This Manual is written and compiled in accordance with the council
Contents
1. typical medical installation Due to the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare environments it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device Examples of noise sources in healthcare environments that could cause electromagnetic interference are e electrosurgical units 21 RX101 PPG Recorder Instruction Manual e cellular phones e mobile two way radios e electrical appliances e high definition television The monitor is not designed for use in environments in which the pulse can be obscured by electromagnetic interference During such interference measurements may seem inappropriate or the monitor may not seem to operate correctly Disruption may be evidenced by erratic readings cessation of operation or other incorrect functioning If this occurs the site of use should be surveyed to determine the source of this disruption and the following actions need to be taken to eliminate the source Turn equipment in the vicinity off and on to isolate the offending equipment e Reorient or relocate the interfering equipment e Increase the separation between the interfering equipment and this equipment The monitor generates uses and can radiate radio frequency energy If it is not installed and used in accordance with these instructions RX 101 may cau2. Sense e Decide e Act RX101 PPG Recorder Instruction Manual Version 1 3 I Version Control May 12 2012 Initialize first draft 1 0 Set table of content May 20 2012 Complete User Instruction m MN ko May 21 2012 Complete Safety and Introduction ed ko June 28 2012 Complete Frist Draft r T II User Instructions This Manual is written and compiled in accordance with the council directive MDD93 42 EEC for medical devices and harmonized standards In case of modifications and software upgrades the information contained in this document is subject to change without notice The Manual describes in accordance with RX101 PPG Recorder s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details Please read the User Manual carefully before using this product The User Manual which describes the operating procedures should be followed strictly Failure to follow the User Manual may cause measuring abnormality equipment damage and human injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality personal injury and equipment damage due to users negligence of the operation instructions The manufacturer s warranty
3. To clean and disinfect a reusable sensor probe e read the directions for use enclosed with the sensor probe Each sensor probe model has cleaning and disinfecting instructions specific to that sensor 24 RX101 PPG Recorder Instruction Manual 10 Menu Structure RX101 PPG Recorder Menu Structure Settings Menu y Brightness Alarm ID Record Wireless Dir SPO2 ALM HI m POZ ALM LO PR ALM HI PR ALM LO Alarm Pulse Sound Exit Figure 12 Settings Menu Structure 25 RX101 PPG Recorder Instruction Manual 11 Principle of Operation This PPG Recorder is powered by lithium polymer battery In addition to viewing the data on the built in OLED display data can also be transmitted via Bluetooth to other portable electronic devices such as computers tablets or smart phones The device algorithm is based on the absorption difference of red and infrared light by oxy hemoglobin HbO2 and deoxy hemoglobin Hb and the Lambert Beer Law The device design is based on photo oximetry and volumetric pulsatile flow monitoring technique By transmitting two different wavelength of light through a fingertip pulsatile flow signals are collected using a photo detector The signal is then processed via the on board microcontroller and the result is displayed on the built in OLED screen Glow and Infrared ay Emission Tube Glow and Infrared ray Receipt Tube Figure 13 Principle of Operation of the PPG Rec
4. default setting To access the device MENU please refer to chapter 6 1 for reference The device may not obtain accurate readings on all users When the device is connected with USB cable always pick up the device itself and do not hold it by the USB cable Stopping using the device if the device is unable to obtain stable readings 7 RX101 PPG Recorder Instruction Manual 2 Introduction A WARNING Do not make any clinical judgments based on RX101 The monitor is intended only for health and wellness applications 2 1 Intended Use The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood also known as the O concentration in the blood It is an important bio parameter for the respiration In