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1. 3 2 Measurement State 3 2 1 Measurement Modes There are two measurement modes which are waveform mode and large numeric mode By default the configuration is waveform mode Large Numeric Mode The oximeter can display SpO oxygen saturation unit PR pulse rate unit bpm TEMP and temperature unit C in large numeric mode as 100 fee PRT 36 5 188m 04 59 Neo DO gt Figure 3 2 Large Numeric Mode 43 H100N Pulse Oximeter User Manual Oximeter Operation Waveform Mode In the normal measurement state oximeter can measure arterial oxygen saturation and pulse rate display oxygen saturation level and symbol SpO gt and PR on interface Besides it can also display pulse bar graph and Plethysmogram In waveform mode oximeter displays SpO and PR information and the TEMP value is not displayed on the screen Figure 3 3 Waveform Mode 3 2 2 Trend Graph In normal measurement state press the Up Arrow button to display SpO2 trend graph press the Down Arrow button to display 10 minute PR trend graph as follows 44 H100N Pulse Oximeter User Manual Oximeter Operation 300 150 aupra a aa 30 19 55 20 00 20 05 Figure 3 4 Display SpO2 and PR Trend Graph 3 2 3 Abnormal Measurement State If the SpO2 sensor does not connect to the oximeter it will give a medium alarm and display in the Information area If the SpOz sensor falls off from the finger
2. 2 Press the battery compartment latch and remove the battery access door 3 Place the Ni MH rechargeable battery package as shown in the follow figure first push it oriented as then press it oriented as 4 Install the battery compartment cover 34 H100N Pulse Oximeter User Manual Introduction Checking the Ni MH Battery Package The performance of a rechargeable Ni MH battery package may deteriorate To check the performance 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 connect the AC mains Allow the battery to be charged uninterruptedly for above 2 5 hours 3 Disconnect AC mains and allow the pulse oximeter to run in the measurement state until it shuts off The operating time of a battery reflects its performance directly If the operating time of a rechargeable Ni MH battery package is noticeably shorter than that stated in the specifications replace it or contact your service personnel 35 H100N Pulse Oximeter User Manual Introduction Low Battery Icon The low battery icon displays and an alarm is given when 15 minutes operation remains available After 15 minutes operation the oximeter will tum off automatically Replace the batteries gt 100s 0 59 ADU egg Ee Figure 2 7 Low Battery Icon 2 5 Accessory List Sta
3. H100N Pulse Oximeter User Manual Oximeter Operation the pulse oximeter responds to the changes in the patient s oxygen saturation level Contrarily the lower the sensitivity is the slower the pulse oximeter responds to the changes in 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 Alarm System Set Alarm System to ON or OFF to turn on or off the alarm system If Alarm system is set to OFF a dialog box pops up as follows Alarm System will be Closed Please confirm this operation YES Figure 3 12 Confirm to Turn off Alarm If Alarm System is ON when an alarm occurs the 56 H100N Pulse Oximeter User Manual Oximeter Operation oximeter gives a visual alarm and an audio alarm Pressing the Alarm Silence button can suspend the alarm system for seconds the pause period can be set to 30 60 90 or 120s by the user see section 3 3 5 the audio alarm off icon displays But the visual alarm is still active For example if the measured SpO value is higher than SpO2 Hi Alarm or lower than SpO Lo Alarm there will be for icon displayed on screen and the SpO 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
4. If a product covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 8 2 Service Policy All repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall be exclusively be performed by EDAN certified service personnel If the product fails to function properly or if you need 97 H100N Pulse Oximeter User Manu Warranty and Service Policy assistance service or spare parts contact EDAN s service center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone or Email avoiding potential unnecessary returns In case a return can not be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA form that includes the appropriate return address and instructions An RMA form must be obtained prior to any return Freight policy Under warranty the service claimer is responsible for freight amp insurance charges when a return is shipped to EDAN for service including custom charges EDAN is respo
5. 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 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 C 212 It should only be subjected to temperatures from 80 C 176 F to 100 C 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 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 a
6. Then confirm the selection by pressing the Function Large numeric mode Waveform mode 50 H100N Pulse Oximeter User Manual Oximeter Operation button 3 3 2 Patient Type Patient Type can be set to Adult Adu or Neonate Neo for different measurement modes Set Patient Type to Adu or Neo and confirm it by pressing the Function button 3 3 3 Alarm Volume Alarm Volume is used to adjust alarm volume and its range is from to 5 When Alarm System is ON if a low alarm a medium alarm or a high alarm occurs the oximeter sounds beep 3 3 4 Pulse Volume The user can turn on or off the pulse volume by pressing Pulse Volume and change volume level to 1 2 3 4 5 or OFF Press the Function button to enter setup state and use the Up Arrow or Down Arrow button to choose 51 H100N Pulse Oximeter User Manual Oximeter Operation the volume and confirm it by pressing the Function button The oximeter 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 the Alarm Silence button can turn off the audio alarm the pause period is set by pressing Audio Paused s 3 3 6 User Maintain Enter the User Maintain menu by inputting 819 Enter Password o 0 0 Confirm Cancel Figure 3 7 Enter Password e H100N Pulse Oximeter User Manual O
7. Transport and 700 hPa 1060 hPa Storage A1 2 3 Display Screen Type 128x64 dot matrix LCD with white LED backlight Large Numeric SpO PR TEMP and Bar Mode graph displayed 101 H100N Pulse Oximeter User Manu Specification Waveform Mode SpO2 PR Bar graph and Plethysmogram displayed A1 2 4 Batteries Alkaline batteries Quantity 4 Total rated voltage 6 V Capacity 2600 mAh Typical battery life 48 hours Ni MH rechargeable battery package Quantity 1 Total rated voltage 4 8 V Capacity 1800 mAh Typical battery life 36 hours Charge time 2 5 hours to 80 4 hours to 100 A1 2 5 Charger Stand Input voltage 100 to 240 VAC 50 60Hz Output voltage 8 VDC Output current 0 8 A Output power 6 4 W 102 H100N Pulse Oximeter User Manu A1 3 Parameters Measurement range Specification SpO 1 100 PR 20 bpm 300 bpm Perfusion range 0 03 20 TEMP 0 C 50 C Accuracy Tolerance Saturation Adult 70 100 2digits Neonate 70 100 3digits Low Perfusion 70 100 2digits Pulse Rate Adult and Neonate 20 bpm 300 bpm 3digits Low Perfusion 20 bpm 300 bpm 3digits Data Update Period 7 seconds TEMP 25 C 45 C 4 E0 1 C 103 H100N Pulse Oximeter
