Braun ThermoScan 7 IRT 6520manual

1 This product is manufactured by Kaz Europe Sàrl under a license to the‘Braun’trademark.‘Braun’is a registered trademark of Braun GmbH, Kronberg, Germany. ThermoScan is a registered trademark of Kaz Europe Sàrl. Kaz Europe Sàrl Place Chauderon 18 CH-1003 Lausanne Switzerland © 2014, Kaz Europe Sàrl www.hot-europe.com Patents: www.kaz.com/patents/braun Made in Mexico. IRT6020/6520 MNLΤ/WE P/N: 31IM0620190 04MΤR14 English . . . . . . . . . . . . . . . . . . 3 Deutsch . . . . . . . . . . . . . . . . 14 Español. . . . . . . . . . . . . . . . . 25 Français . . . . . . . . . . . . . . . . 36 Ελληνικά. . . . . . . . . . . . . . . . 47 Italiano . . . . . . . . . . . . . . . . . 58 Nederlands . . . . . . . . . . . . . 69 Português . . . . . . . . . . . . . . 80 . . . . . . . . . . . 101 Türkçe . . . . . . . . . . . . . . . . . 102 GB DE ES FR GR IT NL PT SΤ TR Printed in USΤ

2 3 The BraunThermoScan thermometer has been carefully developed for accurate, safe and fast temperature measurements in the ear. The shape of the thermometer probe prevents it from being inserted too far into the ear canal, which can hurt the eardrum. However, as with any thermometer, proper technique is critical to obtaining accurate temperatures. Therefore, read the instructions carefully and thoroughly. The BraunThermoScan thermometer is indicated for intermittent measurement and monitoring of human body temperature for people of all ages. It is intended for household use only. Use of IRT 6520 along with Τge Precision™ feature is not intended as a substitute for consultation with your physician. Product description 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 11 10 IRT 6020 3 2 5 9 4 8 6 7 10 1 IRT 6520 3 2 5 10 4 9 6 7 8 11 1 WARNINGS AND PRECAUTIONS • Please consult your doctor if you see symptoms such as unexplained irritability, vomiting, diarrhea, dehydration, changes in appetite or activity, seizure, muscle pain, shivering, stiff neck, pain when urinating, etc. in spite of any color of the background light or absence of fever. • Please consult your doctor if the thermometer shows elevated temperature (yellow or red background lights for IRT 6520). The operating ambient temperature range for this thermometer is 10 – 40 °C (50 – 104 °F). Do not expose the thermometer to temperature extremes (below -25 °C / -13 °F or over 55 °C / 131 °F) or excessive humidity (>95%RH).ThisthermometermustonlybeusedwithgenuineBraunThermoScanlensfilters(LF40). To avoid inaccurate measurements always use this thermometer with a new, clean lens filter attached. If the thermometer is accidentally used without a lens filter attached, clean the lens (see «Care and cleaning» section). Keep lens filters out of reach of children. This thermometer is intended for household use only.This product is not intended to diagnose any disease, but is a useful screening tool for temperature. Use of this thermometer is not intended as a substitute for consultation with your physician. English IRT 6520 Lens filter (Box of 20) Probe tip Probe ExacTemp light Lens filter ejector Display Age Precision and Memory buttons Power button Start button Battery door Protective case IRT 6020 Lens filter (Box of 20) Probe tip Probe ExacTemp light Lens filter ejector Display Power button Start button Battery door Protective cap

4 5 Body temperature Normal body temperature is a range. It varies by site of measurement, and it tends to decrease with age. It also varies from person to person and fluctuates throughout the day.Therefore, it is important to determine normal temperature ranges.This is easily done using BraunThermoScan. Practice taking temperatures on yourself and healthy family members to determine the normal temperature range. Note:When consulting your physician, communicate that theThermoScan temperature is a temperature measured in the ear and if possible, note the individual’s normalThermoScan temperature range as additional reference. The Τge Precision™ feature is not intended for pre-term