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Fresenius Transfusion

Fresenius HemoCare
Competence in Transfusion Technology
and Blood Management

Blood Processing
Disposables

General Catalogue

Blood Processing
Equipment

Apheresis Systems

A company of the Fresenius Kabi group


Content

Page

About us 2

Company policy 4

Blood Processing Systems –


Disposables Page

Introduction to Compoflex®
and Composelect® 08
blood bag and in-line systems

Standard blood bag systems:


Compoflex® 10

In-line filtration systems:


Composelect® 14

Filter systems: BioR and BioP 18

Stemcell collection and processing sets:


Stemcare® 26

Transfer bags:
Compoflex® 28

Cryopreservation systems:
Hemofreeze® 32

Blood bank accessories 35


Blood Processing Systems –
Equipment Page

Blood collection and mixing device:


CompoGuard
HemoLight Plus 38

Donation and apheresis couches:


Compocouch 48

Cooling, transport and storage system:


Compocool®
Compocool II 52

Automatic blood component processing system:


Compomat® G4 56

Docking system for sterile PVC connections:


Compodock® 62

Tube sealing system:


Composeal
HemoSeal
PlaquetaMix H 66

Filtration rack:
Compolift 74

Apheresis Systems Page

Blood cell separator:


COM.TEC 78

Page

Service 88

Internet 90

Sales Regions 91
About us
Success has many reasons

Fresenius HemoCare is an international company and


active in the field of blood treatment. Our customers
are mainly transfusion centers and hospitals.
We provide a total system concept for collecting and
processing extracorporeal blood and offer a range of Blood Processing Disposables

products, services and methods developed to achieve


highest quality blood products. Blood products are
blood components such as erythrocytes, platelets and
plasma which are obtained homologously, i.e. from
donor blood, or autologously, i.e. from the patient’s
own blood.

Blood Processing Equipment Apheresis Systems

Fresenius Transfusion:
8 research and production facilities in 6 countries

The complete product portfolio, which we offer to our customers, ranges from disposable
articles to data management systems for blood component manufacture up to computer-
controlled cell separators to obtain highly-pure stem cell preparations.

Based on a high vertical integration in our worldwide production locations we guarantee


our customers stable high quality with minimized risks of delivery disruptions.

Blood Bag System production in Emmer-Compascuum/The Netherlands,


Sao Paulo/Brazil, Salzburg/Austria and Horatev/Czech Republic
Production of devices in Schweinfurt/Germany and Blumenau/Brazil
Filter production in Cavezzo/Italy
Production of plastic components in Schweinfurt/Germany

2
Friedberg, Germany
General Management and R&D

Horatev, Czech Republic Sao Paulo, Brazil Salzburg, Austria

Emmer-Compascuum, Blumenau, Brazil Cavezzo, Italy


The Netherlands

Schweinfurt, Germany

3
Company policy
Quality - Patient - Customer - Environment – Personnel

These five basic areas are the focus of Fresenius HemoCare.

Fresenius HemoCare regards it as a principal purpose to offer its customers and patients
an optimum product and service quality on a high technical level. Hereby the requests of
the patients and the customers are to be considered with priority.

By the conversion of these requests and needs, Fresenius HemoCare is conscious of its
responsibility to society and the environment. Therefore, Fresenius HemoCare established
workflow and production processes and subjected them to a permanent process of
improvement. The processes are characterized by preservation of resources. The processes
guarantee the fulfilling of the legal requirements of the authorities.
Beyond that the conversion of the requests and needs of our customers and patients
requires a high level of knowledge and experience. To achieve this target, Fresenius HemoCare
therefore gives emphasis to highly motivated and well trained staff.

For our products this means we provide a high quality and the production
methods and products:

meet the state of the art in our field

have life saving and life prolonging function

respect the current and changing value of the society

protect the environment and natural resources e.g. via the use of dual-usage raw
materials

A company of the Fresenius Kabi group

4
The company targets match with the company policy and our commitment for continuous
improvement. The management is responsible for these targets to be communicated,
understood and transferred in the entire company:

Our innovative technologies and methods support cost saving therapies.


Our customers are looking for a long-term collaborative relationship.
Our methods will be designed to optimally satisfy our customers. We will continually analyze and
improve our processes.
We will understand our customers' wishes regarding our products and services and take these into full
consideration within the framework of our organization.
Our work and processes will be designed to optimally meet the requirements of our internal customers.
Our goal is to be first in all of our target markets.

Quality Management

The quality management is


an established management
tool for the realisation of
our company policy and
targets. Our quality mana-
gement system comprises
also the description and
controlling of all business
processes for the realisation
of our optimum product and
service quality.
This includes research and
development, production,
selling, patient treatment
and also management
processes.

The quality management system of Fresenius Transfusion Technology as part of


Fresenius HemoCare is certified according to the international standards ISO 9001,
ISO 13485. The ISO 9001 contains general requirements for quality management systems.
ISO 13485 is an addition for medical device manufacturers. Additionally all products are
certified according to the European Medical Device Directive 93/42/EEC with special
requirements which apply to the quality management for the development, production
and selling of medical devices.
These requirements are also part of the GMP principles (GMP = Good Manufacturing
Practice), which are common standard for the production of medicinal products and
medical devices.

5
Blood Processing Systems –
Disposables

Blood bag systems Compoflex®


In-line filtration systems Composelect®
Filter systems
Stemcare® collection and processing sets
Transfer bags
Processing solutions
Hemofreeze® cryopreservation systems
Blood bank accessories
COMPOFLEX® and COMPOSELECT®
blood bag and in-line systems
The choice of blood bag systems for flexible and
individual processing

Full range of blood bag systems with Optimized bag design for efficient
and without integrated leukodepletion processing and high component yields
filter Various adapters for blood sampling
Excellent biocompatibility and high tubes to reduce of infection and con-
gas permeability for optimal storage tamination risk
conditions (even at -80 °C or - 112°F) Transparent and easy to open over-
Flexible foil with optimized interior/ wrap for visual inspection of the set
exterior surface structure for improved Wide range of blood bag accessories
mixing characteristics

The production facilities are CE certified according to


ISO 9000 standards and meet the requirements of
the Medical Device Directive 93/42/EEC.

A tight in process control during production and a


full Quality Assurance System is established.

Environmental aspects and the requirements of the


European Pharmacopeia are strictly followed.

8
RT-Needle
Post-donation prevention of needle injuries for the
operator
Smallest and lightest needle protector for blood bag
systems on the market
Tamper-proof needle cap to prevent manipulation
Excellent, high standard needle quality

Closed system for blood sampling


Composampler V (for vacuum tubes) or Composampler M
(for syringe systems) and the corresponding Composam-
pling systems with predonation sampling bags allows
blood collection for laboratory testings. Composampling
systems can be chosen to reduce the contamination risk
during phlebotomy. The irreversible clamp closes the
sampling line safely.

Two way flow bag breaker


A break off system specially designed for safe
handling. Can be fixed in a defined and stable
position to guarantee an unhindered flow with
low risk of hemolysis.

Autologous systems
For patients donating their own blood we offer systems with luer lock adapter
available to connect to a butterfly needle.
PAGGS-M red cell storage solution enables storage at 2 – 6 °C for up to 49 days.

Plastic label
Gives high resistance against wear and tear during
component preparation, storage and transport.
It is a tamper-proof material.

9
Blood bag sytems COMPOFLEX®
For flexible and individual whole blood collection
and processing with conventional and T&B systems

Collection
Processing
Transfusion

Compoflex systems combine a longlasting track record in blood bank use and blood bag
production. The blood bag systems are consequently designed to guarantee a top quality
blood product and therapeutic safety. Compoflex systems are available as conventional
systems or as Top&Bottom (T&B) systems.

Features

Blood bag features

single, double, triple, quadruple


blood bag systems available

safe, easy and standardized blood


processing

sucessfully proven quality following


T2101
years in international routine use

excellent material biocompatibility


for all blood components

CE certified according to Medical


Device Directive 93/42/EEC
T2760

10
Conventional systems
Collection of whole blood, preparation of plasma, red cell concentrate and platelet
concentrate in a fast and easy process manner.

high plasma and red cell yields Principle of the component


low hemolysis rate related to separation process separation

(red cells remain in the collection bag while additive


solution will be inserted)
CPD or CPDA-1 as optional whole blood anti
coagulation solution
manual or fully automated and fast whole blood
Steps:
separation process is feasible
1. separate plasma
2. remove buffy coat into extra bag
Blood Bag System Anticoagulant WB Plasma RCC Platelets 3. add additive solution to red cell
Single CPDA-1 + - - - 4. process single donor platelet
concentrate from buffy coat
Double CPDA-1 or CPD + PRP +* -

Triple CPD + PRP +* (+)

Quadruple CPD + + +* +

* RCC without BC removal

T&B systems Principle of the component


separation
Preparation of plasma, red cell concentrate and
platelet leukocyte concentrates with high quality.

low WBC contamination in all blood components


excellent platelet yield
CPD as whole blood anticoagulant only Steps:
1a/b. separate plasma and red cells
optimal buffy coat removal possible 2. process single donor platelet
concentrate from buffy coat

Blood Bag System Anticoagulant WB Plasma RCC Platelets

Triple CPD - + +** +*

Quadruple CPD - + +** +***

* pooled PLT, ** RCC without BC removal, *** single donor

Blood Bag Systems


For detailed information please order the Blood Bag Systems
folder or contact your local sales organization.

11
Ordering information
BLOOD BAG SYSTEMS

Compoflex ® Single bag Compoflex ® Double bag

T 21xx T 22xx

Compoflex ® Triple bag (conventional) Compoflex ® Triple bag (T&B)

T 23xx T 27xx

Compoflex ® Quadruple bag (conventional) Compoflex ® Quadruple bag (T&B)

T 24xx T 28xx

12
Questionnaire
Please answer the following questions before contacting your local
Fresenius distributor.

1. Which blood components do you want to prepare?

2. Give us the intended composition of your required blood bag system.

single double triple quadruple

3. What is the intended donation volume?

450 ml 500 ml ml

4. Which type of collection bag shall be used?

conventional T&B

5. What is the preferred anticoagulant/storage solution?

CPDA-1 (autologous) CPD/SAG-M CPD/PAGGS-M

6. Which sampling system is needed for serological test tubes?

Composampler V Composampler M

Composampling System V Composampling System M

7. Are there any other important requirements?

Notice:
In our Compoflex standard program we offer the most common configurations with fixed settings,
e.g. symbol label, etc. in high quality. Please ask your local distributor for more information.

13
In-line Filtration Systems COMPOSELECT®
Whole blood collection with efficient in-line
white blood cell depletion

Collection
Processing
Filtration
Transfusion

Composelect in-line blood bag systems unite long-standing experience in the production
of blood bags with integrated filters. They are consistently designed for user-friendliness.
The transparent filter housing enables an optical control of the filtration process at any
time. It guarantees, together with the closed bag system, a high blood component and
therapeutic safety.

