Braun ThermoScan® PRO 6000 Ear thermometer

1.0 Scope

The purpose of this document is to provide the necessary information to check the accuracy of the Braun ThermoScan® PRO 6000 Ear thermometer. The document will be used to standardize the procedure of checking the thermometer accuracy.

2.0 General information

The Braun ThermoScan® PRO 6000 Ear thermometer is a clinical grade ear thermometer that in normal operation mode displays an estimate of oral temperature. It is indicated for the intermittent measurement of human body temperature in patients of all ages in a professional use environment.

2.1 Technical specifications

Long term storage ranges

2.2 Serial number encoding

Serial number location

To locate the serial number, open the battery door and then remove the batteries and set aside. The serial number is located on the left side of the battery compartment.

[Diagram: Illustration showing how to open the battery door and remove batteries to access the serial number. A separate illustration shows the serial number's location on the left side of the battery compartment.]

Interpreting the serial number

Example: 00115 k 10101

A: Julian manufacture date: Represents the first 5 numerals of the serial number. Numerals 1 through 3 represent the day of manufacture (e.g., 001=January 1st, ranging from 001 to 365). Numerals 4 and 5 represent the calendar year of manufacture (e.g., 15=2015). In the example, 00115 indicates January 1, 2015.

B: Manufacturer: A letter indicating the manufacturer code.

C: Lot serial number: Represents the manufacturer serial number.

A, B, and C combined represent a unique serial number for the whole device.

2.3 Inspecting the thermometer

Visual inspection

Always start with a visual inspection for any external damage, especially to the probe and probe lens window.

Initial start up

After removing the thermometer from the cradle, the display screen will engage, showing all segments followed by two dashes. If the display shows "ERR" or another error indication, refer to the directions for use, section 12.

[Diagram: Illustration of the thermometer display during initial startup, showing all segments illuminated, followed by two dashes.]

Accuracy verification

Can only be tested using the 9600 Plus Calibration Tester (black body), which has a precisely defined temperature.

3.0 Frequency of calibration check

In general, the accuracy for the Braun ThermoScan® PRO 6000 Ear thermometer should be checked any time you suspect the unit is not reading correctly. Some countries, e.g., Germany, have regulations requiring a regular check of the measuring accuracy for all medical devices used by professionals.

For infrared thermometers, this check must be done yearly and it is required to verify the measuring accuracy for the full temperature range. This implies that the thermometer will be tested at 3 different temperatures, and the results will be documented via test protocol.

The Welch Allyn 9600 Plus Calibration Tester meets this requirement by testing the accuracy at low, mid, and high points of the temperature range. Refer to the 9600 Plus Calibration Tester user's manual for information on testing the Braun ThermoScan® PRO 6000 Ear thermometer.

Note: The BB 3200 test procedure is not sufficient for this purpose. The 9600 PLUS Calibration device can test to these parameters.

The Braun ThermoScan® PRO 6000 Ear thermometer cannot be calibrated in the field. The calibration check is only used to determine that the thermometer measurements are accurate within the specified tolerances across the measurement range.

3.1 Service tool

The Welch Allyn Service Tool is designed to support the Braun ThermoScan® PRO 6000 Ear thermometer and allows the service technician to view device information, install software upgrades, perform a calibration check, and change configurable settings. The service tool software and service tool installation guide are available through an internet link on the Braun ThermoScan® PRO 6000 Ear thermometer CD or from:

http://www.welchallyn.com/en/service-support/service-center/service-tool.html

After downloading and installing the Welch Allyn Service Tool, you can access the Braun ThermoScan® PRO 6000 Ear thermometer help files from the help menu. Here you will find a complete guide on how to use the Welch Allyn Service Tool with the Braun ThermoScan® PRO 6000 Ear thermometer.

If you already have the Welch Allyn Service Tool installed, check the version to see if it supports the Braun ThermoScan® PRO 6000 Ear thermometer; version 1.8 or later is required.

When the Welch Allyn Service Tool is used to perform the calibration check, the measured temperatures are evaluated by the software, and the test results are captured in the service record, which may be printed or archived for later reference.

For more information on using the Welch Allyn Service tool to configure the Braun ThermoScan® PRO 6000 Ear thermometer, see Braun ThermoScan® PRO 6000 Ear thermometer directions for use.

4.0 Test equipment for performing a calibration check

In addition to the Braun ThermoScan® PRO 6000 Ear thermometer, the following test equipment and materials are available from Welch Allyn:

4.1 Using the Welch Allyn 9600 Plus Calibration Tester

Verify that the Welch Allyn 9600 Plus Calibration Tester(s) used to perform this check has been calibrated in the last 12 months. Follow the procedure described in the 9600 Plus Calibration Tester manual to set up the 9600 plus.

