COVIDIEN N65N85_QuickGuide_JA_10006537b00 The Arthrex SynergyResection User’s Guide

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 following 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

Set up the O XIM AX N-65

WARNING: To ensure patient safety, do not place the
XIMAX N-65 in any position that might cause it to fall
O
on the patient.
WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation.
WARNING: Ensure that the speaker is clear of any obstruction and that the speaker holes are not covered. Failure to do so could result in an inaudible alarm tone.
WARNING: Disconnect the OXIMAX N-65 and Nellcor
XIMAX sensor from the patient throughout magnetic
O
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.
OXIMax N-65 Operator’s Manual 25
Set up the OXIMAX N-65
WARNING: Do not use an OXIMAX N-65, OXIMAX sensor, or cables that appear damaged.
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.
WARNING: Use only the Nellcor extension cable DEC-4 with the O that is intended for computer use to the O sensor port. Do not connect any device other than a Nellcor-approved O sensor connector. Do not use the DEC-8 with the monitor.
XIMAX N-65. Do not attach any cable
XIMAX
XIMAX sensor to the OXIMAX
26 OXIMax N-65 Operator’s Manual

List of Components

Quantity Item
1 OXIMAX N-65 handheld pulse oximeter
4 Alkaline “AA” size, 1.5-volt batteries
Set up the OXIMAX N-65
Connect O
1 Nellcor O
pack
1 Compact disk (O
operator’s manual (applicable to country of sale)
1 Quick guide adhesive label
XIMAX sensor or sensor assortment
XIMAX N-65 manuals) and/or
XIMAX Sensor to the Monitor
WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, O
XIMAX sensor application
errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information:
Safety Information on page 1.
OXIMAX Sensor Performance Considerations on page 89.
OXIMAX Sensors and Accessories on page 71.
Caution: Use only Nellcor-approved O
XIMAX sensors
and, if needed, the DEC-4 extension cable.
OXIMax N-65 Operator’s Manual 27
Set up the OXIMAX N-65
Connect a Nellcor OXIMAX SpO2 sensor to the monitor SpO
2 sensor port. You may use an extension cable to
provide more distance between the monitor and the sensor. Use only the DEC-4 extension cable available from Nellcor.
1
SpO2 OXIMAX Sensor Port

Inaccurate Monitor Measurements

Physiological conditions, medical procedures, or external agents that may interfere with the monitor’s ability to detect and display accurate measurements include:
incorrect application of the O
placement of the O
XIMAX sensor on an extremity
with a blood pressure cuff, arterial catheter, or intravascular line
excessive patient activity
intravascular dyes, such as indocyanine green or methylene blue
externally applied coloring agents, such as nail polish, dye, or pigmented cream
28 OXIMax N-65 Operator’s Manual
XIMAX sensor
Set up the OXIMAX N-65
failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions
venous pulsation
dysfunctional hemoglobin
low perfusion
Loss-of-pulse signal can occur for the following reasons:
•the O
XIMAX sensor is applied too tightly
defibrillation
a blood pressure cuff is inflated on the same extremity as the one with the O
XIMAX sensor
attached
there is arterial occlusion proximal to the O
XIMAX
sensor
poor peripheral perfusion
loss of pulse/cardiac arrest
High ambient light sources that can interfere with the performance of an SpO
2 OXIMAX sensor are:
surgical lights (especially those with a xenon light source)
bilirubin lamps
fluorescent lights
infrared heating lamps
direct sunlight
OXIMax N-65 Operator’s Manual 29
Set up the OXIMAX N-65
30 OXIMax N-65 Operator’s Manual

Battery Operation

WARNING: Dispose of battery in accordance with local ordinances and regulations.

Battery Power

The OXIMAX N-65 uses batteries to power the monitor. A new set of batteries provides between 15 to 40 hours of operation depending on the battery type.

Low Battery Indicator

The Low Battery indicator flashes and a low priority alarm sounds when approximately 15 minutes of operation remains available. Replace the batteries. See Battery Installation on page 33.
OXIMax N-65 Operator’s Manual 31
Battery Operation
Caution: 15 minute indicator for remaining battery operating time is approximate and is based on Alkaline AA batteries. Remaining operating time may be different for other types of batteries.
Caution: Periodically check the battery for corrosion. If the O
XIMAX N-65 is to be stored for three months or
longer, remove the batteries from the monitor before storage.

Critical Battery Indication

When the batteries are critically low, the monitor:
displays an error message (Er 521)
sounds a high priority alarm
shuts down
Replace the batteries and restart the monitor. See Battery Installation on page 33.
32 OXIMax N-65 Operator’s Manual

Battery Installation

To install batteries:
1. Turn off the power.
2. Pull the battery compartment latch downward toward
the bottom of the monitor, and remove the battery access door.
3. Install four AA size batteries as shown in Figure 1.
Battery Operation
OXIMax N-65 Operator’s Manual 33
Battery Operation
4. Replace the battery access door.
1 — Battery compartment latch
Figure 1: Battery Installation
WARNING: Explosion hazard. Do not use the
XIMAX N-65 in the presence of flammable anesthetics
O
mixed with air, oxygen, or nitrous oxide.
WARNING: Dispose of batteries in accordance with local ordinances and regulations.
34 OXIMax N-65 Operator’s Manual

