Product Name: Celution 800 Cell Processing Device
Model: Celution 800.CRS
Product Description:
The Celution 800.CRS 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,  which are subsequently added to the washed adipose tissue, The resulting cell-mixed adipose tissue is used for plastic and reconstruction procedures for autologous reimplantation 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.
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.
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