addition to O Saturation the device can also measure heart rate and record the heart waveform AKA photoplethysmogram The device brings excellent value for scientific research education and health and wellness applications To operate the PPG Recorder simply clip the recorder on a finger and the photoplethysmogram heart rate and oxygen saturation will display on the LED screen of the device 2 2 Key Features A Easy to operate using the Home Button located next to the LED screen B Rechargeable battery C Low power consumption D Support wireless data transmission of heart rate Oxygen Saturation and heart waveform photoplethysmogram 2 2 Application and Scope The PPG Recorder measures oxygen s
5. recommended 7 2 Anemia Anemia causes decreased arterial oxygen content Although SpO2 readings may appear normal an anemic person may be hypoxic Correcting anemia can improve arterial oxygen content The PPG Recorder may fail to provide a SpO2 reading if hemoglobin levels fall below 5 gm dl 7 3 Saturation SpO The monitor displays saturation levels between 1 and 99 7 4 Pulse Rate PR The monitor displays pulse rates between 30 and 250 beats per minute The sensor accuracy ranges do not apply to pulse rates above 230 bpm Detected pulse rates below 30 are shown as 0 7 5 Other Inaccuracy Causes e incorrect application of the PPG Recorder e placement of the PPG Recorder on an extremity with a blood pressure cuff arterial catheter or intravascular line e excessive patient activity e intravascular dyes such as indocyanine green or methylene blue e externally applied coloring such as nail polish or pigmented cream e venous pulsation e dysfunctional hemoglobin e low perfusion 7 6 Other Pulse Signal Loss Causes e testee s finger not inserted into the PPG Recorder sufficiently e defibrillation e a blood pressure cuff is inflated on the same extremity as the one with the PPG Recorder attached e there is arterial occlusion proximal to the PPG Recorder e poor peripheral perfusion e loss of pulse cardiac arrest 19 RX101 PPG Recorder Instruction Manual 7 7 To use RX101 PPG Recorder e Apply the sensor as direc
6. Battery status is at the verge of self shutdown Ooo W amp W Charging Indicator behind lanyard through hole A WARNING If the alarm function is on the device will provide high priority alarm signal when the battery is in low power status Intermittent alarm will occur and the battery icon turns red in the state of flashing High priority indicats that immediate response by the operator is required 5 3 Battery Charging There are two battery charging methods a Connect the device to a computer using the USB Cable b Connect the device to the enclosed DC power adaptor using the USB Cable 12 RX101 PPG Recorder Instruction Manual 6 RX101 Operation The parameters of RX101 are set at the factory according to Table 2 The parameters can be customized for each individual user Parameters remain in effect until changed by the user Table 5 Default Parameter Settings Parameter Value Range Default SpO2 Upper Alarm Limit 85 100 99 SpO2 Lower Alarm Limit 0 99 85 Pulse Rate Upper Alarm Limit 50 234 150 Pulse Rate Lower Alarm Limit 0 150 50 Alarm On Off Off Pulse Beep On Off Off LED Display Brightness 1 4 3 Data Recording On Off Off Wireless On Off Off ID Any four alpha numeric characters User can only be set using RX101 software 6 1 Turn on RX101 6 1 2 Discussion The software version appears in the monitor display each time when it successfully completes the power on self test Write the number down so it is available
7. Description 1 RX101 PPG Recorder A finger PPG Recorder 1 USB Cable For charging RX101 1 Lanyard To wear the PPG Recorder as a pendant 1 Instruction Manual The instruction manual is included in the mini CD or is downloadable on www reflexwireless com 1 Quick Start Guide This is a simplified version of the instruction manual 4 2 Inaccurate Monitor Measurements Physiological conditions medical procedures or external agents that may interfere with the PPG Recorder s ability to detect and display accurate measurements include incorrect application of RX101 PPG Recorder placement of RX101 record clip 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 agents such as nail polish dye or pigmented cream 11 RX101 PPG Recorder Instruction Manual 5 Battery Operation Ax WARNING Dispose of battery in accordance with local ordinances and regulations 5 1 Battery Power RX101 uses rechargeable Lithium Polymer battery to power the PPG Recorder Depending on usage the battery can last from 5 hours to 40 hours per charge cycle The battery will drain faster if the Bluetooth connectivity 1s switched on 5 2 Battery Indicator Below are the five battery statuses Power supply by battery only and battery status is full Battery status is not full Low power alarm indicator O ee
