Nellcor OXIMAX N-65 pulse oximeter Service manual

Nellcor OXIMAX N-65 pulse oximeter Service manual
Add to My manuals

Below you will find brief information for pulse oximeter OXIMAX N-65. The pulse oximeter OXIMAX N-65 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.

advertisement

Assistant Bot

Need help? Our chatbot has already read the manual and is ready to assist you. Feel free to ask any questions about the device, but providing details will make the conversation more productive.

Nellcor OXIMAX N-65 Service Manual | Manualzz

N-65

Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor,

OxiCliq, Dura-Y, MAX-FAST, and O

XI

M

AX

are trademarks of Nellcor Puritan Bennett Incorporated or an affiliate.

Cet appareil ISM est conforme à la norme NMB-001 Canada.

To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department, or your local representative.

Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett.

Covered by one or more of the following U.S. Patents and foreign equivalents: 4,802,486; 4,869,254; 4,928,692;

4,934,372; 4,960,126; 5,078,136; 5,485,847; 5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310; 6,591,123;

6,675,031; 6,708,049; 6,801,797; and Re.35,122.

C o n t e n t s

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Manual Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Description of OXIMAX N-65 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Front Panel Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Front Panel Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Rear Panel Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Label Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Menu Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Set Menu Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Set Time/Date Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Periodic Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Functional Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Battery Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Performance Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Equipment Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Power-On-Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Operational Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

General Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Operation with a Live Subject . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Pulse Oximetry Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Test Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

Test 1: BPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

Test 2: SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Test 3: Modulation Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

O

XI

M

AX

N-65 Service Manual i

ii

Contents

Test 4: Light Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

How To Use This Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Who Should Perform Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

Disassembly Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Replacement Level Supported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Prior to Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

Separating the Front and Back Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

SpO2 PCB or User Interface PCB Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

Front Case Assembly Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

Rear Case Assembly Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57

Battery Compartment Door Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61

Obtaining Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61

Parts List and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61

Packing for Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

Returning the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

Repacking in Original Carton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

Packing in a Different Carton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

Technical Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Oximetry Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

Functional versus Fractional Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

Measured versus Calculated Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

OXIMAX Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

O

XI

M

AX

N-65 Service Manual

Contents

Block Diagram Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

SpO

2

Printed Circuit Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Patient Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Power Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

User Interface Printed Circuit Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Backlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

CPU and Flash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Real-Time Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

Audio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86

LCD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

IrDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Power Supply Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109

O

XI

M

AX

N-65 Service Manual iii

Contents

Blank Page iv

O

XI

M

AX

N-65 Service Manual

I n t r o d u c t i o n

Warnings

Warnings are identified by the WARNING symbol shown above.

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

WARNING: The sensor uses the date and time provided by the O

XI

M

AX

N-65 handheld pulse oximeter when the sensor event record is recorded by the sensor. The accuracy of the date/time is dependent on the date/time already set in and provided by the monitor.

WARNING: Explosion hazard. Do not use the O

XI

M

AX

N-65 in the presence of flammable anesthetics mixed with air, oxygen, or nitrous oxide.

WARNING: Do not spray, pour, or spill any liquid on the O

XI

M

AX

N-65, its accessories, connectors, switches, or openings in the enclosure as this may damage the monitor.

WARNING: Chemicals from a broken LCD display panel are toxic when ingested. Use caution when the O

XI

M

AX

N-65 has a broken display panel.

WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or create invalid readings of the O

XI

M

AX

N-65.

WARNING: Do not silence the O

XI

M

AX

N-65 audible alarm or decrease its volume if patient safety could be compromised.

WARNING: To ensure patient safety, do not place the monitor in any

position that might cause it to fall on the patient.

O

XI

M

AX

N-65 Service Manual 1

Introduction

Cautions

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

WARNING: To ensure accurate performance and prevent device failure, do not expose the monitor to extreme moisture such as rain.

Cautions are identified by the CAUTION symbol shown above.

Cautions alert the user to exercise care necessary for the safe and effective use of the O

XI

M

AX

N-65.

Caution: Observe ESD (electrostatic discharge) precautions when working within the unit.

Caution: Observe ESD (electrostatic discharge) precautions when disassembling and reassembling the O

XI

M

AX

N-65 and when handling any of the components of the monitor.

Caution: When reassembling the O

XI

M

AX

N-65, 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.

Notes

Notes are identified by the Note symbol shown above.

Notes provide useful helpful information.

2

O

XI

M

AX

N-65 Service Manual

Introduction

Manual Overview

This manual contains information for service personnel who will service the

Nellcor model O

XI

M

AX

N-65 handheld pulse oximeter, herein referred to as the monitor. Only qualified service personnel should service this product. Read the operator's manual carefully and thoroughly understand the operation of the monitor.

O

XI

M

AX

N-65 Service Manual 3

Introduction

Description of O

XI

M

AX

N-65

The O

XI

M

AX

™ N-65 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO

2

) 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.

Front Panel Description

This section identifies the symbols, controls, displays, and indicators on the

O

XI

M

AX

N-65.

Refer to the O

XI

M

AX

N-65 Operator’s Manual for a complete description of all buttons, symbols, controls, displays and indicators.

4

1 — %SpO

2

area of display

2 — Measured %

SpO

2

3 — Pulse beats per minute (BPM) area of display

4 — Measured BPM

O

XI

M

AX

N-65 Service Manual

Introduction

O

XI

M

AX

N-65 Service Manual

5 — %SpO

2

Lower Alarm Limit

indicator

6 — %SpO

2

Upper Alarm Limit indicator

7 — Pulse Amplitude indicator (Blip bar)

8 — Time Colon time/date field separator

9 — Adjust Time mode indicator

10 — Adjust Volume mode indicator

11 — Set Limit mode indicator

12 — BPM Upper Alarm Limit indicator

13 — BPM Limit Changed indicator

14 — Sensor Off Patient indicator

15 — Sensor Disconnected indicator

16 — %SpO

2

Limit Changed indicator

5

Introduction

6

17 — Low Battery indicator

18 — Data In-Sensor indicator

19 — Alarm Volume Adjust indicator

20 — Pulse Beep Tone Volume Adjust indicator

21 — BPM Lower Alarm Limit indicator

22 — Print indicator

23 — Interference indicator

24 — Pulse Search indicator

25 — Data indicator

26 — Alarm Silenced indicator

O

XI

M

AX

N-65 Service Manual

27 — Power button

28 — Up Arrow button

29 — Backlight button

30 — Menu button

31 — Data (Record/Print) button

32 — Down Arrow button

33 — Alarm Silence button

Introduction

O

XI

M

AX

N-65 Service Manual 7

Introduction

Front Panel Symbols

The follow two symbols are located on the front panel of the monitor.

Displays the measured percent of oxygen saturation.

Displays the measured pulse beats per minute.

Rear Panel Symbols

The following symbols are located on the rear panel of the monitor.

8

1 — Label

2 — Battery Cover

See Instructions for Use

Type BF Applied Part - Not defibrillator proof

Resistant to liquid ingress

Prescription only

O

XI

M

AX

N-65 Service Manual

Date of Manufacture

European union approval

Canadian/USA certification mark (electrical safety)

Russian regulatory approval

Serial number

Label Symbols

These symbols display on the monitor’s labels.

Keep away from heat

Temperature limitation

Protect from moisture

Fragile

Keep upright

Humidity limitation

Introduction

O

XI

M

AX

N-65 Service Manual 9

Introduction

Menu Parameters

This section contains information on how to set monitor parameters and limits using the menu structure.

See Set Menu Parameters on page 11 to set the following parameters:

• high and low SpO

2

limits

• high and low BPM limits

• alarm volume

• pulse beep volume

• data printing

See Set Time/Date Parameters on page 12 to set the following parameters:

• Hour

• Minute

• Day

• Month

• Year

10

O

XI

M

AX

N-65 Service Manual

Introduction

Set Menu Parameters

To set menu parameters, press the Menu button repeatedly during normal operation to display the parameters to set. Use the Up Arrow button or Down

Arrow button to adjust the parameter limit. Press the Menu button to return to the default monitoring display.

1

# of

Presses

Table 1: Menu Structure

Parameter

%SpO

2

Low

Limit

Press Function

Adjust limit

2 Adjust limit

3

%SpO

2

High

Limit

BPM Low

Limit

Adjust limit

4 BPM High

Limit

Adjust limit

5

6

7

Pulse Beep

Volume

Alarm

Volume

Print Data

Adjust volume. Indications on blip bar.

Adjust volume. Indications on blip bar.

Print summary and/or stored snap-shot and sensor-event data.

O

XI

M

AX

N-65 Service Manual 11

Introduction

WARNING: Do not silence the O

XI

M

AX

N-65 audible alarm, or decrease its volume, if patient safety could be compromised.

Set Time/Date Parameters

To access the Time/Date settings menu, press the Menu button during start-up

Power-On-Self-Test (POST). Press the Menu button repeatedly to display the time/date parameters to set. Use the Up Arrow button and Down Arrow button to adjust time/date settings. Press the Menu button to return to the POST display.

When the month entry is made, the monitor checks the day selection to see if it is valid. If the day selection is not valid for the month selected the menu display returns to the day selection display.

When the year entry is made, the monitor checks the day and month selections to see if they are valid. If the day or month selection is not valid for the year selected the menu display returns to the day selection display.

