Cellbox Flight 2.0 Bedienungsanleitung

TECHNICAL MANUAL

Cellbox Flight 2.0

PRODUCED BY

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cellbox-solutions.com

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TECHNICAL MANUAL

Cellbox Flight 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

TABLE OF CONTENT

1SAFEKEEPING OF THE MANUAL....................................................................................................................... 8

2DEVICE DESCRIPTION ...................................................................................................................................... 8

3LIST OF USED SYMBOLD.................................................................................................................................. 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 ..........................................................................................................................14

6.5.4 SETUP –CO2DRY ICE TIMER .............................................................................................................................14

6.5.5 SETUP –DATA LOGGING....................................................................................................................................15

6.5.6 DATA EXPORT ..................................................................................................................................................17

6.5.7 SERVICE ..........................................................................................................................................................17

7OPERATION OF THE DEVICE .......................................................................................................................... 17

7.1 POWER ON /POWER OFF ..........................................................................................................................................17

7.2 CHARGING THE DEVICE..............................................................................................................................................18

7.3 REFILLING THE DRY ICE CONTAINER ............................................................................................................................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 FLIGHT TRANSPORT OF THE CELLBOX ...............................................................................22

8.3 PACKAGING OF BIOLOGICAL MATERIALS .......................................................................................................................27

9ENVIRONMENTAL CONDITIONS FOR THE USE OF THE DEVICE...................................................................... 27

10 STORAGE AND DISPOSAL .......................................................................................................................... 27

10.1 STORAGE.................................................................................................................................................................27

10.2 DISPOSAL ................................................................................................................................................................27

11 TECHNICAL SPECIFICATIONS..................................................................................................................... 27

12 MAINANANCE & WARRANTY....................................................................................................................... 27

13 CLEANING INSTRUCTIONS ......................................................................................................................... 28

14 EC DECLARATION OF CONFORMITY........................................................................................................... 29

1SAFEKEEPING OF THE MANUAL

The technical manual belongs to the Cellbox Flight 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

CO2is available for the entire period of transport, the de-

vice has been fitted with a thermally-insulated container

for the storage of dry ice. Through the process of subli-

mation gaseous CO2is produced for the conditioning of

the transport compartment. A complete fill with dry ice

can maintain a 5% CO2environment for up to 32 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 SYMBOLD

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 Flight 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 use the device for the transport

of infectious substances as classified within Class 6.2 of

Symbols used on Cellbox

Direct Current

Read the manual

Use cold protection gloves when han-

dling dry ice

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

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

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.

Only use the Cellbox Flight 2.0 in well

ventilated areas when filled with dry ice. Due to

the sublimation of dry ice an increase of the CO2

concentration can ensue in the environment

around the device. Depending on the CO2

concentration inhaled and exposure duration,

toxicological symptoms in humans could range

from headaches increased respiratory and heart

rate, dizziness, muscle twitching, confusion,

unconsciousness, coma and death.

6 PRODUCT SPECIFICATION

6.1 Scope of Delivery

Besides the Cellbox Flight 2.0 the following items are in-

cluded in the scope of delivery:

•1x multi-well holder

•3x spacers for multi-well holder

•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

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 Flight 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, air-

plane or during 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 dry ice compartment 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, rail and air.

The following device elements have been highlighted for

the user:

Locking mechanism

Main power switch with protective lid and LED

for device status

Connection/socket for external power supply

4 LEDs for indication of the battery level

Incubation chamber lid

Lid locking mechanism

Chamber for dry ice with lid

Display

6.5 Display Elements

The touch screen of the Cellbox Flight 2.0 indicated the

conditions inside the incubation chamber and allows the

user to adjust incubation parameters as well as access

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 CO2(dry ice) level 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 Flight 2.0 which is in con-

formity with regulations for electronic records and signa-

tures specified in FDA 21 CFR Part 11. This license en-

ables the option for creating users with their own login

information to privatize their data if needed. To use the

Cellbox Flight 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

accounts, 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”.

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.

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.

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