babies or small-for-gestational age babies. The Τge Precision™ feature is not intended to interpret hypothermic temperatures. Do not allow children under 12 to take their temperatures unattended. Do not modify this equipment without authorization of the manufacturer. Parents/guardians should call the pediatrician upon noticing any unusual sign(s) or symptom(s). For example, a child who exhibits irritability, vomiting, diarrhea, dehydration, seizure, changes in appetite or activity, even in the absence of fever, or who exhibits a low temperature, may still need to receive medical attention. Children who are on antibiotics, analgesics, or antipyretics should not be assessed solely on temperature readings to determine the severity of their illness. Temperature elevation as indicated by Τge Precision™ may signal a serious illness, especially in adults who are old, frail, have a weakened immune system, or neonates and infants. Please seek professional advice immediately when there is a temperature elevation and if you are taking temperature on: • neonates and infants under 3 months (consult your physician immediately if the temperature exceeds 37.4 °C or 99.4 °F) • patients over 60 years of age • patients having diabetes mellitus or a weakened immune system (e.g. HIV positive, cancer chemotherapy, chronic steroid treatment, splenectomy) • patients who are bedridden (e.g. nursing home patient, stroke, chronic illness, recovering from surgery) • a transplant patient (e.g. liver, heart, lung, kidney) Fever may be blunted or even absent in elderly patients. This thermometer contains small parts that can be swallowed or produce a choking hazard to children. Τlways keep the thermometer out of children’s reach. Age Precision™ color-coded display Clinical research shows the definition of fever changes as newborns grow into little kids and little kids grow into adults1 . Braun’s Τge Precision™ color-coded display takes the guesswork out of interpreting temperature for the entire family. Simply use the Τge Precision™ button to select the appropriate age setting, take a temperature and the color-coded display will glow green, yellow or red to help you understand the temperature reading. 6520 How does BraunThermoScan work? BraunThermoScan measures the infrared heat generated by the eardrum and surrounding tissues.To help avoid inaccurate temperature measurements, the probe tip is warmed to a temperature close to that of the human body.When the BraunThermoScan is placed in the ear, it continuously monitors the infrared energy.The measurement is finished and the result displayed when the thermometer detects that an accurate temperature measurement has been taken. Why measure in the ear? The goal of thermometry is to measure core body temperature1 , which is the temperature of the vital organs. Ear temperatures accurately reflect core body temperature2 , since the eardrum shares blood supply with the temperature control center in the brain3 , the hypothalamus.Therefore, changes in body temperature are reflected sooner in the ear than at other sites. Τxillary temperatures measure skin temperature and may not be a reliable indicator of core body temperature. Oral temperatures are influenced by drinking, eating and mouth breathing. Rectal temperatures often lag behind changes in core body temperature and there is a risk of cross-contamination. 1 Remove protective cap. 6020 How to use your BraunThermoScan Remove the thermometer from the protective case. 6520 1 Guyton Τ C,Textbook of Medical Physiology,W.B. Saunders, Philadelphia, 1996, p 919. 2 Guyton Τ C,Textbook of Medical Physiology,W.B. Saunders, Philadelphia, 1996, pp 754-5. 3 Netter H F, Τtlas of Human Τnatomy, Novartis Medical Education, East Hanover, NJ, 1997, pp 63, 95. 2 Push the Power button . During an internal self-check, the display shows all segments. Then the last temperature taken will be displayed for 5 seconds. English 1 Herzog L, Phillips S. Τddressing Concerns Τbout Fever. Clinical Pediatrics. 2011; 50(#5): 383-390.

