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Table 2

Guidance and manufacturer’s

declaration-electromagnetic emission

The Fingertip Oximeter is intended for use in the

electromagnetic environment specified below. the

customer or the user of the Fingertip Oximeter

should assure that it is used in such an environment.

Immunity

test

IEC60601 test

level

Complia

nce

level

Electromagne

tic

environment

-guidance

Electrostati

discharge(E

SD)

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%

Содержание OxySmart PC-60FW

Страница 1: ...I OxySmart Fingertip Oximeter User Manual Model PC 60FW ...

Страница 2: ... to be accurate and 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 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 sho...

Страница 3: ...s device The Oximeter must not be used with devices and accessories 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 patient is under MRI or CT scanning This device is NOT MRI Compatible Warnings Discomfort or pain may appear if using the Oximeter continuousl...

Страница 4: ...s Do not stare at the light The Oximeter is not a treatment device Local laws and Regulations must be followed when disposing of the device Attentions 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 ...

Страница 5: ...infection on the Oximeter Refer to the instructions regarding cleaning and disinfection The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid 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 Medic...

Страница 6: ...ipment 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 Caution U S federal law restricts this device to sale or use by or on the order of a physician ...

Страница 7: ...verview 1 2 Battery Installation 3 3 Operation 4 4 Wireless 9 5 Technical Specifications 14 6 Packing List 17 7 Repair and Maintenance 18 8 Troubleshooting 21 9 Key of Symbols 22 10 Frequently Asked Questions 23 Appendix EMC 27 ...

Страница 8: ...1 1 Overview 1 1 Appearance Figure 1 Front View Display Key Nameplate Lanyard Hole Battery Cover Display Screen Figure 2 Rear View ...

Страница 9: ...the pulse rate and functional oxygen saturation SpO2 through a patient s finger It is applicable for checking SpO2 and pulse rate of adult and pediatric patients in homes and medical clinics 1 3 Configuration SpO2 PR PI Plethysmogram Auto on off PR and PI shifts Pulse bar Over limits setting Pulse beep Measuring Mode Continuous Record list Wireless function ...

Страница 10: ...nd note the polarity markings 2 Replace the cover Please make sure that the batteries are correctly installed Incorrect installation may cause the device not to work Please remove batteries if the 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 ...

Страница 11: ... finger is in the correct position and then clip the finger as shown in figure 4 Figure 4 Put finger into the Oximeter Wait 2 seconds the Oximeter will power on automatically and start to measure If you connect device to App you can also check readings in App 2 END When finger is out the Oximeter shuts down automatically ...

Страница 12: ...l functions are available At power off status pressing Display key can bring up record list display screen as shown in figure 7 In record list screen press Display key to shift the records page Figure 6 If the time from displaying valid readings to the end of measurement is less than 5 seconds then no ...

Страница 13: ...ord will override the previous record If the batteries are removed from the device then the records will be not kept or volatile 5 Menu When finger is in oximeter long time pressing display key can enter the setup menu screen Figure 7 Menu setup Short time press Display Key to choose the setting item Longtime press Display Key to active the setting item then short time ...

Страница 14: ...se beep option If it is set to on every pulse beat makes a beep when beep is on and over limits indication sound is activated then Display key will work as the Mute key and short time pressing it can mute the over limits indication sound and pulse beep for 90 seconds Data transmission The user could effectively transmit the data to App via Bluetooth Attention to the operation The finger should be ...

Страница 15: ...nce may affect the measuring accuracy Nail polish may affect the measuring accuracy and too long fingernail may cause failure of measurement or inaccurate result Existence of high intensive light sources such as fluorescence light ruby lamb infrared heater or strong sunshine etc may cause inaccuracy of measurement result Please put an opaque cover on the sensor or change the measuring site if nece...

Страница 16: ...g to establish a wireless connection with the surrounding host Successful wireless connection between the device and a host is established No display icon 1 Wireless function is disabled 2 The device fails to setup a wireless connection with the surrounding host within 3 minutes 3 Hardware failure of wireless transmission function while the Wireless function is enabled ...

Страница 17: ...ing smart phones and tablets 4 3 Compatibility The ViHealth app is compatible with iOS versions 9 0 and Android versions 5 0 The compatible smart device models are listed below Brand Model Apple iPhone5 S iPhone SE iPhone6 S Plus iPhone7 Plus iPhone8 Plus iPhone X iPhone XS iPhone XS Max iPhone XR iPhone11 iPhone11 Pro iPhone11 Pro Max iPad 5 6 7 iPad Mini 1 2 3 4 5 iPad ...

Страница 18: ...ing to the device 1 Keep the device on measuring 2 Run ViHealth App on your smart device 3 Click the device icon when ViHealth finds your Pulse Oximeter see figure 8 4 Follow the screen guide to start pairing 5 Once paired you can log on to ViHealth Caution Do NOT pair the device in your smart device settings For more details about ViHealth App please refer to the ViHealth App user manual ...

Страница 19: ...12 Figure 8 Figure 9 4 5 Real time Monitoring The ViHealth app supports monitoring SpO2 and HR in real time on the Dashboard screen see figure 9 ...

