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H100B Pulse Oximeter User Manual

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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

Summary of Contents for H100B

Page 1: ......

Page 2: ...ation 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 Wit...

Page 3: ...ponsibility 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 modificati...

Page 4: ...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 si...

Page 5: ...duction 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 Tur...

Page 6: ...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...

Page 7: ...ing 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 Ma...

Page 8: ...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 e...

Page 9: ...osion 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 c...

Page 10: ...curate 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 t...

Page 11: ...ilure 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 exte...

Page 12: ...tone 18 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 19 H100...

Page 13: ...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...

Page 14: ...ening in enclosure as this may damage the oximeter 29 Before cleaning the oximeter or the sensor make sure that the equipment is switched off and disconnected from the power line 30 Do not use the cha...

Page 15: ...mbol 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 IEC EN Standard 60...

Page 16: ...purchased the product 3 H100B Pulse Oximeter will not operate with dead batteries Install new batteries 4 The sensor unconnected icon and associated alarm indicate the sensor has disconnected or wire...

Page 17: ...ts 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 harmfu...

Page 18: ...ue 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...

Page 19: ...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 particula...

Page 20: ...or 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...

Page 21: ...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...

Page 22: ...ital grade facilities 2 1 General Introduction H100B Pulse Oximeter hereinafter called oximeter is one model of H100 series Pulse Oximeter It displays SpO2 value pulse rate value plethysmogram bar gra...

Page 23: ...re 2 1 H100B Pulse Oximeter For the oximeter Oximeter Viewer Data Management Software is optional 2 2 Panel Introduction This section identifies the symbols controls displays and buttons on the front...

Page 24: ...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 h...

Page 25: ...tery icon Audio alarm off icon Alarm off icon Data storage icon 04 59 Time display in Information area hour minute ADU NEO Patient type in Information area Adult or Neonate ID 99 Patient ID in Informa...

Page 26: ...a time 2 The ID icon and the icon that indicates the memory space is full are displayed in the Information Area Only one icon can be displayed at a time 2 2 2 Front Panel Buttons This section describ...

Page 27: ...hold the On Off button for two seconds When the oximeter is off synchronously press the On Off button and the Function button for one second the oximeter will enter data transfer state In the Menu sta...

Page 28: ...is still active After the pause period is over the audio alarm is reactivated Set Alarm System to OFF in the menu to turn off the alarm A Pop up dialog box will display to confirm alarm setting See d...

Page 29: ...easurement state to enter the latest 10 minute SpO2 and PR trend table Function Button During the POST the Function button is not available Press this button in normal measurement state to enter funct...

Page 30: ...imeter will enter data transfer state Button Combination When the oximeter is off synchronously press the On Off button and the Function button for one second the oximeter will enter Data transfer sta...

Page 31: ...the top of the oximeter An extension cable can be used between the oximeter and the SpO2 sensor Use only the cable permitted by EDAN The cable for connecting the oximeter and PC with the Oximeter Vie...

Page 32: ...tor Cathode Detector cathode 2 4 Powered by Battery The oximeter can be powered by four 1 5V LR6 AA alkaline batteries It will operate for 48 hours when used for general operation or about 24 hours of...

Page 33: ...as shown in 4 Install the battery compartment cover To install the Ni MH rechargeable battery package 1 Make sure the oximeter is turned off 2 Press the battery compartment latch and remove the batte...

Page 34: ...ce of the battery follow the procedures below 1 Disconnect the pulse oximeter from the patient and stop all monitoring and measuring procedures 2 Place the pulse oximeter in the charger stand and conn...

Page 35: ...f a Ni MH rechargeable battery package is noticeably shorter than that stated in the specifications replace it or contact your service personnel Low Battery Icon The low battery icon displays and an a...

Page 36: ...nsor 12 01 109079 1 H100B Pulse Oximeter User Manual 01 54 109000 1 H100B Pulse Oximeter Reference Card 01 54 109002 1 Carrying case 11 56 110165 Optional configuration including Quantity Items Parts...

Page 37: ...ompatible with EDAN SpO2 module and EDAN SpO2 extension cable 12 01 110515 1 EDAN SH4 Adult Silicone Soft tip SpO2 Sensor DB9 Immersion Disinfection 02 01 110531 1 EDAN SH5 pediatric Silicone Soft tip...

Page 38: ...Oximeter User Manual 30 RS232 interface When selecting SpO2 sensor the following should be considered Patient weight and activity Adequacy of perfusion Available sensor sites Anticipated duration of...

Page 39: ...ng valid data values Verify that all the circuitry and functions of the oximeter work properly during the POST It needs a few seconds to complete the verification procedure POST If it functions incorr...

Page 40: ...l display on the screen Error code Indication Error 01 Indicates error for low battery Error 02 Indicates error for SpO2 board Error 03 Indicates error for main control board 3 2 Measurement State 3 2...

Page 41: ...3 Waveform Mode Large Numeric Mode The oximeter can display SpO2 oxygen saturation unit PR pulse rate unit bpm in large numeric mode Figure 3 4 H100B Large Numeric Mode 3 2 2 Trend Graph and Trend Ta...

