POFCMS50E Pulse Oximeter
Contents
1. and Press the power button to quit the time setting menu the recording will not begin and the data stored in memory will not be deleted 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 the sign Recording would appear on the screen in 30 seconds then the screen will be automatically shut down If press the button shortly at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if press the button long the device would return to the former interface e If turning 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 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 Figure 9 e Uploading the data to the PC after recording a Please connect the device with computer by the data line which2. Signal Description Warning See User Manual The pulse oxygen saturation SpO p yg a r O ga e Bg Close the alarm sound indication B peee meee 6 eenemne menu button power button function button 12 e lt USB 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator Ingress of liquids rank WEEE 2002 96 EC 10 Function Specification Information Display Mode The Pulse Oxygen Saturation SpO 2 digit digital OLED display 3 digit digital OLED display 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 1 bpm Accuracy _ Moving calculate the Average pulse rate every 4 _ cardio beat s cycle Average pulse rate The deviation between average value and true value does not exceed 1 Safety Type Interior Battery BFType Pulse Intensity 13 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 5 VDC 250mA 1 25 W Wavelength 660nm 880nm Dimensions and Weight Dimensions 57 L x 32 W x 30 H mm About 50g with the lithium battery 1 Appendix 1 Alarm condition delay Alarm s
3. 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 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 gt 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
4. 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 N 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 60 b Relative humidity 5 95 c Atmospheric pressure 5OOhPa 1060hPa Operating Environment a Temperature 10 40 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 HbO2 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 photose
5. used repeatedly WARNING 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 Testee can not use enamel or other makeup 6 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 DS ALOE sc cececede cece E A E E O E E AEAEE AEAEE EAEE EEE 1 LA nstochonsTorsale opera ONS sannan a N EN l L2 Wan eea E a l leos Za S E E EA 1 PAE O A A E A A A A E A E E EE 2 2t BCU S ceea E A O 3 2 2 Major applications and scope of application cccccsssseccccccceeceeceeeeseessseseeeeeeeeeeeseeeeeeeaaas 3 2 92 Environment regu eME n Sear E E a oc acs 3 I ErP E ge e a ROAN O A E E O EN 3 A Technicalspecineations Sisessoceecenl cs vsseszsexseustasveevnnssuaeenessaseunuasseesnespsnnesccpaeaseussaneceaes saeveeayseecscssaeeees 4 dle Man porro mane hassles i
6. 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
7. Please choose the accessories which are approved or manufactured by the manufacturer or else it may damage the device Please choose the battery chargers which should be ensured compliance with the requirements of IEC 60601 1 or else it may damage the device Please don t use the device in the course of charging Please don t measure this device with functional tester for the device s related information 1 3 Hazards A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture A Tfthe oximeter gets wet please stop using it immediately 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 A Do not immerse the oximeter in liquid When it needs cleaning please wipe its surface with 1 disinfectant solution using a soft cloth Do not spray any liquid directly onto the device A When cleaning the device with water the temperature should be lower than 60 C A 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 enough into the p
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9. enu interface Click the power button to select Usb then Press the power 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 V spia Figure 7 SpO program v Figure 8 SpO Review program Nit the users choose to turn on the display function on computer it would probably take several seconds for the data to appear on the computer screen d 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 From the Settings Menu Click the power button to select Record then Press the power button to enter the start time of data storage test see figure 9 b Click the power button to move the underline to the time to be set hours and minutes then Press and hold the power button to adjust the time setting After setting the time Click the power button to move the underline to Y Press the power button to exit the time setting menu and recording will begin If you move the underline to n
10. eviation 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 alarm indication pulse sound indication battery capacity indication charging indication light pulse rate Sp0O2 ALM LO pulse bar graph pulse waveform Figure 2 Front View 5 2 Installing the hanging rope A Put the thinner side of the rope through the hole B Put the wider side of the rope through the thinner side which has been put through the hole then tighten it 5 3 USB port L ee i yp USB port Figure 3 USB port It is used to connect a personal computer to export the trend data or charge the lithium battery via a data line 5 4 tS OS 6 1 A a b c Accessories a hanging rope a user manual a power adapter optional GTM41076 0605 CMS0105 a data line a disk PC software Operating Guide Application method Squeeze the clamp put a finger into the rubber hole then release it Press the Power Button on the front panel until the device turns on Do not shake the finger and keep the patient in a stable state during the process The data can be read directly f
11. form 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 10 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 SpOz 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 When using alcohol wipes to disinfect the device please air 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 6 1 B Please recharge the battery when the screen shows E3 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 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 sto
