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 O
XIMAX 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 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; 5,853,364, and 6,083,172.
Table 6: Tone Definition ......................................................98
vi
Safety Information
Warnings
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: Explosion hazard. Do not use the N-550 pulse
oximeter in the presence of flammable anesthetics or gases.
WARNING: Pulse oximetry readings and pulse signals can be
affected by certain ambient environmental conditions, sensor
application errors, and certain patient conditions. See the
appropriate sections of the manual for specific safety
information.
WARNING: Ensure that the speaker is clear of any obstruction.
Failure to do so could result in an inaudible alarm tone.
N-5501
Safety Information
Cautions
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-550.
CAUTION: When connecting the N-550 to any instrument,
verify proper operation before clinical use. Both the N-550 and
the instrument connected to it must be connected to a grounded
outlet. Accessory equipment connected to the N-550's data
interface must be certified according to IEC Standard 60950 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-550 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-550 accuracy may degrade if it is connected to
secondary I/O devices when the instrument is not connected to
earth reference.
CAUTION: Do not lift the N-550 by the sensor cable or power
cord because the cable or cord could disconnect from the N-550,
causing damage to the N-550 or injuring the patient.
CAUTION: Federal law (U.S.A.) restricts this device to sale by or
on the order of a physician.
2
Notes
Safety Information
Notes are identified by the Note symbol shown above.
Notes provide additional useful information.
N-5503
Blank Page
Introduction
WARNING: The N-550 is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and
symptoms. Do not make any clinical judgments based on the
oximeter's measurements only.
Intended Use for the N-550
The N-550 Pulse Oximeter is indicated for the continuous
noninvasive 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.
2) and pulse rate. The N-550 is intended for use
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.
Intra-hospital transport includes transport of a patient within
the hospital or hospital-type facility .
Use with any particular patient requires the selection of an
appropriate oxygen transducer (sensor) as described in this Operator's
Manual.
Motion performance claims are applicable to models MAX-A,
MAX-AL, MAX-P, MAX-N, and MAX-I Nellcor O
Indicator
5 — Pulse Rate Display16 — Sensor Message Indicator
6 — Alarm Silence Button17 — Pulse Search Indicator
7 — Alarm Silence Indicator18 — Data In Sensor Indicator
8 — Adjust Up Button19 — Low Battery Indicator
9 — Adjust Down Button20 — AC Power Indicator
10 — Pulse Rate Alarm Limit
21 — Speaker
Button
11 — SatSeconds
N-5507
TM
Display
Description of Controls, Indicators, and Symbols
Identification of Rear Panel Components
1 — Data Port Connector3 — AC Power Connector
N-550 Symbols
2 — Foot Switch and Visual
Alarm Connector
Figure 2: Rear Panel Symbols
The symbols that are located on the rear panel of the N-550 are as
follows:
1 — Data Interface3 — Foot Switch
2 — Caution - Do not connect
while power is on
4 — Equipotential Connector
(ground)
4 — Equipotential Terminal
(ground)
8
Description of Controls, Indicators, and Symbols
The symbols that are located on the front panel of the N-550 are as
follows:
1 — T ype BF Applied Part -
Not Defibrillator Proof
2 — Pulse Rate7 — Data In Sensor
3 — Motion8 — Low Battery
4 — Sensor Off9 — AC Power/Battery Charge
5 — Sensor Message
Description of Controls
Note: Each button press, except the Power On/Off button, should
result in either a valid or an invalid button tone. If the button
pressed fails to emit a tone, contact qualified service personnel.
6 — Pulse Search
The Power On/Off button is used to turn the N-550 on or off.
N-5509
Description of Controls, Indicators, and Symbols
The Alarm Silence button is 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 Adjust Up button is used to increase alarm limit values, alarm
silence duration, pulse beep volume, alarm volume, and data port
baud rate. The Adjust Up button is used to select the communication
protocol and time settings. Press the Adjust Up button one time to
increase the display by one digit. Holding the Adjust Up button down
for more than one second cause the display digits to scroll.
