O2Health DB12 User Guide / Manual
Contents
1. Contact DELBio s i SAmag ee Pe gee co laura ecclew tio No display on screen Damaged display or connector authorized distributo The Fingertip Pulse Oximeter DB12 is intended for use in the electromagnetic The standard configuration does not include the accessories of the system For the accessories and the detailed information about the Fingertip Pulse Oximeter DB12 please contact the If the pulse wave is not displayed environment specified below The customer or user of the monitor should assure ne 1 Readjust finger position distributor or DELBio Inc No data displayed Low perfusion Hi T A ECEE E i ompliance i i i on device 3 Try another finger Immunity Test Tet evel eo Electromagnetic Environment Guidance 2 3 Fingertip Pulse Oximeter DB12 Instruction LED display not illuminating Contact DELBio s i AUMONZEd UISMIVULOT Electrostatic 26 ki caniael Floors should be wood concrete OPrHGC ALT Hi Fingertip Pulse Oximeter DB12 User Manual 1 Device Appearance and Display Automatic power Contact DEL Bio s Discharge ESD Comag Complies or ceramic tile If floors are covered l Damaged electronic components arie 8 kV air l i l off failure authorized distributor IEC 61000 4 2 with synthetic material the relative Please be sure to read the manufacturer s User Manual humidity should be at least 30 MODEL DB 1 2 first and follow the instructions carefully Power Frequency SN bomi Power frequency ma2. Vi a Nis ea Fingertip Pulse Oximeter DB12 Specifications Temperature 4 F 140 F 20 C 60 C 7 1 Technical Specifications 3 1 Battery Installation and Replacement Ua 50kPa 106kPa 14 7inHg 31 3inHg esa i Relative Humidit o 959 p Interference may occur in the vicinity of equipment marked with this symbol el Naeem Manufacturer s Declaration This device uses one AAA battery for its power supply When the device displays 10 95 non condensing esa low battery level the battery power of the Fingertip Pulse Oximeter DB12 can last Physical 40g battery included l l OSEE System Performance Characteristics only for approximately 15 minutes more However it may vary with different brands Characteristics Dimension 65mm x 37mm x 29mm te a viz eh higher ide m o a EE f tteri Therefor r in th tter imm iatel i r mmen t a 7 ote ese guidelines may not apply In all situations ectromagnetic propagation Is attecte y od aay Customer Service Infomation of batteries erefore replacing the battery ediately is recommended to Electric Electricity Type One AAA alkaline battery absorption and reflection from structures objects and people ensure accurate measurements Specifications Voltage 1 5V DC Battery Indicator Protection Category Type BF applied apart a Field strength from fixed transmitters such as base stations for radio cellular cordless i telephones and land mobile rad
3. Actual Size B4 36 4x25 7cm Folded in 12 8x9 5cm Measurement Principle 7 The measurement of SpO2 blood oxygen saturation concentration is made by determining the Chapter 6 Trouble Shooting absorption of infrared and far infrared passing through the tissues Such absorptions may vary with the blood pulsation in the capillary bed allowing the blood oxygen saturation and pulse Electromagnetic Environment Guidance alteration to be determined In the event of device failure during its use please follow the recommended solutions below The OxiCare uses RF energy only for its 1 internal function Therefore the RF Group emissions are very low and not likely to Table 1 R ded B kd Soluti cause interference in nearby electronic able ecommende reakdown Solutions j 2 2 Package Contents RF Emissions equipment 2 User Manual x 1 Device unable Battery power depleted Replace battery Pere The OxiCare is suitable for use in establishments including diagnostic establishments and those Class B directly connected to the public low voltage power supply network that supplies buildings 3 AAA Alkaline Battery x 1 to power on Battery not installed properly Re install battery Peete uet ipa ieee ane 4 Pouch x 1 Partial damage to metal dome in Contact DELBio s CONEY authorized distributor Table 8 Electromagnetic Immunity Please verify all of the above items are in the package If any one item in this list is missing or istri
