Nellcor N-200 User manual (2003)
OPERATOR’S MANUAL
NELLCOR N-200
Pulse Oximeter
To contact Nellcor’s representative: In the United States, call 1-800-NELLCOR or
510 463-4000; outside of the United States, call Nellcor’s local representative.
Caution: Federal law (U.S.) restricts this device to sale by or on the order of a
physician.
2003 Nellcor Incorporated. All rights reserved. 066515-0203
Tyco Healthcare Group LP
Nellcor Puritan Bennett Division
4280 Hacienda Drive
Pleasanton, CA 94588 USA
Toll Free: 1.800.NELLCOR
Authorized Representative
Tyco Healthcare UK LTD
154 Fareham Road
Gosport, PO13 OAS, U.K.
To obtain information about a warranty, if any, for this product, contact
Nellcor Technical Services or your local Nellcor representative.
NELLCOR, DURASENSOR, DURA-Y, OXIBAND, OXICLIQ, OXISENSOR,
OXISENSOR II, OXINET, C-LOCK, and the Nellcor knob configuration are
trademarks of Nellcor Incorporated.
ThinkJet is a trademark of Hewlett-Packard Company.
Covered by one or more of the following U.S. Patents and foreign equivalents:
4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; 4,911,167; 4,928,692; 4,934,372;
5,078,136.
CONTENTS
Figures
Tables
Safety Information .................................................................. 1
Warnings............................................................................ 1
General ........................................................................ 2
Alarms.......................................................................... 2
Electrical ...................................................................... 2
Sensors ....................................................................... 2
Measurements ............................................................. 3
Symbols ................................................................................... 5
Quick Guide to Operation ...................................................... 7
Basic Operation ................................................................. 7
Alarm Functions ................................................................. 7
Check Alarm Limits...................................................... 7
Adjust Alarm Limits ...................................................... 7
Adjust Alarm Volume ................................................... 8
Silence Alarm Temporarily........................................... 8
Adjust Alarm Silence Period ........................................ 8
Pulse Tone Volume............................................................ 8
Features ................................................................................... 9
Overview ............................................................................ 9
Automatic Self-Test and Startup .................................. 9
Oximeter Configurable Settings................................... 10
Principles of Operation .......................................................... 11
Operating Principles........................................................... 11
C-LOCK ECG Synchronization.................................... 11
Automatic Calibration................................................... 12
Functional versus Fractional Saturation....................... 12
Measured versus Calculated Saturation...................... 13
Setup ........................................................................................ 15
Unpacking and Inspection.................................................. 15
Testing ............................................................................... 15
Components ...................................................................... 16
Display ......................................................................... 16
Controls ....................................................................... 16
Front Panel .................................................................. 16
Interface/Powerbase Rear Panel ................................. 18
iii
Contents
NELLCOR Sensors ................................................................. 23
Guide to Operation ................................................................. 27
Connecting to Other Instruments ......................................... 61
Maintenance ............................................................................ 71
Rear-Panel Switches ................................................... 20
C-13-200 and C-20-200 Patient Modules .................... 20
C-13-200M Patient Module ......................................... 21
Selecting a NELLCOR Sensor........................................... 23
Cleaning and Reuse .......................................................... 24
Performance Considerations ............................................. 25
Basic Operation ................................................................. 27
Pulse Oximetry Subsystem Features................................. 28
Pulse Tone .................................................................. 28
Alarm Functions ........................................................... 29
Oximetry Operating Modes .......................................... 33
C-LOCK ECG Synchronization.................................... 34
Trend and Event Memories ......................................... 38
User-Defined Events.................................................... 43
Limit Events ................................................................. 44
Communications Formats............................................ 49
Interface/Powerbase .................................................... 58
Battery Operation......................................................... 59
Overview ............................................................................ 61
RS-232 Communication Protocol ...................................... 61
Serial Data Connector Pin Assignments ..................... 61
Communications Formats............................................ 63
Setting Baud Rate........................................................ 65
Connecting the N-7000 Interface ....................................... 65
Connecting to the N-7500 Network.................................... 66
Connecting the N-9000 Recorder/Interface ....................... 66
Connecting Other Strip-Chart Recorders........................... 67