8. and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the oximeter is used exceeds the applicable RF compliance level above the oximeter should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the oximeter 116 H100N Pulse Oximeter User Manu EMC Information A2 4 Recommended Separation Distances Recommended separation distances between 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 the user of the oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the oximeter as recommended below according to the maximum output power of the communications equipment 117 H100N Pulse Oximeter User Manu EMC Information Rated Separation distance according to maximum frequency of transmitter m output 150 kHz to 80 MHz 800 MHz to power of 80 MHz to 800 2 5GHz transmi
9. button in normal measuring state to enter function choice or setup menu In the menu state this button is also used as the Enter button Choose one item in menu using the cursor button the Up Arrow button and Down Arrow button and press the Function button to confirm then increase or decrease the value using cursor button When the oximeter is off synchronously press the On Off button and the Function button for 1 second the oximeter will enter Data transfer state 28 H100N Pulse Oximeter User Manual Introduction Button Combination When the oximeter is off synchronously press the On Off button and the Function button for 1 second the oximeter will enter Data transfer state 2 2 3 Rear Panel Figure 2 5 Rear Panel 29 H100N Pulse Oximeter User Manual Introduction 2 3 Connecting Sensor or Cable Figure 2 6 Sensor and Cable Connecting Port SpO gt Sensor and cable port is on the top of the oximeter for connecting the SpO sensor An extension cable can be used between the oximeter and the SpO sensor Use only the cable permitted by the manufacturer The cable for connecting the oximeter and PC with the PatientCare Viewer Data Management Software is also connected to this port The temperature sensor port is only configured for H100N 30 H100N Pulse Oximeter User Manual Introduction AN Symbol for caution Le Type BF applied part gt Auxiliary output connector SIO defi
10. it will give a medium alarm and display i in the information area If the Temp sensor is abnormal it will give a low alarm and display in TEMP parameter area 45 H100N Pulse Oximeter User Manual Oximeter Operation In menu state or trend graph state if there is no operation for 30 seconds the oximeter will return to measurement state In measurement state if there is no measurement data and no operation for 10 minutes the oximeter will turn off automatically In Data transfer state if the oximeter does not receive 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 stored in the oximeter The SpO and PR information can be transferred from oximeter to PatientCare Viewer Data Management Software Data transfer procedure After the measurement and storage are all finished turn off the oximeter 46 H100N Pulse Oximeter User Manual Oximeter Operation Connect the oximeter and the computer with a cable for communication between the oximeter and PatientCare Viewer Data Management Software Synchronously press the On Off button and the Function button after POST the oximeter enters Data Transfer State automatically The interface displays as follows Figure 3 5 Data Transfer State 3 3 System Menu Press the Function button to see the following main menu of ox
11. 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 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 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 batterie
12. oximeter uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The oximeter bases its SpO2 measurements on the difference between maximum and minimum absorption measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of non pulsatile absorbs such as tissue bone and venous blood Wavelength The Oximax sensor contains LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm The total optical output power of the sensor LEDs is less 93 H100N Pulse Oximeter User Manu Principles of Operation than 15 mW This information may be useful to clinicians such as those performing photodynamic therapy 7 2 Functional Versus Fractional Saturation This oximeter measures functional saturation oxygenated hemoglobin expressed 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 as the IL482 report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobins 94
13. range is from 1 to 100 The ID display box on the interface will change from real line to broken line After choosing ID press the Function button to confirm the setup If the ID exists the following confirmation dialog box will pop up This ID s data will be covered Continue 7 YES Figure 3 13 Confirm to cover data 3 3 14 Data Storage Choose Data Storage and set it to ON then the measurement data can be stored 63 H100N Pulse Oximeter User Manual Oximeter Operation During 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 PatientCare Viewer Data Management Software Please refer to 3 2 3 for Data transfer procedure When the memory space is full an icon G displays in Information Area Meanwhile Data Storage changes to OFF automatically Restart the oximeter and a dialog box pops up The user should confirm it to delete all the data The memory space is full Please delete all ID s Data Figure 3 14 The Memory space is full 64 H100N Pulse Oximeter User Manual Oximeter Operation 3 3 15 Deleting 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 This operation will delete all the ID data will you Continue YES Figure 3 15 Delet
14. Cable ceceeeseeereeees 30 2 4 Powered by Battery ccccceccceesceeteeeeteeeeseeenes 32 2 5 Accessory List hrr rE 36 3 Oximeter Operation e seeseesoesossoesossossossossossossossossose 41 3 1 Turning on the Oximeter sneseeeseeeeeeeseeeeeeeeeee 41 3 2 Measurement State cccccsscsssecseteeeeteeeeteeeeees 43 3 3 System MeNU sssini i 47 3 4 Charging the Ni MH Battery Package 66 3 5 PatientCare Viewer Data Management Software Tinthod ction eesess civteee EAR AENEAN AR 67 4 AVAL cicsscicticesccssssoacssboccsccsssses E 70 4 1 Alarm Categories and Levels ceceseeereeeees 70 4 2 Alarm Conditions cccceccccceccccceeessessseeeseeeees 73 5 Performance Considerations ssscccccccccssssssees 79 5 1 Performance Verification ccceccccceeeeeeeeeee 79 5 2 Oximeter Performance Considerations 79 5 3 OxiMax Sensor Performance Considerations 81 6 MaintenaNne scccccccccssssssccsscccccsssssccssccccccssssscccss 85 7 Principles of Operation ccssccscsssscssssssessseeees 90 7 1 Pulse Oximetry Measurement c cceeeeees 91 7 2 Functional Versus Fractional Saturation 94 7 3 Measured Versus Calculated Saturation 95 8 Warranty and Service Policy sssssccsssssssssees 96 Sol OW aTTAM tyres sees E E E eee 96 8 2 Service Policyissiscieneicsesedineesuieseeebectesteeseeiers 97 Appendix I Specific
