Thermoscan: Ear Thermometer Directions For Use
Thermoscan: Ear Thermometer Directions For Use
Thermoscan: Ear Thermometer Directions For Use
Ear thermometer
Directions for use
PRO 6000
English
ThermoScan ®
PRO6000
REF 901083 Product/sales literature or label
Distributed by:
Welch Allyn, Inc.
4341 State Street Road, P.O. Box 220
Skaneateles Falls, NY 13153
USA
Imported by:
Welch Allyn Canada Ltd.
160 Matheson Blvd. East, Unit 2
Mississauga, Ontario L4Z 1V4
Canada
This product is manufactured by Kaz USA, Inc. under license to the ‘Braun’ trademark.
‘Braun’ is a registered trademark of Braun GmbH, Kronberg, Germany.
31IMP6NA190 03JUN15
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1. Braun PRO 6000
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2. Package components
Braun ThermoScan® PRO 6000 thermometer
Cradle
Probe covers (1 or 2 probe cover boxes, depending on model)
CD containing Directions for use, Quick reference guide, Welch Allyn Service Tool software and
Service Tool installation guide.
2 (AA) Duracell® alkaline batteries
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4. Screen elements 8 7
1 Battery
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Full battery - indicates battery is
between 100% and 70% of usable
battery capacity
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artial battery - indicates battery is
P
between 70% and 30% of usable
battery capacity
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ow battery - indicates battery is
L 2
between 30% and 10% of usable
battery capacity
ritically low battery - battery is
C 3 4
between 10% and 1% of usable
4 Alert icon
battery capacity. When final
Icon that appears with error message.
segment flashes, batteries have low
See 12. Errors and notifications
power. The thermometer will take a
proper measurement but batteries
must be replaced soon. If 5 Memory indicator
rechargeable batteries are in use, Indicates the reading shown on the display
batteries should be recharged. is the reading in memory.
See 10.1 Controls, Memory
mpty battery - battery has 1% or
E
less of usable battery capacity.
When battery outline flashes, the 6 C/F scale
thermometer will not operate. Indicates default temperature scale. Either
Replace the batteries. If °C or °F will display, depending on setting.
rechargeable batteries are in use, See 10.2 Controls, C/F Celsius/Fahrenheit
batteries should be recharged.
See 14.7 Maintenance and 7 Security unlock icon and
service, Replacing the batteries countdown time
(Requires charging station or compatible
2 Probe cover icon Welch Allyn Vital Signs device, sold
The icon animates in an upward motion to separately.) If the security function is
remove probe cover. The icon animates in enabled, it requires the thermometer be
a downward motion to apply a probe cover. returned to the charging station within a
See 9. Using the PRO 6000 pre-selected time interval. Countdown time
indicates the amount of time remaining
until the thermometer will be locked if not
3 Timer icon returned to the charging station. See 11.2
The PRO 6000 includes a 60 second timer Settings, Advanced functions
that features an audible notification and
visual indicator at 0, 15, 30, 45, and 60
seconds. The first quadrant begins flashing 8 Security lock icon
when timer starts and becomes solid at 15 (Requires charging station or compatible
seconds. This repeats for each 15 second Welch Allyn Vital Signs device, sold
interval. The timer turns off automatically 5 separately.) Indicates the thermometer
seconds after 60 seconds is completed. is locked. Return the thermometer to the
See 10.3 Controls, Manual timer charging station to reset the countdown
and resume normal operation. See 11.2
Settings, Advanced functions 4
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5. About the Braun PRO 6000
The Braun ThermoScan® thermometer is a clinical grade ear thermometer indicated for the
intermittent measurement of human body temperature in patients of all ages in a professional
use environment.
Please read all instructions carefully and thoroughly before using this product.
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5.4 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:
• A
xillary temperature measurements reflect skin temperature which
may not reliably indicate the internal body temperature.
• R
ectal temperatures often lag significantly behind internal body temperature changes, especially
at times of rapidly changing temperatures. Also, there is a risk of cross contamination.