Features

Filter features
Filter fibres are produced inhouse by a melt-blown woven non-woven process
The fibre surface is neither positively nor negatively charged
The filter material is characterized by high biocompatibility
The filtration principle is based on mechanical and adhesive depletion properties

In-line features
In-line blood bag systems are steam sterilized
In-line blood bag systems have a non-pyrogenic fluid pathway
The plastic label on each bag in the system specifies the volumes and composition of
any liquids present in the respective bags and the application(s) for which these bags
are intended
In accordance with directives by WHO and the Council of Europe, contained in the
“Guide to the preparation, use and quality assurance of blood components”
CE certified according to Medical Device Directive 93/42/EEC

14
Two in-line concepts for flexible and individual processing
Whole blood and Red cell concentrate in-line filtration
Whole blood Red cell concentrate Plasma
in-line filtration in-line filtration in-line filtration

excellent leukocyte depletion excellent leukocyte depletion excellent leukocyte depletion


(WBC ø 0,1 x 106/u) according to (WBC ø 0,2 x 106/u) according to according to WHO and
WHO and European Guidelines WHO and European Guidelines European Guidelines

minimized volume loss minimized volume loss minimized volume loss


RBC recovery > 90% RBC recovery > 90% about 11 ml

short filtration time short filtration time short filtration time


average 16 min (dependent on average 27 min (dependent on • average 1 min (filtration by
whole blood volume, Hct, Temp., volume, Hct, Temp., resting time) pressure during separation)
resting time) • average about 7 min
(filtration by gravity)

flexible start of filtration flexible start of filtration


preferable after 3 h up to 24 h preferable after 3 h up to 24 h
after donation after donation

wide variety of Composelect wide variety of Composelect


in-line systems in-line systems

T&B or conventional system • T&B or conventional system


• Quadruple systems (BC pool)
• Quintuple systems (single PLT)

RCC in-line filter available as hard


housing or soft filter

T3922 Whole blood in-line filter Red cell concentrate in-line filter

T3964 RCC-Soft in-line filter

In-Line Systems
For detailed information please order the In-Line Systems
folder or contact your local sales organization.

15
Ordering information
IN-LINE FILTRATION SYSTEMS

Composelect ® RCC in-line (conventional) Composelect ® RCC in-line (T&B)

T 4011 T 2930

Composelect ® WB in-line (conventional) Composelect ® WB in-line (T&B)

T 3908 T 3999

16
Questionnaire
Please answer the following questions before contacting your local
Fresenius distributor.

1. Which blood components do you want to prepare?

2. Which type of filter is needed?

whole blood filter RCC filter plasma filter

3. Give us the intended composition of your required blood bag system.

single double triple quadruple

4. What is the intended donation volume?

450 ml 500 ml ml

5. Which type of collection bag shall be used?

conventional T&B

6. What is the preferred anticoagulant/storage solution?

CPDA-1 (autologous) CPD/SAG-M CPD/PAGGS-M

7. Which sampling system is needed for serological test tubes?

Composampler V Composampler M

Composampling System V Composampling System M

8. Are there any other important requirements?

Notice:
In our Compoflex standard program we offer the most common configurations with fixed settings,
e.g. symbol label, etc. in high quality. Please ask your local distributor for more information.

17
Filter Systems
Leukocyte depletion filters for blood bank
and bedside use

Filtration
Transfusion

Leukocyte filters for filtration of red cell concentrates, platelet


concentrates and whole blood can be offered with high quality.

Blood bank use (BBS) Bedside use (BS)

Leukocyte filters are characterized by


high filtration efficiency and performance
easy handling
minimal volume loss
short filtration time

18
Features

Minimal volume loss


The unique Autoventing System (with integrated sterile air filter)
allows complete emptying of the filter housing backside as well
as the tubing between drip chamber and filter, after filtration.
The computer designed filter housing guarantees low cell loss.

User friendly
Leukocyte filters are consistently developed to be user-friendly. The transparent filter hou-
sing allows inspection of the filter during the filtration procedure. It ensures an optimized
priming with the blood component within 60 seconds only by hydrostatical pressure.

High quality standard


Consistent control procedures guarantee the high
quality standard. Batch number printing on every
filter housing allows tracebility. The leukocyte filters
are presented in an 'upside down position' fixed by
a red clip. This allows an easy priming of the system
ensuring complete filling of the filter housing and
optimal wetting of the fibre material.

Filtering material
The polyester fibre is produced by a melt-blown woven
non woven process. The fibre surface is treated with a non
ionic coating and therefore neither positively nor negatively
charged. The filter material features excellent wetting and
biocompatibility. The filter function is based on mechanical
and adhesive principles.

19
Filter Systems
Filters for more safety in therapy

The reduction of leukocyte contamination in blood components is important to prevent


or to reduce various side effects as

non-hemolytic febrile transfusion reaction


allo-immunisation against HLA-antibodies
development of refractoriness against platelets
transmission of leukocyte-associated viruses
immuno-suppression

Filter systems

BioR 01 plus / BioR 02 plus


Leukocyte depletion filter for removal of primarily leukocytes and secondarily platelets
from red cell concentrates.

Filtration capacity 1 or 2 units of red blood cell concentrate


(R01 or R02)
Filtration efficiency ≥ 4 log
Filtration loss Bio R 01 plus: 23 ml
Bio R 02 plus: 30 ml
RBC recovery about 95%
Filtration time Bio R 01 plus ≤ 15 minutes
Bio R 02 plus ≤ 30 minutes
Prefilter 170 µm
BioR 02 plus
Integrated microaggregate filter 40 µm

20
BioR max
The high efficiency leukocyte depletion filter for single red cell unit use.

Filtration capacity 1 unit of red cell concentrate


Filtration efficiency ≥ 5 log
Filtration loss with Autoventing System:
BioR 01 max: about 25 ml
RBC recovery about 95% BioR 01 max
Filtration time BioR 01 max ≤ 15 minutes
integrated microaggregate filter 40 µm

BioR mini
Specifically designed for the use in neonatology and
pediatric wards together with syringe pumps.

Filtration capacity 60 ml red cell concentrate


or whole blood BioR mini
Filtration efficiency ≥ 4 log
Filtration loss about 5 - 7 ml

Bio M
Filter for depletion of microaggregates from whole
blood or red cell concentrates.

Filtration capacity > 5 units of whole blood units or red cell


concentrates
Bio M
Filtering material Polyester
Filtration loss about 28 ml
Maximum pressure 300 mm Hg or 0,4 bar

21
Questionnaire BioR filters
This questionnaire shall serve as a tool for finding the right BioR filter configu-
ration. Please answer the questions before you contact your local representative.

1. What should be filtered?

Whole blood Red Cell Concentrate

2. What do you want to remove mainly?

Leukocytes Microaggregates

3. How much volume of chosen component shall be filtered?

60 ml (pediatric) 1 unit 2 units

4. Which leukocyte depletion efficiency is needed?

log 4 log 5

5. When will the filters be used?

pre-storage (blood bank use) post-storage (bedside)

6. Please judge the quality of the blood component to be filtered.

Excellent, i. e. relatively fresh, good flow, no coagulation

Good, i. e. longer storage time, higher viscosity, partly coagulation or lipids

22
BioP Plus
Leukocyte depletion filter for the removal of leukocytes from platelet concentrate.

Filtration capacity For filtration of up to eight single donor


platelet concentrates or one apheresis unit
Filtration efficiency > 4 log
Filtration loss 10 – 12 ml
Platelet recovery > 90% (BS: depending on quality and
age of the platelets)
Filtration time ≤ 5 minutes (BBS)
Prefilter 160 µm
BS=bedside, BBS=blood bank side BioP Plus

BioP 10
The high efficiency depletion filter for a single pooled platelet
concentrate. The polyester fibre is coated by a neutral polymer
to avoid platelet activation during the filter passage.
Filtration capacity For filtration of 1 unit of pooled PLT concentrate
of up to 12 single PC
Filtration efficiency > 3 log
Filtration loss 10 – 12 ml
Platelet recovery ≈ 85% BioP 10
Filtration time ≤ 5 minutes
Maximum pressure Filtration under pressure possible

BioP 05 Plus and BioP 10 Plus


Leukocyte depletion filter for the removal of leukocytes from
platelet concentrate. The polyester fibre is coated by a neutral
polymer to avoid platelet activation during the filter passage.

Filtration capacity For filtration of pooled PLT concentrate of up


to 6 single PC (BioP 05 Plus) or 12 single PC
BioP 10 plus
(BioP 10 Plus)
Filtration efficiency > 4 log
Platelet recovery ≈ 90%

23
Platelet Pool Systems
Compostop and Compostop CS

With 1300 ml Citroflex storage bag for up to 7 days of platelet storage


Can be used for pooled platelet concentrates stored in plasma or additive solution
(e.g. Composol)
Compostop for automatic separation at Compomat
Compostop CS for manual separation including stop functionality when loaded
with erythrocytes

??????

Compostop Compostop CS BioP Plus


Housing material Polycarbonate Polycarbonate Methyl-Methacrylat Copolymer
Volume loss 22 ml 12 ml 27 ml
Sterilisation Steam Steam Gamma
Storage bag Citroflex 1300 ml Citroflex 1300 ml PO 1000 ml
Filtration time* approx. 3 min approx. 7 min approx. 3 min
Automat. Stop No Yes No
* Under pressure approx. 3 min and manually approx. 7 min

Filter sets for blood bank use


For detailed information please order the filter sets for blood
bank use folder or contact your local sales organization.

24
Questionnaire BioP filters
This questionnaire shall serve as a tool for finding the right BioP filter configu-
ration. Please answer the questions before you contact your local responsible.

1. Do you want to filtrate platelet concentrates from pooled single platelet concentrates
or from pooled buffy coats?

from single platelet concentrates from buffy coats

2. How many single platelet concentrates will be put together to a pool?

< 7 units > 7 up to 12 units or one apheresis unit

3. Which leukocyte depletion efficiency is needed?

log 3 log 4

4. When will the filters be used?

pre-storage (blood bank use) post-storage (bedside)

5. Does the filtration procedure take place automatically or manually?

automatically (at a separator) manually (e. g. with plasma extractor)

Filter sets for bedside use


For detailed information please order the filter sets for blood
bank use folder or contact your local sales organization.

25
Blood bag systems
Stemcare® Collection and processing sets

Collection
Processing
Transfusion

The CB Collect blood bag systems are intended for the collection and/or processing of
umbilical cord blood. Three different bag systems are available for collection and / or
processing of cord blood.

Stemcare® CB Collect
Cord blood collection set T2950 (300ml bag filled with
20ml CPD) is designed for easy handling during collection.

Cord blood T&B bag system T2956 (200ml T&B bag filled
with 20ml CPD) can be used for collection and processing.

The small sized T&B bag is optimal for processing of small


volumes and high cell yields. T2950
Both cord blood sets (T2950 and T2956) have two needles
for repeated puncture and the 10ml CPD-satellite bag is
used to flush the donation line after collection to optimize
the cell yield.

T2950 in combination with P4208 (200ml T&B bag


system) is ideal for centres where collection and processing
is running in separate locations.

26
Stemcare® Processing Set

Optimized design of the T&B bag


together with two transfer bags
for preparation process only

Luer-lock adapter for easy connection


T 2956

In combination with T2950 ideal


for institutes where collection and
preparation is running in separate
locations

P 4208

Ordering information

Order number Description Packaging size


T2950 Stemcare CB Collect 2 / 30
2 Bags, 20 ml + 10 ml CPD
300/20

T2956 Stemcare CB Collect T&B 2 / 30


4 Bags, T&B, 20 ml + 10 ml CPD
200/150/20

P4208 Stemcare Processing Set 1 / 15


3 Bags, 200 ml T&B,
200/150/100

27
Blood bag systems
Transfer bags Compoflex®

Processing
Storage
Transfusion

Compoflex® Transfer bag systems are intended for the processing and administration of
blood components in accordance with directives contained in the "Guide to the preparation,
use and quality assurance of blood components" as published by the Council of Europe.

P 4159 P 4213

P 4193

Features
gamma sterilized systems
non pyrogenic fluid pathway

28
The following list will demonstrate the possibilities in blood bag
design. Please ask your local representative or product specialist for
more configuration examples.)

