Pulse Oximeter
Contents
1. User anual Instructions for Use Please read the User Manual carefully before using this product The User Manual which describes the operating procedures should be followed strictly The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality human injury and equipment damage due to users negligence of the operation instructions WARNING 6 It is recommended that the sensor should not be applied to the same finger for longer than 2 hours Uncomfortable or painful feelings may appear if the device is used for extensive periods of time 6 The Infrared light on the device is harmful to the eyes Do Not stare at the light 6 Wash hands before use Device works more accurately when nails and fingers are clean of dirt make up and nail polish 6 Please refer to the manual about the clinical restrictions and cautions This device is not intended for treatment Il Contents MS abet yy RR PEST O 1 1 Instructions for safe operations seen 1 2 VO S ne entire near n entries tt area rien ete E ne de nn Rent RE Mn tr dl Pot nent Pts 2 3 Major applications and scope of application ss 2 A ENVITOnMENtT QUIT MENLS 5 nike a ME en ee MR TE Me wats 3 Principle AAA ossodes iss sse sesso ua rossore soosaar soss esiet seiso 3 1 Principle of measurement cecilia titi a aa EE Era N ete ot ASE EEEIEE ETES SA A AAN SRA enlarge ER 4 Technical specifications 2iss2. Operating Guide 7 1 Open the clip and place finger in as shown in Figure 5 Figure 5 Put finger in position 7 2 Finger should be inbetween the rubber cushions of the clip make sure the finger is in the right position and then close the clip over the finger 7 3 Press the power button once on front panel 7 4 Do not shake the finger and keep the patient at ease during the process Body movement is not recommended while waiting for the reading 7 5 Information and measurement will be displayed on the screen A Fingernails and the LED Display should be on the same side 8 Repairing and Maintenance gt gt Change the batteries when the low voltage display is on the screen Clean the surface of the device before using Wipe the device with medical alcohol and then let it air dry or dry it off with a clean cloth Using the medical alcohol to disinfect the product after use will help to prevent cross contamination Remove Batteries if the oximeter is not going to be used for a long period of time The best storage environment for the device is 40 F to 140 F 40 C to 60 C ambient temperature and relative humidity is not higher than 95 A Do Not use High pressure sterilization on the device A Do not immerse the device in water It is recommended that the device be kept in a dry environment Humidity may reduce the useful life of the device or even damage it 9 Troubleshooting Trouble Possibl
3. SpO and meaningless when stage being smaller than 70 2 bpm or 2 select larger for Pulse Rate 4 6 Measurement Performance in Weak Filling Condition SpO and pulse rate can be shown correctly when pulse filling ratio is 0 4 SpO error is 4 pulse rate error is 2 bpm or 2 select larger 4 7 Resistance to surrounding light The deviation between the value measured in the condition of man made light or indoor natural light and that of darkroom is less than 1 4 8 It is equipped with a function switch so that the Oximeter will be powered off when no finger is the Oximeter for 5 seconds 4 9 Optical Sensor Red light wavelength is 660nm 6 65mW Infrared wavelength is 880nm 6 75mW Accessories Two x AA Batteries NOT Included 5 gt Lanyard gt gt User Manual N Installation 6 1 View of the front panel Power switch p0 Low Voltage Display Pulse rate Bargraph Display BPM IP OXIMETER Figure 2 Front View 6 2 Battery Step 1 Refer to Figure 3 Slid off cover an insert two AAA size batteries properly in the right direction Step 2 Replace the cover NPiease take care when you insert the batteries for improper insertion may damage the device Figure 3 Battery Installation 6 3 Attaching the Lanyard Step 1 Insert the end of the lanyard through the hole Step 2 Slide the other end of the lanyard through the loop and then tighten Figure 4 Attaching the Lanyard 7
