Viatom OxySmart PC-60FW User Manual
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Viatom OxySmart PC-60FW User Manual

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OxySmart
Fingertip Oximeter
User Manual
Model: PC-60FW
I

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Summary of Contents for Viatom OxySmart PC-60FW

  • Page 1 OxySmart Fingertip Oximeter User Manual Model: PC-60FW...
  • Page 2 Notes  Please read the manual very carefully before using this device. Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter.  The contents contained in this manual are subject to change without notice.  Information furnished by our company is believed to be accurate and reliable.
  • Page 3  Special attention should be paid while the Oximeter used constantly under ambient temperature over 37°C, burning hurt may occur because of over-heating of the sensor at this situation.  Necessary maintenance must be performed only by qualified service technicians. Users are not permitted to service this device.
  • Page 4 the Oximeter should not be applied to the same location for 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.
  • Page 5 and humid environment, please do not use it immediately. Allow at least 15 minutes for Oximeter to reach ambient 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.
  • Page 6 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.

  • Page 7: Table Of Contents

    Table of Contents 1 Overview..........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...

  • Page 8: Overview

    1 Overview 1.1 Appearance Display Key Display Screen Figure 1 Front View Battery Cover Nameplate Lanyard Hole Figure 2 Rear View...
  • Page 9 Note: the appearance is for demonstration only, please refer to the oximeter you purchased. 1.2 Intended Use This Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO ) through a patient ’s finger. It is applicable for checking SpO and pulse rate of adult and pediatric patients in homes and medical clinics.

  • Page 10: Battery Installation

    2 Battery Installation Figure 3 Battery Installation 1. Refer to Figure 3, insert two AAA size batteries into the battery compartment properly, and 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.

  • Page 11: Operation

    product warranty. 3 Operation 1. Start. Open the clip and put finger inside the rubber cushions of the clip (make sure the 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;...
  • Page 12 3. Readings display screen The screen displays as below ： Figure 5 4. Recording & recall Recording & recall 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.
  • Page 13 recording will be done. Up to 12 groups of records can be stored in the record list, the newest record is marked as M1, and the oldest record is marked as M12. The new record will override the previous record. If the batteries are removed from the device, then the records will be not kept or volatile.
  • Page 14 press it to modify the setting parameter; Next, longtime press Display Key to confirm the modification and exit from this setting item. At last, move the setting item to “Save, exit menu”, and long time pressing Display Key to store the modification and exit from the setup menu.
  • Page 15  Do not put wet finger directly into sensor.  Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion.  Do not let anything block the emitting light from device, i.e.

  • Page 16: Wireless

    value is expected by waiting for a while, or a restart is needed when necessary. 4 Wireless The wireless icon Definition The icon of Definition The device is being to establish a flashes wireless connection with surrounding host. Successful wireless connection between the device and a host is established.
  • Page 17 4.1 Download the App App name: ViHealth Mobile iOS: App Store Android: Google Play 4.2 Install the App Install the app on an Apple product or Android-powered device, including smart phones and tablets. 4.3 Compatibility The ViHealth app is compatible with iOS versions 9.0+ and Android versions 5.0+.
  • Page 18 Air 1/2/3, iPad Pro 1/2/3/4 Samsung Galaxy S5/6/7/8/9/10, Note 3/5,J7 Huawei P9/10/20/30/40, Mate 10/Pro, Mate 20/Pro, Mate 30/Pro OnePlus OnePlus 5/6/7 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.
  • Page 19 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).
  • Page 20 4.6 Syncing Data to Apple Health To enable/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.

  • Page 21: Technical Specifications

    5 Technical Specifications Measurement Transducer: dual-wavelength LED sensor with wavelength: Red light: 663 nm, Infrared light: 890 nm. Maximal average optical output power: ≤2mW display range: 35%~100% measuring accuracy: ≤ 2% for SpO range from 70% to 100% Pulse Rate measurement PR display range: 30bpm~240bpm PR measuring accuracy: ±2bpm or ±2% (whichever is greater)
  • Page 22 Over-limit settings 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: 5bpm; Default setting: high: 120bpm; low: 50bpm Audible & visual alert function When measuring, if SpO value or pulse rate value exceeds the preset limit, the device will alert with beep automatically and the value...
  • Page 23 Operating Temperature: 5°C ~40°C Operating Humidity: 30%~80% Atmospheric pressure: 70kPa~106kPa I. Low Perfusion Performance: The accuracy of SpO and PR measurement still meet the precision described above when the modulation amplitude is as low as 0.6%. J. Ambient Light Interference: The difference between value...

  • Page 24: Packing List

    Type BF applied parts. The degree of protection against harmful solid foreign objects and ingress of liquid: The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid. Electro-Magnetic Compatibility: Group I, Class 6 Packing List 1) Fingertip Oximeter 2) User Manual 3) Batteries...

