Sartorius Stedim Biotech BioSealer TC User manual

2486866-000-00
Operating Manual
BioSealer®TC

2 Operating Manual BioSealer®TC
Technical Safety Information
for the User
This description contains the necessary information for the designated use of the
product described herein. It is intended for technically qualified personnel.
Qualified personnel are persons who, because of their education, experience and
training as well as their knowledge of relevant standards, specifications, accident-
prevention regulations and operating conditions, have been authorized by persons
responsible for system safety to execute the necessary activities, and can recognize
and avoid possible dangers in such activities.
Change index
Doc new version Change
00.000.000 Document created (copied by BWTC) on 24.04.2015
00.001.000 First draft for the release of prototypes
00.001.001 Draft adapted for prototype 2, beta site tests
01.000.000 TÜV Süd certification
07.06.2019 Release for Marcom

Operating Manual BioSealer®TC 3
Contents
Contents
1 About this Document............................... 4
1.1 Symbols Used .................................. 4
1.1.1 Other Symbols........................... 4
2 Hazard Information ................................ 5
3 General Information ............................... 7
3.1 Disclaimer of liability............................ 7
4 Introduction....................................... 8
4.1 Characteristics ................................. 8
4.2 Safety ........................................ 8
4.3 Limitations .................................... 8
4.4 Function ...................................... 9
4.5 Blocked device ................................. 9
4.6 Cleaning instructions............................ 9
4.7 Decontamination ..............................10
4.8 Carrying Information...........................11
5 Start-up .........................................12
5.1 Delivery kit ...................................12
5.2 Familiarise yourself with the equipment...........12
5.3 Assembly.....................................12
5.4 Log in........................................13
5.5 Maintenance..................................13
5.6 Change settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.7 Initialize axes .................................13
6 Sealing process ...................................14
6.1 Insert tubing and close cover ....................14
6.2 Compression phase ............................15
6.3 Set clamps....................................16
6.4 Sealing process................................16
6.5 Seal log screen (optional) .......................17
6.6 Remove tubing................................17
6.7 Sealing visual inspection........................18
6.8 Clamps (removing).............................18
7 User interface ....................................19
7.1 Mutual exclusion ..............................19
7.2 Touchscreen ..................................20
7.2.1 Menu tree .............................20
7.2.2 Summary of symbols ....................22
7.2.3 Operating elements .....................23
7.2.4 User Login|Logout......................24
7.2.5 Date and time ..........................25
7.2.6 Language..............................25
7.2.7 Tubing ................................26
7.2.8 Network Parameters Reset ...............26
7.2.9 User administration .....................27
7.2.10 Log ...................................28
7.2.11 Info...................................29
7.3 Web browser..................................30
7.3.1 Connecting ............................30
7.3.2 Menu tree .............................30
7.3.3 Operating elements .....................31
7.3.4 Browser appearance.....................31
7.3.5 General parameters .....................32
7.3.6 User Login|-out ........................33
7.3.7 User Management ......................34
7.3.8 Info...................................34
7.3.9 Log ...................................35
7.3.10 Date and time ..........................35
8 Runs.............................................36
8.1 Initialize axes .................................36
8.2 Sealing.......................................36
8.3 Power failure .................................36
8.4 Temperature validation .........................37
8.5 Service position ...............................37
9 Log..............................................38
9.1 Seal Log Screen ...............................39
10 User groups and user interfaces ....................40
11 Operating problems ...............................41
11.1 Switch off the device ..........................41
11.2 Foreign objects in the device ....................41
11.3 Incorrect tubing inserted .......................41
11.4 Memory card .................................41
11.5 Lost password.................................41
11.6 Manual cover opening..........................42
12 Error reports and Warning messages................43
13 Disposal..........................................44
13.1 Information on Decontamination ................44
13.2 Disassembly...................................44
13.3 Disposing of Device and Parts ...................45
13.3.1 Information on Disposal .................45
13.3.2 Disposal ...............................45
14 Technical data ....................................46
14.1 Device .......................................46
14.2 Power supply .................................46
14.3 Dimensions ...................................47
15 Appendix.........................................48
15.1 Copyright ....................................48
15.2 Technical contact..............................48

4 Operating Manual BioSealer®TC
About this Document
1 About this Document
This document is intended for users of BioSealer®TC from the user group “Supervisor”
and “Operator”.
1.1 Symbols Used
WARNING
Denotes a danger with risk that death or severe injury may result if it is not avoided.
CAUTION
Denotes a danger with risk that moderate or minor injury may result if it is not
avoided.
NOTICE
Denotes a danger that can result in property damage if it is not avoided.
1.1.1 Other Symbols
t Required action: Describes actions which must be carried out.
y Result: Describes the result of the activities carried out.
✔Ok, the way it must be. The BioSealer®TC may be used like this.
✘Not ok, must be changed|fixed! The BioSealer®TC must not be used like this!