Examples of invalid dates are:

• 30 February

• 31 February

• 31 April

• 31 June

• 31 September

• 31 November

• 29 February on a non-leap year

12

O

XI

M

AX

N-65 Service Manual

O

XI

M

AX

N-65 Service Manual

Introduction

# of

Presses

Table 2: Time Set Menu

Parameter Press Function

POST.

The Menu button must be pressed during the

1 Hour Adjust 1 to 23

2 Minute

3 Day

4 Month

5 Year

Adjust 1 to 59

Adjust 1 to 31

Adjust 1 to 12

Adjust 2003 to 2099

13

Introduction

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 O

XI

M

AX

N-65. Refer to the O

XI

M

AX

N-65 Operator's Manual. To understand the various Nellcor approved O

XI

M

AX

sensors that work with the monitor, refer to the individual O

XI

M

AX

sensor's Directions For Use.

The latest version of the operator’s manual and the service manual are posted on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

Spare Parts and Accessories are posted on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/Apartweb/main/PartAcceMenu.html

14

O

XI

M

AX

N-65 Service Manual

R o u t i n e M a i n t e n a n c e

Cleaning

WARNING: Do not spray, pour, or spill any liquid on the O

XI

M

AX

N-65 its accessories, connectors, switches, or openings in the enclosure as this may damage the monitor.

For surface-cleaning and disinfecting follow your institution's procedures or:

• The O

XI

M

AX

N-65 may be surface-cleaned by using 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 monitor.

• The monitor may be disinfected using a soft cloth saturated with a ten percent solution of chlorine bleach in tap water.

Before cleaning an SpO

2

O

XI

M

AX

sensor, read the Directions For Use enclosed with the O

XI

M

AX

sensor. Each sensor model has cleaning instructions specific to that sensor.

Periodic Safety Checks

The O

XI

M

AX

N-65 does not require calibration.

A qualified service technician should perform the following safety checks every

24 months.

To perform periodic safety checks:

1. Inspect the equipment for mechanical and functional damage.

2. Inspect safety labels for legibility. If the labels are damaged, contact Nellcor’s

Technical Services Department, 1.800.635.5267, or your local Nellcor representative.

Functional Checks

If the monitor has been visibly damaged or subjected to mechanical shock (for example, if dropped), immediately perform the performance tests. See

Performance Tests on page 17.

Every two years a qualified service technician should perform the electrical safety

tests detailed in Safety Tests on page 37. If the unit fails these electrical safety

tests, refer to Troubleshooting on page 39.

O

XI

M

AX

N-65 Service Manual 15

Routine Maintenance

Battery Installation

Caution: The monitor does not operate with dead batteries. Install new batteries.

To install new batteries:

1. Press the Power button to turn the monitor off.

2. Pull the battery compartment latch downward, toward the bottom of the

monitor, and remove the battery access door. See Figure 1.

3. Install four “AA” size batteries, orientated as shown in Figure 1.

4. Replace the battery access door.

16

1 —

Battery compartment latch

Figure 1: Installing Batteries

WARNING: Explosion hazard. Do not use the O

XI

M

AX

N-65 in the presence of flammable anesthetics mixed with air, oxygen, or nitrous oxide.

O

XI

M

AX

N-65 Service Manual

P e r f o r m a n c e V e r i f i c a t i o n

Introduction

This section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without removing the

O

XI

M

AX

N-65 cover. All tests, except the battery charge and battery performance tests, must be performed as the last operation before the monitor is returned to the user.

If the monitor fails to perform as specified in any test, repairs must be made to correct the problem before the monitor is returned to the user.

Equipment Needed

Equipment Description

Durasensor

®

O

XI

M

AX

oxygen sensor DS-100A

O

XI

M

AX

oxygen sensor

Extension cable

MAX-A

DEC-4

Nellcor model SRC-MAX Tester Provides testing for O

XI

M

AX

compatible monitors

Performance Tests

The Power-On-Self-Test (POST) performance test verifies that the O

XI

M

AX

N-65 is ready for patient monitoring.

Power-On-Self-Test

Discussion

Before using the monitor, 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 10 seconds to complete.

Caution: If any indicator or display element does not light when the monitor is turned on, do not use it. Instead, contact qualified service personnel, your local Nellcor representative, or Nellcor’s Technical Services Department.

Note: Physiological conditions, medical procedures, or external agents that may interfere with the monitor’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.

Note: The O

XI

M

AX

N-65 automatically starts POST, which tests the monitor circuitry and functions.

O

XI

M

AX

N-65 Service Manual 17

Performance Verification

Caution: During POST (immediately after power-up), confirm that all

display segments and icons are shown, and the monitor speaker sounds a

one-second tone.

When the monitor 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.

Procedure

To run POST:

1. Press the Power button to turn on the monitor.

Note: Do not have a sensor connected to the monitor.

The backlight remains on during POST.

All display numbers and icons are shown for three seconds. The backlight is turned on.

18

O

XI

M

AX

N-65 Service Manual

2. The display goes blank for one second.

Performance Verification

3. The software version number displays. The software version is identified by two dashes in the %SpO

2

area of the display.

Note: The software version 001 is an example. Check the monitor for the software version installed. Write down the software version number and have it available prior to requests for technical assistance.

4. The current time displays in a 24-hour format.

O

XI

M

AX

N-65 Service Manual 19

Performance Verification

Note: If the time has never been set, do not continue until you set the time. See Operator’s Manual.

5. If the monitor detects a problem, an error tone sounds and an error code (Er)

and the error number display. See Troubleshooting on page 39.

20

6. Upon successful completion of POST, the monitor sounds a one-second tone to indicate it has passed the test.

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

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.

O

XI

M

AX

N-65 Service Manual

Performance Verification

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.

7. Press the Alarm Silence button. The Alarm Silenced indicator displays.

8. Press the Alarm Silence button. The Alarm Silenced indicator does not display.

9. Press the Backlight button. The backlight turns on.

10. Press the Backlight button. The backlight turns off.

O

XI

M

AX

N-65 Service Manual 21

Performance Verification

Operational Setup

The operational setup procedure sets the time and date into the monitor. Refer to the O

XI

M

AX

N-65 Operator’s Manual for individual parameter settings. The monitor returns to the factory default settings when it is powered on: therefore, individual parameter settings need to be set at that time.

Setting the Time and Date

Discussion

WARNING: The O

XI

M

AX

sensor uses the date and time provided by the

O

XI

M

AX

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 monitor.

Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor 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 %SpO

2

(oxygen saturation percentage) and pulse rate readings (BPM) are being reported

• no error conditions exist

Procedure

To set the time and date:

1. With the monitor in normal operation, press the Power button to turn the monitor off.

2. Press the Power button to turn the monitor on.

22

O

XI

M

AX

N-65 Service Manual

Performance Verification

3. Press the Menu button during the POST operation until the set hours window appears with the hours indication (13) flashing.

4. Press the Up Arrow button or the Down Arrow button until the desired hours appear.

5. Press the Menu button to set the hours and show the minutes set display. The minutes indication (45) flashes.

6. Press the Up Arrow button or the Down Arrow button until the desired minutes appear.

O

XI

M

AX

N-65 Service Manual 23

Performance Verification

7. Press the Menu button to set the minutes and show the day set display. The day indication (29) flashes.

8. Press the Up Arrow button or the Down Arrow button until the desired day appears.

9. Press the Menu button to set the day and show the month set display. The month indication (7) flashes.

24

10. Press the Up Arrow button or the Down Arrow button until the desired month appears.

O

XI

M

AX

N-65 Service Manual

Performance Verification

11. Press the Menu button to set the month and show the year set display. The year indication (2004) flashes.

12. Press the Up Arrow button or the Down Arrow button until the desired year appears.

13. Press the Menu button to set the year and return to normal operation.

O

XI

M

AX

N-65 Service Manual 25

Performance Verification

General Operation

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

Operation with a Live Subject

Patient monitoring involves connecting the O

XI

M

AX

sensor to a live subject for a qualitative test.

.

1

Sensor Port

To connect the O

XI

M

AX

sensor to a live subject for a qualitative test:

1. Connect a Nellcor O

XI

M

AX

MAX-A oxygen O

XI

M

AX

sensor to the monitor.

2. Clip the MAX-A to the subject as recommended in the O

XI

M

AX

sensor's

Directions For Use.

3. Press the Power button to turn the monitor on and verify that it is operating.

The monitor should stabilize on the subject's physiological signal in approximately 30 seconds.

4. Verify that the oxygen saturation and pulse rate values are reasonable for the subject.

5. Press the Data button.

26

O

XI

M

AX

N-65 Service Manual

The monitor records snap-shot data.

Performance Verification

6. Turn off the monitor.

O

XI

M

AX

N-65 Service Manual 27

Performance Verification

Pulse Oximetry Functional Tests

The Pulse Oximetry Functional Tests utilize the pulse oximetry functional tester

(Nellcor model SRC-MAX) to verify the performance of the monitor. See

Figure 2.

28

1 —O

XI

M

AX

N-65 Cable Connector 6 — % Modulation Select Button

2 — RED LED Drive Indicator 7 — % SpO

2

Select Button

3 — Not Used For O

XI

M

AX

N-65

4 — Not Used For O

XI

M

AX

N-65

5 — Battery Low Indicator

8 — Light Level Selection Button

9 — Pulse Rate Selection Button

10 — INFRARED LED Drive Indicator

Figure 2: SRC-MAX O

XI

M

AX

Oximetry Tester

O

XI

M

AX

N-65 Service Manual

Performance Verification

The SRC-MAX functional tester allows qualified technicians to functionally test

Nellcor O

XI

M

AX

technology-based pulse oximeters and OEM O

XI

M

AX

technology-based monitors.

