BRAUN PRO 4000 ThermoScan Ear Thermometer User Manual

BRAUN PRO 4000 ThermoScan Ear Thermometer User Manual

How to use Braun ThermoScan

1. To help to ensure accurate readings, make sure the probe tip and lens are clean and a new, clean probe cover is in place before each measurement.

2. When the probe cover is in place, the thermometer turns on automatically. Wait for the ready signal beep.

3. Fit the probe snuggly into the ear canal, then push and release the Start button.

4. If the probe has been fitted correctly into the ear canal during the complete measuring process, a long beep will signal the end of the measuring process. You can be assured to have taken an accurate temperature reading. The thermometer detects that an accurate temperature measurement has been taken.

If you take the temperature of another person, the «ExacTemp» light can be of help. It flashes during the measuring process as long as the probe is correctly positioned, and lights up continuously when the thermometer detects that an accurate reading has been taken.

Product description

Replacement parts list

Thermometers
US/Canada
04000-200 Braun ThermoScan® PRO 4000 ear thermometer
04000-300 Braun ThermoScan PRO 4000 ear thermometer, with security base station*
04000-400 Braun ThermoScan PRO 4000 ear thermometer, roll stand

EMEA
04000-600 Braun ThermoScan PRO 4000 ear thermometer
04000-500 Braun ThermoScan PRO 4000 ear thermometer, with security base station

Asia Pacific/Latin America
04000-200 Braun ThermoScan PRO 4000 ear thermometer

UK
04000-600 Braun ThermoScan PRO 4000 ear thermometer

Accessories and probe covers
US/Canada
05075-800 Braun ThermoScan disposable probe covers (case of 800 probe covers)
05075-005 Braun ThermoScan disposable probe covers (case of 5,000 probe covers)
24001-1000 PRO 4000 base station and probe cover refill dispenser
24001-0000 PRO 4000 base station with rolling stand
53020-0000 Rechargeable battery pack for PRO 4000
80199-0000 Replacement power cord for PRO 4000 base station (North America)
01802-110 Welch Allyn/Braun 9600 plus calibration tester

EMEA
04000-800 Braun ThermoScan disposable probe covers (case of 800 probe covers)
04000-700 PRO 4000 base station and probe cover refill dispenser
53020-0000 Rechargeable battery pack for PRO 4000
80199-0001 Replacement power cord for PRO 4000 base station (Multi National)
01802-110 Welch Allyn/Braun 9600 plus calibration tester

Asia Pacific/Latin America
05075-800 Braun ThermoScan disposable probe covers (case of 800 probe covers)
05075-005 Braun ThermoScan disposable probe covers (case of 5,000 probe covers)
01802-110 Welch Allyn/Braun 9600 plus calibration tester

UK
04000-800 Braun ThermoScan disposable probe covers (case of 800 probe covers)
01802-110 Welch Allyn/Braun 9600 plus calibration tester

• Available in the US only

Patent numbers

US 6,022,140; 6,149,298; 6,203,194; 6,626,835; 6,694,174; 7,014,358; D460,006
AU 2002250974
CH 0 966 660; 1 664 693
CN ZL96198273.X, ZL99803219.8; ZL00804341.8; ZL00124323.3; ZL01337258.0; ZL02805125.4
DE 40101997; 50011321; 50015741; 59811385; 502004007077
ES 0 966 660; 1 664 693
FR 0 966 660; 1 081 475; 1 166 067; 1 664 693
GB 0 966 660; 1 081 475; 1 166 067; 1 664 693; 2 104 340
HK 1024053; 1042550; 1062043
JP 4052945; 1144805
KR 10-0626189; 10-0628283; 10-0883150; 10-0507716
NL 1 166 067; 1 664 693
TR 1 664 693
TW NI-112501; NI-147458; NI-159809; ND-084456;

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 com-pared.

A person’s normal temperature range tends to decrease with age. The following table shows normal ThermoScan ranges by age.

Normal ThermoScan temperature ranges2 :

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. 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.

Braun ThermoScan

The Braun ThermoScan thermometer has been carefully developed for accurate, 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.
• To avoid inaccurate measurements, always attach a new, clean probe cover for each temperature measurement.

How does Braun ThermoScan work?

The Braun PRO 4000 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 a 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.

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, pp 754-5
3. Netter H F, Atlas of Human Anatomy, Novartis Medical Education, East Hanover, NJ, 1997, pp 63, 95

Package components

• Braun ThermoScan thermometer
• Directions for Use 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. « 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 automatically. Wait for the ready signal beep.

3. Fit the probe snuggly into the ear canal, then push and release the Start button (8).
   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 flashes during 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 start 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 automatically. 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 « » button for at least three seconds. The display will shortly flash «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 influence 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 temperatures, 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.

Memory mode

The last temperature taken before the Braun ThermoScan is turned off is stored in its memory and will be automatically displayed for one second when it is turned on again. For display of the stored measurement for up to 60 seconds, the « » button must be pressed again. The memory mode is left automatically after pressing the « » button again. A reading from memory is indicated on the LCD by «MEM».

Changing the default temperature scale

Your Braun ThermoScan is shipped with a default temperature scale activated. If you wish to switch between Celsius «°C» and Fahrenheit «°F» , proceed as follows:
Make sure the thermometer is turned off. Press and hold down the « » button. After about 3 seconds the display will show this sequence: «°F» / «SET» / «°C» / «SET» …
Release the « » button when the desired scale is shown. There will be a short beep to confirm the new setting, then the thermometer is turned off automatically. When turned on again, temperatures will be shown in the selected scale, 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 inside cover).
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 thermometer will show the hours remaining before it is locked. To turn on the anti-theft function, please refer to the base station manual.

