Product Specifications and Usage Information P4300 Evolution 220 Spectrophotometer

Transcription

1 DESCRIPTION The Thermo Scientific (Evo220) is a state-of-the-art optical measurement device used to record the absorbance measurements of dosimeters in the DoseControl TM dosimetry system. It is designed to be simple and fast with the highest performance and quality. The Evo220 Spectrophotometer uses specially designed dosimeter holders to fit a variety of dosimeters to include the B3 DoseStix and B3 WINdose dosimeters. This spectrophotometer is built for the fast-paced, high-volume processing environment, and reduces time spent at every step of the dosimetry process. A barcode reader can be integrated inside of the instrument, automatically reading B3 DoseStix barcodes while simultaneously reading the absorbed dose of the dosimeter. The Xenon lamp (light source) only needs to be replaced every 3 to 5 years, and has a simple, automated calibration accessory that maximizes quality and efficiency of performance verification. There is no need to warm-up the instrument before use, and the lid may remain open during measurements. Measurement time for each dosimeter is less than 1 second. APPLICATION The Evolution 220 is used for the measurement of optical absorbance of dosimeters using a select wavelength in the ultraviolet (UV) or visible spectrum, such as GEX B3 radiochromic film dosimeters, FWT-60 radiochromic film dosimeters, CTA film, and PMMA (Red or Amber Perspex) dosimeters. SPECIFICATIONS Physical Specifications: GEX Part Description Product Dimensions Packaging Dimensions No. Spectrophotometer US Plug 80.0 cm L x 59.7 cm W x cm L x 48.6 cm W x 27.9 cm H EU Spectrophotometer EU Plug cm H (24 L x 19 W x 11 H) UK Spectrophotometer UK Plug (31.5 L x 23.5 W x 16.5 H) Product Weight 20.0 kg (44 lbs.) Material Color Printing Electrical Supply Optical Design Spectral Bandwidth(s) Light Source Detector Scan Ordinate Modes Resolution Molded plastic Grey or White Thermo Scientific logo plate on front V, Hz, selected automatically; 150 W maximum Double-beam with sample and reference cuvette positions; Application Focused Beam Geometry; Czerny-Turner Monochromator Variable: 1 nm; 2 nm; 2nm - AFBG Microcell optimized; 7nm- AFBG Fiber optic optimized; 15nm - AFBG Materials optimized Xenon flash lamp, 3-year warranty (5 years typical lifetime) Dual Silicon Photodiodes Absorbance, % Transmittance, % Reflectance, Kubelka-Munk, log (1/R), log (Abs), Abs*Factor, Intensity >1.6 (peak-to-valley ratio; toluene in hexane) Range: nm Wavelength Accuracy: ±0.8 nm (full range 190 to 1100 nm) ±0.5 nm ( nm mercury line) Repeatability: 0.1 nm ( nm mercury line, SD of 10 measurements) Scanning Speed <1 to 6000 nm/min; variable Data Intervals 10, 5, 2, 1.0, 0.5, 0.2, 0.1 nm Photometric Range: >3.5 A Rev. B Release Date: 01/18/2017 Page 1 of 21

2 Display Range: Accuracy Instrument: NIST/NPL Noise -0.3 to 4.0 A 0.5 A: ±0.004 A 1A: ±0.006 A 2A: ±0.010 A Measured at 440 nm using neutral density filters traceable to 0A: A 1A: A 2A: A 260 nm, 1.0 nm SBW, RMS Stray Light Baseline Flatness Keypad Local Control Option Drift (Stability) < A/hr 500 nm, 1.0 nm SBW, 1 hour warm-up KCl, 198 nm: 1% T NaI, 220 nm: 0.05% T NaNO2, 340 nm: <0.05% T ± A nm, 1.0 nm SBW, smoothing Sealed Membrane Display: Touchscreen LCD panel; 800 x 480; 17.8 cm (7 in) diagonal Operating System: Microsoft Windows XP embedded Included Components: Aluminum insert plate with cuvette holder USB thumb drive Power cord USB interface cord Packaging: Unit is shipped in a cardboard box with a form-fitting foam enclosure. Storage: Store the instrument in a cool and dry location. INSTALLATION Please refer to the Thermo Scientific User Manual and all other references for explicit detail on the specifications, set up, operation, performance verification, and general care of the instrument. Information supplied herein should be considered supplemental and specific to dosimetry usage. CAUTION! Whenever the spectrophotometer has been stored or shipped, immediate exposure to room air can cause condensation damage. Move the shipping cartons to the installation location at least 24 hours before installation. This allows the instrument to equilibrate at room temperature before the shipping cartons are opened and protective packaging is removed. Unboxing: After at least 24 hours, open the shipping box and remove the documentation packet, aluminum insert plate, and USB thumb drive. Remove the instrument from its shipping box. Operating Environment: Instrument was designed for use under the following conditions: Rev. B Release Date: 01/18/2017 Page 2 of 21

