CMS-50FW Fingertip Pulse Oximeter Manual
Contents
1. Click the button to select Wireless then press the button to turn on off the Wireless function Jit 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 gt value accurately transfer the data to the computer display the data and print reports with the included SpO gt Software SpO2 Assistant 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 i2. one L If some abnormal conditions appear on the screen during test process pull out the finger and reinsert to restore normal use 4A 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 4A 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 4A 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 4A 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 gt in the total Hb in the blood so called the O2 concentration in the blood It is an important bio parameter for the respiration A number of diseases relating to respiratory system may cause the decrease of SpO gt in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body and the corresponding symptoms would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might bring danger to human s life The
3. 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 cannot 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 cannot use enamel or other makeup 6 Testee s fingernail cannot 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 CMS 50FW Medical Test Supply CONTENTS E V od SEG EE EE ee aaa AA A V AA GA A AA D WAN ee 1 1 1 INSTRUCTIONS FOR SAFE OPERATIONS ccc00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 1 WP rn tc dail irae E 1 DE F N sk ER aces GE dea atk aan ig ENO PE OOT apa daa Ags AA N Ge ee ade 1 dd N id N EE EE Ee aa EE EE 2 EE 0272412442724414 577 QE EE EE EE EE EG EE E a 3 3 PRINS TEE ese Ri dr ie NG Gl ek GN eg dk oo ie be ee ie ie GUA 3 4 TECHNICAL PES TENG AT WON ss ede ee ese GES se ie eg
4. the high and low limits of alarms Click the button 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 HI 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 A 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 CMS S50FW Medical Test Supply Figure 6 Alarm S
5. 2 a Put the suitable probe into the jack 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 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 CMS 50FW Medical Test Supply Figure 4 Actual probe may be different with the probe as figure 4 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 measurin
6. Medical Test Supply Instructions for CMS 50FW Pulse Oximeter 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
7. ct s arteriole in a position there between D The SpO gt 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 gt 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 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 CMS 50FW Medical Test Supply 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 SpO2 determination by this monitor may be inaccurate C The drugs like d
8. e bar graph 5p0z ALM LO pulse vaveforn probe jack button Figure 2 Front 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 CMS 50FW Medical Test Supply Pulse Oximeter Me xSpO2 14 42 lt PRbpm Figure 3 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
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10. etting 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 7 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 CMS S50FW Medical Test Supply 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
11. g interface if there 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 CMS S50FW Medical Test Supply Figure 5 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
12. he finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator CMS S50FW Medical Test Supply IPX1 Ingress of liquids rank WEEE 2002 96 EC 10 Function Specification 2 digit digital OLED display 3 digit digital OLED display bar graph OLED display SpO Parameter Specification 70 100 2 Below 70 unspecified Average value Calculate the Average value in every 4 measure value The deviation between average value and true value does not exceed 1 Average pulse rate Moving calculate the Average pulse rate every 4 cardio beat s cycle The deviation between average value and true value does not exceed 1 Safety Type Interior Battery BF Type Pulse Intensity Range Continuous bar graph display the higher display indicates the stronger pulse CMS S50FW Medical Test Supply Input Voltage 100 to 240V AC 50 60 Hz Output voltage 5V DC gt Wireless Module Transmit frequency 2 4GHz Dimensions and Weight About 50g with the lithium battery 1 CMS S50FW Medical Test Supply Appendix State Alarm condition dela Alarm signal generation dela 20ms CMS S50FW
13. ibrated 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 amp 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 amp The person who is allergic to rubber cannot 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 amp Please choose the battery chargers which should be ensured compliance with the requirements of IEC 60601 1 or else 1t may damage the device Please don t use the device in the course of charging The device can only be matched with the compatible probe amp 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 vib
14. n succession after 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 SpO2 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 CMS S50FW Medical Test Supply 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 SpO2 Assistant icon to run the PC software The functions such as uploading s
15. onment a Temperature 10 C 40 C b Relative Humidity 30 75 c Atmospheric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO2 in glow amp near infrared zones Operation principle of the device is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger type sensor Then measured signal can be obtained by a photosensitive element information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor CMS S50FW Medical Test Supply Glow and Infrared ay Emission Tube La Glow and Infraredray Y h Receipt Tube Figure 1 4 Technical specifications 4 1 Main performance A SpO gt 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 st
16. opamine 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 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 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 The SpO and Pulse 1 The finger is not properly 1 Place the finger properly and try Rate cann
17. ored 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 L With clock function M With 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 gt error is 4 pulse rate error is 2 bpm or 2 select larger CMS S50FW Medical Test Supply 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 Pulsoximeter charging indication light battery capacity indication alarm indication Ey MA kitz 14 42 B wireless eee Ei ND ry pulse rate 2 g errs Usb port fi d A Jo N gt puls
18. ot be positioned again displayed normally 2 The patient s SpO is too low to be 2 Try again Go to a hospital for a detected diagnosis if you are sure the device works all right The SpO and Pulse 1 The finger is not placed inside 1 Place the finger properly and try Rate are not deep enough again displayed stably 2 The finger is shaking or the patient 2 Let the patient keep calm is moving CMS S50FW Medical Test Supply The device cannot 1 The batteries are drained or almost 1 Please recharge the battery be turned on drained 2 Please contact the local service 2 The device s malfunction center The display is off 1 The device s malfunction 1 Please contact the local service suddenly 2 The battery is drained away or center 2 Please recharge the battery almost drained away The device cannot 1 The battery is not full charged 1 Please recharge the battery be used for full time 2 The battery is broken 2 Please contact the local service after charge center The battery cannot The battery is broken Please contact the local service center be full charged even after 10 hours charging time 9 Key of Symbols Signal Description A Warning See User Manual The pulse oxygen saturation Pulse rate bpm Open the Wireless indication Close the pulse sound indication x Open the pulse sound indication El i menu button power button function button 1 t
19. ration 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 CMS S50FW Medical Test Supply 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 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 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 L 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 monument is the standard
20. refore 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 CMS S50FW Medical Test Supply 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 N The problem of overrating would emerge when the patient is suffering from toxicities 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 Envir
21. torage data and change device ID can be carried out by the software Please refer to lt SpO gt Assistant user manual gt for details Nit 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 Nit 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 gt sensor and photoelectric receiving tube should be arranged in a way with the subje
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