A variety of different transfer bag systems with different sizes and


adapter are available.
Ordering information

Blood bag Type of adapter Volume Material Usage e.g.


system
P 4159 Spike 4 x 150 ml PVC/DEHP RCC baby bags
P 4160 Spike 150 ml PVC/DEHP Sampling bag
P 4161 Haemonetics 3 x 300 ml PVC/DEHP Apheresis
P 4162 Spike 500 ml PVC/DEHP RCC washing
P 4164 Spike 300 ml PVC/DEHP Washing
P 4165 Spike 3 x 300 ml PVC/DEHP Plasma aliquots
P 4193 Luer Lock male 500 ml PVC/DEHP Heart-lung machine
P 4203 Cannula 2 x 600 ml PVC/DEHP Special collection
P 4206 Closed tube 100 ml PVC/DEHP Test sampling bag
P 4208 Luer Lock female 200/150/100 ml PVC/DEHP Cord blood system
P 4213 Pigtail 400 ml PVC/DEHP BC pooling bag
P 4214 Pigtail 4 x 400 ml PVC/DEHP Plasma aliquots
P 4216 Pigtail 20 ml PVC/DEHP Test sampling bag
T 2110 Pigtail 1300 ml PVC/Citrate PLT storage

Blood bag systems


For detailed information please order the Blood bag
systems folder or contact your local sales organization.

29
Processing Solutions
For storage and washing
Processing

Composol PS
The Composol solution is a multiple electrolyte solution for storage of platelet
concentrates and will be offered in the Dockflex bag with pigtail which can be
used for sterile connection.
Citrate reduces platelet activation
Sodium chloride 5.26 g during storage
Sodium gluconate 5.02 g For 7 days storage of platelets
Sodium acetate anh. 2.22 g
Improved pH control
Potassium chloride 0.373 g
Magnesium chloride hexahydrate 0.305 g
Saves plasma volume
Sodium citrate 3.213 g Standardized platelet processing
pH 7.2 (7.0 –7.4) Reproducible density and viscosity
Water for injection ad 1000 ml
Minimized transfusion reactions

Acetate is used as an energy source by the platelets. Consumption of acetate does not
lower the pH of the supernatant. Plasma bicarbonate is not required to buffer the
H+ produced by glucose degradation.

Red cell freezing solution


Solution for red cell storage at low temperature (nitrogen
method) will be offered in the Dockflex bag with pigtail for
sterile connection.
Glycerol 380.0 g
Sorbitol 29. g
Sodium chloride 6.3 g
Water for injection ad 1000 ml E 1146

Red cell washing solution


Solution for washing of red cell concentrates after thawing and
removing of the freezing solution will be offered in the Dockflex
bag with pigtail which can be used for sterile connection.
Sorbitol 175.0 g
Sodium chloride 0.8 g
Water for injection ad 1000 ml
E 1145

30
Red cell preservation solutions
Storage of red cell concentrates in SAG-M or PAGGS-M solution offered in Dockflex
bag with pigtail which can be used for sterile connection.

SAG-M
Storage of red cell concentrates: max. 42 days (at 2°C - 6°C)

Sodium chloride 8.770 g


Adenine 0.169 g
Glucose monohydrate 9.000 g
Mannitol 5.250 g
Water for injection ad 1000 ml

PAGGS-M
Storage of red cell concentrates: max. 49 days (at 2°C - 6°C)
Sodium chloride 4.210 g
Disodium hydrogenphosphate-dihydrate 1.432 g
Sodium dihydrogenphosphate-dihydrate 1.255 g
Glucose monohydrate 9.400 g
Adenine 0.194 g
Mannitol 10.000 g
Guanosine 0.408 g
Water for injection ad 1000 ml

Ordering information
Order number Description Packaging
size
E2083 Composol PS 1 / 26

E2091 SAG-M solution 100 ml 1 / 24

E2092 SAG-M solution 250 ml 1 / 12

E2081 SAG-M solution 500 ml 1 / 18

9400141 PAGGS-M solution 250 ml 1 / 12

9400151 PAGGS-M solution 500 ml 1 / 18

E1146 Red cell freezing solution (300ml) 1 / 12

E1145 Red cell washing solution (250ml) 1 / 12

Composol PS
For detailed information please order the Composol PS
folder or contact your local sales organization.

31
Hemofreeze Cryopreservation System
Safe and reliable cryogenic preservation

Storage
Transfusion and Transplantation

Freezing bags and accessories for long term storage of blood and tissue
components in liquid or gas-phase nitrogen such as

erythrocytes stem cells bones


platelets bone marrow tissues
leukocytes grafts heart valves

Freezing bags

Features

Material (Kapton/Teflon) does not contain any plasticizers


Highly resistant to mechanical strain at low temperatures
down to -196 °C
Biocompatible foil
Label for quick and safe identification of each bag
Special transfer sets available
Freezing accessories
Special welding device for heat sealing of the bag
Sample storage in a separate pocket in the bag
FDA and CE registered

More than twenty years of experience

32
Hemofreeze Sealer WD3

Special welding device for easy


and durable heat sealing of filled
Hemofreeze bags for long term
storage.

Metal envelopes
Special metal envelopes for spreading
the bags into thin layers before freezing.

Before freezing, the Hemofreeze bag should be placed in


the corresponding metal envelope to spread the contents
of the bag into a thin layer. This allows constant thickness
over the whole freezing bag, better freezing and thawing
results and optimal storage conditions.

33
Ordering information

Order Description Country Packaging


number size

Hemofreeze bags for cryopreservation of blood components and bone marrow


Z 2000 DF 170; 85 ml-bag with 2 connectors NL / IT / GB / DE / FR 2 / 20
Z 2001 DF 200-2; 100 ml-bag with 2 connectors NL / IT / GB / DE / FR 2 / 20
Z 2002 DF 200-3; 100 ml-bag with 3 connectors NL / IT / GB / DE / FR 2 / 20
Z 2003 DF 700-2; 350 ml-bag with 2 connectors NL / IT / GB / DE / FR 2 / 20
Z 2004 DF 700-3; 350 ml-bag with 3 connectors NL / IT / GB / DE / FR 2 / 20
Z 2006 DF 1000-3; 500 ml-bag with 3 connectors NL / IT / GB / DE / FR 2 / 20
Z 2007 DF 1200-2; 600 ml-bag with 2 connectors NL / IT / GB / DE / FR 2 / 20
Z 2008 DF 1200-3; 600 ml-bag with 3 connectors NL / IT / GB / DE / FR 2 / 20
Z 2014 DF 120-3; 60 ml with 3 connectors NL / IT / GB / DE / FR 2 / 20

Hemofreeze bags for cryopreservation of grafts and bones


Z 2009 DF Bone; open bag with 3 connectors NL / IT / GB / DE / FR 2 / 20
630 x 290 mm
Z 2010 DF CVG 1+2; two open bags without connectors NL / IT / GB / DE / FR 2 / 50
95 x 153 mm and 133 x 210 mm
Z 2011 DF CVG 2-3; two open bags without connectors NL / IT / GB / DE / FR 2 / 50
133 x 210 mm and 163 x 250 mm
Z 2012 DF CVG 4-3; open bag with 3 connectors NL / IT / GB / DE / FR 2 / 50
352 x 153 mm
Z 2013 DF CVG 3; two open bags without connectors NL / IT / GB / DE / FR 2 / 50
163 x 250 mm

Hemofreeze sealer, metal envelopes and accessories


9029111 Hemofreeze ® WD3 digital, 230 V, Sealing
device for Hemofreeze bags,
Dimensions (LxWxH) 360 x 430 x 540 mm
Z 2050 e 200, metal envelope for freezing of DF 200-bags NL / IT / GB / DE / FR 1 / 1
Dimensions: 150 x 11 x 129 mm
Z 2051 e 700, metal envelope for freezing of DF 700-bags NL / IT / GB / DE / FR 1 / 1
Dimensions: 155 x 15 x 239 mm
Z 2052 e 1000 metal envelope for freezing of DF 1000-bags NL / IT / GB / DE / FR 1 / 1
Dimensions: 158 x 39 x 300 mm
Z 2080 Glycerolisation set (transfer-set) NL / IT / GB / DE / FR 2 / 20

34
Blood bank accessories

9024211 Tube stripper NPBI

9028171 Tube stripper Möller

9024201 Plasma extractor

9024231 Clips (2.000 pcs.)

9024221 Hand sealer for clips

9024531 Scissor clamps (50 pcs.)

35
Blood Processing Systems –
Equipment

CompoGuard Composeal

HemoLight Plus HemoSeal

Compocouch PlaquetaMix H

Compocool® Compolift

Compocool II

Compomat® G4

CompoDock®
CompoGuard
Combining safety with efficiency in whole blood donation

Prevention in back strain injuries to operators


Unique system of volume and blood flow monitoring for the donors
Prevents venting of primary bag following donation
Improved mixing of in-line systems
Highly efficient mobile data management

RSI prevention (Repetitive Strain Injuries)


The gooseneck feature permits to operate the panel without bending down.
In order to prevent back strain, system loading should be as simple as possible. The new
large in-line tray and the new safety clamp enable faster loading which reduces bending
time for the operator. This results in increased efficiency.

CompoGuard –
innovative blood collection system and mixer technology

Optimal supervision of Reliable prevention of primary Improved donor monitoring


donation process bag ventilation following First time the donor is offered his
A comprehensive safety concept donation / her own display. The remaining
has been realized with Compo- The safety of blood bag systems is blood donation volume needed
Guard. The optenna of the secured because tubes cannot slip can be followed directly. Flow
gooseneck gives an optical alarm out of the new safety clamp du- alarms can be actively prevented
that is seen from a distance and ring donation. The tube sealer is di- by the donor by pumping a stress
directs the operator to the correct rectly integrated into CompoGuard. ball when first blood alarm is given
donor bed. Noise exposure caused The tube clamp can be opened only by the system. This contributes to
by acoustic alarms is reduced. after successful sealing. This pre- increased blood product quality.
vents air from unwanted entering
into the primary bag. The hand
sealer can be used in very flexible
ways. Furthermore CompoGuard
documents the sealing step.

38
Improved mixing of
in-line systems

The new in-line system tray


with integrated filter holder
secures optimal mixing. The
tray is large enough for complex
in-line systems. This results in
fewer microaggregates and better
processing of in-line systems.
By preventing bags and tubes
from hanging outside the tray,
exact weighing is assured.

High efficiency of mobile data management

The protected DECT radio transmission band ensures reliable and safe
data transmission. The bi-directional program selection automatically
loads released batches of bags as well as those of authorized operators
into CompoGuard. The hands-free auto-sense scanner suspended in
the holder enables rapid scanning of test tubes. Correct labelling of
bags and test tubes is supervised and documented according to GMP
requirements.

39
CompoGuard Complete
The top model Complete combines the efficient DECT
RF-technology with new safety standards of the integrated
sealer. It offers all features including optimal in-line
processing and bi-directional data management as well
as RSI prevention by the gooseneck.
CompoGuard
CompoGuard Data Complete
(scanner
The model Data offers the benefits of reliable and optional)
safe data transmission using DECT technology. Data is
equipped with the large in-line tray, bi-directional data
management as well as RSI prevention features.

CompoGuard Seal
The integrated sealing function of the model Seal achie-
ves a new level of safety and comfort. The tube clamp
can only be opened after successful sealing.
Data management is also possible by using a dedicated
cable.

CompoGuard models
Complete - Data - Seal - Basic

CompoGuard Basic
The model Basic is the ideal choice if budgets are limited
and high quality features are required.
Basic still offers many attractive functions. The main
features include the benefits of the safety clamp as well as
the tray for in-line systems. Data management is possible by
use of a cable network. It can be upgraded by sealing- and
DECT optionally.

