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Fingertip Oximeter

User Manual

Shenzhen Creative Industry Co., Ltd.

Содержание PC-60A

Страница 1: ...Fingertip Oximeter User Manual Shenzhen Creative Industry Co Ltd...

Страница 2: ...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 photo...

Страница 3: ...user can enter into our website www creative sz com to download the corresponding latest version data manager software Please contact the manufacturer or your local distributor if anything about softw...

Страница 4: ...d reliable However no responsibility is assumed by us for its use or any infringements of patients or other rights of third parties that may result from its use Instructions for Safe Operation Check t...

Страница 5: ...while the Oximeter is used constantly at ambient temperature above 37 C burns may occur because of over heating of the sensor at this situation Necessary maintenance must be performed only by qualifi...

Страница 6: ...agents DO NOT use the Oximeter while the patient is under MRI or CT scanning This device is NOT MRI Compatible Warnings Discomfort or pain may appear if using the Oximeter continuously on the same loc...

Страница 7: ...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 Do not stare at the light The Oximeter i...

Страница 8: ...he Oximeter gets wet please stop using it and do not resume operation until it is dry and checked for correct operation When it is carried from a cold environment to a warm and humid environment pleas...

Страница 9: ...n The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid So that means the equipment is protected against solid foreign objects of 12 5mm and greater and pro...

Страница 10: ...al equipment Part 1 General requirements for basic safety and essential performance BS EN ISO 9919 2009 or the equivalent ISO 80601 2 61 2011 Medical electrical equipment Part 2 61 Particular requirem...

Страница 11: ...Rules are specifically for PC 60FW This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this d...

Страница 12: ...XI Table of Contents 1 OVERVIEW 1 1 1 APPEARANCE 1 1 2 NAME AND MODEL 3 1 3 INTENDED USE 3 1 4 FEATURE LIST 3 2 BATTERY INSTALLATION 9 3 OPERATION 10 4 DOWNLOAD THE APP SOFTWARE 22...

Страница 13: ...PACKING LIST 29 7 REPAIR AND MAINTENANCE 29 7 1 MAINTENANCE 30 7 2 CLEANING AND DISINFECTING INSTRUCTION 33 8 TROUBLESHOOTING 34 9 KEY OF SYMBOLS 35 10 FREQUENTLY ASKED QUESTIONS 37 APPENDIX I RESULT...

Страница 14: ...1 1 Overview 1 1 Appearance Figure 1 Front View Display Key Display Screen...

Страница 15: ...2 Figure 2 Rear View Note the appearance is for demonstration only please refer to the oximeter you purchased Nameplate Battery Cover...

Страница 16: ...his Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation SpO2 through a patient s finger It is applicable for spot checking SpO2 and pulse rate of adult and ped...

Страница 17: ...ithout this function Display type D O D means dot matrix dual color OLED Model Function PC 60F PC 60FW PC 60A Display type OLED OLED LCD SpO2 PR PI Plethysmogram Auto on off Pulse bar graph PR and PI...

Страница 18: ...n sound Indication sound mute Manual Manual Manual Four directions display Two Setting menu Over limits setting Pulse beep Wireless function Measuring mode Continuous Spot check Continuous Spot check...

Страница 19: ...the Mute key and short time pressing it can mute the over limits indication sound and pulse beep for 90 seconds Measuring mode Spot check mode the measurement starts automatically when the finger is i...

Страница 20: ...rt automatically when finger is inserted into the oximeter SpO2 and PR readings will be displayed until the finger is removed from the oximeter Once finger is removed the Oximeter will automatically t...

Страница 21: ...ecord list the newest record is marked as M1 and the oldest record is marked as M12 The new record will override the previous record When batteries are removed from the device all readings will be del...

Страница 22: ...the Oximeter will power off automatically again 2 Battery Installation 1 Refer to Figure 3 insert two AAA size batteries into the battery compartment properly and note the polarity markings 2 Replace...

Страница 23: ...e device is not being used for more than 7 days to prevent and avoid potential damage from the battery leaking Any such damage is not covered under the product warranty 3 Operation 1 Open the clip and...

Страница 24: ...display screen A short time press of the Display Key can change display direction the four display directions are as shown in figure 5A 5B 5C 5D For display screens of figure 5B and 5D the PI display...

Страница 25: ...12 Figure 5A Figure 5B Figure 5C Figure 5D For PC 60A the display screen is as shown in below figure...

