CMS-P Oximeter user manual
Contents
1. 9 Key of Symbols Signal Description Warning See User Manual The pulse oxygen saturation 96 bpm Pulse rate bpm 10 Function Specification SpO Parameter Specification Measuring range 0 100 the resolution is 1 Calculate the Average value in every 4 measure value The deviation between average value and true value does not exceed 1 30bpm 250bpm the resolution is Ibpm 2bpm or 2 select larger Moving calculate the Average pulse rate every 4 cardio beat s cycle The deviation between average value and true value does not exceed 1 Continuous bar graph display the higher display indicate the stronger pulse Power Supply Requirement 5V DC USB power supply Oximeter Probe Wavelength 660nm 880nm About 40 g2. Users are not permitted to maintain it by themselves lt 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 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 person who is allergic to rubber can not use this device The disposal of scrap instrument and its accessories and packing including 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 which are approved or manufactured by the manufacturer or else it may damage the device 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 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 High te
3. Installation 5 1 View of the device USB Connector Fingertip Sensor Figure 2 sketch map of the device 5 2 Accessories A A User Manual B A disk PC software and the user manual of software 6 Operating Guide 6 1 Application method 6 1 1 Installation and startup of software A First please install the affiliated software into the computer two icons would appear on the desktop after installation The icon of SpO2 is the program for receiving real time data which 1s shown as figure 3 the icon of SpO2 Review is the program for receiving stored data which is shown 4 as figure 4 Figure 3 SpO2 program SPU mney dehy Figure 4 SpO2 Review program B Double click the red icon to start real time measure program If you are using the software for the first time there will appear a dialog box you could choose the language as you like 6 1 2 Collect Data The program could identify the inserted device automatically Connect the device to the computer then place your finger right in the device the real time measure for SpO2 and pulse will begin AN Fingernails and the luminescent tube should be on the same side and try your best to make the position corresponding Figure 5 finger position sketch map 6 1 3 Save data A When real time measuring New Session will appear if you click the waveform area with right key click New Session there will be a dialog box to clew you to close the dialog or not If y
4. 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 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 be not totally in accordance with the description of this User Manual We would sincerely regret for that This product is medical device which can be used
5. ients If you are unable to achieve stable readings discontinue use A Do not contort or drag the wire of the device 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 in the blood furthermore some other causes such as the malfunction of human body s self adjustment damages during surgery and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body and the corresponding symptoms would appear as a consequence such as vertigo impotence vomit etc Serious symptoms might bring danger to human s life Therefore prompt information of patients SpO is of great help for the doctor to discover the potential danger and is of great importance in the clinical medical field The Pulse Oximeter features in small volume low power consumption convenient operation and being portable It is only necessary for patient to put one of his fingers into a probe for diagnosis and a display interface 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 Maj
6. infect the device before using according to the User Manual 7 1 B 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 1 Place the finger properly and try again The SpO and Pulse 1 The finger position is not proper 2 Try a few times again and go Rate can not be 2 The patient s SpO is too low to be o to hospital for a diagnosis if you displayed normally detected are sure the device works all right 1 The finger is not placed inside deep The SpO and Pulse h 1 Place the finger properly and enough Rate are not 7 try again 2 The finger is shaking or the patient 1s displayed stably 2 Let the patient keep still moving 1 Connect the USB plug with computer again It cannot display the 1 The USB plug doesn t connected well 2 Close the software and open it interface of the 2 The software can t identify again software 3 The device is damaged E 3 Please contact the local service center
