 4-3
Figure 4-4: Print Softkeys ........................................................................... 4-4
Figure 4-5: Trend Printout........................................................................... 4-5
Figure 4-6: Errlog Printout........................................................................... 4-5
Figure 4-7: Instat Printout ........................................................................... 4-6
Figure 4-8: INFO Printout............................................................................ 4-6
Figure 4-9: Next Softkeys ........................................................................... 4-7
Figure 4-10: Alarms Softkeys ..................................................................... 4-7
Figure 6-1: Fuse Removal .......................................................................... 6-2
Figure 6-2: NPB-295 Corner Screws .......................................................... 6-3
Figure 6-3: Separating Case Halves........................................................... 6-4
Figure 6-4: NPB-295 Battery....................................................................... 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: UIF PCB ................................................................................. 6-12
Figure 6-10: Alarm Speaker...................................................................... 6-13
Figure 7-1: NPB-295 Expanded View......................................................... 7-2
Figure 8-1: Repacking the NPB-295........................................................... 8-2
Figure 10-1: Data Port Softkeys ............................................................... 10-1
Figure 10-2: Data Port Pin Layout ............................................................ 10-3
Figure 10-3: Real-Time Printout ............................................................... 10-4
Figure 10-4: Trend Data Printout .............................................................. 10-6
Figure 11-1: Oxyhemoglobin Dissociation Curve ..................................... 11-2
Figure 11-2: NPB-295 Functional Block Diagram..................................... 11-3
Figure 11-3: UIF PCB Front End Red/IR Schematic Diagram ............... 11-11
Figure 11-4: Analog Front End Schematic Diagram............................... 11-13
Figure 11-5: Front End Power Supply Schematic Diagram.................... 11-15
Figure 11-6: SIP/SOP Interface Schematic Diagram ............................. 11-17
Figure 11-7: Data Port Drivers Schematic Diagram ............................... 11-19
Figure 11-8: CPU Core Schematic Diagram A ....................................... 11-21
Figure 11-9: CPU Memory Schematic Diagram B.................................. 11-23
Figure 11-10: Contrast and Sound Schematic Diagram A ..................... 11-25
Figure 11-11: UIF PCB Power Supply Schematic Diagram B................ 11-27
Figure 11-12: Display Interface Schematic Diagram .............................. 11-29
Figure 11-13: UIF PCB Parts Locator Diagram ...................................... 11-31
Figure 11-14: Power Supply Schematic Diagram................................... 11-33
v
Table of Contents
LIST OF TABLES
Figure 11-15: Power Supply Parts Locator Diagram ..............................11-33
Table 3-1: Dynamic Operating Range....................................................... 3-7
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...........................................................4-2
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 6-1: Power Supply Leads Connections ...........................................6-8
Table 7-1: Parts List ..................................................................................7-1
Table 9-1: Default Settings........................................................................9-2
Table 10-1: Data Port Pin Outs ............................................................... 10-3
Table 10-2: Status Codes........................................................................ 10-6
Table 10-3: Nurse Call Relay Pin States................................................. 10-7
Table 10-4: Rating of Nurse Call Relay................................................... 10-7
vi
SECTION 1: INTRODUCTION
1.1 Manual Overview
1.2 NPB-295 Pulse Oximeter Description
1.3 Related Documents
1.1 MANUAL OVERVIEW
This manual contains information for servicing the Nellcor model NPB-295 pulse
oximeter. Only qualified service personnel should service this product. Before
servicing the NPB-295, read the operator’s manual carefully for a thorough
understanding of operation.
Warning: Explosion hazard. Do not use the NPB-295 pulse oximeter in the
presence of flammable anesthetics.
1.2 NPB-295 PULSE OXIMETER DESCRIPTION
The NPB-295 is a portable pulse oximeter intended for use as a continuous
noninvasive monitor of arterial oxygen saturation (SpO
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 10-segment
blip bar that indicates pulse intensity. This monitor is intended for use in hospital
and hospital-type facilities, during intra-hospital transport, and in home
environments.
2) and pulse rate.
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-295 can operate on AC
power or on an internal battery. The controls and indicators for the NPB-295 are
illustrated in Figures 1-1 through 1-3.