CompoGuard Basic
(battery pack optional)

40
Donationmaster Net –
PC based network solution for CompoGuard

Part of the Compomation data management system

High efficiency of mobile data management


Radio frequency technology (RF) is by far the most efficient and easiest way of data trans-
mission. Donationmaster Net automatically collects all donation data and also updates the
CompoGuard settings via RF. All data are transferred to a Computer during the donation
session without further intervention. The operators do not have to perform any complicated
computer activities. The auto-sense scanner enables rapid scanning (to streamline the
work flow still further) and reduces workload.

Reliable DECT radio frequency technology


The protected DECT radio transmission band ensures reliable and safe data transmission.
The DECT band is protected, data are transferred encrypted.
DECT works with low power consumption resulting in very low electromagnetic radiation.

Optimal supervision of donation process


A comprehensive safety concept has been achieved by CompoGuard. During initialization all
CompoGuards are set up for the same donation program, settings and barcode lists. The
blood donation process is therefore standardized. This ensures maximum safety during the
daily routine of a donation session. Additionally CompoGuard assures the correct scanning
and labelling of the barcodes on the bags and test tubes.

Bi-directional interface
CompoGuard also offers a comprehensive concept of bi-directional data management.
Barcodes of valid bag lot numbers as well as those of authorized operators are downloaded
into CompoGuard automatically by the bi-directional interface. As with Compomat G4 the
program selection can be done online. For mobile donations there is an option of program
selection by intelligent donation numbers or panel barcodes.

Documentation in terms of GMP


All relevant donation quality data are automatically acquired. The remaining data record
shows each individual donation process in detail. The documentation of the sealing step is
part of this record.

41
CompoGuard Accessories

Transport case for Donationmaster Net CompoRack


CompoGuard PC program rack to staple 4-fold-charger
also available with external Radio frequence network via (4-fold-charger and batteries not
battery charging option DECT communication included in delivery)

Technical data
CompoGuard
Dimensions (LxWxH) 44.5 x 22.5 x 16.5 cm
Gooseneck panel (H) 54.5 cm
Optenna 88.5 cm
Weight CompoGuard: 3.4 kg
Power supply: 100– 240 V, 50 – 60 Hz

Transport cases
Dimensions (LxWxH): 53.5 x 25 x 28 cm
Weight: 2.8 kg

System requirements:
The software Donationmaster Net operates within the following systems: Intel compatible CPU, min. 350 MHz,
min. 128 MB RAM and 10 MB HDD, 1 serial interface available, alternatively 1 USB port for W 2000 and W XP
Operating system: Microsoft Windows 95 b / 98 (second edition) / NT 4.0 (SP 5) and W 2000 (SP 1).
CE / MDD: CE / class IIa

CompoGuard and Donationmaster NT


For detailed information please order the CompoGuard and
Donationmaster folder or contact your local sales organization.

42
Ordering information

CompoGuard models
9028301 CompoGuard Complete, 100-240 V
Basic model + DECT option + sealing option + rechargeable battery + gooseneck
9028291 CompoGuard Data; 100-240 V,
Basic model + DECT option + gooseneck
9028281 CompoGuard Seal; 100-240 V
Basic model + sealing option + rechargeable battery + gooseneck
9028261 CompoGuard Basic, 100-240 V
Basic model (excl. battery)
M 636281 Upgrade Option DECT for models Basic and Seal, order key number + scanner extra
M 636301 Upgrade Option Seal; for models Basic and Data, order battery extra

Data management accessories


9028321 Barcode scanner with integrated auto-sense function
9028341 DECT Fixed-part for radio transmission network; EU *
One per PC/network; includes power supply (230V) and cable
9029001 DECT Fixed-part clone; EU *
Fixed-part clones all have the same DECT-ID number
M 635231 USB adapter cable for Fixed-part
With this adapter cable the Fixed-part can be connected to a PC with USB port
9028401 Donationmaster Net German *
PC program includes installation CD-ROM and manual
9028311 Donationmaster Net English *
PC program includes installation CD-ROM and manual
9028391 Software licence for CompoGuard
Key number for activating the data management; already included in
models Data and Complete
9028331 Network converter RS485; EU (necessary for cable network only) *
Includes power supply (230V) and cable, Amount: one converter per PC/network
M 636701 Y-piece, (necessary for cable network only)
Amount: one less than number of mixers in a network
M 636671 Network cable, 5m, (necessary for cable network only)
Amount: one less than number of mixers in a network
M 635231 USB adapter on RS232
For computer with USB port, released for W 2000 and W XP

Accessories
9028371 Transport case for CompoGuard
Space for all accessories inside the transport case
9028271 Transport case with charging option
External plug for in-case-charging of battery
9028381 Power adapter with charging indication lamp 100-240V; 50-60 Hz
9028361 4-fold charger for CompoGuard; EU *
For four batteries, 230 V, with intelligent battery service
9029501 Rechargeable battery for CompoGuard, NiCd technology
9028381 CompoRack, Rack to staple up to three 4-fold-charger
9028381 Gooseneck
Includes holder for scanner and hand sealer; included in models Data, Seal and Complete
9028381 Gooseneck
Same as above, but without holder for scanner
9028381 Disinfectable filterholder
* additional country/language versions on request
43
HemoLight Plus
Automatic blood collection system for whole blood donation

Easy and reliable operation


3D mixing movement
Suitable for mobile donation, extra low weight
Automated data acquisition (optional)

Easy and reliable operation


The HemoLight Plus device provides an automatic supervision of the whole blood
donation process.

The display guides the operator through the donation process. This results in a very easy
operation. It also informs about donation time, flow and end alarms. Furthermore alarms
are acoustic, informing operators from a distance. In addition to the display, operator is
informed by indicator LEDs.

HemoLight Plus
Blood collection-, mixing- and weighing system

HemoLight Plus has a


three dimensional mixing
movement, assuring a
homogeneous blood mixing
during donation

When the maximum volume or time limit is reached, the tube


will be automatically closed by the clamp.

This feature offers a standardization of the collected blood


volume.

The removable plastic tray is easy to clean and disinfect.

44
Suitable for mobile donation
Due to the low weight of approx. 2.5 kg, HemoLight Plus is ideal
for mobile donations. The battery (optional) lasts for approx. 15
donations and can be charged inside the device. The Acid Lead
technology of the battery prevents a memory effect. Alternatively
HemoLight Plus can operate on main power supply also.

Three dimensional mixing Clamp controlling the


Sealed operator buttons
movement donation volume
- easy to clean

Easy removable tray

Easy to clean

Interface on backside for optio- Acid Lead battery, charging


nal scanner and cable network inside the HemoLight Plus

45
Automated data acquisition (optional)
HemoLight Plus can be equipped with a scanner for data acquisition. Up to 1000
donations can be stored internally, including donation number, time and volume etc.
The function 'Donation Query' allows access to these internal data already without PC:
By scanning of the requested donation number, HemoLight Plus selects automatically
this donation and displays all relevant data (donation volume/-time etc.).

In addition a cable network with up to 32 mixers can be used.


With the help of HemoData Net, the donation data can be transfered to a PC. Further-
more ASCII data can be transmitted via interface to a blood bank information system.

In either case, with or without PC, HemoLight Plus provides full traceability and high
efficiency in data management according to GMP.

HemoLight Plus
For detailed information please order the
HemoLight Plus folder or contact your
local sales organization.

46
Ordering information

HemoLight Plus
81040 HemoLight Plus International

Accessories
81043 Rechargeable battery HemoLight 2.3 Ah
12V Lead-Acid technology

070181040 Transportcase for HemoLight Plus


Space for all accessories inside the transport case

Data Management Accessories


9028321 Barcode scanner with integrated auto-sense function

81044 HemoData Net Kit:


Software on CD-ROM with Easy Install guide

9028331 Network converter (same as for CompoGuard, includes power supply


and cable, amount: one converter per PC / network)

M 636701 Y-piece (same as for CompoGuard, amount: one less than number
of mixers in a network)

M 636671 Network cable, 5m (same as for CompoGuard, amount: one less than
number of mixers in a network)

Technical data
Weight: without batteries 2450 gr
Dimensions: Maximum height during oscillation 19,2 cm
Maximum weidth 26,9 cm
Depth 21,0 cm
Power supply: 110 / 230 V, 50 / 60 Hz
CE / MDD: MDD class II a
Protection against electrical shock: Safety class I
System requirements:
The software HemoData Net operates within the following systems: Intel compatible CPU, min. 16 MB RAM
and 50 MB HDD, 1 serial interface available. Operating system: Microsoft Windows 9X / Me / NT / 2000 XP

Transportcase for
HemoLight Plus

47
Compocouch
The deluxe donation and apheresis couches

More comfort
Improved safety
New design

Design:
Fresh new colours combined
with a wide range of models and
functions for high variability.

Compocouch
The couches for perfect donor care

Quality and Comfort: Safety: Hygiene:


Total relaxation when sitting due to The arm rests can be tilted to The smooth surface is easy to
the twin-belt system and exchange- allow patients to get on and off clean. The arm rests are fully
able bolster pad of highly absorbent safe and easily. Adjustment/con- padded for sturdy and highly resi-
foam material. The arm rests can be trol buttons are arranged logically stant use. In general all seals are
moved in and out to adjust seat on the remote control. No tipping closed to prevent any dirty collec-
width to suit individual requirements. over of the couch in case of tion in recesses. In compliance with
Especially for whole blood donation collaps of a donor (up to 175 kg). the regulations of the MDD class I
the wedge shaped arm support Only one button to immediately the material was improved to
promotes a highly comfortable vena reach shock position. provide stability against UV light
puncture resulting in optimal blood and flames.
flow. The extra long foot section
ensures a comfortable rest even for
tall people.

48
Compocouch models

A wide variety of attractive and useful accessories


are available for the Compocouch models.

NOVO X 220/330 TOP X 220/330 Compochair


The high end model The economical model The compact model
The high end model NOVO X 330 The TOP X models meet the This model is characterized by
with outstanding features. The same construction features as being particularly inexpensive.
optimal solution for highest the NOVO X models. By a simpli- The ideal choice whenever
quality in transfusion medicine. fied basis chassis an additional investments have to be done
NOVO X 330 is delivered with price/benefit relation could be with a reduced budget but high
three motors standard. achieved. Both models are quality product features are
Also a Compocouch meeting available with three (TOP X 330) required.
highest requirements: NOVO X 220. or two motors (TOP X 220).
In comparison to the NOVO X 330
with two motors (no motor for
height adjustments).

49
Compocouch accessories

Wedge shaped arm support Donation comfort tray DT1 Donation standard tray ST1
For whole blood donation Has the same features as ST1 but With spring forced heights adjustment,
the tray can be tilted. Includes plastic user friendly one hand operation and
storage container (optional on ST1). large castor. The tray is removable for
dishwasher cleaning.

