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

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

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  • 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....12 6 Packing List........15 7 Repair and Maintenance....16 8 Troubleshooting........ 19 9 Key of Symbols........20 10 Frequently Asked Questions..21 Appendix EMC........25...

  • 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 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.

  • Page 19: Technical Specifications

    Tips: Please open the APP and Bluetooth, and then pair the app with the device. Only when you wear the device and open the APP at the same time, the data will be synchronized to the APP. For more details about ViHealth App, please refer to the ViHealth App user manual.
  • Page 20 PR measuring accuracy: ±2bpm or ±2% (whichever is greater) Perfusion Index(PI) Display range 0%~20% Preset over-limits low limit: 90% Pulse Rate: high limit: 120bpm low limit: 50bpm Over-limit settings low limit setting range: 85%~99%, step: 1% Default setting: 90% Pulse Rate: Low limit setting range: 30~60bpm, step: 1bpm;...
  • Page 21 alert with beep automatically and the value which exceeds limit will flash on the screen. Power supply requirement: 2 x LR03 (AAA) alkaline batteries Supply voltage: 3.0VDC Operating current: ≤40mA Environmental Conditions: Operating Temperature: 5°C ~40°C Operating Humidity: 30%~80% Atmospheric pressure: 70kPa~106kPa I.

  • Page 22: Packing List

    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 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...

  • Page 23: Repair And Maintenance

    5) Lanyard Note: the items and its quantity are subject to change, please refer to your subject in hand. 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...
  • Page 24 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 Oximeter is calibrated in the factory  before sale, so there is no need to calibrate it during its life cycle.
  • Page 25 (so called R-curve) should be selected when use of SpO simulator, e.g. for Index 2 series simulator from Fluke Biomedical Corporation, please "Make" "DownLoadMake: KRK", then the user can use this particular R-curve to test the Oximeter. If the SpO simulator does not contain "KRK"...

  • Page 26: Troubleshooting

    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 oxide. Do not use the Oximeter if it is damaged. 8 Troubleshooting Problem: 1.

  • Page 27: Key Of Symbols

    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 service center. 9 Key of Symbols Symbol Description %SpO Pulse oxygen saturation Pulse rate (beats per minute) Perfusion Index (%) Pulse Strength Bar Graph...

  • Page 28: Frequently Asked Questions

    Date of manufacture Authorised representative in the European community Manufacturer (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 SpO A: SpO means the saturation percentage of oxygen in the blood.
  • Page 29 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? 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...
  • Page 30 Oximeter and the cuff on the same limb for blood pressure and oxygen saturation measurement simultaneously. 6. Q: How to confirm that the SpO reading is true or accurate? A: Hold breath for a while (50 seconds or more), if the SpO value significantly decreases, it means that reading...
  • Page 31 the Oximeter completely with a hair dryer. 9. Q: What factors will affect the SpO accuracy? A: a) Intravascular dyes such as indocyanine green or methylene blue; b) Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight;...
  • Page 32 g) There is an arterial occlusion proximal to the sensor; Blood vessel contraction caused peripheral vessel hyperkinesias body temperature decreasing; i) Low perfusion condition (Perfusion Index is small). Please contact local distributor manufacturer if necessary. Appendix EMC The equipment meets the requirements of IEC 60601-1-2:2014.
  • Page 33 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. Electromagnetic Complianc environment-guidanc Emissions test The Fingertip Oximeter uses RF energy only for its internal function.
  • Page 34 Voltage establishments and fluctuations/flick those directly network er emissions that supplies buildings IEC61000-3-3 used for domestic purposes. 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.
  • Page 35 Floors should be wood, concrete or Electrostati ceramic tile. if ±8 kV floors are discharge(E ±8 kV contact contact covered with ±15kV air ±15kV synthetic IEC61000-4 material, the relative humidity should be at least 30% Electrical ±2kV for power fast Supply lines transient/ ±1 kV for...
  • Page 36 Voltage <5% U (>95% dip in dips, short ) for 0.5 interruptio cycle ns and <40% U voltage (60% dip in U for 5 cycles variations <70% U on power (30% dip in U supply for 25 cycles input lines <5% U (>95% dip in IEC61000-4...
  • Page 37 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 38 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 39 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 40 (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 41 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 42 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 43 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 44 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 45 Version: A Shenzhen 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 Hamburg Germany...

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