Mallinckrodt NPB-190 Operator`s manual

OPERATOR’S 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’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.
 2002 Mallinckrodt Inc. All rights reserved. 061089C-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 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 Department, 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.
The following are trademarks of Mallinckrodt Inc.: Durasensor, Oxisensor II, Oxinet, Dura-Y,
Oxiband, and OxiCliq.
Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643;
4,653,498; 4,700,708; 4,770,179; 4,869,254; 5,078,136; 5,351,685; 5,368,026; and 5,533,507.
CONTENTS
Figures
Tables
Contents...................................................................................
Figures................................................................................
Tables .................................................................................
Safety Information...................................................................
General Safety Information ................................................
Introduction .............................................................................
Intended Use ......................................................................
General Operating Principles And Conditions....................
Controls, Indicators, And Symbols .......................................
Displays, Controls, Indicators, And Connectors.................
Npb-295 Symbols ...............................................................
Description Of Controls ......................................................
Function Buttons ..........................................................
Description Of Displays And Visual Indicators ...................
Description Of Audible Indicators .......................................
Setup.........................................................................................
Unpacking And Inspection..................................................
Performance Verification ....................................................
List Of Components............................................................
Optional Accessories ...................................................
Monitor Setup .....................................................................
General Warnings ........................................................
Connecting The Npb-295 .............................................
Language Selection............................................................
Tilt-Stand Supports.............................................................
Sensors And Accessories......................................................
Selecting A Sensor .............................................................
Biocompatibility Testing......................................................
Performance Considerations..............................................
Wall Mount Plate ................................................................
Start-Up And Use.....................................................................
Basic Operation ..................................................................
Power-On Self-Test (Post) ...........................................
Contrast........................................................................
Monitoring Mode...........................................................
Pulse Search ................................................................
Automatic Shutdown ....................................................
Alarms.................................................................................
Description Of Alarms ..................................................
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Contents
Management Of Loss-Of-Pulse Alarm.........................
Adjustable Settings ............................................................
Pulse Beep Volume .....................................................
Alarm Volume ..............................................................
Alarm Silence Duration ................................................
Disabling Audible Alarms.............................................
Alarm Silence Reminder ..............................................
Menu ..................................................................................
Menu Structure ............................................................
Limits............................................................................
Trend............................................................................
Setup............................................................................
Light .............................................................................
Default Settings ...........................................................
Nurse Call Feature.......................................................
Battery Operation ...............................................................
Low Battery Indicator ...................................................
Disposal Of Device Components.......................................
Troubleshooting And Maintenance ......................................
Troubleshooting .................................................................
Error Codes .................................................................
Other Messages ..........................................................
Suggested Corrective Actions .....................................
Emi Interference.................................................................
Obtaining Technical Assistance.........................................
Returning The Npb-295 .....................................................
Maintenance.......................................................................
Service .........................................................................
Periodic Safety Checks................................................
Performance Verification .............................................
Cleaning.......................................................................
Specifications..........................................................................
Performance.......................................................................
Measurement Range ...................................................
Accuracy ......................................................................
Pulse Rate Display Update Frequency........................
Radiated Immunity.......................................................
Conducted Immunity....................................................
Electrical.............................................................................
Instrument ....................................................................
Battery..........................................................................
Environmental Conditions ..................................................
Transport And Storage (In Shipping Container) ..........
Transport And Storage (Not In Shipping Container) ...
Operation .....................................................................
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Contents
Physical Characteristics .....................................................
Weight ..........................................................................
Dimensions...................................................................
Emissions Compliance.................................................
Equipment Classification..............................................
Appendix A: Quick Guide To Operation ..............................
Introduction.........................................................................
Settings Adjustments..........................................................
Appendix B: Principles Of Operation...................................
Oximetry Overview .............................................................
Automatic Calibration ...................................................
Functional Versus Fractional Saturation ......................
Measured Versus Calculated Saturation .....................
Appendix C: Data Port Protocol ...........................................
Overview.............................................................................
Connecting To The Data Port.............................................
Baud Rate...........................................................................
Real-Time Display Format..................................................
Column Headings.........................................................
Patient Data And Operating Status ..............................
Trend Data Printout (ASCII Mode) .....................................
Trend Data Printout (Graph Mode).....................................
Trend Data Operation ..................................................
Nurse Call...........................................................................
Analog Outputs...................................................................
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Contents
FIGURES
Figure 1: NPB-295 Front Panel Display (Pleth View).................... 5
Figure 2: NPB-295 Rear Panel ...................................................... 6
Figure 3: Attaching the Tilt-Stand Supports................................. 15
Figure 4: Attaching the Mounting Plate ....................................... 21
Figure 5: Monitoring Mode Display - Pleth View ......................... 25
Figure 6: Monitoring Mode Display - Magnified View .................. 25
Figure 7: Monitoring Conditions and Alarm Responses .............. 30
Figure 8: Menu Items................................................................... 35
Figure 9: Alarm Limits Selection .................................................. 37
Figure 10: SpO2 Trend ................................................................ 38
Figure 11: Histogram ................................................................... 39
Figure 12: 20-Second Trends...................................................... 40
Figure 13: Oxyhemoglobin Dissociation Curve ........................... 69
Figure 14: Data Port Pin Layout .................................................. 73
Figure 15: Real-Time Printout...................................................... 74
Figure 16: Trend Data Printout .................................................... 77
TABLES
Table 1: Nellcor Sensors ............................................................. 18
Table 2: Trend Scale .................................................................. 38
Table 3: Error Codes and Messages........................................... 50
Table 4: Settings Adjustments ..................................................... 63
Table 6: Data Port Pinouts.......................................................... 72
Table 7: Status Codes ................................................................. 76
Table 8: Voltage between pins 10 and 11 .................................. 80
Table 9: Analog Pinouts.............................................................. 80
vi
SAFETY INFORMATION
General Safety Information
GENERAL SAFETY INFORMATION
This section contains important safety information related to
general use of the NPB-295 pulse oximeter. Other important
safety information appears throughout the manual in sections that
relate specifically to the precautionary information. Read all text
surrounding all precautionary information.
Important! Before use, carefully read this manual, accessory
directions for use, all precautionary information in boldface
type, and specifications.
WARNING: Explosion hazard. Do not use the NPB-295
pulse oximeter in the presence of flammable anesthetics or
gases.
WARNING: The NPB-295 is a prescription device and is to
be operated by qualified personnel only.
WARNING: Pulse oximetry readings and pulse signal can be
affected by certain ambient environmental conditions, sensor
application errors, and certain patient conditions. See the
appropriate sections of the manual for specific safety
information.
WARNING: Chemicals from a broken LCD display panel
are toxic when ingested. Use caution when handling a
monitor with a broken display panel.
Caution: When connecting the NPB-295 to any instrument,
verify proper operation before clinical use. Both the NPB-295
and the instrument connected to it must be connected to a
grounded outlet. Accessory equipment connected to the
monitor’s data interface must be certified according to IEC
Standard 950 for data-processing equipment or IEC
1
Safety Information
Standard 601-1 for electromedical equipment. All
combinations of equipment must be in compliance with IEC
Standard 601-1-1 systems requirements. Anyone who
connects additional equipment to the signal input port or
signal output port (NPB-295 data port connector) configures
a medical system and is therefore responsible that the system
complies with the requirements of system standard IEC
Standard 601-1-1 and the electromagnetic compatibility
system standard IEC Standard 601-1-2.
To ensure accurate readings, consider the environmental
conditions that are present and the condition of the patient. See
the appropriate sections of the manual for specific safety
information related to these conditions.
2
INTRODUCTION
Intended Use
General Operating Principles and Conditions
INTENDED USE
The purpose and function of the Nellcor NPB-295 pulse oximeter
is to continuously and noninvasively measure functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate (measured
by an SpO2 sensor). It is also used to display plethysmographic
waveforms. Refer to Appendix A: Principles of Operation for a
more detailed discussion of oximetry.
The monitor is intended for use on adult, pediatric, and neonatal
patients in all hospital areas, hospital-type facilities, and home
environments. It may be used during intra-hospital transport
when powered by its internal battery.
WARNING: The NPB-295 is intended only as an adjunct in
patient assessment. It must be used in conjunction with
clinical signs and symptoms.
GENERAL OPERATING PRINCIPLES AND CONDITIONS
The NPB-295 uses pulse oximetry to measure functional oxygen
saturation in the blood. Pulse oximetry works by applying a
sensor to a pulsating arteriolar vascular bed, such as a finger or
toe. The sensor contains a dual light source and a photodetector.
Bone, tissue, pigmentation, and venous vessels normally absorb a
constant amount of light over time. The arteriolar bed normally
pulsates and absorbs variable amounts of light during the
pulsations. The ratio of light absorbed is translated into a
measurement of functional oxygen saturation (SpO2).
Note:
For an explanation of functional versus fractional
saturation, refer to Appendix B, Principles of Operation.
Because a measurement of SpO2 is dependent upon light from the
sensor, excessive ambient light can interfere with this
measurement.
3
Introduction
Specific information about ambient environmental conditions,
sensor application, and patient conditions is contained throughout
this manual.
4
CONTROLS, INDICATORS, AND SYMBOLS
Displays, Controls, Indicators, and Connectors
NPB-295 Symbols
Description of Controls
Description of Displays and Visual Indicators
Description of Audible Indicators
DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS
Figures 1 and 2 show the front and rear views of the NPB-295
and identify displays, controls, and connectors.
1
2 3 4
5
6
7
8
9
11
10
NPB-295
%SP02
BPM
LIMITS
17
1
2
3
4
5
6
7
8
9
TREND
16 15 14
SpO2 Sensor Port
Power On/Off Button
Low Battery Indicator
AC Power Indicator
Waveform Display
%SpO2 Display
Pulse Rate Display
Alarm Silence Indicator
Alarm Silence Button
SETUP
13
10
11
12
13
14
15
16
17
100
110
LIGHT
12
Adjust Up Button
Adjust Down Button
Contrast Button
Softkeys
Menu Bar
Motion Indicator
Pulse Search Indicator
Speaker
Figure 1: NPB-295 Front Panel Display (Pleth View)
5
Controls, Indicators, and Symbols
1
2
TM
2X
T 0.50A 250V
R
IPX1
NRTL/C
100-120 V 200-240 V
50/60 Hz 20VA
4
1
2
3
4
MADE IN IRELAND
NELLCOR PURITAN BENNETT EUROPE BV,
's-HERTOGENBOSCH, THE NETHERLANDS
CISPR 11
Group 1
Class B
012 3
NPB-295
SN
NELLCOR PURITAN BENNETT, INC.
PLEASANTON, CA 94588, U.S.A.
035554A-0497
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
3
Equipotential (ground) Terminal
Data Port Connector
Fuse Receptacle
Supply Voltage Selector Switch
Figure 2: NPB-295 Rear Panel
NPB-295 SYMBOLS
See Instructions for Use
2X
Fuse Replacement
T 0.50A 250V
Equipotential Terminal
Type BF Applied Part - Not defibrillator proof
Date of Manufacture
Data Interface
6
Controls, Indicators, and Symbols
DESCRIPTION OF CONTROLS
Function Buttons
The Power On/Off Button. Used to turn the
NPB-295 monitor on or off.
The Alarm Silence Button. Used to silence current
alarms for the alarm silence duration period. When
an alarm has been silenced, pressing the button
again reactivates, or “unsilences” the alarm. It is
also used to view and adjust alarm silence duration
and alarm volume.
The Adjust Up Button. Used to increase alarm limit
values, alarm silence duration, pulse beep volume,
alarm volume, contrast, date and time values, data
port baud rate, and to move the cursor to the right
(in the trend view).
The Adjust Down Button. Used to decrease alarm
limit values, alarm silence duration, pulse beep
volume, alarm volume, contrast, date and time
values, data port baud rate, and to move the cursor
to the left (in the trend view).
