Rokit Dr. Invivo AI Regen KIT User manual

Vol. 1

Intended Use
This product is used to separate the autologous
fat for re-application of separated fat to tissue
de󽗉cit/injury of the same donor.
Contraindication
Do not use this product on patients with the
following conditions.
• Patients showing clinical signs of in󽗊ammation or
infection in the tissue de󽗉cit or injury area.
• Patients with severe ischemia to the tissue
de󽗉cit 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 benet
• 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 de󽗉cit 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.

Precautions
Before using Dr. INVIVO AI Regen KIT (“Product”),
carefully read all instructions in this User Manual
and fully understand the precautions and method
of use.
• This Product cannot be used for purpose other
than those specified in the User Manual.
• This Product must be used with Dr. INVIVO 4D2D
(ROKIT Healthcare, Inc.) to perform bioprinting.
• This Product should be used by professional
healthcare providers (i.e., Podiatrist, Plastic
Surgeon, Orthopedist, General Surgeon, Registered
Nurse, WOCN) who have appropriate qualification.
Non-qualified users must not use this Product.
• All components in this Product are for one-time
use only and so reusage of the components in part
or in whole is prohibited.
• The entire process must be sterilized, and
sterilized gloves and other necessary protective gear
must be worn.
• The safety of the Product is only guaranteed
within the stated warranty period. Please refer to
the Product packaging for the expiration date of the
Product.
• Before using this Product, be sure to read the
instructions and check the components in this
Product. After use, the Product components must be
handled as per instructions in the User Manual and
disposed properly in accordance with applicable
law and regulation.
• Do not omit or arbitrarily change the instructions
specified in this User Manual.
• ROKIT Healthcare is not responsible for any
problems caused by user’s carelessness or
management negligence.
• The contents of this User Manual may be changed
without prior notice
• The following terms are used to emphasize
cautions that require extra care.

WARNING:
Warnings to prevent serious accidents or
property damage.

CAUTION:
Cautions to prevent light accidents or property
damage.

NOTE:
Helpful information for users during installation,
usage, storage and etc.
Dr.INVIVO AI Regen KIT Manual
Pictogram
Manufacturer
EC Representative
Serial number
Do not reuse
Use by
Consult Instructions for Use
Manufactured date
Medical device
Do not resterilize
Do not use if damaged
Caution
Sterilized using ethylene oxide
Single sterile barrier system
Prescription Only For USA only: Federal law restricts
this device to sale by or on the order of a dental
professional.
ROKIT Healthcare, Inc.
Certication Experts B.V.
12F, Gasan High-hill bldg, 9 Digital-ro, 10 Gil Geumcheon-gu,
Seoul, Republic of Korea
Tel: [phone], E-mail: [email protected]o.kr
Amerlandseweg 7, 3621 ZC Breukelen, The Netherlands
Tel: [phone], E-amil: [e-mail]

Getting Started
Preparation of Bioink (Adipose Tissue)
Follow the instructions below to prepare the
adipose tissue for bioprinting.
The following process includes adipose micronization
and washing step.
1. Adipose Tissue Micronization
Following the instructions using 4 Adipose
Micronizers from ① to ④ in order.
A. Remove packaging of Adipose Micronizer and
check for any damage.
B. Attach the luer-lock syringe that contains
the adipose tissue to the Left of the arrow (▶)
marked on the side of the Adipose Micronizer
① and attach an empty luer-lock syringe to the
opposite side.
C. Alternately push the plunger of the syringes
that are each attached to the opposite sides of
the Adipose Micronizer ① so that the adipose
tissue can pass through the Adipose Micronizer
① at least 3~5 times in the direction of the arrow
(▶) marked on its side.
D. Transfer the adipose tissue so that the
micronized adipose tissue can finally be
contained in the syringe on the Right side of the
arrow (▶) and then remove the syringe from
Adipose Micronizer ①.
Attach the luer-lock syringe that contains the
adipose tissue to the Left of the arrow (▶)
marked on the side of the Adipose Micronizer
② and attach an empty luer-lock syringe to the
opposite side.
E. Alternately push the plunger of the syringes
that are each attached to the opposite sides of
the Adipose Micronizer ② so that the adipose
tissue can pass through the Adipose Micronizer
② at least 3~5 times in the direction of the arrow
(▶) marked on its side.
F. Transfer the adipose tissue so that the
micronized adipose tissue can finally be
CAUTION:
Do not use in case of damage to sterile
packaging of the product components.