3 Temperature Range* Relative Humidity Altitude 5 C to 35 C (41 F to 95 F) <20% to 80% noncondensing 0m to 200m *Operating the instrument outside of this temperature range may cause permanent damage. Instrument performance should be verified when operating outside of the relative humidity (RH) and altitude ranges. GEX verified instrument performance at an altitude of approximately 1610m without any problems. The instrument should be positioned on a surface that is level and free of vibration. Anytime the instrument location is moved, the user is advised to conduct performance verification testing. Consider all GLP s (Good Laboratory Practices) concerning cleanliness of the area. Thermo Insight2 Software Installation: Insert the USB drive and install the Thermo Insight software to a designated location. Follow the on-screen prompts as necessary. This software is used for various performance verification testing. Power and USB: Connect the power cord and then connect the instrument to the computer using the USB interface cord. Ensure the instrument s sample chamber is empty. Power ON the spectrophotometer. Open the Insight software. The unit will perform a series of self-checks that will take a few minutes. The Insight software will show a green status checkmark when the unit is ready. Dosimeter Holders: Install the hot-swappable baseplate and holders according to GEX Doc# , Evolution 220 Dosimeter Holder System. IQ/OQ, CALIBRATION & PERFORMANCE VERIFICATION An IQ/OQ Package is available from Thermo Scientific for those who do not want to draft their own. This is available as GEX Part# P4380. In addition, on-site IQ/OQ service is available from Thermo in some service areas for those who prefer that the manufacturer install and verify instrument performance - contact GEX customer service for more information. Installation Qualification (IQ): During installation, the user should document setup and verify that the Evolution 220 and the Insight2 Software are functioning (as installed) per the instructions above and the Thermo User Manual. Document the instrument s status to confirm the PC connection is active. A checklist of the activities previously described and verification of all steps constitutes Installation Qualification (IQ) of the Evo220. Calibration: This instrument has been calibrated by Thermo Scientific using standards traceable to the National Institute of Standards and Technology (NIST). A Certificate of Calibration is included with the instrument. The wavelength accuracy of the Evolution 220 can be automatically re-calibrated using the Mercury Lamp accessory (GEX Part# P4310). Click the System Settings button on the instrument panel to display the Calibrations tab in the right pane. Use it to calibrate the instrument wavelength or accessories. Follow the instructions that appear. The system can also use the Xenon light source within the Evo220 for calibration. This feature appears in the same location in the Insight2 Software noted above. Please refer to the respective Thermo user manuals for more information before using any calibration feature. The instrument is not required to be re-calibrated unless it is failing to meet performance verification specifications. See the section on Care & Maintenance below for more information. Performance Verification: Individual performance tests can be conducted manually using certified filters such as the P4220 Spectronic Standards Set, or by automatically using the P4320 CVC (Calibrated Validation Carousel) accessory. Click on the Performance Verification Rev. B Release Date: 01/18/2017 Page 3 of 21

