This Manual is written and compiled in accordance with the council
Contents
1. _ for a diagnosis if you are sure the device works all right 1 The finger is not placed inside deep l 1 Place the finger properly enough The SpO and Pulse Rate 8 and try again display instable 2 The finger is shaking or the patient l 2 Let the patient keep calm is moving 1 The batteries are drained or almost drained 1 Reinstall batteries The device can not turn 2 The batteries are not inserted 2 Please contact the local on properly service center 3 The device s malfunction 1 The device will power off The display is off automatically if no signal is detected 1 Normal within 5 seconds suddenly 2 Change batteries 2 The batteries are almost drained 11 Function Specification Display Information Display Mode 2 digit digital OLED display The Pulse Oxygen Saturation SpO gt 3 digit digital OLED display bar graph OLED display Optical Sensor Red light wavelength is 660nm Infrared wavelength is 940nm photosensor Pulse Parameter Specification Measuring range m 30bpm 240bpm the resolution is Ibpm Accurac _ X2bpm ort2 select larger Pulse Intensity Continuous bar graph display the higher display indicate the stronger Battery Requirement 1 5V AAA size alkaline batteries x 2 Battery useful life The two batteries can work continually 30 hours Dimensions and Weight Dimensions 51L x 31 W x 32 H mm About 50g with the batt2. techoes balli teen aa Geb bobo stel Uschi bela e iid 2 3 ENVIRONMENT REQUIREMENTS abouti ideis PX Bul Rubeo neta 3 PRINCIPEE AND CAUTION 5 oderit teo Rr REIR SP Eee ETE ERR ENERENN RUNI E DUM MEO S T PRINCIPEE OE MEASUREMENT xxiii b iio S ete es actor a uet aes 3 2 THEATIENTION OF OPERATION ecccirdoiefesscbese od A Rede Efron nts tus enr rd opere eia S ACDINIG AE RBSTPICIEIONS E oue oeU CDU MM MEC MM MEME 4 TECHNICAL SPEC TRIGA TIONS ies G5 eee esas oio eu E EE ee eaa ene S ACCESSORIES a ndr RU dpa te uiu tudo dest e Ep UEM Go INSTALEAXDLION ciiieteie orare eee erae teu avi divine dat T OT VIEW OP THE PRONE PANT Dreano dee ete tha duet pi tet bare eaten 06 2 MOUNTING OF THE BATTERY tst aedibus UD UD 6 3 MOUNTING OF THE HANGING RODPE 0 cccsssccosscccesscccsssecessnssevenstecssaccessnecesenecessnenenenetenenass TOPERA TING GUIDE 2 diet EORR ED IE WU UR Dia 8 CLEANING AND DISINFEGCT ING ee eee e eee een ee eene setas o set ea se eaae sten s eese sesta ease tease eas 9 REPAIRINGAND MAINTENANCE 53 iiiiii escit esca ree etu ges oe eov Haeo en Pe tese earet Deve Eii ID TROUBLES HOO ENG sgesvacy soso ve peR E E EE Rete t pe Ye tS bead EAA II FUNCTION SPECIFICATION doctae SU E Er YE EVE A e gU Ee vit eisdem eds I2 KEY OESYMBODBDS 5o tt orci RU p It OR EO FOU EMO RO A IUE M 1 Safety 1 1 Instructions for safe operations NIA SA NU Check the main unit and all accessories periodical
3. user s negligence of the operation instructions The manufacturer s warranty service does not cover such faults This product is medical device and can be used repeatedly Its using life is 3 years WARNING Uncomfortable or painful feeling may appear if using the device ceaselessly especially for the microcirculation barrier patients It is recommended that the sensor should not be applied to the same finger for over 2 hours For the special patients there should be a more prudent inspecting in the placing process The device can not be clipped on the edema and tender tissue The light the infrared is invisible emitted from the device is harmful to the eyes so the user and the maintenance man should not stare at the light Testee can not use enamel or other makeup Testee s fingernail can not be too long Please refer to the correlative literature about the clinical restrictions and caution VS 7N ios VS This device is not intended for treatment II Table of Contents SAFET ee M IREN 1 1 INSTRUCTIONS FOR SAFE OPERATIONS nde teas e RE ERE REOR S Ri eo TRUE RN trc dite dis VARIN OUS oe E E Us aeris ARS Ec AE ta case ences A DN URN ta ED AS IE E SLATTENTIONS eege ne Mo ma ferui Ut eM EM MTM DM RO MEL 2 OVERVIEW innate EIE YENEIO TIT V E VERE MORE M IEEE TEAOR E on NEM MEM NESEME EINE DEMNM ME EMI 2 2 AANTEICIPATEVBAAPPERC ATION 2355s
4. value for judgement of anemic anoxia and toxic anoxia some patients with serious anemia may also report good SpO measurement 4 Technical specifications A Display mode double Color OLED display SpO measuring range 35926 10090 Pulse rate measuring range 30bpm 240bpm Pulse waveform display bar graph display Battery indication OLED Signal B Power supply requirement 1 5V AAA size alkaline batteries x 2 Adaptable range 2 6V 3 6V C Operating current lt 30mA D Resolution SpO 1 Pulse Rate Ibpm E Accuracy SpO 70 to 100 2 digits below 70 unspecified Pulse rate 2 bpm or 2 select larger F Measurement at low perfusion The values of SpO and pulse rate can be displayed properly when pulse saturation is at 0 4 Accuracy of SpO 4 Accuracy of Pulse rate 2bpm or 2 select larger G Resistance to surrounding light The difference between the value measured in the condition of man made light and indoor natural light and that of darkroom is less than 1 H Automatic shutdown function The device will power off automatically within 5 seconds when there is no finger in the device 5 Accessories A A hanging rope B Two batteries C A User Manual 6 Installation 6 1 View of the front panel Voltage Display The display Sp0z _ i Pulse rate Fal Power switch DIL FINGERTIP OXIMETER Pulse rate Bargraph Display Pulse rate W