NOTE:
Prepare at least 4 luer-lock syringes (10~30cc)
Dr.INVIVO AI Regen KIT Manual
EUARK002_Ver.1.0.0
This product is consisted of Adipose Micronizer,
the fat separator device and the accessories.
1. Adipose Micronizer ①
Adipose Micronizer ②
Adipose Micronizer ③
Adipose Micronizer ④
2. Dispenser 1
3. 3D Regen PCL
3D Regen PCL Holder
4. Bed Film
5. Dispenser 2
6. Dispenser 2 Cap
7. Dispenser 2 Tip
8. Dispenser 2 Tube
9. NFC Tag (Packaged with Dispenser 1)
1
5
7
8
9
2 3
4
Dr. INVIVO AI Regen KIT
Components
6

Dr.INVIVO AI Regen KIT Manual
EUARK002_Ver.1.0.0
contained in the syringe on the Right side of the
arrow (▶) and then remove the syringe from
Adipose Micronizer ②.
Attach the luer-lock syringe that contains the
adipose tissue to the Left of the arrow (▶)
marked on the side of the Adipose Micronizer
③ and attach an empty luer-lock syringe to the
opposite side.
G. Alternately push the plunger of the syringes
that are each attached to the opposite sides of
the Adipose Micronizer ③ so that the adipose
tissue can pass through the Adipose Micronizer
③ at least 3~5 times in the direction of the arrow
(▶) marked on its side.
H. Transfer the adipose tissue so that the
micronized adipose tissue can finally be
contained in the syringe on the Right side of the
arrow (▶) and then remove the syringe from
Adipose Micronizer ③.
Attach the luer-lock syringe that contains the
adipose tissue to the Left of the arrow (▶)
marked on the side of the Adipose Micronizer
④ and attach an empty luer-lock syringe to the
opposite side.
I. Alternately push the plunger of the syringes
that are each attached to the opposite sides of
the Adipose Micronizer ④ so that the adipose
tissue can pass through the Adipose Micronizer
④ at least 3~5 times in the direction of the arrow
▶) marked on its side.
J. Adipose Micronizer ④ After moving the adipose
tissue so that the final micronized fat is contained
in the right syringe based on the direction mark
(▶) on the side, separate the right syringe from
the filter and wash according to the following
instructions.
2. Washing Process
The following washing process is performed to
remove blood components mixed with adipose
tissue.
A. After filling the syringe that contains the
micronized adipose tissue with sterile normal
saline, close the Dispenser 2 Cap, gently mix by
inverting.
B. Place the syringe vertically in a stand rack for 7
minutes with Dispenser 2 Cap facing downward.
At this time, the layer separation is divided into
fat and other blood and saline layers.
C. After complete separation of the layers, open
the Dispenser 2 Cap and push the plunger to
discard the blood and normal saline layers
beneath the fat layer.
D. Repeat steps A. to C. 1~3 times for sufficient
washing.
E. Transfer the washed micronized adipose tissue
to Dispenser 2 using Dispenser Tube.
F. Tightly connect Dispenser 2 Tip to Dispenser 2
to complete MA-ECM patch printing preparation.
instructions.

NOTE:
The syringes used for the washing process is not
included in this Product.

Installation of
Dr. INVIVO 4D2D Accessories
The following process includes insertion of NFC
Tag, installation of Dispenser 1, installation of 3D
Regen PCL Holder and attachment of Bed Film.
1. Using the NFC Tag
A. Remove packaging of NFC Tag and insert into
the NFC reader.
2. Installation of Dispenser 1
A. Remove packaging of Dispenser 1 and check
for any damage.
B. Insert the Dispenser 1 into the Dr. INVIVO
4D2D.
3. Installation of 3D Regen PCL Holder
A. Remove packaging of 3D Regen PCL Holder
and check for any damage.
B. Insert the 3D Regen PCL Holder in proper
position.
C. Insert the end of PCL (about 10~20mm) into
the insertion hole above the Dispenser 1.
D. When inserting PCL, check whether it is
automatically loaded into Dispenser 1.
4. Attachment of Bed Film
A. Remove sterile packaging of Bed Film and
check for any damage.
B. Remove the release paper from the Bed Film
and attach on to the center of the Matrix Plate
without air bubbles.
C. Stably attach the Matrix Plate with Bed Film
into Dr. INVIVO 4D2D.
NFC Tag
3D Regen PCL
3D Regen PCL Holder
Dispenser 1
Bed Film
Dispenser 2
Dispenser 2 Cap
Dispenser 2 Tip
Dispenser 2 Tube
Dr.INVIVO AI Regen KIT Manual
EUARK002_Ver.1.0.0

ROKIT Healthcare Inc.
12F, Gasan High-hill Bldg., 9, Digital-ro 10-gil, Geumcheon-gu, Seoul, Republic of Korea, 08514
T+82 1899 7296 E[email protected] rokithealthcare.com