The Pulse Oximetry Functional tests should be completed in the order shown:

• Test Setup

Note: The technician must complete Test Setup before performing tests

1 through 4 as follows.

• Test 1: BPM

• Test 2: SpO

2

• Test 3: Modulation

• Test 4: Light

See Table 3, "Pulse Oximetry Functional Tests", on page 30 for a brief

description of each test.

O

XI

M

AX

N-65 Service Manual 29

Performance Verification

Table 3 shows the Pulse Oximetry Functional Tests you must perform and a

description of each.

Table 3: Pulse Oximetry Functional Tests

Test

Test Setup

Test 1: BPM

Test 2: SpO

Test 4: Light

2

Test 3: Modulation

Description

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.

See Test Setup on page 31.

This procedure simulates an OXIMAX sensor attached to a patient indicating 60 bpm and 200 bpm.

The test sets up Test 1 for 60 bpm.

See Test 1: BPM on page 32.

This 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.

See Test 2: SpO2 on page 33.

This procedure simulates an OXIMAX sensor attached to a patient indicating low and high pulse strength.

The test sets up Test 3 for low pulse strength.

See Test 3: Modulation Level on page 34.

This procedure simulates an OXIMAX 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.

See Test 4: Light Level on page 36.

30

O

XI

M

AX

N-65 Service Manual

Performance Verification

Test Setup

You must complete Test Setup before performing any other pulse oximetry functional tests.

To perform test setup:

1. Press the Power button to turn on the monitor.

2. After the monitor presents the monitoring screen, connect the SRC-MAX tester to the monitor sensor port as shown.

Note: Use a DEC-4 extension cable between the SRC-MAX and the monitor.

O

XI

M

AX

N-65 Service Manual

1 — Sensor Port

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

After the monitor completes POST, the monitor:

• is in SpO

2

alarm

• displays an %SpO

2

of 75 (pass criteria is 73 to 77 %SpO

2

inclusive)

• displays a pulse rate of 60 (pass criteria is 57 to 63 bpm inclusive)

31

Performance Verification

Pulse Amplitude indicator - displays low level modulation (low amplitude pulse amplitude indicator)

Test 1: BPM

To perform Test 1: BPM:

1. Press the SRC-MAX % Pulse Rate selection button.

The SRC-MAX Pulse Rate 200 LED lights.

The monitor bpm increases to 200 and stabilize at 200 bpm. The test pass criteria is 197 to 203 bpm inclusive.

The monitor:

• displays 75 %SpO

2

• displays 200 bpm (pass criteria is 197 to 203 bpm inclusive)

• alarms

Pulse Amplitude indicator displays low level modulation

32

O

XI

M

AX

N-65 Service Manual

Performance Verification

2. Press the SRC-MAX Pulse Rate select button.

The SRC-MAX Pulse Rate 60 LED lights.

The monitor pulse rate decreases to 60 and stabilize at 60 bpm. The test pass criteria is 57 to 63 bpm inclusive.

The monitor:

• displays 75 %SpO

2

• displays 60 bpm (test pass criteria is 57 to 63 bpm inclusive)

• alarms

Pulse Amplitude indicator displays low level modulation

Test 2: SpO

2

To perform Test 2: SpO

2

:

1. Press the SRC-MAX %SpO2 select button.

The SRC-MAX %SpO

2

90 LED lights.

The monitor displays three dashes until the SRC-MAX stabilizes at 90

%SpO

2

. The test pass criteria is 88 to 92 %SpO

2

inclusive.

The monitor:

• displays 90 %SpO

2

(pass criteria is 88 to 92 %SpO

2

inclusive)

• displays 60 bpm

• no alarms

Pulse Amplitude indicator displays low level modulation

O

XI

M

AX

N-65 Service Manual 33

Performance Verification

2. Press the SRC-MAX %SpO

2

select button.

The SRC-MAX %SpO

2

75 LED lights.

The monitor displays two dashes until the SRC-MAX stabilizes at 75 %SpO

2

.

The test pass criteria is 73 to 77 %SpO

2

inclusive.

The monitor:

• displays 75 %SpO

2

(pass criteria is 73 to 77 %SpO

2

inclusive)

• displays 60 bpm

• alarms

Pulse Amplitude indicator displays low level modulation

Test 3: Modulation Level

To perform Test 3: Modulation Level:

1. Press the SRC-MAX % Modulation selection button.

The SRC-MAX % Modulation LED lights.

The monitor pulse blip bar initially increases in amplitude and then stabilizes at the higher level.

34

The monitor:

• displays 75 %SpO

2

(test pass criteria is 73 to 77 %SpO

2 inclusive)

• displays 60 bpm (test pass criteria is 57 to 63 bpm inclusive)

• alarms

Pulse Amplitude indicator displays high level modulation

O

XI

M

AX

N-65 Service Manual

Performance Verification

2. Perform Test 1: BPM on page 32.

The Pulse Amplitude indicator should indicate high level modulation.

3. Perform Test 2: SpO2 on page 33.

The Pulse Amplitude indicator should indicate high level modulation.

4. Press the SRC-MAX % Modulation selection button.

The SRC-MAX % Modulation LED lights.

The monitor pulse blip bar decreases in amplitude.

The monitor:

• displays 75 %SpO

2

• displays 60 bpm

• alarms

Pulse Amplitude indicator displays low level modulation

5. Perform Test 1: BPM on page 32.

The pulse amplitude indicator should indicate low level modulation.

6. Perform Test 2: SpO2 on page 33.

The pulse amplitude indicator should indicate low level modulation.

O

XI

M

AX

N-65 Service Manual 35

Performance Verification

Test 4: Light Level

To perform Test 4: Light Level:

1. Press the SRC-MAX Light Level selection button.

The monitor pulse blip bar initially increases in amplitude and then reduces and stabilizes at 3-5 bars.

36

The monitor:

• displays 75 %SpO

2

(test pass criteria is 73 to 77 %SpO

2

inclusive)

• displays 60 bpm (test pass criteria is 57 to 63 bpm inclusive)

• alarms

• pulse amplitude indicator displays low level modulation

2. Perform Test 1: BPM on page 32.

The pulse amplitude should indicate low level modulation.

3. Perform Test 2: SpO2 on page 33.

The pulse amplitude should indicate low level modulation.

O

XI

M

AX

N-65 Service Manual

4. Press the SRC-MAX Light Level selection button.

Performance Verification

The monitor pulse blip bar initially increases in amplitude and then reduces and stabilizes at 3-5 bars.

The monitor:

• displays 75 %SpO

2

• displays 60 bpm

• alarms

• pulse amplitude indicator displays low level modulation

5. Perform Test 1: BPM on page 32.

The pulse amplitude indicator should indicate low level modulation.

6. Perform Test 2: SpO2 on page 33.

The pulse amplitude indicator should indicate low level modulation.

7. Disconnect all equipment and turn off the monitor.

Safety Tests

The monitor safety tests meet the standards of, and are performed in accordance with, EN 60601-1: 1990 (A1 and A2), IEC 60601-1, UL 60601-1, and CAN/CSA

C22.2 No. 601.1. This product is categorized as internally powered type BF equipment.

O

XI

M

AX

N-65 Service Manual 37

Performance Verification

Blank Page

38

O

XI

M

AX

N-65 Service Manual

T r o u b l e s h o o t i n g

Introduction

This section explains how to troubleshoot the O

XI

M

AX

N-65. Tables list possible monitor difficulties, along with probable causes, and recommended actions to correct the difficulty.

How To Use This Section

Use this section in conjunction with Performance Verification on page 17, and

Spare Parts on page 61. To remove and replace a part suspected of being

defective, follow the instructions in Disassembly Guide on page 47. The circuit

analysis section in the Technical Discussion on page 81, offers information on

how the monitor functions.

Who Should Perform Repairs

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

Nellcor representative.

Troubleshooting Guide

Note: Follow the recommended actions discussed in this section to correct the majority of problems you may encounter. However, problems not covered here can be resolved by calling Nellcor’s Technical Services or your local Nellcor representative.

If you encounter a problem that cannot be resolved through a visual inspection, refer to Table 4: Troubleshooting Guide, on page 40. In the table, find the condition that describes the problem and follow the corrective actions in the order presented. For a symptom that is not listed in Table 4, contact the Nellcor

Technical Services Department at 1.800.635.5267 or your local Nellcor representative.

O

XI

M

AX

N-65 Service Manual 39

Troubleshooting

If an error code is shown on the monitor front panel display, see Figure 3. Turn the monitor off, wait ten seconds, then turn it back on. This clears recoverable errors encountered by the monitor. If the error code persists, refer to Table 5:

Error Codes, on page 43 for an explanation of the error code. Apply the action specified.

40

Figure 3: Typical Error Code Display

Once you have performed the recommended action, reassemble the monitor, refer

to Performance Verification on page 17, and conduct a performance verification

before returning the monitor to service. If the symptom persists continue troubleshooting.

Table 4:

Troubleshooting Guide

Condition Recommended Action

The monitor does not turn on when you press the Power button.

• The Power button was not fully depressed.

Fully press the Power button.

• The batteries are missing.

• The batteries are installed incorrectly.

