ThermoScan PRO 6000 Directions for Use

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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 Kaz USA, Inc. 250 Turnpike Rd. Southborough, MA 01772, USA

Kaz Europe Sàrl Place Chauderon 18 CH-1003 Lausanne - Switzerland 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 For a complete list of parts, go to www.welchallyn.com Patent numbers www.welchallyn.com/patents www.kaz.com/patents/braun

Use only

Braun certified probe covers for accurate readings

© 2015 Kaz USA, Inc. Made in Mexico This product is manufactured by Kaz USA, Inc. under license to the ‘Braun’ trademark. ‘Braun’ is a registered trademark of Braun GmbH, Kronberg, Germany. ThermoScan is a registered trademark of Helen of Troy Limited. 31IMP6NA190

03JUN15

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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

3. Product description (See 1. PRO 6000) 1

Probe lens window

11 Probe cover detect switch

2

Probe

12 Probe cover ejector

3

ExacTemp light

13 Battery door latch

4

Measure button

14 Battery door

5

Measure light

15 Small cradle-one storage box

6

Display

16 Large cradle-two storage boxes

7

C/F button

17 Probe cover

8

Memory button

18 Probe cover box

9

Timer button

10 Tether mount (Tether sold separately)

18a

Probe cover box carrier

19 GTIN code

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4. Screen elements 1 Battery Full battery - indicates battery is between 100% and 70% of usable battery capacity

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8 1

6

 artial battery - indicates battery is P between 70% and 30% of usable battery capacity  ow battery - indicates battery is L between 30% and 10% of usable battery capacity  ritically low battery - battery is C 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 1% or E 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

2 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 PRO 6000

3 Timer icon

The PRO 6000 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

5 2 3

4

4 Alert icon

Icon that appears with error message. See 12. Errors and notifications

5 Memory indicator

Indicates the reading shown on the display is the reading in memory. See 10.1 Controls, Memory

6 C/F scale

Indicates default temperature scale. Either °C or °F will display, depending on setting. See 10.2 Controls, C/F Celsius/Fahrenheit

7 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

8 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

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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.

5.1 How does Braun ThermoScan work? The Braun PRO 6000 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.

5.2 PerfecTemp™ technology 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 PRO 6000 thermometer incorporates a new proprietary technology, PerfecTemp™ technology, 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.

5.3 ExacTemp™ technology The Braun PRO 6000 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.

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English 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: • 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 5.5 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.

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 decrease 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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English 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.

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 may influence ear temperatures, including:

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 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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English 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

1 Remove 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")

2 Mount to wall:

1

2a 2b

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

Note: For a mounting template please reference the PRO 6000 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 PRO 6000 Temperature measurement

1 Remove 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.

 ttach new probe cover by 2 A

pushing probe tip straight into box, then pulling thermometer out.

 ait for the ready indication. Ring around 3 W

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

 lace probe snugly 4 P

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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English 5 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 a measurement.

button before taking

 emperature measurement. A long beep and 6 T

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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English  emove used probe cover by pressing P  robe Cover 7 R 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. The temperature will show with a MEM indicator until 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.

1

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

2

C / F Mem C / F Mem

P  ress and release the C/F button 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 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 “Beep”

2

… 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:

or

2

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

3

P  lace batteries back into thermometer. Snap the battery door back into place and ensure the latch returns to the original latched position. Celsius or Fahrenheit symbol will appear on the display.

ºF

Open 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, C/F switch is accessible.

ºC

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English 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)

Item

Description

Settings

Default Setting

PerfecTemp™

Improves reading accuracy by detecting placement of probe in ear canal

On/Off

On

Celsius only selection (Disables Fahrenheit)

Disables the C/F button and disables the Fahrenheit default selection on the device

Celsius Only On/Off

Celsius Only Off

Security function time

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

Calibration check mode

Places thermometer in CAL mode to test calibration

Selection forces device into Test Mode in place of button press. Device remains in Test mode until unselected, button press sequence on device, or timeout occurs

Not applicable. A transient setting.

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 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.

1 Dock the Braun PRO 6000 thermometer in the Charging Station

2 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.

the Service Tool. If the log on prompt appears 3 Launch enter the User ID “ADMIN” (all caps) with no password and click the log on button.

4 Click the Braun Thermometer

from the device list to highlight, then click the select button.

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English 5

The Device tab opens.

6

Click the Configure tab to the right of the Device information tab.

7

Click the Change button in the current settings box. The configuration settings dialog box opens.

8

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 thermometer and close the box. To close the box without changing the settings click the Cancel button.

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English 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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English

12. Errors and notifications Error message

Situation

Solution

No probe cover is attached (animates ON).

Attach new, clean probe cover.

Used probe cover is attached (animates OFF).

Discard probe cover that is on and attach new, clean probe cover if taking another temperature measurement.

(POS = position error)

Change the probe cover to reset. Restrict patient movement and ensure that the positioning of the probe is correct and remains stable while taking new temperature.

The infrared monitor cannot find a temperature equilibrium and allows no measurement.

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

Wait 20 sec. until thermometer turns off automatically, then turn on again. Ensure thermometer and patient are in an environment for 30 minutes where the temperature is between 50 ºF and 104 ºF or 10 ºC and 40 ºC.

Temperature taken is not within typical human temperature range.

Change probe cover to reset. Then, make sure thermometer is properly inserted and take a new temperature.

HI will be displayed when temperature is higher than 108°F (42.2°C).

LO will be displayed when temperature is lower than 68°F (20°C).

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12. Errors and notifications Error message

or

Situation

Solution

System error (All icons display or display is blank)

Wait 20 seconds until the thermometer turns off automatically, then turn on again.

If error persists,

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

If error still persists,

... batteries are dead. Insert new batteries.

If error still persists,

... contact local Welch Allyn Service Center or representative

Battery is low, but thermometer will still operate correctly.

Insert new batteries.

Battery is too low to allow temperature measurement.

Insert new batteries.

Do you have any further questions?

... contact local Welch Allyn Service Center or representative

13. PerfecTemp™ status Error message

Situation

Solution

PerfecTemp technology is not functioning or disabled.

... contact local Welch Allyn Service Center or representative

U is “Unadjusted Operating Mode”. Mode used for raw temperature measurement. Requires service tool access to enable.

RE an pro

RECHARGAB and flashing, See 11.3 Advanced function settings and adjust settingsprompt via user Service Tool or contact local Welch Allyn Service Center or Representative

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