OPERATOR`S MANUAL
Contents
1. 800 759 3038 Web http www evomedical com Manufacturer Beijing Choice Electronic Technology Co Ltd2. OPERATOR S MANUAL VER2 0C201 Pulse One FingertipPulse Oximeter C E General Description Oxygen Saturation is a percentage of Oxyhemoglobin HbOz capacity compounded with oxygen by all combinative hemoglobin Hb capacity in blood In other words it is consistency of Oxyhemoglobin in blood It is a very important parameter for the Respiratory circulation System Many respiratory diseases can result in oxygen saturation being lowered in human blood Additionally the following factors can reduce oxygen saturation Automatic regulation of organ dysfunction caused by Anesthesia Intensive Postoperative Trauma injuries caused by some medical examinations That situation might result in light headedness asthenia and vomiting Therefore it is very important to know the oxygen saturation of a patient so that doctors can find problems in a timely manner The fingertip pulse Oximeter features small size low power consumption convenient operation and portability It is only necessary for a patient to put one of his fingers into the fingertip photoelectric sensor for diagnosis and a display screen will show oxygen saturation It has been proven in clinical experiments that it also features high precision and repeatability Measurement principle Principle of the Oximeter is as follows A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin RHb and
3. Oximeter Declaration EMC of this product comply with IEC60601 1 2 standard The materials which user can come into contact is no toxicity and no action on tissues l don t know what this means comply with 1S010993 1 5 10 om e Detailed descriptions of product functions 1 Display Type OLED display SpO2 Measurement range 70 99 Accuracy 2 on the stage of 80 99 3 on the stage of 70 80 3 Pulse Rate Measure range 30 235 BPM Accuracy 2 BPM or 2 larger Pulse Intensity Bar graph Indicator 4 Power Requirements Two AAA alkaline Batteries Power consumption Less than 40mA Low power indication q Battery Life Two AAA 1 5V 600mAh alkaline batteries could continuously operate the Oximeter for as long as 30 hours 5 Dimension Length 58mm Width 32mm Height 34mm Weight 50g including two AAA batteries 6 Environment Requirements Operation Temperature 5 40 C Storage Temperature 20 55 C Humidity 15 80 in operation 10 93 in storage Declaration EMC of this product complies with IEC60601 1 2 standard Measurement Performance in Low Perfusion Condition required the test equipment BIO TEK INDEX Pulse Oximeter tester the pulse wave is available without failure when the simulation pulse wave amplitude is at 0 6 9 Interference Resistance Capacity against Ambient Light Device work normally when mixed noise produced by BIO TEK INDEX Pulse Oximeter tester o N Guidance and Manufact
4. Oxyhemoglobin HbOz in glow and near infrared zones Operation principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology so that two beams of different wavelength of lights 660nm glow and 940nm near infrared light can be focused onto a human nail tip through a clamping finger type sensor A measured signal obtained by a photosensitive element will be shown on two groups of LEDs through process in electronic circuits and microprocessor shown on two groups of LEDs through electronic circuits and a Precautions for use microprocessor os a he i Do not use the pulse Oximeter in an MRI or CT environment 2 Do not use the pulse Oximeter in situations where alarms are required The device has no alarms 3 Explosion hazard Do not use the pulse Oximeter in an explosive atmosphere 4 The pulse Oximeter is intended only as an adjunct in patient assessment It must be used in conjunction with other methods of assessing clinical signs and symptoms 5 Check the pulse Oximeter sensor application site frequently to determine the positioning of the sensor circulation and skin sensitivity 6 Do not stretch the adhesive tape while applying the pulse Oximeter sensor This may cause inaccurate readings or skin blisters 7 Before use carefully read the manual 8 The pulse Oximeter has no SpOz alarms it is not for continuous monitoring as indicate
5. d by the symbol 9 Prolonged use or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours 0 Inaccurate measurements may be caused by autoclaving ethylene oxide sterilizing or immersing the sensors in liquid 11 Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin may cause inaccurate readings 12 Intravascular dyes such as indocyanine green or methylene blue may cause inaccurate readings 13 SpO2 measurements may be adversely affected in the presence of bright light Shield the sensor area with a towel from direct sunlight for example if necessary 14 Excessive patient movement may cause inaccurate readings 15 High frequency electrosurgical interference 16 Venous pulsations may cause inaccurate readings 17 Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line may cause inaccurate readings 18 Hypotension severe vasoconstriction severe anemia or hypothermia may cause inaccurate readings 19 Cardiac arrest or shock may cause inaccurate readings 20 Fingernail polish or false fingernails may cause inaccurate SpO2 readings Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components including batteries Diagram of Operation Principle 1 Re