O XIM AX N-65 Operation

Introduction

The parameters of the OXIMAX N-65 are set at the factory according to Table 2. The parameters may be set on an individual basis by the clinician.
Note: This section contains detailed information on setting parameters. For quick reference information, see
Set Menu Parameters on page 108 and Set Time/Date Parameters on page 110.
Parameters remain in effect until the monitor is turned off.
Table 2: Parameter Ranges and Defaults
Parameter
%SpO2 Upper Alarm Limit
%
SpO2 Lower
Alarm Limit
Pulse Rate Upper Alarm Limit
Pulse Rate Lower Alarm Limit
OXIMax N-65 Operator’s Manual 35
Ranges/
Selections
Lower Alarm Limit plus 1 to 100%
20% to Upper Alarm Limit minus 1
Lower Alarm Limit plus 1 to 250 bpm
30 bpm to Upper Alarm Limit minus 1
Factory
Defaults
100%
85%
170 bpm
40 bpm
OXIMAX N-65 Operation
Table 2: Parameter Ranges and Defaults (Continued)
Parameter
Alarm Silence Duration
Alarm Volume 1 to 10 10
Pulse Beep Vo l u m e

Turn On the OXIMAX N-65

Discussion

Verify the monitor works properly and is safe to use. Proper operation of the monitor is verified each time it is turned on as described in this procedure. The verification procedure Power-On-Self-Test (POST) takes approximately 10 seconds to complete. When the monitor is turned on, POST automatically tests the monitor circuitry and functions.
Ranges/
Selections
Alarms 30, 60, 90, 120 seconds, OFF
0 to 10 10
Factory
Defaults
30 seconds
Caution: During the Power-On-Self-Test (POST) immediately after power-up, confirm that all display segments and icons are shown and the monitor speaker sounds a one-second tone.
WARNING: If you do not hear the POST pass tone, do not use the OXIMAX N-65.
36 OXIMax N-65 Operator’s Manual
When the monitor is turned on, the backlight remains on and the display cycles through the following sequence as POST takes place:

Procedure

OXIMAX N-65 Operation
All display graphics are shown for three seconds and the backlight is turned on.
The display goes blank (all display elements off) for one second.
The software version number shows for 3 seconds as a three digit number in the right number field and two dashes in the left number field.
The current time of day is shown in 24 hour format.
Successful completion of POST is announced by a POST pass tone. A failed POST is announced by a high-priority alarm tone.
To turn on the monitor:
1. Press the Power button to turn on the monitor.
The backlight remains on throughout POST.
OXIMax N-65 Operator’s Manual 37
OXIMAX N-65 Operation
All display numbers and icons show for three seconds. The backlight is on while all numbers and icons are shown.
2. The display goes blank for one second.
38 OXIMax N-65 Operator’s Manual
OXIMAX N-65 Operation
3. The software version number appears for 3 seconds as a three digit number in the right number field and two dashes in the left number field.
Note: The software version 001 is an example. Check the monitor for the software version installed. Write down the software version number and have it available prior to requests for technical assistance.
4. The current time displays in a 24-hour format.
OXIMax N-65 Operator’s Manual 39
OXIMAX N-65 Operation
5. If the monitor detects a problem, an error tone sounds and an error code (Er) and the error number displays. See Troubleshooting on page 93.
6. Upon successful completion of POST, the monitor sounds a one-second tone to indicate it has passed the test.
WARNING: Ensure the speaker is clear of any obstructions and the speaker holes are not covered. Failure to do so could result in an inaudible alarm tone.
Note: The POST pass tone also functions as an
audible confirmation that the speaker performs properly.
40 OXIMax N-65 Operator’s Manual

OXIMAX Sensor Attached

When an OXIMAX sensor contains patient event alarm data, and is attached to the monitor, the Data In-Sensor indicator is shown.
OXIMAX N-65 Operation
The monitor shows two dashes in the %SpO
2 and Pulse
Rate displays as it searches for a valid pulse. For optimal performance allow the monitor to search and lock onto a pulse for approximately 10 seconds.
When a valid pulse is detected, the monitor begins monitoring and displays patient parameters.
Movement of the blip bar indicates that real-time data is displayed. Continue to listen for the pulse beep tone as the monitor is used. If it does not sound with each pulse, it indicates one of the following:
pulse beep volume is off
speaker/audio has malfunctioned
signal is corrupted
O
XIMAX N-65 has stopped functioning
OXIMax N-65 Operator’s Manual 41
OXIMAX N-65 Operation
When an OXIMAX sensor is attached to the monitor and applied to a patient, and loses the pulse signal, the monitor displays [- - / - -] (two dashes and two dashes) and displays the Pulse Search icon as shown on the monitor.
re

No OXIMAX Sensor Attached

Upon successful completion of POST, the monitor sounds a one-second tone indicating that it has passed POST.
42 OXIMax N-65 Operator’s Manual
The monitor displays [- - / - -] (two dashes and two dashes) and the Pulse Search indicator does not display when the monitor fails to detect an O invalid sensor.

Backlight On/Off

The backlight turns off after approximately 10 seconds.
With the monitor turned on, press the Backlight button to turn the monitor backlight on or off.
Caution: When adjusting any menu parameter, the SpO display, but they continue to record.

