Cellbox Ground 2.0 User manual

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TECHNICAL MANUAL
Cellbox Ground 2.0

PRODUCED BY
An der Bahn 5
22844 Norderstedt
Germany
T [phone]
Englische Planke 8
20459 Hamburg
Germany
T [phone]
cellbox-solutions.com
[e-mail]

TECHNICAL MANUAL
Cellbox Ground 2.0
21 CFR Part 11 Data Security Software License
DISCLAIMER
The manual is intended as a guideline and that Cellbox Solution GmbH shall in no event be held
liable for any direct, or incidental damages that arises out of, or are related to the use of this manual.
Version 1.3, May 2022, Author: Robin Sieg

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TABLE OF CONTENT
1SAFEKEEPING OF THE MANUAL....................................................................................................................... 8
2DEVICE DESCRIPTION ...................................................................................................................................... 8
3LIST OF USED SYMBOLS.................................................................................................................................. 8
4INTENDED USE................................................................................................................................................. 8
4.1 PURPOSE...................................................................................................................................................................8
4.2 RESTRICTIONS ON THE USE OF THIS DEVICE ...................................................................................................................8
5SAFETY INSTRUCTIONS ................................................................................................................................... 9
6PRODUCT SPECIFICATION ............................................................................................................................... 9
6.1 SCOPE OF DELIVERY ...................................................................................................................................................9
6.2 INSTALLATION.............................................................................................................................................................9
6.3 FEATURES................................................................................................................................................................10
6.4 DEVICE OVERVIEW ....................................................................................................................................................10
6.5 DISPLAY ELEMENTS...................................................................................................................................................11
6.5.1 USER MANAGEMENT .........................................................................................................................................11
6.5.2 SETUP –TEMPERATURE.....................................................................................................................................14
6.5.3 SETUP –CO2CONCENTRATION..........................................................................................................................15
6.5.4 SETUP –CO2CARTRIDGE LEVEL ........................................................................................................................15
6.5.5 SETUP –DATA LOGGING....................................................................................................................................15
6.5.6 DATA EXPORT ..................................................................................................................................................17
6.5.7 SERVICE ..........................................................................................................................................................17
7OPERATION OF THE DEVICE .......................................................................................................................... 18
7.1 POWER ON /POWER OFF ..........................................................................................................................................18
7.2 CHARGING THE DEVICE..............................................................................................................................................18
7.3 EXCHANGE OF CO2MINI CARTRIDGE............................................................................................................................19
7.4 PREPARING THE DEVICE FOR TRANSPORT .....................................................................................................................20
7.5 TRANSPORTING THE DEVICE .......................................................................................................................................20
7.6 SAFE REMOVAL OF LIVE CELLS FROM THE DEVICE ..........................................................................................................21
7.7 CLEANING THE DEVICE ...............................................................................................................................................21
8LABELS ON THE DEVICE ................................................................................................................................ 21
8.1 TYPE PLATE..............................................................................................................................................................21
8.2 LABELING REQUIREMENTS FOR GROUND AND FLIGHT TRANSPORT OF THE CELLBOX ...........................................................21
8.3 PACKAGING OF BIOLOGICAL MATERIALS .......................................................................................................................25
9ENVIRONMENTAL CONDITIONS FOR THE USE OF THE DEVICE...................................................................... 25
10 STORAGE AND DISPOSAL .......................................................................................................................... 25
10.1 STORAGE.................................................................................................................................................................25
10.2 DISPOSAL ................................................................................................................................................................25
11 TECHNICAL SPECIFICATIONS..................................................................................................................... 25
12 MAINANANCE & WARRANTY....................................................................................................................... 25
13 CLEANING INSTRUCTIONS ......................................................................................................................... 26
14 EC DECLARATION OF CONFORMITY........................................................................................................... 27

