Nellcor OXIMAX N-595 User manual

N-595
Pulse Oximeter
Operator’s Manual

Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor,
OxiCliq, Dura-Y, MAX-FAST, and OXIMAX are trademarks of Nellcor Puritan Bennett Inc.
This ISM device complies with Canadian ICES-001.
Cet appareil ISM est conforme à la norme NMB-001 Canada.
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; and 5,853,364.

N-595 i
Contents
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi
Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi
Safety Information and Introduction
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings ...........................................................................................1
Cautions ............................................................................................2
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended Use for the N-595 ...............................................................5
How to Use this Manual ....................................................................6
Using the N-595
Description of Controls, Indicators, and Symbols . . . . . . . . . . . . . . . . . . . . . . 7
Identification of Front Panel Buttons and Symbols ...........................7
Identification of Rear Panel Components ..........................................8
N-595 Symbols ..................................................................................8
Description of Controls ......................................................................9
Description of Displays and Indicators ............................................10
Description of Audible Indicators .....................................................14
Setting up the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
List of Components .........................................................................17
Connecting the N-595 to AC Power ................................................17
Connecting an OXIMAX Sensor to the N-595 ..................................19
Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operating the N-595 on Battery Power ...........................................21
Low Battery Indicator ......................................................................22
Using the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Introduction ....................................................................................27

Contents
ii
Turning On the Monitor ................................................................... 29
OXIMAX Sensor Attached ..................................................... 31
No OXIMAX Sensor Attached ................................................ 33
Turning the Backlight On or Off ...................................................... 34
Adjusting Screen Contrast .............................................................. 34
Selecting the Pleth View ................................................................. 34
Selecting the Blip View ................................................................... 35
Setting the Pulse Beep Volume ...................................................... 36
Setting the Alarm Volume ............................................................... 36
Setting the Date and Time .............................................................. 37
Setting Alarm Silence Duration ....................................................... 38
Disabling Audible Alarms ................................................................ 39
Selecting Standby Mode ................................................................. 41
Adult-Pediatric or Neonatal Settings ............................................... 42
Setting Patient Adult-Pediatric/Neonatal Mode .................... 42
Alarm Limit Changed Indicator ....................................................... 44
Setting Alarm Limits ........................................................................ 44
Setting SatSeconds Alarm Limit ..................................................... 46
Setting Monitor Response Mode .................................................... 47
Selecting the Display Language ..................................................... 48
OXIMAX Sensor Messages .............................................................. 49
OXIMAX Sensor Adjust Condition Messages ........................ 50
OXIMAX Sensor Adjust Messages ........................................ 51
Monitor Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Monitor Trend Data ........................................................................ 53
Trend Data Operation ........................................................... 55
Selecting the Trend Data Display Scale ......................................... 55
Reading the Trend Data Display ..................................................... 57
Dual Trend Data Display ................................................................. 58
SpO2 Trend Display ....................................................................... 59
Pulse Rate Trend Display ............................................................... 59
Histogram Trend Data Display ........................................................ 60
Pulse Amplitude Trend Data Display .............................................. 61
Clearing Trend Information ............................................................. 62
Sensors and Accessories
OXIMAX Sensor Event Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Setting In-Sensor Data Type .......................................................... 66
OXIMAX Sensor Type ...................................................................... 68
OXIMAX Sensor Data Type ............................................................. 68
OXIMAX Sensor Event Record Data Available ................................ 69

Contents
N-595 iii
OXIMAX Sensor Event Record Not Available ..................................70
OXIMAX Sensor Event Record Graphical Data ................................71
Viewing and Printing OXIMAX Sensor Event History Data ...............73
OXIMAX Sensor Tabular Event Data ...............................................75
Viewing and Printing In-Sensor Tabular Event History Data ...........76
Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Printing Monitor Trend Information ..................................................79
Monitor Trend Data in ASCII Mode .................................................81
Trend Data in Graph Mode .............................................................82
Real-Time Display/Printout Format .................................................83
Column Headings .................................................................85
Data Source ..........................................................................85
Software Version ..................................................................85
Alarm Limits ..........................................................................86
Monitor Mode ........................................................................86
Response Mode ....................................................................86
Data Column Headings .........................................................87
Time ......................................................................................87
Patient Data ..........................................................................87
Operating Status ...................................................................88
Using the Data Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Overview .........................................................................................91
Connecting to the Data Port ............................................................91
Data Port Pinouts ..................................................................92
Data Port Setup ...............................................................................93
Using the Nurse Call Interface ........................................................95
Setting Nurse Call RS-232 Polarity .......................................96
Setting Nurse Call Relays Normally Open/Closed ................97
Calculating the Analog Voltage Output ...........................................97
OXIMAX Sensors and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
OXIMAX Sensor Event Record Data ................................................99
Selecting an OXIMAX Sensor ...........................................................99
OXIMAX Sensor Features ..............................................................103
Biocompatibility Testing ................................................................103
Optional Accessories ....................................................................103
GCX Mounting Plate ...........................................................105
GCX Poly-Mount (vertical wall mount with
19-inch channel) ...........................................................106
GCX Poly-Mount (horizontal wall mount with rail adapter) .107
GCX Poly-Mount Roll Stand ...............................................108
GCX Utility Basket ..............................................................109