1 2 3 45 6 79
%SP02
BPM
LIGHTLIMITS TREND SETUP
17
1. SpO2 Sensor Port
2. Low Battery Indicator
3. Power On/Off Button
4. AC/Battery Charging Indicator
5. Waveform Display
6. %SpO2 Indicator
7. Pulse Beats Per Minute display
8. Alarm Silence Indicator
9. Alarm Silence Button
8
NPB-295
100
110
101112141516 13
10. Adjust Up Button
11. Adjust Down Button
12. Contrast Button
13. Softkeys
14. Menu Bar
15. Motion Indicator
16. Pulse Search Indicator
17. Speaker
Figure 1-1: NPB-295 Front Panel
1-1
Section 1: Introduction
Figure 1-2 illustrates the various functions that are available through the use of the
softkeys, and how to access them. A complete explanation of the keys is provided in
the NPB-295 operator's manual.
LIMITS
SELECT
Select alarm limit
to be adjusted
TREND
EXIT
Return to
main display
VIEW CLOCK EXIT
PLETH
VIEW ZOOM EXIT
Select data from last
12/30 min. or last 1,
2, 4, 8, 12, or 24 hrs.
DUAL SPO2 HIST
Display both
SpO
pulse trend
data
Display
2
and
SpO
2
Data
BLIP
PULSE
Display
pulse trend
data
NEXT
SETUP
EXIT
%SPO2
95
Normal
Display Mode
BPM
65
LIGHT
LCD display
backlight ON or OFF
NEXT
COMM LANG EXIT
Adjust baud rate
and protocol
Return to
main display
Select
Language
NCALL
Norm + or
Norm -
SELECT EXIT
NEXT
ANALOG
0 Volt, 1 Volt,
or Step
SET EXIT
NEXT
EXIT
1-2
VIEW
NEXT
EXIT
Return to
main display
DELETE PRINT
YES NO
Deletes all
trend info
Return to prior
trend menu
Figure 1-2: User Softkey Map
Print trends
NEXT
Returns to
prior menu
EXIT
Return to
main display
Section 1: Introduction
1. Equipotential (ground) Terminal
2. AC Inlet
3. DB-15 Interface Connector (Data Port)
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-295 operator’s manual. To understand the various
Nellcor sensors that work with the monitor, refer to the individual sensor’s directions
for use.
1 2
TM
NPB-295
0123
5
2X
T 0.50A 250V
IPX1
CISPR 11
Group 1
Class B
NRTL/C
R
100-120 V 200-240 V
50/60 Hz 20VA
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
4. Fuse Receptacle
5. Voltage Selection Switch
Figure 1-3: NPB-295 Rear Panel
3
MADE IN U.S.A.
1-3
(Blank Page)
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-295 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-295, 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 NPB-295 requires no calibration.
2.3 BATTERY
The battery should be replaced every 2 years. See Battery Replacement on 6-5.
The following checks should be performed at least every 2 years by a qualified
service technician.
1. Inspect the exterior of the NPB-295 for damage.
2. Inspect safety labels for legibility. If the labels are not legible, contact
Mallinckrodt Technical Services Department or your local Mallinckrodt
representative.
3. Verify 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-295. Contact
Mallinckrodt Technical Services Department or your local Mallinckrodt
representative.
5. Inspect the fuses for proper value and rating (F1 & F2 = 0.5 amp slow blow).
Mallinckrodt recommends replacing the instrument's battery every 2 years. When the
NPB-295 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-295 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 with the
monitor in standby, or 18 hours if it is in use, to receive a full charge. The battery is
being charged whenever the instrument is plugged into AC.
2-1
(Blank Page)
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-295 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-295 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 ES1/1993
Sensor extension cable SCP-10 or MC-10
Serial interface cable EIA-232 cable (optional)
Stopwatch Manual or electronic
DS-100A
D-25
& IEC 601-1/1998 specifications
3.3 PERFORMANCE TESTS
The battery charge procedure should be performed before monitor repairs whenever
possible.
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 4.3.3.
3.3.1 Battery Charge
Perform the following procedure to fully charge the battery.
1. Connect the monitor to an AC power source.
2. Verify the monitor is off and that the AC Power/Battery Charging indicator is
lit.
