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Pulse Oximeter

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Summary of Contents for CEM 2998417

  • Page 1 User manual Pulse Oximeter...
  • Page 3: Table Of Contents

    Pulse 0ximeter Table of contents 1.Introduction ........................4 2.Precautions........................5 3.WARNINGS ........................6 4.Specifications ........................8 5.Appearance of the Structure .....................9 6.Screen Display ........................9 7.How to Use........................10 8.Function Description .......................10 9.Replace the Batteries...................... 11 10.Problem Solution......................12 11.Graphic Symbol Description ................... 12.Cleaning and Maintenance ....................14 13.EMC Declaration ......................15 14.Manufacturer's EMC statement ..................16 15.Classification ........................19...
  • Page 4: Introduction

    Pulse 0ximeter 1. Introduction Oxygen saturation is the percentage of oxyhemoglobin (HbO2) that is combined with oxygen against all combinable hemoglobin (Hb). It is an important physiological parameter involved in respiration and circulation. The oxygen saturation of arterial blood in a normal human body is 98%. Oxygen saturation is an important indicator of the oxygen condition in the human body.
  • Page 5: Precautions

    Pulse 0ximeter 1.5 Intended use environment The intended use environment is defined as follows: 1)Clinical institutions and home, 2)Frequency of use is not limited 3) The subject with no-motion, 4)The subject is in an indoor or outside room or public place, 5)Altitude is not more than 3000m.
  • Page 6: Warnings

    Pulse 0ximeter The following factors may interfere or affect the accuracy of the inspection: • This product is not suitable for environments involving high-frequency equipment, such as high-frequency electric knife, CT equipment, etc. • The oximeter probe is placed in the same body part or limb as the blood pressure cuff arterial catheter or intravenous injection.
  • Page 7 Pulse 0ximeter • Close the battery cover when the instrument is in use. • The patient is an intended operator. • Do not modify the device and use the device for other purposes. • This product is calibrated to show functional oxygen saturation. Functional testers cannot be used to evaluate the accuracy of pulse oxygen.
  • Page 8: Specifications

    Pulse 0ximeter 4. Technical Specifications Display mode OLED display Power supply DC 3V 2*1.5V LR03(AAA) Auto power off Switch off after 15 seconds finger out Light Source Radiant Power Wave Length Red Light 660nm <11mW Infrared Light 940nm <4mW Display Range 35%--100% ±2% (80% to 100%);...
  • Page 9: Appearance Of The Structure

    Pulse 0ximeter 5. Appearance of the Structure 1-Screen Display 2-Power 0N/Function Button 3-Battery Cover 6. Screen Display (1)Measured value of oxygen saturation (2)Symbol of Oxygen saturation (3)Battery display (4)Symbol of pulse rate (5)Pulse rate bargraph display (6)Measured value of pulse rate...
  • Page 10: How To Use

    Pulse 0ximeter 7. How to Use Stick one finger completely into the measuring parts of the 0ximeter, keep the fingernail surface upward, and release the clip. lf you do not yet completely insert your finger into the cavity, the measurement result may be inaccurate.
  • Page 11: Replace The Batteries

    Pulse 0ximeter 9. Replace the Batteries • Replace the batteries when the battery capacity is insufficient and the symbol " " flickers on the screen • Open the battery cover with your fingers, you can replace the batteries according to the correct battery polarity.
  • Page 12: Problem Solution

    Pulse 0ximeter 10. Problem Solution Problem Possible Cause Solutions Put it in correctly Blood oxygen or pulse rate Misplaced fingers and retest cannot be displayed normally Fingers with nail polish Remove nail polish The fingers are shaking or Please measure in the body is moving a calm state or pulse rate...
  • Page 13: Graphic Symbol Description

