Clini-Ox II
Contents
1. FINGERTIP PULSE OXIMETER Instructions to User Item 18708 Ls the road ahead www drivemedical com E Dear Users This manual is written for the Clini Ox II Fingertip Pulse Oximeter part number 18708 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 Clini Ox II s features and requirements main structure functions specifications correct meth ods for transportation installation usage operation repair mainte nance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details 1 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 abnor mality 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 manufac turer s warranty service does not cover such faults This expected service life of this device is 3 years WARNING Anuncomfortable or painful feeling may occur if using the device ceaselessly especially for the micro circulation barrier patients It is recommended th2. OPERATING GUIDE 1 Insert the finger into the clip as shown in Figure 5 Figure 5 31 2 Place the patient s finger onto the rubber cushions of the clip make sure the finger is in the right position and then clip the finger 3 Press the switch button once on front panel 4 Do not shake the finger and keep the patient at ease during the process 5 Getthe information directly from screen display 6 The button has three functions When the device is power off pressing the button can turn on the unit When the device is power on pressing the button shortly can change direction of the screen Fig 6 11 When the device is power on pressing the button long can change brightness of the screen 32 Sp02 VPR idea ME Y Figure 6 Display mode 1 Sp02 Figure 8 Display mode 3 Figure 9 Display mode 4 33 Sp02 PR Sp02 PR 90 Figure 10 Display mode 5 Figure 11 Display mode 6 F 2 A Fingernails and the luminescent tube should be on the same side 34 8 35 REPAIRING AND MAINTENANCE Please change the batteries when the low voltage dis played on the screen 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 oxim
3. Inspection Technology is adopted in accordance with Ca pacity 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 ac quired through which will be shown on screen through treatment in electronic circuits and microprocessor 19 Glow and Infrared ray Emission Tube Glow and Infrared ray Receipt Tube Figure 1 20 3 2 Caution ils 21 The finger should be placed properly see the attached illus tration of this manual Figure 5 or else it may cause inaccurate measurement The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject s arteriole in position between the sensors 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 Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight etc Strenuous action of the subject or extreme electro surgical interference may also affect the accuracy Testee cannot use enamel or other makeup Clinical Restrictions As the measure is taken on the basis of arteriole pulse substan t
4. cellular cord less telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromag netic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which The 18708 Pulse Oximeter is used exceeds the applicable RF compliance level above the 18708 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 18708 Pulse Oximeter b Over the frequency range 150 KHz to 80 MHz field strengths should be less than 3V m 52 Recommended Separation Distances between Portable amp Mobile RF Communications Equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended Separation Distances between Portable amp Mobile RF Communications Equipment amp the 18708 Fingertip Pulse Oximeter The Clini Ox Il 18708 Fingertip Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF disturbanc es are controlled The customer or the user of the 18708 can help prevent electromagnetic interference by maintaining a minimum 53 distance between portable and mobile RF communications equipment transmitters and the 18708 as recommended below according to the maximum output power of the co
5. volume light in weight total weight is about 1 80z 509 including batteries and conve nient in carrying Power consumption of the product is low and the two originally equipped AAA batteries can be operated continu ously for 20 hours The product will automatically be powered off when no signal is in the product within 5 seconds 16 2 3 17 gt 4directions display mode without waveform Waveform display mode as line drawing or filling manner The product is not suitable for use in continuous supervision for patients 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 circum stance Environment Requirements Storage Environment a Temperature 40 F 140 F 40 C 60 C b Relative humidity 9596 c Atmospheric pressure 500hPa 1060hPa Operating Environment a Temperature 50 F 104 F 10 C 40 C b Relative Humidity lt 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 accord ing to Spectrum Absorption Characteristics of Reductive Hemoglo 18 bin Hb and Oxyhemoglobin HbO in glow amp near infrared zones Operation principle of the instrument is Photoelectric Oxyhemo globin
6. AAA Az 28 6 1 View of the Front Panel 28 6 2 BALCONY 29 6 3 Mounting the Hanging Rope 30 7 Operating Guide 8 Repairing and Maintenance 9 Troubleshooting eere eere esee estes tata tn tn enenen enean 10 Key 0 5 0 5 44444444 11 Function Specification B Appendix s jCn M 1 1 1 SAFETY 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 user 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 Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves For the individual patients there should be a more prudent inspecting in the placing process The device cannot be clipped on the edema and tender tissue 3 1 2 gt The oximeter cannot be used together with devices not specified in User s Manual Only the accessory recommended and suppled by the manufacture can be used with this device This productis calibrated before leaving factory Warnings gt Explosive hazard DO NOT use the oximeter