Open the battery compartment. If the batteries are missing, install new batteries. Refer to the O

XI

M

AX

N-65 Operator’s

Manual.

Open the battery compartment. If the batteries are not installed correctly, remove and reinstall them. Make sure the batteries are not installed backwards. Refer to the O

XI

M

AX

N-65 Operator’s Manual.

• The batteries are at, or near, a voltage too low for the monitor to operate.

• The flex circuit between the front panel and the SpO

2

PCB is damaged, or not making a good connection.

Install new batteries. Refer to the O

XI

M

AX

N-65 Operator’s

Manual.

Caution: Unlock J4 before attempting to remove and reinsert the flex cable.

• The front panel keypad is defective.

Inspect the flex cable for damage. Inspect the connection to

J4. If there is damage to the flex cable, replace the front case. Otherwise, remove the cable from J4 and reconnect it.

Reassemble the monitor and retest. Refer to Separating the

Front and Back Cases on page 48 and Front Case Assembly

Replacement on page 54.

Caution: Unlock J4 before attempting to remove the flex circuit cable.

Replace the Front Case. Refer to Front Case Assembly

Replacement on page 54.

O

XI

M

AX

N-65 Service Manual

Troubleshooting

Table 4:

Troubleshooting Guide

(Continued)

Condition Recommended Action

• Replacing the front case does not fix the problem.

• Replacing the SpO problem.

2

PCB does not fix the

Replace the SpO

2

PCB. See SpO2 PCB or User Interface

PCB Replacement on page 50.

Replace the User Interface PCB. See SpO2 PCB or User

Interface PCB Replacement on page 50. If this does not fix

the problem, return the monitor to Nellcor.

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

• The flex circuit between the front panel and the SpO

2

PCB is damaged, or not making a good connection.

Caution: Unlock J4 before attempting to remove and reinsert the flex cable.

• The front panel keypad is defective.

Inspect the flex cable for damage. Inspect the connection to

J4. If there is damage to the flex cable, replace the front case. Otherwise, remove the cable from J4 and reconnect it.

Reassemble the monitor and retest. Refer to Separating the

Front and Back Cases on page 48 and Front Case Assembly

Replacement on page 54.

Caution: Unlock J4 before attempting to remove the flex circuit cable.

• Replacing the front case does not fix the problem.

• Replacing the SpO problem.

2

PCB does not fix the

Replace the front case. Refer to Front Case Assembly

Replacement on page 54.

Replace the SpO

2

PCB. SpO2 PCB or User Interface PCB

Replacement on page 50.

Replace the User Interface PCB. See SpO2 PCB or User

Interface PCB Replacement on page 50. If this does not fix

the problem, return the monitor to Nellcor.

One or more display segments does not work.

• A User Interface PCB component has failed.

Inspect the User Interface PCB for cracking, burning, or damage. If damage is found, replace the User Interface PCB.

See SpO2 PCB or User Interface PCB Replacement on page 50.

• The User Interface PCB is defective.

If damage is found, replace the User Interface PCB. See

SpO2 PCB or User Interface PCB Replacement on page 50.

Pulse rate and %SpO

2

value does not display when the monitor is turned on.

• The SpO properly.

2

sensor is not connected Reconnect the SpO

2

sensor to the monitor.

Connect the SpO

2

sensor to the patient. See the sensor

Directions for Use.

• The SpO

2

sensor has failed.

• The User Interface PCB is defective.

Replace the SpO

2

sensor.

Replace the User Interface PCB. See SpO2 PCB or User

Interface PCB Replacement on page 50.

• The SpO

2

PCB is defective.

Replace the SpO

2

PCB. See SpO2 PCB or User Interface

PCB Replacement on page 50.

The display backlight does not come on when you press the Backlight button.

• The flex circuit between the front panel and the SpO

2

PCB is damaged, or not making a good connection.

Caution: Unlock J4 before attempting to remove and reinsert the flex cable.

Inspect the flex cable for damage. Inspect the connection to

J4. If there is damage to the flex cable, replace the front case. Otherwise, remove the cable from J4 and reconnect it.

Reassemble the monitor and retest. See Separating the Front

and Back Cases on page 48 and Front Case Assembly

Replacement on page 54.

O

XI

M

AX

N-65 Service Manual 41

Troubleshooting

Table 4:

Troubleshooting Guide

(Continued)

Condition

• The Backlight button on the front panel keypad is defective.

Recommended Action

Caution: Unlock J4 before attempting to remove the flex circuit cable.

• Replacing the SpO problem.

2

PCB does not fix the

• Replacing the SpO2 PCB does not fix the problem.

Replace the front case. See Front Case Assembly

Replacement on page 54.

Replace the SpO

2

PCB. See SpO2 PCB or User Interface

PCB Replacement on page 50.

Replace the User Interface PCB. See SpO2 PCB or User

Interface PCB Replacement on page 50. If this does not fix

the problem, return the monitor to Nellcor.

• The Backlight LEDs on the User

Interface PCB have failed.

Replace the User Interface PCB. See SpO2 PCB or User

Interface PCB Replacement on page 50.

The monitor shuts off when you press the Backlight button.

• The batteries are, at or near, a voltage too low for the monitor to operate.

The printer does not print.

Install new batteries. See the O

XI

M

AX

N-65 Operator’s

Manual.

• The IrDA between the printer and the monitor is not properly aligned.

• The printer is turned off.

• The printer batteries are at, or near, a voltage too low to operate.

• The Data button on the front panel keypad is defective.

Align the printer and the monitor. See the O

XI

M

AX

N-65

Operator’s Manual for instructions.

Turn the printer on. See the printer documentation.

Install new batteries in the printer. See the printer documentation.

Caution: Unlock J4 before attempting to remove the flex circuit cable.

• Replacing the Front Case does not fix the problem.

• The printer is defective.

Replace the Front Case. See Front Case Assembly

Replacement on page 54.

Replace the User Interface PCB. See SpO2 PCB or User

Interface PCB Replacement on page 50. If this does not fix

the problem, return the monitor to Nellcor.

See the printer documentation, or replace the printer.

Error Codes

An error code displays when the monitor detects a non-correctable failure. Table 5 provides a list of error codes for the monitor. However, you can turn the Power off and on once (called “cycling” the power) to try removing the error code if one of the following occurs:

• monitor sounds a low priority alarm

• measurements stop

• “Er” is shown in the %SpO

2

numeric display area

• Error code is shown in the right numeric display

If the error code remains, see Error Codes on page 43.

42

O

XI

M

AX

N-65 Service Manual

Troubleshooting

Table 5 provides a list of error codes for the monitor.

14

16

11

12

17

18

49

50

19

48

51

53

256

Table 5: Error Codes

Error

Code

Scope of Action

Action Explanation

9

10

5

6

3

4

1

2

1

1

X

X

X

X

X

X

X

X

X

X

2

X

X

2

X

X

X

X

X

X

X

Replace SpO

2

board.

Replace SpO

2

board.

Replace SpO

2

board.

Replace SpO

2

board.

Replace SpO

2

board.

Replace SpO

2

board.

Replace SpO

2

board.

1 — Check/replace sensor/ extension cable.

2 — Replace SpO

2

board.

1 — Replace batteries.

2 — Replace SpO

2

board.

Replace SpO

2

board.

Replace SpO

2

board.

Replace SpO

2

board.

Check/replace sensor/ extension cable.

Replace SpO

2

board.

Check/replace sensor/ extension cable.

Replace SpO

Replace SpO

Replace SpO

Replace SpO

2

2

2

2

board.

board.

board.

board.

Replace SpO

2

board.

Replace SpO

2

board.

SpO

2

front end RAM error.

SpO

2

front end ROM/code integrity error.

SpO

2

front end reported a bad CRC.

SpO

2

front end reported FSP message not allowed.

SpO

2

front end reported illegal value sent in FSP message.

SpO

2

front end reports calibration

(offset) failure.

SpO

2

front end reported syntax error in FSP message.

SpO

2

front end reports over current failure.

SpO

2

front end reports incorrect system voltage.

SpO

2

front end reports other hardware problem.

SpO

2

front end reports communication channel overflow.

SpO

2

front end reports watchdog time out.

SpO

2

front end reports that sensor appears defective.

SpO

2

front end reports internal register appears modified from expected value.

SpO

2

front end reports signal out-ofrange.

SpO

2

front end reports spurious interrupt.

SpO

2

front end reports internal buffer overflow.

SpO

2

front end reports intermittent error.

SpO

2

front end reports digital communication error.

SpO

2

front end data not received.

SpO

2

back end reports beginning of packet missing.

O

XI

M

AX

N-65 Service Manual 43

Troubleshooting

Error

Code

Scope of Action

Table 5: Error Codes (Continued)

Action Explanation

280

281

282

274

275

276

277

1, 2

X

X

X

X

X

X

X

X

X

X

X

X

X

3

X

X

X

261

262

263

264

257

258

259

260

268

269

270

271

265

266

267

272

273

X

X

X

X

X

X

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

Replace SpO

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

board.

board.

board.

board.

board.

board.

board.

board.

board.

board.

board.

board.

board.

board.

board.

Replace SpO

2

board.

1 — Restart the monitor.

2 — Set the time and date.

3 — Replace UI board.

X Return monitor for reprogramming.

Check/replace sensor/ extension cable.

Replace with O

XI

M

AX

sensor/ extension cable.

Check/replace sensor/ extension cable.

Check/replace sensor/ extension cable.

