CMS50DL Pulse Oximeter
Contents
1. explosive materials high temperature and moisture amp Ifthe oximeter gets wet please stop operating it amp 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 amp 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 amp 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 SpO2 and pulse rate please clip the thick finger such as thumb and middle finger deeply enough into the probe amp Do not use the device on infant or neonatal patients amp The product is suitable for children above four years old and adults Weight should be between 15kg to 110kg amp The device may not work for all patients If you are unable to achieve stable readings discontinue use amp The update period of data is less than 5 seconds which is changeable according to different individual pulse rate amp If some abnormal conditions appear on the screen during test process pull out the fing2. 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 Power switch Pulse rate The display Sp0z Low Voltage Display Pulse rate Bargraph Display 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 switch 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 A Fingernails and the luminescent tube should be on the
3. 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 gt sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in a position there between 3 The SpOz sensor should not be used at a location or limb tied with arterial canal or blood pressure cuffor 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 SpO2 waveform PLETH will decrease In this case the measurement 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
4. 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 the device in liquid A It is recommended that the device should be kept in a dry environment Humidity may AA reduce the useful life of the device or even damage it 9 Troubleshooting Possible Reason Solution 1 The finger is not properly 1 Place the finger properly and try The SpO and Pulse positioned again Rate can not be 2 The patient s SpO is too low to be 2 Try again Go to a hospital for a displayed normally detected diagnosis if you are sure the device works all right 1 The finger is not placed inside The SpO and Pulse deep enough Ra
5. the SpO gt 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 SpO2 measurement 4 Technical specifications 4 1 Display Format Digital tube Display SpO2 Measuring Range 0 100 Pulse Rate Measuring Range 30 bpm 250 bpm Pulse Intensity Display columniation display 4 2 Power Requirements 2 X 1 5V AAA alkaline battery or using the rechargeable battery instead adaptable range 2 6V 3 6V 4 3 Power Consumption Smaller than 25 mA 4 4 Resolution 1 for SpO2 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 error is 4 pulse rate error is 2bpm or 2 select larger 4 7 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 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
6. CMSSODL Pulse Oximeter User Wenua CONTEC MEDICAL SYSTEMS CO LTD 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 with the description ofthis User Manual We wo
7. arameter 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 24 hours gt The product will automatically be powered off when no signal is in the product within 5 seconds gt Low battery indicator as battery icon flash manner 2 3 Major applications and scope of application The Pulse Oximeter can be used to measure human Hemoglobin 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 s
8. er and reinsert to restore normal use amp 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 amp Batteries must be removed if the device is going to be stored for more than one month or else batteries may leak amp A flexible circuit connects the two parts of the device Do not twist or pull on the connection 1 4 Indication for Use The Fingertip Pulse Oximeter is a non invasive device intended for the spot check of oxygen saturation of arterial hemoglobin SpO and the pulse rate of adult and pediatric patients in home and hospital environments including clinical use in internist surgery anesthesia intensive care ect This device is not intended for continuous monitoring 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O2 concentration in the blood It is an important bio p
9. ger pulse Battery Requirement 1 5V AAA size alkaline batteries x 2 or rechargeable battery Battery Useful Life Two batteries can work continually for 24 hours Dimensions and Weight Dimensions 57 L x 31 W x 32 H mm Weight About 50g with the batteries
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11. o 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 leav ing 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 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 amp Keep the oximeter away from dust vibration corrosive substances
12. te are not displayed stably 1 Place the finger properly and try again 2 The finger is shaking or the patient 2 Let the patient keep calm is moving 1 The batteries are drained or almost 1 Change batteries N drained i The device can not 2 Reinstall batteries 2 The batteries are not inserted be turned on 3 Please contact the local service properly 3 The malfunction of the device center 1 The device will power off The display is off automatically when it gets no signal 1 Normal suddenly within 5 seconds 2 Change batteries 2 The batteries are almost drained 10 Key of Symbols Description A Warning See User Manual SpO2 The pulse oxygen saturation PRbpm Pulse rate bpm The battery voltage indication is deficient change the battery in time avoiding the inexact measure 1 no finger inserted 2 An indicator of signal inadequacy battery positive electrode battery cathode WEEE 2002 96 EC IPX1 Ingress of liquids rank 11 Function Specification Display Information Display Mode SpO2 Parameter Specification R Measuring range 0 100 the resolution is 1 Accuracy 70 100 2 Below 70 unspecified Optical Sensor Red light wavelength is 660nm Infrared wavelength is 880nm Pulse Parameter Specification 3Obpm 250bpm the resolution i 1 bpm Pulse Intensity Continuous bar graph display the higher display indicate the stron
13. uitable 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 HbO 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 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 TI rN Glow and Infrared ray gt Receipt Tube Figure 1 Operating
14. uld 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 6 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 6 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 6 Testee can not use enamel or other makeup 6 Testee s fingernail can not be too long Please refer to the correlative literature about the clinical restrictions and caution 6 This device is not intended for treatment Caution Federal law restricts this device to sale by or on the order of a physician The User Manual is published by our company All rights reserved Contents ON nn d ddl l Lllnstructions for sate operation Siini peee nine na ER sn 1 PZW amin OS cist iniacaetaitaasaciecda sinned EA A T A TA AR AT AE 1 VSA THEM HOTS Be ee ne nn re ts A ne AEN ENEEIER 1 2 2Features 2 3Major applications and scope of application sn 2 4Environment requirements sn 3Principle and Caution cssrrsss0sssnsnsnssssosnunnnnsnsnsnssonsonnnnsnsnsnssonsunnnnsnsnsnssonsn
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