Page 42: ...ay SpO2 and PR Trend Graph Trend table Figure 3 6 Display SpO2 and PR Trend Table 3 2 3 Abnormal Measurement State If the SpO2 sensor does not connect to the oximeter it will give a medium alarm and d...

Page 43: ...state if the oximeter does not receive any responsible signals for 10 minutes it will turn off automatically 3 2 4 Data Transfer State Set Data Storage in menu to ON the measurement value will be stor...

Page 44: ...fter POST the oximeter enters Data Transfer State automatically The interface displays as below Figure 3 7 Data Transfer State 3 3 System Menu Press the Function button to see the following main menu...

Page 45: ...H100B Pulse Oximeter User Manual 37 Alarm Setup Storage Setup...

Page 46: ...stand for the upper and lower alarm limits of SpO2 respectively 2 The PR Hi Alarm and PR Lo Alarm stand for the upper and lower alarm limits of PR respectively 3 If the user changes the default value...

Page 47: ...Type to Adu or Neo and confirm it by pressing the Function button Note When patient type is changed to Neo please use the Neonate SpO2 Sensor for accurate measurement 3 3 3 Alarm Volume The Alarm Vol...

Page 48: ...eter implements variable pulse tone and its frequency varies with the saturation 3 3 5 Audio Paused s Set the pause period for audio alarm to 30 60 90 or 120 seconds When Alarm System is ON pressing t...

Page 49: ...right the following menu will display Figure 3 11 User Maintain Language the user can select language to be displayed Time Setup select this item the following interface displays Figure 3 12 Time Set...

Page 50: ...ult Configuration is shown as follows System Mode Patient Type ADU Alarm System ON Alarm Volume 3 Pulse Volume 3 Audio Paused s 60 SpO2 Hi Alarm 100 SpO2 Lo Alarm 90 PR Hi Alarm 120 PR Lo Alarm 50 Pat...

Page 51: ...the patient s oxygen saturation level but the measurement accuracy will be improved When a critical patient is monitored selecting high sensitivity will help to understand the patient s state 3 3 9 Al...

Page 52: ...n and the SpO2 or PR character will flash If Alarm system is set to OFF all audio alarms and visual alarms are turned off WARNING When the Alarm system is off the oximeter will not give an alarm promp...

Page 53: ...wer limit of SpO2 to 100 If the value of SpO2 Hi Alarm is set to less than 85 it will restore to default value after the oximeter is turned on again In the NEO mode if the value of SpO2 Hi Alarm is se...

Page 54: ...m the alarm range setup Press the On Off button to exit the menu and return to measurement state 3 3 11 PR Alarm Setup The user can use PR Hi Alarm and PR Lo Alarm in menu to adjust pulse rate alarm l...

Page 55: ...e lower limit of PR Alarm is from 0 to the upper limit of PR Alarm 1 Press the Function button confirm the alarm range setup Hi Alarm is always higher than Lo Alarm by at least 1 bpm Press the On Off...

Page 56: ...uring the data storage patient ID can not be changed If the user wants to change ID he should change Data Storage to OFF then set a new ID Data stored in the oximeter can be exported through Oximeter...

Page 57: ...lete All Data Delete All Data is used to delete all the stored data Choose this item by pressing the Function button a dialog box pops up as follows Figure 3 17 Delete all the data If you choose YES t...

Page 58: ...menu 3 4 Charging the Ni MH Rechargeable Battery Package To charge the Ni MH rechargeable battery package 1 Turn off the device 2 Place the pulse oximeter in the charger stand 3 Connect the power cor...

Page 59: ...device is being charged Green indicates that the charging is complete CAUTION When the device is being charged it can not be operated 3 5 PatientCare Viewer Data Management Software Introduction For...

Page 60: ...nical alarms 1 Physiological alarms Physiological alarms also called patient status alarms are triggered by a monitored parameter value that violates setup alarm limits or an abnormal patient conditio...

Page 61: ...emergency treatment is demanded 2 Medium level alarms The patient s vital signs appear abnormal or the oximeter system status appears abnormal indicate that prompt operator response is required The le...

Page 62: ...shes quickly and sounds triple double triple double beep Medium level alarms character flashes slowly and sounds triple beep The sound pressure range for auditory alarm signal is from 45dB to 85dB 4 2...

Page 63: ...Sensor off When the SpO2 sensor falls off from the finger the oximeter will give a medium alarm and the icon displays in information area SpO2 and PR value area display and give a medium alarm Make su...

Page 64: ...high alarm Make sure alarm system in menu is ON A icon displays near PR which indicates that the measured value is higher than that of PR Hi Alarm it will synchronously flash with PR value 4 2 6 Lower...

Page 65: ...eactivate the audio alarm function 4 2 8 Turning off Alarm System After the alarm system is turned off the oximeter can not give a visual or an audio alarm except for low battery icon alarm Set alarm...

Page 66: ...ting 5 2 Oximeter Performance Considerations There are some patient conditions that can affect the oximeter s measurements Dysfunctional Hemoglobins Dysfunctional hemoglobins such as carboxyhemoglobin...

