SYMS II MANUAL SEALER Dedicated to CBS High Security straws, CBS High Security tubes, and HSV High Security Vitrification Kits Copyright Cryo Bio System 2010 Cryo Bio System - ZI n 1 Est 61300 L Aigle contact@cryobiosystem-imv.com Tel. +33 (0)233 346 464 - Fax +33 (0)233 341 198
Table of contents 1 Foreword...4 2 Introduction...4 2.1 Applications...4 2.2 Protection and safety...5 2.2.1 Electrical safety standards...5 2.3 Installation security requirements...5 2.3.1 Installation...5 2.3.2 Cautionary note...5 2.3.3 Recommendations...5 2.4 Transport and storage...6 3 SYMS II...7 3.1 Overview...7 3.2 Welding unit...8 3.3 Protective cover...9 3.4 Control touch screen... 10 3.5 Supports... 11 3.5.1 CBS Straw and HSV Kit Support... 11 3.5.2 CBS Tube Support... 11 4 First commissioning... 12 4.1 Sealer installation... 12 4.1.1 Electrical connection... 12 4.1.2 Support positioning... 12 4.2 Sealer activation... 13 4.3 Access to settings... 15 4.3.2 Audio settings... 16 4.3.3 Language settings... 16 4.3.4 Screen settings... 17 5 Operating procedure... 18 5.1 Manual mode... 18 5.1.1 CBS High Security straws... 18 5.1.2 CBS High Security tube... 19 5.1.3 HSV High Security Vitrification Kit... 19 5.2 Automated mode... 20 5.2.1 CBS High Security straws... 20 5.2.2 CBS High Security tube... 21 5.2.3 HSV High Security Vitrification Kit... 21 5.3 Run-up time and transfer time from a mode to another... 22 5.4 Welding time... 22 6 Maintenance... 23 6.1 Servicing... 23 6.2 Accessories and spare parts... 23 6.3 Replacing Teflon strips... 24 6.4 Alarm management... 28 6.4.1 Changing Teflon strips... 28 6.4.2 Opening the cover... 29 6.4.3 System error... 29 Version 6/2012 2
7 Maintenance and cleaning... 30 7.1 Precautions... 30 7.2 Cleaning... 30 8 Technical specifications... 31 8.1 General specifications... 31 8.2 Operating conditions... 31 8.3 Power supply... 31 8.4 Statement of Conformity... 32 9 Important information... 33 9.1 Orders... 33 9.2 Warranty conditions for new units... 33 9.3 Exclusion of liability... 34 9.4 Contact... 34 Version 6/2012 3
1 Foreword The operating instructions are designed to provide an accurate description of our SYMS II sealer and provide you with a full description. Included with the operating instructions, you will find a description of the various components of the sealer, in particular the parts with their references, which are required when you order spare parts (see 6.2 Accessories and Spare Parts). The SYMS II sealer cannot be used to seal any products other than those specified on the list below: Sterile products: o CBS High Security 0.3 ml and 0.5 ml straws o Co-X High Security 0.3 ml and 0.5 ml straws o CBS High Security 2 ml straws o CBS High Security tubes o HSV High Security vitrification Kits Non-sterile products: o CBS High Security 0.3 ml and 0.5 ml straws o Co-X High Security 0.3 ml and 0.5 ml straws o CBS High Security 2 ml straws o CBS High Security tubes To maximize seal integrity of Cryo Bio System products, only use Cryo Bio System products and accessories when using the system. Filling nozzles, tips and other items have been specifically designed for use with the CBS High Security 0.3 and 0.5 ml straws, CBS High Security tube, HSV High Security Vitrification Kit and CBS High Security 2 ml straw. Caution: Only products at room temperature can be sealed with the SYMS II sealer. 2 Introduction 2.1 Applications The SYMS II sealer is a bench top unit that can be used under laminar flow cabinet and is using a thermal procedure to seal CBS High Security 0.3 ml, 0.5 ml and 2 ml straws, CBS High Security tubes as well as HSV High Security vitrification Kits for the following applications: Epidemiological research departments Biological research centers Serum banks Cellular and gene therapy sections Vaccine-manufacturing pharmaceutical companies (living cells) Gene pool banks (animal, vegetal, microbiological) Reproduction biology laboratories Gametes and gonadal tissue banks. Version 6/2012 4
