Genius Checker Calibrator Operating Manual Sept 2019

en

Table of Contents Page Section I - Functional Description... 1 Section II - Precautions and Warnings... 2 Section III - Icon Identification... 3 Section IV - Required Equipment... 4 Section V - System Setup... 4 Section VI - Operational Procedure... 5 Installation of USB Flash Drive (Optional)... 5 Apply Power... 5 Start-up Screen... 5 Recalibration Due Screen... 5 Reminder Screen... 5 Ambient Temperature... 5 Main Menu... 5 Preferences... 5 Time Format... 5 Date Format... 5 Language Selection... 5 Set User/Site Information... 6 Set Date and Time... 6 Check Calibration... 6 Section VII - Error Messages... 9 Section VIII - Checker/Calibrator Specifications... 10 Section IX - Cleaning Instructions... 11 Section X - Troubleshooting... 11 Section XI - Customer Service... 12 Section XII - Warranty... 12 Section XIII - Electromagnetic Conformity Declaration... 13

This product contains software solely owned by Covidien. Covidien grants the user a non-exclusive, limited license to use the software according to the operating instructions. A copy of the license can be obtained from Covidien.

Section I - Functional Description This manual describes the operation of the Genius™ Checker/Calibrator. This device has been developed to check the accuracy of the Genius™ 3 Tympanic Thermometer and automatically recalibrate the thermometer, if necessary. In addition, the Genius™ Checker/Calibrator has the capability to generate a test report for each thermometer tested and save it to a USB flash drive. The Genius™ Checker/Calibrator will work with all Genius™ 3 Thermometer software revisions. The Genius™ Checker/Calibrator contains two independently controlled infrared calibration targets that are similar to factory calibration targets. These “blackbody” targets are designed to have efficient radiative heat transfer and produce infrared radiation that approximates the human ear at temperatures of 32.22 °C (90.0 °F) and 40.55 °C (105.0 °F). In addition to supporting the Genius™ 3 Tympanic Thermometer, the Genius™ Checker/ Calibrator also fully supports the Genius™ 2 Tympanic Thermometer. Throughout this document, where a Genius™ 3 Thermometer is noted, the caution, warning or instruction also applies to a Genius™ 2 Thermometer unless otherwise noted.

Figure 1 - Front Panel Layout Legend 1 2 3 4 5 6

Power Connector Power Switch Fuse Holder Low Temperature Target LED Low Temperature Target Genius™ Thermometer Connector

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7 8 9 10 11

High Temperature Target High Temperature Target LED LCD Display Encoder Knob USB port

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Section II - Precautions and Warnings Warning: • The Genius™ Checker/Calibrator is designed to be used in a clinical setting by personnel with basic metrology or biomedical training. • The Genius™ Checker/Calibrator is designed to be operated as specified in this manual. Protection provided by the safety devices in the Genius™ Checker/Calibrator may be impaired if the device is not used in accordance with the directions contained in this manual. • The Genius™ Checker/Calibrator enclosure is not waterproof. Avoid spilling liquid of any kind onto the front panel of the device. Likewise, the Genius™ Checker/Calibrator is powered from an AC power source. Avoid the potential for contact between liquid and any external surface of the device while connected to the mains source. • This device should not be used in the presence of flammable anesthetics. There is risk of an explosion in the presence of these anesthetics. • Use only the supplied power module with this device. • To maintain Electromagnetic Compatibility (EMC) conformance, use a USB flash drive that is CE marked and meets EN55032 standard. • The Genius™ Checker/Calibrator may only be used indoors, in an area free from drafts and wide ambient temperature swings. • The USB port on the front panel is intended to be used with only a USB Flash memory drive with a minimum capacity of 128MB and maximum capacity of 8GB. No other USB devices should be inserted into the USB port. The USB flash memory drive should be installed prior to device power-up. Caution: • The surface quality of the interior of the reference blackbody targets is critical to their operation as efficient infrared radiators. Care should be exercised when working near the entrance to the blackbody targets to ensure that no contact is made with the surface inside the rubber flaps. If interior of the blackbody targets is suspected to be dirty or damaged, unit should be sent to a service center for evaluation. • In the event of a blown fuse, replace the fuse with a fuse that exactly matches the rated voltage, current, and form factor as specified in the Genius™ Checker/Calibrator Specifications section of this manual. Make sure the device is disconnected from the AC power source before changing a blown fuse. • Aside from fuses, there are no user-serviceable components in this device. Do not remove the front panel. Refer servicing to qualified service personnel. • When prompted to insert the Genius™ 3 Thermometer into one of the blackbody targets, there is a 60 second window of time to accomplish the insertion. If the time delay exceeds this period, the procedure will be terminated. • Prior to checking/calibrating a Genius™ 3 Thermometer, ensure that the thermometer lens is clean. Effective cleaning will ensure that the calibration tolerances are correctly verified. Refer to the cleaning instructions in the Genius™ 3 Thermometer operating manual. • All probe covers utilized with this device should be new, clean, Genius™ Probe Covers, still attached to the cassette. Use of covers that have been touched, handled incorrectly, previously used, damaged or faulty, those with wrinkles, holes, or other defects, could cause inaccurate results. Use of other branded probe covers could cause inaccurate results and/or damage to the thermometer and the checker/calibrator unit. • To ensure accurate results, let the Genius™ Checker/Calibrator warm up after power-up for at least 15 minutes before use. Make sure that the Genius™ 3 Thermometers, probe covers and the Genius™ Checker/Calibrator have had enough time to equilibrate to room temperature before proceeding. Allow a longer warm up period if the device or thermometers were at the extreme limits of allowed ambient temperature. The portability of the Genius™ Checker/Calibrator will allow for relocation of the device to areas that meet the ambient temperature requirements. • Do not put or rest the Genius™ 3 Thermometer on the surface of the Genius™ Checker/Calibrator at any time. The thermal sensors inside the thermometer probe tip will detect the heat transferred from the blackbody targets through the front panel surface. This will cause instability of the thermometer sensors, which will produce erroneous temperature readings. • In the event that the Genius™ Checker/Calibrator is dropped, return the unit to the factory for re-calibration. • Ensure that there are no foreign objects such as old probe covers inside the blackbody targets prior to checking a thermometer. • The case of the Genius™ Checker/Calibrator should remain closed when not in use to prevent damage to the unit and to prevent the blackbody targets from getting soiled due to dust. • If the USB flash drive is installed after performing a calibration check, an error message may occur when attempting to write the report file if the operator does not wait for the USB flash drive to complete initialization. If the Genius™ Checker/Calibrator is powered off, all internal memory (not yet saved to the USB flash drive) will be lost. • This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments. Genius Checker/Calibrator 2 Table of Contents TM