15. H100N Pulse Oximeter User Manu Principles of Operation To compare functional saturation measurements to those from an instrument that measures fractional saturation fractional measurements must be converted as follows 7 3 Measured Versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen PO2 the calculated value may differ from the SpO measurement of a pulse oximeter This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO and pH temperature the partial pressure of carbon dioxide PCO 2 3 DPG and fetal hemoglobin 95 H100N Pulse Oximeter User Manu Warranty and Service Policy 8 Warranty and Service Policy 8 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty period begins on the date the products are shipped to distributors The warranty is void in cases 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 authorized by EDAN d damage caused by accidents 96 H100N Pulse Oximeter User Manu Warranty and Service Policy e replacement or removal of serial number label and manufacture label
16. MHz to 2 5GHz 3V m equipment should be used no closer to any part of the oximeter including cables than the recommend separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation 112 H100N Pulse Oximeter User Manu EMC Information distance G29 ip 3 d i JP 80 MHz to 800 MHz d 2yP 800 MHz to 2 5 GHz where p is the maximum output power rating of the transmitter in watts W according to the 113 H100N Pulse Oximeter User Manu EMC Information transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each 114 H100N Pulse Oximeter User Manu EMC Information frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80MHz and 800MHz the applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people frequency range 115 H100N Pulse Oximeter User Manu EMC Information Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones
17. P 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 manufacturers stated range Mechanical shock for example it drops from the table Patient temperature is below ambient temperature For measurement body temperature H100N Pulse Oximeter User Manual Safety Information 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 60825 1 2001 No special safety precautions are required S746 H100N Pulse Oximeter User Manual Safety Information 3 Normal operation means The oximeter is turned on A sensor is connected to the oximeter The sensor is applied to the patient The patients SpO2 Pulse rate or Temperature readings are being reported No error conditions exist 4 Wash the probe with clean water after disinfecting it to remove any remaining solution The probe can only be reused after being dried thoroug
18. SpO sensor is disconnected the oximeter gives a medium alarm The icon c displays in Information area It displays in SpO2 PR area of LCD and gives a medium alarm Make sure Alarm System in menu is set to ON 4 2 3 Alarm for SpO2 Sensor off When the SpO sensor falls off the finger the oximeter will give a medium alarm and the icon Kt displays in information Area It displays in SpO2 PR display area and gives a medium alarm Make sure Alarm System in menu is ON 74 H100N Pulse Oximeter User Manual Alarm 4 2 4 Alarm for Abnormal State of Temp Sensor In the measurement state if the Temp sensor falls off the oximeter it will display in the TEMP display area and give a low alarm Make sure Alarm System in menu is set to ON If the measured value is below 0 C or above 50 C the oximeter will give a low alarm If the Temp sensor is damaged the oximeter will give a low alarm 4 2 5 Alarm for Low Battery When the battery is too low the oximeter gives a medium alarm for low battery After the low battery alarm occurs the oximeter can still be operated for a few minutes before it turns off automatically 75 H100N Pulse Oximeter User Manual Alarm The low battery icon C displays on LCD and gives a medium alarm Make sure Alarm System in menu is set to ON 4 2 6 Higher than Hi Alarm Limit If the measured value is higher than the Hi Alarm upper alarm limit the oximete
19. User Manu Specification 0 C 25 C and 45 50 C 0 2 C Resolution SpO 1 Bpm 1 bpm TEMP 0 1 C 104 H100N Pulse Oximeter User Manu EMC Information Appendix II EMC Information Guidance and Manufacture s Declaration Refer to the following tables for specific information regarding this device s compliance to IEC EN 60601 1 2 A2 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic emissions The oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the oximeter should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance 105 H100N Pulse Oximeter User Manu EMC Information RF emissions CISPRI11 The oximeter uses RF energy only for its internal function Therefore its RF Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions The oximeter is Class B CISPRI1 suitable for use in all establishments other Harmonic than domestic and emissions N A those directly IEC EN61000 3 2 connected to the public Voltage low voltage power N A SER fluctuations supply net work that 106 H100N Pulse Oximeter User Manu EMC Information flicker emission
20. User Manual EDAN H100N Pulse Oximeter Release 1 3 with Software Revision 1 3 C Eus About this Manual P N 01 54 110221 13 Release Date August 2010 Copyright EDAN INSTRUMENTS INC 2008 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 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 Assem
21. a PC Refer to the PatientCare Viewer Data Management Software user manual for detailed information The following figures demonstrate the main interface trend graph and print preview Figure 3 17 Main Interface 68 H100N Pulse Oximeter User Manual Oximeter Operation Figure 3 18 Trend Graph TREND REVIEW Figure 3 19 Print Preview 69 H100N Pulse Oximeter User Manual Alarm 4 Alarm 4 1 Alarm Categories and Levels Alarm Categories The oximeter s alarms can be classified into two categories physiological alarms and technical 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 condition 2 Technical alarms Technical alarms also called system status alarms are triggered by a device malfunction or a patient data distortion due to improper operation or system problems 70 H100N Pulse Oximeter User Manual Alarm Alarm Levels In terms of severity the oximeter s alarms levels can be classified into three categories high level alarms medium level alarms and low level alarms 1 High level alarms Indicate that the patient is in a life threatening situation and an emergency treatment is demanded Medium level alarms The patient s vital signs appear abnormal or the oximeter system status appears abnormal indicate that prompt operator
