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STEMCELL TECHNOLOGIES INC.’S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS. 

FOR RESEARCH USE ONLY. NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES. 

TOLL-FREE PHONE

   1 800 667 0322   

   PHONE   

+1 604 877 0713     

  

VERSION 02

 

[email protected]

   

   

[email protected]

   

   

FOR GLOBAL CONTACT DETAILS VISIT WWW.STEMCELL.COM 

DOCUMENT #10000005578

 

33 

8.4

 

Mechanical Performance Issues 

PROBLEM 

POTENTIAL CAUSE 

SOLUTION 

Barcode scanning fails  

Barcode scanner cannot read 
barcode label on vial. 

Check the barcode label is not 
damaged. Twist the vial and scan 
the barcode again.  

Unsuccessful tip pickup 

Tip rack not secure or seated 
properly in the carousel. 

Ensure tip rack is properly inserted 
and flush against the carousel. 

RoboSep™-S arm disturbed during a 
protocol run. 

Take note of the step that run(s) is 
at. Abort current run. If appropriate, 
finish separation manually, 
otherwise prepare new sample and 
restart the protocol from the 
beginning. If issue persists, contact 
Technical Support. 

Tips not well aligned with tubes 

Tip rack not secure or seated 
properly in the carousel. 

Ensure tip rack is properly inserted 
and flush against the carousel. 

RoboSep™-S arm disturbed during a 
protocol run. 

Take note of the step that run(s) is 
at. Abort current run. If appropriate, 
finish separation manually, 
otherwise prepare new sample and 
restart the protocol from the 
beginning. If issue persists, contact 
Technical Support. 

Tip stripping failure 

Plastic buildup on tip head. 

Clean tip head using RoboSep™ 
Tip Head Polishing Compound 
(section 6.1). Do not use ethanol.  

Robotic arm stuck and bouncing up 
and down in fully extended position 

Homing flag on carousel is 
misaligned. 

Power off the instrument and 
physically move the arm all the way 
down. Start instrument again. If 
issue persists, contact Technical 
Support. 

Tip rack separates when removing 
the lid to open it 

Excess force applied when removing 
the tip rack lid. 

Ensure only the top lid is removed. 

Instrument waits for approximately 
one minute with tip attached 

This is a normal operation to 
optimize the overall run time of the 
instrument. 

Contact STEMCELL Technical 
Support to change the default 
threshold time. 

 

Содержание RoboSep-S

Страница 1: ...USER REFERENCE MANUAL RoboSep S The Fully Automated Cell Separator ...

Страница 2: ......

Страница 3: ...view 2 2 1 1 Robotic Arm and Carousel 4 2 1 2 Tip Stripping Arm 6 2 1 3 Hydraulic System 7 2 2 User Interface Overview 8 2 2 1 Screens 8 2 2 2 Icons 9 3 0 RoboSep S Installation 10 3 1 Placement of the Instrument 10 3 2 Power and Network Connections 11 3 2 1 Connecting to a Network 11 3 3 Startup 12 3 4 Shutdown 12 3 5 Priming the Hydraulic System 13 4 0 Running RoboSep S 14 4 1 User Profiles 14 4...

Страница 4: ...24 4 3 5 Collecting Isolated Cells 25 5 0 Report Files 26 5 1 RoboSep S End of Run Report Files 26 6 0 Care and Maintenance 27 6 1 Cleaning the Tip Head 27 6 2 Cleaning RoboSep S 27 6 2 1 External Surface 27 6 2 2 Internal Surface 28 6 3 Replacing the Fuses 28 6 4 Help Videos 29 7 0 Specifications 30 8 0 Troubleshooting 31 8 1 Log Files 31 8 2 Power Issues 31 8 3 Software Hardware Issues 32 8 4 Me...

Страница 5: ...ncubator or cold room Protect the instrument against dust and moisture Do not exert excess pressure or use sharp objects on the touchscreen It is not recommended to use UV light lamps for prolonged periods of time as exposure to UV light will result in discoloring of external RoboSep S components over time EasySep magnets on the RoboSep S carousel generate strong magnetic fields Keep away from pac...

Страница 6: ......

Страница 7: ...nology EasySep is a powerful immunomagnetic cell separation procedure that combines the specificity of monoclonal antibodies with the simplicity of a column free magnetic system EasySep can be used as either a negative or a positive selection approach to purify your cells of interest For EasySep negative selection applications unwanted cells are targeted for depletion using a cocktail of monoclona...

Страница 8: ...NTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES TOLL FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 VERSION 02 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 2 2 0 RoboSep S System 2 1 Instrument Overview Figure 1 Front View of RoboSep S with the Lid Open ...

