MASSACHUSETTS STATE POLICE CRIME LABORATORY. Certificate of Calibration Procedure for the Alcotest 9510

Transcription

1 MASSACHUSETTS STATE POLICE CRIME LABORATORY Certificate of Calibration Procedure for the Alcotest 9510 Effective Date: May 10, 2017 Page 1 of 23

2 TABLE OF CONTENTS 1 INTRODUCTION ABBREVIATIONS EQUIPMENT REAGENTS AND STANDARDS PREPARATION ADJUSTMENT PROCEDURE CALIBRATION QUALITY CONTROL TEST (0.080% BREATH HOSE) SET BT CERTIFICATION DATE POST-CALIBRATION REVISION HISTORY MANUAL REVIEW AUTHORIZATION Effective Date: May 10, 2017 Page 2 of 23

3 1 INTRODUCTION 1.1 The Draeger Alcotest 9510 breath test instrument (BT) requires an annual certification. This is to be performed by the Office of Alcohol Testing (OAT). 2 ABBREVIATIONS 2.1 OAT: Office of Alcohol Testing 2.2 BT: Draeger Alcotest 9510 Breath Test instrument 2.3 IR: Infrared 2.4 EC: Electrochemical (aka Fuel Cell) 2.5 QC: Quality Control 3 EQUIPMENT 3.1 Alcotest Guth 2100 Simulator, Alcosim Simulator, Draeger Alcotest CU34 Simulator or equivalent 3.3 Dry Gas Regulator Clear tubing Adaptor 3.4 Keyboard 3.5 Printer with USB connection 3.6 CAT 5 Cable 3.7 Barometer 3.8 Draeger Alcotest 9510 USB Access Key Effective Date: May 10, 2017 Page 3 of 23

4 3.9 Phillips Head Screwdriver 3.10 Short Silicone Hose 3.11 NIST traceable clock 4 REAGENTS AND STANDARDS 4.1 Reagents (equivalents may be substituted) % Purchased Ethanol Solution % Purchased Ethanol Solution % and 0.100% OAT Manufactured Ethanol Solution, see OAT Solution Protocol 4.2 Standards (equivalents may be substituted) % Dry Gas cylinder, Intoximeters % Dry Gas cylinder, Intoximeters % Dry Gas cylinder, Intoximeters % Dry Gas cylinder, Intoximeters PREPARATION 5.1 Adjustment and Verification Solutions Fill simulators with approximately 500 ml of the designated OAT manufactured or purchased ethanol solution and check for air leaks The simulators are used in tandem. The solutions contained in each pair of simulators must be from the same lot number Turn on all simulators for at least thirty minutes to prior to testing. 5.2 BT Certification Form (OAT-F008) After solutions, dry gas cylinders, and/or simulators are replaced; verify the lot numbers, expiration dates, model numbers, and serial numbers of all the Effective Date: May 10, 2017 Page 4 of 23

5 solutions, all the dry gas cylinders, and all the simulators at the appropriate stations on the Form. This shall be properly documented on the Lot Number chart Print the Form for the appropriate Police Department or Agency and the appropriate station where the certification will take place Station 1 Certification Form Station 2 Certification Form BP/OAT/BATMOBILE Station 1 Certification Form BP/OAT/BATMOBILE Station 2 Certification Form Document on the Form whether the BT that has been received from the police department or agency has arrived with a top cover, side cover, gas enclosure key, power cord, keyboard, scanner with USB cord, printer USB cord, and CAT All printouts generated during the certification process are retained with the Form for review. 5.3 Removal of Stand and Gas Enclosure (if applicable) Stand Remove gas enclosure cover with the gas enclosure cover key If the police department brought the gas enclosure cover key, leave the key in the keyhole of the enclosure cover to ensure the return of the key If the stand is attached to the BT, remove the bottom cylinder (cylinder 2) to access and remove the two screws Remove the side panel from BT Unplug all cords and cables from the BT Push instrument back before lifting off the stand Gas Enclosure Unplug the two cylinder hoses and the transducer cable Remove the five screws on the bottom of the enclosure to remove the BT from the enclosure. Effective Date: May 10, 2017 Page 5 of 23

6 5.4 Instrument Set-Up At the laboratory bench station printed on the Form, connect the printer, keyboard, CAT 5 cable, and power cord to the BT and power on Insert the Draeger Alcotest 9510 USB Access Key Change the Police Department or Agency network to the OAT Network if the network was not changed through Initial Set-Up Procedure for Draeger Alcotest Use the appropriate IP address, subnet mask, and gateway assigned to that specific laboratory bench station Enter Menu Enter Settings Enter Network Type in the IP address, Subnet Mask, and Gateway Select Save and Press OK. BT will restart to save the settings Remove the black rubber cuvette cap from the Cuvette Inlet (Diagram 1). Diagram 1 Draeger 9510: Back of Instrument Clear Hose Simulator to Cuvette Inlet Effective Date: May 10, 2017 Page 6 of 23