22. ached There is arterial occlusion proximal to the OxiMax sensor Poor peripheral perfusion Loss of pulse cardiac arrest To use the OxiMax sensor Select an appropriate OxiMax sensor 29 H100N Pulse Oximeter User Manu Performance Considerations Apply the OxiMax sensor as directed and observe all warnings and cautions presented in the OxiMax sensor user manual Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the OxiMax sensor remains properly positioned on the patient High ambient light sources that can interfere with the performance of the OxiMax sensor are Surgical lights especially those with a xenon light source Bilirubin lamps Fluorescent lights Infrared heating lamps Direct sunlight To prevent interference from ambient light ensure that the OxiMax sensor is properly applied and cover the OxiMax sensor site with opaque material 83 H100N Pulse Oximeter User Manu Performance Considerations If interference due to patient activity presents a problem try one or more of the following to correct the problem Verify that the OxiMax sensor is properly and securely applied Move the OxiMax sensor to another site Use an adhesive to the OxiMax sensor Use a new the OxiMax sensor with fresh adhesive backing Keep the patient still if possible If interference due to poor perfusion present
23. al company s office If the hospital or agency that is responding to using the oximeter does not follow a satisfactory maintenance schedule the oximeter may become invalid and the human health may be endangered WARNING Before cleaning the oximeter or the sensor make sure that the oximeter is switched off Periodic Safety Checks It is recommended that the following checks be performed every 24 months 86 H100N Pulse Oximeter User Manu Maintenance Inspect the devices for mechanical and functional damage Inspect the relevant labels for legibility 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 87 H100N Pulse Oximeter User Manu Maintenance Cleaning reusable TEMP probes 1 The TEMP probe should not be heated above 100 C 212 F It should only be subjected briefly to temperatures between 80 C 176 and 100 C 212 F 2 The probe must not be sterilized in steam 3 Only detergents containing no alcohol can be used for disinfection 4 To clean the probe hold the tip with one hand and with the other hand rubbing the probe down in the direction of the connector usi
24. ast 1 bpm Press the On Off button to exit the menu and return to measurement state 3 3 12 Temp Alarm Setup The user can use Temp Hi Alarm and Temp Lo Alarm in menu to adjust body temperature alarm limits By default the Temp Hi Alarm and Temp Lo Alarm are set to 39 0 C and 36 0 Crespectively in both Neo and Adu modes Set the Temp limits as follows Choose Temp Hi Alarm in the menu press the 61 H100N Pulse Oximeter User Manual Oximeter Operation Function button to enter setup The Temp Hi Alarm box changes from real line to broken line The adjustable range of the upper limit of Temp Alarm is from 0 1 C the lower limit of Temp Alarm to 50 0 C Press the Up Arrow or the Down Arrow button to increase or decrease values Choose Temp Lo Alarm in menu and press the Function button to enter setup The Temp Lo Alarm box changes from real line to broken line The adjustable range for the lower limit of Temp Alarm is from 0 to the upper limit of Temp Alarm 0 1 C Press the Function button and confirm the alarm range setup Hi Alarm is always higher than Lo Alarm by at least 1 C Press the On Off button to exit the menu and return to measurement state 62 H100N Pulse Oximeter User Manual Oximeter Operation 3 3 13 Patient ID No setup The oximeter can support 100 patient IDs and 300 hour data storage When entering the menu press the Function button to set ID valid
25. ation scccsscsssssssscesees 100 All Classification n n a 100 VI A12 Specification ansians 100 A13 Parameters conin an a 103 Appendix IT EMC Information cscssesseees 105 A2 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS ossos 105 A2 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS ossos 107 A2 3 Electromagnetic emissions for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING 111 A2 4 Recommended Separation Distances 117 Appendix III Record Tablle cccscsssccssesssssees 120 Appendix IV Abbreviations cscsscsscssssscceees 121 Vil 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 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
26. bles When selecting SpO sensor the following should be considered Patient weight and activity Adequacy of perfusion Available sensor sites Anticipated duration of monitoring 40 H100N Pulse Oximeter User Manual Oximeter Operation 3 Oximeter Operation 3 1 Turning on the Oximeter The oximeter is turned on by pressing the on off button it will cycle through a Power On Self Test POST before displaying 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 incorrectly do not use the oximeter Press the On Off button for one second to turn on the oximeter At first the Logo EDAN is shown H100N Pulse Oximeter User Manual Oximeter Operation And then the Logo for product model is shown Pulse Oxirmmeter HIOON NELLCOR INSIDE Figure 3 1 Model If the POST is successfully finished the oximeter sounds a tone and enters the main interface If there is an error during the POST the following error codes will display on the screen Error code Indication Error 01 Indicates error for Low battery Error 02 Indicates error for SpO board A2 H100N Pulse Oximeter User Manual Oximeter Operation Error 03 Indicates error for Temp board Error 04 Indicates error for main control board
27. bly operations extensions re adjustments II 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 ul that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure Table of Contents 1 Safety Information c cccsssccscsscscsscscsecsssessseeees 1 DAW ar Se 3c elccaei ne deie weed Maar eodeewssadevavceadeawesch 1 1 2 Cautions oerein iiin 11 PE es ss E E E E E 14 1 4 Symbols in the oximeter cccceesceeeseeeeteeeeees 17 2 Introduction ccsccssscsscssccssccssccsccssscssccscccsesoneees 19 2 1 General Introduction cecccceessceesseeesreeeeteeees 19 2 2 Panels Introduction ccceessceesseeeseeesteeeeeeees 21 2 3 Connecting Sensor or
28. bol indicates that the x instrument is IEC EN 60601 1 Type BF equipment AN Symbol for Caution ci Consult Instructions for Use SN Serial Number C F CE Mark H100N Pulse Oximeter User Manual Safety Information Date of Manufacture m Manufacturer P N Part Number IPX1 Ingress Protection Degree QOY ex amp Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life Auxiliary Output Connector H100N Pulse Oximeter User Manual Introduction 2 Introduction Intended Use H100N Pulse Oximeter hereinafter called oximeter is one model of H100 series Pulse Oximeter The oximeter is intended for continuous monitoring or spot checking of functional arterial oxygen saturation SpO2 pulse rate and for oral axillary and rectal temperature measurement It is intended to be used on adult pediatric or neonatal patient in hospitals intra hospital transport and hospital type facilities 2 1 General Introduction It displays SpO gt value pulse rate value plethysmogram bar graph temperature etc The oximeter has been installed Nellcor SpO2 module and the manufacturer s TEMP module inside It integrates parameter module display and recorder output 19 H100N Pulse Oximeter User Manual Introduction functions It can be powered by four 1 5V AA bat