• O
ral 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, P 754-5
3. NETTER H F, ATLAS OF HUMAN ANATOMY, NOVARTIS MEDICAL EDUCATION, EAST HANOVER, NJ, 1997, PP 63, 95.
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5.5 Body temperature
Normal body temperature is a range. The following table shows that this
normal range also varies by site. Therefore, measurements from different
sites, even if taken at the same time, should not be directly compared.
1, 2
Oral : 95.7 - 99.9 °F 35.4 - 37.7 °C
1, 2
Rectal : 96.6 - 100.8 °F 35.9 - 38.2 °C
1, 2
ThermoScan : 95.7 - 99.9 °F 35.4 - 37.7 °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. Sund-Levander M, Forsberg C, Wahren LK. Normal oral, rectal, tympanic and axillary body temperature in adult men and
women: a systematic literature review. Scand J Caring Sci 2002 June;16(2):122-8.
2. Herzog L, Phillips SG. Addressing concerns about fever. Clin Pediatr (Phila) 2011 May;50(5):383-90.
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6. Contraindications
Clinical studies have shown the Braun ThermoScan thermometer can obtain accurate temperature
measurements on full term newborn, pediatric and adult patients. 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 (ear wax) in the ear canal, otitis
media and tympanostomy tubes do not significantly impact temperature readings. However, complete ear
canal occlusion due to cerumen (ear wax) can result in lower temperature readings.
• 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.
• This thermometer is not intended for pre-term babies or small-for-gestational age babies.
Ambient temperature
Hearing aid
Lying on pillow
Tympanostomy tubes
In the event of lying on a pillow, ear plugs or hearing aid, remove the individual from the situation
and wait 30 minutes prior to taking a temperature.
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7. Warnings and precautions
This thermometer is for professional use only.
This thermometer must only be used with genuine Braun ThermoScan probe covers.
Do not use any cleaning agent other than isopropyl or ethyl alcohol for cleaning the probe
lens window and probe as specified in the cleaning section of this manual.
Do not use any cleaning agent other than the approved list of cleaners for cleaning the
body of the thermometer.
To avoid inaccurate measurements, always attach a new, clean probe cover for each
temperature measurement.
The probe lens window must be kept clean, dry and undamaged at all times to ensure
accurate measurements. To protect the probe lens window, always keep the thermometer
in the storage cradle while transporting or when not in use.
This thermometer is not intended for pre-term babies or small-for-gestational age babies.
Do not modify this equipment without authorization of manufacturer.
Never use the thermometer for purposes other than those it has been intended for. Please
follow the general safety precautions.
Do not expose the thermometer to temperature extremes (below –4ºF / – 25ºC or over
122ºF / 55ºC) nor excessive humidity (> 95 % RH).
This thermometer complies with current required standards for electromagnetic
interference and should not present a problem to other equipment nor is it effected
by other devices. As a precaution, avoid using this device in close proximity to
other equipment.
8. Setup
8.1 Battery installation
Your Braun PRO 6000 thermometer ships with two (AA) alkaline batteries.
See 14.7 Maintenance and service, Replacing the batteries.
The Braun PRO 6000 Charging station (sold separately) ships with one rechargeable
battery pack.
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8.2 Mounting instructions (Large cradle only)
Mounting hardware not included.
The large cradle (2 box storage) can be mounted as an easily removable wall hanger or a permanent wall
mount. All mounting must be done into a wall stud. To mount the cradle the following items are needed:
• 2 #8 wood or sheet metal, pan head screws, 3.2 cm (1.25”) long
• Ruler (or tape measure could be substituted)
• Screwdriver to match drive of screws
2 Mount to wall:
• Removable wall hanger: 1
107 mm (4.21")
Locate the stud on the wall. Mount the 1st screw
in position 1 and the 2nd screw in position 2a.
126 mm (4.95")
2 A
ttach new probe cover by
pushing probe tip straight into box,
then pulling thermometer out.
3 W
ait for the ready indication. Ring around
MEASURE button turns green, thermometer will beep once
and three lines on display indicate thermometer is ready.
4 P
lace probe snugly
in ear canal and direct
toward opposite temple.
