Product Name: Celution 805 Consumable Set
Model: Celution 805
Product Description:
Celution 805 Consumable Set is designed to be used exclusively with the Celution 800.CRS and Celution 800/GP Device(the Celution device). The Celution 805 Consumable Set is provided in two separate sterile packages consisting of a Tubing Set and a Processing Chamber. The Tubing Set consists of some collection syringe adapters, a lipoaspirate Tissue Collection Container, a Waste Bag, and associated tubing with a spike port, Luer Locks, and connection manifolds.
Specifications：
Sterility
•The Celution 805 Consumable Set is sterilized by Ethylene Oxide.
Storage and Handling
•Use only if sterilization indicator dot is green.
•Store at controlled room temperature, 15C – 30C (59F – 86F).

SAFETY&RISK

Contraindications
Non-autologous use.
Hemodynamic instability.
Intravascular applications.
Collecting from or implanting into tissues with active infections.
Lactating mothers or pregnant women.
Patients with active tumors, chemo or radiation therapy, or any other cancer treatment.
Patients who have aPTT (Activated Partial Thromboplastin Time) values ≥ 1.8 times the normal value.
Patients who have received any anticoagulant within 1 hour prior to liposuction.
Patients with any history of ectopic bone formation disease.
Patients that are actively or recently receiving glycoprotein IIb/IIIa inhibitors.
Warnings (Single-Use Policy)
Do not attempt to re-use the Celution 805 Consumable Set. Components are for single use only and must be used immediately after removal from their sterile package.
Infection Risk: Re-use of a single-use device poses serious risks including loss of sterility, which could lead to patient infection and/or the transmission of infectious disease from one patient to another.
Device Failure Risk: Re-use and/or cleaning of a single-use device poses a serious risk to the patient, including immediate and/or premature mechanical failure due to material degradation or unknown chemical interactions with residual cleaning agents.
Do not re-sterilize this device, as it may result in significant damage or loss of integrity to the device.
Properly dispose of all used Celution 805 Consumable Sets using universal precautions for biohazardous waste.
Precautions (Handling & Storage)
Sterility: The Celution 805 Consumable Set is sterilized by Ethylene Oxide. Use only if the sterilization indicator dot is green. Discard the entire set if the packaging is damaged, opened, or the sterilization marker is invalid.
Storage: Store at controlled room temperature, 15°C – 30°C (59°F – 86°F), and keep the package dry.
Chemical Sensitivity: Plastic materials used in the set may be sensitive to certain chemicals (e.g., solvents, caustic chemicals, detergents). Exposure may cause system failure.
Operation Check: Do not restrict fluid flow through any tubing line. Kinked tubing may cause pressure build-up and leakage. Always verify correct installation.
Always maintain a sterile field at the collection site and treat all blood and fluids using universal precautions.

SYMBOL&IDENTIFICATION

Manufacturer
European Authorized Representative
Catalog Number, Reference Number
Lot Number
Use by
Sterilized using Ethylene Oxide. Sterile Fluid Path.
Do not re-use. For single use only.
Do not use if package is damaged
Do not re-sterilize
Keep Package Dry
Store at 59°F to 86°F (15°C to 30°C)
See Instructions For Use
Manufacturer
European Authorized Representative
CE marking
Single sterile barrier system with protective packaging outside

IFU