Section III - Icon Identification

12V

2.5A

Connection for 12VDC 2.5A input

Class II equipment

Input rating

Fuse

Non-Sterile

USB Port

Caution, consult accompanying documents

TÜV mark (SÜD)

Humidity limitation

CE Mark

High Temperature Target

Authorized representative in the European Community

Low Temperature Target

Manufacturer

Temperature limit

Serial number

Keep away from sunlight

Date of Manufacture

Keep dry

Standby Power

WEEE (Waste from electrical and electronic equipment)

Not made with natural rubber latex

85%

0%

131°F 55°C -13°F -25°C

Caution for indoor use only

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Section IV - Required Equipment 1. Genius™ Checker/Calibrator 2. Power module with AC adapter 3. Probe cable 4. Operator’s Manual 5. Genius™ 3 Thermometers to be tested 6. 8 Genius™ Disposable Probe Covers, part 303030. For calibration check only, 2 probe covers are required. If recalibration is required, 6 additional probe covers are needed. 7. Small Phillips screwdriver

Section V - System Setup The following actions should precede use of the Genius™ Checker/Calibrator: 1. Connect the correct AC plug adapter for your country to the power module. 2. Connect the power module cable to the power jack on the front panel. 3. Connect the power module to an AC power outlet. 4. Turn the unit on via the switch on the front panel. 5. Let the Genius™ Checker/Calibrator unit warm up for at least 15 minutes. 6. Set aside a cassette with new Genius™ probe covers. 7. Let the Genius™ 3 Thermometers equilibrate to the room temperature. 8. Prepare the Genius™ 3 Thermometers by thoroughly cleaning the lenses prior to use. Refer to the Genius™ 3 Thermometer operating manual for cleaning instructions. 9. Remove the battery compartment access panel by using a small Phillips screwdriver. Remove all three AAA batteries. 10. Connect the probe cable round connector to the front panel of the Genius™ Checker/Calibrator. 11. Connect the other end of the probe connector into the battery compartment. The connector will snap into place where the batteries were. Do not move forward until connector is secure. Refer to Figure 2.

2

2

1

1

Genius™ 2

Genius™ 3

Figure 2 - Insertion of Probe Connector into Genius™ 2 or Genius™ 3 Battery Compartment

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Section VI - Operational Procedure The following procedure will describe the steps required to operate the Genius™ Checker/Calibrator. In order to facilitate familiarity with the product, it would be advisable to use this section of the manual during the calibration check of the first few thermometers.