8. and Pulse Perfusion may be too low for the PPG Recorder to track the pulse Rate are not shown or Check the patient Use the monitor on yourself Change the measurement not stabilized after 10 site Try another sensor seconds e Interference due to patient activity may be preventing the PPG Recorder from tracking the pulse Keep the patient still if possible Verify that the PPG Recorder is securely applied and replace it if necessary Change the measurement site e The sensor may be too tight there may be interference due to ambient light or the sensor may be on an extremity with a blood pressure cuff arterial catheter or intravascular line Reposition sensor as necessary e Electromagnetic interference may be preventing the monitor from tracking the pulse Remove the source of interference There is no response to Ensure that the Home Button is fully depressed the Home Button e The batteries may be fully discharged The LED display Please recharge the battery suddenly turns off The device operation 1 Please recharge the battery time appears to be 2 Please contact the local service center shortened 8 2 EMI Electromagnetic Interference Caution This device has been tested and found to comply with the limits for medical devices to the EN60601 1 2 second edition and the Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in a
9. rubber cannot use this device RX101 is not defibrillator proof However it may remain attached to the testee s finger 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 caregiver should not hold RX101 while using a defibrillator on a person To ensure accurate performance and prevent device failure do not subject RX101 to extreme moisture such as direct exposure to rain Such exposure may cause inaccurate performance or device failure Please do not use the device during charging This device can only be matched with compatible probe 6 RX101 PPG Recorder Instruction Manual 1 3 Cautions Q Cautions are identified by the CAUTION symbol shown above Cautions alert the user to exercise care necessary for the safety and effective use of RX101 909090 0 handheld PPG Recorder All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements Keep the PPG Recorder away from dust vibration corrosive substances explosive materials hightemperature and moisture If the PPG Recorder gets wet please stop operating it If the device was previously stored in cold environment please wait for the device to accustom to the environment before using DO NOT operate the button on front panel with sharp materials High temperature o
10. when you request technical assistance Caution During the Power On Self Test immediately after power up confirm that the LED display and icons are shown and the monitor speaker sounds a one second tone A WARNING If do not hear the pass tone do not use RX101 6 1 2 Procedure 1 Press the Home Button for two seconds ReFlex m 2 See the opening screen with the software version number located on the lower right hand corner 3 Wait for 60 seconds for the data to become stabilized if the device has not been used for over two hours Auto shut off 4 The device will shut off automatically after 3 seconds of inactivity 13 RX101 PPG Recorder Instruction Manual Figure 3 Clip the PPG Recorder on the Forefinger To obtain good reading always try clipping the sensor on the forefinger first If unable to obtain readings try clipping the sensor on the thumb to increase contact area between the sensor and the body part 6 2 Menu Access Press the Home Button as shown in figure 1 page 4 for 2 seconds to access the Settings menu This area allows users to modify various device settings such as alarm pulse indicator backlight data storage and user ID The procedure is as follows Figure 4 Settings Menu 6 3 Adjust LED Display Brightness Press the Home Button for 2 seconds to enter the Settings Menu Brightness is lighted with a blue rectangular bar indicating the menu item is currently se
