Nellcor OXIMAX N-560 User manual

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Service.ai 1/24/06 9:25:48 AMService.ai 1/24/06 9:25:48 AM
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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 US patents and foreign equivalents: 4,802,486; 4,869,254; 4,928,692;
4,934,372; 4,960,126; 5,078,136; 5,485,847; 5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310; 6,591,123;
6,675,031; 6,708,049; 6,801,797; Re 35,122.
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Contents
N-560 Service Manual i
Contents
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v
Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings ....................................................................................................................................................1
Cautions .....................................................................................................................................................1
Notes ..........................................................................................................................................................1
Manual Overview ........................................................................................................................................2
Description of N-560 Pulse Oximeter .........................................................................................................2
Related Documents ....................................................................................................................................4
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cleaning .....................................................................................................................................................5
Periodic Safety Checks ..............................................................................................................................5
Functional Checks ......................................................................................................................................5
Battery ........................................................................................................................................................6
Performance Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Introduction .................................................................................................................................................7
Equipment Needed .....................................................................................................................................7
Performance Tests .....................................................................................................................................8
Battery Charge ......................................................................................................................................8
Power-Up Performance .........................................................................................................................8
Power-On Self-Test (POST) ............................................................................................................9
Power-On Defaults and Alarm Limit Ranges .................................................................................11
General Operation ...............................................................................................................................16
LED Excitation Test ........................................................................................................................16
Operation with a Live Subject ........................................................................................................17
Alarm Volume Control ....................................................................................................................18
Pulse Tone Volume Control ...........................................................................................................19
Pulse Oximetry Functional Tests .........................................................................................................19
Introduction ....................................................................................................................................20
Initial Setup ....................................................................................................................................20
Test #1: BPM .................................................................................................................................21
Test #2: SpO2 ................................................................................................................................22
Test #3: Modulation Level ..............................................................................................................23
Test #4: Light .................................................................................................................................25
Safety Tests ..............................................................................................................................................26
Audible Alarm Settings and Service Functions . . . . . . . . . . . . . . . . . . . . 29
Introduction ...............................................................................................................................................29
Audible Alarm Settings .............................................................................................................................29
Alarm Silence State .............................................................................................................................30
Alarm Silence Duration ........................................................................................................................30
Alarm Volume ......................................................................................................................................30
N-560 Menu ..............................................................................................................................................30
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Contents
N-560 Service Manual ii
Operator's Menu Options ..........................................................................................................................32
Accessing Menu Items ........................................................................................................................33
Menu Item 1 (Trend Print) ...................................................................................................................33
Menu Item 2 (Trend Clear) ..................................................................................................................34
Menu Item 3 (Language Selection) .....................................................................................................34
Menu Item 4 (Baud Rate) ....................................................................................................................34
Menu Item 5 (EPP Mode) ....................................................................................................................34
Service Menu Options ..............................................................................................................................35
Menu Item 6 (In-Sensor Trend Mode) .................................................................................................35
Menu Item 7 (RS-232 Nurse Call Polarity) ..........................................................................................35
Menu Item 8 (Time Set) .......................................................................................................................36
Menu Item 9 (Save Current Values as Power-On Defaults) ................................................................37
Menu Item 10 (Restore Factory Default Settings as Power-On Default) .............................................38
Menu Item 11 (Alarm Silence Restrictions) .........................................................................................39
Menu Item 12 (Silence Alarms) ...........................................................................................................40
Menu Item 13 (All Display Off) ............................................................................................................40
Menu Item 14 (Alarm Sound Style Select) ..........................................................................................41
Setting Institutional Defaults (Sample) .....................................................................................................41
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Introduction ...............................................................................................................................................43
How To Use This Section .........................................................................................................................43
Who Should Perform Repairs ...................................................................................................................43
Troubleshooting Guide .............................................................................................................................43
Power ..................................................................................................................................................44
Buttons ................................................................................................................................................46
Display/Alarms ....................................................................................................................................47
Operational Performance ....................................................................................................................48
Data Port .............................................................................................................................................49
Error Codes ..............................................................................................................................................49
Disassembly Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Introduction ...............................................................................................................................................53
Replacement Level Supported .................................................................................................................54
Prior to Disassembly .................................................................................................................................54
Separating Top and Bottom Cases ..........................................................................................................54
Front Case Disassembly ..........................................................................................................................57
