IBA FABian User manual

Document No.: 010
Version: 9
Modification Date: 2020-11-04 © 2020 IBA GmbH
Instruction Manual

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 2of 39
Product Specifications
Item:
FABian®
Product Version:
Laboratory Version
Software Version:
FABian firmware 1.0
Item-No.:
6-6100-260
Delivery Content:
FABian®, PSU & Power Cable, 50 ml Tube Holder, Syringe
Adapter 10 ml, Instruction Manual, SD-Card, Return Form,
Decontamination Declaration
Revision Index / -Date
Rev. 9, 2020/11/04
IBA GmbH
Bosestr. 4
04109 Leipzig
Germany
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
Homepage: www.iba-lifesciences.com
On behalf of the IBA GmbH, the instruction manual has been designed and engineered by Cell.Copedia
GmbH.
©
This instruction manual may not be copied in whole or in part without the authorization of IBA
GmbH. The figures in this instruction manual may differ from the actual design and are not
displayed on full scale (1:1).

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 3of 39
Index
0Preface....................................................................................................................................................... 5
1Explanation of Symbols.............................................................................................................................. 5
2Product Description and Technical Data.................................................................................................... 6
2.1 General Product Information and Unit Design.................................................................................... 6
2.2 Delivery Content.................................................................................................................................. 7
2.3 Technical Data .................................................................................................................................... 7
3For your Safety........................................................................................................................................... 8
3.1 Warning Signs and Security Level...................................................................................................... 8
3.2 Intended Use and Foreseeable Improper Operation .......................................................................... 8
3.3 Target Group, Staff Qualifications....................................................................................................... 9
3.4 Personal Protective Equipment........................................................................................................... 9
3.5 Safety Instructions for Commissioning................................................................................................ 9
3.6 Operating Conditions of the Product................................................................................................... 9
3.7 Safety Instructions For Operation ..................................................................................................... 10
3.8 Safety Instructions for Cleaning, Maintenance ................................................................................. 10
3.8.1 Cleaning..................................................................................................................................... 10
3.8.2 Maintenance .............................................................................................................................. 11
3.9 Decommissioning, Dismantling, Disposal......................................................................................... 11
4Transport and Storage ............................................................................................................................. 12
4.1 Transport........................................................................................................................................... 12
4.2 Storage.............................................................................................................................................. 12
4.3 Storing and Protecting between Usage Periods............................................................................... 12
5Prepare FABian® for Use......................................................................................................................... 13
5.1 Select Installation Place.................................................................................................................... 13
5.2 Prepare Installation ........................................................................................................................... 13
5.3 Install Unit.......................................................................................................................................... 14
6Operation of FABian®.............................................................................................................................. 16
6.1 Commissioning.................................................................................................................................. 16
6.2 Normal Operation.............................................................................................................................. 16
6.2.1 Inserting the Syringe.................................................................................................................. 16
6.2.2 Inserting the Tube Holder .......................................................................................................... 18
6.2.3 Inserting the Tubes .................................................................................................................... 18
6.2.4 Operating Keys and Program Selection .................................................................................... 20
6.2.5 Program Run.............................................................................................................................. 20
6.2.6 Stopping the Program, Removal of the Sample and of the Syringe.......................................... 22
6.3 Fault Repair....................................................................................................................................... 24
6.4 Technical Support ............................................................................................................................. 24
7Maintenance and Cleaning....................................................................................................................... 25
7.1 Cleaning............................................................................................................................................ 25
7.2 Maintenance and Repair by the Customer Service .......................................................................... 26
8Provided Accessories, Consumables, Spare Parts ................................................................................. 27
8.1 Consumables .................................................................................................................................... 27
8.2 Spare- and Replacement Parts......................................................................................................... 28
9Information on Special Tools, Devices, Materials.................................................................................... 31
10 Decommissioning, Dismantling, Disposal............................................................................................. 34
11 Annexes................................................................................................................................................ 35