5. This Manual is written and compiled in accordance with the council directive MDD 93 42 EEC for medical devices and corresponding standards The Manual written is in accordance with the Fingertip Pulse Oximeter In case of modifications and software upgrades you will be advised in due time with a Modification Notice The Manual includes the Fingertip Pulse Oximeter s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details This manual is used for the experienced personnel who is familiar with the measure and the use of the instrument This manual is compiled by our company and the copyright is possessed by our company Instructions to User Dear Users thank you very much for purchasing Fingertip Pulse Oximeter Please read the following two pages very carefully before using this equipment Please read these instructions carefully before using this equipment These instructions describing the operating procedures should be followed strictly Failure to follow these instructions can cause measuring abnormality equipment damage and personal injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality personal injury and equipment damage due to
6. ave Figure2 front view 6 2 Mounting Of The Battery 1 Refer to Figure 3 And insert the two AAA size batteries properly in the right direction according to the and symbol 2 Replace the cover A Please be cautious when you insert the batteries for improper insertion may damage the device Figure 3 batteries installation 6 3 Mounting of the hanging rope Refer to Figure 4 Stepl Put the end of the rope through the hole Step2 Put another end of the rope through the first one and then tighten it Figure4 Mount the hanging rope 7 Operating Guide A Insert the two batteries properly to the direction and then place the cover B Open the clip as shown in Figure 5 FINGERTIP OXIME Figure5 Put finger in position C Let the patient s finger put into the rubber cushions of the clip make sure the finger is in the right position and then clip the finger a Press the Power Button on the front panel b Using first finger middle finger or ring finger when doing test Low finger temperature fat finger thin finger may cause inaccurate measurement c Donot shake the finger and keep the patient at ease during the process D Get the information directly from screen display E When working the display direction can be changed by pressing the button shortly There are six modes of direction F In working item long press can change the lighteness of the screen AN When finger pu
7. eries Description Battery anode Battery cathode 10 KX Alarm inhibit
8. from 70 to 10096 2 1 Features A The device can accurately measure SpO B The device will power off automatically if no signal is detected within 5 seconds C Two AAA size batteries are required for operating and the continuous working time is 30 hours D When Low Voltage Warning is shown on screen the device maybe not operate normally E Light and portable total weight with batteries is about 50g F Classification Class Ila MDD93 A2 EEC IX Rule 10 2 2 Anticipative application The Fingertip Pulse Oximeter can detect SpO and pulse rate through patient s finger and indicate the pulse intensity by the bar display This device is applicable for use in home hospitals ordinary sickroom oxygen bar the community medical treatment physical care in sports you can use the device before or after the sport but it is not recommended to use it during the sport and so on A This device is not appropriate for the ceaseless monitoring of the patients 2 3 Environment requirements Transport and storage a Temperature 20 C 55 C b Humidity lt 95 c Pressure 500hPa 1060hPa Operating a Temperature 10 C 40 C b Humidity 35 75 C Pressure 700hPa 1060hPa 3 Principle and Caution 3 1 Principle of measurement The measurement of pulse oximeter is that it uses a multi functional oxyhemoglobinometer to transmit some narrow spectrum light bands through blood samples and to measure attenuation
9. lood pressure cuff or receiving intravenous injection Make sure the optical path is free from any optical obstacles like rubberized fabric otherwise it may result in venous pulsation and inaccurate measure of SpO Excessive ambient light may affect the measuring result It includes fluorescent lamp dual ruby light infrared heater direct sunlight and etc Strenuous action of the testee or extreme electrosurgical interference may also affect the accuracy Testee can not use enamel or other makeup Please clean and disinfect the device after operating according to the user manual Clinical restrictions As the measure is taken on the basis of arteriole pulse substantial pulsating blood flow of the testee is required For a testee with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO2 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 or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate The drugs like dopamine procaine prilocaine lidocaine and butacaine may also be a major factor blamed for serious error of SpO measure The SpO value serves only as a reference
