NELLCOR NPB-40 User Manual
OPERATOR’S MANUAL
NPB-40
Handheld 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; outside of the United States, call your local Mallinckrodt
representative.
0123
© 2001 Mallinckrodt Inc. All rights reserved. 060328B-0601
Nellcor Puritan Bennett Inc.
4280 Hacienda Drive
Pleasanton, CA 94588 USA
Telephone Toll Free 1.800.NELLCOR
Tyco Healthcare UK LTD
Fareham Road
Gosport
PO13 0AS
U.K.
Tel: 44.1329.224000
Nellcor Puritan Bennett Inc. 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.
The following are trademarks of Mallinckrodt Inc.: Durasensor, Oxiband,
Oxisensor, Oxisensor II, OxiCliq, and Dura-Y.
Covered by one or more of the following U.S. Patents and foreign equivalents:
4,621,643; 4,685,464; 4,700,708; and 4,770,179.
CONTENTS
Figures
Tables
Figures ............................................................................... iii
Tables ................................................................................ iii
SAFETY INFORMATION ......................................................... 1
General Safety Information ................................................ 1
INTRODUCTION ................................ ................................ ...... 3
Intended use ...................................................................... 3
General Operating Principles and Conditions ................... 3
CONTROLS, INDICATORS, AND SYMBOLS ......................... 5
Displays, Controls, Indicators, and Connectors ................ 5
Other NPB-40 Symbols ...................................................... 7
Description of Controls ...................................................... 8
Function Keys .............................................................. 8
Status Icons ................................................................. 8
Description of Visual Indicators and Displays .................... 9
Description of Audible Indicators ....................................... 10
SETUP ...................................................................................... 11
Unpacking and Inspection.................................................. 11
Testing ................................ ................................ ............... 11
List of Components ............................................................ 11
Optional Accessories ................................ ................... 11
Monitor Setup ..................................................................... 12
Installing the Batteries.................................................. 12
General ........................................................................ 13
NELLCOR SENSORS .............................................................. 15
Selecting a Sensor ............................................................. 15
Biocompatibility Testing ............................................... 16
Performance Considerations ............................................. 16
START-UP AND USE............................................................... 19
Basic Operation ................................ ................................ . 19
Power-On Self-Test (POST) ........................................ 20
Monitoring Mode .......................................................... 21
Pulse Search Mode ..................................................... 22
Determining Software Version ........................................... 23
Silencing or Adjusting Pulse Beep Volume ....................... 23
Turning Display Light (Backlight) On or Off ....................... 23
Storing Event Data ............................................................. 23
Printing Event Data ............................................................ 24
iii
Contents
Preparing the NPB-40 for Printing ............................... 24
Single Event Report ..................................................... 26
Multiple Event Report .................................................. 27
Printer and Printer Accessories ................................... 28
Sensor Disconnect Indicator .............................................. 28
Battery Operation............................................................... 28
Disposal of Device Components ....................................... 29
Performance Considerations.............................................. 30
Impact of Patient Conditions on Monitor Readings...... 30
TROUBLESHOOTING AND MAINTENANCE ......................... 31
Troubleshooting ................................ ................................ . 31
EMI Interference ................................................................ 33
Obtaining Technical Assistance ......................................... 34
Returning the NPB-40 ....................................................... 34
Maintenance ...................................................................... 35
Service ......................................................................... 35
Cleaning....................................................................... 35
Periodic Safety Checks ...................................................... 35
SPECIFICATIONS ................................................................... 37
Performance ................................ ................................ ...... 37
Electrical ................................ ................................ ............ 38
Environmental ................................ ................................ .... 38
Physical.............................................................................. 39
APPENDIX: PRINCIPLES OF OPERATION ............................ 41
Oximetry Overview............................................................. 41
Automatic Calibration................................................... 42
Functional Versus Fractional Saturation...................... 42
Measured Versus Calculated Saturation..................... 43
FIGURES
Figure 1: NPB-40 Front/Side View ........................................... 5
Figure 2: NPB-40 Front Panel Display...................................... 6
Figure 3: NPB-40 Rear View .................................................... 6
Figure 4: NPB-40 Top View ...................................................... 7
Figure 5: Installing Batteries ..................................................... 12
Figure 6: Aligning the NPB-40 and Printer ................................ 25
Figure 7: Single Event Report................................................... 26
Figure 8: Multiple Event Report ................................................ 27
Figure 9: Oxyhemoglobin Dissociation Curve........................... 43
TABLES
Table 1: Nellcor Sensors........................................................... 15
iv
SAFETY INFORMATION
General Safety Information
GENERAL SAFETY INFORMATION
This section contains important safety information related to
general use of the NPB-40 monitor. Other important safety
information appears throughout the manual in sections that
relate specifically to the precautionary information. Be sure to
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: The NPB-40 is a prescription device and is to
be operated by qualified personnel only.