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 4of 39
Tables of Figures
Figure 1 –Overview Unit Design....................................................................................................................... 6
Figure 2 –Insert SD-Card ............................................................................................................................... 14
Figure 3 –Power Connection to the Device.................................................................................................... 15
Figure 4: FABian® Syringe.............................................................................................................................. 17
Figure 5: Insertion of the Syringe (1)............................................................................................................... 17
Figure 6: Insertion of the Syringe (2)............................................................................................................... 18
Figure 7 - Notch for Locking Mechanism......................................................................................................... 18
Figure 8 - Tube-Contents ................................................................................................................................ 19
Figure 9 –Operating Keys............................................................................................................................... 20
Figure 10 –Program Selection –Green Illuminated Keys.............................................................................. 20
Figure 11 –Program Selection........................................................................................................................ 21
Figure 12 - Program A Is Running................................................................................................................... 21
Figure 13 –Removal of the Target Product: Tube 9, 10 und 11..................................................................... 23
Figure 14: Image of a Tube............................................................................................................................. 27
Figure 15: Image of a Syringe......................................................................................................................... 27
Figure 16 –Image of the Tube Holder, SD-Card, PSU & Power Cable.......................................................... 29
Figure 17: Image of Syringe Adapter incl. Tool............................................................................................... 30
Figure 18: Removal of the Screws From the Bottom Part of the Adapter....................................................... 31
Figure 19: Unscrewing the Screws From the Upper Part of the Adapter........................................................ 31
Figure 20: Removal of the Syringe Adapter .................................................................................................... 32
Figure 21: Insertion of the Bottom Part of the Adapter.................................................................................... 32
Figure 22: Installation of the Bottom Part of the Adapter ................................................................................ 32
Figure 23: Insertion of the Upper Part of the Adapter ..................................................................................... 33
Figure 24: Tightening the Upper Part of the Adapter ...................................................................................... 33
List of Tables
Table 1 –Explanation of the Appliance Switches and Symbols ....................................................................... 5
Table 2 –List of Supplied Parts......................................................................................................................... 7
Table 3 –Overview Technical Data................................................................................................................... 7
Table 4 - Checklist........................................................................................................................................... 13
Table 5 –Key Functions.................................................................................................................................. 20
Table 6 –List of Consumables........................................................................................................................ 27
Table 7 –List of Spare parts and Accessories................................................................................................ 28
Abbreviations
AC Alternating Current PSU Power Supply Unit
°C Degree Celsius SELV Safety Extra Low
Voltage
DC Direct Current UPS Uninterruptible Power
Supply
EU European Union V Volt
F Fahrenheit W Watt
g Gram
Hz Hertz
Ib Pound
kg Kilogram
m Meter
ml Milliliter
mm Millimeter
PBS Phosphate-Buffered Saline

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 5of 39
0 Preface
In order to ensure a safe and appropriate usage, read the instruction manual and further product-
related documents carefully and keep them in safe custody for future use!
This instruction manual contains important information, which must be read and understood in full
before the device is used. A precondition for safe operation is the observance of all safety and
handling instructions specified in this instruction manual.
This instruction manual is part of the product, must always be kept near the device and should be
available for the personnel at any time.
In case of loss or damage of the instruction manual, please request a replacement.
In addition to the instructions in this manual, the regulations of the employers’ liability insurance
association for health protection and industrial safety apply.
Exclusion of Liability:
The manufacturer will not assume any liability, if:
-the regulations in this manual are not being followed,
-the device has been used improperly or has not been used for the specified purpose,
-spare parts, accessories or consumables are being used, that are not approved by the manufacturer
-the device has not been operated by trained and instructed personnel,
-the housing has been opened or removed,
-the device has been repaired or maintained by a non-authorized person.
Furthermore, users are forbidden to modify FABian®. If there is still any modification, the product warranty
will cease. IBA GmbH is not responsible for possible consequences caused by a modification and will be
exempted from all kinds of customer care commitments. In this case, the safety of FABian® cannot be
guaranteed anymore. The manufacturer will not accept any liability for damages resulting from modifications.
1 Explanation of Symbols
Table 1 –Explanation of the Appliance Switches and Symbols
Symbols und Appliance Switches
Type Plate (placed on the bottom side of the
device)
Do not dispose of the device with normal
household garbage!
Symbol Protection Class III (SELV)
On / Off-Switch →Device is turned on and off;
Initialization of the device
Start-Stop-Button →Program is started / stopped;
device is in transport position
Program Selection Keys

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 6of 39
2 Product Description and Technical Data
2.1 General Product Information and Unit Design
Figure 1 –Overview Unit Design
FABian® is an automatic benchtop device for the selection of cells from a suspension (e.g. blood or other
single cell suspensions) and is designed for research use only. The system may be operated exclusively in a
laboratory environment by qualified and specially trained personnel. The selection process is performed with
the help of disposable products: max. 11 tubes on a round tube holder and the special FABian®-syringe are
necessary to gain the pure, minimal manipulated and non-activated target product. The operation of
FABian® is simple and intuitive. By pushing the on/off-Switch on the right side of the device FABian® starts
the initiation program. For the operation, FABian® is equipped with 5 operating keys –4 program selection
keys and one start-stop-button. After the insertion of the syringe and the tubes and after the program is
chosen, the device is passing the specific selection steps. Depending on the chosen program the whole
selection process takes about 30-90 minutes (duration depending on chosen program) to provide purified
target cells which can be removed from the tubes afterwards.

