Description Of This Thermometer Read And Save These

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TM Digital Clinical Thermometer/ LS-330 Description of this Thermometer ① LCD ② Standby/ scan button ③ Measuring tip Thank you for purchasing this LifeSmart digital thermometer. Read and save these instructions Before using your device, please read these instructions and warnings completely. Remove the transparent protective layer from the thermometer panel before the first use. Features • Big size of LCD. • Have backlight design in order to operate in dark. • Flexible probe enables easy, safe and gentle measurement. • Suitable for oral, rectal and armpit measurement. • High body temperature indication function • Beeping indication at the end of measurement • Last measure memory • Automatic switch off • IPX7, can be water resistance • Aesthetic Design Don’t take temperature after sports, bathing or swimming. ● Playing sports will enhance the body temperature. Please wait for 15 to 30 minutes before taking temperature. Protect the thermometer from impact and dropping! The minimum measurement time until the beep is heard must be maintained without exception! The operating ambient temperature range for this thermometer is 10-35°C(50-84.5°F)。 The thermometer must be stored according to the technical specifications. Strong electromagnetic fields can effect the correct functions of the thermometer. RECOMMENDATIONS ① Don’t use this thermometer for other purposes other than measuring human body temperature. ② It is forbidden to leave the product exposed to any chemical solvent, direct sunshine or high temperature. INTENDED USE Except for measurement of armpit, oral and rectal temperature, don’t use this product for other purposes. It can be used for anybody, e.g. for new-born, for children and adults. HOW TO USE THE THERMOMETER LCD display Safety Precautions MARKS OR SYMBOLS MUST OBSERVE Means Obligatory with detailed items expressed in words or figures within or beside the mark. Left one means General Compulsory. PROHIBITION Means Forbidden with detailed items expressed in words or figures within or beside the mark. Left one means General Forbidden. Turning on the Thermometer To turn on the thermometer, the LCD will be fully display. LCD would show last reading about 2 seconds with backlight flash also, then enter self-check. If the last reading is below 32°C, LCD would show for 2 sec. Function Test Means a possibility of personal injury in case of improper use. Correct functioning of the thermometer is tested automatically each time it is turned on. If a malfunction is detected (thermistor is open-circuit or short-circuit), should be showing the “Err” in the LCD, and a measurement becomes impossible. In this case, the thermometer must be replaced. Means a possibility of personal injury or property damage in case of improper use. °C and °F unit switching function Pressing the Standby/ Scan button ( ) for 4 seconds at power saving mode, after the all segments should be displayed, the temperature unit will be switching “°C” to “°F” or “°F” to “°C”. Before the first use and after every successive use, clean and sanitize the thermometer’s using medical alcohol. ● Use of thermometer without prior disinfection may communicate pathogenic bacteria. To keep healthy, please put on the probe cover when measuring oral temperature. ● You may still get infected by the remaining bacteria when you take the oral temperature even you disinfected the thermometer. If got hemorrhoids, please don’t take rectal temperature. ● The measuring probe of thermometer may hurt the hemorrhoids The thermometer is not a toy; store it in a safe place out of reach of children. ● The children may damage the thermometer or swallow the battery. Avoid temperatures above 60°C. NEVER boil the thermometer! ● The over-heating temperature may damage the device and cause fire. The measuring result can only used for health monitoring and reference. Please don’t conduct diagnose and treatment based on the measuring result, if you find the body temperature is abnormal, please contact your doctor. Don’t use any sharp tool, scissors etc. to scissor, cut , shear, scratch the measuring probe. ● When you use again, the measuring probe parts may be pealed off and swallowed by the bite and pull. Don’t take temperature after drinking hot water. ● The hot water will enhance the oral temperature temporarily,and might cause result variations. Don’t take the temperature immediately when you take the medicine which may enhance the body temperature. ● The body temperature may be enhanced under the drug effect. Don’t talk or eat when you are measuring the oral temperature. During the measurement, use nose to breath to prevent the probe getting exposed to air. High body temperature hint function If the measurement value ≥37.6°C, it would have sound with “Bi Bi……” lasting 3 times, and the red LCD backlight on about 5 seconds. Using the Thermometer Place the thermometer at the measuring site before switching it on in order to achieve the most accurate result. Choose the preferred measuring method. After self-check, LCD shows symbol. After °C the symbol flashs , put the thermometer inside the measuring location. In 8-10 seconds, the measurement will end when the °C the symbol stops flashing. If the beep is heard determined and the thermometer “°C” or “°F” is no loner flashing, the measuring has been completed and the thermometer can be read now. To prolong the battery life, turn off the thermometer or it will automatically turn off after about 3±0.5 minutes. Measuring Methods ◆ In the mouth (oral) Post the thermometer in one of the two pockets under the tongue, to the left or right of the root of the tongue. The measuring probe ( ③ ) must be in good contact with the tissue. Close your mouth and breathe evenly through the nose to prevent the measurement from being influenced by inhaled/exhaled air. After the measurement, LCD would show the value with “BI BI……” sound three times. To reduce the risk of infection it is recommended to use a probe cover while taking measurements. Probe cover is not included in the package, please buy them from professional thermometer market with CE mark and comply with biocompatibility requirements. ◆ In the armpit (axillary) Place the probe tip ( ③ ) under the armpit parallel to the arm, pressing the arm against the body. Hold the thermometer in this position until you Heard the beep sound 3 times, the