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MVE Fusion Series Technical Manual

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MVE Biological Solutions
MVE Fusion
Technical Manual
REF 20994124 Rev G
08/2024
®
Series
Technical Manual

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  • Page 1 MVE Biological Solutions Technical Manual ® MVE Fusion Series Technical Manual REF 20994124 Rev G 08/2024...
  • Page 2 Fusion® and QDRIVE® are trademarks or registered trademarks of MVE Biological Solutions US, LLC. Record the Model and Serial Numbers of all MVE Biological Solutions equipment and date of manufacture. Retain for future reference. Model No. ____________________________ Serial No. ___________________ Date: _________ Model No.

  • Page 3: Table Of Contents

    MVE Biological Solutions Technical Manual Table of Contents Introduction ................................. 7 Indications for use ........................... 7 Contraindications ............................ 7 Symbols Definitions ..........................8 Graphical User Interface icons ......................9 Warnings ...............................9 Precautions ..............................10 Liquid Nitrogen ............................12 1.7.1 Liquid Nitrogen Properties ..................... 12 1.7.2...
  • Page 4 Relief Valve(s) Replacement ......................71 8.19 Control Board Replacement ......................71 8.20 VFD Board Replacement ........................71 8.21 LCD Android Replacement ......................71 8.22 Cryogen Level (MVE Factory Only) ..................... 71 8.23 Firmware Updates (MVE Factory Only) ................... 71 20994124 Rev G • 4...
  • Page 5 MVE Biological Solutions Technical Manual Fusion® Parts List ............................72 10. Technical Specifications ..........................72 10.1 Product Specifications ........................72 10.2 Product Environmental Requirements .................. 74 10.3 Electromagnetic Requirements ....................75 10.4 Essential Performance and Disturbances ................75 Taking Fusion® Out of Service ......................76 12.
  • Page 6 MVE Biological Solutions Technical Manual Intended Use & Indication for Use for Cryogenic Storage LIFE SCIENCE INTENDED USE STATEMENT STORAGE ONLY MVE F REEZERS ARE INTENDED FOR THE INDICATION OF PRESERVING HUMAN BIOLOGICAL PRODUCTS SAMPLES OR SPECIMENS BLOOD BLOOD PRODUCTS...

  • Page 7: Introduction

    Indications for use For Storage Only: MVE Freezers are intended for the indication of preserving human biological products, samples, and/or specimens (e.g., blood, blood products, cells, tissues, etc.) at cryogenic and ultracold temperatures during storage.

  • Page 8: Symbols Definitions

    MVE Biological Solutions Technical Manual Symbols Definitions CAUTION – Signifies potentially hazardous situation that may result in minor to moderate injury or property damage WARNING – Signifies potentially hazardous situation that may result in serious injury or property damage Warning; Asphyxiating Warning;...

  • Page 9: Graphical User Interface Icons

    To avoid injury or equipment damage, read and follow all introduction, product overview, installation and startup, and operation sections before installing and operating MVE Freezers. To avoid risk of electrical shock, this equipment must only be connected to a properly grounded power source or outlet.

  • Page 10: Precautions

    Cryogenic Dewars must be kept in a well- ventilated area protected from weather and away from heat sources. NOTE: Failure to follow MVE’s best operating practices, as set forth in the technical and quick reference user manuals, can result in loss of contents.
  • Page 11 After the first fill of liquid nitrogen, it can take approximately 36 to 48 hours to cool down the freezer. If the isolation valves are not reopened after filling of the MVE Fusion® freezer is complete, the measured "Cryogen Level," "Differential Pressure," and "Gas Pressure"...

  • Page 12: Liquid Nitrogen

    MVE Distributor or Service Technician. The liquid nitrogen level of the Fusions pressure vessel can only be verified via the GUI. The liquid nitrogen level in the MVE Fusion® freezer cannot be manually verified with a dipstick measurement.

  • Page 13: Liquid Nitrogen Safety

    Dewars be stored and operated in well-ventilated areas. Transferring LN and operating the MVE Fusion® freezer should be done in accordance with the manufacturer/supplier instructions. It is important that all safety precautions recommended by MVE be followed.