Adjust Pulse Beep Volume

OXIMAX N-65 Operation
XIMAX sensor or an
2 and BPM do not

Discussion

There are two ways to adjust the pulse beep volume:
during monitoring
using the menu structure
OXIMax N-65 Operator’s Manual 43
OXIMAX N-65 Operation
Procedure — During Monitoring
To change the pulse beep volume during monitoring:
Press the Up Arrow or Down Arrow button while monitoring to increase or decrease the pulse beep volume.
The Pulse Amplitude (blip bar) increments or decrements as a relative indicator of the current volume. Attempted adjustments outside the range generate an invalid key tone.
The minimum pulse rate volume is none, or OFF (no blip bar segments shows.) The maximum pulse rate volume is ten (ten segments.)
The Beep Tone Volume Adjust indicator flashes when the pulse beep volume is adjusted to zero.
Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor display returns to the monitoring mode.
44 OXIMax N-65 Operator’s Manual
Procedure — Using Menu Structure
Note: For quick reference information on using the menu structure to set parameters, see Set Menu Parameters on page 108.
To adjust the pulse beep volume using the menu structure:
1. From the main monitoring screen, press the Menu
button five times until the pulse beep volume level is shown and the monitor sounds.
OXIMAX N-65 Operation
2. Press the Up Arrow button or the Down Arrow button until the desired tone level is heard.
3. Press the Menu button three times to set the tone volume and return to normal operation.
OXIMax N-65 Operator’s Manual 45
OXIMAX N-65 Operation

Adjust Alarm Volume

Discussion

When the Alarm Volume display shows, adjust the alarm volume by pressing the Up Arrow or Down Arrow button. The Pulse Amplitude (blip bar) increments or decrements as a relative indicator of the current alarm volume. Attempted adjustments outside the range generate an invalid key tone.
Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor display returns to the normal mode.

Procedure

To adjust the alarm volume:
WARNING: Do not silence the audible alarm function, or decrease the audible alarm volume, if patient safety could be compromised.
46 OXIMax N-65 Operator’s Manual
OXIMAX N-65 Operation
1. From the main monitor screen, press the Menu button six times until the alarm volume screen appears.
2. Press the Up Arrow or Down Arrow button to increase or decrease alarm volume.
3. Press the Menu button two times to set the alarm level and return to the monitor display screen.
OXIMax N-65 Operator’s Manual 47
OXIMAX N-65 Operation

Set Time and Date

Discussion

When you make the month entry, the monitor checks the day selection to ensure the date is valid. If the day selection is not valid for the month selected, the menu display returns to the day selection display.
WARNING: The OXIMAX sensor uses the date and time provided by the O
XIMAX N-65
when the patient alarm events are recorded to the memory chip in the sensor. The accuracy of the date/time used for patient alarm events depends on the date/time already set in, and provided by the monitor.
Note: When the monitor times-out in 30
seconds, the parameter is set and the monitor display returns to the normal mode.
When you make the year entry, the monitor checks the day and month selections to ensure the selections are valid. If the day or month selection is not valid for the year selected, the menu display returns to the day selection display.
Examples of invalid dates:
30 February
31 February
•31 April
•31 June
31 September
31 November
48 OXIMax N-65 Operator’s Manual

Procedure

To set the time and date:
1. From the main monitor screen, press the Power
2. Press the Power button to turn the monitor on.
3. While the monitor is in the POST mode, press the
OXIMAX N-65 Operation
29 February on a non-leap year
button to turn the monitor off.
Menu button until the set hours display shows. The hours display (13) will flash.
4. Press the Up Arrow button or the Down Arrow button until the desired hours appear.
OXIMax N-65 Operator’s Manual 49
OXIMAX N-65 Operation
5. Press the Menu button to set the hours and show the minutes set display. The minutes display (45) flashes.
6. Press the Up Arrow button or the Down Arrow button until the desired minutes appear.
7. Press the Menu button to set the minutes and show the day set display. The day (29) flashes.
50 OXIMax N-65 Operator’s Manual
OXIMAX N-65 Operation
8. Press the Up Arrow button or the Down Arrow button until the desired day is shown.
9. Press the Menu button to set the day and show the month set display. The month (7) flashes.
10. Press the Up Arrow button or the Down Arrow button until the desired month is shown.
OXIMax N-65 Operator’s Manual 51
OXIMAX N-65 Operation
11. Press the Menu button to set the month and display the year set display. The year (2004) will flash.
12. Press the Up Arrow button or the Down Arrow button until the desired year is shown.
13. Press the Menu button to set the year and return to normal operation.
52 OXIMax N-65 Operator’s Manual

Set Alarm Silence Duration

Discussion

When the Alarm Silence Duration display shows, you can adjust the alarm silence duration of the high, medium, and low-priority alarms.
A low battery low-priority alarm cannot be silenced.
Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor returns to the normal mode.

Procedure

To set the alarm silence duration:
1. From the main monitor screen, press the Alarm Silence button until SEC or OFF appears on the
pulse rate area of the display. Then, release the button.
OXIMAX N-65 Operation
WARNING: Do not silence the audible alarm function, or decrease the audible alarm volume, if patient safety could be compromised.
OXIMax N-65 Operator’s Manual 53
OXIMAX N-65 Operation
Available alarm silence durations are OFF (alarm disabled), 30, 60, 90, and 120 seconds.
2. Press the Up Arrow button or the Down Arrow button until the desired alarm silence duration is shown.
3. Press the Alarm Silence button to set the shown alarm silence duration and return to normal operation.

