Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor,
OxiCliq, Dura-Y, MAX-FAST, and O
XIMAX are trademarks of Nellcor Puritan Bennett Inc.
This ISM device complies with Canadian ICES-001.
Cet appareil ISM est conforme à la norme NMB-001 Canada.
To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department,
or your local representative.
Purchase of this instrument confers no express or implied license under any Nellcor Puritan
Bennett patent to use the instrument with any sensor that is not manufactured or licensed by
Nellcor Puritan Bennett.
Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643;
4,653,498; 4,700,708; 4,770,179; Re. 35,122; 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136;
5,351,685; 5,368,026; 5,485,847; 5,533,507; 5,662,106; and 5,853,364.
Warnings are identified by the WARNING symbol shown above.
W arnings alert the user to potential serious outcomes (death, injury, or
adverse events) to the patient or user.
WARNING: The sensor extrapolates from the date and time
provided by the N-595 when recording the sensor event record to
the sensor. The accuracy of the date/time is the responsibility of
the N-595. It is recommended that the N-595 user set the time/
date to the correct value before a sensor event record-enabled
sensor is connected, and that this date/time not be changed while
the sensor remains connected. Since a sensor with sensor event
record data can be transported from one monitor to another,
having discrepancies in the date/time between monitors and the
sensor event record data will affect the order the sensor event
record data appears. To eliminate this possible problem, all
monitors within an institution should be set to the same time.
WARNING: Explosion hazard. Do not use the N-595 pulse
oximeter in the presence of flammable anesthetics or gases.
WARNING: Chemicals from a broken LCD display panel are
toxic when ingested. Use caution when handling a pulse oximeter
with a broken display panel.
N-5951
Safety Information
WARNING: Pulse oximetry readings and pulse signals can be
affected by certain environmental conditions, O
XIMAX sensor
application errors, and certain patient conditions. See the
appropriate sections of this manual for specific safety
information.
WARNING: The use of accessories, sensor s, and cables other
than those specified may result in increased emission and/or
decreased immunity and inaccurate readings of the N-595 pulse
oximeter.
WARNING: Failure to cover the OXIMAX sensor site with opaque
material in high ambient light conditions may result in inaccurate
measurements.
Cautions
2
Cautions are identified by the CAUTION symbol shown above.
Cautions alert the user to exercise care necessary for the safe and
effective use of the N-595 pulse oximeter.
Safety Information
Caution: When connecting the N-595 to any instrument, verify
proper operation before clinical use. Both the N-595 and the
instrument connected to it must be connected to a grounded
outlet. Accessory equipment connected to the pulse oximeter’s
data interface must be certified according to IEC Standard 950
for data-processing equipment or IEC Standard 60601-1 for
electromedical equipment. All combinations of equipment must
be in compliance with IEC Standard 60601-1-1 systems
requirements. Anyone who connects additional equipment to the
signal input port or signal output port (N-595 data port
connector) configures a medical system and is therefore
responsible for ensuring that the system complies with the
requirements of system standard IEC Standard 60601-1-1 and
the electromagnetic compatibility system standard IEC S tandard
60601-1-2. The N-595 accuracy may degrade if it is connected to
secondary I/O devices when the instrument is not connected to
earth reference.
Caution: Federal law (U.S.A.) restricts this device to sale by or on
the order of a physician.
Caution: Dispose of battery in accordance with local
requirements and regulations.
N-5953
Introduction
WARNING: The N-595 is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and
symptoms.
Intended Use for the N-595
The N-595 pulse oximeter is indicated for the continuous
non-invasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO
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.
2) and pulse rate. The N-595 is intended for use
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 O
Operator's Manual.
N-5955
XIMAX sensors as described in this
Introduction
Motion performance claims are applicable to models MAX-A,
MAX-AL, MAX-P, MAX-N, and MAX-I Nellcor O
oximetry sensors.
How to Use this Manual
All users should read this manual thoroughly . More experienced users
of the N-595 will be able to go to the topics for the information they
require.
