OxiMax N-560 Service Manual Rev A

This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 Canada. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, OxiBand, Dura-Y, MAX-FAST, SatSeconds, PediCheck, Oxismart and OXIMAX are trademarks of Nellcor Puritan Bennett Inc. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Covered by one or more of the following US 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; Re 35,122.

Contents

Contents Contents... i Figures...v Tables...vii Introduction... 1 Warnings ...1 Cautions ...1 Notes ...1 Manual Overview ...2 Description of N-560 Pulse Oximeter ...2 Related Documents ...4

Routine Maintenance... 5 Cleaning ...5 Periodic Safety Checks ...5 Functional Checks ...5 Battery ...6

Performance Verification... 7 Introduction ...7 Equipment Needed ...7 Performance Tests ...8 Battery Charge ...8 Power-Up Performance ...8 Power-On Self-Test (POST) ...9 Power-On Defaults and Alarm Limit Ranges ...11 General Operation ...16 LED Excitation Test ...16 Operation with a Live Subject ...17 Alarm Volume Control ...18 Pulse Tone Volume Control ...19 Pulse Oximetry Functional Tests ...19 Introduction ...20 Initial Setup ...20 Test #1: BPM ...21 Test #2: SpO2 ...22 Test #3: Modulation Level ...23 Test #4: Light ...25 Safety Tests ...26

Audible Alarm Settings and Service Functions... 29 Introduction ...29 Audible Alarm Settings ...29 Alarm Silence State ...30 Alarm Silence Duration ...30 Alarm Volume ...30 N-560 Menu ...30 N-560 Service Manual

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Contents

Operator's Menu Options ...32 Accessing Menu Items ...33 Menu Item 1 (Trend Print) ...33 Menu Item 2 (Trend Clear) ...34 Menu Item 3 (Language Selection) ...34 Menu Item 4 (Baud Rate) ...34 Menu Item 5 (EPP Mode) ...34 Service Menu Options ...35 Menu Item 6 (In-Sensor Trend Mode) ...35 Menu Item 7 (RS-232 Nurse Call Polarity) ...35 Menu Item 8 (Time Set) ...36 Menu Item 9 (Save Current Values as Power-On Defaults) ...37 Menu Item 10 (Restore Factory Default Settings as Power-On Default) ...38 Menu Item 11 (Alarm Silence Restrictions) ...39 Menu Item 12 (Silence Alarms) ...40 Menu Item 13 (All Display Off) ...40 Menu Item 14 (Alarm Sound Style Select) ...41 Setting Institutional Defaults (Sample) ...41

Troubleshooting... 43

Introduction ...43 How To Use This Section ...43 Who Should Perform Repairs ...43 Troubleshooting Guide ...43 Power ...44 Buttons ...46 Display/Alarms ...47 Operational Performance ...48 Data Port ...49 Error Codes ...49

Disassembly Guide... 53 Introduction ...53 Replacement Level Supported ...54 Prior to Disassembly ...54 Separating Top and Bottom Cases ...54 Front Case Disassembly ...57 NELL-3 Removal ...59 Main PCB Removal ...60 Power Supply Removal ...63 Fan Removal ...64 Battery Removal ...66 Equipotential Terminal Removal ...68

Spare Parts... 71 Introduction ...71 Obtaining Replacement Parts ...71 Parts List and Accessories ...71

Packing for Shipment... 75 Introduction ...75 Returning the N-560 ...75 General Instructions ...75 Repacking in Original Carton ...75 N-560 Service Manual

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Contents

Repacking in a Different Carton ...77

Specifications... 79 Performance ...79 Electrical ...82 Environmental Conditions ...83 Physical Characteristics ...85 Compliance ...85 Manufacturer’s Declaration ...86 Safety Tests ...92 Ground Integrity ...92 Earth Leakage Current ...92 Enclosure Leakage Current ...92 Patient Risk Applied Current ...93 Patient Isolation Risk Current ...93

Data Port Interface Protocol... 95 Introduction ...95 Enabling The Data Port ...95 Protocol ...95 Baud Rate ...96 Connecting To The Data Port ...97 Nurse Call Polarity Settings ...99 Nurse Call Relay Pin States ...99 Nurse Call Relay Rating ...99 Real-Time Printout ...100 Column Heading ...100 Printout Source ...101 Software Revision Level ...101 Alarm Limits ...101 Column Headings ...101 Time Tag ...102 Patient Data ...102 Operating Status ...102

