braun thermoscan pro 6000 calibration verification · braun thermoscan ® pro 6000 calibration...

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Welch Allyn European Technical Support Tel.: +353 46 90 67790 Email: [email protected] Braun ThermoScan ® PRO 6000 Calibration Verification What you will need How to Perform the Calibration Verification Preparation The Braun ThermoScan PRO 6000 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. Medical device (93/42/EEC): Class IIa . Notified Body: DQS Medizinprodukte GmbH (CE0297). Manufacturer: Kaz USA, Inc. 250 Turnpike Rd. Southborough, MA 01772, USA. EC Rep.: Kaz Europe Sàrl. Place Chauderon 18. CH‐1003 Lausanne – Switzerland. This medical device is a regulated health product which, pursuant to such regulation bears a CE mark. Welch Allyn recommends that you carefully read the detailed instructions for safe and proper use included in the documents accompanying the medical devices. The personnel of healthcare establishments are responsible for the proper use and maintenance of these medical devices. Welch Allyn reserves the right to make changes without notice in design, specifications and models. The only warranty Welch Allyn makes is the express written warranty extended on the sale its products. * A Braun PRO 6000 Calibration Fixture (material number 411690) is available for use with older 9600 Plus calibration testers where the dust cover screw might interfere with the proper alignment of the Braun 6000 in the ear device port. The older models have a dust cover screw that rises above the O-ring washer. Newer models have a dust cover screw that is recessed into the washer. When using the calibration fixture, follow the instructions provided with the fixture to install it to the calibration tester. ©2017 WELCH ALLYN ALL RIGHTS RESERVED Doc. No.: SM4159EU-RevA1 MC14384 2 1 6 1 1 5 6 7 2 3 4 2 4 7 5 3 3 4 5 Check the probe tip lens window for displacement. There should not be any gap in the seam formed between the bezel and the lens window. If there is a gap, the unit is damaged and must be replaced. Set the first calibration set point temperature (36 ºC) on the 9600 Plus Calibration Tester (it takes approx. 20 minutes to heat). 9600 Plus Calibration Tester and (optional) Braun PRO 6000 Calibration Fixture* Power plug / socket Stable ambient room temperature within the range of 18.3 °C – 26.7 °C Isopropyl or ethyl alcohol Remove the PRO 6000 Thermometer from the 9600 Plus Calibration Tester and read the temperature in the thermometer’s display. If the temperatures are within ±0.2 °C, the thermometer is within calibration. Gently wipe the probe tip with a cotton swab or cloth slightly moistened with isopropyl or ethyl alcohol only. Use care not to displace the lens window. Remove excess alcohol with a clean cotton swab, and let air dry for 5 minutes. Do not use any chemical other than isopropyl or ethyl alcohol to clean the probe window. Place the Braun ThermoScan PRO 6000 in Calibration Mode using the following steps: a. With the thermometer in sleep mode, press and release C/F b. IMMEDIATELY (while all segments of the LCD are illuminated during self-test) press and hold C/F and Mem c. After 5 seconds the thermometer will emit a long beep d. During the beep release Mem and C/F. The thermometer is now in Calibration Check Mode, indicated by CAL displayed on the screen for 0.25 seconds every second After entering calibration mode (CAL), wait 1 minute before taking the first temperature. 1 min Mem C / F Mem C / F 1 min Mem C / F Store thermometers for testing in the same room as the 9600 Plus Calibration Tester for approximately 30 minutes prior to testing to allow for thermal acclimation. Apply a new probe cover. If applied properly a short beep sounds and the flashing probe cover icon will disappear from the display. Wait for the screen to flash three dashes (- - -) alternating with CAL. Wait 5 seconds, press the thermometer Measure button, and watch for the green ExacTemp ® light to flash. Replace the probe cover to reset the thermometer before taking the next measurement. Wait for the thermometer screen to flash three dashes (- - -) alternating with CAL. When using only one 9600 Plus Calibration Tester, test all available thermometers for calibration verification at the current calibration set point temperature before proceeding to the next calibration set point temperature. Wait one full minute before taking another reading with the same thermometer. Repeated measurements in short sequence may cause higher readings. The probe cover must be replaced with a new probe cover before each reading, to remove any residual heat absorbed from the 9600 Plus Calibration Tester. Leave the thermometer in the 9600 Plus Calibration Tester until the ExacTemp light stops flashing and you hear a beep. If you are using the Braun PRO 6000 calibration fixture, place the Braun PRO 6000 in the fixture as shown in the assembly instructions (material number 721533). If the Braun PRO 6000 calibration fixture is not used, place the probe firmly into the ear device port. Firmly push the device down into the well to ensure perpendicularity and that the probe is fully seated in device port. Visually check to ensure proper alignment. Do not apply too much pressure once the device is firmly seated, as this may cause your hand to waiver and tilt or move the device during testing. It is important to ensure that the device is perpendicular in the port, directly aligned with the calibration tester sensor and not at an angle or tilted. Do not hold the thermometer while waiting. This allows the thermometer to remain at ambient room temperature. Mem C / F Mem C / F 1 2 3 Cotton swab or cloth Timer / watch PRO 6000 devices that need to be checked 9600 Plus Calibration Tester Optional Calibration Fixture* (material number 411690) Braun ThermoScan PRO 6000

