Pulso Oximetro Nellcor N-200-Ingles
Pulso Oximetro Nellcor N-200-Ingles
Pulso Oximetro Nellcor N-200-Ingles
NELLCOR N-200
Pulse Oximeter
Caution: Federal law (U.S.) restricts this device to sale by or on the order of a
physician.
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
iii
Contents
iv
Contents
Troubleshooting ..................................................................... 75
Status Messages ............................................................... 75
Troubleshooting Guide....................................................... 77
General System Problems ........................................... 78
General Oximetry Subsystem Problems ..................... 79
Trend Memory Problems ............................................. 84
Specifications ......................................................................... 85
Performance ...................................................................... 85
ECG ................................................................................... 86
Environmental Conditions .................................................. 87
Electrical Characteristics.................................................... 88
Physical Characteristics..................................................... 89
FIGURES
TABLES
v
SAFETY INFORMATION
Warnings
WARNINGS
General
1
Safety Information
Alarms
Electrical
Sensors
2
Safety Information
Measurements
¥ Venous pulsations.
3
SYMBOLS
5
QUICK GUIDE TO OPERATION
Basic Operation
Alarm Functions
Pulse Tone Volume
BASIC OPERATION
ALARM FUNCTIONS
7
Quick Guide to Operation
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.
8
FEATURES
Overview
OVERVIEW
9
Features
10
PRINCIPLES OF OPERATION
Operating Principles
OPERATING PRINCIPLES
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
fractional saturation
functional saturation = x100
100 - (% carboxyhemoglobin + % methemoglobin)
12
Principles of Operation
100 pH
Temperature
PCO2
2,3-DPG
Fetal Hb
Saturation (%)
pH
50 Temperature
PCO2
2,3-DPG
0
50 100
PO2 (mmHg)
13
SETUP
Unpacking and Inspection
Testing
Components
1 interface/powerbase
1 patient module
1 operator’s manual
1 guide to operations
TESTING
15
Setup
COMPONENTS
Display
Controls
Control knob to adjust volume and set alarm limits, and five
buttons to select alarm limits and disable audio alarm.
Front Panel
1 2 3 4 5 6 7
HIGH
SAT
BATT
STD IN LOW
ON BATT
BY USE LOW
SAT
PULSE
SEARCH HIGH
EC
NN TI
SpO2 PERCENT RATE
ON
CO
ECG LOW
REFER
ECG IN RATE
LOST
EL
TO USE
MANUAL AUDIO
TE
C
E
ALARM
IS O L A BEATS PER MINUTE OFF
15 14 13 12 11 10 9 8
16
Setup
1. ON/STDBY switch.
17
Setup
16 17 18 19 20 21
50- 1 2
0-1
ADULT/
22
REPLACE FUSE AS MARKED 100 0-10 IN/OUT 1 NEONATAL
DATA SERIAL COMM 2 ALARM
3
RS232
4
FORMAT
5
6
1 2 3 4 5 6 7 8
7 BAUD
REFER TO MANUAL 8 RATE
MADE IN USA NELLCOR INC, PLEASANTON, CA 94588
33 32 31 30 29 28 27 26
1 2 3 4 5 6 7 8
25 24 23
18. SpO 2% SCALE switch: Sets the analog output scale for
oxygen saturation at 0–100% or 50%–100%.
19. VOLT switch: Sets the voltage output range for the
analog outputs.
18
Setup
23. Baud Rate switches: Set the baud rate for serial
communications.
19
Setup
Rear-Panel Switches
The rear panel includes eight switches for digital output and
adult/neonatal alarm limits.
34
36 35
20
Setup
37
21
NELLCOR SENSORS
Selecting a NELLCOR Sensor
Cleaning and Reuse
Performance Considerations
23
NELLCOR Sensors
Patient
Oxygen Transducer Model Weight
24
NELLCOR Sensors
PERFORMANCE CONSIDERATIONS
25
GUIDE TO OPERATION
Basic Operation
Pulse Oximetry Subsystem Features
BASIC OPERATION
3. Align the red dot on the patient module connector with the
red dot on the patient module connection socket. Push the
connector straight in until it locks; do not twist. Use only
NELLCOR C-13-200, C-20-200, or C-13-200M patient
modules.
27
Guide to Operation
A beep signals each pulse beat, and its pitch increases and
decreases to reflect changes in SpO2. If the oximetry pulse
signal is lost and pulse is measured only from the ECG, the
pulse tone changes from a beep to a warble.
Note: When the N-200 is turned off and back on, all
operator-adjustable features return to their
default state.
Pulse Tone
28
Guide to Operation
Alarm Functions
Audio and visual alarms can be set for high and low oxygen
saturation, high and low pulse rate, loss of pulse, and visual
alarm for loss of ECG. Audio alarms are interrupted briefly for
detected pulses and the volume is adjustable. Audio alarms can
be disabled for a 60-second period by pressing the AUDIO
ALARM OFF button; the disable period is adjustable between
30–120 seconds, or disabled indefinitely by setting the alarm
silence period to OFF. The alarm silence indicator blinks
continuously when the audible alarm has been disabled.
Alarm States
If the oxygen saturation level or pulse rate moves beyond the
alarm limits, the corresponding alarm indicator flashes, the
appropriate display flashes, and an audio alarm sounds (unless
or until it has been silenced).
29
Guide to Operation
If the alarm activates because the ECG signal is lost, the ECG
LOST indicator flashes. This is accompanied by a single low
pitch beep to alert the user.
Note: When the operator turns the N-200 off and back on
again, alarm limits return to default values.
30
Guide to Operation
Note: When the operator turns the N-200 off and back on
again, alarm limits return to default values.
31
Guide to Operation
To adjust audio alarm volume, press and hold both the HIGH
SAT and LOW SAT buttons, and turn the control knob
clockwise to increase the volume or counterclockwise to
decrease it.
32
Guide to Operation
To disable the audio alarm, press and hold the AUDIO ALARM
OFF button, and turn the control knob clockwise until OFF
appears on the OXYGEN SATURATION display. The AUDIO
ALARM OFF indicator light flashes continuously while the
audio alarm is disabled. The audio alarm can be reactivated by
pressing the AUDIO ALARM OFF button again.
Note: When the operator turns the N-200 off and back on
again, the audio alarm is automatically reenabled and
the alarm silence period returns to the default of
60seconds.
33
Guide to Operation
Signal Requirements
For signals from a bedside ECG monitor, the peak of the ECG
signal must be between 0.5 and 15volts. The QRS complex
must be at least 10 milliseconds wide at 50% of peak
amplitude. To ensure optimal performance, the output signal
should be delayed by no more than 40milliseconds from the
actual QRS complex. For direct, patient-connected ECG
signals, the R-wave amplitude must be between 0.5 and
5.0millivolts.
34
Guide to Operation
Finally, plug the ECG cable into the patient module’s direct
ECG connection socket. This is a standard three-lead ECG
connector; a Nellcor-approved three-lead ECG cable should be
used.
35
Guide to Operation
RA I LA
II III
LL
36
Guide to Operation
Should problems arise during any test procedure, first check all
connections. If that does not resolve the problem, contact
qualified service personnel or your local Nellcor representative.
37
Guide to Operation
1. Press and hold the LOW SAT and HIGH RATE buttons
simultaneously. The flashing numbers in the OXYGEN
SATURATION display are the last two digits of the
existing year. While pressing and holding the buttons, turn
the control knob until the display shows the correct year.
Release the buttons and repeat this step for month, day,
hour, and minute.
The N-200 sets the year, month, day, hour, and minute
sequentially. If more than 5 seconds elapse between any of
the steps listed above, the changes made so far are stored
and the N-200 starts the sequence again (beginning with
year).
Trends
Oxygen saturation and pulse rate measurements are sampled
every second and the average of the sampled values is
computed every 5seconds. That average is then stored in the
trend memory. Up to 12hours of this data can be stored. Both
trend and event data can be printed in graphic form with either
high or low resolution, or output to an external device capable
of printing ASCII characters or processing and formatting data.
38
Guide to Operation
39
Guide to Operation
Occurrence Marker
Alarm-limit event L
User-defined event E
Power turned off P
Pulse signal is lost S
Clock is reset C
Signal is acquired A
If events are very frequent and too closely spaced so that all
four lines of text are filled, some identifiers do not print;
however, all events are still identified by tick marks. If more
than 60 events occurred during the period of time covered by
the trend memory, only the last 60 will be identified by type of
event and time of occurrence. The remaining events are
identified only by tick marks on the horizontal axis.
Additionally, there is a limit of 60 minutes of data that can be
stored in event memory, regardless of the number of events.
40
Guide to Operation
41
Guide to Operation
Occurrence Marker
42
Guide to Operation
Events
The event memory stores a snapshot of concurrent oxygen
saturation, pulse rate, and pulse amplitude measurements.