The Contrast Button. Used in conjunction with the
Adjust Up/Down Buttons to lighten or darken the
display screen.
The softkey buttons have multiple uses depending
on the label displayed above the button.
DESCRIPTION OF DISPLAYS AND VISUAL INDICATORS
%SP02
100
The %SpO2 Display. Shows the hemoglobin
oxygen saturation level. It flashes during
loss-of-pulse alarms and when SpO2 is outside of
the alarm limits. During Pulse Search, the display
will alternate between dashed lines and the last
oxygen saturation measurement.
7
Controls, Indicators, and Symbols
BPM
86
The Pulse Amplitude Indicator (blip bar). Indicates
pulse beat and shows the relative pulse amplitude.
As the detected pulse becomes stronger, more bars
light with each pulse. This indicator is available
only in the magnified (blip) view.
The digital Pulse Rate Display. Shows the pulse
rate in beats per minute. It flashes during
loss-of-pulse alarms and when the pulse rate is
outside of the alarm limits. During Pulse Search,
the display will alternate between dashed lines and
the last pulse rate measurement.
The AC Power Indicator. Lights continuously when
the NPB-295 is connected to AC power. It also
indicates that the battery is charging. It is off when
the monitor is being powered by its internal battery.
The Low Battery Indicator. Lights continuously to
indicate that 15 or fewer minutes of battery capacity
remains.
The Alarm Silence Indicator. Lights continuously
when an audible alarm has been silenced. It flashes
when the alarm silence duration has been set to OFF
and the Alarm Silence Button is pressed.
The Motion Indicator. Lights continuously when the
monitor detects motion sufficient enough to affect
readings.
The Pulse Search Indicator. Lights continuously
prior to initial acquisition of a pulse signal, and
during Pulse Search. It flashes during a loss-ofpulse signal.
DESCRIPTION OF AUDIBLE INDICATORS
Following are descriptions of NPB-295 audible indicators.
Power-On Self-Test Pass
8
A 1-second tone indicating that the
NPB-295 has been turned on and
successfully completed the poweron self-test
Controls, Indicators, and Symbols
Valid Button Press
Invalid Button Press
High Priority Alarm
Medium Priority Alarm
Low Priority Alarm
Alarm Silence Reminder
Pulse Beep
A short, medium-pitched tone
indicating that an appropriate button
has been pressed
A short, low-pitched tone indicating
that a button has been pressed that is
not appropriate for the current state
of the monitor
A high-pitched, fast-pulsing tone
indicating loss of pulse
A medium-pitched, pulsing tone
indicating an SpO2 or pulse rate
limit violation
A low-pitched, slow-pulsing tone
indicating a sensor disconnect, low
battery, or monitor failure
Three beeps that sound at least every
3 minutes when alarms are silenced
with the alarm silence duration set to
OFF
A single beep sounds for each
detected pulse
Volume Setting Tone
A continuous tone that is used to
adjust the alarm volume
Confirmation Tone
Three beeps sound to indicate that
default settings have been saved or
reset to factory defaults or trend data
has been deleted
9
(Blank Page)
SETUP
Unpacking and Inspection
Performance Verification
List of Components
Monitor Setup
Language Selection
Tilt-Stand Supports
UNPACKING AND INSPECTION
Notify the carrier if the shipping carton is damaged. Unpack the
NPB-295 and components. If anything is missing or damaged,
contact Mallinckrodt’s Technical Services Department or your
local Mallinckrodt representative.
PERFORMANCE VERIFICATION
Before using the NPB-295 for the first time in a clinical setting,
you must verify that the monitor is working properly as described
in the Power-on Self-test paragraph of the Start-up and Use
section. If the monitor does not operate properly, refer to the
Troubleshooting section. If you cannot resolve the problem,
contact qualified service personnel or your local Mallinckrodt
representative.
LIST OF COMPONENTS
1
Nellcor NPB-295 pulse oximeter
1
Hospital-grade power cord
1
Nellcor Sensor or ASP-3 assortment pack
1
Nellcor pulse oximetry cable, Model MC-10 or SCP-10
1
Pair of tilt-stand supports
1
Operator’s manual
2
Fuses, 0.5 Amps, 250 Volts
11
Setup
Optional Accessories
A wall mount plate, as described in the Sensors and Accessories
section is available from Mallinckrodt for use with this monitor.
MONITOR SETUP
General Warnings
WARNING: To ensure patient safety, do not place the
monitor in any position that might cause it to fall on the
patient.
WARNING: As with all medical equipment, carefully route
patient cabling to reduce the possibility of patient
entanglement or strangulation.
WARNING: Disconnect the NPB-295 and Nellcor sensor
from the patient during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns.
The NPB-295 may affect the MRI image; the MRI unit may
affect the accuracy of oximetry measurements.
WARNING: To ensure accurate performance and prevent
device failure, do not subject the NPB-295 to extreme
moisture, such as direct exposure to rain. Such exposure may
cause inaccurate performance or device failure.
WARNING: Do not use an NPB-295 monitor, sensor, cable,
or connector that appears to be damaged.
WARNING: The NPB-295 is not defibrillator-proof.
However, it may remain attached to the patient during
defibrillation or while an electrosurgical unit is in use, but the
readings may be inaccurate during use and shortly thereafter.
12
Setup
Connecting The NPB-295
The NPB-295 operates on AC power when the hospital-grade
power cord is connected to both the monitor and an AC power
source (wall outlet).
The supply voltage selector switch allows connection of the
monitor to AC power ranging from 100 VAC to 240 VAC. The
switch has two positions: one for 100-120 VAC (“115”), and one
for 200-240 VAC (“230”). Ensure that the supply voltage
selector switch on the rear panel is set to the proper voltage.
Operating on a discharged battery
The NPB-295 will not operate when its internal battery is
discharged, even when the monitor is connected to AC power.
Instead, the error code “EEE 04” will be displayed. This feature
prevents the accidental use of the monitor with a dead battery.
The monitor is only capable of indicating a loss of AC power if
its internal battery is functional.
The battery may discharge during prolonged storage or shipment.
If the monitor has been in storage for more than 2 months it is
important to plug the monitor into an AC outlet and allow the
battery to charge for approximately 30 minutes before attempting
to operate the instrument on AC power.
To charge a low battery, connect the monitor to AC power. A
full charge of a completely discharged battery takes 14 hours
while turned off, or 18 hours during regular use.
If AC power is not available, you may operate the NPB-295 on
battery power for a limited amount of time. In that case, skip
Steps 2, 3, and 4 below.
1. Place the NPB-295 on a flat surface near the patient. With
the optional wall mount plate available from Mallinckrodt,
the monitor may be attached to a GCX Poly-mount bracket.
2. Plug the female connector end of the power cord into the rear
of the monitor. Use only the hospital-grade power cord
provided by Mallinckrodt.
13
Setup
3. Plug the male connector end of the power cord into a
properly grounded AC outlet.
4. Verify that the AC Power Indicator is lit. If it is not, ensure
that the supply voltage selector switch matches your AC
voltage source. If the indicator still does not light, contact
qualified service personnel, your local Mallinckrodt
representative, or the Mallinckrodt’s Technical Services
Department.
WARNING: In the USA, do not connect the monitor to an
electrical outlet controlled by a wall switch because the
monitor may be accidentally turned off.
5. Select a Nellcor sensor appropriate for the patient to be
monitored (see the Sensors and Accessories section of this
manual for sensor selection information).
WARNING: Do not use an extension cable with the NPB-295
monitor (other than the MC-10 or SCP-10 sensor cable). Use
of another sensor extension cable will have an adverse effect
on performance. Do not attach to the sensor port any cable
that is intended for computer use.
6. Plug the sensor into the MC-10 or SCP-10 sensor cable, and
secure the sensor in place by lowering the plastic sensor lock
over the sensor connector until it clicks into place (refer to
the MC-10 or SCP-10 directions for use).
7. Plug the MC-10 or SCP-10 cable into the sensor port located
on the front of the NPB-295.
LANGUAGE SELECTION
The languages available for display on the screen are English,
French, German, Dutch, Portuguese, Spanish, and Italian. The
NPB-295 is shipped with the factory default English language
displayed.
To select the appropriate language after the unit is powered on,
press the SETUP softkey, then the NEXT softkey, then the
LANG softkey. Use the Adjust Up and Adjust Down Buttons to
14
Setup
select the desired language. Press the EXIT button to return to
the main menu.
Service personnel may set the appropriate language as the poweron default using the procedure described in the NPB-295 service
manual.
TILT-STAND SUPPORTS
A pair of tilt-stand supports provide the option of tilting the front
of the monitor upward in order to view the display at an angle.
When not in use, the supports can be folded flat against the
bottom of the monitor.
The supports are attached to the NPB-295 as shown in Figure-3.
Figure 3: Attaching the Tilt-Stand Supports
15
(Blank Page)
SENSORS AND ACCESSORIES
Selecting a Sensor
Biocompatibility Testing
Performance Considerations
Wall Mount Plate
SELECTING A SENSOR
WARNING: Before use, carefully read the sensor directions
for use, including all warnings, cautions, and instructions.
WARNING: Do not use a damaged sensor or sensor cable.
Do not use a sensor with exposed optical components.
WARNING: Use only Nellcor sensors and sensor cables with
this monitor. Other sensors or sensor cables may cause
improper NPB-295 performance.
WARNING: Do not use the NPB-295 or Nellcor sensors
during magnetic resonance imaging (MRI) scanning. Induced
current could potentially cause burns. The NPB-295 may
affect the MRI image; the MRI unit may affect the accuracy
of oximetry measurements.
When selecting a sensor, consider the patient’s weight and
activity level, the adequacy of perfusion, the available sensor
sites, the need for sterility, and the anticipated duration of
monitoring. For more information, refer to Table 1 or contact
your local Mallinckrodt representative.
17
Sensors and Accessories
Table 1: Nellcor Sensors
Sensor
Model
Patient Size
Oxisensor®
II oxygen
transducer (sterile, single-use
only)
N-25/N-25LF
I-20/I-20LF
D-20
D-25/D-25L
R-15
<3 or >40 kg
3 to 20 kg
10 to 50 kg
>30 kg
>50 kg
Oxiband® oxygen transducer
(reusable with disposable
nonsterile adhesive)
OXI-A/N
OXI-P/I
<3 or >40 kg
3 to 40 kg
Durasensor® oxygen transducer DS-100A
(reusable, nonsterile)
>40 kg
Nellcor reflectance oxygen
transducer (reusable/nonsterile)
RS-10
>40 kg
Dura-Y ® multisite oxygen
transducer (reusable/nonsterile)
For use with Dura-Y sensor:
Ear clip (reusable, nonsterile)
Pedi-Check pediatric spotcheck
clip (reusable, nonsterile)
D-YS
>1 kg
D-YSE
D-YSPD
>30 kg
3-40 kg
OxiCliq® oxygen transducers
(sterile, single-use only)
P
N
I
A
10 to 50 kg
<3 or >40 kg
3 to 40 kg
>30 kg
™
BIOCOMPATIBILITY TESTING
Biocompatibility testing has been conducted on Nellcor sensors in
compliance with ISO 10993-1, Biological Evaluation of Medical
Devices, Part 1: Evaluation and Testing. The sensors have passed
the recommended biocompatibility testing and are therefore in
compliance with ISO 10993-1.
18
Sensors and Accessories
PERFORMANCE CONSIDERATIONS
WARNING: Pulse oximetry readings and pulse signal can be
affected by certain ambient environmental conditions, sensor
application errors, and certain patient conditions.
Inaccurate measurements can be caused by:
•
incorrect application of the sensor
•
placement of the sensor on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line
•
ambient light
•
excessive patient movement
•
venous pulsations
•
intravascular dyes, such as indocyanine green or methylene
blue
•
defibrillation
Other physiological conditions or medical procedures that may
interfere with the monitor’s measurements include significant
levels of dysfunctional hemoglobin, low perfusion, and dark
pigment.
