CMS-60C Instruction Manual
Contents
1. 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 25bpm 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 5 Installation 5 1 View of the front panel pulse sound indication alarm indication Sp02 pulse rate battery status indication alarm pause button up button pulse bar graph menu button power on off button gt pulse waveform screen change button d butt lia probe jack Figure 2 Front View 5 2 Accessories A A lithium battery B A User Manual C A power adapter D A data line E A disk PC software F An oximeter probe 6 Operating Guide 6 1 Application method A a Open the lid of battery box and put the battery inside then close b Put the suitable probe into the jack on t2. e Pulse Oximeter User Manual Instructions to User Dear users thank you very much for purchasing the Pulse Oximeter This Manual is written and compiled in accordance with the council directive MDD93 42 EEC for medical devices and harmonized standards In case of modifications and software upgrades the information contained in this document is subject to change without notice The Manual describes in accordance with the Pulse Oximeter s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details Please read the User Manual carefully before using this product The User Manual which describes the operating procedures should be followed strictly Failure to follow the User Manual may cause measuring abnormality equipment damage and human injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality human injury and equipment damage due to users negligence of the operation instructions The manufacturer s warranty service does not cover such faults Owing to the forthcoming renovation the specific products you received may not be totally in accordance with the description of this User Manual We would sincerely regret for that This
3. main menu interface press the up button or down button move the menu choice bar to Pulse Sound then choose the pulse sound indication state on off by pressing the menu button press on to start the function and press off to close it c Backlight adjustment On the main menu interface press the up button or down button move the menu choice bar to Brightness then press the menu button to change the number in order to adjust the brightness of screen d Data storage setting This device has the function of 24 hours data storage it has the capability of accurately storing pulse rate and SpO data then transmit the data to computer with the data line for replay and analysis a On the main menu interface press the up button or down button move the menu choice bar to Record then press the menu button again to enter the dialog box of figure 7 if it is in recording state the Stop is displayed on menu if it is not in recording state the Start is displayed on menu Figure 7 b When the Start is displayed on the menu if the memory still have the former data in storage the Do you really want to recover the memory dialog box will be displayed when pressing the menu button then press the up button or down button to choose setting then press the menu button to confirm setting the dialog box will be displayed as figure 8 It needs to set the starting time for data storage by users users can change the setting value by pressi
4. packed device can be transported by ordinary conveyance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material B The packed device should be stored in room with no corrosive gases and good ventilation Temperature 40 C 60 C Humidity lt 95 8 Troubleshooting Trouble Possible Reason Solution The SpO and Pulse Rate can not be 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 battery is drained away or almost drained away 2 The battery is installed incorrectly 3 The malfunction of the device 1 Please recharge the battery 2 Please Install the battery again 3 Please contact the local service center The display is off suddenly The battery is drained away or almost drained away Please recharge the battery The device can not be used for full time after charge 1 The battery is not full charged 2 The battery is broken 1 Please recharge the
5. provide high priority alarm signal when the battery is in low power status and intermittent alarm will occur 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 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 wav
6. battery 2 Please contact the local service center The battery can not be full charged even after 10 charging time hours The battery is broken Please contact the local service center 11 9 Key of Symbols Signal Description A Warning See User Manual a gt w The pulse oxygen saturation Pulse rate bpm Close the alarm sound indication Open the alarm sound indication Close the pulse sound indication Open the pulse sound indication Power on off button Alarm pause button up button Menu button Screen change button down button Type BF SN Serial number 1 the finger clip falls off no finger inserted ma 2 Probe error 3 Signal inadequacy indicator IPX1 Ingress of liquids rank X WEEE 2002 96 EC e 10 Function Specification Information Display Mode The Pulse Oxygen Saturation SpO 2 digit digital OLED display digit digital OLED display ar graph OLED display 0 100 the resolution is 1 25bpm 250bpm the resolution is 1bpm Accuracy amp 2 select larger Safety Type Interior Battery B F Type Pulse Intensity n Continuous bar graph display the higher display ange E indicate the stronger pulse Battery Requirement Voltage 3 7 rechargeable lithium battery x 1 Battery working life Charge and discharge no less than 500 time
7. eform 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 10 B Please recharge the battery when the screen shows EN 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