  • Page 14: Recommended Protective Clothing

    Additional technical information is available in the Preventative Maintenance Schedule and Maintenance Sections 5 & 8 respectively. NOTE: Appendix IX, Rule 2 of the Medical Device Directive 93/42/EEC classifies all MVE models as a class IIa medical devices in European Union countries. •...

  • Page 15: Equipment Environments

    MVE Biological Solutions Technical Manual Equipment Environments MVE Fusion® Freezers are suitable for use in the below or similar settings. • Hospitals and Clinics except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.

  • Page 16: Product Overview

    Understanding and familiarizing yourself with the MVE Fusion® freezer and its graphical user interface (GUI) is recommended for the user. The MVE Fusion® freezer uses an Android tablet with a custom-built Fusion® application to monitor the freezer’s operation. The MVE Fusion® system consists of several key components identified below: Dewar, Pressure Vessel, Cowling, Liquefier, Graphical User Interface (GUI), USB Port, and Freezer access lid.

  • Page 17: Liquefier (Qdrive® Cryocooler)

    The liquefier contains a QDRIVE® cryocooler and the other support/interface control systems required to operate the MVE Fusion® series freezers. Replacement of liquefier should only be performed by an authorized MVE distributor or a representative from MVE Biological Solutions. The liquefier consists of the following major components and features:...
  • Page 18 NOTE: At this time, MVE Biological Solutions does not provide remote monitoring systems or programmable logic controller (PLC) on the Fusion® freezer. 20994124 Rev G • 18...

  • Page 19: Qdrive® Cryocooler

    Technical Manual QDRIVE® Cryocooler The cryogenic cooler is the refrigeration device for the MVE Fusion® series. It is mounted on top of the MVE Fusion® Dewar. It provides cryogenic cooling by mechanically compressing and acoustically expanding the helium gas in a thermodynamic Stirling cycle.

  • Page 20: Fusion® Dewar

    The difference is that an internal cryogen storage pressure vessel is added along with a QDRIVE® cryocooler to maintain the cryogen in a liquid state. The MVE Dewar consists of the following major components and features: •...
  • Page 21 • Folding ste (model MVE Fusion® 1526 only) – Offer safe, easy access to the freezer storage area. • Access Lid with Cork – Light, easily removable lid with magnetic strip which interacts with a switch on the liquefier to indicate when the lid has been removed or improperly placed.

  • Page 22: Pressure Vessel And Sample Storage Area

    The initial fill of the cryogen tank is performed when the Fusion® freezer is first delivered and set up by an authorized MVE Distributor or MVE personnel.
  • Page 23 Figure 9: Fusion® Freezer lid and cork (gaskets visible on right) • Step assembly – The MVE Fusion® 1526 comes standard with folding steps that provide easy access to the sample storage tank. When not in use the stairs can be folded up against the Fusion®...

  • Page 24: Temperature Sensor

    The MVE Fusion® Freezer is equipped with a Resistance Temperature Detector (RTD) that connects to rear of the Liquefier shroud. The RTD probe is supplied by MVE and is factory installed and calibrated. Silicone is added to prevent moisture ingress. The...

  • Page 25: Accessories And Cables

    SLA Batteries Service ports For advance troubleshooting, Fusion® has additional service ports on back panel that allows authorized MVE Distributor or Service Technicians to connect a computer to retrieve detailed real time data and error codes. Figure 14: Service Ports...

  • Page 26: Navigating Gui

    MVE Biological Solutions Technical Manual Navigating GUI The Fusion® GUI consists of a touch sensitive LCD display. It is for system monitoring only. It is not a controller. Swipe and tap the touchscreen to navigate through the GUI and interact with the menu options.
  • Page 27 MVE Biological Solutions Technical Manual Date & Time Menu Navigation Freezer Temperature alarm setpoint System Parameter Monitoring (various) Alarms screen Allows the user to view historical list of system alarms. See Alarms section 6 for specific alarm details. To clear all messages in “Alarms” screen. Tap “clear” icon in the bottom- right corner.
  • Page 28 MVE Biological Solutions Technical Manual Allows authorized MVE distributor and/or MVE personnel to calibrate the built-in resistance temperature detector (RTD) that comes with the MVE Fusion® freezer. Log screen Allows the user to export system data to external drives by connecting a storage device to the USB port.

