Allergan REVOLVE System User Manual

REVOLVE™ ADVANCED ADIPOSE SYSTEM
USER MANUAL: REVOLVE

Guidelines for Tissue Temperature Management:

1. Use ONLY pre-warmed solutions for washing/filtering, warmed to temperature range of 37°C -39°C (98.6-102.2°F), per
IFU. Cooler fluids cause the adipose to thicken and congeal. If room temperature fluids are used to wash, or the adipose
is allowed to cool for more than a few minutes, the congealed adipose may clog the mesh filter. Utilizing solutions at
temperatures below or above 37-39°C may lead to sub-optimal procedure outcomes.
2. Solutions can be pre-warmed in a fluid warmer or a warming chamber.
Alternately, a one liter bag can be pre-warmed in a microwave –
approximately 90 seconds using an 800 watt microwave;
approximately 72 seconds using a 1000 watt microwave;
approximately 60 seconds using a 1200 watt microwave;
approximately 48 seconds using a 1500 watt microwave.
• Surgeons should confirm their own institutions' policies on use of microwaving prior to proceeding with these
guidelines.
• They should also assure that any microwaved Lactated Ringer's solution is in the 37°C -39°C (98.6-102.2°F) range
prior to inserting it in REVOLVE
• Once warmed, keep the solutions in a warmer to maintain 37°C -39°C (98.6-102.2°F) range until filling canister.
Ensure appropriate temperature prior to use.
3. Begin the washing phase IMMEDIATELY after completion of the harvest phase. Do not let the tissue cool in the
canister.
Guidelines for Tissue Harvest:
1. Harvest at least 100 ml of adipose within the mesh filter. The maximum harvest is 350 ml of adipose within the mesh; do
not overfill the canister, or the mesh filter may clog.
2. Harvest 20% - 30% more adipose than the desired or targeted amount. The washing phase reduces the volume of the
adipose as harvested by washing out oils, interstitial fluids, trapped fluid pockets, and captures and retains collagen and
stringy tissue.

Guidelines for Tissue Transfer:

1. Immediately extract the washed adipose into catheter tip syringes after washing is complete. If fat is thick or difficult
to extract using catheter tip syringes, add a small amount of warm fluid to the tissue, stir, and then extract.
2. Use catheter tip syringes for tissue transfer from the device; Toomey syringes will not work.
Catheter tip syringes are legally, commercially available from all major syringe manufacturers. Common sizes are
30/35 ml, 50/60 ml, and 100/120 ml.
Catheter Toomey
Device Description: REVOLVE
transferring of autologous adipose tissue. The system should be used with a legally marketed vacuum or aspirator apparatus
as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional
manipulation.
System
TM
System.
TM
System is a single use, sterile, disposable canister intended for harvesting, filtering, and
TM