Operating Manual BioSealer®TC 5
Hazard Information
2 Hazard Information
The following information is for the personal safety of operating personnel as well as
the safety of the described product.
Hand injury warning
Never grab hold of anything inside openings during operation.
Noncompliance can lead to serious injury.
Warning of hot surface
Inside the device, the surface can be hot and cause burns|injury. These surfaces must
not be touched. The device must first be cooled before maintenance|cleaning.
Disconnect power
To disconnect the BioSealer®TC from power, turn off the device and unplug the
power plug from the cable of the BioSealer®TC.
Always keep the access to the power plug free!
Electrostatic sensitive devices (ESD)
Ground straps, table mats and tools with conducting grips are used to ground
people, to achieve equipotential welding and to prevent electrostatic discharge. This
is always a requisite measure if electronics or electronic components are handled or
mounted.
WARNING
t Ground conductor connections must function perfectly (power supply
connection).
t The device is not intended for use in|with explosive atmospheres.
t Not following the manual instructions of the manufacturer may lead in to
unreliability, hazardous situations and disturbances of safety.
CAUTION
t Disconnect the device from the power source before cleaning. Never open up the
device!
t The device is intended to use for technical qualified personnel only!
NOTICE
t Follow the accident-prevention and safety regulations relating to the specific
application.
t During the sealing process tubing must not be under pressure. Follow carefully
the instructions on the display to avoid any issues due to overpressure. Read the
relevant chapter „6 Sealing process“, page 14.
t An interruption during the sealing process can lead to an issue and must be
avoided. The device will try to limit the damage. Be sure to follow the operating
instructions to the letter. Read the relevant chapter „8.3 Power failure“,
page 36.
t In the event of an accident, the device must be cleaned and examined by an
authorised specialist.
t The device must be decontaminated before being sent to suppliers or manu-
facturers.

6 Operating Manual BioSealer®TC
Hazard Information
NOTICE
t As the BioSealer®TC is intended to use as a handheld device, the operator must
use safety shoes to prevent harm from a falling device.
t Be aware that microscopic or macroscopic particles|fluids of the tubing inner
may be released into the environment during the sealing process or after
separation.
t Before start-up, check whether the nominal voltage of the power supply matches
the local mains voltage.
t The device was developed for laboratory use and must be protected from every
type of fluid or vapour.
t The device can be operated between +5°C and +40°C. The sealing parameters are
qualified for room temperature operation only.
t Optimal relative humidity is 60%.
t The device is programmed with standard parameter sets for sealing TuFlux®TPE,
C-Flex®374, AdvantaFlex®, PharMed®BPT and SaniPure™ BDF™. These parameter
sets have been validated at ambient temperature.
t The degree of protection is IP20.
t Make sure that the device is not switched off during the sealing process.
t To increase process reliability ensure that there is an uninterrupted power supply
(UPS).
t Use only tested control cables and accessories provided by the manufacturer.
t Fuses may only be exchanged by a service technician.
t The device has an Ethernet connection. Only skilled personnel may connect the
device to a network.
t Only shielded Ethernet cables may be used.
t Only skilled personnel may configure the device for connection to a network.
t It is recommended to operate the device via the touch screen.
t The device contains electric drives which can be blocked|destroyed by foreign
substances. Make sure that no foreign substances reach the interior of the device.
t After using the BioSealer®TC, you should always log out. Otherwise another user
is able to manipulate the device with your account.
t The auto login is used to work more efficiently with the BioSealer®TC. The auto
login can only be activated for one user. This user will be logged in automatically
without entering any username and password after each restart or after chang-
ing the user interface.
t A user of the Supervisor group should not use the auto login because of security
reasons, otherwise any user is able to take critical changes on the BioSealer®TC
under the Supervisor account.
t Extension cord between power supply and BioSealer®TC must not be longer than
3 meters.

