User Manual - nu-beca
Contents
1. PC Mode F sali STEPS For retrieving the recording data L J from the oximeter for POE101B only please connect the USB cable within the package from the micro USB port of POE101B to a computer The oximeter will then show PC mode At this moment POE101B will act only as data storage device and has no more oximetry function After the USB cable is pull out the device will turn off and its oximetry function will be restored Please consult with your local distributor for its download instruction CAUTION For electrical safety and data downloading quality please only use the USB cable enclosed within POE101B package MAINTENANCE AND STORAGE e Remove the batteries inside the battery compartment if the oximeter will not be operated for more than one month It is best to preserve the product in a place where ambient temperature range is from 30 C to 70 C 22 F to 158 F humidity range from 15 to 90 and atmospheric pressure range from 700 hPa to 1013 hPa e The commercially available bench top functional testers and patient simulators may only be suitable to validate the pulse rate but may not be able to verify the proper oximetry of this pulse oximeter Please consultant with your distributor or the manufacturer proper model and the usage of functional testers and patient simulators for this oximeter Furthermore the testers and simulators may be usefu2. Usage life gt 24 hrs typical operation under default settin Atmospheric Pressure Ambient Temperature Operating 5 Cto40 C 41 Fto104 F Storage 30 Cto 70 C 22 Fto158 F Operating amp storage are both 700 hPa to 1013 hPa Humidity Degree of Electrical Protection ype Operating amp storage are both 10 to 90 non condensing This device has been tested under compliance with IEC 60601 1 IEC60601 1 2 IEC80601 2 61 and ISO 10993 requirements e Turn off the oximeter before cleaning e Clean through the entire device include the finger contact spot before use e Wipe the surfaces with a soft cloth damped with a mild detergent or isopropyl alcohol solution If low level disinfection is required a cloth damped with 10 bleach 90 water solution may also be used Do not use undiluted bleach or any cleaning solution other than those recommended here as permanent damage could result e It is recommended that the oximeter should be kept in a dry environment anytime High moisture might affect its lifetime and damage the oximeter C 0434
3. heca POE101B C Fingertip Pulse Oximeter User Manual Ver 1 0 March 2013 SYMBOL INFORMATION fec ree Authorized representative EU X Separate collection for electrical and electronic devices EEE CE Marking CE Read instructions before use Do not use if package is damaged Serial number Resistant to liquid ingress Type BF not defibrillator proof SN IPX2 Caution consult accompanying documents POE101 includes the following items A Fingertip Pulse Oximeter 1 unit B User Manual 1 sheet C Quick reference card 1 piece D Warranty Card 1 piece E AAA Size Alkaline Battery 1 piece F USB cable 1 piece for POE101B only Please make sure all items are packed All items are non sterile If any item missing or damaged contact your distributor DISPLAY INTERFACE Memory Icon Indicate data is Audio Icon recording Indicate audio only for POE1018B reminder is on Battery Icon Indicate the battery ower SpO2 Alarm 7 Turn RED as how SpO2 Sp02 C in sufficient alarm range Percentage BPM Alarm 99 of oxygen Show pulse rate 86 saturation alarm range B SpO2 LERN T Pulse rate Ne 40 BPM Timer Indicator IAM fa SpO2 only turn on at waveform device startup JJ Pulse Amplitude Indicate the strength of the signa
4. Timer gt Alarm gt lt 2 gt Beat gt Record gt Date gt Default gt lt 4Exit NS 2 Setup the initial timer The oximeter provides a simple timing mechanism at the beginning of each measurement For this feature users can set the timing period to be 30 seconds 1 minute or turn it off pulse rate Users can set the recording interval as 30 seconds 1 minute 5 minutes or turn it off The correspond ing time will be from 24 hours to 10 days For delete all the memory please select Clear All for it N lt Exit Setting Brightness gt Timer gt Alarm gt Beat gt Clear All Date gt Default gt lt 4Exit 6 Set date and time only for POE1018B lt Exit Setting Date Brightness gt Timer gt Month 01 gt Alarm gt Day lt 01 gt Beat gt Hour lt 12 gt Record gt Min 00 gt Date gt Sec lt 00 Default gt Exit J J C J depending on the measuring conditions During normal measurement conditions the averaging time is three to six heart beats POE101 automatically adjusts the signal processing during degraded conditions such as low perfusion ambient light electromagnetic interference and patient motion which results in an increase in the dynamic averaging beyond 10 heart beats or may reach 40 heart beats Pulse Amplitude Indicator The Pulse A