29. connected icon E SpO sensor off I Indicates the memory space is full A Weak signal icon 23 H100N Pulse Oximeter User Manual Introduction NOTE 1 The icons for sensor unconnected sensor off or weak signal are displayed on the right of Information area Only one of them can be displayed at 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 describes the buttons on the front panel of the oximeter The controls are activated by pressing the button that corresponds to that control For example press the Alarm Silence button to control the audio alarm 24 H100N Pulse Oximeter User Manual Introduction r Figure 2 4 Front Panel buttons On Off Button Turn on or off the oximeter On Press and hold the On Off button for one second Off Press and hold the On Off button for two seconds When the oximeter is off synchronously press the On Off button and the Function button for 1 second the oximeter will enter Data transfer state In the menu state press this button to return to measurement state 25 H100N Pulse Oximeter User Manual Introduction Backlight Button During the POST the backlight is not available In the normal measurement press this button to turn on or off the backlight Alarm Silence Button Alarms that oc
30. cur during the Power On Self Test POST can not be silenced When Alarm System in menu is set to ON pressing the Alarm Silence button can turn off audio alarm The pause period can be set to 30 60 90 or 120 seconds Although the audio alarm is off the visual alarm is still active After the pause period is over the audio alarm is reactivated Set Alarm System to OFF in menu to turn off the alarm A pop up dialog box will display to confirm alarm setting See details in 3 3 3 26 H100N Pulse Oximeter User Manual Introduction Up Arrow Button In the menu state press the Up Arrow button to choose different items and increase the value of some parameters Press it repeatedly to make a parameter increase by more than one Press and hold this button for more than 1 second to repeat the increment continuously Press this button in measurement state to display the latest 10 minute SpO trend graph Down Arrow Button In the menu state pressing the Down Arrow button can choose different items and decrease the value of some parameters Press it repeatedly to make a parameter decrease by more than one Press and hold the button for more than 1 second to repeat the decrement continuously Press this button in measurement state to display the latest 10 minute PR trend graph 97 H100N Pulse Oximeter User Manual Introduction Function Button D During the POST the Function button is not available Press this
31. d such as a finger or a toe The sensor contains a dual light source and a photonic detector Bone tissue pigmentation and venous vessels normally absorb a constant amount of light 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 saturation SpO Because a measurement of SpO gt is dependent upon light from the sensor excessive ambient light can interfere with this measurement 91 H100N Pulse Oximeter User Manu Principles of Operation Pulse oximetry is based on two principles Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light spectrophotometry The volume of arterial blood in tissue hence light absorption by the blood changes during the pulse plethysmography The oximeter determines SpO by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LED serve as light sources a photonic diode serves as the photo detector Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial 92 H100N Pulse Oximeter User Manu Principles of Operation hemoglobin the
32. hly 5 Do not disinfect the probe with the means of water boiled 6 Any residue should be removed from the probe before being disinfected and avoid contacting corrosive solvent Dip the cable into alcohol or alkalescent solvent for a long time may reduce the flexibility of the scarfskin of the cable Also the 15 H100N Pulse Oximeter User Manual Safety Information connector should not be dipped 7 After monitoring disinfect the probe according to the instruction described in the user manual 8 The materials with which the patient or any other person can come into contact conform with the standard of IS010993 9 The pictures and interfaces in this manual are for reference only 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 16 H100N Pulse Oximeter User Manual Safety Information 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 sym
33. imeter select items by pressing the Up Down button and confirm it by pressing the Function button ZAT H100N Pulse Oximeter User Manual Oximeter Operation System Setup gt gt Alarm Setup gt gt Storage Setup gt gt EXIT System Setup gt gt System Mode LA Patient Type Adu Alarm Volume 3 Pulse Volume 3i audio Paused s 60 User Maintain gt gt i Default Config Sensitivity HI i 48 H100N Pulse Oximeter User Manual Oximeter Operation Alarm Setup gt gt Alarm System LON SpO2 Hi Alarm 100 SpO2LoAlarm 90 i PR Hi Alarm 120 PR LoAlarm 50 Temp Hi Alarm 39 0 Temp Lo Alarm 36 0 Return i Storage Setup gt gt Patient ID No ji Data Storage OFF Delete All Data Return Figure 3 6 Menus NOTE 1 The SpO2 Hi Alarm and SpO Lo Alarm stand for the upper and lower alarm limits of SpOs 49 H100N Pulse Oximeter User Manual Oximeter Operation respectively 2 The PRHi Alarm and PR Lo Alarm stand for the upper and lower alarm limits of PR respectively 3 The Temp Hi Alarm and Temp Lo Alarm stand for the upper and lower alarm limits of Body temperature respectively 4 If the user changes the default value of Lo Alarm or Hi Alarm after restarting the oximeter the value will resume to the default value for corresponding patient type 3 3 1 System Mode There are two items for selecting Ties pa
34. in UT for 25 cycles lt S5 UT gt 95 dip in UT for N A Mains power quality should be that of a typical commercial or hospital environment If the user of the product requires continued operation during power mains interruptions it is recommend 109 H100N Pulse Oximeter User Manu EMC Information 5s 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 characteristic of a typical location in a typical commercial or hospital environment 110 H100N Pulse Oximeter User Manu A2 3 Electromagnetic EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING EMC Information emissions for Guidance and manufacturer s electromagnetic immunity declaration The oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the oximeter should assure that it is used in such an environment Immunity IEC EN Compliance Electromagnetic test 60601 level environment test guidance level Conducted 3Vrms ae Portable and RF 150KHz mobile RF IEC EN to communications 111 H100N Pulse Oximeter User Manu EMC Information 61000 4 6 Radiated RF IEC EN 61000 4 3 80MHz 3V m 80