6 7 3 4 5 6520 Fit the probe snuggly into the ear canal, then push and release the Start button . Select age with Τge Precision™ button as shown below. Press button to toggle through each age group. NOTE: You must select an age in order to take a measurement. The lens filter indicator will blink to signal one is needed. To achieve accurate measurements, make sure a new, clean lens filter is in place before each measurement. Τttach a new lens filter by pushing the thermometer probe straight into the lens filter inside the box and then pulling out. Note:The BraunThermoScan will not work unless a lens filter is attached. ExacTemplightwillpulsewhiletemperaturemeasurementisinprogress.The light will remain solid for 3 seconds to indicate that a successful temperature reading has been achieved. NOTE: If the probe has been properly inserted into the ear canal during the measurement, a long beep will sound to signal the completed measurement. If the probe has NOT been constantly placed in a stable position in the ear canal, a sequence of short beeps will sound, the ExacTemp light will go out and the display will show an error message (POS = position error). See «Errors and troubleshooting» section for more information. 6 7 9 6520 6020 The confirmation beep indicates that an accurate temperature measurement has been taken. The result is shown on the display. Temperature displays. 0-3 3-36 36+ Months 0-3 3-36 36+ Months 0-3 3-36 36+ Months Age range 0-3 Months 3-36 Months 36 Months- adult Green Normal temperature ≥35.8 – ≤37.4 °C (≥96.4 – ≤99.4 °F) ≥35.4 – ≤37.6 °C (≥95.7 – ≤99.6 °F) ≥35.4 – ≤37.7 °C (≥95.7 – ≤99.9 °F) Yellow Elevated temperature >37.6 – ≤38.5 °C (>99.6 – ≤101.3 °F) >37.7 – ≤39.4 °C (>99.9 – ≤103.0 °F) Red High temperature >37.4 °C (>99.4 °F) >38.5 °C (>101.3 °F) >39.4 °C (>103.0 °F) For the next measurement, press Eject button to remove and discard used lens filter, and put on a new, clean lens filter. NOTE: Defaults to last age setting used if you do not change. The BraunThermoScan ear thermometer turns off automatically after 60 seconds of inactivity. The thermometer can also be turned off by pressing the Power button . The display will briefly flash OFF and it will go blank. 8 Temperature-taking hints Τlways replace disposable lens filters to maintain accuracy and hygiene.The right ear measurement may differ from the measurement taken in the left ear.Therefore, always take the temperature in the same ear.The ear must be free from obstructions or excess earwax build-up to take an accurate reading. External factors may influence ear temperatures, including when an individual has: Factor Affects Poor probe placement Used lens filter Dirty lens English 6020 6520 The thermometer is ready to take a temperature when the display looks like the images below.

8 9 This model stores the last 9 temperature measurements. To display the stored measurement, the thermometer must be turned on. Press the Mem button. The display shows the temperature, and when releasing the Mem button, the stored temperature for that memory number is displayed, together with“M”. Each time the Mem button is pushed, the stored reading and an M is displayed to indicate each temperature measurement (eg. M2). Memory mode is automatically exited by not pressing the memory button for 5 seconds. In the cases below, wait 20 minutes prior to taking a temperature. Factor Affects Extreme hot and cold room temperature Hearing aid Lying on pillow Use the untreated ear if ear drops or other ear medications have been placed in the ear canal. Memory mode 1 1 2 3 6520 6520 Night light feature The thermometer includes a convenient night light to illuminate the display in a dim environment. The light will turn on when you press any button. It will stay on until the thermometer is inactive for up to 15 seconds even after temperature is taken. The last temperature taken is stored in its memory and will be automatically displayed for 5 seconds when it is turned on again. Changing the temperature scale Your BraunThermoScan is shipped with the Celsius (°C) temperature scale activated. If you wish to switch to Fahrenheit (°F) and/or back from Fahrenheit to Celsius, proceed as follows: Make sure the thermometer is turned off. Press and hold down the Power button . Τfter about 3 seconds the display will show this sequence: °C / SET / °F / SET. 1 2 Care and cleaning The probe tip is the most delicate part of the thermometer. It must be clean and intact to ensure accurate readings. If the thermometer is ever accidentally used without a lens filter, clean the probe tip as follows: Very gently wipe the surface with a cotton swab or soft cloth moistened with alcohol. Τfter the alcohol has completely dried out, you can put a new lens filter on and take a temperature measurement. If the probe tip is damaged, please contact Consumer Relations. Use a soft, dry cloth to clean the thermometer display and exterior. Do not use abrasive cleaners. Never submerge this thermometer in water or any other liquid. Store thermometer and lens filters in a dry location free from dust and contamination and away from direct sunlight. Τdditional lens filters (LF 40) are available at most stores carrying BraunThermoScan. Replacing the batteries The thermometer is supplied with two 1.5V type ΤΤ (LR 06) batteries. For best performance, we recommend Duracell® alkaline batteries. Insert new batteries when the battery symbol appears on the display. Open the battery compartment. Remove the batteries and replace with new batteries, making sure the poles are in the right direction. Snap battery door into place. 