11. FUNCTIONAL HEMOGLOBINA to sar AAA AAA 19 T2 ANEMIA etnon a a tk ak oie 19 7 3 SATURATION SPO ana 19 7 4 PULSE RAIE Pr E E E oes 19 7 5 OTHERINACCURACY CAUSES ana e E fa ba bek A ERAS 19 7 6 OTHER PULSE SIGNAL LOSS CAUSES io 19 dal TOUSERALO PPG RECORDER dls 20 7 8 HIGH AMBIENT LIGHT SOURCES THAT CAN INTERFERE WITH THE PERFORMANCE OF RX101 IV PPOFRECORDER ARES unta e o a e e kN da sa ef ae 20 8 TROUBLESHOOTIN Gia ie kika e kt kan bi RAI eka ko en aba nee kaka eko seke a 21 8 1 CORRECTIVE ACTIONS ss aa 2l 8 2 EMI ELECTROMAGNETIC INTERFERENCE scccceseccesececsscccescecenecceeceeeeceeeeceeeseceeness 21 8 3 TECHNICAL ASSIS TAN CF a 6000 tb s k aa 22 UE AAA ek ayo ao es sye eks taa boo pa sasa se e spes sazes A ARRE 23 9 1 RETURN RX ato 23 92 TORE LORIN THE Ral OV a acta 25 9 3 RVC Tik ko fo it ok ok e Tesi a n a kn pe n A ke oi ob pe an Aaa 23 9 4 PERIODIC SAFETY CHECKS shies n 23 9 5 LE ANNO f s its ka dak e at te ia a kt ka l nia 23 10 MENU SIRUC TURE ann a 25 12 SPECTET A TIONS iian a NEE EE aa oi 27 13 KEY SYMBOLS crie E A 28 14 DEVICE FUNCTUON Saa 29 APPENDIX oil ola bi vityi pasa RC a on abo ao aa oak ee a ae ea a a OR Site a ener 30 1 1 1 2 Safety Operation Procedures Check the main unit and all accessories periodically to look for visible damages that may affect patient s safety and monitoring performance It 1s recommended that the device be inspected once a week and when a damage is ob
12. ONTRANEL o al 9 3 2 TE AR DANE Ii fie a ak want is fa ko as a E a an a N 10 a SETUP OR RXTO La 11 4 1 EIST OP COMPONENTS cortadas irradia ltda 11 4 2 INACCURATE MONITOR MEASUREMENTS cccccccsssssseccececceeeseeccceeeeeeesseeceseesaueseeeeeeeeas 11 5 BATTERY OPERATION 000 ki osi ene en saka e kt ka en koi e e kane YOn ae kaba es ple 12 5 1 BATTERY POWER Sal de kis fib abse tit asye ka l im lis ik ak e tt kk kis sat d 12 3 2 BANIF RAY TD NO AM Il ae oak joli a a ki r aka a pk e cid a a r n a n a ko aso po 12 5 3 BATTERY CHARGING ds 12 6 RXLOLOPERA ULEAD nn A A 13 6 1 TURN ON RA LO Lao odiada 13 6 2 IVE NUNC O L Soti ik Yo kita po bene ao ia tina a os steacusa a be kok oo A a ina reta ot 14 6 3 ADIUST LED DISPLAY BRIGHTNESS 445500 tee da ossi am 14 6 4 SETALARM LIMI ki ad 15 6 5 ENABEE DISABEE PULSE SOUN Di iii kiy did deta atis kb bo la detzd aa 15 6 6 CHANGE US BRIDE a kis Ge a ta po ii 16 6 7 ENABLE DATA RECORDING UNDER REVISION 00tteeoeoooeoooooeoouooooneoooeoounoooneooooooneooneoouo 16 6 8 ENABLE BLUETOOTH COMMUNICATION ccccccssessssssecccccccssesscccccsecessseesccceseceseseseceaas 16 6 9 CHANGE SCREEN ORIENTATION spa daa 16 6 10 FREN SUN eta tie e OO o A e ii kan Deta e Saa es ea ett at 17 6 11 SOFTWARE OPERATION ida 17 6 12 CAUTIONS a to oo 17 6 13 CLINICAL RESTRICTON Sur aa a 18 7 PERFORMANCE CONSIDERA TION tet s spo sok les akyon dad essye soteasvesssadessspespasasosdssasasososeenssosoue 19 7 1 DYS
13. aturation and pulse rate through a person s fingers and toes in some cases It is designed to be used in scientific research education health and wellness applications A Warning The problem of over estimation may occur when the person is suffering from toxicosis which is caused by carbon monoxide Thus the device is not recommended to be used under this circumstance 2 3 Environment Requirements Storage Environment a Temperature 40 C 60 C b Relative humidity 5 95 c Atmospheric pressure SO0hPa 1060hPa Operating Environment a Temperature 10 C 40 C b Relative Humidity 30 75 c Atmospheric pressure 700hPa 1060hPa 8 RX101 PPG Recorder Instruction Manual 3 3 1 Front Panel Symbols Controls Display and Indicator This section identifies the symbols controls displays and indicators on RX101 Index Name SpO Lower Limit Home Button SpO Alarm Indicator Pulse Beat Sound Battery Indicator Charging Indicator Wireless Indicator Pulse Rate Pulse Amplitude Waveform Screen Wa A 5 6 7 na T 11 Figure 1 RX101 Front Panel Table 1 RX101 Front Panel Description Description Lower Limit Alarm Threshhold set in the Alarm Menu Use this button for Powering Up change Screen Orientation Scroll Down and other features Oxygen Saturation Reading To indicate 1f the alarm is on off or temporarily muted To indicate 1f the pulse beat sound is on off To sh
14. due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more sensitive to interference b For those with a substantial amount of staining dilution drug such as methylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate c The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor resulted in serious error of SpO measure d As the SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia some people with serious anemia may also report good SpO measurement 18 RX101 PPG Recorder Instruction Manual 7 Performance Consideration A WARNING PPG Recorder readings and pulse signals can be affected by ambient environmental conditions OXIMAX sensor application errors and patient conditions This section describes patient conditions that can affect the PPG Recorder s measurements 7 1 Dysfunctional Hemoglobins Dysfunctional hemoglobins such as carboxyhemoglobin methemoglobin and sulfhemoglobin are unable to carry oxygen SpO2 readings may appear normal however a person may be hypoxic because less hemoglobin is available to carry oxygen Further assessment beyond PPG Recorder is
