Instructions to User Notes
Contents
1. Surface clean sensor with a soft gauze by wetting with a solution such as 75 isopropyl alcohol if low level disinfection is required use a 1 10 bleach solution Then surface clean with with a cloth saturated with clean water and dry with a piece of cloth Caution Do not sterilize by irradiation steam or ethylene oxide Do not use the sensor if it is damaged sii User Manual for Fingertip Oximeter 8 Troubleshooting Trouble The SpO and Pulse Rate display instable Can not turn on the device indicator light is off suddenly Possible Reason Solution 1 The finger is not placed far enough inside 2 The finger is shaking or the patient is moving 1 Place the finger correctly inside and try again 2 Let the patient keep calm 1 The batteries are drained or almost drained 2 The batteries are not inserted properly 3 The device is malfunctioning 1 Change batteries 2 Reinstall batteries 3 Please contact the local service center 1 The device will power off automatically when ENa it gets no signal for 8 2 Change batteries seconds 2 The batteries are almost drained 312 User Manual for Fingertip Oximeter Appendix Key of Symbols Symbol Description With Type BF applied part _ Warning See User Manual The pulse oxygen saturation Perfusion Index Pulse rate beats per minute Low battery voltage _ Serial number Separate c2. two AAA size batteries into the battery compartment properly 2 Replace the cover A 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 Operation 1 Open the clip as shown in Figure 4 E J Figure 4 Put Finger into the Sensor 2 Put finger into the rubber cushions of the clip make sure the finger is in the correct position and then clip the finger 3 The device will power on automatically in 2 seconds and start to display software version number 4 Next enter into data display screen as shown in Figure 5 User can view the waveform and read the values 4SpO Pl vw 99 651 99 14 WW WNW Figure 5 Figure 6 SpO SpO symbol 99 SpO value lt gt PR Pulse rate icon 65 Pulse rate value SpO PR 4 a User Manual for Fingertip Oximeter lt gt PF Pulse beat symbol 4b Pulse intensity histogram lt gt PP Perfusion index icon 1 4 Perfusion index value At this time short time press Display Key display screen will be shown as Figure 6 The PR is replaced by PI To return to PR display just press Dsiplay key again If there is no operation in 20 seconds it will return to PR display as well Change display direction Tilt the oximeter to change display direction The display screen is automat
3. DIX ccerererereresererecerneeenenenenenenenenenereseresesesasases 13 User Manual for Fingertip Oximeter 1 Overview 1 1 Appearance Rubber Display ky o 5 cushions Display __ Screen Figure 1 Front View Nameplate Battery cover Hanging hole Figure 2 Rear View User Manual for Fingertip Oximeter 1 2 Features The Fingertip Oximeter can be used to measure pulse oxygen saturation SpO gt value pulse rate PR value and perfusion index PI Simply put your finger into sensor SpO gt value and pulse rate value will be displayed on screen It is lightweight small in size and easy to take Bright color OLED two direction display various display modes Accurately measures SpO value and pulse rate value Perfusion index display is available Automatic starts measuring after putting finger into rubber cushions Power off automatically without signal for about 8 seconds Audible amp visible alarm function Low voltage indication 1 3 Name and Model Name Fingertip Oximeter Model PC 60C User Manual for Fingertip Oximeter 1 4 Applications and Scope Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO2 through a testee s finger It is applicable for spot checking of SpO and pulse rates in homes and clinics 2 Battery Installation Figure 3 Battery Installation 1 Refer to Figure 3 insert
4. 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 0 January 13 2010 All rights reserved Notes The contents contained in this manual are subject to change without notice 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 User Manual for Fingertip Oximeter Instructions for Safe Operations 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 maintain i
5. cal device interference may affect the measuring accuracy Using enamel or other makeup on the nail may affect the accuracy of measurement User Manual for Fingertip Oximeter 5 Technical Specifications A B Display mode OLED Display Power supply requirement 1 5V AAA size alkaline battery x 2 Supply voltage 3VDC Operating current lt 40mA Environment requirement Operating Temperature 5 C 40 C Operating Humidity 30 80 Atmospheric pressure 70kPa 106kPa SpO Parameter Specifications Measuring range 35 99 Accuracy 70 75 3digits 75 99 2digits Pulse Rate Parameter Specifications Measuring range 30bpm 240bpm Accuracy 2bpm or 2 whichever is greater Pulse Rate alarm Upper limit 120bpm Lower limit 50bpm Perfusion Index Display Range 0 20 8 User Manual for Fingertip Oximeter The performance under low perfusion condition The accuracy of SpOz 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 gt value measured in the condition of indoor natural light and that of darkroom is less than 1 Resistance to 50Hz 60Hz interference SpO gt and PR are precise which have been tested by BIO TEK pulse oximeter simulator Dimensions 66 mm L x 36 mm W x 33 mm H Net Weight 60g including batteries Classification The type of protec
