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essential performance;
BS/EN/ISO 9919: 2009 or the equivalent;
ISO 80601-2-61: 2017 Medical electrical equipment

- Part 2-61: Particular requirements for basic safety

and essential performance of pulse oximeter

equipment.
And it also follows the provisions of the council

directive MDD 93/42/EEC.

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Summary of Contents for FO0920A

Page 1: ...Fingertip Pulse Oximeter User Manual Model FO0920A Version V2 0 Revised Date November 1st 2021 ...

Page 2: ...hese instructions may cause inaccurate measurement or damage to the device This Manual is published in English and we have the ultimate right to explain it No part of this Manual may be photocopied reproduced or translated into another language without written consent from us We reserve the right to amend it at any time without prior notice ...

Page 3: ...ny is believed to be accurate and reliable However no responsibility is assumed by us for its use or any infringement of patents or other rights of third parties that may result from its use Instructions for Safe Operation Check the device to make sure that there is no visible damage that may affect user s safety or ...

Page 4: ...please stop using this device Special attention shall be paid when the device is used at an ambient temperature above 98 6 F 37 C as burns may occur due to over heating of the sensor Necessary maintenance must be performed only by qualified service technicians The oximeter shall not be used with devices and accessories not specified in this Manual ...

Page 5: ...such as some ignitable anesthetic 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 location for a long time especially for patient with poor ...

Page 6: ...r 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 Do not stare at the light The Oximeter is not a treatment device ...

Page 7: ...eter 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 and checked for correct operation When it is carried ...

Page 8: ...t temperature DO NOT operate the button on the front panel with sharp materials or sharp point DO NOT use high temperature or high pressure steam disinfection on the Oximeter Refer to Chapter 6 for instructions regarding cleaning and disinfection The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid ...

Page 9: ...water drops when enclosure tilted up to 15 Please pay attention to the effects of lint dust light including sunlight etc Declaration of Conformity The manufacturer hereby declares that this device complies with the following standards IEC 60601 1 2012 Medical electrical equipment Part 1 General requirements for basic safety and ...

Page 10: ...r the equivalent ISO 80601 2 61 2017 Medical electrical equipment Part 2 61 Particular requirements for basic safety and essential performance of pulse oximeter equipment And it also follows the provisions of the council directive MDD 93 42 EEC ...

Page 11: ...W 1 1 1 APPEARANCE 1 1 2 NAME AND MODEL 3 1 3 INTENDED USE 3 1 4 FEATURES AND CONFIGURATION 4 2 BATTERY INSTALLATION 9 3 OPERATION 10 4 TECHNICAL SPECIFICATIONS 19 5 PACKING LIST 25 6 REPAIR AND MAINTENANCE 26 6 1 MAINTENANCE 26 ...

Page 12: ...ND DISINFECTING INSTRUCTIONS 29 7 TROUBLESHOOTING 30 8 KEY SYMBOLS 31 9 FREQUENTLY ASKED QUESTIONS 33 APPENDIX I RESULT DESCRIPTION 38 APPENDIX II EMC 40 THE EQUIPMENT MEETS THE REQUIREMENTS OF IEC 60601 1 2 2014 40 ...

Page 13: ......

Page 14: ...1 1 Overview 1 1 Appearance Figure 1 Front View Plastic Cushions Display Key Display Screen ...

Page 15: ...2 Figure 2 Rear View Nameplate Battery Cover ...

Page 16: ... FO0920A 1 3 IntendedUse This Fingertip Pulse Oximeter is for Over the Counter OTC purchase and is intended for measuring SpO2 and pulse rate of adult and pediatric users through his her finger This oximeter is for sports or aviation use only and not for medical use ...

Page 17: ...res and Configuration Display Type OLED SpO2 PR PI Plethysmogram Auto On Off Pulse Bar Graph PR and PI Shifts Over limits Indication Over limits Indication Sound Indication Sound Mute Manual Four direction Display ...

Page 18: ...Beep Measuring Mode Continuous Spot check Record List Function Description Indication Sound Mute With the over limits indication function and pulse beep function when beep is on and over limits indication sound is activated the Display Key will ...

Page 19: ...urement starts automatically when finger is inserted into the finger clip properly and the measuring time lasts 30 seconds with a counting down indication The SpO2 and PR readings will freeze at the end of the 30 seconds and the analysis for the pulse rhythm will be displayed on the screen as well Once the finger is out the display will turn off and the ...

Page 20: ...nd SpO2 and PR readings will be displayed until the finger is removed from the device Once the finger is out the device will turn off automatically Record List A single group of stable readings will be recorded in the record list each time before the device turns off under both the spot check and continuous mode However if the ...

Page 21: ...to 12 groups of records can be stored in the record list with the newest record marked as M1 and the oldest record marked as M12 New record will override previous record When batteries are removed from the device all readings will be deleted When the device is off long press the Display Key will bring up the record recall ...

