TriCell BMC

Intended Use

The TriCell BMC Kit is intended for used for the safe and rapid preparation of autologous Bone Marrow Concentrate (BMC) from a sample of bone marrow aspirate at the patient's point of care.

The TriCell Kit allows the healthcare professional to produce a specific Platelet Plasma Product to meet individual patient requirements.

Contraindications:

The use of the TriCell BMC Kit may be contraindicated when there is clinical or laboratory evidence of septicemia; and for patients who have taken aspirin, or other medications that alter platelet function within 3 days prior to surgery, or patients with disorders associated with platelet dysfunction.

Indications for Use:

The TriCell BMC Kit is intended for use with an appropriate swing bucket centrifuge.

General Precautions:

- Refer to Centrifuge Operator's Manual for additional information concerning centrifuge operation and maintenance
- Inspect product prior to use, do not use if package is damaged or opened;
- Always follow aseptic technique entering a sterile container.
- Aseptic technique, proper skin preparation, and continued protection of the puncture site are essential;
- Dispose of contaminated process disposable following hospital policy and procedures for biological waste;
- After processing, maintain PD upright. Tilting may disturb fluid layers, affecting process results;
- Separated blood / marrow products should be used within the same surgical procedure.
- Do not re-sterilize, disposable is for single patient use only, discard all unused components at the end of the procedure;
- Re-use may lead to infection or illness/injury/death.




TriCell Bone Marrow Concentrate (BMC) Preparation Steps

BMC
a. Prefill 60ml Syringe with 5ml anti-coagulant (ie ACD-A)
b. Aspirate 35ml marrow
BMC
a. Pass TriCell BMC Kit to Sterile Field
b. Open Filter Screw ( 1/4 Turn)
c. Remove White Access Cap.
d. Attach Luer Lock Syringe
BMC
a. Inject Marrow through Built in Filter Assembly
b. Securely Close Filter Valve
c. Remove Marrow Syringe
BMC
a. Use Sterile Gauze to Draw Excess Marrow from Port
b. Securely Replace White Cap
c. Pass TriCell BMC Kit out of Sterile Field.

BMC
a. Load TriCell BMC Kit
b. Load Opposing Counter-Weight with Equal Weight
c. Process with Program 4 (3500 RPM / 6 Minutes)
BMC
Rotate Marrow Chamber to Transfer ALL
Buffy Coat to Plasma Chamber
BMC
Turn & Tighten Lower Plasma Chamber to Lock Off Marrow Chamber
BMC
a. Invert TriCell BMC Kit
b. Gently Swirl Plasma & Cells
c. Select Final TriCell BMC Volume (1-4mls)

BMC
a. Re-Load TriCell BMC Kit
b. Load Opposing Counter-Weight with Equal Weight
c. Process with Program 5 (3300 RPM / 5 Minutes)
BMC
Turn & Tighten Plasma Chamber to Lock Off Excess Plamsa
BMC
Carefully Remove Protective Aluminum Foil Barrier to Expose Sterile Access Point
BMC
Harvest BMC with 18-21G Needle & Syringe