You are on page 1of 136

Service Manual

Nellcor
TM

OxiMax N-65
Handheld Pulse Oximeter

OxiMax TM
Technology
COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for life are U.S. and
internationally registered trademarks of Covidien AG. Other brands are trademarks of a
Covidien company. ©2011 Covidien.
U.S. Patents: 5,485,847; 5,676,141; 5,743,263; 6,035,223;6,226,539; 6,411,833;
6,463,310; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479;7,120,480; 7,142,142;
7,162,288; 7,190,985;7,194,293; 7,209,774; 7,212,847; 7,400,919.
To obtain information about a warranty, if any, contact Covidien Technical Services at
1.800.635.5267 or your local representative.
Purchase of this instrument confers no express or implied license under any Covidien patent
to use the instrument with any handheld pulse oximeter that is not manufactured or licensed
by Covidien.
Table of Contents
Chapter 1. Safety Information ..................................................................... 7
Overview.................................................................................................. 7
Warnings ................................................................................................. 7
Cautions................................................................................................... 9

Chapter 2. Introduction .............................................................................. 11


Overview................................................................................................ 11
Related Documents............................................................................... 11
Oximeter Description and Intended Use ............................................. 11
Description ...................................................................................... 11
Intended Use ................................................................................... 12
Oximeter Components.......................................................................... 12
Front Panel ...................................................................................... 12
User Interface .................................................................................. 14
Oximeter Visual Indicators ............................................................. 17
Rear Panel........................................................................................ 20
Carton Label Symbols ........................................................................... 21

Chapter 3. Product Specifications .............................................................. 23


Overview................................................................................................ 23
Physical Characteristics ......................................................................... 23
Electrical Requirements ........................................................................ 23
Batteries........................................................................................... 23
Environmental Conditions.................................................................... 23
Operation ........................................................................................ 23
Transport and Storage.................................................................... 24
Performance Specifications .................................................................. 24
Measurement Range....................................................................... 24
OxiMax™ Pulse Oximetry Sensors.................................................. 24
Audible Indicators................................................................................. 27
Product Compliance.............................................................................. 30
Product Standards for Compliance ................................................ 30
Product Safety Standards ............................................................... 30
Electromagnetic Compatibility (EMC) Standards .......................... 31
Manufacturer’s Declaration ................................................................. 31
Basics................................................................................................ 31
Electromagnetic Compatibility (EMC)............................................ 32
Sensors and Compliance ................................................................. 34
Safety Tests............................................................................................ 35
Leakage Current.............................................................................. 35

Service Manual iii


Chapter 4. Theory of Operations ............................................................... 37
Overview................................................................................................ 37
Understanding Pulse Oximetry ............................................................ 37
Theoretical Principals...................................................................... 37
Automatic Calibration .................................................................... 38
Functional versus Fractional Saturation ........................................ 38
Measured versus Calculated Saturation ........................................ 39
OxiMax™ Pulse Oximetry Sensor Technology..................................... 39

Chapter 5. Product Overview ..................................................................... 41


Overview................................................................................................ 41
Oximeter Block Diagram ...................................................................... 42
System Board Components................................................................... 43
System Board Component Overview ............................................. 43
User Interface Printed Circuit Board .............................................. 43
SpO2 Printed Circuit Board ............................................................. 45

Chapter 6. Set-up ........................................................................................ 47


Overview................................................................................................ 47
Using Battery Power ............................................................................. 48
Initial Charging of the Oximeter.................................................... 48
Battery Installation ......................................................................... 49
Low Battery Indicator ..................................................................... 50
Critical Battery Indication............................................................... 51

Chapter 7. Operation .................................................................................. 53


Overview................................................................................................ 53
Monitoring Oximeter Power ................................................................ 53
Overview.......................................................................................... 53
Powering the Oximeter .................................................................. 54
Menu Structure ..................................................................................... 57
Set Menu Parameters...................................................................... 57
Set Time/Date Parameters .............................................................. 58

Chapter 8. Oximeter Preventive Maintenance.......................................... 61


Overview................................................................................................ 61
Cleaning................................................................................................. 61
Periodic Safety Checks .......................................................................... 61

Chapter 9. Performance Verification ......................................................... 63


Overview................................................................................................ 63
Performance Verification ..................................................................... 63
Overview.......................................................................................... 63
Required Equipment....................................................................... 64

iv Service Manual
Safety Testing Standards ...................................................................... 64
Performance Tests................................................................................. 64
Power-On-Self-Test ......................................................................... 64
Operational Setup................................................................................. 67
Overall Performance Check .................................................................. 67
Operation with a Live Subject........................................................ 68
Pulse Oximetry Functional Tests........................................................... 69
Overview.......................................................................................... 69
Test Setup ........................................................................................ 70
BPM Test .......................................................................................... 72
SpO2 Test ......................................................................................... 74
Modulation Level Test .................................................................... 75
Light Level Test ............................................................................... 81

Chapter 10. Troubleshooting ....................................................................... 87


Overview................................................................................................ 87
Help and Support.................................................................................. 87
Documentation ............................................................................... 87
Technical Services............................................................................ 88
Error Codes ............................................................................................ 92

Chapter 11. Ordering Oximeter Spare Parts ............................................... 99


Overview................................................................................................ 99
Obtaining Replacement Parts .............................................................. 99
Spare Parts List and Accessories ......................................................... 100

Chapter 12. Repairing the Oximeter.......................................................... 103


Overview.............................................................................................. 103
Oximeter Disassembly and Reassembly ............................................. 104
Disassembling the Oximeter......................................................... 104
SpO2 PCB or User Interface PCB Replacement .................................. 107
Top Case Assembly Replacement ....................................................... 111
Bottom Case Assembly Replacement................................................. 113
Battery Cover Replacement................................................................ 116
Packing for Shipment ......................................................................... 116
Introduction .................................................................................. 116
Returning the Oximeter ............................................................... 116
Repacking in Original Carton....................................................... 117
Packing in a Different Carton ...................................................... 118

Chapter 13. Schematics............................................................................... 119


Overview.............................................................................................. 119

Service Manual v
Page Left Intentionally Blank

vi Service Manual
1 Safety Information

Overview
This section contains safety information for service personnel who will
service the Nellcor™ OxiMax™ N-65™ handheld pulse oximeter. Only
qualified service personnel should service this product. Read the
Operator's Manual carefully and thoroughly understand the operation
of the oximeter.

The WARNING symbol identifies warnings .


Warnings alert the user to potential serious outcomes (death, injury,
or adverse events) to the patient or user.

The CAUTION symbol identifies cautions.


Cautions alert the user to exercise care necessary for the safe and
effective use of the Nellcor OxiMax N-65 handheld pulse oximeter.

The NOTE symbol identifies notes.


Notes contain important information that may otherwise be
overlooked or missed.

Warnings
WARNING
The OxiMax pulse oximetry sensor extrapolates from the date and time
provided by the Nellcor OxiMax N-65 handheld pulse oximeter when
recording the sensor event record to the sensor. The accuracy of the

7
Safety Information

date/time is determined by the date/time setting of the pulse oximeter.


Set the pulse oximeter date and time to the correct value before
connecting a record-enabled sensor to keep the date and time
consistent for as long as the sensor remains connected. Since a sensor
with sensor event record data can be transported from one oximeter to
another, having discrepancies in the date/time between oximeters and
the sensor event record data will affect the order in which the sensor
event record data appear. To eliminate this potential problem, set all
oximeters within an institution to the same time.

WARNING
Explosion hazard—Do not use the Nellcor OxiMax N-65 handheld pulse
oximeter in the presence of flammable anesthetics.

WARNING
Do not spray, pour, or spill any liquid on the pulse oximeter, its
accessories, connectors, switches, or openings in the enclosure as this
may damage to the oximeter.

WARNING
The LCD panel contains toxic chemicals. Do not touch broken LCD
panels. Physical contact with a broken LCD panel can result in
transmission or ingestion of toxic substances.

WARNING
Do not silence or decrease the volume of the OxiMax N-65 handheld
pulse oximeter’s audible alarm if patient safety could be compromised.

WARNING
The use of accessories, sensors, and cables other than those specified
may result in increased emission and/or create invalid readings of the
Nellcor OxiMax N-65 handheld pulse oximeter.

WARNING
To ensure accurate performance and prevent device failure, do not
subject the Nellcor OxiMax N-65 handheld pulse oximeter to extreme
moisture, such as direct exposure to rain. Such exposure may cause
inaccurate performance or device failure.

WARNING
Do not lift the Nellcor OxiMax N-65 handheld pulse oximeter by the
sensor or extension cable. The cable may disconnect, potentially drop
ppi ng the pulse oximeter on a patient or damaging surface.

8 Service Manual
Cautions

WARNING
As with all medical equipment, carefully route patient cabling to reduce
the possibility of patient entanglement or strangulation.

Cautions
Caution
Dispose of batteries in accordance with local requirements and regulations.
Caution
Observe ESD (electrostatic discharge) precautions when working within the
unit.
Caution
Observe ESD (electrostatic discharge) precautions when disassembling and
reassembling the Nellcor OxiMax N-65 handheld pulse oximeter and when
handling any of the components of the monitor.
Caution
When reassembling the Nellcor OxiMax N-65 handheld pulse oximeter,
tighten the screws that hold the cases together to a maximum of ten
inch-pounds. Over-tightening could strip out the screw holes in the front
case, rendering it unusable.

Service Manual 9
Page Left Intentionally Blank

10 Service Manual
2 Introduction

Overview
The Service Manual contains information for servicing the Nellcor™
OxiMax™ N-65™ handheld pulse oximeter. Only qualified service
personnel should service this product. Before servicing the oximeter,
thoroughly read the Operator's Manual for safe operation. The latest
version of this manual is available on the Internet at:
http://www.nellcor.com/serv/manuals.aspx

Related Documents
To perform test and troubleshooting procedures and to understand
the principles of operation and circuit analysis sections of this manual,
you must know how to operate the Nellcor OxiMax N-65 handheld
pulse oximeter. Refer to the Operator's Manual. To understand the
various OxiMax pulse oximetry sensors that work with the monitor,
refer to the individual OxiMax pulse oximetry sensor's Instructions For
Use.
The latest version of the Operator’s Manual and the Service Manual are
posted on the Internet at:
http://www.nellcor.com/serv/manuals.aspx

Spare parts and accessories are posted on the Internet at:


http://www.nellcor.com/serv/GenParts.aspx

Oximeter Description and Intended Use


Description
The OxiMax N-65 handheld pulse oximeter provides continuous
noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate.

11
Introduction

Intended Use
WARNING
The Nellcor OxiMax N-65 handheld pulse oximeter is a prescription
device to be operated only by trained personnel. The oximeter is for
attended monitoring only.
The Nellcor OxiMax N-65 handheld pulse oximeter is indicated for
continuous or spot check monitoring of functional arterial oxygen
saturation (SpO2) and pulse rate of adult, pediatric and neonatal
patients in hospital, hospital-type facilities, transport and mobile
environments as well as in the homecare environment.
Note:
Intended typical usage may be defined to include the following for the
Nellcor OxiMax N-65 handheld pulse oximeter:
• Hospital use typically covers such areas as general care floors (GCFs), operating rooms,
special procedure areas, intensive and critical care areas within the hospital and in
hospital-type facilities. Hospital-type facilities include physician office-based facilities,
sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers.
• Intra-hospital transport includes transport of a patient within the hospital or hospital-type
facility.
• Homecare use involves a lay person (parent or other similar non-critical caregiver) in the
home environment.

Use with any particular patient requires the selection of an


appropriate OxiMax™ pulse oximetry sensor. Refer to the Operator’s
Manual.
The oximeter can only operate on its internal batteries.

Oximeter Components
Front Panel
This section identifies the symbols, controls, displays, and indicators
on the Nellcor OxiMax N-65 handheld pulse oximeter.
Refer to the Operator’s Manual for a complete description of all keys,
symbols, controls, displays and indicators.
The front panel provides the user with multiple methods not only of
obtaining patient data, but also oximeter and sensor status.

12 Service Manual
Oximeter Components

Note:
Verify oximeter functionality during monitoring of patient data via the
regular updates to patient values and blip bar movement.
Figure 1. Front Panel Keys

1 Alarm Silence key


2 Adjust Down key
3 Data (Record/Print) key
4 Menu key
5 Contrast key
6 Adjust Up key
7 Power key

Service Manual 13
Introduction

Figure 2. Front Panel Primary Display Area

1 %SpO2Value
2 %SpO2 Upper and Lower Limit indicator
3 Pulse Amplitude indicator (Blip Bar)
4 Time Colon time/date field separator
5 Adjust Time Mode indicator
6 Adjust Volume Mode indicator
7 Set Limit Mode indicator
8 Pulse Rate (BPM) Upper and Lower Limit indicator
9 Pulse Rate Value (BPM)
10 Print indicator
11 Sensor Off Patient indicator
12 Interference indicator
13 Sensor Disconnected indicator
14 Pulse Beep Tone Volume Adjust indicator
15 Pulse Search indicator
16 Alarm Volume Adjust indicator
17 Data indicator
18 Data In-Sensor indicator
19 Alarm Silence indicator
20 Low Battery indicator

User Interface
This section describes the control keys on the front panel of the
oximeter. Activate by pressing the appropriate key. Pressing any key
besides the POWER key when the oximeter is turned on results in

14 Service Manual
Oximeter Components

either a valid or invalid key tone. If a tone fails to emit when you press
a key, contact qualified service personnel.
Figure 3. OxiMax N-65 Handheld Pulse Oximeter User Interface

ALARM SILENCE Key—Use to silence all audible alarms for the alarm
silence duration period. After silencing an alarm, press the key again
to reactivate the alarm. Alarms that occur throughout the Power-On
Self-Test (POST) cannot be silenced.
Press and hold the ALARM SILENCE key for three seconds to display the
Alarm Silence Duration menu.
ADJUST DOWN Key—Use to decrease variable parameters of the
oximeter or the pulse beep volume. Press and hold the key for more
than three seconds to repeat the decrement.
DATA (Record/Print) Key—Use to store currently shown SpO2 and
pulse rate values, known as snap-shot data. Use this same key to print
the stored snap-shot data, such as a single-event report, snap-shot,
and/or sensor-event data by pressing the DATA key in print mode.
MENU Key—Press repeatedly during normal operation to display
oximeter parameters.
• Upper and lower SpO2 alarm limits
• Upper and lower Pulse Rate (BPM) alarm limits
• Alarm volume
• Pulse beep volume
• Data print mode
Caution
The oximeter returns to normal operation and incorporates the selected
parameter value after approximately 30 seconds of inactivity. See Menu
Structure, page 57 for additional information about setting parameters.