Disable Audible Alarms

Discussion

When the alarm silence duration is set to OFF the monitor produces no audible alarms. The Alarm Silence indicator flashes while the alarm silence duration is set to OFF.
54 OXIMax N-65 Operator’s Manual

Procedure

To disable audible alarms:
1. From the main monitor screen, press the Alarm
OXIMAX N-65 Operation
Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor display returns to the normal mode.
WARNING: Do not silence the audible alarm function, or decrease the audible alarm volume, if patient safety could be compromised.
Silence button until OFF displays in the pulse rate
area of the monitor. Release the button.
Available Alarm silence durations are OFF, 30, 60, 90, and 120 seconds.
OXIMax N-65 Operator’s Manual 55
OXIMAX N-65 Operation
2. Press the Alarm Silence button to set the alarm silence duration to OFF and return to normal operation.
The Alarm Silence indicator flashes and an audible reminder sounds every three minutes while the alarm silence duration is set to OFF.

Set Alarm Limits

Discussion

The Alarm Limit display allows you to adjust the upper and lower saturation and pulse rate limits.
Press and hold the Up Arrow or Down Arrow buttons to scroll rapidly through the limit values.
The Alarm Limit Changed indicator displays anytime an alarm limit changes. See Alarm Limit Changed Indicator on page 61.
Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor display returns to the normal monitoring.
56 OXIMax N-65 Operator’s Manual

Procedure

To set alarm limits:
1. From the main monitor screen, press the Menu
button once. The SpO
OXIMAX N-65 Operation
2 lower alarm limit displays.
The %SpO The upper value of the %SpO limited to the %SpO
2 low alarm limit range is 20% to 99%.
2 low alarm limit is
2 upper alarm limit. The %SpO2
low alarm limit cannot be set equal to, or higher than, the %SpO
2 upper alarm limit.
2. Press and hold the Up Arrow or Down Arrow buttons to scroll rapidly through the values.
3. Press the Menu button to set the limit value. The SpO
2 upper alarm limit displays.
OXIMax N-65 Operator’s Manual 57
OXIMAX N-65 Operation
The %SpO2 upper alarm limit range is 21% to 100%. The lower value of the %SpO limited to the %SpO upper alarm limit cannot be set equal to or lower than the %SpO
4. Press the Up Arrow or Down Arrow buttons to increase or decrease the upper alarm limit.
2 upper alarm limit is
2 low alarm limit. The %SpO2
2 low alarm limit.
5. Press the Menu button to set the limits value. The BPM lower alarm limit displays.
The pulse rate low alarm limit range is 30 to 249. The upper value of the pulse rate low alarm limit is limited one number lower than the pulse rate upper alarm limit. The pulse rate low alarm limit cannot be set equal to or higher than the pulse rate upper alarm limit.
58 OXIMax N-65 Operator’s Manual
OXIMAX N-65 Operation
6. Press the Up Arrow or Down Arrow buttons to increase or decrease the lower limit.
7. Press the Menu button to set the limit value. The BPM upper alarm limit displays.
The pulse rate upper alarm limit range is 31 to 250. The lower value of the pulse rate upper alarm limit is limited to one number above the pulse rate low alarm limit. The pulse rate upper alarm limit cannot be set equal to or lower than the pulse rate low alarm limit.
OXIMax N-65 Operator’s Manual 59
OXIMAX N-65 Operation
8. Press the Up Arrow or Down Arrow button to increase or decrease the upper pulse rate limit.
9. Press the Menu button to confirm the alarm limit settings.
10. Press the Menu button until you return to normal operation.
Note: Limit changes are in effect only as long as the monitor remains on. When it is turned off, the default limits are restored. When the monitor is turned on, the default limits will be in effect.
60 OXIMax N-65 Operator’s Manual

Alarm Limit Changed Indicator

Alarm limits that have changed from the default values are identified by a decimal point (.) after the shown value (%SpO
The Alarm Limit Changed indicator displays anytime an alarm limit changes.
2 or BPM).
OXIMAX N-65 Operation

Record Snap-Shot Data

Discussion

The monitor contains an internal memory that can store 50 patient data records (snap-shots). You can print data records. Data are retained in the monitor memory while it remains on and cleared when it is turned off, or powers itself off. If the data are cleared, they are not available to print. Replacement of the monitor batteries clears patient data.
The Data indicator flashes at a medium priority rate when the monitor patient memory is full.
OXIMax N-65 Operator’s Manual 61
OXIMAX N-65 Operation

Procedure

To record data:
1. From the main monitor screen, press the Data button
to capture a record of the patient data (snap shot). The captured data displays.
The number (1) in the SpO
2 field is the identification
(ID) number of captured snap-shots.
When you press the Data button, and there is no empty event memory location available, the monitor:
• displays the last ID number assigned (50)
•the Data icon continues to flash at the medium
priority rate
• an invalid key tone sounds
• the monitor returns to the normal mode after
approximately three seconds
62 OXIMax N-65 Operator’s Manual