15. ice Department it 1s not necessary to return the sensor probe or other accessory items with RX101 9 2 To return the RX101 1 Pack RX101 in its original shipping carton If the original carton is not available use a suitable carton with appropriate packing material to protect 1t during shipping 2 Return RX101 by any shipping method that provides proof of delivery 9 3 Service A Warning There are no user serviceable parts inside RX101 The cover should only be removed by qualified service personnel The monitor requires no calibration If service 1s necessary contact qualified service personnel or your local ReFleX Wireless Representative 9 4 Periodic Safety Checks It is recommended that the following checks be performed every 24 months e inspect the equipment for mechanical and functional damage e inspect the safety relevant labels for legibility 9 5 Cleaning Caution Do not spray pour or spill any liquid on RX101 or its accessories connectors switches or openings in the enclosure as this may damage the monitor You can surface clean and disinfect RX101 PPG Recorder and the sensor probe 23 RX101 PPG Recorder Instruction Manual To surface clean the monitor e use a soft cloth dampened with either a commercial nonabrasive cleaner or a solution of 70 alcohol in water e lightly wipe the surfaces of the monitor To disinfect the monitor e use a soft cloth saturated with a solution of 10 chlorine bleach in tap water
16. ing is down give the Home Button a few quick pushes to move the menu selector to one of the menu items Once the desired Alarm setting is highlighted push the Home Button for two seconds to decrease the alarm setting by 1 or push and hold the Home Button to keep decreasing the Alarm setting until the desired number is reached To increase the Alarm setting give the Home Button a few quick pushes until the menu selector highlights Dir and then pushes the Home Button for two seconds to set the adjust direction to Up Give the Home Button a few quick pushes to move the menu selector to the desired Alarm setting and then push and hold the Home Button to increase the Alarm setting A Warning If the alarm function is on the device will provide medium priority alarm signal when the data of SpO or pulse rate is beyond the limit Intermittent alarm will occur and the measurement shows in yellow A Warning Medium priority indicating that prompt operator response is required b Enable Disable Alarm Give the Home Button a few quick pushes until the menu selector highlights Alarm and then push the Home Button for two seconds to change the setting to on to turn on the Alarm Alert 6 5 Enable Disable Pulse Sound Give the Home Button a few quick pushes until the menu selector highlights Pulse Sound and then push the Home Button for two seconds to change
17. lected Push the Home Button again for two seconds to adjust the brightness to the next level The brightness level will rotate from 1 to 4 for each two seconds the Home Button is pushed If only push the Home Button for 1 quick second the menu selection bar the blue rectangular bar will move to the next menu item If this occurs please give a few consecutive quick pushes on the Home Button to return the menu selector back to Brightness To exit the Settings Menu simply give the Home Button a few quick pushes until the menu selector highlights Exit and then push the Home Button for two seconds to exit the menu Figure 5 Exit Settings Menu 14 RX101 PPG Recorder Instruction Manual 6 4 Set Alarm Limit Press the Home Button for 2 seconds to enter the Settings Menu Brightness is lighted with a blue rectangular bar indicating the menu item is currently selected Push the Home Button again for a quick second to enter the Alarm Menu Figure 6 Alarm Menu Access Figure 7 Alarm Settings Menu By default Dir is highlighted with its setting down This sets the adjust direction in the decreasing mode and allows user to adjust the Alarm Settings downward ie from 099 to 098 To change to increasing mode push the Home Button for 2 seconds while the menu selector is on Dir a The Highest Lowest Alarm Limit Setting Assuming the Dir sett
