Welch Allyn PRO 6000 Directions For Use Manual

Ear thermometer Directions for use
C / F
Mem
PRO 6000
ThermoScan
®
PRO 6000 Ear thermometer
This manual applies to 901054 Ear Thermometer, 901009 Accessory, Thermometry
06000-200 06000-300
06000-100 06000-150
06000-125 104894
These instructions for use/directions for use (IFU/DFU) may contain information about products that may or may not be approved for use by a relevant regulatory authority in any particular country or region of the world. Customers and/or End-Users are requested to contact their local sales representative for further information regarding regulatory registration status and availability of products.
Manufactured by: Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA
Welch Allyn Limited Navan business Park Dublin road, Navan, County Meath Republic of Ireland C15 AW22
For information about any Welch Allyn product, contact:
Welch Allyn Technical Support:
www.welchallyn.com/support
visit locations:
www.welchallyn.com/about/company/locations.htm
Replacement parts
Probe covers: 06000-005, 06000-801, 06000-80 0 For a complete list of parts, go to www.welchallyn.com
For patent information, visit
www.welchallyn.com/patents © 2019 All rights reserved.
Made in Mexico
This product is manufactured under license to the ‘Braun’ trademark. ‘Braun’ is a registered trademark of Braun GmbH, Kronberg, Germany.
ThermoScan and ExacTemp, are trademarks of Helen of Troy Limited and/or its affiliates.
Duracell is a registered trademark.
107983 (CD) DIR 80024839 Rev C Revision date: 2019-
Use only
Hillrom
probe covers
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1. Braun Thermoscan® PRO 6000 Ear thermometer

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2. Package components

Braun Thermoscan® PRO 6000 Ear 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 (available via internet link) and Service Tool installation guide (available via internet link).
2 (AA) Duracell® alkaline batteries
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3. Product description

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Probe lens window
2
Probe
3
ExacTemp™ light
4
Measure button
5
Measure light
6
Display
7
C/F button
8
Memory button
9
Timer button
10
Tether mount (Tether sold separately)
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Probe cover detect switch
(See Section 1. Braun Thermoscan® PRO 6000 Ear thermometer)
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Probe cover ejector
13
Battery door latch
14
Battery door
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Small cradle - one storage box
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Large cradle - two storage boxes
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Probe cover
18
Probe cover box
18a
Probe cover box carrier
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GTIN code
Temperature scale switch (inside battery
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compartment)
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4. Screen elements

Battery
Full battery—indicates battery is between 100 % and 70 % of usable battery capacity Partial battery—indicates battery is between 70 % and 30 % of usable battery capacity Low battery—indicates battery is between 30 % and 10 % of usable battery capacity
Critically low battery—battery is between 10 % and 1 % of usable battery capacity. When final segment flashes, batteries have low power. The thermometer will take a proper measurement but batteries must be replaced soon. If rechargeable batteries are in use, batteries should be recharged.
Empty battery—battery has 1 % or less of usable battery capacity. When battery outline flashes, the thermometer will not operate. Replace the batteries. If rechargeable batteries are in use, batteries should be recharged. See 14.7
Maintenance and service, Replacing the batteries
Probe cover icon
The icon animates in an upward motion to remove probe cover. The icon animates in a downward motion to apply a probe cover.
See 9. Using the Braun Thermoscan® PRO 6000 Ear thermometer
 
Timer icon
The Braun Thermoscan® PRO 6000 Ear thermometer includes a 60 second timer that features an audible notification and visual indicator at 0, 15, 30, 45 and 60 seconds. The first quadrant begins flashing when timer starts and becomes solid at 15 seconds. This repeats for each 15 second interval. The timer turns off automatically 5 seconds after 60 seconds is completed. See 10.3
Controls, Manual timer
Alert icon
Icon that appears with error message.
See 12. Errors and notifications
Memory indicator
Indicates the reading shown on the display is the reading in memory.
See 10.1 Controls, Memory
C/F scale
Indicates default temperature scale. Either °C or °F will display, depending on setting. See 10.2 Controls, C/F
Celsius/Fahrenheit
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Security unlock icon and countdown time
(Requires charging station or compatible Welch Allyn Vital Signs device, sold separately.) If the security function is enabled, it requires the thermometer be returned to the charging station within a pre-selected time interval. Countdown time indicates the amount of time remaining until the thermometer will be locked if not returned to the charging station. See 11.2 Settings, Advanced functions
Security lock icon
(Requires charging station or compatible Welch Allyn Vital Signs device, sold separately.) Indicates the thermometer is locked. Return the thermometer to the charging station to reset the countdown and resume normal operation. See 11.2
Settings, Advanced functions

