digipox 閹稿洤顨滃 蹇氬墻閹煎繗顢呭 褌鍗庣拠瀛樻
Contents
1. Low battery voltage With Type BF applied part CE mark Warning See User Manual Disposal of this device according regulations 14 Manufacture s Declaration Refer to the following tables for specific information regarding this device s compliance to IEC60601 1 2 Table 1 Electromagnetic Emissions Guidance and manufacturer s declaration electromagnetic emission The Clini Ox Fingertip Pulse Oximeter 18706 is intended for use in the electromagnetic environment specified below The customer or the user of this device should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance Group 1 The device 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 RF emissions CISPR 11 Clase B NA The device is suitable for use in all establishments including domestic establishments and those directly network that Harmonic emissions 1EC61000 3 2 Voltage fluctuations flicker emissions N A mupplies bullditige tse for damestio purposes 1EC61000 3 3 Table 2 Electromagnetic Immunity tail Shenzhen Creative Industry Co Litd 2iF Block 3 Nanyou Tain an Industry Town 518054 Shenzhen GD People s Republic of China The Clini Ox Fingertip Pulse Oximeter 187062. battery cover Pressure 9 Dimensions sphay key munephie display sereen Figure 1 Front panel Figure 2 Rear panel Figure 3 Battery installation Note the appearance is subject to the Oximeter 6 Battery Installations 1 Insert two AAA size batteries into the battery compartment properly Figure 3 2 Replace the cover Please make sure that the batteries are correctly installed or incorrect installation may cause the device not to work The Fingertip Oximeter can be used to measure pulse oxygen saturation SpOs value and pulse rate PR simply put your finger onto sensor as indicated in Figure 4 andSpO2 value and pulse rate value will be displayed on the screen Its light small in size and portable Accurately measure SpO gt value and pulse rate value Low battery indication 8 Product Intended Use This product is intended for hospital or home application to measure SpO gt and pulse rate 9 Operation 1 Open the clip and put finger into the rubber cushions of the clip make sure the finger is in correct position and then clip the finger as shown in 2 Wait 2 seconds the oximeter will power on automatically and start to measure 3 Next review the data display screen as shown in Figure 5 4 Press and release the Display Key Figure 4 Put finger into the Oximeter gure 1 to change display direction use best satel BPM Figure 5 Display screen 10 Product Accessories A One Lanyard B Two AAA
3. GHz Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d B 5 V VF 3 5 El JP 80MHz to 800MHz d 7 E1 JP 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 meters 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 Table 4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communication the equipment The Clini Ox Fingertip Pulse Oximeter 18706 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter M Meters 80MHz to
4. is intended for use in the electromagnetic environment specified below The customer or the user of the device should ensure that it is used in such an environment Immunity test 1EC60601 test level Compliance level Electromagnetic environment Floors should be wood concrete or ceramic tile if floors are covered with synthetic material thel relative humidity should be at least 30 Shanghai International Trading Corp GmbH Hamburg Eiffestrasse 80 20537 Hamburg Germany Electrostatic discharg 6 kV contact 6 kV contact TEC61000 4 2 8KV air 48kV air Power frequency Power frequency magnetic fields should be at levels C 0123 50Hz 60Hz magnet characteristic of a typical location in a typical TEC61000 4 8 NOTE Uris the a c mains voltage prior to application of the test level ean ue REV1 2 20 14 commercial or hospital environment Table 3 Electromagnetic Immunity Guidance and manufacturer s declaration electromagnetic immunity The Clini Ox Fingertip Pulse Oximeter 18706 is intended for use in the electromagnetic environment specified below The customer or the user of the device should ensure that it is used in such an electromagnetic environment Immunity test TEC60601 test level Compliance level Electromagnetic environment guidance Conducted RF 1EC61000 4 6 Radiated RF 1EC61000 4 3 3 Vrms 150 kHz to 80 MHz 3 Vim 80 MHz to 2 5
5. 800MHz 80MHz to 2 5GHz Rated maximum output of transmitter W Watts d 3 5 E1 JP d 7 E1 JP 0 01 0 12 0 23 0 1 0 38 0 73 1 12 23 10 38 73 100 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 Your Drive brand product is warranted to be free of defects in materials and workmanship for two years from the original purchase date The device was built to exacting standards and carefully inspected prior to shipment This 2 year Limited Liability warranty is an expression of our confidence in the materials and workmanship of our products and our assurance to the consumer of years of dependable service In the event of a defect covered by this warranty we will at our option repair or replace the device This warranty does not cover device failure due to owner misuse or negligence or normal wear and tear If you have questions about
6. User Manual Clini Ox Fingertip Pulse Oximeter REF 18706 1 Measurement Principle Based on Lamber Beer law the light absorbance of a given substance is directly proportional with its density or concentration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO2 and deoxygenated hemoglobin Hb have different absorption character in the spectrum range from red to infrared light 600nm 1000nm wavelength by using these characteristics SpO2 can be determined SpO2 measured by this oximeter is the functional oxygen saturation a percentage of the hemoglobin that can transport oxygen In contrast hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin 2 Precautions for Use Before use carefully read the instruction manual Check the device before use to make sure that there is no visible damage which may affect user s safety or its performance with regard to sensors and clips It is recommended that the device should be inspected minimally once a week When there is any obvious damage stop using the device Be sure to correctly Do NOT shake the finger Keep at ease during measurement Do NOT let anything block the e
