CMS-50D Plus Instruction Manual
Contents
1. d If turning on the data storage function the former data storage will be automatically removed e When the storage space is full it displays Memory is full on the screen and then shut down in a few seconds But it will still display Memory is full by the next time you turn on the device on the purpose of warning the user and a few seconds later enter the measuring interface b Uploading the data to the PC after recording a Please connect the device with computer by the data line which 1s 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 on the main menu interface the users to upload the stored date to computer when the symbol Record shows off c Exit the main menu On the main menu interface Click the button to select Exit then long press the button to exit the main menu E Power off If the measuring finger out of the device on the measuring interface The device will power off automatically when it gets no signal within 5 seconds The device can t being power off when it is in a state of storing 6 2 Attention for operation A Please check the device before using and confirm that it can work normally B The finger should be in a proper position see the attached illustration of figu2. D 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 7 Users can adjust the setting through the main menu such as data storage The specific operation methods are as the following FingertipOximeter Figure 7 Main Menu Interface a Data storage setting This instrument has the ability to store 24 hours worth of data It can store the measured pulse rate and SpO value accurately transfer the data to the computer display the data and print reports with the included SpO Software Green Heart a On the main menu interface short press the button to select Record then long press the button to choose whether store the data or not choose on to permit storing choose off to forbid storing b If the data storage function is being turned on when return to the measuring interface a flashing yellow dot would appear on screen which means the device is in a state of storing c In the state of storing the device is on measuring interface the sign Recording would appear on the screen in 30 seconds and then the screen will be automatically shut down only a flashing yellow dot appear on screen If short press the 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 button the device would return to the measuring interface
3. SpO and Pulse o again Rat t be ne 2 Try again Go to a hospital for a u 2 The patient s SpO is too low to be im displayed normally diagnosis if you are sure the device detected works all right 1 The finger is not placed inside The SpO and Pulse 1 Place the finger properly and try deep enough again ne oe 2 The finger is shaking or the patient displayed stably te 2 Let the patient keep calm 1 The battery is drained away or 1 Please change batteries The device can not almost drained away 2 Please Install the battery again be turned on 2 The battery is installed incorrectly 3 Please contact the local service 3 The malfunction of the device center nee 1 The device s malfunction 1 Please contact the local service TNE ispay ISo 2 The battery is drained away or center suddenly almost drained away 2 Please change batteries 9 Key of Symbols Signal Description AN Warning See User Manual ZSpO The pulse oxygen saturation PRbpm Pulse rate bpm CT ee E y al q gt menu button power button function button Type BF 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator battery positive electrode battery cathode E rio 10 Function Specification Information Display Mode The Pulse Oxygen Saturation SpO 2 digit digital OLED display Pulse Rate PR 3 digit digital OLED display Pulse Intensity bar gra
4. This product is medical device which can be 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 6 The light the infrared is invisible emitted from the device is harmful to the eyes so the user and the maintenance man should not stare at the light 6 Testee can not use enamel or other makeup Testee s fingernail can not be too long 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 II CONTENTS I Saey eea E SE R lsk Instruchons LOL sae OPENS een E SV nn MOP RE ON E E TOO On esse A A 2 COVE VIEW aid aia 2 1 EC AUS ans area ee ee 2 2 Major applications and scope of application aai 2 5 VENVITOnMEenL equine MCN 0S a ein ine 3 A ee RAT SR SE EEEN A TECHNICAL DCCUICAUIONS ran A ir die lie dettes net ee der eine Ady AN o alo aii SES ee ee s a ae hee Cette a A AMan A e eee S Thstallati onssa se entisceacun tate R E E E IL NVewol Teont Pan a ee area 52 Baterista lao dada dad II AECE SOO a Ban Deere one 6 O
5. a 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
6. et the patient s finger put into the rubber cushions of the clip make sure the finger is in the right position and then clip the finger d Do not shake the finger and keep the patient in a stable state during the process e The data can be read directly from the screen on the measuring interface IN Fingernails and the luminescent tube should be on the same side Le of x u aan ae MARA EVE Figure 4 Put finger in position B Change display direction On the measuring interface short press the button to change the display C 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 5 the icon of SpO2 Review is a program for receiving stored data which is shown as figure 6 a Please connect the device to computer with the affiliated data line then double click the SpO2 icon to start the program b When you unplug the data 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 gt Sys Figure 5 SpO program Vv A a Figure 6 SpO2 Review program Mu 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
