Braun 6021, ThermoScan PRO 4000 Owner's Manual

PRO 4000

I / O

mem

Type 6021

Type: 6021

1-800-327-7226

ThermoScan

English 4

Français 16

Español 28

Internet:

www.welchallyn.com

Manufactured by:
Braun GmbH
Frankfurter Straße 145
61476 Kronberg / Germany

6-021-221/01/III-06
USA/CDN/MEX
Printed in Germany

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I / O

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Type: 6021

1-800-327-7226

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English

The Braun ThermoScan thermometer has been carefully developed for ac­curate, safe and fast human body temperature measurements in the ear. The
shape of the thermometer probe prevents it from being inserted too far into the
ear canal which could perforate the tympanic membrane.

However, as with any thermometer, proper technique is critical to ob­taining accurate temperatures. Therefore, please read all instructions
carefully and thoroughly before using this product.

Important

• Do not expose the thermometer to temperature extremes (below –4 ºF /
– 20 ºC or over 122 ºF / 50 ºC) nor excessive humidity (> 95 % RH).

• The probe window must be kept clean, dry, and undamaged at all times to
ensure accurate measurements. To protect the probe window, always keep
the thermometer in the storage cover while transporting or when not in use.

• This thermometer must only be used with genuine Braun ThermoScan
probe covers (PC 800).

• To avoid inaccurate measurements, always attach a new, clean probe cover
for each temperature measurement.

• If the thermometer is accidentally used without a probe cover attached,
clean the lens (see section «Care and cleaning»).

How does Braun ThermoScan work?

Braun ThermoScan measures the infrared heat generated by the eardrum and
surrounding tissues. To help ensure accurate temperature measurements, the
sensor itself is warmed to a temperature close to that of the human body. When
the Braun ThermoScan is placed in the ear, it continuously monitors the in­frared energy until a temperature equilibrium has been reached and an ac­curate measurement can be taken.

Why measure in the ear?

Clinical studies have shown that the ear is an excellent site for temperature
measurement because temperatures taken in the ear reflect the body’s core
temperature1. Body temperature is regulated by the hypothalamus2, which
shares the same blood supply as the tympanic membrane3. Changes in core
body temperature are usually seen sooner at the tympanic membrane than at
other sites, such as the rectum, mouth or under the arm.
Advantages of taking temperatures at the ear versus traditional sites:

• Axillary temperature measurements reflect skin temperature which may not
reliably indicate the internal body temperature.

• Rectal temperatures often lag significantly behind internal body temperature
changes, especially at times of rapidly changing temperatures. Also, there is
a risk of cross contamination.

• Oral temperatures are often influenced by eating, drinking, thermometer
placement, breathing through the mouth, or the inability of the person to
close their mouth completely.

1. Guyton A C, Textbook of medical physiology, W.B. Saunders, Philadelphia, 1996, p 919

2. Guyton A C, Textbook of medical physiology, W.B. Saunders, Philadelphia, 1996, pp 754-5

3. Netter H F, Atlas of Human Anatomy, Novartis Medical Education, East Hanover, NJ, 1997,

pp 63, 95

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Body temperature

Normal body temperature is a range. The following table shows that
ranges of normal also vary by site. Therefore, readings from different
sites, even if taken at the same time, should not be directly compared.

Normal ranges by site:

Axillary1: 94.5 – 99.1 °F 34.7 – 37.3 °C
Oral1: 95.9 – 99.5 °F 35.5 – 37.5 °C

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Rectal
ThermoScan2: 96.4 – 100.4 °F 35.8 – 38.0 °C

• A person’s normal temperature range tends to decrease with age.
The following table shows normal ThermoScan ranges by age:

Normal ThermoScan ranges by age2:

0 – 2 years 97.5 – 100.4 °F 36.4 – 38.0 °C
3 – 10 years 97.0 – 100.0 °F 36.1 – 37.8 °C

: 97.9 – 100.4 °F 36.6 – 38.0 °C

11 – 65 years 96.6 – 99.7 °F 35.9 – 37.6 °C
> 65 years 96.4 – 99.5 °F 35.8 – 37.5 °C

The range of normal varies from person to person and can be
influenced by many factors such as time of day, level of activity,
medications and gender.

1. Chamberlain, J.M., Terndrup, T.E., New Light on Ear Thermometer Readings,

Contemporary Pediatrics,

2. Chamberlain, J.M., et al., Determination of Normal Ear Temperature with an Infrared

Emission Detection Thermometer,

March 1994.

Annals of Emergency Medicine,

January 1995.