Technical Discussion... 105

Oximetry Overview ...105 Automatic Calibration ...106 Functional Versus Fractional Saturation ...106 SatSeconds Alarm Management ...107 Signal Processing ...107 OXIMAX Technology ...109 NELL-3 Interface ...109 Circuit Analysis ...111 Block Diagram Theory ...112 AC Input ...112 Power Supply PCB Theory Of Operation ...113 Battery ...113 Main PCB ...113 Regulated DC Power Supply ...114 Controlling Hardware ...114 CPU ...114 Charging Circuits ...115 Real-Time Clock (RTC) ...115 N-560 Service Manual

iii

Contents

Storage of Patient Data ...115 Front Panel PCB and Controls ...116 Front Panel Display ...116 Button Interface ...116

Index... 143

N-560 Service Manual

iv

List of Figures

Figures Figure 1: N-560 Front Panel ...3 Figure 2: N-560 Rear Panel ...3 Figure 3: N-560 Controls ...9 Figure 4: Adjusting High %SpO2 Alarm Limit ...12 Figure 5: Adjusting Low %SpO2 Alarm Limit ...13 Figure 6: Adjusting High Pulse Rate Alarm Limit ...13 Figure 7: Adjusting Low Pulse Rate Alarm Limit ...14 Figure 8: Adjusting SatSeconds Alarm Limit ...15 Figure 9: N-560 Controls ...29 Figure 10: Year Month Display ...36 Figure 11: Day Hour Display ...36 Figure 12: Minute Second Display ...37 Figure 13: N-560 Rear Panel Screws ...55 Figure 14: N-560 Case Screws ...55 Figure 15: Top Case Removal ...56 Figure 16: Separated Cases ...56 Figure 17: Front case Wiring ...57 Figure 18: Front Case Mounting Screws ...58 Figure 19: Front Case Bracket ...58 Figure 20: Speaker Removal ...59 Figure 21: Front PCB Removed ...59 Figure 22: NELL-3 Cable Connections ...60 Figure 23: NELL-3 Removal ...60 Figure 24: Front case Wiring ...61 Figure 25: Front Case Mounting Screws ...61 Figure 26: Main PCB Removal ...62 Figure 27: Main PCB Removed ...62 Figure 28: Power Supply Wiring ...63 Figure 29: Power Supply Screws ...64 Figure 30: Power Supply Removed ...64 Figure 31: Fan Wires ...65 Figure 32: Fan Bracket Removal ...65 Figure 33: Fan and Bracket Removal ...66 Figure 34: Fan Screws ...66 Figure 35: Battery Screws ...67 Figure 36: Battery Cover ...67 Figure 37: Battery Connector ...67 Figure 38: Battery Removal ...68 Figure 39: Ground Wire ...69 Figure 40: Equipotential Ground Terminal ...69 Figure 41: Equipotential Ground Terminal Removed ...70 Figure 42: Exploded View ...73 Figure 43: Packing ...76 Figure 44: Data Port Pin Layout ...98 Figure 45: Real-Time Printout ...100 N-560 Service Manual

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List of Figures

Figure 46: Oxyhemoglobin Dissociation Curve ...107 Figure 47: NELL-3 Interface ...110 Figure 48: Block Diagram ...112 Figure 49: Main PCB Battery Charger Schematic Diagram ...117 Figure 50: Main PCB Isolation for NELL-3 Schematic Diagram ...119 Figure 51: Main PCB Isolation for External Interface Schematic Diagram ...121 Figure 52: Main PCB DC Battery Input and DC/DC Converter Schematic Diagram ...123 Figure 53: Main PCB Interface and Speaker Control Schematic Diagram ...125 Figure 54: Main PCB MCU and Storage Control Schematic Diagram ...127 Figure 55: Main PCB Parts Locator Diagram ...129 Figure 56: Front Panel PCB 7-Segment Display Schematic Diagram ...131 Figure 57: Front Panel PCB LED Display and Buttons Schematic Diagram ...133 Figure 58: Front Panel PCB Interface and LED Drivers Schematic Diagram ...135 Figure 59: Front Panel Parts Locator Diagram ...137 Figure 60: Power Supply Schematic Diagram ...139 Figure 61: Power Supply Parts Locator Diagram ...141