4 button to set up and run tests to verify performance of the instrument. Refer to page 301 of the Evo220 User Guide for complete information on performance verification. The user must verify the performance of the instrument on a specified frequency. GEX recommends monthly verification, but performance verification may be conducted on a more or less frequency based on instrument usage, elapsed time, or to offset potential risks. Once the user has drafted the internal procedure for performance verification (PV), the user must conduct the first PV on the instrument in its installed location. Upon successful completion of such verification the instrument is ready for OQ. Operational Qualification (OQ): Upon completion of any and all PV activities, the user must verify the operation of the instrument. The user should verify the ability of the instrument to reproducibly perform fixed wavelength measurements. It is suggested to perform a gage R&R study for each dosimeter type that will be used. It is suggested to conduct thirty (30) repeated measurements of single dosimeters irradiated at low, middle and high doses in the user s range, and to reproduce this test for a minimum of three (3) days. GEX has conducted extensive R&R testing - results available upon request. To complete these measurements, the user must use the Thermo Insight2 software. The protocol below must be followed in order to make fixed wavelength dosimeter measurements: Protocol for dosimeter measurements using Thermo Insight Software: 1. From the Insight home screen, select Fixed Rev. B Release Date: 01/18/2017 Page 4 of 21

5 2. Input the measurement parameters by selecting the Settings button and the Instrument tab. The other tabs may be left alone. The bandwidth and wavelength settings are determined by the type of dosimeter being measured. a. For GEX B3 dosimeters, select the Fiber bandwidth from the dropdown options and input the wavelength setting at 552nm: b. For PMMA dosimeters, select the 2nm bandwidth from the dropdown options and input the wavelength setting at 640nm: Rev. B Release Date: 01/18/2017 Page 5 of 21

6 c. For FWT-60 dosimeters, select the Fiber bandwidth from the dropdown options and input the wavelength setting at 605nm: 3. Once the correct settings are entered, select Measure Fixed from the left menu to proceed. 4. Ensure the dosimeter holder is empty, then select Zero from the upper left of the screen. 5. After the instrument is zeroed, insert a dosimeter to be measured. 6. Press the green Measure button (or F6 on your keyboard). You will be prompted to input an ID and description for the sample. Click in the cells and name them as you please Rev. B Release Date: 01/18/2017 Page 6 of 21

7 7. Click Continue to take the measurement. 8. After the measurement is recorded, you may remove the dosimeter and insert the next sample to be measured. Repeat steps 7 and 8 above for all dosimeters. The Sample ID will automatically advance by one number each time a measurement is taken. PERFORMANCE VERIFICATION Instrument performance should be verified at an interval determined by the user. Both Thermo Scientific and GEX recommend a performance verification using the Calibration Verification Carousel (CVC) on a quarterly basis. If using the Spectronic Standards instead of the CVC, a performance verification should be completed at least that often, if not more frequently. CVC protocol: 1. First, performance verification is initiated by assembling the CVC carousel and motorized base. NOTE: Both items must be assembled together before inserting into the Evo, otherwise the CVC filters will not be properly located in the Evo signal path. 2. The bottom of the carousel has an indexing tab that must be inserted into a slot in the motorized base Rev. B Release Date: 01/18/2017 Page 7 of 21

8 3. Rotate the carousel until the tab lines up with the slot and the carousel drops down onto the drive hub. Tighten the knob on top of the carousel to secure both components together. 4. Open the Evo sample compartment and remove the front cover plate. 5. Insert the CVC assembly into the Evo, being careful to line up the connector pins when pressing the assembly into place. 6. Ensure the CVC is fully seated on the sample chamber posts and that the front connector is engaged Rev. B Release Date: 01/18/2017 Page 8 of 21

9 7. Replace the Evo front cover and close the lid. Open the Insight 2 Software. If the CVC is installed correctly, you will receive a message prompt that the accessory must be initialized. 8. Initialization will complete in about 10 seconds, then select the Performance Verification button. 9. Insert the USB drive included with the CVC carousel and select the Load CVC Calibration button in the upper-left of the screen. 10. Navigate to the USB drive and select the calibration file. 11. The list of verification tests to be performed will populate automatically. NOTE: GEX recommends running the default tests listed below. Photometric noise, baseline flatness, and photometric drift may be performed if desired but aren t necessary. 12. Verify the Evo220 s lid is closed and run the Performance Verification. Ensure the sample chamber remains closed throughout the duration of the test. A report will generate when complete Rev. B Release Date: 01/18/2017 Page 9 of 21

