manualshive.com logo in svg

OxySmart PC-60FW, User Manual

Share
Download
OxySmart PC-60FW User Manual Download Page 6

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.

Summary of Contents for PC-60FW

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Reviews:

No comments

Brands by name

Popular brands

Load more brands