Biomeme Franklin User Manual
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Biomeme Franklin User Manual

Real-time pcr thermocycler (eua)
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Franklin™ Real-Time PCR
Thermocycler (EUA)
For IVD Use ONLY. For Emergency Use Authorization ONLY.
This product has not been FDA cleared or approved, but has been authorized by
FDA under an EUA for use by authorized laboratories that are
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA),
42 U.S.C. §263a, that meet requirements to perform high complexity tests.
This product has been authorized only for the detection of nucleic acid from SARS-
CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated
or authorization is revoked sooner.
Last Updated: 3/16/2023

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  • Page 1: Franklin™ Real-Time Pcr Thermocycler (Eua)

    Franklin™ Real-Time PCR Thermocycler (EUA) For IVD Use ONLY. For Emergency Use Authorization ONLY. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.

  • Page 2: Table Of Contents

    Recovering & Reattaching Test Data Transferring Data Loading Pure Sample into Go-Strips Placing Go-Strips into Franklin™ Thermocycler Maintenance & Cleaning Safety Notice General Safety Warnings Declaration of Conformity Troubleshooting Disclaimer Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 3: Franklin™ Thermocycler

    Franklin™ Thermocycler The Biomeme Franklin™ transforms your smartphone into a thermocycler for real-time PCR analysis with results in under an hour. Our mobile thermocycler enables multiplex real-time detection of up to 27 targets from 1 sample or test 9 samples for up to 3 targets each. Just under 3 pounds, hand-held, and battery- operated for maximum portability enabling a full day’s work out in the field on a...

  • Page 4: Technical Specifications

    Franklin™ three9 Fluorophores ATTO647N (Red) Wireless (BLE) System Control & Data Transfer Integrated Barcode Scanner Max Samples per Run Max PCR Targets per Run Weight 1.20 kg / 2.65 pounds Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...
  • Page 5 3,048 m / 10,000 ft Wall Power (VAC) 100 - 240V Voltage Full Load Current 3.3A Internal Battery 5 hours Quantitative IP Rating IP30 Indoor/Outdoor? Indoor or Outdoor in a Covered Area Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 6: Thermocycler Button Layout

    Keep 5 cm Clearance Around the Degree of Ingress Protection Thermocycler for Proper Performance Thermocycler Button Layout There are a total of 4 buttons located on the top of your Franklin™ thermocycler: Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 7: Led Status Indicators

    LED Status Indicators Vertical LED on the front of your thermocycler. The Franklin™ thermocycler has 5 LEDs on the front of the unit. The LEDs are used to convey various states of the thermocycler as outlined in the table below.

  • Page 8: Turning Your Thermocycler On And Off

    (all test data on the unit will be lost). Lastly, when the battery button is held, the Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...
  • Page 9 If your device has not been charged in more than six months and you cannot get the thermocycler to turn back on, please contact support@biomeme.com. Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 10: Enabling & Disabling Bluetooth (Ble )

    Once enabled, tap Connect via BLE when prompted in the smartphone app. If working with multiple Franklin™ thermocyclers, select the appropriate unit and tap Confirm. The LED on the front of your thermocycler will flash white indicating it’s connected.
  • Page 11 “My run has completed, and I’ve pressed a bunch of buttons. I’m feeling flustered, confused, and frustrated; what should I do?” 1. Turn off the thermocycler and close the Biomeme Go Dx app. 2. Follow the steps described in Scenario below.
  • Page 12 Bluetooth back on. 3. Within the Biomeme Go Dx app, you should see a pop-up screen that reads: “Connect via BLE”. If so, press Scan in the Biomeme Go Dx app. If not, power OFF the thermocycler, CLOSE the app, and to Scenario below.
  • Page 13 C: Thermocycler OFF / App OPEN 1. Press the Power button on top of your Franklin™ thermocycler to turn it back on. If your thermocycler doesn’t turn back on, make sure it’s connected to a power source as your battery may have died.

  • Page 14: Transferring Data

    5. Relaunch the Biomeme Go Dx app by selecting the icon on your smartphone’s home screen. 6. From the app’s home screen, tap Incomplete Runs. 7. Select your test from the list of incomplete runs. 8. Press the Scan button in the app and select your thermocycler.

  • Page 15: Loading Pure Sample Into Go-Strips

    Go-Strip wells. Tap the bottom of the sealed Go-Strip gently but firmly against a solid surface before removing the foil seal and adding your sample. 1. Open the contents of a Biomeme SARS-CoV-2 Go-Strips pouch. Do not immediately discard the Go-Strips pouch as you’ll need to scan the QR code in a later step.
  • Page 16 Note: If utilizing a No Template Control (NTC) and/or external Positive Control (PC), add in a similar manner to other samples. It is recommended that the NTC be added first (Well 1) and the PC last (Well 9) after the addition of samples. Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 17: Placing Go-Strips Into Franklin™ Thermocycler

    3. Close the thermocycler lid securely and navigate to the Biomeme Go Dx mobile application on your smartphone to begin your testing protocol. For further instructional information, please contact support@biomeme.com.
  • Page 18 Samples & Controls Note: Transport your Franklin™ thermocycler in its carrying case. Additionally, moving your thermocycler while thermocycling could result in errors. We highly recommend not moving or opening the device while thermocycling to avoid losing your PCR run. After your run has completed, be careful when removing your Go-Strips and void filling caps to avoid liquid splatter and PCR amplicon contamination.

  • Page 19: Maintenance & Cleaning

    The outside of the Franklin™ thermocycler can be cleaned using a 70% ethanol solution which must be sprayed on a cloth rather than directly on the Franklin™ thermocycler. Lysol wipes or Micro-Chem Plus wet paper towels are acceptable as well.

  • Page 20: General Safety Warnings

    CAUTION - Heating wells may be hot. Care must be taken when inserting or removing cuvettes. Electrical Safety Warnings Unplug AC power cord from the wall outlet in case of an emergency. SYMBOL DESCRIPTION Caution, possibility of electric shock Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...
  • Page 21 Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 22: Declaration Of Conformity

    IEC 61326-1:2013 ETSI EN 301 489-1 V2.1.1 ETSI EN 301 489-17 V3.1.1 Hazardous Substances EN 50581:2012 This declaration of conformity is issued under the sole responsibility of the manufacturer. Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 23: Troubleshooting

    If your test fails, the smartphone will notify you of the error returned from the thermocycler. Your last run will be saved in the Biomeme mobile app up to the point of failure, but the data will not be processed resulting in no Cq values, baseline, or graph of smooth data.
  • Page 24 Upon stopping, your run will be saved to the current point, and available in the test results section of the mobile app. Franklin™ PCR Thermocycler User Manual (EUA) © Biomeme, Inc. 2023 Version 2.0...

  • Page 25: Disclaimer

    If your run fails to start, the app will return to the home screen and have you restart the setup of your test. Restart the thermocycler then reconnect the smartphone. If starting still fails after many retries, please contact support@biomeme.com. The USB failed to send the protocol...
  • Page 26 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Biomeme products may not be transferred to third parties, resold, modified for resale or used to manufacture commercial products or to provide a service to third parties without written approval of Biomeme, Inc.

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