Nellcor N-395 User manual

OPERA TOR'S MANUAL
N-395 Pulse Oximeter
Caution: Federal law (U.S.) restricts this device to sale by or 011 the order of a physiciatl.

CONTENTS
Figures
Tables
...
Contents .................................................................................. 111
Figures ................................................................................ vii
...
Tables ................................................................................ VIII
Safety hformation ...................................................................... =!
General Safety Information .................................................. 1
lntmduetion ................................................................................. 3
Intended Use ....................................................................... 3
General Operating Principles and Conditions
..................... 3
Controls, Indicators, And Symbols ............. ... ...................... 5
Displays. Controls. Indicators. and Connectors ................... 5
N-395Symbols
.................................................................... 6
Description of ConZrols ........................................................ 7
Function Buttons ...................................................... 7
Description of Displays and Visual Indicators ...................... 8
Description of Audible Indicators
......................................... 9
Setup ............................................................................... 11
Unpacking and Inspection ................................................. 11
PerformanceVerification
................................................... 11
List Of Components ........................................................... I1
Optional Accessories ............................................. 12
Monitor Setup
.................................................................... 18
General Warnings
.................................................. 18
Connecting The N-395 To AC Power
..................... 19
Operating on a Discharged Battery ........................ j9
Language Selection ........................................................... 21
Sensors .................... .... ................................................... 23
Selecting a Sensor ............................................................. 23
Biocompatibility Testing
..................................................... 24
Performance Considerations
............................................. 25
Stad-Up and Use ....................................................................... 27
Basic Operation ................................................................. 27
Power-On Self-Best (POST) .................................. 28
Adult-Pediatric and Neonatal Settings
................... 30
Contrast
.................................................................. 31
Monitoring Mode
.................................................... 31
Pulse Search
.......................................................... 32

Contents
At Initial Power-Up
(Sensor Attached to Monitor)
..................... 32
At Initial Power-Up
(No Sensor Attached to Monitor)
............... 32
After Taking Measurements
................................... 33
Sensor Disconnected
............................................. 33
Sensor Off
.............................................................. 33
Automatic Shutdown
............................................... 33
................................................................................
Alarms 34
Description of Alarms
............................................. 34
Satseconds Alarm Management ............................ 35
Satseconds "Safety Net" ......................................... 37
Determining the
Satseconds .................................. 37
Satseconds Display ................................................ 38
Adjustable Settings
............................................................ 38
Pulse
Beep Volume ................................................ 38
Alarm Volume ......................................................... 39
Alarm Silence Duration
........................................... 39
Disabling Audible Alarms
........................................ 40
Alarm Silence Reminder
......................................... 40
Menu
.................................................................................. 41
Menu Structure
....................................................... 41
..................................................................................
Limits 42
Overview
................................................................. 42
Viewing Current Alarm Limits
................................. 42
Changing Alarm Limits
........................................... 43
Alarm Limits Changed Indicator
............................. 46
..................................................................................
Trend 46
View
................................................................... 48
.................................................................
Zoom 50
40-Second Trends Table ........................................ 50
Next
................................................................... 51
Delete
................................................................... 51
Print
................................................................... 51
Setup
.................................................................................. 52
...................................................................
View 52
...................................................................
Clock 52
..................................................................
Comm 53
Lang ...................................................................57
...................................................................
Ncall 58
................ ..................................................
Analog ; 58
..................................................................
Light 58

Contents
Default Settings ...................................................... 58
Nurse Call Feature
................................................. 60
BatteryOperation
............................................................... 61
Low Battery Indicator ........................................... 61
Disposal Of Device Components
....................................... 62
.............................................
Performance Considerations 62
Impact of Patient Conditions on
Monitor Readings
...................................... 62
Troubleshooting And Maintenance ......................................... 65
Troubleshooting ................................................................. 65
Error Codes
............................................................ 65
Other Messages
..................................................... 66
Suggested Corrective Actions
................................ 67
€MI (Electromagnetic Interference) ................................... 70
Obtaining Technical Assistance
........................................ 71
Returningthe N-395
.......................................................... 71
......................................................................
Maintenance 71
Service
................................................................... 71
Periodic Safety Checks
.......................................... 72
PerformanceVerification
........................................ 72
.................................................................
Cleaning 72
..... Specifications ........=m..mm ............................................. 73
Performance ...................................................................... 73
Measurement Range
.............................................. 73
Accuracy
................................................................ 73
Electrical
............................................................................ 74
Instrument
.............................................................. 74
...................................................................
Battery 74
Environmental Conditions
.................................................. 75
Transport And Storage (in Shipping Container)
..... 75
Transport And Storage
(Not
in Shipping Container) ....................... 75
Operation ............................................................... 75
Physical Characteristics
..................................................... 75
Compliance
........................................................................ 76
Quick Guide to Operatbn ........................................................ 77
Introduction ........................................................................ 77
Settings Adjustments ......................................................... 77
Principles of Operation ............................................................ 83
Oximetry Overview ............................................................ 83
Automatic Calibration
............................................. 83
Functional versus Fractional Saturation
................. 84

Contents
Measuredversus Calculated Saturation ................. 84
Data Pod Protocol ..................................................................... 87
Overview ............................................................................ 89
Connecting to the Data Port
............................................... 89
Baud Rate
.......................................................................... 89
Setting Data Port Protocol
.................................................. 89
Real-Time Display Format
................................................. 90
Column Headings
................................................... 91
Patient Data and Operating Status
......................... 93
Trend Data Printout (ASCII Mode)
..................................... 94
Trend Data Printout (Graph Mode)
.................................... 95
Nurse Call .......................................................................... 95
Analog Outputs .................................................................. 97
lndex ......................... ....... .......................................... 99

Contents
......................
Figure 1 : N-395 Front Panel Display (Pleth View) 5
Figure 2: N-395 Rear Panel
........................................................ 6
Figure 3: GCX Mounting Plate
.................................................. 13
Figure4: GCX Poly-mount (vertical wall mount
with 19-inch channel)
.............................................. 14
Figure 5: GCX Poly-mount (horizontalwall mount
with rail adapter)
....................................................... 15
Figure 6: GCX Roll Stand Poly-mount ...................................... 16
Figure 7: GCX Utility Basket ..................................................... 17
Figure 8: Soft Sided CarryingCase
.......................................... 18
Figure 9: Monitoring Mode Display
- Pleth View ....................... 30
Figure 10: Monitoring Mode Display
- Blip (Magnified)View .... 30
Figure 11
: Alarm Responsewith Satseconds ............................ 36
Figure 12: Alarm Limits Selection
...............................................46
Figure 13: Sp02Trend
............................................................... 47
Figure 14: DualTrend Display
..................................................... 48
Figure 15: Sp02Trend Display
.................................................. 49
Figure 16: Pulse Rate Trend Display
.......................................... 49
Figure 17: Histogram
.................................................................. 50
Figure 18: AMP Trend Display
................................................... 50
Figure 19: 40-Second Trends
..................................................... 51
Figure 20: SpaceLabs Connection
............................................. 55
Figure 21
: Oxyhemoglobin Dissociation Curve .......................... 85
Figure22: Data Port Pin Layout
................................................. 89
Figure 23: Real-Time Printout
.................................................... 91
Figure 24: Trend Data Printout (ASCII MODE)
.......................... 95
Figure25: Trend Data Printout (GRAPH MODE)
....................... 95

Contents
TABLES
Table I : Nellcor Sensors ........................................................... 24
Table
2:
Limits Menu ................................................................. 43
Table
3: Trend Menu ................................................................. 44
Table 4: Setup Menu
................................................................. 45
Table 5: Trend Scale
................................................................. 47
Table
6:
Factory Default Settings (Adult) .................................. 59
Table 7: Factory Default Settings (Neonate)
.............................60
Table 8: Error Codes and Messages ........................................ 66
Table 9:
Settings Adjustments .................................................. 77
Table
10: Data Port Pinouts ........................................................ 88
Table 11 : Status Codes .............................................................. 94
Table
12: Voltage Between Pins 10 and I 1 ................................ 96
Table 13: Analog Pinouts ............................................................ 97

SAFETY INFORMA TlON
General Safety Information
GENERAL SAFETY INFORMATION
This section contains important safety inforination related to
general use of the N-395 pulse oximeter. Other importailt safety
inforination appears throughout the manual in sections that relate
specifically to the precautiona~yinformation. Read all text
surrounding all precautionary information.
Important! Before use, carefully read this manual, accessory
directions for use, all precautionary informatioil in boldface type,
and specifications.
WARNING: Explosion hazard. donot use the N-395 pulse
oximeter in the presence of flammable anesthetics or gases.
WARNING: The N-395 is a prescription device and is to be
operated by qualified personnel only.
/ WARNING: Pulse oximetry readings and pulse signal can be
I affected by certain ambient environmental conditions, sensor
1 application errors, and certain patient conditions. See the
I appropriate sections of the manual for specific safety
/ information.
I WARNING: Chemicals from a broken LCD display panel
1
1 aretoxic when ingested. Use caution when handling a
1
/ monitor with a broken display panel.
1
gCaution: When connecting the N-395 to any instrument,
verify proper operation before clinical use. Both the
N-395
and the instrument connected to it must be connected to a
grounded outlet. Accessory equipment connected to the
moaitsmr9s data interface ramhast be certified according to IEC
Standard 950 for data-processing equipment or IEC
Standard 601-1 for electromedical equipment. All

combinations of equipment must be in compliance with IIEC
Standard 601-1-1 systems requirements. Anyone who
connects additional equipment to the signal input port or
signal outputport
(N-395 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 6011-1-8 and the electromagnetic
compatibility system standard IEC Standard 601-1-2. The
N-395 accuracy may degradeif it is connected to secondary
110 devices when the instrument is not connected to earth
refereaace.
To ensure accurate readings, consider the environmental
conditions that are present and the condition of the patient. See
the appropriate sections of the manual for specific safety
information related to these conditions.

INTRODUCTION
intended Use
General Operating Principles and Conditions
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INTENDED USE
The N-395 is a portable pulse oximeter intended for use as a
continuous non-invasive monitor of functional oxygen saturation
of arterial hemoglobin (SpOz) and pulse rate. Tlze intended
patient population coinprises adult, pediatric, and neonatal
patients. The intended environments of use are hospitals,
hospital-type facilities, intra-hospital transport environments, and
home care. The N-395 is for prescription use only. 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 such as
surgicenters, sub-acute centers, special nursing facilities, and
sleep labs, outside of the hospital. Intra-hospital transport
includes transport of a patient within the hospital or hospital-type
facility.
WARPJING: The N-395 is intended only as an adjunct in
pakient assessmnt. It must be used in conjunction with
clinical signs and symptoms.
GENERAL OPERATING PRlNClPLES AND CONDInONS
The N-395 uses pulse oximetiy to measure functional oxygen
saturation in the blood. Pulse oximetry works by applying
a
sensor to a pulsating arteriolar vascular bed, such as a finger or
toe. The sensor contains a dual light source and a photodetector.