Service Manual
65 Pages
Preview
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Pulse Oximeter Manual Ver.: 1.0 Release Date: May 2010 Part Number: 01.54.455118-10
P/N: 01.54.455118-10
Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which the manufacturer can not be held liable. The manufacturer owns the copyrights of this manual. Without prior written consent of the manufacturer, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of the manufacturer. The manufacturer holds the rights to modify, update, and ultimately explain this manual.
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Responsibility on the Manufacturer The manufacturer only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by the manufacturer, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, the manufacturer may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which the manufacturer may define as user serviceable.
Using This Label Guide This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death.
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CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE: A NOTE provides useful information regarding a function or a procedure.
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Table of Contents Chapter 1 Safety Information ... 1 1.1 Warnings ... 1 1.2 Cautions ... 5 1.3 Notes ... 6 Chapter 2 Introduction ... 8 2.1 Intended Use ... 8 2.2 General Introduction ... 8 2.3 Panel Introduction... 9 Chapter 3 Routine Maintenance ... 12 3.1 Maintenance Overview ... 12 3.2 Battery Maintenance... 13 Chapter 4 Performance Considerations ... 14 4.1 Performance Verification ... 14 4.2 Performance Considerations ... 15 4.3 Sensor Performance Considerations ... 16 Chapter 5 Disassembly Guide... 19 IV
5.1 Introduction... 19 5.2 System Disassembly and Reassembly... 21 5.3 Spare Parts... 23 Chapter 6 Troubleshooting... 24 6.1 Pulse Oximeter Troubleshooting... 24 6.2 Oximeter Viewer Troubleshooting... 30 6.2.1 Communicate Failures with the Oximeter ... 30 6.2.2 Software Abnormal... 32 6.2.3 Printing Abnormal... 35 6.2.4 Other Failures ... 36 Chapter 7 Technical Supplement ... 37 7.1 Pulse Oximetry Principles ... 37 7.2 Circuit Principle Analysis ... 39 7.3 Main Control Board Introduction ... 41 Chapter 8 After-Sales Service ... 44 AppendixⅠSpecification ... 45 A1.1 Classification ... 45 A1.2 Specification ... 45 V
A1.2.1 Size and Weight ... 45 A1.2.2 Environment ... 45 A1.2.3 Display... 46 A1.2.4 Batteries ... 46 A1.2.5 Charger Stand ... 46 A1.3 Parameters... 47 Appendix Ⅱ EMC Information ... 48 A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ... 48 A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ... 49 A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING... 52 A2.4 Recommended Separation Distances ... 55 Appendix Ⅲ Abbreviations ... 57 Appendix Ⅳ Record Table ... 58
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Pulse Oximeter Service Manual
Chapter 1 Safety Information 1.1 Warnings Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes, such as death, injury, or adverse events to the patient or user.
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WARNING Avoid the explosion hazard. Do not use the oximeter in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide.
2
Chemicals from a broken LCD display panel are toxic when ingested. Use with caution when the oximeter has a broken display.
3
Routinely monitor the patient to make sure the oximeter is functioning and the sensor is correctly placed.
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Oximeter measurements and pulse signals can be affected by certain environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of this manual for specific safety -1-
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information. 5
The use of accessories, sensors, and cables other than those specified may result in increased emission and/or create invalid readings of the oximeter.
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Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.
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Do not silence the audible alarm, or decrease the audible alarm volume, if patient safety could be compromised.
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The oximeter is a prescription device to be operated only by trained personnel. The oximeter is for attended monitoring only.
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The oximeter is not defibrillator-proof. However, it may remain attached to the patient throughout defibrillation or while an electrosurgical unit is in use. The measurements may be inaccurate throughout the defibrillation, or use of an electrosurgical unit, and shortly thereafter. To avoid shock, the caregiver should not hold the oximeter while using a defibrillator on a patient.
10 Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. -2-
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11 To ensure accurate performance and prevent device failure, do not subject the oximeter to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. 12 Do not use an oximeter, sensor, or cables that appear damaged. 13 Do not lift the oximeter by the sensor or extension cable because the oximeter could disconnect from cable and drop on the patient. 14 Do not make any clinical judgment based solely on the oximeter, it is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. 15 To ensure patient safety, do not place the oximeter in any position that might cause it to fall on the patient. 16 As with all medical equipments, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. 17 Ensure that the speaker is clear of any obstruction and that the speaker holes are not covered. Failure to do so could result in an inaudible alarm tone. 18 Use only sensor permitted by the manufacturer, oximeter -3-
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is compatible with Nellcor sensor and BCI DB9 sensor. 19 The oximeter readings and pulse signals can be affected by certain ambient environmental conditions, sensor application error, and certain patient conditions. 20 Dispose of batteries in accordance with local ordinances and regulations. 21 Do not use rechargeable batteries works together with alkaline batteries. 22 During the POST immediately after power-on, confirm all the display segments and icons are shown and the oximeter speaker sounds 300-millisecond tone. 23 If you do not hear the POST pass tone, please do not use the oximeter. 24 Failure to cover the oximeter with opaque materials in high ambient light conditions may leads to inaccurate measurement. 25 Users should carefully read the applicable user manual of sensor, including warning, cautions and instructions before using the sensor. 26 Do not use damaged sensor or extension cables, do not use sensor with exposed optical components. 27 Do not immerse or wet the sensor or this may damage -4-
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the sensor. 28 Tissue damage may be caused by incorrect application or duration use of sensor (about 2hours). Inspect the sensor periodically according to sensor user manual. 29 There are no user-serviceable parts inside the oximeter, the cover should only be removed by qualified service personnel authorized by the manufacturer. 30 Do not spray, pour or spill liquid to oximeter and its accessories, connector, switch or opening in enclosure, or this may damage the oximeter.