NELL-3 Removal ......................................................................................................................................59
Main PCB Removal ..................................................................................................................................60
Power Supply Removal ............................................................................................................................63
Fan Removal ............................................................................................................................................64
Battery Removal .......................................................................................................................................66
Equipotential Terminal Removal ...............................................................................................................68
Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Introduction ...............................................................................................................................................71
Obtaining Replacement Parts ...................................................................................................................71
Parts List and Accessories .......................................................................................................................71
Packing for Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Introduction ...............................................................................................................................................75
Returning the N-560 .................................................................................................................................75
General Instructions .................................................................................................................................75
Repacking in Original Carton ....................................................................................................................75
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Contents
N-560 Service Manual iii
Repacking in a Different Carton ...............................................................................................................77
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Performance .............................................................................................................................................79
Electrical ...................................................................................................................................................82
Environmental Conditions .........................................................................................................................83
Physical Characteristics ...........................................................................................................................85
Compliance ...............................................................................................................................................85
Manufacturer’s Declaration .......................................................................................................................86
Safety Tests ..............................................................................................................................................92
Ground Integrity ...................................................................................................................................92
Earth Leakage Current ........................................................................................................................92
Enclosure Leakage Current .................................................................................................................92
Patient Risk Applied Current ...............................................................................................................93
Patient Isolation Risk Current ..............................................................................................................93
Data Port Interface Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Introduction ...............................................................................................................................................95
Enabling The Data Port ............................................................................................................................95
Protocol ...............................................................................................................................................95
Baud Rate ...........................................................................................................................................96
Connecting To The Data Port ...................................................................................................................97
Nurse Call Polarity Settings .................................................................................................................99
Nurse Call Relay Pin States ................................................................................................................99
Nurse Call Relay Rating ......................................................................................................................99
Real-Time Printout ..................................................................................................................................100
Column Heading ................................................................................................................................100
Printout Source ..................................................................................................................................101
Software Revision Level ....................................................................................................................101
Alarm Limits .......................................................................................................................................101
Column Headings ..............................................................................................................................101
Time Tag ...........................................................................................................................................102
Patient Data .......................................................................................................................................102
Operating Status ...............................................................................................................................102
Technical Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Oximetry Overview .................................................................................................................................105
Automatic Calibration ........................................................................................................................106
Functional Versus Fractional Saturation ...........................................................................................106
SatSeconds Alarm Management ............................................................................................................107
Signal Processing ...................................................................................................................................107
OXIMAX Technology ..............................................................................................................................109
NELL-3 Interface ....................................................................................................................................109
Circuit Analysis .......................................................................................................................................111
Block Diagram Theory ............................................................................................................................112
AC Input ..................................................................................................................................................112
Power Supply PCB Theory Of Operation ...............................................................................................113
Battery ....................................................................................................................................................113
Main PCB ...............................................................................................................................................113
Regulated DC Power Supply .............................................................................................................114
Controlling Hardware .........................................................................................................................114
CPU ...................................................................................................................................................114
Charging Circuits ...............................................................................................................................115
Real-Time Clock (RTC) .....................................................................................................................115
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Contents
N-560 Service Manual iv
Storage of Patient Data .....................................................................................................................115
Front Panel PCB and Controls ...............................................................................................................116
Front Panel Display ...........................................................................................................................116
Button Interface .................................................................................................................................116
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
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List of Figures
N-560 Service Manual v
Figures
Figure 1: N-560 Front Panel ...................................................................................................................3
Figure 2: N-560 Rear Panel ...................................................................................................................3
Figure 3: N-560 Controls ........................................................................................................................9
Figure 4: Adjusting High %SpO2 Alarm Limit .......................................................................................12
Figure 5: Adjusting Low %SpO2 Alarm Limit .......................................................................................13
Figure 6: Adjusting High Pulse Rate Alarm Limit .................................................................................13
