A&D UP-200 User Manual

A&D UP-200 User Manual Manual pdf 1 page image

INSTRUCTIONS TO USERDear Users, thank you very much for purchasing the UP-200 Pulse Oximeter.In case of modifications and software upgrades, the information contained inthis document is subject to change without notice.The Manual describes, in accordance with the Pulse Oximeter’s features andrequirements, product features, functions, specifications, correct methods for:transportation, use, repair, maintenance and storage, as well as the safetyprocedures to protect both the user and equipment. Refer to the respectivechapters for details.Please read the Manual very carefully before using this equipment. Theseinstructions describe the operating procedures to be followed strictly, failure tofollow these instructions can cause measuring abnormality, equipment damageand personal injury. The manufacturer is NOT responsible for the safety,reliability and performance issues and any monitoring abnormality, personalinjury and equipment damage due to user’s negligence of the operationinstructions. The manufacturer’s warranty service does not cover such faults.Due to product updates, the specific products you received may not betotally in accordance with the description of this User Manual. We regret anyconfusion.This product can be used repeatedly. Its useful life is 3 years.If you have any questions regarding to the use of this product, please call us atone of the numbers listed at the end of this manual.WARNING:• An uncomfortable or painful feeling may appear if using the oximetercontinuously, especially for the microcirculation barrier users. It isrecommended that the sensor should not be applied to the samefinger for over 2 hours.• For individual users, ensure proper placement of the oximeter. Theoximeter cannot be clipped on the edema and tender tissue.• The light (the infrared is invisible) emitted from the oximeter is harmfulto the eyes, do not stare at the light.• User cannot use enamel or other fingernail polish.• User’s fingernail cannot be too long.• Please review the relative content about the clinical restrictions andcaution.• This oximeter is not intended for treatment.The User Manual is published by our company. All rights reserved.1 SAFETY1.1 Instructions for Safe Operations• Check the main unit and all accessories periodically to make sure thatthere is no visible damage that may affect user’s safety and monitoringperformance. It is recommended that the oximeter should be inspected atleast once a week. When there is obvious damage, stop using the oximeter.• Necessary maintenance must be performed by qualified service engineersONLY. Users are not permitted to maintain it by themselves.• The oximeter cannot be used together with devices not specified in User’sManual. Only use the type of accessories included in the package.• This product is calibrated before leaving factory.1.2 Warnings• Explosive hazard—DO NOT use the oximeter in environment withinflammable gas such as some ignitable anesthetic agents.• Do not use this oximeter if you are allergic to rubber.• The disposal of the oximeter and its accessories and packaging (includingbatteries, plastic bags, foam inserts and paper boxes) should follow thelocal laws and regulations.• Please check the packing before use to make sure the oximeter andaccessories are in accordance with the packing list, or else the oximetermay not work properly.• Please don’t measure this oximeter with a functional tester for theoximeter’s related information.• Warning against servicing and maintenance while the equipment is in use.• No modification of this equipment is allowed.• The user is an intended operator.• The probe of the oximeter is the applied part.1.3 Attentions• Keep the oximeter away from dust, vibration, corrosive substances,explosive materials, high temperature and moisture.• If the oximeter gets wet, discontinue use.• Do not use immediately after moving it from a cold environment to warm orhumid environment.• Do not operate buttons on front panel with sharp materials.• Do not use high temperature or high pressure steam disinfection of theoximeter. Refer to chapter (8) for instructions of cleaning and disinfection.• Do not immerge the oximeter in liquid. When it needs cleaning, please wipeits surface with medical alcohol by soft material. Do not spray any liquid onthe oximeter directly.• When cleaning the oximeter with water, the temperature should be lowerthan 60 °C.• As to the fingers which are too thin or too cold, it would probably affect thenormal measure of the users’ SpO2 and pulse rate, use a larger finger suchas thumb or middle finger and place finger deeply into the probe.• Do not use the oximeter on infant or neonatal users.