7. at the sensor should not be applied to the same finger for over 2 hours Forthe individual patients there should be a more prudent in specting 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 harm ful to the eyes so the user and technician should not stare at the light Patient should not use enamel or other makeup Patient s fingernail should not be too long 3 Please read the relative content about the clinical restrictions and caution This device is not intended for treatment CAUTION Federal law restricts this device to sale by or on the order of a physician TABLE OF CONTENTS nr 8 1 1 Instructions for Safe Operations 1 2 Warnings 1 3 Attentions 1 4 Indication for 444444444444 14 2 Overview ee eeeenee 2 1 Classification 2 2 Features 2 3 Environment Requirements 17 3 Principle and Caution ne 18 3 1 Principle of Measurement 18 3 2 Caution 3 3 Clinical Restrictions 22 4 Technical 506 0 2 4 4 24 A CS sissescssissssscacessssssicscssdsscstcccascssenceacttescoucseensnocsstccnsssssccttas 27 AA
8. ble battery Battery Useful Life Two batteries can work continually for 20 hours Dimensions amp Weight Dimensions 2 2 L x 1 2 W x 1 3 H in 57 L x 31 W x 32 H mm Weight About 1 80z 500 with the batteries APPENDIX Guidance amp Manufacturer s Declaration Electromagnetic Emission for all EQUIPMENT and SYSTEMS Guidance amp Manufacturer s Declaration Electromagnetic Emission The Clini Ox Il 18708 Fingertip Pulse Oximeter is tended for use in the electromagnetic environment specified below The healthcare provider of the patient of the 18708 should assure that the Clini Ox Il is issued in such an environment 47 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions Not IEC 61000 3 2 Applicable Voltage fluctuations flicker Not emission IEC 61000 3 3 Applicable Electromagnetic environment guidance The 18708 uses RF energy only for their internal function There fore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The 18708 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance amp Manufacturer s Declaration Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance amp Manufacturer s Declaration Electromagnetic Immunity The Clin
9. cover device failure due to owner misuse or neg ligence or normal wear and tear If you have questions about your Drive device or this warranty please contact an authorized Drive Medical pro vider 57 for the road ahead 7Z ve Drive Medical Design amp Manufacturing 99 Seaview Boulevard Port Washington NY 11050 Local 516 998 4600 www drivemedical com Toll Free 877 224 0946 58
10. eter is not in use for a long time The best storage environment of the device is 40 C to 60 C ambient temperature and not higher than 9596 relative humidity Necessary maintenance and calibration may only be per formed by Authorized Drive Medical Service Professionals Users are not permitted to performance product maintenance or calibration of the Clini Ox ll High pressure sterilization cannot be used on the device A Do not immerse the device in liquid A Itis recommended that the device should be kept in a dry environment Humidity may reduce the useful life of the device or even damage it m 9 TROUBLESHOOTING 37 The SpO and Pulse Rate cannot be displayed normally The SpO and Pulse Rate are not displayed stably 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 positioned correctly 2 The finger is shaking or the patient is moving Solution 1 Place the finger properly and try again 2 Try again Contact your physician if you are sure the device is operating correctly 1 Place the finger properly and try again 2 Keep the patient calm 38 9 TROUBLESHOOTING CONTINUED Possible Reason The device cannot 1 The batteries are drained or almost be turned on drained 2 The batteries are not inserted properly 3 Malfunction of the device The display turns off 1 The device will powe
11. gers 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 gt Do not use the device on infant or neonatal patients The productis suitable for children above four years old and adults gt The device may not work for all patients If you are unable to achieve stable readings discontinue use gt The update period of data is less than 5 seconds which is changeable according to different individual pulse rate The waveform is normalized Please read the measured value when the waveform on screen is equably and steady go ing Here this measured value is optimal value And the wave form at the moment is the standard one If some abnormal conditions appear on the screen during 12 13 test process pull out the finger and reinsert to restore normal use gt The device has normal useful life for three years since the first electrified use gt 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 to avoid potential patient injury gt The instrument does not have low voltage alarm function it only shows the low voltage Please change the battery when the low battery warning appears Ba
12. i Ox Il 18708 Fingertip Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of 18708 should assure that it is used in such an environ ment 49 Immunity Test IEC60601 Test level Compliance level Radiated RF 3V m 80MHz to 2 5GHz 3V m ICE 61000 4 3 Electromagnetic Environment guidance Portable and mobile RF communication equipment should be used no closer to any part of the 18708 including cables than the recommend ed separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance EXE _ 52 NP 80MHz to 800 MH a EE z to z 7 ds AG 800MHz to 2 5 GHz 1 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electro magnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 9 51 NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromag netic propagation is affected by absorption and reflection from struc tures objects and people a Field strengths from fixed transmitters such as base stations for radio
