ZacUrate 500BL User Manual

ZacUrate 500BL User Manual Manual pdf 1 page image

FingertipPulse OximeterUSER MANUALVer1.0General DescriptionSpO2 stands for peripheral capillary oxygen saturation. Oxygen saturation is defined as the ratio of oxyhemoglobin (HbO2) to thetotal concentration of hemoglobin (i.e. Oxyhemoglobin + reduced hemoglobin) present in the blood. It is an important physiologicalparameter involved in respiration and circulation. The Pulse Oximeter feature herein is small, portable, non-invasive and easy touse. The user only needs to insert a finger into the chamber to measure his/her SpO2 level and pulse rate. It has also been provento be highly precise and reliable in clinical tests.Measurement PrincipleOxygenated blood absorbs light preferentially at 905nm (near infrared light), whereas deoxygenated blood absorbs lightpreferentially at 660nm (red light). A pulse oximeter works by passing a beam of red and infrared light through a pulsating capillarybed and then measure the amount of red and infrared light emerging from the tissues via a sensor. To improve accuracy, the 500BLuses a proprietary algorithm to collect data from pulsatile arterial blood and excludes noise from the tissues. The relative absorptionof light by oxyhemoglobin (HbO) and deoxyhemoglobin is then calculated according to the Beer-Lambert's law and a quantitativemeasurement of the users’ oxyhemoglobin status i.e. Oxygen saturation level (SpO2) is derived.Diagram of Operation Principle1. Red and Infrared-ray Emission Tube2. SensorPrecautions For Use1 Please read the manual carefully before use.2 Do not use the fingertip pulse oximeter in an MRI or CT environment.3 Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms.4 This device is not for continuous monitoring.5 Do not use the fingertip pulse oximeter in an explosive environment.6 In order to ensure proper sensor alignment and skin integrity, the maximum application time at a single site for the deviceshould be less than half an hour.7 Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is notintended for sterilization.8 Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components,including batteries.9 This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical electrical equipment and/orsystems. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electricalnoise in healthcare and other environments, it is possible that high levels of such interference due to close proximity orstrength of a source might disrupt the performance of this device.10 Portable and mobile RF communications equipment can affect medical electrical equipment.11 Do not disassemble, repair or modify the equipment.12 It may be unsafe to：—use accessories, detachable parts and materials not described in the instructions for use—interconnect this equipment with other equipment not described in the instructions for use—disassemble, repair or modify the equipment13 The medical silicone and ABS plastic enclosure which contact the user’s skin when the device is used have been assessedby and passed the ISO10993-5 Tests for in vitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-typehypersensitivity.14 The fingertip pulse oximeter is dependent on blood flow to obtain an accurate SpO2 measurement. Verify that nothing ishindering your blood flow before taking your SpO2 readings.15 This device is not intended to diagnose or treat any medical condition or disease. It is intended for non-medicaluse by healthy people to monitor their pulse rate and blood oxygen levels. It is for sports and/or aviation use.People who need SpO2 and pulse rate measurements because of a medical condition should not use this pulseoximeter and should consult with their physician.Inaccurate measurements may be caused by1 Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin).2 Intravascular dyes such as indocyanine green or methylene blue.3 High ambient light. Shield the sensor area if necessary.4 Excessive user movement.5 High-frequency electrosurgical interference and defibrillators.6 Venous pulsations.7 Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.8 The user has hypotension, severe vasoconstriction, severe anemia, or hypothermia.9 The user is in cardiac arrest or is in shock.10 Fingernail polish or artificial fingernails.11 Weak pulse quality (low blood perfusion).12 Low hemoglobin.Product Features1 Easy to operate. Measure your SpO2 non-invasively.2 Small, light and portable.3 LED screen displays SpO2, Pulse Rate and Pulse Bar.4 2pcs AAA-size alkaline batteries; low-battery indicator and low power consumption.5 When no or low signal is detected, the device will power off automatically in about 8 seconds.Intended UseThe 500BL Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterialhemoglobin (SpO2) and pulse rate of children (>12 years old) and adult. The device is for sports and/or aviation use.Operation Instructions1 Install two AAA batteries according to the Battery Installation instructions.2 Place one of your fingers into the finger chamber of the pulse oximeter.3 Press the on/off button on the front panel to turn the pulse oximeter on.4 Keep your hand and finger still for the reading. It is recommended that you do not move your bodywhile taking a reading.5 Read the data from the display screen.Tips to getting a good reading1) Make sure that your finger is inserted deep into the chamber so that the fingertip is placed directly in between the LED sensorand the LED