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Package components

• Braun ThermoScan thermometer

• Use and Care Manual

• 2 Duracell Alkaline batteries

• Additional items my be included as noted on outer
packaging

Product description

1. Probe cover

2. Probe

3. Probe cover detector/automatic «on»

4. Probe cover ejector

5. Display

6. «I/O mem» button (On/memory function)

7. «ExacTemp» light

8. Start button

9. Battery door

10. Protective cover

ThermoScan

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How to use your Braun ThermoScan

1.

To achieve accurate measurements, make sure a
new, clean probe cover (1) is in place before each
measurement.
Use the following temperature taking technique:

2.

When the probe cover is in place, the thermometer
turns on automatically. Wait for the ready signal
beep.

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Fit the probe snuggly into the ear canal, then push
and release the Start button (8).

If the probe has been properly inserted into the ear
canal during the complete measuring process, a long
beep will signal the end of the measuring process.
The thermometer detects that an accurate temper­ature measurement has been taken.
The result is shown on the display (5).

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When you take a temperature measurement, the
«ExacTemp» light (7) can be of help. It flashes during

the measuring process when the probe is correctly

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positioned, and lights up continuously when the
thermometer detects that an accurate measurement
has been taken.

4.
If the probe has not been positioned correctly in
the ear canal or was moved during the measuring
process, a sequence of short beeps will sound, the
«ExacTemp» light will go out and the display will
show an error message («POS» = position error).

5.
For the next measurement, eject the used probe
cover (push ejector (4)) and put on a new, clean
probe cover. The thermometer will turn on auto­matically.
Wait for the ready signal. Fit the probe snuggly into
the ear canal, then push and release the Start button.

The Braun ThermoScan ear thermometer turns off
automatically after 60 seconds of inactivity. It can
also be turned off by pressing the «I/O» button for at
least three seconds. The display will shortly flash
«OFF» and steadily display the word «OFF» after
releasing the button.

Temperature taking hints

• A temperature measurement taken in the right ear
may differ from a measurement taken in the left
ear. Therefore, always take the temperature in the
same ear.

• The ear must be free from obstructions or excess
cerumen build-up in order to take an accurate
measurement.

• External factors may influence ear temperatures,
particularly when an individual has:
– been lying on one ear or the other
– had their ears covered
– been exposed to very hot or very cold temper-

atures, or
– been recently swimming or bathing.
In these cases, remove the individual from the
situation and wait 20 minutes prior to taking a
temperature.

• For persons wearing hearing aids or ear plugs,
remove the device and wait 20 minutes prior to
taking a temperature.

• Use the untreated ear if ear drops or other ear
medications have been placed in the ear canal.

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Memory mode

The last temperature taken before the Braun
ThermoScan is turned off is stored in its memory and
will be automatically displayed when it is turned on
again. The display will show «MEM». For longer
display of the stored measurement, the thermometer
must be turned on and the «I/O» button must be
pressed for at least 1 second. The memory mode is
left automatically after pressing the «I/O» button for
at least 1 second.

Changing the temperature scale

Your Braun ThermoScan is shipped with the
Fahrenheit temperature scale activated. If you
wish to switch to Celsius «°C», proceed as follows:

Make sure the thermometer is turned off.
Press and hold down the «I/O» button. After about
3 seconds the display will show this sequence:
«°F» / «SET» / «°C» / «SET» ...
Release the «I/O» button when «°C» is shown.
There will be a short beep to confirm the new setting,
then the thermometer is turned off automatically.
When turned on again, temperatures will be shown
in Celsius, until the above procedure is repeated.

Base station for storage, charging,
anti-theft function (optional)

For your Braun ThermoScan PRO 4000, there is a
Base Station available. Contact your distributor for
details (see page 14).

The station automatically recharges the thermometer
(when using the rechargeable batteries supplied with
the base station), and it has an electronic, individually
adjustable anti-theft function. It also serves as a
convenient storage base (can be wall mounted).
It requires returning the thermometer to the station
within an individually pre-selected time. Otherwise
the thermometer will be locked.

When leaving the factory, the anti-theft function of
the PRO 4000 is turned off.
If the anti-theft function is enabled, and when not in
the measuring process (stand-by mode) the thermo­meter will show the hours remaining before it is
locked.
To turn on the anti-theft function, please refer to the
base station manual.

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If the thermometer shows «RET» (without the battery symbol) on its
display, the anti-theft time has elapsed and the thermometer must be
returned to the station for unlocking.
If the anti-theft function is not enabled, the display will show «off» when
in stand-by mode.

Care and cleaning

Braun ThermoScan probe covers are intended for single use only!
To ensure accurate measurements, always use Braun ThermoScan
disposable probe covers with the Pro 4000 thermometer. Damaged,
perforated, or soiled probe covers can lead to inaccurate temperature
measurements. Additionally, the accuracy of your temperature meas­urement can be affected by damage to the probe window, or the pres­ence of dirt or cerumen on the probe window.

