ThermoScan PRO 6000 Instructions for Use ver A

English

ThermoScan

®

PRO 6000 Ear thermometer

This manual applies to and

901054 Ear Thermometer,

901009 Accessory, Thermometry,

901010 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

107983 (CD) DIR 80029350 Ver. A Revision date: 2021-10

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.html Replacement parts Probe covers: 06000-005, 06000-801, 06000-800 For a complete list of parts, go to www.welchallyn.com

Use only Hillrom probe covers

For patent information, visit www.welchallyn.com/patents © 2021 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.

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1.

Braun Thermoscan® PRO 6000 Ear thermometer 1 2 3 11 4

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5 13 6

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C / F C / F MemMem

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10

C/

C/

F Mem

C/

F Mem

F Mem

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18 18a

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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 Instructions 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

3.

Product description (See Section 1. Braun Thermoscan PRO 6000 Ear thermometer)

1 2 3 4 5 6 7 8 9 10 11

Probe lens window

®

C/F button

12 13 14 15 16 17 18

Memory button

18a Probe cover box carrier

Timer button

19 GTIN code 20 Temperature scale switch (inside battery

Probe ExacTemp™ light Measure button Measure light Display

Tether mount (Tether sold separately) Probe cover detect switch

Probe cover ejector Battery door latch Battery door Small cradle - one storage box Large cradle - two storage boxes Probe cover Probe cover box

compartment)

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4. Screen elements

“ ’

Œ Battery Œ

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  ritically low battery-battery C 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.  mpty battery-battery has E 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

‘ 

 Ž Ž



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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English 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.

Table 1: Ear canal temperature gradient

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.

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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English 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: Axillary1, 2:

95.6–99.4 °F

35.3–37.4 °C

1, 2

95.7–99.9 °F

35.4–37.7 °C

96.6–100.8 °F

35.9–38.2 °C

95.7–99.9 °F

35.4–37.7 °C

Oral : 1, 2

Rectal : 1, 2

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 age1, 2: < 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.

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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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Warnings and cautions 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.

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English WARNING If cleaning instructions are not followed, the device may be exposed to fluid ingress. If this occurs, there is a risk of the probe tip overheating and potentially causing a burn to the user or the ear canal of the patient. In addition, fluid ingress may cause inaccurate temperature readings. 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. 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-for-gestational 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.

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8. Setup 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. 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

ΠRemove probe cover box carrier from the cradle by rotating the probe cover box carrier forward.

• 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.

107 mm (4.21")

• Removable wall hanger: Locate the stud on the wall. Mount the 1st screw in position 1 and the 2nd screw in position 2a.

126 mm (4.95")

 Mount to wall:

1

2a 2b

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Ž Place probe cover box carrier back in cradle by lining up the brackets and pushing down.

NOTE For a mounting template please reference the Braun Thermoscan® PRO 6000 Ear thermometer CD.

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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9.

Using the Braun Thermoscan® PRO 6000 Ear thermometer

Temperature measurement

ΠRemove thermometer from cradle by gripping thermometer at base and pivoting up.

1a

1b

Thermometer will turn on automatically. Probe cover icon will flash on display indicating a new probe cover is needed.

 Attach new probe

cover by pushing probe tip

straight into box, then pulling thermometer out.

Ž Wait for the ready indication. Ring around measure

button turns green, thermometer will beep once and three lines on display indicate thermometer is ready.

 Place 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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 Press and release measure button.

The thermometer will beep once, running dashes will appear on the display then the green ExacTemp light will flash, indicating consistent probe position. NOTE Always press the measure taking a measurement.

button before

‘ Temperature measurement. A long beep and

steady green ExacTemp light will signal the end of the measuring process.

The temperature will show on the display.

If the thermometer is unstable or patient is moving during the measuring process, the device will beep, the green ExacTemp light will flash and POS (Position Error) will flash on the display. Be sure the device is stable and restrict patient movement for the next measurement. Change the probe cover to reset. * See 12. Errors and notifications

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’ Remove used probe cover by pressing Probe 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 MEM (the memory button) to reveal the last completed temperature. The temperature will show with a Mem indicator until MEM (the memory 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.

C/F

Mem

C/F

Mem

10.2 C/F (Celsius/Fahrenheit) Once the temperature scale has been set (See 11.1 Default temperature scale), the alternative scale can be quickly referenced at any time while a temperature is displayed.