7. mperature 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 pulse oximeter is suitable used for adult A Asto the fingers which are too thin or too cold it would probably affect the normal measure of the patients SpO and pulse rate please clip the thicker finger such as thumb and middle finger deeply enough into the probe 4A The update period of data is less than 5 seconds which is changeable according to different individual pulse rate amp The device should be used with computer by affiliated software 1 A Please read the measured value when the waveform on screen is equably and steady going The 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 amp The device has the function of limits alarming When the alarm happens the screen will appear prompt information A The device has normal useful life for three years since the first electrified use 5 The device may not work for all pat
8. nal can be obtained by a photosensitive element information acquired through which will be shown on display of computer through treatment in electronic circuits and microprocessor Glow and Infrared ray NN Emission Tube Glow and Infrared ray Heceipt Tube Figure 1 4 Technical specifications 4 1 Main performance Used with affiliated software SpO gt value display Pulse rate value display bar graph display Pulse waveform display With alarm function mcos With data review 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 7 below 7040 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 SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO error is 4 pulse rate error is 2 bpm or 2 select larger E Resistance to surrounding light The deviation between the value measured in the condition of man made light or indoor natural light and that of darkroom 1s less than 1 F Power supply requirement 5V 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 30bpm 250bpm 5
9. nd direct sunlight 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 according to the User Manual 7 1 after operating 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 ethylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate C The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor 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 dis
10. oC X Y M A Technical nS TIL IU A MEMINI IUIME S UIO HEIN t E ET os AAI Parane i e E AE EAE E AE E AE AEE D gt Installato e E E Sil VeworthedeVi tE anaa a eo ee ee 002 NCCCSSOTICS orar a a a a E EN 0 Operam GUNG risna aa ra A ePi A EE Gel AAD MC AR OM Nod ga a E E E te eet aos CMS Vise eU SCIT v Meesiseresaiaes 6 5 mme abre SIELC MOMS oed ees oo re ee ui abut pe eundo etum bus vei odas bod ben UA atus pu Ue OO dna hed pun Uer pd Stu bu i Ed Ue burn 7 Maintain transportation and storage eee ecce eee e e eee eee eee eese setate e eese ess s s eee ee esses sss stet eee eooas n MEG DEus T T ES EPA ME EET m ES Trans POrAN OM ADOS IDEdPE saroia bores abus bae dioskad uU obse locuti tu wan E ad dil covadas rico td Uia eam EAEAN S niji ru EE Oo Ol SVM ONS eec I0 Fonction SDecIBCatl0D oncaeoei iet ner eE ER tee beo pe II cU Deo sti ee Rd adii Pte dio Io ius II 1 Safety 1 1 Instructions for safe operations lt 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 It 1s recommended that the device should be inspected once a week at least When there is obvious damage stop using the device lt Necessary maintenance must be performed by qualified service engineers ONLY
11. or 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 so on N 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 3096 7590 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 gt 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 sig
12. ou choose yes there will be a saving data dialog box or else measure will be continued B When you close SpO2 program after accomplishing real time measure there will be also a saving data dialog box to clew you to save the measure data If you have filled individual information in the dialog box of patient message before this dialog box will display the content that you have filled in if you have not you could fill information in the dialog box click ok to save data After saving data accurately you have accomplished the whole measurement If you want to review saved data please use SpO2 Review program ZN Please refer to user manual of the software for the particular introduction 6 2 Attention for operation A Please check the device before using and confirm that it can work normally B The finger should be placed in proper position see the attached illustration of figure 5 for reference or else it may result in inaccurate measurement C There should be subject s arteriole between the luminous and photosensitive sensors when measuring 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 barrier such as adhesive or else it may result in inaccurate measure of SpO and pulse rate F Excessive ambient light may affect the measurement result such as fluorescent lamp dual ruby light infrared heater a
13. 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 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 Contents MEE csl HA lsi Instructions TOr Sale OPSTAO s sininesreesdbenwaverrnenswaveieoudedaennees RR UU Pe EU VeRI MM RUE UNIES TD UU LE L2 VV AMINO cha tota Potes a a iae eos ford anie a coitu oc oE Ii LE d ee MEE Vr It T Ar EAT AIT ERAT RIETI EAE DEB T wg d H PX NE uU UU T 2 2 Major applications and scope of application eseslssssseseseeeennn mnm nnn 2 9 Bnvironmenbrequitere Discar Soest radi tasti asa eie ivan oi tus Cad Con bM ri icon edd nea ead ante Los sen id Peg ihn RM aee L A
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