Check/replace sensor/ extension cable.

Check/replace sensor/ extension cable.

SpO

2

back end reports packet start ID

(SID) missing.

SpO

2

back end reports packet length error.

SpO

2

back end reports message length error.

SpO

2

back end reports packet contains unsupported key.

SpO

2

back end reports packet CRC error.

SpO

2

back end reports end of packet missing.

SpO

2

back end reports packet contains unidentified key.

SpO

2

back end reports corrupted variable.

SpO

2

back end reports memory overflow.

SpO

2

back end reports bad pointer.

SpO

2

back end reports parameter value out-of-range.

SpO

2

back end reports reset detected.

SpO

2

back end reports unexpected value.

SpO

2

back end reports time-out.

SpO

2

back end reports not ready/not initialized.

SpO

2

back end reports double fault.

SpO

2

back end reports date out-ofrange error.

SpO

2

back end reports incompatible software version.

SpO

2

back end reports incorrect registration number.

SpO

2

back end reports sensor read failure.

SpO

2

back end reports sensor signature verification fails.

SpO

2

back end reports does not support feature required by sensor.

SpO

2

back end reports overflow/ underflow.

SpO

2

back end reports sensor activation failure.

44

O

XI

M

AX

N-65 Service Manual

Troubleshooting

Error

Code

Scope of Action

Table 5: Error Codes (Continued)

Action Explanation

512

513

514

515

516

518

519

520

521

522

523

528

529

530

531

524

525

526

527

532

533

534

535

536

537

538

X

X

1, 2

X

X

X

X

X

X

X

X

3

1, 2

1, 2

1

1

X

X

1, 2

1, 2

1, 2

1, 2

1, 2

1, 2

X

X

X

X

Replace UI board.

Replace UI board.

Replace UI board.

Replace UI board.

Replace UI board.

Return monitor for repair.

Return monitor for repair.

Replace UI board.

Replace batteries.

Replace batteries.

Communication failure with real time clock.

Real time clock oscillator control problem.

Real time clock failed timing test.

LCD failed feedback test.

LCD failed feedback test.

Various system faults.

Unrecoverable software error.

Unrecoverable error verify real time clock.

Battery power is critically low.

System power levels unacceptable for continued operation.

NVRAM failed consistency check.

1 — Restart the monitor.

2 — Set the time and date.

3 — Replace UI board.

Replace UI board.

Restart, replace UI board.

1 — Replace SpO

2

board.

2 — Replace UI board.

1 — Replace SpO

2

board.

2 — Replace UI board.

2 1 — Replace UI board

2 — Return monitor for repair.

2 1 — Replace UI board

2 — Return monitor for repair.

1 — Replace SpO

2 — Replace UI board.

1 — Replace SpO

2 — Replace UI board.

1 — Replace SpO

2 — Replace UI board.

1 — Replace SpO

2

2

2

2

board.

board.

board.

board.

2 — Replace UI board.

NVRAM failed read-after-write verification.

Time base discrepancy writing error entry.

Fatal error for SpO

2

communication.

Communication failure with SpO board.

Fatal error creating parser.

Fatal error creating parser.

Unrecoverable error with SpO

2 communication.

Unrecoverable error with SpO

2 communication.

Unrecoverable error with SpO

2 communication.

Unrecoverable error with SpO

2 communication.

1 — Replace SpO

2

board.

2 — Replace UI board.

1 — Replace SpO

2

board.

2 — Replace UI board.

Unrecoverable error with SpO

2 communication.

Unrecoverable error with SpO

2 communication.

Replace UI board.

Replace UI board.

Flash memory failed CRC check.

Fatal system error.

Set the monitor time and date. Real time clock value bad.

2

O

XI

M

AX

N-65 Service Manual 45

Troubleshooting

Error

Code

Scope of Action

Table 5: Error Codes (Continued)

Action Explanation

539

540

541

542

543

544

545

546

997

998

999

1

X

2

X

1

X

X

X

X

X

X

1 — Restart the monitor.

2 — Replace membrane switch pad.

Replace UI board.

X Return monitor for repair.

2 1 — Replace UI board.

2 — Return monitor for repair.

Set time and date.

Replace UI board.

Replace SpO

2

board.

Replace UI board.

Replace UI board.

Replace UI board.

Replace UI board.

Erroneous key press detected at start.

Fatal system error reading memory.

Fatal software error.

RAM corruption detected during background check.

Invalid time. Cannot snapshot.

Invalid register value.

SpO

2

board in unexpected state.

IrDA failure.

RAM error.

Spurious Interrupt.

Watchdog protection activated.

46

O

XI

M

AX

N-65 Service Manual

D i s a s s e m b l y G u i d e

Introduction

The O

XI

M

AX

N-65 can be disassembled into all major component parts, including:

• Front case with front panel keypad

• Rear bottom

• User Interface PCB

• SpO

2

PCB

• Battery compartment door

Note: Some spare parts have a business reply card attached. Please fill out and return the business reply card.

Caution: Observe ESD (electrostatic discharge) precautions when disassembling and reassembling the monitor and when handling any components of it.

Tools Required

The tools required to disassemble and reassemble the monitor are:

• Number one (medium) Phillips screwdriver

• Torque driver, four inch/pounds (10 cm/kg)

Replacement Level Supported

The replacement level supported for the monitor is at the printed circuit board

(PCB) and major subassembly level. When a PCB problem is identified, follow

the procedures in Disassembly Guide on page 47 to replace the PCB. Check to

ensure the symptom disappears and that the monitor passes all performance tests.

If the symptom persists, swap the replacement PCB with the malfunctioning PCB

(the original PCB that was installed when you started troubleshooting) and continue troubleshooting.

O

XI

M

AX

N-65 Service Manual 47

Disassembly Guide

Prior to Disassembly

The monitor batteries must be removed prior to disassembly.

To remove the batteries:

1. Press the Power button to turn the monitor off.

2. Remove the battery cover.

3. Pull the battery cover latch downward toward the bottom of the monitor case and lift the battery cover. See Figure 4, item 1.

4. Remove the batteries.

1 —

Batteries

2 —

Battery cover

3 —

Battery cover latch

Figure 4: Removing Batteries

Separating the Front and Back Cases

To separate the monitor front and back cases:

1. Do the procedure in paragraph Prior to Disassembly on page 48.

48

O

XI

M

AX

N-65 Service Manual

Disassembly Guide

2. Remove the four screws holding the monitor front and rear cases together. See

Figure 5, items 1 through 4.

Figure 5: Monitor Case Screws

Caution: A flex cable runs between the monitor front and rear case assemblies. Use care when separating the cases. Do not apply stress to the flex cable.

3. Separate the monitor front and rear case assemblies. See Figure 6.

O

XI

M

AX

N-65 Service Manual

1 — Connector J4

Figure 6: Cases Separated

Caution: Failure to unlock connector J4 on the SpO

2

PCB before removing the front case flex circuit could damage the flex circuit.

49

Disassembly Guide

4. Unlock connector J4 on the SpO

2

PCB. See Figure 6 and Figure 7.

1 — SpO

2

PCB .

2 — J4 lock

3 — Lock direction

4 — Unlock direction

Figure 7: SpO

2

PCB Connector J4 Lock

5. Disconnect the ribbon cable from SpO

2

PCB connector J4.

SpO2 PCB or User Interface PCB Replacement

To replace the SpO

2

PCB or the User Interface PCB:

1. Complete the procedure in Prior to Disassembly on page 48.

2. Complete the procedure in Separating the Front and Back Cases on page 48.

Caution: The battery connectors (spring assemblies) at the bottom of the SpO

2

PCB are held in slots in the battery compartment.

Observe how the connectors are engaged in the slots when you remove the SpO

2

PCB and User Interface PCB. Ensure that the battery connectors are inserted back into these slots when you reassemble the monitor.

50

O

XI

M

AX

N-65 Service Manual

Disassembly Guide

3. Pull the SpO

2

PCB and User Interface PCB to the left to free the case from the

DB-9 connector. Lift the combined SpO

2

and User Interface PCBs from the case. See 8.

Figure 8: User Interface PCB and SpO

2

PCB Removal

Caution: Do not force the User Interface PCB and SpO

2

PCB apart.

This may damage the boards. To separate the User Interface PCB from the SpO

2

PCB, grasp the User Interface PCB in one hand and the SpO

2

PCB in the other. Rotate the ends of the two PCBs as shown in Figure 9 until the two PCBs separate at the connection points. Gently work the boards apart.

4. Separate the User Interface PCB from the SpO

2

PCB. See the Caution above and Figure 9 as follows.

O

XI

M

AX

N-65 Service Manual

1 — Left Connection (J8 on SpO

2

, J4 on User Interface)

2 — User Interface PCB

3 — Right Connection ( J1 on SpO

2

, J5 on User Interface)

4 — SpO

2

PCB

Figure 9: Separating the User Interface PCB and SpO

2

PCB

51

Disassembly Guide

5. Place the defective PCB to the side.

6. Align the replacement PCB with the other PCB at the connectors. When both rows of the connectors are aligned, gently press the PCBs together. See

Figure 10.

1 — Left Connection (J8 on SpO

2

, J4 on User Interface)

2 — User Interface PCB

3 — Right Connection (J1 on SpO

2

, J5 on User Interface)

4 — SpO

2

PCB

Figure 10: Connecting PCBs

7. Install the User Interface PCB and SpO

2

PCB into the monitor case. Ensure that the battery springs are aligned properly in their slots. See Figure 11.