Страница 26: ...r PC 60F and PC 60FW the display direction is remembered at each startup it will display the screen layout display direction from the last time it was used The only difference between PC 60F and PC 60...

Страница 27: ...eless function and thus no wireless icon on the screen Icon on display screen means the counting down time if the Oximeter works at Spot check mode The total measuring time for Spot check mode is 30 s...

Страница 28: ...Other result descriptions see Appendix I Recording recall functions are available for PC 60F and PC 60FW At power off status long time pressing Display key can bring up record list display screen as s...

Страница 29: ...reen PC 60F and PC 60FW Wireless the wireless on off button Transmitting data to PC when it is on on and off can be optional The factory default is on Beep Pulse beep option If it is set to on every p...

Страница 30: ...oose 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 exi...

Страница 31: ...be displayed on the screen 4 Wireless icon The icon of Definition flashes blue The device is being to establish a wireless connection with the surrounding host long lights blue Successful wireless co...

Страница 32: ...ger for detailed information Attention to the operation The finger should be put into the sensor correctly No display icon 1 Wireless function is disabled 2 The device fails to setup a wireless connec...

Страница 33: ...re measurement or during venous infusion Do not let anything block the emitting light from device i e do not use finger nail polish paints Vigorous exercise and electrosurgical device interference may...

Страница 34: ...of orientation detection would be delayed Acceleration needs to be provided to the orientation sensor for quick sensing the orientation change Nail polish may affect the measuring accuracy and too lo...

Страница 35: ...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 4 Download the APP software...

Страница 36: ...iPad please follow this procedure to download 1 On Apple App Store enter Shenzhen Creative into the search box Note if you use an iPad to search please select iPhone only as well for searching 2 Once...

Страница 37: ...dual wavelength LED sensor with wavelength Red light 663 nm Infrared light 890 nm Maximal average optical output power 2mW SpO2 display range 35 100 SpO2 measuring accuracy 2 for SpO2 range from 70 to...

Страница 38: ...s greater C Perfusion Index PI Display range 0 20 D Preset over limits for PC 60A SpO2 low limit 90 Pulse Rate high limit 120bpm low limit 50bpm E Over limit settings for PC 60F PC 60FW SpO2 Low limit...

Страница 39: ...ng high 120bpm low 50bpm F Audible visual alert function When measuring if SpO2 value or pulse rate value exceeds the preset limit the device will alert with beep automatically and the value which exc...

Страница 40: ...ting Humidity 30 80 Atmospheric pressure 70kPa 106kPa J Low Perfusion Performance The accuracy of SpO2 and PR measurement still meet the precision described above when the modulation amplitude is as l...

Страница 41: ...approx 60g including batteries M Classification The type of protection against electric shock Internally powered equipment The degree of protection against electric shock Type BF applied parts The de...

Страница 42: ...ctro Magnetic Compatibility Group I Class B 6 Packing List 1 Fingertip Oximeter 2 User Manual 3 Batteries 4 Pouch optional 5 Lanyard optional Note the items and its quantity are subject to change plea...

Страница 43: ...maintenance Please change the batteries when the low voltage indicator lightens Please clean the surface of the device before using with 75 alcohol wipes then let it air dry or wipe it dry Do not allo...

Страница 44: ...librate it during its life cycle Any SpO2 simulators should not be used to validate the accuracy of the Oximeter they can only be used as functional testers to verify its precision The SpO2 accuracy c...

Страница 45: ...so called R curve should be selected when use of SpO2 simulator e g for Index 2 series SpO2 simulator from Fluke Biomedical Corporation please set Make to DownLoadMake KRK then the user can use this p...

Страница 46: ...damage it 7 2 Cleaning and Disinfecting Instruction Surface clean sensor with a soft cloth damped with a solution such as 75 isopropyl alcohol if low level disinfection is required use a mild bleach...

Страница 47: ...O2 and Pulse Rate display instable 2 Cannot turn on the device 3 No display 4 Display direction doesn t change or changes insensitively 5 No display of the wireless icon Solution 1 Place the finger co...

Страница 48: ...problem still exists maybe the orientation sensor is not working properly 5 Hardware failure of wireless transmission function 6 If the above problem still exists please contact the local service cent...

