Nellcor OXIMAX N-595 User manual

Nellcor Puritan Bennett Inc. is an anaffiliate of Tyco Healthcare. Nellcor, Oxiband, Oxi 1-2-3, Durasensor,
OxiCliq, Dura-Y, 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; and 5,853,364.

Contents
N-595 i
Contents
Introduction .............................................................................................................................. 1
Warnings ....................................................................................................................1
Cautions ..................................................................................................................... 2
Manual Overview ........................................................................................................ 2
Description of N-595 Monitor ...................................................................................... 2
Related Documents .................................................................................................... 6
Routine Maintenance ...............................................................................................................7
Cleaning ..................................................................................................................... 7
Periodic Safety Checks .............................................................................................. 7
Functional Checks ...................................................................................................... 7
Battery ........................................................................................................................8
Performance Verification .........................................................................................................9
Introduction ................................................................................................................. 9
Equipment Needed ..................................................................................................... 9
Performance Tests ..................................................................................................... 9
Battery Charge ............................................................................................. 10
Power-Up Performance ............................................................................... 10
Operational Setup ........................................................................................ 15
General Operation ....................................................................................... 21
Pulse Oximetry Functional Tests ................................................................. 23
Safety Tests .............................................................................................................. 28
Power-On Settings and Service Functions ............................................................................29
Introduction ............................................................................................................... 29
Power-On Settings ................................................................................................... 29
Factory Default Settings ........................................................................................... 29
Neonate Default Settings ............................................................................. 29
Adult Default Settings .................................................................................. 30
Service Functions ..................................................................................................... 31
Accessing the Service Functions ................................................................. 31
Exit Softkey .................................................................................................. 33
Next Softkey ................................................................................................ 33
Param Softkey Menu ................................................................................... 33
Print Softkey Menu ...................................................................................... 34
Next Softkey Menu ...................................................................................... 37
Setting Institutional Defaults (Sample) ..................................................................... 40
Troubleshooting .....................................................................................................................43
Introduction ............................................................................................................... 43
How To Use This Section ......................................................................................... 43
Who Should Perform Repairs ................................................................................... 43
Troubleshooting Guide ............................................................................................. 43
Power ........................................................................................................... 44
Buttons ......................................................................................................... 45
Display/Alarms ............................................................................................. 46
Operational Performance ............................................................................. 47
Data Port ...................................................................................................... 48
Error Codes .............................................................................................................. 48
Other Messages .......................................................................................... 49
Disassembly Guide ................................................................................................................51
Introduction ............................................................................................................... 51

Contents
ii
Replacement Level Supported ................................................................................. 51
Prior to Disassembly ................................................................................................. 52
Fuse Replacement ................................................................................................... 52
Monitor Disassembly ................................................................................................ 53
Monitor Assembly ..................................................................................................... 54
Battery Replacement ................................................................................................ 55
Removal ....................................................................................................... 55
Replacement ................................................................................................ 56
Power Entry Module (PEM) Removal/Replacement ................................................. 56
Removal ....................................................................................................... 56
Replacement ................................................................................................ 57
Power Supply Removal/Replacement ...................................................................... 58
Removal ....................................................................................................... 58
Replacement ................................................................................................ 59
Cooling Fan Removal/Replacement ......................................................................... 60
Removal ....................................................................................................... 60
Replacement ................................................................................................ 61
Display PCB Removal/Replacement ........................................................................ 62
Removal ....................................................................................................... 62
Replacement ................................................................................................ 63
User Interface PCB Removal/Replacement ............................................................. 64
Removal ....................................................................................................... 64
Replacement ................................................................................................ 65
Alarm Speaker Removal/Replacement ..................................................................... 66
Removal ....................................................................................................... 66
Replacement ................................................................................................ 67
Spare Parts ............................................................................................................................69
Introduction ............................................................................................................... 69
Obtaining Replacement Parts ................................................................................... 69
Parts List ................................................................................................................... 69
Packing for Shipment ............................................................................................................71
Introduction ............................................................................................................... 71
Returning the N-595 ................................................................................................. 71
General Instructions ................................................................................................. 71
Repacking in Original Carton .................................................................................... 71
Repacking in a Different Carton ............................................................................... 73
Specifications ........................................................................................................................75
Performance ............................................................................................................. 75
Electrical ................................................................................................................... 76
Environmental Conditions ......................................................................................... 76
Physical Characteristics ........................................................................................... 78
Compliance ............................................................................................................... 78
Manufacturer’s Declaration ....................................................................................... 80
Safety Tests .............................................................................................................. 86
Ground Integrity ........................................................................................... 86
Earth Leakage Current ................................................................................ 86
Enclosure Leakage Current ......................................................................... 87
Patient Applied Risk Current ........................................................................ 87
Patient Isolation Risk Current ...................................................................... 87
Data Port Interface Protocol ..................................................................................................89
Introduction ............................................................................................................... 89
Configuring the Data Port ......................................................................................... 89
Communication Baud Rate .......................................................................... 91
Communication Protocol .............................................................................. 91