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1SAFEKEEPING OF THE MANUAL
The technical manual belongs to the Cellbox Ground 2.0
- 21 CFR Part 11 Data Security Software License - and
must be downloaded digitally. This ensures that persons
operating the device can refer to the content of the man-
ual as required.
The latest version of the technical manual can be
opened by scanning the code on the type plate of the
Cellbox 2.0 or below:
https://cellbox-solutions.com/downloads
2DEVICE DESCRIPTION
The Cellbox 2.0 is an electronic device developed by
Cellbox Solutions GmbH for the safe and documented
transport of living cells. The living cells, which can be
transported in various cell culture vessels, are enclosed
within the incubation chamber of a robust transport trunk.
This creates a controlled environment wherein the phys-
ical parameters, such as the temperature and CO2 con-
centration can be defined and stably maintained for a
period of at least 32 hours without an external power
source.
In order to achieve the optimal conditions for the
transport of living cells, the Cellbox 2.0 is able to control
the ambient temperature around the cell culture vessels
with precision. This function is further supported by the
continuous circulation of air around the cell culture ves-
sels, resulting in an even temperature distribution. The
device also maintains a constant internal CO2concen-
tration by automatically dispensing pure gaseous CO2.
This sustains the vitality of the in vitro cell cultures by
providing a source of environmental CO2that stabilizes
the pH. To ensure that an adequate supply of gaseous
CO2 is available for the entire period of transport, the de-
vice is equipped with a disposable CO2cartridge. Each
disposable cartridge can maintain a 5% CO2environ-
ment for up to 72 hours.
The Cellbox 2.0 can be operated from its built-in re-
chargeable Lithium-Ion Battery packs, an external power
supply or even an automotive/vehicle power adapter
(see chapter 6.1). This provides the user with various op-
tions to ensure an uninterrupted power supply during
transport. Sensors within the transportation compart-
ment of the device log data of the conditions that the
cells (living cargo) experience during transport. These
data logs can easily be transferred to a mobile device
using Bluetooth connectivity to the CELLBOX 2.0 – LIVE
CELL SHIPPER App.
3LIST OF USED SYMBOLS
4INTENDED USE
4.1 Purpose
This device is intended to serve as a protective environ-
ment that can sustain living cells, in various cell culture
vessels, for a defined period of time, with the purpose of
transport. In this context transport can refer to carrying
the device or moving the device with the aid of a vehicle.
When in operation the device can be configured to au-
tomatically maintain a set internal temperature and CO2
concentration.
Power can be supplied to the device by means of an
external power supply or in a portable manner from the
internal battery packs.
The following cell culture vessels are compatible with the
Cellbox Ground 2.0:
•Multiwell-plates with 6, 12, 24, 48, 96 and 384 wells
•Multiwell-plates with standard ANSI/SBS footprint.
•Various chip formats
•Various cell culture bags
•Various cell culture flasks
4.2 Restrictions on the Use of this Device
It is strictly forbidden to transport a device
in operation by aircraft if a mini CO2cartridge is
inserted.
Symbols used on Cellbox
Direct Current
Read the manual
This product is subject to the European
Community Directive 2002/96/EG on
waste electrical and electronic equip-
ment (WEEE).
This product has been tested for electro-
magnetic radiation below the limits spec-
ified by the Federal Communications
Commission.
This product satisfies European harmoni-
sation legislation. (CE Marking)
Symbols used on the Technical Manual
Additional information for the user
Warning: Warning of situations that may
result in personal injury or property dam-
age
Critical Warning: Prohibition of misuse
that may result in personal injury or prop-
erty damage