N-560 Service Manual

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List of Tables

Ta b l e s Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Table 13: Table 14: Table 15: Table 16: Table 17: Table 18: Table 19: Table 20: Table 21: Table 22:

Equipment Needed ...7 N-560 Menu Selections ...30 Institutional Default Values ...37 Factory Default Settings ...38 Problem Categories ...44 Power Problems ...45 Button Problems ...46 Display/Alarms Problems ...47 Operational Performance Problems ...48 Data Port Problems ...49 Error Codes ...50 Spare Parts and Accessories ...71 Tone Definition ...80 Cable Compliance ...87 Electromagnetic Emissions ...88 Electromagnetic Immunity ...88 Electromagnetic Immunity ...90 Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the N-560 ...91 Data Port Pinouts ...97 Status Codes ...103 NELL-3 J1 Pinouts ...110 NELL-3 J2 Pinouts ...111

N-560 Service Manual

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List of Tables

N-560 Service Manual

viii

Introduction

Warnings

Warnings are identified by the WARNING symbol shown above and a line above and below the warning text. The word WARNING and all warning text are boldfaced. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user.

Cautions

Cautions are identified by the CAUTION symbol shown above. The word CAUTION and the caution text are boldfaced. Cautions alert the user to exercise care necessary for the safe and effective use of the N-560™.

Notes

Notes are identified by the Note symbol shown above. Notes provide additional useful information.

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

N-560 Service Manual

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Introduction

Manual Overview This manual contains information for servicing the Nellcor® model N-560 pulse oximeter. Only qualified service personnel should service this product. Before servicing the N-560, read the operator's manual carefully for a thorough understanding of operation.

WARNING: Explosion hazard. Do not use the N-560 pulse oximeter in the presence of flammable anesthetics.

Description of N-560 Pulse Oximeter The N-560 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-560 is intended for use with neonatal, pediatric, and adult patients who are well or poorly perfused in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only.

Note: Hospital use typically covers such areas as general care floors,

operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and subacute centers. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. Use with any particular patient requires the selection of an appropriate oxygen transducer as described in the N-560 Operator's Manual. Digital displays are provided for oxygen saturation and pulse rate, and a 10-segment light-emitting diode (LED) bar indicates pulse amplitude. The controls and indicators for the N-560 are illustrated and defined in Figure 1 and Figure 2 on page 3.

2

Introduction

Sensor Port 2 - Power On/Off Button 3 - % SpO2 Display 4 - Pulse Amplitude Indicator 5 - Pulse Rate Display 6 - Alarm Silence Button 7 - Alarm Silence Indicator 8 - Adjust Up Button 9 - Adjust Down Button 10 - Pulse Rate Alarm Limit Button 11 - SatSeconds Display 1 - SpO

2

12 - SatSeconds Alarm Limit Button 13 - SpO2 Alarm Limit Button 14 - Interference Indicator 15 - Sensor Off Indicator 16 - Sensor Message Indicator 17 - Pulse Search Indicator 18 - Data In Sensor Indicator 19 - Low Battery Indicator 20 - AC Power Indicator 21 - Speaker

Figure 1: N-560 Front Panel

1 - Data Port Connector 3 - AC Power Connector 2 - Visual Alarm Connector 4 - Equipotential Terminal Figure 2: N-560 Rear Panel

N-560 Service Manual

3

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 N-560. Refer to the N-560 operator's manual. To understand the various Nellcor sensors that work with the N-560, refer to the individual sensor's directions for use. The latest versions 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

4

Routine

Maintenance

Cleaning CAUTION: Do not spray, pour, or spill any liquid on the N-560, its accessories, connectors, switches, or openings in the chassis. For surface-cleaning and disinfecting follow your institution's procedures or: •

The N-560 may be surface-cleaned by using a soft cloth dampened with either a commercial, nonabrasive cleaner or a solution of 70% alcohol in water, and lightly wiping the surfaces of the N-560.

•

The N-560 may be disinfected using a soft cloth saturated with a 10% solution of chlorine bleach in tap water.

Before attempting to clean an SpO2 sensor, read the directions for use enclosed with the sensor. Each sensor model has cleaning instructions specific to that sensor.

