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1. the oximeter 2 The test method used to establish the SpO accuracy is clinical testing The SN Serial No oximeter used to measure the arterial haemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from arterial blood F sampling with a CO oximeter Applicable models Index 2 that made by Bioteck company is a function tester Set Tech to 1 R curve SM 210 SM 220 to 2 and then users can use this particular calibration curve to measure the oximeter Declaration EMC of this product complies with IEC60601 1 2 standard Note The illustrations used in this manual may differ slightly from the appearance of the actual product The materials which the user can come into contact have no toxicity and no action on tissues comply with IS010993 1 1S010993 5 and 1SO10993 10 Guidance and manufacture s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The Pulse Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the Pulse Oximeter should assure that it is used in such and environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The Pulse Oximeter uses RF energy only for CISPR 11 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in near2. OPERATOR S MANUAL VER1 0C615 Fingertip Pulse Oximeter General Description Oxygen Saturation is a percentage of Oxyhemoglobin HbO2 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 Oxyhemoglobin HbO2 i
3. Please contact with local customer displayed z P eee EST eres damaged together with broken service center Please insert or remove batteries in right order or j p connector i Da gt i 3 Please contact with local customer may cause damage to the device bracket pan 3 Mechanical malfunction for service center lt Please remove batteries if the Oximeter will not be joy recevo enies onibo A eo ae a e rE used for a long time A 4 Amp circuit malfunction service center Maintenance and Storage Symbol Definitions 1 Replace batteries in time when low voltage lamp is lighted Symbol Definition Clean surface of the fingertip Oximeter before it is used in diagnosis for patients Remove batteries inside the battery cassette if the Oximeter will not be operated Type BF applied part for a long time It is best to preserve the product in a place where ambient temperature 20 55 A Attention consult accompanying documents C and humidity is lt 93 no condensation A 5 o i It is recommended that the product should be kept in a dry environment anytime SpO2 Oxygen saturation Awet ambient might affect its lifetime and even might damage the product BPM Pulse rate BPM Cx Low power indication Calibrating the Oximeter RR Spo2 6 Please follow the law of the local government to deal with used batteries NOT for continuous monitoring 1 The functional tester cannot be used to assess the accuracy of
4. by electronic equipment RF emission Class B The Pulse Oximeter is suitable for use in all Manufactured for IRoams Network CISPR 11 establishments including domestic establishments and those directly connected Add 713 W Duarte Rd G810 to the public low voltage power supply network that supplies buildings used for Arcadia CA 91007 USA domestic purposes ALL RIGHTS RESERVED Possible Problems and resolutions Issue date 2011 2 18 Problems Possible reason Solution
5. components including batteries Product Properties Easy to use Small in volume light in weight Lower power consumption Low voltage warning will be indicated in visual window when battery voltage is low The product will automatically be powered off when no signal is in the product for longer than 8 seconds Operation Instructions Install two AAA batteries into battery cassette and then close its cover Open the clamp as shown in the picture below Insert one finger into the flexible fingertip of the Oximeter fully Press the power switch once on the front panel The patient s finger should remain still while the Oximeter is working Read corresponding data from display screen When you insert a finger into the Oximeter your nail surface must be upward NOTE Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter and clean the test sensor using alcohol before and after operation The rubber inside of the Oximeter is medical rubber which has no toxin and no harm to the skin of human being Product Accessories 1 One strap 2 Two batteries 3 One user s manual Strap Installation 1 Thread thinner end of the strap through the loop 2 Thread thicker end of the strap through the threaded end before pulling it tightly Brief Description of Front Panel SpO or PRcan 1 Finger is not plugged correctly 1 Retry by plugging the finger i hi Spo or Power low indicator E Ow
