Nellcor OxiMax N-550 User manual

N-550
Pulse Oximeter
Operator's Manual
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SpO2
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N-550
SatSeconds
SpO2

This ISM device complies with Canadian ICES-001.
Cet appareil ISM est conforme à la norme NMB-001 Canada.
Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor,
OxiCliq, OxiBand, Dura-Y, MAX-FAST, SatSeconds, PediCheck, Oxismart and OXIMAX are
trademarks of Nellcor Puritan Bennett Inc.
To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department,
or your local representative.
Purchase of this instrument confers no express or implied license under any Nellcor Puritan
Bennett patent to use the instrument with any sensor that is not manufactured or licensed by
Nellcor Puritan Bennett.
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; Re. 35,122; 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136;
5,351,685; 5,368,026; 5,485,847; 5,533,507; 5,662,106; 5,853,364, and 6,083,172.

N-550 i
Contents
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings .................................................................................1
Cautions ..................................................................................1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended Use for the N-550 .....................................................3
Description of Controls, Indicators, and Symbols . . . . . . . . . . . . . 5
Identification of Front Panel Buttons and Symbols ..................5
Identification of Rear Panel Components ................................6
N-550 Symbols ........................................................................7
Description of Controls ............................................................8
Description of Displays and Indicators ....................................9
Description of Audible Indicators ...........................................11
Setting up the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
List of Components ...............................................................14
Connecting the N-550 to AC Power ......................................15
Connecting a Sensor to the N-550 ........................................16
Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Operating the N-550 on Battery Power .................................17
Low Battery Indicator .............................................................18
Using the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Turning on the Monitor ..........................................................19
Sensor Attached ..........................................................22
No Sensor Attached .....................................................23
Sensor Message ...................................................................24

Contents
ii
Setting the Pulse Beep Volume ............................................25
Setting the Alarm Volume .....................................................26
Setting Alarm Silence Duration .............................................26
Disabling Audible Alarms ......................................................28
Verify Patient Settings ...........................................................29
Alarm Limits Changed Indicator ............................................31
Setting Alarm Limits ..............................................................31
Setting SatSeconds Duration ................................................33
Setting the Data Port Baud Rate ...........................................34
Setting the Data Port Protocol ..............................................35
Clearing Trend Information ...................................................36
Monitor Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Trend Data Operation ...........................................................39
Trend Data ............................................................................40
#1: Trend Print .............................................................40
#2: Trend Clear ............................................................40
#3: Not Used ................................................................40
#4: Baud Rate ..............................................................41
#5: Data Port Printout ..................................................41
Option 1 ..............................................................41
Option 2 ..............................................................41
Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Printing Monitor Real-Time Data ...........................................43
Trend Data Printout ...............................................................45
Column Headings ........................................................46
Data Source .................................................................46
Device/Software Revision Level ..................................46
Alarm Limits .................................................................47
Monitor Mode ...............................................................47
Data Column Headings ...............................................47
Time .............................................................................48
Patient Data .................................................................48
Operating Status ..........................................................48

Contents
N-550 iii
Using the Data Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Overview ...............................................................................51
Connecting to the Data Port ..................................................51
Data Port Pinouts ..................................................................52
Sensors and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Selecting a Sensor ................................................................55
Biocompatibility Testing .........................................................57
Optional Accessories .............................................................57
Foot Switch ..................................................................58
Pole Mount Bracket ......................................................58
Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Performance Verification .......................................................59
N-550 Performance Considerations ......................................59
Dysfunctional Hemoglobins .........................................60
Anemia .........................................................................60
Saturation .....................................................................60
Pulse rates ...................................................................60
Sensor Performance Considerations ....................................60
Operator’s Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Error Codes ...........................................................................65
Corrective Action ...................................................................65
EMI (Electro-magnetic Interference) .....................................68
Obtaining Technical Assistance ............................................69
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Returning the N-550 ..............................................................71
Service ..................................................................................71
Periodic Safety Checks .........................................................72
Cleaning ................................................................................72
Technical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Description of Alarms ............................................................73

Contents
iv
Factory Defaults ....................................................................73
SatSeconds Display ..............................................................75
Describing SatSeconds .........................................................75
SatSeconds “Safety Net” ......................................................77
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Oximetry Overview ................................................................79
Automatic Calibration ............................................................80
Functional versus Fractional Saturation ................................81
Measured versus Calculated Saturation ...............................81
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Performance .........................................................................83
Electrical ...............................................................................84
Environmental Conditions .....................................................85
Physical Characteristics ........................................................87
Compliance ...........................................................................87
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

Contents
N-550 v
Figures
Figure 1: Front Panel Buttons and Symbols ......................5
Figure 2: Rear Panel Symbols ..........................................6
Figure 3: Real-Time Data Printout ...................................44
Figure 4: Trend Data Printout ..........................................45
Figure 5: Data Port Pin Layout ........................................53
Figure 6: Alarm Response with SatSeconds ...................77
Figure 7: Oxyhemoglobin Dissociation Curve .................82