Service Manual 15
Introduction

Alarms and alarm indicators are enabled when parameters are set and
display in the event of an alarm condition.
• Sensor Disconnected
• Pulse Search
• Interference
• Low Battery
• Alarm Silence
Press the MENU key during Power-On Self-Test (POST) until the Time/
Date set displays. Repeatedly pressing the MENU key allows users to
set time/date parameters.
• Hour
• Minute
• Day
• Month
• Year
After setting time/date parameters, users may return to the default
display.
BACKLIGHT Key—Press to toggle the backlight ON or OFF. After
activation, the backlight remains on for approximately ten minutes.
ADJUST UP Key—While in menu mode, press repeatedly to increase a
parameter by one increment. Press and hold the key for more than
three seconds to repeat the increment.
Press the ADJUST UP key during normal operation while monitoring to
increase the pulse beep volume.
Note:
Oximeter functions listed below are prerequisites for normal operation.
• Powered on
• Sensor connected to the oximeter
• Sensor applied to a patient
• Oximeter reporting patient’s %SpO2 (oxygen saturation percentage) and pulse rate
readings (BPM)
• No error conditions exist

POWER Key—Press to power ON or OFF the oximeter. For tactile


differentiation from other keys, the POWER key has a raised protrusion
(bump) at its center and a gloss surface finish.

16 Service Manual
Oximeter Components

Front Panel Symbols


The oximeter front panel displays two symbols.
The measured percent of oxygen saturation value displays below this
symbol.
The measured pulse beats per minute value displays below this
symbol.

Oximeter Visual Indicators


Selected display elements, such as indicators or numerals, may flash.
There are three flash rates.

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

%SpO2 Value—Indicates hemoglobin oxygen saturation levels. The


display value flashes zeros during loss-of-pulse alarms and flashes the
%SpO2 value when the SpO2 is outside the alarm limits. The oximeter
continues to update the display during Pulse Search. The oximeter
shows two dashes throughout Sensor Disconnected and Sensor Off
Patient conditions. The oximeter also shows a decimal point (.) after
the SpO2 value (98.0) if alarm limits have changed from their power-
on defaults.
Note:
Decimal points after the %SpO2 or pulse rate indicate that the respective
limits have been changed from the power-on default values.
Snap-shot Data ID Indicator—Displays an alphanumeric ID in the
%SpO2 area of the display for current captured patient (SpO2) and
pulse rate (PR) values.
Upper Alarm Limit Indicator—Indicates the adjustment of upper
alarm limit value for SpO2 or Pulse Rate.
Lower Alarm Limit Indicator—Indicates the adjustment of lower
alarm limit value for SpO2 or Pulse Rate.

Service Manual 17
Introduction

Pulse Amplitude (blip bar)—Indicates pulse beat and relative (non-


normalized) pulse amplitude. As the detected pulse becomes
stronger, more bars light with each pulse. When setting alarm volume,
the pulse amplitude blip bar reflects the alarm volume setting.
Adjust Time Indicator—Displays while setting time and date.
Adjust Volume Mode Indicator—Displays alarm volume levels
adjustment.
Set Limit Mode Indicator—Displays during alarm limit or pulse rate
values adjustment.
Pulse Rate Value—Displays the pulse rate in beats per minute. It
flashes during loss-of-pulse alarms and when the pulse rate is outside
of the alarm limits. During Pulse Search, the oximeter continues to
update the display. Pulse rates outside of the pulse rate range of 20 to
250 beats per minute (bpm) are displayed as 0 and 250, respectively.
The oximeter shows two dashes throughout Sensor Disconnected and
Sensor Off Patient conditions. The oximeter shows a decimal point (.)
after the pulse rate value (123.), if alarm limits have changed from
their power-on defaults.
Note:
Decimal points after the %SpO2 or pulse rate indicate that the respective
limits have been changed from the power-on default values.
Low Battery Indicator—Flashes when 15 or fewer minutes of battery
capacity remain, then displays continuously when the battery
capacity reaches a critically low condition, at which time the oximeter
indicates an error condition and shuts down.
Data In-Sensor Indicator—Lights to indicate the attached OxiMax
pulse oximetry sensor contains a patient sensor event record. The
indicator flashes when the sensor memory is full.
Alarm Volume Adjust Indicator—Displays during alarm volume
adjustment.
Pulse Beep Tone Volume Adjust Indicator—Displays during pulse
beep tone volume adjustment.
Sensor Disconnected Indicator—Displays when disconnecting the
pulse oximetry sensor from the oximeter.
Sensor Off Patient Indicator—Displays after removal of the pulse
oximetry sensor from the patient.

18 Service Manual
Oximeter Components

Alarm Silence Indicator—Displays when audible alarms have been


silenced. It flashes when audible alarms have been disabled.

WARNING
Pressing ALARM SILENCE will keep ALL alarms from sounding for the
alarm silence period.
Data Indicator—Displays during the store snap-shot data or data
print mode and flashes when snap-shot data prints.
Pulse Search Indicator—Lights continuously prior to initial
acquisition of a pulse signal and during prolonged challenging
monitoring conditions. The pulse search indicator flashes throughout
a loss-of-pulse signal.
Interference Indicator—Lights whenever the oximeter algorithm
detects degraded incoming signal quality. An intermittently lit
Interference Indicator is common during patient monitoring, and
indicates the oximeter algorithm dynamically adjusts the amount of
data required for measuring SpO2 and Pulse Rate. When the indicator
is lit continuously, the oximeter algorithm is extending the amount of
data required for measuring SpO2 and Pulse Rate. In this case, fidelity
in tracking rapid changes in these values may be reduced.
Note:
Degradation can be caused by ambient light, poor sensor placement,
electrical noise, electro-surgical interference, patient activity, or other
causes.
Print Indicator—Displays during the print mode and flashes when
the oximeter prints single-event, snap-shot, or patient alarm events
data stored in the sensor.

Service Manual 19
Introduction

Rear Panel
Figure 4. OxiMax N-65 Handheld Pulse Oximeter Rear Panel

1 Rear Panel Label


2 Alarm Speaker Holes
3 Battery Cover

Rear Panel Symbols and Descriptions


The following symbols are located on the rear panel of the oximeter.
Date of manufacture

Type BF applied part - Not defibrillator proof

Warning! See Instructions for Use

Requires four AA batteries

Canadian/USA certification mark (electrical safety)

European union approval

Russian regulatory approval

20 Service Manual
Carton Label Symbols

Proper WEEE Waste Disposal

Resistant to liquid ingress

Rx prescription only

Carton Label Symbols


These symbols display on the oximeter’s carton label.
Keep upright

Fragile

Atmospheric pressure limitation

Humidity limitation

Temperature limitation

Protect from moisture

Keep away from heat

Service Manual 21
Page Left Intentionally Blank

22 Service Manual
3 Product Specifications

Overview
This section contains Nellcor™ OxiMax™ N-65™ handheld pulse
oximeter physical and operational specifications. Ensure all product
requirements are met prior to installation of the oximeter.

Physical Characteristics
Weight 0.62 lbs. (0.28 kg)
Dimensions 2.875 in. x 6.25 in. x 1.375 in.
(7.3 cm x 15.9 cm x 3.5 cm)

Electrical Requirements
Batteries
Type 4 AA alkaline
Voltage 6 Volts DC (with 4 AA batteries)
Typical Battery life Alkaline 15 hours
Lithium 40 hours

Environmental Conditions
Operation
Temperature 5 ºC to 40 ºC (41 ºF to 104 ºF)
Altitude -390 m to 3,012 m (-1,254 ft. to 9,882 ft.)
Atmospheric Pressure 70 kPa to 106 kPa (20.6 in. Hg to 31.3 in. Hg)
Relative Humidity 15% to 95% non-condensing

23
Product Specifications

Transport and Storage


No shipping container Shipping container
Temperature -20 ºC to 60 ºC -20 ºC to 70 ºC
-4 ºF to 140 ºF -4 ºF to 158 ºF
Altitude -390m to 5,574 m -390m to 5,574 m
-1,280 ft. to 18,288 ft. -1,280 ft. to 18,288 ft.
Atmospheric 50 kPa to 106 kPa 50 kPa to 106 kPa
Pressure 14.7 in. Hg to 31.3 in. Hg 14.7 in. Hg to 31.3 in. Hg
Relative Humidity 15% to 95% non-condensing 15% to 95% non-condensing

Performance Specifications
Measurement Range
SpO2 1% to 100%
Pulse Rate 20 to 250 beats per minute (bpm)
Perfusion Range 0.03% to 20%

OxiMax™ Pulse Oximetry Sensors


Note:
For a complete listing of SpO2 accuracy across the full line of available
OxiMax™ pulse oximetry sensors, contact 1.800.635.5267.

24 Service Manual
Performance Specifications

Pulse Oximetry Sensor Accuracy


Table 2. Oxygen Saturation Accuracy1

LoSAT™ Standard Saturation


Range Range
Sensor Model Type 60% to 80% 70% to 100%

MAX-A, MAX-AL ± 3.0 digits ± 2.0 digits

MAX-N2 ± 3.0 digits ± 2.0 digits


(Adult and Neonate)

MAX-P, MAX-I, MAX- ± 3.0 digits ± 2.0 digits


FAST

Softcare™ SC-A, -PR, N/A ± 2.0 digits


-NEO3

MAX-R N/A ± 3.5 digits

Low Perfusion4 N/A ± 2.0 digits

Pulse Rate

Normal Range 20 to 250 bpm ± 3.0 digits

Low Perfusion4 20 to 250 bpm ± 3.0 digits

1
Subjects used to validate SpO2 measurement accuracies were healthy and recruited from the local population.
Comprised of both men and women, subjects spanned a range of skin pigmentations and ranged in age from 18-50
years old. Accuracy specifications are based on controlled hypoxia studies with healthy non-smoking adult volunteers
over the specified saturation SpO2 range(s). Pulse oximeter SpO2 readings were compared to SaO2 values of drawn
blood samples measured by hemoximetry. All accuracies are expressed as ±1 SD. Pulse oximeter equipment
measurements are statistically distributed; about two-thirds of pulse oximeter measurements can be expected to fall
in this accuracy (ARMS) range. Because scatter and bias of pulse oximeter SpO2 and blood SaO2 comparison
commonly increase as the saturation decreases, and accuracy specifications are calculated from data spanning the
stated range, different accuracy values may result when describing partially overlapping ranges.
2
Clinical functionality of the MAX-N has been demonstrated on a population of hospitalized neonate patients. The
observed SpO2 accuracy was 2.5% in a study of 42 patients with ages of 1 to 23 days, weight from 750 to 4,100 grams,
and 63 observations made spanning a range of 85% to 99% SaO2.
3
Clinical functionality has been demonstrated in a population of hospitalized neonate patients. The observed SpO2
accuracy was 3.0% in a study of 57 patients with ages of 24 to 40 weeks, weight from 710 to 5,000 grams, and 185
observations made spanning a range of 63% to 99% SaO2.
4
Specification applies to N-65 oximeter performance. Reading accuracy in the presence of low perfusion (detected IR
pulse modulation amplitude 0.03% - 1.5%) was validated using signals supplied by a patient simulator. SpO2 and
pulse rate values were varied across the monitoring range over a range of weak signal conditions and compared to the
known true saturation and pulse rate of the input signals.

Sensor Power Dissipation


Pulse Oximetry Sensor Dissipation
OxiMax™ MAX-A, -AL, -I, -N, -P, -R 52.5 mW
OxiMax™ Durasensor™ DS-100A 52.5 mW
OxiMax™ OxiCliq™ A, I, N, P 52.5 mW
OxiMax™ Dura-Y™ D-YS 52.5 mW
OxiMax™ Max-Fast™ 52.5 mW
OxiMax™ Softcare™ SC-A, -NEO, -PR 52.5 mW

Service Manual 25
Product Specifications

OxiMax™ Pulse Oximetry Sensor Operating Range


Red Light Wavelength Approximately 660 nm
Infrared Light Wavelength Approximately 900 nm
Optical Output Power Less than 15 mW

26 Service Manual
Audible Indicators

Audible Indicators
Table 3. Audible Indicator Parameters and Values

Audible Indicator Parameter Value

Alarm Volume Volume level Adjustable, 40 to 52 dB(A), at 1m


Setting
Pitch (±30 Hz) 752 Hz

On pulse width (±20 msec) 500 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) N/A

Priority 1

Beep Volume Volume level Adjustable, 42 to 52 dB(A), at 1m


Setting
Pitch (±30 Hz) 1500 Hz

On pulse width (±20 msec) 500 msec

Beep Volume Off Interval (±20 msec) 10 msec


Setting
Number of pulses in burst 1

Repetition Pause (±2 sec.) N/A

Priority 2

POST Pass Volume level Fixed at 45 dB(A), at 1m

Pitch (±30 Hz) 600 Hz

On pulse width (±20 msec) 1000 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) N/A

Priority 3

Service Manual 27
Product Specifications

Table 3. Audible Indicator Parameters and Values (Continued)

Audible Indicator Parameter Value

Invalid Key Press Volume level Fixed at 45 dB(A), at 1m

Pitch (±30 Hz) 200 Hz

On pulse width (±20 msec) 50 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) N/A

Priority 4

Confirmation Volume level Fixed at 45 dB(A), at 1m

Pitch (±30 Hz) 700 Hz

On pulse width (±20 msec) 130 msec

Off Interval (±20 msec) 130 msec

Number of pulses in burst 3

Confirmation Repetition Pause (±2 sec.) N/A

Priority 5

Valid Key Press Volume level Fixed at 45 dB(A), at 1m

Pitch (±30 Hz) 800 Hz

On pulse width (±20 msec) 10 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) N/A

Priority 6

28 Service Manual
Audible Indicators

Table 3. Audible Indicator Parameters and Values (Continued)

Audible Indicator Parameter Value

Pulse Beep Volume level Adjustable, 42 to 52 dB(A), at 1m

Pitch (±30 Hz) 1500 Hz

On pulse width (±20 msec) 50 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) N/A

Priority 7

Alarm Silence Volume level Adjustable, 42 to 52 dB(A), at 1m


Reminder
Pitch (±30 Hz) 500 Hz

On pulse width (±20 msec) 130 msec

Off Interval (±20 msec) 130 msec

Number of pulses in burst 3

Repetition Pause (±2 sec.) 179.27 sec.

