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OxySmart PC-60FW, Руководство пользователя

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VI

safety and essential performance;

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.

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

Содержание 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...

Страница 3: ...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 ignit...

Страница 4: ...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 corrosi...

Страница 5: ...nfection on the Oximeter Refer to the instructions regarding cleaning and disinfection The equipment is IP32 with protection against harmful solid foreign objects and ingress of liquid Please pay atte...

Страница 6: ...pment 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 fed...

Страница 7: ...erview 1 2 Battery Installation 3 3 Operation 4 4 Wireless 9 5 Technical Specifications 12 6 Packing List 15 7 Repair and Maintenance 16 8 Troubleshooting 19 9 Key of Symbols 20 10 Frequently Asked Qu...

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: ...he 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 Config...

Страница 10: ...d 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 devi...

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 yo...

Страница 12: ...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...

Страница 13: ...rd 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 ent...

Страница 14: ...e 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 m...

Страница 15: ...ce 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 sourc...

Страница 16: ...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 f...

Страница 17: ...mart 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...

Страница 18: ...Pro Mate 30 Pro OnePlus OnePlus 5 6 7 LG G7 Google Pixel 1 2 3 4 4 4 Connecting to the device 1 Keep the device on measuring 2 Run ViHealth App on your smart device 3 Click the device icon when ViHea...

Страница 19: ...re details about ViHealth App please refer to the ViHealth App user manual 5 Technical Specifications A SpO2 Measurement Transducer dual wavelength LED sensor with wavelength Red light 663 nm Infrared...

Страница 20: ...pm low limit 50bpm E Over limit settings SpO2 low limit setting range 85 99 step 1 Default setting 90 Pulse Rate Low limit setting range 30 60bpm step 1bpm High limit setting range 100 240bpm step 5bp...

Страница 21: ...tions Operating Temperature 5 C 40 C Operating Humidity 30 80 Atmospheric pressure 70kPa 106kPa I Low Perfusion Performance The accuracy of SpO2 and PR measurement still meet the precision described a...

Страница 22: ...ree of protection against electric shock Type BF applied parts The degree of protection against harmful solid foreign objects and ingress of liquid The equipment is IP32 with protection against harmfu...

Страница 23: ...arranty 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...

Страница 24: ...validate the accuracy of the Oximeter they can only be used as functional testers to verify its precision The SpO2 accuracy claimed in this manual is supported by the clinical study conducted by induc...

Страница 25: ...the manufacturer for helping to download the given R curve into the SpO2 simulator High pressure sterilization cannot be used on the device Do not immerse the device in liquid It is recommended that t...

Страница 26: ...ubleshooting Problem 1 The SpO2 and Pulse Rate display instable 2 Can not turn on the device 3 No display 4 Display direction doesn t change or changes insensitively 5 No display of the wireless icon...

Страница 27: ...f wireless transmission function 6 If the above problem still exists please contact the local service center 9 Key of Symbols Symbol Description SpO2 Pulse oxygen saturation BPM PR Pulse rate beats pe...

Страница 28: ...cturer including address BF type applied part Attention refer to User Manual Follow WEEE regulations for disposal Wireless icon 10 Frequently Asked Questions 1 Q What s SpO2 A SpO2 means the saturatio...

Страница 29: ...ealthy 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 correspondence with the change of patien...

Страница 30: ...conds or more if the SpO2 value significantly decreases it means that the SpO2 reading truly reflects the physiological condition change 7 Q When to replace the batteries A The icon of low battery wil...

Страница 31: ...umination 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...

Страница 32: ...sel hyperkinesias or body temperature decreasing i Low perfusion condition Perfusion Index is small Please contact the local distributor or manufacturer if necessary Appendix EMC The equipment meets t...

Страница 33: ...t Complianc e Electromagnetic environment guidanc e 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 n...

Страница 34: ...e 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 Finge...

Страница 35: ...d be wood concrete or ceramic tile if floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC61000 4 4 2kV for power Supply lines 1 k...

Страница 36: ...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...

Страница 37: ...r 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 intend...

Страница 38: ...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...

Страница 39: ...on 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 rec...

Страница 40: ...m 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...

Страница 41: ...mateur 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...

Страница 42: ...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...

Страница 43: ...nsmitter 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...

Страница 44: ...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...

Страница 45: ...hen Viatom Technology Co Ltd Website www viatomtech com Email info viatomtech com Manufacturer Shenzhen Creative Industry Co Ltd Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 H...

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