CMS-60F Instruction Manual
Contents
1. gt RLL L a User Manual 0 ahad 0 X O Q 2 A 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 wit2. 3 Signal inadequacy indicator WEEE 2002 96 EC 10 Function Specification Information 0 Display Mode The Pulse Oxygen Saturation SpO 2 digit digital TFT display Calculate the Average value in every 4 measure value The deviation between average value and true value does not exceed 1 Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1 bpm Accuracy 0 2bpm or 2 select larger Moving calculate the Average pulse rate every 4 cardio beats cycle Average pulse rate The deviation between average value and true value does not exceed 1 Perfusion Index Specification 0 20 The resolution is 0 1 Pulse Intensity Continuous bar graph display the higher display indicates the stronger pulse 17 Safety Type Interior Battery BF Type Battery Requirement on the battery denotes cathode Input Voltage 100 to 240 VAC 50 60 Hz Output voltage 5 VDC a Output power Dimensions and Weight Dimensions 94 25 L x 55 32 W x 9 6 H mm 11 Factory default a E 0 mens Komi Alarm sound off Spo alarm high limit Alarm pause time Spo alarm low limit Pulse rate alarm high limit 120 Pulse rate alarm low limit bpm 18
3. to disinfect the device nature dry or clean it with clean soft cloth 14 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 red aglimmer Battery Too Low alarm information C Recharge the battery soon after the over discharge The device should be recharged every six months when it is not 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 Relative Humidity 5 95 8 Troubleshooting 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 1 Place the finger properly and try again 2 Let the patient keep calm 1 Please recharge the battery 2 Please contact the local service center 1 Please contact the local service center 2 Please recharge the battery 1 Please recharge the battery 2 P
4. Principle Principle of the Oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO in glow amp near infrared zones Operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then 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 7 Glow and Infraredray Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance 50002 value display Pulse rate value display bar graph display PI value display Pulse waveform display Low power indication low power indication symbol appears before working abnormity which is due to low power Review function Screen brightness can be adjusted Pulse sound indication With alarm function With data record function of multiuser continuous record 24 hours data for each user and the record data can be uploaded to computer Itcan be connected with adult child infant oximeter probe 3 With clock functio
5. QWERTYUIOP ASDFGHJKL 2 5 4 13 57 Back figure 11 Input ID interface b In Input ID interface press menu button to input new ID here aglimmer cursor will appear in the ID input box and the red choice box will appear in the alphabet as figure 12 Press direction key to choose the letter which is wanted to input and press menu button to input You can input 4 letters most After inputting the letters move the choice box to the enter sign and press menu button to confirm input here there is not aglimmer cursor in the ID input box Press menu button again to begin recording and return to measure interface QWERTYUIOP ASDFGHJKL ZXCVBNM lt e figure 12 Input new ID interface c In Input ID interface press direction key to choose the existent ID for data storage here the ID input box will turn to blue at the same time there will be a red choice box on the first ID in the ID listing as figure 13 Press direction key to move the red choice box to the ID which is wanted to choose then press menu button here prompt information whether to erase the storage data for this ID will appear Choose Yes to erase the ID data at the same time begin to record and return to the measure interface choose No to return the Input ID interface 11 QWERTYUIOP ASDFGHJKL ZXCVBNM lt e figure 13 Choose existent ID d Every patient ID could save 24 hour data the device could save 16 patient ID e In the state of stor
6. bient 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 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 device may be inaccurate C The drugs like dopamine procaine prilocaine 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
7. dace tauniseniadiasulaucatanaadeis 3 0000010 classed Environment rog ire men 2 5 1 12 1 000000000000800 3 3 20 0 2 2 2 2 2 2 2 2 2 1 1 1 Technical specifications 4 3 Al Manperf ornano Wo M 0 011112 4 5 0100101012 5 Sel the Pron pane 1 5 22 001010101010101 5 6 I4 ACCESS OMICS yaaa ncn hei ea ate hace ia act occa ia don en occas doa eh Cocca Co oie Mocca doc on hoc ad doc tates 6 6 02 _ _ _ _ 0 202020 GUNG 6 21 102 6 6 0 L 14 0136130101 Attention Tor 6 2 14 03 14 Maintain transportation and storage 7 14 doa Cle aniiys and iSite Cui Dade DOBLE O stead TT a 15 15 Aransportano and Storage acs EA 12 AE TE AOE OE 15 16 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 Key 0 Syml Suasana 9 17 100000000000000 1 1 1 1 1 t0 Factory default 1 AOE ES 18 MI 1 Safety 1 1 Instructions for safe operations gt Check the main unit and all accessories periodically to make sure that th
8. ere is no visible damage that may affect patient s safety and monitoring performance It is recommended that the device should be inspected weekly at least When there is obvious damage stop using the device lt 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 is 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 the environment with tinder such as anesthetic 6 DO NOT use the oximeter while the patient is being scanned by MRI or CT 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 6 Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device The device can only be matched with the compatible probe Please don t measure this device with functional tester for the d
9. evice s related information 1 3 Attention A Keep the oximeter away from dust vibration corrosive substances tinder high temperature and moisture amp 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 A When cleaning the device with water the temperature should be lower than 60 C A The fingers which are too thin or too cold may affect the measure accuracy please clip the thicker finger such as thumb and middle finger deeply enough into the probe A The pulse oximeter can be used to adult or children Whether the device is used to adult or children it depends on the probe selected 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 15 the standard one A If some abnormal conditi