13. ial 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 22 23 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 The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor blamed for serious error of SpO measure 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 4 1 3 4 TECHNICAL SPECIFICATIONS 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 Power Requirements 2 x 1 5V AAA alkaline battery or using the rechargeable battery instead adaptable range 2 6V 3 6V Power Consumption Smaller than 30mA Resolution 1 for SpO and 1 bpm for Pulse Rate 25 Measurement Accuracy 2 in stage of 70 100 SpO and meaningless when stage being smaller than 70 2 bp
14. in environ ment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the patient is measured by MRI and CT gt The person who is allergic to rubber cannot use this device gt The disposal of scrap instrument and its accessories and 1 3 packing including battery 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 pack ing list or else the device may have the possibility of working abnormally Attentions Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and mois ture gt Ifthe oximeter gets wet please stop operating it When it is carried from cold environment to warm or 10 11 humid environment please do not use it immediately gt DO NOT operate keys on front panel with sharp materials gt 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 gt Donot have the oximeter immersed 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 gt When cleaning the device with water the temperature should be lower than 140 F 60 C gt As to the fin
15. m during the pulse rate range of 30 99 bpm and 2 during the pulse rate range of 100 250 bpm Measurement Performance in Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 496 SpO error is 4 pulse rate error is 2 bpm during the pulse rate range of 30 99 bpm and 2 during the pulse rate range of 100 250 bpm 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 It is equipped with a function switch The oximeter will power off automatically after 5 seconds without a finger present between the sensors 9 Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW 26 27 ACCESSORIES gt One hanging rope Two batteries gt OneUser manual 6 INSTALLATION 6 1 View of the Front Panel Figure 2 pulse rate button pulse bar graph pulse waveform 28 6 2 Battery Step 1 Refer to Figure 3 and insert the two AAA size batteries properly in the right direction Step2 Replace the cover AN Please take care when you insert the batteries for the improper insertion may damage the device Figure 3 29 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 30 7
16. mmunications equipment 54 Separation Distance According to Frequenc Rated Maximum Output 150KHz to 80MHz 80MHz to 800MHz Power of Transmitter W 35 aS ale epe 0 12 0 37 1 17 3 69 11 67 55 y of Transmitter m 800MHz to 2 5GHz i o 0 23 0 74 2 33 7 38 23 33 For transmitters rated at a maximum output power not listed above the recommended sepa ration distanced in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum out put 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 NOTE 2 These guidelines may not apply in all sit uations Electromagnetic propagation is affect ed by absorption and reflection from structures objects and people peop 56 WARRANTY Your Drive brand product is warrantied to be free of defects in materials and workmanship for two years from the original purchase date The device was built to exacting standards and carefully inspected prior to shipment This 2 year Limited Liability warranty is an expression of our confidence in the materials and workmanship of our products and our assurance to the consumer of years of dependable service In the event of a defect covered by this warranty we will at our option repair or re place the device This warranty does not
17. r off automatically suddenly when it gets no signal within 5 seconds 2 The batteries are almost drained 39 Solution 1 Change batteries 2 Reinstall batteries 3 Please contact your local equipment provider 1 Normal 2 Change batteries 10 41 KEY OF SYMBOLS symbol Descipton 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 1 Power switch 2 Change direction of the screen 3 Lane brightness of the screen Alarm inhibit 42 WEEE 2002 96 EC IP22 International Protection 43 10 FUNCTION SPECIFICATION Display Information Display Mode The Pulse Oxygen Saturation 3500 OLED Pulse Rate PR OLED Pulse Intensity bar graph OLED bar graph display Pulse wave OLED 44 SpO Parameter Specification 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 Measuring range 30bpm 250bpm the resolution is 1 bpm Accuracy 2bpm or 2 select larger 45 Pulse Intensity Range Continuous bar graph display the higher display indicates a stronger pulse Battery Requirement 1 5V AAA size alkaline batteries x 2 or rechargea
18. tteries must be removed if the device is going to be stored for more than one month or else batteries may leak Aflexible circuit connects the two parts of the device Do not twist or pull on the connection 1 4 Indications for Use The Clini Ox Il Fingertip Pulse Oximeter is a non invasive device intended for the spot check of oxygen saturation of arterial hemo globin 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 14 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 the Clini Ox II Pulse Oximeter was developed At the same time the device can measure the pulse rate simultaneously The Clini Ox Il Pulse Oximeter convenient operation low power consumption and is compact and portable It is only necessary for patient to put one of his fingers into a fingertip photoelectric sen sor for diagnosis and a display screen will directly show measured value of Hemoglobin Saturation 15 2 1 2 2 Classification Class Il b MDD93 42 EEC IX Rule 10 Features gt Operation of the product is simple and convenient The productis small in
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