Instructions to User 1 Safety 2 Overview 3 Principle and
Contents
1. ATE Pulse Oximeter User Manual CONTEC MEDICAL SYSTEMS CO LTD Address No 112 Qinhuang West Street Economic amp Technical Development Zone Qinhuangdao Hebei Province PEOPLE S REPUBLIC OF CHINA Tel 0086 335 8015430 Fax 0086 335 8015588 Manufactured for and Distributed by CMS MOBILITY INC Instructions to User Dear users thank you for purchasing the Acc U Rate CMS 50D 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 lead to measurement 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 warranty service does not cover such faults Due to constant revision the specific produ2. silicon cover gt One User Manual 6 Installation 6 1 View of the Front Panel Low battery indication Sp0 0 SpO2 PRomp nS 198 070 S ne A ooo T pulse waveform pulse rate button pulse bar graph 8 070 b spoz P Rbmp i Wh F Figure 2 Front view Mounting the hanging rope 6 2 Battery Step 1 Refer to Figure 3 and insert two AAA size batteries properly in the right direction Step 2 Replace the cover Figure 3 Batteries installation Figure 4 Please take care when you insert the batteries Improper insertion may damage the device 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 7 Operating Guide 1 Insert the two batteries properly to the direction and then replace the cover 2 Open the clip as shown in Figure 5 0 SpO2 PRpmp n 98 070 _ S Figure 5 Put finger in position 3 Put your finger into the rubber cushions of the clip make sure the finger is in the right position and then clip the finger The CMS50D Pulse Oximeter is tended for use in the electromagnetic environment specified below The customer of the user 4 Press the switch button once on front panel of the CMS50D Pulse Oximeter should assure that it isused in such an environment 5 Do not move the finger and try t
3. the device is between 10 C to 60 C and lower than 95 humidity A High pressure sterilization cannot be used on the device Guidance and manufacture s declaration electromagnetic immunity A Do not immerse the device in liquid for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING A It is recommended that the device should be kept in a dry environment Humidity may reduce the useful life of the Guidance and manufacture s declaration electromagnetic immunity device or even damage it The CMS50D Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of CMS50D Pulse Oximeter should assure that it is used in such an environment 9 Troubleshooting Trouble Possible Reason Solution c li l he fi ly and cama Hane sail l a _ Electromagnetic environment guidance Th Pul a 1 P t t in eve C RDS ANA e 1 The finger is not properly positioned R T E ee test level Rate cannot be 2 Try again Make sure nothing is 2 The user s SpO is too low to be detected displayed normally impeding your blood flow Radiated RF Portabl ile RF icati i t should b d The SpO and Pulse 1 The finger is not placed deep enough into the 1 Place the finger properly and try again acai Eee nen ae aus as SR PAET j ni eel i i ICE closer to any part of the CMS50D Pulse Oximeter including cables than Rate values change device 2 Keep stationary as much as possible 61000 4 3
4. 2 An indicator of signal inadequacy Ko 4 battery positive electrode A NOTE 1 At 80MHz and 800MHzZz the higher frequency range applies battery cathode NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and 1 Power switch reflection from structures objects and people f W 2 change direction of the screen Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile 3 Change brightness of the screen radios amateur radio AM and FM radio broadcast and TV broadcastcannot be predicted theoretically with accuracy To SN Serial number assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which The CMS50D Pulse Oximeter is used exceeds the applicable RF AX Alarm inhibit compliance level above the CMS50D Pulse Oximeter should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the CMS50D Pulse et WEEE 2002 96 EC ee are Over the frequency range 150 KHz to 80 MHz field strengths should be less than 3V m IP22 International Protection This item is compliant with Medical Device Directive 93 42 EEC of June 14 1993 a directive of the Recommended separation distances between portable and mobile C iss European Economic Co
5. 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 affect the accuracy of your SpO levels 4 Technical Specifications 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 2 Power Requirements 2 1 5V AAA alkaline battery adaptable range 2 6V 3 6V 3 Power Consumption Less than 30mA 4 Resolution 1 for SpO and 1 bpm for Pulse Rate 5 Measurement Accuracy 2 in stage of 70 100 SpO and meaningless when stage being smaller than 70 2 bpm during the pulse rate range of 30 99 bpm and 2 during the pulse rate range of 100 250 bpm 7 Measurement Performance in low blood perfusion condition SpO2 and pulse rate can be shown during low blood perfusion However SpO2 error is 4 pulse rate error is 2 bpm or 2 select larger 8 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 8 Equipped with a function switch The Oximeter will automatically power off if the finger is removed after 5 seconds 9 Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW 5 Accessories gt One hanging rope gt Two AAA batteries gt One
6. cts you received may not be totally in accordance with the description of this User Manual We sincerely apologize for that WARNING User might experience discomfort if the device is used for a prolong period of time It is recommended that the sensor should not be applied to the same finger for over 2 hours The device should not be clipped on tender tissue 6 The light infrared is invisible emitted from the device is harmful to the eyes The user should not stare at the light User should not use apply enamel or other makeup on the fingertip Warning Keep unit and lanyard away from children as the included lanyard may present an entanglement or choking hazard to small children Adult supervision required never leave children unattended with unit or lanyard The user s fingernail should not be too long 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 your safety and monitoring performance 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 should not be used together with devices not specified in User s Manual Only accompanied accessories should be used with this