12. g performance about cables and transducers It is recommended that the device should be inspected at least once a week Please stop using the monitor if there is obvious damage to 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 service the device 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 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 Be careful 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 disposal of scrap instrument and its accessories and packings including battery plastic bags foams and paper boxes should follow the local laws and regulations 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
13. ignal generation delay 14
14. is affiliated with the device then double click SpO Review icon to open SpO 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 power button to enter the Settings Menu and then Click the power button to select Upload Press the power button to select on then the data will be transferred to your computer c In the state of storing it is not applicable for the users to upload the stored date to computer d In the state of uploaging you cannot end it artificially when the upload of stored data is finished the menu choice bar will move to Exit automatically f Exit the main menu Click the power button to select EXIT then Press the power 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 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 battery charging the indication light is on when the battery capacity is full the indication light would be off accordingly Ait 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 turn
15. n the Settings Menu Backlight Brightness Alarm high low limits data transmission data storage recording data upload to computer Please note in the Settings Menu CLICK short press of power button and PRESS prolonged push of power button 1sec Figure 5 Main Menu Interface a Backlight adjustment On the main menu interface click the power 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 power 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 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 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 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 7 choose the parameter to be adjusted Press the p
16. nsitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor Glow and Infrared ay Emission Tube a Glow and Intraretray Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance A SpOz 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 The display mode can be changed Screen brightness can be changed Apulse rate sound indication F G H I With alarm function J With SpO value and pulse rate value of storage the storage data can be uploaded to computers K Data can be transmitted to computers 4 2 Main Parameters A Measurement of SpO gt Measurement Range 0 100 Accuracy 70 100 2 0 69 unspecified B Measurement of pulse rate Measurement 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 gt error is 4 pulse rate erroris 2 bpm or 2 select larger E Resistance to surrounding light The d
17. ower 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 A it 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 measurement shows in yellow Medium priority indicating that prompt operator response is required b The alarm state setting 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 Figure 6 Alarm Setting Menu c Pulse sound indication setting Click the power button to select Pulse Sound then Press the power button to choose to have the Pulse Sound heart beat alarm on or off d Exit the Alarm settings Click the power button to select EXIT then Press the power button to exit the Alarm Settings Menu c Data transmission setting Firstly please install the affiliated software into the computer and then 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 7 the icon of SpO2 Review is a program for receiving stored data which is shown as figure 8 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 m
18. rage 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 best storage environment of the device is 40 C 60 C ambient temperature and not higher than 95 relative humidity 8 Troubleshooting 1 Place the finger properly and The SpO2 and Pulse 1 The finger is not properly positioned try again Rate can not be 2 The patient s SpO is too low to be 2 Try again Go to a hospital for displayed normally detected a diagnosis if you are sure the device works all right 1 The finger is not placed inside deep The SpO2 and Pulse i 1 Place the finger properly and enough Rate are not j o try again 2 The finger is shaking or the patient is displayed stably l 2 Let the patient keep calm moving 11 1 The batteries are drained or almost 1 Please recharge the battery The device can not drained 2 Please contact the local be turned on 2 The device s malfunction service center 1 This device is set to be automatically power off within 5 seconds when it The display is off 1 Normal cannot detect any signal suddenly 2 Please recharge the battery 2 The battery is drained away or almost drained away The battery can not be full charged even l Please contact the local service The battery is broken after 10 hours center charging time 9 Key of Symbols
19. robe 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 moment 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 s This device has the function of alarming users can check on this function according to chapter 5 1 as a reference 5 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 1 as a reference A The device may not work for all patients If you are unable to achieve stable readings discontinue use A
20. rom 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 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 B Change display direction On the measuring interface you can change the display direction by pressing the button shortly 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 60 seconds c If you want to turn off the alarm for good you should enter the menu for operation D Menu operations On the measuring interface the display direction can be changed by pressing the power button with a short push click There are four 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 Figure 5 Please Note When the display direction on the screen is in the Portrait View you can not enter the Menu Interface click the power button to switch to Landscape View The user can setup the following parameters i
21. s 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 3 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 gt 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 6 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 SpO2 wave
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