1 2 3 Only discard empty batteries.To protect the environment, dispose of empty batteries at your retail store or at appropriate collection sites according to national or local regulations. Calibration This device was designed and manufactured for a long service life, however it is generally recommended to have the device inspected once a year to ensure correct function and accuracy. Please contact the authorized service centre located in your country. Note:The calibration checking is not a free service. Please contact the Τuthorized Service Centre to get a quotation before you send out the product. Manufacturing date is given by the LOT number located in the battery compartment. The first three (3) digits after LOT represent the Julian date that the product was manufactured and the next two (2) digits represent the last two numbers of the calendar year the product was manufactured.The last identifiers are the letters that represent the manufacturer. Τnexample:LOT11614k,thisproducthasbeenmanufacturedonthe116thdayoftheyear2014. Release the Power button when the desired temperature scale is shown. There will be a short beep to confirm the new setting, then the thermometer is turned off automatically. 3 English

10 11 Errors and troubleshooting Product specifications Displayed temperature range: 34 – 42.2 °C (93.2 – 108 °F) Operating ambient temperature range: 10 – 40 °C (50 – 104 °F) Storage temperature range: -25 – 55 °C (-13 – 131 °F) Operating and storage relative humidity: 10-95% RH (non condensing) Display resolution: 0.1 °C or °F Accuracy for displayed temperature range Maximum Laboratory Error 35 – 42 °C (95 – 107.6 °F): ±0.2 °C (±0.4 °F) Outside this range: ±0.3 °C (±0.5 °F) Clinical repeatability: ±0.14 °C (±0.26 °F) Battery life: 2 years / 600 measurements Service life: 5 years This thermometer is specified to operate at 1 atmospheric pressure or at altitudes with an atmospheric pressure up to 1 atmospheric pressure (700 - 1060 hPa). SeeInstructionforuse Equipmentwith typeBFappliedparts 10 °C 40 °C Operatingtemperature Keepitdry Storagetemperature Subject to change without notice. This appliance conforms to the following standards: Standard Reference EditionTitle: EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device). EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN ISO 14971: 2012 Medical devices – Τpplication of risk management to medical devices. EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN 980: 2008 Symbols for use in labeling of medical devices. EN 1041: 2008 Information supplied by the manufacturer of medical devices. EN 60601-1-11: 2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. This product conforms to the provisions of the EC directive 93/42/EEC. MEDICΤL ELECTRICΤL EQUIPMENT needs special precautions regarding EMC. For detailed description of EMC requirements please contact your authorized local Service Centre (See guarantee card). Portable and mobile RF communications equipment can affect MEDICΤL ELECTRICΤL EQUIPMENT. Please do not dispose of the product in the household waste at the end of it useful life. To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations. Guarantee Consumer Card available on our website at www.hot-europe.com/after-sales Please see last page of this manual to find the contact for the Kaz Τuthorized Service Center in your country. UK only:This guarantee in no way affects your rights under statutory law. English Error Message Situation Solution No lens filter is attached. Τttach new, clean lens filter. The thermometer probe was not positioned securely in the ear. Τn accurate measurement was not possible. POS = position error Take care that the positioning of the probe is correct and remains stable. Replace lens filter and reposition. Press Start button to begin a new measurement. Τmbient temperature is not within the allowed operating range (10 – 40 °C or 50 – 104 °F). Τllow the thermometer to remain for 30 minutes in a room where the temperature is between 10 and 40 °C or 50 and 104 °F . Temperature taken is not within typical human temperature range (34 – 42.2 °C or 93.2 – 108 °F). HI = too high LO = too low Make sure the probe tip and lens are clean and a new, clean lens filter is attached. Make sure the thermometer is properly inserted.Then, take a new temperature. System error – self-check display flashes continuously and will not be followed by the ready beep and the ready symbol. If error persists, If error still persists, Wait 1 minute until the thermometer turns off automatically, then turn on again. ... reset the thermometer by removing the batteries and putting them back in. ... please contact the Service Centre. Battery is low, but thermometer will still operate correctly. Insert new batteries. Battery is too low to take correct temperature measurement. Insert new batteries.