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It is strictly forbidden to use the device for the transport
of infectious substances as classified within Class 6.2 of
the ADR (European Agreement concerning the Interna-
tional Carriage of Dangerous Goods by Road, applicable
as from 01.01.2015) as well as Class 3.6.2 of the IATA
(International Air Transport Association - Dangerous
Goods Regulations, applicable as from 01.01.2021).
Use of the device for any purpose other than the in-
tended purpose described in section 4.1 is classified as
misuse and can result in danger or damage.
The device may not be used for the transport of materials
and substances that could produce toxic vapors or ex-
plosive fumes at the set temperature. Furthermore, ma-
terials and substances that pose a risk of exploding,
bursting or igniting may not be transported in this device.
If any doubt arises about the composition of the materials
or substances to be transported, they must not be
loaded in the device.
Potentially explosive gas-air mixtures may not be formed
in the transportation compartment, nor may the device
be operated in their immediate vicinity.
5SAFETY INSTRUCTIONS
The device may only be operated in a good work-
ing order. When the user identifies any irregularities, dis-
turbances or damage before or during the operation of
the device, it should immediately be decommissioned.
After decommissioning the device, the user should con-
tact the manufacturer.
The device may not be rebuilt, modified or altered
in any way without the authorization of the manufacturer.
In the event of any unauthorized modification or altera-
tion, the declaration of conformity is declared invalid and
the device must be decommissioned.
During the transport of unsuitable goods, the pos-
sibility exists that toxic vapors or explosive fumes may be
formed. This may cause the device to explode and result
in serious injury or poisoning. The device is only intended
for the transport of goods that do not form any toxic va-
pors or explosive fumes when heated (also see section
4)
The device must not be sprayed with or sub-
merged in water. As the device is only resistant to low
quantities of dripping water, larger quantities of water
could reach the internal electronics and cause damage.
As a result of partial disassembly or damage to
the casing of the trunk, electrical wires could be exposed
and pose a risk of electric shock to the user. Repairs and
maintenance of the electric components must only be
performed by the manufacturer and authorised partners.
The use of the device in potentially
explosive areas (containing flammable
substances, gases, fumes or mixtures of gas and
air) is strictly forbidden. The device does not have
any measure of explosion protection.
6 PRODUCT SPECIFICATION
6.1 Scope of Delivery
Besides the Cellbox Ground 2.0 the following items are
included in the scope of delivery:
•1x multi-well holder
•3x spacers for multi-well holder
•3x spare disposable CO2cartridges
•1x power adapter for operation of the device or for
charging the battery packs
•1x car adapter
•Technical Manual (Online)
•Power plugs with wall socket compatibility for
EU, Japan, UK, USA, Switzerland and Australia.
6.2 Installation
Place the polystyrene carton overpack for best ergonom-
ics onto a clean floor. Open the carton as well as the
isolating polystyrene lid. Pull the lid handle and lift the
Cellbox 2.0 out of its isolating overpack with care and
place on to an even and clean surface. Remove the pro-
tective plastic bag and discard it.
Operate (Charge & Power On/Off) the device as de-
scribed in Chapter 7.
Do not use the Cellbox 2.0 inside of the plastic
bag! Please make sure that the plastic bag is also not

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placed into the bottom of the polystyrene housing to
avoid CO2build up by blocking the integrated CO2over-
flow tube.
The Cellbox 2.0 is a heavy load. Lifting and
carrying loads for many years can lead to serious
damage to the musculoskeletal system and
especially to the intervertebral discs. In general,
therefore, always use a carrying or pulling aid if
possible or carry the Cellbox preferably together
with another person.
6.3 Features
The Cellbox Ground 2.0 has the following features:
•Protective environment for the temporary storage
and transport of cells and culture media within a va-
riety of cell culture vessels.
•Mechanical protection of goods when the device is
carried or transported in a vehicle, train, ship or dur-
ing stationary application.
•Simple-to-use touch screen interface for the opera-
tion of the device.
•Incubation range 3°C above ambient temperature
and programmable between 28°C and 38°C.
•Programmable CO2 concentration between 0% and
18%.
•Display that is updated with the internal CO2concen-
tration and temperature in real-time.
•The Cellbox 2.0 logs the history of the internal set
and actual temperature, actual ambient temperature,
internal set and actual CO2concentration, incubation
lid status, actual ambient pressure, remaining CO2in
the CO2mini cartridge as well as the maximum tilt,
acceleration and impacts within the last minute as
events and the battery percentage.
•Additional device events such as technical settings
are logged in the event log (Audit Trial) as well.
•Bluetooth connection for communication with smart
devices.
•Cellbox 2.0 App for data and event log export and
graphical presentation of logged environmental con-
ditions.
6.4 Device Overview
The outer case of the Cellbox is a robust transport box
made to withstand mechanical impact. It is therefore the
ideal device for the transport of biological material by
road, sea and rail.
The following device elements have been highlighted for
the user:
A Locking mechanism
B Main power switch with protective lid and LED
for device status
C Connection/socket for external power supply
D 4 LEDs for indication of the battery level
E Incubation chamber lid
F Lid locking mechanism
G Chamber for CO2mini cartridge with lid
B
C
D