4. ed from Probe as resulting in incorrect result the user shall consult the physician prior to using it Oximeter DB12 and detach the battery cover C hapte r 9 Syste m Performance Characteristics e In the event of malfunction please do not use this device Step 3 Install one AAA alkaline battery as illustrated in the figure below a e This device is able to accurately measure the pulse and blood oxygen saturation When the Step 4 Put the battery cover back on Chapter 8 Manufacturer s Declaration Measurement Validation blood flow is limited such as using a sphygmomanometer the pulse measurement may be The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with CO Oximeter In a affected The device function may be influenced if the test object is moving UV l l l l P The Fingertip Pulse Oximeter DB12 is intended for use in an electromagnetic controlled desaturation study healthy adult volunteers with saturation levels between 70 and 100 SpO2 were studied 1 2 Caution GY environment in which radiated RF disturbances are controlled The customer or user DB12 Inner Probe M of the monitor can help prevent electromagnetic interference by maintaining a minimum a The table below shows Arms values measured using DB12 in a clinical study e This is a device with a highly sophisticated electronic instrument and its maintenance and Battery Cover ee eer oe para ee ee 90 100 80 lt 90 repair ca
5. gnetic fields i i i ifi i 50 60 H m omplies should be at levels characteristic of Chapter 7 Fingertip Pulse Oximeter DB12 Specifications Uae Spite ion he ji commercial or hospital environment Spot Monitor for Sports and Outdoor Use 7 1 Technical Specifications idade alle mobile RF eroi F F communications equipment snou Power Switch amp Bakclight ON OFF ety ene Radiated RF 3y OxiCare including the cables than IEC 61000 4 3 ns the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Incident Potential Cause Solution The Fingertip Pulse Oximeter DB12 package includes the following Battery Level Displa Blood Oxygen Display ry pay Contents Pulse Strength Display Pulse Rate Display Battery Box oN aa Safety Information J 1 1 Warnings 1 2 Cautions re ot O O O oO i f To turn on the backlight pleae insert your fingertip into the device and press the Introduction of Fingertip Pulse Oximeter DB12 power switch to turn on the device then press the switch again to trun on and off the backlight E ES 2 1 Product Introduction 2 2 Package Contents Range E gt p 2 3 Fingertip Pulse Oximeter Introduction 2 The Fingertip Pulse Oximeter DB12 Display Alarm Ree ee OO When test dat ds the factory default setting the reading will flash Oxygen Saturation eee eee a i a a i i i i en test data exceeds the factory default setti
6. ios amateur radio AM and FM radio broadcast and TV Chapter 1 Safety Information e W Indicates full of power Operating Mode Spot Checking broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic F deme os Safety Standard IEC 80601 1 environment due to fixed RF transmitters an electromagnetic site survey should S Indicates tne device may be out of power in 15 minutes Compliance be considered If the measured field strength in which the OxiCare is used exceeds SRN J the device wil ehut dowi Peamine Giandard ISO 80601 2 61 normal operation If abnormal performance is observed additional measures may be e Explosion Hazard Please do not use this device in the presence of flammable gas an ET necessary such as reorienting or relocating the monitor C lease 00 not ae this device in an MRI environment a n Please follow the steps below for battery replacement l e The sole objective for the use of this device is to serve as an aid in clinical diagnosis It must Wavelength 660 nm gt 905 nm b Over the frequency range 150 kHz to 80 MHz field strength should be less than V1 V m be used in combination with clinical manifestations and symptoms for the diagnosis e Step 1 Turn off power Blood Oxygen Probe ses e e Should the subject s measurement site experiences trauma or other medical conditions e Step 2 Push the battery back cover down toward the end of the Fingertip Pulse Releas