Figure 7: Adjusting Low Pulse Rate Alarm Limit ..................................................................................14
Figure 8: Adjusting SatSeconds Alarm Limit ........................................................................................15
Figure 9: N-560 Controls ......................................................................................................................29
Figure 10: Year Month Display ...............................................................................................................36
Figure 11: Day Hour Display ..................................................................................................................36
Figure 12: Minute Second Display .........................................................................................................37
Figure 13: N-560 Rear Panel Screws .....................................................................................................55
Figure 14: N-560 Case Screws ..............................................................................................................55
Figure 15: Top Case Removal ...............................................................................................................56
Figure 16: Separated Cases ..................................................................................................................56
Figure 17: Front case Wiring ..................................................................................................................57
Figure 18: Front Case Mounting Screws ................................................................................................58
Figure 19: Front Case Bracket ...............................................................................................................58
Figure 20: Speaker Removal ..................................................................................................................59
Figure 21: Front PCB Removed .............................................................................................................59
Figure 22: NELL-3 Cable Connections ...................................................................................................60
Figure 23: NELL-3 Removal ...................................................................................................................60
Figure 24: Front case Wiring ..................................................................................................................61
Figure 25: Front Case Mounting Screws ................................................................................................61
Figure 26: Main PCB Removal ...............................................................................................................62
Figure 27: Main PCB Removed ..............................................................................................................62
Figure 28: Power Supply Wiring .............................................................................................................63
Figure 29: Power Supply Screws ...........................................................................................................64
Figure 30: Power Supply Removed ........................................................................................................64
Figure 31: Fan Wires ..............................................................................................................................65
Figure 32: Fan Bracket Removal ............................................................................................................65
Figure 33: Fan and Bracket Removal .....................................................................................................66
Figure 34: Fan Screws ...........................................................................................................................66
Figure 35: Battery Screws ......................................................................................................................67
Figure 36: Battery Cover ........................................................................................................................67
Figure 37: Battery Connector .................................................................................................................67
Figure 38: Battery Removal ....................................................................................................................68
Figure 39: Ground Wire ..........................................................................................................................69
Figure 40: Equipotential Ground Terminal .............................................................................................69
Figure 41: Equipotential Ground Terminal Removed .............................................................................70
Figure 42: Exploded View ......................................................................................................................73
Figure 43: Packing .................................................................................................................................76
Figure 44: Data Port Pin Layout .............................................................................................................98
Figure 45: Real-Time Printout ..............................................................................................................100
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List of Figures
N-560 Service Manual vi
Figure 46: Oxyhemoglobin Dissociation Curve ....................................................................................107
Figure 47: NELL-3 Interface .................................................................................................................110
Figure 48: Block Diagram .....................................................................................................................112
Figure 49: Main PCB Battery Charger Schematic Diagram .................................................................117
Figure 50: Main PCB Isolation for NELL-3 Schematic Diagram ...........................................................119
Figure 51: Main PCB Isolation for External Interface Schematic Diagram ...........................................121
Figure 52: Main PCB DC Battery Input and DC/DC Converter Schematic Diagram ............................123
Figure 53: Main PCB Interface and Speaker Control Schematic Diagram ...........................................125
Figure 54: Main PCB MCU and Storage Control Schematic Diagram .................................................127
Figure 55: Main PCB Parts Locator Diagram .......................................................................................129
Figure 56: Front Panel PCB 7-Segment Display Schematic Diagram .................................................131
Figure 57: Front Panel PCB LED Display and Buttons Schematic Diagram ........................................133
Figure 58: Front Panel PCB Interface and LED Drivers Schematic Diagram ......................................135
Figure 59: Front Panel Parts Locator Diagram .....................................................................................137
Figure 60: Power Supply Schematic Diagram ......................................................................................139
Figure 61: Power Supply Parts Locator Diagram .................................................................................141
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List of Tables
N-560 Service Manual vii
Tables
Table 1: Equipment Needed .................................................................................................................7
Table 2: N-560 Menu Selections .........................................................................................................30
Table 3: Institutional Default Values ....................................................................................................37
Table 4: Factory Default Settings ........................................................................................................38
Table 5: Problem Categories ..............................................................................................................44
Table 6: Power Problems ....................................................................................................................45
Table 7: Button Problems ....................................................................................................................46
Table 8: Display/Alarms Problems ......................................................................................................47
Table 9: Operational Performance Problems ......................................................................................48
Table 10: Data Port Problems ...............................................................................................................49
Table 11: Error Codes ...........................................................................................................................50
Table 12: Spare Parts and Accessories ................................................................................................71
Table 13: Tone Definition ......................................................................................................................80
Table 14: Cable Compliance .................................................................................................................87
Table 15: Electromagnetic Emissions ...................................................................................................88
Table 16: Electromagnetic Immunity .....................................................................................................88
Table 17: Electromagnetic Immunity .....................................................................................................90
Table 18: Recommended Separation Distances Between Portable and Mobile RF Communication
Equipment and the N-560 ............................................................................................91
Table 19: Data Port Pinouts ..................................................................................................................97
Table 20: Status Codes .......................................................................................................................103
Table 21: NELL-3 J1 Pinouts ..............................................................................................................110
Table 22: NELL-3 J2 Pinouts ..............................................................................................................111
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List of Tables
N-560 Service Manual viii
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N-560 Service Manual 1
Introduction
Warnings
Warnings are identified by the WARNING symbol shown above and a line
above and below the warning text. The word WARNING and all warning text
are boldfaced.