Periodic Safety Checks The N-560 requires no routine service or calibration other than changing the battery at least every two years. See Battery Removal on page 66. The following checks should be performed at least every two years by a qualified service technician. 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 1. If the N-560 has been visibly damaged or subjected to mechanical shock (for example, if dropped), perform the performance tests. See Performance Tests on page 8. N-560 Service Manual

5

Routine Maintenance

2. Perform the electrical safety tests detailed in Safety Tests on page 26. If the N-560 fails these electrical safety tests, refer to Troubleshooting on page 43. 3. Inspect the fuses for proper value and rating (F1 and F2 = 2 amp, 250 volts).

Battery Nellcor recommends replacing the N-560's battery every two years. When the N-560 is going to be stored for two months or more, remove the battery prior to storage. To replace or remove the battery, refer to Disassembly Guide on page 53. If the N-560 has been stored for more than 30 days, charge the battery as described in Battery Charge on page 8. A fully discharged battery requires 6 hours to receive a full charge. The battery is being charged whenever the N-560 is plugged into an AC power source.

6

Per for mance Verification Introduction This section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without removing the N-560 cover. All tests except the battery charge and battery performance tests must be performed as the last operation before the N-560 is returned to the user. If the N-560 fails to perform as specified in any test, repairs must be made to correct the problem before the N-560 is returned to the user.

Equipment Needed Table 1: Equipment Needed Equipment Digital multimeter (DMM)

Fluke Model 87 or equivalent

Durasensor oxygen transducer (sensor)

DS-100A

OXIMAX oxygen transducer

MAX-A

Pulse oximeter tester

SRC-MAX (must meet current EN 61326-1, FCC Part 15, and UL 1010-1, or IEC 61010-1, or CSA 22.2 No. 1010-1 specifications)

Safety analyzer

Must meet current AAMI ESI/1993 & IEC 60601-1/1998 specifications

Pulse oximetry cable

DOC-10

Data interface cable

EIA-232 cable (optional)

Stopwatch

Manual or electronic

®

N-560 Service Manual

Description

7

Performance Verification

Performance Tests Note: This section is written using Nellcor factory-set defaults. If your

institution has preconfigured custom defaults, those values will be displayed. Factory defaults can be restored. See Menu Item 10 (Restore Factory Default Settings as Power-On Default) on page 38.

Battery Charge Perform the following procedure to fully charge the battery. 1. Connect the N-560 to an AC power source. 2. Verify that the N-560 is off and that the AC Power indicator is lit. 3. Charge the battery for at least 6 hours in standby.

Power-Up Performance The power-up performance tests verify the following N-560 functions:

8

•

Power-On Self-Test (POST) on page 9

•

Power-On Defaults and Alarm Limit Ranges on page 11

Performance Verification

Power On/Off Alarm Silence 3 - Adjust Up Button 4 - Adjust Down Button

1 -

Button

2 -

Button

Pulse Rate Alarm Limit SatSeconds Alarm Limit Button 7 - SpO2 Alarm Limit Button 5 -

Button

6 -

Figure 3: N-560 Controls

Power-On Self-Test (POST)

CAUTION: If any indicator or display element does not light, or the speaker does not sound, do not use the N-560. Instead, contact qualified service personnel, your local Nellcor representative, or Nellcor's Technical Services Department, 1.800.635.5267. Note: The N-560 should complete the POST function within 12 seconds. 1. Turn on the N-560 by pressing the Power On/Off button for greater than 0.5 seconds. 2. The N-560 displays/sounds:

Display

Sound

5 (in pulse rate left window)

low priority alarm

6 (in pulse rate center window)

medium priority alarm

0 (in pulse rate right window)

high priority alarm

n (in SpO2 left window) n (in SpO2 center window)

N-560 Service Manual

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Performance Verification

3. The N-560 automatically starts the Power-On Self-Test (POST), which tests N-560 circuitry and functions.

CAUTION: During POST (immediately after power-up), confirm that all display segments and indicators light, and the speaker sounds a one-second pass tone. 4. While performing POST, the self-test display appears for approximately five seconds. During this time: •

All indicators illuminate

•

All segments of all numeric digits light and change from red to green

•

All segments of the Pulse Amplitude Display light

•

All segments of the SatSeconds indicator light

5. Once the display test portion of POST is complete, the N-560 version is displayed for approximately two seconds.

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