10. ght button to move the red triangle ID HHN 09 1 1 00 01 49 figure 15 Trend review mode H Close the device a In the main menu interface move the choice bar to the Power off item then press menu button to close the device If the storage function has been opened the prompt interface of Recording will appear when closing the device It means that the device is in the state of storing can t be closed b In the state of boot strap long press power button could close the device too A If finger out appearing and no turning on record function and no operation in 10 minutes the device will close automatically 6 1 4 PC software operation Please connect the device to the computer by USB data line which 1s affiliated with the device then double click SpO2 Assistant icon to run the PC software The functions such as uploading record data and change device ID could be carried out by the software Please refer to lt SpO gt Assistant user manual gt for detail Art 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 If there is no data on the computer screen unplug USB data line then repeat step 6 1 4 again 6 1 5 Charge There are two kinds of charge method A Connect the device to computer with data line then the device should be in charge state B Connect the device to power supply with power adaptor t
11. h the description of this User Manual We would sincerely regret for that This 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 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 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 1 Contents L 111 einai akan 1 1 00000 E JEISGHUCHONS TOR SAC OC FALIOMNS i 1 L2 Wanne E SSS ee ee 1 ees EY ANis ESE 2 2 2 2 1212121212 1 1 1 1 1 1 1 1 12 va 2 2 1 2 1 2 E dt 2 031301013 Major applications and scope of 2 2
12. hen the device should be in charge state When pressing power button if the device is closed the charge icon will display and when the battery 13 status is full the icon of full power will display If there is no operation in 30 seconds the display will closed automatically here short press power button to turn on display When charging long press power button to turn on the device here the battery status icon on the right top will display dynamically It means that the device is charging up When the battery status is full the icon of full power will display Art 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 High priority indicating requires that operator responds immediately 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 5 for reference or else it may result in inaccurate measure C The ray between luminescent tube and photoelectric receiving tube must get across subject s arteriole D The oximeter probe 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 and PI F Excessive am
13. ht View 5 3 Probe connection Figure 4 Installation Inserting the oximeter probe into the USB port of the pulse oximeter as figure 4 The probe is limited to the one that is produced by our company and can t be replaced with the similar one by other manufacturers 5 4 Accessories A User Manual A power adapter A data line A disk PC software An oximeter probe 6 Operating Guide 6 1 Application method 6 1 1 Connect the probe well according to the method introduced in chapter 5 3 then put the finger into the probe Refer to Figure 5 A Long press the power button until the device turns on B Do not shake the finger and keep the patient in a stable state during the process C The data can be read directly from the screen on the measuring interface A Fingernails and the luminescent tube should be in the same side A 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 Figure 5 Actual probe may be different with the probe as figure 5 please accept the actual probe with the device 6 1 2 Pause alarm A Alarm including the alarm of measure data s going beyond the limits the alarm of low voltage the alarm of finger out B When alarm is on short press the power button can pa
14. ing whatever interfaces the device 1s in measure interface menu interface clock interface if there 1s no operation in 30 seconds the display screen will closed automatically If pressing power button the device will return the measure interface f After the display screen closed automatically the pulse sound will close automatically too for saving electricity under recording state F Demo function setting In the main menu interface move the choice bar to the Demo item then press the right button to turn on demo mode G Review function setting In the main menu interface move the choice bar to the Review item then press the right button to choose review mode There are two review mode of value and trend Under value review mode as figure 14 press left button or right button to page up or page down press up button or down button to page up or page down quickly The displayed time on the right top is the total recording time Time SpO2 PR 56 99 077 56 99 078 56 99 079 56 99 080 56 99 081 56 99 082 56 99 083 56 99 083 56 99 083 56 99 082 98 082 figure 14 Value review mode 12 Under trend review mode as figure 15 the white number on the left bottom is current recording time point the middle blue number is SpO2 value green number is pulse rate value the white number on the right bottom is PI value Press up button or down button to page up or page down press left button or ri
15. lease contact the local service center Please contact the local service center 1 The finger is not properly positioned 2 The patient s SpO is too low to be detected 1 The finger is not placed inside deep enough 2 The finger is shaking or the patient is moving 1 The battery is drained away or almost drained away 2 The malfunction of the device 1 The device is damaged 2 The battery is drained away or almost drained away 1 The battery is not full charged 15 2 The battery is broken The battery is broken The SpO and Pulse Rate can not be displayed normally The SpO and Pulse Rate displayed stably are not The device can not be turned on The display is off suddenly The device can not be used for full time after charge The battery can not be full charged even after 10 hours charging time 9 Key of Symbols Signal Description Warning See User Manual Te The pulse oxygen saturation The battery power is full The lack of battery power Please change batteries in time for exact measuring Close the alarm sound indication Pause the alarm sound indication Open the alarm sound indication Close the pulse sound indication Open the pulse sound indication Open the demo mode Power on off button Type BF IPX1 Ingress of liquids rank HOLD 16 N R NY 1 the finger clip falls off no finger inserted 2 Probe error