Page 22: ...l shift the records display If there is no key operation for 6 seconds the device will power off automatically again 2 Battery Installation Install Batteries As shown in Figure 3 please insert 2 AAA size batteries into the battery compartment Figure 3 Battery Installation ...

Page 23: ...y installed Incorrect installation may cause the device not to work Replace Batteries Please remove batteries if the device is not being used for more than 90 days to prevent and avoid potential damage from battery leaking Any such damage is not covered under the product warranty 3 Operation ...

Page 24: ... in the correct position and clip the finger Next enter into data display screen Short pressing of the Display Key will change display direction the four display directions are as shown in Figure 5A 5B 5C and 5D For display screens of Figure 5B and 5D the PI display value will be replaced Figure 4 Put Finger In ...

Page 25: ...12 with PR display value after 20 seconds if no key operation is made Figure 5A Figure 5B Figure 5C Figure 5D ...

Page 26: ...means it will display the same screen layout display direction as was set up during last use At the end of Spot Check Mode the measured SpO2 PR value and the analysis result of pulse rhythm will be displayed on the screen as shown in Figure 5E Figure 5E Figure 6 ...

Page 27: ...device is off long press the Display Key to bring up record list display screen as shown in Figure 6 In the record list screen short press the Display key to shift the records page Settings Menu When finger is in long press the Display Key will enter the settings menu screen as shown in Figure 7 ...

Page 28: ...s set to On then every pulse beat makes a beep Mode Measuring mode setting You may choose either Continuous or Spot Check and the default is set to be Spot Check Short press the Display Key to choose the setting Figure 7 Settings Menu ...

Page 29: ...ss Exit to store the modification and exit from the settings menu Measuring Tips 1 Please insert your finger into the finger clip correctly 2 Do not move your finger during measurement 3 Do not put wet finger directly into the clip 4 Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure ...

Page 30: ...acy of measurement 6 Vigorous exercise and electrosurgical device interference may affect the accuracy of measurement 7 Long fingernail may cause failure of measurement or inaccurate result 8 The orientation sensor works on the basis of gravity A small movable metal ball is built in the orientation sensor for detecting the orientation of ...

Page 31: ...response of orientation detection would be delayed Acceleration needs to be provided to the orientation sensor for quick sensing of the orientation change 9 Existence of highly intensive light sources such as fluorescence light ruby lamb infrared heater or strong sunshine may lead to inaccurate measurement Please put an opaque cover over the device or change the measuring site if ...

Page 32: ...t smooth then the reading is unlikely true A more stable value might be obtained by waiting for a while or a restart is needed when necessary 4 Technical Specifications A SpO2 Measurement Transducer dual wavelength LED sensor with wavelength Red light 663 nm infrared light 890 nm ...

Page 33: ...O2 Display Range 35 100 SpO2 Measuring Accuracy 2 for SpO2 range from 70 to 100 B Pulse Rate Measurement PR Display Range 30bpm 240bpm PR Measuring Accuracy 2bpm or 2 whichever is greater C Perfusion Index PI Display Range 0 20 D Preset Over limits ...

Page 34: ...O2 Low Limit 90 Pulse Rate high limit 120bpm low limit 50bpm E Over limit Settings SpO2 Low limit setting range 85 99 increment 1 Default setting 90 Pulse Rate Low limit setting range 30 60bpm increment 1bpm ...

Page 35: ... 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 exceeds limit will flash on the screen H Power Supply Requirement 2 x LR03 AAA alkaline batteries Supply Voltage 3 0V DC ...

Page 36: ...ature 41 F 104 F 5 C 40 C Operating Humidity 30 80 Atmospheric Pressure 70kPa 106kPa J Low Perfusion Performance The accuracy of SpO2 and PR measurement still meets the precision described above when the modulation amplitude is as low as 0 6 K Ambient Light Interference ...

Page 37: ...room is less than 1 Dimensions 2 6 in L 1 4 in W 1 3 in H 66 mm L 36 mm W 33 mm H Net Weight approx 2 1 oz 60 g L Classification Type of protection against electric shock Internally powered equipment Degree of protection against electric shock Type BF applied parts Degree of protection against harmful solid ...

Page 38: ... ingress of liquid IP22 with protection against harmful solid foreign objects and ingress of liquid Electro Magnetic Compatibility Group I Class B 5 Packing List 1 Fingertip Pulse Oximeter 2 User Manual 3 Batteries 4 Lanyard ...

Page 39: ...n Please clean the surface of the device with 75 alcohol wipes before use and let it air dry or wipe it dry Do not allow liquid to enter the device Please take out the batteries if the device is not used for a period over 90 days Recommended storage environment of the device Ambient temperature 4ºF 140ºF ...

Page 40: ...alibrate it during its life cycle No SpO2 simulators shall be used to validate the accuracy of the device although they can be used as functional testers to verify its precision The SpO2 accuracy claimed in this Manual is supported by clinical study conducted by inducing hypoxia on healthy non smoking light to dark skinned subjects in an independent ...

