Nellcor OxiMax N-550 User manual

N-550
Pulse Oximeter
Operator's Manual
/min
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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.