Instructions to User
Contents
1. a state of storing 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 10 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 operating 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 sens2. 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 is medical device which can be us
3. ad directly from the screen on the measuring interface AN Fingernails and the luminescent tube should be on the same side AN If the alarm function is on the device will provide midium priority alarm signal when finger is out o Intermittent alarm will occur and the user interface presents FINGER OUT Medium priority indicating that prompt operator response is required Figure 4 Put finger in position B Change display direction On the measuring interface short press the button to change the display C Pause alarm a Alarm including the alarm of measure data s going beyond the limits the alarm of low voltage the alarm of 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 pressing the button shortly but the function will be renewed in about 30 seconds c If you want to turn off the alarm for good you should enter the menu for operation D 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 5 the icon of SpO2 Review is a program for receiving stored data which is shown as figure 6 a Please connect the device to computer with the affiliated data line then double click the SpO2 icon to start the program b When you unplug the data lin
4. d by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor Glow and Infrared ray Emission Tube X Glow and Infrared ray 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 E Automatically power off function when the device is under the state of measuring interface it will automatically power off within 5 seconds if the finger falls out of probe F The display mode can be changed G A pulse rate sound indication H With alarm function I With SpO value and pulse rate value of storage the stored data can be uploaded to computers J Data can be transmitted to computers 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 2 below 70 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 er
5. e Paese te Rege arbos 3 Se Prime ple er 3 4 Technical specifications RR 4 431 Main performance oae eter oda eee er e dalla 4 4 2 Main Patairietets ess eT e Rae be RR RR rS QU SER RE ER O NM cveneonaaes e E ER e IRR aie 4 5 5 1 View of the front panel pe e oo b dt 5 5 2 Battery installation 5 ore aaa o I Beste id bete fee teen or perge ree decret 6 S F ACCOSSOMES Sic sey 6 6 Operating GUIDE C aSa 6 6 Application method eae sux eot poe p eap pep tei pp ees 6 6 2 Attention for Operation e e P NE e EO p UE EN RR UAR DER AR Ae ea 10 6 3 Chinical restrictions eee det eet et ba e rau ven etn reed de EE tege 11 7 Maintain transportation and storage eerie esee esses esee etes nenatis essa etas tn sensns essa sensn sensns 11 7 Cleamng and Disinfectinp geo ite een p rad epp qur RR edi qeriittg 11 FR REIR ch vaeveas cea len a E dun loead eu outons E E N gestae dualecisivensaes Seecsceteues 11 7 3 Transportation and Storage ice ee isa acess eite Rb ct IPRC po ca SE RETRO c HORE HY ded 12 S beni OT APTE DATO TTL 12 MACULIS T 13 10 Function Specification eeeeeee eee teen teens entes tn etna tn sensns enses eins en etas ea sensns esses sensn sensu 14 1 Safety 1 1 Instr
6. e 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 Ww sisse Figure 5 SpO program Vv SPUCBRETI EH Figure 6 SpO2 Review program Aire 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 Menu operations On the measuring interface the display direction can be changed by pressing the power button with a short push click There are six modes of data display that can be viewed Press the power button with a prolonged push 1 second to enter the Settings Menu Interface see Figure7 The user can setup the following parameters in the Settings Menu Turn on alarm turn on pulse sound alarm high low limits data storage recording Please note in the Settings Menu CLICK short press of power button and PRESS prolonged push of power button 1sec Figure 7 Main Menu Interface a Alarm setting On the main menu interface click the power button to select Alarm Press the power button 1sec to enter the alarm setting interface as shown in Figure 8 Figure 8 a Adjusting the high and low limits of alarms On the alarm setting interface Click the power button to select Dir then Press the button 1sec to enter the alarm direction setting interface as shown in Figure 9 Figure 9 On t
7. ed 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 6 Testee can not use enamel or other makeup Testee s fingernail can not be too long Please refer to the correlative literature about the clinical restrictions and caution This device is not intended for treatment The User Manual is published by our company All rights reserved CONTENTS IE Pi dy C 1 1 1 Instructions for safe operations seessseeseeeeeeeeeeneneeneneeneneennne enne nnnm ennt ennnsenent enne ennt eerte enne 1 1 2 Warning eee secrete Iv eR ERR eee ae es eae 1 LS Attention ied ee deed bp d e e cad dest uses de dep ek b eo tans sce eed Ep cede 1 j 2 PAM ICI MEE PEE 2 2 2 Major applications and scope of application eesseessesseeeeseeeeeeeeee enne nnne 2 2 3 Environment requirements reete egent ec tua E See ponduesecedeuavuceuetess eban
