SPO-500 - Sensoronics
Contents
1. 15 II 1 Safety 1 1 Instructions 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 1s obvious damage stop using the device Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain 1t 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 1 2 Warning Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents 6 DO NOT use the oximeter while the testee measured by MRI and CT 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 Theperson who is allergic to rubber can not use this device 6 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 62. 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 AN 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 meas
3. Figure 5 Main Menu Interface a Backlight adjustment On the main menu interface Click the button to select Brightness Press the power button and hold to adjust the backlight brightness b Alarm setting On the main menu interface click the button to select Alarm Press the power button 1sec to enter the alarm setting interface as shown in Figure 6 a Adjusting the high and low limits of alarms Click the button to select Direction 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 Direction as up then Click the button to highlight the parameter to be adjusted SpO high limit SpO ALM HI SpO low limit SpO ALM LO Pulse rate high limit PR ALM HI Pulse rate low limit PR ALM LO Press the button and hold to adjust the selected limit to the desired higher value and release the button once the higher limit has been reached To lower the SpO and pulse rate limit choose Direction as down then Click the button to choose the parameter to be adjusted Press the button and hold to adjust the selected limit to the desired lower value and release the button once the lower limit has been reached AN If 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
4. alarm will occur and the measurement shows in yellow Medium priority indicating that prompt operator response is required b Thealarm state setting Click the button to select Alarm then Press the button to choose alarm on or off press on to turn on the alarms and off to turn off the alarms Figure 6 Alarm Setting Menu c Pulse sound indication setting Click the button to select Pulse Sound then Press the button to choose to have the Pulse Sound heart beat alarm on or off d Exit the Alarm settings Click the button to select EXIT then Press the button to exit the Alarm Settings Menu c Clock setting On the main menu interface Click the button to select Clock then enter the clock setting interface by press 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 press the button choose yes to reset the time choose no to forbid time resetting b Click the button to select the parameter that you want to change then adjust the data by press the button c Click the button to select Exit then exit the clock setting menu by press the button If you have reset the time or date when exitin
5. 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 Click the button to select Record then Press the button to choose whether store the data or not choose Yes to permit storing choose No 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 10 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 W
6. recharge the battery when the screen shows C 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 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 12 8 Troubleshooting Trouble Possible Reason Solution The SpO and Pulse Rate can not be displayed normally 1 The finger is not properly positioned 2 The patient s SpO is too low to be detected 1 Place the finger properly and try again 2 Try again Go to a hospital for a diagnosis if you are sure the device works all right The SpO and Pulse Rate are not displayed stably 1 The finger is not placed inside deep enough 2 The finger is shaking or the patient is moving 1 Place the finger properly and try again 2 Let the patient keep calm The device can not be turned on 1 The batteries are drained or almost drained 2 The device s malfunction 1 Please recharge the battery 2 Please contact the local service center The display is off suddenly 1 The device s malfunction 2 The ba
7. temperature should be lower than 60 C amp As to 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 amp The pulse oximeter can be used to adult or infant Whether the device is used to adult or infant it depends on the probe selected amp 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 amp 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 amp The device has normal useful life for three years since the first electrified use amp 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 amp The device has the function of alarming this function can either be paused or closed for good please check the chapter
8. the device then plug the probe into the jack C Itappears as the following figure after installation Pulse Oximeter fk xspoz 14 42 4X PRopm Figure 3 5 3 Accessories A awristband B aUser Manual C apower adapter D adataline E adisk PC software F An adult oximeter probe Model CMS04 An infant oximeter probe May purchase selectively 6 Operating Guide 6 1 Application method A Install the wristband according to the instructions of chapter 4 2 a Put the suitable probe into the jack on the right side of the oximeter The probe is limited to be produced by our company never replace it with the similar ones by other manufacturers b Put the finger into the probe c Turn on the device by long pressing the button on the panel d Do not shake the finger and keep the patient in a stable state during the process e The data can be read 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 probe or finger is out Intermittent alarm will occur and the user interface presents FINGER OUT Medium priority indicating that prompt operator response is required Figure 4 CActual probe may be different with the probe as figure 4 please accept the actual probe with the device Attention CLICK short press of power button and PRESS pro
9. 0 unspecified Calculate the Average value in every 4 measure value The deviation between average value and true value does not xceed 1 Pulse Parameter Specification Measuring range Average pulse rate 30bpm 250bpm the resolution is 1bpm 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 1 Safety Type Interior Battery B F Type Pulse Intensity 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 Power Adapter Input Voltage 100 to 240 VAC 50 60 Hz Output voltage 5 VDC Output current 250mA Output power 1 25 W Oximeter Probe Wavelength 660nm 880nm 1 L x 56 W x 24 H mm _ About 50g with the lithium battery 1 Appendix 1 State Alarm condition delay Alarm signal generation delay Low voltage alarm 0 6s 20ms Spo alarm 400ms 20ms Pulse rate alarm 400ms 20ms Probe error alarm 400ms 20ms
10. 6 1 as a reference amp 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 O2 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 gt 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
11. 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 used repe