WARNING: The NPB-40 is not equipped with alarms.
The monitor is for attended monitoring only, and must
be used under the direct supervision of a qualified
health care provider.
WARNING: Explosion hazard. Do not use the NPB-40
pulse oximeter in the presence of flammable
anesthetics.
WARNING: The cover should be removed only by
qualified service personnel. There are no userserviceable parts inside.
WARNING: To ensure accurate performance and
prevent device failure, do not expose the NPB-40 to
extreme moisture, such as rain.
Caution: The NPB-40 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.
1
Safety Information
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.
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.
2
INTRODUCTION
Intended Use
General Operating Principles and Conditions
INTENDED USE
The Nellcor NPB-40 handheld pulse oximeter is intended for
noninvasive spot-check measurement of functional oxygen
saturation of arterial hemoglobin (SpO2 ), and pulse rate
(measured by SpO2 sensor).
The monitor is intended for use on adult, pediatric, and
neonatal patients. It can be used in mobile environments when
protected from excessive moisture such as direct rainfall.
Caution: The NPB-40 is intended only as an adjunct in
patient assessment. It must be used in conjunction with
clinical signs and symptoms.
WARNING: The NPB-40 is not equipped with alarms.
The monitor is for attended monitoring only, and must
be used under the direct supervision of a qualified
health care provider.
WARNING: Do not use the NPB-40 or Nellcor sensors
during magnetic resonance imaging (MRI) scanning.
Induced current could potentially cause burns. The
NPB-40 may affect the MRI image; the MRI unit may
affect the accuracy of oximetry measurements.
Caution: The NPB-40 may be used during defibrillation,
but the readings may be inaccurate for a short time.
The battery-operated NPB-40 is designed to send previously
stored patient data to an external Hewlett-Packard HP82240B
printer, available from Mallinckrodt.
GENERAL OPERATING PRINCIPLES AND CONDITIONS
The NPB-40 uses pulse oximetry to measure oxygen saturation
in the blood. Pulse oximetry works by applying a sensor to
pulsating arteriolar vascular bed, such as a finger or toe. The
sensor contains a dual light source and a photodetector.
3
Introduction
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 in an
oxygen saturation measurement (SpO2).
Because a measurement of SpO2 is dependent on light from the
sensor, excessive ambient light can interfere with this
measurement.
WARNING: Pulse oximetry readings and pulse signal
can be affected by certain ambient environmental
conditions, sensor application errors, and certain
patient conditions.
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
Other NPB-40 Symbols
Description of Controls
Description of Visible Indicators and Displays
Description of Audible Indicators
DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS
Figures 1 through 4 show the front, side, rear, and top views of
the NPB-40 and identify displays, controls, and connectors.
3
2
1
4
1. Function keys
2. Status icons
3. Digital display
4. Sensor port
Figure 1: NPB-40 Front/Side View
5
Controls, Indicators, and Symbols
15
14
13
12
1
2
3
4
5
11
10
9 78
1. Pulse Amplitude indicator
2. Pulse Rate display
3. Pulse Search indicator
4. Low Battery indicator
5. Sensor Disconnect indicator
6. Power On/Off key
7. (Shift+) Beep On/Off key
8. Display Light key
10. Store Data key
11. Shift Key
12. Store Data icon
13. Shift Key icon
14. Print icon
15. SpO2% display
Figure 2: NPB-40 Front Panel Display
6
9. (Shift+) Print key
1
2
3
1. Sound ports
2. Battery compar tment latch
3. Battery compar tment door
Figure 3: NPB-40 Rear View
6
1
Figure 4: NPB-40 Top View
OTHER NPB-40 SYMBOLS
Attention: See Instructions for Use
Controls, Indicators, and Symbols
1. Printer infrared window
Percent oxygen saturation
/min
Pulse rate, measured in beats per minute (bpm)
Type BF equipment
Alkaline “AA” size, 1.5 V batteries
7
Controls, Indicators, and Symbols
DESCRIPTION OF CONTROLS
Function Keys
Power On/Off key. This key is used to turn the
NPB-40 monitor on or off.
