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繁體中文 ThermoScan® Infrared ear thermometer IRT 6030 IRT 6520 百靈耳溫槍
1 繁體中文 This product is manufactured by Kaz Europe Sàrl under license to the ‘Braun’ trademark. ‘Braun’ is a registered trademark of Braun GmbH, Kronberg, Germany. 此產品由歐洲卡舒公司(Kaz Europe Sàrl)以百靈牌商標認可生產， 德國百靈公司(Braun GmbH, Kronberg, Germany)為百靈牌商標持有人。 ThermoScan is a registered trademark of Kaz Europe Sàrl ThermoScan 是Kaz Europe Sàrl的註冊商標 Manufactured by Kaz Europe Sàrl Place Chauderon 18 CH-1003 Lausanne Switzerland © 2014, Kaz Europe Sàrl. All rights reserved. Patents / 專利: www.kaz.com/patents/braun Designed in Germany, Made in Mexico. 0297 IRT 6030/6520AP P/N: 31IM65AP190 13JUN14 English..................................1 繁體中文..............................14
2 3 English The Braun ThermoScan® 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 Braun ThermoScan® 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 AgeSmart™ feature is not intended as a substitute for consultation with your physician. Product description IRT 6030 Lens filter (Box of 20) Probe tip Probe ExacTemp light Lens filter ejector Display Power button Start button Battery door Protective case 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 11 10 IRT 6030 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). This thermometer must only be used with genuine Braun ThermoScan® lens filters (LF 40). 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. IRT 6520 Lens filter (Box of 20) Probe tip Probe ExacTemp light Lens filter ejector Display AgeSmart and Memory buttons Power button Start button Battery door Protective case
4 5 English 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 Braun ThermoScan® . Practice taking temperatures on yourself and healthy family members to determine the normal temperature range. Note: When consulting your physician, communicate that the ThermoScan® temperature is a temperature measured in the ear and if possible, note the individual’s normal ThermoScan® temperature range as additional reference. 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. The AgeSmartTM feature is not intended for pre-term babies or small-for-gestational age babies. The AgeSmart™ feature is not intended to interpret hypothermic temperatures. Do not allow children 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 AgeSmart™ 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. Always keep the thermometer out of children’s reach. AgeSmart™ 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 AgeSmart™ color-coded display takes the guess work out of interpreting temperature for the entire family. Simply use the AgeSmart™ 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. A green screen suggests no fever, a yellow screen suggests moderate fever, and red signals high fever. 6520 How does Braun ThermoScan® work? Braun ThermoScan® 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 Braun ThermoScan® 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. Axillary 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 How to use your Braun ThermoScan® Remove the thermometer from the protective case. 1. Guyton A C, Textbook of medical physiology, W.B. Saunders, Philadelphia, 1996, p 919 2. Guyton A C, Textbook of medical physiology, W.B. Saunders, Philadelphia, 1996, p 754-5 3. Netter H F, Atlas of Human Anatomy, 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. 1. Herzog L, Phillips S. Addressing Concerns About Fever. Clinical Pediatrics. 2011; 50(#5): 383-390.
6 7 English 0-3 Mos >3-36 Mos >36 Mos – adult 3 4 5 6520 Fit the probe snuggly into the ear canal, then push and release the Start button . Select age with AgeSmart™ 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 thermometer is ready to take temperature when the display looks like the images below. 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. Attach a new lens filter by pushing the thermometer probe straight into the lens filter inside the box and then pulling out. Note: The Braun ThermoScan® will not work unless a lens filter is attached. ExacTemp light will pulse while temperature is in progress. 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 6030 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 Moderate fever >37.6 – ≤38.5 °C (>99.6 – ≤101.3 °F) >37.7 – ≤39.4 °C (>99.9 – ≤103.0 °F) Red High fever >37.4 °C (>99.4 °F) >38.5 °C (>101.3 °F) >39.4 °C (>103.3 °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 Braun ThermoScan® 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 Always 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 Yes affects Poor probe placement Used lens filter Dirty lens 6030 6520
8 9 English In the cases below, wait 20 minutes prior to taking a temperature. Factor Yes 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 Night light feature 1 1 2 3 6520 15 sec 6030 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. 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. The last temperature taken is stored in its memory and will be automatically displayed for 5 seconds when it is turned on again. Your Braun ThermoScan® 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 . After 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. After 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 the local service center. 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. Additional lens filters (LF 40) are available at most stores carrying Braun ThermoScan® . Replacing the batteries The thermometer is supplied with two 1.5 V type AA (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. Th er m oS ca n 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 The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according to the use instructions, periodic re-adjustment is not required. If at any time you question the accuracy of the temperature measurement, please contact your authorized service center. 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. An example: LOT 11614K, this product has been manufactured on the 116th day of the year 2014. 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 Changing the temperature scale Changing the temperature scale Changing the temperature scale
10 11 English Errors and troubleshooting Situation No lens filter is attached. The thermometer probe was not positioned securely in the ear. An accurate measurement was not possible. POS = position error Ambient temperature is not within the allowed operating range (10 – 40 °C or 50 – 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 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, Battery is low, but thermometer will still operate correctly. Battery is too low to take correct temperature measurement. Error Message Solution Attach new, clean lens filter. 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. Allow the thermometer to remain for 30 minutes in a room where the temperature is between 10 and 40 °C or 50 and 104 °F . 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. Wait 1 minute until the thermometer turns off automatically, then turn on again. ... reset the thermometer by re-moving the batteries and putting them back in. … please contact the service centre. Insert new batteries. Insert new batteries. 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 °C – 42 °C (95 °F – 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 / 350 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 (700-1060hPa). See Instruction for use Equipment with type BF applied parts 10 °C 40 °C Operating temperature Keep it dry Subject to change without notice. This appliance conforms to the following standards: Standard Reference Edition Title: 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 – Application 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. Medical electrical 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 Medical electrical 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. -25 °C 55 °C Storage temperature
12 13 English Guidance and manufacturer’s declaration – electromagnetic emissions The IR thermometer equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the IR thermometer should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment – guidance RF Emissions CISPR 11 Group 1 The ME equipment uses RF energy only for it’s internal func- tion. 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 Applicable The ME equipment is solely battery powered. Voltage fluctuations / flicker emissions Not Applicable Guidance and manufacturer’s declaration – electromagnetic immunity The IR thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the IR thermometer should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6kV Contact ±8kwww Air Complies Floors should be wood, con- crete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Radiated RF IEC 61000-4-3 3 V/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 3 V/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 Applicable (no electrical cabling) Electrical fast transient IEC 61000-4-4 ±2kV power line ±1kV I/O lines Not Applicable The ME equipment is solely battery powered. Surge IEC 61000-4-5 ±1kV differential ±2kV common Not Applicable Power frequency magnetic field IEC 61000-4-8 3 A/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 Applicable The ME equipment is solely battery powered. 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 Limited warranty This product comes with limited warranty commencing on the date of purchase (See warranty card for details). Within the warranty period we will eliminate, free of charge, any defects in the appliance resulting from faults in materials or workmanship, by replacing the complete appliance. This warranty is applicable only for the appliance supplied by the appointed distributor. This warranty does not cover: damage due to improper use, normal wear or use as well as defects that have a negligible effect on the value or operation of the appliance. The warranty becomes void if repairs are undertaken by unauthorized persons and if original Braun parts are not used. d = [ 3.5 ] P V1 d = [ 3.5 ] P E1 d = [ 7 ] P E1
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