Contents
vi
Tables
Table 1: Data Port Pinouts .............................................52
Table 2: Sensors by Model Number and Patient Size ... 56
Table 3: Operator’s Menu ..............................................63
Table 4: Factory Default Settings ..................................73

N-550 1
Safety Information
Warnings
Warnings are identified by the WARNING symbol shown above.
Warnings alert the user to potential serious outcomes (death, injury, or
adverse events) to the patient or user.
WARNING: Explosion hazard. Do not use the N-550 pulse
oximeter in the presence of flammable anesthetics or gases.
WARNING: Pulse oximetry readings and pulse signals 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: Ensure that the speaker is clear of any obstruction.
Failure to do so could result in an inaudible alarm tone.
Cautions
Cautions are identified by the CAUTION symbol shown above.
Cautions alert the user to exercise care necessary for the safe and
effective use of the N-550 monitor.

Safety Information
2
CAUTION: When connecting the N-550 to any instrument,
verify proper operation before clinical use. Both the N-550 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 60950 for
data-processing equipment or IEC Standard 60601-1 for
electromedical equipment. All combinations of equipment must
be in compliance with IEC Standard 60601-1-1 systems
requirements. Anyone who connects additional equipment to the
signal input port or signal output port (N-550 data port
connector) configures a medical system and is therefore
responsible for ensuring that the system complies with the
requirements of system standard IEC Standard 60601-1-1 and
the electromagnetic compatibility system standard IEC Standard
60601-1-2. The N-550 accuracy may degrade if it is connected to
secondary I/O devices when the instrument is not connected to
earth reference.
CAUTION: Do not lift the monitor by the sensor cable or power
cord because the cable or cord could disconnect from the monitor,
causing damage to the monitor or injuring the patient.
CAUTION: Federal law (U.S.A.) restricts this device to sale by or
on the order of a physician.

N-550 3
Introduction
WARNING: The N-550 is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and
symptoms. Do not make any clinical judgments based on the
oximeter's measurements only.
Intended Use for the N-550
The N-550 Pulse Oximeter is indicated for the continuous
non-invasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate. The N-550 is intended for use
with neonatal, pediatric, and adult patients during both no-motion and
motion conditions and for patients who are well or poorly perfused, in
hospitals, hospital-type facilities, intra-hospital transport, and home
environments. For prescription use only.
Note: Hospital use typically covers such areas as general care floors,
operating rooms, special procedure areas, intensive and critical
care areas, within the hospital plus hospital-type facilities.
Hospital-type facilities include physician office-based
facilities, sleep labs, skilled nursing facilities, surgicenters, and
sub-acute centers.
Intra-hospital transport includes transport of a patient within
the hospital or hospital-type facility.
Use with any particular patient requires the selection of an
appropriate oxygen transducer (sensor) as described in this
Operator's Manual.
Motion performance claims are applicable to models MAX-A,
MAX-AL, MAX-P, MAX-N, and MAX-I Nellcor OXIMAXTM
oximetry sensors.

(Blank Page)

N-550 5
Description of Controls, Indicators,
and Symbols
Identification of Front Panel Buttons and Symbols
Figure 1: Front Panel Buttons and Symbols
1. SpO2Sensor Port 11. SatSecondsTM Display
2. Power On/Off Button 12. SatSeconds Alarm Limit
Button
3. %SpO2Display 13. SpO2Alarm Limit Button
4. Pulse Amplitude
Indicator 14. Motion Indicator
5. Pulse Rate Display 15. Sensor Off Indicator
6. Alarm Silence Button 16. Sensor Message Indicator
7. Alarm Silence Indicator 17. Pulse Search Indicator
8. Adjust Up Button 18. Low Battery Indicator
9 Adjust Down Button 19. AC Power Indicator
10. Pulse Rate Alarm Limit
Button 20. Speaker

Description of Controls, Indicators, and Symbols
6
Identification of Rear Panel Components
Figure 2: Rear Panel Symbols
1. Data Port Connector 3. AC Power Connector
2. Foot Switch Connector 4. Equipotential Connector
(ground)

Description of Controls, Indicators, and Symbols
N-550 7
N-550 Symbols
The symbols that are located on the rear panel of the N-550 are as
follows:
The symbols that are located on the front panel of the N-550 are as
follows:
1. Data Interface 3. Foot Switch
2. Caution -Do not connect while
power is on 4. Equipotential Terminal (ground)
1. Type BF Applied Part -Not
Defibrillator Proof 5. Sensor Message
2. Pulse Rate 6. Pulse Search
3. Motion 7. Low Battery
4. Sensor Off 8. AC Power/Battery Charge

Description of Controls, Indicators, and Symbols
8
Description of Controls
The Power On/Off button is used to turn the N-550 monitor on or off.
Note: Each button press, except the Power On/Off button, should
result in either a valid or an invalid button tone. If the button
pressed fails to emit a tone, contact qualified service personnel.
The Alarm Silence button is 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 is used to increase alarm limit values, alarm
silence duration, pulse beep volume, alarm volume, and data port
baud rate. The Adjust Up button is used to select the communication
protocol and time settings.
The Adjust Down button is used to decrease alarm limit values, alarm
silence duration, pulse beep volume, alarm volume, and data port
baud rate. The Adjust Down button is used to select the
communication protocol, and time settings.
The SpO2Alarm Limit button is used to view the SpO2alarm limit.
When the SpO2Alarm Limit button is pressed at the same time as the
Pulse Rate Alarm Limit button, after three seconds, the menu options
are enabled.
The Pulse Rate Alarm Limit button is used to view the pulse rate
alarm limit. When the Pulse Rate Alarm Limit button is pressed at the
same time as the SpO2Alarm Limit button, after three seconds, the
menu options are enabled.