10 SPECTRONIC STANDARDS PROTOCOL (optional alternate) The Spectronic standards may be used as an alternative to the CVC. The Insight 2 Software is designed to run performance verification tests using the CVC, so there are no automated tests available for the Spectronic standards. The same types of tests may be performed using the Spectronic standards, but they will have to be measured manually. One option may be to use the Thermo CUE program to write a script that will execute the performance verification. Consult the user manual for instructions on the CUE script. 1. Obtain the Spectronic standards, a baseplate assembly, and a WINdose insert. Install the baseplate and WINdose insert (cuvette holder) into the Evo sample chamber. FIXED WAVELENGTH MEASUREMENT: 2. To perform a measurement at a set wavelength, select the Fixed button from the home screen Rev. B Release Date: 01/18/2017 Page 10 of 21

11 3. Press the Settings button at the lower left of the screen to set the measurement parameters. 4. From the Instrument tab, set the data mode to Absorbance, use an integration time of 0.30 seconds, set the bandwidth to 2nm, and input the wavelength that matches the actual Spectronic standards filter you will be measuring. NOTE: The filter wavelengths are labeled on each filter and are listed on the calibration certificate that accompanies the Spectronic standards. 5. Press the Measure Fixed button at the lower left of the screen. 6. With the WINdose insert (cuvette holder) empty, press the Zero button, or F5 on your keyboard, to zero the Evo. 7. Insert the Spectronic filter you wish to measure and press the Measure button, or F6 on your keyboard, to perform the measurement. A screen will appear for you to input a sample ID or description if you wish Rev. B Release Date: 01/18/2017 Page 11 of 21

12 8. Compare the displayed measurement to the value listed on the Spectronic standards calibration certificate. The measurement should fall within the listed acceptance criteria. 9. Repeat steps 7 and 8 for each filter you wish to measure. WAVELENGTH SCAN: 1. From the home screen, select the Scan button. 2. From the Instrument tab, set the data mode to Absorbance, select Very High smoothing, set the bandwidth to 2nm, the integration time to 0.30 seconds and input the start and end wavelengths that you wish to bracket the Wavelength filter. NOTE: GEX recommends using a wavelength scanning range that is ±10nm from the certified wavelength value listed on the Spectronic standards calibration certificate. 3. Press the Measure Scan button at the lower left of the screen. 4. With the WINdose insert empty, press the Zero button, or F5 on your keyboard, to zero the Evo Rev. B Release Date: 01/18/2017 Page 12 of 21

13 5. Insert the Spectronic filter you wish to measure and press the Measure button, or F6 on your keyboard, to perform the measurement. A screen will appear for you to input a sample ID or description if you wish. 6. Once the scan completes and a graph is displayed, you may zoom in to the peak by first clicking and dragging an area you wish to zoom. 7. Release the mouse button and left-click anywhere inside the highlighted region to zoom. 8. The peak will be the lowest point on the graph. NOTE: Because the Absorbance function was used, the displayed graph will be an inverse function and therefore the peak value will be the lowest point on the graph. If % Transmittance was selected as the Data Mode from the Settings screen, the peak value will be the highest point on the graph. Either method is acceptable and should return the same value. 9. Compare the displayed measurement to the value listed on the Spectronic standards calibration certificate. The measurement should fall within the listed acceptance criteria Rev. B Release Date: 01/18/2017 Page 13 of 21

14 MERCURY (Hg) LAMP PERFORMANCE VERIFICATION: 1. Clear the Evo sample chamber of all hardware, including the base plate assembly and any dosimeter holders. 2. Lift the flap on the right side of the Evo and insert the Hg lamp into the cavity. There is a spring-loaded detent that will allow the lamp to snap into position. 3. Insert the lamp cord into the connector on the rear of the Evo. The lamp power light will illuminate, indicating that it is connected properly. NOTE: The Hg lamp emits intense light that may damage unprotected eyes. It is recommended to insert the lamp into the Evo before connecting the cord to avoid exposure. 4. Open the Insight 2 Software. Select the Performance Verification button. 5. From the list of available tests, unselect all but the Hg lamp wavelength accuracy and repeatability. See image below: Rev. B Release Date: 01/18/2017 Page 14 of 21

