Sterile Docking Workstation
Contents
1. 16 2014 SynGen 13 After all four DCs are filled remove the collection bags for processing of the pre sample Lift the DC CM Holder to transport for centrifugation Sterile Connection of DC to the CryoPRO 2 Bag Set Repeat the steps for each DC in the DC CM Holder 1 After centrifugation place all four DC CMs onto the DC CM Holder Place the sample access tubing of the BC chamber of the DC into the rear groove of the Tubing Welder clamp Position the tube so that there is little to no slack in the tubing 2 Place the input tubing of the CryoPRO 2 Bag set into the front groove of the sterile docking station clamp Position the tube so that there is little to no slack in the tubing Close the sterile docking station clamp Operate the sterile docking station to create the weld as per the manufacture s instructions Open the sterile docking station clamp Inspect the welding point If the weld is complete gently massage the weld until the tubing is open 14 02 024 A 11 Effective 09 16 2014 S SynGen 3 Attach the same Blood Unit ID label as on the DC to the Freezing Bag of the CryoPRO 2 Bag set 4 Repeat Step 3 for all other DCs 5 After all four DCs are attached to the four CryoPRO 2 Bag sets lift the tray to transport the DC CryoPRO 2 Bag sets pair for addition and mixing of cryoprotectant see SynGenX 1000 User Manual 14 02 024 A 12 Effective 09 16 2014 G SynGen Maintenance and Dis2. In 0 1 2 1 era 6 DP ui UC ANG rte seine op scien curse EEE EEFENEEENENERENESENERR E E E E GER 6 a NE 6 Species 6 Operatine EOvionmen E een orden oe ae 6 Operates under standard laboratory environment conditions uurssssnrssnnnensnnnnenennnen nenn 6 Oprane era TONE ose nern een 7 Transfer of Cord Blood From Blood Bag Collection To Disposable Cartridge 7 Sterile Connection Of DC Sample Access Tube To The Input Tube Of The CryoPRO 2 Bagset Repeat the steps for each DC in the DC CM Holder ooooonnnnncccccnnncncnnnnnnononinoccnccnnnnnnos 11 Maintenance and Disinfection ccccccsscscecscsscsceccccccsceccccccsceccccccscececcccscucecscsccucecscescuces 13 Customer Service amp Technical Assistance cccccccccccccscscscscecsceccceccccccccccccccscscscscececes 13 Waranty ra is 13 14 02 024 A 3 Effective 09 16 2014 SynGen Introduction The Sterile Docking Workstation SDW provides an easy and convenient means of sterile docking up to four cord blood collection bags to the input tubing of up to four SynGenX 1000 Disposable Cartridges DC and the buffy coat transfer tubing of the Disposable Cartridges to up to four CryoPRO 2 Cryopreservation Storage Bag Sets It also facilitates the transfer of the cord blood from the collection bag into the disposable cartridge by gravity SynGen Sterile Docking Workstation 1 The Collection Bag Hanger is used to hang the blood bag received from the c
3. ate the weld as per the manufacture s instructions Open the Tubing Welder clamp Inspect the welding point If the weld is complete gently massage the weld until the tubing is open Attach 14 02 024 A Q Effective 09 16 2014 SynGen the Blood Unit ID label to the DC and verify that it is same as on the Blood Collection Bag 8 Keeping the collection bag on the surface of the sterile docking workstation attach a syringe filled with approximately 20 ml of air to the HES filter Inject the air into the collection bag and recap the HES filter 9 Mix the collection bag thoroughly by inverting the bag 10 times 14 02 024 A 9 Effective 09 16 2014 SynGen 10 Hang the blood bag on the Blood Bag Hanger above the DC Open the pinch clamp on the disposable cartridge input tubing Allow the blood to flow into the disposable cartridge for 10 seconds 11 Take a pre sample by pressing then releasing the sample bulb on the input tubing Each line on the sample tube is 0 5 ml Allow the blood to finish flowing into the DC Manipulate the bag to get as much blood into the DC as possible Attach the Blood Unit ID label same as on DC and Blood Collection bag to the sampling bulb 12 Seal the DC input tubing 1 inch above the top of the cartridge Ov US f r fal g7 a l pe PH y a Ga o 7 We i 4 k a 7 Sr 2A w l y u i 2 N A es J 14 02 024 A 10 Effective 09
4. e SynGen PT E Sterile Docking Workstation USER MANUAL 2125 19 Street Suite 120 Sacramento CA 95818 info syngeninc com Customer Service 1 916 706 0923 Fax 1 916 706 0832 M G SynGen Copyright 2014 by SynGen Inc All rights reserved Permission is granted to the owner to make one copy for record retention and internal personal use This does not create a license to the owner under any copyright trademark patent or to other intellectual property right of SynGen Inc For additional copies of this manual contact SynGen Inc or your local representative Trademark SynGen Inc propriety trademarks are property of SynGen Inc and are protected under U S trademark laws and international treaties SynGen Inc SynGen Sterile Docking Workstation and proprietary trademarks and service marks may not be used except as provided by law without prior written consent of SynGen Inc European Union Authorized Representative MDSS GmbH Schiffgraben 41 D 30175 Hannover It is strongly recommended that all users read this information for use document in its entirety before using the SynGen Sterile Docking Workstation 14 02 024 A 2 Effective 09 16 2014 IPA TM GC gt SynGen Table of Contents Ent ug ae 1 5 ai a 4 Symbol Rev E E E E E E 5 A 5 o 5 A RUN IHR EEE A ibe NENNE AEEA EA IRRE TEE eons ease estas wld AANA AAA A EEE ats eats EAA AEE NE E ANA AE AE 5 SII parrot oran 5 VY AEN EEE A 5 Poe 1a
