Instructions to Users
Contents
1. Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical 23 User Manual for Fingertip Oximeter lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight Vascular dyes or external used color up product such as nail enamel or color skin care Excessive patient movement Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line Exposure to the chamber with High pressure oxygen There is an arterial occlusion proximal to the sensor Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing 4 Factors causing low SpO Measuring value pathology reason Hypoxemia disease functional lack of HbO Pigmentation or abnormal oxyhemoglobin level lt Abnormal oxyhemoglobin variation lt Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough 24 User Manual for Fingertip Oximeter enug sJes u spuepueys eiu BOUBPJOOOR payadsul usaq SUL VO aeg GWEN 252. see figure 5 Figure 5 Figure 6 Short time press display key display screen including values pulse intensity histogram pulse beat symbol and waveform will be flipped 180 see figure 6 Note The two figures both show that SpO 2 value is 99 and PR value is 86bpm 11 User Manual for Fingertip Oximeter 6 Instructions for Operation The finger should be put in properly and correctly Do not shake the finger Keep at ease during measurement Do not put wet finger directly into sensor Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion Do not let anything block the emitting light from device Vigorous exercise and electrosurgical device interference may affect the measuring accuracy The orientation sensor works on the basis of the gravity A small movable metal ball is built in the orientation sensor for detecting the orientation of the oximeter When you want to change the oximeter s display direction if you move the oximeter too slowly the movable metal ball will also move slowly because of not enough acceleration Consequently the response of orientation detection would be delayed Please move the oximeter with a bit of force if you want to change the display direction such as bend extend your finger quickly so an acceleration is provided to the orientation sensor for quick sensing the orientation change 12 User
3. Lm x x olx x were x x x x x x x x x x x 4 x User Manual for Fingertip Oximeter 2 Battery Installation C M Me 552 XR 2 lt ON z 1 Y s 4 PLS Y A 3 S EN e gt 3 Figure 3 Battery Installation 1 Refer to Figure 3 insert two AAA size batteries into the battery compartment properly 2 Replace the cover Please make sure that the batteries are correctly installed or incorrect installation may cause the device not to work User Manual for Fingertip Oximeter 3 External SpO Probe Connection Connect the external SpO probe to SpO sensor connector in the following way Make sure the side with Arrow faces upwards Figure 4 Probe Connection Special for Style E Note when the external SpO probe is connected well the built in finger clip sensor will be disabled The measurement is detected from the external SpO probe Meanwhile the alarm limits for SpO and PR have changed to be SpO gt alarm Lower limit 95 Pulse Rate alarm Upper limit 160bpm Lower limit 60bpm 6 User Manual for Fingertip Oximeter 4 Quick Guide to Operation Step Operation for Style A Style B and Style E Open the clip and put finger into the rubber cushions of the clip make sure the finger is in the correct position and then c
4. Lower limit 50bpm Alarm setting for StyleC1 SpO alarm limit Low limit setting range 8590 9590 Pulse Rate alarm limit Low limit setting range 30 60bpm High limit setting range 100 240bpm SpO alarm default low limit 85 Pulse Rate alarm 14 User Manual for Fingertip Oximeter default high limit 120bpm default low limit 50bpm Audible amp visual alarm function When measuring if SpO 2 value or pulse rate value exceeds the preset alarm limit the device will alarm automatically and the value which exceeds limit on the screen will flash Environment requirement Operating Temperature 5 40 C Operating Humidity 3090 8090 Atmospheric pressure 70kPa 106kPa The performance under low perfusion condition The accuracy of SpO and PR measurement still meet the precision described above when the modulation amplitude is as low as 0 6 Resistance to interference of surrounding light The difference between the SpO value measured in the condition of indoor natural light and that of darkroom is less than 1 Resistance to 50Hz 60Hz interference SpO and PR are precise which have been tested by BIO TEK pulse oximeter simulator 15 L M User Manual for Fingertip Oximeter Dimensions 66 mm L x 36 mm W x 33 mm Net Weight 60g including batteries Classification The type of protection against electric shock Internally powered equipment The degree of protection a