16. n With locking touch key 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 Measurement of PI Range 0 20 D Resolution SpO 1 Pulse rate 1bpm E 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 F 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 1s less than 1 G Power supply requirement 3 6 V DC 4 2V DC H Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW I Adjustable alarm range SpO 096 7606 Pulse Rate Obpm 254bpm 5 Installation 5 1 View of the front panel Left Bu Button Back Button Menu Butt ton Probe Jack Reset USB Port Figure 2 Front View Probe jack It 1s used to connect oximeter probe to measure the oxygen saturation and pulse rate USB port It 1s used to connect a personal computer to export the trend data by a data line 5 2 Left View and Right View Left Side Right Side Power Button Figure 3 Left View and Rig
17. ons 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 The device has alarm function users can check on this function according to chapter 6 1 as reference A The device has the function of limit alarm when the measure data is beyond the highest or lowest limit the device would start to alarm automatically on the premise of the alarming function is on A The device has alarm function This function can either be paused or closed for good This function could be turned on through menu operation if you need Please check the chapter 6 1 as 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 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 Therefo
18. re prompt information of patients SpO gt 1s of great help for the doctor to discover the potential danger and 1s of great importance in the clinical medical field The Pulse Oximeter is small in volume convenient in operation and portable It is only necessary for patient to put one his finger into probe for diagnosis and display screen will directly show the measure value of pulse oxygen saturation with the high veracity and repetition 2 1 Features A Operation is simple and convenient B 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 15 not recommended to use the device during the process of having sport and etc 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 5OOhPa 1060hPa Operating Environment a Temperature 10 C 40 C b Relative Humidity 30 75 c Atmospheric pressure 700hPa 1060hPa 3
19. the Memory Manager item then press the right button to enter Select ID interface as figure 10 Select the patient ID that you want to delete then press menu button to delete the patient ID and storage data HHN MM GG Back figure 10 Select ID interface d In System Menu interface move the choice bar to the Factory Default item and press the right button to choose Yes then press menu button and the device will resume leave factory State e In System Menu interface move the choice bar to the Volume item then you can set the volume of voice f In System Menu interface move the choice bar to the Pause Time item then you can set the pause time of alarm The default of pause time is 60 seconds and press the right button to adjust the pause time of alarm g In System Menu interface move the choice bar to the Key Sound item and press the right button to turn on off the key sound D Brightness adjustment In the main menu interface move the choice bar to the Brightness item then press the right button to adjust the brightness of screen E Data storage setting a Inthe main menu interface press the up button or down button to select Record then press right button here the off will turn to black display Press right button again and the black off will turn to black on Press menu button to enter the Input ID interface as figure 11 10 Input ID EAM
20. tion setting In alarm setting menu move the choice bar to the Pulse Sound item then press right button to set state choose on to turn on pulse sound and choose off to turn off pulse sound B Clock setting In the main menu interface move the choice bar to Clock item then press the right button to enter the clock setting menu of figure 8 Figure 8 clock setting menu Move the choice bar to the menu item that you want to set and press right button to begin to set Press menu button for affirming After resetting time press return button and the prompt information whether to affirm setting will appear The interface will return to main menu after choosing C System setting In the main menu interface move the choice bar to the System item then press the right button to enter the System setting menu as figure 9 Version Equipment Memory Manager Factory Default Volume _ Pause Time Key Sound figure 9 System setting menu a In System Menu interface move the choice bar to the Version item then press the right button to see the edition information of hardware and software b In System Menu interface move the choice bar to the Equipment ID item then press the right button to see the ID information of device The ID of the device can be set by the PC software Please refer to lt SpO gt Assistant user manual gt for detail c Move the choice bar to
21. use the alarm it can renew alarm after period of time alarm pause time can be set by menu C Only alarm sound can be closed the prompt information displayed can t be closed 6 1 3 Menu operations In the measuring interface press the menu button can enter the main menu interface of figure 6 via Alarm Clock System Brightness Record Demo Review Power off Figure 6 Main Menu Interface A Alarm setting In the main menu interface move the choice bar to Alarm item then press right button to enter the alarm setting menu of figure 7 Alarm Menu High Limit 5002 PR Low Limit Sele PR _ Alarm Pulse Sound ToT ack Figure 7 Alarm Setting Menu a The high low limit of alarm setting In alarm setting menu you can set the high low limit of alarm Move the choice bar to the menu item that you want to set and press right button to begin to set value Press menu button for affirming Art 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 value shows in yellow Medium priority indicating that prompt operator response is required b The alarm state setting In alarm setting menu move the choice bar to the Alarm item then set the alarm state by pressing right button Choose on to turn on the alarm and choose off to turn off the alarm c Pulse sound indica
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