Operating Manual BioSealer®TC 7
General Information
3 General Information
Please read this operating manual carefully. It allows you to start up and operate the
device safely and successfully.
3.1 Disclaimer of liability
Sartorius Stedim Biotech SA cannot accept any liability for errors and damages that
occur caused by improper handling and by improper use of the device. Improper
handling arises if the operating instructions, in particular the instructions for
start-up, are not followed. Device returns must be made only in the original packag-
ing or in accordance with safe packaging. No liability is assumed for transport
damage. The BioSealer®TC is intended for industrial use and should not be used for
human medical applications. No liability is assumed for errors when connecting the
device to a network.
The system is intended for the purpose described above only. Any other use or
change of the device without written agreement with the manufacturer is considered
to be improper. The manufacturer is not liable for any resulting damage. The risk is
borne solely by the operator.
The manufacturer assumes no liability for any damage or consequential damage to
the device or the application resulting from an accident.

8 Operating Manual BioSealer®TC
Introduction
4 Introduction
The inserted dry or liquid filled tubing is compressed between two heating elements.
The heat and the compression force generate a homogeneous sealing of the tubing
section. The resulting sealing can be cut through the embedded guideline using
scissors.
The BioSealer®TC device is capable of sealing TPE tubing, either gamma-irradiated or
autoclaved, from ¼” up to 1” OD. Sealing parameters for all tubing dimensions and
materials are pre-installed on the system and simple to select via touch screen.
Disconnections can be performed on dry, wet or liquid filled tubing. Due to its
weight and small dimensions the unit is portable and can be easily used in a variety
of locations.
4.1 Characteristics
Feature Benefit
Sealing of dry or liquid filled tubing
from ¼” to 1” OD without the need for
accessories
One device to seal all tubing sizes under
different process conditions
Larger sealing area with cutting guide Increased sealing robustness and safer dis-
connection
Fully automated portable device without
accessory required
Reusable and easy to use
Standard programs for TPE tubings Ready to use for TuFlux®TPE, C-Flex®374,
AdvantaFlex®, SaniPure™ BDFTM (except
¾”×1”) and PharMed®BPT
New design − Ergonomic
− Operator friendly
− Easy to use
4.2 Safety
Since drives are moved with strong forces, the cover or finger protections must not
be opened during a run in order to avoid injuries. The cover is automatically released
by the device as soon as the user’s safety is ensured. Use only tubing which is
compatible with the device.
t WARNING If any parts are broken, do not continue to use the device!
4.3 Limitations
The sealings performed with the BioSealer®TC guarantee adequate quality and
strength for the transfer. Ultimately, however, it is the responsibility of the end user
to verify and validate the device for its suitability. Under no circumstances may data
from this operation manual be used as a reference for the manufacture of a clinical
product at an official location without the written permission of the manufacturer.
The BioSealer®TC is designed for industrial use and may not be used for medical
applications. Further restrictions are given in chapter „2 Hazard Information“,
page 5. Sealings must be thoroughly tested before use.