7. batteries C One instruction manual 11 Cleaning and Maintenance Maintenance Paleo tar pare l 5 Remove your finger the Oximeter will power off automatically The estimated 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 illuminates Please clean the surface of the device before using Wipe the device with alcohol and then let it air dry or wipe it dry Please take out the batteries if the oximeter will not be used for an extended period of time tory before sale there is no need to calibrate it during its life cycle tion by means of an SpO2 simulator The oximeter is calibrated in the fi f it is necessary to verify its accuracy routinely the user can do the verifi or it can be done by the local third party test house A High pressure sterilization cannot be used on the device Howev 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 Cleaning and Disinfecting Instruction Surface clean sensor with a soft cloth by wetting with a solution such as 75 isopropyl alcohol disinfection is required use a 1 10 bleach solution Then surface clean with a cloth saturated with clean water and dry with a clean soft cloth Caution Do no
8. mitting light from the device Do NOT put a wet finger directly onto the sensor Special attention should be paid while the oximeter is used constantly in ambient temperature of 98 F 37 C or greater fix the pulse oximeter to the finger Injury may occur due to sensor over heating An uncomfortable or painful feeling may result if the oximeter is used continuously in the same place for an extended period of time especially in patients with poor microcirculation It s 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 placing site of oximeter Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion Do NOT clip this device on edema or tender tissue The light the infrared light is invisible emitting from the device is harmful to the eyes Do not stare at the li The oximeter is not a treatment device Follow local ordinances and recycling instructions for disposal of device device components and batteries Ensure that there is an artery vessel within the measuring site where the light transmits Vigorous exercise and interference from electrosurgical devices may affect the measuring accuracy Nail polish may affect the measuring accuracy Long fingernails may cause failure of measurement or inaccurate results due to poor placement on the finger Keep the oximeter away fr
9. om dust vibration corrosive substances explosive materials high temperature and moisture Existence of high intensive light sources such as fluorescence light ruby lamb infrared heater or strong sunshine etc may cause inaccurate measurements Please put an opaque cover on the sensor or change the measuring location if necessary 1 Display type LCD display 2 SpO measurement SpOz measuring range 35 100 SpO1 measuring accuracy 75 100 PR measuring range 30bpm 240bpm PR measuring accuracy 2 or 2bpm which is greater SpO gt low limit 90 Pulse Rate High Limit 120bpm Low Limit 50bpm 2xLRO3 AAA alkaline batteries Operating Current lt 50mA Operating Temperature 41 to 104 F 5 to 40 C Storage Temperature 4 to 140 F 20 to 60 C 3 Pulse rate measurement 4 Preset over limit 5 Power supply requirement 6 Environment requirement Operating Relative Humidity 30 80 10 95 70kPa 106kPa 50kPa 107 4kPa Storage Relative Humidity Atmospheric Pressure Storage Atmospheri 7 The performance under low perfusion condition The accuracy of SpOzand PR measurement still meet the precision described above when the modulation amplitude is as low as 0 6 8 Resistance to interference of surrounding light he difference between the SpOz value measured in the condition of indoor natural light and that of darkroom is less than 1 60mm L x33mm W x30mm H Net weight 60g including batteries
10. t sterilize by irradiation steam or ethylene oxide A A If low level Do not use the sensor if it is damaged 12 Troubleshooting Solutions Possible Reason Solution Please shake the oximeter with a certain force to make the movable metal ball move freely If the problem still exists maybe the orientation sensor is not working properly Please contact the local service center Maybe the oximeter is not used for a long time the movable metal ball within the orientation sensor cannot move freely Display direction does not change or changes insensitively 1 The finger is not placed far enough inside 1 Place the finger correctly inside and try 2 The finger is shaking or the patient is gain 2 Let the patient keep calm and Pulse instable moving 1 The batteries are drained or almost drained 1 Change batteries The batteries are not inserted properly 2 Reinstall batteries 3 The device is malfunctioning 3 Please contact the local serv Cannot turn on the device center 1 The device will power off automatically when it gets no signal for 8 seconds 2 The batteries are almost drained Normal No display Change batteries 13 Symbol Definitions Symbol Description Spo Pulse oxygen saturation Date of manufacture Authorized representative in the European BPM PR Pulse rate beats per minute cooimamitnity Pulse intensity bar graph Manufacturer including address
11. your Drive device or this warranty please contact an authorized Drive Medical provider Drive Medical Design amp Manufacturing 99 Seaview Boulevard Port Washington NY 11050 www drivemedical com Local 516 998 4600 Toll Free 877 224 0946
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