7. n only be performed by professionally trained personnel N pmen i i e Please do not expose this device to sterilization under high pressure or immerse it in liquid ie a all such us directly under the rain as it may cause device malfunction or inaccurate measurement e Please refer to the cleaning procedure in this User Manual Please do not use corrosive or corrosive detergent or cleansing apparatus equipment and the OxiCare IEC 60601 1 2 e This device is not intended for respiratory measurement e This device is designed to measure the ratio of the artery blood oxygen saturation to the i Frequency of Transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz functional hemoglobulin Functional disorders such as carboxyhemoglobinemia or methemoglobinemia may affect measurement accuracy 41Finaertio Pulse Oximeter Measurement 73 570 6 735706 B 7 e Indigo cyanine green or certain pigments in the blood vessels may have an impact on the J s Pn F j E i j e A Table 5 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications b Bland Altman Plot compares the SpO2 difference of the DB12 fingertip pulse oximeter to the reference CO Oximeter under non motion conditions Chapter 4 Fingertip Pulse Oximeter DB12 Operations Upper 95 limit Regression line blood oxygen concentration measured depending on its concentration e Step 1 Press the
8. ng ing wi be a sss sss SANASA Fingertip Pulse ee ieee PIA OPAT TO Ea i C e Neal TAC SA A d 32 vP Where P is the maximum output power rating of the transmitter 3 1 Battery Installation and Replacement Blood Oxygen Alarm When the test result falls below 90 the reading of SpOz will flash Pulse Rate Lo eee 30 bpm 200 bpm Tolerance 3 bpm Vy in watts W according to the transmitter manufacturer and d eae Fingertip Pulse Oximeter DB12 Operations Pulse Rate Alarm When the test result falls below 50 or goes above 160 the PR reading will flash Precision 30 bpm 200 bpm Tolerance 3 bpm is the recommended separation distance in meters m f The Fingertip Pulse Oximeter DB12 has no audible alarms It will not sound if the amount of Measurement Duration 30s Field stren ae a arts TC gths from fixed RF transmitters as determined by an 4 1 Fingertip Pulse Oximeter Measurement oxygen in your blood is low or if your pulse rate is too high or too low Temperature 41 F 113 F 5 C 45 C d z JP 80MHz to 800MHz electromagnetic site survey should be less than the compliance Nae Fingertip Pulse Oximeter DB12 Cleaning amp Maintenance Environmental Monospace Pressure 70kPa 106kPa 25 4 inHg 31 3 inHg level in each frequency range a a g Conditions z Manna oM Trouble shooting Chapter 3 Fingertip Pulse Oximeter DB12 Pre operational Procedures Relative Humidity 15 95 non condensing T P 800MHz 2 5GHz
9. power switch to turn on the device i Line of identity e Defibrillators may influence the functioning of this device e Step 2 Insert the finger ee A y e This device may not be used under all kinds of circumstances If unstable readings appear e Step 3 When the pulse signal is detected the oxygen saturation level and pulse ae e ew Ms Mean difference during measurement please cease to use it rate will be displayed 6 8 seconds later T l o e This device possesses some resistance to shaking However under certain circumstances e Step 4 Take the finger out of the device The results will be displayed on the screen 0 1 ign mrp as ap Lower 95 limit the movement may be accepted as normal pulses Therefore moving the patient should be avoided as much as possible e lf the battery has not been used for a long period of time some chemical substances may be released If the device is to be left unused for more than 3 months the battery should be For the cleaning and maintenance of the Fingertip Pulse Oximeter DB12 please removed follow the following recommendations For transmitters rated at a maximum output power not listed above the separation e After the battery is installed properly turn on the device The device will detect the pulse distance can be estimated using the equation in the corresponding column where signals after the finger is placed inside the device The standby mode will be displayed within P is the maximum o