Warnings alert the user to potential serious outcomes (death, injury, or
adverse events) to the patient or user.
Cautions
Cautions are identified by the CAUTION symbol shown above. The word
CAUTION and the caution text are boldfaced.
Cautions alert the user to exercise care necessary for the safe and effective use
of the N-560™.
Notes
Notes are identified by the Note symbol shown above.
Notes provide additional useful information.
Note: Sensor LED light emissions fall within Class 1 level, according to IEC
60825-1:2001. No special safety precautions are required.
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Introduction
2
Manual Overview
This manual contains information for servicing the Nellcor
®
model N-560
pulse oximeter. Only qualified service personnel should service this product.
Before servicing the N-560, read the operator's manual carefully for a
thorough understanding of operation.
WARNING: Explosion hazard. Do not use the N-560 pulse oximeter in
the presence of flammable anesthetics.
Description of N-560 Pulse Oximeter
The N-560 Pulse Oximeter is indicated for the continuous noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO
2 ) and
pulse rate. The N-560 is intended for use with neonatal, pediatric, and adult
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 subacute centers.
Intra-hospital transport includes transport of a patient within the
hospital or hospital-type facility.
Use with any particularpatient requires the selection of an appropriate oxygen
transducer as described in the N-560 Operator's Manual.
Digital displays are provided for oxygen saturation and pulse rate, and a
10-segment light-emitting diode (LED) bar indicates pulse amplitude. The
controls and indicators for the N-560 are illustrated and defined in Figure 1
and Figure 2 on page 3.
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Introduction
N-560 Service Manual 3
Figure 1: N-560 Front Panel
Figure 2: N-560 Rear Panel
1 — SpO 2 Sensor Port 12 — SatSeconds Alarm Limit Button
2 —
Power On/Off Button 13 — SpO 2 Alarm Limit Button
3 —
% SpO 2 Display 14 — Interference Indicator
4 —
Pulse Amplitude Indicator 15 — Sensor Off Indicator
5 —
Pulse Rate Display 16 — Sensor Message Indicator
6 —
Alarm Silence Button 17 — Pulse Search Indicator
7 —
Alarm Silence Indicator 18 — Data In Sensor Indicator
8 —
Adjust Up Button 19 — Low Battery Indicator
9 —
Adjust Down Button 20 — AC Power Indicator
10 —
Pulse Rate Alarm Limit
Button 21 — Speaker
11 —
SatSeconds Display
1 — Data Port Connector 3 — AC Power Connector
2 — Visual Alarm Connector 4 — Equipotential Terminal
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Introduction
4
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 N-560. Refer to the N-560 operator's manual. To
understand the various Nellcor sensors that work with the N-560, refer to the
individual sensor's directions for use.
The latestversions of the operator’s manual and the service manual are posted
on the Internet at:
http://www.mallinckrodt.com/respiratory/resp/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
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N-560 Service Manual 5
Routine Maintenance
Cleaning
CAUTION: Do not spray, pour, or spill any liquid on the N-560, its
accessories, connectors, switches, or openings in the chassis.
For surface-cleaning and disinfecting follow your institution's procedures or:
• The N-560 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 N-560.
