VisioFocus PRO 06480 User manual

Operating instructions
EN
Rev. 9/6480-2021-09
Read these instructions carefully
before using the thermometer
CAUTION: read the warnings
PRO
06480

1
Fig. 1
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 (intended for reactivating the display backlight for 3
seconds, showing the last 9 measurements - if “Mem” is enabled - and
to changing the settings/modes)
9. Protective cap
10. Label with serial number
11. Battery door (4 x AAA) with brief instructions
12. Special lanyard with additional brief instructions - to be worn around
the neck
10 11
12
9
6
5
8
7
CALIBRATE VISIOFOCUS:
at start or at room change or if appears
press together and release and ; appears.
Within 10 sec open the cap, press and focus the
projection on an internal wall far from windows
and heat or cold sources; release and wait for the
projection to flash slowly. Ready for measurements
in the middle of forehead with .
1234

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INTENDED USE: VisioFocus®PRO is an infrared medical thermometer intended for
non-contact measurement of body temperature in children and adults (professional
use). It can also be used to monitor the temperature of inammations, ulcers, wounds
(e.g. on diabetics), internal organs during surgery or to detect the temperature of in-
travenous uid bags.
IMPORTANT: Each non-contact thermometer needs to be stabilized at the room tem-
perature. VisioFocus PRO is equipped with 2 quick calibration systems, which allow
the thermometer to quickly stabilize itself at the room temperature: the MQCS (Manual
Quick Calibration System) and the AQCS (Automatic Quick Calibration System). See
par. #8. Additionally, VisioFocus PRO foresees two dierent settings:
- “NURS” (default setting): the MQCS is requested and mandatory every 30 or 60
minutes, depending on the version. This setting is highly recommended for nurses
who take many measurements moving from room to room as well as for any intensive
use, such as in airports etc.
The “HOME” button is disabled in “NURS” mode. The “Mem” button is di-
sabled and it can be enabled by changing the settings (see par. #7).
- “DOCT” mode: the MQCS is not mandatory, but if the thermometer’s temperature
is changing, the AQCS system is automatically activated and allows the rapid sta-
bilization of the thermometer at room temperature: the display shows a countdown
indicating the time required for its stabilization. To make a measurement it is necessary
to wait for the end of the countdown without touching the device. Alternatively, at any
time, it is possible to do the manual MQCS (suggested procedure).
Please note that if the thermometer set in “DOCT” is used too frequently and inten-
sively (as in a hospital department) the system will ask the user to make the MQCS
anyway (although with some delay).
In “DOCT” mode the “HOME” and the “Mem” buttons are enabled.
To change the setting from “NURS” to “DOCT” – and vice-versa – see par. #7.
ATTENTION: in some versions the DOCT setting is disabled; to enable it write to info@
tecnimed.eu and specify the new use, the reason for change and the serial number.
1. FOREWORD
VisioFocus PRO is specically studied to be used in hospitals, ambulances or clinic
environments, but also airports, schools, factories, etc. in case of emergency and/or
pandemic situations where it is necessary to take several fast and hygienic tempera-
ture readings. VisioFocus PRO is:
- hygienic: it never touches the patient, it does not need disinfection and does not
require expensive disposable caps;
- comfortable: as it is totally not invasive, there is no need to wake up the patient or to
ask for his cooperation while taking the temperature;
- accurate: detects the body temperature with constancy, repeatability and accuracy;