Installation of USB Flash Drive (Optional) Install a USB flash drive into the USB port located on the front panel if a report file written to the USB flash drive is desired. If the USB flash drive is installed after performing a calibration check, an error message may occur when attempting to write the report file if the operator does not wait for the USB flash drive to complete initialization. If the Genius™ Checker/Calibrator is powered off, all internal memory (not yet saved to the USB flash drive) will be lost.

Apply Power Make sure the AC-adapter end of the power module is plugged into a 100-240VAC outlet. Connect the power module to the front panel power connector. Apply power to the Genius™ Checker/Calibrator by using the power switch on the front panel.

Start-up Screen The first screen on the LCD display is the Initialization Screen, which displays the software revision and date of the Genius™ Checker/Calibrator. If there is an internal problem during initialization, an Error screen will be displayed (See Section VII).

Recalibration Due Screen An optional screen will appear if the Genius™ Checker/Calibrator is overdue or due very soon for recalibration. The Genius™ Checker/Calibrator is overdue if it has been more than 1 year since its last calibration, and a reminder will appear if it is due for recalibration within 1 month. This is a reminder to the user to return the Genius™ Checker/Calibrator to a customer service center for recalibration.

Reminder Screen The next screen on the LCD display is a reminder to let the Genius™ Checker/Calibrator warm-up for at least 15 minutes after applying power. This will let the infrared blackbody targets warm up to the proper temperatures. To exit this screen, press the encoder knob.

Ambient Temperature The next screen on the LCD display has important instructions to use the Genius™ Checker/Calibrator in an environment free from drafts and within the ambient temperature operating range. To exit this screen, press the encoder knob.

Main Menu The Main Menu screen is displayed next. This screen has four menu options: Check Calibration Preferences Set User/Site Information Set Time/Date To enter any menu option, use the encoder knob to scroll over and highlight the desired menu option, then press the encoder knob.

Preferences When the Preferences screen is entered, the following choices are available: Time Format Date Format Language Back Use the encoder knob to scroll over and highlight the desired menu option, then press the encoder knob.

Time Format Two time format options are available: 12-hour and 24-hour. The currently selection option has an asterisk “*” character to the left of the option. To select a time format, highlight the option and press the encoder knob. This selects the highlighted option as the new time format and returns to the Main Menu screen. Choosing “Back” returns to the Main Menu without changing the format.

Date Format Three date format options are available: MM/DD/YYYY, DD/MM/YYYY and YYYY/MM/DD. The currently selection option has an asterisk “*” character to the left of the option. To select a date format, highlight the option and press the encoder knob. This selects the highlighted option as the new date format and returns to the Main Menu screen. Choosing “Back” returns to the Main Menu without changing the format.

Language Selection The Language Selection screen lists the available languages for the LCD screen text. To select a language, scroll over the selection and it will be highlighted. Press the encoder knob to complete the selection and return to the Main Menu screen. The selected language will be stored in non-volatile memory and will continue to be used next time the unit is powered on.

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Set User/Site Information The Set User/Site Information screen is used to enter the operator’s name and the organization and/or site information. This information will be written to the test report file. To enter the information, use the encoder knob to scroll through the alphabet for a given letter position in the operator name or site information. When the correct letter is shown, press the encoder knob to select the letter and advance to the next letter position. To enter a space, just press the encoder knob when a space or blank letter is shown in that letter position. The user name can be up to 20 characters long. Use the encoder knob to scroll to the organization field and enter a name for the site in a similar manner. To exit the menu, scroll to the DONE text and press the encoder knob.

Set Date and Time The Set Date and Time screen menu option is used to setup the date and time that is used on the test report. The time and date are internally stored and automatically updated when the unit is powered up. To enter time, use the encoder knob to select the hours and minutes. Note: the time is setup using the currently selected time format: 12 hour clock format using AM/PM, or a 24 hour clock format, where 1PM is entered as 13:00 etc. When the value is correct, push the encoder knob to move to the next field of the time and then to the date field. The date field is setup using a MMDDYYYY, DDMMYYYY or YYYYMMDD format depending on the currently selected date format. After the last field of the date is entered, the next encoder push will exit this menu and return to the Main Menu. Note: the time and date are shown at the bottom of the Main Menu.

Check Calibration This menu option performs the calibration check of a Genius™ 3 Thermometer, and if required, automatically recalibrates the thermometer using a series of step-by-step screens. Before entering this menu option, make sure that the required equipment listed in Section IV is available. This includes a cassette with unused (new) probe covers.

Step 1: Warm up of infrared blackbody targets. This screen is displayed while the targets are checked for proper temperature. Both the Low Target and the High Target are checked, and when they are at the correct temperature, the screen will change to “OK” for each target. There is a prompt to press the encoder knob to continue to the next screen. If either target cannot reach the correct temperature, an Error message screen will be displayed. If this happens, check to be sure the Genius™ Checker/Calibrator is within the correct ambient (room) temperature range, and has been given at least 15 minutes of warm up time since power was switched on.