Alarm Silence Priority 8


Reminder

High Priority Volume level Adjustable, 42 to 52 dB(A), at 1m


Alarm
Pitch (±30 Hz) 1200 Hz

On pulse width (±20 msec) 250 msec

Off Interval (±20 msec) 80 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) 0 sec.

Priority 9

Service Manual 29
Product Specifications

Table 3. Audible Indicator Parameters and Values (Continued)

Audible Indicator Parameter Value

Medium Priority Volume level Adjustable, 42 to 52 dB(A), at 1m


Alarm
Pitch (±30 Hz) 752 Hz

On pulse width (±20 msec) 400 msec

Off Interval (±20 msec) 300 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) 0 sec.

Priority 10

Low Priority Alarm Volume level Adjustable, 42 to 52 dB(A), at 1m

Pitch (±30 Hz) 500 Hz

On pulse width (±20 msec) 400 msec

Off Interval (±20 msec) 3200 msec

Number of pulses in burst 1

Repetition Pause (±2 sec.) 0 sec.

Priority 11

Product Compliance
Product Standards for Compliance
ISO 9919: 2005
EN ISO 9919: 2005
RoHS EU Directive 2011/65/EU

Product Safety Standards


IEC 60601-1: 1988 + A1: 1991 + A2: 1995
EN 60601-1: 1990 + A11: 1993 + A12: 1993 + A13: 1996
UL 60601-1 1st edition
CSA C22.2 No. 601.1 M90
Protection Type Internally powered
Mode of Operation Continuous
Liquid Ingress IPX1
Degree of Safety Not suitable for use in the presence of a flammable anaesthetic gas

30 Service Manual
Manufacturer’s Declaration

Electromagnetic Compatibility (EMC) Standards


IEC 60601-1-2: 2001 + A1: 2004
EN 60601-1-2: 2001 + A1: 2006

Manufacturer’s Declaration
Basics
WARNING
The use of accessories, sensors, and cables other than those specified
may result in inaccurate readings of the Nellcor OxiMax N-65 handheld
pulse oximeter and increased emission or decreased immunity of the
oximeter.
The Nellcor OxiMax N-65 handheld pulse oximeter is suitable for
prescription use only in the specified electromagnetic environments.
Use the unit in accordance with the electromagnetic environments
described in this section.
Note:
The OXIMAX N-65 is RoHS compliant for products manufactured as of July 2014.

Service Manual 31
Product Specifications

Electromagnetic Compatibility (EMC)


Electromagnetic Emissions
Table 4. Electromagnetic Emissions Guidance

Emissions Test Compliance Electromagnetic Environment Guidance

RF emissions Group 1 The oximeter is suitable for use in all


CISPR 11: 2004 Class B establishments.

Harmonic emissions Not applicable.


IEC 61000-3-2: 2005

Voltage fluctuations/
flicker emission
IEC 61000-3-3: 2005

Electromagnetic Immunity
Note:
Use the unit in accordance with the electromagnetic environments
described in this section.
Table 5. Electromagnetic Immunity Testing

IEC 60601-1-2 Compliance Electromagnetic


Immunity Test Test Level Level Environment Guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floor should be wood,
discharge (ESD) ± 8 kV air ± 8 kV air concrete, or ceramic tile. If
IEC 61000-4-2: floors are covered with
2008 synthetic material, the
relative humidity should be
at least 30%.
Power 3 A/m 3 A/m The power frequency
frequency (50/ magnetic field should be
60 Hz) measured in the intended
magnetic field installation location to
IEC 61000-4-8: assure that it is sufficiently
2001 low.

32 Service Manual
Manufacturer’s Declaration

Table 6. Immunity Test Levels

IEC 60601-1-2 Equation for


Immunity Test Test Level Compliance Level Separation Distance
Conducted RF IEC 3 Vrms
61000-4-6: 2008 150 kHz 3 Vrms
80 MHz d = 1.2 P

Radiated RF IEC 3 V/ma


61000-4-3: 2008 80 MHz 3 V/m (non-transport)a
800 MHz d = 1.2 P

d = 0.2 P
20 V/m (transport)
3 V/ma
800 MHz 3 V/m (non-transport)a
2.5 GHz d = 2.3 P

d = 0.4 P
20 V/m (transport)
a
Per ISO 9919:2005, compliance level is 20 V/m when used with the transport cover and the included ferrite bead on
the sensor cable.

The N-65 handheld pulse oximeter is intended for use in


electromagnetic environments where radiated RF disturbances are
controlled. Portable and mobile RF communications equipment
should be used no closer to any part of the Nellcor OxiMax N-65
handheld pulse oximeter, including cables, than the recommended
separation distance calculated from the equation appropriate for the
frequency of the transmitter, according to the maximum output
power of the communications equipment.
For transmitters rated at a maximum output power not listed,
estimate the recommended separation distance d in meters using the
equation applicable to the frequency of the transmitter where P is the
maximum output power rating of the transmitter in watts, according
to the equipment manufacturer.

Service Manual 33
Product Specifications

These guidelines may not apply in all situations. Absorption and reflection
from structures, objects, and people affect electromagnetic propagation.

Table 7. Recommended Separation Distances

Separation Distance in Meters for Non-Transport Use


150 kHz to 80 MHz to 800 MHz to
Rated Maximum 80 MHz 800 MHza 2.5 GHz
Output Power of
Transmitter in Watts d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.10 0.38 0.38 0.73
1.00 1.20 1.20 2.30
10.00 3.80 3.80 7.30
100.00 12.00 12.00 23.00
Separation Distance in Meters for Transport Use
150 kHz to 80 MHz to 800 MHz to
Rated Maximum 80 MHz 800 MHza 2.5 GHz
Output Power of
Transmitter in Watts d = 1.2 P d = 0.2 P d = 0.4 P
0.01 0.12 0.02 0.04
0.10 0.40 0.10 0.10
1.00 1.20 0.20 0.40
10.00 3.80 0.60 1.30
100.00 12.00 2.00 4.00
a
The separation distance for the higher frequency range applies at 80 MHz to 800 MHz.

Sensors and Compliance


WARNING
The use of accessories, OxiMax sensors, and cables other than those
specified may result in inaccurate readings of the Nellcor OxiMax N-65
handheld pulse oximeter and increased emission or decreased
immunity of the oximeter.

34 Service Manual
Safety Tests

Table 8. Sensors and Sensor Cables

Item Maximum Length

Sensors

MAX-FAST 30 in. (76.2 cm)

MAX-A, MAX-I, MAX-N, MAX-P, MAX-R 1.5 ft. (0.5 m)

MAX-AL 3 ft. (0.9 m)

Softcare™ SC-A, SC-NEO, SC-PR 3 ft. (0.9 m)

Durasensor™ DS-100A 3 ft. (0.9 m)

Oxiband™ OXI-A/N, OXI-P/I 3 ft. (0.9 m)

D-YS, D-YSE, D-YSPD 4 ft. (1.2 m)

Sensor Cables

OxiCliq-OC-3 sensor cable 3 ft. (0.9 m)

DEC-4/DEC-8 sensor extension cable 4 ft. (1.2 m)/8 ft. (2.4m)

Note:
The sensors and sensor cables are RoHS compliant for products
manufactured as of July 2014.

Safety Tests
Leakage Current
The following table displays the maximum patient leakage current
allowed.
Table 9. Patient Applied and Patient Isolation Risk Current

IEC 60601-1
Condition UL 60601-1

Patient Applied Risk Current

Normal 100 μA

Patient Isolation Risk Current

Single Fault 5000 μA

Service Manual 35
Page Left Intentionally Blank

36 Service Manual
4 Theory of Operations

Overview
This section explains the theory behind Nellcor™ OxiMax™ N-65™
handheld pulse oximeter operations.

Understanding Pulse Oximetry


Theoretical Principals
The Nellcor OxiMax N-65 handheld pulse oximeter uses pulse
oximetry to measure functional oxygen saturation in the blood. Pulse
oximetry works by applying an OxiMax™ pulse oximetry sensor to a
pulsating arteriolar vascular bed, such as a finger or toe. The sensor
contains a dual light source and a photo detector.
Bone, tissue, pigmentation, and venous vessels normally absorb a
constant amount of light over time. The arteriolar bed normally
pulsates and absorbs variable amounts of light during the pulsations.
The ratio of light absorbed is translated into a measurement of
functional oxygen saturation (SpO2).
Ambient conditions, sensor application, and patient conditions can
influence the ability of the oximeter to accurately measure SpO2.
Pulse oximetry is based on two principles: oxyhemoglobin and
deoxyhemoglobin differ in their absorption of red and infrared light
(measured using spectrophotometry), and the volume of arterial
blood in tissue (and hence, light absorption by that blood) changes
during the pulse (registered using plethysmography). A pulse
oximeter determines SpO2 by passing red and infrared light into an
arteriolar bed and measuring changes in light absorption during the
pulsatile cycle. Red and infrared low-voltage light-emitting diodes
(LED) in the sensor serve as light sources; a photo diode serves as the
photo detector.

37
Theory of Operations

Since oxyhemoglobin and deoxyhemoglobin differ in light


absorption, the amount of red and infrared light absorbed by blood is
related to hemoglobin oxygen saturation.
The oximeter uses the pulsatile nature of arterial flow to identify the
oxygen saturation of arterial hemoglobin. During systole, a new pulse
of arterial blood enters the vascular bed, and blood volume, and light
absorption increase. During diastole, blood volume, and light
absorption reach their lowest point. The pulse oximeter bases its SpO2
measurements on the difference between maximum and minimum
absorption (measurements at systole and diastole). By doing so, it
focuses on light absorption by pulsatile arterial blood, eliminating the
effects of nonpulsatile absorbers such as tissue, bone, and venous
blood.

Automatic Calibration
Because light absorption by hemoglobin is wavelength dependent
and because the mean wavelength of LEDs varies, an oximeter must
identify the mean wavelength of the OxiMax sensor's red LED to
accurately measure SpO2.
During monitoring, the oximeter’s software selects coefficients
appropriate for the wavelength of that individual OxiMax sensor's red
LED; these coefficients are then used to determine SpO2.
Additionally, to compensate for differences in tissue thickness, the
light intensity of the OxiMax sensor's LEDs adjusts automatically.

Functional versus Fractional Saturation


This pulse oximeter measures functional saturation -- oxygenated
hemoglobin expressed as a percentage of the hemoglobin that can
transport oxygen. It does not detect significant amounts of
dysfunctional hemoglobin, such as carboxyhemoglobin or
methemoglobin. In contrast, hemoximeters such as the IL482 report
fractional saturation -- oxygenated hemoglobin expressed as a
percentage of all measured hemoglobin, including measured
dysfunctional hemoglobins. To compare functional saturation

38 Service Manual
OxiMax™ Pulse Oximetry Sensor Technology

measurements to those from an instrument that measures fractional


saturation, fractional measurements must be converted as follows:
Figure 5. Fractional Saturation Conversion Equation

Measured versus Calculated Saturation


When saturation is calculated from a blood gas partial pressure of
oxygen (PO2), the calculated value may differ from the SpO2
measurement of a pulse oximeter. This usually occurs because the
calculated saturation was not appropriately corrected for the effects
of variables that shift the relationship between PO2 and pH,
temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG,
and fetal hemoglobin.
Figure 6. Oxyhemoglobin Dissociation Curve

OxiMax™ Pulse Oximetry Sensor Technology


Use OxiMax™ pulse oximetry sensors specifically designed for use with
the oximeter. Identify OxiMax pulse oximetry by the deep blue color
and/or white colors of their plugs. All OxiMax pulse oximetry sensors
contain a memory chip carrying information about the sensor the
oximeter needs for correct operation, including the sensor’s

Service Manual 39
Theory of Operations

calibration data, model type, troubleshooting codes, and error


detection data.
This unique oximetry architecture enables several new features. When
an OxiMax pulse oximetry sensor is connected to the Nellcor OxiMax
N-65 handheld pulse oximeter, the oximeter reads the information
from the OxiMax pulse oximetry sensor memory chip, ensures it is
error free, and then loads the sensor data prior to monitoring for new
information. As the oximeter reads sensor information, it flashes the
DATA IN-SENSOR indicator. This process takes a few seconds. Once the
reading process is complete, the oximeter begins monitoring.
Pulse oximeters containing OxiMax technology, including the Nellcor
OxiMax N-65 handheld pulse oximeter, use calibration data contained
in the OxiMax pulse oximetry sensor in calculating the patient’s SpO2.