Print Data

Discussion

OXIMAX N-65 Operation
The monitor can print data when used with a Citizen PD­22T portable printer, which is available from Nellcor Customer Services at 1.800.635.5267, or your local Nellcor representative.
Caution: Ensure that the printer model number contains a “T,” which indicates that the printer has been configured for use with the O
XIMAX N-65.
Note: Read the entire user’s manual for the Citizen PD-22T portable printer prior to operating the printer with the monitor.
The monitor must be linked via infrared (IR) to a compatible printer to print.
Note: The monitor remains on if there are patient alarm event data stored.
Print data contains one or more of the following:
a summary report, if currently connected to a patient
The summary report includes the date, current time, duration of the current monitoring session, and the minimum, maximum, and mean of the SpO
2 and pulse rate.
a snap-shot report, if any are stored
OXIMax N-65 Operator’s Manual 63
OXIMAX N-65 Operation
sensor event data (patient alarm event data), if a
The monitor prints all available data as shown in Figure 2.
sensor with patient event data is connected to the monitor
Figure 2: Combined Printed Data
64 OXIMax N-65 Operator’s Manual
OXIMAX N-65 Operation
Print Mode
If you press the Data button in the print menu when no data is stored, and the device is not connected to a patient, an invalid key tone sounds and the monitor transitions to normal mode.
The Print-mode indicator (page icon) flashes at the medium rate throughout print mode.
When the print function is complete, the display returns to the normal mode. If the monitor times-out before the Data button is pressed, the display returns to the normal mode.
The Menu button is disabled during print mode.
If there is no communication with the printer for 30 seconds, print mode is aborted and the display returns to normal mode.
After Printing Data
The summary report data is purged after it is printed or on time-out due to printer communication failure.
Snap-shot or sensor-event data is not purged after printing or time-out due to printer communication failure. Instead, it is purged from the monitor’s memory at power off. Sensor-event data is retained in the sensor and loads/ reloads to the monitor memory at power on.
Alarm annunciation and patient monitoring is disabled during active printing when the monitor is communicating with printer.
OXIMax N-65 Operator’s Manual 65
OXIMAX N-65 Operation
If snap-shot data are stored in the monitor memory, the Data icon shows on the print data display. If sensor-event data are stored in sensor memory, the Data In-Sensor icon shows on the print data display. If both types of data are stored, both icons show. If no data are stored, neither icon shows and the display is blank.
The monitor and sensor does not differentiate between patients. Use caution when reviewing the report as the list of snap-shots may contain data from more than one patient. Also, if a single-use sensor is used more than once, the sensor trend report section can contain data from more than one patient.
Note: The snap-shot list is deleted when the monitor is turned on. When first connecting a single-use sensor, look for the Data In-Sensor icon.
66 OXIMax N-65 Operator’s Manual

Procedure

To print data:
1. Align the printer and the monitor.
2. Orient the printer and monitor as shown in Figure 3.
OXIMAX N-65 Operation
The alignment of the infrared ports of the printer and the monitor must not exceed two feet and must not be closer than six inches (15 cm).
Figure 3: Printer Alignment
OXIMax N-65 Operator’s Manual 67
OXIMAX N-65 Operation
3. From the main monitor screen, press the Menu button seven times. The print display is shown.
4. Press the Data button to start printing. During printing, the stored snap-shot number displays for each snap-shot.
68 OXIMax N-65 Operator’s Manual

O XIM A X Sensor Event Record

Event Records

WARNING: The OXIMAX sensor uses the date and time provided by the O 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 monitor.
XIMAX N-65 when the sensor
The adhesive O
XIMAX sensors are capable of storing
patient alarm events in the memory chip. The sensor-event data record allows alarm event history to travel with the patient on the sensor’s memory chip for quick assessment at every point of care where O
XIMAX
monitors are used.
The patient alarm data are stored (recorded) with the monitor limit/threshold settings that were active at the time of the event on the recording monitor. These events can be viewed on the next O
XIMAX enabled monitor to
which the patient is connected when the patient moves to a new point of care.
An event occurs when the %SpO
2 value exceeds either
the upper or lower alarm limit for at least 15 seconds. The monitor records patient alarm events to the memory chip in the sensor every 5 minutes. The maximum number of events that can be stored in an O
XIMAX sensor
is typically 100.
OXIMax N-65 Operator’s Manual 69
OXIMAX Sensor Event Record
Event records can be viewed only after an OXIMAX sensor containing patient alarm events has been connected to an
O
XIMAX monitor capable of displaying sensor event
records. The O sensor event records, but does support printing sensor event records. Event records are designed to view patient events from prior areas of care or transport (history), while monitor trend should be used to view data or events from a patient currently being monitored.
The Data In-Sensor indicator displays when the sensor contains patient alarm events. The Data In-Sensor indicator flashes when the sensory memory is full.
XIMAX N-65 does not support viewing
Recording and viewing of O only available on O
XIMAX enabled monitors. The OXIMAX
XIMAX sensor-event data is
sensors may function on older technology monitors, but the O
XIMAX sensor event record feature is not available.
70 OXIMax N-65 Operaotr’s Manual