Probe Window

To assure a high level of accuracy, it is very important to keep this
window clean, dry and undamaged. Fingerprints, cerumen, dust and
other soiling compounds reduce transparency of the window and
result in lower temperature measurements. If the thermometer is
accidentally placed in the ear without a probe cover installed, the
window must be cleaned immediately. Additionally, the window and/or
probe tip area should never be modified, changed, or adjusted. These
changes will affect calibration and accuracy of the thermometer.

To clean the window, gently wipe its surface with a cotton swab slightly
moistened with alcohol and immediately wipe dry with a clean cotton
swab. After cleaning, allow at least 5 minutes drying time before taking
temperatures. Make sure probe window is clean and dry. Avoid
touching the window except when cleaning is required. If the window
is damaged, the thermometer must be returned to Welch Allyn for
service.

Note: Do not use any chemical other than alcohol to clean the probe
window.

Thermometer

Use a soft cloth slightly moistened with alcohol to clean the thermo­meter display and exterior. Do not use abrasive cleaners. Never sub­merge the thermometer in water or any other liquid. Store thermometer
and probe covers in a dry location (the thermometer is not protected
against ingress of water), free from dust and contamination and away
from direct sunlight. The ambient temperature at the storage location
should remain fairly constant and within the range of 50 °F to 104 °F
(10 °C to 40 °C).

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Trouble-shooting

Error message Situation Solution

No probe cover is attached. Attach new, clean probe cover.

(flashing)

(POS = position error)
The infrared monitor cannot find
a temperature equilibrium and
allows no measurement.

Ambient temperature is not within
the allowed operating range
50–104 °F (10–40 °C) or
changing too rapidly.

Temperature taken is not within
typical human temperature range
(93.2–108 °F (34–42.2 °C).

HI = too high

Clear the display by pushing the
«Start» button once.
Ensure that the positioning of the
probe is correct and remains
stable.

Allow the thermometer to remain
for 30 minutes in a room where the
temperature is between 50 and
104 °F / 10 and 40 °C.

Make sure the probe tip and lens
are clean and a new, clean probe
cover is attached. Make sure the
thermometer is properly inserted
into the ear canal.
Then, take a new temperature.

LO = too low

System error

If error persists,

If error still persists,

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Wait 1 minute until the thermo­meter turns off automatically,
then turn on again.

... reset the thermometer by re­moving the batteries and putting
them back in.

... contact Welch Allyn at
1-800-535-6663
(in Canada at 1-800-561-8797).

Trouble-shooting

Error message Situation Solution

Battery is low, but thermometer

Insert new batteries.

will still operate correctly.

Battery is too low to take

Insert new batteries.
correct temperature
measurements.

Do you have any further
questions?

... contact Welch Allyn at

1-800-535-6663

(in Canada at 1-800-561-8797).

Replacing the batteries

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The thermometer is supplied with two 1.5 V batteries type AA (LR 6).
For best performance, we recommend Duracell® alkaline batteries.
Insert new batteries when the battery symbol appears on the display.

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Open the battery compartment. Remove the batteries and replace with
new batteries, making sure the poles are in the right direction.
Slide battery door back until it snaps in place.

To protect the environment, dispose of empty batteries
according to national or local regulations.

Calibration

The thermometer is initially calibrated at the time of manufacture.
If this thermometer is used according to the use instructions, periodic
readjustment is not required. If at any time you question the accuracy of
temperature measurements, please contact Welch Allyn (see page 14).

Manufacturing date is given by the LOT number located in the battery
compartment. The first number after LOT represents the last digit of the
year of manufacture.
The next three digits give the day of the year of manufacture.
An example: LOT 0116 xx xx – this product has been manufactured on
the 116th day of the year 2000.

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Special situations

Clinical studies have shown the Braun ThermoScan thermometer can obtain accurate tem­perature measurements on persons of all ages. However, there are special situations when an
ear thermometer should not be used. These include, but may not be limited to the following
situations:

• Do not use an ear thermometer if there is blood or drainage in the external ear canal.

• An ear thermometer should not be used on a patient who exhibits symptoms of an acute or
chronic inflammatory condition of the external ear canal.

• Common situations like the presence of moderate amounts of cerumen in the ear canal, otitis
media and tympanostomy tubes do not significantly impact temperature readings. However,
complete ear canal occlusion due to cerumen can result in lower temperature readings.

• For persons using hearing aids or ear plugs, remove the device and wait 20 minutes prior to
taking a temperature.

• Use the untreated ear if prescription ear drops or other ear medications have been placed in
the ear canal.

• Patients who have deformities of the face and/or ear may not be able to have a temperature
taken with an ear thermometer.