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- unique: it cancels all variables which cannot be monitored by and do not depend on
the healthcare worker (i.e. the presence of earwax during a tympanic measurement or.
the displacement of the thermometer during the armpit or oral measurement).
With VisioFocus PRO the user can be sure of having the total control on all measure-
ments made in the hospital ward.
2. WARNINGS
Read these instructions carefully before using the thermometer
2.1 Precautions
1. To avoid reading anomalies, use VisioFocus PRO according to this user manual.
2. Use VisioFocus PRO in a draft-free room, at a steady temperature between 16,0
and 40,0°C (60.8/104°F). It can also work if room temperature is in the ranges from
-10,0 to 15,9°C (14.0/60.7°F) and from 40,1 to 45,0°C (104.1/113.0°F), but accuracy
is not guaranteed - see also par. #13.
3. If the thermometer was stored in another room (or even in a drawer, etc…), before
using it, run the manual calibration procedure (MQCS – par. #8). No matter if it is set
in “NURS” or “DOCT”.
4. To take the temperature on newborns in incubators, rst stabilize the thermometer
inside the temperature of the incubator (see par. 4.3)
5. Do not take a temperature reading in the following situations:
• if the subject is sitting in a draft or has come from another room that was ventilated
or at a dierent temperature than the room where the thermometer is used; in these
cases, wait for the stabilization of the subject’s temperature or, in case it is not pos-
sible, take the measurement on the closed eyelid (par. 4.2);
• if, in the minutes before the reading, the subject has:
- been walking, running or exercising;
- been wearing a cap, hat or scarf;
- been cool sponged on the forehead;
- been exposed to agents that could alter forehead temperature, e.g. shower, sham-
poo, hair-drier, direct sunlight, replace heat, cold compresses therapies, air conditio-
ner ow etc.; even touching the forehead can alter the temperature.
In all the above cases, interrupt the exposition of the subject to these agents and wait
a few minutes for the forehead temperature to stabilize.
6. Changing the reading point will bring to dierent results. Therefore, remember,
always aim the projection on the same spot, precisely at the centre of the
forehead (midway between the top of the nose and the hairline) and keep the ther-
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.
7. The temperature reading is taken in the area where the temperature is projected.
Make certain that a 1 cm area is free all the way around the temperature projection
area: it is of major importance to make sure that this area does not include eyebrows,

4
hair or clothing. If necessary, brush away any hair from the forehead but remember,
this must be done a few minutes beforehand or the temperature reading will be higher
than the actual body temperature.
8. When taking a temperature reading, please note that in the presence of oils,
make-up or an oxygen mask, and in the case of elderly, the temperature detected may
be lower than the actual body temperature (see also par. #4.2).
9. The forehead temperature reading can be aected by profuse sweating, super-
cial wounds or head injury.
10. Do not use the thermometer on a sweaty forehead, since the temperature rea-
ding would be unreliable. Read the par. #4.2.
11. In the cases at #7, #8, #9, take the temperature reading on the alternative area
(read the par. #4.2.).
12. The gilt waveguide (g. 1) is the most delicate part of the thermometer. It is
composed of a gold-plated concave mirror that must be kept clean, crystal clear and
intact. Any damage, dust or dirt will alter the temperature reading. To prevent dust or
dirt inltrations in the waveguide, always close the cap.
13. Do not handle the thermometer for longer than strictly necessary before taking
the reading.
14. Do not use the thermometer in direct contact with the ear or other parts of the body.
15. Do not use the thermometer in direct contact with objects or liquids. Do not
submerge the thermometer in water or other liquids and keep it away from sources
of heat and out of direct sunlight. If water seeps into the thermometer, contact your
Dealer im-mediately for Technical Service.
16. Do not use VisioFocus PRO on a subject making a call with a mobile or cordless
telephone or in the presence of strong electromagnetic elds.
17. Avoid knocking and dropping it, and do not use it if damaged or if not functioning
properly.
2.2 Attention
1. Failure to observe the above-mentioned precautions (par. #2.1) may lead
to very low or very high temperature readings, which cannot be attributed to
product’s malfunctions.
2. The aiming lights meet the photo-biological safety requirements outlined
in standard EN 62471. No harm can be caused should the aiming lights be acciden-
tally pointed in the eyes: the beams are harmless!
3. The unit is a delicate measurement instrument and must not be used by little
children. It is not a toy. Keep it out of the reach of children or persons with limited
sensorimotor skills. Small parts can be ingested or inhaled.
4. If the patient’s dgeting makes it dicult to take a correct reading (especially in
case of children), rst become familiar with the device in order to take the measure-
ment rapidly.
5. Since it never comes into contact with the body, VisioFocus PRO does not require
any disposable protection covers.
6. ATTENTION: any serious incident that occurs in relation to the device should be
reported to the manufacturer ([email protected])and the competent authority of your