6. d and Infrared ray Emission Tube 2 Red and Infrared ray Receipt Tube o_o Product Properties Operation of the product is simple and convenient 2 The product is small in size light in weight total weight is about 50g including batteries h amp Power consumption of the product is low and the twe originally equipped two AAA batteries can be operated continuously for 30 hours 4 A low voltage warning will be shown on the display when battery voltage is so low that the Oximeter might not operate normally O1 The product will automatically be powered off when no signal is detected for longer than 8 seconds Product Operation Scope The fingertip Oximeter can be used to measure human Oxygen Saturation and heart rate through the finger The product is suitable for use in families hospitals including clinical use in internist surgery anesthesia pediatrics intensive care etc Oxygen Clubs social medical organizations and in sports It can be used before or after sports Operation during sports is not recommended The product is not suitable to monitor a patient continuously Operation Instructions 1 Install two AAA batteries into battery cassette before closing its cover Insert a finger into the rubber hole of the Oximeter as shown in the diagram below It is best to insert the finger as far as possible before releasing the clamp Press the switch button once on front panel While using the Oxime
7. ove around is moving around Batteries might be low or missing 1 Replace the batteries The Oximeter can N 2 Please reinstall the batteries 3 Please contact a customer service center not be powered on Batteries might be installed incorrectly 3 The Oximeter might be damaged 1 Normal Indication lamps are The product is automatically powered suddenly off off when no signal is detected for longer than 8 seconds 2 Batteries might be low 2 Replace the batteries Error3 or 1 Low power 1 Replace the batteries N Receiving tube being shielded or 2 Please contact a customer service center Error4 Displayed damaged together with broken 3 Please contact a customer service center on screen connector 4 Please contact a customer service center oO Mechanical Misplace for receive emission tube Amp circuit malfunction l Error7 displayed on Low power 1 Replace the batteries screen Emission tube damaged 2 Please contact a customer service center Current control circuit malfunction 3 Please contact a customer service center Symbol Definitions The equipment type is BF BPM Heart rate BPM Refer to user manual before Lavrpawerindicaiion application p Not for continuous monitoring Date of manufacture Distributor EVO Medical Solutions 26378 289th Place Adel IA 50003 TEL 515 993 5001 FAX 515 993 4172 Toll free
8. r remove batteries in right order or is likely to damage the device bracket Please remove the batteries if the Oximeter will not be used for a long time Hang Lace Installation 1 Thread thinner end of the hang lace through the hanging hole 2 Thread thicker end of the lace through the threaded end before pulling it tightly Maintenance and Storage 1 Replace the batteries when low voltage lamp is lighted 2 Clean surface of the fingertip Oximeter before it is used in diagnosis for patients 3 Remove the batteries from the battery cassette if the Oximeter will not be operated for a long time 4 Itis best to store the product in a place where ambient temperatures are 20 55 C 4 131 F and humidity is 10 93 5 Itis recommended that the product should be kept in a dry environment High humidity might affect its lifetime or even damage the product 6 Please follow local ordinances regarding the disposal of used batteries Calibrating 1 The functional tester cannot be used to assess the accuracy of the Oximeter 2 Index 2 that made by Bioteck company is a function tester Set Tech to 1 R curve to 2 then user can use this particular calibration curve to measure the Oximeter 3 The test methods used to establish the SpO2 accuracy is clinical testing The Oximeter used to measure the arterial hemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from arterial blood sampling with a CO
9. ter your finger should not tremble and you should not move around 4 Read corresponding data on the display screen 5 Two display modes After turning on the Oximeter each time you press the power switch the Oximeter will switch to another display mode There are two display modes shown as follows FINGERTIP FINGERTIP When you press the power switch for a long time more than one second the brightness of the Oximeter will be changed by degrees there are 10 levels on brightness the default level is level four Note Please use medical alcohol to clean the rubber inside the Oximeter that touches the finger Also clean the test finger with alcohol before and after each test The rubber inside of the Oximeter is medical rubber which has no toxins and is not harmful to the skin When your finger is inserted into the Oximeter your nail surface must be upward lt Brief Description of Front Panel SPO ot z a D PR bar graph a PR Power Swith The pulse rate bar graph display corresponds with pulse rate Product Accessories 1 One hang lace 2 Two batteries 3 One user manual Battery Installation 1 Put two AAA batteries into the battery cassette observing correct polarities 2 Install the battery cover by sliding it horizontally in the direction of the arrow as shown below Notes Batteries must be correctly installed Otherwise damage might be caused to the device Please put o
10. urer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and Manufacturer s declaration electromagnetic emission The Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer ef or the user of the Pulse Oximeter should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The Pulse Oximeter uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission Class B The Pulse Oximeter is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Possible Problems and resolutions Problems Possible reason Solution SpO or PR can not 1 Finger is not inserted correctly 1 Retry by reinserting the finger be shown normally 2 Patient s oxygen saturation value is 2 Try some more times If you can make sure no too low to be measured problems exist with the product please go toa __ hospital in a timely manner for exact diagnosis Finger might not be inserted deep 1 Retry by reinserting the finger enough SpO2 or PR is erratic N Finger is trembling or patient s body 2 Try not to m
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