Fever facts

Many persons may not have an elevated temperature even when they are ill. These include, but
are not limited to infants under 90 days of age, persons taking steroids, antibiotics or antipyretics
(acetaminophen, ibuprofen, aspirin), persons with compromised immune systems, including the
elderly or persons with some chronic illnesses.

Fever is described as an elevation of body temperature over an individual’s «normal» temper­ature.

An elevated temperature or fever is often viewed as a danger sign. In fact, a fever can be very
beneficial, and helps our immune system work more effectively. A fever should be evaluated
along with other physical symptoms. With the exception of newborn infants, the presence of
fever, without any other symptoms of illness, or in a child who is behaving normally may not be
cause of concern.

Some people, such as the elderly, infants under 90 days of age, those with compromised
immune systems, or persons who take steroids for example are often unable to build a response
to illness or environmental conditions. These individuals may not have a fever when they are ill,
or their elevated temperature may be lower than expected for the severity of their illness. Other
medications such as anti-inflammatories and some analgesics may also mask fever.

The presence or absence of fever should not be used as the only measurement of the signifi­cance of the illness.

Febrile seizures, or convulsions, which usually occur in children six months to six years of age,
are thought to occur not because a fever is present, but because of the rapid rise of the child’s
temperature.

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Product specifications

Displayed temperature range: 68–108 °F (20–42.2 °C)
Operating ambient temperature range: 50–104 °F (10–40 °C)
Display resolution: 0.1 °F or °C
Accuracy for displayed temperature range: ±0.4 °F (95.9–107.6 °F) (35.5 °C–42 °C)

±0.5 °F (outside this temperature range)

Long term storage ranges

Temperature: –4 °F to 122 °F (–20 °C to 50 °C)
Humidity: 95% non condensing
Shock: withstands drop of 3 feet
Measurement time: 3–7 seconds
Automatic «power down»: 60 seconds
Battery life: 6 months/1000 measurements
Battery type: 2 x MN 1500 or 1.5 V AA (LR6)
Thermometer dimension: 6˝ x 1.7˝ x 1.3˝ (152 mm x 44 mm x 33 mm)
Thermometer weight: 3.6 oz (100 g) without batteries

This infrared thermometer meets requirements established in ASTM Standard E 1965-98 (for the
thermometer system [thermometer with probe cover]). Full responsibility for the conformance of
the product to the standard is assumed by Braun GmbH, 61476 Kronberg, Germany.

ASTM laboratory accuracy requirements for the thermometer only (not including a probe cover)
in the display range of 96.8 °F to 102.2 °F (36 °C to 39 °C) for infrared thermometers is ± 0.4 °F
(± 0.2 °C), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM
Standards E 667-86 and E 1112-86 is ± 0.2 °F ( ± 0.1 °C).

A clinical summary is available upon request.

This device conforms to the following standards:
DIN EN 60601-1: 3/96 «Medical electrical equipment» –
Part 1: General requirements for safety
DIN EN 12470-5: 2003 «Clinical thermometers» –
Part 5: Performance of infrared ear thermometers (with maximum device)

The Braun ThermoScan thermometer has been proven to be safe. To ensure the best results,
please take the time to read this manual completely and keep it handy for future reference. In the
unlikely event you experience any difficulty using the Braun ThermoScan thermometer, simply
call Welch Allyn toll free at: 1-800-535-6663 (in Canada:1-800-561-8797).

This products conforms to the provisions of the EC directive 93/42/EEC
(Medical Device Directive).

0297

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TYPE BF Attention, consult EAR THERMOMETER

EQUIPMENT ACCOMPANYING WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND

Internally Powered Equipment
Continuous Operation
Not protected against ingress of water
Patents Pending

DOCUMENTS MECHANICAL HAZARDS ONLY

IN ACCORDANCE WITH UL60601 – 1/10 HK

Service

The Braun ThermoScan thermometer has a limited three year warranty. Should service be
required during or after the warranty period you must call Welch Allyn’s Customer Service
Department at 1-800-535-6663 (in Canada: 1-800-561-8797) to obtain a return authorization
number and shipping address. Repackage the thermometer carefully in its original packaging or
securely packed to avoid damage during shipping. Include the original sales slip indicating the
date of purchase, a note describing the problem, your authorization number, and your return
address. Send the Braun ThermoScan thermometer prepaid and insured.

Note: Shipping address varies by country.

Answers to any questions regarding operation of the Braun ThermoScan thermometer may be
obtained by calling Welch Allyn toll-free at:

1-800-535-6663 (in Canada: 1-800-561-8797)
Monday–Friday
8:00 A.M. to 8:00 P.M. Eastern Time
www.welchallyn.com

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