Operating Manual BioSealer®TC 9
Introduction
4.4 Function
The BioSealer®TC is used for the sterile separation of tubing. For this purpose, tubing
is inserted, the cover is closed and a run is initiated with the start button. During the
run, the tubing is automatically squeezed and heated. Subsequently, the tubing is
cooled, the tubing is released again and the cover is opened. The resulting sealing
has now a guideline indicating where it can be separated with a cutting tool. The
BioSealer®TC is a fully automatic device and indicates the completion of the sealing
when all steps have been completed.
In order to simplify the logging of the sealing data for the user, the BioSealer®TC
is equipped with a memory card, which can be used to write the data as required.
In addition, the data can be loaded onto a computer using a web browser. See
chapter 7.2.10, page 28 and chapter 7.3.9, page 35 for details.
To simplify the temperature validation or to enable it for the customer, a temperature
validation kit adapted to the device can be purchased as an accessory for the
BioSealer®TC.
4.5 Blocked device
All operating equipment within the BioSealer®TC device is constantly checked for its
proper functioning. In addition, each step is monitored during a run. If an operating
equipment, e.g. a drive or the heater breaks down, or fails to execute a step during a
run, then an error is present. Such an error results in a blocked device. If the device is
blocked, all running processes are stopped and a message is issued to the operators.
In the English language this message is: “All runs blocked (X)”
t NOTICE A blocked device is present when the following text is displayed:
“All runs blocked (X)”
If a run cannot be completed for any reason, this does not necessarily mean that the
device is defective. For example, the user may have chosen incorrect tubing.
t A blocked device does not necessarily have to contain a defective component.
t See chapter „12 Error reports and Warning messages“, page 43 for trouble
shooting information.
t WARNING If the device is defective, it must be repaired urgently. In such a
case, contact your local service contact.
t Before you contact your sales representative, describe the error in detail and save
the “All” log as described in the chapter „7.2.10 Log“, page 28. Please submit
these data together with the error description to your local service contact.
4.6 Cleaning instructions
t Before cleaning, the cleaning agent must be tested on compatibility with the
respective materials.
t NOTICE The BioSealer®TC may not be cleaned with a spray- or steam procedure.
Spray- or steam cleaning can cause a reduced life time of single components or
lead to damage of single components.
t The manufacturer disclaims any liability if components are damaged by improper
cleaning or in the case of non-observance of the cleaning instructions or when
persons are being injured by not observing the proper cleaning instructions.
t Use service position for better accessibility to the sealing area. See chapter „8.5
Service position“, page 37.

10 Operating Manual BioSealer®TC
Introduction
Recommended cleaning agents:
− Ethanol 70% (e.g. Klericide 70/30)
− Sodium hypochlorite 6% (e.g. Klericide-CR)
− Propanol 45%, Isopropanol 25%, Ethanol 4.7% (e.g. Bacillol AF)
Process description:
1. Move the drives to the service position (see chapter „8.5 Service position“,
page 37)
2. Immerse a cleaning tissue with a standard cleaning agent.
3. Clean the following areas marked in green. Do not clean red marked areas!
4. Clean the whole case.
It is recommended to clean the device on a weekly base.
4.7 Decontamination
The machine must be decontaminated with either:
− Ethanol 70% (e.g. Klericide 70/30)
− Sodium hypochlorite 6% (e.g. Klericide-CR)
− Propanol 45%, Isopropanol 25%, Ethanol 4.7% (e.g. Bacillol AF)
t NOTICE The customer is responsible for correct decontamination!
After correct decontamination, the customer must fill out the “Decontamination
form” that the device is free from biological, chemical or radioactive contaminants.
This form can be obtained from the local Sartorius Stedim Biotech SA representative.

Operating Manual BioSealer®TC 11
Introduction
4.8 Carrying Information
CAUTION
Carry|Hold the BioSealer®TC only the way shown in the picture below.
Not following these instructions may lead in to unreliability, hazardous situations
and disturbances of safety.
CAUTION
Do not carry|hold the BioSealer®TC like shown in the picture below!
✔
✘

12 Operating Manual BioSealer®TC
Start-up
5 Start-up
This chapter is a step by step guide for the start-up of the BioSealer®TC.
5.1 Delivery kit
− BioSealer®TC device
− Power supply
− Power cord
− SD memory card inserted into slot
− Quick starting guide and operating manual
− Product certificate BioSealer®TC
− Calibration certificates
5.2 Familiarise yourself with the equipment
Item Designation
1 Cover
2 Heating element
3 Finger protection
4 Carrying handle, see chapter „4.8 Carrying Information“, page 11
5 Device cable
6 Ethernet connection
7 Slot SD memory card
8 Power switch
9 Touchscreen
5.3 Assembly
The BioSealer®TC is a portable device. Use a safe surface for installation. Connect the
power supply to the appliance inlet and switch the device on. After a brief start-up
phase, the device is ready for operation.
2
6
3
1
45
7
98