7 6 ADJUSTMENT PROCEDURE 6.1 Database Management Enter Menu Enter Settings Enter Database Management Check Evid90-24 Number of records and record the number in the box on the Form as well as for the 90B, PC, and Training Tests If greater or equal to 150 tests for any of the categories, verify and document all records have sent to CJIS server. When confirmed, delete records Less than 150 tests, check Evid90B in dropdown and follow same process as Follow this process for PC, Train, and Periodic Test Press Cancel when finished. 6.2 Set Date and Time Enter Set Date and Time Set the date and time using a NIST traceable clock Save settings, then x to leave menu. 6.3 Check Internal Printer Paper Press the black button on the paper flap of the BT to open the Internal Printer to check if the paper needs replacement If the paper does not need to be replaced, continue to Check Firmware Version If the paper needs to be replaced, remove the current paper roll and replace with a new roll Ensure the paper is fed through the compartment of the paper flap. 6.4 Check Firmware Version Enter Menu. Effective Date: May 10, 2017 Page 7 of 23

8 6.4.2 Enter About Verify the M16, WinCE, and Cfg Versions with the Form Note: If the version is not correct, the updated version will need to be downloaded. Follow Initial Set-Up Procedure for Draeger Alcotest 9510 (OAT-D004) to update the firmware Print, then x to leave the menu. 6.5 Update Barometric Pressure Enter Menu Enter Maintenance Enter Calibration Enter Ambient Pressure Correction Record BT Ambient Pressure readingas Initial BT Ambient Pressure on the Form Record the MKS Baratron Pressure Sensor reading as External Ambient Pressure, and circle which MKS Baratron Pressure Sensor is being used on the Form Calculate the acceptable range from the MKS Baratron Pressure Sensor, truncating to one decimal place. Acceptable range is determined as +/- 0.25% of the MKS Baratron Pressure Sensor reading. Record this range on the Form as Acceptable Range Determine if BT Ambient Pressure is within the acceptable range of the MKS Baratron Pressure Sensor Since the first decimal is not known on the BT reading, then assume that it is a zero If the BT Ambient Pressure is within the acceptable range of the MKS Baratron Pressure Sensor, then no adjustment is necessary on the BT. If the BT Ambient Pressure is not within the acceptable range, then adjust the External Ambient Pressure to the MKS Baratron Pressure Sensor reading and record on the form, truncating the decimal places Record on the Form the Final BT Ambient Pressure Save settings Effective Date: May 10, 2017 Page 8 of 23

9 Cancel to exit screen, then x to leave menu. 6.6 Adjustment (0.100% Wet) Once instrument is Ready, enter Menu Enter Maintenance Enter Calibration Procedure Enter assigned username (no password), then OK Verify your user information. If information is correct, press OK If information is incorrect, answer No to the prompt and make the appropriate edits to the operator database and then send the operator database to BT Follow the screen prompts along with the Form to enter information including, but not limited to: adjustment and adjustment check lot numbers and solution concentrations with expiration dates, and simulator serial and model numbers with expiration dates that are connected to the BT. Document all information on the Form Verify if entered information is correct on the screen. If it is not correct, then double click on the incorrect information and make the necessary changes. If the entered information is correct, then enter Save On the Form, record the temperature of the simulators that will be connected to the BT Attach 0.100% purchased solution tandem simulators. Connect the short silicone hose to the Cuvette Inlet (Diagram 1) and insert the adaptor connected to the clear hose to the Simulator Standard Pump Outlet Port (Diagram 1) Initiate adjustment process. 6.7 Adjustment Check (0.100% Wet) When BT screen prompts for the calibration check, remove simulators and attach 0.100% OAT manufactured solution tandem simulators. Connect the short silicone hose to the Cuvette Inlet (Diagram 1) and insert the adaptor connected to the clear hose to the Simulator Standard Pump Outlet Port (Diagram 1) Initiate adjustment check process. Effective Date: May 10, 2017 Page 9 of 23

