Nellcor OxiMax N-65 User manual
Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare.
Nellcor, Oxiband, Durasensor, OxiCliq, Dura-Y, MAX-FAST, and O
XIMAX
are trademarks of Nellcor Puritan Bennett Incorporated or an affiliate.
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 fo llowing U.S. Patents and foreign
equivalents: 4,802,486; 4,869,254; 4,928,692; 4,934,372; 4,960,126;
5,078,136; 5,485,847; 5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310;
6,591,123; 6,675,031; 6,708,049; 6,801,797; and Re.35,122.
Contents
Safety Information ...................................................................... 1
Warnings ...................................... .....................................................1
Cautions .................................... ........................................................ 4
Notes ..................................... .......................... .......................... ........5
Introduction .................................................................................7
Intended Use for the OXIMAX N-65 .................... ......................... .....7
How to Use this Manual ....................................................................7
Symbols, Controls, Displays, and Indicators ........................... 9
Front Panel Description ....................................................................9
Front Panel Symbols .......................................................................13
Rear Panel Symbols .......................................................................14
Label Symbols ................................................ .... ... ... ... ... .... ............15
Controls ................................. .......................... .......................... ......16
Displays and Indicators ...................................................................19
Audible Indicators ........................................................................... 24
Set up the OXIMAX N-65 .......................................................... 25
List of Components ......................................................................... 27
Connect OXIMAX Sensor to the Monitor ........................................ 27
Inaccurate Monitor Measurements ........................................... 28
Battery Operation ..................................................................... 31
Battery Power ................................................................................. 31
Low Battery Indicator ................... ... ... .... ... ... ... ................................31
Critical Battery Indication ................................................................32
Battery Installation ..........................................................................33
OXIMAX N-65 Operation ........................................................... 35
Introduction ..................................................................................... 35
Turn On the OXIMAX N-65 .............................................................36
Discussion ................................................................................ 36
Procedure ................................................................................. 37
OXIMAX Sensor Attached ........................................................ 41
No OXIMAX Sensor Attached .................................................. 42
OXIMAX N-65 Operator’s Manual i
Backlight On/Off .............................................................................. 43
Adjust Pulse Beep Volume ............................................................. 43
Discussion ................................................................................ 43
Procedure — During Monitoring ...............................................44
Procedure — Using Menu Structure ................... ... ... .... ... ... ......45
Adjust Alarm Volume ......................................................................46
Discussion ................................................................................ 46
Procedure ................................................................................. 46
Set Time and Date .............................................................. ............48
Discussion ................................................................................ 48
Procedure ................................................................................. 49
Set Alarm Silence Duration .............................................................53
Discussion ................................................................................ 53
Procedure ................................................................................. 53
Disable Audible Alarms ...................................................................54
Discussion ................................................................................ 54
Procedure ................................................................................. 55
Set Alarm Limits ..............................................................................56
Discussion ................................................................................ 56
Procedure ................................................................................. 57
Alarm Limit Changed Indicator ........................................................61
Record Snap-Shot Data ..................................................................61
Discussion ................................................................................ 61
Procedure ................................................................................. 62
Print Data .................................................. ... ... .... ... ... ......................63
Discussion ................................................................................ 63
Print Mode ....... ....................................... ... ... ... ... .... ... ... ......65
After Printing Data ..............................................................65
Procedure ................................................................................. 67
OXIMAX Sensor Event Record ................................................ 69
Event Records ................................................................................ 69
OXIMAX Sensors and Accessories ......................................... 71
Select an OXIMAX Sensor .............................................................. 71
OXIMAX Sensor Features ..............................................................76
Biocompatibility Test ....................................................................... 77
Optional Accessories ......................................................................77
Rubber Boot With Clip ..............................................................78
Functional Thermoformed Holster ............................................79
