User Manual
98 Pages
Preview
Page 1
About this Manual P/N: 21.54.109000-15 Release Date: Dec 2010 © Copyright EDAN INSTRUMENTS, INC. 2007-2010. All rights reserved.
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 EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, 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 I
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 EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility
of
the
Manufacturer EDAN 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 EDAN, 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, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help II
qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.
Terms Used in this Manual 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. 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 1 Safety Information ... 1 1.1 Warnings ... 1 1.2 Cautions ... 7 1.3 Notes ... 9 1.4 Symbols in the Oximeter ... 11 2 Introduction ...14 2.1 General Introduction...14 2.2 Panel Introduction ...15 2.2.1 Symbols on Screen ...16 2.2.2 Front Panel Buttons...18 2.2.3 Rear Panel ...22 2.3 Connecting Sensor or Cable...23 2.4 Powered by Battery...24 2.5 Accessory List ...27 3 Oximeter Operation ...31 3.1 Turning on the Oximeter ...31 3.2 Measurement State...32 3.2.1 Measurement Modes...32 3.2.2 Trend Graph and Trend Table ...33 3.2.3 Abnormal Measurement State ...34 3.2.4 Data Transfer State ...35 IV
3.3 System Menu ...36 3.3.1 System Mode ...38 3.3.2 Patient Type ...39 3.3.3 Alarm Volume...39 3.3.4 Pulse Volume ...39 3.3.5 Audio Paused (s)...40 3.3.6 User Maintain ...40 3.3.7 Default Config...41 3.3.8 Sensitivity ...42 3.3.9 Alarm System ...42 3.3.10 SpO2 Alarm setup...44 3.3.11 PR Alarm setup ...46 3.3.12 Patient ID No. Setup...47 3.3.13 Data Storage ...48 3.3.14 Delete All Data ...49 3.3.15 Exit (Return) ...50 3.4 Charging the Ni-MH Battery Package...50 3.5 PatientCare Viewer Data Management Software Introduction ...51 4 Alarm ...52 4.1 Alarm Categories and Levels...52 4.2 Alarm Conditions...54 V
4.2.1 Alarm off Before the First Measurement ..54 4.2.2 Alarm for SpO2 Sensor Unconnected...55 4.2.3 Alarm for SpO2 Sensor off ...55 4.2.4 Alarm for Low Battery...55 4.2.5 Higher than Hi Alarm Limit ...56 4.2.6 Lower than Lo Alarm Limit ...56 4.2.7 Alarm Silence ...57 4.2.8 Turning off Alarm System...57 4.2.9 Alarm Priority...57 5 Performance Considerations...58 5.1 Performance Verification...58 5.2 Oximeter Performance Considerations...58 5.3 Sensor Performance Considerations ...59 6 Maintenance ...63 7 Principles of Operation ...66 7.1 Pulse Oximetry Measurement...67 7.2 Functional Versus Fractional Saturation ...69 7.3 Measured Versus Calculated Saturation ...70 8 Warranty and Service Policy...71 8.1 Warranty...71 8.2 Service Policy...72 AppendixⅠSpecification...74 VI
A1.1 Classification...74 A1.2 Specification ...74 A1.2.1 Size and Weight ...74 A1.2.2 Environment ...74 A1.2.3 Display ...75 A1.2.4 Batteries ...75 A1.2.5 Charger Stand...76 A1.3 Parameters ...76 Appendix II EMC Information...78 A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS...78 A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS...80 A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING.83 A2.4 Recommended Separation Distances ...87 Appendix Ⅲ Record Table...89 Appendix Ⅳ Abbreviations ...90
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H100B Pulse Oximeter User Manual
1 Safety Information 1.1 Warnings Warnings are identified by the WARNING symbol shown above. A WARNING label advises against certain actions or situations that could result in personal injury or death. 1
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WARNING Avoid explosion hazard. Do not use the oximeter in the presence of flammable anesthetic mixtures with air, or with oxygen or nitrous oxide. Chemicals from a broken LCD display panel are toxic when ingested. Use cautions when the oximeter has a broken display panel. Routinely monitor the patient to make sure the oximeter is functioning and the sensor is correctly placed. Oximetry measurements and pulse signals can be affected by certain environmental conditions, -1-
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sensor application errors, and certain patient conditions. 5 The use of accessories, sensors, and cables other than those specified may result in increased emission of electromagnetic radiation and/or invalid readings of the oximeter. 6 Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements. 7 Do not silence the audio alarm function, or decrease the audio alarm volume, if patient safety could be compromised. 8 The oximeter is a prescription device to be operated only by trained personnel. The oximeter is for attended monitoring only. 9 Dispose of batteries in accordance with local ordinances and regulations. 10 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 -2-
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electrosurgical unit, and shortly thereafter. To avoid shock, the caregiver should not hold the oximeter while using a defibrillator on a patient. Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. 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. Do not lift the oximeter by the sensor or extension cable because the cable could disconnect from the oximeter and the oximeter may drop on the patient. 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. To ensure patient safety, do not place the oximeter in any position that might cause it to -3-
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fall on the patient. As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. 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. Use only EDAN permitted sensors and extension cables with the oximeter. Other sensors or extension cables may fail and/or cause improper monitor performance and/or minor personal injury. H100B Pulse Oximeter readings and pulse signals can be affected by certain ambient environmental conditions, sensor application error, and certain patient conditions. See the appropriate sections of the manual for specific safety information. Don’t mix new and old batteries together. Don’t mix rechargeable batteries with alkaline batteries. -4-