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 standby mode.

Care and cleaning

Braun ThermoScan probe covers are intended for single use only! To ensure accurate readings, always use Braun ThermoScan disposable probe covers with the PRO 4000 thermometer. Damaged, perforated, or soiled probe covers can lead to inaccurate temperature readings. Additionally, the accuracy of your temperature readings can be affected by damage to the probe window, or the presence of dirt or cerumen on the 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 modified, 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 isopropyl 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 isopropyl alcohol to clean the probe window.

Thermometer
Use a soft cloth slightly moistened with isopropyl alcohol to clean the thermometer display and exterior. As needed, clean the thermometer and probe with a 70% isopropyl alcohol solution or a 10% chlorine bleach solution or a nonstinging disinfectant such as Avicide® or its equivalent. Do not use abrasive cleaners. Never submerge 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).

Trouble-shooting

Replacing the batteries

To protect the environment, dispose of empty batteries according to national or local regulations.

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.

To open the battery compartment, depress the button in the door as shown using a pen or other pointed object, while lifting the door. 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.

Calibration

The thermometer is initially calibrated at the time of manufacture. If the thermometer is used according to the use instruction, periodic readjustment is not required. However, Welch Allyn recommends checking calibration on an annual basis or whenever clinical accuracy of the thermometer is in question. Procedures for checking calibration are outlined in the 9600 Plus Calibration Tester (REF 01802-110) directions for use manual.

The above recommendations do not supersede the legal requirements. The user must always comply with legal requirements for the control of the measurement, functionality, and accuracy of the device which are required by the scope of relevant laws, directives or ordinances where the device is used.

Manufacturing date is given by the LOT number located on front of the product. The first three digits give the day of the year manufactured. The second two digits give the year of manufacture. The last six digits represent the serial number of the device.

An example: LOT 27710KTC this product has been manufactured on the 277 day of the year 2010.

Special situations

Clinical studies have shown the Braun ThermoScan thermometer can obtain accurate temperature measurements on full term new-born, paediatric 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 in the ear canal, otitis media and tympanostomy tubes do not significantly 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» temperature.

An elevated temperature or fever is often viewed as a danger sign. In fact, a fever can be very beneficial, and helps our immune system work more effectively. A fever should be evaluated along with other physical symptoms. With the exception of new-born 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-inflammatories and some analgesics may also mask fever.

The presence or absence of fever should not be used as the only measurement of the significance 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.

Product specifications

Displayed temperature range: 68­108 °F (20­42.2 °C)
Operating ambient temperature range: 50­104 °F (10­40 °C)
Display resolution: 0.1 °F or °C
Accuracy for displayed temperature range: ±0.4 °F (95.9­107.6 °F) (35.5 °C­42 °C) ±0.5 °F (outside this temperature range)
Clinical repeatability: ± 0.26 °F (± 0.14 °C)

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: Initial start-up time: 3–4 seconds
Measurement time: 2–3 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 USA, Inc., 250 Turnpike Road, Southborough, MA 01772, USA.

ASTM laboratory accuracy requirements 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» ­

This products conforms to the provisions of the EC directive 93/42/EEC (Medical Device Directive).

To protect the environment, dispose of empty batteries according to national or local regulations.

WELCH ALLYN A USTRALIA PTY LTD UNIT 5 38 SOUTH STREET R Y D A L M E R E , N S W 2 116 AUSTRALIA

Internally powered equipment. Continuous operation. Not protected against ingress of water.

Medical Equipment with respect to electrical shock, fire and mechanical hazards only in accordance with UL60601-1

Service
The Braun ThermoScan thermometer has a limited three year warranty. Should service be required during or after the warranty period you must contact Welch Allyn at one of the locations listed on the inside cover 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 contacting Welch Allyn at one of the numbers listed on the inside cover.

Limited three year manufacturer’s warranty
For Model PRO 4000

The PRO 4000 instrument is warranted by Kaz to be free from defects in material and workmanship under normal use and service for a period of three years from the date of delivery to the first professional user who purchases the instrument.

This warranty does not cover batteries, damage to the probe window, or damage to the instrument caused by misuse, negligence or accident, and extends to only to the first purchaser of the product. Additionally this warranty becomes void, if the thermometer is operated with anything other than genuine Braun ThermoScan® Probe Covers.

Thermometer service or replacement will be carried out by Kaz subject to the terms of this warranty. Loss or damage in return shipment to Kaz shall be at purchaser’s risk. Kaz reserves the right to replace a non-conforming product with the most comparable product currently available. This product has a five year minimum expected lifetime.

IN NO EVENT SHALL KAZ BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THE PURCHASE OR USE OF ANY PRODUCT. This warranty shall not apply to, and Kaz shall not be responsible for, any loss arising in connection with the purchase or use of any product which has been serviced by anyone other than a Kaz authorized service representative or altered in any way so as, in Kaz’s judgment, to affect its stability or reliability, or which has been subject to misuse or negligence or accident, or which has the serial number or lot number altered, effaced or removed, or which has been used other than in accordance with the instructions furnished by Kaz. IN NO EVENT SHALL KAZ’S LIABILITY EXCEED THE ORIGINAL COST OF THE PRODUCT.

This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities on Kaz’s part, and Kaz neither assumes nor authorizes any representatives or other person to assume for it any other liability in connection with the sale of its products.

TO THE EXTENT PERMITTED BY LAW, KAZ DISCLAIMS ALL STATUTORY AND IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF MERCHANTIBILITY AND FITNESS FOR A PARTICULAR PURPOSE.

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