Carrying Case ...........................................................................80
Water-Resistant Jacket ............................................................81
ii OXIMAX N-65 Operator’s Manual
Infrared Printer ..........................................................................82
Thermal Paper ..........................................................................83
DEC-4 Extension Cable ............................................................84
Transport Boot ..........................................................................85
Performance Considerations ................................................... 87
Performance Verification ........... ... ... ... .... ... ... ... .... ... .........................87
OXIMAX N-65 Performance Considerations ................................... 87
Dysfunctional Hemoglobins ...................................................... 88
Anemia .....................................................................................88
Saturation ................................................................................. 88
Pulse Rates ..................................... ... ... ... .... ... .........................88
OXIMAX Sensor Performance Considerations ............................... 89
Troubleshooting ....................................................................... 93
Error Codes .....................................................................................93
Corrective Action ............................................................................. 95
EMI (Electromagnetic Interference) ................................................ 99
Technical Assistance ....................................................................100
Maintenance ............................................................................ 103
Return the OXIMAX N-65 .............................................................103
Service .......................................................................................... 104
Periodic Safety Checks ............. ... ... ... .... ... ... ... .... ... ... ... .................104
Cleaning ....................................... .................................................105
Menu Structure ....................................................................... 107
Set Menus Quick Reference .........................................................107
Set Menu Parameters .............................................................108
Set Time/Date Parameters .....................................................110
Principles of Operation .......................................................... 113
Oximetry Overview ....................................................................... 113
Automatic Calibration ......................................... ... ... .... ... ... ... . 114
Functional versus Fractional Saturation .................................115
Measured versus Calculated Saturation ................................. 115
OXIMAX Technology .................................................................... 116
Functional Testers and Patient Simulators ...................................117
Specifications ......................................................................... 119
Performance .................................................................................119
OXIMAX N-65 Operator’s Manual iii
Electrical .......................................................................................126
Environmental Conditions ............................................................. 128
Physical Characteristics ................................................................129
Compliance ................................................................................... 129
Manufacturer’s Declaration ................................................. ... ... ... . 130
Index ........................................................................................ 137
iv OXIMAX N-65 Operator’s Manual
Safety Information
Warnings
Warnings are identified by the WARNING symbol
shown above.
Warnings alert the user to potential serious outcomes,
such as death, injury, or adverse events to the patient or
user.
WARNING: The OXIMAX sensor uses the date and
time provided by the
oximeter when the sensor event record is recorded by
the sensor. The accuracy of the date/time is dependent
on the date/time already set in and provided by the
OXIMAX N-65.
OXIMAX N-65 handheld pulse
WARNING: Explosion hazard. Do not use the
XIMAX N-65 in the presence of flammable anesthetics
O
mixture with air, oxygen, or nitrous oxide.
WARNING: Chemicals from a broken LCD display
panel are toxic when ingested. Use caution when the
OXIMAX N-65 has a broken display panel.
OXIMax N-65 Operator’s Manual 1
Safety Information
WARNING: Routinely monitor the patient to make
sure the O
XIMAX N-65 is functioning and the sensor is
correctly placed.
WARNING: Pulse oximetry measurements 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, sensors, and
cables other than those specified may result in
increased emission and/or create invalid readings of
the OXIMAX N-65.
WARNING: Failure to cover the OXIMAX sensor site
with opaque material in high ambient light conditions
may result in inaccurate measurements.
WARNING: Do not silence the audible alarm
function, or decrease the audible alarm volume, if
patient safety could be compromised.
WARNING: The OXIMAX N-65 is a prescription
device to be operated only by trained personnel. The
monitor is for attended monitoring only.
2 OXIMax N-65 Operator’s Manual
Safety Information
WARNING: Dispose of batteries in accordance with
local ordinances and regulations.
WARNING: The OXIMAX N-65 is not
defibrillator-proof. However, it may remain attached
to the patient throughout defibrillation or while an
electrosurgical unit is in use. The measurements may
be inaccurate throughout the defibrillation, or use of
an electrosurgial unit, and shortly thereafter. To
avoid shock, the caregiver should not hold the
OXIMAX N-65 while using a defibrillator on a patient.
WARNING: Disconnect the OXIMAX N-65 and Nellcor
O
XIMAX sensor from the patient throughout magnetic
resonance imaging (MRI) scanning. Induced current
could potentially cause burns.
WARNING: To ensure accurate performance and
prevent device failure, do not subject the O
XIMAX
N-65 to extreme moisture, such as direct exposure to
rain. Such exposure may cause inaccurate
performance or device failure.
WARNING: Do not use an OXIMAX N-65, OXIMAX
sensor, or cables that appear damaged.
OXIMax N-65 Operator’s Manual 3
Safety Information
Cautions
WARNING: Do not lift the OXIMAX N-65 by the
sensor or extension cable because the cable could
disconnect from the monitor and the monitor may
drop on the patient.
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 O
XIMAX N-65 handheld pulse
oximeter.
Caution: All combinations of equipment must be in
compliance with IEC Standard 60601-1-1 systems
requirements.
