FrontlineODP System Quick Guide

FrontlineODP System

TM

Quick Guide

veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

Quick Guide 1.

Frontline Dryer Daily Maintenance

3

2.

Frontline Sealer Daily Maintenance

4-5

3.

Step 1: Pretreatment

6

4.

Step 2: Spray Drying

7-8

5.

Step 3: Seal-and-Separate

9-10

6.

Step 4: Storage

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veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

Frontline Dryer Daily Maintenance 1.

Open the enclosure door of the Dryer.

2.

Spray a 70% isopropyl alcohol solution or a 10% bleach solution onto a lint-free wipe.

3.

With the wipe, clean the Dryer interior and exterior. Ensure cleaning of the following areas:

4.

Inspect the entirety of the gasket. Ensure the gasket is undamaged and seated properly within the groove.

Peristaltic pump and surrounding area

Drying nozzle *DON’T ATTEMPT WHILE HOT*

Dislodged locations

PDC air exhaust port Enclosure inlet and exhaust air ports

Enclosure door handle

Damaged location

*Note: An improperly seated or damaged gasket can cause enclosure leaks and/or enclosure pressurizing issues. These will prevent the integrity checks from completing and the spray-drying run from beginning.

UI and surrounding area

ww

veli.co FrontlineODPTM System Quick Guide

Enclosure door key

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Frontline Sealer Daily Maintenance 1.

Spray a 70% isopropyl alcohol solution or a 10% bleach solution onto a lint-free wipe.

3.

Press the CLEAN button on the STANDBY UI screen. This will unlock and open the door.

2.

With the wipe, clean the Sealer exterior.

Ensure cleaning of the following areas:

4.

With the wipe, clean the Sealer interior.

Ensure cleaning of the following areas:

Shuttle and shuttle handles

Air extraction gasket

Inspection light

Finger safety buttons

Tensioning assemblies

Exhaust port fixture

Sealing Jaws

Separating Jaws Top cover Inside face of sealing jaws (heater band cover tape) and separating jaws (separate wire cover tape). *Note: Will need to slide out seal and separate module to access jaws.

veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

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Frontline Sealer Daily Maintenance 5.

Visually inspect the heater band and separate wire cover tape for any burn marks, scratches, tears, and or deep-set creases.

If there is any damage, contact Velico Medical (support@veli.co) to schedule maintenance.

veli.co FrontlineODPTM System Quick Guide

6.

When cleaning is complete, slide the sealand-separate modules back into place behind the frame and are returned to the vertical position. Drawers are locked into the correct position when tugging on the drawer yields no movement.

7.

Close the door firmly to properly engage the door lock. Errors can occur if the door is not fully closed or if the door lock has not been fully engaged. The UI provides warnings of shuttle motion and prompts operator to hold safety buttons.

AW-03744-2 Rev 11.0 Revised February 2026

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Step 1: Pretreatment 1.

Inspect the PPC for damage.

2.

Ensure plasma has a sterile connection compatible pigtail length, a minimum of 6 inches (15 cm) is recommended.

3.

Apply a hemostat or clamp to the PPC tubing.

4.

Connect the PPC to the plasma unit by SCD. Do not exceed 20 in (51 cm) of tubing length between them post-SCD.

6.

7.

Seal and separate the plasma unit from the PPC when the target volume is transferred.

Inspect the PDC lid/tray and the PDC for damage. Clamp the white clamp on the PDC plasma line.

8.

Connect the PDC to the PPC unit by SCD.

9.

Confirm tubing length from end of opaque section of PDC plasma line to PPC is approximately 10-16 in (25-41 cm). *Note: Measurement is from end of opaque section closest to PDC plenum to point of PPC connection.

White clamp on plasma line

5.

Transfer a target volume of 275 mL of plasma (range of 265-285 mL) into the PPC using a Fresenius Kabi CompoGuard blood collection monitor or manually using a scale.

veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

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Step 2: Spray Drying 1.

2.

WARNING: If the Clean Dry Air (CDA) system dewpoint is warmer than -40°C, do not conduct drying operations. If it is not capable of maintaining the dewpoint at or below -40°C, notify Velico Medical and the CDA system manufacturer for guidance and service.

5.

Connect exhaust of the PDC to the exhaust port of the Dryer. Ensure the connection is fully seated.

6.

Tuck PDC spike ports into the enclosure recess. Ensure the PDC is curved inward into the enclosure cavity. Tuck the corners and edges of the PDC fully into the enclosure cavity.

Verify user interface (UI) shows READY. If not, then tap WAKE button. Do not proceed to Step 3 until the Dryer completes self-checks and the UI shows READY.

8.

Open the peristaltic pump latch and feed the opaque section of the PDC plasma line through the peristaltic pump and up through the retention slot.

9.

Close pump latch once tubing is routed.

VS. Recess for PDC spike ports

3.

11.

Open Dryer enclosure door and hang pretreated plasma unit on the plasma scale.

Exhaust port connection

7.

4.

10. Ensure the PDC is not pinched and close the Dryer door.

Insert manual door lock key (lower left side of the dryer).

Feed PDC aerosol tubing through the retention slot and attach the aerosol filter to the aerosol line connection. Ensure the connection is flush and secure.

Place PDC purple plenum into the enclosure.

The plenum fits in one way.