Page 67: ...levels fall below 5 gm dl Saturation The oximeter displays saturation level between 1 and 100 Pulse rate The oximeter displays pulse rate between 30 and 254 beats per minute bpm The sensor accuracy ra...

Page 68: ...l polish or pigmented cream Failure to cover the sensor site with opaque materials in high ambient light conditions Venous pulsation Dysfunctional hemoglobin Low perfusion Loss of pulse signal occurs...

Page 69: ...remains properly positioned on the patient High ambient light sources that can interfere with the performance of the sensor are Surgical lights especially those with a xenon light source Bilirubin lam...

Page 70: ...ter User Manual 62 Verify that the sensor is properly and securely applied Move the sensor to another site Use an adhesive to the sensor Use a new sensor with fresh adhesive backing Keep the patient s...

Page 71: ...meter do the following Check if there is any mechanical damage Check if all the outer cables inserted modules and accessories are in good condition Check all the functions of the oximeter to make sure...

Page 72: ...material about the customer service contract from the local company s office If the hospital or agency that is responding to using the oximeter does not follow a satisfactory maintenance schedule the...

Page 73: ...e disinfecting it The recommended disinfectants include ethanol 70 isopropanol 70 glutaraldehyde type 2 liquid disinfectants WARNING Sterilization may cause damage to the equipment and is therefore no...

Page 74: ...measure SpO2 and PR It can perform spot and continuous measurement for a short time The system consists of Central Processing Unit Signal Collection Signal Input Data Output Display and User Input mo...

Page 75: ...ight 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 satura...

Page 76: ...is related to hemoglobin oxygen saturation To identify the 0oxygen saturation of arterial hemoglobin the oximeter uses the pulsatile nature of arterial flow During systole a new pulse of arterial bloo...

Page 77: ...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 hemoximeter such a...

Page 78: ...ressure of oxygen PO2 the calculated value may differ from the SpO2 measurement of a pulse oximeter This usually occurs because the calculated saturation was not appropriately corrected for the effect...

Page 79: ...ors The warranty is void in case of a damage caused by handling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authoriz...

Page 80: ...d by EDAN certified service personnel If the product fails to function properly or if you need assistance service or spare parts contact EDAN s service center A representative will assist you troubles...

Page 81: ...e for freight insurance custom charges from EDAN to service claimer Out of warranty the service claimer is responsible for any freight insurance custom charges for product Contact information If you h...

Page 82: ...X2 Mode of operation Continuous measuring and spot checking Compliant with Safety Standards UL 60601 1 CAN CSA C22 2 No 601 1 IEC 60601 1 1988 A1 A2 EN 60601 1 1990 A1 A2 IEC EN 60601 1 2 2001 A1 ISO...

Page 83: ...rage 700 hPa 1060 hPa A1 2 3 Display Screen Type 128 64 dot matrix LCD with white LED backlight Big Numeric Mode SpO2 PR and Bar graph displayed Waveform Mode SpO2 PR Bar graph and Plethysmogram displ...

Page 84: ...Only the battery of 1500mAh capacity meets the UL requirements A1 2 5 Charger Stand Input 100 to 240 VAC 50Hz 60Hz 0 4A 0 15A Output 6 0VDC 0 8 A A1 3 Parameters Measurement Range SpO2 0 100 PR 25 bpm...

Page 85: ...H100B Pulse Oximeter User Manual 77 Pulse Rate Accuracy 25bpm 300bpm 2bpm Resolution SpO2 1 Bpm 1 bpm...

Page 86: ...Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure...

Page 87: ...armonic emissions IEC EN61000 3 2 N A Voltage fluctuations flicker emissions IEC EN61000 3 3 N A The device is suitable for use in all establishments other than domestic and those directly connected t...

Page 88: ...ironment specified below The customer or the user of the oximeter should assure that it is used in such an environment Emissions test Compliance Compliance level Electromagneti c environment guidance...

Page 89: ...be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC EN61000 4 1 1 5 UT 95 dip in UT for 0 5 cycle 40 UT 60...

Page 90: ...that the product be powered from an uninterruptible power supply or a battery Power Frequency 50 60 Hz Magnetic Field IEC EN 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels ch...

Page 91: ...environment specified below The customer or the user of the oximeter should assure that it is used in such an environment Immunity test IEC EN 60601 test level Compliance level Electromagnetic environ...

Page 92: ...l 84 than the recommend separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P d 3 5 3 P d 3 5 3 80 MHz to 800 MHz P d 3 7 80...

Page 93: ...the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagn...

Page 94: ...Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless tel...

Page 95: ...portable and mobile RF communications equipment and the oximeter The oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or th...

Page 96: ...in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter man...

Page 97: ...H100B Pulse Oximeter User Manual 89 Appendix Record Table ID No Name Time SpO2 PR NOTE...

Page 98: ...Radio Interference EEC European Economic Community EMC Electromagnetic Compatibility ID Identification IEC International Electrotechnical Commission LCD Liquid Crystal Display LED Light Emitting Diode...

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