3-1
Section 3: Performance Verification
3. Charge the battery for at least 14 hours in standby.
3.3.2 Power-up Performance
The power-up performance tests (3.3.2.1 through 3.3.2.2) verify the following
monitor functions:
• Power-On Self-Test
• Power-On Defaults and Alarm Limit Ranges
Power On/Off Alarm Silence
NPB-295
%SP02
100
BPM
110
LIGHTLIMITS TREND SETUP
3.3.2.1 Power-On Self-Test
1. Connect the monitor to an AC power source and verify 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/Off button. The monitor must perform the following sequence.
a. Within 2 seconds all LEDs are illuminated, then all pixels on the LCD
b. The indicators remain lighted.
c. The LCD display shows the Nellcor Puritan Bennett logo and the
Adjust
Softkeys Contrast
Adjust
Down
Up
Figure 3-1: NPB-295 Controls
display are illuminated, after which the backlight comes on.
software version of the NPB-295 (Figure 3-2).
NPB-295
Nellcor
Puritan
NPB-295 Version 1.1.0.5
Bennett
3-2
Figure 3-2: Self-Test Display
d. A 1-second beep sound indicating proper operation of the speaker, and
all indicators turn off except the AC Power/Battery Charging
indicators.
e. The NPB-295 begins normal operation.
3.3.2.2 Power-On Defaults and Alarm Limit Ranges
Note: When observing or changing default limits, a 10-second time-out 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 change 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 the
monitor emits a single beep and the plethysmograph waveform is replaced
with a display of the alarm limits. The high alarm limit for %SpO
indicate an alarm limit of “100” inside a box (Figure 3.3).
ALARM LIMITS
UPPER
LOWER
SPO2
100
85
Section 3: Performance Verification
NPB-295
%SP02
BPM
170
40
100
BPM
110
EXITSELECT
2 will
Figure 3-3: Adjusting %SpO
2 Upper Alarm Limit
2. Press the Limits softkey. Press and hold the Down Arrow button. Verify the
boxed number for %SpO
2 upper alarm limit reduces to a minimum of “85.”
Note: A decimal point in the display indicates that the alarm limits have been
changed from factory default values.
3. Press the SELECT softkey. Verify the monitor emits a single beep and the
box moves to the %SpO
2 lower alarm limit of “85”.
ALARM LIMITS
UPPER
LOWER
SPO2
100
85
BPM
170
40
%SP02
BPM
EXITSEL
NPB-295
100
110
Figure 3-4: Adjusting % SpO
4. Press and hold the Down Arrow button and verify the %SpO
2 Lower Alarm Limit
2 lower alarm
limit display reduces to a minimum of “20”.
5. Press and hold the Up Arrow button and verify the %SpO
display cannot be raised past the upper alarm limit setting of “85”.
6. Press the Exit button.
2 lower alarm limit
3-3
Section 3: Performance Verification
7. Press the Limits softkey then press the SELECT softkey two times Verify the
monitor emits a beep after each keystroke. The Pulse upper alarm limit should
be “170” and should be boxed.
8. Press and hold the Down Arrow button. Verify the minimum displayed value
is “40” for the Pulse upper alarm limit.
9. Press the exit button.
10. Press the Limits softkey then press the SELECT softkey three times. Verify
the Pulse lower alarm limit display indicates an alarm limit of “40” and is
boxed.
NPB-295
ALARM LIMITS
UPPER
LOWER
SPO2
100
85
BPM
170
40
%SP02
BPM
EXITSEL
100
110
Figure 3-5: Adjusting High Pulse Rate Alarm
NPB-295
ALARM LIMITS
UPPER
LOWER
SPO2 BPM
100
85
170
%SP02
100
BPM
40
110
EXITSEL
Figure 3-6: Adjusting Low Pulse Rate Alarm
11. Press and hold the Down Arrow button. Verify the boxed Pulse lower alarm
limit display reduces to a minimum of “30”.
12. Press and hold the Up Arrow button and verify the boxed Pulse lower alarm
limit display cannot be adjusted above the Pulse high limit of “40”.
13. Press the Power On/Off button to turn the monitor off.
14. Press the Power On/Off button to turn the NPB-295 back on.
15. Press and release the Limits softkey. Verify the %SpO
2 upper alarm limit
display is boxed and indicates an alarm limit of “100”.