During the snapshot, measurements are obtained once every
second, resulting in a data display that has higher resolution
than the trend memory. Up to 1 hour of event data may be
stored. Both trend and event data can be printed in graphic
form with either high or low resolution, or output to an
external device capable of printing ASCII characters or
processing and formatting data. See the Connecting to Other
Instruments section for further information on available
formats.
There are two kinds of events: limit events that occur each time
the saturation or pulse rate moves beyond the established
limits, and user-defined events that the operator initiates.
User-Defined Events
43
Guide to Operation
Limit Events
To set event limits that differ from the alarm limits, the N-200
must be operating on AC power. Press and hold the applicable
alarm button (HIGH SAT, LOW SAT, HIGH RATE, or LOW
RATE) and the rear-panel EVENT button; while continuing to
press and hold the buttons, turn the control knob until the
desired setting appears in the display. The saturation event
limits may be set for any value from 20% to 100%, and the
pulse rate event limits may be set for any value from 20 to
250beats per minute.
When the N-200 is turned off and back on again, the event
limits are reset to the alarm-limit values.
44
Guide to Operation
45
Guide to Operation
46
Guide to Operation
The identifiers for events are the same as those printed on the
ThinkJet output: a letter that indicates the type of event, and
the hour and minute at which the event started.
47
Guide to Operation
Occurrence Marker
48
Guide to Operation
To Erase the Stored Trend and Event Data: press and hold
the HIGH SAT and HIGH RATE buttons (CLr t E appears in
the display); at the same time, turn the control knob to the
right until ALL clr appears in the display. Then release the
buttons. The contents of both memories will be erased.
When the memories are disabled, the operator can still trigger
a user-defined event, as previously described.
When the N-200 is turned off and back on again, the memories
are made active again.
Communications Formats
Of the nine RS-232 formats used with the N-200, six produce
ASCII trend and event data output (Full, Conditional Full,
Computer, Alternate Computer, Conversation, and Beat-to-
Beat). Conversation format is recommended for accessing trend
and event data.
49
Guide to Operation
or
50
Guide to Operation
51
Guide to Operation
<STX>RnnnSnnnPnnnLnnnHnnnOnnnAnnnMnnnTnnnnnn
Qnnn<CR><LF><ETX><CHKSM><ETX>
<STX>RnnnSnnnPnnnLnnnHnnnOnnnAnnnMnnnTnnnnnn
Qnnn<CR><LF><CHKSM><ETX>
R= Pulse Rate
S= Saturation %
P= Pulse Amplitude (current sample)
L= Low Rate Alarm Limit
H= High Rate Alarm Limit
O= Low Saturation Alarm Limit
A= Alarm Status in ASCII-coded decimal: logic 1 = alarm
condition
Bit 0 = High Rate
Bit 1 = Low Rate
Bit 2 = Low Sat
Bit 3 = High Sat
For example, ASCII 005 = binary 0101 = low sat and high rate
alarms.
52
Guide to Operation
T = Time hhmmss
Q = High Saturation Alarm Limit
n = ASCII character, normally a number
Conversation Format
In this mode, the output is a single parameter, sent by request
only. For example, the computer requests the current pulse
rate by sending an R. The interface responds with
STX/Rnnn/CR/LF where (nnn is the pulse rate). Other request
codes are listed in the preceding section.
Beat-to-Beat Format
This mode transmits saturation and pulse rate data once per
beat in the following format:
STXRnnnSnnnCRLF
53
Guide to Operation
N-200 Responds: < STX > W < CRLF > < ETX > — Sent once
when command received.
Z, W, [Y] *
< STX > E < CRLF > < ETX > — End of data,
normal completion
N-200 Responds: < STX > X < CRLF > < ETX > — Sent once
when command received.
Z, X, [Y] *
54
Guide to Operation
< STX > E < CRLF > < ETX > — End of data,
normal completion
N-200 Responds: < STX > V128< CRLF > < ETX > — Sent once
when command received.
Note: The Y data packets may occur at any time during the
trend or event dump. The positions of the Y packets
indicate when the associated event occurred.
55
Guide to Operation
E Packet < STX > E < CRLF > < ETX >
V Packet < STX > Vnnn < CRLF > < ETX >
This is sent only if the N-200 stops before the requested data
transmission is complete. It indicates why the N-200 stopped.
