Related Manuals for OxySmart PC-60F
Summary of Contents for OxySmart PC-60F
- Page 1 OxySmart Fingertip Oximeter User Manual Model:PC-60F This product is intended for sports or aviation use only. It should not used to diagnose or treat any medical condition.
- 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 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.
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Page 7: Table Of Contents
Table of Contents 1 OVERVIEW..............1 2 BATTERY INSTALLATION........3 3 OPERATION..............4 4 TECHNICAL SPECIFICATIONS........10 5 PACKING LIST............. 13 6 REPAIR AND MAINTENANCE........14 7 TROUBLESHOOTING..........17 8 KEY OF SYMBOLS............17 9 FREQUENTLY ASKED QUESTIONS......19 APPENDIX EMC..............23... -
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 user’s finger. It is intended for sports or aviation use only.
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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 Figure 6 Icon “ ” on display screen means the counting-down time if the Oximeter works at Spot check mode. The total measuring time for Spot check mode is 30 seconds. 4.
- Page 13 Figure 7 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.
- Page 14 display key can enter the setup menu screen. Figure 8 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.
- Page 15 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 mute the over-limits indication sound and pulse beep for 90 seconds.
- Page 16 Nail polish affect 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.
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Page 17: Technical Specifications
4 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 18 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 19 Environmental Conditions: 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...
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Page 20: Packing List
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. -
Page 21: Repair And Maintenance
6 Repair and Maintenance 6.1 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 22 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 23 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 6.2 Cleaning and Disinfecting Instruction Surface-clean sensor with a soft cloth damped ...
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Page 24: Troubleshooting
7 Troubleshooting Problem: 1. The SpO and Pulse Rate display instable 2. Can not turn on the device 3. No display Solution 1. Place the finger correctly inside and try again. 2. Changing batteries. 3. Let the patient keep calm. 4. - Page 25 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...
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Page 26: Frequently Asked Questions
9 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 27 physiological conditions. 5. Q: What to do if there is no SpO 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.
- Page 28 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.
- Page 29 e) Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, intravascular line; f) Exposure to the chamber with High pressure oxygen; g) There is an arterial occlusion proximal to the sensor; Blood vessel contraction caused peripheral vessel hyperkinesias...
- Page 30 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 31 RF emissions The Fingertip Class B CISPR 11 Oximeter suitable for use in all Harmonic establishments, emissions including domestic IEC61000-3-2 establishments and Voltage 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.
- Page 32 Electromagne Complia Immunity IEC60601 test test level environment level -guidance 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...
- Page 33 ±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 for 5 cycles variations <70% U on power (30% dip in U supply for 25 cycles...
- Page 34 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 35 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 36 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 37 (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 38 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 39 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 40 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 41 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 42 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...
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