Expedited testing practices:

• Use three testers set to different set points to eliminate wait time for the tester to heat to the next set point.
• When using only one tester to test several thermometers at all three temperatures, test all thermometers at one set point before proceeding to the next set point.
• When using only one tester, start at the lowest set point to eliminate waiting for the tester to cool, because the tester does not have an internal fan and requires more time to cool down than to heat up.

To scroll from one set point to the next, press and hold the temperature selection button until a beep sounds. The new set point appears in the upper left corner of the display. The device's current temperature appears, flashes, and continues flashing until the cavity reaches equilibrium at the new set point. The 9600 Plus beeps when the set point is reached.

5.0 To begin calibration verification of the thermometer

Caution: 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 accommodation.

Caution: The ambient temperature must be stable and within the range of 18.3°C (65.0°F) – 26.7°C (80.0°F).

Caution: Set the temperature scales on the 9600 Plus to match the Braun ThermoScan PRO 6000's default temperature scale.

Caution: Set up the 9600 Plus away from sunlight, drafts, and other sources of heat or cold. Fluctuations will impact the calibration check.

1. Check the probe tip lens window for displacement. There shouldn't be any gap in the seam formed between the bezel and the lens window. If a gap exists, the unit is damaged and must be replaced.
   [Diagram: Illustration of checking the probe tip lens window for displacement.]
2. Gently wipe the probe tip with a cotton swab slightly moistened with Isopropyl or Ethyl alcohol, using 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 alcohol to clean the probe window.
   [Diagram: Illustration of cleaning the probe tip with a cotton swab.]
3. Place the Braun ThermoScan® PRO 6000 Ear thermometer in calibration mode using the following steps:
   1. With the thermometer in sleep mode, press and release the C/F button.
   2. Immediately (while all segments of the LCD are illuminated during self-test), press and hold the C/F button and the Mem button.
   3. After 5 seconds, the thermometer will begin a long beep. During the beep, release the Mem button and the C/F button. The thermometer is now in Calibration check mode, indicated by "CAL" flashing on the screen for 0.25 seconds every second.
   [Diagram: Sequence of button presses (C/F, Mem) to enter calibration mode, showing display changes.]
4. After entering calibration mode (CAL), wait for 1 minute before taking the first temperature.
   Note: Do not hold the thermometer while waiting to allow it to remain at ambient room temperature.
   [Icon: 1 minute timer symbol.]
5. If testing with a probe cover, apply a new probe cover. If testing without a probe cover, go to the next step. If the probe cover is applied properly, a short beep will sound, and the flashing probe cover icon will disappear from the display.
   [Diagram: Illustration of applying a new probe cover.]
6. Wait for the screen to flash three dashes (---) alternating with "CAL".
   [Diagram: Thermometer display showing dashes alternating with "CAL".]
7. Place the probe firmly into the ear device port. 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. Firmly push the device down into the well to ensure perpendicularity, that the probe is fully seated in the device port, and 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 waver and tilt or move the device during testing.
   [Diagram: Illustration of placing the thermometer probe firmly and perpendicularly into the calibration tester's ear device port.]
8. Wait 5 seconds. Press the thermometer measure button, and watch for the green ExacTemp light to flash.
9. Leave the thermometer in the 9600 Plus Calibration Tester until the ExacTemp light stops flashing and you hear a beep.
10. Remove the Braun Thermoscan® PRO 6000 Ear thermometer from the 9600 Plus Calibration Tester and compare the temperature displayed on the tester with the temperature in the thermometer's display. If the temperatures are within +/- 0.2° C (+/-0.4° F) when testing with a probe cover installed, or +/- 0.1 C (+/-0.2 F) if a probe cover is not installed, the thermometer is within calibration.
    Note: It is recommended that all calibration testing be performed with a probe cover installed.
    If temperatures are outside +/-0.2° C, verify the test procedure was strictly observed and repeat the calibration check 2 more times at this temperature. If any two subsequent tests are within the acceptable limits, the test may be considered a pass. If all 3 readings are out of calibration, see section 7.2.
    [Diagram: Illustration of the thermometer display showing a temperature reading, e.g., 36.0.]

6.0 Interpreting results

6.1 The thermometer is within calibration range if the measured values are at:

Tenth degree

Hundredth degree (high resolution)

The smallest significant digit is the tenths digit (0.X); therefore, when interpreting data at the hundredths digit (0.XX), the reading must be rounded to the nearest tenth prior to interpretation. As such, the accuracy ranges are as follows:

6.2 If results are outside the allowable tolerances, contact your local Welch Allyn Customer Care Representative:

Go to www.welchallyn.com to find the contact information for technical support in your region.

