CMS-50D Instruction Manual
Contents
1. 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 rx Glow and Infrared ray gt Receipt Tube Figure 1 Operating Principle 3 2 Caution 1 The finger should be placed properly see the attached illustration of this manual Figure 5 or else it may cause inaccurate measurement 2 The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between 3 The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection Make sure the optical path is free from any optical obstacles like rubberized fabric 5 Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc 6 Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy 7 Testee can not use enamel or other makeup 3 3 Clinical restrictions 1 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 m2. is allergic to rubber can not use this device gt The disposal of scrap instrument and its accessories and packings including battery plastic bags foams and paper boxes should follow the local laws and regulations gt 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 gt Please don t measure this device with function test paper for the device s related information 1 3 Attentions 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 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 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
3. thick finger such as thumb and middle finger deeply enough into the probe A Do not use the device on infant or neonatal patients A The product is suitable for children above four years old and adults Weight should be between 15kg to 110kg A The device may not work for all patients If you are unable to achieve stable readings discontinue use A The update period of data is less than 5 seconds which is changeable according to different individual pulse rate A Please read the measured value when the waveform on screen is equably and steady going This measured value is optimal value And the waveform at the monment is the standard one A If some abnormal conditions appear on the screen during test process pull out the finger and reinsert to restore normal use A The device has normal useful life for three years since the first electrified use A The hanging rope attached the product is made from Non allergy material if particular group are sensitive to the hanging rope stop using it In addition pay attention to the use of the hanging rope do not wear it around the neck avoiding cause harm to the patient A The instrument dose not have low voltage alarm function it only shows the low voltage please change the battery when the battery energy is used out A When the parameter is particularly The instrument dose not have alarm function Do not use the device in situations where alarms are required A Batteries must be remo
4. Instruction Manual CMS 50DL Instructions to User Dear Users thank you very much for purchasing our product This Manual is written and compiled in accordance with the council directive MDD93 42 EEC for medical devices and harmonized standards The Manual is written for the current Pulse Oximeter 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 Manual very carefully before using this equipment These instructions describe the operating procedures to be followed strictly failure to follow these instructions can cause measuring abnormality equipment damage and personal injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality personal injury and equipment damage due to user s negligence of the operation instructions The manufacturer s watranty 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
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6. User Manual We would sincerely regret for that This product is medical device and can be used repeatedly Its using life is 3 years WARNING The 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 individual 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 can not stare at the light Testee can not use enamel or other makeup Testee s fingernail can not be too long Please peruse the relative content about the clinical restrictions and caution zgo This device is not intended for treatment The User Manual is published by our company All rights reserved H Table of Contents DS AL CbY O E E A A A EE E E E E E Error Bookmark not defined 1 lInstructions for safe operations s eesseeseseeeseeesrsreeseseeerssrereesesreneesee Error Bookmark not defined L 2Warnings ies opan t Bain Seeds BAS ihe Sei S Error Bookmark not defined T SALON EIOMS es sd sends ses sbcedhiasiedescevhseonen Oa EE AA EREA ANET Error Bookmark not defined ZOVELVIEW aira A EA A A Error Bookmark not defined 2 AC Lassi Cations enie e e E EE EER E
7. and Maintenance cccsccscscsscsscssscscsssscscssescesssesesoees Error Bookmark not defined DTroubleshooting cesccscsccssssscscsscscccscsccscscsssssssssssescssescscssossssees Error Bookmark not defined LOK GY OF Symbols vi visecccisieesccevssasscesteesceetecasectsGeesecetaneseceeabesceevensssceeasesces Error Bookmark not defined L1FunnctionS pecification sessossossossosscsscsscsscsscssossossossossosscssesscssessesse Error Bookmark not defined Il 1 Safety 1 1 Instructions for safe operations gt Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and monitoring performance about cables and transducers It is recommended that the device should be inspected once a week at least When there is obvious damage stop using the monitor gt Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves gt 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 gt This product is calibrated before leaving factory 1 2 Warnings gt Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents gt DO NOT use the oximeter while the testee measured by MRI and CT gt The person who
