DIGIPOX 指套式脉搏血氧仪说明书
Contents
1. 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 Diagram of Operation Principle 1 Red and Infrared ray Emission Tube 2 Red and Infrared ray Receipt Tube Precautions for use 1 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 wo Explosion hazard Do not use the pulse oximeter in an explosive atmosphere A 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 and circulation and skin sensitivity of the patient 6 Do not stretch the adhesive tape while applying the pulse oximeter sensor This may Cause inaccurate readings or skin blisters J Before use2. as 30 hours 5 Dimension Length 56mm 62mm Width 32mm 38mm Height 34mm 38mm Weight 45g 60g including two AAA 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 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 6 8 Interference Resistance Capacity against Ambient Light Device works normally when mixed noise produced by BIO TEK INDEX Pulse Oximeter tester Declaration 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 IS010993 1 ISO010993 5 and IS010993 10 Guidance and manufacturer 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 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 em
3. 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 Operation Instructions Power Switch Low Voltage Lamp Pulse bar graph Oxygen Saturation Pulse Rate The Pulse 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 strap 2 Two batteries 3 One user s manual Battery Installation 1 Put the two AAA batteries into battery compartment in correct polarities 2 Push the battery cover horizontally along the arrow shown as below Notes Battery polarities should be correctly installed Otherwise damage may be caused to the device Please put in or remove batteries in right order or may cause damage to the device bracket lt gt Please remove the batteries if the Oximeter will not be used for a long time Strap installation i Thread thinner end of the strap through the loop 2 Thread thicker end of the strap through the threaded end before pulling it tightly Calibrating the pulse oximeter 1 The functional tester cannot be used to assess the accuracy of the oximeter 2 The test methods used to establish the SpO accuracy is clinical testing The oximeter used to measure the arterial haemoglobin
4. oxygen saturation levels and these levels are to be compared to the levels determined from arterial blood sampling with a CO oximeter 3 Index 2 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 Maintenance and Storage le 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 the 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 temperatures is 20 C 55 C 4 131 F and relative humidity is lt 93 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 battery Detailed descriptions of product functions 1 Display Type LED 2 SpO Measurement range 70 99 Accuracy 80 99 2 70 80 3 lt 69 no definition 3 Pulse Rate Measure range 30 235 BPM Accuracy 30 99bpm 2bpm 100 235bpm 2 Pulse Intensity Bargraph Indicator 4 Power Requirements Two AAA alkaline Batteries Power consumption Less than 40mA Low power indication Xh Battery Life Two AAA 1 5V 600mAh alkaline batteries could be continuously operated as long
5. OPERATOR S MANUAL V4 0C1 Fingertip Pulse Oximeter sm 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
6. carefully read the manual The pulse oximeter has no SpOz alarms it is not for continuous monitoring 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 11 Significant levels of dysfunctional hemoglobins such as carbonxy hemoglobin or methemoglobin may affect the readings 12 Intravascular dyes such as indocyanine green or methylene blue 13 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 14 Excessive patient movement may cause inaccurate readings 15 High frequency electrosurgical interference may cause inaccurate readings 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 18 The patient has hypotension severe vasoconstriction severe anemia or hypothermia 19 The patient is in cardiac arrest or is in shock 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 incl
7. issions 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 1 Finger is not inserted correctly 1 Retry by inserting the finger can not be 2 Patients Oxyhemoglobin value is 2 Try some more times If you shown too low to be measured can make sure no problem is normally existing in the product Please go to a hospital timely for exact diagnosis SpO or PRis 1 Finger might not be inserted deep 1 Retry by inserting the finger shown enough 2 Try not to move unstably 2 Finger is trembling or patient s body is in movement status The Oximeter 1 Power of batteries might be 1 Please replace batteries can not be inadequate or not be there at all 2 Please reinstall the batteries poweredon 2 Batteries might be installed 3 Please contact with local incorrectly customer service centre 3 The Oximeter might be damaged Indication 1 The product is automatically 1 Normal lamps are powered off when no signalis 2 Replace the batteries suddenly off detected longer than 8 seconds 2 Power quantity of the batteries is started being inadequate Error3 or 1 Low power 1 Change ba
8. tteries Error4 is 2 Receiving tube being shielded or 2 Please contact local customer displayed on damaged together with broken service center screen connector 3 Please contact local customer 3 Mechanical Misplace for service center receive emission tube 4 Please contact local 4 Amp circuit malfunctions customer service center Error is 1 Low power 1 Please change battery displayed on 2 Emission tube damaged 2 Please contact local screen 3 Current control circuit customer service center 3 Please contact local customer service center Symbol Definitions malfunctions Symbol Definition Type BF applied part N Attention consult accompanying documents SpO2 Oxygen saturation BPM Heart rate BPM Low power indication 2X No SpO Alarm C Power switch SN Serial No Applicable models MD300C1 MD300C1C MD300C12 MD300C12 P MD300C13 MD300C14 MD300C1 E MD300C15 MD300C16 MD300C17 MD300C18 MD300C19 MD300C10 MD3800C1A MD300C1B MD300C1D MD300C1E Note The illustration used in this manual may differ slightly from the appearance of the actual product ad 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 February 2010
9. uding batteries Product Properties 1 Operation of the product is simple and convenient 2 The product is small in volume light in weight and convenient in carrying 3 Power consumption of the product is low and the two AAA batteries can be operated continuously for 30 hours 4 A low voltage warning will be indicated in visual window when battery voltage is so low that normal operation of the oximeter might be influenced 5 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 SpO and pulse rate of adult and pediatric patient at home and hospital including clinical use in internist surgery Anesthesia intensive care etc It is not for continuously monitoring The PULSE OXIMETER requires no routine calibration or maintenance other than replacement of batteries Operation Instructions 1 Install two AAA batteries into battery cassette before closing its cover 2 Place clamp over finger nail as the following diagram 3 Insert one finger into rubber hole of the Oximeter fully 4 Press the switch for one time on front panel 5 Finger and body should not tremble during measuring 6 Read corresponding data on the display screen Note Please use medical alcohol to clean the rubber inside the Oximeter that touches the finger Also clean the test
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