Related Manuals for Tecnimed Visiofocus Smart 06470
Summary of Contents for Tecnimed Visiofocus Smart 06470
- Page 1 06470 Operating instructions Read these instructions carefully before using the thermometer CAUTION: read the warnings Rev. 9/6470-2021-09...
- Page 2 Fig. 1 SMART 1. Aiming light 2. Waveguide 3. Sensor (at the bottom of the waveguide) 4. Aiming light 5. LCD display 6. FACE button for forehead temperature readings 7. HOME button for other readings 8. MEMORY button 9. Label with serial number 10.
- Page 3 INTENDED USE: VisioFocus SMART is an infrared medical thermometer intended ® for non-contact measurement of body temperature in children and adults. It can also be used to monitor the temperature of inflammations, ulcers, wounds (e.g. on diabetics and under medical supervision). 1.
- Page 4 mometer perpendicular to the forehead. Do not take measurements on areas other than the centre of the forehead, except for the case at #4.2. ATTENTION: measurements on areas other than the centre of forehead (e.g. temples, neck, wrists) have not been clinically validated. 6.
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Page 5: How It Works
7. Since it never comes into contact with the body, VisioFocus SMART does not require any disposable protection covers. 8. ATTENTION: any serious incident that occurs in relation to the device should be reported to the manufacturer (info@tecnimed.eu) and the competent authority of your country. 3. HOW IT WORKS VisioFocus SMART detects the infrared radiation coming from the human body. - Page 6 To help you with this, fill out the table “FA- MILY MEMBER TEMPERATURES at different times of day and when in good health conditions” and keep it as a reference: https://www.tecnimed.it/download/Tables.pdf 4. HOW to USE IT 4.1 Taking the body temperature: FOREHEAD •...
- Page 7 mode (par. #7). 4.2 In case of sweating: take the reading on the eyelid At times, the forehead can show signs of Fig. 6 sweat, for example as a fever drops, and this can result in a low reading. Dry the forehead is not enough.
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Page 8: Room Temperature
5. ROOM TEMPERATURE When the thermometer is in stand-by mode (“Peak Performance” - see par. #4.1 and #7), the room temperature remains displayed automatically for 4 hours after the last reading is taken and the symbol flashes. To display the room temperature when the display is off, press the “Mem” button once: the display shows the room temperature and the symbol flashing. - Page 9 forehead (par. #4.1) or at the eyelid (par. #4.2), no matter what the current setting is: in fact, the axillary, oral, rectal or core settings provide a forehead temperature value that is a valid approximation of the axillary, oral or rectal/internal temperature respectively (see par.
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Page 10: Replacing The Batteries
example, you are moving between rooms with different temperatures. This system, too, enables the thermometer to take sufficiently accurate readings. In this case, “MQCS” appears on the display indicating that manual quick calibration has been performed. The MQCS is possible only if the room temperature is in the 10,0-45,0°C (50.0- 113.0°F) temperature range. - Page 11 11. MEANING OF DISPLAY MESSAGES Messages about batteries DESCRIPTION: during normal operation, the symbol “bAt” appears. PROBLEM: the batteries are running low but it is still possible to take several readings. SOLUTION: obtain new batteries for changing them when the signal “E.1” appears. DESCRIPTION: “E.1”...
- Page 12 DESCRIPTION: the projection/display shows “Hi.4”. PROBLEM: the room temperature is too high (above 45,0°C/113.0°F). SOLUTION: move to another, cooler site and, if you are taking the body temperature, wait for the stabilization of the device and of the subject. DESCRIPTION: the projection/display shows «Lo.5» and the value alternately.
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Page 13: Troubleshooting
DESCRIPTION: the projection/display shows “Lo.3”. PROBLEM: - reading with “face” button: the forehead temperature appears to be too low (<34,0°C / <93.2°F). - reading with “home” button: the surface temperature read is below the operating limit (<1.0°C / <33.8°F). SOLUTION: - reading with “face”... -
Page 14: Technical Characteristics
13. TECHNICAL CHARACTERISTICS 13. Measuring specifications Resolution: 0.1 Body temperature readings Measurement range: 34,0/43,0°C (93.2/109.4°F) Room temperature working range: - standard range: 16,0/40,0°C (69.8/104.0°F) - extended range: 10,0/45,0°C (50.0/113°F) Accuracy: from 34,0 to 35,9°C: ±0,3°C from 93.2 to 96.7°F: ±0,5°F from 36,0 to 39,0°C: ±0,2°C from 96.8 to 102.2°F:... - Page 15 13.3 Declaration of Conformity UE Tecnimed srl, P.le Cocchi, 12 - 21040 Vedano Olona (VA) - Italy is the manufacturer of the VisioFocus SMART 06470 non-contact clinical infrared thermometer. TECNIMED guarantees that VisioFocus SMART 06470 meets all the provisions appli- cable in the Regulation (UE) 2017/745.
- Page 16 SYMBOLS on the thermometer, on its packaging or in this user manual Manufacturer UDI code Medical Device Serial Number European Conformity mark. The product conforms to: - Regulation (EU) 2017/745 on medical devices. The Conformity to the Regulation (EU) 2017/745 applies to the medical use only and it is 0051 verified by the notified body no.
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Page 17: Warranty
WARRANTY Tecnimed s.r.l. guarantees this product against any lack of conformity for 24 months as of the date of purchase (indicated on the cash register receipt or other fiscal document). Follow the instructions given by your Dealer for the technical service procedures. - Page 18 - EP 1.283.983 - EP 1.886.106 - EP 2577242(B1) - KR 10-1898897 - CN 103026192B. Other international patents pending. 0051 Manufactured in Italy by: TECNIMED srl P.le Cocchi, 12 -21040 Vedano O. (VA) - ITALY Tel. +39 0332 402350 - info@tecnimed.eu www.visiofocus.com...
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