52

Figure 11: Battery Spring Alignment

O

XI

M

AX

N-65 Service Manual

Disassembly Guide

Note: The longer screws install at the top of the case. See Figure 12, items 1 and 4.

8. Align the front and rear cases. See Figure 12.

Figure 12: Installing The Case Screws

9. Install the four screws (Figure 12, items 1 through 4).

10. Install the batteries and battery cover. See Figure 13.

O

XI

M

AX

N-65 Service Manual

1 —

Batteries

2 —

Battery cover

3 —

Battery cover latch

Figure 13: Battery Installation

53

Disassembly Guide

11. Perform the performance verification tests before placing the monitor into

service. See Pulse Oximetry Functional Tests on page 28.

Front Case Assembly Replacement

The front case assembly contains the keypad.

To replace the front case assembly:

1. Remove the batteries from the monitor. See Prior to Disassembly on page 48.

2. Separate the front and rear case assemblies. See Separating the Front and

Back Cases on page 48.

3. Dispose of the front case assembly in accordance with local regulations.

4. Connect the new front case assembly ribbon cable to the SpO

2

PCB connector

J4. See Figure 14.

54

1 — J4

Figure 14: Front Case Ribbon Cable Connection

O

XI

M

AX

N-65 Service Manual

5. Lock the ribbon cable connector. See Figure 15.

Disassembly Guide

1 — SpO

2

PCB

2 — J4 lock

3 — Lock direction

4 — Unlock direction

Figure 15: Locking SpO

2

PCB Connection to J4

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

Figure 16, items 1 through 4.

Figure 16: Installing The Case Screws

O

XI

M

AX

N-65 Service Manual 55

Disassembly Guide

7. Install the batteries and battery cover as shown in Figure 17.

1 —

Batteries

2 —

Battery cover

3 —

Battery cover latch

Figure 17: Battery Installation

8. Perform the performance verification tests before placing the monitor into

service. See Pulse Oximetry Functional Tests on page 28.

56

O

XI

M

AX

N-65 Service Manual

Disassembly Guide

Rear Case Assembly Replacement

To replace the rear case assembly:

1. Remove the batteries from the monitor. See Prior to Disassembly on page 48.

2. Separate the front and rear case assemblies. See Separating the Front and

Back Cases on page 48.

Caution: The battery connectors (spring assemblies) at the bottom of the SpO

2

PCB are held in slots in the battery compartment.

Observe how these connectors are engaged in these slots when you remove the SpO

2

PCB and User Interface PCB and ensure that the battery connectors are inserted back in these slots when you reassemble the monitor.

3. Lift the SpO

2

PCB and User Interface from the case. See 18.

Figure 18: User Interface PCB and SpO

2

PCB Removal

4. Discard the rear case assembly in accordance with local regulations.

O

XI

M

AX

N-65 Service Manual 57

Disassembly Guide

5. Install the User Interface PCB and SpO

2

PCB into the monitor case. Ensure that the battery springs slip into place. See Figure 19.

Figure 19: Battery Spring Alignment

Note: The longer screws install at the top of the case. See Figure 20, items 1 and 4.

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

Figure 20.

58

Figure 20: Installing The Case Screws

O

XI

M

AX

N-65 Service Manual

7. Install the batteries and battery cover. See Figure 21.

Disassembly Guide

Figure 21: Battery Installation

8. Perform the performance verification tests before placing the monitor into

service. See Pulse Oximetry Functional Tests on page 28.

Battery Compartment Door Replacement

To replace the battery compartment door:

1. Press the battery door latch (Figure 22, item 1) and lift the batter door from the monitor rear case.

Figure 22: Battery Compartment Door Latch

2. Insert the new battery compartment door in the case and close until the battery door latch snaps in place.

O

XI

M

AX

N-65 Service Manual 59

Disassembly Guide

60

Blank Page

O

XI

M

AX

N-65 Service Manual

S p a r e P a r t s

Introduction

The latest version of this manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

Spare parts are shown in Table 6. Item numbers correspond to the callout numbers

in Figure 23.

Obtaining Replacement Parts

Nellcor's Technical Services provides technical assistance information and replacement parts. To obtain replacement parts, contact Nellcor's Technical

Services or your local Nellcor representative. Refer to parts by the part names and part numbers.

Spare parts and accessories for the O

XI

M

AX

N-65 are listed on the Internet at: http://mallinckrodt.com/respiratory/resp/Serv_Supp/Apartweb/main/PartAcceMenu.html

Parts List and Accessories

O

XI

M

AX

N-65 Service Manual

Figure 23

Reference

Spare Parts

1

--

--

--

--

--

4

5

2

3

Table 6: Parts and Accessories List

Description

Top enclosure with membrane panel

SpO

2

PCB

User interface (UI)

Bottom enclosure

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

61

Spare Parts

62

Figure 23

Reference

--

--

Accessories

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

--

Table 6: Parts and Accessories List

Description

Product data label

Quick guide label

Boot, protective, silicone, yellow

Case, carry, fabric, black with shoulder strap

DEC-4 sensor extension cable

Jacket, water resistant, clear, plastic

Transport Boot

CD, operator and service manuals

Home Use Guide, English

Operator’s manual, Arabic

Operator’s manual, Chinese

Operator’s manual, Czechoslovakian

Operator’s manual, Danish

Operator’s manual, Dutch

Operator’s manual, English

Operator’s manual, Finnish

Operator’s manual, French

Operator’s manual, German

Operator’s manual, Greek

Operator’s manual, Hungarian

Operator’s manual, Italian

Operator’s manual, Japanese

Operator’s manual, Norwegian

Operator’s manual, Polish

Operator’s manual, Portuguese (Brazilian)

Operator’s manual, Russian

Operator’s manual, Spanish (Latin American)

Operator’s manual, Swedish

Operator’s manual, Turkish

O

XI

M

AX

N-65 Service Manual

Spare Parts

Figure 23 shows the monitor exploded view with numbers relating to the spare

parts list.

O

XI

M

AX

N-65 Service Manual

Figure 23: Exploded View

63

Spare Parts

64

Blank Page

O

XI

M

AX

N-65 Service Manual

P a c k i n g f o r S h i p m e n t

Introduction

To ship the O

XI

M

AX

N-65, follow the instructions in this section.

Returning the Monitor

Contact Nellcor’s Technical Services Department for shipping instructions, including a Returned Goods Authorization (RGA) number. Unless otherwise instructed by Nellcor's Technical Services Department, it is not necessary to return the O

XI

M

AX

sensor or other accessory items with the monitor. Pack the monitor 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 monitor by any shipping method that provides proof of delivery.

Repacking in Original Carton

If available, use the original carton and packing materials. See Figure 24. Pack the

monitor as follows:

O

XI

M

AX

N-65 Service Manual 65

Packing for Shipment

To repackage the monitor in the original carton:

1. Place the monitor in original packaging.

66

Figure 24: Packing

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

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

O

XI

M

AX

N-65 Service Manual

Packing for Shipment

Packing in a Different Carton

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

To repackage the monitor in a different carton:

1. Place the monitor 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.

O

XI

M

AX

N-65 Service Manual 67

Packing for Shipment

Blank Page

68

O

XI

M

AX

N-65 Service Manual

S p e c i f i c a t i o n s

Performance

Measurement Range

SpO

2

Pulse Rate

Perfusion Range

1% to 100%

20 beats per minute (bpm) to 250 bpm

0.03% to 20%

Accuracy Tolerance

Saturation

Adult

1 70 to 100% ±2 digits

Neonate

Low Perfusion

2

Pulse Rate

Adult and Neonate

1

Low Perfusion

2

70 to 100% ±3 digits

70 to 100% ±2 digits

20 to 250 bpm ±3 digits

20 to 250 bpm ±3 digits

1

Adult specifications are shown for O

XI

M

AX

MAX-A and MAX-N sensors with the N-65. Neonate specifications are shown for O

XI

M

AX

MAX-N sensors with the N-65. Saturation accuracy will vary by sensor type. Refer to the Sensor Accuracy Grid. The Sensor Accuracy Grid is shipped with the N-65. The latest version of the Sensor Accuracy Grid is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

2

Reading accuracy in the presence of low perfusion (detected IR pulse modulation amplitude <1.5%) was validated using signals supplied by a patient simulator. SpO

2

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.

Display Update Interval

100 millisecond

O

XI

M

AX

N-65 Service Manual 69

Specifications

Audible Indicators

Audible

Indicator

Parameter Value

Alarm Volume

Setting

Beep Volume setting

POST Pass

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

Priority

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

Adjustable, 40 to 52 dB(A), at one meter

752 Hz

500 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

N/A

1

Adjustable, 42 to 52 dB(A), at one meter

1500 Hz

500 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

N/A

Priority

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

2

Fixed at 45 dB(A), at one meter

600 Hz

1000 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

N/A

Priority

Invalid Key Press Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

3

Fixed at 45 dB(A), at one meter

200 Hz

50 msec

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

Priority

N/A

4

70

O

XI

M

AX

N-65 Service Manual

O

XI

M

AX

N-65 Service Manual

Specifications

Audible Indicators (Continued)

Audible

Indicator

Parameter Value

Confirmation Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

Priority

Valid Key Press Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

Fixed at 45 dB(A), at one meter

700 Hz

130 msec

Off Interval (±20 msec) 130 msec

Number of pulses in burst 3

Repetition Pause

(±2 sec.)

