Cepheid — Technical Presentation (August 2021)
39 slides from Cepheid's technical presentation, August 2021
Slide 1: GeneXpert Maintenance: GeneXpert Dx System
GeneXpert® Maintenance: GeneXpert Dx System US-IVD and CE-IVD. For in vitro diagnostic use. ©2017-2021 1 © CepheidCepheid All Rights Reserved. Public 301-7990 Rev C. August 2021
Slide 2: GeneXpert System Maintenance: Training Agenda
GeneXpert® System Maintenance: Training Agenda • Why & when set maintenance should be completed • Required tools • How to order replacement filters & optics cleaning kit • Daily, Weekly, Monthly, Quarterly & As Required Maintenance • Annual Xpert Check • Maintenance Log • Operator Manual • Technical
Slide 3: Overview of Maintenance Tasks
Overview of Maintenance Tasks * Maintenance procedures may be performed more frequently according to your environmental conditions. US-IVD and CE-IVD. For in vitro diagnostic use. 3 © Cepheid Public
Slide 4: Maintenance of GeneXpert System
Maintenance of GeneXpert® System • Preventative maintenance tasks: ‒ Performed on regular basis by end-users: as necessary, daily, weekly, monthly, quarterly and yearly ‒ Ensures performance of the system ‒ Helps to avoid GeneXpert system malfunctions and errors US-IVD and CE-IVD. For in vitro diagn
Slide 5: Required and NOT supplied tools/products
Required and NOT supplied tools/products • Use a final concentration of 1:10 dilution of household chlorine bleach used within 1 day of preparation (final chlorine concentration of 0.5%) • 70% ethanol solution or denatured ethanol (70% ethanol containing 5% methanol and 5% isopropanol). • Lint-free
Slide 6: Required and Ordered from Cepheid
Required and Ordered from Cepheid GeneXpert® Description and Part Number (PN) System GeneXpert® GX-IV Filter (PN 001-1537) replacement GeneXpert® High Efficiency (HE) Filter Kit (P/N GX- fan filters HE-FILTERKIT) GeneXpert® GX-XVI R1 Filter (PN 001-1271) GeneXpert® GX-II (PN 001-1271) GeneXpert® GX-
Slide 7: Daily Maintenance Tasks
Daily Maintenance Tasks US-IVD and CE-IVD. For in vitro diagnostic use. 7 © Cepheid Public
Slide 8: Daily Maintenance
Daily Maintenance 1. Clean work area (following your institution’s guidelines) 2. Remove and discard used cartridges 3. Close all module doors US-IVD and CE-IVD. For in vitro diagnostic use. 8 © Cepheid Public
Slide 9: Weekly Maintenance Tasks
Weekly Maintenance Tasks US-IVD and CE-IVD. For in vitro diagnostic use. 9 © Cepheid Public
Slide 10: 1. Reboot the system
1. Reboot the system • Reboot the GeneXpert® instrument and computer 2. Power down the GeneXpert instrument 1. Power down the GeneXpert computer …wait 2 minutes… 3. Turn on the GeneXpert instrument 4. Turn on the on GeneXpert computer US-IVD and CE-IVD. For in vitro diagnostic use. 10 © Cepheid Publ
Slide 11: Protecting your GeneXpert Instrument
Protecting your GeneXpert® Instrument Whenever the GeneXpert instrument is not in use: 1. Power down the GeneXpert instrument 2. Protect the instrument with the GeneXpert dust cover, if available. (provided with GX-IV in HBDC specific environments only) US-IVD and CE-IVD. For in vitro diagnostic use
Slide 12: Clean Fan Filters
Clean Fan Filters • There are 2 styles of fan filters on the GX-II and GX-IV: under a filter guard & under a back panel • Clean fan filters weekly if you operate in an area of high pollution, dust or smoke, otherwise quarterly is sufficient. US-IVD and CE-IVD. For in vitro diagnostic use. 12 © Cephe
Slide 13: Cleaning Fan Filters
Cleaning Fan Filters 2 Wash the filter with running 3 water and detergent 1 Clean the old filter by washing it. Place this cleaned filter Remove and replace the between two paper towels filter with a clean filter and allow it to air-dry US-IVD and CE-IVD. For in vitro diagnostic use. 13 © Cepheid Pu
Slide 14: Monthly Maintenance Tasks
Monthly Maintenance Tasks US-IVD and CE-IVD. For in vitro diagnostic use. 14 © Cepheid Public
Slide 15: Archive and purge (delete) runs
Archive and purge (delete) runs Choose Archive Test Select the runs with the button “Select New archive” 1 2 Check the appropriate boxes to purge the runs 3 Name given automatically US-IVD and CE-IVD. For in vitro diagnostic use. 15 © Cepheid Public
Slide 16: Save data on an External Device
Save data on an External Device US-IVD and CE-IVD. For in vitro diagnostic use. 16 © Cepheid Public
Slide 17: Quarterly Maintenance Tasks
Quarterly Maintenance Tasks US-IVD and CE-IVD. For in vitro diagnostic use. 17 © Cepheid Public
Slide 18: Quarterly Maintenance
Quarterly Maintenance 1. Clean instrument surfaces 4. Replace fan filters 2. Clean cartridge bays 3. Clean plunger rods US-IVD and CE-IVD. For in vitro diagnostic use. 18 © Cepheid Public
Slide 19: 1. Cleaning the instrument surface
1. Cleaning the instrument surface 1. Shut down the GeneXpert® system before cleaning the surfaces. 2. Moisten a lint-free wipe with 70% ethanol solution 3. Wipe all outside surfaces of the instrument 4. Wipe table surfaces around the instrument Use one lint-free wipe for the instrument and one for
Slide 20: 2. Cleaning the Cartridge Bay