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 7of 39
2.2 Delivery Content
Table 2 –List of Supplied Parts
Amount
Item-No.
Description
Additional Information
1
6-6100-260
FABian® Device
Spare Part
1
6-6104-050
50 ml Tube Holder
Spare Part
1
6-6105-010 /
6-6106-010
Syringe Adapter 10 ml (already mounted
in the cover)
Spare Part
1
6-6103-000
SD-Card with preinstalled program
selection
Spare Part
1
6-6101-000
PSU
Spare Part
1
6-6102-000
Power Cable
Spare Part
1
FABian® Instruction Manual, english
Keep in safe custody!
1
Return Form
to complete by the customer
1
Decontamination Declaration
to complete by the customer
2.3 Technical Data
Table 3 –Overview Technical Data
Dimensions / Weight (Mass, Capacity, Power)
Measurements
Width
198 mm
Depth
315 mm
Height
230 mm
Operation Height
455 mm
Weight (net)
3840 g (Basic Unit 3088 g, Tube Holder 752
g)
Power Supply Data
Power Supply Unit
Input Voltage
90…264 V AC
Frequence
47 - 63 Hz
Power
max. 20 W
Input Voltage Device
24V DC
Safety Devices
integral, self-resetting
Protection Class (according to
DIN 61140)
III (SELV)
Protection Type (IP-Code)
IP30
Environmental Conditions
Environment
Use indoors only!
Ambient Temperature
Operation
+10 °C (50 F) - +35 °C (95 F)
Storage
+10 °C (50 F) - +35 °C (95 F)
Humidity
No condensating humidity
Operation
0% - 75%
Storage
0% - 75%
Air Pressure
Usage up to 2.000 m above sea level
Application Parameters
Device Temperature
25 °C
Maximum Load
Tubes
11 Tubes à 30 - 50 ml
Syringe
1 Syringe à 10 ml

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 8of 39
3 For your Safety
3.1 Warning Signs and Security Level
Security Level
DANGER
Will lead to serious injuries or
death
WARNING
Can lead to serious injuries or
death
CAUTION
Can lead to moderate or minor
injuries
ATTENTION
Can lead to property damage
Note
Indicates useful information
3.2 Intended Use and Foreseeable Improper Operation
FABian® is an automatic device for the selection of cells from a suspension (e.g. blood or other single cell
suspensions) with the help of a syringe and tubes and is designed for research use only. The selection
device is intended only for the purposes determined and any other application (e.g. therapeutic application)
or any further purposes shall be considered as improper.
IBA GmbH shall not accept liability for any damage arising as a result of the above mentioned modifications.
The intended use also includes the attention of all references of the instruction manual, the compliance with
maintenance and inspection work as well as the observation of the installation instructions and of the
cleaning and maintenance notes.
Residual Risks
Although the device is constructed and qualified in accordance with the current state of the art and with
recognized safety regulations and standards, the operation of the device involves a certain amount of risks.
Residual risks result from crushing fingers by the piston- and syringe lift stages in the event of non-
compliance with the safety regulations as well as from electric shock, if you operate the device with a power
supply unit which is not indicated here.
Faults which may adversely affect the safety shall be promptly notified to the IBA GmbH.
According to the fault type it will be decided individually, if the error can be resolved by the user or by the
service personnel of the IBA GmbH.
Warning Signs
General Danger
Electric Shock Danger
Risk of Crushing
Explosion Danger
Biological Hazard
Note
WARNING!
➔The non-compliance with the described safety regulation may result in health
damages or may lead to damages to the device. The manufacturer cannot be
made liable for any damage caused by the non-compliance with the safety
regulation.