Страница 9: ...RESEARCH USE ONLY NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES TOLL FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 VERSION 02 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 3 Figure 2 Back View of RoboSep S with the Lid Open ...

Страница 10: ...into cell samples using disposable 1 mL tips Mixing and transfer of the sample between tubes using disposable 5 mL tips Transfer of buffer solution from the buffer bottle to tubes on the carousel using disposable 5 mL tips Simultaneous tracking of incubation times for all separation protocols RoboSep S automatically executes all actions required to process up to four samples with the flexibility t...

Страница 11: ...a for processing a single sample Figure 5 Up to four different samples can be processed simultaneously Each quadrant is numbered on the carousel and can accommodate the following 1 x 14 mL sample tube 1 x The Big Easy EasySep magnet containing a 14 mL separation tube Ensure that a magnet shield is placed on The Big Easy EasySep magnet and that it faces the 14 mL sample tube Up to 3 x EasySep reage...

Страница 12: ...matically at startup at the beginning of each cell isolation protocol and after the instrument has been paused during a run Figure 7 Carousel Homing Flag To ensure accurate homing it is essential that the arm and carousel are not obstructed while RoboSep S is performing a cell separation protocol To prevent such disruptions RoboSep S operates with a transparent lid over the arm and carousel If the...

Страница 13: ...System The hydraulic system uses sterile deionized water driven by a positive displacement piston pump The pipette handling tip head is connected to a hydraulic fluid bottle containing sterile deionized water located behind the front access panel of RoboSep S Figure 1 The only visible part of this system is the tubing running from the console to the robotic arm The hydraulic fluid does not make co...

Страница 14: ...L FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 VERSION 02 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 8 2 2 User Interface Overview 2 2 1 Screens The Home screen allows you to access six different screens and contains the Power button for shutting down the instrument Figure 9 Figure 9 Screens Accessed from the Home Screen ...

Страница 15: ...ples screen Navigates to the Protocols screen Scroll up Add protocols from the All Protocols tab to the My Protocols tab Scroll down Remove protocols from the My Protocols tab Scroll left Protocols added from the All Protocols tab to the My Protocols tab only visible in the All Protocols tab Scroll right Load next quadrant or Selected option Run protocols Unselected option Barcode scanner Currentl...

Страница 16: ...clearance on each side of the instrument to ensure adequate cooling RoboSep S is not specified for use inside an incubator or cold room See section 7 0 for detailed RoboSep S specifications It is recommended to operate RoboSep S with the lid in place to prevent accidental interference with the operation of the robotic arm RoboSep S is designed to fit in chemical hoods and biohazard safety cabinets...

Страница 17: ...back of the instrument Figure 11 3 x USB ports located on the front of the instrument Figure 1 3 2 1 Connecting to a Network RoboSep S can be connected to networks via the Ethernet port The instrument will automatically assign itself an IP address when connected to a Local Area Network LAN Shared documents can then be accessed by all other computers also connected to the LAN To access RoboSep S sh...

Страница 18: ...e main power switch located on the back of the instrument Figure 2 and will also prime the hydraulic system It is recommended not to attach any USB drives to the instrument at the time of startup 1 Turn ON the power switch located on the front of the instrument Figure 1 Note A green indicator light on the front of the instrument will light up indicating that the instrument is turned on 2 Wait for ...

Страница 19: ...e access panel This is to be used only by a STEMCELL Technologies representative for servicing purposes 2 Unscrew the cap and fill the bottle with 250 mL of sterile deionized water 3 Screw the cap back on reconnect the bottle to the hydraulic system tubing and place back into the instrument Figure 14B 4 If necessary start up the instrument section 3 3 5 Select Maintenance on the Home screen Select...

Страница 20: ...r of user profiles that can be created but the creation of over 15 profiles may reduce instrument speed To access user profiles select Users on the Home screen or simply select the User Profile tab at the top of the Run Samples screen All RoboSep S user profiles will be listed in the User Profile screen Figure 15 To choose a user profile simply scroll through the list and select the desired profil...

Страница 21: ... 4 1 3 4 Select Save The new copied user profile will be added to the list of all user profiles 4 1 2 Deleting a User Profile Note A user profile cannot be deleted if that user is currently logged into RoboSep S i e if the user name is present in the User Profile tab The user must first select another user profile and then delete the unwanted user profile 1 Select Delete user profile from the User...