Caution: Federal law (U.S.A.) restricts this device to
sale by or on the order of a physician.
4 OXIMax N-65 Operator’s Manual
Notes
Safety Information
Notes are identified by the Note symbol shown above.
Notes contain important information that may otherwise
be overlooked or missed.
OXIMax N-65 Operator’s Manual 5
Safety Information
6 OXIMax N-65 Operator’s Manual
Introduction
WARNING: Do not make any clinical judgments
based solely on the O
intended only as an adjunct in patient assessment. It
must be used in conjunction with clinical signs and
symptoms.
Intended Use for the OXIMAX N-65
The OXIMAX™ N-65 handheld pulse oximeter is
indicated for continuous or spot check monitoring of
functional arterial oxygen saturation (SpO
rate of adult, pediatric and neonatal patients in hospital,
hospital type facilities, transport and mobile
environments as well as in the home care environment.
How to Use this Manual
XIMAX N-65. The monitor is
2) and pulse
All users should read this manual thoroughly. More
experienced users of the monitor can refer directly to the
topics for the information they require.
The current copy of this manual is available on the
internet at:
http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html
OXIMax N-65 Operator’s Manual 7
Introduction
8OXIMax N-65 Operator’s Manual
Symbols, Controls, Displays, and Indicators
Front Panel Description
This section identifies the symbols, controls, displays,
and indicators on the O
XIMAX N-65.
1 — %SpO2 area of display
2 — Measured %SpO2
3 — Pulse beats per minute (BPM) area of display
4 — Measured BPM
OXIMax N-65 Operator’s Manual 9
Symbols, Controls, Displays, and Indicators
5 — %SpO2 Lower Alarm Limit indicator
6 — %SpO
2 Upper Alarm Limit indicator
7 — Pulse Amplitude indicator (Blip bar)
8 — Time Colon time/date field separator
9 — Adjust Time mode indicator
10 — Adjust Volume mode indicator
11 — Set Limit mode indicator
12 — BPM Upper Alarm Limit
indicator
13 — BPM Limit Changed indicator
14 — Sensor Off Patient indicator
15 — Sensor Disconnected indicator
16 — %SpO
2 Limit Changed indicator
10 OXIMax N-65 Operator’s Manual
Symbols, Controls, Displays, and Indicators
17 — Low Battery indicator
18 — Data In-Sensor indicator
19 — Alarm Volume Adjust indicator
20 — Pulse Beep Tone Volume Adjust indicator
21 — BPM Lower Alarm Limit indicator
22 — Print indicator
23 — Interference indicator
24 — Pulse Search indicator
25 — Data indicator
26 — Alarm Silenced indicator
OXIMax N-65 Operator’s Manual 11
Symbols, Controls, Displays, and Indicators
27 — Power button
28 — Up Arrow button
29 — Backlight button
30 — Menu button
31 — Data (Record/Print) button
32 — Down Arrow button
33 — Alarm Silence button
12 OXIMax N-65 Operator’s Manual
Front Panel Symbols
The following two symbols are located on the front panel
of the monitor.
Displays the measured percent of oxygen saturation.
Displays the measured pulse beats per minute.
Symbols, Controls, Displays, and Indicators
OXIMax N-65 Operator’s Manual 13
Rear Panel Symbols
The following symbols are located on the rear panel of
the monitor.
Symbols, Controls, Displays, and Indicators
1 — Label
2 — Battery Cover
See Instructions for Use
Type BF Applied Part - Not defibrillator proof
Resistant to liquid ingress
Rx Prescription only
Date of Manufacture
European union approval
14 OXIMax N-65 Operator’s Manual
Canadian/USA certification mark (electrical safety)
Russian regulatory approval
Serial number
Label Symbols
These symbols display on the monitor’s labels.
Keep away from heat
Temperature limitation
Symbols, Controls, Displays, and Indicators
Protect from moisture
Fragile
Keep upright
Humidity limitation
OXIMax N-65 Operator’s Manual 15
Controls
Symbols, Controls, Displays, and Indicators
This section describes the controls on the front panel of
the monitor. The controls are activated by pressing the
button that corresponds to that control. For example,
press the Alarm Silence button to control the audible
alarm.
When the monitor is turned on, if you press a button,
except the Power button, it results in either a valid or
invalid key tone. See Audible Indicators on page 24. If a
tone fails to emit when you press a button, contact
qualified service personnel.
The following monitor display shows the buttons
described in this section.
The Alarm Silence button. Silences the audible alarms.