5. XQ CAUTION e This oximeter is not an apnea monitor e Significant levels of dysfunctional hemoglobin such as carbonxyhemoglobin gt Setup the Device The device allows user to setup the 1 OLED brightness 2 initial timer option 3 SpO2 amp pulse rate alarm range 4 audio reminder 5 data recording interval 6 date amp time and 7 factory default by LONG pressing the key The setting mode can be entered either when the device is off or under operation CAUTION ip QKey right to enter a sub menu For exit tip it left at Exit selection Under adjustment menu tip OKey right or left to increase or decrease value or change selection and press down for confirma tion ee Brightness gt Timer gt Alarm gt Beat gt Record gt Date p 1 Adjust the brightness Default gt Tip OKey right to enter Z Exit Setting Alarm Brightness gt Timer gt SpO2Hi 99 SpO2L0 lt 86 gt Beat gt PRLo lt 40 gt Record gt PRLo lt 1 70 gt Date gt Default gt lt 4Exit NS 4 Setup the audio reminder The oximeter can give a audio pulse sound Please use this submenu to turn it on off Exit Setting Brightness gt Beat Timer gt Sound Alarm gt Record gt Date gt Default gt J lt Exit G W 5 Setup the data recording interval only for POE101B
6. with a new battery Verify correct battery orientations Finger might be trembling or place incorrectly Keep the finger steady or align the finger inward at veritcal middle of the device Display lockup or blank If the device is on a finger changes will appear at wave form or pulse amplitude bar OLED displays is malfunction discontinue using the device The reading might not be reliable Electromagnetic interference EMI devices away Remove the surrounding electronic Finger might be trembling or place incorrectly Keep the finger steady or align the finger inward at veritcal middle of the device No reading of SpO2 or pulse rate and shows dash line Low finger pulse quality please try the following 1 Reposition the finger 2 Warm the finger by rubbing 3 Select another finger If it shows less than 2 amplitude bars SpO2 or pulse rate alarm appears A patient s condition is abnormal this patient Provide immediately mdeical attention to Date amp time or initial timer is not correct The internal 0 004 correct date amp time variation from timming circuit Enter the setting mode and setup to Timing circuit is malfunction Replace with a new battery Unable to enter the setting mode The battery power is low key might be the battery Try to restart the device through reinstall Low battery 0
7. The oximeter can record the SpO2 and POE101 is intended for measuring functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate for both adults and children as non invasive spot checking and continuous monitoring in home and professional caring environment and transport and mobile environment It is designed for fingers between 0 8cm and 2 3cm 0 3 inch 0 9 inch and for patients during no motion condition PRINCIPLE OF OPERATION p gt physiological Principle POE101 determines SpO2 by measuring the absorption of red amp infrared light passing through perfused tissue Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate p Data Update and Signal Processing POE101 in the algorithms automatically extends the amount of data required for measuring SpOQ2 and pulse rate WARNINGS e Do not use the oximeter in an MRI or CT environment e The oximeter is intended as an adjunct in subject assessment It must be used in conjugation with other methods to assess clinical signs and symptoms e Do not use the oximeter in an explosive atmosphere to avoid explosion hazard e If the monitoring sites have trauma disability or other medical conditions users should consult doctors before use e The oximeter has to measure the pulse properly to obtain accurate SpO2 reading Blood flow restrictors e g blood pressure cuffs may hinder pulse measu
