Troubleshooting Gene Expert Machine

Troubleshooting Cepheid HBDC Training Centre 1 Cepheid © © Cepheid D25056 – Confidential. Rev Draft Troubleshooting Approach 1. In case of an issue, a message will be displayed (often, with an error code) 2. Check if the error affects one particular module 3. Refer to the Operator Manual and look for the error code, and follow the recommended corrective actions 4. If the problem remains, contact your local service provider or Cepheid Service 2 Telephone Email address Training Center (Europe) +33.5.63.82.53.94 training@cepheidhbdc.com Technical hotline (Europe based)- Instrument errors +33.5.63.82.53.19 support@cepheideurope.com Technical hotline ( U.S.A based)Instrument errors 888-838-3222, Option 2 techsupport@cepheid.com © Cepheid – Confidential. Most common situations • GeneXpert or module(s) not detected • Failures without error codes ‒ « INVALID » result ‒ « NO RESULT » ‒ Cartridge stuck in a GeneXpert module • Failures with error codes ‒ Temperature errors: codes 1001, 1002, 2014, 4009, 4017… ‒ Probe Check failures: codes 5006 or 5007 ‒ Syringe pressure failure: code 2008 ‒ Communication loss: codes 2120, 2120, 2122, 2124 ‒ Signal loss: code 5011 4 © Cepheid – Confidential. Software Messages 5 Cepheid © © Cepheid – Confidential. – Confidential. Where to find Software messages? 6 © Cepheid – Confidential. Where to find Software messages? 7 © Cepheid – Confidential. Refer to the Operator Manual Look for the specific Error Code in the Troubleshooting Section of the latest Operator Manual 8 © Cepheid – Confidential. COMMUNICATION ISSUES GeneXpert not detected or Module not detected 9 Cepheid © © Cepheid – Confidential. – Confidential. Whole GeneXpert not detected First check external parts Then, check internal Parts Main Power Source Virus or antivirus updates Ethernet cable UPS Ethernet port Gateway Board PS Power Supply GeneXpert GX front LED 10 © Cepheid – Confidential. Module IP address Module Computer Module Network adapter Module Ethernet port GX Internal temperature out of range Whole GeneXpert not detected Troubleshooting Checklist: external parts GeneXpert 1. 2. 3. 4. 5. First switch on the GeneXpert then, the computer (restart) Is the front blue LED illuminated? If not, check the power source is functional Ethernet cable : check for visible damage + Reconnect Room temperature (15-30°C) Fan functionality and filter cleanliness UPS 1. The status of your UPS (fully charged?) Computer 1. 2. 3. 4. 11 Ethernet cable is in the right computer port (as indicated by a white label) Check for visible damage on the ethernet cable+ Reconnect Check the IP address: refer to Operator Manual (Chapter 2.4.1) Scan for computer virus/ check if antivirus is updating (disable it, if required) © Cepheid – Confidential. Whole GeneXpert not detected Troubleshooting Checklist: internal parts Only upon request of Cepheid Technical Support Specialist, you may have to check: 1. 2. 3. 4. 12 GeneXpert power supply GeneXpert gateway board… Ethernet ports (Computer & GX): swap with another GX/computer Network adaptor: wobbling, loose? © Cepheid – Confidential. Individual module(s) not detected Main Power Source 4. Specific position on the gateway UPS Module Module Module 3. Module connections Module Gateway Board GeneXpert GX front LED 13 © Cepheid – Confidential. PS 1. Module Internal temperature out of range or 2. Defective module Module(s) not detected: Troubleshooting checklist: External parts • Identify the affected module (s): Serial number and position • Check the module(s) internal temperature ‒ Click on the Maintenance icon and check « Ambient Temp » for each module. You may have to report these values when you contact Cepheid Technical Support ‒ Check fan functionality* and filter cleanliness *Place a wipe on the filter and check if it remains stuck to the back panel • Restart the system (GeneXpert and Computer) ‒ If the module is still not detected, please contact Technical Suppot for guidance 14 © Cepheid – Confidential. Module(s) not detected: Troubleshooting checklist: Internal parts Only upon request of Cepheid Technical Support Specialist, you may have to check: 1. Connection between module and gateway board 2. Gateway failure (specific position) or module failure: Swap module position UPS 1 Gateway2 2 Module Module Module Module PS GX front LED 15 © Cepheid – Confidential. Failures without error codes 17Cepheid © © Cepheid – Confidential. – Confidential. INVALID INVALID An Internal Control failed (for a negative result) SPC/CIC* or IQS* or SAC* * (assay dependent) Origin(s) • • • • PCR was inhibited due to inferring substances Inadequate sample was used Improper specimen storage/collection/preparation Improper kit storage conditions Solution(s) Use the correct specimen type Check the sample quality (density, viscosity, purity, etc.) Follow recommended instructions on sample collection, preparation and storage Check Xpert kit storage conditions and shelf life Collect a new sample when necessary and retest 18 © Cepheid – Confidential. NO RESULT NO RESULT Test could not be completed and insufficient data was collected Origin(s) • • • Power failure during test “Stop Test” function was used. Computer freeze or crash during test Solution(s) Ensure there is a consistent power supply Use “Stop Test” only when it is necessary Do not open other applications on the computer while a test is running 19 © Cepheid – Confidential. Cartridge stuck inside a GeneXpert module Causes: Module mechanical malfunction during the test Electrical failure Solutions: 1. Remove the cartridge using the software - Select the module. Click “Open Door” to open the module door. - If the door does not open, restart the system and repeat the above steps. 