Technical data:
Technical data NOVO X 220 NOVO X 330 TOP X 220 TOP X 330 Compochair
Width of arm rest 14.5 cm 14.5 cm 15 cm 15 cm 15 cm
Length of arm rest 55 cm 55 cm 55 cm 55 cm 57 cm
Base width 60 cm 60 cm 60 cm 60 cm 54 cm
Base length 213 cm 213 cm 213 cm 213 cm 188 cm
Total overall width 89 cm 89 cm 89 cm 89 cm 81 cm
Distance between arm rests (adjustable) 60 cm 60 cm 60 cm 60 cm 52 cm
Seat/base height 60 cm 53 - 76 cm 50 - 76 cm 60 cm 55.5 – 57.5 cm
Padding and neck support upholstery Skai, flame retardent Skai, flame retardent Skai, flame retardent Skai, flame retardent
Thickness of padding 8 cm 8 cm 8 cm 8 cm 6 cm
Colour frame light grey light grey light grey light grey white
Colour arm and foot rest middle grey / dark blue middle grey / dark blue middle grey / dark blue middle grey / dark blue
4 castors, antistatic d = 10 cm, d = 10 cm, d = 10 cm, d = 10 cm, d = 7.5 cm,
all lockable all lockable all lockable all lockable 2 lockable
Electric motor with limit switch 2 x 24 V 3 x 24 V 2 x 24 V 3 x 24 V 1 x 24 V
Transformer protection class II protection class II protection class II protection class II
Transformer nominal power:
Primary 230 V / 50 Hz 230 V / 50 Hz 230 V / 50 Hz 230 V / 50 Hz 230 V / 50 Hz
Optional 110 V / 50 Hz 110 V / 50 Hz 110 V / 50 Hz 110 V / 50 Hz 110 V / 50 Hz
Fuse 1 A/T, slow blow 1 A/T, slow blow 1 A/T, slow blow 1 A/T, slow blow 1 A/T, slow blow
Secondary 25 V 25 V 28 V 28 V 27 V
Maximum load 175 kg 175 kg 175 kg 175 kg 175 kg
Net weight 80 kg 80 kg 80 kg 80 kg 48 kg
Gross weight (incl. packaging) 110 kg 110 kg 110 kg 110 kg 55 kg
Dimensions packaging (LxWxH) 800 x 1200 x 1460 cm 800 x 1200 x 1460 cm 800 x 1200 x 1460 cm 800 x 1200 x 1460 cm 600 x 600 x 1800 cm
Base adjustments to 70°
Back rest tilt 0° -75° 0° -75° 0° -75° 0° -75°
Seat rest tilt 0° -20° 0° -20° 0° -20° 0° -20°
Leg rest tilt to 35° to 35° to 35° to 35°
Shock position:
Back rest tilt 0° 0° 0° 0°
Leg and seat rest tilt 20° 20° 20° 20°
Room temperature 3 - 40 °C 3 - 40 °C 3 - 40 °C 3 - 40 °C 3 - 40 °C
Relative humidity 30 - 75% 30 - 75% 30 - 75% 30 - 75% 30 - 75%
CE / MDD: CE / Class I CE / Class I CE / Class I CE / Class I CE / Class I

50
The fresh new colours:
Couch colours: grey, red, yellow, mint, pastel and dark blue

Arm and foot rests: middle grey and dark blue Compocouch
For detailed information please
order the Compocouch folder
or contact your local sales orga-
nization.

Ordering information
9028471 NOVO X 220 with wedge shaped arm rest All standard couches come with:
9028461 NOVO X 220 standard • Paper holder

9028491 NOVO X 330 with wedge shaped arm rest • Relax pillow (except Compochair)
9028481 NOVO X 330 standard

9028511 TOP X 220 with wedge shaped arm rest


9028501 TOP X 220 standard

TOP X 330 on request

9024751 Compochair with wedge shaped arm rest


9024501 Compochair standard

Accessories
5067371 Infusion stand (excludes holder)

5067361 Holder for infusion stand, adjustable, right or left (only for NOVO
X models)

5067391 Reading lamp (available for all models)

M649161 Adjustable foot rest (all models)

M613231 Transparent plastic cover for foot part (all models except
Compochair)

9028141 Donation tray ST1


9028131 Donation tray DT1

5067851 Wedge shaped arm rest left


5067841 Wedge shaped arm rest right

5067871 Tilt down arm rest left


5067861 Tilt down arm rest right

5067871 Relax pillow, (see photo above)


colour standard grey, other colours on request

51
Compocool®
Whole blood cooling, transport and storage system

Improves quality of blood components


Rapid cooling of whole blood directly after donation
Reduces the need for component preparation outside normal working hours

Compocool
The Compocool concept consists down to 20 ± 24°C immediately Compocool system reduces com-
of a unique cooling, transport and after donation for optimal com- ponent processing outside normal
storage system for whole blood, ponent yield and improved quality. working hours and solves logistic
improving quality and standar- By using Compocool, the storage problems for mobile donations.
dization of blood component temperature of whole blood The shelf life of Compocool
preparation. Compocool enables units is standardized for up to cartridges is 5 years.
rapid cooling of whole blood 24 hours. This benefit of the

Compocool
Contributes to quality and standardization of blood
component preparation

Increased and more consistent platelet yield

Stabilized factor VIII during storage

Improves in-line filtration process

Compocool
For detailed information please order the Compocool folder or contact
your local sales organization.

52
Crates are used to store 6-8 units of whole blood
Aluminum cooling cartridges are pre-cooled by putting them in
a refrigerator easily (min. 16 hours at 4°C)
Easy cleaning
Colour coding: stack with alternate colours when filled with bags
Crates can be stored on top of each other and transported on
the trolley with a push bar

Compocool® cartridges:
Robust aluminum cooling cartridges

Ordering information
902 425 1 Compocool cartridge (standard)
(6-8 whole blood units fit on one cartridge)
Minimum order quantity: 4 units
Dimensions: 460 x 335 x 25 mm (LxWxH), weight: 3 kg

902 426 1 Compocool crate for cooling cartrigdes


Minimum order quantity: 4 units
Height of 5 stacked crates (LxWxH): 600 x 400 x 120 mm
600 mm with blood, weight: 1 kg

902 816 1 Compocool cartridge (small)


Special dimensions (LxWxH): 190 x 290 x 25 mm, weight 1.2 kg

902 427 1 Transport trolley for 5 crates


Dimensions (LxWxH): 620 x 420 x 150 m, weight 3.9 kg

902 454 1 Push bar for transport trolley


Position dimension (H): 87 cm, weight 4.9 kg

53
Compocool II - The new cooling system
for protected whole blood during transport and storage

Insulated transport boxes Ergonomic box; (washable) cartridge


and trolley
Small cooling element with
integrated temperature control Secure blood transport

Smaller and lighter cooling Each cooling element is


element optimizes equipped with a serial no.
handling and storage for shelf life indication.
in the refrigerator Clear and easy indications
(min. 16 h at 4°C). with pictures, attached to
Thermo foil on each the box lid.
cooling element indicates
the actual temperature.

Compocool II
Improved cooling system for standardized, controlled, secured storage
and transport of donated whole blood

Improved cooling system for safe and standardized cooling and/or transport
of whole blood to 20-24°C.

Closed and lockable transport box with integrated insulation against warm and cold
environmental conditions. Enables a controlled cooling process and continuous cooling
chain for long term storage also.

Enables cooling to 22°C (+/- 2°C) within 2 hours for up to 24 hours.

Improved quality and processing of filtration, higher and reliable PTL-yield, stabilization
of factor VIII during storage. (Vox. Sang. 1989; 56: 145-150)

Small cooling cartridge with temperature and shelf life indication for fail-save operation.

Small, stackable box for 6 blood bags enables ergonomic carrying and easy handling.

Easy to clean - suitable for automated washing systems.

Foldable trolley, easy to carry - optimal for mobile use.

Classification: Medical device Class IIa (according to 93/42/EEC).

54
Sealing with plastic plugs (seals)
warranties the cooling chain
according to the validated
temperatures.

Ergonomic handling

Trolley requires minimum space during Transportation box capacity


transport and can easily be loaded. for 6 filled in-line blood bag
Safe transportation of 4 full boxes. systems

Ordering information
9028821 Compocool II insulated transport box + cooling element
Dimensions: 418 x 334 x 242 mm (l x w x h), weight 5,4 kg

9028841 Compocool II insulated transport box,


Dimensions: 418 x 334 x 242 mm (l x w x h), weight 2,9 kg

9028751 Compocool II cooling element


Dimensions: 306 x 160 x 40 mm (l x w x h), weight 2,5 kg

9028831 Compocool II trolley


Transport position, weight 4,7 kg, 6 x 49 x 78 cm (l x w x h) Extended position, 56 x 50 x 109 cm (l x w x h)

M658391 Compocool II plugs (seal) colour: yellow, packaging size: 1000 pcs

M653801 Compocool II instruction for use

Compocool II
For detailed information please order the Compocool II folder
or contact your local sales organization.

55
Compomat® G4
Automatic blood component processing system

Highest efficiency in blood component preparation


Optimized and standardized product quality
Automatic documentation of process data and bi-directional interface
Compomat G4 and Compomaster NT are according to GMP guidelines

The Compomat G4 system offers flexibility and automation of blood component


preparation on a high level. The flexibility of this system ensures the adaptability for all
common preparation methods. With Compomat G4 you are well prepared for future
requirements.

The fully automated preparation leeds to results in standardized product quality and
reduced manual workload in daily routine production.

Compomat® G4
A long-lasting and successful track record in automated blood processing

Efficient design of work-flow and reduced staff workload


Preparation of all common blood bag systems
Flexible and consistent production
Highest product quality and yield

Unique pressing principle: Multi detection field: Display:


Patented technique with upper Optical sensors for variable Clear operator instructions for
and lower press and slide for and reliable cell layer detection, a user friendly handling.
best product quality and fast no day light disturbance.
pressing.

56
1 Detector B for flow
regulation and smooth pressing: 2 Top press for quick pressing:
With integrated optical sensor For Top & Top systems and
for minimizing cell contamination in specific processes, optional removal
plasma or platelet concentrates. of air bubble in plasma bag possible.

10 Balance:
Automatic documentation of
10
2
plasma and platelet weights

1
9 Multi-functional heads: 9
For clamping and sealing

3 Pins:
Easy to fit with
any type of bag
3

8 Upper and 8
lower presses:
Unique pressing 4
principle for fast
and reliable 4 Slide:
preparation
8 For reliable buffy
coat removal
from red cells

5
7 Head 6: 7
For processing of
Top & Bottom systems

6 5 Balance:
6 Scanner: Automatic documentation of
For data acquisition red cell concentrate weights
Technical data
Dimensions: Width: 380 mm
Depth: 500 mm
Height: 450 mm Compomat® G4
Weight 30 kg For detailed information please order the
Compomat® G4 folder or contact your
Compressed air supply 6 bar local sales organization.

Electrical supply 230/240 V AC, 50/60 Hz


100/120 V AC, 50/60 Hz

57
Compomaster® NT
PC program to support fully automatic
preparation process

Automatic data acquisition


Very flexible programming
Bi-directional interface to blood bank information system
Standard ASCII interface
Automatic online program selection on Compomat G4
Automatic documentation in terms of GMP
Optimized processing of Top & Top bag systems and in-line systems
Increased efficiency by new watch dog features
Improved security levels to support online GMP production

Compomaster combines the benefits of the previous Compomaster II


program with the advantages of Windows® technology.

Compomaster NT provides bi-directional online data transfer system between


Compomat G4 and the blood bank system.
Fully automatic and online controlled selection of the preparation program on
Compomat G4 and online based on the individual donation number
Direct online management of preparation data
Monitoring module: live monitoring of all Compomat G4 devices’ status

The Compomaster NT system is delivered preliminary configurated. When integrating the


Compomaster NT into the blood bank system, we always assist you with our know-how.

Native Windows NT 32 bit application


Reliable and robust performance
Password protection for network access
Standard support of the most common networks (Ethernet, Token ring)

58
The input of two major European
user groups was the basis to improve
the existing system. The security
level of the software was to catch
up with the state-of-the-art of
leading blood bank software systems.
To reduce the failure rate of the
fully automated production more
control mechanisms on the
Compomat G4 have been realized.
This control mechanisms are also
dedicated to improve the complete
processing of Top & Top bag systems
significantly.

Security in a fully automated GMP production


Only authorized staff is allowed to change preparation programs. Therefore a third
security level for the Head of Production was introduced.
A direct online check of the operator ID on the blood bank system assures that only
well trained personnel performs preparations.
All important changes on the system have to be documented to meet
GMP requirements. The documented history was therefore extended.

The watch dog supervises the blood preparation process


A maximum time limit can be defined for each individual preparation program.
All Compomat G4 devices are monitored during the preparation process.
If a Compomat G4 exceeds the time limit an acoustic alarm is given to the operator,
who can either stop or restart the process. This assures efficiency in the use of all
Compomat G4 devices.
All these extended preparation processes will be summarized in a list at the end of
each shift. Shift time is free definable.

59
Only a safe barcode identification assures correct documentation
The barcode identification feature of the Compomat G4 assures the correct barcode to be
scanned when requested in the display. All common barcodes, incl. Eurocode and ISBT Code
128 can be processed with the new software.
A second operator and the LOT code of the disposable can be scanned now.

The use of Top & Top systems is improved significantly

With the introduction of whole blood in-line systems Top & Top configurations have
become more attractive. Compared to Top & Bottom configurations the preparation time
is reduced by approx. 50%. To reduce the failure rate and automate the process the follo-
wing features have been added:
an automatic supervision of pressing back the additive solution by the top press
the weighing of the red cell concentrate was implemented to complete the process

Compomaster NT is part of Compomation data management system

Compomaster NT
For detailed information please order the
Compomaster NT folder or contact your
local sales organization.

60
Ordering information
Compomat G4 models / PC
9028211 Compomat G4 standard (software V 3.0x), 230V

9028411 Compomat G4 standard (software V 3.0x); 100V

9028221 Compomat G4 standard (software V 3.0x); 230V


inclusive control unit for top press

9028661 Compomat G4 standard (software V 3.0x); 120V


inclusive control unit for top press

9024071 Compomat G4, previous software version (V2.01); 230V


backward compatible

9024101GB PC for Compomat G4 with Compomaster NT, 230V


obligatory for Compomat G4; preinstalled,
standard version 1.2x; GB = English (standard)

9024091 D PC for Compomat G4 with Compomaster NT,230V


obligatory for Compomat G4; D = German

9024161 GB PC for Compomat G4 with Compomaster NT, 120V


obligatory for Compomat G4; GB = English

Accessories
9024281 Compressor 220V; one compressor for two G4; standard with autodrain

9024291 Compressor 110V; one compressor for two G4; standard with autodrain

M 611911 Auto drain upgrade kit 220V; one kit per Compressor, automated
evacuation of compressor
9024391 Barcode scanner

M 608141 Scanner holder for Compomat G4 / Table scanner holder

9024081 Weighing balance (for weighing the red cell concentrate)

9024181 Weighing balance with clamp (for weighing the plasma on top of the
Compomat G4 with a fixation clamp) (remark: no certified balance)

6793551 Evacuation blocks for G4, T & B systems


Modification kit for top press Compomat G4 for fully
automatic evacuation of plasma bags for T&B systems

9023711 RCC in-line priming holder

Hardware (per Compomat G4)


M 613931 EPROM 1

M 613961 EPROM 2

M 615081 EPROM 3

M 615121 EPROM 4

optional
M 615221 Upgrade kit control units for top press

61
CompoDock®
Sterile PVC connections in just two steps

Unique waferless technology


Fully closed system
Quick and easy handling
New position cover
Significantly reduced odour
compared to systems using wafers

Unique waferless technology:


CompoDock is a unique machine that does not require wafers as it has
a permantent heating element. This leads to a number of benefits on
environmental/health and safety aspects in operation:

CompoDock®
The patented technology for sterile connection of PVC tubing –
new and improved

Quick and easy handling:


Operation is quick, as no wafer loading is necessary. Wafer loss caused by jamming cannot occur. The loading
of the system takes place in just two steps and is designed to prevent any problems with tube mix up. Finally, no
contaminated wafers have to be disposed.

New tube alignment:


The new position cover prevents fail docks due to misalignment. Tube guards station the tubes automatically in
the right place, whenever the cover is closed. This construction of the new tube alignment supports fail-safe
handling, which is intended especially for intensive use.

Fully closed system / reduced odour and exhaust:


The element heats the sealed tube ends without touching them. The tube ends of the docked tube remain sealed
until the dock is completed and the waste tube ends remain closed for disposal (no risk of contamination).
The smell and exhaust caused by burned PVC material is significantly reduced compared to systems using
wafers. This is very much appreciated by operators using existing systems.

Reduced tube length:


By introducing the new moving bag support trays the disposables are transported together with the clamps
during the docking process. The benefit is a minimum required tube length of 10 cm.

62
1 New and Improved
Also tested by the
Moving bag support trays reduce the
Paul-Ehrlich-Institut (PEI)
required tube length and ensure correct
positioning of tubes

2 New and Improved


Clamps to secure optimal
tube alignment and fine
positioning by guide pins

1
3 New - Position Cover
The construction of the 4
position cover supports 3
fail-safe handling 2

4 New and Improved


Re-designed middle block for easier
tube positioning; also supporting
correct tube alignment

CompoDock Counter
Counter with 500, 1000 and
2500 docks available

Patented technology for a sterile connection of medical PVC tubes

1 2 1: The tubes are placed inside the clamps.


As there is only one tube channel, a mix
up by mistake is impossible.
2: The docking process is fully automated –
after the clamps are closed the tube ends
are sealed.
3 4
3: The clamps move to the upper heater
and docking chamber.
4: The permanent heating element comes
out – and heats the sealed tube ends
without touching them – resulting in only
little odour and exhaust.
5 6
5: The docking process – both clamps move
together to connect the heated tube ends.
6: The dock is now ready and can easily be
opened by pressing the seal.

63
Field of application: Tube compatibility and processing time
Pooling of buffy coats and/or CompoDock enables you to make sterile connections
platelet concentrates between medical PVC tubing:
Sterile docking of filters between all wet and dry tubing combinations
Sterile docking of platelet (wet - wet / wet - dry / dry - dry)
additive solution with outer diameter varying between 3.9 mm
Paediatric use and 4.6 mm (3.9 - 3.9 / 3.9 - 4.6 / 4.6 - 4.6)
and a wall thickness of 0.5 - 0.85 mm
Virus inactivation procedures
process cycle time of approx. 20 seconds
Sampling
Modifying apheresis sets

Very simple loading of bag


systems as the clamps only
have one tube channel:
a mix up by mistake is not
possible!

Just two manual steps to create a sterile connection:

1. Place the tubing inside 2. Finally, take out the dock


the tube channels, press and press the START button
down the position cover to reset the clamps for the
and close the clamps. next process cycle. That`s it!
The docking process starts
automatically.

64
CompoDock with
plexiglass tables
A pair of plexiglass tables
is available as an optional
extra to support bags during
docking

Ordering information
9028651 CompoDock
delivered with a counter of 100 docks,
230/240V AC; 50/60 Hz
Dimensions (LxWxH): 340 x 220 x 450 mm
Weight: 22.8 kg

9028721 CompoDock 100V AC; 50/60 Hz

9028681 CompoDock Counter 2500 docks

9028691 CompoDock Counter 1000 docks

9028701 CompoDock Counter 500 docks


M 63985 Plexiglass tables left/right

Upgrade information for the previous CompoDock version


Main components of CompoDock are backward compatible so that installed
CompoDock versions can be upgraded to improve reliability and dock quality.

M 659191 Upgrade Kit New Position Cover


one kit / device, including new clamps with
guide pm, new middle block with enlayed
tube trace, improved position cover,
neco software
(compatible to yellow CompoDock only)

Upgrade Kit New Clamp

CompoDock®
For detailed information please order the
CompoDock folder or contact your local
sales organization.

65
Composeal
Tube sealing system for perfect and reliable seals

High quality seals


Reliable operation
Quick and easy handling
Process control ensures leakage detection

The choice for a new standard of controlled and safe tube sealing

Composeal product line offers a sealer range that meets the specific demands of the
professional in sealing medical tubing.

Composeal Universal, heavy duty and flexible sealing system


Composeal Mobilea, portable sealer

Composeal models
Universal and Mobilea

Composeal Universal – the flexible desktop sealing system


with patented auto-tuning function

Auto-tuning function up to 6 mm tube


diameter for optimized sealing time and
identical seal thickness

Designed for heavy duty use

Spark detection and seal time limiter for


controlled handling

Automatic tubing grips to ensure seal quality

Indication of sealing progress

Detachable head is easy to clean

Additional hand sealer for simultaneous


operation

66
Composeal Mobilea – the portable sealer
light weight, short charging cycle for the battery pack.

High capacity battery


with improved robustness

Small and light weight,


shoulder carrying bag (optional)

Visual and acoustic alarm for


low battery capacity

Approved for bedside sealing

Charger Hand held sealer


Easy plug in system Visual and
acoustic alarm
Charging within 1 hour
Detachable head
Overload protection
is easy to clean
for battery

Composeal Mobilea:
Optimal ergonomic design,
needs very low hand force
necessary for operation

67
Technical data
Composeal Universal
Dimension (WxDxH) 150x280x260 mm
Weight approx. 7 kg
Power supply 230V AC, 50 Hz
Sealing time Approx. 0.5 sec. (standard tube)
Composeal Mobilea
Dimension (WxDxH) 140x110x50 mm
Weight approx. 800 g
Power supply internal NiCd-Battery (12V/1.2Ah)
CE / MDD CE/class I (all models)
Battery Charger
Dimension (WxDxH) 150x140x80 mm
Weight 1.6 kg
Power supply 230V AC 50 Hz
Hand sealer*
Dimension (WxDxH) 200x65x30 mm
Weight 300 g
*The hand sealer is also compatible to Composeal Universal

Composeal Mobilea Transport Case


The Composeal Mobilea is delivered
in a durable transport case.

Composeal Universal
Transport Case
available on request

68
Ordering information

Composeal models
9024061 Composeal Universal, 220V

9024661 Composeal Universal, 110V

9024051 Composeal Mobilea, 220V


Complete with power pack, hand sealer, charger and transport case

9024401 Composeal Mobilea, 110V


Complete with power pack, hand sealer, charger and transport case

Accessories
M 616481 Modification kit: Exchangeable hand sealer cable

9024021 Power pack for Composeal Mobilea

9024031 Hand held sealer for Composeal Mobilea and Universal

9024041 Charger for Composeal Mobilea 220V

9024001 Charger for Composeal Mobilea 110V


M 600431 Transport case for Composeal Mobilea

9024331 Shoulder carrying bag for Composeal Mobilea power pack


902881 Transport case for Composeal Universal

Composeal
For detailed information please order
the Composeal folder or contact your
local sales organization.

69
HemoSeal
The choice for controlled and safe tube sealing

High quality seals


Reliable operation
Quick and easy handling

HemoSeal is a desktop sealer, able to make continuous quality seals for PVC tubings up to
4,5 mm diameter. The sealing process is automatically triggered by placing a tube inside
the head. Therefore operation is very efficient.

With an audio-visual alarm, the sealer is equipped with an reliable process control, that
ensures leakage detection. The seals are well defined in shape and provide a rupture line,
enabling the operator to separate the seals without contamination risk.

HemoSeal
Tube Sealing System for perfect and reliable seals

HemoSeal is LED's for


provided with visual process
an additional control
adapter on the
backside in
order to use an
extra hand sea-
ler (optional).

The HemoSeal has


a detachable head,
which is very
easy to clean.

70
Ordering information

HemoSeal
81039 HemoSeal International

Accessories
M638371 Hand Sealer

Technical data
HemoSeal Dimension (WxDxH) 190x320x190 mm
Weight approx. 8 kg
Power supply 110 V/230 V / 50 – 60 Hz
Hand sealer Dimension (WxDxH) 200x65x30 mm
Weight 300 g
CE marked acc. to EMC- and LV-Directive
protection against electrical shock: class I

HemoSeal
For detailed information please order the
HemoSeal folder or contact your local
sales organization.

71
PlaquetaMix H
High Quality - Platelet Shakers

Silent agitation system


for platelets
Easy to use
Safe and reliable
“Open-View” cabinet and drawers
Performance not affected
by motor waste heat
Smooth and constant agitation
Low noise level

PlaquetaMix H
Automatic system for platelet concentrates agitation with
horizontal movement

Evolution
PlaquetaMix H is an automatic shaker for platelet concentrates provided with an exclusive
oscillation system.
The pendulous construction of the oscillation system eliminates the friction of the rollers and
consequently reduces the noise level. Furthermore, the rollers are located at the rear part of the
device and do not suffer the weight impact of the drawers cabinet. Its cabinet and drawers made
of stainless steel facilitate the cleaning and disinfection process. It is available in two models to
fulfill the necessity of the blood bank.
PlaquetaMix H merges innovation and technology to accomplish a reliable and safe performance.

Safe design with rounded Adequate distance between Pull-out drawers


edges the drawers The drawers may be removed
Innovative design that provides Allow platelet storage with good while the shaker is working.
minimum risk of injury for the air circulation. Made in screen shape that allows
users. easy visual inspection.

72
1. Silent while shaking.

2. Easy to use - simple user-friendly operation.

3. Unique device with mechanic system


and fan for forced air-cooling at the rear side.
Avoids the heating of the platelets and
maintains quality requirements.

4. Cabinet and drawers made of stainless steel


with rounded edges. Easy to clean and sanitize.
This avoids bacterial growth and accumulation.

5. “Open-View” cabinet and drawers –


facilitates the visual observation of the
platelets motion that guarantees an
excellent O2 exchange.

Audible and visual stop alarm Rear engine and mechanic Start/Pause push-button
Warning signal to the operator parts Allows temporary interruption of
when the agitation is interrupted The difference that makes the high- the movement – for loading and
by more than 1 minute. est quality of platelet storage. The unloading the bags on the drawers.
This avoids damage to the platelets. design allows the system to blow the To restart the agitation it is neces-
heat out of the device. sary to press the button again only.

Ordering information
PlaquetaMix H
81041 PlaquetaMix H 48

81042 PlaquetaMix H 96

Technical data
PlaquetaMix H 48
Storage Capacity: 48 random bags or 24 apheresis bags - 12 pull-out drawers
Dimensions: Height 400 mm
Width 450 mm
Depth 430 mm
Net Weight: 23,9 Kg
PlaquetaMix H 96
Storage Capacity: 96 random bags or 48 apheresis bags - 24 pull-out drawers
Dimensions: Height 400 mm 400 mm
Width 815 mm
Depth 430 mm
Net Weight: 33,0 Kg
Cabinet and drawers made of stainless steel
Movement Frequency: 70 cycles per minute
Lateral Motion Length: 1 and 1/2 inches to right and left
Power Supply: 110-127 / 220-230 VAC, 50-60 Hz

73
Compolift
Filtration Rack

High capacity rack with 48 filtration hooks


Ergonomic
Comfortable
Mobile

Comfortable and ergonomic:


Compolift allows filtration in a very comfortable and ergo-
nomic way. Both the upper - and the lower shelf can be
lifted up and down for loading and unloading the filter
systems. No bending down is necessary for the operator,
so that repetitive strain injuries (RSI) can be prevented.

Compolift
The ergonomic in-line filtration process solution

Ordering information
Filtration rack
9028231 Compolift, 48 hooks
Ergonomic high capacity filtration rack including reduction valves
(Please order separately according to your country!)

Reduction valves for Compolift


-> Obligatory for CO 2 cylinder, not necessary in case of compressor use.
M 63488 Reduction valve Germany

M 63489 Reduction valve Austria

M 63490 Reduction valve Sweden

M 63491 Reduction valve Norway

M 63492 Reduction valve Netherlands

M 63493 Reduction valve France

M 63494 Reduction valve Finland

M 63495 Reduction valve Denmark

M 63496 Reduction valve UK


Please be aware that the air pres-
M 63497 Reduction valve Switzerland
sure cylinder is not delivered by
M 63498 Reduction valve Italy Fresenius.
Please contact a local dealership
M 63499 Reduction valve Belgium for CO2 gas.

74
Mobile use:
Compolift can be powered
by an air cylinder on board
for movable application or
by a central air supply. It
can be equipped with a
Composeal Mobilea on its
central table.
With its four swing
wheels Compolift is very
manoevrable.

High capacity:
Compolift is a high capacity
rack with 48 filtration
hooks. For optimal use of
space it can easily be
moved around on its four
big wheels. The whole
construction is very solid
and easy to clean.

Accessories for Filtration racks


9024281 Compressor 220V; one for each Compolift
(see Compomat G4 accessories)
9024051 Composeal Mobilea 230V/50 Hz (see Composeal)

Additional desk top filtration racks


9023671 Filter rack, 4 hooks
Dimensions (W x D x H) 83 x 51 x 97 cm (max.134)

9023651 Filtration carousel, 8 hooks


Dimensions (Diameter x H): 44 x 116 cm (max.158)

75
Apheresis System

COM.TEC
COM.TEC
Innovative Apheresis Technology

Platelets Stem cells Therapy

Unexcelled donor / patient and operator safety


Plasma "recirculation" for optimized flow conditions
in platelet apheresis
Leukocyte-depleted platelet concentrates
New single needle process; separation time
< 60 minutes for 3 x 1011 platelets
Improved apheresis set design
Colour display
Ease of use
Innovative data transfer software available

COM.TEC -
CONFIDENCE IN QUALITY AND PERFORMANCE

C5 separation chamber: the principle becomes the function

platelet collection bags whole blood inlet

Plasma recirculation:
recirculation whole blood plasma drip chamber
pump pump pump
The plasma recirculation
allows constant separation
conditions to be set in the
separation chamber by
cell
pump
return line regulating the hematocrit
to 35%.
Interface variations are
prevented and the product
separation chamber

qualities remain constantly


high. The RBC barrier
ensures the constant flow
of the platelets in the
second separation step.

78
Separation chamber
High-quality platelet products,
collected in only one processing
step outside of the centrifuge.

C5 chamber – Our platform for your future

”Best flow option“ for optimal separation


and high quality products

Plasma recirculation for optimized flow conditions

The separation chamber is the heart of the cell


separator. The efficiency of this central element
is decisive for the quality of the blood products
obtained. Our development objective was based
on your demands for platelet preparation with
reliable leukocyte depletion and fastest possible
collection.

COM.TEC
For detailed information please order
the COM.TEC folder or contact your
local sales organization.

79
Programs & Disposables
COM.TEC

Programs & Disposables COM.TEC

Programs Disposables

Platelet PLT 5d Platelet apheresis, 5 days storage C5L


(simultaneous plasma harvest possible)
PLT 5d Platelet apheresis, Triple-concentrates, 5 days storage C5LT
(simultaneous plasma harvest possible)
PLT 5d-SN Single needle platelet apheresis, 5 days storage S5L
(simultaneous plasma harvest possible)

Stem cell PBSC-Lym Peripheral blood stem cell collection, C4Y


lymphocyte collection or depletion
RV-PBSC Peripheral blood stem cell collection, RVY
reduced collection volume
MNC Peripheral blood stem cell collection, P1Y
mononuclear cell collection or depletion
autoMNC Automatic collection of peripheral blood stem cells, P1YA
mononuclear cell collection
Granulo Granulocyte collection P1Y
BMSC Bone marrow stem cell processing P1Y

Therapy Deplet Depletion of platelets or white blood cells C4L


RBC Therapeutic red cell exchange or depletion PL1; US: RBC
TPE Therapeutic plasma exchange PL1; US: TPE
Adsorb Therapeutic plasma treatment e.g. immunoadsorption P1R

Short description of programs COM.TEC

PLT-5d: The PLT-5d program uses the C5L-set and the C5LT-set (triple units) for COM.TEC and the
C4L-set for AS.TEC. Platelets are separated continuously in the dual needle mode via two
separate venous accesses. The C5L-, C5LT- and C4L-set are closed systems which enable
platelets to be stored for up to 5 days:

PLT-5d SN: The PLT-5d SN program uses the S5L-set for COM.TEC and the S4L-set for AS.TEC. Platelets
are separated continuously in the single needle mode. The blood flow alternates between
collection- and return phase. During collection phase the processed blood is collected in the
SN bag. After a specific preset collection volume has been processed, the machine automati-
cally switches to the return phase and returns the blood from the SN bag to the donor.
The S5L- and S4L-set are closed systems which enable platelets to be stored for up to 5 days.

80
PBSC-Lym: The PBSC-Lymphocyte program uses the C4Y-set and serves to blood stem cell collection,
lymphocyte collection or depletion. Moreover, the program provides the option to collect an
additional volume of up to 500 ml plasma. It can be used for separation of autologous and
homologous donations.
The PBSC-Lymphocyte program is a continuous procedure with cyclic collection. Each cycle
comprises five phases: collection-, condensation-, spill-over-, waiting and buffy coat phase.

RV-PBSC: The RV-PBSC program uses the RVY-set and serves to blood stem cell collection, with reduced
collection volume. Moreover, the program provides the option to collect an additional
volume of up to 500 ml plasma. It can be used for separation of autologous and homologous
donations. The RV-PBSC program is a continuous procedure with cyclic collection. Each cycle
comprises five phases: collection-, condensation-, spill-over-, waiting and buffy coat phase.

MNC: The MNC program uses the P1Y-set and serves to peripheral blood stem cell collection, mono-
nuclear cell collection or depletion. Moreover, the program provides the option to collect an
additional volume of up to 500 ml plasma. It can be used for separation of autologous and
homologous donations.
The MNC program is a continuous procedure with cyclic collection. Each cycle comprises four
phases: collection-, condensation-, spill-over- and buffy coat phase.

autoMNC: The autoMNC program uses the P1YA-set and serves automatically to peripheral blood stem
cell collection and mononuclear cell collection. Moreover, the program provides the option to
collect an additional volume of up to 500 ml plasma. It can be used for separation of autologous
and homologous donations.
The autoMNC program is a continuous procedure with cyclic collection. Each cycle comprises
four phases: collection-, condensation-, spill-over- and buffy coat phase.

Granulo: The Granulocyte program uses the P1Y-set and serves to granulocyte collection.
Moreover, the program provides the option to collect an additional volume of up to 500 ml
plasma. It can be used for separation of autologous and homologous donations.
The Granulo program is a continuous procedure with cyclic collection.
Each cycle comprises four phases: collection-, condensation-, spill-over- and buffy coat phase.

BMSC: The BMSC program uses the P1Y- and BMSC-set and serves to bone marrow stem cell
collection. BMSC is a continuous in-vitro procedure with cyclic collection. Each cycle comprises
four phases: collection-, condensation-, spill-over- and buffy coat phase.

Deplet: The Deplet program uses the C4L-set and serves to therapeutic depletion of platelets or
platelets and white blood cells. The program is a continuous procedure with cyclic collection.
Each cycle comprises five phases: collection-, condensation-, spill-over-waiting and buffy-coat
phase.

Adsorb: The Adsorb program uses the P1R-set and serves to therapeutic plasma treatment
(e.g. immuno adsorption). Separation is performed until a specific target plasma volume has
been reached.

TPE: The TPE program uses the PL1-set and serves to therapeutic plasma exchange or depletion.
Separation continues until a specific target replacement fluid volume (= plasma volume with
100% balance) has been reached.

RBC: The RBC program uses the PL1-set for therapeutic red cell exchange or depletion.
Separation continues until a specific target replacement fluid volume (= RBC volume with
100% balance + cell balance) has been reached.