8. and pulse rate reading Users can select the different SoO2 high SpO2 low pulse rate PR high and pulse rate low limit to trig the alarm or turn it off under this submenu Please refer to SPECIFICATION table for allowable setting range of the different parameters The alarm range will be shown next to the measurement on the display when the alarm option is turned on The date and time will be collect with each measurement Please make sure it is correct before recording 7 Back to factory default setting The option takes all of the setting except date amp time back to the factory default It only resets the parameters and does not be erased the recording data Exit Setting Date Brightness gt Timer gt Month 01 Alarm gt Day 01 Beat gt Hour 12 Record gt Min 00 gt Date gt Sec 00 Default gt lt 4Exit SS Parameter Default Setting Brightness _ Level 2 Timer Off Alarm SpO2 Hi off SpO2 Lo 87 PR Hi off PR Lo off Beat sound On Record Off CAUTION 1 POE101 can be operated by either a patient or a trained personnel Consult healthcare professionals before use 2 The oximeter might not work on cold extremities due to poor circulation Please warm or rub the finger or reposition the device to improve it Check the applied site of a patient frequently to evaluate body circulation a
9. appears on display malfunction The battery power is low Replace with a new battery If you have followed the actions recommended above but the problem keeps unresolved please call you agent for assistance SPECIFICATION Symbols and terminology m SpO2 The symbol shows the oxygen saturation in percentage m BPM The pulse rate symbol shows pulse rate in beats per minute E Pulse Amplitude It shows the strength of signal being detected by the oximeter m Battery condition symbol When gt Is shown battery is at low voltage m 30 Initial Timer A timing icon appears at the beginning of each measurement for breath timing m a Audio is on The symbol indicate audio alarm and beating sound option is turned on Data recording is on for POE101B only Record SpO2 and pulse rate measurement with corresponding date and time CLEANING THE OXIMETER Cleaning is as important as proper use For surface cleaning and disinfecting the oximeter please refer to the following procedures properly evaluate the accuracy of a system s SpO2 measurements CAUTION e Do not spray pour or spill any liquid on the oximeter accessories switches or openings e Do not use caustic or abrasive cleaning agents on the oximeter e This is a precision medical instrument and must be repaired by qualified personnel from manufacturer only e Please follow local governing ordinances and recyclin
10. g instructions regards disposal or recycling of the device and components e Manufacturer will provide at least 3 years product service after manufacturing Dimension amp Weight Without battery lt 26g L 67 5 mm 2 63 x W 38mm 1 48 x H 25mm 0 98 0 92 ounces Display Full color OLED display Auto on off Input Key When a finger is inserted urns on automatically vise verso the device turns off when the finger is removed A 5 directional key for screen rotate and device setting Measurement Method Dual wavelength LED 660 nanometers 0 8mW and 940 nanometers 1 2mW both as max average SpO2 Range amp Resolution Range 0 to 100 Resolution 1 SpO2 Accuracy Range 0 to100 2 less than 70 unspecified Pulse Rate Range amp Resolution Range 30 to 250bpm resolution 1bpm Alarm Range Pulse Rate Accuracy 1bpm or 1 whichever is greater High SpO2 alarm default off range 80 100 Low SpO2 alarm default 87 range 50 95 High heart rate alarm default off range 75BPM 250BPM Low heart rate alarm default off range 30BPM 110BPM Data Storage Store SpO2 and pulse rate reading with corresponding date and time for up to 960 sets of data 8 hours to 3 5 days USB Port POE101B only USB2 0 with Micro USB connector Water resistance Against water splash IPX2 Approved Battery Type 1 AAA size alkaline battery
11. l for verifying that the pulse oximeter being incapable of providing the data required to on automatically K after finger is inserted STEP3 If timer indicator option is on it will start to count down right away The time left will be showed in the square beneath BMP When time is up OFF will be showed This feature can serve as timer for patients or care givers to keep track of the breath rate or other Spo2 h applications By remove the finger 99 from the device and insert it back it can re trig the timer BPM BPM S Y STEP4 After detecting the pulse signal the oximeter shows SpO2 and pulse rate on the display The readings will be updated based on the signal received with each pulse If pais on the beat sound will be generated STEP5 If the alarm option I is on the SpO2 and pulse rate PR Aa alarm range will be Bsn p oe showed on the left gt P Veen side beside the PR HieH 470 SpO2 and pulse rate PRLo lt 40 reading Normally alarm condition delay is less than 7 heart beats for SpO2 and less than 6 heart beats for pulse rate after oximetry condition is altered in the finger For alarm signal generation delay TROUBLESHOOTING Problem Possible Causes Solutions The oximeter won t turn on The battery is dead The battery is installed incorrectly Replace