2.2 Protection and Safety 2.2.1 Electrical Safety Standards Class I product requiring installation with properly protected earth connection. Pollution degree 2. 2.3 Installation Security Requirements 2.3.1 Installation Safe use of this unit requires its connection to a grounded, compliant electrical source. The SYMS II sealer is supplied with low tension current through an external power supply. The voltage and frequency should comply with the instructions in the rating plate. The power cable should be in good working order and without any damage. If the cable is damaged in any way, power off the sealer until a replacement cord is available. 2.3.2 Cautionary Note If the unit is used in a manner that is not compliant with the specifications of these operating instructions, the warranty provided with the unit may be compromised. Any change and/or electrical repair should be made solely by a qualified individual under the supervision of a customer service technician of Cryo Bio System. 2.3.3 Recommendations The full seal of all CBS High Security products (specified on page 4) is made by the precise combination of three welding parameters. The parameters include temperature, pressure and time. These parameters are different for each of the different types of CBS High Security products. Failure to use the pre-determined parameters could compromise the integrity of the seal. Under no circumstances should the user modify the parameters. Keep the inside and outside of the CBS High Security products sealing area clean and dry. The sealing support must be adapted to the welding product (3.5: Supports ). Version 6/2012 5
Do not operate the sealer without a CBS High Security product loaded into the machine (CBS High Security straw, CBS High Security tube or HSV High Security Vitrification Kit). Follow the safety instructions on the rating plate. Make sure to install the sealer on a flat and stable surface. 2.4 Transport and Storage Disconnect the unit from the power system. Store and transport the unit and its accessories in the original packaging to prevent any damage. Store the unit in a dry place. Avoid any shock or motion during transportation of the SYMS II. Version 6/2012 6
SYMS II SYMS II 3 3.1 Overview The SYMS II unit consists of the following: the sealer, and Touch screen Protective cover ON/OFF switch Presence detectors Base Side view Version 6/2012 7
external power supply. 3.2 Welding Unit Front view Top view Version 6/2012 8
3.3 Protective Cover When the SYMS II sealer is operating, the removal of the protective cover will immediately trigger an audible signal. The display will show an alarm message and ask you to replace the cover or power down the sealing unit. Version 6/2012 9
3.4 Control Touch Screen 3 The MAIN MENU consists of three areas: 1 1. Types of welding o Automatic o Manual The selected type remains highlighted. 2. Handling and parameters o Cleaning o Teflon change o Set up 2 3. Types of container o Sterile products o Non-sterile products Arborescent software diagram Version 6/2012 10
3.5 Supports Two types of supports are delivered with the SYMS II sealer to provide optimal welding of all the products suggested by Cryo Bio System: CBS Straw and HSV Kit Support for CBS High Security 0.3, 0.5 and 2 ml straws and the HSV High Security Vitrification Kit, and CBS Tube Support for CBS High Security tube. 3.5.1 CBS Straw and HSV Kit Support 3.5.2 CBS Tube Support Version 6/2012 11
4 First commissioning Reminder: The SYMS II sealer is configured only for the welding of CBS High Security sterile and non-sterile products (specified on page 4). 4.1 Sealer Installation 4.1.1 Electrical Connection Connect to power supply as follows: Connect the plug to a grounded electrical source Connect the 4-pin connector to the back of the sealer 4.1.2 Support Positioning Place the CBS straw and HSV kit support or the CBS tube support corresponding to the type of CBS High Security product you are intending to seal. Version 6/2012 12
4.2 Sealer Activation Turn the ON/OFF button on position I. The following screen will display for about 3 seconds: The following display allows for the changing of the Teflon strip: Teflon must be changed within 125 weldings Do it now? YES NO If YES is selected, the following displays will appear successively: TEFLON CHANGE MAIN MENU Version 6/2012 13
Please refer to 6.3 : Replacing Teflon Strips. If NO is selected, the MAIN MENU will be displayed: Version 6/2012 14
4.3 Access to Settings The SETUP menu groups the standard parameters: 1. Standard settings: o Language o Audio o Screen o Exit SETUP menu Version 6/2012 15
4.3.1 Audio Settings By default, the acoustic warning signals are activated. These alarms can be deactivated by selecting the SETUP menu in the MAIN MENU, then AUDIO. 4.3.2 Language Settings By default, the menus on the touch screen are displayed in French. The language can be changed by selecting the SETUP submenu in the main menu, then LANGUAGE. Two languages are available: English and Spanish. Version 6/2012 16
4.3.3 Screen Settings In case of display errors, the screen settings can be reconfigured by selecting the SETUP submenu of the MAIN SCREEN then SCREEN. Version 6/2012 17
5 Operating Procedure 5.1 Manual Mode Manual sealing can be completed as soon as two requirements are met: The presence detector must detect a container (CBS High Security products specified on page 4) and The operator must press the WELDING button. 5.1.1 CBS High Security Straws 1. Select MANUAL in the main menu, then select sterile or non-sterile, and choose the CBS High Security product to be sealed 2. Wait until the preheating is completed 3. When the preheating temperature is reached, the unit will make an audible signal 4. Place the straw on the CBS straw and HSV Kit support and advance it away from the user until the straw stops against the presence detector, 5. Press the WELD button keeping the straw in position, 6. Wait until the seal is completed, it is indicated by a blue bar, 7. Upon completion of the seal, the jaws will re-open and the READY screen is displayed again, 8. Remove the straw from its support, 9. Repeat to seal the other end of the straw (steps 4 to 8). AUTOMATIC MAIN MENU STERILE 0.3/0.5ml CBS High Security MANUAL STERILE MANUAL STERILE MANUAL STERILE MANUAL STERILE NON STERILE 0.3/0.5ml Co-X High Security 2 ml CBS High Security 0.3/0.5 ml CBS High Security HEATING UP 0.3/0.5 ml CBS High Security READY BIP 0.3/0.5 ml CBS High Security WELDING IN PROGRESS CLEANING TEFLON CHANGE SETUP BACK HSV Straw High Security TUBE BACK WELD BACK Back to the previous screen Back to MAIN MENU Back to MAIN MENU Back to MAIN MENU Version 6/2012 18
AUTOMATIC MAIN MENU NON STERILE 0.3/0.5ml CBS High Security MANUAL NON STERILE MANUAL NON STERILE MANUAL NON STERILE MANUAL STERILE NON STERILE 0.3/0.5ml Co-X High Security 2 ml CBS High Security 0.3/0.5 ml CBS High Security HEATING UP 0.3/0.5 ml CBS High Security READY BIP 0.3/0.5 ml CBS High Security WELDING IN PROGRESS CLEANING TEFLON CHANGE High Security TUBE BACK WELD BACK SETUP BACK Back to the previous screen Back to MAIN MENU Back to MAIN MENU Back to MAIN MENU 5.1.2 CBS High Security Tube Follow the same procedure for the CBS High Security straw, selecting TUBE CBS High Security in step 1 and using the support adapted to CBS High Security tube in step 4. 5.1.3 HSV High Security Vitrification Kit Follow the same procedure for the CBS High Security straw and select HSV Kit in step 1. Version 6/2012 19
5.2 Automated Mode The automated welding starts when the presence detector detects one of the containers supported by the SYMS II sealer. 5.2.1 CBS High Security Straws 1. Select AUTOMATIC in the main menu, then select sterile or non sterile, and choose the CBS High Security product to be sealed 2. Wait until the preheating is completed 3. When the preheating temperature is reached, the unit will make an audible signal 4. Place the straw on the CBS straw and HSV Kit support and advance it away from the user until the straw stops against the presence detector 5. When the end of the straw is detected, it is sealed automatically 6. Wait until the seal is completed, it is indicated by a blue bar 7. Upon completion of the seal, the jaws will re-open and READY screen is displayed again, 8. Remove the straw from its support, 9. Repeat to seal the other end of the straw (steps 4 to 8). AUTOMATIC MAIN MENU STERILE 0.3/0.5ml CBS High Security AUTOMATIC STERILE AUTOMATIC STERILE AUTOMATIC STERILE MANUAL CLEANING TEFLON CHANGE SETUP STERILE NON STERILE BACK 0.3/0.5ml Co-X High Security 2 ml CBS High Security HSV Straw High Security TUBE 0.3/0.5 ml CBS High Security HEATING UP BACK 0.3/0.5 ml CBS High Security READY BIP YOU CAN WELD BACK 0.3/0.5 ml CBS High Security WELDING IN PROGRESS Back to the previous screen Back to MAIN MENU Back to MAIN MENU Back to MAIN MENU Version 6/2012 20