Страница 49: ...36 PI Perfusion Index Pulse Strength Bar Graph Low battery voltage CE mark SN Serial number Date of manufacture Authorised representative in the European community Manufacturer including address...

Страница 50: ...refer to User Manual Wireless icon Follow WEEE regulations for disposal 10 Frequently Asked Questions 1 Q What s SpO2 A SpO2 means the saturation percentage of oxygen in the blood 2 Q What s the norma...

Страница 51: ...t s the normal range of PR value for healthy people A Usually the normal range is 60bpm 100bpm 4 Q Why do the display value of SpO2 and PR vary with time A The measured SpO2 and PR value changes in co...

Страница 52: ...ultaneously 6 Q How to confirm that the SpO2 reading is true or accurate A Hold breath for a while 50 seconds or more if the SpO2 value significantly decreases it means that the SpO2 reading truly ref...

Страница 53: ...r completely with a hair dryer 9 Q What factors will affect the SpO2 accuracy A a Intravascular dyes such as indocyanine green or methylene blue b Exposure to excessive illumination such as surgical l...

Страница 54: ...r or intravascular line f Exposure to the chamber with High pressure oxygen g There is an arterial occlusion proximal to the sensor h Blood vessel contraction caused by peripheral vessel hyperkinesias...

Страница 55: ...No irregularity found 2 Suspected a little fast pulse 3 Suspected fast pulse 4 Suspected short run of fast pulse 5 Suspected a little slow pulse 6 Suspected slow pulse 7 Suspected occasional short pu...

Страница 56: ...ulse interval 12 Poor signal Measure again Appendix II EMC The equipment meets the requirements of IEC 60601 1 2 2014 Table 1 Guidance and manufacturer s declaration electromagnetic emission The Finge...

Страница 57: ...ce RF emissions CISPR 11 Group 1 The Fingertip Oximeter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby ele...

Страница 58: ...missions IEC61000 3 2 N A Voltage fluctuations fli cker emissions IEC61000 3 3 N A Table 2 Guidance and manufacturer s declaration electromagnetic emission The Fingertip Oximeter is intended for use i...

Страница 59: ...Compli ance level Electromagneti c environment guidance Electrostatic discharge ESD IEC61000 4 2 8 kV contact 15kV air 8 kV contact 15kV air Floors should be wood concrete or ceramic tile if floors a...

Страница 60: ...47 be at least 30 Electrical fast transient burst IEC61000 4 4 2kV for power Supply lines 1 kV for input output lines N A N A Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth N A N A...

Страница 61: ...nd voltage variations on power supply input lines IEC61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s N A N A Power...

Страница 62: ...field IEC61000 4 8 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of th...

Страница 63: ...n the electromagnetic environment specified below The customer or the user of The Fingertip Oximeter should assure that it is used in such an electromagnetic environment Immunity test IEC60601 test le...

Страница 64: ...Vrms 150 kHz to 80 MHz N A be used no closer to any part of The Fingertip Oximeter including cables than the recommended separation distance calculated from the equation applicable to the frequency o...

Страница 65: ...61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m separation distance d 1 2 P d 1 2 P 80MHz to 800MHz d 2 3 P 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according...

Страница 66: ...ufacturer and d is the recommended separation distance in metres m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance lev...

Страница 67: ...equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affec...

Страница 68: ...s the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured field strength in the location in which The Fingertip Oximeter is us...

Страница 69: ...4 Recommended separation distances between portable and mobile RF communication the equipment The Fingertip Oximeter is intended for use in an electromagnetic environment in which radiated RF disturba...

Страница 70: ...ortable and mobile RF communications equipment transmitters and the Fingertip Oximeter as recommended below according to the maximum output power of the communications equipment Rated maximum Separati...

Страница 71: ...nsmitter W Watts 150kHz to 80MHz d 1 2 P 80MHz to 800MHz d 1 2 P 80MHz to 2 5GHz d 2 3 P 0 01 N A 0 12 0 23 0 1 N A 0 38 0 73 1 N A 1 2 2 3 10 N A 3 8 7 3 100 N A 12 23 For transmitters rated at a max...

Страница 72: ...s the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NO...

Страница 73: ...60...

Страница 74: ...Industrial Park Songbai Road Xili Street Nanshan District 518110 Shenzhen P R China Tel 86 755 2643 3514 Fax 86 755 2643 0930 E mail info creative sz com Website www creative sz com Shanghai Internat...

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