AVITA TSW-15XX Infrared Thermometer User Manual TS42B Manual 150922 final

AVITA Corporation Infrared Thermometer TS42B Manual 150922 final

User Manual

 Model: TS42B     INSTRUCTION MANUAL Please read this instruction manual carefully before using your ear thermometer  Contents  Introduction  1 Important Information Before Use  2 Product Identification  3 Description of LCD Display  4 Battery Installation  5 Setting °C/°F and Date/Time  6 Tips for Measuring Human Temperature  10 Measuring Body Temperature on the Forehead  11 Measuring Body Temperature in the Ear  12 Clinical Accuracy Validation Method  13 Measuring Object/Liquid Temperature  14 Memory Function  15 Care and Maintenance  16 Applied Standards  16 Error Codes  17 Operating the Bluetooth function  18 Technical Specifications  19 EMC Tables  20 Explanation of Symbols  23 FCC Statement                                 24
  Introduction  for Use: The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages. This thermometer takes temperatures in seconds by measuring the heat generated by the earcanal or other objects. This product conforms to the provisions of the EC directive MDD(93/42/EEC).Its advantages include:  1.  Bluetooth Low Energy v4.0 2.   7 in 1 functions  Ear/Forehead/Object/Date-Time-Stamp/  30 User Memory/Fever Alarm/Backlight/ 3.   Red LED Light for Fever Alarm  ≧38°C: LED light Red 4.   30 User Memory 5.   Illuminated Backlight Display 6.   °C/°F Switch-able Function 7.   Probe Cover Free 8.   Waterproof Probe Design 9.  One-second Reading 10. Auto power off for power saving 11. Low-battery  Indicator 12. Warning  indication   Indications for battery condition and measuring range. 13.Large LCD Display     1   Important Information Before Use  When using this product, please be sure to follow all the notes listed below. Any action against these notices may cause injury or affect the accuracy. 1.   Do not disassemble, repair, or remodel the thermometer.2.   Be sure to clean the thermometer lens each time after usage. 3.   Avoid direct finger contact with the lens. 4.   No modification of this equipment is allowed. 5.   It is recommended that user may take 3 temperatures. If they are different, use the highest reading. 6.   Do not expose the thermometer to extreme temperature, very high humidity, or direct sunlight. 7.   Avoid extreme shock or dropping the device. 8.   Before the measurement, patients and thermometer should stay in steady state room condition for at least 30 minutes. 9.   Avoid measuring temperature in 30 minutes after exercise, bathing, or returning from outdoor. 10. To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations. 11. It is ill-advised to disassemble the thermometer. 12. Please use the thermometer solely for its intended purpose. 13. Carefully hold the device when in use to avoid dropping the device. 14. Allow one minute between successive measurements as slight variations may occur if measurements are taken over a short period of time. Use average temperatures instead. 15. There are no absolute body temperature standards. Keep reliable records of your personal temperature to serve as a reference for judging a fever. 16. Under any circumstances, the temperature taking result is ONLY for reference. Before taking any medical action, please consult your physician. 2
  Product Identification  3   Description of LCD Display   4
  Battery Installation  Low battery warning:   When the battery power becomes low, the low battery symbol will appear on the display. The thermometer can still be used during this time, but the batteries should be replaced as soon as possible. If the batteries run out completely, “Lo” will be displayed along with the low battery symbol. In this case, the batteries will need to be replaced before using the thermometer again. Replacing the Battery: 1.  Use a Phillips head screwdriver to loosen battery cover screw. Remove the battery cover. 2.  Insert or replace 2 x 1.5 V AAA alkaline batteries into the battery compartment, ensuring to match the indicated polarity symbols. Always use new batteries. 3.  Place the battery cover on the thermometer and tighten the screw to secure it in place.  NOTE: Battery-operated 1.  Please properly dispose of the batteries away from small children and heat. 2.   It is recommended to remove the batteries if the unit will not be used for an extended period of time. 3.   For long durations of non-operation, please remove all batteries from the device. 4.   Batteries must be disposed of in accordance with local environmental and institutional policies. 5.   Dispose of used batteries in accordance with the applicable legal regulations. Never dispose of batteries in the normal household waste. 5   Setting °C/°F and Date/Time         6
  Setting °C/°F and Date/Time  When the thermometer is used for the first time and each time the batteries are changed, the date and time are displayed in the format 1-1 00:00 during the basic set-up (after the self test). Set each of the following settings in turn : unit in which the temperature will be displayed, date and time. To set the device, proceed in stages: Unit – year – month – day – hours – minutes (there is no voice output when setting date and time).  Press the SET button for 5 second to switch the thermometer on. The device performs a brief self test: all elements of the display are shown for approx. 1 second.  Following a successful self test, the device emits two short beeps. In Standby mode, the date and time are shown and “--” is displayed.   7   Setting °C/°F and Date/Time  1. Changing from Fahrenheit to Celsius (1) Press the "SET" button to set the °C/°F function on or off. (2) Press the “Memory” button to confirm entry.  2. Date/Time Function (1)  Press the "SET" button to change. (2)  Press the "Memory" button to confirm entry. (3)  The blinking Date, followed by Year, Hour and Minutes will display. Repeat steps (2) and (3) to adjust the date/time setting. (4)  Your unit is now ready to take a reading, or press the “MEM” button to turn the unit off.   (5)  After this process, the thermometer shows the word “OFF” in the display and switches off automatically.      8
