H 100 N User Manual Release 1.3 Aug 2010

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 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, II

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 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 III

that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.

IV

Table of Contents 1 Safety Information ... 1 1.1 Warnings ... 1 1.2 Cautions...11 1.3 Notes... 14 1.4 Symbols in the oximeter... 17 2 Introduction ... 19 2.1 General Introduction... 19 2.2 Panels Introduction... 21 2.3 Connecting Sensor or Cable ... 30 2.4 Powered by Battery ... 32 2.5 Accessory List ... 36 3 Oximeter Operation ... 41 3.1 Turning on the Oximeter ... 41 3.2 Measurement State ... 43 3.3 System Menu... 47 3.4 Charging the Ni-MH Battery Package... 66 3.5 PatientCare Viewer Data Management Software Introduction ... 67 V

4 Alarm ... 70 4.1 Alarm Categories and Levels ... 70 4.2 Alarm Conditions ... 73 5 Performance Considerations ... 79 5.1 Performance Verification ... 79 5.2 Oximeter Performance Considerations... 79 5.3 OxiMax Sensor Performance Considerations... 81 6 Maintenance... 85 7 Principles of Operation ... 90 7.1 Pulse Oximetry Measurement ... 91 7.2 Functional Versus Fractional Saturation ... 94 7.3 Measured Versus Calculated Saturation... 95 8 Warranty and Service Policy... 96 8.1 Warranty... 96 8.2 Service Policy... 97 AppendixⅠ Specification ... 100 A1.1 Classification ... 100 VI

A1.2 Specification ... 100 A1.3 Parameters ... 103 Appendix II EMC Information ... 105 A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ... 105 A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ... 107 A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING ..111 A2.4 Recommended Separation Distances...117 Appendix Ⅲ Record Table... 120 Appendix Ⅳ Abbreviations ... 121

VII

H100N Pulse Oximeter User Manual

Safety Information

1 Safety Information 1.1 Warnings A WARNING label advises against certain actions or situations that could result in personal injury or death. WARNING 1

Avoid explosion hazard. Do not use the

oximeter in the presence of flammable anesthetic mixtures with air, or with oxygen or nitrous oxide. 2

Chemicals from a broken LCD display panel

are toxic when ingested. Use cautions when the oximeter has a broken display panel. 3

Routinely monitor the patient to make sure the

oximeter is functioning and the sensor is correctly placed.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 4

Oximetry measurements and pulse signals can

be affected by certain environmental conditions, 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.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 8

H100N Pulse 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 electrosurgical unit, and shortly thereafter. To avoid shock, the caregiver should not hold the oximeter while using a defibrillator on a patient.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 11 Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. 12 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. 13 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.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 14 Do not make any clinical judgment based solely on the oximeter, and 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 equipment, 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.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 18 Use only Nellcor-approved OxiMax Sensors and extension cables with the H100N Pulse Oximeter. Other sensors or extension cables may cause improper monitor performance or minor personal injury. 19 H100N 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. 20 Don’t mix new and old batteries together. Don’t mix rechargeable batteries with alkaline batteries. 21 Periodically check the battery for corrosion. Remove the batteries from the oximeter if you do not expect to use it within one month. -6-

H100N Pulse Oximeter User Manual

Safety Information

WARNING 22 The device enters POST (Power-On-Self-Test) immediately after power-on. During the POST, confirm all the display segments and icons are shown and the speaker sounds a few seconds tone. Do not use the H100N Pulse Oximeter if you do not hear the POST pass tone. Do not use the oximeter if the POST has not been finished successfully. 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.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 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 manual. 26 Do not immerse or wet the sensor, as this may damage the sensor. 27 There are no user-serviceable parts inside the oximeter, the cover should only be removed by qualified service personnel. 28 Do not spray, pour, spill liquid to H100N Pulse Oximeter and its accessories, connector, switch or opening in enclosure, as this may damage the oximeter.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 29 Before cleaning the oximeter or the sensor, make sure that the equipment is switched off and disconnected from the power line. 30 Setting the alarm limits to extreme values can cause the alarm system useless. 31 Do not use the charger stand when the alkaline battery is depleted or no battery is installed. 32 Do not monitor the patient while the battery is being charged. 33 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. 34 Only

use

EDAN

approved

rechargeable

batteries and charger stand for H100N pulse oximeter.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 35 The temperature sensor should be disinfected after each measurement. The probe must not be sterilized in steam. Only detergents containing no alcohol can be used for disinfection. 36 The temperature sensor should not be heated above 100℃ (212℉). It should only be subjected to temperatures from 80℃ (176℉) to 100℃ (212℉). 37 The calibration of the temperature module is necessary for every two years (or as frequently as dictated by your Hospital Procedures Policy). When you need to calibrate the temperature measurement, please contact the manufacturer.

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H100N Pulse Oximeter User Manual

Safety Information

WARNING 38 Take the TEMP probe and cable carefully. If you do not use them for a long time, you should coil up the probe and cable into a loose circle. If the wire inside the cable is tensely pulled, it may cause mechanical damage to the probe and the cable.

1.2 Cautions A Caution label alerts the user to exercise care necessary for the safe and effective use of the H100N Pulse Oximeter. CAUTION 1

All combinations of equipment must be in

compliance

with

IEC/EN

requirements. - 11 -

60601-1-1

system

H100N Pulse Oximeter User Manual

Safety Information

CAUTION 2

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 waste. Do NOT dispose of 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. 3

H100N Pulse Oximeter will not operate with

dead batteries. Install new batteries.

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H100N Pulse Oximeter User Manual

Safety Information

CAUTION 4 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. 5 When adjusting any menu parameters, the oximeter does not display SpO2, PR or TEMP, but it is still recording. 6 The performance of the oximeter may be degraded if the following occur: - Operation or storage temperature and humidity outside the manufacturer’s stated range; - Mechanical shock (for example, it drops from the table). - Patient temperature is below ambient temperature (For measurement body temperature). - 13 -