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Related Manuals for FingerTip LT-F20
Summary of Contents for FingerTip LT-F20
- Page 1 Fingertip Pulse Oximeter User manual （MODLE：LT-F20/LT-F21） Welcome to use our product fingertip pulse oximeter. This manual introduces the product performance, operation method and other safety information in detail. Please read this manual carefully before using this device.
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Page 2: Chapter 1 Safety Guide
Chapter 1 Safety Guide 1.1 Electrical safety Classified according to MDR: it is a Class IIa active (non-implanted) medical device. Classified according to the type of protection against electric shock: equipment with internal power supply. Classified according to the degree of protection against electric shock: Type BF Applied Part. Classified according to the degree of protection against harmful liquids: IP22. - Page 3 10) Do not use the instrument when the performance of the instrument changes. 11) Some patients may be allergic after prolonged exposure to the instrument. When allergy occurs, please stop using the instrument immediately. 12) Use the battery recommended by the manufacturer. Use of other batteries may cause heat or damage to the instrument.
- Page 4 greater. And protected against vertically falling water drops when enclosure tilted up to 15° Non-ionizing radiation Date of manufacture Manufacturer Authorized representative in the European Community Use-by date Atmospheric pressure limitation Temperature limit Humidity limitation CE mark: indicates that the device complies with the EU 2017/745 NOTE: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or...
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Page 5: Chapter 2 Product Overview
Contraindications: Do not use in patients with finger trauma. The Fingertip Pulse Oximeter is forbidden for use in the patient with hypotension, severe vasoconstriction, severe anemia or hypothermia and the patient in immediate danger. 2.4 Product Features It can be used under the guidance of the doctor or by the patient himself, by holding it on the finger to measure the blood oxygen saturation and pulse rate. - Page 6 Power supply Working current 30mA- 80mA Direction sensor LT-F20: Digital and waveform display on the same screen, manual display in four directions LT-F21: Digital display, manual display in two directions. Light sensor Red light wave length (657nm-663nm 7mW,Low power light in this wavelength range is safe for the human body.)
- Page 7 Humidity : ≤93%(No condensation) Atmospheric pressure :70-106 kPa Caution: The time from extreme storage environment to normal use of the instrument should be no less than 3h. 2.9 Biocompatibility The product is proved to be non-cytotoxic, non-allergenic and minimal skin irritation when contacting with human body.
- Page 8 Adult volunteers should be able to withstand the minimal risk of an agreement for controlled blood oxygen test requirement. 2.15 The incompleteness of blood oxygen signals This product adopts normalized waveform, “---” is displayed to indicate signal inadequacy. 2.16 According to ISO 80601-2-61 standards, arterial blood oxygen saturation (SpO2) value depends on the accuracy of the calibration curve of the pulse oximetry is properly reflected pulse oximetry interact with pulse oximetry - the organization of the optical properties, functional tester is unable to confirm the SpO2 accuracy calibration curve, also cannot fully evaluate the...
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Page 9: Chapter 3 Battery Installation
Figure 2.1 product structure Chapter 3 Battery Installation 3.1.Open the battery cover on the rear panel of the instrument. 3.2. Install two batteries of 1.5V AAA Alkaline correctly in the battery slot according to the positive and negative polarity indication symbol. 3.Close the battery cover.(as figure 3.1) Figure 3.1 close the battery over Caution:... -
Page 10: Chapter 4 Operation Method
If the finger insert into the fingertip pulse ,the screen only show the bar chart and pulse sound, it means the signal of product is not sufficient to show the spO2 value and pulse value. (as figure 4.2 & 4.3) Figure4.2 F20 unstable signal... - Page 11 ① Manual operation :When the pulse oximeter is turned on, press the power switch every time, the display rotates 90 degrees.(suitable for LT-F20) ② Manual operation :When the pulse oximeter is turned on, press the power switch every time, the display rotates 180 degrees.(suitable for LT-F21) 4.5.After reading the data, remove the finger, and the device will automatically turn off within 15...