Loss-of-pulse signal can occur for the following reasons:
•
the sensor is too tight
•
a blood pressure cuff is inflated on the same extremity as the
one with the sensor attached
•
there is arterial occlusion proximal to the sensor
Select an appropriate sensor, apply it as directed, and observe all
warnings and cautions presented in the directions for use
accompanying the sensor. Clean and remove any substances such
as nail polish from the application site. Periodically check to
ensure that the sensor remains properly positioned on the patient.
19
Sensors and Accessories
WARNING: Tissue damage can be caused by incorrect
application or duration of use of an SpO2 sensor. Inspect the
sensor site as directed in the sensor directions for use.
High ambient light sources such as surgical lights (especially
those with a xenon light source), bilirubin lamps, fluorescent
lights, infrared heating lamps, and direct sunlight can interfere
with the performance of an SpO2 sensor. To prevent interference
from ambient light, ensure that the sensor is properly applied, and
cover the sensor site with opaque material.
Note:
Failure to take this precaution in high ambient light
conditions may result in inaccurate measurements.
If patient movement presents a problem, try one or more of the
following remedies to correct the problem.
•
verify that the sensor is properly and securely applied
•
move the sensor to a less active site
•
use an adhesive sensor that tolerates some patient motion
•
use a new sensor with fresh adhesive backing
If poor perfusion affects performance, consider using the
Oxisensor R-15 sensor; it obtains measurements from the nasal
septal anterior ethmoid artery, an artery supplied by the internal
carotid. This sensor may obtain measurements when peripheral
perfusion is relatively poor. For low peripheral perfusion,
consider using the Nellcor RS-10 sensor, which is applied to the
forehead or temple. These are sites that may be spared during
peripheral vasoconstriction.
WALL MOUNT PLATE
A wall mount plate is available by contacting Mallinckrodt
Technical Services or your local Mallinckrodt representative.
The wall mount plate fits standard, commercially available GCX
Poly-mount brackets, and is used to securely mount the monitor
to a wall.
20
Sensors and Accessories
The plate attaches to the bottom of the NPB-295 monitor as
shown in Figure 4. If the tilt-stand supports are attached, remove
them before attaching the mounting plate.
Figure 4: Attaching the Mounting Plate
21
(Blank Page)
START-UP AND USE
Basic Operation
Alarms
Adjustable Settings
Menu
Battery Operation
Disposal of Device Components
BASIC OPERATION
WARNING: The NPB-295 is a prescription device and is to
be operated by qualified personnel only.
WARNING: Do not lift the monitor by the sensor cable or
power cord because the cable or cord could disconnect from
the monitor, causing the monitor to drop on the patient.
WARNING: The NPB-295 is intended only as an adjunct in
patient assessment. It must be used in conjunction with
clinical signs and symptoms.
WARNING: Pulse oximetry readings and pulse signal can be
affected by certain ambient environmental conditions, sensor
application errors, and certain patient conditions. See the
appropriate sections of the manual for specific safety
information.
Important! Prior to using the NPB-295, carefully read this
manual, accessory directions for use, all precautionary
information in boldface type, and all specifications.
Before using the NPB-295 in a clinical setting, you must verify
that the monitor is working properly and is safe to use. Proper
working condition can be verified by successful completion of the
power-on self-test described in the following steps, and by
following instructions contained in the “Monitoring Mode”
paragraph of this section.
23
Start-Up and Use
Ensure that the supply voltage selector switch on the rear panel is
set to the proper voltage.
Power-On Self-Test (POST)
WARNING: Ensure that the speaker is clear of any
obstruction. Failure to do so could result in an inaudible
alarm tone.
1. Plug an appropriate Nellcor sensor firmly into the MC-10 or
SCP-10 and lower the MC-10 or SCP-10 sensor lock over
the sensor connector until it clicks into place. Insert the MC10 or SCP-10 into the NPB-295 sensor port. Apply the
sensor to the patient as described in the sensor directions for
use.
2. Turn on the NPB-295 by pressing the Power On/Off Button.
The monitor automatically starts a power-on self-test
(POST), which tests its circuitry.
3. During the POST, the entire display lights and then the
Nellcor logo with model number and software version are
displayed for approximately 3 seconds. All indicator lights
illuminate briefly.
Caution: If any indicator or display element does not light,
do not use the monitor. Instead, contact qualified service
personnel, your local Mallinckrodt representative, or the
Mallinckrodt’s Technical Services Department.
4. If the NPB-295 detects an internal problem during POST, an
error code or error message may be displayed and a low
priority alarm will sound. Depending on the reason for the
failure, the screen may be blank or the low priority alarm
may not sound. Refer to the Troubleshooting section for a
list of correctable error messages.
5. Upon successful completion of the POST, the NPB-295
sounds a 1-second tone indicating that the monitor has
passed the test.
WARNING: If you do not hear the POST pass tone, do not
use the monitor.
24
Start-Up and Use
6. If a sensor is connected to the monitor and the patient, the
Pulse Search Indicator lights and the NPB-295 displays
zeroes in the %SpO2 and Pulse Rate Displays while it
searches for a valid pulse. If a sensor is not attached to the
monitor, dashes are displayed and the Pulse Search Indicator
is not lit.
When a valid pulse is detected, the NPB-295 enters
Monitoring Mode and a display similar to the one indicated
in either Figure 5 or Figure 6 is displayed.
NPB-295
%SP02
BPM
LIMITS
TREND
SETUP
81
112
LIGHT
Figure 5: Monitoring Mode Display - Pleth View
NPB-295
BPM
%SP02
81
LIMITS
TREND
SETUP
112
LIGHT
Figure 6: Monitoring Mode Display - Magnified View
Contrast
To adjust the screen contrast, press and hold the Contrast Button.
Press the Adjust Up or Adjust Down Button to increase or
decrease the contrast. Continue to press and hold the buttons to
adjust the value at a faster rate.
25
Start-Up and Use
Monitoring Mode
In Monitoring Mode - Pleth View (Figure 5), the NPB-295
displays SpO2 readings, pulse rate readings, and a pleth
waveform. In the Monitoring Mode - Magnified (blip) View
(Figure 6), the Pulse Amplitude Indicator and a larger %SpO2 and
pulse rate reading are displayed. The pleth waveform is not
displayed. How to select one of the two views by using the
softkeys will be discussed later in this section.
%SpO2 is displayed for values between 0% and 100%. Pulse
rates are displayed for values from 20 to 250 beats per minute and
zero beats per minute. Pulse rates below 20 (except zero) will be
displayed as 20, and pulse rates above 250 will be displayed as
250. A pulse rate of zero is used to indicate that the monitor is
not monitoring a pulse.
A variable-pitch beep sounds once for each pulse, and the Pulse
Amplitude Indicator (in the Magnified View) visually displays
relative pulse strength at the sensor site. The pitch of the beep
decreases as %SpO2 decreases.
Note:
Verify that indicators, display information, and audible
sounds including alarms are operational, indicating that
the monitor is functioning. Each valid button push
should generate an appropriate audible or visual action.
Observe movement of the Pulse Amplitude Indicator or
pleth waveform, and listen for pulse beeps to verify that
measurements are being made.
If any action does not seem appropriate, do not use the
monitor. Instead, contact Mallinckrodt’s Technical
Services Department or your local Mallinckrodt
representative.
In Monitoring Mode, if the acquired pulse is lost, the monitor
enters Pulse Search Mode.
26
Start-Up and Use
Pulse Search
If the acquired pulse is lost during monitoring, the NPB-295
enters Pulse Search. During Pulse Search, the monitor attempts
to detect a pulse from which to take a measurement.
Note:
Pulse Search is a normal function of the monitor, and
entering this mode does not necessarily mean that the
patient has no pulse.
At Initial Power-Up (Sensor Attached to Monitor)
Immediately after POST is completed and the NPB-295 displays
its software version number, the monitor enters Pulse Search
Mode and the Pulse Search Indicator lights. If an attached sensor
is not connected to a patient, the display reads zeroes and the
monitor remains in the Pulse Search Mode. If the sensor is
connected to the patient, the NPB-295 enters the Monitoring
Mode when a pulse is detected.
At Initial Power-Up (No Sensor Attached to Monitor)
Immediately after POST is completed and the NPB-295 displays
its software version number, the monitor displays dashes. It does
not enter the Pulse Search Mode.
After Taking Measurements
If a pulse was previously acquired and then lost, the NPB-295
enters Pulse Search, and the Pulse Search indicator lights. The
display flashes the last detected readings while the monitor
searches for a valid pulse. When the monitor considers the pulse
“lost,” it displays flashing zeroes and a high priority alarm
sounds.
When a valid pulse is detected, the NPB-295 exits the Pulse
Search Mode and displays the current readings. The Pulse Search
indicator goes out.
Refer to the “Management of the Loss-of-Pulse Alarm” paragraph
later in this section for a detailed description of Pulse Search,
motion, and the loss-of-pulse alarm.
Automatic Shutdown
27
Start-Up and Use
When all of the following conditions are present for 15 minutes,
the NPB-295 automatically shuts down:
•
Running on battery power
•
No buttons have been pressed
•
No pulse has been detected (for example, when no patient is
connected to the sensor or the sensor is disconnected)
•
No alarms are present (other than low battery or a noncorrectable error)
ALARMS
Description of Alarms
The NPB-295 has three levels of audible alarms.
1. High-priority alarm: Indicated by a fast-rate, high-pitched,
pulsing tone. A high-priority alarm sounds after loss-ofpulse is detected.
Refer to the “Management of the Loss-of-Pulse Alarm”
paragraph in this section for a detailed description of the
loss-of-pulse alarm.
2. Medium-priority alarm: Indicated by a medium-rate,
medium-pitched, pulsing tone. A medium-priority alarm
sounds when any measured patient parameter moves outside
the set alarm limits.
During a medium-priority alarm, the display flashes with the
patient parameter that violated the limit (%SpO2 or Pulse
Rate).
3. Low-priority alarm: Indicated by a slow, low-pitched,
pulsing tone. A low-priority alarm sounds during the
following conditions:
28
•
low battery (while operating on battery power)
•
when an SpO2 cable has been disconnected
•
monitor failure
Start-Up and Use
•
50 seconds after loss of pulse is detected in the presence
of continuous motion
When operating on DC power, during a low battery
condition, the Low Battery Indicator illuminates and the
alarm tone sounds immediately, even if the alarms are
silenced or set to OFF.
Management of Loss-of-Pulse Alarm
The NPB-295 signal processing is designed to reduce the adverse
effects of normal interference associated with motion, low patient
perfusion, and spurious electrical or optical signals. Figure 7
illustrates monitor response in sporadic or lost pulse situations
with and without continuous motion.
Losing the pulse presents an alarm-management challenge for any
oximeter—sometimes it is caused by a clinical emergency,
sometimes by signal distortion. When the pulse is lost because of
deteriorating patient condition, the oximeter should alarm
quickly. However, normal interference can obscure the pulsatile
signal. If interference is short-lived, no alarm will sound. Such
alarms are distracting and potentially time-consuming. However,
if interference persists, an alarm should notify the attendant.
The NPB-295 loss-of-pulse alarm is designed for use in
environments in which the pulse can be obscured by interference.
Most loss-of-pulse alarms are attributable to interference from
patient motion, which typically is brief.
When the pulsatile signal is lost, the NPB-295’s ability to identify
interference from motion becomes particularly important because
the response of the monitor is determined by the presence or
absence of interference from patient motion. Because a
spontaneously moving patient can be assumed to have a pulse, as
long as continuous motion is detected, the NPB-295 continues to
search for the pulse.