8. evice has normal useful life for three years since the first electrified use A This device has the function of alarming users can check on this function according to chapter 6 1 as a reference amp The device has the function of limits alarming when the measured data is beyond the highest or lowest limit the device would start alarming automatically on the premise of the alarming function is on A The device has the function of alarming this function can either be paused or closed for good please check the chapter 6 1 as a reference A The device may not work for all patients If you are unable to achieve stable readings discontinue use 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O concentration in the blood It is an important bio parameter for the respiration A number of diseases relating to respiratory system may cause the decrease of SpO in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body and the corresponding symptoms would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might bring danger to human s life Therefore prompt information of patients SpO is of great help for the doctor to discover the potential danger and is of great importance in t
9. he 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 5 95 c Atmospheric pressure 500hPa 1060hPa Operating Environment a Temperature 0 C 50 C b Relative Humidity 15 95 c Atmospheric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter is as follows An experience fo
10. he 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 c Put the finger into the probe d Press the power on off button long about a few seconds the power is on and the device will start to self inspect The device displays the measuring interface after self inspecting e Do not shake the finger and keep the patient in a stable state during the process f The data can be read directly from the screen on the measuring interface A Fingernails and the luminescent tube should be on the same side A If the alarm function is on the device will provide midium priority alarm signal when probe or finger is out and intermittent alarm will occur Figure 3 Actual probe may be different with the probe as figure 3 please accept the actual probe with the device B Change display direction On the measuring interface press the screen change button can change the display direction C 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 When alarm is on press the alarm pause button can pause the alarm it can renew alarm in about 60s and if pressing the alarm pause button Again with in 60s it can renew alarm c Ifyou want to turn off the alarm for good you should enter the menu for operation D Menu operations On the measuring
11. ication would be off for saving power h 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 any button power on off excluded again it will enter the measuring interface e Stored 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 9 the icon of SpO2 Review is a program for receiving stored data which is shown as figure 10 sue Figure 9 SpO2 program Figure 10 SpO2 Review program a Please connect the device to computer with the affiliated data line then double click SpO2 Review icon to start the program b On the main menu interface press the up button or down button in order to move the menu choice bar to Upload then press the menu button to transmit the stored data to computer for replay and analysis c In the state of storing it is not applicable for the users to upload the stored date to computer d When the stored data is being uploaded the screen displays as figure 11 Figure 11 e When the upload of stored data is finished the device will automatically return to the main menu and the menu choice bar will move to Exit automa
12. interface press the menu button can enter the menu of figure 4 Users can adjust the setting through the main menu such as alarm pulse sound indication backlight data storage data transmission with the use of data line the specific method is as follows Figure 4 Main Menu Interface a Alarm setting On the main menu interface press the up button or down button move the menu choice bar to Alarm then press the menu button to enter the alarm setting menu of figure 5 Figure 5 Alarm Setting Menu a The highest lowest alarm limit setting Press the up button or down button to choose the parameter to be adjusted then press the menu button again to enter the similar dialog box shown as figure 6 then press the up button or down button to change data Each press of the up button or down button the data will raise or descend for one time accordingly until it gets to the required number then press the menu button for another time to end the setting Ait the alarm function is on the device will provide midium priority alarm signal when the data of SpO or pulse rate is beyond the limit and intermittent alarm will occur Figure 6 b The alarm state setting Press the up button or down button move the menu choice bar to Alarm then choose the alarm state on off by pressing the menu button choose on to start the alarm function and choose off to close it for good b Pulse sound indication setting On the
13. ng the up button or down button and confirm the setting value by pressing the menu button the black cursor will move to next place after setting When the black cursor move to Yes store or No don t store press the up button or down button to choose setting then press the menu button to confirm setting When the Stop is displayed on menu the Do you really want to stop recording dialog box will be displayed when pressing the menu button then press the up button or down button to choose setting then press the menu button to confirm setting rime 12 05 Yes Figure 8 d 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 e 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 and then the screen will be automatically shut down If pressing any button power on off excluded at this moment the sign Recording would appear on the screen and then the screen will be automatically shut down again if pressing the power on off button the device would return to the former interface f Ifturning on the data storage function the former data storage will be automatically removed g In the state of data storing after the screen is automatically shut down the pulse sound ind