8. e device in liquid A It is recommended that the device should be kept in a dry environment Humidity may reduce the useful life of the device or even damage it 9 Troubleshooting Trouble The SpO and Pulse Rate can not be displayed normally The SpO and Pulse Rate are not displayed stably The device can not be turned on The display is off suddenly 10 Key of Symbols Possible Reason 1 The finger is not properly positioned 2 The patient s SpO is too low to be detected 1 The finger is not placed insid deep enough 2 2 The finger is shaking or th patient is moving 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The malfunction of the device 1 The device will power off automatically when it gets no signal within 5 seconds 2 The batteries are almost drained Solution 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 Place the finger properly and try gain Let the patient keep calm 1 Change batteries 2 Reinstall batteries 3 Please contact the local service center Normal Change batteries Symbol Description 1 no finger inserted 2 An indicator of signal inadequacy l battery positive electrode battery cathode 1 Power switch 2 change direction of the screen 3 Change brightness of the scr
9. easurement will be more sensitive to interference 2 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 monitor may be inaccurate 3 The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor blamed for serious error of SpO measure 4 As the SpO value serves as a reference value for judgement of anemic anoxia and toxic anoxia some patients with serious anemia may also report good SpO measurement 4 Technical specifications 4 1 Display Format OLED Display SpO Measuring Range 0 100 Pulse Rate Measuring Range 30 bpm 250 bpm Pulse Wave Display columniation display and the waveform display 4 2 Power Requirements 2 X1 5V AAA alkaline battery Cor using the rechargeable battery instead adaptable range 2 6V 3 6V 4 3 Power Consumption Smaller than 30mA 4 4 Resolution 1 for SpO and 1 bpm for Pulse Rate 4 5 Measurement Accuracy 2 in stage of 70 100 SpO2 and meaningless when stage being smaller than 70 2 bpm or 2 select larger for Pulse Rate 4 6 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 bpmor 2 select larger 4 7 R
10. een Red light wavelength is 660nm Infrared wavelength is 880nm 51L x 31 W x 32 H mm l About 50g with the batteries
11. emoglobin Saturation and pulse rate through finger and indicate the pulse intensity by the bar display The product is suitable for use in family hospital Ordinary sickroom Oxygen Bar social medical organizations and also the measure of saturation oxygen and pulse rate A The product is not suitable for use in continuous supervision for patients A The problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon monoxide the device is not recommended to be used under this circumstance 2 4 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 and Caution 3 1 Principle of measurement 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 HbOz in glow amp near infrared zones Operation principle of the instrument 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
12. esistance 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 4 8 It is equipped with a function switch The Oximeter can be powered off in case no finger is the Oximeter within 5 seconds 4 9 Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW 5 Accessories gt One hanging rope gt Two batteries gt One User Manual 6 Installation 6 1 View of the front panel low battery indication FINGERTIP OXIMETER pulse bar graph pulse waveform Figure 2 Front View 6 2 Battery Step 1 Refer to Figure 3 and insert the two AAA size batteries properly in the right direction Step 2 Replace the cover A Please take care when you insert the batteries for the improper insertion may damage the device Figure 3 Batteries Installation 6 3 Mounting the hanging rope Step 1 Put the end of the rope through the hole Step 2 Put another end of the rope through the first one and then tighten it Figure 4 Mounting the hanging rope 7 Operating Guide 7 1 Insert the two batteries properly to the direction and then replace the cover 7 2 Open the clip as shown in Figure 5 Figure 5 Put finger in position 7 3 Let the patient s finger put into the rubber cushions of the clip make sure the finger is in the right position and then clip the finger 7 4 Press the s
13. ved if the device is going to be stored for more than one month or else batteries may leak A A flexible circuit connects the two parts of the device Do not twist or pull on the connection 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 For the purpose of measuring the SpO more easily and accurately our company developed the Pulse Oximeter At the same time the device can measure the pulse rate simultaneously 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 fingertip photoelectric sensor for diagnosis and a display screen will directly show measured value of Hemoglobin Saturation 2 1 Classification Class IIb MDD93 42 EEC IX Rule 10 2 2 Features gt Operation of the product is simple and convenient gt The product is small in volume light in weight total weight is about 50g including batteries and convenient in carrying gt Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for 20 hours gt The product will automatically be powered off when no signal is in the product within 5 seconds 2 3 Major applications and scope of application The Pulse Oximeter can be used to measure human H
14. witch button once on front panel 7 5 Do not shake the finger and keep the patient at ease during the process Meanwhile human body is not recommended in movement status 7 6 Get the information directly from screen display d 7 7 The button has three functions When the device is power off pressing the button can open it When the device is power on pressing the button shortly can change direction of the screen When the device is power on pressing the button long can change brightness of the screen A Fingernails and the luminescent tube should be on the same side 8 Repairing and Maintenance gt Please change the batteries when the low voltage displayed on the screen gt Please clean the surface of the device before using Wipe the device with medical alcohol first and then let it dry in air or clean it by dry clean fabric gt Using the medical alcohol to disinfect the product after use prevent from cross infection for next time use gt Please take out the batteries if the oximeter is not in use for a long time gt The best storage environment of the device is 40 C to 60 C ambient temperature and not higher than 95 relative humidity 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 A High pressure sterilization cannot be used on the device A Do not immerse th
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