29
Start-Up and Use
SPORADIC OR LOST PULSE WITH CONTINUOUS MOTION
Low priority
alarm sounds
Pulse Search Indicator lights continuously
Pulse Search
Indicator flashes
%SpO2 and Pulse Rate Displays
alternate between previous
display and dashes
Zeros displayed
Motion Indicator lights continuously*
0 seconds
10 seconds
60 seconds
50 seconds
SPORADIC OR LOST PULSE WITHOUT CONTINUOUS MOTION
High priority alarm sounds
Pulse Search
Indicator lights
continuously
Pulse Search Indicator flashes
%SpO2 and Pulse
%SpO2 and pulse rate flashes zeros
Rate Displays alternate
between previous
display and dashes
0 seconds
10 seconds
16 seconds
60 seconds
6 seconds
50 seconds
*If during motion the NPB-295 detects a qualified pulse, the values on the display are updated.
If motion stops at any time during the pulse search mode, and no qualified pulse is detected,
the high priority alarm will immediately sound after 6 seconds.
Figure 7: Monitoring Conditions and Alarm Responses
The NPB-295 manages loss-of-pulse alarms as follows, and as
illustrated in Figure 7. If the NPB-295 fails to detect at least one
qualified pulse during any 10-second period, it enters pulse
search, the Pulse Search Indicator lights, the displays alternate
between data and dashes, and the data evaluation period starts.
30
Start-Up and Use
During that data evaluation period:
•
If the patient is not moving (for example, because of cardiac
arrest, shock, paralysis, anesthesia) and has no qualified
pulse for 6 seconds, a high-priority alarm immediately
sounds, the Pulse Search Indicator flashes, and the data
displays flash zeroes.
• If the patient is constantly moving, the NPB-295 searches for
qualified pulses for up to 50 seconds. Each time a qualified
pulse is detected, even during motion, the data displays are
updated.
The NPB-295 returns to normal operation as soon as it
detects one of the following: three consecutive qualified
pulses (when there is no motion), five consecutive qualified
pulses (when there is motion), or a total of 10 qualified
pulses. Otherwise, at the end of the data evaluation period,
the data displays flash zeroes and, if motion is still present, a
low-priority alarm sounds; if there is no motion, a highpriority alarm sounds.
If, during the 50-second data evaluation period, motion stops
and no qualified pulse is found for 6 seconds, a high-priority
alarm sounds immediately.
NPB-295 alarm management can therefore be considered a threetier system:
• Normal Monitoring mode, during which qualified pulses are
being detected and the data display is routinely updated.
• Pulse Search mode, during which the Pulse Search Indicator
lights, the data display alternates between data and dashes,
and the data evaluation period is ongoing. The data display
is updated when a qualified pulse is detected.
• Loss-of-pulse mode, during which an alarm sounds, the Pulse
Search Indicator flashes, and the data displays flash zeroes.
31
Start-Up and Use
ADJUSTABLE SETTINGS
The following adjustments can be made using the Adjust
Up/Down and Alarm Silence Buttons.
•
•
•
•
Pulse beep volume
Alarm volume
Alarm silence duration
Disabling audible alarms
Pulse Beep Volume
To adjust the pulse beep volume during normal monitoring, press
and hold the Adjust Up or Adjust Down Button to change the
setting. Pressing and holding the Adjust Down Button will cause
the volume to decrease until it is no longer heard.
Alarm Volume
To view the current volume of the audible alarm, press and hold
the Alarm Silence Button for more than 3 seconds. The current
volume level is indicated in the Pulse Rate Display as a value
from 1 (lowest) to 10 (highest). A tone at the displayed level
sounds.
To adjust the volume, press and hold the Alarm Silence Button
for more than 3 seconds, then press the Adjust Up or Adjust
Down Button to change the setting. The volume cannot be set to
zero.
Alarm Silence Duration
Alarms can be silenced for a preset period called the audible
alarm silence duration. To view the current setting, press and
hold the Alarm Silence Button for less than 3 seconds. To adjust
the setting, press and hold the Alarm Silence Button (for less than
3 seconds) and use the Adjust Up or Adjust Down Buttons to
increase or decrease the value. Possible values are 30, 60, 90, or
120 seconds, or OFF. (The OFF selection is discussed later in
this section.)
The audible alarm silence duration begins when the Alarm
Silence Button is pressed (for less than 3 seconds) and released.
32
Start-Up and Use
(If the button is pressed for more than 3 seconds or the duration is
changed, the Alarm Silence Button must be pressed again to start
the alarm silence duration.)
Subsequently, if any alarm condition (other than a low battery
alarm) occurs while the alarm is silenced, the alarm will not
sound until the alarm silence duration is ended. Operating on
battery power during a low battery alarm condition will cause an
alarm to sound, even if the duration time has not elapsed.
If the Alarm Silence Button is pressed during the alarm silence
duration, the alarm silence duration is ended and the audible
alarms are re-enabled.
Visual indications of an alarm condition cannot be turned off.
For example, if the %SpO2 upper alarm limit is exceeded, the
alarm can be silenced for the alarm silence duration, but the
%SpO2 value will continue to flash.
If the alarm condition is still present when the alarm silence
duration has elapsed, the alarm will sound.
WARNING: Do not silence an audible alarm or decrease its
volume if patient safety could be compromised.
Disabling Audible Alarms
Setting the alarm silence duration to OFF means that no audible
alarms will be produced by the monitor.
To set the alarm silence duration to OFF, press and hold the
Alarm Silence Button for less than 3 seconds and use the Adjust
Up Button to increase the current setting until “OFF” is
displayed. The next time the Alarm Silence Button is pressed, the
Alarm Silence Indicator flashes, indicating that audible alarms
have been disabled. If the Alarm Silence Button is pressed again,
the Alarm Silence Indicator stops flashing.
Visual indications of an alarm condition are not affected by
disabling the audible alarms.
The ability to set the alarm silence duration to OFF can be
enabled or disabled by qualified service personnel as described in
the service manual.
33
Start-Up and Use
The factory default is that the capability of setting the alarm
silence duration to OFF is enabled.
Alarm Silence Reminder
The alarm silence reminder (three beeps) will sound at least every
3 minutes while the alarm silence duration is set to OFF and the
Alarm Silence Indicator is flashing.
The alarm silence reminder may also be disabled by service
personnel using the procedures described in the service manual.
The factory default is that the reminder is enabled.
MENU
Menu Structure
The four softkeys on the front panel are used to view or adjust the
following NPB-295 settings or functions:
•
•
•
•
•
•
•
•
•
•
•
•
%SpO2 and pulse rate alarm limits
Pleth or magnified view
Time and date settings
Data port baud rate settings
Trend data viewed (%SpO2, pulse, or both)
“Zoom” factor of trend data
Graph of trend data (histogram)
Delete all trend data
Print trends
Language displayed on screen or data port
Nurse call settings
Analog output settings
Menu items are selected by pressing and releasing the
corresponding softkey directly below the item. Refer to Figure 8
to access menu items.
Note:
34
If, after accessing a submenu, no buttons are pressed for
10 seconds, the display will timeout and return to the
main menu. Exceptions to this are the clock and trend
Start-Up and Use
menus, which will timeout in 5 minutes and the analog
port calibration menu, which times out in 2 minutes.
LIMITS
TREND
SETUP
LIGHT
LCD display
backlight ON or OFF
SELECT
VIEW
EXIT
Select alarm limit
to be adjusted
CLOCK
NEXT
COMM
PLETH
BLIP
LANG
Adjust baud
rate and
protocol
EXIT
VIEW
ZOOM
NEXT
SPO2
Display both
SpO2 and
pulse trend
data
VIEW
DELETE
PRINT
Print HIST
Trends
YES
Clears all
trend info
NO
Return to prior
trend menu
NEXT
EXIT
NEXT
EXIT
SELECT
EXIT
DELETE
EXIT
Return to
prior menu
SET
HIST
Display
pulse trend
data
NEXT
ANALOG
Return to
main display
PULSE
Display
SpO2 Data
EXIT
0 Volt, 1 Volt,
or Step
Nurse Call
Norm + or
Norm -
EXIT
Select data from last
20 sec. 12/30 min. or 1,
2, 4, 8, 12, or 24 hrs.
NEXT
Select
language
NCALL
DUAL
EXIT
Return to
main display
PRINT
NEXT
Print trends
Return to
prior display
EXIT
Return to
main menu
EXIT
Return to
main display
YES
NO
Clears all
trend info
Return to prior
trend menu
Figure 8: Menu Items
A description of each menu item is included in the following
paragraphs.
35
Start-Up and Use
LIMITS
WARNING: Each time the monitor is used, check alarm
limits to ensure that they are appropriate for the patient
being monitored.
Overview
When the NPB-295 is first turned on, alarm limits are set to their
power-on default values. Power-on default alarm limits can be
changed by qualified service personnel, using the instructions
described in the NPB-295 service manual.
You can temporarily change alarm limits from their power-on
default values if necessary, as described below. Changes you
make will remain in effect until you change them again, or until
you turn off the NPB-295.
Viewing Current Alarm Limits
To view the current alarm limit values from the main menu, press
the LIMITS softkey. The current upper and lower alarm limits
for %SpO2 and pulse rate are displayed.
Changing Alarm Limits
Use the SELECT softkey to select the parameter whose value you
want to change. Use the Adjust Up/Down Buttons to change the
settings. The setting takes effect immediately and remains in
effect when the alarm setting menu is exited.
Alarm Limits Changed Indicator
If alarm limits are changed from the NPB-295’s power-on
defaults, a decimal point appears after the displayed value and in
the %SpO2 and Pulse Rate Display as illustrated in Figure-9. The
decimal point remains on the display until the NPB-295 is turned
off or the limit is returned to its default value.
36
Start-Up and Use
ALARM LIMITS
BPM
%SPO2
100
UPPER
170
80.
40
LOWER
SELECT
%SP02
BPM
96.
79
EXIT
Figure 9: Alarm Limits Selection
TREND
The NPB-295 can graphically display trends for SpO2, pulse rate.
The NPB-295 can store up to 24 hours of trend data. 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.
Trend data is stored at 2-second intervals. When the TREND
softkey is pressed, “READING TRENDS . .” is displayed at the
bottom of the screen, indicating that the monitor is collecting the
trend data.
The amount of trend data displayed on the screen is determined
using the ZOOM softkey. Settings available are 20 seconds, 12
or 30 minutes, and 1, 2, 4, 8, 12, and 24 hours. All data is
displayed in a graph format except the 20-second setting, which is
shown in tabular format.
When the trends are displayed, the most recent readings are on
the right side of the graph. The graph indicates the highest and
lowest parameter values during the period of time represented by
the width of the cursor (vertical dotted line).
The highest and lowest values of the parameter at the cursor are
indicated on the left side of the screen (“95” and “98” in Figure
10). These values are not the current patient readings but
represent the highest/lowest trend values at the cursor.
37
Start-Up and Use
12HR TREND
100
90
%SPO2
95 : 98
80
70
VIEW
25JUL98
ZOOM
NEXT
14 : 35 : 05
EXIT
Figure 10: SpO2 Trend
Periods of time when no measurements were acquired are
indicated by blank spaces in the graph as shown in Figure 10.
The number of trend hours or minutes currently displayed on the
screen is indicated in the upper left corner. The location of the
cursor is indicated by the date and time on the top middle and
right of the screen.
The cursor is moved right or left by using the Adjust Up/Down
Buttons. Each press of the button causes the cursor to move a
certain period of time depending on the trend scale, as indicated
in Table 2.
Table 2: Trend Scale
Trend
Scale
Amount of Time Represented by One Press of
the Adjust Up/Down Button
20 seconds
2 seconds
12 minutes
4 seconds
30 minutes
10 seconds
1 hour
20 seconds
2 hours
40 seconds
4 hours
1 minute, 20 seconds
8 hours
2 minutes, 40 seconds
12 hours
4 minutes
24 hours
8 minutes
Scrolling past the limits of the right or left edges of the screen
causes the viewing area to jump, relocating the cursor to the
middle of the screen if enough trend data is available.