40 Service Manual
5 Product Overview

Overview
The Nellcor™ OxiMax™ N-65™ handheld pulse oximeter relies on
unique oximetry technology and design in providing hospitals,
clinicians, and caregivers accurate, timely data.

41
Product Overview

Oximeter Block Diagram


The following block diagram shows the flow of data in the Nellcor™
OxiMax™ N-65™ handheld pulse oximeter, including input and output.
Figure 7. Block Diagram

42 Service Manual
System Board Components

System Board Components


System Board Component Overview
The Nellcor OxiMax N-65 handheld pulse oximeter consists of two
printed circuit boards (PCB), the user interface PCB and the SpO2 PCB.
These two components provide support for data exchange and input
from the clinician, technician, or caregiver during use. For printed
circuit board (PCB) design, see Schematics, page 119.

User Interface Printed Circuit Board


The user interface (UIF) receives signals from the OxiMax pulse
oximetry sensor. These signals are converted and supplied to the user
interface PCB central processing unit (CPU). The user interface receives
control signals from the CPU. These control signals are used to control
the light emitting diodes in the OxiMax pulse oximetry sensor.
The user interface PCB provides:
• User setup of the monitor via the keypad
• Patient %SpO2 and pulse rate via the display
• Monitor status via the display and audio function
• Printed reports via the IrDA (Infrared Data Association) and external
printer
• Display readability in dark environments via the display backlight
• Operating voltages for the user interface circuits
• Operating voltage monitoring

CPU and Flash


The CPU controls all functions and timing for the oximeter. The CPU
communicates with the SpO2 PCB patient interface. The patient
interface signal are sent to the CPU for processing. The CPU sends
signals to the patient sensor via the patient interface for controlling
the sensor light levels.

Service Manual 43
Product Overview

Keypad
The user interface PCB keypad contains seven keys. These keys allow
the user to setup and control of the oximeter. The keys are:
• Alarm Silence
• Adjust Down
• Data
• Menu
• Backlight
• Adjust Up
• Power

The signals from the keys pass directly through the SpO2 PCB, then
applied to the user interface PCB CPU. The POWER key signal is applied
to the SpO2 power supply, turning the oximeter on or off.

LCD
The liquid crystal display (LCD) is driven by the CPU. The LCD displays
the patient’s %SpO2 and pulse rate, as well as status and function
indicators. See User Interface, page 14.

Audio
The audio circuit drives a transducer to provide the oximeter tones.

Real-Time Clock
The real-time clock and non-volatile random access memory (RAM)
chip maintain time and date used in the monitor. These circuits utilize
a gold electrolytic super-capacitor for power when the oximeter is
turned off.

IrDA
The IrDA (Infrared Data Association) is an industry standard for
infrared communications. The IrDA receives information from the CPU,
converts it, and sends it to an external printer. The external printer
communicates with the IrDA. Refer to the printer manual for more
information.

44 Service Manual
System Board Components

Backlight
The backlight illuminates the display for better viewing.

User Interface PCB Power Supply


The user interface PCB power supply receives power from the SpO2
PCB power supply. The power supply provides a regulated 3.0 volts DC
to the CPU.

User Interface PCB Power Monitoring


The power supply outputs are monitored by the power monitoring
function to ensure stability. The power supply monitoring circuit
sends a reset signal to the watchdog circuits to shut down the
oximeter when voltages are out of tolerance.
The power supply monitoring circuit monitors the battery output
voltage and shuts down the oximeter when the battery voltage is
critically low. The circuit provides the low battery signal.

SpO2 Printed Circuit Board


The SpO2 PCB provides patient interface and oximeter operating
power.

SpO2 PCB Power Supply


The power supply provides operating voltages to the SpO2 PCB and
the user interface PCB. These voltages are supplied to the:
• SpO2 PCB power monitoring function
• SpO2 PCB circuits
• User interface PCB power supply
• User interface PCB CPU
• User interface PCB audio circuits

SpO2 PCB Power Monitoring


The SpO2 power monitoring function monitors and controls the
outputs of the SpO2 power supply. The SpO2 power monitoring
function provides the user interface CPU and SpO2 patient interface
with status information on the power supply output signals.

Service Manual 45
Page Left Intentionally Blank

46 Service Manual
6 Set-up

Overview
This section provides information on setting up the Nellcor™ OxiMax™
N-65™ handheld pulse oximeter prior to first time usage.

WARNING
To ensure patient safety, do not place the Nellcor OxiMax N-65
handheld pulse oximeter in any position that might tip or fall on the
patient.

WARNING
As with all medical equipment, carefully route cables to reduce the
possibility of patient entanglement or strangulation.

WARNING
Ensure the speaker is clear of any obstruction and speaker holes are not
covered. Failure to do so could result in an inaudible alarm tone.

WARNING
Disconnect the oximeter and OxiMax pulse oximetry sensor from the
patient throughout magnetic resonance imaging (MRI) scanning.
Objects containing metal can become dangerous projectiles when
subjected to the strong magnetic fields created by MRI equipment.
Also, induced current could potentially cause burns.

WARNING
To ensure accurate performance and prevent device failure, do not
subject the Nellcor OxiMax N-65 handheld pulse oximeter to extreme
moisture, such as direct exposure to rain. Such exposure may cause
inaccurate performance or device failure.

WARNING
Do not use an Nellcor OxiMax N-65 handheld pulse oximeter, OxiMax
pulse oximetry sensor, cables, or connectors that appear damaged.

47
Set-up

WARNING
Do not lift the Nellcor OxiMax N-65 handheld pulse oximeter by the
sensor or extension cable. The cable may disconnect, potentially
dropping the pulse oximeter on a patient or a damaging surface.

WARNING
The Nellcor OxiMax N-65 handheld pulse oximeter is not defibrillator-
proof. It may remain attached to the patient during defibrillation or
during use of an electrosurgical unit, however readings may be
inaccurate during the defibrillation and shortly thereafter.

WARNING
Use only Nellcor-approved OxiMax pulse oximetry sensors when
connecting to the OxiMax sensor connector. Connecting any other
sensor influences the accuracy of sensor data, which may lead to
adverse results.

WARNING
Use only the Nellcor DEC-4 or DEC-8 extension cable with the Nellcor
OxiMax N-65 handheld pulse oximeter. Use of another pulse oximetry
cable will have an adverse effect on performance. Do not attach any
cable intended for computer use to the sensor port.

Using Battery Power


WARNING
Explosion hazard. Do not use the Nellcor OxiMax N-65 handheld pulse
oximeter in the presence of flammable anesthetics.
Caution
Dispose of batteries in accordance with local requirements and regulations.
The Nellcor OxiMax N-65 handheld pulse oximeter uses batteries to
power the oximeter. A new set of batteries provides between 15 to 40
hours of operation, depending on the battery type.

Initial Charging of the Oximeter


The Nellcor OxiMax N-65 handheld pulse oximeter requires a charging
period before initial power on for the first time or any time after the
battery and internal capacitors completely drain. There are several
requirements for this charging period.

48 Service Manual
Using Battery Power

1. Attach an OxiMax™ pulse oximetry sensor to the SpO2 port


connector to keep the oximeter from powering off prior to charge
completion.
2. Press the POWER key to turn ON the oximeter.
3. Wait twenty minutes for the oximeter to fully charge.
Note:
Users must install the four AA batteries, keep a sensor plugged into the
oximeter, and leave the unit ON for 20 minutes before the oximeter retains
time and date information. This is only necessary for retaining time and date
information the first time the time/date is set. If batteries are removed after
being installed for five hours, the oximeter retains time and date information
for approximately 20 minutes.
Note:
Continue to monitor the display for the low battery indicator during power-
on self-test.

Battery Installation
To install batteries
1. Turn OFF the power.
2. Pull the battery compartment latch downward toward the bottom
of the oximeter, and remove the battery access door.
3. Properly orient and install four AA size batteries.

Service Manual 49
Set-up

4. Replace the battery access door.


Figure 8. Battery Installation

Low Battery Indicator


Caution
The low battery indicator is based on Alkaline AA batteries and provides an
approximate fifteen minute warning. Remaining operating time may be
different for other types of batteries.
Caution
Periodically check the batteries for corrosion. If the Nellcor OxiMax N-65
handheld pulse oximeter is to be stored for three months or longer, remove
the batteries from the oximeter before storage.
Caution
Dispose of batteries in accordance with local requirements and regulations.

50 Service Manual
Using Battery Power

The LOW BATTERY indicator flashes and a low priority alarm sounds
when approximately 15 minutes of operation remains available.
Replace the batteries.
Figure 9. Display with Low Battery Indicator

Critical Battery Indication


When the batteries are critically low, the oximeter:
1. Displays an error message (Er 521),
2. Sounds a high priority alarm,
3. Shuts down.
Replace the batteries and restart the oximeter.
Figure 10. Critical Battery Error Message

Service Manual 51
Page Left Intentionally Blank

52 Service Manual
7 Operation

Overview
Default parameters for the Nellcor™ OxiMax™ N-65™ handheld pulse
oximeter are set at the factory. Institutional parameters may be set on
an individual basis by the clinician.
Institutional parameters remain in effect until power off. At power off,
the oximeter returns to the factory default parameters.
Table 10. Parameter Ranges and Defaults

Factory
Parameter Ranges/Selections Defaults

%SpO2 Upper Alarm Lower Alarm Limit, 100%


Limit plus 1 to 100%

%SpO2 Lower Alarm 20% to Upper Alarm Limit, 85%


Limit minus 1

Pulse Rate Upper Alarm Lower Alarm Limit, 170 bpm


Limit plus 1 to 250 bpm

Pulse Rate Lower Alarm 30 bpm to Upper Alarm Limit, 40 bpm


Limit minus 1

Alarm Silence Duration Alarms 30, 60, 90, 120 seconds, 30 secs
OFF

Alarm Volume 1 to 10 10

Pulse Beep Volume 0 to 10 10

Monitoring Oximeter Power


Overview
WARNING
If you do not hear the POST pass tone, do not use the Nellcor OxiMax N-
65 handheld pulse oximeter.

53
Operation

Caution
During the Power-On-Self-Test (POST) immediately after power-up, confirm
all display segments and indicators display and the oximeter speaker sounds
a one-second tone.
Note:
Users must install the four AA batteries, keep a sensor plugged into the
oximeter, and leave the unit ON for 20 minutes before the oximeter retains
time and date information. This is only necessary the first time the time/date
is set. If batteries are removed after being installed for five hours, the
oximeter retains time and date information for approximately 20 minutes.
Note:
Continue to monitor the display for the low battery indicator during power-
on self test.
At every power up, verify the oximeter works properly and is safe to
use. Power-On Self-Test (POST) takes approximately ten seconds to
complete. At power on, POST automatically tests the oximeter
circuitry and functions.

Powering the Oximeter


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.

To turn on the oximeter


1. Press the POWER key to turn on the oximeter. The backlight remains
on throughout POST.
2. Ensure all numbers and indicators display for three seconds.

Figure 11. Stage 1 of POST

54 Service Manual
Monitoring Oximeter Power

3. Ensure the display goes blank for one second.


Figure 12. Stage 2 of POST

4. Ensure the software version number appears for three 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 oximeter for the software
version installed. Write down the software version number and have it
available prior to requests for technical assistance.
Figure 13. Stage 3 of POST

Service Manual 55
Operation

5. Ensure the current time displays in a 24-hour format.


Figure 14. Stage 4 of POST

6. Ensure the oximeter sounds a one-second tone to indicate it


successfully passed POST.
7. If the oximeter detects a problem, listen for an error tone and
watch the display. An error code (Er) and the error number display.
See Troubleshooting, page 87.
Figure 15. Error During POST

Note:
The POST pass tone also functions as an audible confirmation that the
speaker performs properly.
Note:
Continue to monitor the display for the low battery indicator during power-
on self test.

56 Service Manual
Menu Structure

Menu Structure
This section contains quick reference information on how to set
oximeter parameters and limits using the menu structure.
See Set Menu Parameters, page 57, to change oximeter default
parameters.
• Upper and lower SpO2 limits
• Upper and lower BPM limits
• Alarm volume
• Pulse beep volume
• Data printing
See Set Time/Date Parameters, page 58, to set the time and date.

Set Menu Parameters


To set menu parameters, press the MENU key repeatedly during
normal operation to display the parameters to set. Use the ADJUST UP
or ADJUST DOWN key to adjust the parameter limit. Press the MENU key
to return to the default display.

Table 11. Menu Structure

# of Presses Parameter Press Function

1 %SpO2 Lower Limit Adjust limit.

2 %SpO2 Upper Limit Adjust limit.

3 Pulse Rate Lower Limit Adjust limit.

4 Pulse Rate Upper Limit Adjust limit.

5 Pulse Beep Volume Adjust volume.


Indications on blip bar.

6 Alarm Volume Adjust volume.


Indications on blip bar.

7 Print Data Print summary and/or


stored snap-shot and
sensor-event data.

WARNING
Do not silence the OxiMax N-65 audible alarm, or decrease its volume, if
patient safety could be compromised.

Service Manual 57
Operation

WARNING
The OxiMax sensor uses the date and time provided by the OxiMax 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 set in the oximeter.

Set Time/Date Parameters


To access the Time/Date settings menu, press the MENU key during
start-up Power-On-Self-Test (POST). Press the MENU key repeatedly to
display time/date parameters. Use the ADJUST UP and ADJUST DOWN
key to adjust time/date settings. Press the MENU key to return to the
initial display.
Note:
When the oximeter times-out in 30 seconds, the parameter is set and the
oximeter display returns to the normal operation. 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%SpO2 (oxygen saturation percentage) and pulse rate readings (BPM) are
being reported.
• No error conditions exist.
When entering the month, the oximeter checks for a valid day
selection. If the day selection is not valid for the month selected the
menu display returns to the day selection display.
When entering the year, the oximeter checks for valid day and month
selections. 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 are:
• 30 February
• 31 November
• 29 February on a non-leap year

58 Service Manual
Menu Structure

Note:
To set the date and time, press the MENU key during POST.