The current copy of this manual is available on the internet at:
2 Display, page 1218. Data In Sensor Indicator, page 13
12. ADJUST DOWN Button, page 10
14. CONTRAST Button, page 10
17. Menu Bar, page 10
Figure 1: Front Panel Buttons and Symbols
N-5957
Description of Controls, Indicators, and Symbols
Identification of Rear Panel Components
1. Equipotential Terminal (Ground) 4. Fuse Holder
2. AC Power Connector, page 175. Supply Voltage Selector Switch, page 17
3. Data Port Connector, page 91
Figure 2: Rear Panel Components
N-595 Symbols
8
The symbols that are located on the rear panel of the N-595 are as
follows:
See Instructions for Use
Fuse Replacement
Equipotential Terminal (ground)
Date of Manufacture
Data Interface
There is one symbol located on the front panel of the N-595.
Type BF Applied Part - Not defibrillator proof.
Description of Controls
Description of Controls, Indicators, and Symbols
Note: A button press, except the ON/STANDBY button, should
result in either a valid or an invalid key tone (refer to Table 1
on page 14). If the key pressed fails to emit a tone, contact
qualified service personnel.
The ON/ST ANDBY button. Used to turn the N-595 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 alarm. It is
also used to view and adjust alarm silence duration and alarm volume.
N-5959
Description of Controls, Indicators, and Symbols
The ALARM SILENCE button clears “SENSOR OFF,” “LOW
BATTERY,” and “SENSOR DISCONNECT” messages from the
display.
The ADJUST UP button. Used to increase variable parameters of the
monitor.
The ADJUST DOWN button. Used to decrease variable parameters
in the monitor.
The CONTRAST button. Used in conjunction with the ADJUST UP
and ADJUST DOWN buttons to lighten or darken the display screen.
The softkey buttons have multiple uses depending on the legend
displayed above the button.
Description of Displays and Indicators
The type of display is user selectable. Refer to Selecting the Pleth
View on page 34.
10
The pleth display includes a “wiper bar” plethysmographic
waveform, menu bar, and current measured %SpO
2 and pulse rate. If
SatSeconds are enabled, the pleth display includes the SatSeconds
indicator and SatSeconds setting. A decimal point after the %SpO
2 or
Description of Controls, Indicators, and Symbols
pulse rate indicate that the respective limits have been changed from
the power on defaults (Monitor Trend Data on page 53).
The blip display includes a pulse amplitude blip bar, current measured
%SpO
2 and pulse rate, and current upper and lower %SpO2 and pulse
rate limits. If SatSeconds are enabled, the blip display includes the
SatSeconds indicator and SatSeconds setting. Decimal points after the
%SpO
2 or pulse rate indicate that the respective limits have been
changed from the power-on defaults.
There are various matrixes within the O
XIMAX algorithm. Some of
these, are used to assess the severity of conditions presented to the
N-595 in measuring SpO
2 and pulse rate on a patient. These
individual matrices or combinations of these matrices are used to
drive the LED indicators on the N-595 front panel.
The OxiMax algorithm automatically extends the amount of data
required for measuring SpO2 and pulse rate depending on the
measurement conditions. During normal measurement conditions the
averaging time is 6-7 seconds. During challenging measurement
conditions which could be caused by low perfusion, motion, external
interference like ambient light, or a combination of these, the
OXIMAX algorithm automatically extends the amount of data
required beyond 7 seconds. If the resulting dynamic averaging time
exceeds 20 seconds, the pulse search indicator is lit solid and SpO2
and Pulse Rate will continue to be updated every second. As these
conditions become even more challenging, the amount of data
required continues to extend. If the dynamic averaging time reaches
40 seconds, the pulse search indicator begins flashing, the SpO2 and
pulse rate displays flash zeros indicating a loss-of-pulse condition.
N-59511
Description of Controls, Indicators, and Symbols
WARNING: Failure to cover the OXIMAX sensor site with opaque
material in high ambient light conditions may result in inaccurate
measurements.
The %SpO
2 Display. Shows the hemoglobin oxygen saturation level.
The display value flashes zeros during loss-of-pulse alarms and
flashes the SpO
2 value when the SpO2 is outside 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 SpO
2 value (81.).
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 view.