35. ing all the data If you choose YES to delete all the data the deleting progress shows A Dale Deleting e E Figure 3 16 All Data Deleting 3 3 16 Exit Return Exit menu by pressing Exit in the menu 65 H100N Pulse Oximeter User Manual Oximeter Operation Return to the previous menu by pressing Return in the menu 3 4 Charging the Ni MH Battery Package To charge the rechargeable Ni MH battery package 1 Turn off the device 2 Place the pulse oximeter in the charger stand 3 Connect the power cord 4 Plug the power cord into the AC mains A tricolor LED display indicates the charging state Red indicates no rechargeable battery package in the machine or the device is not placed properly Yellow indicates the device is being charged Green indicates that the charging is complete 66 H100N Pulse Oximeter User Manual Oximeter Operation Power Cord Charging Status Battery Chamer 3 5 PatientCare Viewer Data Management Software Introduction Connect the oximeter to PC through the cable before running the PatientCare Viewer Data Management Software This Software implements the following functions 1 Query or save the oximeter s data based on the patient ID 67 H100N Pulse Oximeter User Manual Oximeter Operation 2 Edit and manage patient information 3 Review each ID s data in trend graph format 4 Print all data information vi
36. n From Pulse Oximeter 121 P N 01 54 110221 13 EDAN www edan com cn EC REPRESENTATIVE Shanghai International Hoking Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipment Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 PR CHINA Email info edan com cn TEL 86 755 2689 8326 FAX 86 755 2689 8330
37. nd 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 60601 1 1 system requirements 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 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 TEM
38. ndard configuration including Quantity Items Parts No H100N Pulse 1 MS8 110185 Oximeter 1 5V AA alkaline 4 i M21R 064086 batteries IEC LR6 36 H100N Pulse Oximeter User Manual Introduction Nellcor Reusable Adult SpO Sensor 1 DS 100A OxiMax MS2 30043 Weak Perfusion Resistance Skin Temperature 1 MI15R 040156 Probe H100N Pulse 1 Oximeter User MSIR 110221 Manual H100N Pulse 1 Oximeter Reference MSIR 110222 Card 1 Carrying case MS1 110165 ziga H100N Pulse Oximeter User Manual Optional configuration including Introduction Quantity Items Parts No H100N Pulse Oximeter Service Manual MS1R 110223 i H100N Protective Cover MS1 110164 Rechargeable Ni MH 4 M21R 064133 battery package 1 Battery charger MS8 112410 Nellcor Reusable Adult SpO gt Sensor DS 100A 1 OxiMax MS2 30043 Weak Perfusion Resistance 38 H100N Pulse Oximeter User Manual Introduction Nellcor ReusableAdult Neonate SpO Sensor OXI A N 1 OxiMax M15 40096 Weak Perfusion Resistance Rectal Oral 1 M15R 040157 Temperature Probe H100N Patient Information management accessory package include IxCD USB cable User manual 39 H100N Pulse Oximeter User Manual Introduction The oximeter is compatible with Nellcor approved OxiMax Sensors and extension ca
39. ng a moist lint free cloth Disinfecting Clean the pulse oximeter before disinfecting it The recommended disinfectants include ethanol 70 isopropanol 70 glutaraldehyde type 2 liquid disinfectants 88 H100N Pulse Oximeter User Manu Maintenance WARNING Sterilization may cause damage to the equipment and is therefore not recommended for this pulse oximeter unless otherwise indicated in your hospital s servicing schedule CAUTION Never use EtO or formaldehyde for disinfection 89 H100N Pulse Oximeter User Manu Principles of Operation 7 Principles of Operation H100N Pulse Oximeter adopts non invasive double wavelength to measure SpO gt and PR It can perform spot measuring and continuous measuring for a short time It can also measure TEMP by a thermistor probe a semiconductor whose resistance changes with temperature The system consists of Central Processing Unit Signal Collection Signal Input Data Output Display and User Input module as shown in figure 7 1 Disphy Signal Input f Signal Collection CPU D Data Output User Input Figure 7 1 System Principle 90 H100N Pulse Oximeter User Manu Principles of Operation The oximeter communicates with external devices through RS 232 interface 7 1 Pulse Oximetry Measurement The oximeter uses oximetry to measure functional oxygen saturation in the blood Pulse oximetry works by applying sensor to a pulsating arteriolar vascular be
40. nition PIN Name Description 1 GND GND 2 LED LED drive signal IR Anode 3 LED LED drive signal Red Anode 4 TXD Sensor UART Tx Memory Return DigiCAL communication signal return signal return 31 lt H100N Pulse Oximeter User Manual Introduction 5 Detector Anode Detector anode connection 6 Inner Shield Detector shield to GND 7 Outer Shield Outer cable shield to GND 8 RXD Sensor UART Rx DigiCAL Memory Data communication signal 9 Detector Cathode Detector cathode connection 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 operation with the backlight and alarm on The oximeter does not support built in recharging mode The oximeter can also be powered by 4 1 2V Ni MH rechargeable batteries 39 H100N Pulse Oximeter User Manual Introduction Battery Installation To install the alkaline batteries 1 Make sure the oximeter is turned off 2 Press the battery compartment latch and remove the battery access door 3 Place four AA batteries as shown in the following figure first push it oriented as shown in then press it oriented as shown in 4 Install the battery compartment cover H100N Pulse Oximeter User Manual Introduction To install the rechargeable Ni MH battery package 1 Make sure the oximeter is turned off
41. nsible for freight insurance amp custom charges from EDAN to service claimer Out of warranty the service claimer is responsible for 98 H100N Pulse Oximeter User Manu Warranty and Service Policy any freight insurance amp custom charges for product Contact information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at support edan com cn 99 H100N Pulse Oximeter User Manu Specification Appendix I Specification A1 1 Classification Type of Protection Internally powered equipment EMC Compliance Class B Degree of Protection Type BF Applied part Ingress Protection IPX1 Mode of operation Continuous measuring and spot measuring Compliant with IEC 60601 1 1988 A1 A2 Safety Standards EN 60601 1 1990 A1 A2 IEC EN 60601 1 2 2001 A1 ISO 9919 EN 12470 4 A1 2 Specification A1 2 1 Size and Weight Size 160 mm L x 70 mm W x 37 6 mm H 100 H100N Pulse Oximeter User Manu Specification Weight 185 g without battery A1 2 2 Environment Temperature Working 5 C 40 C Storage 20 C 55 C Humidity Working 25 80 No coagulate Storage 25 93 No coagulate Atmospheric pressure Working 860 hPa 1060 hPa