16. Press the SELECT softkey. Verify the %SpO
2 lower alarm limit display is
boxed and indicates an alarm limit of “85”.
17. Press the SELECT softkey a second time. Verify the Pulse upper alarm limit
display is boxed and indicates an alarm limit of “170”.
18. Press the SELECT softkey a third time. Verify the Pulse lower alarm limit
display is boxed and indicates an alarm limit of “40”.
19. Press the Power On/Off button to turn the monitor off.
3-4
3.3.3 Hardware and Software Tests
Hardware and software testing includes 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
• Analog Output
• Operation on Battery
3.3.3.1.1 Alarms and Alarm Silence
Section 3: Performance Verification
1. Connect the SRC-2 pulse oximeter tester to the sensor-input cable and connect
the cable to the monitor. Set the SRC-2 as follows:
SWITCH
RATE
LIGHT
MODULATION
RCAL/MODE
POSITION
38
LOW
OFF
RCAL 63/LOCAL
2. Press the Power On/Off button to turn the monitor on. After the normal
power-up sequence, press the following softkeys; Setup, View, and Pleth.
Verify the %SpO
2 and Pulse initially indicates zeroes.
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 saturation and pulse
rate as specified by the tester. Verify 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 displays flash,
indicating 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.
3-5
Section 3: Performance Verification
6. Verify the %SpO2 display indicates “60” and the Pulse display indicates
“SEC” while the Alarm Silence button is pressed.
7. When the button is released the alarm is silenced.
8. With the alarm silenced, verify the following:
a. The alarm remains silenced.
b. The Audible Silence indicator lights.
c. The %SpO
d. The pulse tone is still audible.
e. The audible alarm returns in approximately 60 seconds.
9. While pressing the Alarm Silence button, press the Down Arrow button until
the Pulse display indicates “30”.
10. Press the Up Arrow button and verify the displays indicate 60 SEC, 90 SEC,
120 SEC, and OFF. Release the button when the display indicates “OFF”.
11. Press and release the Alarm Silence button. Verify the Alarm Silence
Indicator flashes.
12. Wait approximately 3 minutes. Verify the alarm does not return.
13. After 3 minutes, the alarm silence reminder beeps three times, and will
continue to do so at approximately 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 and verify the following:
a. “OFF” is displayed for approximately 3 seconds.
2 and Pulse displays continue to flash.
3-6
b. After 3 seconds:
• a steady tone is heard at the default alarm volume setting
• the %SpO
2 display indicates “VOL”
• 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.
3. Verify the volume of the alarm has decreased but is still audible.
4. Continue pressing the Alarm Silence button and press the Up Arrow button to
increase the alarm volume setting to a maximum value of 10.
5. Verify the volume increases. Press the Down Arrow button until a
comfortable audio level is attained.
6. Release the Alarm Silence button. The tone stops.
3.3.3.1.3 Pulse Tone Volume Control
1. Press the Up Arrow button and verify the beeping pulse tone sound level
increases.
2. Press the Down Arrow button and verify the beeping pulse tone decreases until
it is no longer audible.
3. Press the Up Arrow 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 SCP-10 or MC-10, which is connected to the NPB295, and turn the NPB-295 on.
2. Place the SRC-2 in the RCAL 63/LOCAL mode.
3. Set the SRC-2 as indicated in Table 3-1.
Note: An “*” indicates values that produce an alarm. Press the Alarm Silence
button to silence the alarm.
Section 3: Performance Verification
3.3.3.1.5 Nurse Call
Table 3-1: Dynamic Operating Range
SRC-2 Settings NPB-295 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*
Note: Allow the monitor several seconds to stabilize the readings.
4. Verify the NPB-295 readings are within the indicated tolerances.
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 5 and positive to pin 11 of the
data port on the back of the instrument (Figure A-2 in Appendix). Ensure that
the audible alarm is not silenced or turned off.
2. Set the SRC-2 to create an alarm condition.
3. Verify an output voltage at pins 5 and 11 between +5 and +12 volts DC.
4. Press the Alarm Silence button. With no active audible alarm, the output
voltage at pins 5 and 11 must be between -5 and -12 volts DC.
