OPERATOR`S MANUAL
Contents
1. 2 Measurement range 70 100 Accuracy 70 100 3 lt 69 no definition 3 Pulse Rate Measure range 30 235 BPM Accuracy 30 99bpm 2bpm 100 235bpm 2 Pulse Intensity Bar graph Indicator 4 Power Requirements Two AAA alkaline Batteries Power consumption Less than 30mA Low power indication 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 C 40 C Storage Temperature 20 C 55 C Ambient Temperature lt 80 in operation no condensation lt 93 in storage no condensation 7 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 8 Interference Resistance Capacity against Ambient Light Device works normally when mixed noise produced by BIO TEK INDEX Pulse Oximeter tester 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 of the user of the Pulse Oximeter should assure that it is used in such and environment Group 1 Emis2. OPERATOR S MANUAL Fingertip Pulse Oximeter Cex MD300C63 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 H
3. bO2 in 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 1 a e Diagram of Operation Principle 1 Red and Infrared ray Emission Tube 2 Red and Infrared ray Receipt Tube 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 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 he sensor and circulation and skin sensitivity of the patient Do not stretch the adhesive tape while applying the pulse oximeter sensor This may cause inaccurate readings or skin blisters Before use carefully
4. ce and Storage 1 Replace the batteries in time when low voltage lamp is lighted 2 Clean surface of the fingertip Oximeter before it is used in diagnosis for patients 3 Remove batteries inside the battery cassette if the Oximeter will not be operated for a long time 4 It is best to preserve the product in a place where ambient temperature 20 C 55 C and humidity is lt 93 no condensation 5 It is recommended that the product should be kept in a dry environment anytime A wet ambient might affect its lifetime and even might damage the product 6 Please follow the law of the local government to deal with used batteries Calibration 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 and then a 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 haemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from arterial blood sampling with a CO Oximeter EMC of this product complies with IEC60601 1 2 standard The materials which the user can come into contact have no toxicity and no action on tissues comply with 1S010993 1 IS010993 5 and ISO10993 10 Detailed descriptions of product functions 1 Display Type OLED display 2 SpO
5. ight in weight and convenient in carrying Power consumption of the product is low Low voltage warning will be indicated in visual window when battery voltage is so low that normal operation of the Oximeter might be influenced The product will automatically be powered off when no signal is in the product for longer than 8 seconds Product Operation Scope Fingertip PULSE OXIMETER is a portable non invasive spot check oxygen saturation of arterial hemoglobin SpO2 and pulse rate of adult and pediatric patient at home and hospital including clinical use in internist surgery Anesthesia intensive care monitoring etc It s not for continuously monitoring The PULSE OXIMETER requires no routine calibration or maintenance other than replacement of batteries Operation Instructions Installing two AAA batteries correctly Nip the clamp as diagram Insert one finger into rubber hole of the Oximeter fully Press the switch button once on front panel Your finger and body do not tremble during measuring Read corresponding data from display screen Six display modes After turning on the Oximeter each time you press the power switch the Oximeter will switch to another display mode There are 6 display modes shown as follows SpOz PR bpm LL Q6I maa id zods 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 o
6. n brightness the default is level four NOTE Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter and clean the test finger using alcohol before and after each use The rubber inside of the Oximeter belongs to medical rubber which has no toxin and no harm to the skin of human being When your finger is plugged into the Oximeter your nail surface must be upward Brief Description of Front Panel Low power indicator SpO2 PR bpm 95 84 PR Bar graph SpO2 waveform SpO2 Pulse Rate The PR Bar graph displays corresponding with the patient s pulse beat The height of the bar graph shows the patient s pulse strength Product Accessories 1 One lanyard 2 Two batteries 3 One user manual Battery Installation 1 Put the two AAA batteries into battery cassette with correct polarities 2 Press the button down on the rear panel and push the battery cover horizontally along the arrow shown as below Press the button down Notes e Battery polarities must be correctly installed Otherwise damage might be caused to device Please put or remove batteries in right order or is likely to damage the device bracket e Please remove batteries if the Oximeter will not be used for a long time Lanyard 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 Maintenan
7. read the manual The pulse oximeter has no SpO2 alarms it is not for continuous monitoring as indicated by he 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 10 Inaccurate measurements may be caused by autoclaving ethylene oxide sterilizing or immersing the sensors in liquid may cause inaccurate readings 11 Significant levels of dysfunctional hemoglobins such as carbonxy hemoglobin or methemoglobin Intravascular dyes such as indocyanine green or methylene blue SpO2 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 Venous pulsations Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line The patient has hypotension severe vasoconstriction severe anemia or hypothermia The patient is in cardiac arrest or is in shock 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 Product Properties Operation of the product is simple and convenient The product is small in volume l
8. sion test Electromagnetic environment guidance The Pulse Oximeter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 The Pulse Oximeter is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RF emission Class B CISPR 11 Syme Betton Symbol Definition Type BF applied part EA Low power indication Attention consult E NON k Not for continuous monitoring accompanying documents SpO2 Possible Problems and resolutions Problems Possible reason Solution Retry by plugging the finger Try some more times If you can make sure about no problem existing in the product Please go to a hospital timely for exact diagnosis Finger is not plugged correctly Patient s SpO2 value is too low to be measured SpOz2 or PR is not displayed SpOz2 or PR reading is unstable Finger is not inserted correctly k Re insert the finger Excessive patient movement Restrict patient oximeter movement No battery or low power of battery Batteries might be installed incorrectly The Oximeter might be damaged Replace batteries Reinstall batteries Contact with local customer service centre The Oxime
9. ter can not be powered on Display The oximeter will automatically suddenly turns power off when no signal is off detected longer than 8 seconds Battery power is low Normal Replace the batteries Low power Receiving tube being shielded or damaged together with broken connector Mechanical Misplace for receive emission tube 4 Amp circuit malfunction Change new battery Please contact with local customer service center Please contact with local customer service center Please contact with local customer service center Error3 or Error4 is Displayed on screen Error is displayed on screen Low power Emission tube damaged Current control circuit malfunction Please change battery Please contact with local customer service center Please contact with local customer service center Applicable models MD300C63_ MD300C631 MD300C632 MD300C633 MD300C634 MD300C635 MD300C636 MD300C637 MD300C638 MD300C639 MD300C630 MD300C63A MD300C63B MD300C63C MD300C63D MD300C63E MD300C63F MD300C63H MD300C631_ MD300C63J wd Beijing Choice Electronic Technology Co Ltd BailangyuanB1127 1128 Fuxing R A36 100039 Beijing PEOPLE S REPUBLIC OF CHINA EiffestraBe 80 20537 EC REP Hamburg GERMANY Shanghai International Holding Corp GmbH Europe 0123 ALL RIGHTS RESERVED Issue date 25 December 2009
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