Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor,
OxiCliq, Dura-Y, Max-Fast, SoftCare, and OxiMax are trademarks of Nellcor Puritan Bennett Inc.
Cet appareil ISM est conforme à la norme NMB-001 Canada.
To obtain information about a warranty, if any, contact Nellcor’s Customer 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.
Warnings are identified by the WARNING symbol shown above.
Warnings alert the user to potential serious outcomes (death, injury, or
adverse events) to the patient or user.
WARNING: The sensor extrapolates from the date and time
provided by the N-600 when recording the sensor event record to
the sensor. The accuracy of the date/time is the responsibility of
the N-600. It is recommended that the N-600 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-600 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.
OxiMax N-6001
Safety Information
WARNING: Pulse oximetry readings and pulse signals can be
affected by certain environmental conditions, OxiMax sensor
application errors, and certain patient conditions. See the
appropriate sections of this manual for specific safety
information.
WARNING: The use of accessories, sensors, and cables other
than those specified may result in increased emission and/or
decreased immunity and inaccurate readings of the N-600 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-600 pulse oximeter.
Safety Information
Caution: When connecting the N-600 to any instrument, verify
proper operation before clinical use. Both the N-600 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-600 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 Standard
60601-1-2. The N-600 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.
Notes
Notes are identified by the Note symbol shown above.
Notes provide additional useful information.
OxiMax N-6003
Blank Page
Introduction
WARNING: The N-600 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-600
The OxiMax® N-600 pulse oximeter is indicated for the continuous
non-invasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO
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
sub-acute centers.
2) and pulse rate. The N-600 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 OxiMax sensors as described in this
manual.
OxiMax N-6005
Introduction
How to Use this Manual
All users should read this manual thoroughly. More experienced users
of the N-600 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:
Alarm Silence Button, page 10
Adjust Up Button,page 10
TM
Indicator, page 13
12.
Contrast Button, page 10
14.
page 13
17. Menu Bar, page 10
18.
Data In Sensor Indicator, page 13
19.
Interference Indicator, page 13
21. Speaker
Figure 1: Front Panel Buttons and Symbols
OxiMax N-6007
Description of Controls, Indicators, and Symbols
Identification of Rear Panel Components
1. Equipotential Terminal (Ground) 4. Fuse Holder
2. AC Power Connector, page 195. Supply Voltage Selector Switch, page 17
3. Data Port Connector, page 97
Figure 2: Rear Panel Components
N-600 Symbols
8
The symbols that are located on the rear panel of the N-600 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-600.
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/Standby button. Used to turn the N-600 on or off.
OxiMax N-6009
Description of Controls, Indicators, and Symbols
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.
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
N-600.
The
Adjust Down button. Used to decrease variable parameters in
the N-600.
Contrast button. Used in conjunction with the Adjust Up and
The
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 40.
10
Description of Controls, Indicators, and Symbols
The pleth display includes a “wiper bar” plethysmographic
waveform, menu bar, and current measured %SpO
SatSeconds are enabled, the pleth display includes the
Indicator and SatSeconds setting. A decimal point after the %SpO
2 and pulse rate. If
SatSeconds
2 or
pulse rate indicate that the respective limits have been changed from
the power on defaults (N-600 Trend Data on page 59).
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 matrices within the N-600 algorithm. Some of
these, are used to assess the severity of conditions presented to the
N-600 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-600 front panel.
The advanced signal processing in the N-600 algorithm automatically
extends the amount of data required for measuring SpO
2 and pulse
rate depending on the measurement conditions. During normal
measurement conditions the averaging time is six seconds to seven
seconds (approximately three seconds in Fast Mode). During
conditions such as those caused by low perfusion, interference (e.g.,
external interference like ambient light), or a combination of the two,
the N-600 algorithm automatically extends the amount of data
required beyond the minimum as set by the response mode. See
Setting the N-600 Response Mode on page 53. If the resulting
dynamic averaging time exceeds 20 seconds, the
indicator is lit solid and SpO
OxiMax N-60011
2 and Pulse Rate will continue to be
Pulse Search
Description of Controls, Indicators, and Symbols
updated every second. As these conditions extend, the amount of data
required continues to increase. If the dynamic averaging time reaches
40 seconds, the pulse search indicator begins flashing, the SpO
pulse rate displays flash zeros indicating a loss-of-pulse condition.