• The product is suitable for adults (weight should be between 40 kg to 110kg).• The oximeter may not work for all users. If you are unable to achieve stablereadings, discontinue use.• The update period of data is less than 5 seconds, which is changeableaccording to different individual pulse rate.• The waveform is normalized. Please read the measured value when thewaveform on the screen is steady. This measured value is optimal value,and the waveform at the moment is the standard one.• If some abnormal conditions appear on the screen during test process, pullout the finger and reinsert to restore normal use.• The lanyard is made from non-allergy material, if you are sensitive to thelanyard, stop using it. In addition, do not wear it around the neck to avoidharm to the users.• The oximeter does not have low-voltage alarm function, it only shows thelow-voltage. Please change the battery when the battery energy is used up.• The instrument does not have alarm function. Do not use the device insituations where alarms are required.• Batteries must be removed if the oximeter is going to be stored for morethan one month, or else batteries may leak.• A flexible circuit connects the two parts of the oximeter. Do not twist or pullon the connection.1.4 Indication for UseThe Pulse Oximeter is a non-invasive device intended for the spot-check ofsaturation of arterial hemoglobin(SpO2) and the pulse rate of adult in home useenvironments. This oximeter is not intended for continuous monitoring. Thedevice can be used multiple times.Pulse oximeter intended for wellness use.2 OVERVIEWThe pulse oxygen saturation is the percentage of HbO2 in the total Hb in theblood - the O2 concentration in the blood. It is an important bio-parameter forrespiration. This Pulse Oximeter was developed for the purpose of measuringthe SpO2 more easily and accurately. At the same time, the oximeter canmeasure the pulse rate.The Pulse Oximeter features a compact design, low power consumption,and convenient operation. It is only necessary for user to put one finger intoa fingertip photoelectric sensor for measurement, and a display screen willdirectly show measured value of Hemoglobin Saturation.2.1 Features• Easy to use• Easy to view with a display that changes direction automatically.• Small, lightweight design• Convenient carrying case.• Low power consumption – allowing for 20 hours of continuous operation ona new set of batteries.• Standby mode when no signal is received within 5 seconds.2.2 Major Applications and Scope of ApplicationThe Pulse Oximeter can be used in measuring pulse oxygen saturation andpulse rate through finger. The product is suitable for family use (It can be usedbefore or after doing sports, and it is not recommended to use the oximeterduring sports activity).The problem of overrating would emerge when the user issuffering from toxicosis which caused by carbon monoxide, theoximeter is not recommended to be used under thiscircumstance.2.3 Environment RequirementsStorage Environmenta. Temperature: -40°C ~ +60°Cb. Relative humidity: ≤95%c. Atmospheric pressure: 500hPa ~ 1060hPaOperating Environmenta. Temperature: 10°C ~ 40°Cb. Relative humidity: ≤75%c. Atmospheric pressure: 700hPa ~ 1060hPa3 ACCESSORIES• 1 Lanyard• 2 Batteries• 1 User Manual• 1 Carrying Case4 SET UP4.1 View of the Front Panelpulse bar graph pulse waveformLow-battery indication SpO2pulse ratebuttonFigure 1: Front View4.2 BatteryStep 1.Insert the two AAA size batteries in the proper direction (Refer to Figure2).Step 2. Put the cover back on.Please take care when you insert the batteries for the improperinsertion may damage the device.Figure 2: Batteries Installation4.3 Attaching the lanyardStep 1. Put the thin loop through the hole on the oximeter.Step 2. Put the lanyard strap through the thin loop and tighten.Figure 3: Attaching the LanyardFigure 4: Put Finger in Position5 USING THE OXIMETER5.1 Insert the two batteries properly to the direction, and then replace thecover.5.2 Open the clip as shown in Figure 4.5.3 Place your finger into the rubber cushions with the nail towards the top ofthe oximeter, and then clip your finger.5.4 Press the switch button once on front panel.5.5 Do not shake your finger and remain still.5.6 See your results from screen display.5.7 The button has two functions. When the oximeter is in standby mode,pressing the button can exit it; When the oximeter is in operation status,pressing the button for longer can change brightness of the screen.5.8 The oximeter changes display direction according to the direction youhold it.Fingernails and the luminescent tube (emission tube) should beon the same side.6 PRINCIPLE AND CAUTION6.1 Principle of MeasurementPrinciple of the Oximeter is as follows: An experience formula of