CMS50F User Manual
Contents
1. c Atmospheric pressure SOOhPa 1060hPa Operating Environment a Temperature 10 C 40 C b Relative Humidity lt 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 gt 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 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 E The display mode can be changed F Screen brightness can be changed G Pulse sound indication H Alarm function I With SpO value and pulse rate2. 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 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 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 lt 95
3. ORI ANN oto calle cite alta E cule celibate EO 6 4 ZM A E II II SARRA REGRETA 6 DS 453 2 lanon iio 7 dl Vie OL the Front Pane logori e E E T a Latr tin EA al 5 2 Wristband Installation and Probe Connection cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 7 5 5 ACCESSONME at NOA AR ENANA Ae LAN ENSA NAAR ENANA AA LA L ERAN ALS EARO TN AA LN L A9 0A OA H 8 GO Operate Guide siana e a e aa a e eE Aoi 8 6 1Applicatron Metadata or To ONES 8 AA A AE R AUE A ES DE 13 0 gt Clinical CSE ON acid 14 7 Maintain Transportation and Storage 00000000000000000000000000000000000000000000000000000000000000000000000000000000000 14 Pol le amin and Ni SIME CU la e Rehna At tan o loose 14 AAA E A E E E A t T 14 Te Transportation and Storage eri e EE A E E 14 SA O 14 OKey DOES MDO Sta da 15 10 Function Specification sssi ana aaa anaa aa a a aaae aaiae 16 A E 18 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 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 themselves lt gt The oximeter cannot be used together with devices not specifi
4. 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 in the measuring interface A Fingernails and the luminescent tube should be in the same side ZA If the alarm function is on the device will provide medium 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 Met OT trp L na 98 117 H LEN f i P L i a i i 7 Figure 5 Actual probe may be different with the probe as figure 5 please accept the actual probe with the device Attention CLICK short press of power button and PRESS prolonged push of power button 1sec B Change display direction In the measuring interface enter the clock interface by click the button then click the button to return the measuring interface and then Click the button to change the display direction within 30 seconds C Enter and exit the clock interface a In the measuring interface Click the button in order to enter the clock interface and it will automatically return to the measuring interface if th
5. Click the button to select Wireless then press the button to turn on off the Wireless function ZNIt is recommended to use the 2 4GHZ Wireless adapter which uses CSR as main chip Please don t pull out the USB data line or Wireless adapter when the data is being transmitted between device and computer when the data is being transmitted between device and computer the user can t set Wireless If the user can t set Wireless after cutting connecting please try again after waiting 30 seconds e Data storage setting This instrument has the ability to store 24 hours 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 SpO Assistan a In 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 save starting time automatically 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 in screen which means the device is in a state of storing d In the state of storing whatever interfaces the device is in measuring interface menu interface and clock interface the sign Recording would appear in the screen in 30 seconds then the clock interface would appear in succession af
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 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
7. ba Figure 7 Alarm Setting Menu c Pulse sound indication setting Click the button to select Pulse Sound and 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 and then Press the button to exit the Alarm Settings Menu c Clock setting In the main menu interface Click the button to select Clock and then enter the clock setting interface by press the button Figure 8 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 and then adjust the data by press the button c Click the button to select Exit and then exit the clock setting menu by press the button If you have reset the time or date when exiting the clock setting menu firstly the renewed time and date 11 would be displayed in the screen then it returns to the main menu if you didn t reset the time and date when exiting the clock setting menu the device would return to the main menu directly d Wireless setting
8. e lidocaine and butacaine may also be a major factor resulted in serious error of SpO measure D As the SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia some 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 i 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 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 Possible Reason 1 Place the finger properly and try 1 The finger is not properly The SpO and Pulse again Rate ca
9. ed 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 the environment with tinder such as anesthetic DO NOT use the oximeter while the patient is being scanned by MRI or 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 are not recommended to use it The person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packing 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 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 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 6 The device can only be matched with the compatible probe Please d
10. ed 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 6 Testee can not use enamel or other makeup 6 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 O A 3 LI Instructions OF sale Operation rana adiccion 3 L2 Warni Sosio Guay See sti daa cats aud isa ou 7 A ben N O tied anal T O N E T AG 7 Ol uT Dn 7 3 AAA O IN II nies de chaste O ERE 2615174 9002011 3 PA ONCE VIEW iii idas EEA 4 O RATO 4 2 2 Major Applications and Scope of ApplicatiON ccccccccccnnnnnononannnnnnnnnnnnnonononononnnnononnnnnnnnnnnnnnnnnnnnnnnnnnos 5 2 35 Environment Requirements e oo ios llore 5 A sacs cucevsuesveceusvecuetsvenecvccduccssetes seceecusetesesaveseovas secewoesen sentuuenceseediees 5 4 Technical SPE CHICA ONS A A A ET A T N E 6 A V Mai Te CEE
11. ere are no more operations within 30 seconds b In the measuring interface click the button in order to enter the clock interface and the device would return to the measuring interface by click 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 In 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 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 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 Wireless transmission with Wireless adapter data storage and power off The specific operation methods are as the following Figure 6 Main Menu Interface a Backlight adjustment In the main menu interface Click the button to select Brightness Press the power button and hold to adjust the backlight brightness b Alarm setting In 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 butto