Aerosol filter connection

Final Setup Door Open and Closing

12. Follow prompt on user interface, “Unclamp Plasma Line”. Pinch open the SCD connection, open the white clamp of the plasma line, and then press CONFIRM.

PDC plenum

veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

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Step 2: Spray Drying 13. When the spray drying is complete, remove the PPC from the Dryer scale hook if it was not sealed and separated.

NOTE: Velico recommends not to wait more than 15 minutes between the end of the drying run and the start of seal-and-separation process. The PDC stiffens when it cools down, making it more difficult to load the PDC into the Frontline Sealer. Keeping the Enclosure closed after spray drying will help keep the PDC warm.

14. Carry the PDC and PPC to the tube sealer.

15. Using a tube sealer, seal and separate the PDC from the PPC as close to the PDC cap as possible.

16. Discard the PPC in accordance with facility biohazard policy.

Common Error Codes Error Code Fault Display Cause 5105

No Plasma Flow

PDC clamp or hemostat clamp engaged on plasma line tubing.

Kink/obstruction in plasma line.

4701

Aerosol Line Disconnected

Aerosol line disconnected or improperly connected.

4200

Mass Disturbance Detected

PPC disturbed on plasma scale.

4700

Aerosol Pressure too High

Aerosol line pinched or clamped.

4604

Door Not Sealed

Exhaust port not seated or Dryer gasket misalignment.

4605

Door Not Sealed

Dryer gasket misalignment/possible damage.

veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

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Step 3: Seal-and-Separate 1.

Press Wake on the Frontline Sealer.

Complete homing if required.

2.

Load the purple plenum of the PDC onto the shuttle in the down position.

3.

Press CONFIRM and wait for the shuttle to rise.

4.

2.

6.

9.

Press CONFIRM and hold finger safety buttons.

10. Inspect Seal #2. See Step 7 for details.

7.

Inspect seal #1. If acceptable press ACCEPT. If there is an incomplete seal and/or ODP powder is visible on the outside of the seal, contact Velico before continuing. If there is a question about the seal, contact Velico.

(See reverse side for examples).

11.

Attach the exhaust port (1) and 2 lower grommets (2).

Remove the final ODP unit.

12. Dispose of lower portion and rotate the shuttle.

1.

8.

5.

Press CONFIRM and hold finger safety buttons.

Dispose of upper section and rotate the shuttle.

Attach the 8 upper grommets.

13. Press CONFIRM after rotation and hold the finger safety buttons to lower the shuttle back to Load PDC position.

veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

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Step 3: Seal-and-Separate Acceptable Welds = Press ACCEPT Typical welds in ODP Unit

Unacceptable Welds (Operator Error) = Press REJECT

Unacceptable Welds (Sealer Failure) = Press REJECT

Loading the PDC into the Sealer without attaching the 2 grommets and 8 small pins will result in the seals in the incorrect location.

Burned (black or green) seals, incomplete seals, or exposed plasma are not typical. Contact Velico Medical (support@veli.co) to schedule maintenance.

Example of burned discolored seal:

Complete seals have a roughly uniform width along their length, do not show signs of incomplete melting where the seal is formed, do not intersect with any labels, and do not have any exposed plasma showing.

Partially cut welds are acceptable if the seal is complete and they can be separated by running a finger through the weld.

Common Error Codes Error Code

Fault Display

Cause

7011

Workflow Shuttle Not Rotated

The shuttle is not in the correct orientation. The operator forgot to rotate the shuttle.

7012

Workflow Shuttle Not Extended

The shuttle is not in the correct orientation. The operator forgot to extend the shuttle.

7013

Workflow Vacuum Target Timeout

Exhaust port seated incorrectly. Obstruction/debris on air extraction nozzle.

veli.co FrontlineODPTM System Quick Guide

AW-03744-2 Rev 11.0 Revised February 2026

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Step 4: Storage 1.

Weigh and record weight on the ODP unit.

4.

a. Weight ≥ 48g

Place the desiccant between the ODP unit and the foil side of the overwrap pouch so the ODP unit label is not blocked from view.

8.

Acceptable Seal Criteria: - No gaps, or unsealed areas through the width of the seal - No discoloration - Note: Wrinkles allowed

b. If weight < 48g, discard 2.

Inspect the seal. Pull gently to confirm the weld does not open.

Place the ODP unit into the overwrap pouch making sure that the label on the ODP unit is visible through the clear side of the pouch and the spike ports are facing up.

Unacceptable Seal Criteria: - A seal with gaps or unsealed area running through the weld - A seal that can be pulled open with gentle force NOTE: It the seal is unacceptable, open the pouch, retrieve the ODP unit and start at step 2 again.

5.

3.

a. The sealing band is between the edge of the pouch and the first tear notch.

Open the desiccant pack and check the moisture indicator. a. If it is blue: pull one desiccant and immediately close the outer desiccant package to maintain shelf life. b. If pink, discard the bag of desiccants and get a new one.

Place the overwrap pouch across the sealing band of the heat sealer ensuring that:

b. The pouch is not wrinkled.

6.

Verify impulse settings: Heat dial = 6 Cool dial = 1

7.

Close the welding arm. Wait for welding arm to pop up.

9.

veli.co FrontlineODPTM System Quick Guide

Store the sealed package at refrigeration (1-6°C) up to 24 months or at 1-24°C up to 6 months.

AW-03744-2 Rev 11.0 Revised February 2026

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