AUTOMATIC MAIN MENU NON STERILE 0.3/0.5ml CBS High Security AUTOMATIC NON STERILE AUTOMATIC NON STERILE AUTOMATIC NON STERILE MANUAL STERILE NON STERILE 0.3/0.5ml Co-X High Security 2 ml CBS High Security 0.3/0.5 ml CBS High Security HEATING UP 0.3/0.5 ml CBS High Security READY BIP 0.3/0.5 ml CBS High Security WELDING IN PROGRESS CLEANING TEFLON CHANGE High Security TUBE BACK YOU CAN WELD BACK SETUP BACK Back to the previous screen Back to MAIN MENU Back to MAIN MENU Back to MAIN MENU 5.2.2 CBS High Security Tube Follow the same procedure for the CBS High Security straw, selecting TUBE CBS High Security in step 1 and using the support adapted to CBS High Security tube in step 4. 5.2.3 HSV High Security Vitrification Kit Follow the same procedure for the CBS High Security straw and select HSV Kit in step 1. Version 6/2012 21
5.3 Run-up Time and Transfer Time Between Modes The following data are provided for your information only and were measured during the use of the SYMS II unit at an ambient temperature of 25 C. Data Run-up time for HSV Kit Run-up time for CBS straws Run-up time for CBS tube HSV Kit/CBS straws transfer time HSV Kit/CBS tube transfer time CBS straws/hsv Kit transfer time CBS tube/hsv Kit transfer time CBS tube/cbs straws transfer time CBS straws/tube transfer time Hold time at temperature before standby Tube or straws cooling time up to 39 C Time 1 min 25 s 2 min 20 s 2 min 30 s 1 min 1 min 10 s 30 s 40 s 10 s with support change 10 s with support change 30 min 24 min 5.4 Welding Time The following data are provided for your information only and were measured during the use of the SYMS II unit at an ambient temperature of 25 C. Container For 10 prefilled CBS straws For 10 prefilled CBS tubes For 10 prefilled HSV Kits Welding time 2 min 20 s 2 min 20 s 1 min 20 s Version 6/2012 22
6 Maintenance 6.1 Servicing There is no specific maintenance required for the main mechanical and electrical parts of the sealer. However, it is strongly recommended to regularly clean the sealing plates, especially after heat sealing of the CBS High Security straws, HSV High Security Vitrification Kit, and CBS High Security tube. In the event of stain or area of burns on the Teflon strips, the Teflon should be replaced. 6.2 Accessories and Spare Parts Name Reference CBS straw and HSV Kit Support 022285 CBS Tube Support 022286 Protective cover 022288 Teflon strip / 2 022847 Reminder: Only a professional who is authorized by Cryo Bio System or a customer service technician of Cryo Bio System shall perform potential repairs. Version 6/2012 23
6.3 Replacing Teflon Strips The TEFLON CHANGE function keeps the sealing plates split in order to replace the Teflon strips. The Teflon strips must be replaced every 1,000 welds or in case of stains or area of burns on the Teflon strips. 1. Remove the protective cover Version 6/2012 24
2. Remove the sealing plate 3. Remove the sealing plate clip Version 6/2012 25
4. Remove the worn Teflon strip or the strip showing burn marks 5. Apply a new Teflon strip, then close the sealing plate clip 6. Reposition the sealing plate on its support Version 6/2012 26
7. Follow the same procedure to replace the second Teflon strip 8. Replace the protective cover Version 6/2012 27
6.4 Alarm Management 6.4.1 Changing Teflon Strips The Teflon strips can be replaced only if the temperature of the dies is lower than 40 C. Version 6/2012 28
6.4.2 Opening the Cover As the protective cover is removed, an ALERT screen is displayed on the touch screen and the sealer will generate an audible signal. As the cover is closed, the MAIN MENU appears. 6.4.3 System Error In case of system error, an ALERT screen is displayed on the touch screen and the sealer will generate 3 audible signals every 2 seconds. The sealer is automatically locked. You should restart the sealer. If the problem remains, please contact a customer service technician of Cryo Bio System. Version 6/2012 29