data processis established taking use of Lambert Beer Law according to SpectrumAbsorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin(HbO2) in glow & near-infrared zones. Operation principle of the instrument is:Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordancewith Capacity Pulse Scanning & Recording Technology, so that two beamsof different wavelength of lights can be focused onto human nail tip throughperspective clamp finger-type sensor. Then measured signal can be obtainedby a photosensitive element, information acquired through which will be shownon screen through treatment in electronic circuits and microprocessor.Glow and Infrared-rayEmission TubeGlow and Infrared-rayReceipt TubeFigure 5: Operating Principle6.2 Caution1. The finger should be placed properly (see the attached illustration of thismanual, Figure 4), or else it may cause inaccurate measurement.2. The SpO2 sensor and photoelectric receiving tube should be arranged in away with the subject’s arteriole in a position there between.3. The SpO2 sensor should not be used at a location or limb tied with arterialcanal or blood pressure cuff or receiving intravenous injection.4. Make sure the optical path is free from any optical obstacles like rubberizedfabric.5. Excessive ambient light may affect the measuring result. It includesfluorescent lamp, dual ruby light, infrared heater, direct sunlight etc.6. Strenuous action of the subject or extreme electrosurgical interference mayalso affect the accuracy.7. User cannot use fingernail polish.6.3 Clinical Restrictions1. As the measurement is taken on the basis of arteriole pulse, substantialpulsating blood flow of subject is required. For a subject with weak pulsedue to shock, low ambient/body temperature, major bleeding, or use ofvascular contracting drug, the SpO2 waveform (PLETH) will decrease. Inthis case, the measurement will be more sensitive to interference.2. For those with a substantial amount of staining dilution drug (such asmethylene blue, indigo green and acid indigo blue), carbon monoxidehemoglobin (COHb), methionine (Me+Hb) or thiosalicylic hemoglobin, andsome with icterus problem, the SpO2 determination by this monitor may beinaccurate.3. Drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may alsocause inaccurate SpO2 measurements.4. As the SpO2 value serves as a reference value for anemic anoxia andtoxic anoxia, some users with serious anemia may report good SpO2measurement.7 TECHNICAL SPECIFICATIONS1. Display Format: LCD DisplaySpO2 Measurement Range: 0 ~ 100%Pulse Rate Measuring Range: 30 bpm ~ 250 bpmPulse Wave Display: bar-graph display and the waveform display.2. Power Requirements: 2 × 1.5 V AAA alkaline battery (or rechargeablebattery), adaptable range: 2.6 V ~ 3.6 V.3. Power Consumption: Less than 30 mA.4. Resolution: 1% for SpO2 and 1 bpm for Pulse Rate.5. Measurement Accuracy:SpO2: ±2% for 70% ~ 100%; not applicable if < 70%Pulse Rate: ±2 bpm or ±2% (whichever is larger)Clinical Trial: SpO2 regression plot & Bland–Altman plot,Refer to Figures6 and 7.6. Measurement Performance in Weak Filling Condition: SpO2 and pulserate can be shown correctly when pulse-filling ratio is 0.4%. SpO2 error is±4%, pulse rate error is ±2 bpm or ±2% (select larger).7. Resistance to surrounding light: The deviation between the valuemeasured in the condition of man-made light, indoor natural light anddarkroom is less than ±1%.8. It is equipped with a switch function: The product will enter standbymode when no signal is in the product within 5 seconds.9. Optical SensorRed light (wavelength is 660 nm, 6.65 mW)Infrared (wavelength is 905 nm, 6.75 mW)Figure 6: SpO2 regression plotFigure 7: Bland–Altman plot8 REPAIRING AND MAINTENANCE• Please change the batteries when low-voltage is displayed on the screen.• Clean the surface of the oximeter before using. Wipe the oximeter withmedical alcohol first, and then let it dry in air.• Using the medical alcohol to disinfect after use prevents cross infection fornext use.• Please take out the batteries if the oximeter is not used for a long time.• The oximeter can be transported by ordinary conveyance or according totransport contract. The oximeter can not be transported mixed with toxic,harmful, corrosive material.• The best storage environment of the oximeter is - 40ºC to 60ºC ambienttemperature and not higher than 95% relative humidity.• There is no need to calibrate the oximeter.High-pressure sterilization cannot be used on the oximeter.Do not immerse the oximeter in liquid.It is recommended that the oximeter should be kept in a dryenvironment. Humidity may reduce the useful life of the oximeter,or even damage it.Pulse Oximeter User ManualUP-200

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