Connecting the Thinkjet Printer.......................................... 68
Connecting the P-200 Printer ............................................ 69
Service ............................................................................... 71
Cleaning ............................................................................. 71
Battery Testing................................................................... 71
Determining Software Version ........................................... 72
Technical Assistance ......................................................... 72
Returning the N-200........................................................... 73
iv
Troubleshooting ..................................................................... 75
Specifications ......................................................................... 85
FIGURES
1 Oxyhemoglobin Dissociation Curve ................................... 13
2 N-200 Front Panel ............................................................. 16
3 Interface/Powerbase Rear Panel ....................................... 18
4 C-13-200 and C-20-200 Patient Modules .......................... 20
5 C-13-200M Patient Module ................................................ 21
6 Standard Limb Lead Selection........................................... 36
7 Sample ThinkJet Trend Graph........................................... 41
8 Sample ThinkJet Event Graph ........................................... 46
Contents
Status Messages ............................................................... 75
Troubleshooting Guide....................................................... 77
General System Problems ........................................... 78
General Oximetry Subsystem Problems ..................... 79
Trend Memory Problems ............................................. 84
Performance ...................................................................... 85
ECG ................................................................................... 86
Environmental Conditions .................................................. 87
Electrical Characteristics.................................................... 88
Physical Characteristics..................................................... 89
TABLES
1 Rear-Panel Dip Switch ....................................................... 20
2 Selected NELLCOR Sensors............................................. 24
3 Default Alarm Settings ....................................................... 31
4 SERIAL COMM Connector Pin Assignments .................... 62
5 Output Format Switch Settings .......................................... 63
6 Baud Rate Switch Settings ................................................ 65
v
SAFETY INFORMATION
Warnings
WARNINGS
General
DANGER! Explosion hazard. Do not use in the presence
of flammable anesthetics.
The N-200 is to be operated by qualified personnel only.
Before use, carefully read this manual, accessory
directions for use, all precautionary information, and
specifications. The user must check that the equipment
functions safely and see that it is in proper working
condition before being used.
The N-200 is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical
signs and symptoms.
Do not use NELLCOR pulse oximeters during magnetic
resonance image (MRI) scanning. Adverse reactions
include: potential burns to patients as a result of contact
with attachments heated by the MRI RF pulse; potential
degradation of the MR image; and, potential reduced
accuracy of oximeter measurements. Always remove
oximetry devices and attachments from the MR imaging
environment before scanning a patient.
For preamplification requirements, only an N-200
patient module should be used with the N-200 pulse
oximeter. Do not use any other patient module (for
example, the N-100 patient module).
1
Safety Information
Alarms
Do not silence the audible alarm or decrease its volume
if patient safety could be compromised.
Check the audible alarm silence duration before
temporarily silencing the audible alarm.
Each time the monitor is used, check alarm limits to
ensure they are appropriate for the patient being
monitored.
Electrical
Electric shock hazard. Cover to be removed only by
qualified service personnel. There are no userserviceable parts inside.
Note: Do not connect to an electrical outlet controlled
by a wall switch because power to the monitor
could be inadvertently turned off.
Sensors
Before use, carefully read the sensor Directions for Use.
Use only NELLCORoxygen transducers (sensors). Use of
other oxygen transducers may cause improper oximeter
performance.
Tissue damage can be caused by incorrect application
or use of a sensor (for example, wrapping the sensor too
tightly or applying supplemental tape). Inspect the
sensor site routinely to ensure skin integrity and
correct positioning and adhesion of the sensor. If skin
integrity changes, move the sensor to another site.
Inspect the sensor and cable for fraying, cracking,
breakage, or other damage. If defects are noted, do not
use the sensor. Do not immerse sensor completely in
water, solvents, or cleaning solutions (because the
connector is not waterproof). Do not sterilize by
irradiation, steam, or ethylene oxide.
2
Measurements
Loss of pulse signal can occur for the following reasons:
¥ The sensor is too tight.
¥ There is excessive illumination, such as from
sunlight or a surgical or bilirubin lamp.
¥ The sensor is placed on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line.
¥ The patient is in shock, has hypotension, severe
vasoconstriction or anemia, hypothermia, arterial
occlusion proximal to the sensor, or cardiac arrest.
Inaccurate measurements may be caused by:
¥ Incorrect application or use of a sensor.
¥ Significant levels of dysfunctional hemoglobins, such
as carboxyhemoglobin or methemoglobin.
Safety Information
¥ Significant levels of indocyanine green, methylene
blue, or other intravascular dyes.
¥ Exposure to excessive illumination, such as surgical
lamps (especially ones with a xenon light source),
bilirubin lamps, fluorescent lights, infrared heating
lamps, or direct sunlight. Exposure to excessive
illumination can be corrected by covering the sensor
with a dark or opaque material.
¥ Excessive patient movement.
