Braun WelchAllyn ThermoScan PRO 4000 User Manual
Pro 4000 Vorserie KURTZ DESIGN 12.01.03
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ThermoScan
PRO 4000
I / O
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Type: 6021
1-800-327-7226
Type 6021
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English 4
Français 16
Español 28
Internet:
www.welchallyn.com
6-021-360/00/VIII-07 USA/
CDN/MEX
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English
The Braun ThermoScan thermometer has been carefully developed for ac-curate,
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»).
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 in-frared
energy until a temperature equilibrium has been reached and an ac-curate 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 reect 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 reect skin temperature which may not
reliably indicate the internal body temperature.
• Rectal temperatures often lag signicantly behind internal body temperature
changes, especially at times of rapidly changing temperatures. Also, there is
a risk of cross contamination.
• Oral temperatures are often inuenced 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,
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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
Rectal1: 97.9 – 100.4 °F 36.6 – 38.0 °C
ThermoScan2: 96.4 – 100.4 °F 35.8 – 38.0 °C
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 11 – 65 years 96.6
– 99.7 °F 35.9 – 37.6 °C > 65 years 96.4 – 99.5 °F
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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.
• A person’s normal temperature range tends to decrease with age.
The following table shows normal ThermoScan ranges by age:
The range of normal varies from person to person and can be inuenced 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, March 1994.
2. Chamberlain, J.M., et al., Determination of Normal Ear Temperature with an Infrared
Emission Detection Thermometer, 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
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 auto-
matically. Wait for the ready signal beep.
3.
Fit the probe snuggly into the ear canal, then push and release the
Start button (8).
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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).
When you take a temperature measurement, the «ExacTemp» light (7)
can be of help. It ashes during
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start
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the measuring process when the probe is correctly 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
auto-matically.
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 ash «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 inuence 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 conrm 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 thermo-meter 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 pres-ence 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 modied, 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 thermo-meter display and exterior.
Do not use abrasive cleaners. Never sub-merge 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
Situation Solution
Error message
No probe cover is attached. Attach new, clean probe cover.
(POS = position error)
The infrared monitor cannot nd a
temperature equilibrium and allows no
measurement.
Clear the display by pushing the «Start»
button once.
Ensure that the positioning of the probe is
correct and remains stable.
(ashing)
Ambient temperature is not within the allowed operating range 50–104 °F (10–40 °C)
or changing too rapidly.
Allow the thermometer to remain for 30
minutes in a room where the temperature is
between 50 and 104 °F / 10 and 40 °C.
Temperature taken is not within typical
human temperature range (93.2–108 °F
(34–42.2 °C).
HI = too high
LO = too low
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.
System error
If error persists,
If error still persists,
Wait 1 minute until the thermo-meter turns
off automatically, then turn on again.
... reset the thermometer by re-moving the
batteries and putting them back in.
... contact Welch Allyn at 1-800-535-6663
(in Canada at 1-800-561-8797).
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Trouble-shooting
Situation Solution
Error message
Battery is low, but thermometer will still
operate correctly.
Insert new batteries.
Battery is too low to take correct
temperature measurements.
Insert new batteries.
Do you have any further
questions?
... contact Welch Allyn at 1-800-535-6663
(in Canada at 1-800-561-8797).
Replacing the batteries
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.
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.
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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
rst 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 tem-perature 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 inammatory 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 signicantly 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» temper-ature.
An elevated temperature or fever is often viewed as a danger sign. In fact, a fever can be very benecial, and helps our im-
mune 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-inammatories and some analgesics may also mask fever.
The presence or absence of fever should not be used as the only measurement of the signi-cance 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 Kaz, Inc.
Hudson NY, 12534 USA.
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 difculty 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).
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TYPE BF Attention, consult EAR THERMOMETER
EQUIPMENT ACCOMPANYING WITH RESPECT TO ELECTRICAL SHOCK, FIRE
DOCUMENTS MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL60601 – 1/10 HK
Internally Powered Equipment
Continuous Operation
Not protected against ingress of water
Patents Pending
Service
The Braun ThermoScan thermometer has a limited three year warranty. Should service be required during or after the war-
ranty 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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