Related Manuals for Tecnimed VisioFocus LIGHT 06710
Summary of Contents for Tecnimed VisioFocus LIGHT 06710
- Page 1 LIGHT 06710 Operating instructions Read these instructions carefully before using the thermometer CAUTION: read the warnings Rev. 9/6710-2021-09...
- Page 2 Fig. 1 LIGHT 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 LIGHT 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 LIGHT 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 LIGHT 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 When the thermometer remains idle for 20 seconds, it reverts to stand-by mode and will display the room temperature for 4 hours before shutting off. If you want it to shut down immediately after the 20 second interval, read the chapter on “Energy Saving” mode (par.
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Page 8: Room Temperature
NOTE: this intended use is not subject to assessment by the Notified Body. 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. - Page 9 - if the thermometer was produced with the sole internal temperature setting, the ORAL, RECTAL, AX. and CORE settings would not be available for changing. - The measurement of the body temperature must be taken always at the centre of the forehead (par.
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Page 10: Replacing The Batteries
• The thermometer is now ready to take a reading and will keep the MQCS for 30 minutes. Manual quick calibration (MQCS) can also be performed without the countdown if, for example, you are moving between rooms with different temperatures. This system, too, enables the thermometer to take sufficiently accurate readings. - 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 LIGHT 06710 non-contact clinical infrared thermometer. TECNIMED guarantees that VisioFocus LIGHT 06710 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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