¥ Venous pulsations.
¥ High-frequency electrosurgical interference and
defibrillators.
¥ Placement of the sensor on an extremity that has a
blood pressure cuff, arterial catheter, or
intravascular line.
3
SYMBOLS
Attention: Refer to Manual
Fuse Replacement Symbol
Caution: Shock Hazard
5
QUICK GUIDE TO OPERATION
Basic Operation
Alarm Functions
Pulse Tone Volume
BASIC OPERATION
1. Select the appropriate NELLCOR sensor and apply it to
the patient, following sensor directions for use. Connect the
sensor to the patient module.
2. Plug the N-200 into a properly grounded AC outlet using a
hospital-grade power cord. Alternatively, operate the N-200
on its internal battery. Turn on the system: switch the
ON/STDBY switch to the ON position.
3. For C-LOCK® ECG synchronization, connect an
appropriate ECG signal source to the N-200.
4. Check alarm limits. If necessary, adjust them to suit the
patient’s needs.
ALARM FUNCTIONS
Check Alarm Limits
Press the appropriate alarm button (HIGH SAT, LOW SAT,
HIGH RATE, or LOW RATE). When the button is pressed, the
selected limit will show in the display.
Adjust Alarm Limits
Press the appropriate alarm button (HIGH SAT, LOW SAT,
HIGH RATE, or LOW RATE), and turn the control knob until
the desired setting appears.
7
Quick Guide to Operation
Adjust Alarm Volume
Simultaneously, press the LOW SAT and HIGH SAT buttons.
Turn the control knob until the desired setting appears in
OXYGEN SATURATION display. Pushing the LOW SAT and
HIGH SAT buttons activates the audible alarm to indicate
volume.
Silence Alarm Temporarily
Press the AUDIO ALARM OFF button. The ALARM OFF
indicator lights steadily during the alarm-off period. Do not
silence the alarm if patient safety could be compromised.
Adjust Alarm Silence Period
Press and hold AUDIO ALARM OFF button and turn the
control knob until the desired setting (30–120 seconds) appears
in the OXYGEN SATURATION display.
PULSE TONE VOLUME
Turn the control knob to adjust the pulse tone volume.
8
FEATURES
Overview
OVERVIEW
The NELLCOR N-200 pulse oximeter measures functional
oxygen saturation of arterial hemoglobin (SpO2), and pulse
rate. The system consists of three components: the N-200 pulse
oximeter, an interface/powerbase, and a patient module. The
N-200 monitors SpO2 and pulse rate continuously and
noninvasively, with measurements updated at each pulse beat.
The interface/powerbase is a detachable AC power supply and
external interface for the N-200. It provides isolated power for
operating the monitor and charging its internal batteries. In
addition, the interface/powerbase provides analog and digital
outputs for external data recording devices and an input for
C-LOCK ECG synchronization. A fiber optic output can be used
to connect the N-200 to a NELLCOR N-7500 pulse oximetry
network. The patient module (models C-13-200, C-20-200, or
C-13-200M) provides a connector for the oximetry sensor and
provides initial oximetry signal processing; models C-13-200
and C-20-200 also provide an ECG input connector.
Automatic Self-Test and Startup
The N-200 provides immediate use after startup, without need
for operator calibration or configuration. It offers:
• Automatic self-test and error messages
• Automatic oximetry calibration
• Visible oximetry display
• An early warning system that provides an audible
indicator for both SpO2 and pulse rate: a tone sounds on
each pulse, and its pitch varies with changes in SpO2
• Operator-configured visible and audible oximetry alarms,
with default alarm limits preset for adults or neonates
9
Features
Oximeter Configurable Settings
The N-200 provides the operator with the capability to tailor
the system for specific clinical applications. Capabilities
include:
• Audible alarms that can be silenced; the alarm has
adjustable volume.
• C-LOCK ECG synchronization that enhances oximetry
signal processing during patient movement or for patients
with low perfusion.
• Three oximetry operating modes that change measurement
averaging time to suit varied clinical applications.
• Oximetry trend memory, with up to 12-hour SpO2 and
pulse rate trend data storage.
• Oximetry and pulse rate event memory, with 1-hour event
data storage. Data storage of event memory markers
includes: alarm-limit-defined events and user-defined
events.
10
• Analog and digital output of saturation, pulse rate, and
pulse waveform data. When an ECG signal is provided to
the patient module three-lead ECG connector, the N-200
provides an analog output of the ECG waveform.
WARNING: Do not use the ECG analog output as a
trigger for synchronous defibrillation.
PRINCIPLES OF OPERATION
Operating Principles
OPERATING PRINCIPLES
Pulse oximetry is based on two principles: that oxyhemoglobin
and deoxyhemoglobin differ in their absorption of red and
infrared light (that is, spectrophotometry), and that the volume
of arterial blood in tissue (and hence, light absorption by that
blood) changes during the pulse (that is, plethysmography). A
pulse oximeter determines SpO
light into an arteriolar bed and measuring changes in light
absorption during the pulsatile cycle. Red and infrared lowpower light-emitting diodes (LEDs) in the oximetry sensor
serve as light sources; a photodiode serves as the
photodetector.
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 SpO
2 measurements on the difference
between maximum and minimum absorption (that is,
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.
C-LOCK ECG Synchronization
C-LOCK ECG synchronization: read through motion to provide
valid readings for many types of motion. During C-LOCK
signal processing, the monitor requires two signals that reflect
cardiac activity: the electrical pulse from the ECG and the
optical pulse from the oximetry sensor.
2 by passing red and infrared
11
Principles of Operation
The delay between the electrical ECG pulse and the optical
pulse at the sensor site is relatively stable for a given patient
and sensor site. C-LOCKprocessing takes advantage of this
temporal relationship, using the QRS complex as a reference
point for identifying the oximetry pulse and for timing SpO2
measurements. This enhances “good” pulses and minimizes the
effect of random artifacts associated with motion and low
perfusion.
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. 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, laboratory hemoximeters 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 =
100 - (% carboxyhemoglobin + %methemoglobin)
fractional saturation
12
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 1): pH, temperature, the partial
pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal
hemoglobin.
Principles of Operation
0
pH
Temperature
PCO
2
2,3-DPG
Fetal Hb
PO2 (mmHg)
pH
Temperature
PCO
2
2,3-DPG
10050
100
50
Saturation (%)
Figure 1: Oxyhemoglobin Dissociation Curve
13
SETUP
Unpacking and Inspection
Testing
Components
UNPACKING AND INSPECTION
Notify the carrier immediately if the N-200 shipping carton is
damaged. Carefully unpack the instrument and its accessories.
Confirm that the following items are included:
1 N-200 pulse oximeter
1 interface/powerbase
1 hospital-grade power cord
1 patient module
1 operator’s manual
1 guide to operations
Inspect each component. If any component is missing or
damaged, contact Nellcor’s Customer Service Department or
your local Nellcor representative.
TESTING
Verify all functions as described in the Guide to Operation
section. If a difficulty occurs, refer to the Troubleshooting
section. If that does not resolve the difficulty, contact qualified
service personnel or your local Nellcor representative.
15
Setup
COMPONENTS
Display
Two three-digit red alphanumeric displays for oxygen
saturation and pulse rate. Sixteen-segment bar graph for pulse
amplitude indicator. Indicators for LOW BATT, PULSE
SEARCH, HIGH SAT, LOW SAT, HIGH RATE, and LOW
RATE alarms, ECG LOST, and AUDIO ALARM OFF.
Annunciators for BATT IN USE and ECG IN USE.
Controls
Control knob to adjust volume and set alarm limits, and five
buttons to select alarm limits and disable audio alarm.
Rear-panel switches for adult/neonatal alarm settings, analog
voltage output range (0–1 V or 0–10 V), analog saturation
output scale (0–100% or 50–100%), RS-232 format, baud rate;
rear-panel buttons for printing trend and event data, analog
full scale output, and analog zero output.
Front Panel
16
1234 5 6
BATT
STD
BY
C
E
T
N
N
O
C
E
L
E
C
I
S
L
O
LOW
IN
ON
BATT
USE
PULSE
I
O
N
T
A
SEARCH
ECG
ECG
REFER
D
MANUAL
E
IN
LOST
TO
USE
SpO2 PERCENT
BEATS PER MINUTE
15 14 13 11 10 812
Figure 2: N-200 Front Panel
7
HIGH
SAT
LOW
SAT
HIGH
RATE
LOW
RATE
AUDIO
ALARM
OFF
9
Setup
1. ON/STDBY switch.
2. BATT IN USE indicator.
3. LOW BATT indicator: Flashes when five or fewer
minutes of battery power remain.
4. PULSE SEARCH indicator: Flashes when the N-200 is
attempting to locate the patient’s pulse.
5. OXYGEN SATURATION display.
6. Control knob: Changes instrument settings or limits.
7. HIGH SAT, LOW SAT, HIGH RATE, LOW RATE
indicators: Flash during an alarm state.
8. HIGH SAT, LOW SAT, HIGH RATE, LOW RATE
buttons: Display alarm limits.
9. AUDIO ALARM OFF button: Temporarily silences
audible alarms.
10. AUDIO ALARM OFF indicator: Lights steadily when
the audio alarm has been temporarily silenced; flashes
when the audio alarm has been disabled.
11. PULSE RATE display.
12. Pulse amplitude indicator: Vertical column of light bars
that qualitatively indicates pulse amplitude.
13. ECG IN USE indicator: Flashes when the N-200 locates
an ECG signal; lights steadily when the N-200 locks onto
the signal.
14. ECG LOST indicator.
15. Patient module connection socket.
17
Setup
Interface/Powerbase Rear Panel
212019181716
NELLCOR INCORPORATED
INTERFACE/POWERBASE
SERIAL NO.
ELETRICAL RATING
100-120 Vac .3A 50/60 Hz
WARNING
REPLACE FUSE AS MARKED
MADE IN USA NELLCOR INC, PLEASANTON, CA 94588
USE .5A
SLOW BLOW
FUSE ONLY
33 32 31 29 27 26
ZERO FULL TREND EVENT
S O %
a 2
DATA
SCALE
0-
100
50-
12
100
SERIAL COMM
PULSE SAT ECG
30 28
VOLT
0-1
0-10
RATE
12345678
REFER TO MANUAL
IN/OUT
ADULT/
1
NEONATAL
ALARM
2
3
RS232
4
FORMAT
5
6
BAUD
7
8
RATE
12345678
25 24 23
Figure 3: Interface/Powerbase Rear Panel
16. ZERO button: Provides a zero-volt signal on PULSE,
SAT, and RATE analog outputs.
17. FULL button: Provides a full-scale signal on PULSE,
SAT, and RATE analog outputs. (The voltage depends on
VOLT switch setting).
18. SpO2% SCALE switch: Sets the analog output scale for
oxygen saturation at 0–100% or 50%–100%.
22
18
19. VOLT switch: Sets the voltage output range for the
analog outputs.
20. TREND button: Initiates a trend memory output sequence.
21. EVENT button: Initiates an event memory output
sequence.
22. ECG IN/OUT connector: Provides an analog ECG output
signal or can be used for an input from an external ECG
monitor.
Setup
23. Baud Rate switches: Set the baud rate for serial
communications.
24. RS-232 Format switches: Set the RS-232 format.
25. Adult/Neonatal Alarm switch: Sets the default alarm
limits for adults or neonates.
26. RATE connector: Provides analog voltage output of pulse
rate in beats per minute, with a range of 0–250 bpm.
27. SERIAL COMM connector: Provides RS-232 digital
interface via a 9-pin “D” connector.
28. SAT connector: Provides analog output of oxygen
saturation data.
29. DATA connector: Provides a digital signal via fiber-optic
output.
30. PULSE connector: Provides analog output of pulse
waveform.
31. AC power inlet.
32. Fuse compartment.
33. Fuse label.
19
Setup
Rear-Panel Switches
The rear panel includes eight switches for digital output and
adult/neonatal alarm limits.
Table 1: Rear-Panel Dip Switch
Switch Section
Function
1 Adult/neonatal alarm settings
2, 3, 4, 5 RS-232 format
6 Not used
7, 8 Baud rate select
C-13-200 and C-20-200 Patient Modules
Caution: Use only an N-200 patient module. Using an
N-100 patient module may adversely affect oximeter
performance.
34
20
36 35
Figure 4: C-13-200 and C-20-200 Patient Modules
34. Self-adhering strap
35. Sensor connector: For NELLCOR sensors.
36. ECG connector: For a Nellcor-approved ECG cable.
C-13-200M Patient Module
37
Figure 5: C-13-200M Patient Module
37. Sensor lock and connector: For NELLCOR sensors;
includes lock to hold sensor in place.
Setup
21
NELLCOR SENSORS
Selecting a NELLCOR Sensor
Cleaning and Reuse
Performance Considerations
WARNING: Use only NELLCORoxygen transducers
(sensors). Other oxygen transducers may cause
improper oximeter performance.
WARNING: Before use, carefully read the sensor
directions for use.
SELECTING A NELLCOR SENSOR
When selecting a sensor, consider the patient’s weight and
activity, the adequacy of perfusion, the available sensor sites,
the need for sterility, and the anticipated duration of
monitoring. For more information, refer to Table 2 or your local
Nellcor representative.
23
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