Tecnimed Visiofocus Smart 06470 Скачать руководство пользователя

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Ambient temperature

(shown when in stand-by)

Measurement range: 5,0/45,0°C (41.0/113.0°F)

Accuracy: ±1.0°C (±1.8°F)

13.2 General specifications

- Power supply: 4 AAA (LR03) alkaline batteries - 1.5 V (included)

- Life of high quality batteries: up to 3 years or 30,000 readings (depending on use)

- Dimensions: mm 138 x 43,5 x 21,5 (inches 5.67 x 1.71 x 0.85)

- Weight: gr. 90 (3.17 oz) - (included batteries)

- Distance from the subject: calculated using an optical aiming system (approx. 6

cm/2.36 inches).

- Expected life: 10 years.

- Atmospheric pressure range of operating conditions: from 700 hPa to 1,060 hPa.

- Relative humidity range of operating conditions: from 15% to 93%, non-condensing.

- Keep in a clean, dry place, preferably at a temperature ranging b16 and

+40°C (60.8 and 104°F). Store at a temperature not lower than -25°C (-13°F) or higher

than +70°C (158°F).

- Internally powered equipment; mode of operation: continuous.

- The VisioFocus SMART LEDs emit low light radiation in compliance with EN 62471.

- Measuring system tested in hospitals, private clinics and medical offices. Clinical

accuracy, characteristics and procedures are available from the manufacturer on re-

quest.

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.

VisioFocus SMART 06470 is a class

a medical device manufactured following ap-

propriate production processes in accordance with an EN ISO 9001:2015 and EN ISO

13485:2016 certified Quality System, with GMP requirements and with the following

standards: EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 60601-1-11, EN 62366,

EN 62471, EN 62304, EN 80601-2-56, ASTM E 1965-98.

Full responsibility for the conformance of this product to the standards is assumed by

Tecnimed srl, P.le Cocchi, 12 - 21040 Vedano Olona (VA) – ITALY.

Complete Declaration of Conformity is available from the manufacturer on request:

[email protected]

Содержание Visiofocus Smart 06470

Страница 1: ...Operating instructions EN Rev 9 6470 2021 09 Read these instructions carefully before using the thermometer CAUTION read the warnings 06470 ...

Страница 2: ...iming 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 Battery door 4 x AAA ...

Страница 3: ... C 60 8 and 104 0 F VisioFocus SMART can also work if room tem perature is in the ranges 10 0 15 9 C 50 0 60 7 F and 40 1 45 0 C 104 1 113 0ºF but accuracy is not guaranteed see also par 13 3 If the device comes from a room having an ambient temperature different from the one of the room in which you are taking the reading or even from a drawer etc it needs to be stabilized Do the MQCS before usin...

Страница 4: ...sor and the most delicate part of the thermometer It must be kept clean and intact Any damage dust or dirt will alter the temperature reading 12 Do not handle the thermometer for longer than strictly necessary before taking the reading 13 Do not use the thermometer in direct contact with the ear or other parts of the body 14 Do not use the thermometer in direct contact with objects or liquids Do n...

Страница 5: ...gh the projection Please note that that body temperature varies among individuals moreo ver individual temperature varies according to the measurement s site and throughout the day also in response to physical or mental effort for example a baby s crying Moreover the body temperature can be affected by the outside tem perature and depending on the type of reading taken other factors may also come ...

Страница 6: ...overlapping the sides of the projected rec tangle shape While keeping the VisioFocus SMART per pendicular to the center of the forehead move it in or back away from the forehead until the temperature reading is positioned evenly inside the rectangle fig 2 If the thermometer is too far away or too close the temperature will will overlap the sides of the rectangle fig 3 and 4 When you see the temper...

Страница 7: ...n the skin surface temperature this can be useful to monitor the temperature of inflammations ulcers wounds for example on diabetic patients and under control of your physician Proceed as you would for a forehead reading but press the home button NOTE skin surface temperature is NOT body temperature To measure body tempe rature proceed as described in par 4 1 4 4 Other readings non medical use Vis...