Step 2: Inspect the Genius™ 3 Thermometer that will be tested. Ensure that the thermometer lens is not scratched and is free from ear wax and/or other contaminants. If the thermometer lens is ‘‘dirty’’, clean the lens according to the instructions in the Genius™ 3 Thermometer operating manual. The confirmation screen will be shown, asking for confirmation that the Genius™ 3 Thermometer’s lens is clean. If lens is not clean, failed calibration may occur or the unit may be calibrated incorrectly.

Step 3: Connect the Genius™ 3 Thermometer to the Genius™ Checker/Calibrator by plugging the round end of the thermometer interface cable into the round connector socket on the Genius™ Checker/Calibrator front panel (refer to Figure 2). Open the battery door of the thermometer by using a small Phillips screwdriver. Remove the batteries and set aside. Connect the other end of the thermometer probe cable into the battery compartment, making sure the connector ‘‘snaps’’ into place securely. Refer to Figure 2 in Section V. Press the scan button on the Genius™ 3 Thermometer, so that it is powered on and ready to communicate with the Genius™ Checker/Calibrator. If the Genius™ Checker/Calibrator is unable to initiate communication with the thermometer, an informational message will be shown prompting the user to ensure that there is no probe cover present on the thermometer tip and that the scan button has been pressed. Note: A new, clean, Genius™ probe cover must be used prior to every target insertion. Finger oils on previously used probe covers or reused probe covers that have been heated by Genius™ Checker/Calibrator target can cause erroneous readings which may result in a failed calibration check or an inaccurate calibration. Therefore, it is extremely important that a new probe cover is used each time.

Step 4: Press the encoder knob to continue, and then install a new Genius™ probe cover onto the Genius™ 3 Thermometer. Make sure to use a cover that is held in the cassette. Once the cover is on the thermometer, do not point the probe tip at any object, including hands, fingers or LCD display, as this will cause an inaccurate temperature reading. Inspect the probe cover to make sure it is fully seated (no space between the cover and the tip base) and no holes, tears, or wrinkles are present in the plastic film. When the cover is on, insert the probe tip into the Low temperature target, which will have a blinking LED indicator next to it. Make sure that the probe tip is fully inserted into the target well. Refer to Figure 3a for proper insertion. In order to avoid a time-out error, insert the covered probe tip into the target within 60 seconds from the time the encoder knob is pressed.

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Step 5:

Figure 3a - Proper Insertion of Genius™ Probe Tip into Low Temperature Target

The insertion of the probe tip into the target will automatically be detected and the screen display will change to “Press Genius Scan Button.” Press the Genius™ Thermometer scan button while it is inserted into the Low temperature target. The Genius™ 3 Thermometer will output 3 short beeps as it takes the temperature of the blackbody target. After the temperature is taken, the next screen will display.

Step 6: Withdraw the thermometer from the Low temperature target and eject the probe cover. The screen display will change to “Install a new probe cover. Then insert Genius in High Target Next To Blinking LED.” Again, use a new Genius™ probe cover from the cassette and be careful not to point the probe tip at any object, including hands, fingers or LCD display. Inspect the probe covers to make sure it is fully seated (no space between the cover and the tip base) and no holes, tears, or wrinkles are present in the plastic film. When the cover is on, insert the probe tip into the High temperature target, which will have a blinking LED indicator next to it. Make sure that the probe tip is fully inserted into the target well.

Step 7:

Figure 3b - Proper Insertion of Genius™ Probe Tip into High Temperature Target

The insertion of the probe tip into the High target will automatically be detected and the screen display will change to “Press Genius Scan Button.” Press the scan button on the Genius™ Thermometer while it is inserted into the High temperature target. The Genius™ 3 Thermometer will output 3 short beeps as it takes the temperature of the blackbody target. After the temperature is taken, the next screen will display. Refer to Figure 3b.

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Step 8: If the Genius™ 3 Thermometer is within specified accuracy limits, a Results screen will be displayed showing the thermometer serial number along with an indication that the thermometer passed calibration check. If the Genius™ 3 Thermometer is found to be outside the specified accuracy limits , the display will indicate to the user that the Genius™ Checker/Calibrator is entering into a calibration sequence that requires the user to repeat Steps 4 through 7 three more times in order to gather recalibration data. Following the last pass through Steps 4 through 7, the Genius™ Checker/Calibrator will attempt to recalibrate the Genius™ 3 Thermometer. If the recalibration is successful, a Results screen will be displayed showing the thermometer serial number along with an indication that the thermometer passed calibration. If the recalibration is unsuccessful or the thermometer is unable to be calibrated, a Results screen will be displayed showing the thermometer serial number along with an indication that the thermometer failed calibration.