ΠIf the temperature scale is set to Celsius, press and release

C/F (the C/F button) to view the temperature in Fahrenheit. If the temperature scale is set to Fahrenheit, press and release C/F to view the temperature in Celsius.

C/F

Mem

C/F

Mem

 Press and release C/F again to revert back to default scale.

NOTE If temperature conversion is disabled, refer to the Service Manual for more information.

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English 10.3 Manual timer 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 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:

ΠPress 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 “Beep”

… 15 “Beep”

… 30 “Beep”

… 45 “Beep”

60 “Beep”

 To stop the timer at any time, press the timer button. 11. Settings 11.1 Default temperature scale To set the default temperature scale:

ΠOpen battery door by sliding

spring latch to the right using your finger or a pointed object such as a pen. While holding the latch in the open position, grasp the battery door and remove it. Remove batteries and set aside. Once batteries are removed, the C/F switch is accessible.

or

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English back into place and ensure the latch returns to the original latched position. Celsius or Fahrenheit symbol will appear on the display.

ºC

Ž Place batteries back into thermometer. Snap the battery door

ºF

 Slide switch to C or F using a pen or pointed object.

11.2 Advanced functions The Welch Allyn Service tool software is required to modify the thermometer’s configuration. A charging station and rechargeable batteries or compatible Welch Allyn Device is required to connect to the PC running the Welch Allyn Service Tool. (See 11.3 Advanced function settings and 11.4 Service tools)

Item

Description

Settings

Default setting

PerfecTemp™

Improves reading accuracy by detecting placement of probe in ear canal

On/Off

On

C/F button

Use the C/F button to view measurements in the nondefault (alternate) temperature scale. When off (disabled) only the default scale is available.

On/Off

On

Default C/F manual switch

When on (enabled), the default scale can be set using the manual switch in the battery compartment. When the control is off (disabled), the radio buttons for Celsius and Fahrenheit are enabled allowing the service tool to set the default scale.

On/Off

On

Security function

Sets countdown time after removal from charging dock to lock

1 through 12 hours

Off

Timer icon

Displays an icon along with the timer counter

On/Off

On

Unadjusted operating mode

Places thermometer in mode to detect raw ear temperature only

Allows user to set device to unadjusted operating mode

Off

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English 11.3 Advanced function settings The Welch Allyn Service tool software is required to modify the thermometer’s configuration. A charging station and rechargeable batteries or compatible Welch Allyn Device is required to connect to the PC running the Welch Allyn Service Tool. Follow the instructions to access Braun Thermoscan® PRO 6000 Ear thermometer advanced settings using the Welch Allyn Service Tool.

Œ Dock the Braun Thermoscan PRO 6000 Ear thermometer in ®

the Charging Station

 The recommended action is to use the USB cable that

connects to the wall adapter-unplug it from the wall adapter and plug it into your computer.

Ž a. Launch the Welch Allyn Service Tool.

b. If the startup screen with the “Add new features” and “Service” button appears click “Service”. c. L  og in as ADMIN with no password or use any account you previously created. NOTE If the log on prompt does not appear click the Log on button. You must be logged on to access the configuration dialog.

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 Click the Braun Thermoscan PRO 6000 ®

Ear thermometer from the Device list (Device list) to highlight, then click the select button.

 The device tab opens.

‘ Click the Configure tab to the right of the device information tab.

’ Click the Change button in the current

settings box. The configuration settings dialog box opens.

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“ Select the setting you wish to enable or

disable by clicking the check box next to the setting. A check mark indicates the setting will be enabled, an empty check box indicates the setting will be disabled. To select the Security function click the drop down menu and click the desired time or Off to disable. To restore the factory default settings click Restore Defaults. Once the desired settings are selected click the Save button to send the settings to the Braun Thermoscan® PRO 6000 Ear thermometer and close the box. To close the box without changing the settings click the Cancel button.

11.4 Service tools For more information​on the​Service Tool and Service Tool installation guide go to www.hillrom.com/en/services/welch-allyn-service-tool/ and download the service tool found under the Services & Support Tab/Service Centers/Download service tool.

11.5 Charging station for storage, charging, and security function (optional) A charging station is available for the Braun Thermoscan® PRO 6000 Ear thermometer. 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.html

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