  • Page 29: Installation And Startup

    MVE Fusion® Freezer. Always inspect the bill of lading for accuracy and external crate packaging for damage before accepting the shipment. Included with each MVE Fusion® Freezer: • Literature Packet o Fusion® Quick Reference User Manual – PN 21205647 o Warranty Statement / Certificate •...
  • Page 30 WARNING: Do not modify the MVE Fusion® freezer without authorization from the manufacturer. NOTE: Do not power on the MVE Fusion® freezer until it has been filled and all steps outlined for first fill have been completed. WARNING: The MVE Fusion® freezer’s pressure vessel must be filled with LN before mains electrical power is applied.
  • Page 31 MVE Biological Solutions Technical Manual Figure 15: View inside Fusion 1526 Sample storage area with inventory systems Figure 16: Inventory system layout (a) Fusion® 1526, qty 20, 13-2 Large Racks, qty 16, 13-2 Mini Racks Connect the candy cane end of the transfer hose to the LN supply tank.
  • Page 32 (right) NOTE : The purpose of closing the isolation valves is to isolate Fusion® electronics from potential exposure to liquid during the LN fill and top off processes. MVE 20994124 Rev G • 32...
  • Page 33 MVE Biological Solutions Technical Manual ships the Fusion® freezer with both isolation valves closed after adding a small amount of nitrogen gas, less than 7 psi (< 0.5 bar). WARNING: If the isolation valves are open during the fill, there is potential for the electronics inside Liquefier be exposed to liquid.
  • Page 34 MVE Biological Solutions Technical Manual Figure 19: Vent port, dual Pressure relief valves, LN fill valve While the Fusion® freezer’s cryogen pressure vessel is being filled, use a second liquid nitrogen cylinder with a second LN transfer hose and phase separator (not supplied), to precool inventory system (racks and boxes) within the sample storage area.
  • Page 35 250 V, 10A Japan (with transformer kit) 100 V, 15A Connect Fusion® power cord to MVE Fusion® freezer input power receptacle at the rear. Figure 20: Power cord connected to Fusion input power receptacle Switch On System Main Power, then the battery backup (“BB Enable/Disable”) power switches.

  • Page 36: Fill Procedure

    MVE Biological Solutions Technical Manual • The Fusion® freezer’s pressure relief valves will begin to release gaseous nitrogen as the liquid boils off and the pressure may build (above 50 PSIG) inside of the storage tank. After the internal chamber and storage racks cooldown to -150°C or less, the “relief”...
  • Page 37 MVE Biological Solutions Technical Manual Open the LN fill port by turning it counterclockwise. Both LN fill and vent ports should remain open until the cryogen storage vessel is filled with LN (approximately 35 to 45 minutes). Figure 24: Vent port, dual Pressure relief valves, LN fill valve NOTE: Once the Fusion’s cryogen storage vessel has been filled, the pressure relief...
  • Page 38 250 V, 10A Japan (with transformer kit) 100 V, 15A Connect Fusion® power cord to MVE Fusion® freezer input power receptacle at the rear. Figure 26: Power cord connected to Fusion input power receptacle Switch On System Main Power, then the battery backup (“BB Enable/Disable”) power switches.
  • Page 39 MVE Biological Solutions Technical Manual (1.5 to 2bar), the touchscreen Cryogen level should be accurate. If the pressure is too high or too low touchscreen Cryogen level will be incorrect. • Wait approximately 24 hours to refill/top off pressurized cryogen storage vessel.

  • Page 40: Operation

    Technical Manual 4. Operation Routine Operation Under normal operation, MVE’s Fusion® freezer operates without any user intervention. The user can simply load (pre-cooled to -150°C recommended) racks and samples or remove samples from the sample storage area as desired. Nonetheless, there are a few recommendations that will result in optimum operation.