12. mplitude Indicator indicates pulse beat and shows the relative non normalized pulse amplitude As the detected pulse becomes stronger the bar will go higher with each pulse SpO2 Waveform Display Similarly when a waveform is selected the display provides the non normalized real time sensor signal The relative pulsatile strength and quality of the incoming signal can be observed DEVICE FEATURES Full color OLED display Setting amp Direction Key Press to setting and direction key to rotate the screen Micro USB AEN Port onlyfor X 4 POE101B of the oximeter Please remove the plastic membrane to allow the OLED display to show its best performance gt Battery Replacement Before start any measurement please make sure the battery power is sufficient and the setting is correct If not please refer to the following procedures Make sure the oximeter is off when replacing the battery The device is powered by one AAA size alkaline battery Please press the 0000 mark on the battery cover to open it up and installing a new battery 4 CAUTION Please dispose the battery according the proper procedure e D k N lt Exit Setting Brightness gt Timer Timer gt Alarm gt Beat gt Record gt Date gt Default gt lt 4Exit S J SA 3 Setup SpO2 and pulse rate alarm range POE101B C provide alarm option for abnormal SpO2
13. nd skin sensitivity The recommended maximum applied time at a single spot is 4 hours Misapplication of the oximeter on applied site with excessive pressure for prolonged periods can introduce pressure injury OPERATION STEP1 Open up the oximeter and put one of your fingers into the opening Please make sure that your finger face up and touch the bottom of the opening before releasing the clamp OJ it is less than 100 milliseconds for both SpO2 and pulse rate Ifthe function is completed turned off the icons will not be showned at all STEP5 During the opera tion If you tip key up down left or right the screen will rotate in its direction to allow users viewing the results in desired view angle STEP6 Press the Key on top and the device will enter the setting mode CAUTION If the device experiences a data or alarm condition update period exceeding 30 seconds the display will shows RED 00 for both SpO2 and pulse rate reading STEP7 If the finger is not detected or removed the oximeter will show FingerOut As the finger keeps to be undetectable the device will turn off automatically in about 3 seconds STEP8 If the data recording option is on for POE101B only will be showed on the display and the SpO2 and pulse rate measurement with corresponding date and time in a preset interval will be recorded within the oximeter
14. rements Remove any objects that may hinder the performance of the oximeter e Please do not leave the device to a child and always keep the battery cover in attach to avoid swallowing by a child e Federal law USA restricts this device to sale by or on the order of a physician or methemoglobin may affect the accuracy of the measurement e Cardio green and intravascular dyes may affect the accuracy of POE101 e The performance of the oximeter might be affected by the presence of a defibrillator e The oximeter may not work on all subjects If you are unable to achieve stable readings please discontinue use e The oximeter has motion tolerant algorism to minimize the possible motion artifact However the oximeter may be still interpreted by motion Please minimize subject motion as much as possible e All the materials of the oximeter in contact with a patient or a user have passed ISO10993 Biological evaluation of medical devices accordingly It shall be no toxicity harm to children pregnant or nursing women gt First Time Use For the first time use a protective plastic membrane is attached to the front panel the sub menu please select among level 1 4 to adjust OLED brightness Level 4 is the brightest and level 1 is the lowest Please select higher level for high ambient light environment and lower level for power conservation press down for confirmation Z G N lt Exit Setting Brightness
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