4 Timeout error
8 Data error
16 Timed out error
32 Communications lost
64 Data recall error
128 By operator request
These are the actual trend data points. Data is sampled every
second, so each packet represents 5 seconds of saturation and
pulse rate data.
These are the actual event data sampled every second. There is
no averaging, so each packet represents 1 second of saturation,
pulse rate, and pulse amplitude data.
56
Guide to Operation
Y Packet < STX > YnDnnnnnnnn < CRLF > < ETX >
Yn Event Type
0 User-defined event
1 Alarm limit exceeded
2 Patient signal lost
3 Unused
4 Time mark (on hour for trend, on min for event)
5 Power turned off
6 Patient signal acquired
7 Clock reset
57
Guide to Operation
Interface/Powerbase
58
Guide to Operation
Battery Operation
59
CONNECTING TO OTHER INSTRUMENTS
Overview
RS-232 Communication Protocol
Connecting the N-7000 Interface
Connecting the N-7500 Network
Connecting the N-9000 Recorder/Interface
Connecting Other Strip-Chart Recorders
Connecting the ThinkJet Printer
Connecting the P-200 Printer
OVERVIEW
61
Connecting to Other Instruments
Output Output
Connector Signal Device Device
Pin Direction Pin Signal
2 Rx data ← 2 Tx data
3 Tx data → 3 Rx data
4 DTR → 6 DSR
6 DSR ← 4 RTS
7 RTS → 5 CTS
8 CTS ← 20 DTR
62
Connecting to Other Instruments
Communications Formats
* Up or down
** This feature is only available for monitor and powerbase software
versions 2.5.0 and higher.
63
Connecting to Other Instruments
* Up or down
*** This feature is only available for monitor and powerbase software
versions 2.7.3 and higher.
64
Connecting to Other Instruments
7 8
1200 Down Down
2400 Down (off) Up
9600 Up (on) Down
19200 Up (on) Up
65
Connecting to Other Instruments
66
Connecting to Other Instruments
To print oxygen saturation and pulse rate, use the SAT and
RATE connectors. Use the ZERO and FULL buttons to
generate zero and full-scale voltage signals in order to adjust
the recorder controls.
67
Connecting to Other Instruments
1. Set the N-200’s baud rate to 19.2 K using the baud rate
switches: 7 and 8 up.
68
Connecting to Other Instruments
69
MAINTENANCE
Service
Cleaning
Battery Testing
Determining Software Version
Technical Assistance
Returning the N-200
SERVICE
CLEANING
BATTERY TESTING
71
Maintenance
TECHNICAL ASSISTANCE
72
Maintenance
73
TROUBLESHOOTING
Status Messages
Troubleshooting Guide
STATUS MESSAGES
This section lists status messages, along with the actions that
the operator should take. If the recommended actions do not
cause the message to disappear, contact qualified service
personnel or your local Nellcor representative. The service
manual describes additional suggested actions for use by
qualified service personnel.
ALL clr
Trend and event memory has been erased.
Note: When ALL clr appears because the memory data was
corrupted or erased, a simultaneous 5-second alarm
sounds.
CLr t E
Stored trend and event data has been erased by the operator.
75
Troubleshooting
Err Pb
The powerbase is not communicating with the N-200.
Disconnect the powerbase from AC power, turn the N-200 off
and back on again, and reconnect the powerbase to AC power.
If this does not solve the problem, contact qualified service
personnel.
Err 1
Defective data memory. Contact qualified service personnel.
Err 2
Defective program memory. Contact qualified service
personnel.
Err 3
Err 4
The N-200 lost power without going through the normal
shutdown procedure. Turn the ON/STDBY switch to STDBY
and back to ON. Contact qualified service personnel if error
persists.
76
Troubleshooting
Err 5
Hardware error. Contact qualified service personnel.
Err 6
Battery-backed memory contents have been lost, and the trend
memory was erased and reinitialized. The trend memory
operates normally as long as the N-200 is turned on, but when
the ON/STDBY switch is set to STDBY, the trend memory will
be erased. Contact qualified service personnel.
Note: This message may also appear briefly when the N-200
is first turned on after software has been replaced with
a different version. No action is required.
t E On
Trend memory is active.
t E diS
Trend memory is disabled.
TROUBLESHOOTING GUIDE
77
Troubleshooting
• Check AC fuse.
• Check fuse.
78
Troubleshooting
79
Troubleshooting
80
Troubleshooting
81
Troubleshooting
10. Displayed pulse rate does not agree with that of ECG
monitor.