6. imeter sensor This may cause inaccurate readings or skin blisters Before use carefully read the manual The pulse oximeter has no SpO alarms it is not for continuous monitoring as indicated by the symbol 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 Inaccurate measurements may be caused by autoclaving ethylene oxide sterilizing or immersing the sensors in liquid may cause inaccurate readings Significant levels of dysfunctional hemoglobins such as carbonxy hemoglobin or methemoglobin Intravascular dyes such as indocyanine green or methylene blue SpO measurements may be adversely affected in the presence of high ambient light Shield the sensor area with a surgical towel or direct sunlight for example if necessary Excessive patient movement may cause accurate readings Venous pulsations may cause accurate readings Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line may cause accurate readings The patient has hypotension severe vasoconstriction severe anemia or hypothermia The patient is in cardiac arrest or in shock Fingernail polish or false fingernails may cause inaccurate SpO readings Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device
7. line Batteries Power consumption Less than 30mA Low power indication h Battery Life Two AAA 1 5V 800mAh alkaline batteries could be continuously operated as long as 30 hours 5 Dimension Length 58mm Width 32mm Height 37mm Weight 33g without batteries 6 Environment Requirements Operation Temperature 5 40 C Storage Temperature 20 55 C Ambient Humidity lt 80 no condensation in operation lt 93 no condensation in storage 7 Measurement Performance in Low Perfusion Condition The pulse wave is available without failure when the simulation pulse wave amplitude is at 0 6 using the test equipment BIO TEK INDEX Pulse Oximeter Tester 8 Interference Resistance Capacity against Ambient Light Device works normally when mixed noise produced by BIO TEK INDEX Pulse Oximeter Tester Precautions for use Do not use the pulse oximeter in an MRI or CT environment Do not use the pulse oximeter in situations where alarms are required The device has no alarms Explosion hazard Do not use the pulse oximeter in an explosive atmosphere 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 Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation and skin sensitivity of the patient Do not stretch the adhesive tape while applying the pulse ox
8. n 2 Patient s Oxyhemoglobin value is too 2 Try some more times If you can make a low to be measured sure about no problem existing in the Pulse Bar graph E BH Oxygen Saturation product Please go to a hospital for exact diagnosis HHH Pulse Rate SpO or PR is 1 Finger might not be plugged deeply 1 Retry by plugging the finger PR BPM shown unstably enough PTRO TOE 2 Finger is trembling or patient s body is in movement status The Pulse Bar graph displays the strength of the pulse rate signal The height of the bar graph shows the patient s pulse strength The Oximeter 1 Power of batteries might be 1 Please replace batteries can not be inadequate or not be there at all 5 i powered on Ee Sy eee er 2 Please reinstall the batteries Battery Installation incorrectly SS please contact with local customer i service centre 1 Put the two AAA batteries into battery cassette in correct polarities 3 The Oximeter might be damaged 2 Press the button down along the arrow and push the battery cover shown as Indication lamps 1 The product is automatically 1 Normal below are suddenly off powered off when no signal is e detected longer than 8 seconds 2 Replace the batteries Notes Press the button down 2 Lower power lt Battery polarities must be correctly installed to avoid gt mg Error3 or 1 Low power 1 Change new batteries a a a i Error4 i damage to the device m h S 2 Receiving tube being shielded or 2
9. n glow and near infrared zones Operation principle of the instrument 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 the Oximeter s display through process in electronic circuits and microprocessor shown on the Oximeter s display through electronic circuits and a microprocessor Diagram of Operation Principle 1 Red and Infrared ray Emission Tube 2 Red and Infrared ray Receipt Tube Product Operation Scope Fingertip Pulse Oximeter is a portable non invasive spot check oxygen saturation of arterial hemoglobin SpO and pulse rate of adult and pediatric patients at home and hospital including clinical use in internal medicine surgery anesthesia intensive care and etc The device is not intended for continuously monitoring The PULE OXIMETER requires no routine calibration or maintenance other than replacement of batteries Technical Specifications 1 Display LED 2 SpOz Measurement range 70 99 Accuracy 70 99 3 lt 70 no definition 3 Pulse Rate Measure range 30 235 bpm Accuracy 30 100bpm 2bpm 101 235bpm 2 Pulse Intensity Bar graph Indicator 4 Power Requirements Two AAA alka
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