CMS-60C Handheld Pulse Oximeter Manual
Contents
1. A A lithium battery B A User Manual C A power adapter D A data line E A disk PC software F An adult oximeter probe An infant oximeter probe May purchase selectively 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 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 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 N Fingernails and the luminescent tube should be on the same side N 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 B Change display direction CMS 60C Medical Test Supply On the measuring interface press the screen change button2. 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 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 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 60C Medical Test Supply Contents L ALET baai 1 Ji Fi ley taon ri i k U Z uui kasuni u er een er ener sum rere L SI A x 5 5 LW BY oad h eT eee eT AAI en IAIA Te kunu mauka AS rey PTT E E m ia asua LAN ERVI bnaaai a kkaa 2 lI L eee eee Te Teer een eT eee eT u nus a 2 L P EINUCI CE aca 3 t TECHNICAL SPECIPICATIUN 5 bariai aaaeaii 4 da SI 1 Oi T uu uuu usu Z un 2 uussusassanayaanasssssa 4 TU Su T u us suku aaa aaa a alee eal teins 4 3 INSTALLATE P ucu uaassuaispiqastasaqiqassskkaqsaws askaqauakkkaaysasakashasakantastasp
3. about 60 seconds for saving power However the sign will appear again if you press any button power on off excluded at this moment 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 3 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 subject 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 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 CMS 60C Medical Test Supply G Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy H Testee cannot use enamel or other makeup I Please clean and disi
4. recharged every six mo nths when it is no regular used It can extend the battery life following this guidance D Please take out the batteries if the oximeter is not in use for a long time E 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 cannot 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 CMS 60C Medical Test Supply The SpO and Pulse 1 The finger Is not properly positioned 1 Place the finger properly and Rate cannot be 2 The patient s SpO gt is too low to be try again displayed normally alacaq 2 Try again Go to a hospital for a diagnosis if you are sure the device works all right The SpO and Pulse 1 The finger is not placed inside deep 1 Place the finger properly and Rate are not enough try again displayed stably 2 The finger is shaking or the patient is 2 Let the patient keep calm moving The device cannot 1 The battery is drained away or almost 1 Please recharge the battery be turned on drained away 2 Please Install the batte
5. to confirm setting a gees a pe te aEs TFI L II E rs D ime nn TaS m Figure 10 d Ifthe data storage function is being turned on when return to the measuring interface a red RE C 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 t he sign Recording would appear on the screen in 30 seconds and then the screen will be automatic ally 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 th e power on off button the device would return to the former interface f If turning on the data storage function the former data storage will be automatically removed g In te state of data storing after the screen is automatically shut down the pulse sound indication would be off for saving power h When the storage space is full it displays Memory 1s 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 Device ID The user could modify device ID by software SpO gt Assistant f Exit the main menu On the main menu interface p
6. Medical Test Supply Instructions for CMS 60C 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 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 accor dance with the description of this User Manual We would sincerely regret for that
7. 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 th e 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 If you want to turn off the alarm for good you should enter the menu for operation D Menu operations On the measuring interface press the menu button can enter the menu of figure 6 Users can adjust th e setting through the main menu such as alarm pulse sound indication backlight data storage ID fun ction the specific method is as follows Figure 6 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 7 SOO HLM AL Ff Figure 7 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 but ton again to enter the similar dialog box shown as figure 8 then press the up button or down butto n 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 ti me to end the setti
8. ht and convenient in carrying CMS 60C Medical Test Supply 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 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 circu mstance 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 Atmospheric pressure 700hPa 1060hPa 3 Principle Principle of the Oximeter is as follows An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO 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
9. l Test Supply 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 4A 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 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 4A The device 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 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 default setting for good This function could be turned on through me
10. 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 gt im Glow and Infrarettray Receipt Tube ES Figure 1 CMS 60C Medical Test Supply 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 0 100 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 1 bpm D Measurement Performance in Weak Filling Condition SpO and pulse rate can be shown correctly when
11. nfect 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 SpO2 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 gt 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 EE C Recharge the battery soon after the over discharge The device should be
12. ng NIt 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 CMS 60C Medical Test Supply Medium priority indicating that prompt operator response is required When operating at the beginning the operator inserts his finger and setup the Spo2 ALM HI lower than the current measured value then the machine will start alarm The pulse rate alarm test is the same with the above Figure 8 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 main menu interface press the up button or down button move the menu choice bar to Puls e 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 s creen d Data storage setting This device has the function of 24 hours data storage it has the capability of accurately storing