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21 Periodically check the battery for corrosion. Remove the batteries from the oximeter if you do not expect to use it within one month. 22 The device enters POST (Power-On-Self-Test) immediately after power-on to confirm all the display segments and icons are shown and the speaker sounds a few seconds tone. If you do not hear the POST pass tone, it indicates the alarm system does not work well. Please do not use the H100B Pulse Oximeter and contact qualified service personnel or your local EDAN representative. 23 Before using it, the user should carefully read the applicable user manual of sensor, including warnings, cautions and instructions. 24 Do not use damaged sensor or extension cables, do not use sensor with exposed optical components. 25 Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor (more than 2 hours). Inspect the sensor periodically according to sensor user -5-
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manual. Do not immerse or wet the sensor, as this may damage the sensor. There are no user-serviceable parts inside the oximeter, the cover should only be removed by qualified service personnel. Do not spray, pour, spill liquid to the oximeter and its accessories, connector, switch or opening in enclosure, as this may damage the oximeter. Before cleaning the oximeter or the sensor, make sure that the equipment is switched off and disconnected from the power line. Do not use the charger stand when the alkaline battery is depleted or no battery is installed. Do not monitor the patient while the battery is being charged. Do not disassemble batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak, or cause personal injury. Only use EDAN approved rechargeable -6-
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batteries and charger stand for H100B pulse oximeter. 34 A potential hazard can exist if different alarm presets are used. 35 This equipment is not intended for family usage.
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. 1
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CAUTION All combinations of equipment must be in compliance with IEC/EN Standard 60601-1-1 systems requirements. The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous -7-
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waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. H100B Pulse Oximeter will not operate with dead batteries. Install new batteries. 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. When adjusting any menu parameters, the oximeter does not display SpO2 or PR, but it is still recording. Do not run the pulse oximeter when alkaline batteries of different types are used at the same time. Federal (U.S.) Law restricts this device to sale -8-
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by or on the order of a physician.
1.3 Notes NOTE: Notes are identified by the symbol shown above. Notes contain important information that may be overlooked or missed. NOTE: 1 This device has been tested and found to comply with the limits for medical device in IEC/EN60601-1-2 (International standard for EMC testing of Medical Electrical Equipment, second edition). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. 2 Sensor LED light emissions fall within Class 1 level, according to IEC/EN 60825-1:2001. No special safety precautions are required. 3 Normal operation means: The oximeter is turned on; A sensor is connected to the oximeter; -9-
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The sensor is applied to the patient; The patient’s SpO2, Pulse rate are being reported; No error conditions exist. Wash the probe with clean water after disinfecting it to remove any remaining solution. The probe can only be reused after dried thoroughly. Do not disinfect the probe with the water boiled. Any residue should be removed from the probe before being disinfected, and avoid contacting corrosive solvent. Dipping the cable into alcohol or alkalescent solvent for a long time may reduce the flexibility of the scarfskin of the cable. Also, the connector should not be dipped. After monitoring, disinfect the probe according to the instruction described in the user manual. The materials with which the patient or any other person can come into contact conform with the standard of ISO10993. The pictures and interfaces in this manual are for reference only. - 10 -
H100B Pulse Oximeter User Manual
10 A functional tester cannot be used to assess the accuracy of the pulse oximeter probe or the pulse oximeter monitor. 11 If there is independent demonstration that the particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter probe, then a functional tester can measure the contribution of a monitor to the total error of a monitor/probe system. The functional tester can then measure how accurately a particular pulse oximeter monitor is reproducing that calibration curve. 12 The operating time of the Ni-MH rechargeable battery package depends on the configuration and operation of the pulse oximeter.
1.4 Symbols in the Oximeter This symbol indicates that the instrument is IEC/EN 60601-1 Type BF equipment.
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H100B Pulse Oximeter User Manual
Symbol for CAUTION
Serial number The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. Authorized representative in the European community Date of manufacture Manufacturer P/N
Part Number
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H100B Pulse Oximeter User Manual
The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Federal (U.S.) Law restricts this device to sale by or on the order of a physician. Auxiliary output connector Recycle MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1 and CAN / CSA C22.2 No. 601.1.
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