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Page 1: Braun ThermoScan PRO 6000 Calibration Verification · Braun ThermoScan ® PRO 6000 Calibration Verification What you will need Preparation How to Perform the Calibration Verification

Welch Allyn European Technical SupportTel.: +353 46 90 67790 Email: [email protected]

Braun ThermoScan® PRO 6000 Calibration Verification

What you will need

How to Perform the Calibration VerificationPreparation

The Braun ThermoScan PRO 6000 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. Medical device (93/42/EEC): Class IIa . Notified Body: DQS Medizinprodukte GmbH (CE0297). Manufacturer: Kaz USA, Inc. 250 Turnpike Rd. Southborough, MA 01772, USA. EC Rep.: Kaz Europe Sàrl. Place Chauderon 18. CH‐1003 Lausanne – Switzerland. This medical device is a regulated health product which, pursuant to such regulation bears a CE mark. Welch Allyn recommends that you carefully read the detailed instructions for safe and proper use included in the documents accompanying the medical devices. The personnel of healthcare establishments are responsible for the proper use and maintenance of these medical devices. Welch Allyn reserves the right to make changes without notice in design, specifications and models. The only warranty Welch Allyn makes is the express written warranty extended on the sale its products.

* A Braun PRO 6000 Calibration Fixture (material number 411690) is available for use with older 9600 Plus calibration testers where the dust cover screw might interfere with the proper alignment of the Braun 6000 in the ear device port. The older models have a dust cover screw that rises above the O-ring washer. Newer models have a dust cover screw that is recessed into the washer. When using the calibration fixture, follow the instructions provided with the fixture to install it to the calibration tester.

©2017 WELCH ALLYN ALL RIGHTS RESERVED Doc. No.: SM4159EU-RevA1 MC14384

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Check the probe tip lens window for displacement. There should not be any gap in the seam formed between the bezel and the lens window. If there is a gap, the unit is damaged and must be replaced.

Set the first calibration set point temperature (36 ºC) on the 9600 Plus Calibration Tester (it takes approx. 20 minutes to heat).

9600 Plus Calibration Tester and (optional) Braun PRO 6000 Calibration Fixture*

Power plug / socket

Stable ambient room temperature within the range of 18.3 °C – 26.7 °C

Isopropyl or ethyl alcohol

Remove the PRO 6000 Thermometer from the 9600 Plus Calibration Tester and read the temperature in the thermometer’s display. If the temperatures are within ±0.2 °C, the thermometer is within calibration.

Gently wipe the probe tip with a cotton swab or cloth slightly moistened with isopropyl or ethyl alcohol only. Use care not to displace the lens window. Remove excess alcohol with a clean cotton swab, and let air dry for 5 minutes. Do not use any chemical other than isopropyl or ethyl alcohol to clean the probe window.

Place the Braun ThermoScan PRO 6000 in Calibration Mode using the following steps:

a. With the thermometer in sleep mode, press and release C/F

b. IMMEDIATELY (while all segments of the LCD are illuminated during self-test) press and hold C/F and Mem

c. After 5 seconds the thermometer will emit a long beep

d. During the beep release Mem and C/F. The thermometer is now in Calibration Check Mode, indicated by CAL displayed on the screen for 0.25 seconds every second

After entering calibration mode (CAL), wait 1 minute before taking the first temperature.

1 min

MemC / F

3.000SCALE

MemC / F

1 min

MemC / F

Store thermometers for testing in the same room as the 9600 Plus Calibration Tester for approximately 30 minutes prior to testing to allow for thermal acclimation. Apply a new probe cover. If applied properly a short beep

sounds and the flashing probe cover icon will disappear from the display.

Wait for the screen to flash three dashes (- - -) alternating with CAL.

Wait 5 seconds, press the thermometer Measure button, and watch for the green ExacTemp® light to flash.

Replace the probe cover to reset the thermometer before taking the next measurement. Wait for the thermometer screen to flash three dashes (- - -) alternating with CAL.

When using only one 9600 Plus Calibration Tester, test all available thermometers for calibration verification at the current calibration set point temperature before proceeding to the next calibration set point temperature.

Wait one full minute before taking another reading with the same thermometer. Repeated measurements in short sequence may cause higher readings.

The probe cover must be replaced with a new probe cover before each reading, to remove any residual heat absorbed from the 9600 Plus Calibration Tester.

Leave the thermometer in the 9600 Plus Calibration Tester until the ExacTemp light stops flashing and you hear a beep.

If you are using the Braun PRO 6000 calibration fixture, place the Braun PRO 6000 in the fixture as shown in the assembly instructions (material number 721533). If the Braun PRO 6000 calibration fixture is not used, place the probe firmly into the ear device port.

Firmly push the device down into the well to ensure perpendicularity and that the probe is fully seated in device port. Visually check to ensure proper alignment. Do not apply too much pressure once the device is firmly seated, as this may cause your hand to waiver and tilt or move the device during testing.

It is important to ensure that the device is perpendicular in the port, directly aligned with the calibration tester sensor and not at an angle or tilted.

Do not hold the thermometer while waiting. This allows the thermometer to remain at ambient room temperature.

MemC / F

MemC / F

1 2 3

Cotton swab or cloth

Timer / watch

PRO 6000 devices that need to be checked

9600 Plus Calibration TesterOptional Calibration Fixture* (material number 411690)Braun ThermoScan PRO 6000