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country.
3. HOW IT WORKS
VisioFocus PRO detects the infrared radiation naturally emitted by the body and, in
particular, from the human forehead.
The forehead is the ideal site for taking a temperature reading because it is crossed
by the temporal artery which receives blood owing from the aorta and carotid artery.
Moreover, the forehead is the only part of the head in direct contact with the brain
that is not covered by hair. The brain is the most important, most delicate organ in the
human body and it is the most susceptible to injury from fever. The head is also the rst
part of the body to change its temperature as a fever rises and falls.
With each temperature measurement, your VisioFocus PRO takes a series of 125
readings a tenth of a second. Its sophisticated microprocessor then amplies and
processes this information along with the room temperature and shows the correct
body temperature through 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 eort (for example
a baby’s crying).
Moreover, the body temperature can be aected by the outside temperature and,
depending on the type of reading taken, other factors may also come into play.
Due to heat dispersion from uncovered parts of the body, the actual temperature
at the forehead is generally lower than that in covered zones. Therefore, when the
“FACE” button is pressed, the VisioFocus PRO software automatically applies
a correction factor and thus the resulting value is comparable to that given by other
more usual temperature reading sites commonly used in the countries where the unit
is sold - axillary, oral or rectal reading, or internal temperature reading -, according to
the customer’s choice.
Nevertheless, the reference value can be changed. Remember, an “oral” reading is
generally 0,2°C (0.4°F) higher than an axillary reading while a “rectal” or “core” reading
is 0,8°C (1.4°F) higher (see par. #7).
The VisioFocus PRO temperature reading taken on the forehead of a healthy person
can range between 35,0 and 37,5°C (95.0 and 99.5ºF), in axillary mode, although in
an adult it may even be below 35,0°C (95.0°F).

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4. HOW to USE IT
4.1 Taking the body temperature: FOREHEAD
• At the rst use, insert 4 AAA batteries as ex-
plained at #9.
• Open the protective cap by rotating it 90° (g.
2).
• Press the “FACE” button. If the display
shows it indicates that it is necessary to stabilize the thermometer
(AQCS or MQCS) before proceeding with the body temperature measurement.
Proceed as follows:
- press and release at the same time “FACE” and “HOME” buttons: the word
CAL will appear on the display;
- within 10 seconds point the thermometer towards an internal wall (not the inside of
an external wall), pressing the “HOME” button;
- release the button: lights will ash twice slowly and then the display will show the
acquired temperature.
VisioFocus PRO is now ready to take a measurement.
For more details about MQCS see par. #8.
• To take a reading, press the “FACE” button and hold it down.
The two aiming lights turn on and you will begin to see the temperature reading,
projected onto the forehead between two arches. The display starts to show the tem-
perature, together with the symbol .
• While keeping the VisioFocus PRO perpen-
dicular to the center of the forehead, move
it in or back away from the forehead until the
temperature reading is set squarely between
the two arches (g. 3).
If the thermometer is too far away, or too close,
the temperature will not fall between the two
arches (g. 4 and 5).
Fig. 3
Fig. 4NO
too far
NO
too close
Fig. 5
correct distance
and thermometer
perpendicular
Fig. 2
90°

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• When you see the temperature at the
midpoint between the two arches (g. 6), the
thermometer is at the right distance: release
the button and keep the device steady while
the lights ash. You can also read the tempera-
ture on the display, lit in light blue. If necessary,
you can immediately take another reading.
• Close the protective cap.
When the thermometer remains idle for 20 seconds, it reverts to stand-by mode
and will display the room temperature for 45 minutes (“DOCT” mode) or 30 minutes
(“NURS” mode) before shutting o.
4.2 In case of sweating, oxygen mask, elderly patients:
take the reading on the eyelid
In case of perspiring forehead, oxygen mask, elderly patients - especially with wrinkled
forehead -, the measurement must be taken on the eyelid.
Proceed as you would do for a forehead rea-
ding using the “FACE” button (g. 7).
No need to worry that the patient could open its
eyes while you are taking the reading: the lights
are harmless.
Precision is not guaranteed, but such reading
can be considered a valid approximation of
one’s body temperature.
Such reading is also indicated when one has
oil or make-up on the forehead. or when the subject is not perfectly stabilized in the
environment, like for example in the case of readings in airports or when entering in
stations, companies, schools, emergency room.
4.3 Use on newborns in incubators
Before taking the temperature on newborns in incubators, rst you need to do the
MQCS inside the incubator, as follows (see par. #8):
• press simultaneously “FACE” and “HOME”
buttons. The word CAL appears on the display;
• within 10 sec open the protective cap and, hand-
ling the device according to the position of the fore-
head of the baby, introduce it in the incubator, press
the “HOME” button and focus the lights on the
inner wall of the incubator.
• Release the button. Now, using the “FACE” button, take the temperature on the
forehead of the baby as described in par. 4.1 (g. 8).
Fig. 6OK
correct
distance
Fig. 7
aternative
reading on eyelid
Fig. 8