10 6.7.3 Printout appears when the procedure is complete. Review the report to determine if results are within the following acceptable tolerances: The IR and EC results must fall between 0.097%-0.103% alcohol content The IR and EC results (n=6) must agree within +/ alcohol content of each other If the results are within the acceptable tolerances, remove simulators from the BT and proceed to Verification Test and Manual Adjustment (6.8) Repeat the adjustment (6.6) and adjustment check (6.7) once if the adjustment check results are outside the acceptable tolerances. If the results still do not meet acceptance tolerances, consult with a supervisor to determine if further testing is required or if the BT should be set aside until a later date and the Certification repeated. If the results are still unacceptable, mark the instrument as Out of Service. 6.8 Verification Test and Manual Adjustment (0.100% Dry, Inlet 1) Activate Cylinder Enter Menu Enter Maintenance Enter Set Active Cylinder Set Cyl 1 Active OK Insert 0.100% dry gas cylinder adaptor hose into Dry Gas Inlet 1 (Diagram 2) of BT. Effective Date: May 10, 2017 Page 10 of 23

11 Clear Hose of Dry Gas Inlet 1 Diagram 2 Draeger 9510: Back of Instrument Enter Menu Enter Maintenance Enter Verification Test Enter assigned username (no password), then OK Follow screen prompts along with the Form to enter information including dry gas concentration, lot number, and expiration date. Document all information on the Form Verify if entered information is correct on the screen. If it is not correct, then double click on the incorrect information and make the necessary changes. If the entered information is correct, then enter Save. Effective Date: May 10, 2017 Page 11 of 23

12 6.8.8 When prompted, set Test-Gas to Dry and Gas-Input to Cal Gas Inlet 1 then Save Set Number of Tests to 1 then Save Review the Verification Report to determine if the results are within the following acceptable tolerances: The IR and EC results must fall between 0.099%-0.101% alcohol content The IR and EC results must agree within +/ alcohol content of each other If the results are within the acceptable tolerances, remove adaptor hose for cylinder for Dry Gas Inlet 1 (Diagram 2) and proceed to the next verification test (6.9) If the results of the 0.100% Verification Test are outside the acceptable tolerances perform the following manual adjustments: Answer No to Perform another verification test Enter Menu Enter Maintenance Enter Calibration Enter EC Sensor Configuration Document the EC dry gas offset Initial value number on the Form. If the IR and EC results do not match, adjust the EC Drygas Offset to match the IR result. For example, if the EC result is 0.098%, IR result is 0.101% and the EC Drygas Offset is 6, the EC Dry gas Offset would need to be changed to 9 (0.099, 0.100, and is a difference of 3, 6 plus 3 is 9). Record the changed number on the Form as the EC drygas offset Final. Save the changes Enter IR/EC Correction Document the Calgas Inlet Initial value on the Form. If the IR result is not 0.100%, adjust Drygas % for Calgas Inlet. For example, if the IR result is 0.101% and the Drygas % is set to 3, the Drygas % would need to be changed to 2 (0.101% down to 0.100% is 1, 3 minus 1 is 2). Record the Dry gas % for Calgas Inlet Final number on Form. Save the Effective Date: May 10, 2017 Page 12 of 23

13 changes Repeat the above steps for 0.100% Verification Test Review the Verification Report to determine if the results are within the acceptable tolerances (0.099%-0.101%) If the results are acceptable, proceed to the 0.400% Verification Test (6.9) If the results are not within acceptable tolerances, repeat the adjustment process one more time. If the results still do not meet the acceptance tolerances, consult with a supervisor to determine if further testing is required or if the BT should be set aside for a later date and repeat the Certification Remove cylinder from Dry Gas Inlet 1 (Diagram 2). 6.9 Verification Test and Manual Adjustment (0.400% Wet) Attach 0.400% purchased solution tandem simulators. Connect the short silicone hose to the Cuvette Inlet (Diagram 1) and insert the clear hose with adaptor to the Simulator Standard Pump Outlet Port (Diagram 1) Answer Yes to the prompt Perform another verification test Follow the screen prompts along with the Form to enter information including, but not limited to, solution lot number and solution concentration with expiration date, and simulator serial and model number with expiration date that are connected to the BT. Document all information on the Form Verify if entered information is correct on the screen. If it is not correct, then double click on the incorrect information and make the necessary changes. If the entered information is correct, then enter Save On the Form, record the temperature of the simulator connected to the BT When prompted, set Test-Gas to Wet and Gas-Input to Cuvette Inlet then Save Set Number of Tests to 1 then Save Review the Verification Report to determine if the results are within the following acceptable tolerances: The IR and EC results must fall between 0.392%-0.408% alcohol content. Effective Date: May 10, 2017 Page 13 of 23