10. rtip Pulse Oximeter DB1 2 a keeping tne Fingertip P RIMELEG ene omy ar all Mmes Be highly EN 60601 1 2 2001 to charge a fee for a warranty repair request on any Fingertip Pulse Oximeter DB12 found to be within specifications recommended Placing it in a humid environment may affect the life of the Instruments subjected to misuse abuse neglect unauthorized repair or modification would be excluded from this device or even cause Cables and OxiCare Sensors Maximum Length warranty If you are not fully satisfied with your Fingertip Pulse Oximeter DB12 please contact TURNER MEDICAL INC damage to it for more information 2 1 Product Introduction e Caution Do not spray spill or dump any liquid on the Fingertip Pulse Oximeter 300 mm Manufacturer DB12 its components power switch or crevices DELBio Incorporation 3F amp 6F No 252 Shangying Road Guishan Industrial Zone Intended Use e If the Fingertip Pulse Oximeter DB12 will not be used for a certain period of time Table 7 Electronic Emissions AOZ2HEALUTH Taoyuan County 33341 Taiwan R O C The Fingertip Pulse Oximeter DB12 is used for spot checking of functional arterial oxygen please take the battery out of the battery chamber The Fingertip Pulse Oximeter DB12 is intended for use in the electromagnetic E CEBIGALINe ee as aes Ny ais i in oe ne outdoor mP RE TE A E AEE displace E E E E N wilh environment specified below The customer or user of the monitor should as
11. sure that 74 Chestnut St Willimantic CT 06226 U S A Penge Popa ee een enone S E a E it is used in such an environment If you have any questions regarding this product please contact 1 866 778 5890 the local government regulations to dispose of the dead batteries P N 13 11 REV 00
12. the device are not polluted by dust or soil absorption and reflection from structures objects and people CAUTION This device is not for continuous monitoring use for the Fingertip Pulse Oximeter at one single location e The silicon used in the Fingertip Pulse Oximeter to be in contact with the finger is a bio compatible material and not harmful to the human body You can therefore use it at without e The same solution can be used for the cleaning and sterilization of the internal l TURNER MEDICAL INC warrants to the purchaser for 2 year from the date of purchase each Fingertip Pulse Oximeter probe of the Fingertip Pulse Oximeter DB12 Please ensure that the probe is Tape o Cae Compliance DB12 exclusive of the battery TURNER MEDICAL will repair or replace any Fingertip Pulse Oximeter DB12 found to har wiped dry prior to another use The plastic material of the probe of the Fingertip Cables Comply With be defective in accordance with this warranty for which TURNER MEDICAL has been notified by the purchaser by serial l Pulse Oximeter DB12 is of medical grade Therefore it is not harmful or number that there is a defect provided notification occurs within the applicable warranty period poisonous to the human skin RF Emissions EN 55011 Class B Group 1 l ant E 2 k This warranty excludes cost of delivery to and from TURNER MEDICAL INC TURNER MEDICAL INC reserves the right Chapter 2 Introduction of Finge
13. utput power rating of the transmitter in watts W according 30 seconds if no finger is placed inside the device Please do not use it and contact the dealer to the transmitter manufacturer for instruction if there is no display e The disposal and recycling of the device and its components should be incompliance with local are ee ad Points analyzed Sres Standard deviation 95 limits of agreement of Mean 2SD_ beyond the 95 limits of agreement Chapter 5 Fingertip Pulse Oximeter DB12 Cleaning amp Maintenance e Prior to cleaning turn off the Oxicare Pulse Oximeter e Use a gentle detergent or medical grade alcohol 75 ethanol solution to moisturize a swab to wipe the surface of the Oxicare Pulse Oximeter Note At 80 MHz to 800 MHz the separation distance for the higher frequency range applies e When you spot any soiling dust or clogging on the surface of the Fingertip Pulse Chapter 10 Customer Service Information WARNING This device is a precision medical instrument and should be only repaired by qualified technical environmental regulations Oximeter DB12 please clean it Note These guidelines may not apply in all situations Electromagnetic propagation is affected by professions Attempt to open the case without professional training may damage the device e Under conallions of normal battery power supply there is no limitation on the longest time of e Make sure the optical components of
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