12 13 Guidance and manufacturer’s declaration – electromagnetic emissions The IRT 6020/6520 equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the IRT 6020/6520 should ensure that it is used in such an environment. EmissionsTest Compliance Electromagnetic environment – guidance RF Emissions CISPR 11 Group 1 The ME equipment 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 Class B Complies Harmonic emissions IEC 61000-3-2 Not Τpplicable The ME equipment is solely battery powered. Voltagefluctuations/ flicker emissions Not Τpplicable English Non-Life Support Equipment Separation Distance Calculation (3Vrms / 3V/m compliance) Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz in ISM bands 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33 Guidance and manufacturer’s declaration – electromagnetic immunity The IRT 6020/6520 is intended for use in the electromagnetic environment specified below. The customer or the user of the IRT 6020/6520 should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6kV Contact ±8kV Τir Complies Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Radiated RF IEC 61000-4-3 3V/m 80MHz to 2.5GHz Complies Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than 3V/m. Interference may occur in the vicinity of equipment marked with the following symbol: Separation distance calculation provided above. If a known transmitter is present the specific distance can be calculated using the equations. Conducted RF IEC 61000-4-6 3Vrms 150kHz to 80MHz Not Τpplicable (no electrical cabling) Electrical fast transient IEC 61000-4-4 ±2kV power line ±1kV I/O lines Not Τpplicable The ME equipment is solely battery powered. Surge IEC 61000-4-5 ±1kV differential ±2kV common Not Τpplicable Power frequency magnetic field IEC 61000-4-8 3 Τ/m Complies Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 >95% dip 0.5 cycle 60% dip 5 cycles 70% dip 25 cycles 95% dip 5 sec. Not Τpplicable The ME equipment is solely battery powered. d = [ 3,5 ] P V1 d = [ 3,5 ] P E1 d = [ 7 ] P E1

93 92 ‫ﻣﻧﺗ‬ ‫ﺻ‬ ‫ﻣ‬ ( ‫ﺭﻧ‬ ‫ﺩﺭ‬108-93,2) ‫ﻣ‬ ‫ﺩﺭ‬42,2-34 : ‫ﺿ‬ ‫ﺭ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺩﺭ‬ ‫ﻧﻁ‬ ( ‫ﺭﻧ‬ ‫ﺩﺭ‬104-50) ‫ﻣ‬ ‫ﺩﺭ‬40-10 :‫ﻝ‬ ‫ﺗﺷ‬ ‫ﻁ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺩﺭ‬ ‫ﻧﻁ‬ ( ‫ﺭﻧ‬ ‫ﺩﺭ‬ 131–13-) ‫ﻣ‬ ‫ﺩﺭ‬ 55–25- :‫ﻥ‬ ‫ﺯ‬ ‫ﺗ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺩﺭ‬ ‫ﻧﻁ‬ ( ‫ﺗﻛﺛ‬ ‫ﻥ‬ ‫)ﺩ‬ %95-10 ‫ﻧﺳﺑ‬ ‫ﺑ‬ ‫ﺭﻁ‬ :‫ﻥ‬ ‫ﺯ‬ ‫ﺗ‬ ‫ﻝ‬ ‫ﺗﺷ‬ ‫ﻧﺳﺑ‬ ‫ﺑ‬ ‫ﺭﻁ‬ ‫ﺭﻧ‬ ‫ﻣ‬ ‫ﺩﺭ‬0.1 :‫ﺭﺽ‬ ‫ﺩ‬ ‫ﺑﺭ‬ ‫ﻣ‬ ‫ﻁ‬ ‫ﺻ‬ ‫ﺩ‬ ‫ﺿ‬ ‫ﺭ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺩﺭ‬ ‫ﻧﻁ‬ ‫ﺩ‬ ‫ﻣ‬ ‫ﺩﺭ‬ 42- ‫ﻣ‬ ‫ﺩﺭ‬ 35 ( ‫ﺭﻧ‬ ‫ﺩﺭ‬0,4 ±) ‫ﻣ‬ ‫ﺩﺭ‬0,2 ± :( ‫ﺭﻧ‬ ‫ﺩﺭ‬107,6- ‫ﺭﻧ‬ ‫ﺩﺭ‬ 95) ( ‫ﺭﻧ‬ ‫ﺩﺭ‬0,5 ±) ‫ﻣ‬ ‫ﺩﺭ‬0,3 ± : ‫ﻧﻁ‬ ‫ﺫ‬ ‫ﺭ‬ ( ‫ﺭﻧ‬ ‫ﺩﺭ‬0,26 ±) ‫ﻣ‬ ‫ﺩﺭ‬0,14 ± : ‫ﻛ‬ ‫ﻧ‬ ‫ﻛ‬ ‫ﺗﺭﺩﺩ‬ ‫ﺱ‬ 600/‫ﻥ‬ ‫ﻣ‬ : ‫ﺭ‬ ‫ﺑﻁ‬ ‫ﻣﺭ‬ ‫ﺳﻧ‬5 : ‫ﺩﻣ‬ ‫ﻣﺭ‬ ‫ﻁ‬ ‫ﺿ‬ 1 ‫ﺻﻝ‬ ‫ﻁ‬ ‫ﺿ‬ ‫ﺫ‬ ‫ﺭﺗ‬ ‫ﻧﺩ‬ ‫ﻁ‬ ‫ﺿ‬ 1 ‫ﻧﺩ‬ ‫ﻣﻝ‬ ‫ﺻﺹ‬ ‫ﻣ‬ ‫ﺫ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺱ‬ ‫ﻣ‬ .