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).
Contraindications
Non-autologous use: The system is for single patient use only.
Hemodynamic instability: Patients who are hemodynamically unstable are not suitable for any surgical procedure.
Active infection: At the donor or recipient site, or systemic infection.
Active malignancy: Patients with known active cancer, or who are undergoing chemotherapy or radiation therapy.
Pregnancy and Lactation: Safety in pregnant or lactating women has not been established.
Uncorrected coagulopathy: Patients with aPTT values ≥ 1.8 times normal or INR > 1.5.
Anticoagulant therapy: Patients who have received any anticoagulant therapy within 24 hours prior to the liposuction procedure, including glycoprotein IIb/IIIa inhibitors.
Intravascular injection: The cell product is not intended for intravascular administration.
Known hypersensitivity to Celase or its components: Or to any of the processing fluids used (e.g., Lactated Ringer’s).
Severe organ failure: For specific indications, such as severe hepatic encephalopathy for liver cirrhosis or severe pulmonary hypertension.
For Osteoarthritis: Patients with septic arthritis, Charcot joint, or severe joint deformity.
For SSc: Patients with severe pulmonary arterial hypertension or a recent scleroderma renal crisis.
For BCRL: Patients with active cancer or where lymphedema is caused by other factors (e.g., filariasis).
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.
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Manufacturer |
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European Authorized Representative |
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Catalog Number, Reference Number |
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Lot Number |
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Use by |
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Sterilized using Ethylene Oxide. Sterile Fluid Path. |
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Do not re-use. For single use only. |
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Do not use if package is damaged |
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Do not re-sterilize |
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Keep Package Dry |
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Store at 59°F to 86°F (15°C to 30°C) |
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See Instructions For Use |
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Manufacturer |
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European Authorized Representative |
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CE marking |
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Single sterile barrier system with protective packaging outside |