  Setting °C/°F and Date/Time            9   Tips for Measuring Human Temperature  Bear in mind that the thermometer needs to have been in the room in which the measurement is taken for at least 30 minutes before use. •    Some people produce different readings in their left and right ear. In order to record temperature changes, always measure a person’s temperature in the same ear. •    The ear thermometer may be used by children only under adult supervision. Measurement is usually possible over the age of 6 months. In infants under 6 months, the ear canal is still very narrow so the temperature of the eardrum often cannot be recorded and the result displayed is often too low. •    The measurement must not be taken in an ear affected by inflammatory diseases (e.g. discharging pus or secretion), after possible ear injuries (e.g. eardrum damage) or in the healing period after operative procedures. In all of these cases, please consult your doctor. •    Use of the thermometer on different persons can be inappropriate in the event of certain acute infectious diseases because of the possible spread of germs despite cleaning and disinfection. If you have any doubts, please consult your doctor. •    This thermometer may only be used without a disposable protective cover.   •    If you have been lying on one ear for some time, the temperature is slightly raised. Wait a little while or measure in the other ear. •    As ear wax can affect the measurement, you should clean the ear before measuring if necessary. 10
  Measuring Body Temperature on the Forehead  NOTE: The forehead/temples must be free from sweat and cosmetics and that taking medication and skin irritations can distort the result when measuring temperature on the forehead.  1.   Press the Forehead mode button or On botton for 1 second to switch the thermometer on. Following a successful self test, the device emits two short beeps.   2.   Place the measuring head with the Forehead/Cover cap fitted on the temples, hold on the Forehead mode Button and move the thermometer smoothly over the forehead to the other temple.  3.   Release the Forehead Scan Button. The end of the measuring time is signaled with a short beep and the measured value appears on the display.        11   Measuring Body Temperature in the Ear  1.   Press the Power button for 1 second to switch the thermometer on. Following a successful self test, the device emits two short beeps. 2.   Remove the cap by gently pushing it up (1) and then pulling it off forwards (2).      3.   Make sure that the sensor tip and also the ear canal are clean. As the ear canal is slightly curved, you have to pull the ear slightly up and backwards before inserting the sensor tip. This is important so that the sensor tip can be pointed directly at the eardrum.  Position thermometer probe properly in ear canal: •  Under 1 year: Have child lay flat with the head sideways, so that the ear is facing upwards. Gently pull the ear straight back. •  1 year +: Stand behind and slightly to the side of the child/adult. Gently pull the ear up and back to straighten the ear canal.         4.   Insert the sensor tip carefully and press the Power button for 1 second.  12
  Measuring Body Temperature in the Ear  5.   Release the button. The end of the measuring time is signaled with a short beep and the measured value appears on the display.      NOTE: Fever Alarm: Only in Human Mode  ≧38°C: LED light Red If the temperature measurement is 38°C or above, meanwhile the backlight and alert light (RED) will light for 3 sec and then the voice pronouncing.  Clinical accuracy validation method  TS42B is an adjusted mode clinical thermometer the validated information for clinical accuracy in each adjusted mode are:  GroupA1:    cb=-0.01°C, LA=0.18, σr=±0.08°C GroupA2:    cb= 0.06°C, LA=0.22, σr=±0.08°C GroupB :    cb=-0.01°C, LA=0.20, σr=±0.07°C GroupC :    cb=-0.01°C, LA=0.18, σr=±0.07°C  cb: CLINICAL BIAS LA: LlMITS OF AGREEMENT σr:CLINICALREPEATABILITY 13   Measuring Object/Liquid Temperature    1.   Press the Power button for 1 second to switch the thermometer on. Following a successful self test, the device emits two short beeps. 2.   Then press the “Memory” and “SET” buttons simultaneously for 3 seconds to switch to the  “Object Scan Mode ”.   The    symbol appears in the display. 3.   Point the sensor tip towards the object or liquid (maintaining a distance of 3 cm), then take one press on Forehead mode button or Ear mode button to take a measurement (never immerse in liquids). 4.   After the measurement process is complete, there comes a short beep and the measured value appears on the display. 5.   Please note that the displayed temperature is the measured and not the adapted surface temperature. It is not the same as the temperature. 6.  To switch back to the thermometer mode, press the “Memory” and “SET” buttons simultaneously for 3 seconds until the “ ” symbol disappears and there is a short beep.    14