7. device gt This product is calibrated before leaving factory 1 2 Warnings Explosive hazard DO NOT use the oximeter in environment with inflammable gas Individuals who are allergic to rubber should not use this device This pulse oximeter has no SpO alarms and it is not meant for continuous monitoring The disposal of the pulse oximeters accessories and packing material including battery plastic bags foams and paper boxes should follow local laws and regulations gt Please make sure that the device and accessories are in complete accordance with the packing list or the device might not function normally 1 3 Attentions YYYY 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 the pulse oximeter is moved from a cold environment to a warm and 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 immerse the oximeter 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 For fingers w
8. er 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 designed to be used by athletes pilots or anyone who wants to obtain their SpO and pulse rate on the go A The product is not suitable for continuous use The device is inaccurate if the user is suffering from toxicosis by carbon monoxide The device should not be used under such circumstance 2 4 Environment Requirements Storage Environment a Temperature 40 C 60 C b Relative humidity lt 95 c Atmospheric pressure 500hPa 1060hPa Operating Environment a Temperature 10 C 40 C b Relative Humidity lt 75 c Atmospheric pressure 700hPa 1060hPa 3 Principle and Caution 3 1 Principle of Measurement Oxygenated blood absorbs light at 660nm red light whereas deoxygenated blood absorbs light preferentially at 880nm infra red A pulse oximeter works by passing a beam of red and infrared light through a pulsating capillary bed and then measure the amount of red and infrared light emerging from the human nail tip via a sensor The relative absorption of light by oxyhemoglobin HbO and deoxyhemoglobin is then processed according to the Beer Lambert s law and the result is a qualitative measurement of the users oxyhemoglobin status 1 e Oxygen saturation level SpO gt Glow and Infrared ray Emission Tube Glow and Infrared ray Receipt Tube Figure 1 Operating
9. hich are too thin or too cold it would probably affect the normal measurement of the users SpO and pulse rate Please clip on a thicker finger such as the thumb index or middle finger deeply into the probe Do not use the device on infant or new born child 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 everyone If you are unable to achieve stable readings discontinue use A The update period of data is less than 5 seconds but might change based on different individual pulse rate If abnormal conditions appear on the screen during the test process pull out the finger and reinsert to restore normal use A The normal shelf life of the device is three years A The lanyard attached the product is made from non allergic material If you are sensitive to it stop using it In addition the lanyard could present a choking hazard Please use extreme caution when using it A The instrument does not have a low voltage alarm function It only shows the low voltage on the LED screen Please change the battery when the battery is used up A The instrument does not have alarm functions Do not use the device in situations where alarms are required A Batteries must be removed if the device is going to be stored for more than one month or the batteries may leak A A flexible circuit connects the two parts of the device Do not twist or pull on the co
10. mmunity However this is not a medical device and is not intended RF communications equipment and the EQUIPMENT or SYSTEM to diagnose or treat any medical condition or disease for EQUIPMENT or SYSTEM that not LIFE SUPPORTING 11 Function Specification Recommended separation distances between Display Information Display Mode portable and mobile RF communications equipment and the CMS50D Pulse Oximeter The Pulse Oxygen Saturation SpO2 OLED The CMS50D Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances are Pulse Rate PR OLED controlled The customer or the user of the CMS50D Pulse Oximeter can help prevent electromagnetic interference by Pulse Intensity bar graph OLED bar graph display maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CMS50D Pulse Oximeter as recommended below according to the maximum output power of the communications equipment Pulse wave OLED SpO Parameter Specification Measuring range 0 100 the resolution is 1 Accuracy 70 100 42 Below 70 unspecified Rated maximum output power Optical Sensor Red light wavelength is 660nm of transmitter Infrared wavelength is 880nm Pulse Parameter Specification Measuring range 30bpm 250bpm the resolution is 1 bpm Accuracy 2bpm or 2 select larger Pulse Intensity Range Continuous bar graph display Increased height indicates s
11. nd manufacture s declaration electromagnetic immunity SpO2 VPR SpO2 MPR The CMS50D Pulse Oximeter is intended for use in the electromagnetic environment specified specified below The the user of 9 r 8 4 9 T 8 4 CMS50D Pulse Oximeter should assure that it is used in such an environment Elect ti ILIA hpbbbhbhbb bh Immunity test IEC60601 test level Compliance level rere amas ea environment guidance Figure 9 Display mode four Figure 10 Display mode five Figure 11 Display mode six Electrostatic discharge 6KV contact 6KV contact Floors should be wood concrete or r i i ESD IEC 61000 4 2 8KV ai 8KV ai ic tile If fl d with F ingernails and the luminescent tube should be on the same side TBD i i Orig ee synthetic material the relative 8 Repairing and Maintenance humidity should be at least 30 gt Please change the batteries when the low voltage symbol is displayed on the screen gt Please clean the surface of the device before use Wipe the device with medical alcohol first and then let it dry in air or Power frequency Power frequency magnetic fields clean it by dry clean fabric 50Hz magnetic field should be at levels characteristic of a gt Use medical alcohol to disinfect the product after use IEC 61000 4 8 typical location in a typical gt Please take out the batteries if you are not planning to use the oximeter for a long time commercial or hospital environment gt The best storage environment of
12. nnection 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 gt and the pulse rate of adult and children This device is not intended for continuous monitoring 2 Overview SpO stands for peripheral capillary oxygen saturation Oxygen saturation is defined as the ratio of oxyhemoglobin HbO to the total concentration of hemoglobin i e Oxyhemoglobin reduced hemoglobin present in the blood It is an important physiological parameter involved in respiration and circulation For that purpose our company developed the Pulse Oximeter which can measure your SpO and pulse rate simultaneously The Pulse Oximeter feature herein is small portable non invasive and easy to use The user only needs to insert a finger into the chamber to measure his her SpO and Pulse Rate 2 1 Features Operation of the product is simple and convenient gt The product is small light total weight is about 50g including batteries and easy to use gt Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for 20 hours gt gt Vv The product will automatically be powered off when no signal is in the product within 5 seconds Includes Plethymosgraph to indicate strength of blood flow gt Rotational OLED display for viewing convenience 2 2 Major Applications and Scope of Application The Pulse Oximet
13. o keep the body stationary Electromagnetic environment guidance 6 Get the information directly from screen display ly at a RF emissions The CMS50D Pulse Oximeter uses RF energy only for their 7 The button e9has three functions When the device is powered off pressing the button will power it CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic Guidance and manufacture s declaration electromagnetic emission on When the device is powered on pressing the button quickly lt 1 sec will change the direction of the e Sa screen See Figure 6 11 holding the button for longer than a second will change the brightness of the Rr cmiceons Class B The COMOD Puke Orma Js salable for we in al CISPR 11 establishments including domestic establishments and those ee ee f Harmonic emissions Not applicable directly connected to the public low voltage power supply 8 Wait for the wavelength and amplitude of the plethysmograph wave to stabilized before taking reading IEC 61000 3 2 ae Gor that capplies buildincwased Mr donesti mmpoii Voltage fluctuations Not applicable flicker emission SpO2 VPR Yd zodsy SpO2 MPR 9 l Pa lt f IEC 61000 3 3 O f 84 JA 6 o gt oO Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Figure 6 Display mode one Figure 7 Display mode two Figure 8 Display mode three Guidance a
14. principle 3 2 Caution l The finger should be placed properly such that it is exactly in between the infra red Emission tube and infra red sensor see the attached illustration of this manual Figure 1 amp 5 or else it may cause inaccurate measurement EA The pulse oximeter should not be used on any finger where blood flow might be restricted For example a limb tied with arterial canal or blood pressure cuff or receiving intravenous injection J Make sure the optical path is free from any optical obstacles like rubberized fabric 4 Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc 5 Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy 6 Testee cannot use enamel or other makeup on the finger 3 3 Limitations l As the measurement is taken on the basis of the 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 pulse oximeter might not be able to take a reading In this case the measurement will also 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
15. the recommended separation distance calculated from the equation erratically 2 The finger or the user is moving during measurement l l applicable to the frequency of the transmitter The device canot ie 1 The batteries are drained or almost drained 1 Change batteries recommended separation distance 2 The batteries are not inserted properly 2 Reinstall batteries turned on 3 The malfunction of the device 3 Please contact the local service center 35 1 The device will power off automatically if the d mian 4 pP 80MHEz to 800MHz The display turns off suddenly 1 Press the power button to turn it back on fi ith ft inger is withdrawn after 5 seconds 2 Change batteries 2 The batteries are almost drained 10 Key of Symbols l Symbol Description Ja x2 JP 00MHz to 2 5GHz Type BF E A Warning See User Manual Where P is the maximum output power rating of the transmitter in watts a Spl Biodoen O0 ue et pier aaa and d is the recommended PRbpm Pulse rate bpm Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range The battery voltage indication is deficient change the battery in time avoiding the inexact measure Interference may occur in the vicinity of equipment marked with the following symbol ee 1 no finger inserted
16. tronger pulse Battery Requirement 1 5V AAA size alkaline batteries x 2 or rechargeable battery Battery Useful Life For transmitters rated at a maximum output power not listed above the recommended separation distanced in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies Two batteries can work continuously for 20 hours Dimensions and Weight i i L x 31 x 32 H ie ae Baa riae oi ar Ee a a a NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and Weight About 50g with the batteries i reflection from structures objects and people Appendix Guidance and manufacture s declaration electromagnetic emission for all EQUIPMENT and SYSTEMS
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