Operating Manual BioSealer®TC 13
Start-up
5.4 Log in
On delivery, the device is set so that a user with the name “Supervisor” is automati-
cally logged in by the “Supervisor” user group. In this case, the instructions which are
necessary to carry out an initialization are displayed on the touch screen.
If no user has the automatic login attribute, the user must login with the user name
and password. See chapter „7.2.4 User Login|Logout“, page 24 or chapter „7.3.6
User Login|-out“, page 33.
5.5 Maintenance
Periodic maintenance is required for an optimal working BioSealer®TC. A message on
the touch screen indicates if maintenance should be carried out. The criteria for this
are internal counters which are linked to the service maintenance schedule of
Sartorius.
If a corresponding message appears on the display after logging in, the device must
be serviced. This message must be confirmed by the user with the OK key to be able
to continue working.
5.6 Change settings
Various settings can be made via the menu, such as: Language, date, time, and
tubing type.
t Read the corresponding chapter „7.2 Touchscreen“, page 20
5.7 Initialize axes
After starting up the device or if tubing with a different outside diameter is selected,
an initialisation must necessarily be carried out. Follow the instructions on the touch
screen.
t NOTICE Everything must be removed from the squeezing area. The cover is then
closed by the user and the device initializes automatically.

14 Operating Manual BioSealer®TC
Sealing process
6 Sealing process
To perform a sealing, follow the instructions on the touch screen. If the device has
not previously been initialised, no sealing can be performed at this status. Proceed as
follows:
t NOTICE Verify that tubing is available and the correct tubing is set in the device.
See chapter „7.2.7 Tubing“, page 26.
t NOTICE Only use tubing which is dry and cleaned from the outside. Tubing which
are externally wet can be damaged.
t NOTICE Tubing must not be under pressure during the sealing process.
6.1 Insert tubing and close cover
t NOTICE Please insert the tubing according to the following orientations:
✔
✘

Operating Manual BioSealer®TC 15
Sealing process
t NOTICE Check on the user interface whether the selected tubing matches the
inserted tubing. Internal and external diameters must also be checked. If all
details match, press the start button to start the compression phase.
6.2 Compression phase

16 Operating Manual BioSealer®TC
Sealing process
6.3 Set clamps
On both sides of the sealer, the tubing must be clamped.
t NOTICE The distance between the clamp and the sealer should be around
4 cm|1.6 in.
6.4 Sealing process

Operating Manual BioSealer®TC 17
Sealing process
6.5 Seal log screen (optional)
6.6 Remove tubing
Sealing process is completed when the cover opens automatically.

18 Operating Manual BioSealer®TC
Sealing process
6.7 Sealing visual inspection
The operator must visually check the sealing. He bears the responsibility. In order to
help the operator to assess the sealing quality there is a verification template (see
picture left) included into the delivery box that can be used. If the sealing reopening
crosses the limit, a new sealing must be performed. If the quality is satisfactory (refer
to picture beside), the sealing can be cut following the cutting guideline with
rounded scissors.
t NOTICE For optimal sealing, allow the tubing to cool down (approx. 5 min)
completely before stressing the sealing mechanically.
6.8 Clamps (removing)
If the quality is good and the tubing has been successfully separated, the clamps can
now be removed (after 5 min).
t NOTICE To ensure a higher safety it is recommended to leave the clamps on the
tubing (especially for sizes with OD >½”).

Operating Manual BioSealer®TC 19
User interface
7 User interface
The BioSealer®TC is delivered with two user interfaces which partially cover common
functionalities. On one hand, the device can be operated via the touch screen
integrated in the device, on the other hand via Ethernet over a web browser.
NOTICE
As far as possible, the user should operate the device with the local touch screen.
Switching back and forth between touch screen and web browser is not
recommended.
The following chapters highlight the differences between the two user interfaces.
7.1 Mutual exclusion
In order to make it clear which user interface has control over the device, rules are
implemented:
t It is only possible to work actively with one user interface at the same time. The
other user interface is passive.
t No user interface is active or passive after a start of the device.
t Web browser or touch screen are activated as soon as the interface is used e.g. by
pressing a key.
Display on a passive touch screen user interface:
Display on a passive web browser user interface:

20 Operating Manual BioSealer®TC
User interface
Rules for activating|switching a user interface:
t The touch screen can always be instantly activated by touching it.
t The web browser can only be activated if no user is logged into the device or
after restarting. If you want to activate the web browser user interface, logout
on the touchscreen is mandatory.
t The common factor is that the current user is logged out by switching. If a user
has activated automatic login, this user will be logged in, otherwise the login
dialogue will appear.
7.2 Touchscreen
The touchscreen is a capacitive touch. The control elements shown can be operated
directly.
7.2.1 Menu tree
The following figure shows the menu tree of the touchscreen for the user group
“Supervisor”.
1 2 3
4 5 6
7 8 9
10 11 12
121 3