38
Start-Up and Use
For example, suppose the time represented by the right-hand edge
of the screen in Figure 10 is 14:54:05. Scrolling one time period
to the right (4 minutes) results in the cursor relocating to the
center of the screen at the time period 14:58:05, with 6 hours of
data on both sides of the cursor. If no data was available to the
right of the screen, an invalid tone would sound. If only 3 hours
of data was to the right of the screen, the cursor would relocate to
approximately 3/4 of the way to the right of the screen, at the time
period 14:58:05.
Note:
The screen will return to the monitoring mode if an alarm
sounds, the Alarm Silence Button is pressed or a trend or
histogram has been displayed for 5 minutes with no
button presses.
View
Pressing the VIEW softkey allows you to select the %SpO2 or
pulse rate trend or both (DUAL). You can also select the
histogram view as illustrated in Figure 11.
12HR HISTOGRAM
%SPO2
96-100
91-95
86-90
81-85
0-80
VIEW
68%
7%
0%
0%
25%
EXIT
25JUL 04:02--25JUL 16:02
BPM
201-250
0%
151-200
0%
101-150
18%
51-100
57%
0-50
25%
NEXT
Figure 11: Histogram
Histogram
The histogram graphically illustrates the percentage of time a
given range of values has been measured. The period of time
covered is given in the upper left corner of the display. Only
points with data are included in the histogram.
39
Start-Up and Use
For example, in Figure 11, the histogram is for the last 12 hours.
During those 12 hours, 68% of the %SpO2 measurements were
from 96 to 100, 7% of the measurements were from 91 to 95, and
25% of the measurements were from 0 to 80.
Zoom
Pressing the ZOOM softkey changes the period of time indicated
on a trend graph. Selectable times displayed graphically are 24,
12, 8, 4, 2, or 1 hours, and 30 or 12 minutes. The location of the
cursor, as indicated by the time in the upper right-hand corner of
the screen, remains the same.
A table is used to display 20-second trends.
The ZOOM softkey is not displayed for the histogram trend view.
20-second trends table
The 20-second trends table is available by continuing to press the
ZOOM softkey. As indicated in Figure 12, the time indicated on
trend graphs by the cursor is displayed in the upper right-hand
corner of the screen and is highlighted in the table. Press the
Down Arrow button to highlight the time of the trends readings.
The readings are in 2-second increments and go back in time as
the Down Arrow button is pressed and forward in time as the Up
Arrow button is pressed.
20SEC TREND
%SPO2
TIME
21:31:38
96
21:31:36
97
21:31:34
97
21:31:32
97
21:31:30
97
VIEW
28JUL98
TIME
BPM
21:31:48
78
2
1
:
31:46
79
21:31:44
78
21:31:42
78
21:31:40
78
ZOOM
NEXT
21:31:48
%SPO2 BPM
97
78
97
79
97
80
96
78
96
78
EXIT
Figure 12: 20-Second Trends
When the oldest reading on the screen is highlighted and the
Down Arrow button is pressed again, the screen shifts to display
an older column of readings. Similarly, if the newest reading on
the screen is highlighted and the Up Arrow button is pressed, the
screen shifts to display a newer column of readings.
40
Start-Up and Use
Next
The NEXT softkey gives you access to the DELETE and PRINT
softkeys.
Delete
Pressing the DELETE softkey presents two options: YES or NO.
YES deletes all trend information from the NPB-295 memory and
the display. NO returns you to the previous menu.
Print
Note:
The protocol setting must be set to ASCII MODE or
GRAPH MODE to transmit text or graphical data. Check
this setting using the COMM softkey as indicated in the
following paragraphs.
ASCII MODE: Pressing the PRINT softkey begins the
transmission of data via the data port to a connected PC or serial
printer.
GRAPH MODE: The graph mode disables all printouts except
for trend printouts. Pressing the PRINT softkey from the trend
menu will print graphical printout of the displayed graphical trend
data.
Refer to Appendix C of this manual for more information
concerning the data port.
SETUP
The SETUP softkey allows you to select or view the following
settings:
•
view displayed on the screen (PLETH or BLIP)
•
time and date
•
data port baud rate and protocol
•
language displayed on the screen
•
data port nurse call normally high or normally low setting
41
Start-Up and Use
•
data port analog voltage.
Press the SETUP softkey once to display VIEW and CLOCK.
Then press NEXT to display COMM and LANG. Press NEXT
again to display NCALL and ANALOG.
VIEW
The VIEW softkey allows you to select the view displayed on the
screen, PLETH or BLIP (magnified). The pleth view displays the
pleth waveform. The BLIP view displays the Pulse Amplitude
Indicator and larger numerical values for easier viewing.
CLOCK
The CLOCK softkey allows you to set the time and date.
Press the SET softkey to access the SELECT softkey. Use the
SELECT softkey to select the item you wish to change. Use the
Adjust Up/Down Buttons to adjust the setting. The date is
expressed as DD-MMM-YY. For example, November 29, 1998,
would be expressed as 29 - NOV - 98.
Note:
The NPB-295 will timeout in 5 minutes when the SET
and EXIT softkeys are displayed. However, it will
timeout in 10 seconds after the SET button is pressed if
there are no further button presses.
Press the EXIT button to accept the new settings. Press EXIT
again to return to the previous menu.
COMM
Press the NEXT softkey to access the COMM softkey. The
COMM softkey allows you to select the baud rate and the
protocol of the data port.
After pressing the COMM softkey, use the Adjust Up/Down
Buttons to select a baud rate of 2400, 9600, or 19200. Press Exit
to return to the SETUP submenu.
Press the SELECT softkey to highlight the protocol setting. Use
the Adjust Up/Down Buttons to select the desired setting. ASCII
is used during normal operation and for serial printers. GRAPH
is used to print copies of the NPB-295 trend displays when you
42
Start-Up and Use
have an ESC/P compatible graphical serial printer is attached to
the NPB-295 serial port. Select OXINET if you are connecting to
an Oxinet® II central station network or Score software. Do
not use the CLINICAL setting unless instructed to do so by
Mallinckrodt customer service personnel. Press Exit to return to
the SETUP submenu.
Note:
When using Score software use the latest version.
Contact Mallinckrodt’s Technical Services
Department or your local Mallinckrodt representative
to determine the latest version of Score software.
LANG
The LANG softkey allows you to select the language displayed
on the screen.
Press the NEXT softkey to access the LANG softkey. After
pressing the LANG softkey, use the Adjust Up/Down Buttons to
select Dutch, English, French, German, Italian, Portuguese, or
Spanish.
If the language is changed and EXIT is pressed, (or a 10-second
timeout occurs), the monitor begins displaying data in the
selected language.
NCALL
The NCALL softkey allows you to set the alarm voltage at a
normally high (NORM +) or normally low (NORM -). Refer to
the “Nurse Call” heading of Appendix C: Data Port Protocol for
a more thorough explanation of these settings. The nurse call
feature is also discussed later in this section.
ANALOG
The ANALOG softkey allows you to calibrate the NPB-295 data
port voltages with instruments such as a chart recorder. Refer to
the “Analog Outputs” heading of Appendix C: Data Port
Protocol for a more thorough explanation of these settings.
43
Start-Up and Use
LIGHT
The LIGHT softkey allows you to turn the backlight on or off.
Default Settings
The NPB-295 is shipped with factory default settings. Default
settings can be changed by authorized technical personnel using
the procedures described in the NPB-295 service manual.
The factory default settings are as follows:
%SpO2 Upper Alarm Limit:
%SpO2 Lower Alarm Limit:
Pulse Rate Upper Alarm Limit:
Pulse Rate Lower Alarm Limit:
Alarm Volume:
Alarm Silence Duration:
Alarm Silence Duration OFF
Setting:
Alarm Silence Reminder:
Pulse Beep Volume:
Data Port Baud Rate:
Data Port Protocol:
Display Format:
Trend Display:
Display Contrast:
Language:
Nurse Call Polarity:
44
100%
85%
170 beats per minute
40 beats per minute
75 dB(A) peak at 1 meter
(volume setting of 5)
60 seconds
Enabled
Enabled
72 dB(A) at 1 meter
(volume setting of 4)
9600
ASCII
Pleth
%SpO2
Midrange
English
Normally Low
Start-Up and Use
Nurse Call Feature
WARNING: The nurse call feature should not be used as the
primary source of alarm notification. The audible and visual
alarms of the monitor, used in conjunction with clinical signs
and symptoms, are the primary sources for notifying medical
personnel that an alarm condition exists.
The nurse call feature of the NPB-295 works in conjunction with
the nurse call system of your institution when the monitor sounds
an audible alarm. It is accessed through the data port (pins 7, 8,
10, 11, or 15, as indicated in Table 5 in Appendix C).
WARNING: The nurse call feature is not functional
whenever the monitor alarms are silenced.
The nurse call feature is available when the NPB-295 is operated
on AC power and the monitor has been electronically connected
to the hospital’s nurse call system. Depending on the method of
installation used by the service technicians in your institution, it
may by available when the monitor is running on its internal
battery. Qualified service personnel may refer to the NPB-295
service manual for complete connection instructions.
Prior to using the monitor in a clinical setting, test the nurse call
feature by creating an alarm condition, then verifying that the
hospital’s nurse call system is activated.
BATTERY OPERATION
The NPB-295 has an internal battery that may be used to power
the monitor during transport or when AC power is not available.
A new, fully charged battery will provide at least 8 hours of
monitoring time under the following conditions: no audible
alarms, no analog or serial output devices attached, and no
backlight.
Note:
Whenever the monitor is connected to AC power, the
battery is being charged. Therefore, it is recommended
that the monitor remain connected to AC power when not
in use. This will make available a fully charged battery
for use at any time.
45
Start-Up and Use
Since the monitor cannot operate with a fully discharged battery,
before attempting to turn on an NPB-295 whose battery charge
has been depleted, first plug the monitor into an AC outlet to
allow the battery to charge for a few minutes. The monitor may
then be powered on.
To charge a dead battery, connect the monitor to AC power. A
full charge takes 14 hours while turned off, or 18 hours during
regular use.
When all of the following conditions are present for 15 minutes,
the NPB-295 will automatically shutdown:
•
Running on battery power
•
No buttons have been pressed
•
No pulse has been detected (for example, when no patient is
connected to the sensor or the sensor is disconnected)
•
No alarms are present (other than low battery or a noncorrectable error)
Low Battery Indicator
The Low Battery Indicator lights and a low priority alarm begins
to sound when approximately 15 minutes of monitoring time is
available on the existing battery charge. This alarm cannot be
silenced while running on battery power. Connect to AC power
to silence the alarm.
Note:
If the AC voltage selector switch on the rear panel does
not match your AC voltage source, the monitor may run
on battery power, even though it is plugged in, which will
eventually result in a low priority alarm and a lighted low
battery indicator. Ensure the switch setting matches your
AC voltage source.
If the monitor is not connected to AC power within
approximately 15 minutes, it will shut down.
46
Start-Up and Use
Note:
As the battery is used and recharged over a period of
time, the amount of time between the onset of the low
battery alarm and the instrument shut-off may become
shorter.
If the backlight is turned off during a low battery condition, it
cannot be turned back on.
It is recommended that the internal battery be replaced by
qualified service personnel every 24 months.
Caution: If the NPB-295 is to be stored for a period of 2
months or longer, notify service personnel to remove the
battery from the monitor prior to storage. Recharge the
battery when it has not been charged for 2 or more months.
DISPOSAL OF DEVICE COMPONENTS
Caution: Follow local governing ordinances and recycling
instructions regarding disposal or recycling of device
components, including batteries.
