Instructions to User - Pulse Oximeter, Pulse Oximeters
Contents
1. firstly the renewed time and date would be displayed on the screen then it returns to the main menu if you did t reset the time and date when exiting the clock setting menu the device would return to the main menu directly d Real time data transmission setting Firstly please install the affiliated software into the computer and two icons would appear on the desktop after installation The icon of SpO2 is a program for receiving real time data which is shown as figure 8 the icon of SpO2 Review is a program for receiving stored data which is shown as figure 9 a Please connect the device to computer with the affiliated data line then double click the SpO2 icon to start the program b On the main menu interface short press the button to move the menu choice bar to Usb long press the button to choose whether transmit the real time data to computer which displays the data Synchronously or not choose on to permit transmission choose off to forbid transmission c When you unplug the data line from computer there is a dialog box Save data at view appearing on the desktop in which you can input some patient s basic information Vv Spe Figure 8 SpO2 program Y SU AS Figure 9 SpO2 Review program Art the users choose to turn on the synchronizing display function on computer it would probably take several seconds for the data to appear on the computer screen e Data storage setting This device2. and choose off to close it for good Figure 6 Alarm Setting Menu c Pulse sound indication setting Short press the button to move the menu choice bar to Pulse Sound then choose the pulse sound indication state on off by long pressing the button press on to open the function and press off to close it d Exit Short press the button to move the menu choice bar to Exit you can exit the alarm setting menu as well as return to the main menu by long pressing the button c Clock setting On the main menu interface short press the button to move the menu choice bar to Clock then enter the clock setting interface by long pressing the button Figure 7 Clock Setting Menu a When entering the clock setting menu the menu choice bar would be on the item of set time and the state would always be no whenever it enters the clock setting menu on the purpose of avoiding unexpected changes of time due to improper operation You can change the state by long pressing the button choose yes to reset the time choose no to forbid time resetting b Short press the button to move the menu choice bar to the parameter that you want to change then adjust the data by long pressing the button c Short press the button to move the menu choice bar to Exit then exit the clock setting menu by long pressing the button If you have reset the time or date when exiting the clock setting menu
3. With clock function 4 2 Main Parameters A Measurement of SpO Measuring range 0 100 Accuracy When the SpO measuring range is 70 100 the permission of absolute error is 12 below 70 unspecified B Measurement of pulse rate Measuring range 25bpm 250bpm Accuracy 2 bpm or 2 select larger C Resolution SpO 1 Pulse rate lbpm 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 is 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 5 Installation 5 1 View of the front panel ell pulse sound indication charging indication light alarm indication battery capacity indication pulse rate SpO2 pulse bar graph pulse waveform probe jack button Figure 2 front view 5 2 Wristband installation and probe connection A Put one side of the wristband on which there is no ring through the belt hole above the device then put it through the other belt hole under the device B Make the alignment signs on the probe in accordance with the alignment signs on the device then plug
4. contact the local service center PEU Gn 2 The device s malfunction de 1 The device s malfunction ipi ida f i i Please contact the local service center Thedsplay iso 2 The battery is drained away or almost suddenly 2 Please recharge the battery drained away The device can not be used for full time after chagre 1 The battery is not full charged 2 The battery is broken 1 Please recharge the battery 2 Please contact the local service center The battery can not be full charged even after 10 hours charg The battery is broken Please contact the local service center ing time 9 Key of Symbols Signal Description A Warning See User Manual Sp o e pulse oxygen saturation PR Pulse rate bpm Full voltage de 8 lt D Low voltage Close the alarm sound indication Open the alarm sound indication Close the pulse sound indication Open the pulse sound indication lh d D i Zj y menu button power button function button Type BF SN Serial number 1 the finger clip falls off no finger inserted a o 2 Probe error 3 Signal inadequacy indicator IPX1 Ingress of liquids rank yd WEEE 2002 96 EC 10 Function Specification Information Pulse Rate PR Display Mode Pulse Intensity bar graph bar graph OLED display 0 100 the resolution is 1 25bpm 250bpm t
5. is medical device which can be used repeatedly WARNING 6 Uncomfortable or painful feeling may appear if using the device ceaselessly especially for the microcirculation barrier patients It is recommended that the sensor should not be applied to the same finger for over 2 hours 6 For the special patients there should be a more prudent inspecting in the placing process The device can not be clipped on the edema and tender tissue 6 The light the infrared is invisible emitted from the device is harmful to the eyes so the user and the maintenance man should not stare at the light Testee can not use enamel or other makeup Testee s fingernail can not be too long 6 Please refer to the correlative literature about the clinical restrictions and caution 6 This device is not intended for treatment The User Manual is published by our company All rights reserved CONTENTS REA AAAA TOT A A T 1 TlInstructions f r safe PE nn e a E ada 1 A A 1 LIA A A A E 1 20 Ver vie A EE T T r T EE 2 ZA SALES en A A A dd lt 2 2 2Major applications and scope of application cceccessecssessecsecesececeseeseceseeecesceseeeseeeeeeneeeeeeseeeeeneenaes 2 ZIMIO a eee 3 SPinciple rssosscreresosscsevsesesesesecsecescvesvesssvsssvesssvsseesssvesssssessesessssssessssescnesssvescessessessssssesessesssvessesesssessaves Y 4Technical specificatioNS oooomosmmmmmmrr 3 A Main performance ii ti A 3 ELMO PAM
6. oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture amp Tfthe oximeter gets wet please stop operating it A When it is carried from cold environment to warm or humid environment please do not use it immediately A DO NOT operate keys on front panel with sharp materials A High temperature or high pressure steam disinfection of the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for instructions of cleaning and disinfection amp Do not have the oximeter 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 A When cleaning the device with water the temperature should be lower than 60 C amp Asto the fingers which are too thin or too cold it would probably affect the normal measure of the patients SpO and pulse rate please clip the thick finger such as thumb and middle finger deeply enought into the probe A Whether the device is used to adult or infant it depends on the probe selected A The update period of data is less than 5 seconds which is changeable according to different individual pulse rate A Please read the measured value when the waveform on screen is equably and steady going This measured value is optimal value And the waveform at the monment is the standard one A If some abnormal conditions appear on the screen during test proc
7. press the button for about 10 seconds in order to enter the clock interface and the device would return to the measuring interface by long pressing the button again D Pause alarm a Alarm including the alarm of measure data s going beyond the limits the alarm of low voltage the alarm of probe or finger s out of position b On the measuring interface if the alarm function is on during the period of alarming you can pause it by short pressing the button but the function will be renewed in about 60 seconds c If you want to turn off the alarm for good you should enter the menu for operation E Menu operations When the device is under the measuring interface long press the button for about 1 second in order to enter the menu interface shown as figure 5 when the display mode is upright mode the device cannot enter the menu interface in this situation you need to short press the button again to adjust the display mode to transverse mode so that the device can enter the menu interface Users can adjust the setting through the main menu such as backlight alarm clock data transmission with the data line data storage and power off The specific operation methods are as the following Figure 5 Main Menu Interface a Backlight adjustment On the main menu interface short press the button to move the menu choice bar to Brightness then you can adjust the brightness of the screen by long pressing the button b Alar
8. space is full it displays Memory is full on the screen and then shut down in a few seconds But it will still display Memory is full by the next time you turn on the device on the purpose of warning the user if press the button again it will enter the measuring interface f Stored data transmission setting a Please connect the device with computer by the data line which is equipped with the device then double click SpO2 Review icon to open SpO2 Review program click the New Session Icon in the software enter the patient data and then click ok The Software will then display device connected waiting for data b On the main menu interface short press the button to move the menu choice bar to Upload then long press the button to choose whether transmitt the data to computer for displaying and analysing or not Choose on to permit transmission choose off to forbid transmission c In the state of storing it is not applicable for the users to upload the stored date to computer d When the upload of stored data is finished the menu choice bar will move to Power off automatically g Power off 10 On the main menu interface short press the button to move the menu choice bar to Power off then long press the button to shut down the device h Exit the main menu On the main menu interface short press the button to move the menu choice bar to Exit then long press the button to exit the ma
9. A A a irik 4 5InstallatioN ooomommosssssmsmssmrrrs 5 5 View of the front Palais i 5 5 2Wristband installation and probe connection ssssessssssseeeesersrseeseesessesessteestereseestssesesesstsreseereseene 5 5 ZACCESSOTIES as to e tae A ae 5 6Operating Guide ccccsoccrscscsccceccsccssscssesescesssescessesscsssssscsesceessesssessessseesessseesesesessescessesscessessssessosssess 6 6 lApplication Method oiii eaii E E E E EE REEE S E a 6 Io A E A A 11 63 lmicalrestricuons nd a a a e al lts rl lead 11 7Maintain transportation and StOrage cccccsccsscssssescssscescecscsscecsssesscscsessssssessscssecsescsessesesesesssoes 12 7 VGleaning DO stad Rees E TE E ER EERE E REEERE 12 MA tt ad ee ote a 12 7 3Transportation and stora ei izo is A Bde hs AA 12 8STroubleshootinNg o ooomosmmomssmsmsimssmsmss 12 9Key of SymbolS mcommmomssimimsmsmimssmoorsrssms 13 10Function SpecificatioN o omoomsmss 13 HI 1 Safety 1 1 Instructions for safe operations lt gt Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and monitoring performance about cables and transducers It is recommended that the device should be inspected once a week at least When there is obvious damage stop using the device lt gt Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themsel