10. ly 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 once a week at least Please stop using the monitor when there is obvious damage Necessary maintenance must be performed by qualified service engineers ONLY Users are not permitted to maintain it by themselves The oximeter cannot be used together with devices not specified in User s Manual Please use the devices recommend by Manufacturer 1 2 Warnings SZA Explosive hazard DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents DO NOT use the oximeter while the testee is under measurement of MRI and CT Be cautious of the hanging rope please do not break the hanging rope during usage to avoid device damage Please don t use hanging rope if allergic to hanging rope Please don t use this product if allergic to rubber cushion Please dispose the device accessory and packing including plastic bag foam and carton according to local law 1 3 Attentions A A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture If the oximeter gets wet please stop using When it is carried from cold environment to warm and humid environment please not use it immediately DO NOT operate keys on front panel with sharp materials High te
11. mperature or high pressure steam disinfection of the oximeter is not permitted Refer to User s Manual for instructions of cleaning and disinfection Do not have the oximeter immerged in liquid When it needs cleaning please wipe its surface with disinfect solution by soft material Do not spray any liquid on the device directly When cleaning the device with water the temperature should be less than 60 C 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 the respiration Many of the respiration disease will cause hypoxemia even damage the patient s life As a result monitoring the SpO is indispensable in the clinical rescuing The traditional method to measure SpO is to analyze the sample of the patient s blood to get the partial pressure of oxygen and calculate the SpO by use the blood gas analyzer This method is inconvenient and discontinuous For the purpose of measuring the SpO2 more easily and accurately our company developed the Fingertip Pulse Oximeter The device can measure the pulse rate simultaneously The Fingertip Pulse Oximeter is tiny and with low power consumption convenient to use and carry You just need to put the fingertip into the sensor of the device the SpO value will appear on the screen immediately In the clinical practice the tolerance is smaller than 2 in the range
12. of spectrum with different wavelengths according to the characteristic that RHb O Hb Met Hb and COHb absorb the light of different wavelength thereby determining O2Hb saturation of different fractions O5Hb saturation is called fractional OHb saturation Fractional O3Hb saturation O5Hb RHb O Hb Met Hb COHb x 100 Oppositely pulse oxygen oximeter measures functional O2Hb saturation Functional O5Hb saturation O Hb RHb O5Hb x 100 Present SpO oximeter transmits light of two wavelengths only red light wavelength 660 nm and infrared wavelength 940nm to differentiate HbO from HbR One side of the sensor contains two LEDs and the other side contains a photoelectric detector SpO2 oximeter measures HbO saturation in the blood by the light plethysmograph when the pulse beats The result is quite precise when HbO saturation is over 70 100 SpO02 PRopm Red light amp infrared receiver 2 Figurel Operating Principle 3 2 The attention of Operation A The equipment should be fully tested to see if it can be used normally before using B The finger should be placed properly see the attached illustration of this manual or else it may cause inaccurate measurement C The SpO sensor and photoelectric receiving tube should be arranged in a way with the testee s arteriole in a position in between 3 The SpO sensor should not be used at a location or limb tied with arterial canal or b
13. t into the rubber cushions of the clip make sure nail is upturned 8 Cleaning and Disinfecting Using alcohol to disinfect the device nature dry or clean it with clean soft cloth 9 Repairing and Maintenance 1 Please change the batteries when the low voltage indicator lightens 2 Please clean the surface of the device before using Wipe the device with alcohol first and then let it dry in air or clean it by dry clean fabric 3 Please take out the batteries if the oximeter is not in use for a long time 4 The best storage environment of the device is 20 C to 55 C ambient temperature and not higher than 9546 relative humidity Please maintain properly for ensuring the device can be used normally The device needs to be calibrated once a year or according to the calibrating program of hospital It also can be performed at the state appointed agent or just contact us for calibration A High pressure sterilization cannot be used on the device A Do not immerse the device in liquid A It is recommended that the device should be kept in a dry environment Humidity may reduce the using life of the device or even damage it 10 Troubleshooting Trouble Possible Reason Solution 1 Place the finger properly 1 The finger is not properly The SpO and Pulse Rate positioned and try again can not be displayed 2 Try again Go to a hospital 2 The patient s SpO is too low to be normally detected
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