14 The IR and EC results must agree within +/ alcohol content of each other If the results are within the acceptable tolerances, continue to the Calibration (7.0) If the results of the 0.400% Verification Test are outside the acceptable tolerances perform the following manual adjustments: Answer No to the prompt Perform another verification test Enter Menu Enter Maintenance Enter Calibration Enter EC Sensor Configuration On the Form, document current EC Quadratic Correction Factor as the initial value. If the value is a zero or a negative number, enter 1 on the Form Press Cancel to Exit the screen Enter IR/EC Correction On the Form, document current IR Slope Multiplier as the Initial value Using the Draeger Quadr computer program; enter IR Slope Multiplier in the quadratic IR field, EC Quadratic Correction Factor in the quadratic EC field, Result IR and Result EC Enter Calculate tab On the Form, document the New IR-corr. in Final IR Slope Multiplier and New EC-corr. in Final EC Quadratic Correction Factor Enter the new EC Quadratic Correction Factor and IR Slope Multiplier in the proper screens in the BT and save settings Repeat steps for 0.400% Verification Test If results are acceptable, proceed to the Calibration (7). If the desired result is still not obtained, consult with a supervisor to determine if further testing is required or if the BT should be set aside until a later date and repeat the Certification. Effective Date: May 10, 2017 Page 14 of 23

15 7 CALIBRATION Remove simulators from the BT. 7.1 Calibration 0.200% Dry Gas Insert 0.200% dry gas cylinder hose adaptor into Dry Gas Inlet 1 (Diagram 2) of BT Answer Yes to the prompt Perform another verification test Follow screen prompt requests along with the Form to enter information including concentration, dry gas lot number, and expiration date Verify if entered information is correct on the screen. If it is not correct, then double click on the incorrect information and make the necessary changes. If the entered information is correct, then enter Save When prompted, set Test-Gas to Dry and Gas-Input to Cal Gas Inlet 1 then Save Set the number of tests to ensure that at a minimum three tests are completed Review the Verification Report to determine results are within the following acceptable tolerances: The IR and EC results must fall between 0.192%-0.208% alcohol content The IR and EC results (n=6) must agree within +/ alcohol content of each other If the results are within the acceptable tolerances, proceed to the next calibration (7.2) test If the results are not within acceptable tolerances, repeat the 0.200% calibration. (7.1) If the results still do not meet acceptance tolerances, consult with a supervisor to determine if further testing is required or if the BT should be set aside until a later date and repeat the Certification Remove cylinder from Dry Gas Inlet 1 (Diagram 2). 7.2 Calibration 0.080% Dry Gas Effective Date: May 10, 2017 Page 15 of 23

16 7.2.1 Repeat the steps for the above 0.200% verification using a 0.080% cylinder Review the Verification Report to determine if the results are within the following acceptable tolerances: The IR and EC results must fall between 0.074%-0.086% alcohol content The IR and EC results (n=6) must agree within +/ alcohol content of each other If the results are within the acceptable tolerances, proceed to the next calibration (7.3) Because the next calibration concentration uses a different inlet, answer No to Perform another verification test. Remove cylinder from Dry Gas Inlet 1 (Diagram 2) If the results are not within acceptable tolerances, repeat the 0.080% calibration (7.2) If the results still do not meet acceptance tolerances, consult with a supervisor to determine if further testing is required or if the BT should be set aside until a later date and repeat the Certification. 7.3 Calibration 0.020% Dry Gas Activate Cylinder Enter Menu Enter Maintenance Enter Set Active Cylinder Set Cyl 2 Active OK Insert 0.020% dry gas cylinder hose into Dry Gas Inlet 2 (Diagram 3) of BT. Effective Date: May 10, 2017 Page 16 of 23

17 Clear Hose of Dry Gas, Inlet 2 Diagram 3 Draeger 9510: Back of Instrument Enter Menu Enter Maintenance Enter Verification Test Enter assigned username (no password), then OK if information is correct Follow screen prompts along with the Form to enter information including concentration, dry gas lot number, and expiration date Verify if entered information is correct on the screen. If it is not correct, then double click on the incorrect information and make the necessary changes. If the entered information is correct, then enter Save When prompted, set Test-Gas to Dry and Gas-Input to Cal Gas Inlet 2 then Save Set the number of tests to ensure that at a minimum, three tests are completed Review the Verification Report to determine if the results are within the following acceptable tolerances: Effective Date: May 10, 2017 Page 17 of 23