6. ically adjusted for easy reading Setup menu On measuring screen longtime press Display Key to enter setup menu screen Refer to Figure 7 SpO2 alm Lo 85 PR alm Hi 120 PR alm Lo 50 Pulse beep on Save exit menu Restore default Figure 7 Setup menu screen 5 User Manual for Fingertip Oximeter Setting steps Short time press Display Key to choose the setting item e 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 8 Suspending the alarm When measuring if SpO2 value or PR value exceeds the preset alarm limit the device will alarm automatically and the relevant value will flash on the screen At this time press Display Key to suspend the alarm beep User Manual for Fingertip Oximeter 4 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 electrosurgi
7. ith serious respiratory disease patients under anesthesia during operation and premature and neonatal infants The status of SpO gt 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 Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight lt gt Vascular dyes or external used color up product such as nail enamel or color skin care lt gt Excessive patient movement lt gt Placement of a sensor on an extremity with a blood 15 User Manual for Fingertip Oximeter pressure cuff arterial catheter or intravascular line lt gt Exposure to the chamber with High pressure oxygen lt gt 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 lt gt Hypoxemia disease functional lack of HbO lt gt Pigmentation or abnormal oxyhemoglobin level lt gt Abnormal oxyhemoglobin variation lt gt Methemoglobin disease lt gt Sulfhemoglobinemia or arterial occlusion exists near sensor lt gt Obvious venous pul
8. ollection for this device 2194 User Manual for Fingertip Oximeter Common Knowledge for SpO2 Measurement 1 Meaning of SpO SpO is the saturation percentage of oxygen in the blood so called O concentration in the blood it is defined by the percentage of oxyhemoglobin HbO2 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 HbO HbO 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 concentration 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 HbO and Hb have different absorption character in the spectrum range from red to infrared light 600nm 1000nm wavelength by using these 14 User Manual for Fingertip Oximeter characteristics SpO can be determined Clinical application of pulse oximeters SpO gt is an important physiological parameter to reflect the respiration and ventilation function so SpO gt monitoring used in treatment has become more popular For example such as monitoring patients w
9. sations Peripheral arterial pulsation becomes weak lt gt Peripheral blood supply is not enough 16
10. sharp materials DO NOT use high temperature or high pressure steam disinfection on the oximeter Refer to HI User Manual for Fingertip Oximeter Chapter 7 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 Caution U S federal law restricts this device to sale or use by or on the order of a physician IV User Manual for Fingertip Oximeter Table of Contents 1 OVERVIEW sacar cccasscencarstssccisesssscerssucscconsssscteoarascesesse 1 1I APPEARANCE coeur asian aaa cido 1 122 FEATURES sateicyesecscsecccsssorssansssescesearnesnssaseshsctageseacsdsisne 2 1 3 NAME AND MODEL ccccssssscssssessssccecsscesessesecseseseceoes 2 1 4 APPLICATIONS AND SCOPE 2 BATTERY INSTALLATION 3 OPERATION erereerenenencerenenencesenensnsasenencasasesensasass 4 4 INSTRUCTIONS FOR OPERATION cerenseses 7 5 TECHNICAL SPECIFICATIONS cerenesserenensases 8 6 ACCESSORIES cerereerenencesenenencaserenensaserenencasesenensas 10 7 REPAIR AND MAINTENANCE cceeeesenenensesenensas 10 7 1 MAINTENANCE cccecessesneeneseeseesnesessessessesmesmesmsenesaesa 10 7 2 CLEANING AND DISINFECTING INSTRUCTION 1 8 TROUBLESHOOTING ccereecereneneaserenencasesenenses 12 APPEN
11. t 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 I 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 a Keep the oximeter away from dust vibration corrosive substances explosive materials high temperature and moisture The device should be kept out of the reach of children 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 on the front panel with
12. tion against electric shock Internally powered equipment The degree of protection against electric shock Type BF applied part The degree of protection against harmful ingress of liquids Ordinary equipment without protection against ingress of water Electro Magnetic Compatibility Group I Class B 9 User Manual for Fingertip Oximeter 6 Accessories A Alanyard B Two batteries C Apouch D A User Manual E Quality Certificate Note The accessories are subject to change Detailed items and quantity see the Packing List 7 Repair and Maintenance 7 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 air dry or wipe it dry Please take out the batteries if the oximeter will not be used for a long time The best storage environment of the device is 20 C 10 User Manual for Fingertip Oximeter to 55 C ambient temperature and less than 95 relative humidity 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 life of the device or even damage it 7 2 Cleaning and Disinfecting Instruction
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