5. ice failure or malfunction for reasons other than those caused by defects in materials or manufacturing defect such as improper handling of the device misuse accident or non compliance with the User Manual is not covered under the SynGen warranty program and such device will be replaced or repaired at the charge of the end user 14 02 024 A 13 Effective 09 16 2014 G SynGen Any alterations or modification made to the device other than those made by SynGen will render the warranty null and void SynGen will not be responsible for any consequential or incidental damages resulting from device malfunction or loss of use of device SynGen shall under no circumstances be liable for consequential or economic damage that may be an indirect or direct consequence of a defective part 14 02 024 A 14 Effective 09 16 2014
6. infection Use a dry cloth or paper towel to wipe away any liquid that maybe present Then wet a paper towel with a 10 bleach solution or a 70 isopropyl alcohol solution and wipe down all outside surfaces Allow the solution to stay on the surface for 5 minutes then dry with a paper towel Besides disinfection there is no other routine maintenance required Customer Service amp Technical Assistance For assistance with technical or application issues please contact your account representative or SynGen Customer Service at 844 363 0709 USA or 916 256 2423 International SynGen Inc 2125 19th Street Suite 120 Sacramento CA 95818 Website www syngeninc com Email support syngeninc com Fax 916 706 0832 Warranty SynGen warrants to original purchaser that the SynGen Sterile Docking Workstation will be free from defects in material or workmanship for one 1 year from date of shipment SynGen also warrants that spare parts will be free from defects in material workmanship for a period of ninety days 90 or maximum time required by applicable local law from date of shipment of spare part SynGen products are designed and manufactured to provide trouble free and reliable performance when properly maintained and used in accordance with the instructions provided in this manual In case of device failure or malfunction SynGen will replace or repair the Sterile Docking Workstation according to the agreement in place Dev
7. ollection center to be transferred to the DC 2 The Tray is used to seat the DC CM holder in place 3 The DC CM Holder is used to hold a maximum of four Disposable Cartridges or Disposable Cartridges with Control Modules for easy and convenient transfer to the centrifuge 4 The Base has sufficient area to hold a Tube Welder 14 02 024 A 4 Effective 09 16 2014 G SynGen Symbol Key The following symbols and abbreviations are used on the Sterile Docking Workstation labeling packaging or within the User Manual Product or Part Number a a N Warning to be observed by the user A Precaution to be observed by the user Warning A warning is a statement that alerts the user to the possibility of injury death or other serious adverse reactions associated with the use or misuse of the device READ THIS USER MANUAL COMPLETELY PRIOR TO USING THE SYNGEN STERILE DOCKING WORKSTATION e Always follow internal policy for personal protective equipment such as gloves gowns eyewear or masks when using the SynGen Sterile Docking Workstation e Always follow established procedures for handling bio hazardous materials 14 02 024 A 5 Effective 09 16 2014 M zZ GC gt SynGen Precautions A precaution is a statement that alerts the user to the possibility of a problem with AN the device associated with its use or misuse Such problems include device malfunction device failure damage to the device or damage to other proper
8. ty The caution statement includes the precaution that should be taken to avoid the hazard e Follow aseptic procedures e Users should be trained on the Sterile Docking Workstation prior to initial use e Handle the Sterile Docking Workstation with care e Avoid dropping the Sterile Docking Workstation as it may cause damage or injury Specifications Height Width Depth Weight 8 40 Ibs 3 81 kg Operating Environment Operates under standard laboratory environment conditions 14 02 024 A 6 Effective 09 16 2014 SynGen Operating Instructions A It is strongly recommended that users review the entire manual and operating instructions prior to initial system use The instructions below are performed using a Terumo Sterile Tubing Welder TSCD II for sterile docking SynGen Disposable Cartridges and CryoPRO 2 Bag Sets Transfer of Cord Blood From Blood Bag Collection To Disposable Cartridge 2 Close the clamp on the DCs input tubing for all four DCs 3 Repeat the following steps for all four DCs 14 02 024 A 7 Effective 09 16 2014 SynGen 4 Place the input tubing of the DCs into the rear groove of the Tubing Welder clamp Position the tube so that the welding point is half way between the spike and the HES filter 5 Place the Blood Collection Bag to the left side of the Tubing Welder similar to the image above 7 Close the Tubing Welder clamp Operate the Tubing Welder to cre
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