Drive Medical Clini-Ox II Page 51 Instructions To User Download

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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:

Immunity Test

IEC60601 Test level

Compliance level

Radiated RF

ICE 61000-4-3

3V/m 80MHz to 2.5GHz

3V/m

√P

80MHz to 800 MHz

d =

[

3.5

]

√P

800MHz to 2.5 GHz

d =

[

]

Summary of Contents for Clini-Ox II

Page 1: ...Clini Ox II FINGERTIP PULSE OXIMETER Instructions to User Item 18708 www drivemedical com ...

Page 2: ... 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 nanceandstorage etc aswellasthesafetyprocedurestoprotectboth the user and equipment Refer to the respective chapters for details 1 ...

Page 3: ...easuringabnor 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 2 ...

Page 4: ...or over 2 hours For the 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...

Page 5: ...lease 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 4 ...

Page 6: ...Operations 1 2 Warnings 1 3 Attentions 1 4 Indication for Use 2 Overview 2 1 Classification 2 2 Features 2 3 Environment Requirements 3 Principle and Caution 3 1 Principle of Measurement TABLE OF CONTENTS 8 8 9 10 14 15 16 16 17 18 18 5 ...

Page 7: ...ctions 4 Technical Specifications 5 Accessories 6 Installation 6 1 View of the Front Panel 6 2 Battery 6 3 Mounting the Hanging Rope 7 Operating Guide 8 Repairing and Maintenance 9 Troubleshooting 6 21 22 24 27 28 28 29 30 31 31 37 40 ...

Page 8: ...10 Key of Symbols 11 Function Specification Appendix Warranty 7 41 43 44 46 47 56 57 ...

Page 9: ...ransducers 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 edem...

Page 10: ...ce This product is calibrated before leaving factory 1 2 Warnings Explosive hazard DO NOT use the oximeter 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 The person who is allergic to rubber cannot use this device The disposal of scrap instrument and its accessories and 9 ...

Page 11: ... and accessories are totally in accordance with the pack ing list or else the device may have the possibility of working abnormally 1 3 Attentions Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and mois ture If the oximeter gets wet please stop operating it When it is carried from cold environment to warm or 10 ...

Page 12: ...eaning and disinfection Do not 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 When cleaning the device with water the temperature should be lower than 140 F 60 C As to the fingers which are too thin or too cold it would probably affect the normal measure of the patients SpO2 an...

Page 13: ... to achieve stable readings discontinue use 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 appea...

Page 14: ...ergy 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 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 Batteries must be removed if the device is goin...

Page 15: ...s for Use The Clini Ox II Fingertip Pulse Oximeter is a non invasive device intended for the spot check of oxygen saturation of arterial hemo globin SpO2 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 ...

Page 16: ... 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 II 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...

Page 17: ...ll in volume light in weight total weight is about 1 8oz 50g 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 ...

Page 18: ...itable 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 2 3 Environment Requirements Storage Environment a Temperature 40 F 140 F 40 C 60 C 17 ...

Page 19: ...0 C b Relative Humidity 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 ...

Page 20: ...ce with Ca pacity Pulse Scanning 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 ...

Page 21: ...Figure 1 20 ...

Page 22: ...iving tube should be arranged in a way with the subject s arteriole in position between the sensors 3 The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection 4 Make sure the optical path is free from any optical obstacles like rubberized fabric 5 Excessive ambient light may affect the measuring result It 21 ...

Page 23: ...use enamel or other makeup 3 3 Clinical Restrictions 1 As the measure is taken on the basis of arteriole pulse substan tial 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 22 ...

Page 24: ...lobin and some with icterus problem the SpO2 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 SpO2 measure 4 As the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia some patients with serious anemia may also report good SpO2 measurement 23...

Page 25: ...asuring Range 30 bpm 250 bpm PulseWave Display Columniation display and the waveform display 2 Power Requirements 2 1 5V AAA alkaline battery or using the rechargeable battery instead adaptable range 2 6V 3 6V 3 Power Consumption Smaller than 30mA 4 Resolution 1 for SpO2 and 1 bpm for Pulse Rate 24 ...

Page 26: ...formance inWeak Filling Condition SpO2 and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO2 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 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 l...

Page 27: ...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 ...

Page 28: ...5 ACCESSORIES One hanging rope Two batteries One User manual 27 ...

Page 29: ...6 INSTALLATION 6 1 View of the Front Panel Figure 2 28 pulse waveform pulse bar graph pulse rate button SpO2 ...

Page 30: ...Refer to Figure 3 and insert the two AAA size batteries properly in the right direction Step 2 Replace the cover Please take care when you insert the batteries for the improper insertion may damage the device Figure 3 29 ...