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 9of 39
WARNING!
Risk of Biological and Chemical Contamination by Used Reagents
➔
If biological or chemical hazardous materials are involved, please observe the
relevant warnings and protection provisions for those materials and wear
appropriate personal protective equipment.
3.3 Target Group, Staff Qualifications
FABian® may be operated exclusively for commercial use by trained and qualified personnel, who have fully
read and understood the instruction manual. The user must be familiar with the unit´s functions. This
knowledge can be achieved by reading the instruction manual and by additional information- and training
offers by the IBA GmbH.
By purchasing the first devices we recommend training courses for a safe and appropriate usage.
3.4 Personal Protective Equipment
The device shall only be used with laboratory protective equipment. The users must observe the
occupational safety regulations of the operating company as well as the national regulations for occupational
safety.
In case of usage of biological or chemical hazardous materials protective gloves, protective clothing and
safety glasses shall be worn.
3.5 Safety Instructions for Commissioning
The power cable must be routed in such a way that it does not represent a tripping hazard and that no
damages can be caused by other devices. Use only the original power cable.
3.6 Operating Conditions of the Product
FABian® is designed to be used exclusively indoors. For a safe usage a dry condition is required (see
ambient temperature and humidity chapter 2.3), e.g. a ventilated laboratory.
DANGER!
Electric shock Caused by Device Damages or Power Cable
➔
Activate the unit only if it is secured that the device and the power cable are
intact.
➔Only start up devices, which are professionally installed or properly maintained.
WARNING!
Danger Causes by Improper Power Supply
➔
FABian® may only be operated with the voltage specified on the power supply
unit. Connect the device to a properly earthed and fused power socket only.
WARNING!
Danger of Injuries and Device Damages as a Result of Incorrect Operation by Non-
qualified Personnel
➔
Misapplications of FABian® and the non-compliance with security regulations
may result in injuries caused by e.g. electric shock or crushing.
➔
An improper operation of the device can lead to total loss of the target product,
accessories and consumables and can cause serious damages to the device.
Explosion Danger
➔Do not use FABian® in rooms susceptible to explosions.
➔Do not use FABian® with radioactive, explosive or corrosive materials.
DANGER
!

Product: FABian® Item-No.: 6-6100-260
Instruction Manual, Revision 9 Doc.-No.: 010 Date of Issue: 2020/11/04 Page 10 of 39
3.7 Safety Instructions For Operation
Protection Devices, Emergency Stop
An emergency stop, which is installed inside or outside of the laboratory, is desirable for disconnecting the
power supply in case of failures. We recommend the connection to an in-house emergency power unit that
will take over the power supply in case of an electricity failure. This can often be identified by green labeled
power sockets.
Precautions during operation
For the operation of the device movable components are required. The tube holder and the inserted tubes
can fall from accidental collisions. To avoid risks and accidents, do not touch the device during operation.
We recommend placing the device as far away as possible from table edges, to prevent a falling of the
device and personal injury. Do not under any circumstances connect an injection needle to the syringe for
device operation. There is a risk of puncturing the fingers, if you accidentally place your fingers under the
injection needle during operation.
Should your fingers nevertheless become trapped between the device levels, you can release your fingers
with your other hand or with the help of another person by lifting the device level manually.
Never leave the device unattended while in operation. Please stop the process in case of device damages,
abnormal sounds, odors or any other irregularities; switch the device off, pull out the power plug and call the
service technician. When unplugging the power plug hold it by the plug only and remove it carefully.
3.8 Safety Instructions for Cleaning, Maintenance
3.8.1 Cleaning
The device must always be cleaned after use.
DANGER!
Life-Threatening Voltage by Opening the Device
➔
Make sure, that the housing is intact and closed, so that no risks can arise from
the inside of the device.
➔
It is not allowed to remove the cover of the device. All work on the device should
be performed exclusively by service personnel of the IBA GmbH.
DANGER!
Electric Shock Caused by Damp Device and Leaking Liquids
➔
Switch off the device and disconnect the power supply previous to the cleaning
process.
➔Ensure that no liquids leak into the inside of the device.
➔
Only if the device and the power cord are completely dry, connect the device to
the power supply and switch it on again.
ATTENTION
Damaged Component Parts Can Lead to Injuries and to a Loss of the Target
Product
➔
Periodically check all component parts of the device and make sure that they
work perfectly.
➔
Damaged tubes and syringes can lead to damaged samples / target product and
can cause damages to the device.
➔
Be sure that there are no component parts in use, whose expiry date has passed.
CAUTION!
Crushing of Fingers by Device Levels
➔
Do not touch the device during commissioning and operation. Do not place your
fingers between the device levels. Your fingers may get between the device
levels and the process might be interrupted.