18 The IR and EC results must fall between 0.016%-0.024% alcohol content The IR and EC results (n=6) must agree within +/ alcohol content of each other If the results are within the acceptable tolerances, proceed to the Quality Control Test (8) If the results are not within acceptable tolerances, repeat the 0.020% calibration (7.3) If the results still do not meet acceptance tolerances, consult with a supervisor to determine if further testing is required or if the BT should be set aside until a later date and repeat the Certification Remove cylinder from Dry Gas Inlet 2 (Diagram 3). 8 QUALITY CONTROL TEST (0.080% BREATH HOSE) 8.1 Attach 0.080% OAT manufactured solution tandem simulators. Connect the clear hose in the Simulator Standard Pump Outlet Port (Diagram 1). 8.2 Answer Yes to the prompt Perform another verification test. 8.3 Follow the screen prompts along with the Form to enter information including, but not limited to, solution lot number and solution concentration with expiration date, and simulator serial and model number with expiration date that are connected to the BT. Document all information on the Form Verify if entered information is correct on the screen. If it is not correct, then double click on the incorrect information and make the necessary changes. If the entered information is correct, then enter Save. 8.4 On the Form, record the temperature of the simulator connected to the BT. 8.5 When prompted, set Test-Gas to Wet and Gas-Input to Breath Hose then Save. Effective Date: May 10, 2017 Page 18 of 23

19 8.6 Set the number of tests to ensure at minimum three tests are completed. 8.7 When prompted by the prompts on the display, connect and disconnect the breath hose to the output port on the simulator. 8.8 Review the Verification Report to determine if the results are within the following acceptable tolerances: The IR and EC results must fall between 0.074%-0.086% alcohol content The IR and EC results (n=6) must agree within +/ alcohol content of each other If the results are within the acceptable tolerances, then answer No to Perform another verification test and proceed to Set BT Certification Date (9) If the results are not within the acceptable tolerances, repeat quality control breath hose test If the results still do not meet acceptance tolerances, consult with a supervisor to determine if further testing is required or if the BT should be set aside until a later date and repeat the Certification. 9 SET BT CERTIFICATION DATE 9.1 Replace Cuvette Cap Replace black rubber cuvette cap on the Cuvette Inlet (Diagram 1). 9.2 Cylinder Check Connect the transducer cable on the gas enclosure to BT. Make sure the transducer plugs in smoothly and check BT display for connectivity. Connect the gas hoses to the proper inlets Attach a 0.080% dry gas cylinder to the BT via gas enclosure on each inlet. Make sure the BT screen displays the pressures of each inlet Remove cylinders. 9.3 Set BT Certification Date After Technical and Administrative review, the analyst that performed the certification or that supervised the analyst in training performing the certification will set the BT Certification Date. Effective Date: May 10, 2017 Page 19 of 23

20 9.3.2 Enter Menu Enter Maintenance Enter Set BT Certification Start Date The analyst (and the analyst in training, if applicable) must sign the printout The BT Certification Date must be done on the same day the BT was certified Place a label on the BT that includes: Police Department or Agency Model Number Serial Number Expiration Date 9.4 Department Network Enter Menu Enter Settings Enter Network Adjust the IP address, subnet mask, and gateway settings back to the Police Department or Agency s information After verification of the network settings by another analyst (who did not perform the calibration), press Save and restart BT The BT display should read PER TEST REQUIRED upon restart. 10 POST-CALIBRATION 10.1 Power down the BT Unplug all cords and cables Remove Draeger Alcotest 9510 USB Access Key Attach the gas enclosure to the BT using five screws. Effective Date: May 10, 2017 Page 20 of 23

21 10.5 Reassemble the BT and gas enclosure with the stand and reconnect all the cords and cables that were provided by the police department or agency Call Police Department or Agency to notify that the instrument is ready Document the use of the tandem simulators on the BT Solution Use Log. The solutions may be used up to 30 times. Effective Date: May 10, 2017 Page 21 of 23

22 11 REVISION HISTORY REVISION DATE VERSION REVISED BY TOTAL PAGES REVISION 9/15/ OAT 21 Original 5/18/ OAT 19 Updated acceptance criteria 5/10/ OAT 23 Minor updates throughout, see tracked changes in QA Effective Date: May 10, 2017 Page 22 of 23

23 12 MANUAL REVIEW ALL SIGNATURES ON FILE IN QUALITY ASSURANCE Melissa O Meara SECTION SUPERVISOR OAT DATE Nancy W. Brooks SECTION MANAGER OF FORENSIC CHEMISTRY DATE Albert A. Elian DEPUTY DIRECTOR OF FORENSIC CHEMISTRY DATE Kim Anderson QUALITY ASSURANCE MANAGER DATE 13 AUTHORIZATION Kristen L. Sullivan LABORATORY DIRECTOR DATE Effective Date: May 10, 2017 Page 23 of 23