5. Manual for Fingertip Oximeter Using enamel or other makeup on the nail may affect the accuracy of measurement f the first reading appears with poor waveform irregular or not smooth then the reading is unlikely true the more stable value is expected by waiting for a while or a restart is needed when necessary Note Due to the working principle of orientation sensor used in Oximeter there is a small metal ball which is movable within its compartment of the orientation sensor Therefore you can hear a slight clatter sound when you wave or shake the oximeter It is normal and not caused by unwanted part 7 Technical Specifications A Powersupply requirement 2 x LR03 AAA alkaline batteries Supply voltage 3 0VDC Operating current lt 40 B SpO Parameter Specifications Transducer dual wavelength LED sensor Measurement wavelength Red light 663 nm Infrared light 890 nm Maximal optical output power less than 1 5mW maximum average 13 User Manual for Fingertip Oximeter Measuring range 35 99 Measuring accuracy Not greater than 3 for SpO range from 70 to 100 NOTE Accuracy defined as root mean square value of deviation according to ISO 9919 Pulse Rate Parameter Specifications Measuring range 30bpm 240bpm Accuracy 2bpm or 2 whichever is greater Perfusion Index PI Display Range 096 2090 Preset alarm limits SpO alarm Lower limit 9096 Pulse Rate alarm Upper limit 120bpm
6. parameter display between PR and PI Longtime press Display Key to enter setup menu screen On setup menu screen Short time press Display Key to choose the setting item Longtime press Display Key to active the setting item then short time press it to modify the setting parameter Next longtime press Display Key to confirm the modification and exit from this setting item At last move the setting item to Save exit menu and long time pressing Display Key to store the modification and exit from the setup menu Remove your finger the oximeter will power off automatically User Manual for Fingertip Oximeter 5 Display Screen S BPM Measuring screen PI display screen Style A B Style B 99 14 NNNSN Default measuring screen SpO amp PI display screen Style B1 B2 B3 B5 Style B1 B2 B3 C C1 C2 D2 E B5 C C1 C2 D2 SpO2 alm Lo 85 Note The Setup menu screen of PR alm Hi 120 PC 60C1 shows the factory default PR alm Lo 50 alarm limits setting value which is Pulse beep different from other models Save exit menu ER Restore default Lov settin g range 30 60bpm High limit setting range 100 240bpm Setup menu screen Low limit setting range 85 95 Style C1 10 User Manual for Fingertip Oximeter For your oximeter SpO and PR symbols are imprinted on the front panel and its corresponding value displays on display screen below the symbol
7. User Manual for Fingertip Oximeter Instructions to User Dear Users Thank you very much for purchasing our product Please read the manual very carefully before using this device Failure to follow these instructions can cause measuring abnormality or damage to the oximeter The manual is published in English and we have the ultimate right to explain the Manual No part of this manual may be photocopied reproduced or translated into another language without the prior written consent We reserve the right to improve and amend it at any time without prior notice Version of the Manual Ver 1 3 Revised date March 6 2012 All rights reserved Notes e The contents contained in this manual are subject to change without notice e Information furnished by our company is believed to be accurate and reliable However no responsibility is assumed by us for its use or any infringements of patents or other rights of third parties that may result from its use 3502 1290050 User Manual for Fingertip Oximeter Instructions for Safe Operations g Check the device to make sure that there is no visible damage that may affect user s safety or measurement performance with regard to sensors and clips It is recommended that the device should be inspected minimally once a week When there is obvious damage stop using the device Necessary maintenance must be performed only by qualified service technicians Users are not permitted to