Table 12. Time Set Menu

# of
Presses Parameter Press Function

1 Hour Adjust 1 to 23

2 Minute Adjust 1 to 59

3 Day Adjust 1 to 31

4 Month Adjust 1 to 12

5 Year Adjust 2003 to 2099

Service Manual 59
Page Left Intentionally Blank

60 Service Manual
8 Oximeter Preventive
Maintenance

Overview
This section describes the steps required to maintain, service, and
properly clean the Nellcor™ OxiMax™ N-65™ handheld pulse oximeter.
Follow local governing ordinance and recycling instructions regarding
the disposal or recycling of the oximeter and its accessories.

Cleaning
WARNING
Do not spray, pour, or spill any liquid on the Nellcor OxiMax N-65
handheld pulse oximeter, its accessories, connectors, switches, or
openings in the enclosure.
For surface cleaning and disinfecting the oximeter, follow your
institution's procedures or the recommended actions below.
• Surface cleaning—Use a soft cloth dampened with either a commercial,
nonabrasive cleaner or a solution of 70 percent alcohol in water, and
lightly wiping the surfaces of the oximeter.
• Disinfection—Use a soft cloth saturated with a ten percent solution of
chlorine bleach in tap water, lightly wiping the surfaces of the oximeter.
Before cleaning an OxiMax™ pulse oximetry sensor, read the
Instructions For Use enclosed with the sensor. Each sensor model has
cleaning instructions specific to that sensor. Follow the OxiMax pulse
oximetry sensor cleaning and disinfecting procedures in the particular
sensor's Instructions for Use.

Periodic Safety Checks


The Nellcor OxiMax N-65 handheld pulse oximeter does not require
calibration.

61
Oximeter Preventive Maintenance

Perform the following safety checks every 24 months.


• Inspect the equipment for mechanical and functional damage or
deterioration.
• Inspect safety relevant labels for legibility. Contact Nellcor Technical
Services, 1.800.635.5267, or your local Nellcor representative if labels are
damaged or illegible.
• Perform a baseline functional check at least every 24 months.

To perform a baseline functional check


If the monitor has been visibly damaged or subjected to mechanical shock
(for example, if dropped), immediately perform the performance tests. See
Safety Testing Standards, page 64.
Perform the electrical safety tests detailed in Safety Testing Standards,
page 64. If the unit fails these electrical safety tests, refer to
Troubleshooting, page 87.
Note:
For extensive functional testing, see Performance Verification, page 63.

62 Service Manual
9 Performance Verification

Overview
This section provides information to trained service technicians on
setting institutional defaults, verifying Nellcor™ OxiMax™ N-65™
handheld pulse oximeter performance, and accessing service
functions.

WARNING
Only qualified service personnel should open the oximeter housing,
remove and replace components, or make adjustments. If your medical
facility does not have a qualified service technician, please contact
Nellcor Technical Services or your local Nellcor representative.

Performance Verification
Overview
This section discusses the tests used to verify performance following
repairs or during routine maintenance. All tests can be performed
without removing the Nellcor OxiMax N-65 handheld pulse oximeter
cover. Perform all tests before the battery charge and battery
performance checks, then perform both battery checks as the last
operation before returning the pulse oximeter to the caregiver.
If the oximeter fails to perform as specified in any test, correct the
problem before returning the oximeter to the caregiver.

63
Performance Verification

Required Equipment

Table 13. Equipment and Descriptions

Equipment Description

Durasensor™ Adult Finger Clip DS-100A sensor


Sensor

OxiMax™ pulse oximetry sensor MAX-A sensor

Extension cable DEC-4 extension cable

Nellcor model SRC-MAX Provides testing for OxiMax


functional oximetry tester compatible oximeters

Safety Testing Standards


The Nellcor OxiMax N-65 handheld pulse oximeter safety tests are
performed in accordance with and meet the following standards.
• IEC 60601-1: 1988 + A1: 1991 + A2: 1995
• EN 60601-1: 1990 + A11: 1993 + A12: 1993 + A13: 1996
• UL 60601-1 1st edition
• CSA C22.2 No. 601.1 M90
This product is categorized as internally powered type BF equipment.

Performance Tests
The Power-On-Self-Test (POST) performance test verifies that the
Nellcor OxiMax N-65 handheld pulse oximeter is ready for patient
monitoring.

Power-On-Self-Test
Discussion

WARNING
If you do not hear the POST pass tone, do not use the oximeter.

WARNING
Ensure that the speaker is clear of any obstructions and that the speaker
holes are not covered. Failure to do so could result in an inaudible alarm
tone.

64 Service Manual
Performance Tests

Caution
If any indicator or display element does not light when the oximeter is
turned on, do not use it. Instead, contact qualified service personnel, your
local Nellcor representative, or Nellcor Technical Services.
Caution
During POST (immediately after power-up), confirm that all segments and
indicators display, and the oximeter speaker sounds a one-second tone.
Note:
In addition to serving as the POST pass verification, the POST pass tone also
functions as audible confirmation that the speaker is performing properly. If
the speaker does not function, the alarm warning sounds cannot be heard.
Note:
The OxiMax N-65 automatically starts POST, which tests the oximeter
circuitry and functions.
Before using the oximeter, you must verify that it is working properly
and is safe to use. Proper working conditions are verified each time
the monitor is turned on as described in the following procedure. The
POST verification procedure takes approximately ten seconds to
complete.
When the oximeter is turned on, the backlight remains on. The display
displays the following sequence, in order, as POST takes place:
• 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 displays for three seconds as a three digit
number in the right number field (with leading zeros if the version
number is less than 100) 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.
Note:
Physiological conditions, medical procedures, or external agents that may
interfere with the oximeter’s ability to detect and display accurate
measurements include: dysfunctional hemoglobin, arterial dyes, low
perfusion, dark pigment, and externally applied coloring agents, such as nail
polish, dye, or pigmented cream.

Service Manual 65
Performance Verification

Note:
Do not connect a sensor the oximeter for this procedure. The backlight
remains on during POST. All display numbers and indicators appear for three
seconds.
1. Perform POST, following the procedure listed in Power-On-Self-Test,
page 64, writing down the displayed current software version to
have available when requesting technical assistance from Nellcor
Technical Services. Upon successful completion of POST, the
monitor sounds a one-second tone to indicate it has passed the
test.
2. Ensure the time is properly set. If it has never been set, do not
continue prior to setting the date and time following the
procedure listed in Set Time/Date Parameters, page 58.
Note:
Current time displays in a 24-hour format.
3. Press the ALARM SILENCE key. The ALARM SILENCE indicator displays.
Figure 16. Sensor Disconnected with Alarm Silence Indicator at Lower Left

66 Service Manual
Operational Setup

4. Press the ALARM SILENCE key. The ALARM SILENCE indicator does not
display.
Figure 17. Sensor Disconnected Indicator, no Alarm Silence

5. Press the BACKLIGHT key. The backlight turns on.


6. Press the BACKLIGHT key. The backlight turns off.
7. .If the monitor detects a problem, an error tone sounds and an error
code (Er) and the error number display. See Error Codes, page 92.

Operational Setup
The operational setup procedure sets the time and date into the
oximeter. See Set Time/Date Parameters, page 58, or Set Menu
Parameters, page 57, for individual parameter settings. The oximeter
returns to the factory default settings when it is powered on, so set
individual parameter settings at power up.

Overall Performance Check


The Operation with a Live Subject test provides an overall performance
check of the system.

Service Manual 67
Performance Verification

Operation with a Live Subject


Patient monitoring involves connecting the Nellcor™ MAX-A adult
SpO2 sensor to a live subject for a qualitative test.
.

To test using a live subject:


1. Connect the Nellcor™ MAX-A adult SpO2 sensor to the oximeter.
2. Attach the sensor to the live subject as recommended in the
OxiMax pulse oximetry sensor's Instructions For Use.
3. Press the POWER key to turn on the oximeter and verify the
oximeter is operating. The oximeter should stabilize on the
subject's physiological signal in about 15 to 30 seconds.
4. Verify that the oxygen saturation and pulse rate values are
reasonable for the subject.
5. Press the DATA key.
6. The oximeter records snap-shot data.
Figure 18. .Snap-shot Data Indicator and Display

7. Turn off the oximeter.

68 Service Manual
Pulse Oximetry Functional Tests

Pulse Oximetry Functional Tests


The these tests utilize the pulse oximetry functional tester (Nellcor
model SRC-MAX) to verify the performance of the oximeter.
Figure 19. SRC-MAX OxiMax Oximetry Tester

1. OxiMax N-65 Cable Connector


2. Infrared LED Drive Indicator
3. Pulse Rate Selection Key
4. Light Level Selection Key
5. % SpO2 Select Key
6. % Modulation Select Key
7. Battery Low Indicator
8. RED LED Drive Indicator

Overview
The SRC-MAX functional tester enables qualified technicians to
functionally test Nellcor OxiMax technology- based pulse oximeters
and OEM OxiMax technology-based oximeters. After attaching the

Service Manual 69
Performance Verification

functional tester to the cable, complete all of the tests in sequence,


beginning with the test setup, proceeding with BPM, then %SpO2,
then Modulation, and finally Light Level.
Table 14. Pulse Oximetry Functional Tests

Test Description
Test Setup This procedure establishes the baseline for all the other tests.
Test Setup must be performed before performing any or all of
the SRC-MAX tests.
BPM Test The test procedure simulates an OxiMax sensor attached to a
patient indicating 60 bpm and 200 bpm. The test sets up Test
1 for 60 bpm.
SpO2 Test The test procedure simulates an OxiMax sensor attached to a
patient, indicating 75 percent blood oxygen saturation and 90
percent blood oxygen saturation. The test sets up Test 2 for
75 percent blood oxygen saturation.
Modulation Level The test procedure simulates an OxiMax sensor attached to a
Test patient indicating low and high pulse strength. The test sets
up Test 3 for low pulse strength.
Light Level Test The test procedure simulates an OxiMax pulse oximetry
sensor attached to a patient indicating low and high light level
passing through the patient at the sensor site. The test sets up
Test 4 for low light level.

Note:
The SRC-MAX selectable indicator LEDs may extinguish if there is a delay in
proceeding through the above tests. This is normal operation in order to
increase the battery time.
Note:
Pressing a key on the SRC-MAX during the test procedures may be
requested, changing a certain parameter. If the SRC-MAX LEDs are not lit,
press the key twice. Pressing the key once causes the indicators to relight
and pressing twice initiates the change.

Test Setup
Note:
Use a DEC-4 extension cable between the SRC-MAX and the monitor.
You must complete Test Setup before performing any other pulse
oximetry functional tests. Ensure all initial procedures for oximeter
setup are complete, following Power-On-Self-Test, page 64.

70 Service Manual
Pulse Oximetry Functional Tests

To perform test setup


1. Press the POWER key to turn on the oximeter.
Figure 20. Sensor Port

2. After the oximeter completes POST, connect the DEC-4 extension


cable to the sensor port and then the SRC-MAX tester. The

Service Manual 71
Performance Verification

SRC-MAX panel lights and in a few seconds the oximeter tracks the
simulator.

Ensure the oximeter exhibits the following behaviors.


• Sounds SpO2 audio alarm
• Displays an %SpO2 of 75 (pass criteria is 73 to 77 %SpO2 inclusive)
• Displays a pulse rate of 60 (pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation
Figure 21. Oximeter Tracking Unchanged Simulator

BPM Test
1. Press the SRC-MAX PULSE RATE selection key. The SRC-MAX PULSE
RATE 200 LED lights. The oximeter BPM increases until stabilizing at
200 BPM. The test pass criteria is 197 to 203 BPM inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 200 bpm (pass criteria is 197 to 203 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation

72 Service Manual
Pulse Oximetry Functional Tests

Figure 22. BPM Test increase to 200 BPM

2. Press the SRC-MAX PULSE RATE select key. The SRC-MAX PULSE RATE
60 LED lights. The oximeter registers BPM decreases until
stabilizing at 60 BPM. (The test pass criteria is 57 to 63 BPM
inclusive.)
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 60 BPM (test pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation

Service Manual 73
Performance Verification

SpO2 Test
1. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 90 LED
lights. The oximeter displays two sets of dashes [ - - ] until the
%SpO2stabilizes at a value between 88 to 92 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds no audible alarm
• Displays 90 %SpO2 (pass criteria is 88 to 92 %SpO2 inclusive)
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation
Figure 23. SpO2 Test Increase to 90 SpO2

2. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 75 LED
lights. The oximeter displays two sets of dashes [ - - ] until
stabilizing at a value between 73 to 77 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds SpO2 audio alarm
• Displays 75 %SpO2 (pass criteria is 73 to 77 %SpO2 inclusive)
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation

74 Service Manual
Pulse Oximetry Functional Tests

Modulation Level Test


1. Press the SRC-MAX MODULATION selection key. The SRC-MAX
MODULATION LED lights. The oximeter pulse blip bar initially
increases in amplitude and then stabilizes at the higher level.
Figure 24. Mod Test with Increase in Modulation

Ensure the oximeter exhibits the following behaviors.