7 Maintenance and Cleaning 7.1 Precautions All the maintenance operations for the SYMS II sealer must be performed with the unit turned off. In case of injury, Cryo Bio System disclaims responsibility. Cleaning can be performed only if the temperature of the sealing plates is lower than 40 C. 7.2 Cleaning The CLEANING function spreads the sealing jaws in order to clean the unit. If the sealing plate temperature is higher than 40 C, an ALERT screen appears and indicates the exact temperature. It is essential to wait until the welding unit cools down. When the temperature is lower than 40 C, the jaws separate. The decontamination can be done as follows: clean with non-woven towel soaked with laboratory machine disinfectant fluid rinse with distilled water dry with non-woven towel soaked with alcohol. The SYMS II sealer can be decontaminated, provided that the unit is not immersed. Version 6/2012 30
8 Technical Specifications 8.1 General Specifications Dimensions Length: 363 mm Width: 276 mm Height: 152 mm Weight: 6 kg Welding temperature from 40 to 140 C, constantly adjustable by 1 C at a time Dies speed: 20 mm / sec Dies opening: adjustable from 1 to 10 8.2 Operating Conditions Indoor use Operating temperature: from 5 to 30 C Maximum relative ambient humidity: 80% Usage environment The unit cannot be used at an altitude higher than 2,000 m, or in an explosive or corrosive environment. 8.3 Power Supply External power supply Supply voltage: 100-240 V Supply frequency: 50-60 Hz Consumed power: 120 W max Output 12V with a 4-pin DIN miniconnector Sealing Plates Voltage: 12 15 V Version 6/2012 31
8.4 Statement of Conformity We, the undersigned, Cryo Bio System, ZI n 1 Est, 61300 L Aigle, certify that: The SYMS II sealer ref. 022319 Serial number: - complies with the existing European Directives: 2004-108/CE and 2006-95/CE. Executed in L Aigle, on / / Mr. BEAU Version 6/2012 32
9 Important Information 9.1 Orders For any spare parts order, thank you for referring to 6.2 : Accessories and Spare Parts in these operating instructions. 9.2 Warranty Conditions for New Units Cryo Bio System guarantees its equipment against all malfunctions caused by faulty material, manufacturing defect, or design error for one year from the date which is provided on the certificate of guarantee. Free parts and service will be included during this period. Warranty exclusions include the following: If the malfunction is caused by an unauthorized procedure on the unit If the malfunction is caused by a non-compliance with technical specifications and the operating instructions of the seller If the malfunction is caused by fortuitous events. Based on the above warranty, Cryo Bio System will repair or replace the parts that become unusable during the warranty period for reasons outlined above. The implementation of this warranty - that is, the repairs and replacements of the whole unit or parts of the delivered unit, is not likely to extend the warranty time. Any dispute caused by the interpretation and/or execution of these warranty conditions, shall be exclusively subjected to the French law. The Courts of Alençon shall be the only competent courts including in the event of a third party complaint and several defendants. Version 6/2012 33
9.3 Exclusion of Liability The Cryo Bio System Company is not responsible for damages caused by external influences as well as inappropriate and non-compliant treatments with the recommendations stipulated in these operating instructions. Refer to the application fields (see 2.1 Applications) and electrical specifications (see 8.3 Power supply) of these instructions. 9.4 Contact Cryo Bio System ZI n 1 Est 61300 L Aigle Tel. +33 (0)233 346 464 Fax +33 (0)233 341 198 Tel. Customer Service +33 (0)233 346 444 Fax Customer Service +33 (0)233 849 504 contact@cryobiosystem-imv.com Version 6/2012 34
Notes: Version 6/2012 35