Step 9: After the pass/fail Results screen has been displayed, press the encoder knob to display a second Results screen containing the target temperatures, the Genius™ 3 Thermometer readings, and the target versus thermometer variances.

Step 10: The next screen will display “Write report to USB drive?” and display Yes and No below. If a report is desired, insert a flash drive into the front panel USB port. Note: allow about 30 seconds after insertion for the USB flash drive to initialize. Use the encoder knob to scroll to either Yes or No and press the encoder knob to make a selection. If No is selected, the screen returns to the Main Menu. If Yes is selected, a report is written to the USB flash drive, using the thermometer serial number for filename and .TXT as the file extension. The file contains the test results as well as other information such as serial number, date, time, user name, and organization. This file is a simple ASCII text file and is only available in English. This file can be read by Microsoft Windows® operating system and Microsoft Windows® notepad and sent to a printer. After the file is written, the display will show “Push knob to continue.” Press the encoder knob to return to the Main Menu. If the thermometer fails recalibration, reattempt calibration by repeating the Check Calibration steps. If the thermometer persistently fails recalibration, the thermometer should be returned for service.

Step 11: After completing a calibration check/recalibration, remove the probe connector from the battery compartment by pulling straight back on the connector and rotating up and out of the thermometer as shown in Figure 4. Then reinstall the 3 AAA batteries, observing the proper polarity orientation. Finally, reinstall the battery compartment cover and tighten the screw or screws.

Step 12: Remove USB flash drive and power connector from the Genius™ Checker/Calibrator front panel before closing the lid. The lid should be closed when the Genius™ Checker/Calibrator is not in use.

Genius™ 2

Genius™ 3

Figure 4: Probe Connector removal

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Section VII - Error Messages The error messages will have a number associated with them, such as Error 1, etc. The following is an explanation of the errors:

Error 1: Internal Error

This error is an indication of a problem within the Genius™ Checker/Calibrator. If this error persists after cycling power off and back on, return the unit for factory servicing.

Error 2: Unable to communicate with Genius™ Thermometer.

This error is an indication of either a lack of communication or a miscommunication between the Genius™ 3 Thermometer and the Genius™ Checker/Calibrator. Check both ends of the thermometer probe cable, especially the end that connects inside the battery compartment. The pins in the thermometer probe cable can lose spring action if they are bent or damaged. After inspecting the probe cable, re-attempt the calibration check. If the problem persists, try a different Genius™ 3 Thermometer, if available. If this does not resolve the problem, return the unit for factory servicing, along with the thermometer cable and the Genius™ 3 Thermometer that indicated this error.

Error 3: Timeout

This error is an indication that the operator took too long to perform an operation. This error might be seen when connecting to the Genius™ 3 Thermometer, or while installing a probe cover on the thermometer. The timeout is set for one minute. Try repeating the operation that gave this error.

Error 4: Target Out of Range

This error is an indication that one of the blackbody targets is not within the range of temperature allowed. Check that the unit is being operated within the allowed ambient temperature operating range. Refer to Section VIII. If operating within the specified ambient conditions does not eliminate the error, the blackbody target(s) may be damaged. Return the unit for factory servicing.

Error 5: USB Flash Drive Write Error

This error is an indication of a problem when writing the report file to a USB flash drive. Check that the write protect switch on the USB drive is in the “off ” position. Make sure that there is sufficient free space on the drive, and that security or encryption features are not in use.

Error 6: Ambient Temperature Out of Range

This error is an indication that the ambient temperature is not within the specified range for performing an accurate recalibration. Check that the unit is being operated within the allowed ambient temperature operating range. Refer to Section VIII.

Error 7: Wrong Target

This error is an indication that the Genius™ 3 Thermometer has been inserted into wrong target or was inserted into the target prematurely. Please take care to follow the instructions on the screen and not perform steps prior to the instructions being displayed.

Error 8: Genius™ Thermometer Hardware Error

This error is an indication that a hardware error has been detected in the Genius™ 3 Thermometer, and the thermometer cannot be calibrated. The Genius™ 3 Thermometer should be returned to the factory for service. The Calibrator provides the option for a report to be written to a USB drive, following the error screen.

Error 9: Genius™ Thermometer readings Not Consistent

This error is an indication of the temperature readings received from the Genius™ 3 Thermometer not being consistent. Try repeating the check/calibrate operation taking care to not point the probe tip at any heat source, including hands, fingers or LCD display once the cover is on the thermometer.

Error 10: Removal From Target

This error is an indication of the Genius™ 3 Thermometer being removed from the blackbody target before the temperature reading is completed. Ensure that the thermometer tip remains inserted in the target until after the temperature reading is finished.