14. product is medical device which can be used repeatedly WARNING 6 Uncomfortable or painful feeling may appear if using the device ceaselessly especially for the microcirculation barrier patients It is recommended that the sensor should not be applied to the same finger for over 2 hours 6 For the special patients there should be a more prudent inspecting in the placing process The device can not be clipped on the edema and tender tissue The light the infrared is invisible emitted from the device is harmful to the eyes so the user and the maintenance man should not stare at the light Testee can not use enamel or other makeup Testee s fingernail can not be too long 6 Please refer to the correlative literature about the clinical restrictions and caution This device is not intended for treatment The User Manual is published by our company All rights reserved Contents 1S afOtY ooonoomsssmssmsms DL Str OSA A eee 1 A A 1 LIA A A 1 2 0Overvie Worms 2 ZAS A A A A td 2 2 2Majorapplicationsandscopeofapplication cccesceessesceesecseecsecsseeseceaeesecsensecesceseseeeeesenseseesseeseeeseenaes 2 ZII AMO a dee 3 S Principle ssssosscreresssscsevssssesesccsesescsccvesssvsssvssesvsssesssvesesssessesescsssvessssescnesssvsscosssssessssssesessessssvessesescsessaves Y 4 TechnicalspecificatioNS ooooosmmmmmsmmr 3 A WMainperformances ii id ebeeuss caste tense 3 4 2DMainParameters ae nn
15. rmula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO in glow amp near infrared zones Operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor Glow and Infrared ay Emission Tube ON 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 A pulse 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 It can be connected with an external oximeter probe K Real time data can be transmitted to computers 4 2 Main Parameters A Measurement of SpO Measuring range 0
16. s KL x 45 W x 22 H mm About 180 g with the lithium battery 1
17. t e ts 4 SInstallation ccssossssssssssecosscsssevessscesevessevsscesensvesssseesessesccsesssseseessevescssessssssssessesesssssessesesssessesssenesees 4 SV View ol the fron tpatiel usina 4 S DACCESSOTICS A a eae ee ed AER 5 6OperatingGuide sessesssssosssosossesssosossesssosososossosssosososossosososossosososososossosossessoosososossosssssososssessosososossosssososssssso D 6 TApplicationmethod 2 12 08 ak eases Mie Ah ie eed ed SAM ee ee 5 O 2Attentionforoperationys 2 cccicscedsccetesc A cats 10 6 3C lmicalrestrict Os A cade ass cevecs ah teases as tlace fete ass depeide EE 10 7Maintain transportationandstOrage cccccccsscsssercsccseccsccsescscssescessesscecssssssescsessesssessesssessesssessesees 10 7 1 GleaningandDisinfecting taco 10 TDM anit anil 2 25 A A A CEE ETE ped seas eats estan ee 10 7 3 Transportation andstorag eescici ices A ea asin tees 11 BTroubleshooting ccccccscccscssssescccsseccsccsesescsesesesssscessesssesssssseesssessesssessesssesseesseesesenessesssesesssossssssecsoees 11 9KeyofSymbolS mo mommmsssmimsmsmmmsmmssssss 12 10FunctionSpecificatioN mmmmmmmmsms 13 HI 1 Safety 1 1 Instructions for safe operations lt gt Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and monitoring performance about cables and transducers It is recommended that the device should be inspected once a week at least When
18. terials high temperature and moisture amp Tfthe oximeter gets wet please stop operating it A When it is carried from cold environment to warm or humid environment please do not use it immediately A DO NOT operate keys on front panel with sharp materials A High temperature or high pressure steam disinfection of the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for instructions of cleaning and disinfection amp Do not have the oximeter immerged in liquid When it needs cleaning please wipe its surface with medical alcohol by soft material Do not spray any liquid on the device directly A When cleaning the device with water the temperature should be lower than 60 C amp Asto the fingers which are too thin or too cold it would probably affect the normal measure of the patients SpO and pulse rate please clip the thick finger such as thumb and middle finger deeply enought into the probe A Whether the device is used to adult or infant it depends on the probe selected A The update period of data is less than 5 seconds which is changeable according to different individual pulse rate A Please read the measured value when the waveform on screen is equably and steady going This measured value is optimal value And the waveform at the monment is the standard one A If some abnormal conditions appear on the screen during test process pull out the finger and reinsert to restore normal use A The d
19. 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 specified in User s Manual Only the accessory that appointed or recommendatory by manufacture can be used with this device lt gt This product is calibrated before leaving factory 1 2 Warning 6 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 6 The person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packings including battery plastic bags foams and paper boxes should follow the local laws and regulations 6 Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list or else the device may have the possibility of working abnormally 6 Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device 6 The device can only be matched with the compatible probe 6 Please don t measure this device with function test paper for the device s related information 1 3 Attention A Keep the oximeter away from dust vibration corrosive substances explosive ma
20. tically as well f Exit the main menu On the main menu interface press the up button or down button in order to move the menu choice bar to Exit then press the menu button to exit the main menu E Real time data transmission a Please connect the device with computer by the data line which is equipped with the device then double click SpO2 icon to open SpO2 program b The data can be displayed on computer screen in a few seconds 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 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 The five status of battery power are shown as follows E Power supply by battery only and battery status is full EED Battery status is not full 9 D D Battery status is draining away the four status above shows Battery is under charging dynamically in turn d When charging the battery in the state of power off the sign of battery status still exists on the screen but it will disappear in about 60 seconds for saving power However the sign will appear again if you press any button power on off excluded at this moment Ar the alarm function is on the device will
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