Contents
N-595 iii
Language Selection ..................................................................................... 92
Nurse Call Setup .......................................................................................... 93
Analog Calibration Setup ............................................................................. 94
Agilent (HP) Communications ...................................................................... 95
SpaceLabs Communications ....................................................................... 95
Marquette Communications ......................................................................... 96
Datex-Ohmeda Communications ................................................................. 96
Connecting to the Data Port ..................................................................................... 97
Communication With a PC ....................................................................................... 98
Dump Instrument Info (Option 1) ................................................................. 99
Set Date and Time (Option 2) ...................................................................... 99
Dump Trend (Option 3) ................................................................................ 99
Dump Error Log (Option 4) ........................................................................ 100
Exit Interactive Mode (Option 5) ................................................................ 100
Using Data on the PC ............................................................................................. 100
Real-Time Printout .................................................................................................. 100
Column Heading ........................................................................................ 101
Patient Data and Operating Status ............................................................ 103
Trend Data Printout (ASCII Mode) ......................................................................... 104
Trend Printout (Graph Mode) ................................................................................. 105
Nurse Call ............................................................................................................... 105
Analog Output ......................................................................................................... 106
Technical Discussion ...........................................................................................................109
Oximetry Overview ................................................................................................. 109
Automatic Calibration ................................................................................. 110
Functional versus Fractional Saturation .................................................... 110
Measured versus Calculated Saturation .................................................... 110
SatSeconds Alarm Management ............................................................................ 111
Reads Through Motion ........................................................................................... 111
OXIMAX Technology .............................................................................................. 111
Block Diagram Theory ............................................................................................ 113
Schematic Diagrams and Assembly Drawings ....................................................... 115

Contents
N-595 iv
Figures
Figure 1: N-595 Front Panel ................................................................................................ 3
Figure 2: N-595 Rear Panel ................................................................................................ 4
Figure 3: Limits Softkey Map ............................................................................................... 4
Figure 4: Trend Softkey Map ............................................................................................... 5
Figure 5: Setup Softkey Map............................................................................................... 6
Figure 6: Service Function Menu ...................................................................................... 33
Figure 7: Fuse Removal .................................................................................................... 52
Figure 8: Corner Screws ................................................................................................... 53
Figure 9: Separating Case Halves .................................................................................... 54
Figure 10: Removing the Battery ......................................................................................... 55
Figure 11: Power Entry Module ........................................................................................... 57
Figure 12: Power Supply ..................................................................................................... 59
Figure 13: Cooling Fan ........................................................................................................ 61
Figure 14: Display PCB ....................................................................................................... 63
Figure 15: User Interface PCB ............................................................................................ 65
Figure 16: Alarm Speaker ................................................................................................... 67
Figure 17: Exploded View ................................................................................................... 70
Figure 18: Packing ..............................................................................................................72
Figure 19: Data Port Setup .................................................................................................. 90
Figure 20: Data Port Pin Layout .......................................................................................... 98
Figure 21: Real-Time Printout ........................................................................................... 101
Figure 22: Trend Data Printout (ASCII Mode) ................................................................... 105
Figure 23: Monitor Trend Data Printout (Graph Mode) ..................................................... 105
Figure 24: In-Sensor Event Trend Data Printout (Graph Mode) ........................................ 105
Figure 25: Oxyhemoglobin Dissociation Curve ................................................................. 111
Figure 26: Block Diagram .................................................................................................. 113

Contents
N-595 v
Tables
Table 1: Equipment Needed .................................................................................................. 9
Table 2: Neonate Alarm Limit Factory Defaults ................................................................... 29
Table 3: Adult Alarm Factory Defaults ................................................................................. 30
Table 4: Problem Categories ............................................................................................... 43
Table 5: Power Problems .................................................................................................... 44
Table 6: Button Problems .................................................................................................... 45
Table 7: Display/Alarms Problems ...................................................................................... 46
Table 8: Operational Performance Problems ...................................................................... 47
Table 9: Data Port Problems ............................................................................................... 48
Table 10: Error Code Problems ............................................................................................. 49
Table 11: Power Supply Lead Connections .......................................................................... 59
Table 12: Parts List ............................................................................................................... 69
Table 13: Electromagnetic Emissions (IEC 60601-1-2) ........................................................ 80
Table 14: Electromagnetic Immunity (IEC 60601-1-2) .......................................................... 81
Table 15: Electrostatic Immunity (IEC 60601-1-2) ................................................................ 83
Table 16: Recommended Separation Distances ................................................................... 84
Table 17: Cables (IEC 60601-1-2) ........................................................................................ 85
Table 18: Data Port Pin Outs ................................................................................................ 97
Table 19: Operating Status Codes ...................................................................................... 104
Table 20: Nurse Call Relay Pin States ................................................................................ 106
Table 21: Rating of Nurse Call Relay .................................................................................. 106

[This page intentionally left blank]

N-595 1
Introduction
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-595 pulse oximeter in
the presence of flammable anesthetics.
WARNING: Do not spray, pour, or spill any liquid on the N-595, its
accessories, connectors, switches, or openings in the chassis.
WARNING: Before attempting to open or disassemble the N-595,
disconnect the power cord from the N-595.
WARNING: The LCD panel contains toxic chemicals. Do not ingest
chemicals from a broken LCD panel.
WARNING: The use of accessories, transducers, and cables other than
those specified may result in increased emission and/or decreased
immunity of the N-595 pulse oximeter.
WARNING: Do not silence the N-595 audible alarm or decrease its
volume if patient safety could be compromised.

Introduction
2
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.
Caution: Observe ESD (electrostatic discharge) precautions when
working within the unit.
Caution: Observe ESD (electrostatic discharge) precautions when
disassembling and reassembling the N-595 and when handling any of the
components of the N-595.
Caution: When reassembling the N-595, tighten the screws that hold the
cases together to a maximum of 10 inch-pounds. Over-tightening could
strip out the screw holes in the top case, rendering it unusable.
Caution: When installing the Power Supply or the User Interface PCB,
tighten the seven screws to a maximum of 4 inch-pounds. Over-tightening
could strip out the screw holes in the bottom case, rendering it unusable.
Manual
Overview This manual contains information for servicing the Nellcor®model
N-595 pulse oximeter. Only qualified service personnel should service this
product. Before servicing the N-595, read the operator's manual carefully for
a thorough understanding of safe operation of the N-595.
WARNING: Explosion hazard. Do not use the N-595 pulse oximeter in
the presence of flammable anesthetics.
Description of
N-595 Monitor The N-595 Monitor is intended 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.