5. With the instrument in an alarm condition, use a DVM to verify there is no
continuity between pins 8 and 15 and that there is continuity between pins 7
and 15.
3-7
Section 3: Performance Verification
6. Adjust the alarm limits so that there is no alarm condition. Use a DVM to
verify 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 positive to pin 6 of the
data port on the back of the instrument (Figure A-1 in Appendix).
2. Press the following softkeys: Setup, Next, Next, and Analog. Press the 1-volt
softkey.
3. Verify the output voltage is 1.0 ± 0.025 volts DC.
4. Leave the negative lead connected to pin 10 and verify 1.0 ± 0.025 volts DC
on pins 13 and 14.
Note: If step 4 takes more than 2 minutes to complete, the analog output will time
out. Repeat step 2 to initiate the analog output.
5. Move the positive lead back to pin 6.
6. Press the following softkeys; Setup, Next, Next, and Analog. Press the 0-volt
softkey.
7. Verify the output voltage is 0.0 ± 0.025 volts DC.
8. Leave the negative lead connected to pin 10 and verify 0.0 ± 0.025 volts DC
on pins 13 and 14.
Note: If step 8 takes more than 2 minutes to complete, the analog output will time
out. Repeat step 2 to initiate the analog output.
9. Disconnect the voltmeter from the instrument.
3.3.3.1.7 Operation on Battery Power
1. With the instrument operating on AC, turn on the backlight.
2. Disconnect the instrument from AC and verify the AC/Battery Charging
indicator and the backlight turn off.
3. Verify the instrument continues monitoring normally and that the low battery
indicator is not lit.
Note: If the low battery indicator is illuminated, perform the procedure outlined in
step 3.3.1.
4. Connect the instrument to AC and verify the backlight and AC/Battery
Charging indicator turn 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:
• 3.3.3.2.1 LED Excitation Test
• 3.3.3.2.2 Operation with a Live Subject
3-8
3.3.3.2.1 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 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 optical sensor, that the LED
intensity decreases.
8. Open the sensor and notice that the LED intensity increases.
Section 3: Performance Verification
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-295 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.
1. Ensure that the monitor is connected to an AC power source.
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 the subject as recommended in the sensor's directions for
use.
5. Press the Power On/Off button to turn the monitor on and verify the monitor is
operating.
6. The monitor should stabilize on the subject's physiological signal in about 15
to 30 seconds.
7. Verify the oxygen saturation and pulse rate values are reasonable for the
subject.
3.4 SAFETY TESTS
NPB-295 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
3-9
Section 3: Performance Verification
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 <
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.
3. Verify 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
6 volts RMS,
• 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 volts
AC 60 Hz, for IEC 601-1 the voltage is 264 volts AC, 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
Table 3-2: Earth Leakage Current Limits
LINE
CORD
NEUTRAL
CORD
LEAKAGE
CURRENT
3-10
3.4.2.2 Enclosure Leakage Current
This test is in compliance with IEC 601-1 (enclosure leakage current) and AAMI
Standard ES1 (enclosure risk current). This test is for ungrounded enclosure current,
measured between enclosure parts and earth. The applied voltage for AAMI/ANSI is
120 volts AC, 60 Hz, and for IEC 601-1 the applied voltage is 264 volts AC, 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 piece of 200 cm
the foil is not in contact with any metal parts of the enclosure that may be
grounded.
3. Measure the leakage current between the foil and earth.
Note: The analyzer leakage indication must not exceed values listed in Table 3-3.
Section 3: Performance Verification
2
foil in contact with the instrument case making sure
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
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 volts AC, 60 Hz, and for IEC 601-1 the applied voltage is 264
volts AC, 50 to 60 Hz.
1. Configure the electrical safety analyzer as follows:
2. Connect the monitor AC plug to the electrical safety analyzer as recommended
by the analyzer operating instructions for Patient Leakage Current.
NEUTRAL
LINE
CORD
POWER
LINE
GROUND
CABLE
IEC 601-1 AAMI/ANSI
Function: Patient Leakage
Range: µA
ES1
STANDARD
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 volts AC, 60 Hz,
and for IEC 601-1 the applied voltage is 264 volts AC, 50 to 60 Hz.