If you press the button when no audible alarm is active,
alarms during the selected alarm silence duration are
silenced. In all cases, the alarm silence times out after the
selected alarm silence duration and auditory alarm
capability reactivates.
Alarms that occur throughout the Power-On-Self-Test
(POST) cannot be silenced.
16 OXIMax N-65 Operator’s Manual
Symbols, Controls, Displays, and Indicators
Press and hold the Alarm Silence button for three
seconds to display the Alarm Silence Duration menu,
which allows you to adjust the alarm silence interval
from 30, 60, 90, or 120 seconds, or to OFF (alarms
disabled). See Set Alarm Silence Duration on page 53.
The Down Arrow button. Sequentially decreases the
parameter under adjustment by one decrement. If you
press and hold the button for more than three seconds it
may cause the decrement to repeat.
Press the Down Arrow button during normal operation
to decrease the pulse beep volume.
The Data (Record/Print) button. Stores the currently
shown SpO
2 and BPM values (snap-shot data.) You can
print the stored snap-shot data, such as a single-event
report, snap-shot, and/or sensor-event data by pressing
the Data button in print mode.
The Menu button. Press repeatedly during normal
operation to display the parameters. Parameters you can
set include:
• high and low SpO
2 limits
• high and low BPM limits
• alarm volume
• pulse beep volume
• data print
If you do not press any buttons for approximately 30
seconds, the monitor returns to normal operation and
incorporates the selected parameter value.
See Menu Structure on page 107 for additional
information about setting parameters.
OXIMax N-65 Operator’s Manual 17
Symbols, Controls, Displays, and Indicators
Alarms and alarm icons are enabled when parameters are
set and display in the event of an alarm condition.
Examples of alarms and alarm icons are:
• Sensor Disconnected
• Pulse Search
• Interference
• Low Battery
• Alarm Silenced indicator
If you press the Menu button while Power-On-Self-Test
(POST) is activated, the Time/Date set displays.
Repeatedly pressing the Menu button displays the
following time/date parameters you can set:
•Hour
•Minute
•Day
•Month
• Year
After the time/date parameters are set, you can return to
the POST display.
The Backlight button. Press to toggle the backlight ON
or OFF. The backlight remains on for approximately 10
minutes.
The Up Arrow button. While in menu mode, press
repeatedly to increase a parameter by one increment.
Press and hold the button for more than three seconds to
repeat the increment.
Press the Up Arrow button during normal operation
while monitoring to increase the pulse beep volume.
18 OXIMax N-65 Operator’s Manual
Note: Normal operation means:
• the monitor is turned on
• a sensor is connected to the monitor
• the sensor is applied to the patient
• the patient’s %SpO
percentage) and pulse rate readings (BM) are
being reported
• no error conditions exist
The Power button. Press to toggle the monitor power ON
or OFF. The Power button has a raised protrusion
(bump) at its center and a gloss surface finish for tactile
differentiation from other buttons.
Displays and Indicators
The monitor display as shown below includes:
•a Pulse Amplitude blip bar
• functional icons
• current measured %SpO
Symbols, Controls, Displays, and Indicators
2 (oxygen saturation
2
• pulse rate
OXIMax N-65 Operator’s Manual 19
Symbols, Controls, Displays, and Indicators
Decimal points after the %SpO2 or pulse rate indicate
that the respective limits have been changed from the
power-on default values.
There are various matrices within the signal processing
algorithm. Some of these are used to assess the severity
of conditions presented to the monitor in SpO
2 and pulse
rate measurements on a patient. Individual matrices, or
combinations of them, are used to drive the icon
indicators on the monitor front panel.
The signal processing algorithm increases the amount of
data required for measurements of SpO
2 and pulse rate
dependent on the measurement conditions. Throughout
normal measurement conditions, the averaging time is six
to seven seconds.
The signal processing algorithm extends the amount of
data required beyond seven seconds for measurement
conditions in which incoming signal quality is degraded,
such as:
• low perfusion
• active patients
• ambient light
• electromagnetic interference (EMI)
If the resulting dynamic averaging time exceeds 20
seconds, the Pulse Search indicator appears and SpO
2
and Pulse Rate displays continue updating 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 flashes and the SpO
2 and pulse
rate displays flashing zeros to indicate a loss-of-pulse
condition.
20 OXIMax N-65 Operator’s Manual
Symbols, Controls, Displays, and Indicators
Selected display elements, such as, icons or numerals,
may flash. There are three flash rates. See Table 1.