The Error screen will be displayed for 60 seconds before returning to the Main Menu. To exit the Error screen sooner, press the encoder knob.

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Section VIII - Checker/Calibrator Specifications Temperature Set Points Low Target... 32.22 °C +/- 0.3 °C (90.0 °F +/- 0.5 °F) High Target... 40.55 °C +/- 0.3 °C (105.0 °F +/- 0.5 °F) Target Temperature Accuracy... Initial Limit +/- 0.03 °C (0.05 °F) ... Post 6 months +/- 0.06 °C (0.10 °F) Genius™ 2 Thermometer Accuracy After Recalibration* Readings between 36.0 °C and 39.0 °C (96.8 °F and 102.2 °F)...+/- 0.2 °C (+/- 0.4 °F) Readings less than 36.0 °C (96.8 °F) or greater than 39.0 °C (102.2 °F)...+/- 0.3 °C (+/- 0.5 °F) Genius™ 3 Thermometer Accuracy After Recalibration* Readings between 33.0 °C and 42.0 °C (91.4 °F and 107.6 °F)...+/- 0.3 °C (+/- 0.5 °F) Warm-up Time Before Use... 15 minutes (from non-extreme ambient) Ambient Temperature Operating Range... 21.1-26.7 °C (70-80 °F) Relative Humidity Operating Range... 50 +/- 20%, non-condensing Altitude Range...Up to 2000 meters (6563 feet ) Storage Temperature Range...-25 °C - 55 °C (-13 °F - 131 °F ) 85% RH non-condensing Approximate Size Length... 31.1 cm (12.25” ) Depth...15.9 cm (6.25” ) Width... 26.0 cm (10.25” ) Weight... 3.3 kg (7.2 lbs ) Power Requirements... 12VDC 2.5A Fuse Requirements... Schurter FSF 5 x 20mm Fast Blow ... Low Breaking Capacity 250 V, 3.15A Power Module with AC adapter... Cincon Electronics, Model TR30RAM120 ... Input: 100-240VAC 0.8-.4A 47-63Hz, Output: 12VDC 2.5A Recommended Checker/Calibrator Calibration Interval... One Year Pollution Degree... 2 Installation Category... II ... Indoor Use Only *Post recalibration accuracy using the Genius™ Checker/Calibrator may not necessarily be equivalent to factory calibration

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Section IX - Cleaning Instructions Caution: Do not immerse the checker/calibrator, cables, or power cord in water or other cleaning solution; clean using a damp (not wet) cloth. Failure to follow cleaning procedures described herein could result in hazards to users. As with any AC powered electrical device, care must be taken to prevent liquid from entering the Genius™ Checker/Calibrator to avoid electrical shock hazard, fire hazard, or damage to electrical components.

General Cleaning Instructions Cleaning of the Genius™ Checker/Calibrator may be performed as follows: • First, unplug the Genius™ Checker/Calibrator from power source. Never clean the device while connected to the mains supply. • A mild detergent should be used for general cleaning of outside surfaces. Also, a cloth damped with isopropyl alcohol can be used to clean the unit. Do not use abrasives or solvents. Avoid excess moisture around the target assemblies and the electrical connectors. • Do not attempt to clean the target below the rubber flaps. • Do not clean the target nests or flaps with alcohol. • If target is suspected to be dirty or damaged, contact customer service to have the unit sent to a service facility. If there is any doubt about the compatibility of a cleaning agent with part of this equipment or its materials contact Covidien customer service (See Section XI).

Section X - Troubleshooting Some of the common problems are as follows: Problem

Probable Cause

Corrections

Genius™ Checker / Calibrator will not power up

Genius™ Checker / Calibrator not receiving AC power

Check AC power connections

Blown fuse

Replace fuse

Test report does not write to USB flash drive

USB flash drive not formatted

Use PC or laptop to format flash drive

USB flash drive write protected

Use PC or laptop to turn off write protection

USB flash drive does not contain enough free memory space

Use PC or laptop to delete unnecessary items or use different USB flash drive

USB flash drive incompatible with Genius™ Checker/Calibrator

Use different USB flash drive

Genius™ Checker / Calibrator has not had enough time to detect the newly inserted USB flash drive

Retry write process

Probe cover stuck in one of the blackbody targets

Remove probe cover from blackbody target using small needle-nose pliers or hemostats. Do not scratch the interior surface of the target.

Dirty probe cover

Use a new probe cover for each reading. Do not re-use a probe cover. Probe covers should never be touched by hand.

Dirty thermometer lens

Clean the thermometer lens per the instructions in the Genius™ operating manual.

Genius™ Thermometer not seated correctly

Ensure that the Genius™ Thermometer is completely seated in the target and at the proper angle.