Shift key. When pressed in conjunction with
another Function key, the Shift key changes the
function of the other key to that designated by its
upper icon.
Combo 1 key. When pressed by itself, this key
functions as the Store Data key (lower icon). It
stores the currently displayed patient data for
printing at a later time.
Pressing the Shift key before pressing the
Combo1 key, changes the function to that of a
Print key (upper icon). This action sends patient
data to an active, properly aligned, HewlettPackard printer, to generate a printed report.
Combo 2 key. When pressed by itself, this key
functions as the Display Light key (lower icon).
It turns the display backlight on or off.
Status Icons
8
Pressing the Shift key before pressing the Combo
2 key, changes the function that of a Beep On/Off
key (upper icon). This action silences or adjusts
the pulse beep volume (see “Silencing or
Adjusting Beep Volume” in the Start-Up and Use
section of this manual).
Shift icon lights when the Shift key function
is in use.
Store Data icon lights when the Store Data
function is in use. While the icon is lit, either
during data storage or printing, the event number
is shown on the display.
Controls, Indicators, and Symbols
Print icon lights when the Print function is in
use. Note: while printing, the monitor does not
measure SpO2 .
The Pulse Search icon lights prior to initial
acquisition of a pulse signal, and during Pulse
Search mode.
The Low Battery icon flashes when 45 minutes or
less battery capacity remains (with disposable
batteries). The icon flashes at least once per
second. Refer to “Battery Operation” in the Start-
Up and Use section for a discussion regarding use
of disposable and rechargeable batteries.
The Sensor Disconnect icon lights when the
NPB-40 does not detect the connection of an
SpO 2 sensor to the monitor.
DESCRIPTION OF VISUAL INDICATORS AND DISPLAYS
The SpO2% display show hemoglobin oxygen
saturation level. It is updated with each pulse.
Synchronous with each pulse, the monitor beeps.
If the SpO2 level drops by more than 2%, the
monitor will emit a double-beep tone.
The Pulse Amplitude indicator is a 10-segment
display that shows the relative pulse amplitude.
As the detected pulse becomes stronger, more
contiguous segments light with each pulse.
The digital Pulse Rate display shows the pulse
rate in beats per minute. It is updated with each
pulse.
9
Controls, Indicators, and Symbols
DESCRIPTION OF AUDIBLE INDICATORS
Following are audible indicators for which there are no
accompanying symbols, keys, or visual indicators.
WARNING: The NPB-40 is not equipped with alarms.
The monitor is for attended monitoring only, and must
be used under the direct observation of a qualified
health care provider.
Power-Up Self-Test pass One 2-second tone
No sensor connected at startup (or sensor disconnected)
Error tone (dual-pitch tone)
for 3 seconds
SpO 2 drop of more than 2% 1 double-beep tone
No Pulse detected for
30 seconds after power-up
Pulse acquired, then lost. No
pulse detected for 15 minutes,
2 triple-beeps, then NPB-40
turns itself off
2 triple-beeps, then NPB-40
turns itself off
and event memory is empty.
Pulse acquired, then lost. No
pulse detected for 60 minutes,
1 triple-beep every
10 seconds
and event memory is not
empty.
Low Battery 1 triple-beep tone at
3-minute intervals
Impending Dead Battery 2 triple-beep tones, then
NPB-40 turns itself off
10
SETUP
Unpacking and Inspection
Testing
List of Components
Monitor Setup
UNPACKING AND INSPECTION
Notify the carrier if the shipping carton is damaged. Unpack
the NPB-40 and components. If anything is missing or
damaged, contact Mallinckrodt Technical Services Department
or your local Mallinckrodt representative.
TESTING
Before using the NPB-40 in a clinical setting, verify that the
monitor functions properly by following the instructions in the
Start-Up and Use section of this manual.
LIST OF COMPONENTS
1 Nellcor NPB-40 handheld pulse oximeter
4 Alkaline “AA” size, 1.5 V batteries
1 Durasensor
1 Operator’s manual
1 Quick Guide adhesive label
®
oxygen transducer, model DS-100A
Optional Accessories
The following items are available from Mallinckrodt for use
with this monitor:
• Protective “Boot”
• Rain Jacket
• Carrying Case
• Hewlett-Packard printer, model HP82240B
• Hewlett-Packard printer paper
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