7. heric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter 1s as follows An experience formula of data process 1s 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 ray Emission Tube IR 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 With SpO value and pulse rate value of storage the stored data can be uploaded to computers 4 2 Main Parameters A Measurement of SpO Measuring range 0 100 Accuracy When the SpO measuring range is 70 100 the permission of absolute error
8. is 12 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 Ibpm D Measurement Performance in Weak Filling Condition 3 SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO error is 44 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 2 6 V DC 3 6V 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 low battery indication pulse rate Ui E e button o euf FingertipOximeter pulse bar graph pulse waveform Figure 2 front view 5 2 Battery installation A Refer to Figure 3 and insert the two AAA size batteries properly in the right direction B Replace the cover IN Please take care when you insert the batteries for the improper insertion may damage the device Figure 3 5 3 Accessories A One hanging rope B Two dry batteries AAA C A User Manual D a data line E a disk PC software 6 Operating Guide 6 1 Application method A a Insert the two batteries properly to the direction and then replace the cover b Open the clip as shown in Figure 4 c L
9. lobin 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 change the battery when the screen shows 0 C Take out the battery if leave the equipment unused for long time D The device needs to be calibrated once a year or according to the calibrating program of hospital It also can be performed at the state appointed agent or just contact us for calibration 7 3 Transportation and storage A The packed device can be transported by ordinary conveyance or according to transport contract The device can not be transported mixed with toxic harmful corrosive material B The 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 1s not properly The
10. of the patients SpO and pulse rate please clip the thick finger such as thumb and middle finger deeply enought into the probe 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 equably and steady going This measured value is optimal value And the waveform at the monment is the standard one A If some abnormal conditions appear on the screen during test process pull out the finger and reinsert to restore normal use A The device has normal useful life for three years since the first electrified use A The 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 S
11. pO 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 s 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 10 C 40 C b Relative Humidity 30 75 c Atmosp
12. perating Guid e ds nie ceauecavesaecseveeisecduseeesuaecsecesasssuesveveuiuavasscaueeduesssssesserseetiesieueevers Gel Applicaton MENA ia 02 Attention to OP RATION a S or Cli al Tes ICONS ne A IIS er 7 Maintain transportation and SOFA in ia AREAS 7 1 Cleaning and site Cue a ta nation SA O 7 3 Transportation and Ora id idas A A A D EVOL SMS E rE EEE ERa 10 FURCUON Specie aO EEE Re SR RER RnB O MI 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 1s 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 it by themselves 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 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 The person who is allergic to rubber can not use this device 6 The disposal of scrap inst
13. ph SpO Parameter Specification Measuring range Accuracy Calculate the Average value in every 4 measure value Average value The deviation between average value and true value does not exceed 1 Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1bpm 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 B F Type Pulse Intensity Continuous bar graph display the higher display indicate the stronger pulse Battery Requirement 1 5V AAA size alkaline batteries x 2 or rechargeable battery Battery working life Twol 5V AAA size 600mAh alkaline batteries can work continually for 24 hours Dimensions and Weight Dimensions 58 5 L x 31 W x 32 H mm Weight About 52g with the batteries 10
14. re 4 for reference or else it may result in inaccurate measure C The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between D The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection E Do not fix the SpO sensor with adhesive or else it may result in venous pulsation and inaccurate measure of SpO and pulse rate F Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc G Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy H Testee can not use enamel or other makeup I Please clean and disinfect the device after operating according to the User Manual 7 1 6 3 Clinical restrictions A As the measure is taken on the basis of arteriole pulse substantial pulsating blood flow of subject is required For a subject with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more 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 hemog
15. rument 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 6 Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device 6 Please don t measure this device with functional tester for the device s related information 1 3 Attention A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture A Ifthe 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 3 High temperature or high pressure steam disinfection of the oximeter is not permitted Refer to User Manual in the relative chapter 7 1 for instructions of cleaning and disinfection A Do not have the oximeter immerged in liquid When it needs cleaning please wipe its surface with medical alcohol by soft material Do not spray any liquid on the device directly A When cleaning the device with water the temperature should be lower than 60 C A Asto the fingers which are too thin or too cold it would probably affect the normal measure
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