Keep thermometer probe steady
in the ear canal. Correct probe
placement is essential for accurate
measurements.
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5 Press and release MEASURE button.
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emperature measurement. A long beep and
steady green ExacTemp light will signal the end of the
measuring process.
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7 R
emove used probe cover by pressing P
robe Cover
Ejector button .
To achieve accurate measurements, use a new, clean probe cover for
each measurement.
To take another measurement, place a new, clean probe cover on the
thermometer. If no action is taken the thermometer will enter SLEEP
mode after 10 seconds or upon return to the thermometer cradle or
host device.
10. Controls
10.1 Memory
Press the MEMORY button to reveal the last completed temperature. C / F Mem
The temperature will show with a MEM indicator until the MEMORY C / F Mem
button is pushed again, a new probe cover is applied, or the
thermometer enters sleep state. Memory can also be accessed from
the thermometer sleep mode and will display for 5 seconds before
returning to sleep.
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10.3 Manual timer
The Braun PRO 6000 includes a 60 second timer that features an audible notification and visual
indicator at 0, 15, 30, 45, and 60 seconds. The timer turns off automatically 5 seconds after
60 seconds is completed. The timer can be stopped at any time by pressing the Timer button or
applying a probe cover. This feature can be used to time pulse, respirations, etc. To use this feature:
1 P
ress and hold timer button for one second to activate timer.
A beep is heard at initiation of the timer.
The display will show timer counting up in seconds.
The display will show an icon that has four 15 second quadrants.
The timer will beep at the completion of each 15 second interval
to provide audible notification. Then the current segment will
become solid and the next segment will flash.
At 60 seconds a long beep will sound, all quadrants will appear
solid ending the timer function. The thermometer will exit the
timer mode after an additional 5 seconds.
… … … …
0 sec 15 30 45 60
“Beep” “Beep” “Beep” “Beep” “Beep”
2 To stop the timer at any time, press the timer button.
11. Settings
11.1 Default temperature scale
To set the default temperature scale:
3 P
lace batteries back into thermometer. Snap the battery
ºF
door back into place and ensure the latch returns to the
original latched position. Celsius or Fahrenheit symbol will
appear on the display.
ºC
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11.2 Advanced functions
The following device settings must be completed using the Welch Allyn Service Tool
(See 11.3 Advanced function settings and 11.4 Service tools)
Default
Item Description Settings
Setting
PerfecTemp™ Improves reading On/Off On
accuracy by detecting
placement of probe in
ear canal
Celsius only selection Disables the C/F Celsius Only On/Off Celsius Only Off
(Disables Fahrenheit) button and disables
the Fahrenheit default
selection on the device
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11.3 Advanced function settings
The charging station or compatible Welch Allyn Vital Signs device can be used with the Welch Allyn
Service Tool to modify settings on the thermometer.
Follow the instructions to access Braun Pro 6000 advanced settings using the Welch Allyn Service Tool.
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5 The Device tab opens.
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11.4 Service tools Service tools
For more information, refer to the Service Tool installation guide. The service tool software
and service tool installation guide are available on the CD provided with the Braun PRO 6000
thermometer or from http://www.welchallyn.com/promotions/services/servicetool.htm
11.5 Charging station for storage, charging and security function (optional)
A charging station is available for the Braun PRO 6000. The charging
station automatically recharges the thermometer when using the
rechargeable battery which is included. Use of alkaline batteries in
the thermometer while using the charging station is permitted but
the alkaline batteries will not be charged.
The charging station has an electronic, individually adjustable
security function which requires the thermometer to be returned
to the station within an individually pre-selected time or the
thermometer will be locked. The charging station serves as a
convenient storage base which can also be wall mounted.
Contact Welch Allyn for details.
Welch Allyn Technical Support:
www.welchallyn.com/support
visit locations:
www.welchallyn.com/about/company/locations.htm
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12. Errors and notifications
Do you have any further ... contact local Welch Allyn Service
questions? Center or representative
RECHARGAB
U is “Unadjusted Operating See 11.3 Advanced function
and flashing,
Mode”. Mode used for raw settings and adjust settingsprompt
via user
temperature measurement. Service Tool or contact local
Requires service tool access Welch Allyn Service Center or
to enable. Representative
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14. Maintenance and service
14.1 Cleaning and disinfecting the probe lens window and probe
Only use Braun ThermoScan® disposable probe covers.