Introduction
N-595 3
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 transducer 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.
Through the use of the four softkeys, the operator can access trend
information, select an alarm limit to be changed, choose the language to be
used, adjust the internal time clock, and change communications protocol.
The N-595 can operate on AC power or on an internal battery. The controls
and indicators for the N-595 are illustrated and identified in Figure 1 on
page 3 and Figure 2 on page 4.
1. SpO2Sensor Port 11. ADJUST UP Button
2. AC Power Indicator 12. ADJUST DOWN Button
3. POWER ON/OFF Button 13. CONTRAST Button
4. Low Battery Indicator 14. Softkeys
5. Waveform Display 15. Menu Bar
6. SatSecondsTM Timer 16. Trend In-Sensor Indicator
7. %SpO2Display 17. Motion Indicator
8. Pulse Rate Display 18. Pulse Search Indicator
9. Alarm Silence Display 19. Speaker
10. ALARM SILENCE Button
Figure 1: N-595 Front Panel

Introduction
4
1. Equipotential Terminal (Ground) 4. Fuse Receptacle
2. AC Power Connector 5. Supply Voltage Selector Switch
3. Data Port Connector
Figure 2: N-595 Rear Panel
Figure 3 on page 4, Figure 4 on page 5, and Figure 5 on page 6 illustrate the
various functions that are available through the use of the softkeys, and how
to access them. A complete explanation of the keys is provided in the N-595
operator's manual.
Figure 3: Limits Softkey Map

Introduction
N-595 5
Figure 4: Trend Softkey Map

Introduction
6
Figure 5: Setup Softkey Map
Related
Documents To perform test and troubleshooting procedures, and to understand the
principles of operation and circuit analysis sections of this manual, you must
know how to operate the monitor. Refer to the N-595 operator's manual. To
understand the various Nellcor approved sensors that work with the monitor,
refer to the individual sensor's directions for use.
The latest version of the operator’s manual and the service manual are posted
on the Internet at:
http://www.mallinckrodt.com/respiratory/Serv_Supp/ProductManuals.html
Spare Parts and Accessories are posted on the Internet at:
http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/Apartweb/main/PartAcceMenu.html

N-595 7
Routine Maintenance
Cleaning
WARNING: Do not spray, pour, or spill any liquid on the N-595, its
accessories, connectors, switches, or openings in the chassis.
For surface-cleaning and disinfecting follow your institution's procedures or:
• The N-595 may be surface-cleaned by using a soft cloth dampened
with either a commercial, nonabrasive cleaner or a solution of 70%
alcohol in water, and lightly wiping the surfaces of the monitor.
• The N-595 may be disinfected using a soft cloth saturated with a 10%
solution of chlorine bleach in tap water.
Before attempting to clean an SpO2sensor, read the directions for use
enclosed with the sensor. Each sensor model has cleaning instructions specific
to that sensor.
Periodic Safety
Checks The N-595 requires no routine service or calibration other than changing the
battery at least every 2 years. See Battery Replacement on page 55. The
following checks should be performed at least every 24 months by a qualified
service technician.
1. Inspect the equipment for mechanical and functional damage.
2. Inspect safety labels for legibility. If the labels are damaged, contact
Nellcor’s Technical Services Department, 1.800.635.5267, or your local
Nellcor representative.
Functional
Checks The following checks should be performed at least every 2 years by a
qualified service technician.
1. If the monitor has been visibly damaged or subjected to mechanical shock
(for example, if dropped), perform the performance tests. See
Performance Tests on page 9.

Routine Maintenance
8
2. Perform the electrical safety tests detailed in Safety Tests on page 28. If
the unit fails these electrical safety tests, refer to Troubleshooting on
page 43.
3. Inspect the fuses for proper value and rating (F1 & F2 = 0.5 amp, 250
volts).
Battery Nellcor recommends replacing the instrument's battery every 2 years. When
the N-595 is going to be stored for 3 months or more, remove the battery prior
to storage. To replace or remove the battery, refer to Disassembly Guide on
page 51.
If the N-595 has been stored for more than 30 days, charge the battery as
described in Battery Charge on page 10. A fully discharged battery requires
14 hours with the monitor turned off, or 18 hours if it is in use, to receive a
full charge. The battery is being charged whenever the instrument is plugged
into AC.
Note: If power stored in the battery is too low, the unit will not operate even
when plugged into AC. If this occurs, leave the unit plugged in to
allow the battery to charge as described in Battery Charge on
page 10. After approximately 10 minutes, the battery should have
enough charge to allow the unit to operate on AC.