Страница 20: ...able disable syncing measurement data to Apple Health App tap Setting Apple Health On Off The measurement data will be transferred to Apple Health App when ViHealth App is running Figure 10 Note Refer the ViHealth user manual for more details ...

Страница 21: ...al average optical output power 2mW SpO2 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 SpO2 low limit 90 Pulse Rate high limit 120bpm low limit 50bpm ...

Страница 22: ...bpm Default setting 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 exceeds limit will flash on the screen G Power supply requirement 2 x LR03 AAA alkaline batteries Supply voltage 3 0VDC Operating current 40mA H Environmental Conditions ...

Страница 23: ...the modulation amplitude is as low as 0 6 J Ambient Light Interference The difference between the SpO2 value measured in the condition of indoor natural light and that of darkroom is less than 1 K Dimensions 56 mm L 34 mm W 30 mm H Net Weight approx 60g L Display OLED M Classification The type of protection against electric shock Internally powered equipment The degree of protection against electr...

Страница 24: ...e equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid Electro Magnetic Compatibility Group I Class B 6 Packing List 1 Fingertip Oximeter 2 User Manual 3 Batteries 4 Pouch 5 Lanyard Note the items and its quantity are subject to change please refer to your subject in hand ...

Страница 25: ...tage 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 allow liquid to enter the device Please take out the batteries if the Oximeter will not be used any more than 7 days The recommended storage environment of the device ambient temperature 20ºC 60ºC relative humidity 10 95 atmospheric pressure 50kPa 107 4kPa The...

Страница 26: ...n independent research laboratory If it is necessary to verify the precision of the Oximeter routinely the user can do the verification by means of SpO2 simulator or it can be done by the local third party test house Please note that the specific calibration curve so called R curve should be selected when use of SpO2 simulator e g for Index 2 series SpO2 simulator from Fluke Biomedical Corporation...

Страница 27: ...reduce the life of the device or even 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 solution Then surface clean with a cloth damped ONLY with clean water and dry with a clean soft cloth Caution Do not sterilize by irradiation steam or ethylene oxi...

Страница 28: ...Solution 1 Place the finger correctly inside and try again 2 Changing batteries 3 Let the patient keep calm 4 Please shake the Oximeter with a certain force to make the movable metal ball move freely If the 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 servi...

Страница 29: ...PR Pulse rate beats per minute 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 BF type applied part Attention refer to User Manual ...

Страница 30: ...at s SpO2 A SpO2 means the saturation percentage of oxygen in the blood 2 Q What s the normal range of SpO2 value for healthy people A The normal range varies by individual but usually over 95 otherwise please consult your physician 3 Q What s the normal range of PR value for healthy people ...

Страница 31: ... patient s physiological conditions 5 Q What to do if there is no SpO2 and PR reading A Do not shake the finger and keep calm during the measurement Please also avoid the Oximeter and the cuff on the same limb for blood pressure and oxygen saturation measurement simultaneously 6 Q How to confirm that the SpO2 reading is true or accurate A Hold breath for a while 50 seconds or more ...

Страница 32: ... battery voltages are low By then 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 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 lamps bilirubin lam...

Страница 33: ...nt e Placement of a sensor on an extremity with a blood pressure cuff arterial catheter 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 or body temperature decreasing i Low perfusion condition Perfusion Index is ...

Страница 34: ...2 2014 Table 1 Guidance and manufacturer s declaration electromagnetic emission The Fingertip Oximeter is intended for use in the electromagnetic environment specified below The customer or the user of the Fingertip Oximeter should assure that it is used in such an environment Emissions test Complianc e Electromagnetic environment guidanc e ...

Страница 35: ...kely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Fingertip Oximeter suitable for use in all establishments including domestic establishments and those directly network that supplies buildings used for domestic purposes Harmonic emissions IEC61000 3 2 N A Voltage fluctuations flick er emissions IEC61000 3 3 N A ...

Страница 36: ...r of the Fingertip Oximeter should assure that it is used in such an environment Immunity test IEC60601 test level Complia nce level Electromagne tic environment guidance Electrostati c discharge E SD 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 ...

Страница 37: ... A N A Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth N A N A Voltage dips short interruptio ns 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 UT for 5 s N A N A ...

Страница 38: ...or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Table 3 Guidance and manufacturer s declaration electromagnetic immunity The Fingertip Oximeter is intended for use in 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 ...

Страница 39: ...4 6 Radiated RF IEC61000 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz N A 3 V m Portable and mobile RF communications equipment should 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 of the transmitter ...

Страница 40: ...ion 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 to the transmitter manufacturer and d is the recommended separation distance in metres ...

Страница 41: ...om fixed RF transmitters as determined by an electromagnetic 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 following symbol ...

Страница 42: ...amateur radio AM and FM radio broadcast and TV 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 Fingertip Oximeter is used exceeds the applicable RF compliance level above The Fingertip Oximeter should be ob...

Страница 43: ... is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of The Fingertip Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Fingertip Oximeter as recommended below according to the maximum output power of the com...

Страница 44: ...ansmitter W Watts Separation distance according to frequency of transmitter M Meters 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 ...

Страница 45: ...of 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 ...

Страница 46: ...gy Co Ltd Website www getwellue com Email service getwellue com Manufacturer Shenzhen Creative Industry Co Ltd Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany shholding hotmail com 49 40 25 2513175 ...

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