2. Cleaning the Cartridge Bay 1. Moisten a lint-free wipe with a 1:10 solution of household chlorine bleach 3x 2. Wipe the inside of the cartridge bay, the inside of the door and the top lip of the door 3. Wait 2 minutes 4. Moisten a lint-free wipe with 70% ethanol solution 5. Wipe the parts describ
Slide 21: 2. Cleaning the Cartridge Bay
2. Cleaning the Cartridge Bay Wipe the inside of the cartridge bay, the inside of the door and the top lip of the door Cartridge bay interior Inside of the door Top lip of the door US-IVD and CE-IVD. For in vitro diagnostic use. 21 © Cepheid Public
Slide 22: 3. Cleaning the Plunger Rods
3. Cleaning the Plunger Rods 1. Moisten a lint-free wipe with a 1:10 solution of household chlorine bleach 3x 2. After the plunger rods are lowered, gently wipe the plunger rods 3. Wait 2 minutes (never longer than 5 minutes) 4. Moisten a lint-free wipe with 70% ethanol solution 5. Wipe the plunger
Slide 23: 3. Cleaning the Plunger Rods
3. Cleaning the Plunger Rods 2 1 In the Maintenance menu select 2 Maintenance then Plunger Maintenance In the Plunger Maintenance window 3 select Clean All Follow the instructions in the dialog 4 window and click OK US-IVD and CE-IVD. For in vitro diagnostic use. 23 © Cepheid Public
Slide 24: 3. Cleaning the Plunger Rods
3. Cleaning the Plunger Rods The plunger rods will be lowered in 5 the selected modules. Wipe gently to remove any dust off the plunger rod Plunger Cartridge bay interior Top lip of the door US-IVD and CE-IVD. For in vitro diagnostic use. 24 © Cepheid Public
Slide 25: 3. Cleaning the Plunger Rods
3. Cleaning the Plunger Rods After cleaning the plungers select Move Up All 6 The plungers will return to their initial position 7 Select Close US-IVD and CE-IVD. For in vitro diagnostic use. 25 © Cepheid Public
Slide 26: 4. Replacing the Fan Filters
4. Replacing the Fan Filters Under a Filter Guard Turn off the system Unclip 4 clips one by one US-IVD and CE-IVD. For in vitro diagnostic use. 26 © Cepheid Public
Slide 27: 4. Replacing the Fan Filters
4. Replacing the Fan Filters Under a Filter Guard • 4 filters on a GX-XVI R2. US-IVD and CE-IVD. For in vitro diagnostic use. 27 © Cepheid Public
Slide 28: 4. Replacing the Fan Filters
4. Replacing the Fan Filters Under a Back Panel • The instrument must be unplugged 4 screws from all electrical outlets. • Remove the 4 back panel screws using a Philips/star head screwdriver. • Pull off the panel and remove the gray foam filter. • Clean the filter with water & soap. Dry the filter
Slide 29: 4. Replacing High Efficiency (HE) Filters
4. Replacing High Efficiency (HE) Filters* • Only for specifically-configured GX-IV systems • Prefilter replacement - once every 3 months (minimum) Turn off the System Place the prefilter on Remove the prefilter Replace with a clean 3 1 2 prefilter top of the HE filter retainer retainer * - HE filte
Slide 30: As-necessary Maintenance
As-necessary Maintenance US-IVD and CE-IVD. For in vitro diagnostic use. 30 © Cepheid Public
Slide 31: As-necessary Maintenance
As-necessary Maintenance Note: If you operate in an area with a high level of dust or air pollution, please ensure to clean the optics monthly. 1. Clean I-CORE® 2. Print system log report 3. Back up database US-IVD and CE-IVD. For in vitro diagnostic use. 31 © Cepheid Public
Slide 32: Clean the I-CORE module
Clean the I-CORE® module 1. Wear laboratory gloves 2. Remove cartridges from the modules 3. Make sure that all the bristles are fully inserted (up to the shoulder of the plastic shank of the brush) 4. Brush the inside of the slot with up and down movements 5. Rotate the brush for approx. 180° and ba
Slide 33: Annual Instrument Maintenance
Annual Instrument Maintenance US-IVD and CE-IVD. For in vitro diagnostic use. 33 © Cepheid Public
Slide 34: Annual Instrument Maintenance
Annual Instrument Maintenance • Calibration is performed before a system is shipped. • Xpert® Check is performed annually by Cepheid Authorized Personnel. • Replacement modules are calibrated prior to shipment from the Cepheid Repair Center. • Contact Cepheid Technical Support for further informatio
Slide 35: Xpert Check
Xpert® Check • Measures and confirms module performance • Performed by Cepheid Authorized Personnel STEP 1 STEP 2 STEP 3 OBTAIN KIT CHECK MODULE CONFIRM PERFORMANCE FUNCTIONALITY US-IVD and CE-IVD. For in vitro diagnostic use. 35 © Cepheid Public
Slide 36: Maintenance Log
Maintenance Log US-IVD and CE-IVD. For in vitro diagnostic use. 36 © Cepheid Public
Slide 37: For more information on Maintenance of GeneXpert System
For more information on Maintenance of GeneXpert® System • GeneXpert Operator Manual: Chapter 9 http://www.cepheid.com/us/support/package-inserts/package-insert-entry-form US-IVD and CE-IVD. For in vitro diagnostic use. 37 © Cepheid Public
Slide 38: Technical Assistance
Technical Assistance • Before contacting Cepheid Technical Support, collect the following information: ‒ Product name ‒ Lot number ‒ Serial number of the System ‒ Error messages (if any) ‒ Software version and, if applicable, Computer Service Tag number • Log your complaint online using the followin
Slide 39: Public
US-IVD and CE-IVD. For in vitro diagnostic use. 39 © Cepheid Public