Страница 8: ...HANGE the SETTINGS Depending on where it is to be sold your thermometer leaves the factory as follows preset to Celsius C or Fahrenheit F referred to oral ORAL or rectal RECTAL or axillary AX or internal tempera ture readings CorE or only internal temperature readings no symbol will be shown with display off when in stand by mode Energy Saving off or always on Peak Performance on If necessary thes...

Страница 9: ...ly accurate readings When the thermometer is in stand by mode AQCS appears on the display indicating that automatic quick calibration has been performed 2 Manual Quick Calibration System MQCS the alternative is to promptly correct the thermometer temperature adapting it to the real temperature of the room where the reading has to be taken Proceed as follows press the face and home buttons fig 8 si...

Страница 10: ... batteries let the thermometer stabilize for 20 minutes before taking a temperature reading or run a manual quick calibration MQCS par 8 Remove the batteries if you do not expect to use the thermometer for a long time 10 CLEANING CLEANING THE WAVEGUIDE the thermometer waveguide fig 1 is very delicate and must be kept clean Store the device in a dry clean place away from dust However if you need to...

Страница 11: ...the lights flash before moving the thermometer make certain that there are no mobile or cordless telephones in the vicinity DESCRIPTION the display shows C AL and or a count down in minutes and seconds PROBLEM the thermometer has not stabilized The sym bols prompt you to choose between SOLUTION wait until the AQCS countdown has run its course wit hout touching the thermometer or perform an MQCS pa...

Страница 12: ...face button or below 5 0 C 41 0 F if you ve pressed the home button SOLUTION move to another warmer room and if you are taking the body temperature wait for the stabilization of the device and of the subject Messages about the detected temperature DESCRIPTION the projection display shows Hi 2 and the value alternately when you press the face button MEANING ATTENTION The temperature is 40 0 C 104 0...

Страница 13: ...gle fig 5 3 The projected temperature is not clearly visible there is too much light in the room or the batteries are low cast a shadow over the subject or replace the batteries 4 The sensor fig 1 is damaged or water has seeped into the thermometer contact your Dealer right away for technical service 5 The thermometer temperature reading is too low make certain that the conditions outlined in the ...

Страница 14: ...requirements in the display range of 37 to 39 C 98 to 102 F for IR thermometers is 0 2 C 0 4 F whereas for mercury in glass and electronic thermome ters the requirement per ASTM Standards E 667 86 and E 1112 86 is 0 1 C 0 2 F Other readings Measurement range 1 0 80 0 C 33 8 176 0 F Room temperature working range standard range 16 0 40 0 C 69 8 104 0 F extended range 5 0 45 0 C 41 0 113 F 3 Accurac...

Страница 15: ...light radiation in compliance with EN 62471 Measuring system tested in hospitals private clinics and medical offices Clinical accuracy characteristics and procedures are available from the manufacturer on re quest 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 TECN...

Страница 16: ...ting instructions Refer to the instruction manual CAUTION read the warnings Direct current Applied part type BF Recyclable material Keep dry Crossed out wheeled bin WEEE and batteries Instructions for disposal this product contains electrical and electronic components and batteries that may contain materials which if disposed with general waste could be damaging to the en vironment Residents of th...

Страница 17: ...s given in this manual If Technical Service is required contact the Manufacturer or your Dealer In case the Product was purchased through an Online store warranty service can only be provided through the Internet Seller where the product was pur chased In case of any lack of conformity the product will be either repaired or replaced as decided by the Manufacturer or Dealer at their sole discretion...

Страница 18: ... 066 US 7 651 266B2 US 8 128 280 US 8 821 010 EP 1 283 983 EP 1 886 106 EP 2577242 B1 KR 10 1898897 CN 103026192B Other international patents pending 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 0051 ...

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