82
Troubleshooting
83
Troubleshooting
84
SPECIFICATIONS
Performance
ECG
Environmental Conditions
Electrical Characteristics
Physical Characteristics
PERFORMANCE
Range
Saturation
0–100%
Pulse Rate
20–250 bpm (beats per minute)
85
Specifications
1, 2
Accuracy and Motion Tolerance
Saturation
Without Motion—Adults: 70 to 100% ±2 digits
3
Without Motion—Neonate : 70 to 100% ±3 digits
3
With Motion—Adults and Neonates : 70 to 100% ±3 digits
4,5
Low Perfusion : 70 to 100% ±2 digits
Pulse Rate
5
Without Motion 20 to 250 bpm ±3 digits
With Motion normal physiologic range
(55 – 125 bpm) ±5 digits
4,5
Low Perfusion 20 to 250 bpm ±3 digits
1
Applicability: D-25, D-25L, and N-25 sensors.
2
Definition of Nellcor Standard Motion:
Tapping: 1-2 cm amplitude at an aperiodic* frequency between 1-4 Hz
Rubbing: 1-2 cm amplitude at an aperiodic* frequency between 1-4 Hz
(*Note: “aperiodic” is a randomly changing frequency)
3
Adult specification is shown for D-25 and N-25 sensors with the N-200. Neonate specification
shown for N-25 sensors with the N-200. Validation testing of D-25 and N-25 sensors was
conducted on adult volunteers. Saturation accuracy will vary by sensor type. Refer to the Sensor
Accuracy Grid.
4
Definition of Low Perfusion:
Low perfusion in the context of oximetry is generally used to mean that the detected signal
modulation (pulsatility) is low at the monitoring site. Low percent modulation is defined as a value
of 1.5% modulation or less for the infrared (IR) signal.
51
Specification applies to monitor performance and was validated with Biotek and Nellcor
simulators.
86
Specifications
ECG
Input
Defibrillator protected, differential; Lead II only
Bandwidth
0.5–40 Hz (monitoring bandwidth)
CMRR
Greater than 100 dB at 50 or 60 Hz with 5 kilohms source
imbalance
Input Range
±0.5-5.0 mV for QRS detection
Input Impedance
greater than 10 megohms
Input
Defibrillator sync or ECG output waveform from bedside ECG
monitor. Defibrillator protected, differential, standard Lead II
configuration. For optimum performance, waveform with
positive deflection recommended.
Input Range
±0.5 V minimum input signal; should not exceed ±15 V.
Minimum of 10 ms wide at 50% of peak amplitude, delayed by
no more than 40 ms from actual QRS complex.
87
Specifications
RS-232
Connector: 9-pin D-type, subminiature, female
Fiber-optic transmitter
Baud rate: 2400
Outputs
SpO2, Pulse Rate, Pulse Wave
Output/Input
ECG wave out or ECG wave/defib sync input
Voltage
0–1 V or 0–10 V (switch-selectable)
Range Set
SpO2 0–100% or SpO2 50–100% (switch-selectable)
Accuracy
±20 mV at zero, ±0.5% of full scale, referred to front-panel
display
ENVIRONMENTAL CONDITIONS
Temperature
N-200
41–107.6°F (5–42°C) operating
32–122°F (0–50°C) storage
88
Specifications
Sensor
Within physiologic range 82.4–107.6°F (28–42°C) for accurate
measurement.
Humidity
Altitude
0–10,000 ft (0–3,048 m)
ELECTRICAL CHARACTERISTICS
Protective Class
Degree of Protection
Voltage
Power Consumption
Maximum rating: 25 VA
Leakage Current
89
Specifications
Battery
Type
Lead-acid battery pack, 2.4 AH
Battery Life
90 minutes typical on new, fully charged battery; age and
usage affect battery performance.
Recharge Period
14 hours minimum; 80% charge after 8 hours
Charger Type
Float voltage, 450 mA current limit
PHYSICAL CHARACTERISTICS
Dimensions
N-200 only
2.5 high x 10 wide x 7 in. deep (64 x 254 x 178 mm)
With powerbase
6.5 high x 10 wide x 10 in. deep (165 x 254 x 254 mm)
Weight
N-200 only
5 lb (2.3 kg)
With powerbase
8 lb (3.7 kg)
Patient Module
Cable length
13 ft (4 m) cable (C-13-200, C-13-200M)
20 ft (6 m) cable (C-20-200)
Connector
Lemo B-series, mates with 12-pin connector on N-200 front
panel
90