  • Page 41: Temperature Alarm Setpoint Change Procedure

    MVE Biological Solutions Technical Manual Temperature Alarm Setpoint Change procedure The “Freezer Temp” displayed is the air temperature measured at or near the top of sample storage area. To change the Fusion freezer’s temperature alarm setpoint: Tap “Freezer temp” on the “Levels” screen.
  • Page 42 MVE Biological Solutions Technical Manual From the bottom edge of the screen swipe up to reveal the Android application bar. 2. Tap the Android home icon (circle) on the center of the application bar. 3. Tap Settings icon. 4. Scroll up or down menu to “Date & time”.

  • Page 43: Log Data Transfer

    MVE Biological Solutions Technical Manual 8. Tap the MVE Fusion® icon to return to the Fusion® monitoring system. Log Data Transfer Insert a USB memory drive into the Fusion’s USB port below the LCD touchscreen. 2. On the GUI, the confirmation message shown below should appear.
  • Page 44 MVE Biological Solutions Technical Manual 5. Tap the password field. 6. Enter the password - Fusion01 7. Tap the check mark “ ” icon on keyboard. 8. Tap “AUTHENTICATE”. 9. A “Success! File saved to disk” message will display indicating that the data has been transferred.

  • Page 45: Settings

    MVE Biological Solutions Technical Manual Table 4: Sample Log File Reject Left Motor Right Motor Freezer Level Differential Tip Temperature Date Gas Pressure Temperature Temperature Temperature Alarms Temp (°C) Pressure (psi) (°C) (°C) (°C) (°C) 9/19/2022 7:00 -164.1 0.72 -188.2 22.62...

  • Page 46: Password Reset

    MVE Biological Solutions Technical Manual 6. A message indicating that the password change was successfully will appear. An error message will display if the password was not changed. 4.5.3 Password reset Tap “Reset Password”. 2. A message will appear “Are you sure?”.
  • Page 47 MVE Biological Solutions Technical Manual MVE supplies one transfer hose with a pressure relief valve attached to a “candy cane”. Connect the “candy cane” end of that hose to the LN supply tank, with the “candy cane” oriented in the vertical position so the pressure relief valve vents LN2 downwards.

  • Page 48: Preventative Maintenance Schedule

    Any services and/or repairs done by any unauthorized personnel may result in reduced performance of the Fusion® freezer and is not recommended. NOTE: This is the MVE recommended preventative maintenance schedule. MVE Distributors may have a more comprehensive maintenance/service plan.

  • Page 49: Alarms (Notifications)

    Contact authorized MVE Distributor or MVE Technical Service for any sustained alarms. Alarms MVE’s Fusion® freezer notifies the user when the system is operating outside of any predefined parameters. Alarm notifications contain a message that includes the alarm type, date and time. If enabled, the alarm buzzer will sound.

  • Page 50: Alarms And Descriptions

    VFD OVER TEMPERATURE Fusion® electronics temperature is above the allowable s e t p o i n t . ELECTRONICS FAULT Issue with the Fusion’s electronics. CAUTION: If any alarms are sustained, please contact your authorized MVE Distributor or MVE Technical Service. Global Alarm Dry Contacts The MVE Fusion®...