• Sounds audio alarm
• Displays 75 %SpO2 (test pass criteria is 73 to 77 %SpO2 inclusive)
• Displays 60 BPM (test pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at high level modulation

Service Manual 75
Performance Verification

2. Press the SRC-MAX PULSE RATE selection key. The SRC-MAX PULSE
RATE 200 LED lights. The oximeter BPM increases until stabilizing at
200 BPM. The test pass criteria is 197 to 203 BPM inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 200 bpm (pass criteria is 197 to 203 bpm inclusive)
• Displays pulse amplitude indicator at high level modulation
Figure 25. Mod Test with Increase to 200 BPM at High Modulation

3. Press the SRC-MAX PULSE RATE select key. The SRC-MAX PULSE RATE
60 LED lights. The oximeter registers BPM decreases until
stabilizing at 60 BPM. (The test pass criteria is 57 to 63 BPM
inclusive.)
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 60 BPM (test pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at high level modulation

76 Service Manual
Pulse Oximetry Functional Tests

4. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 90 LED
lights. The oximeter displays two sets of dashes [ - - ] until the
%SpO2stabilizes at a value between 88 to 92 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds no audible alarm
• Displays 90 %SpO2 (pass criteria is 88 to 92 %SpO2 inclusive)
• Displays 60 BPM
• Displays pulse amplitude indicator at high level modulation
Figure 26. Mod Test with Increase to 90 SpO2 at High Modulation

5. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 75 LED
lights. The oximeter displays two sets of dashes [ - - ] until
stabilizing at a value between 73 to 77 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds SpO2 audio alarm
• Displays %SpO2 value between 73 to 77 inclusive
• Displays 60 BPM
• Displays pulse amplitude indicator at high level modulation

Service Manual 77
Performance Verification

6. Press the SRC-MAX Modulation selection key. The SRC-MAX


Modulation LED lights. The oximeter pulse blip bar decreases in
amplitude.
Figure 27. Mod Test with Decrease in Amplitude and Modulation

Ensure the oximeter exhibits the following behaviors.


• Sounds audio alarm
• Displays 75 %SpO2
• Displays 60 bpm
• Displays pulse amplitude indicator at low level modulation

78 Service Manual
Pulse Oximetry Functional Tests

7. Press the SRC-MAX PULSE RATE selection key. The SRC-MAX PULSE
RATE 200 LED lights. The oximeter BPM increases until stabilizing at
200 BPM. The test pass criteria is 197 to 203 BPM inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 200 bpm (pass criteria is 197 to 203 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation
Figure 28. Mod Test Increase to 200 BPM at Low Modulation

8. Press the SRC-MAX PULSE RATE select key. The SRC-MAX PULSE RATE
60 LED lights. The oximeter registers BPM decreases until
stabilizing at 60 BPM. (The test pass criteria is 57 to 63 BPM
inclusive.)
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 60 BPM (test pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation

Service Manual 79
Performance Verification

9. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 90 LED
lights. The oximeter displays two sets of dashes [ - - ] until the
%SpO2 stabilizes at a value between 88 to 92 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds no audible alarm
• Displays 90 %SpO2 (pass criteria is 88 to 92 %SpO2 inclusive)
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation
Figure 29. Mod Test Increase to 90 SpO2 at Low Modulation

10.Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 75 LED
lights. The oximeter displays two sets of dashes [ - - ] until
stabilizing at a value between 73 to 77 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds SpO2 audio alarm
• Displays %SpO2 value between 73 to 77 inclusive
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation

80 Service Manual
Pulse Oximetry Functional Tests

Light Level Test


1. Press the SRC-MAX LIGHT LEVEL selection key. The SRC-MAX LIGHT
LEVEL LED lights. The oximeter pulse blip bar initially increases in
amplitude and then reduces and stabilizes at 3-5 bars.
Figure 30. Light Level Test Increase in HIgh Light Level

Ensure the oximeter exhibits the following behaviors.


• Sounds audio alarms
• Displays 75 %SpO2 (test pass criteria is 73 to 77 %SpO2 inclusive)
• Displays 60 bpm (test pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation

Service Manual 81
Performance Verification

2. Press the SRC-MAX PULSE RATE selection key. The SRC-MAX PULSE
RATE 200 LED lights. The oximeter BPM increases until stabilizing at
200 BPM. The test pass criteria is 197 to 203 BPM inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 200 bpm (pass criteria is 197 to 203 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation
Figure 31. Light Level Test Increase to 200 BPM with HIgh Light Level

3. Press the SRC-MAX PULSE RATE select key. The SRC-MAX PULSE RATE
60 LED lights. The oximeter registers BPM decreases until
stabilizing at 60 BPM. (The test pass criteria is 57 to 63 BPM
inclusive.)
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 60 BPM (test pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation

82 Service Manual
Pulse Oximetry Functional Tests

4. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 90 LED
lights. The oximeter displays two sets of dashes [ - - ] until the
%SpO2 stabilizes at a value between 88 to 92 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds no audible alarm
• Displays 90 %SpO2 (pass criteria is 88 to 92 %SpO2 inclusive)
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation
Figure 32. Light Level Test Increase to 90 SpO2 with HIgh Light Level

5. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 75 LED
lights. The oximeter displays two sets of dashes [ - - ] until
stabilizing at a value between 73 to 77 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds SpO2 audio alarm
• Displays %SpO2 value between 73 to 77 inclusive
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation
6. Press the SRC-MAX LIGHT LEVEL selection key. The SRC-MAX LIGHT
LEVEL LED lights. The oximeter pulse blip bar initially increases in
amplitude and then reduces and stabilizes at 3-5 bars.

Service Manual 83
Performance Verification

Ensure the oximeter exhibits the following behaviors.


• Sounds BPM alarm
• Displays 75 %SpO2
• Displays 60 bpm
• Displays pulse amplitude indicator at low level modulation
7. Press the SRC-MAX PULSE RATE selection key. The SRC-MAX PULSE
RATE 200 LED lights. The oximeter BPM increases until stabilizing at
200 BPM. The test pass criteria is 197 to 203 BPM inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 200 bpm (pass criteria is 197 to 203 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation
Figure 33. Light Level Test Increase to 200 BPM with Low Light Level

8. Press the SRC-MAX PULSE RATE select key. The SRC-MAX PULSE RATE
60 LED lights. The oximeter registers BPM decreases until
stabilizing at 60 BPM. (The test pass criteria is 57 to 63 BPM
inclusive.)
Ensure the oximeter exhibits the following behaviors.
• Sounds BPM audio alarm
• Displays 75 %SpO2
• Displays 60 BPM (test pass criteria is 57 to 63 bpm inclusive)
• Displays pulse amplitude indicator at low level modulation

84 Service Manual
Pulse Oximetry Functional Tests

9. Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 90 LED
lights. The oximeter displays two sets of dashes [ - - ] until the
%SpO2 stabilizes at a value between 88 to 92 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds no audible alarm
• Displays 90 %SpO2 (pass criteria is 88 to 92 %SpO2 inclusive)
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation
Figure 34. Light Level Test Increase to 90 SpO2 with Low Light Level

10.Press the SRC-MAX %SpO2 select key. The SRC-MAX %SpO2 75 LED
lights. The oximeter displays two sets of dashes [ - - ] until
stabilizing at a value between 73 to 77 inclusive.
Ensure the oximeter exhibits the following behaviors.
• Sounds SpO2 audio alarm
• Displays %SpO2 value between 73 to 77 inclusive
• Displays 60 BPM
• Displays pulse amplitude indicator at low level modulation
11.Disconnect all equipment and turn off the oximeter.

Service Manual 85
Page Left Intentionally Blank

86 Service Manual
10 Troubleshooting

Overview
This section explains how to troubleshoot common problems while
using the Nellcor™ OxiMax™ N-65™ handheld pulse oximeter. This
section also includes possible oximeter difficulties, along with
probable causes, recommended actions to correct the difficulty, and
how to obtain technical help and support.

WARNING
Only qualified service personnel should open the oximeter housing,
remove and replace components, or make adjustments. If your medical
facility does not have qualified service personnel, contact Nellcor
Technical Services or your local Nellcor representative.

WARNING
Do not spray, pour, or spill any liquid on the Nellcor OxiMax N-65
handheld pulse oximeter, its accessories, connectors, switches, or
openings in the enclosure.

Help and Support


Documentation
Use this section in conjunction with Performance Verification, page 63,
and Obtaining Replacement Parts, page 99. To remove and replace a
part suspected of being defective, follow the instructions in Repairing
the Oximeter, page 103. The circuit analysis section in the Oximeter
Block Diagram, page 42, offers information on how the oximeter
functions.

87
Troubleshooting

Technical Services
When encountering a problem while using the Nellcor OxiMax N-65
handheld pulse oximeter which cannot be resolved through a visual
inspection, refer to Table 15: Troubleshooting Guide, on page 89.
Locate the condition and follow corrective actions in the order
presented. For a symptom not listed in Table 15, contact Nellcor
Technical Services Department at 1.800.635.5267, or your local Nellcor
representative.
If an error code is shown on the oximeter front panel display, turn the
oximeter off, wait ten seconds, then turn it back on. This clears
recoverable errors encountered by the oximeter. If the error code
persists, refer to Table 16: Error Codes, on page 93 for an explanation of
the error code. Take the action specified.
Figure 35. Typical Error Code Display

After performing the recommended action, reassemble the oximeter,


refer to Performance Verification, page 63, and conduct a performance

88 Service Manual
Help and Support

verification before returning the oximeter to service. If the symptom


persists, continue troubleshooting.

Table 15. Troubleshooting Guide

Condition Recommended Action

The oximeter does not turn on after pressing the POWER key.

The POWER key not fully depressed. Fully press the POWER key.

The batteries are missing. Open the battery compartment. If missing


batteries, install new batteries. Refer to
Battery Installation, page 49.

The batteries are installed incorrectly. Open battery compartment. If batteries


not installed correctly, remove and
reinstall. Make sure batteries are not
installed backwards. Refer to Battery
Installation, page 49.

The batteries are at, or near, a voltage Install new batteries. Refer to Battery
too low for the oximeter to operate. Installation, page 49.

The flex circuit between the front Caution: Unlock J4 before


panel and the SpO2 PCB is damaged, attempting to remove and
or not making a good connection. reinsert flex cable.

Inspect flex cable for damage. Inspect


connection to J4. With damage to flex
cable, replace front case. Otherwise,
remove cable from J4 and reconnect it.
See Oximeter Disassembly and Reassembly,
page 104, and To separate the oximeter top
and bottom cases, page 105. Reassemble
oximeter and retest. Refer to Oximeter
Disassembly and Reassembly, page 104.

The front panel keypad is defective. Caution: Unlock J4 before


attempting to remove flex
circuit cable.

Replace the Front Case. See Top Case


Assembly Replacement, page 111.

Replacing the front case does not fix Replace the SpO2 PCB. See SpO2 PCB or
the problem. User Interface PCB Replacement, page 107.

Replacing the SpO2 PCB does not fix Replace User Interface PCB. See SpO2 PCB
the problem. or User Interface PCB Replacement, page
107. If this does not fix problem, return
oximeter to Nellcor.

Service Manual 89
Troubleshooting

Table 15. Troubleshooting Guide (Continued)

Condition Recommended Action

One or more keys on the front panel keypad does not work.

The flex circuit between the front Caution: Unlock J4 before


panel and the SpO2 PCB is damaged, attempting to remove and
or not making a good connection. reinsert flex cable.

Inspect flex cable for damage. Inspect


connection to J4. With damage to flex
cable, replace front case. Otherwise,
remove cable from J4 and reconnect.
Reassemble oximeter and retest. Refer to
Oximeter Disassembly and Reassembly,
page 104 and SpO2 PCB Connector J4 Lock,
page 106.

The front panel keypad is defective. Caution: Unlock J4 before


attempting to remove flex
circuit cable.

Replace front case. Refer to Top Case


Assembly Replacement, page 111.

Replacing the front case does not fix Replace SpO2 PCB. page 107, SpO2 PCB or
the problem. User Interface PCB Replacement.

Replacing the SpO2 PCB does not fix Replace User Interface PCB. See page 107,
the problem. SpO2 PCB or User Interface PCB
Replacement. If this does not fix problem,
return oximeter to Nellcor.

One or more display segments does not work.

A User Interface PCB component has Inspect User Interface PCB for cracking,
failed. burning, or damage. If damage is found,
replace User Interface PCB. See SpO2 PCB
or User Interface PCB Replacement, page
107.

The User Interface PCB is defective. If damage is found, replace User Interface
PCB. See SpO2 PCB or User Interface PCB
Replacement, page 107.

Pulse rate and %SpO2 value does not display when the oximeter is turned on.

The SpO2 sensor is not connected Reconnect SpO2 sensor to oximeter.


properly. Connect SpO2 sensor to patient. See
sensor Directions for Use.

90 Service Manual
Help and Support

Table 15. Troubleshooting Guide (Continued)

Condition Recommended Action

The SpO2 sensor has failed. Replace SpO2 sensor.

The User Interface PCB is defective. Replace User Interface PCB. See SpO2 PCB
or User Interface PCB Replacement, page
107.

The SpO2 PCB is defective. Replace SpO2 PCB. See SpO2 PCB or User
Interface PCB Replacement, page 107.

The display backlight does not come on when pressing the BACKLIGHT key.

The flex circuit between the front Caution: Unlock J4 before


panel and the SpO2 PCB is damaged, attempting to remove and
or not making a good connection. reinsert the flex cable.

Inspect flex cable for damage. Inspect


connection to J4. With flex cable damage,
replace front case. Otherwise, remove
cable from J4 and reconnect. Reassemble
oximeter and retest. See page 111, Top
Case Assembly Replacement and page 113,
Bottom Case Assembly Replacement.

The BACKLIGHT key on the front panel Caution: Unlock J4 before


keypad is defective. attempting to remove the flex
circuit cable.

Replace front case. See page 111, Top Case


Assembly Replacement.

Replacing the SpO2 PCB does not fix Replace SpO2 PCB. See page 107, SpO2
the problem. PCB or User Interface PCB Replacement.

Replacing the SpO2 PCB does not fix Replace User Interface PCB. See page 107,
the problem. SpO2 PCB or User Interface PCB
Replacement. If this does not fix the
problem, return oximeter to Nellcor.