12. he 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 Ensure nothing such as a plaster can impede the light passage or else it may result in inaccurate measure of SpO 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 Exquisite 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 13 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 prilocain
13. ied out by the software Please refer to lt SpO Assistant user manual gt for details ANA El s pUZ ASSETS tant Figure 9 Software Symbol NIf the users choose to turn on the synchronizing display function on computer it would probably take several seconds for the data to appear in the computer screen If there is no data in the computer screen unplug the Wireless adapter or data line then try again G Charge There are two kinds of charge method a Connect the device with computer by data line then the device should be under charge state b Connect the device with power supply by power adaptor and then the device should be under charge state c When the device is in the state of battery charge the indication light appears to be orange and when the battery status is full the light turns to green If the alarm function is on the device will provide high priority alarm signal when the battery is in low power status Intermittent alarm will occur and the battery icon turns red in the state of flashing High priority 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 C The SpO sensor and photoelectric receiving tube should be arranged in a way with t
14. inserted 2 Probe error 3 Signal inadequacy indicator IPX1 Ingress of liquids rank a 10 Function Specification The Pulse Oxygen Saturation SpO 2 digit digital OLED display Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1 bpm Accuracy 2bpm or 2 select larger 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 BF Type Pulse Intensity Continuous bar graph display the higher display indicates the Range stronger pulse Battery Requirement Voltage 3 7 rechargeable lithium battery x 1 16 Battery working life Charge and discharge no less than 500 times Power Adapter Input Voltage 100 to 240V AC 50 60 Hz Output voltage Output current Wireless Module Transmit frequency Dimensions and Weight Dimensions 61 L x 56 W x 24 H mm Weight About 50g with the lithium battery 1 17 Appendix Alarm condition delay Alarm signal generation delay 18
15. n not be pee 2 Try again Go to a hospital for a anal 2 The patient s SpO is too low to be aw l displayed normally diagnosis if you are sure the device detected j works all right 1 The finger is not placed inside The SpO and Pulse 1 Place the finger properly and try R deep enough l again aan nor 2 The finger is shaking or the patient l displayed stably l 2 Let the patient keep calm is moving 14 1 The batteries are drained or almost 1 Please recharge the battery The device can not drained 2 Please contact the local service be turned on 2 The device s malfunction center 1 The device s malfunction 1 Please contact the local service The display is off 2 The battery is drained away or center suddenly almost drained away 2 Please recharge the battery Th i nn 1 Please recharge the batter crac te 1 The battery is not full charged 4 l be used for full time 2 Please contact the local service 2 The battery is broken after charge center The battery can not be full charged even The battery is broken Please contact the local service center after 10 hours charging time 9 Key of Symbols Signal Description Spe Spo e The pulse oxygensaturaon gt gt gt oxygen saturation m een ee DUNE peoo enana V II ECT ori a gt Ej m i menu button power button function button 15 SN Serial number 1 the finger clip falls off no finger
16. n to select Direction and 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 HD 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 If the alarm function is on the device will provide medium priority alarm signal when the data of SpO or pulse rate is beyond the limit Intermittent alarm will occur and the measurement shows in yellow Medium priority indicating that prompt operator response is required b The alarm state setting Click the button to select Alarm and then Press the button to choose alarm on or off press on to turn on the alarms and off to turn off the alarms 10 SE Om daun C r V VY wl b LIT ca t L ty M i H i i I f Nana L i a
17. obe as figure 4 please accept the actual probe with the device 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 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 the probe into the jack The probe for the device is limit to the probe that is produced by our company don t use the other similar products to replace C It appears as the following figure after installation Figure 4 5 3 Accessories A a wristband B a User Manual C a power adapter D a data line E a disk PC software F An adult oximeter probe Model S6RXTH024 An infant oximeter probe May purchase selectively 6 Operating Guide 6 1 Application Method A Install the wristband and probe according to the instructions of chapter 5 2 a Put the suitable probe into the jack
18. on t measure this device with functional tester for the device s related information 1 3 Attention TA Keep the oximeter away from dust vibration corrosive substances explosive materials exorbitant or overly low temperature and humidity A If the 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 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 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 probe A The pulse oximeter can be used to adult or infant Whether the device is used to adult or infant 1t depends on the probe selected 4A 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 equabl
19. ter several seconds And then the screen will be automatically shut down If short press the button at this moment the sign Recording would appear in 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 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 in 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 Device ID The user can modify device ID by software SpO Assistant g Power off In 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 In the main menu interface Click the button to select Exit and then Press the button to exit the main menu 12 F PC software operation Please connect the device with computer by the USB data line or Wireless which is affiliated with the device then double click SpO Assistant icon to run the PC software The functions such as uploading storage data and change device ID can be carr
20. value of storage the stored data can be uploaded to computers J It can be connected with an external oximeter probe K Real time data can be transmitted to computer L Clock function M Wireless transmission 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 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 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 H Adjustable alarm range SpO 0 100 Pulse Rate Obpm 254bpm 5 Installation 5 1 View of the Front Panel Pulse sound indication Clock Alarm indication a T Battery capacity indication Wireless indication SpO2 Pulse rate SpO2 ALM LO Pulse bar graph USB port Pulse waveform Button Figure 2 Front view Actual probe may be different with the pr
21. y and steady going this measured value is optimal value And the waveform at the monument 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 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 1s 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
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