The Pulse Rate Display. Shows the pulse rate in beats per minute. It
flashes during loss-of-pulse alarms and when the pulse rate is outside
of the alarm limits. During Pulse Search, the monitor continues to
update the display. Pulse rates outside of the pulse rate range (20 to
250 bpm) are displayed as the closest value within the range. If alarm
limits have been changed from their power-on defaults, a decimal
point (.) is displayed after the BPM value (112.).
The AC Power Indicator. Lights continuously when the N-595 is
connected to AC power. It also indicates that the battery is charging.
It is off when the monitor is being powered by internal battery.
12
The Low Battery Indicator. Lights continuously when 15 or fewer
minutes of battery capacity remain. Flashes when the battery capacity
reaches critical condition.
The Alarm Silence Indicator. Lights continuously when an audible
alarm has been silenced. It flashes when the alarm silence duration
has been set to Off.
The Motion Indicator. The motion indicator is lit whenever the
O
XIMAX algorithm detects the presence of artifacts
its severity or the impact on the SpO
2 or pulse rate values. When the
1
independent of
Description of Controls, Indicators, and Symbols
motion indicator and the pulse search indicator are simultaneously lit,
it is an indication that the artifact is significant and/or has been
persistent.
The Pulse Search Indicator. Lights continuo usly prior to initial
acquisition of a pulse signal and during prolonged and challenging
monitoring conditions. The pulse search indicator flashes during a
loss-of-pulse signal.
The Data In-Sensor Indicator. Lights to indicate that the attached
O
XIMAX sensor contains a patient sensor event record. The sensor
event record information may be viewed or printed.
The SatSeconds Indicator. Fills in clockwise as the SatSeconds alarm
management system detects a %SpO
setting. Empties in counterclockwise direction when %SpO
2 reading outside of the limit
2 reading
is within limits. When the indicator is full, a medium priority alarm
will sound.
The Fast Response Mode Indicator. The response mode setting
dictates the response time (2 to 4 seconds in fast mode and 4 to 7
seconds in normal mode) applied by the O
calculation of SpO
2. The OXIMAX algorithm’s calculation of pulse rate
XIMAX algorithm in its
is unaffected by the response mode setting. The trending interval
(2-seconds or 4-seconds) is updated automatically by the monitor to
roughly correspond with the SpO
2 calculation response time.
The Neonate Alarm Limits Indicator. This symbol is displayed when
the alarm limits are set to neonate. No symbol is displayed when the
monitor is set to adult limits.
1
Artifacts are events contained in the in-sensor data.
N-59513
Description of Controls, Indicators, and Symbols
Description of Audible Indicators
Table 1 identifies the audible indicators of the N-595 indicators.
Table 1: Audible Indicators
FunctionDescription
Alarm Silence
Reminder
Confirmation ToneThree beeps sound to indicate that default
Invalid Button Press
Valid Button Press
High Priority Alarm
Medium Priority
Alarm
Low Priority Alarm
Three beeps that sound approximately every 3
minutes when alarms are silenced with the
alarm silence duration set to Off and the alarm
silence reminder function is enabled.
settings have been saved or reset to factory
defaults or trend data has been deleted.
A short, low
button has been pressed that is not appropriate
for the current state of the monitor.
A short, medium
an appropriate button has been pressed.
A high
loss
-of-pulse.
A medium
SpO
2 or pulse rate limit violation.
A low
-pitched tone indicating that a
-pitched tone indicating that
-pitched, fast-pulsing tone indicating
-pitched, pulsing tone indicating an
-pitched, slow-pulsing tone indicating an
OXIMAX sensor disconnect, low battery, or
monitor failure.
Power
-On Self-Test
Pass
A 1-second tone indicating that the N-595 has
been turned on and has successfully completed
the power
-on self-test.
14
Pulse BeepA single beep sounds for each detected pulse.
Volume Setting ToneA continuous tone that is used when adjusting
The pitch of the pulse beep signal changes with
-by-point rise or fall in the saturation
a point
level.
the alarm volume.
Setting up the Monitor
WARNING: To ensure patient safety, do not place the pulse
oximeter in any position that might cause it to fall on the patient.
WARNING: As with all medical equipment, carefully route
patient cabling to reduce the possibility of patient entanglement
or strangulation.
WARNING: Ensure that the speaker is clear of any obstruction.
Failure to do so could result in an inaudible alarm tone.
WARNING: Disconnect the N-595 and Nellcor OXIMAX se nsor
from the patient during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns.
WARNING: To ensure accurate performance and prevent device
failure, do not subject the N-595 to extreme moisture, such as
direct exposure to rain. Such exposure may cause inaccurate
performance or device failure.
WARNING: Do not use an N-595 pulse oximeter, OXIMAX sensor,
cables, or connectors that appear damaged.
WARNING: Do not lift the pulse oximeter by the pulse oxime try
cable or power cord because the cable or cord could disconnect
from the pulse oximeter, causing the pulse oximeter to drop on
the patient.
N-59515
Setting up the Monitor
WARNING: The N-595 is not defibrillator-proof. However, it
may remain attached to the patient during defibrillation or while
an electrosurgical unit is in use, but the readings may be
inaccurate during the defibrillation and shortly thereafter.
WARNING: In the USA, do not connect the pulse oximeter to an
electrical outlet controlled by a wall switch, because the pulse
oximeter may be accidentally turned off.
WARNING: Use only the Nellcor pulse oximetry cable DOC-10
with the N-595 pulse oximeter. Use of another pulse oximetry
cable will have an adverse effect on performance. Do not attach
any cable that is intended for computer use to the O
XIMAX sensor
port. Do not connect any device other than a Nellcor -approved
OXIMAX sensor to the OXIMAX sensor connector.
16
WARNING: The N-595 should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the
N-595 should be observed to verify normal operation in the
configuration it is to be used.
List of Components
Setting up the Monitor
QuantityItem
1
1Nellcor O
1
1
1Power Cord (applicable to country of sale)
2
1Sensor Accuracy Grid
1Quick Guide
N
DOC
N
country of sale) and/or Compact Disk
Fuses, 0.5 A, 250 volts, slow
20 mm)
Connecting the N-595 to AC Power
WARNING: In the USA, do not connect the pulse oximeter to an
electrical outlet controlled by a wall switch, because the pulse
oximeter may be accidentally turned off.
-595 Pulse Oximeter
XIMAX Sensor or Assortment Pack
-10 Pulse Oximetry Cable
-595 Operator’s Manual (applicable to
-blow, IEC (5 x
Caution: The SUPPLY VOLTAGE SELECTOR switch must be
set to the correct voltage (1 15 or 230) to avoid equipment dama ge
and ensure battery charging.
N-59517
Setting up the Monitor
Caution: Use only the hospital-grade power cord provided by
Nellcor.
1. Power Connector2. Supply Voltage Selector
1. Set the SUPPLY VOLTAGE SELECTOR (2) switch to the
applicable voltage.
2. Plug the female connector end of the power cord into the N-595
POWER CONNECTOR (1) on the rear of the monitor.
3. Plug the male connector of the power cord into a properly
grounded AC outlet.
4. Verify that the monitor’s AC POWER INDICATOR is lit.
Note: If the AC POWER INDICATOR is not lit, check:
•the power cord
•the SUPPLY VOLTAGE SELECTOR switch
•the user-accessible fuses
•the AC power outlet
18
Connecting an OXIMAX Sensor to the N-595
The OXIMAX sensor type is displayed at the bottom of the display
when an O
completes POST with an O
XIMAX sensor is connected to the N-595 or when the N-595
XIMAX sensor attached.
Setting up the Monitor
Caution: Use only Nellcor-approved O
XIMAX sensors and pulse
oximetry cables.
Note: Physiological conditions, medical procedures, or external
agents that may interfere with the monitor’s ability to detect
and display measurements include dysfunctional hemoglobin,
arterial dyes, low perfusion, dark pigment, and externally
applied coloring agents, such as nail polish, dye, or pigmented
cream.
1. SpO2 O
XIMAX Sensor Port
1. Connect a DOC-10 pulse oximetry cable to the SpO
2OXIMAX
sensor port (1) of the monitor.
2. Connect a Nellcor O
XIMAX SpO2 sensor to the other end of the
DOC-10 pulse oximetry cable.
N-59519
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