The BACKLIGHT LEDs on the User Replace User Interface PCB. See page 107,
Interface PCB have failed. SpO2 PCB or User Interface PCB
Replacement.

The oximeter shuts off when you press the Backlight key.

The batteries are, at or near, a voltage Install new batteries. See Battery
too low for the oximeter to operate. Installation, page 49.

The printer does not print.

Service Manual 91
Troubleshooting

Table 15. Troubleshooting Guide (Continued)

Condition Recommended Action

The IrDA between the printer and the Align printer and oximeter. See the
oximeter is not properly aligned. Operator’s Manual for instructions.

The printer is turned off. Turn printer on. See printer


documentation.

The printer batteries are at, or near, a Install new batteries in printer. See printer
voltage too low to operate. documentation.

The DATA key on the front panel Caution: Unlock J4 before


keypad is defective. attempting to remove flex
circuit cable.
Replace front case. See page
111, Top Case Assembly Replacement.

Replacing the Front Case does not fix Replace User Interface PCB. See page 107,
the problem. SpO2 PCB or User Interface PCB
Replacement. If this does not fix problem,
return oximeter to Nellcor.

The printer is defective. See printer documentation, or replace


printer.

Error Codes
An error code displays when the oximeter detects a non-correctable
failure. Table 16 provides a list of error codes for the oximeter.
However, turn the POWER off and on once (cycling power) to remove
the error code if one of the following occurs:
• Oximeter sounds a low priority alarm
• Measurements stop
• “Er” is shown in the %SpO2 numeric display area
• Error code is shown in the right numeric display
If the error code remains, see Error Codes, page 93.

92 Service Manual
Error Codes

Table 16 provides a list of error codes for the oximeter.

Table 16. Error Codes

Scope of
Action

Clinician

Return
Repair
Error
Code Action Explanation

1 X Replace SpO2 board. SpO2 front end RAM error.

2 X Replace SpO2 board. SpO2 front end ROM/code


integrity error.

3 X Replace SpO2 board. SpO2 front end reported a bad


CRC.

4 X Replace SpO2 board. SpO2 front end reported FSP


message not allowed.

5 X Replace SpO2 board. SpO2 front end reported illegal


value sent in FSP message.

6 X Replace SpO2 board. SpO2 front end reports calibration


(offset) failure.

9 X Replace SpO2 board. SpO2 front end reported syntax


error in FSP message.

10 1 2 Check/replace SpO2 front end reports over


sensor/extension current failure.
cable.
Replace SpO2 board.

11 1 2 Replace batteries. SpO2 front end reports incorrect


Replace SpO2 board. system voltage.

12 X Replace SpO2 board. SpO2 front end reports other


hardware problem.

14 X Replace SpO2 board. SpO2 front end reports


communication channel
overflow.

16 X Replace SpO2 board. SpO2 front end reports watchdog


time out.

17 X Check/replace SpO2 front end reports that


sensor/extension sensor appears defective.
cable.

Service Manual 93
Troubleshooting

Table 16. Error Codes (Continued)

Scope of
Action

Clinician

Return
Repair
Error
Code Action Explanation

18 X Replace SpO2 board. SpO2 front end reports internal


register appears modified from
expected value.

19 X Check/replace SpO2 front end reports signal out-


sensor/extension of-range.
cable.

48 X Replace SpO2 board. SpO2 front end reports spurious


interrupt.

49 X Replace SpO2 board. SpO2 front end reports internal


buffer overflow.

50 X Replace SpO2 board. SpO2 front end reports


intermittent error.

51 X Replace SpO2 board. SpO2 front end reports digital


communication error.

53 X Replace SpO2 board. SpO2 front end data not received.

256 X Replace SpO2 board. SpO2 back end reports beginning


of packet missing.

257 X Replace SpO2 board. SpO2 back end reports packet


start ID (SID) missing.

258 X Replace SpO2 board. SpO2 back end reports packet


length error.

259 X Replace SpO2 board. SpO2 back end reports message


length error.

260 X Replace SpO2 board. SpO2 back end reports packet


contains unsupported key.

261 X Replace SpO2 board. SpO2 back end reports packet


CRC error.

262 X Replace SpO2 board. SpO2 back end reports end of


packet missing.

263 X Replace SpO2 board. SpO2 back end reports packet


contains unidentified key.

94 Service Manual
Error Codes

Table 16. Error Codes (Continued)

Scope of
Action

Clinician

Return
Repair
Error
Code Action Explanation

264 X Replace SpO2 board. SpO2 back end reports corrupted


variable.

265 X Replace SpO2 board. SpO2 back end reports memory


overflow.

266 X Replace SpO2 board. SpO2 back end reports bad


pointer.

267 X Replace SpO2 board. SpO2 back end reports parameter


value out-of-range.

268 X Replace SpO2 board. SpO2 back end reports reset


detected.

269 X Replace SpO2 board. SpO2 back end reports


unexpected value.

270 X Replace SpO2 board. SpO2 back end reports time-out.

271 X Replace SpO2 board. SpO2 back end reports not ready/
not initialized.

272 X Replace SpO2 board. SpO2 back end reports double


fault.

273 1, 3 Restart the oximeter. SpO2 back end reports date out-
2 Set the time and of-range error.
date.
Replace UI board.

274 X Return oximeter for SpO2 back end reports


reprogramming. incompatible software version.

275 X Check/replace SpO2 back end reports incorrect


sensor/extension registration number.
cable.

276 X Replace with OxiMax SpO2 back end reports sensor


sensor/extension read failure.
cable.

277 X Check/replace SpO2 back end reports sensor


sensor/extension signature verification fails.
cable.

Service Manual 95
Troubleshooting

Table 16. Error Codes (Continued)

Scope of
Action

Clinician

Return
Repair
Error
Code Action Explanation

280 X Check/replace SpO2 back end reports does not


sensor/extension support feature required by
cable. sensor.

281 X Check/replace SpO2 back end reports overflow/


sensor/extension underflow.
cable.

282 X Check/replace SpO2 back end reports sensor


sensor/extension activation failure.
cable.

512 X Replace UI board. Communication failure with real


time clock.

513 X Replace UI board. Real time clock oscillator control


problem.

514 X Replace UI board. Real time clock failed timing test.

515 X Replace UI board. LCD failed feedback test.

516 X Replace UI board. LCD failed feedback test.

518 X Return oximeter for Various system faults.


repair.

519 X Return oximeter for Unrecoverable software error.


repair.

520 X Replace UI board. Unrecoverable error verify real


time clock.

521 X Replace batteries. Battery power is critically low.

522 X Replace batteries. System power levels


unacceptable for continued
operation.

523 1, 3 Restart the oximeter. NVRAM failed consistency check.


2 Set the time and
date.
Replace UI board.

524 X Replace UI board. NVRAM failed read-after-write


verification.

96 Service Manual
Error Codes

Table 16. Error Codes (Continued)

Scope of
Action

Clinician

Return
Repair
Error
Code Action Explanation

525 X X Restart, replace UI Time base discrepancy writing


board. error entry.

526 1, Replace SpO2 board. Fatal error for SpO2


2 Replace UI board. communication.

527 1, Replace SpO2 board. Communication failure with SpO2


2 Replace UI board. board.

528 1 2 Replace UI board Fatal error creating parser.


Return oximeter for
repair.

529 1 2 Replace UI board Fatal error creating parser.


Return oximeter for
repair.

530 1, Replace SpO2 board. Unrecoverable error with SpO2


2 Replace UI board. communication.

531 1, Replace SpO2 board. Unrecoverable error with SpO2


2 Replace UI board. communication.

532 1, Replace SpO2 board. Unrecoverable error with SpO2


2 Replace UI board. communication.

533 1, Replace SpO2 board. Unrecoverable error with SpO2


2 Replace UI board. communication.

534 1, Replace SpO2 board. Unrecoverable error with SpO2


2 Replace UI board. communication.

535 1, Replace SpO2 board. Unrecoverable error with SpO2


2 Replace UI board. communication.

536 X Replace UI board. Flash memory failed CRC check.

537 X Replace UI board. Fatal system error.

538 X Set the oximeter Real time clock value bad.


time and date.

Service Manual 97
Troubleshooting

Table 16. Error Codes (Continued)

Scope of
Action

Clinician

Return
Repair
Error
Code Action Explanation

539 1 2 Restart the oximeter. Erroneous key press detected at


Replace membrane start.
switch pad.

540 X Replace UI board. Fatal system error reading


memory.

541 X Return oximeter for Fatal software error.


repair.

542 1 2 Replace UI board. RAM corruption detected during


Return oximeter for background check.
repair.

543 X Set time and date. Invalid time. Cannot snapshot.

544 X Replace UI board. Invalid register value.

545 X Replace SpO2 board. SpO2 board in unexpected state.

546 X Replace UI board. IrDA failure.

997 X Replace UI board. RAM error.

998 X Replace UI board. Spurious Interrupt.

999 X Replace UI board. Watchdog protection activated.

98 Service Manual
11 Ordering Oximeter Spare
Parts

Overview
This section describes how to order spare parts for the Nellcor™
OxiMax™ N-65™ handheld pulse oximeter. Item numbers correspond
to the call-out numbers in Figure 36, Exploded View on page 100.
This manual is available on the Internet at:
http://www.nellcor.com/

Obtaining Replacement Parts


Nellcor Technical Services provides technical assistance information
and replacement parts. Contact Nellcor Technical Services or your
local Nellcor representative to obtain replacement parts. Refer to parts
by the part names and part numbers.
A listing of the spare parts and accessories for the Nellcor OxiMax N-65
handheld pulse oximeter are listed on the Internet at:
http://www.nellcor.com/
Note:
The OXIMAX N-65 is RoHS compliant for products manufactured as of July
2014. The RoHS compliant spare parts, including the SpO2 PCBA and User
Interface PCBA, are compatible with OXIMAX N-65 Handheld Pulse
Oximeters manufactured prior to this date.

99
Ordering Oximeter Spare Parts

Spare Parts List and Accessories


See Parts and Accessories List, page 101, for descriptions. Order spare
parts and accessories listed on the Internet at:
http://www.nellcor.com/

Figure 36. Exploded View

100 Service Manual


Spare Parts List and Accessories

Table 17. Parts and Accessories List

Reference Description

Spare Parts

1 Top enclosure cover with membrane panel

2 SpO2 PCB

3 User interface (UI)

4 Bottom enclosure cover

5 Battery cover

-- Membrane switch panel

-- LCD assembly

-- Battery, alkaline, 1.5V, type AA

-- Screw, PH, 4 X /16 inch

-- Screw, PH, 4 X 3/16 inch

-- Product data label

-- Quick guide label

Accessories

-- Boot, protective, silicone, yellow

-- Boot, thermoform protective plastic

-- Case, carry, fabric, black with shoulder strap

-- CD, operator and service manuals

-- DEC-4 sensor extension cable

-- Home Use Guide, English

-- Jacket, water resistant, clear, plastic

-- Paper Rolls, Citizen PD22 Printer

-- Printer Case, Soft

-- Printer, Citizen PD22

-- Transport Boot

Service Manual 101


Page Left Intentionally Blank

102 Service Manual


12 Repairing the Oximeter

Overview
WARNING
Only qualified service personnel should open the oximeter housing,
remove and replace components, or make adjustments. If your medical
facility does not have qualified service personnel, contact Nellcor
Technical Services or your local Nellcor representative.
Caution
Observe ESD (electrostatic discharge) precautions when disassembling and
reassembling the oximeter and when handling any components of it.
Nellcor™ OxiMax™ N-65™ handheld pulse oximeter major component
parts include all PCBs and subassemblies.
• Top case with front panel keypad
• Bottom case
• Battery cover
• User Interface PCB
• SpO2 PCB
Collect the following tools prior to disassembly of the oximeter.
• Number one (medium) phillips-head screwdriver
• Torque wrench, 4-in lbs. (10 cm/kg)
Only the qualified service technician may disassemble the oximeter to
its major component parts. The supported replacement level for the
Nellcor OxiMax N-65 handheld pulse oximeter is to the printed circuit
board (PCB) and major subassembly level. After isolating the problem
to a suspected PCB, follow the procedures in page 103, Repairing the
Oximeter, then proceed to replace the faulty PCB with a known good
PCB. Verify the symptom disappears and ensure the oximeter passes
all performance tests. If the symptom persists, swap the replacement
PCB with the suspected malfunctioning PCB (the original PCB installed
when you started troubleshooting) and continue troubleshooting.

103
Repairing the Oximeter

Note:
Some spare parts have a business reply card attached. After receiving the
spare parts, please complete and return the business reply card.
Note:
The OXIMAX N-65 is RoHS compliant for products manufactured as of July
2014. The RoHS compliant spare parts, including the SpO2 PCBA and User
Interface PCBA, are compatible with OXIMAX N-65 Handheld Pulse
Oximeters manufactured prior to this date.

Oximeter Disassembly and Reassembly


Disassembling the Oximeter
Caution
Observe ESD (electrostatic discharge) precautions when disassembling and
reassembling the oximeter and when handling any components of it.
The oximeter batteries must be removed prior to disassembly.

To remove the old batteries


1. Press the POWER key to turn off the oximeter.
2. Remove the battery cover.
3. Pull the battery cover latch downward toward the bottom of the
oximeter case and lift the battery cover.

104 Service Manual


Oximeter Disassembly and Reassembly

4. Remove the batteries.


Figure 37. Removing Batteries

To separate the oximeter top and bottom cases


1. After removing batteries, remove the four screws holding the
oximeter top and bottom case assemblies together.
Figure 38. Oximeter Case Screws

Caution
A flex cable runs between the oximeter top and bottom case assemblies. Use
care when separating the cases. Do not apply stress to the flex cable.

Service Manual 105


Repairing the Oximeter

2. Separate the oximeter top and bottom case assemblies.

Figure 39. J4 Connector and Flex Cable Between Separated Cases

Caution
Failure to unlock connector J4 on the SpO2 PCB before removing the flex
cable could damage the flex circuit.
3. Unlock connector J4 on the SpO2 PCB.