The Adjust Down button is used to decrease alarm limit values, alarm
silence duration, pulse beep volume, alarm volume, and data port
baud rate. The Adjust Down button is used to select the
communication protocol and time settings. Press the Adjust Down
button one time to decrease the display by one digit. Holding the
Adjust Down button down for more than one second cause the
display digits to scroll.
The SpO
When the SpO
2 Alarm Limit button is used to view the SpO2 alarm limit.
2 Alarm Limit button is pressed at the same time as the
Pulse Rate Alarm Limit button for approximately three seconds, the
menu options are enabled.
The Pulse Rate Alarm Limit button is used to view the pulse rate
alarm limit. When the Pulse Rate Alarm Limit button is pressed at the
same time as the SpO
2 Alarm Limit button for approximately three
seconds, the menu options are enabled.
The SatSeconds Alarm Limit button is used to view the SatSeconds
alarm limit. When pressed, the menu options are enabled. The Adjust
Up and Adjust Down buttons are used to change the SatSeconds limit
settings.
10
Description of Controls, Indicators, and Symbols
Description of Displays and Indicators
The Pulse Amplitude Indicator (blip bar). A 10-segment LED that
indicates pulse beat and shows the relative pulse amplitude. As the
detected pulse becomes stronger, more bars light with each pulse.
The %SpO
2 Display. Shows the saturation level of oxygenated
hemoglobin. The display value flashes zero during loss-of-pulse
alarms and flashes the SpO
2 value when the SpO2 is outside the alarm
limits. During pulse search, the N-550 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 (100.).
The Pulse Rate Display . Shows the pulse rate in beats per minute. It
flashes zeros during loss-of-pulse alarms and flashes the beats per
minute value in red when the pulse rate is outside of the alarm limit.
During pulse search, the N-550 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
pulse rate value (112.).
The AC Power Indicator. Lights continuously when the N-550 is
connected to AC power. It also indicates that the battery is charging.
It is off when the N-550 is being powered by its internal battery.
The Low Battery Indicator. Lights cont inuously to indicate that 15 or
fewer minutes of battery capacity remain. The Low Battery indicator
flashes when the battery is critically low.
N-55011
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 Motion Indicator. Lights continuously whenever the O
algorithm detects the presence of artifact independent of its severity
or the impact on the SpO
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 continuously prior to initial
acquisition of a pulse signal and during prolonged and challenging
monitoring conditions. It flashes during a loss-of-pulse signal.
The Sensor Off Indicator is lit when either the sensor is invalid, or no
longer on the patient’ s finger. It usually indicates that the sensor is not
on the patient.
The Sensor Message Indicator. Lights when the N-550 cannot
determine an SpO
2 level or a pulse rate. The Sensor Message
recommendations for improving the signal are:
®
XIMAX
2 or pulse rate values. Whenever the motion
12
•Reposition sensor
•Check or change adhesive wrap
•Choose alternate site
•Warm site
•Cover sensor
•Use forehead, nasal, or ear sensor (adult patients only)
The Data In Sensor Indicator. The indicator blinks for approximately
one minute when initially connected to the N-550 to indicate that the
attached O
XIMAX sensor contains a patient sensor event record. The
indicator lights continuously to indicate that the attached sensor
memory is full. The indicator does not light when there is no data in
the sensor, ev en though a valid sensor is connected to the N-550.
TM
The SatSeconds
Indicator. Fills in clockwise as the SatSeconds
alarm management approaches the SatSeconds alarm limit threshold.
All segments of the SatSeconds indicator flash during a SatSeconds
alarm. When a SatSeconds setting other than OFF is selected, the
green LED at the top of the SatSeconds indicator will light. The green
LED at the 12-o'clock position indicates that SatSeconds alarm
management is engaged.
Description of Audible Indicators
Following are descriptions of N-550 audible indicators.
