General Hardware and Software Questions:
1. What is the battery life of the SynGenX® Control Module?
The Control Module battery will last approximately 1 week between charges assuming normal usage (3-6 centrifugation runs per day). However, it is always recommended that you check the battery status indicator when the Control Module is placed on the docking station before proceeding with a new run.
2. Since the Control Module battery is lithium ion, does it need to be drained?
The battery does not need to be drained. There is no need to do anything special with respect to the battery. Unlike Ni-CAD batteries, it has no “memory”.
3. What is the best way to store the Control Modules for long term?
The Control Modules can be stored safely on a shelf at room temperature for long term. After such storage, however, it is a good idea to charge the battery overnight prior to initial use.
4. How do I return the Control Modules for annual maintenance?
In order to return a Control Module for its annual maintenance, you will need to:
a. Contact Customer Service and request a Return Merchandise Authorization (RMA) for your Control Module.
b. Customer service will provide you with:
• An RMA Form to send back with your Control Module
• A decontamination form to be completed and returned with the Control Module
• Instructions for cleaning your Control Module
• A Return Shipping Label
c. You will need to follow the cleaning instructions and complete the decontamination form.
d. Pack up the Control Module for shipment in the original box (if this is not available, we will supply a replacement).
• An original copy of the decontamination form and a copy of the RMA form need to be included with the shipment.
e. Ship the unit back to SynGen.
5. If I get an error message indicating the Control Module is no longer working correctly, how do I exchange it?
Control Modules under warranty will be replaced. A replacement Control Module will be shipped to your site. Your current Control Module can then be returned in the same packaging that your replacement was shipped in, following the instructions under step 4 above, indicating this is an under-warranty replacement.
If you would prefer to not have an exchange and wish to keep your current Control Module, you will need to ship that Control Module back to the SynGen, following the steps in step 4, above. Indicate that you want to receive the same Control Module back after repair.
• Please note – not all Control Modules can be repaired. If the evaluation shows the Control Module cannot be repaired, you will be notified and a replacement will be shipped out.
For Control Modules that are not under warranty or service contract, contact SynGen directly for instructions.
6. Can I use a different centrifuge than specified?
We do not advise doing so. Only the Thermo Fisher Sorvall™ Legend™ XT-Series centrifuge can be programmed to provide the linked cycle steps of g-force and time that SynGen has validated. The 750 mL buckets are an exact fit for the SynGenX®– Disposable Cartridge.
7. With what computer operating systems is the SynGen® DataTrak software compatible?
Windows® 7 and Windows 8.1
For the SynGenX®-1000 System and its Auxiliary Products:
1. How much cord blood can be processed in a single SynGenX®-1000 Disposable Cartridge?
The Disposable Cartridge can process from 40mL to 220mL of cord blood.
2. What is the volume of the Mixing Chamber of the CryoPRO™-2 Cryopreservation/Storage Bag Set?
The Mixing Chamber is designed to allow optimum mixing with 20-25 mL of buffy coat and cryoprotectant, but can hold a maximum of 30 mL of fluid.
3. What is the volume of the segment line tubing on the Freezing Bag?
The segment line tubing connecting to each of the compartments holds 0.1 mL/inch
4. Do I need to use HES when processing cord blood with the SynGenX-1000 System?
HES is not required, but may be used if desired.
5. Should I choose to use HES, what is the recommended mixing time after adding HES to the blood in the collection bag?
Any added HES should be mixed in the collection bag by gently rocking about 45 degrees from side to side for a minute or so. After this mixing, follow any additional protocols that have been established and validated within your lab.
After the HES and cord blood have been mixed in the collection bag, transfer the contents of the bag to the central compartment of the Disposable Cartridge and gently rock the cartridge about 45 degrees from side to side for a minute or so.
For the SynGenX®-LAB System:
1. What sources of cells can be processed with the SynGenX-LAB system?
Bone marrow, peripheral blood, cord blood, Leukapheresis product, and thawed cellular products.
2. Can I use Ficoll in the SynGenX-LAB system?
No. The SynGenX-LAB system was designed to replace the Ficoll process.
3. What volumes of cell sources can I process in a single SynGenX®-LAB Disposable Cartridge?
40 mL to 220 mL
4. What types of processes can be performed with the SynGenX-LAB System?
• Cell Harvesting
• Cell Washing
• Volume Reduction and Concentration
• Cell Separation
5. What final volumes can I harvest my target cells into?
There are a number of variables that impact the final harvest volume, including:
• The initial volume placed into the disposable cartridge for processing.
• The volume of depleted cells removed and the target harvest volume
With the above considerations in mind, customized programming of the centrifuge and the Control Module allow a final target volume ranging from 3 to 25 mL. Contact SynGen for details.