4. ails are not too long 3 3 Clinical restrictions 1 Because the measurement is taken on the basis of arteriole pulse substantial pulsating blood flow of subject is required For a subject with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more sensitive to interference For those with a substantial amount of staining dilution drug such as methylene blue indigo green and acid indigo blue carbon monoxide hemoglobin COHb methionine Me Hb thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate Drugs such as dopamine procaine prilocaine lidocaine and butacaine may also be a major factor for serious errors of SpO measurement Becasue the SpO value serves as a reference of anemic anoxia and toxic anoxia some patients with serious anemia may also report good SpO measurement 4 Technical specifications 4 1 Display Format LED Display SpO Measuring Range 0 100 Pulse Rate Measuring Range 30 bpm 250 bpm Pulse Intensity Display Columniation display 4 2 Power Requirements 2 X1 5V AAA alkaline batteries Rechargeable batteries can also be used adaptable range 2 6V 3 6V 4 3 Power Consumption Smaller than 25 mA 4 4 Resolution 1 for SpO and 1 bpm for Pulse Rate 4 5 Measurement Accuracy 2 in stage of 70 100
5. ccccesscssscscessccceccsesetscnsscecseveccesscssssccssececessacsssacsesdeseesccesedesssensceacvesecesesenscons SACCESSOTIES NO 6 Installation 20esscsnesesnesnesnensenesnesnennenennennennennenennesnssnensnnennesnennenennennssnensenesnennennensnnesnesnensenesnesnesnennen 6 1 Viewiot the Front panel rn er tetes 6 2 TIG D een an esse ii adas 6 3 Attach ngithe l anyard tr A si te na dass 7 Operating AAA A 8 Repairing and Maintenance lt cccccccccseccssscsessonccsasssoosssssensssesssecscsessosstesssesesessorsnessonssssacsceensssonsssses NES O NA nenne loin ehe ae 11 Function Specification iecei cccseciecsecsscccecctsscecteccassuncestuescscsaceuntesseesesasessectssdcecsecdeccuecdoieeesuctesesceesceees Il 1 Safety 1 1 Instructions for Safe Operation gt Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient s safety and monitoring performance It is recommended that the device should be inspected at least once a week When there is obvious damage stop using the device gt Qualified service engineers should perform necessary maintenance ONLY gt The oximeter cannot be used together with devices not specified in User s Manual Only accessories that are included or are recommended by the manufacturer should be used with this device gt This product is calibrated before leaving the factory 1 2 Warnings gt Explosive hazard DO NOT use the o
6. ce may not work for all patients If you are unable to achieve stable readings discontinue use A Data will update every 5 seconds A If abnormal readings are displayed during use pull out finger and try again amp The lanyard attached to the product is made from non allergy material if sensitive to the Lanyard stop using it In addition do not wear the lanyard around your neck The oximeter does not have low voltage alarm function it only shows the low voltage on the screen Change the batteries when batteries are low A Batteries should be removed if the device is going to be stored for a month or longer A There is a flexible circuit that connects the two halves of the device Do not twist or pull on the connection 2 Overview The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood so called the O concentration in the blood It is an important bio parameter for respiration The Pulse Oximeter was developed for the purpose of measuring the SpO more easily and accurately At the same time the device can measure pulse rate The Pulse Oximeter features in small volume low power consumption convenient operation and portability It is only necessary for patients to put one finger into the fingertip photoelectric sensor for diagnosis and a display screen will show measured value of Hemoglobin Saturation 2 1 Classification Class Ib MDD93 42 EEC IX Rule 10 2 2 Features gt Operation of the p
7. e Reason Solution 1 The finger is not positioned properl Readjust the finger and try again The SpO and Pulse a j POSE J ak Rate can not be 2 The patient s SpO is too low to be Try again Go to a hospital for a detected agnosis if you are sure the device is displayed normally orking properly Readjust the finger and try again The SpO and Pulse enough Rate are not displayed E j 2 The finger is shaking or the patient Keep the patient calm The batteries are drained or almost T Change batteries drained f Reinstall batteries 2 The batteries are not inserted properly The device is malfunctioning Please contact your local service 1 The device will power off The display is off automatically when it gets no signal Normal suddenly within 5 seconds Change batteries 2 The batteries are almost drained 10 Key of Symbols Description Low Battery Change the battery to avoid an inaccurate reading 1 No finger inserted 2 An indicator of signal inadequacy Battery positive electrode Alarm inhibit WEEE 2002 96 EC Ingress of liquids rank 11 Function Specification Display Information Display Mode The Pulse Oxygen Saturation SpO Pulse Rate BPM Pulse Intensity bar graph LED bar graph display SS N TT Measuring range 0 100 the resolution is 1 70 100 2 Below 70 unspecified Red light wavelength is 660nm Battery R