O XIM AX Sensors and Accessories

Select an OXIMAX Sensor

WARNING: The OXIMAX sensor uses the date and time provided by the O 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 monitor.
WARNING: Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.
WARNING: Before use, carefully read the applicable
O
XIMAX sensor Directions For Use, including all
warnings, cautions, and instructions.
XIMAX N-65 when the sensor
WARNING: Do not use a damaged OXIMAX sensor or extension cable. Do not use an O exposed optical components.
WARNING: Use only Nellcor-approved OXIMAX sensors and extension cables with the O Other sensors or extension cables may cause improper monitor performance.
OXIMax N-65 Operator’s Manual 71
XIMAX sensor with
XIMAX N-65.
OXIMAX Sensors and Accessories
WARNING: Do not attach any cable to the OXIMAX sensor port connector that is intended for computer use.
WARNING: Tissue damage can be caused by incorrect application or duration of use of an O sensor. Inspect the O directed in the OXIMAX sensor Directions For Use.
WARNING: Pulse oximetry readings and pulse signals can be affected by ambient environmental conditions, O patient conditions.
WARNING: Do not immerse or wet the OXIMAX sensor as this may damage the sensor.
XIMAX
XIMAX sensor site periodically as
XIMAX sensor application errors, and
WARNING: Do not lift the monitor by the OXIMAX sensor or extension cable because the cable could disconnect from the monitor, causing the monitor to drop on the patient.
72 OXIMax N-65 Operator’s Manual
OXIMAX Sensors and Accessories
Caution: The OXIMAX Sensor Disconnected icon and associated alarm indicate that either the O
XIMAX
sensor is disconnected or the wiring is faulty. Check
XIMAX sensor connection and, if necessary,
the O replace the O
XIMAX sensor, extension cable, or both.
For additional information on monitor measurements, see Inaccurate Monitor Measurements on page 28.
For a complete current list of all O applicable to the O
XIMAX N-65 refer to the latest Sensor
XIMAX sensors
Accuracy Grid posted on the Internet at:
http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html
When selecting an OXIMAX sensor consider the following:
patient weight and activity
adequacy of perfusion
available O
XIMAX sensor sites
need for sterility
anticipated duration of monitoring
OXIMax N-65 Operator’s Manual 73
OXIMAX Sensors and Accessories
For additional information refer to Table 3 or contact your local Nellcor Representative. Refer to OXIMAX Sensor Performance Considerations on page 89 for additional information on O
Table 3: Nellcor Oximetry Sensor Models and Patient
OXIMAX Sensor Model
XIMAX sensor performance.
Weights
Patient Size
> = greater than
< = less than
OXIMAX MAX- FAST adhesive forehead sensor, single-patient use
XIMAX Softcare
O
nonadhesive sensor, single­patient use, preterm infant
XIMAX Softcare
O
nonadhesive sensor, single­patient use, neonate
XIMAX Softcare
O
nonadhesive sensor, single­patient use, adult
XIMAX adhesive sensor,
O
single-patient use, adult
O
XIMAX adhesive sensor,
single-patient use, adult, longer cable 36 inches (91.44 cm)
O
XIMAX adhesive sensor,
single-patient use, neonatal/adult
O
XIMAX adhesive sensor,
single-patient use, pediatric
MAX-FAST >10 kg (22 lbs)
SC-PR <1.5 kg (3.3 lbs)
SC-NEO 1.5 kg to 5 kg
(3.3 to 11 lbs)
SC-A >40 kg (88 lbs)
MAX-A >30 kg (66 lbs)
MAX-AL >30 kg (66 lbs)
MAX-N <3 kg or >40 kg
(<6.6 lbs or >88 lbs)
MAX-P 10 to 50 kg
(22 to 110 lbs)
O
XIMAX adhesive sensor,
single-patient use, infant
74 OXIMax N-65 Operator’s Manual
MAX-I 3 to 20 kg
(6.6 to 44 lbs)
OXIMAX Sensors and Accessories
Table 3: Nellcor Oximetry Sensor Models and Patient
Weights (Continued)
Patient Size
OXIMAX Sensor Model
> = greater than
< = less than
OXIMAX adhesive sensor, single-patient use, adult nasal
O
XIMAX OxiCliq
®
adhesive sensor, single­patient use, adult reusable cable
O
XIMAX OxiCliq adhesive
sensor, single-patient use, neonatal/adult, reusable cable
O
XIMAX OxiCliq adhesive
sensor, single-patient use, pediatric, reusable cable
XIMAX OxiCliq adhesive
O
sensor, single-patient use, infant, reusable cable
O
XIMAX Durasensor
®
finger-clip sensor, reusable, adult
O
XIMAX Oxiband
®
sensor, reusable, neonatal/ adult
MAX-R >50 kg (110 lbs)
OxiCliq A >30 kg (66 lbs)
OxiCliq N <3 kg or >40 kg
(<6.6 lbs or >88 lbs)
OxiCliq P 10 to 50 kg (22 to 110 lbs)
OxiCliq I 3 kg to 20 kg
(6.6 to 44 lbs)
DS-100A >40 kg (88 lbs)
OXI-A/N <3 kg or >40kg
(<6.6 lbs or >88 lbs)
O
XIMAX Oxiband sensor,
reusable, pediatric/infant
OXIMax N-65 Operator’s Manual 75
OXI-P/I 3 kg to 40 kg
(6.6 lbs to 88 lbs)
OXIMAX Sensors and Accessories
Table 3: Nellcor Oximetry Sensor Models and Patient
Weights (Continued)
OXIMAX Sensor Model
Patient Size
> = greater than
< = less than
OXIMAX Dura-Y
®
D-YS >1 kg (>2.2 lbs)
multisite sensor, reusable
For use with the Dura-Y sensor:
Ear clip (Reusable,
D-YSE >30 kg (66 lbs)
nonsterile)
Pedi-Check
TM
pediatric
D-YSPD 3 kg to 40 kg spot-check clip (Reusable, nonsterile)