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H Display
6.5 Display Elements
The touch screen of the Cellbox Ground 2.0 indicated
the conditions inside the incubation chamber and allows
the user to adjust incubation parameters as well as ac-
cess to the logging feature.
The Cellbox 2.0 Homescreen becomes visible when the
device is switched on. The following is displayed:
•Internal actual temperature in °C
•Internal set (user-defined) temperature in °C
•Internal actual CO2level in %
•Internal set (user-defined) CO2level in %
•Elapsed episode logging time in hh:mm:ss
•Bluetooth toggle on/off
•Remaining CO2level in CO2mini cartridge in %
•Battery Management and level in %
Tap the respective field to enter its sub menu.
6.5.1 User Management
The CBS 21 CFR Part 11 Data Security Software is a
license version of the Cellbox Ground 2.0 which is in
conformity with regulations for electronic records and
signatures specified in FDA 21 CFR Part 11. This license
enables the option for creating users with their own login
information to privatize their data if needed. To use the
Cellbox Ground 2.0 in this mode, it is mandatory that the
user logs only into their assigned account to track any
changes made to the Cellbox 2.0 e.g., changing param-
eters.
In 21 CFR Part 11 data security software mode, simply
every user action on the Cellbox is constantly logged by
into the audit trail and can be verified. The audit trail can
be downloaded via the Cellbox 2.0 App in its entirety and
partwise over the defined period of an episode.
User management structure:
The admin is the most responsible person for the Cellbox
2.0. He has the capability of the general functionalities of
the Cellbox 2.0 and is allowed to add new user ac-
counts, edit existing accounts or to delete user ac-
counts. Additionally, he has the exclusive rights to deter-
mine which log parameters are being exported.
A user is assigned to an admin and is able to operate the
general functionality of the Cellbox 2.0 like defining val-
ues for target conditions (CO2and Temperature), “Start
Episodes”, “Stop Episodes”, “Create Episodes”, “Plot
Episodes” and to choose if the episode shall be public
or private creation. Private Episodes can only be seen by
the user him-/ herself. Public Episodes can be seen,
plotted and downloaded via the Cellbox 2.0 App by all
users. Additionally, a user is capable to change its own
password.
6.5.1.1 User Management Setup
When you start the Cellbox 2.0 CFR for the first time you
will be asked to log in with the default information of the
admin.
Touch the text field to let the keyboard appear and enter
following default information:
Default Username: Admin
Default Password: AdminDev123
You can switch between the input lines by touching
them. To leave the line and let the keyboard disappear
press “OK”.

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When information is entered and “Login” button is
pressed you will be asked to change the password.
After successfully changing your password, you need
to enter a new username for the admin which has to
differ from the default name and only contains letters
and numbers.
Now the initialization process for the admin is done and
by navigating to the service menu (button with the gear)
you will have access to the user management as shown
below.
To enter the user management menu, tap the “User
Management” button. The next screen will give you ac-
cess to the different sub menus to add new users (“Add
User” button), edit existing users (“Edit User” button) or
delete all users (“Delete All Users” button).
To add a new user, navigate in the submenu as de-
scribed above. You need to enter the full name of the
person you want to add, a username and a default pass-
word and then touch the “Confirm” button. The recently
added user is now able to login with this defined login
information in the exact same way as it was described
for the admin before.
When you like to change the password of an existing
user or delete a user navigate to the “Edit user” sub-
menu. A list of existing users will appear and you can
select a user by touching its username.
When you tap the user, you want to edit a window will
pop-up as shown.

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To change the user’s password, press the “Change
Password” button and in the next screen you will be
asked to enter the new password twice and confirm it.
To delete a user completely press the “Delete User” but-
ton and a list of existing users will appear where you can
select a user by tapping its username. In a pop-up win-
dow you will get asked if you want to delete the selected
user with the option to confirm or deny your decision.
The option to delete all users simultaneously can be ac-
cessed by taping the “Delete All Users” button. When
pressing the button, a pop-up window will appear and
you will get asked to confirm or cancel your decision.
To exit the User management menu, tap “ ” to return.
When you want to log out as an admin (or as a basic
user) just navigate to the main menu, press the logout
button and confirm the logout.
The active user is also being logged out after three
minutes of inactivity.
6.5.1.2 Select Logging Parameters:
As an admin you have the option to define the parame-
ters which shall be logged from the Cellbox 2.0.
To enter the submenu, navigate to the data logging
menu.
The button “Data Recording Parameters” will lead you in-
side the parameter’s selection pop-up window.
In this window you have the option switch parameters on
and off for logging just by touching the toggle switch.
After touching the toggle, the selected parameter will be
turned off and the green “on” indication will switch to a
grey “off” indication.