8. ed zones Operation principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning amp Recording Technology so that two beams of different wavelengths of light can be focused onto the human nail tip through a perspective clamp finger type sensor Then a measured signal can be obtained using a photosensitive element information acquired through which will be shown on a screen via the electronic circuits and microprocessor Glow and Infrared ray Emission Tube EU N Glow and Infraredray Receipt Tube Figure 1 Operating Principle 3 2 Caution 1 The finger should be placed properly see the attached illustration in Figure 5 on pg 7 or it may cause inaccurate measurements The SpO sensor and photoelectric receiving tube should be arranged in a way where the subject s arteriole is positioned in between The SpO sensor should not be used when subject is receiving intravenous injections or wearing a blood pressure cuff Make sure the optical path is free from any objects Excessive ambient light may affect the measuring results This includes but is not limited to fluorescent lamps infrared heat lamps and direct sunlight Strenuous activity or extreme electrosurgical interference may also affect the accuracy Makeup or nail polish will affect the accuracy Remove any makeup or nail polish before use Make sure fingern
9. equirement 2 x 1 5V AAA size Alkaline batteries Battery Useful Life Two batteries can work continually for 24 hours Dimensions and Weight S5 L x 1 25 W x 1 25 H About 2 ounces with the batteries
10. roduct is simple and convenient gt The product is small in volume light in weight total weight is approximately 2 ounces including batteries and convenient for carrying gt Power consumption of the product is low and the two AAA batteries can be operated continuously for 24 hours gt The product will automatically power off within 5 seconds when there is no signal to the product 2 3 Major applications and scope of application The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate and indicate the pulse intensity by the bar display A The product is not suitable for continuous use on patients A Overrating will occur when the patient is suffering from toxicosis which may be caused by carbon monoxide The device is not recommended to be used under these circumstances 2 4 Environment requirements Storage Environment a Temperature 40 F to 140 F 40 C to 60 C b Relative humidity 5 95 c Atmospheric pressure 500hPa 1060hPa Operating Environment a Temperature 50 F to 104 F 10 C to 40 C b Relative Humidity 30 75 c Atmospheric pressure 700hPa 1060hPa 3 Principle and Caution 3 1 Principle of Measurement Principle of the Oximeter is as follows An experience formula of data process is established by making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin Hb and Oxyhemoglobin HbO in glow amp near infrar
11. ximeter in environments with flammable gases such as ignitable anesthetic agents gt DO NOT use the oximeter at the same time as MRI and CT testing gt DO NOT use if allergic to Rubber gt Follow local laws and regulations for the disposal of packaging and accessories Including batteries plastic bags foam and boxes gt Before throwing away the packaging Please check to make sure the device and accessories are all included and the device works properly 1 3 Attention A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture A Tf the oximeter gets wet please stop use Do Not leave in extreme heat or cold A DO NOT use sharp instruments to press buttons on Oximeter Do Not Use high temperature or high pressure steam to clean and disinfect Oximeter Refer to User Manual in chapter 8 for instructions on cleaning and disinfecting Do not completely emerge oximeter in water When cleaning is needed wipe the surface with a soft cloth dampened with medical alcohol Do not spray any liquid directly on the device A It would most likely affect the normal measurement of the patients SpO and pulse rate if fingers are too cold or too small It is recommended to place the oximeter on your thumb or middle finger for most accurate readings A Do not use the device on infants or neonatal patients A The product is suitable for anyone 4 years of age and older A The devi
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