N/A

5

Fixed at 45 dB(A), at one meter

800 Hz

10 msec

Pulse Beep

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

N/A

Priority

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

6

Adjustable, 42 to 52 dB(A), at one meter

1500 Hz

50 msec

Alarm Silence

Reminder

Off Interval (±20 msec) 10 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

N/A

Priority

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

7

Adjustable, 42 to 52 dB(A), at one meter

500 Hz

130 msec

Off Interval (±20 msec) 130 msec

Number of pulses in burst 3

Repetition Pause

(±2 sec.)

Priority

179.27 sec.

8

71

Specifications

Audible Indicators (Continued)

Audible

Indicator

High Priority

Alarm

Medium Priority

Alarm

Low priority

Alarm

Parameter Value

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

Priority

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

Adjustable, 42 to 52 dB(A), at one meter

1200 Hz

250 msec

Off Interval (±20 msec) 80 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

0 sec.

9

Adjustable, 42 to 52 dB(A), at one meter

752 Hz

400 msec

Off Interval (±20 msec) 300 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

0 sec.

Priority

Volume level

Pitch (±30 Hz)

On pulse width

(±20 msec)

10

Adjustable, 42 to 52 dB(A), at one meter

500 Hz

400 msec

Off Interval (±20 msec) 3200 msec

Number of pulses in burst 1

Repetition Pause

(±2 sec.)

Priority

0 sec.

11

72

O

XI

M

AX

N-65 Service Manual

Electrical

Specifications

Batteries

Type

4 AA alkaline

Battery life is typically:

• Alkaline 15 hours

• Lithium 40 hours

Voltage

6 Volts DC (as per 4 AA batteries)

O

XI

M

AX

Sensors

Wavelength Nellcor pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm. The total optical output power of the sensor LEDs is less than 15 mW. This information may be useful to clinicians, such as those performing photodynamic therapy.

Note: Sensor LED light emissions fall within Class 1 level, according to IEC 60825-1:2001. No special safety precautions are required.

O

XI

M

AX

Sensor Power Dissipation

Sensor

O

XI

M

AX

MAX-N

O

XI

M

AX

MAX-I

O

XI

M

AX

MAX-P

O

XI

M

AX

MAX-A

O

XI

M

AX

MAX-AL

O

XI

M

AX

MAX-R

O

XI

M

AX

Durasensor DS-100A

O

XI

M

AX

OxiCliq

®

P

O

XI

M

AX

OxiCliq N

O

XI

M

AX

OxiCliq I

O

XI

M

AX

OxiCliq A

O

XI

M

AX

Dura-Y

®

D-YS

O

XI

M

AX

MAX-FAST

O

XI

M

AX

Softcare SC-PR

O

XI

M

AX

Softcare SC-NEO

O

XI

M

AX

Softcare SC-A

O

XI

M

AX

Oxiband OXI-A/N

Dissipation

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

52.5 mW

O

XI

M

AX

N-65 Service Manual 73

Specifications

Environmental Conditions

Operation

Temperature

Altitude

5 ºC to 40 ºC (41 ºF to 104 ºF)

-

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

Transport and Storage (not in shipping container)

Temperature

Altitude

-20 ºC to 60 ºC (-4 ºF to 140 ºF)

-390 m to 5,574 m (-1,280 ft. to 18,288 ft.)

Atmospheric Pressure 50 kPa to 106 kPa (14.7 in. Hg to 31.3 in. Hg)

Relative Humidity

15% to 95% non

condensing

Transport and Storage (in shipping container)

Temperature

Altitude

-20 ºC to 70 ºC (-4 ºF to 158 ºF)

-390 m to 5,574 m (-1,280 ft. to 18,288 ft.)

Atmospheric Pressure 50 kPa to 106 kPa (14.7 in. Hg to 31.3 in. Hg)

Relative Humidity

15% to 95% non

condensing

74

O

XI

M

AX

N-65 Service Manual

Specifications

Physical Characteristics

Weight

Dimensions

Compliance

0.62 lbs. (0.28 kg)

2.875 in. x 6.25 in. x 1.375 in.

(7.3 cm x 15.9 cm x 3.5 cm)

Item Compliant With

Equipment classification

Type of protection

Degree of protection

Safety Standards: EN 60601-1: 1990 (A1

+ A2), EN 60601-1-2: 2001, UL 60601-1,

CAN/CSA C22.2 No. 601.1

Internally powered equipment (on battery power)

Type BF

-

Applied part

Mode of operation Continuous

Front panel and case labeling IEC 60878, EN 980, ISO 7000, EN

60417-1, EN 60417-2

Button spacing

Year of manufacture symbol

ISO 7250

EN 980

Operation during physical shock IEC 60068-2-27 at 100 g

Alarm requirements EN 60601-1-8

Pulse oximeters EN 865 and ISO 9919 with Transport

Boot (Part number 10007434)

Operation during vibration

Radiated and conducted emissions

IEC 60068-2-6 and IEC 60068-2-34

EN 55011, Group 1, Class B

Manufacturer’s Declaration

WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or create invalid readings of the O

XI

M

AX

N-65.

O

XI

M

AX

N-65 Service Manual 75

Specifications

The O

XI

M

AX

N-65 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the monitor as recommended below, according to the maximum output of the communications equipment.

Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and the O

XI

M

AX

N-65 (IEC 60601

-

1

-

2)

Frequency of

Transmitter

Equation

150 kHz to

80 MHz

80 MHz to

800 MHz

800 MHz to

2.5 GHz

d

=

3.5

P

V1

d

=

3.5

P

E1

d

=

7

P

V1

Rated Maximum

Output Power of

Transmitter in

Watts

0.01

0.1

1

10

Separation

Distance in

Meters

0.12

0.38

1.2

3.8

Separation

Distance in

Meters

0.12

0.38

1.2

3.8

Separation

Distance in

Meters

0.23

0.73

2.3

7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the separation distance can be estimated using the equation in the corresponding column, where P is the maximum output [power rating of the transmitter in watts (W)] according to the transmitter manufacturer.

Note: At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies.

Note: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

76

O

XI

M

AX

N-65 Service Manual

Table 7: Electronic Emissions

The monitor is intended for use in the electromagnetic environment specified below. The customer or user of the monitor should assure that it is used in such an environment.

Emission Test

RF emissions

CISPR 11

RF emissions

CISPR 11

Compliance

Group 1

Class B

Electromagnetic

Environment -

Guidance

The monitor uses RF energy only for its internal function.

Therefore, the RF emissions are very low and not likely to cause interference in nearby electronic equipment.

The monitor is suitable for use in establishments, including diagnostic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Specifications

O

XI

M

AX

N-65 Service Manual 77

Specifications

78

Table 8: Electromagnetic Immunity

The monitor is intended for use in the electromagnetic environment specified below. The customer or user of the monitor should assure that it is used in such an environment.

Immunity Test

Electrostatic

Discharge (ESD)

IEC 61000-4-2

Electrical fast transient/burst

IEC 61000-4-4

IEC 60601

Test Level

+ 6 kV contact

+ 8 kV air

+ 2 kV power supply lines

+ 1 kV for input/output lines

3 A/m

Compliance

Level

Complies

Complies

Complies

Electromagnetic

Environment

Guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least

30%.

Main power should be that of a typical commercial or hospital environment.

Power

Frequency

(50/60 Hz) magnetic field

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80

MHz

3 V/m

80 MHz to 2.5

GHz

3 Vrms

3 Vrms

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Portable and mobile

RF communications equipment should be used no closer to any part of the

Monitor, including the cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended Separation Distance

d

=

3.5

V1

P

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

O

XI

M

AX

N-65 Service Manual

Specifications

Table 8: Electromagnetic Immunity (Continued)

The monitor is intended for use in the electromagnetic environment specified below. The customer or user of the monitor should assure that it is used in such an environment.

d

=

3.5

P

E1

80 MHz to 800

MHz

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey each frequency range.

b a

, should be less than the compliance level in

d

=

7

P

V1

800 MHz to

2.5 GHz

Interference may occur in the vicinity of equipment marked with this symbol.

Note 1: At 80 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a

Field strength from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in which the monitor is used exceeds the applicable

RF compliance level above, the monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the monitor. b

Over the frequency range 150 kHz to 80 MHz, field strength should be less than [V

1

} V/m.

O

XI

M

AX

N-65 Service Manual 79

Specifications

80

Blank Page

O

XI

M

AX

N-65 Service Manual

T e c h n i c a l D i s c u s s i o n

Oximetry Overview

The O

XI

M

AX

N-65 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying an O

XI

M

AX

sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The O

XI

M

AX

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 (SpO

2

).

Because a measurement of SpO

2

is dependent upon light from the O

XI

M

AX

sensor, ambient light can interfere with this measurement.

Specific information about ambient conditions, O

XI

M

AX

sensor application, and patient conditions is contained throughout this manual.

Pulse oximetry is based on two principles: that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (i.e., spectrophotometry), and that the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (i.e., plethysmography).

A pulse oximeter determines SpO

2

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 oximetry

O

XI

M

AX

sensor serve as light sources; a photo diode serves as the photo detector.

Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation. To identify the oxygen saturation of arterial hemoglobin, the pulse oximeter uses the pulsatile nature of arterial flow. 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 SpO

2

measurements on the difference between maximum and minimum absorption (i.e., 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.