  • Page 51: Troubleshooting

    MVE Biological Solutions Technical Manual Figure 30: Global contacts (Dry contacts) 7. Troubleshooting CAUTION: This information is included primarily for reference. MVE recommends any advance troubleshooting be performed by an authorized MVE distributor or representative. Contact MVE Technical service with any questions.
  • Page 52 MVE Biological Solutions Technical Manual ALARM/SYMPTOM POSSIBLE CAUSES ACTION /TROUBLESHOOTING TIPS Verify QDRIVE® cryocooler operation. Tap “Dismiss” alarm and verify if the alarm continues. If the alarm clears, the alarm condition has been resolved. Measure the temperature probe's resistance value. It should be approximately 1080 Ohms at 23°C and...
  • Page 53 Alarm / Out of range is warmer than -170°C. Check/Verify the A/C power source, 100- 230 V, 50-60Hz. MVE recommends the use of a dedicated 15-amp circuit breaker outlet for operating one Fusion®. MVE recommends the use of a dedicated 15-amp circuit breaker outlet for operating one Fusion®.
  • Page 54 MVE Biological Solutions Technical Manual ALARM/SYMPTOM POSSIBLE CAUSES ACTION /TROUBLESHOOTING TIPS Verify QDRIVE® cryocooler is operating. Verify and check the QDRIVE® cryocooler fuse. Thermocouple issue. Power the Fusion® off/on and verify thermocouple performance. Tap “Dismiss” alarm and verify if the alarm continues.
  • Page 55 MVE Biological Solutions Technical Manual ALARM/SYMPTOM POSSIBLE CAUSES ACTION /TROUBLESHOOTING TIPS Verify the environmental humidity conditions are within operating specifications. Visually verify the thermocouple(s) are attached to the motors through the back opening. Thermocouple issues Verify the thermocouples are properly seated in their respective screw in terminal.
  • Page 56 MVE Biological Solutions Technical Manual ALARM/SYMPTOM POSSIBLE CAUSES ACTION /TROUBLESHOOTING TIPS Fusion® was first filled or recently refilled/topped off. Allow to stabilize. Verify the QDRIVE® cryocooler is operating. Verify the A/C line voltage meets power specifications. Tap “Dismiss” alarm and verify if the alarm continues.
  • Page 57 15 LCD may be in seconds, then power back on by turning daydream mode on the mains power switch then the backup battery switch. Contact MVE LCD touchscreen is technical service. black Restart Fusion® by turning off both...

  • Page 58: Maintenance Instruction

    LCD may be in sleep Check/Verify the A/C source, 100-230 V, 50- mode. 60Hz. 8. Maintenance Instruction WARNING: Do not modify this equipment without the authorization of MVE. Figure 31: Front Panel Figure 32: Back Panel Connections Fusion® 1526 20994124 Rev G • 58...

  • Page 59: Cowl And Liquefier Shroud Removal

    MVE Biological Solutions Technical Manual Figure 33: Fusion 1526 Internal Components Cowling and liquefier shroud removal Several maintenance operations require removal of the Fusion’s black cowling and liquefier shroud to access its components. Required tools: • 5/32 in (4 mm) Allen wrench Turn off the battery backup “BB”...

  • Page 60: Safety Relief Valves And Global Valves Inspection

    MVE Biological Solutions Technical Manual Carefully remove the cowling. The removed foam padding should be kept as it can be reused. Use the 5/32 in Allen wrench to remove the 28 screws on the metal liquefier shroud. Carefully lift the liquefier shroud and unplug the communication and power connectors to disconnect the liquefier shroud from the control board.

  • Page 61: Lid, Lid Thaw, Gasket, And Freezer Neck Gasket O-Ring Inspection

    MVE Biological Solutions Technical Manual CAUTION: Ensure that the pressure vessel has vented to atmospheric pressure before removing the relief valve(s). Note, it may be necessary to refill/top off the pressurized cryogen storage vessel. Required tools: • Soap solution (snoop) •...

  • Page 62: Fusion® Lid Gasket Replacement

    SAFETY NOTE: Unplug the Fusion’s power cord from the power source or wall outlet and carefully open the liquefier shroud to access its internal components. WARNING: Only authorized MVE Distributor or Service Technician should carry out this activity. Required tools: •...

  • Page 63: Temperature Probe Replacement

    NOTE: Depending on the Fusion’s environmental operating conditions, the fans and cabinet cleaning may need to be performed more frequently to ensure optimal performance of the MVE Fusion® freezer. Temperature probe (RTD) replacement Disconnect the temperature probe from the liquefier housing.

  • Page 64: Temperature Calibration

    Repeat calibration steps as necessary. CAUTION: MVE recommends the RTD calibration be performed by an authorized MVE distributor, end user trained by the distributor and/or MVE personnel. The RTD probe must be removed from freezer to be calibrated. Required equipment: •...
  • Page 65 MVE Biological Solutions Technical Manual Tap password field. Keyboard will appear. Enter password “Fusion01”. Tap “ ” icon. Keyboard will disappear. Tap “Authenticate”. Tap “Start” calibration icon. Optional: Calibration may be cancelled by tapping the “End Calibration” icon. If cancelled, a message will be displayed indicating no calibration was performed.