Complaints or concerns:

Welch Allyn encourages all service centers to report customer complaints. This information is valuable for the improvements of products.

All complaints where it is alleged that the product has caused or contributed to a death or a serious deterioration in the state of health of a patient, user, or other person, must be reported immediately to your local Welch Allyn Organization.

A serious deterioration in the state of health can include a life-threatening illness or a condition necessitating medical intervention to prevent permanent damage.

Also, all cases should be reported where the circumstances indicate that the incident was such that, if it occurred again, it may lead to death or serious deterioration in health.

7.0 Additional display screens in calibration mode

7.1 High resolution reading:

The normal resolution of the thermometer is shown to the tenth of a degree (Celsius or Fahrenheit). If resolution to the hundredth of a degree is desired, upon completion of a reading, press and release the timer button. The "CAL" display will change to "hr", and the temperature reading will show the last 3 digits of the reading to the hundredth of a degree. A reading such as 99.2°F would, in high resolution, be shown as 924 (99.24) or 917 (99.17) as applicable.

To return to the calibration check mode ready state and prepare the thermometer to take a second reading, press and release the measure button.

[Diagram: Thermometer display showing "hr" and a high-resolution temperature reading.]

7.2 Ambient temperature reading:

The ambient temperature as read by the thermometer can be displayed next. Press and release the Timer button to display the ambient temperature reading. The "hr" display will change to "At", and display the ambient temperature to a tenth of a degree.

To return to the calibration check mode ready state and prepare the thermometer to take a second reading, press and release the measure button.

A second ambient sensor (thermistor) is also used (the lower of the two ambient temperatures is used by the thermometer) and can be accessed by pressing the Timer button once more. The screen will display "th" alternating with the display.

[Diagram: Thermometer display showing "At" and ambient temperature, and then "th" alternating with ambient temperature.]

7.3 Sensor temperature reading:

The temperature of the thermopile sensor of the thermometer can be displayed next. Press and release the Timer button to change from the ambient temperature reading to the temperature of the thermopile sensor. The display will change "th" to "St" and display the temperature of the sensor to a tenth of a degree.

NOTE: Dependent upon the actions taken prior to entering this display, the temperature may remain steady at the heated level or may decrease until equilibrium with ambient is reached.

To return to the calibration check mode ready state and prepare the thermometer to take a second reading, press and release the measure button.

[Diagram: Thermometer display showing "St" and sensor temperature.]

7.4 Target temperature reading prior to measure button press:

The target temperature reading immediately prior to pressing the measure button can be displayed next. Press and release the timer button from the sensor temperature reading to display the pre-button press target temperature reading. This will change the "St" display to "Pb" and show the target temperature reading prior to the measure button being pressed.

Note: This reading is taken with the sensor heater activated and does not maintain or achieve the same accuracy as the reading following the Measure button press. Do not evaluate the calibration of the thermometer using this display.

To return to the calibration check mode ready state and prepare the thermometer to take a second reading, press and release the measure button or the timer button.

[Diagram: Thermometer display showing "Pb" and the pre-measure target temperature.]

Standards and compliance

This device conforms to the following Safety and Performance Standards:

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 37°C to 39°C (98°F to 102°F) for infrared thermometers is ± 0.2°C (±0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM Standards E 667-86 and E 1112-86 is ± 0.1°C (± 0.2°F).

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

A clinical summary is available upon request.

Standards listed:

• ANSI/AAMI STD ES60601-1, UL STD 60601-1, CAN/CSA STD C22.2 No. 60601-1
• IEC 60601-1:1988 + A1:1991 + A2:1995, IEC 60601-1:2005, EN 60601-1:2006, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• EN 12470-5:2003 Clinical thermometers—Part 5: Performance of infra-red ear thermometers (with maximum device)
• Meets CB Scheme
• EN 60601-1-2:2007, IEC 60601-1-2:2007 General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic Compatibility—Requirement & Tests Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and test
• IEC 62304:2006 Medical device software—Software life cycle processes
• IEC 62366:2007 (IEC 60601-1-6:2010) Medical devices—Application of usability engineering to medical devices
• EN980:2008 Symbols for use in the labeling of medical devices
• ISO14971:2007 Medical devices—Application of risk management to medical devices
• ISO 80601-2-56:2009 Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
• ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (includes US FDA Blue book memo G95-1-100 Title)
• GBT 21417.1:2008

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed description of EMC requirements please contact an authorized local Service Centre.

Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.

Internally powered ME equipment.

Continuous operation.

Not protected against ingress of water. ? IPX0

Test record Braun ThermoScan® PRO 6000 Ear thermometer manual calibration test

This section provides a template for recording calibration test results.

Temperature tested specification ± 0.4 °F (± 0.2 °C) with probe cover

Date:

Technician:

Time: