INTRODUCTION:

The Fersenius kabi COM.TEC cell separator System will perform all types of apheresis
procedures. One of its main procedures is to collect single donor platelets. Because of the
unique abilities of this device, the procedures are individualized by the control of several
algorithms. Prior to the beginning of the run, a platelet yield is predicted using the entered
platelet count. Based upon this information, changes can be made in the operating parameters
to optimize the collection. Leuko-poor thrombocytes are produced which can be stored for 5
days. The collect concentration monitor, an on-line device, provides information on the use of
thrombocyte concentration and yield, without the use of probes.

I. PRINCIPLE:
The system draws whole blood from a donor or patient, adds anticoagulant, separates the
blood components, collects or removes specific components and returns uncollected
components to the donor or patient. In therapeutic plasma exchange and red blood cell
exchange procedures, appropriate replacement fluid is continuously returned.

II. Specifications:
 Five (5) self-loading peristaltic pumps with one of them for plasma recirculation inside
the separation chamber in order to stabilize the interface and regulate the hematocrit
on it, in productive procedures.

 Three (3) exchangeable centrifugation plates, in order to hold different separation

chambers for different type of procedures. Fast easy and safe locking.

 Color display with surrounding soft-keys to handle easy-to-use software.

 With online help to advice the operator about the steps to follow.

 With Donor/Patient/Operator dedicated display to monitor the procedure separately.

 With dedicated printer (included) to register all the events occurred during the
procedure. With comprehensive printout for reporting.

 Double needle Patient/Donor vein access, with single needle capabilities in selected
procedures.

 Exchangeable printed layout to help the operator on the mounting of the different kits

 Automatic saline perfusion system in case that procedure holds, or type “Keep Vein
Open” system.

 Total extracorporeal volemia < 180ml for all DN procedures.

 Hemolysis/Red cell sensor for Plasma line monitoring and Platelet’s sensor on Cell line.
 Wireless connection capabilities to be linked with dedicated data management
software.

 Big rear wheels in order to improve the equipment handling.

Eleven (11) treatment and productivity programs present, with the following
characteristics:

a) Platelet:

1. Double needle PLT collection with Five (5) days storage bags.

2. Single needle PLT collection with Five (5) days storage bags.

 Both procedures with Plasma collection capabilities and performed.

 Leukocyte-depleted product by the centrifugation system itself (not filtered),

with WBC contamination < 5 x 10E5.

b) Stem Cells:

3. Peripheral blood stem cell collection, lymphocyte collection or depletion.

4. Peripheral blood stem cell collection with reduced volume capability.

5. Mononuclear cell collection or depletion.

6. Granulocyte collection.

7. Bone Marrow stem cell processing with automatic transfer between the donation and
reinfusion bag (BMSC).

 All Stem Cell procedures with CD34+ cell estimation and procedure time
forecast.

 All Stem Cell procedures with automatic Plasma collection capabilities.

c) Therapy:

8. Depletion of platelets or white blood cells.

9. Therapeutic Red Cell exchange or depletion.

10. Therapeutic Plasma exchange with isovolemic and automatic fluid balancing and Buffy
Coat reinfusion.

11. Therapeutic plasma treatment (e.g., immunoadsorption, plasma filtration) with

isovolemic and automatic fluid balancing and Buffy Coat reinfusion, (no additional hardware
required and integrated Pressure Monitor for Column/Filter monitoring).
III. Features:
 It is versatile, confidence in quality and performance

 Possessing good average in Platelet collection efficiency.

 Leukocyte depleted platelet concentrates collection with reliable WBC reduction
technology.
 collection outside of centrifuge, is visible during collection with lower cell activation
 It has five pumps, one separate pump for ACD-A.
 Centrifuge speed upto 2200 rpm with high gm force which increases purity.
 Unexcelled donor safety, having fully automated ACD-A drip detector/leak sensor test,
with automatic
  Keep-vein-opened (KVO) in stop-mode.
 Newly designed apheresis sets, with new single needle process, having hemolysis
monitor.
 Incomparable operating comfort, color displays having table and support for holding the
chamber.

It has effect noise reduction measures.

 Innovative software for interconnection of several cell separators through “Apheresis

Master”
 Weight 130 kg Size 60 x 66 cm.

IV. MATERIAL & REAGENTS:

 Disposable kit
 Gloves
 ACDA
 Normal Saline
 Fistula Needle
 Physio Ball Hand exerciser
 Surgical tape
 Emergency kit

V. Operating Procedure:
 Check power supply.
 Clean all sensor and valves with gauze piece.
 Switch on power button by press button 1.
 Select program C5L for Platelet pheresis.
 Install C5L
 Open pump lids.
 Hang up blood lines.
 Close red inlet clamp just beyond Y piece to the pre sampling clamp.
 Close white needle clamp.
 Hang up bags and containers.
 Close clamp between concentrate bags.
 Close clamp at pc sample bag.
 Insert four pump segments hit<Turn pumps>.
 Close pump
 Insert drip chamber in air detector.
 Insert plasma line in valve 4.
 Insert plasma line Hemolysis detector.
 Insert diversion line in valve 5.
 Insert return line in valve 1.
 Insert inlet line to cell pump in cell detector.
 Insert ACD drip chamber in ACD detector.
 Insert ACD pump segment.
 Insert red saline line in valve 2.
 Insert blue line in valve 3.
 Connect the pressure lines.
 Insert separation chamber.
 Lock housing and rotor.
 Insert centrifuge lines in tubing guide (hook at rotor).
 Close centrifuge door.
 Insert air protector in holder.
 Open bags and containers.
 Set saline and ACD level.
 Blue return line clamp opened.
 Prepare priming.
 Start priming.
 Feed donor Data gender, Hight, weight, Hematocrit and platelet count.
 Select program and platelet yield.
 Prepare donor.
 Connect inlet and return pressure lines.
 Press continue to start draw.
 When the required volume obtained disconnect inlet pressure line and platelet
collection bag and rinse back.
 After the rinse back complete disconnect the return line and apply bandage.
 Remove the tubing set and discard.