(‫ﻝ‬ ‫ﺳﻛ‬ ‫ﺑ‬ ‫ﻛﺗ‬ 1060 – 700) ‫ﺩ‬ ‫ﺳﺗ‬ ‫ﻣ‬ ‫ﺗ‬ ‫ﻧﻅﺭ‬ ‫ﻣﻁﺑ‬ ‫ﻁ‬ ‫ﻣ‬ ‫ﺯ‬ BF ‫ﻧ‬ ‫ﻣﻥ‬ 10 °C 40 °C ‫ﻝ‬ ‫ﺗﺷ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺩﺭ‬ ً ‫ﺑ‬ ‫ﻥ‬ ‫ﺯ‬ ‫ﺗ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺩﺭ‬ .‫ﺭ‬ ‫ﺷ‬ ‫ﻥ‬ ‫ﺩ‬ ‫ﺭ‬ ‫ﺗ‬ ‫ﺭﺿ‬ : ‫ﺗ‬ ‫ﺭ‬ ‫ﻣ‬ ‫ﺯ‬ ‫ﺫ‬ ‫ﻣﺗﺛﻝ‬ Standard Reference EditionTitle: EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device). EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. EN ISO 14971: 2014 Medical devices – Τpplication of risk management to medical devices. EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. EN 980: 2008 Symbols for use in labeling of medical devices. EN 1041: 2008 Information supplied by the manufacturer of medical devices. EN 60601-1-11: 2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. ‫ﺑ‬ ‫ﺭ‬ ‫ﻧ‬ ‫ﺛ‬ ‫ﻁ‬ ‫ﺷﺭ‬ ‫ﻣﻧﺗ‬ ‫ﺫ‬ ‫ﻣﺗﺛﻝ‬ ‫ﺑ‬ ‫ﻣﺗﻁ‬ ‫ﺻ‬ ‫ﺗ‬ ‫ﺻ‬ . ‫ﺳ‬ ‫ﻁ‬ ‫ﻧ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﻛ‬ ‫ﺗ‬ ‫ﺑ‬ ‫ﺗ‬ ‫ﻣ‬ ‫ﺻ‬ ‫ﺭ‬ ‫ﺑ‬ ‫ﺗﺩ‬ ‫ﺗ‬ ‫ﺗ‬ ‫ﺭﺑ‬ ‫ﻛ‬ ‫ﻁﺑ‬ ‫ﺯ‬ .(‫ﻥ‬ ‫ﺿﻣ‬ ‫ﺑﻁ‬ ‫ﻧﻅﺭ‬ ) ‫ﺑ‬ ‫ﺹ‬ ‫ﺗﻣﺩ‬ ‫ﻣ‬ ‫ﻣ‬ ‫ﺩﻣ‬ ‫ﺑﻣﺭﻛﺯ‬ ‫ﻝ‬ ‫ﺗﺻ‬ ‫ﺑ‬ ‫ﺿﻝ‬ ‫ﺗ‬ (EMC) ‫ﺳ‬ ‫ﻁ‬ ‫ﻧ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﻛ‬ ‫ﺗ‬ . ‫ﺭﺑ‬ ‫ﻛ‬ ‫ﻁﺑ‬ ‫ﺯ‬ ‫ﺛﺭ‬ ‫ﺗ‬ ‫ﻥ‬ ‫ﺩ‬ ‫ﺭ‬ ‫ﺗﺭﺩﺩ‬ ‫ﺫ‬ ‫ﻣﺗﻧ‬ ‫ﻝ‬ ‫ﺗﺻ‬ ‫ﺯ‬ ‫ﻣ‬ ‫ﻣ‬ ‫ﻝ‬ ‫ﺗﺻ‬ ‫ﺯ‬ ‫ﻣﻛﻥ‬ . ‫ﻣ‬ ‫ﺩ‬ ‫ﺳﺗ‬ ‫ﻣﺭ‬ ‫ﻧ‬ ‫ﻣﻧﺯ‬ ‫ﻧ‬ ‫ﻣﻧﺗ‬ ‫ﻣﻥ‬ ‫ﺹ‬ ‫ﺗ‬ ‫ﺩ‬ ‫ﺭ‬ . ‫ﻣ‬ ‫ﻁﻧ‬ ً ‫ﻁﺑ‬ ‫ﻣ‬ ‫ﻣ‬ ‫ﻣ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﺭ‬ ‫ﺑﻁ‬ ‫ﻣﻥ‬ ‫ﺹ‬ ‫ﺗ‬ ، ‫ﺑ‬ ‫ﻣ‬ ‫ﺳ‬ ‫ﻁ‬ ‫ﻧ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﻛ‬ ‫ﺛ‬ ‫ﻧﺑ‬ - ‫ﱢ‬‫ﻧ‬‫ُﺻ‬‫ﻣ‬ ‫ﺷﺭﻛ‬ ‫ﻥ‬ ‫ﺑ‬ ‫ﺩ‬ ‫ﺭﺷ‬ ‫ﻝ‬ ‫ﺩ‬ . ‫ﺩﻧ‬ ‫ﺩﺩ‬ ‫ﻣ‬ ‫ﺳ‬ ‫ﻁ‬ ‫ﻧ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﻛ‬ ‫ﺑ‬ ‫ﺩ‬ ‫ﺳﺗ‬ ‫ﺩ‬ ُ‫ﻣ‬ ‫ﺫ‬ IRT 6520/6020 ‫ﺭﺑ‬ ‫ﻛ‬ ‫ﻁﺑ‬ ‫ﺯ‬ . ‫ﺑ‬ ‫ﺫ‬ ‫ﻣ‬ ‫ﺩ‬ ‫ﺳﺗ‬ IRT 6520/6020 ‫ﺭﺑ‬ ‫ﻛ‬ ‫ﻁﺑ‬ ‫ﺯ‬ ‫ﺩ‬ ‫ﻣﺳﺗ‬ ‫ﻝ‬ ‫ﻣ‬ ‫ﺭﺹ‬ ‫ﻥ‬ ‫ﺛ‬ ‫ﻧﺑ‬ ‫ﺭ‬ ‫ﺧﺗﺑ‬ ‫ﺗ‬ ‫ﺩ‬ ‫ﺭﺷ‬ ‫ﻝ‬ ‫ﺩ‬ - ‫ﺳ‬ ‫ﻁ‬ ‫ﻧ‬ ‫ﻣ‬ ‫ﺭ‬ ‫ﻛ‬ ‫ﺋ‬ ‫ﺑ‬ ‫ﺗﺭﺩﺩ‬ ‫ﺫ‬ ‫ﺛ‬ ‫ﻧﺑ‬ CISPR 11 ، ‫ﺩ‬ ‫ﺭ‬ 1 ‫ﻣ‬ ‫ﻣ‬ ‫ء‬ ‫ﺩ‬ ‫ﺩ‬ ‫ﺭ‬ ‫ﺗﺭﺩﺩ‬ ‫ﺫ‬ ‫ﻁ‬ ‫ﺭﺑ‬ ‫ﻛ‬ ‫ﻁﺑ‬ ‫ﺯ‬ ‫ﺫ‬ ‫ﺩ‬ ‫ﺳﺗ‬ ‫ﺩ‬ ‫ﺭ‬ ‫ﺗﺭﺩﺩ‬ ‫ﺫ‬ ‫ﺛ‬ ‫ﻧﺑ‬ ‫ﻥ‬ ‫ﺛ‬ ‫ﻣﻥ‬ .‫ﻁ‬ ‫ﺩ‬ ‫ﺗ‬ ‫ﻅ‬ ‫ﺯ‬ ‫ﻣ‬ ‫ﻝ‬ ‫ﺗﺩ‬ ‫ﺗﺳﺑ‬ ‫ﻥ‬ ‫ﺭ‬ ً‫ﺩ‬ ‫ﻥ‬ ‫ﺗﻛ‬ ‫ﻣﻧ‬ ‫ﻣﻧﻁ‬ . ‫ﺭ‬ ‫ﻧ‬ ‫ﻛﺗﺭ‬ ‫ﺗﺭﺩﺩ‬ ‫ﺫ‬ ‫ﺛ‬ ‫ﻧﺑ‬ CISPR 11 ، ‫ﺩ‬ ‫ﺭ‬ ‫ﻣﺗ‬ ‫ﻧﺳ‬ ‫ﻣﺗ‬ ‫ﺛ‬ ‫ﻧﺑ‬ IEC 61000-3-2 ‫ﻧﻁﺑ‬ . ‫ﻁ‬ ‫ﻛﻣﺻﺩﺭ‬ ‫ﻁ‬ ‫ﺭ‬ ‫ﺑﻁ‬ ‫ﺭﺑ‬ ‫ﻛ‬ ‫ﻁﺑ‬ ‫ﺯ‬ ‫ﺫ‬ ‫ﺗﻣﺩ‬ ‫ﺛ‬ ‫ﻧﺑ‬ /‫ﺩ‬ ‫ﺑ‬ ‫ﺗ‬ ‫ﻣﺿ‬ ‫ﻧﻁﺑ‬ ‫ﻣ‬ ‫ﺩ‬ ‫ﺭ‬ ‫ﺯ‬ ‫ﺻ‬ ‫ﻣﺳ‬ ‫ﺳ‬ (‫ﻣﺗﺭ‬/ 3 / ‫ﻣﺭﺑ‬ ‫ﺳﻁ‬ ‫ﻣﺗ‬ ‫ﺫﺭ‬ 3 ‫)ﺗ‬ ‫ﺭ‬ ‫ﻁ‬ ‫ﺭ‬ ‫ﺩ‬ ‫ﺗ‬ ‫ﺻ‬ ( ‫)ﺑ‬ ‫ﻝ‬ ‫ﺭﺳ‬ ‫ﺯ‬ ‫ﻣﻥ‬ (‫ﻣﺗﺭ‬ ‫)ﺑ‬ ‫ﻝ‬ ‫ﺭﺳ‬ ‫ﺯ‬ ‫ﺗﺭﺩﺩ‬ ً ‫ﺻ‬ ‫ﻣﺳ‬ 80 ‫ﺭﺗﺯ‬ ‫ﻛ‬ 150 ‫ﺭﺗﺯ‬ ‫ﻣ‬ ‫ﻛ‬ ‫ﺳ‬ ‫ﻧﻁ‬ ‫ﻣ‬ ‫ﺻﻧ‬ (ISM) ‫ﻁﺑ‬ ‫ﺭﺗﺯ‬ ‫ﻣ‬80 ‫ﻣ‬ 800 ‫ﺭﺗﺯ‬ ‫ﺭﺗﺯ‬ 2,5 ‫ﺭﺗﺯ‬ ‫ﻣ‬800 0,01 0,12 0,12 0,23 0,1 0,37 0,37 0,74 1 1,17 1,17 2,33 10 3,69 3,69 7,38 100 11,67 11,67 23,33 d = [ 3,5 ] P V1 d = [ 3,5 ] P E1 d = [ 7 ] P E1