47
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TROUBLESHOOTING AND MAINTENANCE
Troubleshooting
EMI Interference
Obtaining Technical Assistance
Returning the NPB-295
Maintenance
TROUBLESHOOTING
WARNING: If you are uncertain about the accuracy of any
measurement, check the patient’s vital signs by alternate
means; then make sure the monitor is functioning correctly.
WARNING: The cover should be removed only by qualified
service personnel. There are no user-serviceable parts inside.
Error Codes
When the NPB-295 detects an error condition, it may display the
letters “EEE” followed by an error code.
When an error code (other than the ones listed in Table 3) is
displayed, turn the instrument off and back on again. If the error
code reappears, record it and notify service personnel.
Error messages will be displayed along with the error codes listed
in Table 3. If the error codes are encountered, perform the
prescribed action as indicated in the table.
49
Troubleshooting and Maintenance
Table 3: Error Codes and Messages
Error
Code
Error
Message
Action
4
LOW
BATTERY
The battery is discharged to a critically low level.
Check to ensure that the voltage selector switch is
set to the proper voltage.
Turn the monitor off and let it charge for about 10
minutes and then turn the unit back on. If the error
code is still present, turn the unit off and let it
continue to charge. If the monitor has been
charged for 30 minutes and the error code is still
present, notify service personnel.
80
DEFAULTS
LOST
The current power-on default settings have been
lost and returned to factory defaults. Qualified
service personnel can use the service manual to
restore the desired power-on default settings.
81
SETTINGS
LOST
The current settings (for example, alarm limits,
alarm and pulse beep volumes, alarm silence
duration) have been lost and returned to power-on
defaults. Turn the monitor off and back on again.
If it is necessary to have settings different from the
power-on default settings, turn the monitor off and
back on again, and reenter the desired settings.
82
CLOCK
SETTING
LOST
The date and time settings have been lost. Reenter
the date and time.
Other Messages
In addition to the messages listed in Table 3, the following
messages may be encountered:
SENSOR DISCONNECTED - The sensor has disconnected from
the cable or the cable has disconnected from the monitor. Press
the Alarm Silence Button to silence the alarm. Check the
connections. If this does not correct the problem, replace the
sensor and/or cable.
50
Troubleshooting and Maintenance
DISALLOWED ON BATTERY - An attempt to print or
download data port information while operating on battery power
has been made. Connect to AC power and retry.
DISALLOWED ON LOW BATTERY - An attempt to turn on
the backlight has been made while in a low battery condition. If
the backlight is turned off during a low battery condition, it
cannot be turned back on.
READING TRENDS - The monitor is gathering trend
information for display.
INVALID SILENCE DURATION - An attempt has been made to
set the alarm silence duration power-on default to “OFF”. The
power-on default cannot be set to “OFF”.
INVALID SPO2 LIMIT - An attempt has been made to set either
the upper or lower alarm limit power-on default below 80. The
power-on default cannot be set below 80.
Suggested Corrective Actions
If you experience a problem while using the NPB-295 and are
unable to correct it, contact qualified service personnel or your
local Mallinckrodt representative. The NPB-295 service manual,
which is for use by qualified service personnel, provides
additional troubleshooting information.
Following is a list of possible errors and suggestions for
correcting them.
1. There is no response to the Power On/Off Button.
•
If operating on AC power, ensure that the supply voltage
selector switch is set to the proper voltage.
•
If operating on AC power, the fuse may be blown.
Notify service personnel to check and, if necessary,
replace the fuse.
•
If operating on battery power, the battery may be
missing or discharged. If the battery is discharged,
notify service personnel to charge or replace the battery.
51
Troubleshooting and Maintenance
2. One or more display elements or indicators do not light
during the power-on self-test.
•
Do not use the NPB-295; contact qualified service
personnel or your local Mallinckrodt representative.
3. The monitor is operating on battery power, even though
it is connected to AC.
•
Ensure that the supply voltage selector switch is set to
the proper voltage.
•
Make sure that the power cord is properly connected to
the NPB-295.
•
Check to see if power is available to other equipment on
the same AC circuit.
4. The Pulse Search Indicator is lit for more than 10seconds (before any measurements are taken).
•
•
•
•
52
Check the sensor directions for use to determine if an
appropriate sensor is being used and if it is applied
properly. Check sensor and extension cable
connections. Test the sensor on someone else. Try
another sensor or extension cable.
Perfusion may be too low for the NPB-295 to track the
pulse. Check the patient. Test the instrument on
someone else. Change the sensor site. Try another type
of sensor.
Excessive patient motion may be preventing the
NPB-295 from tracking the pulse. Keep the patient still,
if possible. Verify that the sensor is securely applied,
and replace it if necessary. Change the sensor site. Use
a type of sensor that tolerates more patient movement,
for example, an adhesive sensor.
The sensor may be too tight, there may be excessive
ambient light, or the sensor may be on an extremity with
a blood pressure cuff, arterial catheter, or intravascular
line. Reposition sensor, as necessary.
Troubleshooting and Maintenance
•
Excessive environmental motion or electromagnetic
interference may be preventing the NPB-295 from
tracking the pulse. Remove the source of interference or
try to stabilize the environment, or do both.
5. The Pulse Search Indicator lights after successful
measurements have been made.
•
Check the patient.
•
Perfusion may be too low for the NPB-295 to track the
pulse. Test the instrument on someone else. Change the
sensor site. Try another type of sensor.
•
Excessive patient motion may be preventing the
NPB-295 from tracking the pulse. Verify that the sensor
is securely applied and replace it if necessary. Change
the sensor site. Use a type of sensor that tolerates more
patient movement, for example, an adhesive sensor.
•
The sensor may be too tight, there may be excessive
ambient light, or the sensor may be on an extremity with
a blood pressure cuff, arterial catheter, or intravascular
line. Reposition sensor, as necessary.
•
Excessive environmental motion or electromagnetic
interference may be preventing the NPB-295 from
tracking the pulse. Remove the source of interference or
try to stabilize the environment, or do both.
Other physiological conditions or medical procedures that may
interfere with the monitor’s measurements include dysfunctional
hemoglobin, arterial dyes, low perfusion, and dark pigment.
EMI INTERFERENCE
Caution: This device has been tested and found to comply
with the limits for medical devices to the IEC 601-1-2:1993,
EN60601-1-2:1994, Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation.
However, because of the proliferation of radio-frequency
transmitting equipment and other sources of electrical noise
in healthcare environments (for example, electrosurgical
53
Troubleshooting and Maintenance
units, cellular phones, mobile two-way radios, electrical
appliances), it is possible that high levels of such interference
due to close proximity or strength of a source, may result in
disruption of performance of this device.
The NPB-295 is designed for use in environments in which the
pulse can be obscured by electromagnetic interference. During
such interference, measurements may seem inappropriate or the
monitor may not seem to operate correctly.
Disruption may be evidenced by erratic readings, cessation of
operation, or other incorrect functioning. If this occurs, the site
of use should be surveyed to determine the source of this
disruption, and the following actions taken to eliminate the
source:
•
Turn equipment in the vicinity off and on to isolate the
offending equipment.
•
Reorient or relocate the other receiving device.
•
Increase the separation between the interfering equipment
and this equipment.
The NPB-295 generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with these
instructions, may cause harmful interference with other devices in
the vicinity.
If assistance is required, contact Mallinckrodt’s Technical
Services Department or your local Mallinckrodt representative.
OBTAINING TECHNICAL ASSISTANCE
For technical information and assistance, or to order parts or a
service manual, contact Mallinckrodt’s Technical Services
Department or your local Mallinckrodt representative. The
service manual includes block diagrams and a parts list required
by qualified personnel when servicing the NPB-295.
When calling Mallinckrodt’s Technical Services Department or
your local Mallinckrodt representative, you may be asked to tell
the representative the software version number of your NPB-295.
54
Troubleshooting and Maintenance
The software version appears in the monitor display each time the
monitor successfully completes the power-on self-test. Write the
number down and have it available whenever requesting technical
assistance.
RETURNING THE NPB-295
Contact Mallinckrodt’s Technical Services Department or your
local Mallinckrodt representative for shipping instructions
including a Returned Goods Authorization number. It is not
necessary to return the sensor. Pack the NPB-295 in its original
shipping carton. If the original carton is not available, use a
suitable carton with appropriate packing material to protect it
during shipping.
Return the NPB-295 by any shipping method that provides proof
of delivery.
MAINTENANCE
Service
The NPB-295 requires no calibration.
The battery should be replaced at least every 24 months. Refer to
the NPB-295 service manual for the battery changing procedure.
If service is necessary, contact qualified service personnel or your
local Mallinckrodt representative.
Periodic Safety Checks
It is recommended that the following checks be performed every
24 months.
•
Inspect the equipment for mechanical and functional damage.
•
Inspect the safety relevant labels for legibility.
Performance Verification
If the monitor has been visibly damaged or subjected to
mechanical shock (for example, if dropped), qualified service
personnel should perform the procedure in the Performance
Verification section of the service manual.
55
Troubleshooting and Maintenance
Cleaning
WARNING: Do not spray, pour, or spill any liquid on the
NPB-295, its accessories, connectors, switches, or openings in
the chassis.
To clean the NPB-295, dampen a cloth with a commercial,
nonabrasive cleaner or a solution of 70% isopropanol in water,
and lightly wipe the surfaces of the monitor. Do not spray or
pour liquid on the instrument or accessories.
The NPB-295 may be disinfected using a soft cloth saturated with
one of the following solutions:
•
10% chlorine bleach in tap water
•
Glutaraldehyde (cidex or equivalent)
Before attempting to clean an SpO2 sensor, read the directions for
use enclosed with the sensor. Each sensor model has cleaning
instructions specific to that sensor.
56
SPECIFICATIONS
Performance
Electrical
Environmental Conditions
Physical Characteristics
PERFORMANCE
Measurement Range
SpO2
0–100%
Pulse Rate
20–250 beats per minute (bpm)
Accuracy
SpO2
Adults
70–100%
0–69%
±2 digits
unspecified
Neonates
70–100%
0–69%
±3 digits
unspecified
Note:
Accuracies are expressed as plus or minus “X” digits
(oxygen saturation percentage points) between
saturations of 70–100%. This variation equals plus or
minus one standard deviation (1SD), which encompasses
68% of the population. All accuracy specifications are
based on testing the subject monitor on healthy adult
volunteers in induced hypoxia studies across the specified
range. Adult accuracy is determined with Oxisensor II
D-25 sensors. Neonatal accuracy is determined with
Oxisensor II N-25 sensors. In addition, the neonatal
accuracy specification is adjusted to take into account the
theoretical effect of fetal hemoglobin in neonatal blood
on oximetry measurements.
57
Specifications
Pulse Rate
20–250 bpm
Note:
±3 bpm
Pulse Rate accuracy is expressed as ±3 bpm across the
display range. This variation equals ± one standard
deviation (1SD), which encompasses 68% of the
population.
Pulse Rate Display Update Frequency
The Pulse Rate Display updates in less than 2.5-seconds with a
one-second change in SpO2-derived pulse rate from 30 pulses per
minute (ppm) to 200 ppm.
Radiated Immunity
The NPB-295 is immune to radiated radio-frequency
electromagnetic fields of up to 3 volts per meter from 80 MHz to
1 GHz.
Conducted Immunity
The NPB-295 is immune to conducted radio-frequency
electromagnetic energy of up to 3 volts from 150 kHz to 80 MHz.
ELECTRICAL
Instrument
Power Requirements
100 - 120 VAC, 200 -240 VAC, 50/60 Hz, 20 VA
Patient Isolation
Type BF
Battery
Type
Lead-Acid
58
Specifications
Battery Capacity
A minimum of 8 hours with a new, fully charged battery under
the following conditions: no alarms, no analog or serial output
devices attached, and no backlight. A completely discharged
battery can be fully recharged in approximately 14 hours while
turned off or 18 hours while turned on.
