Rokit Dr. Invivo AI Regen KIT, Manual

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Intended Use
This product is used to separate the autologous
fat for re-application of separated fat to tissue
deficit/injury of the same donor.
Contraindication
Do not use this product on patients with the
following conditions.
•
Patients showing clinical signs of inflammation or
infection in the tissue deficit or injury area.
•
Patients with severe ischemia to the tissue
deficit or injury area.
•
Patients with severe cardiovascular disease,
Wthrombophilia, and disorders of lipid metabolism.
•
Patients during pregnancy.
•
Patients who are considered as unsuitable to get
this procedure by healthcare professioals.
Shelf-Life
• 3 year
※ The user and the patient to report any serious
incident that has occurred in relation to the
medical device to the manufacturer and the
authority having jurisdiction in their locale.
Safety
• Be sure to read the safety precautions before
using this Product.
• This Product must be used only by either medical
doctor or personnel approved by medical doctor
who are qualified to use medical devices.
• Check for any damage to the Product packaging
and do not use this Product in case of noticing any
damage to the packaging.
• Before using this Product, check for any
deformation, damage, presence of foreign
substance or expiration of the product.
Storage
• This Product should be stored in temperatures
between 1℃ and 25℃ under low humidity.
• This Product is stable until expiration date
stated on the Product label.
• This Product is not reusable. Any unused
components after opening and usage of the Product
must be discarded.
Clinical benefit
• Effective in the treatment of tissue deficit or
injury site.
• Micronized adipose tissue is a rich, ubiquitous
and easily accessible source for extracellular
substances including growth factors (insulin-
like growth factor, hepatocyte growth factor,
transforming growth factor–β 1, and vascular
endothelial growth factor) consequently stimulating
angiogenesis and promote healing the damaged
tissue area.
Dr.INVIVO AI Regen KIT Manual EUARK002_Ver.1.0.0
Dr. INVIVO AI Regen KIT
‘Sterile Single-use Fat separator’
This product is a single-use medical device that separates fat derived the human body for re-application
to the tissue deficit or injury of the same donor. This product is consisted of Adipose Micronizer, the fat
separator device and the accessories. By using this product, micronized fat tissue with a particle size
smaller than 200㎛ can be obtained without alteration of original characteristics.
Version Date Page Note
EUARK002_Ver.1.0.0 2021. 11. 24. 4 Initial Release
Revision History
The revision history of this manual is as follows.
CAUTION:
The Product must be stored according to
the storage temperature mentioned above
upon its receipt.