N-595 9
Performance Verification
Introduction This section discusses the tests used to verify performance following repairs
or during routine maintenance. All tests can be performed without removing
the N-595 cover. All tests except the battery charge and battery performance
tests must be performed as the last operation before the monitor is returned to
the user.
If the N-595 fails to perform as specified in any test, repairs must be made to
correct the problem before the monitor is returned to the user.
Equipment
Needed
Performance
Tests The battery charge procedure should be performed before monitor repairs
whenever possible.
Note: This section is written using Nellcor factory-set defaults. If your
institution has preconfigured custom defaults, those values will be
displayed. Factory defaults can be restored (see Reset Softkey,
page 34).
Table 1: Equipment Needed
Equipment Description
Digital Multimeter (DMM) Fluke Model 87 or equivalent
Durasensor®oxygen transducer DS-100A
OXIMAX oxygen transducer MAX-A
Safety Analyzer Must meet current AAMI ESI/1993 & IEC
60601-1/1998 specifications
Pulse oximetry cable DOC-10
Data interface cable EIA-232 cable (optional)
Stopwatch Manual or electronic
SRC-MAX Tester Provides testing for DigiCal compatible
Monitors

Performance Verification
10
Battery Charge Perform the following procedure to fully charge the battery.
1. Connect the monitor to an AC power source.
2. Verify that the monitor is off and that the AC Power/Battery Charging
indicator is lit.
3. Charge the battery for at least 14 hours with the monitor turned off or 18
hours with the monitor turned on.
Power-Up
Performance The power-up performance tests verify the following monitor functions:
•Power-On Self-Test, page 10
•Power-On Defaults and Alarm Limit Ranges, page 11
Power-On Self-Test 1. Connect the monitor to an AC power source.
2. Verify that the monitor is off and that the AC Power/Battery Charging
indicator is lit.
3. Do not connect any cables to the monitor.
4. Turn on the N-595 by pressing the POWER ON/OFF button. Observe the
monitor front panel. The monitor must perform the following sequence:
• Within 2 seconds all LEDs are illuminated, all pixels on the LCD
display are illuminated, and the backlight comes on.
• The indicators remain lighted.
• The LCD display shows NELLCOR and the software version of the
N-595.
Note: The software “Version” displayed in the example below is
X.X.X.X.The actual software version will be displayed on your
monitor.

Performance Verification
N-595 11
• A 1-second beep sounds, indicating proper operation of the speaker,
and all indicators turn off except the AC Power/Battery Charging
indicator and the LCD screen.
• The N-595 begins normal operation.
PLETH VIEW:
BLIP (MAGNIFIED) VIEW
Power-On Defaults
and Alarm Range
Limits
Note: When observing or changing alarm limits, a time-out is in effect
(approximately 10 seconds). If no action is taken within the time-out,
the monitor automatically returns to the monitoring display.
Note: The descriptions that follow are based on the assumption that Pleth
view is the view that has been selected.
The steps for changing an alarm limit are the same if the view being used is
Blip (Magnified) view.
Note: Power-on defaults will be the factory-set defaults or the defaults set
by your institution.
1. Turn on the N-595 by pressing the POWER ON/OFF button.
2. Press the LIMITS softkey. Verify that the monitor emits a single beep and
the pleth view is replaced with a display of the alarm limits. The upper

Performance Verification
12
alarm limit for %SpO2will indicate an alarm limit of “100” (or
institutional default setting) inside a box.
3. Press and hold the ADJUST DOWN button. Verify that the boxed number
for %SpO2upper alarm limit reduces to a minimum of “86.”
Note: A decimal point in the display indicates that the alarm limits have
been changed from factory default values.
4. Press the SELECT softkey. Verify that the monitor emits a single beep
and the box moves to the %SpO2lower alarm limit of “85” (or your
institutional default setting).
5. Press and hold the ADJUST DOWN button and verify that the %SpO2
lower alarm limit display reduces to a minimum of “20.”
6. Press and hold the ADJUST UP button and verify that the %SpO2lower
alarm limit display cannot be raised past the upper alarm limit setting of
“85.”
7. Press the EXIT softkey.
8. Press the LIMITS softkey