81
Technical data
COM.TEC

Intended use • Blood cell separation • Plasma separation • Plasma exchange

Machine group IIb according to MDD (MPG), MedGV group 1

Degree of protection Type B


against electric shock

Dimensions Width: 60 cm, Depth: 66 cm, Height: 140/180 cm

Weight 130 kg

Housing • Material: High-resistance polyurethane foam


• Type of moisture protection: Drip-proof according to IEC 529, IPX 1
• Stability: 10°

Materials used Housing • High-resistance polyurethane foam • Aluminum


• Steel • PVC
• PMMA • Glass

Electrical components • Electronic components (no toxic substances) • Electronic boards


• Electric motors • Lead-acid storage battery
• NiCd accumulator • Lithium batteries
• Electric lines

Mechanical components • Aluminum, steel, brass • Plastic toothed belt


• Bearings • Small plastic parts

Operating conditions

Storage temperature -15°C to +50°C


Air humidity 30 - 75% rel. humidity
Operating temperature +18°C to +27°C

Power supply

Nominal voltage 100-240 V, 50-60 Hz


Nominal power consumption 3.8 A
Peak power consumption 4.0 A
Power backup battery 24 V (2x12 V) / 3 Ah

82
Apheresismaster
the intelligent system

The "Apheresismaster" is a software package for the COM.TEC cell separator. With this
program it is possible to monitor and document the complete apheresis collection process
via a personal computer (Server computer).

The system offers following functions:

Generation and filing of printer protocols Generation and filing of production protocols

Generation and filing of service protocols Monitoring of cell separator data at the server PC

Transfer of donor data from a central Transfer of cell separator data to a central data
data base to a cell separator base

Central data base

COM.TEC 1 COM.TEC 3

Server PC

COM.TEC 2 COM.TEC 4

The Apheresismaster consists of a Server PC which is connected via radio transmission with one or more Fresenius
cell separators. It‘s possible to connect the system using an additional network card with the central data base.

For detailed information please contact your local sales organization.

83
Ordering information
COM.TEC

Devices
900 801 1 AS.TEC 204 (100-240 V, 50/60 HZ)

900 802 1 COM.TEC (100-240 V, 50/60 HZ)


(including: device; PLA-, C4-, C5- Chamber holder; donor display printer)

Accessories AS.TEC 204 COM.TEC


661 052 1 Chamber holder for chamber C4 (dual stage chamber) * *

661 038 1 Chamber holder for chamber PL1 (single stage chamber) * *

661 114 1 Chamber holder for chamber C5 (single stage chamber) *

679 182 1 Printer * *

679 181 1 Printer cable * *

679 201 1 Printer holder * *

900 930 1 SN bag press (only for emergency TPE single needle necessary)

674 701 1 Donor display * *

671 140 1 Pressure cuff (for single needle necessary)

679 744 1 Table *


679 750 1 Rubber pad (table) *

673 074 1 Rubber pad (device) * *

679 757 1 Storage bar for chamber holder *

902 439 1 Bar code scanner

M60 814 1 Holder for bar code scanner

Data communication system COM.TEC


902 824 1 Apheresismaster package complete (German version)

902 825 1 Apheresismaster package complete (English version)

M63792 COM.TEC modification kit DCS (data communication system)


for Apheresismaster (one kit per device)

* included in delivery

84
Solutions AS.TEC 204 COM.TEC
900 728 1 "Frekaflex ACD-A anticoagulant solution, 600ml,
Luer lock and Spike connection with
barcode (ISBT 128) for Art. No and Batch"

900 738 1 "Frekaflex ACD-A anticoagulant solution, 1000ml,


Luer lock connection"

892 030 1 "Frekaflex isotonic saline solution, 1000ml,


Luer lock connection, with barcode (ISBT 128)
for Art. No. And Batch"

131 053 E Freeflex isotonic saline solution, 1000 ml


(drug admission)

940 014 1 PAGGS-M Red cell storage solution, 150ml,


Luer lock and Spike connection, Pigtail with
barcode (ISBT 128) for Art. No and Batch

940 015 1 PAGGS-M Red cell storage solution, 300ml,


Luer lock and Spike connection, Pigtail with
barcode (ISBT 128) for Art. No and Batch
E 2091 SAG-M, 100ml, Spike and Pigtail

E 2092 SAG-M, 250ml, Spike and Pigtail

Consumables AS.TEC 204 COM.TEC


502 801 1 "V651 apheresis cannula for venous puncture,
16g, 1.6mm x 25mm"

900 732 1 Spike with luer lock, female

900 730 1 Blood component collection bag, with luer lock, 500 ml

900 745 1 500-ml transfer bag for simultaneous plasma collection

502 785 1 SN adaptor, luer lock

641 469 1 Printer paper, type 4401

COM.TEC
Confidence in quality and performance

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Ordering information
Sets for AS.TEC 204 and COM.TEC

Order number Set DN/SN AS.TEC 204 COM.TEC Product bags Product
new/old for PLT and sample
stem cells (ml) bag

94009401 / 9007201 PL1 DN

9400411 / 9007211 P1R DN

9400421 / 9007231 P1Y DN 2 x 500

9400301 / 9007251 C4Y DN 500

9400351 / 9007261 S4L SN 2 x 500

9400361 / 9007291 RVY DN 500

9007341 BMSC 2 x 5000

9400311 / 9007371 C4F DN 3 x 1000 (2)

9400441 / 9007601 RBC Ex. DN

9400211 / 9007661 S5L SN 2 x 1000

9400201 / 9007681 C5L DN 2 x 1000

9400321 / 9007771 C4L DN 2 x 1000

9400451 / 9008201 TPE DN


9400331 / 9008241 C4 DN 500

9400371 / 9008271 C4L DN 2 x 500

9009271 C4L DN 2 x 1000

9400221 C5LT DN 3 x 1000

9400431 P1YA DN 2 x 500

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Plasma bags SN bag Waste Spike Luer-Lock Chamber Precon- Special
(ml) (ml) Priming nected Regions
bags (ml) inlet
needle

500, 5000 PL1

500 PL1
500 500 PL1
500 500 C4
500 500 500 C4
500 500 C4

500 500 C4

500, 5000 PL1 USA


500 500

500 500 C5
500 500 C5

500 C4

500 PL1 USA


500 500 C4 USA
500 500 C4
500 500 C4 USA
500

87
Fresenius Transfusion Services
Technical and Educational Services

World wide service:

For medical devices our customers need a specialized and reliable service! This is the
strength of the Fresenius Transfusion Service Team. The world wide service of Fresenius
Transfusion is standardized and trained at highest level. We know all about your special
national and the international regulations for medical device management.

Installation

Maintenance
Safety Checks

Repairs

Our technical service takes charge


Customized services, technical hotline and training

Customized services:

The customers receive the service they prefer:


Our field service offers all services in your center
Our central service offers all services for shipped
devices and equipments

To make the service schedule easy for the customer, we


offer different service contracts and maintenance and
safety checks for the (Fresenius Transfusion) medical
devices.

88
Technical Hotline:

Our Technical Hotline works in close cooperation with the


world wide Fresenius technicians.
This is a network of experience for our customers
for service
for applications
for development

Transferring Know-how
Technical trainings:

At the production plant we train service technicians with


up to 15 seminars per year. We inform them about latest
software updates, about new products and product
changes, service manuals and applications.
This guarantees competence and efficiency for the future.

Customer trainings:

Not only for our own staff we offer training possibilities.


Our customers can profit from our know-how to optimize
the handling of their Fresenius Transfusion products. They
have the possibility to apply for seminars at their local sales
organizations. The offer varies from country to country.

89
Internet
The world wide web

You can find our products and more information about us on the internet. The content
is updated regularly, so if you need the latest information, use the world wide web!

As we are member of the Fresenius Kabi AG, you can find us at:
www.fresenius-kabi.com

This is the way to find our products:


Touch the button products on the homepage of the Fresenius Kabi site with your mouse; a
window opens. The right column with the headline “Transfusion” is the one you have to go to.

Screenshot

If you then click on a product group like "Blood Processing Equipment”, the product site
will be opened:

Screenshot:
Example CompoGuard

On the product site you will find


then besides the product info,
the technical data, accessories
if available, disposables
(especially for Apheresis Systems)
and information about different
procedures.

90
Sales Regions and Sales Organizations
Fresenius Transfusion worldwide

D Sales Region Central Europe: A Sales Region Austria:


Please contact Germany also for Gerätezentrale für Bluttransfusion
Switzerland, Turkey, Eastern Europe des Österreichischen Roten Kreuzes GmbH
& and Middle East Pebering 19
Fresenius Transfusions GmbH 5301 Eugendorf
Pfingstweide 53 Tel.: +43-62 25-7 70 10
61169 Friedberg Fax: +43-62 25-76 33
Tel.: +49-6172-608 8457 Office@gzbt.com
Fax: +49-6172-608 8498
transfusion@fresenius-hemocare.com BR Sales Region South and Central America:
Please contact Brazil for all countries of
NL Sales Region Northwest Europe: Latin America
Please contact the Netherlands for Ireland, Fresenius HemoCare Brasil Ltd.
all Scandinavian and Benelux countries Rua Roque Gonzáles, 128
NPBI International BV 06855-690 - Itapecerica da Serra/SP
Runde ZZ 41 Tel.: +55-11 2183-88 60/88 61
7881 HM Emmer-Compascuum Fax: +55-11 2183-88 13
Tel.: +31-591-355 700 IntlSales.Asembr@fresenius-hemocare.com
Fax: +31-591-352 758
info.NPBI@fresenius-hemocare.com USA Sales Region North America:
CAN Fresenius HemoCare, Inc.
UK NPBI (UK) Ltd. 14715 NE 95th street
205 B&C Milton Park Abingdon Redmond, WA 98052
OX14 4TF OXON UK Tel.: +1-425-497 1197
Phone: +44-123 583 2177 Fax: +1-425-497 0547
Fax: +44-123 583 2178
Info@npbiuk.co.uk ASIA Sales Region Asia Pacific:
NZ Fresenius Asia Pacific Limited
I Sales Region South Europe: AUS Rm. 5101-23
Please contact Italy also for the countries 51/F Sun Hung Kai Centre
Portugal, Spain, Greece, Cyprus, Malta, 30 Harbour Road
Slovenia and Croatia Wanchai, Hong Kong
Fresenius HemoCare Italia S.r.l. Tel.: +852-2116 2683
Via Santi, 293 Fax: +852-2116 3420
41032 Cavezzo - Modena asia-pacific@fresenius-kabi.com
Tel.: +39-0535-45411
Fax: +39-0535-46812 CN Fresenius Kabi China Co. Ltd.
fhcitalia@fresenius-hemocare.com Rm. 2105 Ocean Centre
No. 24 A Jianguomenwai Street
F Sales Region France: Chaoyang District
Please contact France also for Algeria, Beijing, 100004
Tunisia and Morocco Tel.: +86-10-6568-7358 ext. 696
Fresenius VIAL Fax: +86-10-6515-5900
weiping.yang@fresenius-kabi.com
Le Grand Chemin
38590 Brézins D For all other countries:
Tel.: +33-4 74-71 00 71
Fresenius Transfusions GmbH
Fax: +33-4 74-71 00 74
Pfingstweide 53
france-transfusion@fresenius-hemocare.com
61169 Friedberg
Tel.: +49-6172-608 8457
Fax: +49-6172-608 8498
transfusion@fresenius-hemocare.com

91
B 401 E 01/2006

A company of the Fresenius Kabi group


Fresenius HemoCare GmbH . Pfingstweide 53 . 61169 Friedberg . Germany
Phone: +49-61 72-6 08 8457. Fax: +49-61 72-6 08 8498
www.fresenius-kabi.com

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