Allergan REVOLVE System Operating instructions

Brand: Allergan

Model: REVOLVE System

Type: Operating instructions

Allergan REVOLVE System is a medical device designed to assist in the harvesting and purification of adipose tissue. This advanced system utilizes a unique washing and filtration process to effectively remove impurities and concentrate the adipose tissue, making it suitable for various clinical applications.

With its intuitive design and user-friendly interface, the REVOLVE System streamlines the adipose tissue processing workflow. The system is equipped with a vacuum port that can be connected to a medical-grade vacuum source, enabling efficient tissue harvesting.

The built-in filtration mechanism effectively removes cellular debris, blood, and other impurities, resulting in a purified adipose tissue concentrate. Moreover, the system's temperature monitoring capabilities ensure the optimal temperature of the irrigation solution throughout the washing process, promoting tissue viability.

REVOLVE

™

System Components

REVOLVE

™

System Unit Parts

User Provided Components

Sterile barrier

inside box contains:

REVOLVE

™

System

Vacuum

Connecon Tubing

Irrigaon Tubing

Elbow is removable

on this end

5. Lactated Ringer’s

Soluon

Handle

1. Liposucon Tube

2. Connect to

medical grade

vacuum source

with clamp.

3/8” post-use blue elbow

1/4” post-remove blue elbow

3. Waste Canister

REVOLVE

™

Canister

Vent Port

Vacuum Port

Paent Port

Luer Port

Handle

Waste

Canister

4. Catheter-p Syringe

or Luer Lock Syringe

Minimum ll:

100 ml

Maximum ll:

350 ml

Volume inside mesh

Disposable

Adapter

Temperature

Strip

REVOLVE

SySTEM — MaTERiaLS

REVOLVE

adVancEd adipOsE systEm

Connect to

medical grade

vacuum source.

Waste

Canister

Connecng Tube

Liposucon Tube

Luer

Port

Paent

Port

Step 1: Harvest

Step 3: Transfer – IMMEDIATELY aer Step 2

1. Leave REVOLVE™ System in tray.

2. Connect Vacuum Port to

Waste Canister with connecng tube.

3. Connect Liposucon Tube to

elbow (yellow) on Paent Port.

4. Hold device rmly to prevent pping.

5. Harvest ssue into REVOLVE™

System using liposucon. Minimum

harvest volume inside of mesh 100 ml.

L00-7037 Rev E

A. Catheter-p Syringe

(Recommended method of extracon.)

1. KEEP VENT PORT OPEN.

2. Insert Catheter-

p Syringe into

Paent Port.

3. Tilt Canister

toward syringe,

gently shake Canister

to slide ssue toward

syringe, then

extract ssue.

B. Luer Lock Syringe

1. Replace cap on Paent Port, open

Vent Port.

2. KEEP VENT PORT OPEN.

3. Aach Luer Lock

Syringe to Luer Port.

4. Tilt canister toward

Syringe, gently shake

Canister to slide

ssue toward syringe,

then extract ssue.

If a syringe becomes clogged during

extracon, push syringe plunger

toward Canister to release clog and

then connue to extract.

4. Transfer to Luer Lock Syringe

via disposable adapter.

Warning: Do not overghten luer connecons

Temperature Strip

Note: Temperature strips will provide a visual indicaon of the Lactated Ringer’s Soluon temperature aer it has been warmed to the appropriate temperature.

Do not apply the temperature strip before warming the soluon.

1. Remove liner from self-adhesive backing and ensure that the applicaon surface of the Lactated Ringer’s Soluon is clean and dry before applying.

2. Green indicates the temperature. If green is not visible, the temperature will be mid way between the illuminated blue and tan windows.

3. The temperature will only display if the Lactated Ringer’s Soluon is between 35°C-41°C.

1. Remove

Liposucon Tube

4. Irrigaon Tubing

37-39°C Lactated

Ringer’s Soluon.

Fluid must be warmed.

Step 2: Wash, Filter and Concentrate

1. Disconnect/clamp Liposucon Tube from Paent Port.