Product Name: Celution 800 Cell Processing Device
Model: Celution 800/GP
Product Description:
The Celution 800/GP Device is intended to be used in conjunction with the Celution 805 Consumable Set, which uses shaking, static centrifugation to process human adipose tissue in order to further to extract, wash, and concentrate mesenchymal cells intended for autologous reinfusion into the same patient.
Specifications：
EMC Compliance Standard:
IEC 60601-1-2:2014+A1:2020
Electrical Compliance Standard:
IEC 60601-1:2005+AMD1:2012+AMD2:2020
IEC 61010-2-020:2016
Power:
Voltage:220 VAC
Frequency:50 Hz
Phase:Single
Current:2.5 A
Dimensions:
Width:96 cm (38 inches)
Height:99 cm (39 inches)
Depth:61 cm (24 inches)
Weight:99 kg (218 lbs)
Temperature Limit:
Operational:15 – 30°C (59 – 86°F)
Storage:-40 – 60°C (-40 – 140°F)
Relative Humidity Range:
Operational:10 – 95 % non-condensing
Storage:10 – 95 % non-condensing
Atmospheric Pressure
Operational:700-1060 hPa
Storage:500 hPa – 1060 hPa
Control Panel: The control panel consists of 3 keys (back, next, stop) and a 32 character by 4-line display.

SAFETY&RISK

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).
Therapeutic Precautions
Multiple therapeutic applications may be required to achieve the desired effect.
Repeat treatments should follow a sufficient interval to allow for healing from the initial procedure.
The use of immunosuppressive therapies in conjunction with this procedure is not recommended.
Replacement of > 300 mL (or twice the volume of the native tissue) in any one anatomical location is contraindicated.
Replacement of graft tissue in excess of twice the volume of the native tissues should be avoided.
Potential Adverse Events
Common temporary side effects associated with liposuction and local administration may include: localized swelling/edema, infection, bruising, redness, pain, tenderness, numbness, hematoma, and minor/major skin necrosis. Side effects requiring repeat treatment may include: anatomically asymmetric or uneven graft retention, partial or complete graft resorption, under-correction, over-correction, micro-calcifications, cysts, and lumps. No adverse events directly related to the cell product are expected.
Warnings
CAUTION: Only qualified surgeons trained in lipoplasty procedures should perform the procedure.
The safe operation of the device requires the presence of a dedicated, properly trained operator. Never leave the device unattended during operation.
The therapeutic use of stromal stem cells and other associated progenitor cells in humans must be consistent with applicable national laws and regulations.
Some error messages that occur during tissue processing are not recoverable. The product could be compromised and must be discarded if an unrecoverable error message is displayed.

SYMBOL&IDENTIFICATION

Attention: See Instructions for use
Fuses
Alternating current
Temperature limit
Humidity limitation
Atmosphere Pressure limitation
Equipotential Bonding
Catalog number
Serial number
Date of manufacture
Manufacturer
Caution, consult accompanying documents
Keep package dry
Do not use if package is damaged
European Authorized Representative
Fragile
This side up
Keep away from heat
Stacking limit : 2
Maximum load weight
Warning hands pinching
Biohazard
No pushing
Medical Device
Power on/off toggle
CE marking
NOTE
Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately and must be disposed as per local regulations. Contact Cytori authorized representative for information concerning the decommissioning of your equipment.

IFU