18. n specified in the software applications For Android applications they can be downloaded via Google Play search keyword AQWave As for the PC software please download it on WWW aQWavVe com 6 12 Cautions 0 Please check if the device is functioning properly prior each use Attach the sensor probe at the appropriate locations such as the one illustrated in figure 3 to ensure device reading accuracy The SpO sensor and photoelectric receiving tube should be arranged in a sequence such that the subject s arteriole is in between the light emitter and the light sensor The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or at a site where intravenous injection is applied Do not fix the SpO sensor with adhesive as it may be affected by venous pulsation and produces inaccurate measure of SpO and pulse rate Excessive ambient light may affect the measuring result This includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy of the sensor reading Please clean and disinfect the device after each use according to the User Manual 17 RX101 PPG Recorder Instruction Manual 6 13 Clinical Restrictions a Since the measurement is taken on the basis of arteriole pulse substantial pulsating blood flow of subject is required A subject with weak pulse
19. ntage of Oxygen Concentration Pulse rate 3 3 Beat per Minute Alarm sound disabled Pause the alarm sound indicator Alarm sound enabled Disable the pulse sound indication Open the pulse sound indication Power on off Menu Change Screen Orientation BF Type application part Serial number 1 The measured part falls off no measured part inserted 2 Probe error 3 Signal inadequacy indicator IPXI Ingress of liquids rank WEEE 2002 96 EC 28 RX101 PPG Recorder Instruction Manual 14 Device Functions Information Display Mode The Oxygen Saturation SpO 2 digit digital TFT display Calculate the Average value of every 4 measure value The deviation between average value and true value does not exceed 1 30bpm 250bpm the resolution is 1bpm Average pulse rate is computed based on every four _ cardio beat per cycle Average pulse rate te The deviation between average value and true value does not exceed 1 Safety Type Interior Battery BF Type application part Pulse Intensity Continuous bar graph display indicates the pulse strength Battery Requirement 3 7 V rechargeable lithium polymer battery x 1 Battery working life Charge and discharge no less than 500 times Power Adapter Input Voltage 100 240 VAC 50 60 Hz Output Voltage 5 V DC 29 RX101 PPG Recorder Instruction Manual Oximeter Probe Wavelength 660nm 880nm Ab
20. order The data 1s collected at the sampling frequency of 120Hz Upon processed by the main board the processed data is then displayed To transmit the data wirelessly via Bluetooth the wireless feature in the device menu needs to be enabled using the Home Button next to the device display Alarm feature can also be activated via the same menu 26 RX101 PPG Recorder Instruction Manual 12 Specifications A Measurement of SpO Measuring range 0 100 Accuracy When the SpO5 measuring range is 70 100 the permission of absolute error is 2 below 70 is unspecified B Measurement of Pulse Rate Measuring range 30bpm 250bpm Accuracy 2 bpm or 2 select larger C Resolution SpO 1 Pulse rate 1bpm D Measurement Performance in Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO error is 4 pulse rate error is 2 bpm or 2 select larger E Resistance to surrounding light The deviation between the value measured in the condition of man made light or indoor natural light and that of darkroom 1s less than 1 F Power supply requirement 3 6 V DC 4 2V DC G Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW H Adjustable alarm range SpO 0 100 Pulse Rate Obpm 254bpm A7 RX101 PPG Recorder Instruction Manual 13 Key Symbols Symbols Description Warning See User Manual Spo Perce
21. out 175 g with the lithium polymer battery 1 Appendix Alarm condition delay Alarm signal generation delay 30 RX101 PPG Recorder Instruction Manual