    Pulse 0ximeter 11. Graphic Symbol Description Means "Must read the operating instructions" Means "Meets MDR(EU) 2017/745 requirements" Means "Manufacturer" Means "Direct current" Means "Authorized Representative of the European Union" Represents "BF type of applied part" Means "Environmental protection-Waste electrical products should not be disposed of together with household garbage.
  • Page 14: Cleaning And Maintenance

    Pulse 0ximeter 12. Cleaning and Maintenance Disposing Period Use a cotton swab slightly moistened with Ethanol 96% to clean the surface of the window during 15s and immediately wipe dry with a clean cotton swab during 20s. Clean in time when there is dirt (at least Gently wipe the display screen and the outside Cleaning...
  • Page 15: Emc Declaration

    Pulse 0ximeter Maintenance • Remove the batteries from the battery slot and properly store them if you do not plan to use the oximeter for a long period of time. • Avoid using the oximeter in an environment with inflammable gases or using it in an environment where the temperature or humidityis excessively high or low.
  • Page 16: Manufacturer's Emc Statement

    Pulse 0ximeter 14. Manufacturer's EMC statement Guidelines and manufacturer's declaration-electromagnetic radiation Pulse oximeter applicable to the following electromagnetic environment. Pulse oximeter customers or users should be sure to use in this environment. Radiation In line with Electromagnetic Environment Guidance Pulse oximeter RF energy only for its internal functions.
  • Page 17 Pulse 0ximeter The power quality of the power ±2kV for Electrical fast supply should be power cord transient/ the quality of a Not applicable ±1kV for input/ burst lEC 61000-4-4 typical commercial output line or hospital environment. The power quality of the power ±...
  • Page 18 Pulse 0ximeter The power frequency magnetic field should be at the Power frequency characteristic (50/60Hz) magnetic 30 A/m 30 A/m level of a typical field IEC 61000-4-8 location in a typical commercial or hospital environment. Note: UT is the AC power supply voltage before the test level is applied. Guidance and manufacturer's declaration-electromagnetic immunity The pulse oximeter is suitable for the following electromagnetic environment.
  • Page 19: Classification

    Pulse 0ximeter Anti-interference IEC 60601 Compliance Electromagnetic test test level level environment-guide Portable and mobile radio frequency communication equipment must be used from any part of the pulse oximeter (including cables) not to exceed the recommended 3Vrms 150kHz separation distance calculated to 80MHz based on the eguation for the transmitter frequency.
  • Page 20 Operating Instruction for Pulse 0ximeter Pulse 0ximeter a. The field strenath of fixed transmitters, such as base stations of radio (cellular/ cordless) telephones and land mobile radios, amateur radio. AM and FM radio broadcasting, and TV broadcasting cannot be accurately predicted in theory. ln order to assess the electromagnetit environment of fixed RF transmiters.
  • Page 21: Clinical Spo 2 Accuracy And Pulse Rate Accuracy

    Pulse 0ximeter Electric shock protection type: Internal power supply Electric shock protection level: Type BF applied parts Waterproof rating: IPX2,normal protection IP22 IP rating: Sterilization or disinfection method: 75% medical alcohol The degree of application safety in 0X-97 is not suitable for the presence of the presence of flammable anesthetic a flammable anesthetic mixture with air, mixtures with air or oxygen or nitrous...
  • Page 22: Warranty Lnformation

    Pulse 0ximeter • Pulse rate accuracy The 4 prototypes were placed in a constant temperature room (ambient temperature was set at 25°C, ambient humidity was set at 50%RH) and stood for 2 hours. 4 points were selected from the PR value of 25~250bmp to verify the test data of the four products and record them.Compare the prototypes with the PR value of the pulse oximeter simulator to verify accuracy.
  • Page 24 Shenzhen Everbest Machinery lndustry Co.,Ltd. No.101-501, 19th Building & 21st Building, Baiwangxin Industrial Park, No.1002, Songbai Road, Yangguang Community, Xili Street, Nanshan District, Shenzhen, 518108, Guangdong, P.R. China Tel:+86-755-27353188 www.cem-instruments.com Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com 0197...

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