42. pO2 Lo Alarm is set to less than 85 it will restore to 85 after the oximeter is turned on again Press the Up Arrow or Down Arrow button to increase or decrease values SpO Hi Alarm is always higher than SpO Lo Alarm by at least 1 Press the Function button and confirm the alarm range setup Press the On Off button to exit the menu and return to measurement state 59 H100N Pulse Oximeter User Manual Oximeter Operation 3 3 11 PR Alarm setup The user can use PR Hi Alarm and PR Lo Alarm in menu to adjust pulse rate alarm limits By default PR Hi Alarm and PR Lo Alarm in Neo mode are 200 and 100 respectively while they are 120 and 50 in Adu mode respectively Set the PR limits as follows Choose PR Hi Alarm in the menu press the Function button to enter setup The PR Hi Alarm box changes from real line to broken line The adjustable range of the upper limit of PR Alarm is from 1 the lower limit of PR Alarm to 300 Press the Up Arrow or Down Arrow button to increase or decrease values Choose PR Lo Alarm in menu press the Function button to enter setup The PR Lo Alarm box changes from real line to broken line The adjustable range for 60 H100N Pulse Oximeter User Manual Oximeter Operation the 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 le
43. r gives a high alarm for SpO gt or PR and gives a medium alarm for TEMP Here we take PR for example When the measured PR value is higher than the set PR Hi Alarm the oximeter gives a high alarm Make sure Alarm System in menu is set to ON A f 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 7 Lower than Lo Alarm limit If the measured value is lower than the Lo Alarm lower 76 H100N Pulse Oximeter User Manual Alarm alarm limit the oximeter gives a high alarm for SpO2 PR and gives a medium alarm for TEMP Here we take SpO for example When the measured SpO value is lower than the set SpO Lo Alarm the oximeter gives a low SpO gt alarm Make sure Alarm System in menu is set to ON A icon displays near SpO which indicates the measured value is lower than that of SpO Lo Alarm it will synchronously flash with SpO value Likewise when measured SpO is lower than SpO Lo Alarm or measured Temp is lower than Temp Lo Alarm it will also give an alarm 4 2 8 Alarm Silence If Alarm System in menu is set to ON pressing the Alarm Silence button the audio alarm will be off for the pause period set by the user but the visual alarm is still active eG ae H100N Pulse Oximeter User Manual Alarm When the audio alarm is off press Alarm Silence button to reactivate the audio alarm function 4 2 9 T
44. response is required Low level alarms The patient s vital signs appear abnormal or the oximeter system status appears abnormal indicate that operator awareness is required The levels for both technical alarms and physiological alarms are predefined and can not be changed by the user 271 2 H100N Pulse Oximeter User Manual Alarm Alarm Categories Table High i Medium Low Level Level Level Alarm Alarm Alarm SpO Too High SpO Temp Too Physiological Too Low High alarm PR Too Temp Too High Low PR Too Low SpO Sensor Unconnected T Technical emp SpO Sensor Sensor alarm off Abnormal Low Battery 92 H100N Pulse Oximeter User Manual Alarm Alarm Indicators When an alarm occurs the oximeter will indicate it through the following indications Character flash Alarm tone High level alarms character flashes quickly and sounds triple double triple double beep Medium level alarms character flashes slowly and sounds triple beep Low level alarms character display constantly and sounds a single beep 4 2 Alarm Conditions 4 2 1 Alarm Off Before the First Measurement Before the first measurement the alarm system is 932 H100N Pulse Oximeter User Manual Alarm configured to be off At this time if the SpO2 or Temp sensor is unconnected or the sensor is off the oximeter will not give an alarm 4 2 2 Alarm for SpO2 Sensor Unconnected When the
45. s a problem consider using the MAX R OXIMAX sensor or the MAXFAST OXIMAX sensor The MAX R OXIMAX sensor obtains measurements from the nasal septal anterior ethmoid artery an artery supplied by the internal carotid These OXIMAX sensors may obtain measurements when peripheral perfusion is relatively poor 84 H100N Pulse Oximeter User Manu Maintenance 6 Maintenance The oximeter does not require calibration If the service is necessary contact qualified service personnel or your local the manufacturer representative Before using the oximeter 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 that the oximeter is in good condition If you find any damage on the oximeter stop using the oximeter on the patient and contact the biomedical engineer of the hospital or Customer service immediately The overall check of the oximeter including the safety check should be performed only by qualified personnel once every 6 to 12 months and each time after fix up 85 H100N Pulse Oximeter User Manu Maintenance All the checks that need to open the oximeter should be performed by qualified customer service technician The safety and maintenance check can be conducted by persons from this company You can obtain the material about the customer service contract from the loc
46. s supplies buildings used IEC EN61000 3 3 for domestic purpose A2 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the oximeter should assure that it is used in such an environment Emissions test Compliance Compliance Electromagnetic level environment guidance Electrostatic Floors should be 6kV discharge ESD _ 6kV contact wood concrete contact IEC EN61000 4 2 8kV air or ceramic tile If 8kV air floors are 107 H100N Pulse Oximeter User Manu EMC Information covered with synthetic material the relative humidity should be at least 30 Electrical Fast 2kV for Transient Burst power supply TEC EN61000 4 4 lines N A 1kV for input output lines gt 3m Surge 1kV for line TEC EN61000 4 5 to line N A 2kV for line to ground Mains power quality should be that of a typical commercial or hospital environment 108 H100N Pulse Oximeter User Manu EMC Information Voltage dips short interruptions and voltage variations on power supply input lines IEC EN61000 4 11 lt S5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip
47. s 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 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 H100N Pulse Oximeter User Manual Safety