Warning: AC mains voltage will be present on the patient cable 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
2. Connect the monitor AC plug to the electrical safety analyzer as recommended
by the operating instructions for patient sink (leakage) current.
ES1
STANDARD
3-12
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 Table 3-5.
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
SECTION 4: POWER-ON SETTINGS AND SERVICE FUNCTIONS
4.1 Introduction
4.2 Power-on Settings
4.3 Service Functions
4.1 INTRODUCTION
This section discusses how to reconfigure power-on default values, and access the
service functions.
4.2 POWER-ON SETTINGS
The following paragraphs describe how to change power-on default settings.
Through the use of softkeys shown in Figure 1-2, the user can change:
• alarm limits
• type of display
• baud rate
• time and date
• trends to view
A decimal point is added to the right of a display when the alarm limit for that
display has been changed to a value that is not a power-on default value. If the new
value is saved as a power on default value, the decimal point will be removed. By
using the service functions, changes can be saved as power-on default values.
Some values cannot be saved as power-on default values. A SpO2 Low limit less
than 80 will not be saved as a power-on default. Audible Alarm Off will not be
accepted as a power-on default. An attempt to save either of these values as default
will result in an invalid tone. Both values can be selected for the current patient, but
they will be lost when the instrument is turned off.
4.2.1 Factory Default Settings
Factory power-on default settings for the NPB-295 are listed in Table 4-1. Following
the procedures listed in the paragraphs that follow can change these settings.
4-1
Section 4: Power-On Settings and Service Functions
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
Alarm Volume Level 5
Alarm Silence Duration 60 seconds
Alarm Silence Restriction Sound Reminder
Pulse Beep Volume Level 4
Data Port Mode ASCII
Baud Rate 9600
Display Pleth
Trend Saturation
Contrast Mid-range
Language English
Nurse Call Polarity Positive (NCALL+)
4.3 SERVICE FUNCTIONS
4.3.1 Introduction
These functions can be used to select institutional defaults, and to access information
about the patient or instrument. A Mallinckrodt Customer Service Engineer should
only access some of the items available through the service functions. These
functions will be noted in the text.
4.3.2 Accessing the Service Functions
The sensor cable must be disconnected from the instrument to access service
functions. Simultaneously press the 4th softkey from the left and the contrast button
for more than 3 seconds. The menu bar will change to the headings listed in Figure
4-1.
Note: If a “Sensor Disconnected” prompt appears on the screen, press the Alarm
Silence button and repeat the above procedure.
Note: If the above steps are performed with a sensor cable connected, only the
Param and Exit softkeys appear on the screen.
%SP02
NEXTPARAM PRINT EXIT
BPM
NPB-295
- - -
- - -
4-2
Figure 4-1: Service Function Softkeys
Section 4: Power-On Settings and Service Functions
Figure 4-2 can be used as a quick reference showing how to reach different softkey
functions. Items reached through the Param softkey can be accessed during normal
operation. Functions provided by the Print and Next softkeys cannot be accessed
when a sensor cable is connected to the instrument. Each of the various functions is
described in the text to follow.
Reset
Yes
4.3.2.1 Exit & Next Softkeys
NEXT
Param Print
Paragraph 4.3.2.2
Save
No
Yes
No
Figure 4-2: Service Function Softkey Map
Paragraph 4.3.2.3
Exit
Trend
Paragraph 4.3.2.1
and 4.3.2.4
Errlog Instat
Downld
SELECT
Next
Alarms
Exit
Paragraph 4.3.2.1
Info
Next
Exit
Contrast
Exit
4.3.2.2 Param
There are not enough buttons to display all of the options that are available at some
levels of the menu. Pressing the Next button allows you to view additional options
available at a given menu level.
EXIT
To back up one menu level, press the Exit button. The service functions can be
exited by repeatedly pressing the Exit button.
When the Param softkey is pressed, the function of the softkeys changes as shown in
figure 4-3. These options can be accessed without disconnecting the sensor cable
from the instrument.
NPB-295
%SP02
- - -
BPM
RESET SAVE EXIT
- - -
Figure 4-3: Param Softkeys
4-3
Section 4: Power-On Settings and Service Functions
RESET
The Reset button is used to return to the factory default settings. If Yes is pressed,
the instrument sounds three tones and the settings return to factory default values.
