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Viatom Technology: Pulse Oximeters, ECG Monitors, and Wearable Medical Devices
User Manual for Wellue models including: PC-60FW, PC-60FW Bluetooth Pulse Oximeter Fingertip, Bluetooth Pulse Oximeter Fingertip, Pulse Oximeter Fingertip, Oximeter Fingertip, Fingertip
Wellue Bluetooth Pulse Oximeter Fingertip, Blood Oxygen Saturation Monitor with Free APP, Batteries, Carry Bag & Lanyard : Health & Household
Amazon.com: Wellue Bluetooth Pulse Oximeter Fingertip, Blood Oxygen Saturation Monitor with Free APP, Batteries, Carry Bag & Lanyard : Health & Household
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DocumentDocumentOxySmart Fingertip Oximeter User Manual Model: PC-60FW It's not a medical device. This device is for Sports and Aviation use only and not intended for medical use. 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. However, no responsibility is assumed by us for its use, or any infringements of users 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 should be inspected minimally before each use. If there is obvious damage, stop using the device. Special attention should be paid while the Oximeter is used constantly under the 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. 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 user is under MRI or CT scanning. This device is NOT MRI Compatible. Warnings Discomfort or pain may appear if using the Oximeter continuously on the same location for a long time, especially for user with poor microcirculation. It is recommended that 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. 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 it is dry and checked for correct operation. When it is carried from a cold environment to a warm 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. 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 Medical electrical equipment-Part 1: General requirements for basic 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. 1 Overview 1.1 Appearance Display Key Display Screen Figure 1 Front View Battery Cover Nameplate Lanyard Hole Figure 2 Rear View 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 (SpO2) through a user's finger. It is intended for sports or aviation use only. It should not be used to diagnose or treat any medical condition. 1.3 Configuration SpO2, PR Plethysmogram Auto on/off Pulse bar Pulse beep Measuring Mode: Continuous Record list Wireless function 2 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. Figure 3 Battery Installation 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 product warranty. 3 Operation 3.1. 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; If you connect device to App, you can also check readings in App. 3.2. END. When finger is out, the Oximeter shuts down automatically. 3.3. Readings display screen The screen displays as below Figure 5 3.4 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. Figure 6 If the time from displaying valid readings to the end of measurement is less than 5 seconds, then no 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. 3.5 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 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. "Beep"Pulse beep option. If it is set to on, every pulse beat makes a beep. Data transmission The user could effectively transmit the data to App via Bluetooth. Attention to the operation The finger should be put into the sensor correctly. Do not shake the finger and relax during measurement. 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. do not use finger nail polish/paints. Vigorous exercise and electrosurgical device interference 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 necessary. If the first reading appears with poor waveform (irregular or not smooth), then the reading is unlikely true, the more stable 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 flashes The device is being 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. 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+. 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 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 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 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. 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). 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. 5 Technical Specifications A. SpO2 Measurement Transducer: dual-wavelength LED sensor with wavelength: Red light: 663 nm, Infrared light: 890 nm. Maximal 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. Power supply requirement: 2 x LR03 (AAA) alkaline batteries Supply voltage: 3.0VDC Operating current: 40mA D. Environmental Conditions: Operating Temperature: 5°C ~40°C Operating Humidity: 30%~80% Atmospheric pressure: 70kPa~106kPa E. Low Perfusion Performance: The accuracy of SpO2 and PR measurement still meet the precision described above when the modulation amplitude is as low as 0.6%. F. 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%. G. Dimensions: 56 mm (L) × 34 mm (W) × 30 mm (H) Net Weight: approx. 60g H. Display: OLED I. 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 IP22 with protection against harmful solid foreign objects and ingress of liquid. Electro-Magnetic Compatibility: Group I, Class B 6 Packing List Fingertip Oximeter User Manual Batteries Pouch 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 pay attention to the maintenance. Please change the batteries when the low-voltage 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 Oximeter is calibrated in the factory before sale, so there is no need to calibrate it during its life cycle. Any SpO2 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 SpO2 accuracy claimed in this manual is supported by the clinical study conducted by inducing hypoxia on healthy, non-smoking, light-to-dark skinned subjects in an 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, please set "Make" to "DownLoadMake: KRK", then the user can use this particular R-curve to test the Oximeter. If the SpO2 simulator does not contain "KRK" R-curve, please ask 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 the device should be kept in a dry environment. Humidity may 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 oxide. Do not use the Oximeter if it is damaged. 8 Troubleshooting Problem: The SpO2 and Pulse Rate display instable Can not turn on the device No display No display of the wireless icon " " Solution Place the finger correctly inside and try again. Changing batteries. Let the user keep calm. Hardware failure of wireless transmission function. If the above problem still exists please contact the local service center. 9 Key of Symbols Symbol Description %SpO2 BPM/PR PI% / / SN 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 refer to User Manual Follow WEEE regulations for disposal Wireless icon 10 Frequently Asked Questions 1. Q: What'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? 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 user'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), 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 will appear on the screen when the 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 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) Excessive user movement; 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 small). Please contact the local distributor or 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. Emissions test Compliance Electromagnetic environment-guidance 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 not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Harmonic emissions IEC61000-3-2 Voltage fluctuations/flicker emissions IEC61000-3-3 Class B N/A N/A The Fingertip Oximeter suitable for use in all establishments, including domestic establishments and those directly network that supplies buildings 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. Immunity test IEC60601 test level Compliance level Electromagnetic environment -guidance Electrostatic discharge(ESD) 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% Electrical fast ±2kV for power transient/ burst Supply lines ±1 kV for N/A N/A IEC61000-4-4 input/output lines ±1kV line (s) to Surge line(s) IEC 61000-4-5 ±2kV line(s) to N/A N/A earth <5% UT (>95% dip in UT) for Voltage dips, 0.5 cycle short <40% UT interruptions (60% dip in UT) for 5 and voltage cycles variations on <70% UT N/A N/A power supply input lines (30% dip in UT) for 25 cycles IEC61000-4-11 <5% UT (>95% dip in UT) for 5s Power frequency( 50Hz/60Hz) magnetic field IEC61000-4-8 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial 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. Immunity IEC60601 Compliance Electromagnetic test test level level environment -guidance Conducted 3 Vrms RF 150 kHz to N/A IEC61000-4-6 80 MHz Radiated RF IEC61000-4-3 3 V/m 80 MHz to 2.5 GHz 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. Recommended 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 (m). b Field strengths from 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. 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 for radio (cellular / cordless) telephones and land mobile radios, 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 observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The Fingertip 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. 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 communications equipment. Rated maximum output power of transmitter W(Watts) Separation distance according to frequency of transmitter M(Meters) 150kHz to 80MHz 80MHz to 80MHz to 2,5GHz 800MHz d=1.2 P d=1.2 P 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 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. 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. 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