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
The latest version of this manual is available 011 the Internet at:
http:llwww.mallinckrodt.com~respiratorylresp/Serv Suppl
ProductManuals.html
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.

Bone, tissue, pigmentation, and venous vessels normally absorb a
constant amount of light over time. The arteriolar bed normally
pulsates and absorbs variable amounts of light during the
pulsations. The ratio of light absorbed is translated into
a
measurement of functional oxygen saturation (Sp02).
Note: For an explanation of functional versus fractional
saturation, refer to
Principles of Operation.
Because a measurement of Sp02 is dependent upon light from the
sensor, excessive ambient light can interfere with this
measurement.
Specific inforination about ambient environmental conditions,
sensor application, and patient conditions is contained throughout
tliis manual.

CONTROLS, INDICA TORS, AND SYMBOLS
Displays, Controls, Indicators, and Connectors
N-395 Symbols
Description of Controls
Description of Displays and Visual lndicators
Description of Audible lndicators
DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS
Figure 1 and Figure 2 show the front and rear views of the N-395
and identify displays, controls, and connectors.
SpO2 Sensor Port 10
AC Power Indicator 11
Power OdOffButton
12
Low Battery Indicator 13
Waveforin Display 14
SatSecona's Timer 15
%SpOz Display 16
Pulse Rate Display 17
Alarm Silence Indicator 18
ALARM SILENCE Button
ADJUST UP Button
ADJUST
DOWN Button
CONTRAST Button
Softkeys
Menu Bar
Motion Indicator
Pulse Search Indicator
Speaker
Figure 1: N-395 Front Panel Display (Pleth View)

Controls. indicators, and Svmbols
1 . Equipotential (ground) Terminal 3. Fuse Receptacle
2. Data Port Connector
4. Supply Voltage Selector
Switch
Figure 2: N-395 Rear Panel
N-395 SYMBOLS
/i\ See Instructions for Use
Fuse Replacement
T 0 25A 250V
Type BF Applied Part - Not defibrillator proof
(wT( Date of Manufacture
Data Interface

DESCRIPTION OF CONTROLS
Function Buttons
The Power 0id0ffButton. Used to turn the 74-395
monitor on or off.
The ALARM SILENCE Button. Used to silence
current alarms for the alarm silence duration period.
When an alarm has been silenced, pressing the
button again reactivates, or "unsilences," the alarin.
It is also used to view and adjust alarm silence
duration and alarm volume. The ALARM
SILENCE button clears "Sensor Off' and 66Sei~sor
Disconnect" messages from the display.
The ADJUST UP Button. Used to increase alarm
limit values, alarin silence duration, pulse beep
voluine, alarin volume, contrast, date and time
values, data port baud rate, and to move the cursor
to the right (in the trend view).
The ADJUST DOWN Button. Used to decrease
alarm limit values, alarin silence duration, pulse
beep volume, alarm volume, contrast, date and time
values, data port baud rate, and to move the cursor
to the left (in the trend view).
The CONTRAST Button. Used in conjunction with
the ADJUST UPiDOWN Buttons to lighten or
darken the display screen.
.,..e.r . > ,, .<?:,
5:%@,14&bg@::,
$qh>&s?&s,>*:*$:%<. 8,
&21$T;:<*ff~s<$$~~:.y
The softkey buttons have multiple uses depending
.i~~&:,,y&;:~s&~:~~;&
,$v vw.,F ?,.. ....
on the legend displayed above the button.

DESCRIP"B"0N OF DISPLAYS AND VISUAL INDlCATORS
The %SpOz Display. Shows the saturation of
loo
hemoglobin oxygen. The displayed value flashes
zeros during loss-of-pulse alarms and flashes the
SpOz value when SpOz is outside of the alarm
limits. During Pulse Search, the monitor continues
to update the display. If alarm limits have been
changed from their power-on defaults, a decimal
point
(.) is displayed after the SpOz value (100.).
111
I
I
The Pulse Amplitude Indicator (blip bar). Indicates
-
pulse beat and shows the relative pulse amplitude.
As the detected pulse becomes stronger, more bars
light with each pulse. This indicator is available
only in the blip (magnified) view. The displayed
value flashes zeros during loss-of-pulse alarms and
flashes the pulse rate value when pulse rate is
outside of the alarm limits. During Pulse Search,
the monitor continues to update the display. If
alarm limits have been changed from their power-on
defaults, a decimal point
(.) is displayed after the
pulse rate value
(95.).
BpM 86
The Pulse Rate Display. Shows the pulse rate in
beats per minute.
It flashes during loss-of-pulse
alanns and when the pulse rate is outside of the
alarm limits. During Pulse Search, the monitor
continues to update the display.
@ bq,
The AC Power Indicator. Lights continuously when
the
N-395 is coilnected to AC power. It also
indicates that the battery is charging. It is off when
the monitor is being powered by its internal battery.
@ Q
The Low Battery Indicator. Lights continuously to
indicate that
15 or fewer minutes of battery capacity
remains.