WARNING: Failure to cover the OxiMax sensor site with opaque
material in high ambient light conditions may result in inaccurate
measurements.
2 and
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 N-600 continues to update the display. If
alarm limits have been changed from their power-on defaults, a
decimal point (.) is displayed after the SpO
The
Pulse Amplitude Indicator (blip bar). Indicates pulse beat and
2 value (81.).
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 N-600 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-600 is
connected to AC power. It also indicates that the battery is charging.
It is off when the N-600 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.
Description of Controls, Indicators, and Symbols
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
Interference Indicator. The Interference Indicator lights
whenever the N-600 algorithm detects that the incoming signal
1
quality is degraded
.
An intermittently lit
Interference Indicator is common during
patient monitoring, and indicates the N-600 algorithm is dynamically
adjusting the amount of data required for measuring SpO
2 and Pulse
Rate. When lit continuously, it indicates the N-600 algorithm has
extended the amount of data required for measuring SpO
2 and Pulse
Rate and, consequently, fidelity in tracking rapid changes in these
values may be reduced (see Description of Displays and Indicators
on page 10).
The
Pulse Search Indicator. Lights continuously 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
OxiMax 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
limit setting. Empties in counterclockwise direction when %SpO
2 reading outside of the
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 (two-seconds to four-seconds in fast mode
and four-seconds to seven-seconds in normal mode) applied by the N-600 algorithm in its calculation of SpO
1
Degradations can be caused by ambient light, electrical noise, electro-surgical
interference, patient activity, or other causes.
OxiMax N-60013
2. The N-600 algorithm
Description of Controls, Indicators, and Symbols
calculation of pulse rate is unaffected by the response mode setting.
The trending interval (two-seconds or four-seconds) is updated
automatically by the N-600 to roughly correspond with the SpO
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 N-600 is set to adult limits.
Description of Audible Indicators
Table 1 identifies the audible indicators of the N-600 indicators.
Table 1: Audible Indicators
FunctionDescription
2
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
three 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 N-600.
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
N-600 failure.
14
Description of Controls, Indicators, and Symbols
Table 1: Audible Indicators
FunctionDescription
Power
-On Self-Tes t
Pass
A 1-second tone indicating that the N-600 has
been turned on and has successfully completed
the power
-on self-test.
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.
OxiMax N-60015
Blank Page
Setting up the N-600
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-600 and Nellcor OxiMax sensor
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-600 to extreme moisture, such as
direct exposure to rain. Such exposure may cause inaccurate
performance or device failure.
WARNING: Do not use an N-600 pulse oximeter, OxiMax sensor,
cables, or connectors that appear damaged.
WARNING: Do not lift the pulse oximeter by the pulse oximetry
cable or power cord because the cable or cord could disconnect
from the pulse oximeter, causing the pulse oximeter to drop on
the patient.
OxiMax N-60017
Setting up the N-600
WARNING: The N-600 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-600 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 OxiMax sensor
port. Do not connect any device other than a Nellcor-approved
OxiMax sensor to the OxiMax sensor connector.
18
WARNING: The N-600 should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the
N-600 should be observed to verify normal operation in the
configuration it is to be used.
List of Components
Setting up the N-600
QuantityItem
1N-600 Pulse Oximeter
1Nellcor OxiMax Sensor or Assortment Pack
1
1N-600 Operator’s Manual (applicable to
1Power Cord (applicable to country of sale)
1Quick Guide
DOC
country of sale) and/or Compact Disc
Connecting the N-600 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.
Caution: The SUPPLY VOLTAGE SELECTOR switch must be
set to the correct voltage (115 or 230) to avoid equipment damage
and ensure battery charging.
-10 Pulse Oximetry Cable
OxiMax N-60019
Setting up the N-600
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.
20
2.Plug the female connector end of the power cord into the N-600
POWER CONNECTOR (1) on the rear of the N-600.
3.Plug the male connector of the power cord into a properly
grounded AC outlet.
4.Verify that the N-600’s
Note: If the
AC Power Indicator is not lit, check:
AC Power Indicator is lit.
•the power cord
•the SUPPLY VOLTAGE SELECTOR switch
•the user-accessible fuses
•the AC power outlet
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