Page 41: ...ator or by third party test house Please note that the specific calibration curve so called R curve shall be selected when use a SpO2 simulator High pressure sterilization shall not be used on the device Do not immerse the device in liquid It is recommended that the device be kept in a dry environment Humidity may reduce the life of ...

Page 42: ...ft cloth damped with a solution such as 75 isopropyl alcohol If low level disinfection is required use a mild bleach solution Clean the surface with a cloth damped ONLY with clean water and dry with a clean soft cloth Do not sterilize with irradiation steam or ethylene oxide Do not use the device if it is damaged ...

Page 43: ...ace the finger correctly inside and try again 2 The device cannot be turned on Solution Change batteries 3 There is no display Solution Try to have the patient user stay calm 4 Display direction doesn t change or changes insensitively Solution Please shake the device with a certain ...

Page 44: ...s the orientation sensor might not be working properly If the above problems still exist after trying the solutions please contact our Customer Support team at support livinwells com 8 Key Symbols Symbol Description SpO2 Pulse oxygen saturation BPM PR Pulse rate beats per minute ...

Page 45: ...se Strength Bar Graph Low battery voltage CE mark SN Serial number Date of manufacture Authorized representative in the European community BF type applied part Attention refer to the Manual Follow WEEE regulations for disposal ...

Page 46: ...the blood 2 Q What s the normal range of SpO2 value for healthy people A The normal range varies by individual but is usually over 95 If your result is out of this range please consult your physician 3 Q What s the normal range of PR value for healthy people A Usually the normal range is 60bpm 100bpm ...

Page 47: ... with the change of patient s user s physiological conditions 5 Q What to do if there is no SpO2 and PR reading A Do not move finger and keep calm during the measurement Please also avoid using the oximeter and blood pressure monitors on the same limb at the same time 6 Q How to confirm that the SpO2 reading is true or accurate ...

Page 48: ...physiological condition change 7 Q When to replace the batteries A The icon of low battery will appear on the screen when the battery voltages are low which means batteries need to be replaced 8 Q What to do if the Oximeter is moistened or sprayed by water A Remove the batteries immediately and dry the oximeter completely with a hair dryer ...

Page 49: ...ve illumination such as surgical lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight c Vascular dyes or external used color up product such as nail enamel or color skin care d Excessive patient movement e Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line ...

Page 50: ...oximal to the sensor h Blood vessel contraction caused by peripheral vessel hyperkinesia or body temperature decreasing i Low perfusion condition Perfusion Index is small If you have further questions or concerns please feel free to contact our Customer Support team at support livinwells com ...

Page 51: ... 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 pulse interval 8 Suspected irregular pulse interval 9 Suspected fast pulse with short pulse interval ...

Page 52: ...39 10 Suspected slow pulse with short pulse interval 11 Suspected slow pulse with irregular pulse interval 12 Poor signal Measure again ...

Page 53: ...uidance and Manufacturer s Declaration Electromagnetic Emission This oximeter is intended for use in the electromagnetic environment specified below The user of the oximeter shall assure that it is used in such an environment Emissions test Complia nce Electromagnetic environment guidance ...

Page 54: ...likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The oximeter is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC61000 3 2 N A ...

Page 55: ...3 N A Table 2 Guidance and Manufacturer s Declaration Electromagnetic Emission The oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the oximeter shall assure that it is used in such an environment ...

Page 56: ...lectromagnetic 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 are covered with synthetic material the relative humidity should be at least 30 ...

Page 57: ...44 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 ...

Page 58: ...e dips short interruptions and 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 N A N A ...

Page 59: ...for 5 s Power frequency 50Hz 60Hz magnetic field IEC61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment ...

Page 60: ...Declaration Electromagnetic Immunity The oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the oximeter shall assure that it is used in such an electromagnetic environment Immunity test IEC6060 1 test Complia nce level Electromagnetic environment guidance ...

Page 61: ...Portable and mobile RF communications equipment should be used no closer to any part of the oximeter including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance ...

Page 62: ... 2 5 GHz 3 V m d 1 2 d 1 2 80MHz to 800MHz d 2 3 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m b P P P ...

Page 63: ...tic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations ...

Page 64: ...V broadcast cannot be predicted theoretically with accuracy To assess 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 oximeter is used exceeds the applicable RF compliance level above the oximeter should be observed to verify normal operation If abnormal performance is obse...

Page 65: ...ation the equipment The oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the oximeter as recommended below according to the ...

Page 66: ... maximum output power of transmitter W Watts Separation distance according to frequency of transmitter M Meters 150kHz to 80MHz d 1 2 80MHz to 800MHz d 1 2 80MHz to 2 5GHz d 2 3 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 P P P ...

Page 67: ...f the transmitter where P is 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 NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ...

Page 68: ...LIVIN WELLNESS LLC 2 YEAR WARRANTY Customer Support support livinwells com ...

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