  Memory Function    You can recall up to 30 measurements plus an average    of all currently stored measurements in memory to share with your physician or trained healthcare professional.  1.   Press the “Memory” button. The first reading displayed is the latest measurement stored in memory.   2.  Continue to press the  “Memory” button to view the next previously stored measurement.   3. Automatically on the 31th measurement: when the 30 memories have been used up, any new measurement will be recorded and the oldest memory deleted without you having to do anything.        15   Care and Maintenance •  Probe and Tip: Clean the probe and tip with an alcohol swab before and after each measurement. •  Thermometer: Use a soft, dry cloth to clean thermometer body. Never use abrasive cleaning agents, thinners or benzene for cleaning. Do not scratch the surface of the probe lens or the display. Do not expose the thermometer to extreme temperatures, humidity, direct sunlight, or shock.     Applied Standards  This product conforms to the provisions of the EC directive MDD(93/ 42/ EEC). The following standards apply to design and/or manufacture of the products:  ‧  ISO 80601-2-56 Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ‧  IEC/EN 60601-1 Medical electrical equipment- Part 1: General requirement for safety ‧  IEC/EN 60601-1-2 Medical electrical equipment- Part 2: Collateral standard: Electromagnetic compatibility - Requirements and tests    16
  Error Codes  When a malfunction or incorrect temperature measurement occurs, an error message will appear as described below (comes with backlight).  LCD Display  Cause  Solution  The temperature measured is higher than 1. Human thermometer mode:  42°C (107.6°F) 2. Object temperature mode:   100°C (212.0°F)  The temperature measured is lower than 1. Human thermometer mode:  35°C (95°F) 2. Object temperature mode:  10°C (50°F) Operate the thermometer only between the specified temperature ranges. If necessary, clean the sensor tip. In the event of a repeated error message, contact your retailer or Customer Services.  The operating temperature is not in the range 15°C~35°C (59°F~95°F) Operate the thermometer only between the specified temperature ranges.      17   Operating the Bluetooth function  What You Need TS42B Bluetooth IR Ear Thermometer An Android device with Android version 4.3 or above and hardware support for Bluetooth 4.0. An iOS device with iOS version 5 or above and hardware support for Bluetooth 4.0. All devices Apple released since the iPhone 4S (including the 4S) do, the older ones don’t.  Note: Please refer to the instruction manual of your smart phone for how to activate the Bluetooth function.  Set Up Process 1. Download an app which supports Bluetooth 4.0 from the iTune App Store or Google Play. 2. Enable Bluetooth on your mobile device. 3. Open the app and activate the scan function. 4. Turn on the TS42B. 5. The app should automatically detect your TS42B. Tap the TS42B that is showed in the device list. 6. Your TS42B is now successfully connected to your mobile device. Every temperature reading will be transfer to your mobile device automatically.   18
  Technical Specifications  •  Range of Measurement : Human Body: 35°C – 42°C (95°F – 107.6°F) Object Mode: 10°C – 100°C (50°F – 212°F) •  Measuring accuracy : Human Body:  35°C – 42°C (95°F – 107.6°F)  ±0.2°C (0.4°F) Object Mode:  ±2°C(±4°F) or  ±5% •  Operating environment : 15°C – 35°C   (59°F – 95°F)     with relative humidity up to 85% (noncondensing) •  Storage/ Transportation environment : -25°C – 55°C   (-13°F ~+131°F)   with relative humidity up to 85% (noncondensing) •  Display resolution : 0.1°C or  °F •  Power supply : 2 X 1.5V AAA size alkaline batteries •  Memory: 30 sets •  Weight : 65g (exclude batteries) •  Dimensions : 134.3mmX42.4mmX47.6mm (L×W×H) •  Bluetooth : Bluetooth Low Energy v4.0               19   EMC Tables     20
  EMC Tables             21   EMC Tables                22
  Explanation of Symbols   Notified Body (TÜV Rheinland)  Consult the instruction for use  Disposal information: Should you wish to dispose of the article, do so in accordance with current regulations. Details are available from your local authority  Type BF applied part  Basic safety and essential performance requirement  Temperature limits  European Authorized Representative  Manufacturer LOT  Manufacture batch code    23  FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.  This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.  However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:  1.  Reorient or relocate the receiving antenna. 2.  Increase the separation between the equipment and receiver. 3.  Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 4.  Consult the dealer or an experienced adio/TV technician for help. 5.  FCC Caution: To assure continued compliance, (example – use only shielded interface cables when connecting to computer or peripheral devices). Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. 6.  This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 7.   This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be colocated or operating in conjunction with any other antenna or transmitter. 24
                    72-T42MN-AV1 2015-09-03

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