0
The Alarm SilenceIndicator. Lights continuously
when an audible alarm has been silenced. It flashes
when the alarm silence duration has been set to
OFF.
Q
The Motion Indicator. Lights when the inonitor
detects motion artifact.
The Pulse Search Indicator. Lights continuously
(SZI)
prior to initial acquisition of a pulse signal, and
during prolonged and challenging monitoring
conditions. It flashes during a loss-of-pulse signal.
..... iora
The SatSecondsTMIndicator. Fills in clockwise as
......+
the SatSeconds alarin management system
approaches the Satseconds alarm limit threshold.
DESCRIPTION OF AUDIBLE lNDllCATORS
Followiiig are descriptions of N-395 audible indicators.
Power-On Self-Test Pass
A l-second tone indicating that the
N-395 has been turned on and
successfully coinpleted the power-
on self-test
Valid Button Press
A short, medium-pitched tone
indicating that an appropriate button
has been pressed
Invalid Button Press
A short, low-pitched tone indicating
that a button has been pressed that is
not appropriate for the current state
of the monitor
High Priority Alarm
A high-pitched, fast-pulsing tone
indicating loss of pulse
Medium Priority Alarm
A medium-pitched, pulsing tone
indicating an
Sp02 or pulse rate
limit violation

Low Priority Alarm
A low-pitched, slow-pulsing tone
indicating a sensor disconnect,
sensor off, low battery, or monitor
failure
Alarm Silence Reininder Three beeps that sound
approximately every 3 minutes
when alarms are silenced with the
alarm silence duration set to OFF
Pulse Beep A single beep sounds for each
detected pulse. The pitch changes
as inonitored SpOz values increase
or decrease.
Volume Setting Tone A continuous tone that is used to
adjust the alarin volume
Confirination Tone Three beeps sound to indicate that
default settings have been saved or
reset to factory defaults or trend
data has been deleted

SETUP
Unpacking and Inspection
Performance Verification
List of Components
Monitor Setup
Language Selection
UNPACKING AND INSPECTION
Notify the carrier if the shipping carton is damaged. Unpack the
N-395 and coinponents. If anything is inissing or damaged,
contact Mallinckrodt Technical Services Department or your
local Mallinckrodt representative.
PERFORMANCEVERIFICATION
TheN-395 performance can be verified by following the
procedures outlined in the
Performance Vevzjication section of
the N-395 service manual. Qualified service persoilnel should
perform this procedure before using the monitor for the first time
in a clinical setting.
LIST OF COMPONENTS
1 N-395 Pulse Oximeter
1 ~ellcor"sensor or assortment pack
1
SCP-10 or MG- 10Pulse Oxiineter Sensor Cable
1 N-395 Operator's Manual
1 Hospital Grade Power Cord
2 Fuses

Optional Accessories
Several mounting configurations, a utility basket, and a carrying
case are offered with the N-395. Contact Mallinckrodt's
Technical Services Departinent or your local Mallinckrodt
representative for infonnatioil about these accessories.
GCX Mounting Plate. See Figure 3,page 13.
e
GCX Poly-mount (vertical wall mount with 19-inch channel).
See Figure 4, page 14.
GCX Poly-mount (horizontal wall mount with rail adapter).
See Figure
5, page 15.
GCX Roll Stand Poly-mount. See Figure 6, page 16.
CCX Utility Basket. See Figure 7, page 17.
Soft Sided Carrying Case. See Figure 8, page 18.

GCX Mounting Plate
An optional mounting plate is available froin Mallinckrodt for the
N-395. This mounting plate fits standard, commercially available
GCX inount brackets, and is used to securely mount the inonitor
to a wall or roll stand.
The plate attaches to the bottom of the N-395 monitor as shown
in Figure
3. For further instructions regarding connecting the
plate to GCX brackets, refer to the illustrated directioils for use
included with the GCX mounting plate.
Figure 3: GCX Mounting Plate