Table 1: Flash Rates
Priority Hertz Duty Cycle
High 1.4 Hz to 2.8 Hz 20% to 60%
Medium 0.4 Hz to 0.8 Hz 20% to 60%
Low N/A Constant on
%SpO
2 display:
• shows the oxygen saturation level of functional
hemoglobin
• shows two dashes throughout Sensor Disconnected
and Sensor Off Patient conditions
• flashes the SpO
2 value when the SpO2 is outside
the alarm limits
• shows a decimal point (.) after the SpO
2 value
(98.0), if alarm limits have changed from their
power-on defaults
Pulse Amplitude indicator (blip bar). Indicates the
dynamic pulse amplitude and rate. As the detected pulse
becomes stronger, more bars light with each pulse. The
reverse is true for weak pulses.
When setting alarm volume, the Pulse Amplitude blip
bar reflects the alarm volume setting.
OXIMax N-65 Operator’s Manual 21
Symbols, Controls, Displays, and Indicators
Pulse Rate display:
• shows the pulse rate in beats per minute
• flashes throughout loss-of-pulse alarms and when
the pulse rate is outside of the alarm limits
• shows two dashes throughout Sensor Disconnected
and Sensor Off Patient conditions
• shows pulse rates outside of the pulse rate range
(0, 20 to 300 bpm) as the closest value within the
range
• shows a decimal point (.) after the BPM value
(123.), if alarm limits have changed from their
power-on defaults
Low Battery indicator. Flashes when 15 or fewer
minutes of battery capacity remain. The indicator
displays constantly when the battery capacity reaches
critical condition at which time the monitor indicates an
error condition and shuts down.
Alarm Silenced indicator. Displays when audible alarms
have been silenced. It flashes when the audible alarms are
disabled.
Interference indicator. Lights when the N-65 algorithm
detects the incoming signal quality is degraded.
Degradations can be caused by ambient light, electrical
noise, electrosurgical interference, patient activity, or
other causes. An intermittently lit Interference indicator
is common during patient monitoring, and indicates that
the N-65 algorithm is dynamically adjusting the amount
of data required for measuring SpO
2 and Pulse Rate.
When lit continuously, it indicates the N-65 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 Front Panel Description on page 9.
22 OXIMax N-65 Operator’s Manual
Symbols, Controls, Displays, and Indicators
Pulse Search indicator. Displays before initial
acquisition of a pulse signal and throughout prolonged
challenging monitoring conditions. The Indicator
flashes throughout a loss-of-pulse signal.
Data In-Sensor indicator. Displays when the sensor
contains patient alarm events. The indicator flashes when
the sensor memory is full.
Upper Alarm Limit indicator. Indicates that the
displayed value is the upper alarm limit for SpO
2 or Pulse
Rate.
Lower Alarm Limit indicator. Indicates that the
displayed value is the lower alarm limit for SpO
2 or Pulse
Rate.
Data indicator. Displays when the monitor is in the store
snap-shot data or data print mode. The indicator flashes
when snap-shot data prints.
Print indicator. Displays when the monitor is in print
mode. The indicator flashes when the monitor prints
single-event, snap-shot, or patient alarm events data,
which is stored in the sensor.
Sensor Disconnected indicator. Displays when the
patient sensor is disconnected from the monitor.
Alarm Volume Adjust indicator. Displays when the
monitor is in the alarm volume adjust menu.
Pulse Beep Tone Volume Adjust indicator. Displays
when the monitor is in the pulse beep tone volume adjust
menu.
Adjust Time indicator. Displays when the monitor is in
the time/date set menu.
OXIMax N-65 Operator’s Manual 23
Set Limit mode indicator. Displays when the monitor
alarm limit values, or pulse rate values, are being
adjusted.
Adjust Volume mode indicator. Displays when the
monitor alarm volume levels are being adjusted.
Sensor Off Patient indicator . Displays when the monitor
detects the sensor has come off the patient.
SNAP-SHOT DATA ID indicator. An alphanumeric
display that shows the number of the current captured
patient (SpO
ID to the data captured. The ID number is shown in the
%SpO
2 area of the display.
Audible Indicators
The monitor generates auditory signals for use as alarms,
status indicators, and feedback. See Audible Indicators
on page 121.
Symbols, Controls, Displays, and Indicators
2) and pulse rate (PR) values. It assigns an
24 OXIMax N-65 Operator’s Manual
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