Charge/discharge cycles: at least 400
ENVIRONMENTAL CONDITIONS
Transport and Storage (in shipping container)
Temperature
-20°C to 70°C (-4°F to +158°F)
Altitude/Barometric Pressure
-457 m to 4,573 m (-1280 ft. to 15,000 ft.)
1060 hPa to 500 hPa (31.3 in. Hg to +14 in. Hg)
Relative Humidity
15-95% noncondensing
Transport and Storage (not in shipping container)
Temperature
-20°C to +60°C (-4°F to +140°F)
Altitude/Barometric Pressure
-457 m to 4,573 m (-1280 ft. to 15,000 ft.)
1060 hPa to 500 hPa (31.3 in. Hg to +14 in. Hg)
Relative Humidity
15-95% noncondensing over temperature range of -20°C to 60°C
(-4°F to +140°F)
59
Specifications
Operation
Temperature
+5°C to +40°C (+41°F to +104°F)
Altitude/Barometric Pressure
-390 m to 3,658 m (-1280 ft. to 12,000 ft.)
+1060 hPa to +700 hPa (+31.3 in. Hg to +20.6 in. Hg)
Relative Humidity
15-95% noncondensing
PHYSICAL CHARACTERISTICS
Weight
5.7 lbs.
2.6 kg
Dimensions
3.3 in. x 10.4 in. x 6 .8 in.
8.4 cm x 26.4 cm x 17.3 cm
Emissions Compliance
EN55011 Emissions Classification
CISPR 11, Group 1, Class B
Equipment Classification (IEC 601-1 / CSA 601.1 / UL 2601-1)
Type of Protection
Class 1 (on AC power)
Internally powered (on battery power)
Degree of Protection
Type BF - Applied part
Enclosure Degree of Ingress Protection from Solids/Liquid
IPX1
60
Specifications
Mode of Operation
Continuous
61
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APPENDIX A: QUICK GUIDE TO OPERATION
Introduction
Settings Adjustments
INTRODUCTION
This Quick Guide to Operation is intended for use by experienced
NPB-295 users. First-time users of the monitor should read the
entire manual before use.
To turn the monitor on or off press
SETTINGS ADJUSTMENTS
Table 4 contains the procedures necessary to adjust or view the
basic NPB-295 settings. In general, press EXIT to return to the
main menu.
Table 4: Settings Adjustments
To Adjust
Action
Pulse Beep Volume
Press and hold
Contrast
Press and hold
Button
or
or
Press
Pleth or Magnified (blip) Press
View
Press
SETUP
VIEW
Select
PLETH or BLIP
Press
EXIT
63
Appendix A: Quick Guide to Operation
Table 4: Settings Adjustments
To Adjust
Action
Button
Alarm Limits
Press
LIMITS
Press
(to select parameter)
SELECT
Press
Press
Alarm Volume
or
Press and hold
(for less than 3
seconds)
then,
Press
64
EXIT
Press and hold
(for more than 3
seconds)
then,
Press
Alarm Silence Duration
or
or
Appendix A: Quick Guide to Operation
Table 4: Settings Adjustments
To Adjust
Action
Button
Time and Date Settings
Press
SETUP
Press
CLOCK
Press
SET
Press
(to select setting)
SELECT
or
Press
Trends
Press (to return to
main menu)
EXIT, EXIT, EXIT
Press
TREND
Press
VIEW
Select desired view
65
Appendix A: Quick Guide to Operation
Table 4: Settings Adjustments
To Adjust
Action
Button
Language
Press
SETUP
Press
NEXT
Press
LANG
Press
Press
66
or
EXIT
APPENDIX B: PRINCIPLES OF OPERATION
Oximetry Overview
OXIMETRY OVERVIEW
Pulse oximetry is based on two principles: that oxyhemoglobin
and deoxyhemoglobin differ in their absorption of red and
infrared light (i.e., spectrophotometry), and that the volume of
arterial blood in tissue (and hence, light absorption by that blood)
changes during the pulse (i.e., plethysmography). A pulse
oximeter determines SpO2 by passing red and infrared light into
an arteriolar bed and measuring changes in light absorption
during the pulsatile cycle. Red and infrared low-voltage lightemitting diodes (LEDs) in the oximetry sensor serve as light
sources; a photodiode serves as the photo detector.
Because oxyhemoglobin and deoxyhemoglobin differ in light
absorption, the amount of red and infrared light absorbed by
blood is related to hemoglobin oxygen saturation. To identify the
oxygen saturation of arterial hemoglobin, the monitor uses the
pulsatile nature of arterial flow. During systole, a new pulse of
arterial blood enters the vascular bed, and blood volume and light
absorption increase. During diastole, blood volume and light
absorption reach their lowest point. The monitor bases its SpO2
measurements on the difference between maximum and minimum
absorption (i.e., measurements at systole and diastole). By doing
so, it focuses on light absorption by pulsatile arterial blood,
eliminating the effects of nonpulsatile absorbers such as tissue,
bone, and venous blood.
Automatic Calibration
Because light absorption by hemoglobin is wavelength dependent
and because the mean wavelength of LEDs varies, an oximeter
must know the mean wavelength of the sensor’s red LED to
accurately measure SpO2. During manufacturing, the mean
wavelength of the red LED is encoded in a resistor in the sensor.
67
Appendix B: Principles of Operation
During monitoring, the instrument’s software reads this resistor
and selects coefficients that are appropriate for the wavelength of
that sensor’s red LED; these coefficients are then used to
determine SpO2. This resistor is read when the monitor is turned
on, periodically thereafter, and each time a new sensor is
connected.
Additionally, to compensate for differences in tissue thickness,
the intensity of the sensor’s LEDs are adjusted automatically.
Functional versus Fractional Saturation
This monitor measures functional saturation — oxygenated
hemoglobin expressed as a percentage of the hemoglobin that can
transport oxygen. It does not detect significant amounts of
dysfunctional hemoglobin, such as carboxyhemoglobin or
methemoglobin. In contrast, hemoximeters such as the IL482
report fractional saturation — oxygenated hemoglobin expressed
as a percentage of all measured hemoglobin, including measured
dysfunctional hemoglobins. To compare functional saturation
measurements to those from an instrument that measures
fractional saturation, fractional measurements must be converted
as follows:
functional saturation =
fractional saturation
100 - (% carboxyhemoglobin + % methemoglobin )
x100
Measured versus Calculated Saturation
When saturation is calculated from a blood gas partial pressure of
oxygen (PO2), the calculated value may differ from the SpO2
measurement of a pulse oximeter. This usually occurs because the
calculated saturation was not appropriately corrected for the
effects of variables that shift the relationship between PO2 and
saturation (Figure 13): pH, temperature, the partial pressure of
carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin.
68
Appendix B: Principles of Operation
Saturation (%)
100
pH
Temperature
PCO2
2,3-DPG
Fetal Hb
pH
Temperature
PCO2
2,3-DPG
50
0
50
100
PO2 (mmHg)
Figure 13: Oxyhemoglobin Dissociation Curve
69
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APPENDIX C: DATA PORT PROTOCOL
Overview
Connecting to the Data Port
Baud Rate
Real-Time Display Format
Trend Data Printout
Nurse Call
Analog Outputs
OVERVIEW
Patient data can be obtained through the data port on the back of
the NPB-295 by connecting it to an attached PC or serial printer.
When connecting the NPB-295 to a printer or PC, verify proper
operation before clinical use. Both the NPB-295 and the printer
or PC must be connected to a grounded AC outlet. The NPB-295
protocol setting must be in the ASCII mode as described in the
“COMM” paragraph of the Start-Up and Use section.
Any printer or PC connected to the monitor’s data port must be
certified according to IEC Standard 950. All combinations of
equipment must be in compliance with IEC Standard 601-1-1
systems requirements. Anyone who connects a printer or PC to
the data output port configures a medical system and is therefore
responsible that the system complies with the requirements of
system standard IEC Standard 601-1-1 and the electromagnetic
compatibility system standard IEC Standard 601-1-2.
CONNECTING TO THE DATA PORT
The NPB-295 data port may be connected to the printer or PC by
using a cable terminated with an AMP connector (AMP part
number 747538-1), ferrule (AMP part number 1-747579-2), and
compatible pins (AMP part number 66570-2). The cable should
be no more than 25 feet (7.6 meters) in length.
71
Appendix C: Data Port Protocol
The cable used must have a braided shield providing 100%
coverage, such as a Belden cable (Belden part number 9609) or
equivalent. The shield must have a 360-degree connection to the
metal shell on the NPB-295’s DB-15 connector and to the
connector on the PC or serial printer. Do not create sharp bends
in the cable, as this may tear or break the shielding.
The pinouts (as illustrated in Figure 14) for the data port are listed
in Table 5.
Table 5: Data Port Pinouts
Pin
Signal Name
1
RxD+ (RS-422[+] input)
2
RxD_232 (RS-232 input)
3
TxD_232 (RS-232 output)
4
TxD+ (RS-422[+] output)
5
Signal Ground (isolated from Earth Ground)
6
AN_SPO2 (analog saturation output)
7
NC_NO (relay closure nurse call, normally open)
8
NC_NC (relay closure nurse call, normally closed)
9
RxD- (RS-422 [-] input)
10
Signal Ground (isolated from Earth Ground)
11
Nurse Call (232-level output)
12
TxD- (RS-422 [-] output)
13
AN-PULSE (analog pulse rate output)
14
AN-PLETH (analog pleth wave output)
15
NC-COM (relay closure nurse call common lead)
GND is ground, TxD represents the Transmit Data line, and RxD
is the Receive Data line.
The pin layouts (as viewed from the rear panel of the NPB-295)
are illustrated in Figure 14. The conductive shell is connected to
earth ground when connected to a PC or printer.
72
Appendix C: Data Port Protocol
9
1
10 11 12 13 14 15
2
3
4
5
6
7
8
Figure 14: Data Port Pin Layout
Pins 2, 3, and 5 provide data in RS-232 format.
Pins 1, 4, 9, and 12 provide data in RS-422 format. TxD+ and
TxD- are the differential transmit data pair. RxD+ and RxD- are
the differential receive pair.
No hardware flow control is used. However, in the ASCII mode
XON/XOFF flow control is supported.
BAUD RATE
The baud rate can be changed by pressing the SETUP softkey, the
NEXT softkey, and then the COMM softkey. Use the Adjust
Up/Down Buttons to select a baud rate of 2400, 9600, or 19200,
depending on the capabilities of the attached equipment.
REAL-TIME DISPLAY FORMAT
While on AC power and while the NPB-295 data port protocol
setting is set to ASCII (refer to Start-Up and Use section),
real-time data is continuously sent to the data port on the back of
the NPB-295. Patient data can be obtained through the data port
by connecting it to an attached PC or serial printer. When a
real-time printout or display is being transmitted to a printer or
PC, a new line of data is displayed every 2 seconds. Column
headings will be displayed or printed after every 25 lines, or if
one of the values in the column heading changes.
Data cannot be obtained if the NPB-295 is operating on battery
power.
Note:
If the data output stops transmitting, turn the power off
and back on again or, if connected to a PC, send an XON
(Ctrl-q) to reset the monitor.
An example of a real-time printout is shown in Figure 15.
