Cytori Therapeutics celution GP User manual

QUICK REFERENCE GUIDE
DEVICE OVERVIEW
Centrifuge
Chamber
Centrifuge
Cradle
Pressure
Sensor (x2)
LR Hanger
Optical
Sensor
Pinch Valve (x6)
Collection
Container
Pump
®

Waste Bag
Tissue
Collection
Container
Processing
Chamber
LIST OF NEEDED SUPPLIES
• Celution Consumable Set
• Collection Syringe
Adapter (CSA)
(Attach to Toomey syringe-
used for tissue addition)
• Celase® Enzyme
(Stored at -15°C to -25°C)
• 1L Lactated Ringer’s
Bags (x2)
(Heated to 37°C)
• Syringes:
60 mL Toomey
(Tissue addition)
10 mL Luer-lock
(Celase addition,
Cell output removal)
• Digital Infrared (IR)
Thermometer
• Toomey Syringe
Stand
(Not supplied)
• Toomey Syringe
Caps
• Sterile Gauze
(Not supplied)
Tubing Set
• Needles:
18G x 1.5”
1.02 x 40mm
(Celase addition)
18G x 3.5” Spinal
1.2mm x 90mm
(Cell output removal)

CELUTION PROCESSING
1. Lock wheels (x4) and turn on
power switch
2. Hang waste bag
3. Attach collection container
Route tubing around the
handle
DO NOT LOAD THE CONSUMABLE UNTIL PROMPTED BY THE DEVICE
STEP 1: DEVICE SETUP
1 2
3
56Open pump, then insert
tubing in to 6 valves and the
pump
Close container port
4

6. Insert tubing in pressure sensors
by flossing back and forth
Close centrifuge lid
CELUTION PROCESSING
STEP 1: DEVICE SETUP (CONTINUED)
3
10. Close pump lid
Press down rmly to fully insert
processing chamber
Insert tubing in the optical
sensor by gently pressing
down
Remove caps from both the
processing chamber and tubing
set, then connect tubing
78
910
11 12

Celase addition
port “2”
Lipoaspirate addition
port “3”
DO NOT ATTACH THE LACTATED
RINGER’S BAG UNTIL PROMPTED
BY THE DEVICE!
CELUTION PROCESSING
When prompted to add tissue,
rst remove cap from tissue port
“3” and place on sterile gauze
Attach a collection syringe adapter
(CSA) to the tissue port
Attach a tissue-lled toomey syringe
to the CSA and add the syringe
contents to the container
[
Lipoaspirate
]
]
Adipose
Tissue
Tumescent
STEP 1: DEVICE SETUP (CONTINUED)
CSA
STEP 2: TISSUE ADDITION
Spike a 1L bag of 37°C Lactated
Ringer’s, then place on hanger
A.
B.
C.
13
14

CELUTION PROCESSING
STEP 3: CELASE ADDITION
Aspirate 5 mL of LR into a luer-lock
syringe
Reconstitute Celase using the 5 mL
LR solution and thoroughly mix
Aspirate the Celase amount shown
on the device promp into a syringe
Add the Celase to port “2” and cap
aer addition
STEP 4: CELL OUTPUT REMOVAL
Attach wrench as shown
Rotate clockwise
Remove the luer cap on the
processing chamber
Using a spinal needle and
a 10 mL syringe, slowly
reconstitute cell output,
then aspirate into syringe
Repeat 16A-16D on the
opposite side. Total output
volume is approximately
5 mL
16
15 A.
B.
C.
D.
A.
B.
D.
E.
C.
CELUTION PROCESSING
IS FINISHED
Manufacturer:
Cytori Therapeutics, Inc.
3020 Callan Road
San Diego, CA 92121, USA
Tel: [phone]
[email protected]
CUSTOMER SUPPORT
USA: +1.858.875.5245
EU: +44.1244.360.426
customerservic[email protected]
T026-USA-EN_A
Cytori, the Cytori Logo, Celution, the Celution Logo,
Celase and Intravase are registered trademarks of
Cytori Therapeutics, Inc.
© 2015 Cytori Therapeutics, Inc. All rights reserved.
DO NOT ADD CELASE UNTIL PROMPTED
BY THE DEVICE!
European Authorized
Representative:
RSQR Ltd.
Ludgate House
107 Fleet Street
London EC4A 2AB, UK
[email protected]o.uk