OXIMAX Sensor Features

OXIMAX sensor features are different for OXIMAX sensors
XIMAX sensor type, such as adhesive, recycled, and
by O reusable. The O
O
XIMAX sensor plug.
Tabl e 4 : OXIMAX Sensor Features
Feature
XIMAX sensor type is located on the
Adhesive
Sensors
(6.6 lbs to 88 lbs)
Recycled
Sensors
Reusable
Sensors
OXIMAX Sensor Event Record
Ye s N o N o
Sensor Messages Yes Yes Yes
Sensor ID Message Yes Yes Yes
76 OXIMax N-65 Operator’s Manual

Biocompatibility Test

Biocompatibility testing has been conducted on Nellcor
O
XIMAX sensors in compliance with ISO 10993-1,
Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The O the recommended biocompatibility testing and are, therefore, in compliance with ISO 10993-1.

Optional Accessories

The optional accessories offered with the monitor are:
rubber boot with clip, page 78
functional thermoformed holster, page 79
carrying case, page 80
water-resistant jacket, page 81
printer, page 82
thermal paper, page 83
DEC-4 extension cable, page 84
OXIMAX Sensors and Accessories
XIMAX sensors have passed
transport boot, page 85
OXIMax N-65 Operator’s Manual 77
OXIMAX Sensors and Accessories

Rubber Boot With Clip

This accessory protects the monitor.
1 — Front view 2 — Rear view
Figure 4: Rubber Boot with Clip
78 OXIMax N-65 Operator’s Manual
OXIMAX Sensors and Accessories

Functional Thermoformed Holster

This accessory protects the monitor.
1 — Front view 2 — Rear view
Figure 5: Functional Thermoformed Holster
OXIMax N-65 Operator’s Manual 79
OXIMAX Sensors and Accessories

Carrying Case

The Nylon carrying case is equipped with compartments for:
the monitor
Operator’s manual
compact disk containing all manuals
sensors
and,
a carrying strap that is adjustable from 71 cm to 135 cm (28 inches to 53 inches)
Figure 6: Carrying Case
80 OXIMax N-65 Operator’s Manual

Water-Resistant Jacket

The water-resistant jacket is made of clear plastic to facilitate use of the monitor in inclement weather or similar conditions.
Figure 7: Water-Resistant Jacket
OXIMAX Sensors and Accessories
OXIMax N-65 Operator’s Manual 81
OXIMAX Sensors and Accessories

Infrared Printer

The Citizen PD-22T portable printer is used to print selected data from the monitor. The monitor uses the printer IrDA infrared interface. Refer to the User’s Manual supplied with the printer for details on the PD-22T printer.
Figure 8: Printer
82 OXIMax N-65 Operator’s Manual

Thermal Paper

The thermal paper is for the Citizen PD-22T infrared printer. Refer to the User’s Manual supplied with the printer for details on the thermal paper.
OXIMAX Sensors and Accessories
Figure 9: Thermal Paper
OXIMax N-65 Operator’s Manual 83
OXIMAX Sensors and Accessories

DEC-4 Extension Cable

The DEC-4 extension cable provides 1.2 m (4 ft.) of cable extension between the monitor and the sensor.
1 — DEC-4 extension cable
2 — Sensor connector
Figure 10: DEC-4 Extension Cable
84 OXIMax N-65 Operator’s Manual

Transport Boot

This accessory is used in the transport environment for compliance with ISO 9919 outside of a hospital, such as ambulance transport.
OXIMAX Sensors and Accessories
1 — Front view 2 — Rear view
Figure 11: Transport Boot
OXIMax N-65 Operator’s Manual 85
OXIMAX Sensors and Accessories
86 OXIMax N-65 Operator’s Manual

Performance Considerations

WARNING: Pulse oximetry readings and pulse signals can be affected by ambient environmental conditions, O patient conditions. See the appropriate sections of the manual for specific safety information, such as Safety
Information on page 1 and OXIMAX Sensors and Accessories on page 71.

Performance Verification

The performance of the OXIMAX N-65 is verified by following the procedures outlined in the Performance Verification section of the monitor service manual. Qualified service personnel should perform these procedures before using the monitor for the first time in a clinical setting.
XIMAX sensor application errors, and

OXIMAX N-65 Performance Considerations

This section describes patient conditions that can affect the monitor’s measurements.
OXIMax N-65 Operator’s Manual 87
Performance Considerations

Dysfunctional Hemoglobins

Dysfunctional hemoglobins, such as, carboxyhemoglobin, methemoglobin, and sulfhemoglobin, are unable to carry oxygen. SpO readings may appear normal; however, a patient may be hypoxic because less hemoglobin is available to carry oxygen. Further assessment beyond pulse oximetry is recommended.

