QuantStudio 6 Flex and QuantStudio 7 Flex Real-Time PCR Systems Planned Maintenance Protocol

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1 QuantStudio 6 Flex and QuantStudio 7 Flex Real-Time PCR Systems Planned Maintenance Protocol Pub Rev. A Customer information Customer Organization Name: Customer Contact Name: Hvidovre Hospital Lene Werge Customer Contact Title: Customer Organization Location: Hvidovre Date Planned Maintenance Performed: Planned Maintenance Performed By: Service Order Number: May Carsten Nielsen Instrument information Instrument model: Instrument serial number: Thermal cycler block type: QuantStudio 6 Flex QuantStudio 7 Flex Block Included? Serial number Array Card 384-Well 96-Well Fast 96-Well For Research Use Only. t for use in diagnostic procedures.

2 Heated cover type: Block Included? Serial number Array Card / 384-Well 96-Well Fast 96-Well Optional Twister Robot: The system includes the optional Twister Robot: If yes, record the serial number: Responsibilities Required tools and parts Planned maintenance procedure 2 QuantStudio 6 Flex andquantstudio 7 Flex Real-Time PCR Systems Planned Maintenance Protocol

3 Service contract verification Check the serial number of the instrument, and ensure the system is under contract. The system is on a Service Contract: Contract type: SC QuantStudio 6 Flex System SC QuantStudio 7 Flex System SC QuantStudio 7 Flex System + Twister RobotTwister FPPM FPPM + PureDye If there is no Service Contract, a purchase order must be issued for this visit. This service is covered by a purchase order: If applicable, enter the Purchase Order #: Pre-planned maintenance Review with customer if they have any system concerns. List their concerns in the Comments section below. te that resolving some customers concerns may require a separate billable service call. Review customer records and/or logbooks and check if the instrument has been upgraded to the latest Engineering Change Order. te: Due to system validation issues, some customers may not want the latest upgrades installed. Instrument firmware information Record the instrument firmware version: Computer information Record the computer hardware and software information. Computer model: Service tag: Computer operating system: OS service pack version: QuantStudio software version: Optiplex XE2 B2RNM22 Win 7 SP tify the customer if the Software and Operating System versions are not in accordance with QuantStudio 6 Flex and QuantStudio 7 Flex Real-Time PCR Systems Software Compatibility Matrix and User Document Reference (Pub. no Verify that the Smart Monitor agent has been activated on the QuantStudio 6 Flex System or QuantStudio 7 Flex System egui. QuantStudio 6 Flex andquantstudio 7 Flex Real-Time PCR Systems Planned Maintenance Protocol 3

4 Computer maintenance tify the customer that computer maintenance will be performed. Check that the customer has backed up all necessary files. Ensure that there is only one instance of the QuantStudio Software on the computer and that it is installed on the D drive. With customer permission, remove any extra versions, folders, etc., from previous installations of that software. te: Consult with the customer before moving or removing files, and make sure that the files are backed up. Verify with the customer that an anti-virus software auto-scan and auto-update options are disabled. General maintenance recommendations Recommend that the customer run the disk defragmenter tool monthly or as needed to defragment the C and D drives. Recommend that the customer check for block contamination weekly and clean the block as needed. Recommend that the customer perform background and pure dye calibrations or purchase a Pure Dye Calibration Service for all blocks every 6 months or as needed. System maintenance IMPORTANT! Ensure that the equipment is unplugged, then remove the instrument covers and inspect all interior surfaces and wiring. Wipe any dust or debris from surfaces. Clean all fans of dust and debris. Ensure that all cables are properly secured and not being crimped or pinched, and that all electrical connections are tight. Visually inspect the field lens for smudges and fingerprints. Visually inspect the emission and excitation filters for smudges and fingerprints. Record the following lamp information: Date last replaced: Condition: Usage (hours): Good 303 Select one: Lamp was changed using Part no due to any or all of the above parameters failing specification. Lamp hours were reset to zero. Lamp was not changed, because the life and current performance did not require it. Left spare lamp with customer. Run the Self Test from the instrument egui. Troubleshoot and repair as necessary, following the standard service procedures. 4 QuantStudio 6 Flex andquantstudio 7 Flex Real-Time PCR Systems Planned Maintenance Protocol

5 Thermal cycler maintenance Verify the calibration of the sample block. Record the average temperature. Calibration Verification 85 C ±0.25 C 45 C ±0.25 C Array Card 384-Well 96-Well Fast 96-Well 85,02 45,04 Record the TNU. TNU (<0.50 C) 95 C 60 C Array Card 384-Well 96-Well Fast 96-Well 0,12 0,14 Run the heated cover temperature accuracy test and record the heated cover temperature. Array Card 384-Well 96-Well Fast 96-Well 105 C ±3.0 C N/A 104,7 85 C ±3.0 C N/A N/A N/A Pure dye calibrations The PM covers ROI, background, uniformity, pure dye, and normalization calibrations for a single block. Discuss with your customer which block to calibrate. Additional blocks can be calibrated with the purchase of additional Pure Dye Calibration Services. Select the block(s) calibrated: Array Card 384-Well 96-Well Fast 96-Well Perform the ROI calibration. Perform the background calibration. te: If the background calibration fails, clean the block according to standard service procedures. Perform the uniformity calibration. QuantStudio 6 Flex andquantstudio 7 Flex Real-Time PCR Systems Planned Maintenance Protocol 5

6 Perform the pure dye calibration. Pure dyes calibrated: FAM TAMRA ROX VIC NED (optional) SYBR Green (optional) Perform the normalization calibration. FAM / ROX VIC / ROX Twister Robot maintenance Lubricate the vertical bearings according to Service Bulletin 3. Clean the gripper finger pads and replace as necessary (Part no ). Clean the underside of the gripper plate of any sticky adhesive. Perform any outstanding ECOs. Check for any loose screws/bolts on the underside of the stacks. Check belts for proper tensioning. Check for binding in movement in all five axes. Check lubrication of vertical lead screw, and clean/lubricate as necessary, being careful not to use too much lubricant. Check calibrations by performing a batch test run and recalibrate positions if necessary. Completion Update customer contact information. Review the Planned Maintenance with the customer, and obtain customer signature. Comments, 6 QuantStudio 6 Flex andquantstudio 7 Flex Real-Time PCR Systems Planned Maintenance Protocol

7 Approval FSE Name: FSE Signature: Carsten Nielsen Nielsen, Carsten Digitally signed by Nielsen, Carsten DN: dc=net, dc=invitrogen, dc=ads, ou=regions, ou=people, ou=employees, ou=emea, cn=nielsen, Carsten Date: :56:18 +02'00' Date: May Customer Name: Customer Signature: Date: May The information in this guide is subject to change without notice. DISCLAIMER LIFE TECHNOLOGIES CORPORATION AND/OR ITS AFFILIATE(S) DISCLAIM ALL WARRANTIES WITH RESPECT TO THIS DOCUMENT, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO THOSE OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. TO THE EXTENT ALLOWED BY LAW, IN NO EVENT SHALL LIFE TECHNOLOGIES AND/OR ITS AFFILIATE(S) BE LIABLE, WHETHER IN CONTRACT, TORT, WARRANTY, OR UNDER ANY STATUTE OR ON ANY OTHER BASIS FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING BUT NOT LIMITED TO THE USE THEREOF Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Twister is a trademark of Caliper Life Sciences, Inc. For support visit lifetechnologies.com/support or techsupport@lifetech.com lifetechnologies.com 11 August 2014

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