1.2 Cautions 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 oximeter. CAUTION 1
All combinations of equipment must be in compliance with IEC60601-1-1 requirements.
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It is restricted that this device to sale by or on the order of a physician. -5-
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The institution should follow local government regulations and recycling instructions regarding disposal or recycling of the batteries and components or end of life of the oximeter.
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The sensor unconnected icon and associated alarm indicate the sensor has disconnected or wire fault. So check the sensor connection and, if necessary, replace the sensor, extension cables or both.
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Periodically check the battery for corrosion. Take out the batteries if the oximeter will be stored for more than one month.
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At menu state, SpO2 and PR will not be displayed, while the oximeter is still measuring.
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Observe ESD (electrostatic discharge) precautions when disassembling and reassembling the oximeter and when handling any of the components of the oximeter.
1.3 Notes NOTE: 1
Notes are identified by the symbol shown above. Notes contain important information that may otherwise be overlooked or missed.
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This device has been tested and found to comply with the -6-
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limits for medical devices to the EN60601-1-2（second edition）and the Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. 3
Normal operation means: The oximeter is turned on; A sensor is connected to the oximeter; The sensor is applied to the patient; The patient’s %SpO2 and pulse rate readings (BPM) are being reported; No error conditions exist.
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Before you begin to disassemble the oximeter, remove the battery compartment door and remove the batteries.
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Chapter 2 Introduction 2.1 Intended Use The oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric or neonatal patients in hospitals, intra-hospital transport and hospital grade facilities.
2.2 General Introduction Pulse Oximeter (hereinafter called oximeter) is one model of the series Pulse Oximeter. It displays SpO2 value, pulse rate value, plethysmogram, bar graph, etc. The oximeter has been installed with SpO2 module inside. It integrates parameter module, display and recorder output functions. It can be powered by four 1.5V AA batteries or four 1.2V Ni-MH rechargeable AA batteries. It can clearly display all the parameter information on LCD.
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Figure 2-1 Pulse Oximeter
For the oximeter, Oximeter Viewer Data Management Software (hereinafter called oximeter viewer) is optional.
2.3 Panel Introduction This section identifies the symbols, controls, displays, and buttons on the front panel of the oximeter and the rear panel.
Figure 2-2 Waveform Mode
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Figure 2-3 Large Numeric Mode
Icons on the screen and their meanings: SpO2
SpO2 value display area
100%
Measured SpO2%
PR
Pulse Rate value display area
60 bpm
Measured Pulse rate (bpm) Displays when measurement value is higher than the upper alarm limit Displays when measurement value is lower than the lower alarm limit SpO2 waveform display
Pulse amplitude display
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Low battery icon
Audio alarm off icon
Alarm off icon
Data storage icon
04: 59
ADU/NEO
ID: 99
Time display in Information area: “hour: minute” Patient type in Information area: Adult or Neonate. Patient ID in Information area SpO2 sensor unconnected icon SpO2 sensor off
Indicates the memory space is full
Weak signal icon - 11 -
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Chapter 3 Routine Maintenance 3.1 Maintenance Overview Oximeter requires no routine service or calibration. The performance considerations in Chapter 4 may be used during the following repairs or routine maintenance (if required by your local institution). Periodic Safety Checks It is recommended that the following checks be performed every 24 months:
Inspect the devices for mechanical and functional
Inspect the safety labels for legibility.
damage
Cleaning You can surface-clean and disinfect the oximeter and sensor. To surface-clean the oximeter:
Use a soft cloth dampened with either a commercial, nonabrasive cleaner, or a solution of 70% alcohol in water.
Lightly wipe the surfaces of the oximeter.
To disinfect the oximeter:
Use a soft cloth saturated with a solution of 10% chlorine bleach in tap water. - 12 -
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3.2 Battery Maintenance When inserting the positive end of each battery, be cautious not to damage the small coiled spring contact. The oximeter could be damaged by batteries that are left in the oximeter and begin to leak. The batteries should be replaced whenever a low battery icon is displayed on the screen. When batteries have been replaced, dispose of the old batteries following local ordinances.
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