48. t In order to avoid endangering the patient s life the user should use this function cautiously 57 H100N Pulse Oximeter User Manual Oximeter Operation 3 3 10 SpO2 Alarm Setup The user can choose SpO Hi Alarm and SpO Lo Alarm in menu to adjust SpO alarm limit Press the Up Arrow button or Down Arrow button to increase or decrease alarm limit By default SpO2 Hi Alarm and SpO Lo Alarm in Neo mode are set to 95 and 90 respectively while they are 100 and 90 in Adu mode respectively Set the SpO alarm limits as follows Choose SpO Hi Alarm in the menu and press the Function button to enter setup The SpO2 Hi Alarm box will change from real line box to broken line box The adjustable range for upper limit of SpO2 is from 1 the lower limit of SpO 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 set to higher than 95 it will restore to 95 after the oximeter is turned 58 H100N Pulse Oximeter User Manual Oximeter Operation on again Press the Up Arrow or Down Arrow button to increase or decrease values Choose SpO Lo Alarm in the menu press the Function button to set it The SpO2 Lo Alarm box will change from real line box to broken line box The adjustable range for the lower limit of SpO Alarm is from 0 to the upper limit of SpO2 Alarm 1 If the value of S
49. ter may fail to provide SpO if hemoglobin levels fall below 5 gm dl Saturation The oximeter displays saturation level between 1 and 100 Pulse rate The oximeter displays pulse rate between 20 and 300 beats per minute bpm The sensor accuracy ranges do not apply to pulse rates above 300 bpm Detected pulse rates less than 20 are shown as 0 80 H100N Pulse Oximeter User Manu Performance Considerations Temperature The oximeter normally displays temperature from 0 C to 50 C there are abnormal state if the temperature is out of the range 5 3 OxiMax Sensor Performance Considerations Inaccurate measurements can be caused by Incorrect application of the OxiMax sensor Placement of the OxiMax sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line Excessive patient activity Intravascular dyes such as indocyanine green or methylene blue Externally applied coloring such as nail polish or 81 H100N Pulse Oximeter User Manu Performance Considerations pigmented cream Failure to cover the OxiMax sensor site with opaque materials in high ambient light conditions Venous pulsation Dysfunctional hemoglobin Low perfusion Loss of pulse signal occurs for the following reasons The OxiMax sensor is applied too tightly Defibrillation A blood pressure cuff is inflated on the same extremity as the one with the OxiMax sensor att
50. teries or four 1 2V Rechargeable Ni MH AA batteries It can clearly display all the parameter information on LCD P 98 Teme PR 36 8 700m 18 30 ADU 10 100 Figure 2 1 H100N Pulse Oximeter For the oximeter PatientCare Viewer Data Management Software is optional 20 H100N Pulse Oximeter User Manual Introduction 2 2 Panels Introduction This section identifies the symbols controls displays and buttons on the front panel and rear panel of the oximeter 2 2 1 Symbols on Screen 400 7 TEMP PRT 36 5 1880 04 59 Neo 6G OS Figure 2 2 Large Numeric Mode Figure 2 3 Waveform Mode Soy H100N Pulse Oximeter User Manual Introduction Icons on display screen and their meanings SpO SpO gt value display area PR Pulse Rate value display area Temperature value display area 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 Low battery icon Audio alarm off icon amz 7 2 H100N Pulse Oximeter User Manual Introduction oes Alarm off icon Data st i Fy ata 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 Information area E SpO sensor un
51. tter MHz 7 wW j Bg d pg V 1 d Bg E 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 118 H100N Pulse Oximeter User Manu EMC Information For transmitters rated at a maximum output power not listed above the recommended separation distance d 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 manufacturer NOTE1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 119 H100N Pulse Oximeter User Manu Record Table Appendix III Record Table ID No Name Time SpO PR Temp NOTE 120 H100N Pulse Oximeter User Manu Abbreviations Appendix IV Abbreviations Abbr English Full Name Description CISPR International Special Committee on Radio Interference EMC Electromagnetic Compatibility ID Identification IEC International Electrotechnical Commission LCD Liquid Crystal Display LED Light Emitting Diode MDD Medical Device Directive PC Personal Computer PR Pulse Rate RF Radio Frequency SpO Arterial Oxygen Saturatio
52. urning off Alarm System After Alarm system is turned off the oximeter can not give a visual and an audio alarm except for low battery icon alarm Set Alarm system to ON the alarm system will be active It will give an audio alarm and a visual alarm if an alarm occurs 4 2 10 Alarm Priority Only one kind of alarm can be given at once For example if a medium alarm and a high alarm occur at the same time the high alarm will take priority 78 H100N Pulse Oximeter User Manu Performance Considerations 5 Performance Considerations 5 1 Performance Verification Qualified service personnel are responsible for performance verification procedures before the oximeter is used for the first time in a clinical setting 5 2 Oximeter Performance Considerations There are some patient conditions that can affect the oximeter s measurements Dysfunctional Hemoglobins Dysfunctional hemoglobins such as carboxyhemoglobin methemoglobin and sulfhemoglobin are unable to carry oxygen SpO readings may appear normal however a 79 H100N Pulse Oximeter User Manu Performance Considerations patient may be hypoxic because less hemoglobin is available to carry oxygen Further assessment beyond pulse oximeter is recommended Anemia Anemia causes decreased arterial oxygen content Although SpO readings may appear normal an anemic patient may be hypoxic Correcting anemia can improve arterial oxygen content The oxime
53. 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 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 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
54. ximeter Operation If the password is wrong the following dialog box will pop up Wrong Password Please Retry Figure 3 8 Wrong Password If the password is right the following menu will display angquage ENG emp Unit C Time Setup gt Return Figure 3 9 User Maintain Language the user can select language to be displayed Temp Unit the user can set the temperature unit to Cor F Time Setup gt gt select this item the following 53 H100N Pulse Oximeter User Manual Oximeter Operation interface displays 2008 01 01 18 56 59 Confirm Cancel Figure 3 10 Time Setup 3 3 7 Default Config Choose this item to resume factory default configuration A dialog box pops up Menu items will adopt the factory default configuration Yes YES Figure 3 11 Factory Default Config Factory Default Configuration is shown as follows System Mode bo Patient Type ADU 54 H100N Pulse Oximeter User Manual Alarm System Alarm Volume Pulse Volume Audio Paused s SpO2 Hi Alarm SpO2 Lo Alarm PR Hi Alarm PR Lo Alarm Temp Hi Alarm Temp Lo Alarm Patient ID No Data Storage 3 3 8 Sensitivity Oximeter Operation ON 60 100 90 120 50 39 36 OFF The SpO2 reading is the average of data collected within a specific time You can set the Sensitivity to Hi or Low via the menu The higher the sensitivity is the quicker

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