O

XI

M

AX

N-65 Service Manual 81

Technical Discussion

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 measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted as follows: fractional saturation functional saturation =

100 - (% carboxyhemoglobin + % methemoglobin ) x100

Measured versus Calculated Saturation

When saturation is calculated from a blood gas partial pressure of oxygen (PO

2

), the calculated value may differ from the SpO

2

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 PO

2

and pH, temperature, the partial pressure of carbon dioxide (PCO

2

), 2,3-DPG, and

fetal hemoglobin. See Figure 25.

82

Figure 25: Oxyhemoglobin Dissociation Curve

O

XI

M

AX

N-65 Service Manual

Technical Discussion

O

XI

M

AX

Technology

The monitor is designed to use Nellcor brand O

XI

M

AX

sensors containing O

XI

M

AX

technology. These O

XI

M

AX

sensors can be identified by the deep blue color of their plug. All O

XI

M

AX

sensors contain a memory chip carrying information about the O

XI

M

AX

sensor which the monitor needs for correct operation, including the

O

XI

M

AX

sensor’s calibration data, model type, troubleshooting codes, and error detection data. This unique oximetry architecture enables several new features with the monitor.

When an O

XI

M

AX

sensor is connected to the monitor, the monitor first reads the information in the O

XI

M

AX

sensor memory chip, checks it to make sure that there are no errors, and then loads the data to begin monitoring. As the monitor reads the information, it flashes the Data In-Sensor icon. This process takes a couple of seconds. Once the reading process is complete the monitor begins monitoring.

Pulse Oximeters containing O

XI

M

AX

technology, including the monitor, use calibration data contained in the O

XI

M

AX

sensor in calculating the patient’s SpO

2

.

O

XI

M

AX

N-65 Service Manual 83

Technical Discussion

Block Diagram Theory

This section provides an explanation of O

XI

M

AX

N-65 block diagram theory of operation. Schematic diagrams and are provided at the end of this section.

The monitor consists of two printed circuit boards (PCB), the user interface PCB and the SpO

2

PCB. The relationship between these two components and their

interconnections is shown in the block diagram. See Figure 26.

84

Figure 26: Block Diagram

O

XI

M

AX

N-65 Service Manual

Technical Discussion

SpO

2

Printed Circuit Board

The SpO

2

PCB provides patient interface and monitor operating power.

Patient Interface

The patient interface receives signals from the O

XI

M

AX

sensor. These signal are converted and supplied to the user interface PCB central processing unit (CPU).

The patient interface receives control signals from the CPU. These control signals are used to control the light emitting diodes in the O

XI

M

AX

sensor.

Power Supply

The power supply provides operating voltages to the SpO

2

PCB and the user interface PCB. These voltages are supplied to the:

• SpO

2

PCB power monitoring function

• SpO

2

PCB circuits

• user interface PCB power supply

• user interface PCB CPU

• user interface PCB audio circuits

Power Monitoring

The SpO

2

power monitoring function monitors and controls the outputs of the

SpO

2

power supply. The SpO

2

power monitoring function provides the user interface CPU and SpO

2

patient interface with status information on the power supply output signals.

User Interface Printed Circuit Board

The user interface PCB provides:

• User setup of the monitor via the keypad

• Patient %SpO

2

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

O

XI

M

AX

N-65 Service Manual 85

Technical Discussion

Keypad

The user interface PCB keypad contains seven push buttons. These buttons allow the user to setup and control of the monitor. The buttons are:

1 — Alarm Silence

2 — Down Arrow

3 — Data

4 — Menu

5 — Backlight

6 — Up Arrow

7 — Power

The signals from the buttons pass directly through the SpO

2

PCB and are applied to the user interface PCB CPU. The Power button signal is applied to the SpO

2 power supply turning the monitor on or off.

Backlight

The backlight illuminates the display for better viewing.

CPU and Flash

The CPU controls all functions and timing for the monitor. The CPU communicates with the SpO

2

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.

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 monitor is turned off.

Audio

The audio circuit drives a transducer to provide the monitor tones.

86 O

XI

M

AX

N-65 Service Manual

Technical Discussion

LCD

The liquid crystal display (LCD) is driven by the CPU. The LCD displays the patient’s %SpO

2

and pulse rate. The LCD also displays icons indicating the status and functions of the monitor. Refer to the O

XI

M

AX

N-65 Operator’s Manual for a description of the icons.

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.

Power Supply

The user interface PCB power supply receives power from the SpO

2

PCB power supply. The power supply provides a regulated 3.0 volts DC to the CPU.

Power Supply 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 monitor when voltages are out of tolerance.

The power supply monitoring circuit monitors the battery output voltage and shuts down the monitor when the battery voltage is critically low. The circuit provides the low battery signal.

O

XI

M

AX

N-65 Service Manual 87

Blank Page

N-65 89

Blank Page

N-65 91

Blank Page

N-65 93

Blank Page

N-65 95

Blank Page

N-65 97

Blank Page

N-65 99

Blank Page

N-65

101

Blank Page

N-65 103

Blank Page

N-65 105

Blank Page

N-65 107

Blank Page

I n d e x

Symbols

%SpO2 high limit

11

%SpO2 low limit

11

A

accessories on internet

14

accuracy

69

alarm volume

11

arterial dyes

17

audible indicator

70

B

battery compartment door replacement

59

battery installation

16

block diagram theory

84

bpm high limit

11 bpm low limit

11

business reply card

47

C

calculated saturation

82

calibration

15

cautions

2

cleaning

15

D

date and time

22

day

13

description of OxiMax N-65

4

disassembly guide

47

disinfecting

15

display update interval

69

DS-100A

17 dysfunctional hemoglobin

17

E

equipment needed for performance checks

17

error codes

42

exploded view

63

explosion hazard

1

extension cable

17 external agents

17

O

XI

M

AX

N-65 Service Manual

F

fractional saturation

82

front case assembly replacement

54

front panel description

4

front panel symbols

8

function menu

10

functional checks

15

functional saturation

82

functional tests

28

H

hour

13

L

label symbols

9

low perfusion

17

M

manufacturer’s declaration

75

measured saturation

82

medical procedures

17

menu

set time and date 12

minute

13

monitor

measurement range 69

returning the monitor 65

month

13

N

nitrous oxide

16

O

obtaining replacement parts

61

obtaining spare parts

61

operating

altitude 74 relative humidity 74 temperature 74

operation with a live subject

26

operational setup

22

109

Index

operator’s manual

14

OXIMAX technology

83

oximetry overview

81

P

packing for shipment

65

packing in a different carton

67

parts list

61

performance verification

17

periodic safety checks

15

physiological conditions

17

POST pass tone

20

power-on self-test

17

print data

11

pulse beep volume

11

R

rear case assembly replacement

57

rear panel symbols

8

related documents

14

repacking in original carton

65

replacement

battery compartment door 59

front case assembly 54

rear case assembly 57

user interface pcb 50

replacement level supported

47

Returned Goods Authorization (RGA) number

65

RGA number

65

routine maintenance

15

S

safety tests

37

sensors

73

separating the front and back cases

48

service manual

14

spare parts

61

spare parts on internet

14

specifications

69

battery 73

compliance 75

electrical 73

environmental 74

performance 69

physical 75

SRC-MAX

28

SRC-MAX tester

17

storage

altitude 74 relative humidity 74 temperature 74

strangulation

2

surface-cleaning

15

symbols

Canadian ICES-001 approval 9 date of manufacture 9

European union approval 9 fragile 9 keep away from heat 9 keep upright 9 label 9 protect from moisture 9

rear panel 8 resistant to liquid ingress 8

Russian regulatory approval 9

see instructions for use 8

serial number 9 temperature limitation 9

type BF applied part 8

T

technical discussion

81

test #1

SpO2 33

test #2

bpm 32

test #3

modulation level 34

test #4

light level 36

time set menu

13

transport

altitude 74 relative humidity 74 temperature 74

troubleshooting guide

39

V

verify performance

17

W

wavelength

73 wavelength, sensor

73

who should perform repairs

39

110

O

XI

M

AX

N-65 Service Manual

Y

year

13

Index

O

XI

M

AX

N-65 Service Manual 111

Tyco Healthcare Group LP

Nellcor Puritan Bennett Division

4280 Hacienda Drive

Pleasanton, CA 94588 U.S.A.

Telephone 1.800.635.5267

Authorized Representative

Tyco Healthcare UK LTD

154 Fareham Road

Gosport PO13 0AS, U.K.

© 2006 Nellcor Puritan Bennett Inc.

All rights reserved.

Rx ONLY

10006573C-0306

advertisement

Key Features

  • Continuous or spot check SpO2 and pulse rate monitoring
  • Suitable for adult, pediatric, and neonatal patients
  • Use in various environments: hospital, transport, homecare
  • Handheld design for convenience
  • Data recording and printing capabilities
  • Alarm features for critical situations

Frequently Answers and Questions

What is the purpose of this monitor?
The OXIMAX N-65 is designed for continuous or spot-check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in adults, children, and infants. It's used for various settings like hospitals, transport, and homecare.
What are the limitations of this monitor?
The monitor’s ability to detect and display accurate measurements may be affected by factors like dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents.
How often should I perform safety checks on this monitor?
The OXIMAX N-65 requires a safety check every 24 months. This check should be performed by a qualified service technician.

Related manuals

Download PDF

advertisement

Table of contents