• The N-560 may be disinfected using a soft cloth saturated with a 10%
solution of chlorine bleach in tap water.
Before attempting to clean an SpO
2 sensor, read the directions for use
enclosed with the sensor. Each sensor model has cleaning instructions specific
to that sensor.
Periodic Safety Checks
The N-560 requires no routine service or calibration other than changing the
battery at least every two years. See Battery Removal on page 66. The
following checks should be performed at least every two years 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
1. If the N-560 has been visibly damaged or subjected to mechanical shock
(for example, if dropped), perform the performance tests. See
Performance Tests on page 8.
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Routine Maintenance
6
2. Perform the electrical safety tests detailed in Safety Tests on page 26. If
the N-560 fails these electrical safety tests, refer to Troubleshooting on
page 43.
3. Inspect the fuses for proper value and rating (F1 and F2 = 2 amp,
250 volts).
Battery
Nellcor recommends replacing the N-560's battery every two years. When the
N-560 is going to be stored for two months or more, remove the battery prior
to storage. To replace or remove the battery, refer to Disassembly Guide on
page 53.
If the N-560 has been stored for more than 30 days, charge the battery as
described in Battery Charge on page 8. A fully discharged battery requires
6 hours to receive a full charge. The battery is being charged whenever the
N-560 is plugged into an AC power source.
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N-560 Service Manual 7
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-560 cover. All tests except the battery charge and battery performance
tests must be performed as the last operation before the N-560 is returned to
the user.
If the N-560 fails to perform as specified in any test, repairs must be made to
correct the problem before the N-560 is returned to the user.
Equipment Needed
Table 1: Equipment Needed
Equipment Description
Digital multimeter (DMM) Fluke Model 87 or equivalent
Durasensor
®
oxygen transducer
(sensor)
DS-100A
O
XI M AX oxygen transducer MAX-A
Pulse oximeter tester SRC-MAX (must meet current EN
61326-1, FCC Part 15, and UL 1010-1,
or IEC 61010-1, or CSA 22.2 No.
1010-1 specifications)
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
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Performance Verification
8
Performance Tests
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 Menu Item 10 (Restore Factory Default
Settings as Power-On Default) on page 38.
Battery Charge
Perform the following procedure to fully charge the battery.
1. Connect the N-560 to an AC power source.
2. Verify that the N-560 is off and that the
AC Power indicator is lit.
3. Charge the battery for at least 6 hours in standby.
Power-Up Performance
The power-up performance tests verify the following N-560 functions:
• Power-On Self-Test (POST) on page 9
• Power-On Defaults and Alarm Limit Ranges on page 11
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Performance Verification
N-560 Service Manual 9
Figure 3: N-560 Controls
Power-On Self-Test (POST)
CAUTION: If any indicator or display element does not light, or the
speaker does not sound, do not use the N-560. Instead, contact qualified
service personnel, your local Nellcor representative, or Nellcor's
Technical Services Department, 1.800.635.5267.
Note: The N-560 should complete the POST function within 12 seconds.
1. Turn on the N-560 by pressing the
Power On/Off button for greater than
0.5 seconds.
2. The N-560 displays/sounds:
1 — Power On/Off Button 5 — Pulse Rate Alarm Limit Button
2 —
Alarm Silence Button 6 —
SatSeconds Alarm Limit Button
3 —
Adjust Up Button 7 — SpO 2 Alarm Limit Button
4 —
Adjust Down Button
Display Sound
5 (in pulse rate left window) low priority alarm
6 (in pulse rate center window) medium priority alarm
0 (in pulse rate right window) high priority alarm
n (in SpO
2 left window)
n (in SpO
2 center window)
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Performance Verification
10
3. The N-560 automatically starts the Power-On Self-Test (POST), which
tests N-560 circuitry and functions.
CAUTION: During POST (immediately after power-up), confirm that all
display segments and indicators light, and the speaker sounds a
one-second pass tone.
4. While performing POST, the self-test display appears for approximately
five seconds. During this time:
• All indicators illuminate
• All segments of all numeric digits light and change from red to green
• All segments of the Pulse Amplitude Display light
• All segments of the
SatSeconds indicator light
5. Once the display test portion of POST is complete, the N-560 version is
displayed for approximately two seconds.
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