2. Remove the cartridge manually If the above steps did not resolve this issue, contact Cepheid in order to receive guidance 20 © Cepheid – Confidential. Error messages 21Cepheid © © Cepheid – Confidential. – Confidential. Error Messages An Error is displayed • Click on the Error tab to get error code & description Origin(s) • • Mainly linked to sample preparation Addressed in the next slides All other issues should be reported to Cepheid Technical Support Recommended action(s) It is essential that all operators understand and identify the root causes of errors that may occur in order to avoid high (rising) error rates 22 © Cepheid – Confidential. Temperature issues: codes 1001, 1002, 2014, 4009, 4010, 4017, Causes: - Ambient temperature is not within acceptable range - GeneXpert fan failure (broken or filter is dirty) - Module Heater component is malfunctioning Key Question: Does this error affect only one module? Recommended actions: - Check room temperature (must be 15 to 300C) - Check clearance around the system (must be 10-15 cm on all sides) - Check the internal temperature of the modules (in the Maintenance menu < 390C) - Check the fan functionality (exhaust at rear of the instrument) - Check the filters are clean 23 © Cepheid – Confidential. Probe check failed: codes 5006/5007 Error 5006 or 5007 Probe Check control failed and test was stopped before amplification Origin(s) • • • • • • Sample density (viscosity) Incorrect sample volume Improper fluid transfer (bubbles) Incorrect storage of cartridges (damaged reagent) Insufficient maintenance Xpert Check overdue Recommended actions • Make sure the sample is liquid before transferring to the cartridges • Add correct volume of specimen (per Package insert) • Avoid transferring bubbles • Store the cartridges as per Package Inserts instructions (temperature+humidity) • Perform regular maintenance as advised in HBDC Maintenance Presentation 24 © Cepheid – Confidential. Abnormal Pressure detected: codes 2008 Error 2008 Pressure reading exceeds the maximum Origin(s) • Cartridge filter is clogged (due to highly viscous sample or debris) • Pressure sensor failure Recommended actions - Make sure sample does not contain any solid particles - Make sure the sample is liquid before transferring to the cartridge - Use a new cartridge and add DEPC treated water (same volume as sample). Load cartridge and note final result. If this problem persists it’s likely module related: contact Cepheid 25 © Cepheid – Confidential. Module communication loss was detected: codes 212X Errors 212X Loss of communication between module(s) and software, while test is running Origin(s) • • • • Power supply issue (Mains or UPS) Faulty PC-GX Ethernet connections Faulty connections between gateway board and modules Room temperature above or below expected range Recommended actions • Check mains supply and use appropriate UPS with surge protector • Unplug and replug Ethernet cable between computer and instrument, restart the system • Check the module internal temperature in the Maintenance menu • 26 Unplug and replug the communication cables inside GX, upon Technical Support request © Cepheid – Confidential. Signal loss detected in the amplification curve: code 5011 Error 5011 Signal loss detected in the amplification curve Origin Loss of PCR tube pressure because the cartridge tube is not airtight, or cartridge valve is not working correctly Recommended actions Avoid transferring bubbles to the cartridge Use a new cartridge. If the error persists, this can be module related. Contact Cepheid Support • • 27 © Cepheid – Confidential. Training and assistance Should you need some training please contact us or your local service provider if available in your country Service Telephone Training Center (Europe) +33.5.63.82.53.94 training@cepheidhbdc.com Technical hotline (Europe based)Instrument errors +33.5.63.82.53.19 support@cepheideurope.com Technical hotline ( U.S.A based)Instrument errors 888-838-3222, Option 2 techsupport@cepheid.com For more information please visit http://www.cepheidcares.com/tb/index.php 30 Email address © Cepheid – Confidential. Technical information of your Genexpert Information of your GeneXpert Person in charge (name) Phone number Serial number of your GeneXpert (on the back panel) E-mail address Address City Country Computer Service Express Service Tag Number Installation date of the system Windows Password (Should never be changed) …… / …… / ……. cphd UPS (manufacturer, model) UPS Battery (V and AH) 31 © Cepheid – Confidential. When Contacting Cepheid, please prepare this information in advance Thank You. Visit us at www.cepheidcares.com 32 © Cepheid – Confidential.