8. gainst electric shock Type BF applied parts The degree of protection against harmful ingress of liquids Ordinary equipment without protection against ingress of water Electro Magnetic Compatibility Group I Class B 8 Accessories PUE SES A lanyard Two batteries A pouch An External SpO Probe optional A User Manual Quality Certificate Note The accessories are subject to change Detailed items and quantity see the Packing List 16 User Manual for Fingertip Oximeter 9 Repair and Maintenance 9 1 Maintenance The life of this device is 5 years In order to ensure its long service life please pay attention to the maintenance Please change the batteries when the low voltage indicator lightens Please clean the surface of the device before using Wipe the device with alcohol first and then let it air dry or wipe it dry Please take out the batteries if the oximeter will not be used for a long time The recommended storage environment of the device ambient temperature 20 C 60 C relative humidity 1090 9590 atmospheric pressure 5 107 4 The oximeter is calibrated in the factory before sale there is no need to calibrate it during its life cycle However if it is necessary to verify its accuracy routinely the user can do the verification by means of SpO gt simulator or it can be done by the local third party test house 17 User Manual for Fingertip Oximeter Hig
9. h pressure sterilization cannot be used on the device Do not immerse the device in liquid It is recommended that the device should be kept in a dry environment Humidity may reduce the life of the device or even damage it 9 2 Cleaning and Disinfecting Instruction e Surface clean sensor with a soft cloth by wetting with a solution such as 75 isopropyl alcohol if low level disinfection is required use a 1 10 bleach solution e Then surface clean with a cloth saturated with clean water and dry with a clean soft cloth Caution Do not sterilize by irradiation steam or ethylene oxide Do not use the sensor if it is damaged 18 10 Troubleshooting Trouble Display direction doesn t change or changes insensitively Possible Reason Maybe the i oximeter is not i used for a long i time the movable metal ball within i the i orientation sensor can not move i freely 19 User Manual for Fingertip Oximeter Solution Please shake the j oximeter with a certain force to i make the movable metal ball move freely i If the problem still exists i maybe the i orientation sensor is not working properly Please contact the local service center The Pulse Rate display instable Can not turn on the device No display 1 The finger is not SpOzand i inside i 2 The finger is shaking or the i patient is moving User Manua
10. l for Fingertip Oximeter Possible Reason Solution Place the finger i correctly inside and i try again 2 Let the patient keep calm placed far enough 1 The batteries are i drained or almost drained 2 The batteries i not inserted properly 3 The device is i malfunctioning i 1 Change batteries i 2 Reinstall batteries i 3 Please contact the local service center 1 The device will i power off i automatically when i it gets no signal for 8 j seconds 2 The batteries almost drained 2 Change batteries 20 User Manual for Fingertip Oximeter Appendix I Key of Symbols Description Disposal of this device according i to WEEE regulations 21 User Manual for Fingertip Oximeter II Common Knowledge 1 Meaning of SpO SpO gt is the saturation percentage of oxygen in the blood so called O concentration in the blood it is defined by the percentage of oxyhemoglobin HbO 2 in the total hemoglobin of the arterial blood SpO is an important physiological parameter to reflect the respiration function it is calculated by the following method SpO Hb x100 HbO are the oxyhemoglobins oxygenized hemoglobin Hb are those hemoglobins which release oxygen 2 Principle of Measurement Based on Lamber Beer law the light absorbance of a given substance is directly proportional with its density or concent
11. lip the finger For Style B Wait 2 seconds the oximeter Style E will power on automatically and start to measure For Style A Press the display key to start the measurement For Style B Short time press Display Key to turn on off the backlight For Style B Longtime press Display Key to shift the parameter display between PR and PI For Style E Tilt the oximeter to change display direction Remove your finger the oximeter will power off automatically User Manual for Fingertip Oximeter Operation for Style B1 Style B2 Style B3 Style B5 Style C Style C2 and Style D2 Open the clip and put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip the finger Wait 2 seconds the oximeter will power on automatically and start to measure Short time press Display Key to change display direction Longtime press Display Key to shift the parameter display between PR and PI Remove your finger the oximeter will power off automatically User Manual for Fingertip Oximeter Step Operation for Style Open the clip and put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip the finger Wait 2 seconds the oximeter will power on automatically and start to measure Tilt the oximeter to change display direction Short time press Display Key to shift the