73
Appendix C: Data Port Protocol
NPB-295
VERSION 2.0.0.0
TIME
12-NOV-98 14:00:05
12-NOV-98 14:00:07
12-NOV-98 14:00:09
12-NOV-98 14:00:11
12-NOV-98 14:00:13
12-NOV-98 14:00:15
12-NOV-98 14:00:17
12-NOV-98 14:00:19
12-NOV-98 14:00:21
12-NOV-98 14:00:23
12-NOV-98 14:00:25
12-NOV-98 14:00:27
12-NOV-98 14:00:29
12-NOV-98 14:00:31
12-NOV-98 14:00:33
12-NOV-98 14:00:35
12-NOV-98 14:00:37
12-NOV-98 14:00:39
12-NOV-98 14:00:41
12-NOV-98 14:00:43
12-NOV-98 14:00:45
12-NOV-98 14:00:47
12-NOV-98 14:00:49
NPB-295
VERSION 2.0.0.0
TIME
12-NOV-98 14:00:51
NPB-295
VERSION 2.0.0.0
TIME
12-NOV-98 14:00:53
12-NOV-98 14:00:55
CRC: XXXX
BPM
120
124
190*
190*
190*
190*
190*
190*
190*
190*
190*
------------------------CRC: XXXX
%SPO2
BPM
----CRC: XXXX
%SPO2
BPM
79*
59*
79*
59*
%SPO2
100
100
100
100
100
100
100
100
100
100
100
-------------------------
SpO2 Limit: 70-100%
PR Limit: 60-160BPM
PA
Status
50
50
52
PH
50
PH
51
PH
50
PH
50
PH
51
PH
53
PH LB
50
PH LB
50
PH LB
--SD
LB
--SD
LB
--SD
--SD
--SD
--SD
--SD
--SD
--SD
--SD
--SD
--SD
SpO2 Limit: 70-100%
PR Limit: 60-160BPM
PA
Status
--SD
SpO2 Limit: 80-100%
PR Limit: 60-160BPM
PA
Status
50
SL PL LB
52
PS SL PL LB
Figure 15: Real-Time Printout
Column Headings
Every 25th line of the data is a column heading.
NPB-295
TIME
VERSION 2.0.0.0
%SPO2
CRC: XXXX
BPM
SpO2 Limit: 70-100%
PA
Status
PR Limit: 60-160BPM
A column heading is also displayed whenever a value of the
column heading is changed. There are three column heading lines
shown in Figure 15. Using the top row as the starting point there
are 25 lines before the second column heading is printed. The
third column heading was displayed because the SpO2 limits
changed from 70-100% to 80-100%.
Data Source
NPB-295
TIME
VERSION 2.0.0.0
%SPO2
CRC: XXXX
BPM
SpO2 Limit: 70-100%
PA
Status
PR Limit: 60-160BPM
Data in the highlighted box above represents the model number of
the monitor, in this case the NPB-295.
74
Appendix C: Data Port Protocol
Software Revision Level
NPB-295
TIME
VERSION 2.0.0.0
%SPO2
CRC: XXXX
BPM
SpO2 Limit: 70-100%
PA
Status
PR Limit: 60-160BPM
The next data field tells the user the software level, (Version
2.0.0.0) and a software verification number (CRC: XXXX).
Neither of these numbers should change during normal operation.
The numbers may change if the monitor is serviced and receives a
software upgrade.
Alarm Limits
NPB-295
TIME
VERSION 2.0.0.0
%SPO2
CRC: XXXX
BPM
SpO2 Limit: 70-100%
PA
Status
PR Limit: 60-160BPM
The last data field in the top line indicates the high and the low
alarm limits for %SpO2 and for the pulse rate (PR). In the
example above the low alarm limit for SpO2 is 70% and the high
alarm limit is 100%. Pulse Rate alarm limits are 60 and 160 bpm.
Column Headings
NPB-295
TIME
VERSION 2.0.0.0
%SPO2
CRC: XXXX
BPM
SpO2 Limit: 70-100%
PA
Status
PR Limit: 60-160BPM
Actual column headings are in the second row of the column
heading line. Patient data that is presented in the chart, from left
to right, is the time that the patient data on the row was obtained,
the current %SpO2 value being measured, the current Pulse Rate
in beats per minute (BPM), the current Pulse Amplitude (PA),
and the operating status of the NPB-295.
Patient Data and Operating Status
Time
TIME
12-NOV-98 14:00:05
%SPO2
100
BPM
120
PA
50
Status
The Time column represents the NPB-295 real-time clock.
75
Appendix C: Data Port Protocol
Patient Data
NPB-295
VERSION 2.0.0.0
CRC: XXXX
TIME
%SPO2
BPM
12-NOV-98 14:00:05
100
190*
SpO2 Limit: 70-100%
PA
Status
50
PR Limit: 60-160BPM
Patient data is highlighted in the display above. Parameter values
are displayed directly beneath the heading for each parameter. In
this example the %SpO2 is 100, and the pulse rate is 190 beats per
minute. The “*” next to the 190 indicates that 190 beats per
minute is outside of the alarm limits, indicated in the top row, for
pulse rate. If no data for a parameter is available three dashes
(- - -) will be displayed.
PA is an indication of pulse amplitude. The number can range
from 0 to 254. There are no alarm parameters for this value. It
can be used for trending information as an indication of a change
in pulse volume, relative pulse strength, or circulation.
Operating Status
NPB-295
VERSION 2.0.0.0
CRC: XXXX
TIME
%SPO2
BPM
12-NOV-98 14:00:11
100
190*
SpO2 Limit: 70-100%
PA
Status
50
PR Limit: 60-160BPM
PH
The Status column indicates alarm conditions and operating status
of the NPB-295. In this example, the PH means that the pulse rate
upper alarm limit (Pulse High) has been exceeded. A complete
listing of the status codes is listed in Table 6. As many as 4 codes
can be displayed at one time in the Status column.
Table 6: Status Codes
76
Code
Meaning
AO
Alarm Off
AS
Alarm Silence
LB
Low Battery
LP
Loss of Pulse
MO
Patient Motion
PH
Pulse Rate High Limit Alarm
PL
Pulse Rate Low Limit Alarm
PS
Pulse Search
Appendix C: Data Port Protocol
SH
Sat High Limit Alarm
SL
Sat Low Limit Alarm
SD
Sensor Disconnect
Note:
A sensor disconnect will also cause three dashes (- - -) to
be displayed in the patient data section of the display or
printout.
TREND DATA PRINTOUT (ASCII MODE)
The format of data displayed when a trend printout is requested is
similar to that of the real-time data. The only differences are that
“TREND” is displayed in the top row instead of the “CRC:
XXXX” software verification number and there is no “Status”
column.
Readings are displayed in 2-second intervals. The values on each
row are an average for the 2-second period.
At the end of the printout an “Output Complete” line indicates
that the transmission was successful. If the “Output Complete”
line is not present, a corruption of the data may have been
detected and the data should be ignored.
NPB-295
VERSION 2.0.0.0
TREND
TIME
%SPO2
BPM
22-NOV-98 14:00:05
100
120
22-NOV-98 14:00:07
100
121
22-NOV-98 14:00:09
100
120
Output Complete
SpO2 Limit: 70-100%
PA
150
154
150
PR Limit: 60-160BPM
Figure 16: Trend Data Printout (ASCII MODE)
Once a trend printout has begun, the NPB-295 must be turned off
and back on again before a new trend printout can begin. A trend
printout cannot be aborted without turning off the NPB-295 or the
printer.
TREND DATA PRINTOUT (GRAPH MODE)
The graph mode disables all printout functions except trend data.
Trend printouts will be graphical if connected to a serial printer.
77
Appendix C: Data Port Protocol
2HR TREND
100
%SPO2
90
82: 83 80
70
10APR98
10:00:00
Figure 17: Trend Data Printout (GRAPH MODE)
Trend Data Operation
Whenever the NPB-295 is turned on, it stores a “data point” in
memory every 2 seconds (regardless of whether the NPB-295 is
monitoring a patient or not). Up to 50 alarm limit changes will
also be stored in trend data. The NPB-295 can store up to 24
hours of trend data. . 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.
Caution: Changing alarm limit settings uses up trend
memory space. Change alarm limits only as needed.
78
Note:
Trend memory always contains the MOST RECENT 24
hours of data, with newly collected data over-writing the
oldest data on a rolling basis. The NPB-295 continues to
record data points as long as the monitor is powered on,
with “blank” data points collected if no sensor is
connected to the monitor or patient. “Blank” data will
over-write older patient data if the memory becomes full.
Therefore, if you want to save old patient data, it is
important that you turn your monitor off when you are not
monitoring a patient, and that you download the trend
memory, using Score software, before it fills up and overwrites the old data with new data (or “blank” data).
Note:
When using Score software use the latest version.
Contact Mallinckrodt’s Technical Services Department or
your local Mallinckrodt representative to determine the
latest version of Score software.
Appendix C: Data Port Protocol
If battery power is disconnected or depleted, trend data and user
settings will be lost. All data is stored with error detection
coding. If data stored in memory is found to be corrupted, it is
discarded.
NURSE CALL
The NPB-295 provides two different types of nurse call
interfaces; an RS-232 level and relay closure. The RS-232 level
nurse call function only operates when the monitor is connected
to AC power. It will not operate when running on battery. The
relay-based nurse call function is available when the monitor is
operating either on AC power or when powered by battery.
The remote location will be signaled anytime there is an audible
alarm.
Pin 11 on the data port is the RS-232 level nurse call signal and
pin 10 is ground (see Table 5). The voltage between these pins is
determined by the nurse call polarity setting (normally high or
normally low) and whether the monitor is in alarm state. The
nurse call polarity setting by using the procedures in the Start-up
and Use section. To access the nurse call menu from the main
menu, press softkeys SETUP, NEXT, NEXT and NCALL.
When the nurse call polarity setting is normally high (NORM +)
and there is no alarm condition, the voltage between pins 11 and
5 will be +5 to +12 VDC. Whenever the monitor is in an alarm
condition, the output between pins 11 and 5 will be -5 to -12
VDC. When the setting is normally low (NORM -), the readings
are opposite, as indicated in Table 7.
These voltages are present only the monitor is operating on AC
power.
If the audible alarm has been turned off, or silenced, the nurse call
alarm is also silenced.
79
Appendix C: Data Port Protocol
Table 7: Voltage between pins 10 and 11
Alarm State
Nurse Call
Polarity Setting
Voltage from pins
10 to 11
No current alarms
Normally high
+5 to +12 VDC
Alarm condition
Normally high
-5 to -12 VDC
No current alarms
Normally low
-5 to -12 VDC
Alarm condition
Normally low
+5 to +12 VDC
Pins 7 and 15 provide a relay that closes when an alarm is
sounding on the monitor. Pins 8 and 15 provide a relay that opens
when an alarm is sounding. Pin 15 is a common lead for both
relays. The relay operates whether the monitor is operating on AC
power or battery.
ANALOG OUTPUTS
The NPB-295 data port also provides analog voltage outputs
between pins 6, 13, 14, and ground (pin 10), which can be used to
calibrate the NPB-295 data port voltages with instruments such as
a chart recorder. The voltage represents a specific measured
parameter’s current value. The voltage differential varies
proportionally from 0 to 1 volt as the pin’s parameter varies over
its full range of values, as indicated in Table 8.
Table 8: Analog Pinouts
Pin
Parameter
Parameter Range
6
%SpO2
0 - 100%
13
Pulse rate
0 - 250 bpm
14
Pleth wave
0 - 255
For example, as the current value of %SpO2 varies from 0 to
100%, the voltage from pin 6 to ground (pin 10) would vary from
0 to 1 volt. A voltage of .94 volts indicates a current %SpO2
value of 94.
80
Appendix C: Data Port Protocol
The analog function can be accessed from the main menu by
pressing SETUP, NEXT, NEXT, ANALOG. Selecting “0 VOLT”
or “1 VOLT” causes that voltage to appear at pins 6, 3, or 10.
Selecting “STEP” causes the voltage to increase from 0 to 1 volt
at 1/10th second increments, with each step lasting at least 1
second.
Calibration of the analog output and the attached device can be
performed by qualified service personnel using the procedure
described in the NPB-295 service manual.
81