When No is pressed, there are no changes made to the settings stored in memory.
SAVE
When adjustable values are changed from factory default, the Save button can be
used to preserve the settings as institutional power-on default values. Pressing Yes
stores the current settings in memory. The instrument sounds three tones indicating
that the changes have been saved as power-on default values. The new saved values
will continue to be used through power-on and off cycles until they are changed and
saved again, or until they are reset. If No is pressed, the changed values will not be
saved.
Note: An invalid tone indicates a parameter value cannot be saved as a power on
default (refer to paragraph 4.2). Along with the invalid tone, a message will
be displayed indicating which parameter could not be saved as a power-on
default.
4.3.2.3 Print
Accessing the Print softkey makes four printouts available. Refer to the Appendix
for information about how to make connections to the data port and how data is
presented in a printout. The appropriate printout can be selected by pressing the
corresponding softkey. Figure 4-4 represents the softkey configuration after the Print
softkey has been selected.
Up to 24 hours of trend data can be viewed on the printouts described below. When
the instrument is turned on, trend data is recorded every 2 seconds. As an example,
an instrument that is used 6 hours a week would take approximately 4 weeks to fill its
memory. . The 24 hours of stored trend data is available for downloading to Score
software for 45 days. There are no limitations for displaying or printing data.
Note: The two-letter codes and the symbols that occur in the printout are described
in Table 10-3.
NPB-295
%SP02
- - -
BPM
INSTATTREND ERRLOG INFO
- - -
Figure 4-4: Print Softkeys
4-4
Section 4: Power-On Settings and Service Functions
TREND
A Trend printout will include all data recorded for up to 24 hours of monitoring since
the last Delete Trends was performed. A new trend point is recorded every 2
seconds. Figure 4-5 is an example of a Trend printout.
NPB-295 Version 1.0.0.000 TREND SpO2 Limit: 30-100% PR Limit: 100-180 bpm
TIME %SpO2 PR (bpm) PA
01-Jul-97 14:00:00 100 120 220
01-Jul-97 14:00:05 100 124 220
01-Jul-97 14:00:10 100 190 220
01-Jul-97 14:00:15 100 190 220
01-Jul-97 18:00:43 - - - - - - - - -
01-Jul-97 18:00:48 - - - - - - - - -
NPB-295 Version 1.0.0.000 Trend SpO2 Limit: 80-100% PR Limit: 60-180 bpm
Time %SpO2 PR (bpm) PA
01-Jul-97 18:00:53 - - - - - - - - -
01-Jul-97 18:00:58 - - - - - - - - -
01-Jul-97 18:01:03 98 100 140
01-Jul-97 18:01:08 98 181* 190
01-Jul-97 18:01:13 99 122 232
Output Complete
Figure 4-5: Trend Printout
The first two lines are the column heading lines. The first line includes information
about the:
• type of instrument delivering the information
• software level, type of printout
• alarm parameters
The second line is the headings for the columns. The first and second lines are
printed out every 25 lines, or when a change to an alarm limit is made. Patient data is
represented with a date and time stamp for the data. In the example above, the “- - -”
means that a sensor was connected but no data was being received (patient
disconnect). Patient data that is outside of an alarm limit is marked with an *.
At the end of the printout “Output Complete” will be printed. This indicates that
there was no corruption of data. If the Output Complete statement is not printed at
the end of the printout, the data must be considered invalid.
ERRLOG (Mallinckrodt Customer Service Engineer Only)
A list of all the errors recorded in memory can be obtained by pressing the Errlog
softkey. The first two lines are the column heading lines. The type of instrument
producing the printout, software level, type of printout, and the time of the printout
are listed in the first line. The second line of the printout is column headings. If
nothing prints out, there have been no errors. An example of an Errlog printout is
shown in Figure 4-6.
NPB-295 Version 1.0.0.000 Error Log Time: 14600:00:07
Op Time Error Task Addr Count
10713:21:03 52 12 48F9 100
00634:26:01 37 4 31A2 3
Output Complete
Figure 4-6: Errlog Printout
INSTAT (Mallinckrodt Customer Service Engineer Only)
4-5
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