light source.2) Avoid making any body movement, especially your finger while taking measurement.3) Long fingernails may obstruct the light sensor and prevent accurate measurement. Please keep the fingernails short while usingthe device.4) Excessive ambient infra-red light, especially in an overly bright lit room, can interfere with the sensor, preventing an accuratemeasurement.5) Poor blood circulation can affect oximeter readings. Warm your hands and fingers before taking your measurements. Note thatthe pulse oximeter is measuring your SpO2 and PR based on your blood flow. If the blood flow in your finger drops below a certainlevel, the pulse oximeter will not be able to get a reading.6) Some people with medical conditions such as anemia, hypotension and hypothermia may experience an inaccurate readingduring use. In such case, we suggest that you consult a physician.Front PanelThe pulse bar graph is a useful feature that can be used to determine the reliability of a reading. If the height of the pulse bar is lessthan 30%, this indicates signal inadequacy and the displayed SpO2 or pulse rate value is potentially incorrect. Adjust your finger sothat it is directly between the LED lights and sensor.Box Content1. One pulse oximeter2. One lanyard3. Two AAA batteries4. One instruction manualBattery Installation1. Open the battery compartment.2. Install two AAA batteries by matching the plus (+) andminus (-) signs in the compartment. Note: incorrectlyinstalled batteries may damage the device.3. Slide battery cover back until it snaps in place.Notes: Please remove the batteries if the pulse oximeter will notbe used for a long period of time. Please replace the batteries when the battery levelindicator is low.Using the Lanyard1. Thread the thin end of the lanyard through the lanyard hole on the device.2. Thread the thick end of the lanyard through the thin loop (threaded in step 1)and pull to tighten.Warnings! Keep the oximeter away from young children. Small items such as the batterydoor, battery, and lanyard are choking hazards. Do not hang the lanyard from the device’s electrical wire. Please note that the lanyard tied to the oximeter may cause strangulation due toits length.Maintenance and Storage1. Replace the batteries when the battery level indicator is low.2. Clean the finger chamber and surface of the oximeter before use.3. Remove the batteries if you are not planning to use the oximeter for a long period of time.4. Store the product in a cool and dry place, Extreme moisture may damage the oximeter or affect its lifespan.5. Dispose battery properly; follow any applicable local battery disposal laws.Cleaning the fingertip pulse oximeterIt is recommended to clean the oximeter before and after use. To clean, use a soft cloth lightly dampened with water to wipe thefinger chamber and the surface of the oximeter. Allow the oximeter to dry thoroughly before use.CAUTION: Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device.Disinfecting the fingertip pulse oximeterThe oximeter can be disinfected as needed. To disinfect, use a soft cloth lightly dampened with 70% isopropyl alcohol. Otherrecommended disinfectants include: 70% ethanol or glutaraldehyde-type 2% liquid disinfectants.CAUTION: Do not use EtO (Ethylene oxide) or formaldehyde for disinfection.The lifespan of the pulse oximeter is estimated to be five years if 15 measurements are taken per day and eachmeasurement takes 10 minutes. Stop using and contact local service center if one of the following incidents occurs: An error in the Possible Problems and Solutions is displayed on the screen. The oximeter cannot be powered on even though new batteries are installed. There is a crack on the oximeter or damage to the display resulting in unidentifiable readings. The spring is defective. The button is unresponsive.The pulse oximeter is factory calibrated. You do not need to calibrate it again during its lifespan.Specifications1. Display TypeLED display2. SpO2Display range: 0%~99%Measurement range: 70%~99%Accuracy: 70%~99%: ±2%; 0%~69% no definitionResolution: 1%A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used to establishthe SpO2 accuracy. The measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobinoxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison tothe CO-oximeter samples measured over the SpO2 range of 70%~100%. Accuracy data is calculated using the root-mean-squared(Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment–Particular requirements for the basic safety andessential performance of pulse oximeter equipment for medical use.A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the specified calibration curve andthe PR accuracy.The model of functional tester is Index2 FLUKE simulator and the version is 2.1.3.3. Pulse RateDisplay range: 30bpm~250bpmMeasurement range: 30bpm~250bpmAccuracy: 30bpm~99bpm, ±2bpm; 100~250bpm, ±2%Resolution: 1bpm4. Probe LED SpecificationsWavelength Radiant PowerRED 660±2nm 3.2mWIR 905±10nm 2.4mW5. Power RequirementsTwo AAA alkaline batteriesPower consumption: Less than 25mABattery life: Two AAA 1.5V, 1200mAh alkaline batteries could be continuously operated as long as 16 hours.6. Environment RequirementsOperation Temperature: 5°C ~40°CStorage Temperature: -25°C ~+70°CAmbient Humidity: 15%～93% no condensation in operation; ≤93% no condensation in storage/transportAtmosphere pressure: 70kPa~106kPa500BL

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