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Page 12: Chapter 5 Cleaning And Disinfection
Chapter 5 Cleaning and Disinfection The product housing and silicone liners can be cleaned and disinfected. Cleaning agent for water, disinfectant for medical alcohol. 5.1 Cleaning Please shut down and remove the battery before cleaning. The instrument should be kept clean and free from dust or dirt. Use before and after usable a clean, soft gauze dips in after taking clear water to undertake wiping. -
Page 13: Chapter 6 Maintenance And Troubleshooting
Chapter 6 Maintenance and Troubleshooting 6.1 Maintenance In order to ensure the service life of the machine, please pay attention to maintenance. ⚫ Please replace the battery when the battery is low. If not in use for a long time, please take out the battery. - Page 14 ①Fingers may not be in the right ① Retry to plug the finger or pulse rate place. Are unstable ②fingers tremble or people are in ② Remain still motion. ① battery power is too low or not ① replacing the battery No boot installed ②battery is not properly installed...
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Page 15: Chapter 7 Electromagnetic Compatibility Information
Chapter 7 Electromagnetic Compatibility Information Electromagnetic Compatibility Caution: ⚫ The instrument conforms to the requirements of IEC 60601-1-2 standard for electromagnetic compatibility. ⚫ The users shall install and use according to the EMC information provided in random file. ⚫ Portable and mobile RF communication equipment may affect the performance of the instrument, avoid strong electromagnetic interference when using, such as close to the mobile phone, microwave oven, etc. - Page 16 Voltage fluctuation/flicker emission IEC 61000-3-3 Guidelines and manufacturer's statement – Electromagnetic immunity The instrument is intended to be used in the electromagnetic environment specified below, and the purchaser or user of the instrument should guarantee that it is used in this electromagnetic environment: electroma Immunity test...
- Page 17 70%UT;25/30 cycles Single phase: at 0° Voltage interruptions 0%UT;250/300 cycle IEC 61000-4-11 RATED power frequency magnetic fields 30A/m 30A/m,50/60Hz IEC 61000-4-8 Note: U refers to the voltage of the AC network before the test voltage is applied. Guidelines and manufacturer's statement – Electromagnetic immunity The instrument is intended to be used in the electromagnetic environment specified below，and the purchaser or user of the instrument should guarantee that it is used in this electromagnetic environment：...
- Page 18 Portable and mobile RF communications equipment should not be used closer to any part of the instrument than recommended isolation distances, including cables. The distance shall be Conducted disturbances 3 Vrms calculated by a induced by RF fields 150 kHz to 80 MHz formula IEC 61000-4-6 corresponding to the...
- Page 19 The field strength of a stationary RF transmitter is determined by surveying (c) the electromagnetic site,and (d) should be lower than the applicability level in each frequency range . Interference may occur near the device that marks the following symbol...
- Page 20 Note1：In the frequency of 80MHz and 800MHz, the higher frequency formula is adopted. Note2：These guidelines may not be suitable for all situations, where electromagnetic transmission is affected by the absorption and reflection of buildings, objects and bodies. a. Stationary transmitter，such as base stations for wireless (cellular/cordless) telephones and ground-based mobile radios, amateur radios, AM and FM radio broadcasts and television broadcasting, are theoretically predicted accurately in the field strength.
- Page 21 For the rated maximum output power of the transmitter not listed in the table above, the recommended isolation distance d, in meters (m), can be determined by the formula in the corresponding transmitter frequency bar, where p is the transmitter manufacturer's maximum output power rating, in Watts (W) units.
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Page 22: Chapter8 Warranty And After Sales Service
Chapter8 Warranty and After sales service 8.1 Warranty The service life of this equipment is 1 year. The instrument can’t be maintained by the users themselves. All maintenance and repair processes shall be carried out by the company's accredited technicians. The scope of warranty of this machine covers all equipment failures due to the failure of the device or the production process. - Page 23 Company Information Zhuhai Linte Medical Instrument Co., Ltd. 4th Floor, Building 1, No.66, Yongda Road, Hongqi Town, Jinwan District, 519090 Zhuhai, Guangdong, PEOPLE’S REPUBLIC OF CHINA Tel: 0756-2133996 Fax: 0756-2133237 Email: lintemed@lintemed.com Website: www.lintemed.com Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany Tel: +49-40-2513175 Fax: +49-40-255726...
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