22. ow the current battery status The Blue LED indicates the device is charging To indicate if Bluetooth is on To indicate the number of pulse per minute To indicate the normalized pulse strength To show the photoplethysmogram Heart Waveform 9 RX101 PPG Recorder Instruction Manual 3 2 Rear Panel Index Name USB Port Through Hole Device Label Speaker Hole Figure 2 RX101 Back Panel Table 2 RX101 Back Panel Description Description For battery charging or attaching external sensor probe For lanyard installation The label contains the technical specifications manufacturing details and certification information The is where the alarm speaker is mounted 10 RX101 PPG Recorder Instruction Manual 4 Setup of RX101 A A WARNING To ensure patient safety do not place RX101 in any position that might cause it to fall on the patient WARNING As with all medical equipment carefully route patient s cables to reduce the possibility of patient entanglement or strangulation WARNING 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 WARNING To ensure accurate performance and prevent device failure do not subject RX101 to extreme moisture such as direct exposure to rain Such exposure may cause inaccurate performance or device failure 4 1 List of Components Table 3 List of Components Quantity Name
23. r high pressure steam disinfection of the PPG Recorder is not permitted Refer to User Manual in the relative chapter 10 5 for instru ctions of cleaning and disinfection Do not have the PPG Recorder immerged in liquid When it needs cleaning please wipe its surface with medical alcohol by soft material Do not spray any liquid on the device directly When cleaning the device with water the temperature should be lower than 60 C If the testee s finger is too thin or cold The readings may not be accurate Please clip the PPG Recorder on the thicker finger such as thumb or middle finger with sufficient depth to obtain better reading The PPG Recorder is designed for adult measurements only Proper measurement should take less than 5 seconds how this may change depending on each individual s pulse rate Please take the measurement when the waveform on screen becomes stabilized to ensure the accuracy of the readings If some abnormal conditions appear on the screen during test process remove the PPG Recorder from the finger and then re clip the recorder on the finger to reset the reading on the display The device has normal useful life of three years counting from its first day of use This device has an alarm function Please refer to chapter 6 4 for reference The device has audible alert which is sounded when the highest or lowest limit are reached The device has the function of alarming this function can either be paused or closed
24. se harmful interference with other devices in the vicinity 8 3 Technical Assistance For technical information and assistance or to order parts or a service manual contact ReFleX Wireless s Technical Service Department at supportO reflexwireless com Or call your local ReFleX Wireless representative The service manual includes block diagrams and a parts list required by qualified personnel when servicing RX101 Be sure to provide the software version number of the monitor when you request technical assistance The software version appears in the monitor display each time when it successfully completes the power on self test Write the number down so it is available when you request technical assistance 22 RX101 PPG Recorder Instruction Manual 9 Maintenance A Warning There are no user serviceable parts inside RX101 The cover should only be removed by qualified service personnel Caution The institution should follow local government regulations and recycling instructions regarding disposal or recycling of the batteries and RX101 components or end of life of RX101 Caution RX101 will not operate with dead batteries Please check the battery prior each use 9 1 Return RX101 Contact ReFleX Wireless s Technical Service Department at support reflexwireless com for shipping instructions including a Returned Merchandise Authorization RMA number Unless otherwise instructed by ReFleX Wireless s Technical Serv
25. served stop using the device Technical maintenance must be performed by qualified service engineers ONLY The device cannot be used together with devices not specified in the User Manual Only the accessories appointed or recommended by the manufacturer can be used with this device The product is pre calibrated at the factory Warning A Warnings are identified by the WARNING symbol shown above Warnings alert the user to potential serious outcomes such as death injury or adverse events to the user A Explosive hazard DO NOT use the PPG Recorder in environment with inflammable gas such A A bb bbb bb as some ignitable anesthetic agents DO NOT use the PPG Recorder while the testee is measured by MRI and CT DO NOT strand the lanyard in order to avoid device drop and damage The lanyard 1s made of non sensitive material Please do not use lanyard if the user is allergic to lanyard Do not enwind neck with lanyard in order to avoid accident Follow the local laws and regulations when disposing a defective instrument its accessories and packaging including battery plastic bags foams and paper boxes Please ensure that all items are present in the package prior using the device Only use accessories and probe approved or manufactured by the manufacturer to prevent damages to the PPG Recorder Please choose the battery chargers that are compliant with the requirements of IEC 60601 1 People who are allergic to