Description of Controls, Indicators, and Symbols
N-550 9
The SatSeconds Alarm Limit button is used to view the SatSeconds
alarm limit. When pressed the menu options are enabled. The Adjust
Up and Adjust Down buttons are used to change the SatSeconds limit
settings.
Description of Displays and Indicators
The Pulse Amplitude Indicator (blip bar). A 10-segment LED that
indicates pulse beat and shows the relative pulse amplitude. As the
detected pulse becomes stronger, more bars light with each pulse.
The %SpO2Display. Shows the saturation level of oxygenated
hemoglobin. The display value flashes zero during loss-of-pulse
alarms and flashes the SpO2value when the SpO2is outside the alarm
limits. During pulse search, the monitor continues to update the
display. If alarm limits have been changed from their power-on
defaults, a decimal point (.) is displayed after the SpO2value (100.).
The Pulse Rate Display. Shows the pulse rate in beats per minute. It
flashes zeros during loss-of-pulse alarms and flashes the beats per
minute value in red when the pulse rate is outside of the alarm limit.
During pulse search, the monitor continues to update the display.
Pulse rates outside of the pulse rate range (20 to 250 bpm) are
displayed as the closest value within the range. If alarm limits have
been changed from their power-on defaults, a decimal point (.) is
displayed after the pulse rate value (112.).
The AC Power Indicator. Lights continuously when the N-550 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 remain. The Low Battery indicator
flashes when the battery is critically low.

Description of Controls, Indicators, and Symbols
10
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.
The Motion Indicator. Lights continuously whenever the OxiSmart®
XL algorithm detects the presence of artifact independent of its
severity or the impact on the SpO2or pulse rate values. Whenever the
motion indicator and the pulse search indicator are simultaneously lit,
it is an indication that the artifact is significant and/or has been
persistent.
The Pulse Search Indicator. Lights continuously prior to initial
acquisition of a pulse signal and during prolonged and challenging
monitoring conditions. It flashes during a loss-of-pulse signal.
The Sensor Off/Signal Loss Indicator is lit when either the sensor is
invalid, or no longer on the patient’s finger. It usually indicates that
the sensor is not on the patient.
The Sensor Message Indicator. Lights when the monitor cannot
determine an SpO2level or a pulse rate. The Sensor Message
recommendations for improving the signal are:
• Reposition sensor
• Check or change adhesive wrap
• Choose alternate site
• Warm site
• Cover sensor
• Use forehead, nasal, or ear sensor (adult patients only)
•UseOXIMAX adhesive sensor
• Secure cable
• Secure with headband (MAX-FAST)
• Remove nail polish
• Loosen sensor (too tight)
• Isolate external interference (electrosurgical device, cell
phone)
• Clean site (MAX-R)

Description of Controls, Indicators, and Symbols
N-550 11
The SatSecondsTM Indicator. Fills in clockwise as the SatSeconds
alarm management approaches the SatSeconds alarm limit threshold.
When a SatSeconds setting other than OFF is selected, the green LED
at the top of the SatSeconds indicator will light. The green LED at the
12-o'clock position indicates that SatSeconds are engaged.
Description of Audible Indicators
Following are descriptions of N-550 audible indicators.
Power-On Self-Test
Pass A 1-second tone indicating that the N-550 has been turned on and has successfully
completed the power-on self-test
Valid Button Press A short, medium-pitched tone indicating
that an appropriate button has been
pressed
Invalid Button Press A short, low-pitched tone indicating that a
button has been pressed that is not
appropriate for the current state of the
monitor
High Priority Alarm A high-pitched, fast-pulsating tone
indicating loss of pulse with no patient
motion
Medium Priority
Alarm A medium-pitched, normal-pulsating tone indicating an SpO2or pulse rate limit
violation
Low Priority Alarm A low-pitched, slow-pulsating tone
indicating a sensor disconnect, low
battery, or monitor failure
Alarm Silence
Reminder Three beeps that sound approximately every 3 minutes when alarms are silenced
with the alarm silence duration set to OFF
Pulse Beep A single beep sounds for each detected
pulse. The pitch changes as monitored
SpO2values increase or decrease.
Volume Setting Tone A continuous tone that is used to adjust
the alarm volume

Description of Controls, Indicators, and Symbols
12
Confirmation Tone Three beeps sound to indicate that default
settings have been saved or reset to
factory defaults or trend data has been
deleted