13. nu operation if you need 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 gt 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 Therefore prompt information of patients SpO gt is of great help for the doctor to discover the potential danger and is of great importance in the clinical medical field The Pulse Oximeter features in small volume low power consumption convenient operation and being portable It is only necessary for patients to put one of his fingers into a probe for diagnosis and a display screen will directly show the measured value of pulse oxygen saturation with the high veracity and repetition 2 1 Features A Operation of the product is simple and convenient B The product is small in volume light in weig
14. pulse filling ratio is 0 4 SpO gt error is 4 pulse rate error is 2 bpm or 2 select larger E Resistance to surrounding light The deviation between the value measured in the condition of man made light or indoor natural light and that of darkroom is less than 1 F Power supply requirement 3 6 V DC 4 2V DC G Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW H Adjustable alarm range SpO 0 100 Pulse Rate Obpm 254bpm CMS 60C Medical Test Supply 5 Installation 5 1 View of the front panel pulse sound indication alarm indication SpOz pulse rate battery status indication alarm pulse button up button tSp0e PRbpa a pulse bar graph 99 El 5 power on off button pulse waveform menu button screen change button down button probe jack sp02 ALH HI sp02 ALH LO Figure 2 Front View 5 2 Underside View and Left View Finger 3 Underside View and Left 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 real time data or charge the lithium battery via a data line 5 3 RearView x Lu gt wd O O ad Finger 4 RearView Refer to Figure 4 and insert the lithium battery properly in the right direction CMS 60C Medical Test Supply 5 4 Accessories
15. pulse rate and SpO gt 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 t o Record then press the menu button again to enter the dialog box of figure 9 1f it is in recording s tate the Stop is displayed on menu if it is not In recording state the Start is displayed on menu PCOFO Fare Figure 9 b When the Start is displayed on the menu if the memory still have the former data in storage the CMS 60C Medical Test Supply Do you really want to recover the memory dialog box will be displayed when pressing the men u 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 10 It needs to set the starting time for data storage by users users can change the setting value by pressing 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 dow n button to choose setting then press the menu button to confirm setting c When the Stop 1s 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 s etting then press the menu button
16. ress 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 PC software operation Please connect the device with computer by the USB data line then double click SpO2 Assistant 1 con to run the PC software The functions such as uploading data and change device ID could be carried out by the software Please refer to lt SpO Assistant user manual gt for detail CMS 60C Medical Test Supply ANIt 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 E again 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 Power supply by battery only and battery status is full Battery status is not full Battery status is draining away Low power alarm indication Please charge the battery 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
17. ry again 2 The battery is installed incorrectly 3 Please contact the local service 3 The malfunction of the device center The display is off The battery is drained away or almost Please recharge the battery suddenly 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 be full charged even center after 10 hours charging time 9 Key of Symbols Signal Description O A The pulse oxygen saturation Spo PRbpm Pulse rate bpm Close the alarm sound indication forever Open the alarm sound indication E Close the pulse sound indication CMS 60C _ Pause the alarm sound indication Medical Test Supply ee Open the pulse sound indication A V Alarm pause button up button A N 7 Screen change button down button BFType application part 1 the finger clip falls off no finger inserted 2 Probe error 3 Signal inadequacy indicator IPX1 Ingress of liquids rank Dae WEEE 2002 96 EC This item is compliant with Medical Device Directive 93 42 EEC of a 0123 June 14 1993 a directive of the European Economic Community 10 Function Specification The Pulse Oxygen Saturation SpO 2 digit digital TFT display Pulse Rate PR 3 digi
18. t digital TFT display Pulse Intensity bar graph bar graph TFT display EN S 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 CMS 60C Medical Test Supply Pulse Parameter Specification Average pulse rate Moving calculate the Average pulse rate every 4 cardio beat cycle The deviation between average value and true value does not exceed 1 Safety Type Interior Battery BF Type application part Pulse Intensity Continuous bar graph display the higher display indicate the stronger pulse Power Adapter Input Voltage 100 to 240 VAC 50 60 Hz Output voltage 5 VDC Output current 250mA Dimensions and Weight About 175 g with the lithium battery 1 Appendix Alarm condition dela Alarm signal generation dela CMS 60C Medical Test Supply CMS 60C
19. uasyashaskaasipsiukiakapiksapaphaaa aqa 5 LET iain staan hi bccn cs ae 5 Ze Tisi ap DN 1 e 5 FL A eT Ree aa i llapi T A E 11 J TROCTORT i rap RA anaia aa 11 S TROLELESHRITIN G onii aiaiai aaa taiii 11 TRETO SIME Douce ai 12 10 FUNCTION SPELI A CO oa 13 CMS 60C APPENDIX CMS 60C Medical Test Supply Medical Test Supply 1 Safety 1 1 Instructions for safe operations 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 there is 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 NI Explosive hazard DO NOT use the oximeter In environment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the testee measured by MRI and CT The disposal of scrap instrument and its accessories and packing s including battery plastic The person who is allergic to rubber cannot use this de
20. vice bags foams and paper boxes should follow the local laws and regulations Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list or else the device may have the possibility of working abnormally Please choose the accessories and probe which are approved or manufactured by the manufacturer or else it may damage the device Please choose the battery chargers which should be ensured compliance with the requirements of IEC 60601 1 or else 1t 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 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 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 CMS 60C Medica
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