Genius™ Thermometers, probe covers, and/or checker/calibrator not at room temperature.

Ensure that the Genius™ Thermometers, probe covers, and/or checker/ calibrator have had enough time to equilibrate to room temperature before proceeding.

Error 2 or Error 3 repeatedly appears

Residue present on pins of connector on the cable or on the pads of Genius™ Thermometer board in battery compartment, interfering with electrical contact.

Clean pins of cable connector or pads of thermometer board with a cotton swab dipped in isopropyl alcohol. Allow the isopropyl alcohol to evaporate fully before continuing.

Error 6 repeatedly appears while testing the same Genius™ Thermometer

Potential power consumption issue with Genius™ Thermometer

Repeat calibration check / recalibration with a different Genius™ Thermometer and return problem thermometer for factory servicing.

Genius™ Thermometer seems to read high or low following a successful recalibration

Probe cover reused during calibration check / recalibration

Repeat calibration check / recalibration using a new probe cover prior to every target insertion during the process.

Multiple Genius™ Thermometers fail recalibration

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Section XI - Customer Service The Genius™ Checker/Calibrator requires factory calibration and inspection once a year. Notify and return the device to Covidien on or before the calibration date for the Genius™ Checker/Calibrator. The Genius™ Checker/Calibrator will display a message one month prior to the calibration date as a reminder. Caution: There are no serviceable parts inside, return to factory for service. In the event that it is necessary to return a unit for repair, please observe the following: 1. Contact Covidien as shown below, or your local customer service representative for an Authorized Return Number and shipping instructions. 2. Ship insured parcel to your local service contact or the appropriate location below.

United States Covidien 2824 Airwest Blvd. Plainfield, IN 46168 1-800-448-0190

EMEA Covidien EMEA Customer Care & Supply ChainSolution Management & Operation Excellence Earl Bakkenstraat 10, Heerlen, 6422 PJ The Netherlands

Outside US & Canada Covidien Unit 2 Talisman Business Center, London Road Bicester, OX266HR, UK 1+44-1869-32806

Parts Listing

Please contact your local customer service center or sales representative for the parts listed below. Description

Genius™ Checker/Calibrator... 303097 Refurbished Genius™ Checker/Calibrator... 303096

Section XII - Warranty Covidien warrants the Genius™ Checker/Calibrator to be free of defects in materials and workmanship under normal use and service for a period of 1 year from the date of delivery by Covidien to the first purchaser. Liability hereunder is limited to repair or replacement, at Covidien’s option, at Covidien service facility for any product, which shall under normal use and service, appear to Covidien to have been defective in material or workmanship. This warranty shall not apply to, and Covidien shall not be responsible for, any loss arising in connection with the purchase of any product that has been repaired by anyone other than Covidien or its authorized representative, or which has been subject to misuse, neglect, or accident, or which has been used otherwise than in accordance with the instructions furnished by Covidien. Covidien neither assumes nor authorizes any representative or other person to assume for it any liability other than as expressly set forth herein. Covidien disclaims all other warranties, expressed or implied, including any implied warranty of merchantability or fitness for a particular purpose or application other than as expressly set forth in the product labeling. In no event will Covidien be liable for any incidental, indirect, or consequential damages in connection with the purchase or use of this product.

Genius Checker/Calibrator TM

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Table of Contents

Section XIII - Electromagnetic Conformity Declaration The Genius™ Checker/Calibrator has been built and tested according to IEC/EN61010-1 and EN61326-1 standards. This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, third edition, including Update 2, or a later version of the same standard incorporating the same level of testing requirements. The Genius™ Checker/Calibrator is intended for use in the electromagnetic environment specified below. The user of the equipment should assure that it is used in such an environment.

Emissions Test

Compliance

Conducted and Radiated Emissions (EN61326-1)

Group 1, Class A

Harmonic Current (EN61000-3-2)

Class A

Voltage Fluctuation and Flicker (EN61000-3-3)

Complies

Radiated Disturbance Immunity (EN61000-4-3)

Complies

Conducted Disturbance Immunity (EN61000-4-6)

Complies

Power Frequency Magnetic Field Immunity (EN61000-4-8)

Complies

Voltage Dips and Interrupts Immunity (EN61000-4-11)

Complies

Electrical Fast Transient/Bursts Immunity (EN61000-4-4)

Complies

Surge Immunity (EN61000-4-5)

Complies

Electrostatic Discharge (EN61000-4-2)

Complies

Genius Checker/Calibrator TM

Electromagnetic Environment -Guidance The Genius™ Checker / Calibrator is suitable for all locations other than residential environments and those directly connected to a low voltage power supply network which supplies power to buildings used for domestic purposes (residential). There is a possibility of radio frequency interference origination from operation of class A equipment in certain environments.