Страница 22: ...ailed view of the progress bar during sample runs Load the most recently used protocols at startup RoboSep S will remember the most recent protocols and sample volumes a user last ran and will automatically assign them to the Run Samples screen This setting is helpful for users who routinely perform the same separation protocols Skip the Carousel Loading screen Bypass the guided Carousel Loading s...

Страница 23: ... to NOT make such information accessible to STEMCELL Technologies Sensitive information includes any information concerning personal material circumstances of an identified individual Users shall not hold STEMCELL Technologies liable for any data or sensitive information that is disclosed To comply with your region and institution s privacy policies update these settings as needed 4 2 RoboSep Prot...

Страница 24: ...ave Select Protocol listed under Protocol Name 2 Select Protocols on the Home Screen The Protocols screen will appear Figure 16 3 Select the All Protocols tab and search for the desired protocol using at least one of the following options o Use the Search box to type in key words related to a protocol name For example enter the EasySep kit catalog number o Scroll up and down the All Protocols list...

Страница 25: ... RoboSep S New RoboSep protocols can be added to RoboSep S simply by using a USB drive Contact STEMCELL Technologies at techsupport stemcell com for more information on how to customize existing protocols or add new protocols to RoboSep S Once you have a new RoboSep protocol transfer it onto a USB drive and use the following set of instructions to add it onto RoboSep S 1 Select Protocols on the Ho...

Страница 26: ... of the detailed instructions described below 1 Select a user profile section 4 1 2 Select Select Protocol and choose the desired RoboSep protocol from the My Protocols tab A Select will appear next to the selected protocol Note Only protocols listed under the My Protocols tab can be assigned to a quadrant Refer to section 4 2 1 for instructions on how to add protocols to the My Protocols tab 3 Se...

Страница 27: ... a protocol from an assigned quadrant select the quadrant number icon on the Run Samples screen An X will appear on the quadrant number icon Figure 20 Select Delete to remove the selected protocol from the assigned quadrant Any combination of quadrants can be selected in this manner Figure 20 Removing a Protocol from an Assigned Quadrant 4 3 2 Preparing the Cells Refer to the Product Information S...

Страница 28: ... placed in the carousel Note The position for the RoboSep Buffer Bottle will not appear on the carousel schematic on the Carousel Loading screen The buffer bottle should be loaded in its compartment Figure 1 5 Optional Scan barcodes to record reagent specific information such as catalog and lot numbers section 4 3 4 Select Barcode scanner on the Carousel Loading screen Figure 22 to scan desired ba...

Страница 29: ...SEARCH USE ONLY NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES TOLL FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 VERSION 02 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 23 Figure 22 Loading the Carousel and Running a Protocol ...

Страница 30: ...canned by the user with a manual barcode scanner By default all barcodes will be scanned If you do not want to scan all barcodes at once during each run edit the user profile preferences and deselect the Enable autoscanning of barcodes option section 4 1 3 Then select Barcode scanner on the Carousel Loading screen Figure 22 to scan desired barcodes for resources loaded in each quadrant Once all sc...

Страница 31: ...cells 1 Select Unload from the Run Progress screen Figure 23 2 Open the RoboSep S lid if necessary 3 Collect the tube s from the quadrant containing the desired isolated cells as indicated on the Unloading screen Figure 23 Click on each quadrant icon on the screen to ensure you have collected all of the tubes 4 Unload the rest of the carousel Store reagents appropriately and discard the used RoboS...

Страница 32: ...h run as entered by the operator while log files contain more detailed information about instrument operation 5 1 RoboSep S End of Run Report Files RoboSep S End of Run Reports contain information such as the operator ID User Profile protocol name run time reagent information sample ID and volumes used EasySep reagent lot numbers as well as sample ID information can be entered before each run at t...

Страница 33: ... stored in its designated compartment in the instrument Figure 1 Over time the tip head can accumulate a thin film of plastic from repeated loading and unloading of pipette tips This accumulation can prevent RoboSep S from stripping the disposable pipette tips from the tip head RoboSep Tip Head Polishing Compound is specially formulated to help remove this build up and disinfect the tip head when ...

Страница 34: ...a soft clean towel Exercise caution when cleaning the gaskets located within the reagent vial and 14 mL sample tube locations Ensure you do not overly bend or permanently crease the plastic fingers of the gaskets during the cleaning process 6 Place the carousel back into the instrument so that quadrant 1 faces the front side of the instrument and screw the central knob clockwise until locked back ...

Страница 35: ...to view the list of videos available Figure 25 Use the scroll bar on the right side of the screen to scroll through the list of videos available Selecting a video will automatically play the video at full screen via Windows Media Player Videos can be paused or stopped using Windows Media Player s user interface If a video is played to the end or stopped Windows Media Player closes and the software...

Страница 36: ... Certified to CAN CSA STD 22 2 No 61010 1 12 Conforms to UL STD 61010 1 2012 Conforms to IEC STD 61326 1 2012 EN STD 61326 1 2013 FCC Part 15 Subpart B 2014 ICES 003 2014 Meets all the Provisions of the Indicated European Directives 2014 35 EU Low Voltage Directive and 2014 30 EU EMC Directive RoboSep S is designed and manufactured so that it does not endanger the safety of operators when properly...

Страница 37: ...o receive the log files To access RoboSep S log files 1 Select Maintenance from the Home screen 2 Select Diagnostic Package 3 Insert a USB drive into one of the USB ports of the RoboSep S Figure 1 4 Select USB as a destination and navigate to the USB drive folder where you want to save the log files The files will automatically be transferred onto the USB drive 5 Remove the USB drive 8 2 Power Iss...

Страница 38: ... of instrument not left off long enough after shutdown It takes up to 10 seconds for the electronics to fully reset after the power switch has been turned off After shutdown turn off the power switch and count to 10 before turning the power back on again RoboSep S software application fails to start Ethernet cable is connected Disconnect Ethernet cable and restart the instrument If issue persists ...

Страница 39: ...ontact Technical Support Tips not well aligned with tubes Tip rack not secure or seated properly in the carousel Ensure tip rack is properly inserted and flush against the carousel RoboSep S arm disturbed during a protocol run Take note of the step that run s is at Abort current run If appropriate finish separation manually otherwise prepare new sample and restart the protocol from the beginning I...

Страница 40: ...ate during a protocol run Hydraulic fluid bottle has run out of water Refill hydraulic fluid bottle and run Prime protocol section 3 5 3 5 times Compromised Teflon tube or leak in the hydraulic system Take photo of the end of the tip head and Contact Technical Support Hydraulic fluid sputtering out of tip head particulate matter present in hydraulic fluid lines Hydraulic fluid line contamination R...

Страница 41: ... SCREEN MESSAGE EXPLANATION Scanned Catalog shown in resource screen Scanned Catalog matches the expected Catalog based on chosen protocol Yellow flashing warning message NO BARCODE SHOULD BE READ Scanned Catalog was not expected due to use of custom protocol etc Red flashing error message INCORRECT BARCODE Scanned Catalog does not match the expected Catalog based on chosen protocol Yellow flashin...

Страница 42: ...FUNCTIONALITY FIX 1 2 1 1 Pre set user profiles removed Updated branding Barcode scanning updated to include reagent lot number Bug fixes 1 3 0 0 Customization of reagent names displayed on graphical user interface GUI Reagent names can now be customized via the Protocol Editor Update to barcode scanning logic as required for new format of catalog numbers Update to End of Run report template Bug f...

Страница 43: ...ted Products PRODUCT SIZE CATALOG RoboSep Service Rack 1 Rack 20101 RoboSep Buffer 250 mL 20104 RoboSep Buffer 5X Concentrate 250 mL 20124 RoboSep Filter Tips 8 Racks 20125 RoboSep Tip Head Polishing Compound 7 mL 20119 11 0 Appendix A Running RoboSep S Quick Start Instructions The following is a brief guide to using the RoboSep S Detailed instructions on running RoboSep S are provided in section ...

Страница 44: ...CAL DEVICE STANDARDS FOR RESEARCH USE ONLY NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES TOLL FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 VERSION 02 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 38 ...

Страница 45: ...CAL DEVICE STANDARDS FOR RESEARCH USE ONLY NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES TOLL FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 VERSION 02 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 39 ...

Страница 46: ...CAL DEVICE STANDARDS FOR RESEARCH USE ONLY NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES TOLL FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 VERSION 02 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 40 ...

Страница 47: ...LL has made all reasonable efforts to ensure that the information provided by STEMCELL and its suppliers is correct it makes no warranties or representations as to the accuracy or completeness of such information STEMCELL TECHNOLOGIES INC S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485 MEDICAL DEVICE STANDARDS FOR RESEARCH USE ONLY NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC U...

Страница 48: ...tomated Cell Separator TOLL FREE PHONE 1 800 667 0322 PHONE 1 604 877 0713 INFO STEMCELL COM TECHSUPPORT STEMCELL COM FOR GLOBAL CONTACT DETAILS VISIT WWW STEMCELL COM DOCUMENT 10000005578 VERSION 02 OCT 2019 FOR INTERNAL USE MATERIAL 29792 ...

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