Page 31: ...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 ...

Page 32: ...7 OPERATING GUIDE 1 Insert the finger into the clip as shown in Figure 5 Figure 5 31 ...

Page 33: ...e finger and keep the patient at ease during the process 5 Get the 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 ...

Page 34: ...Figure 6 Display mode 1 Figure 8 Display mode 3 Figure 9 Display mode 4 Figure 7 Display mode 2 33 ...

Page 35: ...Figure 10 Display mode 5 Figure 11 Display mode 6 Fingernails and the luminescent tube should be on the same side 34 ...

Page 36: ... using Wipe the device with medical alcohol first and then let it dry in air or clean it by dry clean fabric Using the medical alcohol to disinfect the product after use prevent from cross infection for next time use Please take out the batteries if the oximeter is not in use for a long time The best storage environment of the device is 40 C to 35 ...

Page 37: ...cal Service Professionals Users are not permitted to performance product maintenance or calibration of the Clini Ox II High pressure sterilization cannot be used on the device Do not immerse the device in liquid 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 36 ...

Page 38: ...Rate cannot be displayed normally 1 The finger is not properly positioned 2 The patient s SpO2 is too low to be detected The SpO2 and Pulse Rate are not displayed stably 1 The finger is not positioned correctly 2 The finger is shaking or the patient is moving 37 ...

Page 39: ...olution 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 ...

Page 40: ... drained or almost drained 2 The batteries are not inserted properly 3 Malfunction of the device The display turns off suddenly 1 The device will power off automatically when it gets no signal within 5 seconds 2 The batteries are almost drained 9 TROUBLESHOOTING CONTINUED 39 ...

Page 41: ...Solution 1 Change batteries 2 Reinstall batteries 3 Please contact your local equipment provider 1 Normal 2 Change batteries 40 ...

Page 42: ...ype BF Warning See User Manual 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 41 ...

Page 43: ...Symbol Description Battery positive electrode Battery cathode 1 Power switch 2 Change direction of the screen 3 Change brightness of the screen SN Serial number Alarm inhibit 42 ...

Page 44: ...Symbol Description WEEE 2002 96 EC IP22 International Protection 43 ...

Page 45: ...Display Information Display Mode The Pulse Oxygen Saturation SpO2 OLED Pulse Rate PR OLED Pulse Intensity bar graph OLED bar graph display Pulse wave OLED 10 FUNCTION SPECIFICATION 44 ...

Page 46: ... 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 ...

Page 47: ... a stronger pulse Dimensions Weight Dimensions 2 2 L x 1 2 W x 1 3 H in 57 L 31 W 32 H mm Weight About 1 8oz 50g with the batteries Battery Requirement 1 5V AAA size alkaline batteries 2 or rechargeable battery Battery Useful Life Two batteries can work continually for 20 hours 46 ...

Page 48: ... Guidance Manufacturer s Declaration Electromagnetic Emission The Clini Ox II 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 II is issued in such an environment 47 ...

Page 49: ...cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B 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 Harmonic emissions IEC 61000 3 2 Not Applicable Voltage fluctuations flicker emission IEC 61000 3 3 Not...

Page 50: ...are not LIFE SUPPORTING Guidance Manufacturer s Declaration Electromagnetic Immunity The Clini Ox II 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 ...

Page 51: ...8708 including cables than the recommend ed separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance ImmunityTest IEC60601Test level Compliance level Radiated RF ICE 61000 4 3 3V m 80MHz to 2 5GHz 3V m P 80MHz to 800 MHz E1 d 3 5 P 800MHz to 2 5 GHz E1 d 7 50 ...

Page 52: ...turer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electro magnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 51 ...

Page 53: ...ast 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 per...

Page 54: ...ded Separation Distances between Portable Mobile RF Communications Equipment the 18708 Fingertip Pulse Oximeter The Clini Ox II 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 ...

Page 55: ...distance between portable and mobile RF communications equipment transmitters and the 18708 as recommended below according to the maximum output power of the communications equipment 54 ...

Page 56: ... Maximum Output Power ofTransmitter W Separation Distance According to Frequenc 150KHz to 80MHz 80MHz to 800MHz 0 01 0 12 0 12 0 1 0 37 0 37 1 1 17 1 17 10 3 69 3 69 100 11 67 11 67 P E1 d 3 5 P E1 d 3 5 55 ...

Page 57: ...ion 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 ...

Page 58: ...s 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 cover device failure due to owner misuse or neg ligence or normal wear and tear If you have questions about your Drive device o...

Page 59: ...Drive Medical Design Manufacturing 99 Seaview Boulevard Port Washington NY 11050 www drivemedical com Local 516 998 4600 Toll Free 877 224 0946 58 ...

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