8. he alarm direction setting interface Click the power button to select SpO Alm or PR Alm then Press the button 1sec to enter the SpO or PR direction setting interface as shown in Figure 10 Figure 10 Click the power button to select Dir then Press the button to choose Up or Down this will be the direction the value of the high low limits of SpO and pulse rate will be adjusted To raise the SpO and pulse rate limit choose Dir as Up then Click the power button to select high limit High or low limit Low Press the power button and hold to adjust the selected limit to the desired higher value and release the power button once the higher limit has been reached To lower the SpO and pulse rate limit choose Dir as Down then Click the power button to select high limit High or low limit Low Press the power button and hold to adjust the selected limit to the desired lower value and release the power button once the lower limit has been reached 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 Intermittent alarm will occur and the measuring value will be flashing Medium priority indicating that prompt operator response is required b Pulse sound indication setting On the alarm setting interface as shown in Figure 8 Click the power button to select Psound then Press the power button to ch
9. into the probe 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 process 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 The hanging rope attached to the device is made from Non allergy material if particular group are sensitive to the hanging rope stop using it In addition pay attention to the use of the hanging rope do not wear it around the neck on the purpose of avoiding harm to the patient A This device has the function of alarming users can check on this function according to chapter 6 2 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 default setting for good This function could be turned on through menu operation if you need Please check the chapter 6 2 as a reference A The device may not work for all patients If you are unable to achieve stable readings discontinue u
10. itive 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 some patients with serious anemia may also report good SpO2 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 change the battery when the screen shows 11 C Take out the battery if leave the equipment unused for long time 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 pac
11. ked 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 di is if the devi displayed normally detected iagnosis you are sure the device works all right 1 The finger is not placed inside The SpO and Pulse 1 Place the finger properly and try Rate are not displayed stably deep enough 2 The finger is shaking or the patient is moving again 2 Let the patient keep calm The device can not be turned on 1 The battery is drained away or almost drained away 2 The battery is installed incorrectly Please change batteries 2 Please Install the battery again 3 Please contact the local service 3 The device s malfunction center 1 This device is set to be automatically power off within 5 The display is off seconds when it cannot detect any 1 Normal suddenly signal 2 Please change batteries 2 The battery is drained away or almost drained away 12 9 Key of Symbols Signal Description IN Warning See User Manual SpO gt r The pulse oxygen saturation PRbpm Pulse rate bpm Low voltage Open the ala
12. nd regulations amp 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 Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device Please don t measure this device with functional tester for the device s related information 1 3 Attention Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture A If the oximeter gets wet please stop operating it X Whenitis 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 A 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 A 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
13. ntinually for 24 hours Dimensions and Weight Dimensions Weight 58 5 L x 31 W x 32 H mm _ About 52g with the batteries 14 15
14. on 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 measuring interface d If turning on the data storage function the former data storage will be automatically removed e When the storage 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 and a few seconds later enter the measuring interface c Uploading the data to the PC after recording a Please connect the device with computer by the data line which is equipped with the device then double click SpO2 Review icon which is shown as figure 5 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 the users to upload the stored date to computer when the symbol Record shows off d Exit the main menu On the main menu interface Click the button to select Exit then press the button to exit the main menu F Power off If the measuring finger out of the device on the measuring interface The device will power off automatically when it gets no signal within 5 seconds The device can t being power off when it is in