  • Page 66: Muffler Replacement

    MVE Biological Solutions Technical Manual Remove temperature sensor from Fusion® and place into a cup of ice water. Sensor temperature on the GUI should begin approach 0°C. Allow the value to stabilize to approximately 0°C before proceeding to the next step.

  • Page 67: Battery Replacement

    MVE Biological Solutions Technical Manual In the event of a power loss, the backup battery will provide power to the LCD touchscreen display for a minimum of 24 hours. The GUI will start to lose functionality when the Battery Backup is not capable of providing the required DC voltage.

  • Page 68: Fan Replacement

    MVE Biological Solutions Technical Manual 8.12 Fan Replacement SAFETY NOTE: Do not pull on or damage the wire harnesses inside Liquefier. Both fans should be replaced at the same time. Switch off the battery backup switch followed by the system power switch.

  • Page 69: Fuse Replacement

    Do not pull on or damage the wire harnesses inside Liquefier. Isolation valve tube replacement • MVE will supply three tubes; each will be preassembled with stainless steel Swagelok ferrules and nuts. Figure 36: Clear Vinyl Tube Hose Replacements •...
  • Page 70 MVE Biological Solutions Technical Manual Remove and replace one clear tube at a time. Run new tube through the same cutout holes underneath the metal shroud into the cryocooler assembly. The tubes will be longer than needed. Compare the length to the old tube and trim as needed.

  • Page 71: Relief Valve(S) Replacement

    MVE Biological Solutions Technical Manual Reinstall the liquefier shroud and cowling. Connect the power supply to power source or outlet. Switch on system power switch followed by the battery backup power switch. 8.14 Relief Valve(s) Replacement CAUTION: Ensure that the LN...

  • Page 72: Fusion® Parts List

    Unit should be placed with 12 inches (305 mm) clearance on all sides. System Power: Class I, 9 A, 100-230 V, 50-60Hz Consumption: ~950 W (Maximum) NOTE: MVE recommends use of dedicated 15-amp circuit breaker outlet for operating one Fusion. Note generator power may be inconsistent as Electrical Power Fusion’s electronics can experience voltage fluctuations so avoid wall...
  • Page 73 NOTE: Appendix IX, Rule 2 of the Medical Device Directive 93/42/EEC classifies MVE’s Fusion® freezer as a class IIa medical device in European Union countries. All MVE Fusion® freezers have a Class I protection class per IEC 61140, as the AC electrical supply requires a protective earth ground. These devices are externally powered and intended for continuous operation.

  • Page 74: Product Environmental Requirements

    Non-Condensing Ambient Temperature and Relative Humidity MVE cryogenic freezers and controllers are designed to be operated in environments near room temperature 18°C – 27°C (65°F – 80°F) and a relative humidity below 50%. The relative humidity should be maintained low enough so that condensation does not form on the electronics.

  • Page 75: Electromagnetic Requirements

    WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MVE Fusion® Freezer, including cables specified by the manufacturer. 20994124 Rev G • 75...

  • Page 76: Taking Fusion® Out Of Service

    MVE Biological Solutions Technical Manual Otherwise, degradation of the performance of this equipment could result. If any persisting alarms occur, please contact your authorized MVE Distributor or Customer / Technical Service. 11. Taking Fusion® Out of Service SAFETY NOTE: The LN fill and vent valves on empty pressure vessel should always be kept closed to protect the Fusion®...
  • Page 77 MVE Biological Solutions Technical Manual Continue with the following steps for long term storage. Leave the freezer lid off. Raise the turn tray bottom access panel. Place a fan on neck of the Fusion® to blow ambient air into the sample storage area for at least 24 hours.

  • Page 78: End Of Life Disposal

    MVE Biological Solutions Technical Manual 12. End of Life Disposal The Fusion® freezer should be returned to MVE at the end of its useful life for proper disposal. Please contact an MVE Customer or Technical Service Representative to discuss the arrangements.
  • Page 79 Ball Ground, GA 30107 USA. +49-6442-962073 www.mvebio.com MVE Biological Solutions US, LLC reserves the right to discontinue its products, or change the prices, materials, equipment, quality, descriptions, specifications and/or processes to its products at any time without prior notice and with no further obligation or consequence.

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