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4.4 Readings of skin surface temperature
In “DOCT” mode, using the “home” button, VisioFocus PRO can also be used to:
1) monitor the temperature of inammations, ulcers, wounds (e.g. on diabetics);
2) monitor the temperature of internal organs during surgery ensuring maximum hygie-
ne thanks to the total absence of contact;
3) detect the temperature of intravenous uid bags.
These measurements are not entirely accurate and must be considered as relative
rather than absolute values. If taken on the skin, they can show the dierence between
two close or symmetrical areas.
Proceed as you would for a forehead reading but press the “home” button; the
display will light up in green and show the “home” symbol .
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)
In “DOCT” mode, VisioFocus PRO can also be used to read the temperature of ob-
jects, food and liquids in the 1,0-80,0°C (33.8-176.0°F) temperature range.
Proceed as you would for a forehead reading but press the “home” button; the
display will light up in green and will show the “home” symbol .
NOTE: this intended use is not subject to assessment by the Notied Body.
5. ROOM TEMPERATURE
When the thermometer is in stand-by, the room temperature and the ashing symbol
appear and remain displayed automatically for 45 minutes (DOCT mode) or 30
minutes (NURS mode) after the last reading is taken.
To display the room temperature on the backlit display, while the thermometer is in
stand-by mode, press the “Mem” button once: the display illuminates in orange
showing the room temperature and the symbol ashing.
6. MEMORY FUNCTION
The “Mem” button (in DOCT mode or in NURS mode if it is enabled) lets you call
up the last 9 temperature readings.
To activate this function, press the “Mem” button twice: the display will light up
in violet and the value of the last reading will be shown accompanied by the number
1 and the symbol or depending on which button was used for that reading.
Pressing the button again calls up the second to last, third to last reading and so on,
accompanied by the numbers 2, 3, etc.

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7. HOW TO CHANGE the SETTINGS
Depending on where it is going 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 (“AXILLA”) or internal tem-
perature readings (“CorE”) or only internal temperature readings (no symbol will be
shown);
• “NURS” mode, (highly recommended if used by nurses, in ambulances and for
any intensive use, such as in airports, factories, etc: “HOME” and “Mem” buttons are
disabled; MQCS is requested and mandatory every 30 minutes) or
“DOCT” mode, (suggested for doctors’ use: “HOME” and “Mem” buttons are en-
abled; AQCS is automatic and MQCS is optional);
• ≥37.0°C (≥98.6°F), ≥37.5°C (≥99.5°F) or ≥38.0°C (≥100.4°F) temperature level
alarm: you can choose the temperature threshold beyond which the thermometer
alternates the projection of “Hi.2” and the temperature (for 7 seconds);
• memory function enabled (MEM on) or disabled (MEM oFF);
• “air” function enabled (AIR on) or disabled (AIR oFF): to be activated in case of
high air conditioning in the room, to minimize the cooling eect on the subject/patient.
If necessary, these settings can be modied as follows:
1. while the thermometer is o or in stand-by mode, press the “Mem” button and
hold it down; after about 8 seconds the visualization on the display changes showing
in rotation the following combinations:
The current settings are highlighted by the green backlight.
2. When the new desired setting appears, release the button. The purple backlight will
turn green. Only one setting can be modied at a time.
Notes:
- The measurement of the body temperature must be taken always at the centre of the
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. #3).
- if the thermometer was produced with the sole internal temperature setting, the
ORAL, RECTAL, AX-ILLA and CORE settings would not be available for changing.
- In some versions the DOCT setting is disabled; to enable it write to [email protected]
and detail the new use, the reason for change and the serial number.