Anemia

Anemia causes decreased arterial oxygen content. Although SpO patient may be hypoxic. Correcting anemia can improve arterial oxygen content. The monitor may fail to provide an SpO
2 if hemoglobin levels fall below 5 gm/dl.

Saturation

2
2 readings may appear normal, an anemic
The monitor displays saturation levels between 1% and 100%.

Pulse Rates

The monitor displays pulse rates between 20 and 300 beats per minute. The sensor accuracy ranges do not apply to pulse rates above 250 bpm. Detected pulse rates below 20 are shown as 0.
88 OXIMax N-65 Operator’s Manual
Performance Considerations

OXIMAX Sensor Performance Considerations

WARNING: Pulse oximetry readings and pulse signal can be affected by ambient conditions, O application errors, and patient conditions.
WARNING: Tissue damage can be caused by incorrect application or inappropriate duration of use of an SpO site as directed in the O
2 OXIMAX sensor. Inspect the OXIMAX sensor
XIMAX sensor directions for
use.
WARNING: Use only Nellcor-approved OXIMAX sensors and extension cables. Do not use cables more than 4 feet in length. Use only the DEC-4 extension cable or only the OXIMAX sensor.
XIMAX sensor
Inaccurate measurements can be caused by:
incorrect application of the O
placement of the O
XIMAX sensor on an extremity
XIMAX sensor
with a blood pressure cuff, arterial catheter, or intravascular line
excessive patient activity
intravascular dyes, such as indocyanine green or methylene blue
externally applied coloring, such as nail polish or pigmented cream
failure to cover the O
XIMAX sensor site with opaque
material in high ambient light conditions
venous pulsation
dysfunctional hemoglobin
OXIMax N-65 Operator’s Manual 89
Performance Considerations
low perfusion
Loss-of-pulse signal can occur for the following reasons:
•the O
XIMAX sensor is applied too tightly
defibrillation
a blood pressure cuff is inflated on the same extremity as the one with the O
XIMAX sensor
attached
there is arterial occlusion proximal to the O sensor
poor peripheral perfusion
loss of pulse/cardiac arrest
To use the O
Select an appropriate O
XIMAX sensor:
XIMAX sensor.
Apply the sensor as directed, and observe all warnings and cautions presented in the Directions For Use accompanying the O
XIMAX sensor.
Clean and remove any substances, such as nail polish, from the application site.
Periodically check to ensure that the O
XIMAX
sensor remains properly positioned on the patient.
XIMAX
High ambient light sources that can interfere with the performance of an SpO
2 OXIMAX sensor are:
surgical lights (especially those with a xenon light source)
bilirubin lamps
fluorescent lights
infrared heating lamps
direct sunlight
90 OXIMax N-65 Operator’s Manual
Performance Considerations
To prevent interference from ambient light, ensure that the O
XIMAX sensor is properly applied, and cover the
O
XIMAX sensor site with opaque material.
If interference due to patient activity presents a problem, try one or more of the following to correct the problem:
verify that the O
XIMAX sensor is properly and
securely applied
•move the O
use an adhesive O
•use a new O
XIMAX sensor to another site
XIMAX sensor
XIMAX sensor with fresh adhesive
backing
keep the patient still, if possible
If interference due to poor perfusion presents a problem, consider using the MAX-R O FAST O
XIMAX sensor. The MAX-R OXIMAX sensor
XIMAX sensor or the MAX-
obtains measurements from the nasal septal anterior ethmoid artery, an artery supplied by the internal carotid. These O
XIMAX sensors may obtain measurements when
peripheral perfusion is relatively poor.
OXIMax N-65 Operator’s Manual 91
Performance Considerations
92 OXIMax N-65 Operator’s Manual

Troubleshooting

WARNING: If you are uncertain about the accuracy of any measurement, check the patient's vital signs by alternate means; then make sure the O functioning correctly.
WARNING: There are no user-serviceable parts inside the O removed by qualified service personnel.
Caution: Do not spray, pour, or spill any liquid on the
O
openings in the enclosure as this may damage the monitor.

Error Codes

XIMAX N-65, its accessories, connectors, switches, or
XIMAX N-65. The cover should only be
XIMAX N-65 is
When the monitor detects an error condition, it may display “Er” followed by the error code.
OXIMax N-65 Operator’s Manual 93
Troubleshooting
See Table 5, "Error Codes", on page 94 for a list of error codes and corrective actions.
When an error occurs, the unit:
stops monitoring
removes all information from the display and displays the message “Er XXX”
sounds a low priority alarm
When an error occurs, you must:
Turn the monitor off.
Wait 10 seconds and turn the monitor on.
If the error appears, follow the action(s) listed in Table 5 .
Table 5: Error Codes
Error Code
10 Check/replace sensor/extension cable.
11
1 — Replace batteries.
Action
2 — Notify service personnel.
17 Check/replace sensor/extension cable.
19 Check/replace sensor/extension cable.
273
1 — Restart the monitor.
2 — Set the time and date.
3 — Notify service personnel.
274 Return the monitor for reprogramming.
275 Check/replace sensor/extension cable.
276 Replace with O
94 OXIMax N-65 Operator’s Manual
XIMAX sensor.
Loading...