15. oose to have the Pulse Sound heart beat alarm on or off c The alarm state setting On the alarm setting interface as shown in Figure 8 Click the power button to select Alarm then Press the power button to choose alarm on or off press on to turn on the alarms and off to turn off the alarms d Exit the Alarm settings the alarm direction setting the SpO2 or PR direction setting Click the power button to select Exit then Press the power button to exit the Menu and return to the previous Menu b Data storage setting This instrument has the ability to store 24 hours worth of data It can store the measured pulse rate and SpO value accurately transfer the data to the computer display the data and print reports with the included SpO Software Green Heart a On the main menu interface as shown in Figure 7 Click the button to select Record then press the button to choose whether store the data or not choose on to permit storing choose off to forbid storing b Ifthe data storage function is being turned on when return to the measuring interface a flashing yellow dot would appear on screen which means the device is in a state of storing c In the state of storing the device is on measuring interface the sign Recording would appear on the screen in 30 seconds and then the screen will be automatically shut down only a flashing yellow dot appear on screen If short press the butt
16. pe 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 A 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 10 C 40 C b Relative Humidity 30 75 C Atmospheric pressure 700hPa 1060hPa 3 Principle 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 obtaine
17. rm sound indication Open the pulse sound indication menu button power button function button Type BF Serial number 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator battery positive electrode battery cathode USB IPXI Ingress of liquids rank A WEEE 2002 96 EC mm 13 10 Function Specification Information The Pulse Oxygen Saturation SpO Pulse Intensity bar graph SpO Parameter Specification Measuring range Accuracy Average value Pulse Parameter Specification Measuring range Accuracy Average pulse rate Safety Type Battery Requirement Display Mode 2 digit digital OLED display 3 digit digital OLED display bar graph the resolution is 196 10 100 2 Below 70 unspecified Calculate the Average value in every 4 measure value The deviation between average value and true value does not exceed 1 30bpm 250bpm the resolution is 1bpm 2bpm or 2 select larger Moving calculate the Average pulse rate every 4 cardio beat s cycle The deviation between average value and true value does not exceed 196 Interior Battery B F Type Pulse Intensity Continuous bar graph display the higher display indicate the stronger pulse 1 5V AAA size alkaline batteries x 2 Battery working life Twol 5V AAA size 600mAh alkaline batteries can work co
18. ror 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 2 6 V DC 3 6V 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 250bpm 5 Installation 5 1 View of the front panel pulse sound indication low battery indication 2 alarm indication pulse rate button FingertipOximeter pulse bar graph graph pulse waveform Figure 2 front view 5 2 Battery installation A Refer to Figure 3 and insert the two AAA size batteries properly in the right direction B Replace the cover AN Please take care when you insert the batteries for the improper insertion may damage the device Figure 3 5 3 Accessories A ahanging rope B two dry batteries AA A C auser manual D a data line E adisk PC software 6 Operating Guide 6 1 Application method A a Insert the two batteries properly to the direction and then replace the cover b Open the clip as shown in Figure 4 c Let the patient s finger put into the rubber cushions of the clip make sure the finger is in the right position and then clip the finger d Do not shake the finger and keep the patient in a stable state during the process e The data can be re
19. se A A flexible circuit connects the two parts of the device Do not twist or pull on the connection 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 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 sco
20. uctions for safe operations lt 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 Necessary maintenance must be performed by qualified service engineers ONLY There are no user serviceable parts and users are not permitted to maintain it by themselves lt 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 This product is calibrated before leaving factory 12 Warning 6 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 Becareful with the use of the lanyard cord Improper use of the lanyard cord will cause device damage not covered under the manufacturer s warranty Swinging the device by the lanyard cord will void the warranty Please do not use lanyard cord if allergic to lanyard cord 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 a
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