15 6. Press the Run button in the upper-left of the screen, or F6 on your keyboard, to begin the tests. 7. A screen will appear showing a warmup countdown for the Hg lamp. 8. After the countdown completes, the tests will begin. When prompted to verify that the Hg lamp is installed and to clear the sample compartment, select OK to continue. 9. After all tests have been completed, a test report is generated and displayed. See image below: Rev. B Release Date: 01/18/2017 Page 15 of 21

16 10. If all tests pass, no further actions are required and the Hg lamp may be removed in the reverse order it was installed. If any tests fail, the Evo will need to be calibrated using the Hg lamp. MERCURY (Hg) LAMP CALIBRATION: 1. Install the Hg lamp into the Evo as described above. From the Insight 2 home screen, select the System Settings button from the lower-left of the screen. 2. Select the Calibrations tab at the top of the next screen. 3. Under Hg Lamp, press the button labeled Calibrate. 4. When prompted, press OK to begin calibration. The process will take about 10 minutes to complete. 5. A message will appear to remove the Hg lamp before proceeding Rev. B Release Date: 01/18/2017 Page 16 of 21

17 NOTE: The Hg lamp must be physically removed from the Evo at this point. Do not simply unplug the lamp cord. When inserted, the Hg lamp blocks the internal Xenon lamp and must be removed from the Evo to allow the Xenon lamp to function. 6. After removing the Hg lamp and selecting OK, the internal Xenon lamp will emit a buzzing sound. This is normal. 7. When Hg lamp calibration completes, a message should appear that calibration was successful. 8. After calibration, repeat Hg lamp Performance Verification. XENON LAMP PERFORMANCE VERIFICATION (optional) If neither the CVC nor the Hg lamp is available for use, Performance Verification may still be performed using the internal Xenon lamp in the Evo. 1. With the Evo220 sample chamber empty, select Performance Verification from the Insight 2 Software s home screen. From the list of available tests, unselect all but Xe lamp accuracy and repeatability Rev. B Release Date: 01/18/2017 Page 17 of 21

18 2. Select Run in the upper-left of the screen (or F6 on your keyboard) to begin the tests. Select OK when prompted to clear the sample compartment. NOTE: There will be a few prompts to clear the sample compartment before proceeding. Select OK at each prompt to continue the tests. 3. After the Performance Verification completes, a test report is generated and displayed. See image below: 4. If all tests pass, no further actions are required. If any tests fail, the Evo220 will need to be calibrated using the Xenon lamp. See below for further instruction. XENON LAMP CALIBRATION: 1. From the Insight 2 Software s home screen, select the System Settings button from the lower-left of the screen. 2. Select the Calibrations tab at the top of the next screen. 3. Under Xe Lamp, select the button labeled Calibrate. 4. When prompted, press OK to begin calibration. The process will take about 5 minutes to complete. NOTE: No message will appear after the calibration completes Rev. B Release Date: 01/18/2017 Page 18 of 21

19 5. After calibration, repeat Xenon Lamp Performance Verification. See section above for detail. CARE & MAINTENANCE Cleaning: The instrument s exterior and the sample compartment should be periodically cleaned as part of a Preventative Maintenance program along with the the dosimeter holder system. An instrument that is maintained and cared for will perform better and have a longer life. Complete cleaning instructions which include the proper materials can be found in the Evo220 User Guide beginning on page 39. Instructions for cleaning the dosimeter holder system are located in GEX Doc# , Evolution 220 Dosimeter Holder System. Lamp Replacement: The Xenon Flash Lamp has a three (3) year warranty (5 years is the typical lifespan). The lamp must be replaced by an authorized Thermo Service Technician at the customer site, or the user may send the instrument back to Thermo for lamp replacement using their Depot Services. Contact GEX Customer Service for more information. To view status information regarding the xenon lamp, use the System Settings button on the Home Screen in the Insight2 Software to display the Lamp tab in the right pane. If the device requires service for any reason there are two options: (Note: not all services are available with both options. Please consult with GEX or Thermo for more detail.) 1. Depot Service: The Evolution 220 is designed to be serviced on-site, but from time to time it may need to be sent to Thermo Scientific in Madison, WI U.S.A. for repair or other services. Please contact GEX Customer Service for more information if depot service is required. 2. On-site Service & Service Agreements: On-site service is available in some areas. A qualified technician can arrive on-site for cleaning, calibration, and maintenance on your Evo220. Service agreements may also be available in your area. Contact GEX Customer Service for details. PRODUCT PHOTOS Thermo Scientific Rev. B Release Date: 01/18/2017 Page 19 of 21

