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

This document cannot be disclosed to third parties without written authorization by Cryo Bio System.

Cryo Bio System - ZI n°1 Est – 61300 L’Aigle

[email protected] – Tel. +33 (0)233 346 464 - Fax +33 (0)233 341 198
 SYMS II® Operating instructions

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

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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

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 SYMS II® Operating instructions

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.

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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”).

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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®.

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3 SYMS II®

3.1 Overview

The SYMS II® unit consists of the following:

• the sealer, and

Touch screen
Protective
cover ON/OFF
switch

Presence Base
detectors

Side view

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• external power supply.

3.2 Welding Unit

Front view

Top view

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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.

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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 2
o Set up

3. Types of container
o Sterile products
o Non-sterile products

Arborescent software diagram

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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

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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.

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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”

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Please refer to 6.3 : “Replacing Teflon Strips”.

If “NO” is selected, the “MAIN MENU” will be displayed:

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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

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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.

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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”.

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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).

MAIN MENU STERILE MANUAL MANUAL MANUAL

0.3/0.5ml
CBS
AUTOMATIC High
Security STERILE STERILE STERILE

0.3/0.5ml 0.3/0.5 ml CBS 0.3/0.5 ml CBS 0.3/0.5 ml CBS

MANUAL Co-X High Security High Security High Security
High
Security HEATING UP WELDING IN PROGRESS
STERILE
2 ml
CBS READY
NON STERILE High BIP
Security

CLEANING
HSV
Straw
TEFLON
CHANGE WELD
BACK BACK
High
SETUP BACK Security
TUBE

Back to the previous screen

Back to MAIN MENU Back to MAIN MENU Back to MAIN MENU

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MAIN MENU NON STERILE MANUAL MANUAL MANUAL

0.3/0.5ml
CBS
AUTOMATIC High
Security NON STERILE NON STERILE NON STERILE

0.3/0.5ml 0.3/0.5 ml CBS 0.3/0.5 ml CBS 0.3/0.5 ml CBS

MANUAL Co-X High Security High Security High Security
High
Security HEATING UP WELDING IN PROGRESS
STERILE
2 ml
CBS READY
NON STERILE High BIP
Security

CLEANING
High
Security
TEFLON TUBE
CHANGE WELD
BACK 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.

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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).

MAIN MENU STERILE AUTOMATIC AUTOMATIC AUTOMATIC

0.3/0.5ml
CBS
AUTOMATIC High
Security STERILE STERILE STERILE

0.3/0.5ml 0.3/0.5 ml CBS 0.3/0.5 ml CBS 0.3/0.5 ml CBS

MANUAL Co-X High Security High Security High Security
High
Security HEATING UP WELDING IN PROGRESS
STERILE
2 ml
CBS READY
NON STERILE High BIP
Security
YOU CAN WELD
CLEANING
HSV
Straw
TEFLON
CHANGE
BACK BACK
High
SETUP BACK Security
TUBE

Back to the previous screen

Back to MAIN MENU Back to MAIN MENU Back to MAIN MENU

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MAIN MENU NON STERILE AUTOMATIC AUTOMATIC AUTOMATIC

0.3/0.5ml
CBS
AUTOMATIC High
Security NON STERILE NON STERILE NON STERILE

0.3/0.5ml 0.3/0.5 ml CBS 0.3/0.5 ml CBS 0.3/0.5 ml CBS

MANUAL Co-X High Security High Security High Security
High
Security HEATING UP WELDING IN PROGRESS
STERILE
2 ml
CBS READY
NON STERILE High BIP
Security

CLEANING YOU CAN WELD

High
Security
TEFLON TUBE
CHANGE
BACK 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.

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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 Time
Run-up time for HSV Kit 1 min 25 s
Run-up time for CBS™ straws 2 min 20 s
Run-up time for CBS™ tube 2 min 30 s
HSV Kit/CBS™ straws transfer time 1 min
HSV Kit/CBS tube transfer time 1 min 10 s
CBS™ straws/HSV Kit transfer time 30 s
CBS™ tube/HSV Kit transfer time 40 s
CBS™ tube/CBS™ straws transfer time 10 s with support change
CBS™ straws/tube transfer time 10 s with support change
Hold time at temperature before standby 30 min
Tube or straws cooling time up to 39°C 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 Welding time

For 10 prefilled CBS™ straws 2 min 20 s
For 10 prefilled CBS™ tubes 2 min 20 s
For 10 prefilled HSV Kits 1 min 20 s

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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.

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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

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2. Remove the sealing plate

3. Remove the sealing plate clip

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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

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7. Follow the same procedure to replace the second Teflon strip

8. Replace the protective cover

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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.

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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.

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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.

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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

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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

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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.

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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
[email protected]

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Notes:

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