5. About the Braun Thermoscan® PRO 6000 Ear thermometer

5.1 Intended Use
The Braun Thermoscan® PRO 6000 Ear thermometer is indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. The probe cover is used as a sanitary barrier between the infrared thermometer and the ear canal.
5.2 How does Braun ThermoScan work?
The Braun Thermoscan® PRO 6000 Ear thermometer technology reads the infrared energy emitted by the tympanic membrane and surrounding tissues to determine the patient’s temperature. 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. The thermometer displays an actual measured ear temperature or clinically accurate, oral equivalent temperature that has been validated in clinical studies by comparing IR measurements with the oral readings from afebrile and febrile patients of various ages. Unadjusted operating mode ear temperature readings are available via unadjusted mode, which can be accessed using the Welch Allyn Service Tool.
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5.3 PerfecTemp™ Sensor System
Speed and ease of access are two key advantages of ear thermometry. Concerns regarding accuracy and reliability have hindered adoption of this technology. In clinical studies, the precision of ear temperature measurement has been shown to be influenced by ear canal anatomy and variability in user technique. Proper probe placement can also be a challenge, particularly with young patients that move around during measurement. Shallow probe placement, coupled with anatomical variabilities such as ear canals with a small circumference and poor visibility of the tympanic membrane, can result in readings that are low compared to core temperature because the thermometer could be focused on the cooler outer ear canal.
The Braun Thermoscan® PRO 6000 Ear thermometer incorporates a new proprietary sensor system, PerfecTemp™, that overcomes the challenges presented by ear canal anatomy and variations in technique among clinicians. The thermometer collects information about the direction and depth of ear probe placement as it is placed into the ear canal and automatically incorporates this information into the temperature calculation. Incorporating information related to patient specific anatomy and exact ear probe placement in the ear canal increases the accuracy of the measurement as compared to core temperature, especially when probe positioning is not ideal.
Table 1: Ear canal temperature gradient
5.4 ExacTemp™ technology
The Braun Thermoscan® PRO 6000 Ear thermometer also features ExacTemp™ technology which supports temperature measurement reliability by detecting the stability of the probe placement during the measurement. The ExacTemp light flashes during the measuring process and remains illuminated when the measurement is complete, indicating consistent placement of the probe during the measurement process. Consistent probe placement helps support accurate temperature measurement.
5.5 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, 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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5.6 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.
Normal ranges by site1:
1, 2
Axillary
: 95.6–99.4 °F 35.3–37.4 °C
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
ThermoScan
A person’s normal temperature range tends to vary with age. The following table shows normal ThermoScan ranges by age.
Normal ThermoScan ranges by age
< 3 months 96.4–99.4 °F 35.8–37.4 °C
3–36 months 95.7–99.6 °F 35.4–37.6 °C
> 36 months 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.
1, 2
: 95.7–99.9 °F 35.4–37.7 °C
1, 2
:
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6. Contraindications

None
6.1 What affects accuracy
Always use a new disposable probe cover for each measurement to maintain accuracy and hygiene. The right ear measurement may differ from the measurement taken in the left ear. Therefore, always take the temperature in the same ear. The ear must be free from obstructions or excess earwax build-up to take an accurate reading.
External factors that may influence ear temperatures include:
Factor Affected Not affected
Used probe cover
Ambient temperature
Wet / dirty / damaged lens
Hearing aid
Lying on pillow
Moderate cerumen (ear wax)
Otitis media (ear infections)
Tympanostomy tubes
In the event the patient is lying on a pillow or wearing ear plugs or a 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

WARNING This thermometer is for professional use only.
WARNING This thermometer must only be used with genuine Hillrom probe covers.
WARNING 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.
CAUTION Do not use any cleaning agent other than those on the approved list of cleaners for cleaning the body of the thermometer.
WARNING To avoid inaccurate measurements, always attach a new, clean probe cover for each temperature measurement.
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WARNING 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.
WARNING This thermometer is not intended for pre-term babies or small-for­gestational age babies.
WARNING Do not modify this equipment without authorization of manufacturer.
CAUTION Never use the thermometer for purposes other than those it has been
intended for. Please follow the general safety precautions.
CAUTION Do not expose the thermometer to temperature extremes (below –25 ºC / –13 ºF or over 55 ºC / 131 ºF) nor excessive humidity (> 95 % RH).
CAUTION This thermometer complies with current required standards for electromagnetic interference and should not present a problem to other equipment nor is it affected by other devices. As a precaution, avoid using this device in close proximity to other equipment.
WARNING Do not use an ear thermometer if there is blood or drainage in the external ear canal.
WARNING 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.
WARNING 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.
WARNING If prescription ear drops or other medications have been placed in the ear canal, use the untreated ear to take a measurement.
WARNING Patients who have deformities of the face and/or ear may not be able to have a temperature taken with an ear thermometer.

8. Setup

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8.1 Battery installation
Your Braun Thermoscan® PRO 6000 Ear thermometer ships with two (AA) alkaline batteries.
See 14.7 Maintenance and service, Replacing the batteries.
The Braun Thermoscan® Charging station (sold separately) ships with one rechargeable battery pack.
8.2 Mounting instructions (Large cradle only)
Mounting hardware not included.
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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 can be substituted)
• Screwdriver to match drive of screws
Remove probe cover box carrier from the cradle
by rotating the probe cover box carrier forward.
Mount to wall:
Removable wall hanger:
Locate the stud on the wall. Mount the 1st screw in position 1 and the 2nd screw in position 2a.
Permanent wall mounting:
Locate the stud on the wall. Mount the 1st screw in position 1 and the 2nd screw in position 2b. Tighten screws.
Note: Permanent mounting is not recommended if using the charging station to access the security function, other advanced functions or charge the rechargeable battery.
Place probe cover box carrier back in cradle by
107 mm (4.21")
126 mm (4.95")
1
2a 2b
lining up the brackets and pushing down.
Note: For a mounting template please reference the Braun Thermoscan® PRO 6000 Ear thermometer CD.
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8.3 Tether installation
A kit to tether the thermometer to the cradle is available separately. Installation instructions are provided with the tethering kit. Contact Welch Allyn for details.
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