20 ACCESSORIES GEX Part No. Description Purpose P4220 Spectronic Standards Set Photometric accuracy, wavelength accuracy verification P4310 Mercury Lamp Accessory Wavelength accuracy verification and calibration tool for Evolution 220 Spectrophotometer P4320 Thermo Scientific CVC Carousel Automated instrument performance verification for Evolution 220 Spectrophotometer to one of four standards: NIST, NPL, U.S. or EU Pharmacopeia P4330 GEX Hot-Swappable Base Plate The base platform is the mount for all dosimeter holders as well as the laser micrometer and barcode reader. Beam tubes allow user to leave the lid open during measurements: protects measurements from stray light. P4332 DoseStix Dosimeter Holder Dosimeter positioning for GEX DoseStix style dosimeters P4334 WINdose Dosimeter Holder Dosimeter positioning for 1cm 2 radiochromic film dosimeters P4336 PMMA Dosimeter Holder Dosimeter positioning for Red and Amber Perspex PMMA dosimeters P4350 Laser Micrometer Measures thickness of PMMA dosimeter inside the Evo220 P4355 Custom Gage blocks For calibrating the P4350 Laser Micrometer P4360 B3 DoseStix Barcode Scanner Barcode scanner and mounting post for automated B3 DoseStix barcode reading PRECAUTIONS Please refer to the Thermo Scientific Site and Safety User Guide for additional information and the full listing of precautions. NOTICE: Immediate exposure to room (ambient) air can cause condensation damage whenever the spectrophotometer has been stored or shipped. Move the shipping cartons to the installation location at least 24 hours before installation. This allows the instrument to equilibrate with the room temperature before the shipping cartons are opened and protective packaging is removed. Keep shipping cartons upright at all times. Damages due to improper moving techniques are not covered by the warranty. Connect the Evolution to a suitable uninterruptable power supply to minimize line current fluctuations that may alter the measurement or damage the spectrophotometer. Keep the top cover closed and latched as much as possible. Minimize exposure of the spectrophotometer to airborne contaminants like smoke, dust, oil vapor, or chemical fumes. WARRANTY/GUARANTEE Warranty: Please refer to the Thermo Scientific product information for warranty information. User modifications are not warranted and are the sole responsibility of the user. Guarantee: 1 year GEX satisfaction guarantee. Product may be returned within one year from the date of delivery for any customer dissatisfaction. REFERENCES References: ISO 10012: Measurement Management Systems -- Requirements for Measurement Processes and Measuring Equipment ISO/ASTM 51261: Calibration of Routine Dosimetry Systems for Use in Radiation Processing ISO/ASTM 52628: Dosimetry for Use in Radiation Processing Rev. B Release Date: 01/18/2017 Page 20 of 21

21 Thermo Fisher Scientific Documents: Evolution 200 Series User Guide Evolution 200 Series QuickStart Installation Guide Evolution 200 Series Getting Started Site & Safety User Guide for UV-Visible & Fluorescence Evolution Series Mercury Lamp User Guide Evolution Series CVC User Guide GEX Product Specification and Usage (PSU): GEX Doc # Hg Lamp GEX Doc # Calibration Validation Carousel (CVC) GEX Doc # Evolution 220 Dosimeter Holder System To learn more about GEX products and services, visit or contact a GEX representative at Rev. B Release Date: 01/18/2017 Page 21 of 21