Contents
iv
Soft-Sided Carrying Case ................................................... 110
Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Performance Verification .............................................................. 111
N-595 Monitor Performance Considerations ................................ 111
Dysfunctional Hemoglobins ................................................ 112
Anemia ............................................................................... 112
Saturation ........................................................................... 112
Pulse Rates ........................................................................ 112
OXIMAX Sensor Performance Considerations .............................. 113
Troubleshooting
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117
Error Codes .................................................................................. 117
Prompts and Error Messages ....................................................... 119
Corrective Action .......................................................................... 122
EMI (Electro-magnetic Interference) ............................................. 125
Obtaining Technical Assistance .................................................... 126
OXIMAX Sensor Message Setup ................................................... 127
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Returning the N-595 ..................................................................... 129
Service .......................................................................................... 129
Periodic Safety Checks ................................................................. 130
Cleaning ........................................................................................ 130
Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
N-595 Menu Description ............................................................... 131
Technical Information
SatSeconds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
Describing SatSeconds ................................................................ 135
SatSeconds “Safety Net” .............................................................. 137
SatSeconds Display ...................................................................... 137
Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
Neonate Default Settings .............................................................. 139
Adult Default Settings ................................................................... 140

Contents
N-595 v
Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Oximetry Overview .......................................................................143
Automatic Calibration ..........................................................144
Functional versus Fractional Saturation .............................144
Measured versus Calculated Saturation .............................145
OXIMAX Technology ......................................................................145
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Performance .................................................................................147
Electrical ........................................................................................148
Environmental Conditions .............................................................149
Physical Characteristics ................................................................151
Compliance ...................................................................................152
Manufacturer’s Declaration ...........................................................155
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Contents
vi
Figures
Figure 1: Front Panel Buttons and Symbols .............................7
Figure 2: Rear Panel Components ...........................................8
Figure 3: ASCII Mode Printout ...............................................82
Figure 4: Graph Mode Printout ...............................................83
Figure 5: Real-Time Printout ...................................................84
Figure 6: Data Port Pin Layout ................................................93
Figure 7: GCX Mounting Plate ..............................................105
Figure 8: GCX Poly-Mount (vertical wall mount with
19-inch channel) ....................................................106
Figure 9: GCX Poly-mount (horizontal wall mount with
rail adapter) ............................................................107
Figure 10: GCX Poly-mount Roll Stand ..................................108
Figure 11: GCX Utility Basket .................................................109
Figure 12: Soft-Sided Carrying Case ......................................110
Figure 13: Alarm Response with SatSeconds ........................136
Figure 14: Oxyhemoglobin Dissociation Curve .......................145

Contents
N-595 vi
Tables
Table 1: Audible Indicators ....................................................14
Table 2: Low Battery and Critical Battery ..............................23
Table 3: Parameter Ranges ...................................................27
Table 4: Reading Trend Display ............................................57
Table 5: Data Port Pinouts .....................................................92
Table 6: Analog Pinouts .........................................................97
Table 7: Nellcor OXIMAX Sensor Models and
Patient Sizes ..........................................................101
Table 8: OXIMAX Sensor Features .....................................103
Table 9: Error Codes ...........................................................118
Table 10: Prompt/Error Messages .........................................120
Table 11: Neonate Factory Defaults ......................................139
Table 12: Adult Factory Defaults ...........................................140
Table 13: Electromagnetic Emissions ....................................155
Table 14: Electromagnetic Immunity .....................................156
Table 15: Electromagnetic Immunity, RF Portable
Equipment ..............................................................159
Table 16: Recommended Separation Distances ...................161
Table 17: Cables ....................................................................162

N-595 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: The sensor extrapolates from the date and time
provided by the N-595 when recording the sensor event record to
the sensor. The accuracy of the date/time is the responsibility of
the N-595. It is recommended that the N-595 user set the time/
date to the correct value before a sensor event record-enabled
sensor is connected, and that this date/time not be changed while
the sensor remains connected. Since a sensor with sensor event
record data can be transported from one monitor to another,
having discrepancies in the date/time between monitors and the
sensor event record data will affect the order the sensor event
record data appears. To eliminate this possible problem, all
monitors within an institution should be set to the same time.
WARNING: Explosion hazard. Do not use the N-595 pulse
oximeter in the presence of flammable anesthetics or gases.
WARNING: Chemicals from a broken LCD display panel are
toxic when ingested. Use caution when handling a pulse oximeter
with a broken display panel.