Figure 40. SpO2 PCB Connector J4 Lock


2

1 — SpO2 PCB
2 — J4 lock
3 — Lock direction
4 — Unlock direction

4. Disconnect the flex cable from SpO2 PCB connector J4.

106 Service Manual


SpO2 PCB or User Interface PCB Replacement

SpO2 PCB or User Interface PCB Replacement


To replace the SpO2 PCB or the User Interface PCB
1. Complete the procedure in To remove the old batteries, page 104.
2. Complete the procedure in To separate the oximeter top and
bottom cases, page 105.
Caution
The battery connectors (spring assemblies) at the bottom of the SpO2 PCB
are held in slots in the battery compartment. Observe how the connectors
are engaged in the slots when removing the SpO2 PCB and User Interface
PCB. Insert battery connectors back into these slots when reassembling the
oximeter.
3. Pull the SpO2 PCB and User Interface PCB to the left to free the
case from the DB-9 connector.
4. Lift the combined SpO2 and User Interface PCBs from the case.

Figure 41. User Interface PCB and SpO2 PCB Removal

Caution
Do not force the User Interface PCB and SpO2 PCB apart. This may damage
the boards.

Service Manual 107


Repairing the Oximeter

5. Separate the User Interface PCB from the SpO2 PCB using the
following steps.
a. Grasp the User Interface PCB in one hand and the SpO2 PCB in the
other.
b. Rotate the ends of the two PCBs until they separate at the connection
points.
c. Gently work the boards apart.
Figure 42. Separating the User Interface PCB and SpO2 PCB

1 — Left Connection (J8 on SpO2, J4 on User Interface)


2 — User Interface PCB
3 — Right Connection ( J1 on SpO2, J5 on User Interface)
4 — SpO2 PCB

6. Place the defective PCB to the side.


7. Align the replacement PCB with the other PCB at the connectors.
8. Align both rows of the connectors.

108 Service Manual


SpO2 PCB or User Interface PCB Replacement

9. Gently press the PCBs together.


Figure 43. Connecting PCBs

1 — Left Connection (J8 on SpO2, J4 on User Interface)


2 — User Interface PCB
3 — Right Connection (J1 on SpO2, J5 on User Interface)
4 — SpO2 PCB

10. Install the User Interface PCB and SpO2 PCB into the bottom case,
aligning battery springs properly in their slots.

Figure 44. Battery Spring Alignment

Note:
The longer screws install at the top of the case.

Service Manual 109


Repairing the Oximeter

11. Align the top and bottom cases and install the four screws.

Figure 45. Installing The Case Screws

12. Install the batteries and battery cover.


Figure 46. Battery Installation

13. Perform the performance verification tests before placing the


oximeter into service. See Pulse Oximetry Functional Tests, page 69.

110 Service Manual


Top Case Assembly Replacement

Top Case Assembly Replacement


The top case assembly contains the keypad.

To replace the top case assembly


1. Remove the batteries from the oximeter. See Low Battery
Indicator, page 50.
2. Separate the top and bottom case assemblies. See To separate the
oximeter top and bottom cases, page 105.
3. Dispose of the top case assembly in accordance with local
regulations.
4. Connect the new top case assembly flex cable to the SpO2 PCB
connector J4.

Figure 47. Top Case Flex Cable Connection

Service Manual 111


Repairing the Oximeter

5. Lock the J4 flex cable connector.


Figure 48. Locking SpO2 PCB Connection to J4

1 — SpO2 PCB
2 — J4 lock
3 — Lock direction
4 — Unlock direction

6. Align the top and bottom cases and install the four screws.

Figure 49. Installing The Case Screws

112 Service Manual


Bottom Case Assembly Replacement

7. Install the batteries and battery cover.


Figure 50. Battery Installation

8. Perform the performance verification tests before placing the


oximeter into service. See Pulse Oximetry Functional Tests, page 69.

Bottom Case Assembly Replacement


To replace the bottom case assembly
1. Remove the batteries from the monitor. See To remove the old
batteries, page 104.
2. Separate the top and bottom case assemblies. See To separate the
oximeter top and bottom cases, page 105.
Caution
The battery connectors (spring assemblies) at the bottom of the SpO2 PCB
are held in slots in the battery compartment. Observe how these connectors
are engaged in these slots when you remove the SpO2 PCB and User
Interface PCB and ensure the battery connectors are inserted back in these
slots when reassembling the oximeter.

Service Manual 113


Repairing the Oximeter

3. Lift the SpO2 PCB and User Interface from the case.

Figure 51. User Interface PCB and SpO2 PCB Removal

4. Discard the bottom case assembly in accordance with local


regulations.
5. Install the User Interface PCB and SpO2 PCB into the new bottom
case assembly. Ensure that the battery springs slip into place.

Figure 52. Battery Spring Alignment

Note:
The longer screws install at the top of the case.

114 Service Manual


Bottom Case Assembly Replacement

6. Place the front and rear cases together and install the four screws.

Figure 53. Installing The Case Screws

7. Install the batteries and battery cover.

Figure 54. Battery Installation

8. Perform the performance verification tests before placing the


oximeter into service. See Pulse Oximetry Functional Tests, page 69.

Service Manual 115


Repairing the Oximeter

Battery Cover Replacement


To replace the battery cover
1. Press the battery cover latch and lift the battery cover from the
bottom case assembly.

Figure 55. Battery Cover Latch

2. Insert the new battery cover in the bottom case assembly and
close until the latch snaps in place.

Packing for Shipment


Introduction
To ship the Nellcor OxiMax N-65 handheld pulse oximeter, follow the
instructions in this section.

Returning the Oximeter


Contact Nellcor Technical Services Department for shipping
instructions, including a Returned Goods Authorization (RGA)
number. Unless otherwise instructed by Nellcor Technical Services
Department, it is not necessary to return the OxiMax pulse oximetry
sensor or other accessory items with the oximeter. Pack the oximeter
in its original shipping carton. If the original carton is not available, use
a suitable carton with appropriate packing material to protect it
during shipping.
Return the oximeter by any shipping method that provides proof of
delivery.

116 Service Manual


Packing for Shipment

Repacking in Original Carton


If available, use the original carton and packing materials.

To repackage the oximeter in the original carton


1. Place the oximeter in original packaging.

Figure 56. Packing

2. Place in shipping carton and seal carton with packing tape.


3. Label carton with shipping address, return address, and RGA
number.

Service Manual 117


Repairing the Oximeter

Packing in a Different Carton


If the original carton is not available, repackage the oximeter in a
different carton.

To repackage the oximeter in a different carton


1. Place the oximeter in a plastic bag.
2. Locate a corrugated cardboard shipping carton with a bursting
strength of at least 200 pounds per square inch (psi).
3. Fill the bottom of the carton with at least two inches of packing
material.
4. Place the bagged unit on the layer of packing material and fill the
box completely with packing material.
5. Seal the carton with packing tape.
6. Label the carton with the shipping address, return address, and
RGA number.

118 Service Manual


13 Schematics

Overview
This section focuses specifically on Nellcor™ OxiMax™ N-65™ handheld
pulse oximeter printed circuit board (PCB) design and schematics.
The Nellcor OxiMax N-65 handheld pulse oximeter consists of two
printed circuit boards (PCB), the user interface PCB and the SpO2 PCB.
These two components provide support for data exchange and input
from the clinician, technician, or caregiver during use.
For system component descriptions, see Schematics, page 119.
• User Interface Printed Circuit Board (Sheets 1 through 3)
• SpO2 Printed Circuit Board (Sheets 1 through 7)

119
Schematics

120 Service Manual


Overview

Service Manual 121


Schematics

122 Service Manual


Overview

Service Manual 123


Schematics

124 Service Manual


Overview

Service Manual 125


Schematics

126 Service Manual


Overview

Service Manual 127


Schematics

128 Service Manual


Overview

Service Manual 129


Page Left Intentionally Blank

130 Service Manual


Index

Power key 16
A Current, Leakage 35
Accessories
Internet address 11 D
Alarm, Volume 57
Date
As 9 Set the day 59
Set the month 59
B Set the year 59
Description
Battery Front panel 12
Critically low battery indication 51 Front panel symbols 14
Low battery, 15-minute warning 50 Pulse oximeter product 11
Using battery power 48 Rear panel symbols 14
Battery cover, replacement 116 Disassembly
Block diagram 42 Required tools 103
Disinfecting the pulse oximeter 61
C Display
%SpO2 value 17
Cable, extension 64 Pulse rate (BPM) value 18
Calibration, not required 61 Display elements, pulse oximeter 17
Carton label symbols, see Symbol 21 Dyes, arterial 65
Case
Bottom case assembly removal 113
Top case assembly removal 111 E
Caution EMC standards 31
Battery disposal 9 Entanglement, warning 9
ESD precautions 9 Error codes 92
Maximum screw tightness 9 Exploded view 101
Cautions, general 7
External agents 65
Cleaning
Disinfection 61
Surface cleaning 61 F
Cleaning the pulse oximeter 61
Front panel, symbols 14
Conditions, Performance issues 65
Functional checks, see Performance veri-
Controls
fication 62
Adjust down key 15
Adjust up key 16
Alarm silence key 15 H
Backlight key 16
Data (record/print) key 15 Help and support, documentation 87
Menu key 15 Hemoglobin, dysfunctional 65

Service Manual 131


I P
Indicator Parameters
Alarm silence 19 Audible indicator 27
Data In-Sensor 70 Default settings, selection ranges 53
Interference 19 Printing summary 57
Low battery 18, 51 Using the function menu 57
Pulse amplitude 18 Parts
Intended use, pulse oximeter product 12 Accessories list 101
Obtaining spares 99
Parts list 101
K
Performance verification 63
Keep upright symbol 21 Perfusion, low 65
Key Pigmentation, dark or applied coloring 65
Adjust down 15 Power, oximeter 53
Adjust up 16 Power-on self-test (POST)
Alarm silence 15 Performance test 64
Backlight 16 Test pass tone 64
Data (record/print) 15 Time to complete 54
Menu 15 Product overview, pulse oximeter 42
Power 16 Protect from moisture symbol 21
Pulse rate
L BPM lower limit, adjust 57
BPM upper limit, adjust 57
Leakage Current Specifications 35 Pulse search indicator 19
Low battery indicator 18
R
M
Rear panel symbols 20
Maintenance, Restricted to qualified ser- Related documents 11
vice personnel 103 Repair, Restricted to qualified service per-
Manufacturer’s declaration 31 sonnel 103
Measurement range, pulse oximeter 24 Replacement
Medical procedures 65 Battery cover 116
Bottom case assembly 113
O Replacement level supported 103
SpO2 interface PCB 107
Obtaining replacement parts 99 User interface PCB 107
Operation Required equipment, performance
Altitude considerations 23 checks 64, 67
Atmospheric pressure considerations 23 Resistant to liquid ingress symbol 21
Relative humidity considerations 23 Return
Temperature considerations 23 Instructions for returning the monitor
Operator’s manual, Internet address 11 116
Oximeter, Physical Characteristics 32 Packing for shipment 116

132 Service Manual


Packing in a different carton 118 Symbol
Repacking in original carton 117 Canadian ICES-001 approval 20
Returned Goods Authorization (RGA) Carton label 21
number 116 Date of manufacture 20
RGA number 116 Decimal points 17
European union approval 20
Fragile 21
S Front panel 17
Safety checks, periodic 61 Keep away from heat 21
Saturation Keep upright 21
Calculated 39 Protect from moisture 21
Fractional 38 Resistant to liquid ingress 21
Functional 38 Russian regulatory approval 20
Measured 39 See instructions for use 20
Sensor SpO2 indicator 17
Accuracy 24 Temperature limitation 21
DS-100A 64 Type BF applied part 21
Separation distance, recommended 33 WEEE waste disposal 21
Service Symbols, Carton label 21
Required tools 103
Restricted to qualified service personnel T
103
Service manual, Internet address 11 Temperature limitation symbol 21
Setting up the oximeter prior to first-time Test
use 47 Functional 69
Light level 81
Set-up, operational 67
Live subject 68
Spare parts, Internet address 11 Modulation level 75
Specifications SpO2 74
Battery 23 Theory of pulse oximetry 37
Electrical requirements 23
Time
EMC Compatibility 31
Set the hour 59
Environmental 24
Set the minute 59
Performance 25
Physical characteristics 23
To separate the oximeter top and bottom
Range for oximeter measurements 24 cases 105
SpO2 PCB Connector J4 Lock 106 Transport
SRC-MAX OxiMax Oximetry Tester 64, 69 Altitude 24
Standards
Relative humidity 24
Temperature 24
EMC 31
Safety test 64 Type BF applied part symbol 20
Storage
Relative humidity 24 V
Temperature 24
Strangulation, warning 9 Verification, performance 63
Support, technical 87 Volume, adjusting pulse beep tone 57

Service Manual 133


Lifting the oximeter 8
W Liquid ingress 8
Silencing the oximeter 8
Warning Strangulation 9
Date and time accuracy 7 Use of non-approved equipment or ac-
Entanglement 9 cessories 8
Explosion hazard 8 WEEE waste disposal symbol 21
Exposure to moisture 8
LCD panel, broken 8

134 Service Manual


Part No. 10073799 Rev. B 10/2012

COVIDIEN, COVIDIEN with logo and Covidien logo are U.S.


and internationally registered trademarks of Covidien AG.

™* Trademark of its respective owner.


Other brands are trademarks of a Covidien company.

©2011 Covidien.

Covidien llc,
15 Hampshire Street, Mansfield, MA 02048 USA.
Covidien Ireland Limited,
IDA Business & Technology Park,Tullamore.

www.covidien.com [T] 1-800-635-5267

You might also like