  • Page 25: Repair And Maintenance

    7 Repair and Maintenance 7.1 Maintenance The expected service life (not a warranty) of this device is 5 years. In order to ensure its long service life, please attention maintenance. Please change batteries when  low-voltage indicator lightens. Please clean the surface of the device before ...
  • Page 26 before sale, so there is no need to calibrate it during its life cycle. Any SpO 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 SpO accuracy claimed in this manual is supported by the clinical study conducted by inducing hypoxia on healthy, non-smoking, light-to-dark...
  • Page 27 helping to download the given R-curve into the simulator. High-pressure sterilization cannot be used on the device. Do not immerse the device in liquid. It is recommended that the device should be kept in a dry environment. Humidity may reduce the life of the device, or even damage 7.2 Cleaning and Disinfecting Instruction Surface-clean sensor with a soft cloth damped ...

  • Page 28: Troubleshooting

    8 Troubleshooting Problem: 1. The SpO and Pulse Rate display instable 2. Can not turn on the device 3. No display direction doesn’t change or changes Display insensitively. 5. No display of the wireless icon “ ” Solution 1. Place the finger correctly inside and try again. 2.

  • Page 29: Key Of Symbols

    9 Key of Symbols Symbol Description %SpO Pulse oxygen saturation Pulse rate (beats per minute) Perfusion Index (%) Pulse Strength Bar Graph Low battery voltage CE mark Serial number Date of manufacture Authorised representative in the European community Manufacturer (including address) BF type applied part Attention ─...

  • Page 30: Frequently Asked Questions

    Follow WEEE regulations for disposal Wireless icon 10 Frequently Asked Questions 1. Q: What's SpO A: SpO means the saturation percentage of oxygen in the blood. 2. Q: What's the normal range of SpO value for healthy people? A: The normal range varies by individual, but usually over 95%, otherwise, please consult your physician.
  • Page 31 A: Usually, the normal range is 60bpm~100bpm. 4. Q: Why do the display value of SpO and PR vary with time? A: The measured SpO and PR value changes in correspondence with the change of patient's physiological conditions. 5. Q: What to do if there is no SpO and PR reading? A: Do not shake the finger, and keep calm...
  • Page 32 if the SpO value significantly decreases, it means that reading truly reflects 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. By then, batteries need to be replaced.
  • Page 33 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, intravascular line;...
  • Page 34 small). Please contact local distributor manufacturer if necessary. Appendix EMC The equipment meets the requirements of IEC 60601-1-2:2014. 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.
  • Page 35 The Fingertip Oximeter uses RF energy only for its internal function. RF emissions Therefore, its RF Group 1 CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions The Fingertip Class B CISPR 11 Oximeter suitable for...
  • Page 36 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. Electromagne Complia Immunity IEC60601 test...
  • Page 37 Electrical ±2kV for power fast Supply lines transient/ ±1 kV for burst input/output IEC61000-4 lines ±1kV line (s) to Surge line(s) ±2kV line(s) to 61000-4-5 earth Voltage <5% U (>95% dip in dips, short ) for 0.5 interruptio cycle ns and <40% U voltage (60% dip in U...
  • Page 38 Power frequency magnetic Power fields should frequency( be at levels 50Hz/60Hz) characteristic magnetic 3A/m 3A/m of a typical field location in a IEC61000-4 typical commercial or hospital environment. NOTE : U is the a.c. mains voltage prior to application of the test level. Table 3 Guidance and manufacturer’s declaration –...
  • Page 39 Electromagnetic Immunity IEC60601 Complianc environment test test level e level -guidance Portable and mobile RF communications equipment should be used no closer to any part of The Fingertip Conducte 3 Vrms Oximeter, d RF 150 kHz including cables, IEC61000- to 80 than the recommended separation...
  • Page 40 Recommended to 2.5 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 to the transmitter manufacturer and d is the recommended separation distance in metres...
  • Page 41 (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in each frequency range . Interference may occur in the vicinity of equipment marked with the following symbol.
  • Page 42 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 affected by absorption and reflection from structures, objects and people. a: Field strengths from fixed transmitters, such as base stations radio...
  • Page 43 Oximeter. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. Table 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 disturbances are controlled.
  • Page 44 Separation distance according to Rated frequency of transmitter M(Meters) maximum 150kHz to 80MHz to 80MHz to output 80MHz 800MHz 2,5GHz power of transmitter d=1.2 d=1.2 d=2.3 W(Watts) 0,01 0.12 0.23 0.38 0.73...
  • Page 45 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 46 Version: A Shenzhen Viatom Technology 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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