Safety Information
2
WARNING: Pulse oximetry readings and pulse signals can be
affected by certain environmental conditions, OXIMAX sensor
application errors, and certain patient conditions. See the
appropriate sections of this manual for specific safety
information.
WARNING: The use of accessories, sensors, and cables other
than those specified may result in increased emission and/or
decreased immunity and inaccurate readings of the N-595 pulse
oximeter.
WARNING: Failure to cover the OXIMAX sensor site with opaque
material in high ambient light conditions may result in inaccurate
measurements.
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-595 pulse oximeter.

Safety Information
N-595 3
Caution: When connecting the N-595 to any instrument, verify
proper operation before clinical use. Both the N-595 and the
instrument connected to it must be connected to a grounded
outlet. Accessory equipment connected to the pulse oximeter’s
data interface must be certified according to IEC Standard 950
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-595 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-595 accuracy may degrade if it is connected to
secondary I/O devices when the instrument is not connected to
earth reference.
Caution: Federal law (U.S.A.) restricts this device to sale by or on
the order of a physician.
Caution: Dispose of battery in accordance with local
requirements and regulations.

N-595 5
Introduction
WARNING: The N-595 is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and
symptoms.
Intended Use for the N-595
The N-595 pulse oximeter is indicated for the continuous
non-invasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate. The N-595 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.
Home Care use is defined as managed/used by a lay person
(parent or other similar non-critical caregiver) in the home
environment.
Use with any particular patient requires the selection of an
appropriate oxygen OXIMAX sensors as described in this
Operator's Manual.

Introduction
6
Motion performance claims are applicable to models MAX-A,
MAX-AL, MAX-P, MAX-N, and MAX-I Nellcor OXIMAX TM
oximetry sensors.
How to Use this Manual
All users should read this manual thoroughly. More experienced users
of the N-595 will be able to go to the topics for the information they
require.
The current copy of this manual is available on the internet at:
http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

N-595 7
Description of Controls, Indicators,
and Symbols
Identification of Front Panel Buttons and Symbols
Figure 1: Front Panel Buttons and Symbols
1. SpO2 OXIMAX Sensor Port, page 19 12. ADJUST DOWN Button, page 10
2. AC Power Indicator, page 12 13. Neonate Mode Indicator, page 13
3. ON/STANDBY Button, page 9 14. CONTRAST Button, page 10
4. Low Battery Indicator, page 12 15. Fast Response Mode Indicator, page 13
5. Waveform Display, page 10 16. Softkeys, page 10
6. SatSecondsTM Indicator, page 13 17. Menu Bar, page 10
7. %SpO2 Display, page 12 18. Data In Sensor Indicator, page 13
8. Pulse Rate Display, page 12 19. Motion Indicator, page 12
9. Alarm Silence Indicator, page 12 20. Pulse Search Indicator, page 13
10. ALARM SILENCE Button, page 9 21. Speaker
11. ADJUST UP Button,page 10

Description of Controls, Indicators, and Symbols
8
Identification of Rear Panel Components
Figure 2: Rear Panel Components
N-595 Symbols
The symbols that are located on the rear panel of the N-595 are as
follows:
See Instructions for Use
Fuse Replacement
1. Equipotential Terminal (Ground) 4. Fuse Holder
2. AC Power Connector, page 17 5. Supply Voltage Selector Switch, page 17
3. Data Port Connector, page 91

Description of Controls, Indicators, and Symbols
N-595 9
Equipotential Terminal (ground)
Date of Manufacture
Data Interface
There is one symbol located on the front panel of the N-595.
Type BF Applied Part -Not defibrillator proof.
Description of Controls
Note: A button press, except the ON/STANDBY button, should
result in either a valid or an invalid key tone (refer to Table 1
on page 14). If the key pressed fails to emit a tone, contact
qualified service personnel.
The ON/STANDBY button. Used to turn the N-595 monitor on or off.
The ALARM SILENCE button. Used to silence current alarms forthe
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.

Description of Controls, Indicators, and Symbols
10
The ALARM SILENCE button clears “SENSOR OFF,” “LOW
BATTERY,” and “SENSOR DISCONNECT” messages from the
display.
The ADJUST UP button. Used to increase variable parameters of the
monitor.
The ADJUST DOWN button. Used to decrease variable parameters
in the monitor.
The CONTRAST button. Used in conjunction with the ADJUST UP
and ADJUST DOWN buttons to lighten or darken the display screen.
The softkey buttons have multiple uses depending on the legend
displayed above the button.
Description of Displays and Indicators
The type of display is user selectable. Refer to Selecting the Pleth
View on page 34.
The pleth display includes a “wiper bar” plethysmographic
waveform, menu bar, and current measured %SpO2and pulse rate. If
SatSeconds are enabled, the pleth display includes the SatSeconds
indicator and SatSeconds setting. A decimal point after the %SpO2or