Power-On Self-Test
Pass
A 1-second tone indicating that the N-550
has been turned on and has successfully
completed the power-on self-test
Valid Button PressA short, medium-pitched tone indicating
that an appropriate button has been
pressed
Invalid Button PressA short, low-pitched tone indicating that a
button has been pressed that is not
appropriate for the current state of the
N-550
High Priority AlarmA high-pitched, fast-pulsating tone
indicating loss of pulse with no patient
motion
Medium Priority
Alarm
A medium-pitched, normal-pulsating tone
indicating an SpO
2 or pulse rate limit
violation
N-55013
Description of Controls, Indicators, and Symbols
Low Priority AlarmA low-pitched, slow-pulsating tone
indicating a sensor disconnect, low
battery, or N-550 failure
Alarm Silence
Reminder
Three beeps that sound approximately
every 3 minutes when alarms are silenced
with the alarm silence duration set to OFF
Pulse BeepA single beep sounds for each detected
pulse. The pitch changes as monitored
2 values increase or decrease.
SpO
Volume Setting ToneA continuous tone that is used to adjust
the alarm volume
Confirmation T o neThree beeps sound to indicate that default
settings have been saved or reset to
factory defaults or trend data has been
deleted
14
Setting up the N-550
WARNING: Explosion hazard. Do not use the N-550 pulse
oximeter in the presence of flammable anesthetics or gases.
WARNING: Pulse oximetry readings and pulse signals can be
affected by certain ambient environmental conditions, sensor
application errors, and certain patient conditions. See the
appropriate sections of the manual for specific safety
information.
WARNING: To ensure patient safety, do not place the N-550 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: Disconnect the N-550 and Nellcor sensor from the
patient during magnetic resonance imaging (MRI) scanning.
Induced current could potentially cause burns. The N-550 may
affect the MRI image; the MRI unit may affect the accuracy of
oximeter measurements.
WARNING: To ensure accurate performance and prevent device
failure, do not subject the N-550 to extreme moisture, such as
direct exposure to rain. Such exposure may cause inaccurate
performance or device failure.
N-55015
Setting up the N-550
WARNING: Do not use an N-550, sensor, cables, or connectors
that appear to be damaged.
WARNING: The N-550 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 use and shortly thereafter.
WARNING: In the USA, do not connect the N-550 to an electrical
outlet controlled by a wall switch because the N-550 may be
accidentally turned off.
WARNING: Use only the DOC-10 pulse oximetry cable with the
N-550. Use of another sensor cable will have an adverse effect on
performance. Do not attach any cable that is intended for
computer use to the sensor port. Do not connect any device other
than a Nellcor-approved sensor to the sensor connector.
List of Components
1 — N-550 Pulse Oximeter
1 — Nellcor Sensor or Assortment Pack
1 — DOC-10 Pulse Oximeter Cable
1 — N-550 Operator's Manual
1 — Hospital-Grade Power Cord or power cord appropriate for
1 — Sensor Accuracy Grid
1 — Quick Guide
16
country of sale
Connecting the N-550 to AC Power
1 — Power Connector
1. Plug the female connector of the power cord into the N-550 AC
power connector (1).
2. Plug the male connector of the power cord into a properly
grounded AC outlet.
Setting up the N-550
3. Verify that the AC POWER INDICATOR is lit.
Connecting a Sensor to the N-550
WARNING: Use only the DOC-10 pulse oximetry cable with the
N-550. Use of another sensor cable will have an adverse effect on
performance. Do not attach any cable that is intended for
computer use to the sensor port. Do not connect any device other
than a Nellcor-approved sensor to the sensor connector.
N-55017
Setting up the N-550
.
1 — SpO2 Sensor Port
1. Connect a DOC-10 pulse oximetry cable to the SpO2 Sensor Port
(1) on the front of the N-550.
2. Connect an SpO
2 Sensor to the other end of the DOC-10 pulse
oximetry cable. Plug the sensor connector firmly into the
DOC-10 pulse oximetry cable.