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Table of Contents

Not made with natural rubber latex Ce produit n’est pas fait de latex de caoutchouc naturel Nicht aus Naturlatex hergestellt Non contiene lattice di gomma naturale No fabricado con látex de caucho natural Ej tillverkad av naturgummilatex Niet vervaardigd met natuurlijke rubberen latex Não foi fabricado com látex de borracha natural Ei valmistettu luonnonkumilateksista Ikke fremstillet af naturligt gummilatex Δεν είναι φτιαγμένο από φυσικό ελαστικό λατέξ Není vyrobeno za použití přírodního latexu Nem tartalmaz természetes gumilatexet При изготовлении натуральный латекс не используется Nie zawiera naturalnego lateksu Doğal kauçuk lateks ile üretilmemiştir Ikke laget av naturgummilateks

Manual No. HP112002 COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and other countries. Other brands are trademarks of a Covidien company. © 2012 Covidien. Made in USA. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. REV 09/2019

Not made with natural rubber latex Ce produit n’est pas fait de latex de caoutchouc naturel Nicht aus Naturlatex hergestellt Non contiene lattice di gomma naturale No fabricado con látex de caucho natural Ej tillverkad av naturgummilatex Niet vervaardigd met natuurlijke rubberen latex Não foi fabricado com látex de borracha natural Ei valmistettu luonnonkumilateksista Ikke fremstillet af naturligt gummilatex Δεν είναι φτιαγμένο από φυσικό ελαστικό λατέξ Není vyrobeno za použití přírodního latexu Nem tartalmaz természetes gumilatexet При изготовлении натуральный латекс не используется Nie zawiera naturalnego lateksu Doğal kauçuk lateks ile üretilmemiştir Ikke laget av naturgummilateks

Manual No. HP112002 COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and other countries. Other brands are trademarks of a Covidien company. © 2012 Covidien. Made in USA. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. REV 09/2019

Not made with natural rubber latex Ce produit n’est pas fait de latex de caoutchouc naturel Nicht aus Naturlatex hergestellt Non contiene lattice di gomma naturale No fabricado con látex de caucho natural Ej tillverkad av naturgummilatex Niet vervaardigd met natuurlijke rubberen latex Não foi fabricado com látex de borracha natural Ei valmistettu luonnonkumilateksista Ikke fremstillet af naturligt gummilatex Δεν είναι φτιαγμένο από φυσικό ελαστικό λατέξ Není vyrobeno za použití přírodního latexu Nem tartalmaz természetes gumilatexet При изготовлении натуральный латекс не используется Nie zawiera naturalnego lateksu Doğal kauçuk lateks ile üretilmemiştir Ikke laget av naturgummilateks

Manual No. HP112002 COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and other countries. Other brands are trademarks of a Covidien company. © 2012 Covidien. Made in USA. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. REV 09/2019

Not made with natural rubber latex Ce produit n’est pas fait de latex de caoutchouc naturel Nicht aus Naturlatex hergestellt Non contiene lattice di gomma naturale No fabricado con látex de caucho natural Ej tillverkad av naturgummilatex Niet vervaardigd met natuurlijke rubberen latex Não foi fabricado com látex de borracha natural Ei valmistettu luonnonkumilateksista Ikke fremstillet af naturligt gummilatex Δεν είναι φτιαγμένο από φυσικό ελαστικό λατέξ Není vyrobeno za použití přírodního latexu Nem tartalmaz természetes gumilatexet При изготовлении натуральный латекс не используется Nie zawiera naturalnego lateksu Doğal kauçuk lateks ile üretilmemiştir Ikke laget av naturgummilateks

Manual No. HP112002 COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and other countries. Other brands are trademarks of a Covidien company. © 2012 Covidien. Made in USA. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. REV 09/2019

Not made with natural rubber latex Ce produit n’est pas fait de latex de caoutchouc naturel Nicht aus Naturlatex hergestellt Non contiene lattice di gomma naturale No fabricado con látex de caucho natural Ej tillverkad av naturgummilatex Niet vervaardigd met natuurlijke rubberen latex Não foi fabricado com látex de borracha natural Ei valmistettu luonnonkumilateksista Ikke fremstillet af naturligt gummilatex Δεν είναι φτιαγμένο από φυσικό ελαστικό λατέξ Není vyrobeno za použití přírodního latexu Nem tartalmaz természetes gumilatexet При изготовлении натуральный латекс не используется Nie zawiera naturalnego lateksu Doğal kauçuk lateks ile üretilmemiştir Ikke laget av naturgummilateks

Manual No. HP112002 COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and other countries. Other brands are trademarks of a Covidien company. © 2012 Covidien. Made in USA. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. REV 06/2019