12. OUS 3 KM sid ee X E 3 4 Technical specifications MM n 3 4 T Main performance sis eie seach t e etna eee aetna tiation tee 3 4 2 Main Parameters cys eotcetule cte teen EH aie e eren eti a Ei 4 S5 Installation e 4 5 1 View of the front panel x nen eren P RE ade EH GEO IRE DD a DA EMRE RUE 4 5 2 Wrist band installation and probe connection eere nennen 5 3 9 ACCOSSOLIOS eoe ee de de S o rede e E RR e ase ean ER FUORI s TER ERE 6 6 Operating Guide 6 GVA pplication metliod ico he REEF EF sisaysdeabanseascsavunsepanindgncndeaotetey 6 6 2 Attention Tor operation 2 dede et ehe tetra RE conde I OH a Ure eg ducks con EI eae gea ive Pests 11 6 3Clmnical TestiCt ONS vis use esters remote e PET Oe der eed Ae ERE eb TE UR URS 12 7 Maintain transportation and storage eese eese eene eese en estes tn asta seen a sensa sss ense sens en seen sena stans ena 12 7 1 Cleaning and Disinfecting nt be d op obneherobe PREIS 12 VALENCIE D 12 7 3 Transportation and Storage sissioni iiine E e eae dene ne Rae eee nnt akon de dea nes 12 8 Troubleshooting M 13 9 Key of AA L KEEA E E E E E EE TR 13 10 Function Specification eese eese esee eene seinen nesese soeesos oseke s ooe s toss eskok iSi tenens sees 14 FIDEM M
13. 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 choose the battery chagers which should be ensured compliance with the requirements of IEC 601 1 or else it may damage the device Please don t use the device in the course of charging The device can only be matched with the compatible probe Please don t measure this device with functional tester for the device s related information 13 Attention amp Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture amp If the oximeter gets wet please stop operating it amp When it is carried from cold environment to warm or humid environment please do not use it immediately amp DO NOT operate keys on front panel with sharp materials amp 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
14. atedly 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 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 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 6 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 I5Salety 5 36 29 1 Mee sosseues T E a E savusSesacpaseenscnebssseeseassssacoustecaranbeuscsecsedessse 1 1 1Instructions for safe operations sesseseeeeeeeeneeneenn nennen entren enenn terrere nennen nne 1 12Watnimpg oce re en e dap oad aa canbe mette ade oh pe E D MEO 1 1S Attention cee AAR RUPEE RE RI ta Oly a ERREUR 1 PAS ag d X 2 P lEeatulesi ecco NA EE NM A Ne Me MR M ML ME tM Tm 2 2 2Major applications and scope of application sssesseseeeeeseeee enne 2 25bnvironment requirements onte edere pepe ee eie OF WE c ERR PON
15. e 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 Arr 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 indicating that immediate operator response is required 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 11 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 electrosurg
16. g the clock setting menu 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 Click the button to select Usb then 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 Y Sma Figure 8 SpO2 program Salle fila Figure 9 SpO2 Review program ANir 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 instrument
17. hen 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 if Click the button again it will enter the measuring interface f 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 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 At this time Press the button to enter the Main Menu and then Click the button to select Upload Press the button to select on then the data will be transferred to your computer c Inthe 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 Exit automatically g Power off On the main menu interface Click the button to select Power off then Press the button to shut down the device h Exit the main menu On the main menu interface Click the button to select Exit hen Press the button to exit the main menu F Charge There are two kinds of charging methods a Connect the device with computer by data line then the device should b
18. ical 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 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 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
19. longed push of power button 1sec B Change display direction On the measuring interface enter the clock interface by Click the button and then Click the button to change the display direction within 30 seconds C Enter and exit the clock interface a On the measuring interface Click the button in order to enter the clock interface and it will automatically return to the measuring interface if there is no more operations within 30 seconds b On the measuring interface Press the button for about 10 seconds in order to enter the clock interface and the device would return to the measuring interface by Press the button for about 10 seconds again D Pausealarm 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 Click the button but the function will be renewed in about 60 seconds Ifyou 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 Press the button for about 1 second in order to enter the menu interface shown as figure 5 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
20. stance 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 H Adjustable alarm range SpO 0 100 Pulse Rate Obpm 254bpm 5 Installation 5 1 View of the front panel pulse sound indication charging indication light l clock A T battery capacity indication uisi d mme alarm indication mw 2 14 42 pulse rate Sp02 Sp02 ALM LO pulse bar graph pulse waveform probe jack button Figure 2 front view Left view right view Figure 3 left and right view 1 Probe jack It is used to connect a SpO sensor to measure the oxygen saturation and pulse rate 2 USB port It is used to connect a personal computer to export the trend data or charge the lithium battery via a data line 3 Charging indication light 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 5 2 Wristband installation and probe connection A Putone 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
21. ttery is drained away or almost drained away 1 Please contact the local service center 2 Please recharge the battery 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 charging time The battery is broken Please contact the local service center 9 Key of Symbols Signal Description A Warning See User Manual Spo The pulse oxygen saturation PR Pulse rate bpm Full voltage Low voltage Close the alarm sound indication Pause the alarm sound indication Open the alarm sound indication qx Close the pulse sound indication 4 Open the pulse sound indication E e OS oe menu button power button function button Type BF SN Serial number 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator IPX1 Ingress of liquids rank WEEE 2002 96 EC mem 10 Function Specification Information Display Mode The Pulse Oxygen Saturation SpO 2 digit digital OLED display 3 digit digital OLED display bar graph OLED display SpO Parameter Specification Measuring range Average value 0 10095 the resolution is 1 9 10096 2 Below 7
22. ured 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 t V X Glow and Infrared ray Receipt Tube Figure 1 4 Technical specifications 4 4 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 It can be connected with an external oximeter probe Real time data can be transmitted to computers With clock function PRO ese mom 4 0 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 bpmor 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 Resi
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