18
Battery Operation
WARNING: Dispose of an old battery by following local
guidelines for disposal of lead acid batteries.
Operating the N-550 on Battery Power
The N-550 has an internal battery that may be used to power the
N-550 during transport or when AC power is not available. A new,
fully charged battery will provide at least 1.5 to 2 hours of monitoring
time under the following conditions: no audible alarms sound and no
serial output devices are attached.
Note: Whenever the N-550 is connected to AC power, the battery is
being charged. Therefore, it is recommended that the N-550
remain connected to AC power when not in use. This will
make a fully charged battery availabl e for use at any t ime .
The N-550 cannot operate with a dead battery (even when plugged
in). Before attempting to turn on an N-550 with a depleted battery,
first plug the N-550 into an AC outlet to allow the battery to charge
for a few minutes. The N-550 may then be powered on.
To charge a low or dead battery, connect the N-550 to AC power. A
full charge of a dead battery takes 11 hours while the N-550 is turned
off or 12 hours while the N-550 is on.
When all of the following conditions are present for 15 minutes, the
N-550 will automatically shut down:
•N-550 is running on battery power
•No buttons have been pressed
•No pulse has been detected (for example, when no patient is
connected to the sensor or the sensor is disconnected)
N-55019
Battery Operation
•No alarms are present (other than low battery or a
Low Battery Indicator
The Low Battery Indicator lights and a low priority alarm begins to
sound when 15 minutes but not more than 20 minutes of monitoring
time remain on the existing battery charge. This alarm cannot be
silenced while running on battery power. Connecting the N-550 to
AC power will silence the alarm. If the N-550 is not connected to AC
power within approximately 15 minutes, the N-550 will shut off.
Note: As the battery is used and recharged over a period of time, the
It is recommended that qualified service personnel replace the
internal battery every 24 months.
non-correctable error)
amount of time between the onset of the low battery alarm and
the N-550 shut-off may become shorter.
20
CAUTION: If the N-550 is to be stored for 2 months or longer,
notify service personnel to remove the battery from the N-550
prior to storage. Recharge the battery when it has not been
charged for 2 or more months.
The Low Battery Indicator flashes and a high priority alarm begins to
sound when the battery reaches the lowest battery voltage at which an
N-550 can support normal operation. This alarm cannot be silenced
while running on battery power. If the N-550 is not connected to AC
power, the N-550 will shut off after 10 seconds.
Using the N-550
Turning on the N-550
Discussion
Before using the N-550 in a clinical setting, you must verify that the
N-550 is working properly and is safe to use. Proper working
condition can be verified by successful completion of the Power-On
Self-Test (POST), described in the following section.
WARNING: The N-550 should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the
N-550 should be observed to verify normal operation in the
configuration in which it is used.
CAUTION: If any indicator or display element does not light, or
the speaker does not sound, do not use the N-550. Instead, contact
qualified service personnel, your local Nellcor representative, or
Nellcor's Technical Services Department, 1.800.635.5267.
Note:The N-550 should complete the POST function within 12
seconds.
Procedure
1. Turn on the N-550 by pressing and holding the Power On/Off
button for more than one second.
N-55021
Using the N-550
2. The N-550 displays/sounds:
DisplaySound
5 (in pulse rate left window)one beep tone
5 (in pulse rate center window)one beep tone
0 (in pulse rate right window)one beep tone
n (in SpO
n (in SpO
2 left window)none
2 center window)none
3. The N-550 automatically starts the Power-On Self-Test (POST),
which tests N-550 circuitry and functions.
CAUTION: During POST (immediately after power-up), confirm
that all display segments and indicators light, and the speaker
sounds a 1-second pass tone.
22
4. While performing POST, the self-test display appears for
approximately 2 to 4 seconds. During this time:
•All indicators illuminate
•All segments of all numeric digits light and change from red
to green
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