12. maintain it by themselves The oximeter cannot be used together with devices not specified in User Manual Cautions 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 MRI or CT scanning Warnings An uncomfortable or painful feeling may appear if using the oximeter continuously on the same place for a long time especially for poor microcirculation patients It is recommended that the oximeter II User Manual for Fingertip Oximeter should not be applied to the same location for longer than 2 hours If any abnormal condition is found please change the position of oximeter DO NOT clip this device on edema or tender tissue The light the infrared light is invisible emitted from the device is harmful to the eyes so service technician or testee should not stare at the light The local law must be followed when disposing of the device Attentions A Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture a The device should be kept out of the reach of children A If the oximeter gets wet please stop using it and do not resume operation until it is dry When it is carried from a cold environment to a warm and humid environment please do not use it immediately DO NOT operate the button front panel with sharp mate
13. ration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO2 and deoxygenated hemoglobin Hb have different absorption character in the spectrum range from red to infrared light 22 User Manual for Fingertip Oximeter 600nm 1000nm wavelength by using these characteristics SpO2 can be determined SpO measured by this oximeter is the functional oxygen saturation a percentage of the hemoglobin that can transport oxygen In contrast hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin Clinical application of pulse oximeters SpO gt 15 an important physiological parameter to reflect the respiration and ventilation function so SpO monitoring used in treatment has become more popular For example such as monitoring patients with serious respiratory disease patients under anesthesia during operation and premature and neonatal infants The status of SpO can be determined in timely manner by measurement and will allow finding the hypoxemia patient earlier thereby preventing or reducing accidental death caused by hypoxia effectively 3 Factors affecting SpO measuring accuracy interference reason
14. rials a DO NOT use high temperature or high pressure steam disinfection on the oximeter Refer to User Manual for Fingertip Oximeter Chapter 9 for instructions of cleaning and disinfection Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 ISO 9919 and follows the provisions of the council directive MDD93 42 EEC User Manual for Fingertip Oximeter Table of Contents 1 1 1 APPEARANCE 25255 1 L2 NAMIE EM 2 1 3 INTENDED USE EEEE re 2 1 4 FEATURE LIST e 2 2 BATTERY 5 3 EXTERNAL SPO PROBE CONNECTION 6 4 QUICK GUIDE TO OPERATION 7 10 6 INSTRUCTIONS FOR OPERATION 12 7 TECHNICAL SPECIFICATIONS 13 SACCESSORIES oO RR ON nn 16 9 REPAIR AND MAINTENANCE 17 9 1 17 9 2 CLEANING AND DISINFECTING INSTRUCTION 18 10 TROUBLESHOOTING sssscssssssscsccccccccceessees 19 APPENDIX d ee 21 KEY OP SYMBOLS 21 COMMON KNOWLEDGE eee 22 V User Manual for Fingertip Oximeter 1 Overview 1 1 Appearance Rubber Cushions Display Key 4O Di
15. splay Screen Figure 1 Front View Nameplate Battery Cover Hanging Hole Figure 2 Rear View User Manual for Fingertip Oximeter 1 2 Name Name Fingertip Oximeter 1 3 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO through patient s finger It is applicable for spot checking SpO and pulse rate of adult and pediatric patients in homes and clinics 1 4 Feature List Explanation of abbreviations Mark x this function is available without this function Display type X Y Z M monochrome D dual color C full color L LCD O OLED S segment D dot matrix Note The finger clip of Style D2 is suitable for small fingers especially for pediatric patients 2 User Manual for Fingertip Oximeter Style A Style Style Style B2 Style B3 Style B5 pismom sim sim pre pom pop e fx xfx F x x ae 2 ee ES ES Low indication Desain 1 81 HE xIx XxX HERE XIXIXIXIXIXIX x x x User Manual for Fingertip Oximeter ade StyleC Style C1 StyleC2 StyleD2 Style E Ls p x o x o x o u u in x x x x x ox px xxx x x x x x wom x wem x
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