10. Recharge the battery soon after the over discharge The device should be recharged every six months when it is no regular used It can extend the battery life following this guidance D The device needs to be calibrated once a year or according to the calibrating program of hospital It also can be performed at the state appointed agent or just contact us for calibration 7 3 Transportation and storage A The packed device can be transported by ordinary conveyance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material B The packed device should be stored in room with no corrosive gases and good ventilation Temperature 40 C 60 C Humidity lt 95 8 Troubleshooting Trouble Possible Reason Solution The SpO and Pulse Rate can not be 1 The finger is not properly positioned 2 The patient s SpO is too low to be 1 Place the finger properly and try again 2 Try again Go to a hospital for a diagnosis if you are sure the device i detected displayed normally etecte EA The SpO Pul 1 The finger is not placed inside deep e SpO and Pulse enough 1 Place the finger properly and try again Rate are not 2 The finger is shaking or the patient is 2 Let the patient keep calm displayed stably moving The device can not 1 The batteries are drained or almost 1 Please recharge the battery ee 2 Pl tact the local servi t Please
11. e Pulse Oximeter User Manual Instructions to User Dear users thank you very much for purchasing the Pulse Oximeter 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 the Pulse Oximeter s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and 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 human injury and equipment damage due to users negligence of the operation instructions The manufacturer s warranty 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
12. ess pull out the finger and reinsert to restore normal use A The device has normal useful life for three years since the first electrified use A This device has the function of alarming users can check on this function according to chapter 6 1 as a reference A The device has the function of limits alarming when the measured data is beyond the highest or lowest limit the device would start alarming automatically on the premise of the alarming function is on A The device has the function of alarming this function can either be paused or closed for good please check the chapter 6 1 as a reference A The device may not work for all patients If you are unable to achieve stable readings discontinue use 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O concentration in the blood It is an important bio parameter for the respiration A number of diseases relating to respiratory system may cause the decrease of SpO in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body and the corresponding symptoms would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might bring danger to human s life Therefore prompt information of patients SpO is of great help for the doctor
13. has the function of 24 hours data storage it has the capability of accurately storing pulse rate and SpO data then transmit the data to computer with the data line for replay and analysis a On the main menu interface short press the button to move the menu choice bar to Record then long press the button to choose whether store the data or not choose on to permit storing choose off to forbid storing b The device can storage starting time automaticly c If the data storage function is being turned on when return to the measuring interface a red REC sign and a flashing red dot would appear on screen which means the device is in a state of storing d In the state of storing whatever interface the device is on measuring interface menu interface clock interface the sign Recording would appear on the screen in 30 seconds then the clock interface would appear in succession after several seconds and then the screen will be automatically shut down If short press the button at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if long press the button the device would return to the former interface e Ifturning on the data storage function the former data storage will be automatically removed f In the state of data storing after the screen is automatically shut down the pulse sound indication would be off for saving power g When the storage
14. he resolution is 1bpm Accuracy 2bpm or 2 select larger Safety Type Interior Battery B F Type Pulse Intensity Range Continuous bar graph display the higher display indicate the stronger pulse Battery Requirement Voltage 3 7 rechargeable lithium battery x 1 Battery working life Charge and discharge no less than 500 times L L x 56 W x 24 H mm About 50g with the lithium battery 1
15. in menu F Charge There are two kinds of charging methods a Connect the device with computer by data line then the device should be under charging state b Connect the device with power supply by power adaptor then the device should be under charging state c When the device is in the state of battering charging the indication light appears to be orange and when the battery status is full the light turns to green 6 2 Attention for operation A Please check the device before using and confirm that it can work normally B The finger should be in a proper position see the attached illustration of figure 4 for reference or else it may result in inaccurate measure C The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between D The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Do not fix the SpO sensor with adhesive or else it may result in venous pulsation and inaccurate measure of SpO and pulse rate F Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy H Testee can not use enamel or other makeup I Please clean and disinfect the device after opera
16. m setting On the main menu interface short press the button to move the menu choice bar to Alarm then the device would enter the alarm setting menu which is shown as figure 6 if you long press the button a The highest lowest alarm limit setting Short press the button to move the menu choice bar to Direction then you can choose the highest lowest limit by long pressing the button If you want to raise the alarm limit of SpO or pulse rate you should move the Direction to up then short press the button in order to choose the parameter that you want to raise The highest limit of SpO SpO ALM HI the lowest limit of SpO SpO ALM LO the highest limit of pulse rate PR ALM HI the lowest limit of pulse rate PR ALM LO then you can raise the data to the number that you want by long pressing the button In the same way if you want to reduce the alarm limit of SpO or pulse rate you should move the Direction to down short press the button to choose the parameter that you want to reduce then adjust the number by long pressing the button Ar the alarm function is on the device will provide midium priority alarm signal when the data of SpO or pulse rate is beyond the limit and intermittent alarm will occur b The alarm state setting Short press the button to move the menu choice bar to Alarm then choose the alarm state on off by long pressing the button choose on to open the alarm function
17. nciple Principle of the Oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO in glow amp near infrared zones Operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor Glow and Infrared ay Emission Tube P ee Glow and Infrared ray gt Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance A SpO value display B Pulse rate value display bar graph display C Pulse waveform display D Low voltage indication low voltage indicator appears before working abnormally which is due to low voltage The display mode can be changed Screen brightness can be changed A pulse sound indication With alarm function With SpO value and pulse rate value of storage the stored data can be uploaded to computers FU A A It can be connected with an external oximeter probe K Real time data can be transmitted to computers L
18. the probe into the jack C It appears as the following figure after installation Pulse Oximeter Figure 3 5 3 Accessories A a wristband B a User Manual C a power adapter D a data line E a disk PC software F 6 6 an oximeter probe Operating Guide 1 Application method A Install the wristband and probe according to the instructions of chapter 4 2 then put the finger into the probe a Turn on the device by long pressing the button on the panel b Do not shake the finger and keep the patient in a stable state during the process c The data can be read directly from the screen on the measuring interface A Fingernails and the luminescent tube should be on the same side A If the alarm function is on the device will provide midium priority alarm signal when probe or finger is out and intermittent alarm will occur Figure 4 Actual probe may be different with the probe as figure 4 please accept the actual probe with the device B Change display direction On the measuring interface short press the button to enter the clock interface and then change the display direction by short pressing the button within 30 seconds C Enter and exit the clock interface a On the measuring interface short press the button in order to enter the clock interface and it will automatically return to the measuring interface if there is no other operations within 30 seconds b On the measuring interface long
19. ting according to the User Manual 7 1 6 3 Clinical restrictions A As the measure is taken on the basis of arteriole pulse substantial pulsating blood flow of subject is required For a subject with weak pulse 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 blamed for serious error of SpO measure D As the SpO value serves as a reference value for judgement of anemic anoxia and toxic anoxia 11 some patients with serious anemia may also report good SpO measurement 7 Maintain transportation and storage 7 1 Cleaning and Disinfecting Using medical alcohol to disinfect the device nature dry or clean it with clean soft cloth 7 2 Maintain A Please clean and disinfect the device before using according to the User Manual 7 1 B Please recharge the battery when the screen shows 3 or else the device will power off automatically if 1t detects the shortage of power C
20. to discover the potential danger and is of great importance in the clinical medical field The Pulse Oximeter features in small volume low power consumption convenient operation and being portable It is only necessary for patients to put one of his fingers into a probe for diagnosis and a display screen will directly show the measured value of pulse oxygen saturation with the high veracity and repetition 2 1 Features A Operation of the product is simple and convenient B The product is small in volume light in weight and convenient in carrying C Low power consumption 2 2 Major applications and scope of application The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger The product is suitable for being used in family hospital oxygen bar community healthcare physical care in sports It can be used before or after doing sports and it is not recommended to use the device during the process of having sport and etc AX the problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon monoxide 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 500hPa 1060hPa Operating Environment a Temperature 0 C 50 C b Relative Humidity 15 95 c Atmospheric pressure 700hPa 1060hPa 3 Pri
21. ves lt gt The oximeter cannot be used together with devices not specified in User s Manual Only the accessory that appointed or recommendatory by manufacture can be used with this device lt gt This product is calibrated before leaving factory 1 2 Warning Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the testee measured by MRI and CT 6 Please do not break the wristband for fear it becomes out of use or the unexpected drop of the device which is due to the looseness of the wristband in the process of using Users who are allergic to the wristband is not recommended to use it 6 The person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packings including battery plastic bags foams and paper boxes should follow the local laws and regulations 6 Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list or else the device may have the possibility of working abnormally 6 Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device 6 The device can only be matched with the compatible probe 6 Please don t measure this device with function test paper for the device s related information 1 3 Attention A Keep the
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