Do not use damaged, perforated, soiled or poor fitting probe covers. Do not reuse probe covers.
Dirty probe lens window = lower readings. Fingerprints, cerumen, dust and other soiling
components reduce transparency of the tip and result in lower temperature measurements.
If thermometer is placed in ear without a probe cover, clean immediately.
Do not damage probe lens window. Avoid touching probe lens window except when cleaning.
If probe lens window is damaged return to Welch Allyn for service.
Do not modify, change or adjust probe lens window. These changes will affect calibration and
accuracy of the thermometer. If probe lens window is damaged return to Welch Allyn for service.
Do not use cleaning solution other than isopropyl or ethyl alcohol to clean probe lens window
and probe. Other cleaning agents can damage probe lens window and probe.
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4 With probe facing down, wipe the probe with a damp cloth or
cleaning wipe moistened with isopropyl or ethyl alcohol.
1 F
or additional protection, we recommend placing a new probe
cover on the thermometer probe to protect this area when
cleaning the body of the thermometer.
4 ipe the cradle and probe cover carrier with a damp cloth
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or cleaning wipe with cleaning solution from the Approved
Cleaning Solutions Table.
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14.3 Cleaning and disinfecting tether (sold separately)
1 o clean the tether, ensure that the wipe is moist, not saturated.
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Wipe the tether with a damp cloth or cleaning wipe with
cleaning solution from the Approved Cleaning Solutions Table.
1 emove empty probe cover box from probe cover box carrier
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by pulling up.
2 Open the new probe cover box. Pull down on the perforated
strip. Discard perforated strips.
3 Insert new probe cover box into probe cover carrier by placing
inside brackets and pushing down
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14.5 Removing and installing probe cover box carrier
2 Remove probe cover box carrier from the cradle by rotating the
probe cover box carrier forward.
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14.7 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.
3 emove the batteries and replace with new batteries, making sure
R
the poles are in the right direction.
Th
erm
oS
ca
n
4 nap battery door back into place and ensure the latch returns to
S
original latch position.
T
his product contains batteries and recyclable electronic waste. To protect the
environment, do not dispose of it in the trash, but take it to appropriate local collection
points according to national or local regulations.
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15. 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 ( (±0.2°C) (35.0°C-42°C) (95°F - 107.6°F)
±0.5°F (±0.3°C) (outside this temperature range)
Clinical repeatability: <0.57°F (0.3°C)
CAUTION: Do not use this device in the presence of electromagnetic or other interference
outside the normal range specified in IEC 60601-1-2.
W E L C H A L LY N A U S T R A L I A P T Y LT D
UNIT 5 38 SOUTH STREET
R Y D A L M E R E , N S W 2 116
AUSTRALIA
This product conforms to the provisions of the EC directive 93/42/EEC (Medical Device Directive).
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EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers
(with maximum device)
Meets CB Scheme
EN 60601-1-2 :2007, IEC 60601-1-2:2007 General requirements for basic safety and essential
performance—Collateral Standard: Electromagnetic Compatibility–Requirement & Tests
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and test
IEC 62304 :2006 Medical device software- Software life cycle processes
IPX00
Symbol definitions:
Consult instructions
BF APPLIED PART for use.
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Guidance and manufacturers declaration- electromagnetic Immunity
Electrical fast
±2kV power line
transient Not applicable
± 1kV I/O lines
IEC 61000-4-4 The PRO 6000 is solely battery powered
Surge ± 1kV differential
Not applicable
IEC 61000-4-5 ± 2kV common
Voltage dips,
short interrupts and > 95% dip 0.5 cycle
voltage variations 60% dip 5 cycles
Not applicable The PRO 6000 is solely battery powered
on power supply 70% dip 25 cycles
input lines 95% dip 5 sec.
IEC61000-4-11
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Guidance and manufacturer’s declaration – electromagnetic emissions
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