26. service does not cover such faults Owing to the forthcoming renovation the specific products you received may not be totally in accordance with the description of this User Manual We would sincerely regret for that This product is designed for medical research education and health and wellness applications WARNING A It is recommended that the sensor should not be applied to the same finger for over 2 hours as the device may disrupt microcirculation on the body part A Be advised that the device cannot be clipped on the edema and tender tissue A Do not stare directly at the LED lights as the light the infrared is invisible emitted from the device is harmful to the eyes A Please refer to the correlative literature about the clinical restrictions and caution A Testee cannot use enamel or other makeup A Testees fingernail cannot be too long A This device is not intended for treatment The User Manual is published by ReFleX Wireless Inc All rights reserved MI Contents A assesses RAS 6 1 1 OPERATION PROCEDURES curas lidia 6 1 2 WARNING kat ot a a n a e ees tomas a iaean A 6 1 3 AU TON S is 7 Z INTRODUCTION dis 8 2 1 INTENDED U Sos chee e Sen kone tb ae e pab E a ae tk pa ot da eta 8 22 KEY PERATURES a a tk Soni au dee 8 22 APPLICATION AND SO OPE ott le las 8 23 ENVIRONMENT REQUIREMENTS iaa 8 3 SYMBOLS CONTROLS DISPLAY AND INDICATOR sccccsssssssssscccsssssscsssccsssssssscces 9 3 1 FR
27. ted and observe all warnings and cautions presented in the Directions e Clean and remove any substances such as nail polish from the application site e Periodically check to ensure that the PPG Recorder remains properly positioned on the testee s finger 7 8 High ambient light sources that can interfere with the performance of RX101 PPG Recorder are e surgical lights especially those with a xenon light source e bilirubin lamps e fluorescent lights e infrared heating lamps e direct sunlight 7 9 To prevent interference from ambient light ensure that the PPG Recorder is properly applied If interference due to testee s activity presents a problem try one or more of the following to correct the problem e verify that RX101 PPG Recorder is properly and securely applied e move the PPG Recorder to another site e keep the testee still if possible 20 RX101 PPG Recorder Instruction Manual 8 Troubleshooting A Warning If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure RX101 is functioning correctly A Warning There are no user serviceable parts inside RX101 The cover should only be removed by qualified service personnel Caution Do not spray pour or spill any liquid on RX101 its accessories connectors switches or openings in the enclosure as this may damage the device 8 1 Corrective Actions O Bus O Corrective Action s The SpO
28. the setting to on to turn on the Pulse 15 RX101 PPG Recorder Instruction Manual Sound 6 6 Change USER ID The user can modify device ID by AQWave AQwave Software is currently available in Android and PC MAC and 10S version will be released in December 2012 Figure 8 Set User ID 6 7 Enable Data Recording Under Revision Figure 9 Record Data 6 8 Enable Bluetooth Communication Turn on the Wireless Feature on the PPG Recorder by moving the menu selector to highlight Wireless and then push the Home Button for 2 seconds to enable Wireless communication To connect to the PPG Recorder using your Android 10S device or desktop computer please follow the instructions provided the mobile or PC application and use the passcode 7762 to have the data from the PPG Recorder stream to the software applications Figure 10 Enable Wireless Communication 6 9 Change Screen Orientation On the measuring interface press the Home Button to change the display orientation 16 RX101 PPG Recorder Instruction Manual 6 10 Exit Menu To exit the Settings Menu simply give the Home Button a few quick pushes until the menu selector highlights Exit and then push the Home Button for two seconds to exit the menu Figure 11 Exit the Settings Menu 6 11 Software Operation Please connect the device with computer by a USB Cable or Bluetooth connection and then follow the instructio
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