measuring is finishing. To receive more reliable results we recommend to Measure temperature orally or rectally. ◆ In the anus (rectal) This is the most reliable measuring method, and is especially suitable for infants and small children. Carefully insert the measuring probe ( ③ ) of the thermometer 2 to 3cm into the anal aperture. Note: To take the rectal temperature of a new born, baby, lay the baby on its back on a hard surface and lift its legs to an angle of approximately 90°. Hold them by the ankles in order to prevent their body from turning while taking the temperature. Remember that the internal body temperature is always slightly higher than the external temperature (about 0.5°C). When the measuring is completed, read the measurement value by LCD. It activates the backlight according to the temperature range. - If the value is between 37.6°C-43.9°C, it has “BI BI……”sound three times,and the red LED light on 5 second. - If the value is between 32°C-37.5°C, it has “BI BI……”sound three times,at 36.2°C-37.5°C (97.2°F-99.5°F) range, the green LED light on 5 second. After taking the temperature, press the “Standby/ Scan button” ( ② ) (if you forget to thermometer off, it is switched off automatically after about 3±0.5 minutes). After the measurement, put the thermometer into the protective cover. High body temperature hint ≥37.6°C(99.7°F) Grade of waterproof IP22 Electric shock Internally powered ME equipment Applied part Type BF applied part Mode of operation Continuous operation Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT Standard list Famidoc Technology Co., Ltd declares that the FDTH-V0-4 complies with following applicable standards: EN ISO 15223-1 EN 1041 Information supplied by the manufacturer with medical devices EN 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance EN 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests Clinical thermometers- Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Medical device software - Software life-cycle processes EN 12470-3 Cleaning and disinfecting EN 62304 Use an medical alcohol ( ≧ 75%) swab or cotton tissue moistened with alcohol (70% Isopropyl) to clean the measuring probe of thermometer. In order to guarantee your health, please disinfect the measuring probe according to above procedures before and after the measurement. If the unit body is smudged, use a soft, dry cloth to clean the thermometer display and exterior. EN ISO 10993-1 NOTES: ● Don not use abrasive cleaners. ● Don’t use other non-recommended methods to perform disinfection. Storage ● Don’t leave the thermometer exposed to high risk, direct sunshine, high temperature, dampness, fire, flame, vibration or impact. ● Remove the battery for long time of no use. Calibration The thermometer is initially calibrated at the time of manufacture. We recommend this thermometer is tested for accuracy every two years or after device impact (e.g. being dropped). Accessories Only use original accessories. Check that the contents of the delivery are complete. Quantity 1pc 1pc 1pc Parts LS-330 device Transparent protective cover User Manual Checklists or situation Countermeasures or solution No response/ Automatically Battery used up? Replace new battery reset Battery in wrong polarity or Take out battery, reinsert type? it correcty Poor battery contact Follow User’s Manual to reTemperature taken is not measurement; within typical human temperature range (32.0Make sure a new, clean 43.9°C or 89.6-111.0°F) probe cover is attached and Hi= too high thermometer is properly inserted. Then, take a new --- = too low temperature. Technical Specifi ations Model Measurement mode Measurement type Measurement range Measurement accuracy Disposal Dispose of the device in accordance with the regulations applicable at the place of operation. Dispose of at public collection point in the EU countries – 2002/96/EC WEEE Directive. If you have any queries, please refer to the local authorities responsible for waste disposal. NOTES: • Handling of battery and wastes method, please act according to the native law to proceed to handle. • Take out the battery if you are not going to use the unit for a long time. To protect the environment, dispose of empty battery at your retail store or at appropriate collection sites according to national or local regulations. NORMALIZED SYMBOLS Follow operating instructions BF type applied part Disposal in accordance with Directive 2002/96/EC (WEEE) Trouble-shooting Troubles or error message IEC 60601-1-11 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 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 LS-330 Highest temperature hold Predictive thermometer 32.0-43.9°C(89.6-111.0°F) ±0.1°C(or±0.2°F): from 35.5-42.0°C(95.9-107.6°F) ±0.2°C(or±0.4°F): form other ranges Digital increment of displayed tem0.1°C/ 0.1°F perature Operation environment: 10-35°C (50-95°F); 20-85% RH Storage environment: -25-55°C (-13-131°F); 20-85% RH Power supply d.c. 3V, one CR1632 battery Measurement time 8-12s (for human body) Measurement memory Last time memory display Complies with the European Medical Device Directive (93/42/EEC and amended Directive 2007/47/EC.Notified Body is SGS United Kingdom Ltd. Manufacturer information: The manufacturer is: Famidoc Technology Co., Ltd. Batch code Date of manufacture WARRANTY One year warranty + One year extended warranty Your digital thermometer is durable and manufactured for normal household use. Following directions carefully will ensure years of dependable operation. If for any reason (other than misuse and normal battery replacement) you are dissatisfied with your thermometer, we will repair or replace it, at our option, free during the warranty period. Modification to the product by the consumer is not authorised and voids the warranty. Manufactured For: GENESIS BIOTECH PTY LTD Address: Level 1, 16 McDougall Street, MILTON QLD 4064 Australia www.mylifesmart.net.au For Australia & New Zealand customers [email protected] Australian customers 1300 110 155 Famidoc Technology Co., Ltd. Add. : No. 212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town, Dongguan, Guangdong Province, P.R. China. PC: 523853 Tel: +86-769-89272488 Fax: +86-769-89272498 Website: www.famidoc.com Shanghai International Holding Corp. GmbH(Europe) Add: Eiffestrasse 80, 20537 Hamburg Germany Tel: +49-40-2513175 Fax: +49-40-255726 Copyright 2015 Edition: V1.0 ● Medical device – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements