Cellbox Flight CDI Manuale utente

TECHNICAL MANUAL

Cellbox Flight CDI

PRODUCED BY

Cellbox is a registered trademark of Cellbox Solutions.

SOLUTIONS GMBH

Holtenauer Str. 74

24105 Kiel I Germany

Englische Planke 8

20459 Hamburg I Germany

T +49 40 226316410

cellbox-solutions.com

office@cellbox-solutions.com

TECHNICAL MANUAL

Cellbox Flight CDI

For Research Use Only (RUO)

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 1.6, January 2021

TABLE OF CONTENT

1. SAFEKEEPING OF THE MANUAL 5

2. DEVICE DESCRIPTION 5

3. INTENDED USE 5

3.1 Purpose 5

3.2 Restrictions on the Use of this Device 5

4. SAFETY INSTRUCTIONS 6

5. SCOPE OF DELIVERY, FEATURES AND DEVICE OVERVIEW 6

5.1 Scope of Delivery 6

5.2 Features 6

5.3 Device Overview 7

5.4 Display Elements 7

6. OPERATION OF THE DEVICE 11

6.1 Charging the Device 11

6.2 Refilling CO2 12

6.3 Preparing the device for transport 13

6.4 Transporting the Device 13

6.5 Safe Removal of the Live Cells from the Device 14

6.6 Cleaning the Device 14

7. LABELS ON THE DEVICE 14

7.1 Type Plate 14

7.2 Labeling requirements for ground transport of the Cellbox 14

7.3 Packaging of biological materials 17

8. ENVIRONMENTAL CONDITIONS FOR THE USE OF THE DEVICE 17

9. STORAGE AND DISPOSAL 17

9.1 Storage 17

9.2 Disposal 17

10 TECHNICAL SPECIFICATIONS 17

1. SAFEKEEPING OF THE MANUAL

The technical manual belongs to the Cellbox Flight CDI

and must accompany the device at all times. This en-

sures that persons operating the device can refer to the

content of the manual as required.

The latest version of the technical manual can be

opened by scanning the code on the type plate

of the Cellbox or below:

2. DEVICE DESCRIPTION

The Cellbox 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 incu-

bation chamber of a robust transport trunk. This creates a

controlled environment wherein the physical parameters,

such as the temperature and CO2 concentration (to main-

tain the pH value of the medium buffer system) can be

defined and stably maintained for a period of at least 24

hours without an external power source.

In order to achieve the optimal conditions for the

transport of living cells, the Cellbox is able to control the

ambient temperature around the cell culture vessels with

precision. This function is further supported by the con-

tinuous circulation of air around the cell culture vessels,

resulting in an even temperature distribution. The device

also maintains a constant internal CO2concentration by

automatically dispensing pure gaseous CO2. This sus-

tains 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 avail-

able for the entire period of transport, the device has

been fitted with a thermally-insulated container for the

storage of dry ice. Through the process of sublimation

gaseous CO2is produced for the conditioning of the

transport compartment. A complete fill with dry ice can

maintain a 5% CO2environment for up to 24 hours.

The Cellbox can be operated from its built-in rechargea-

ble Lithium-Ion Battery packs, an external power supply

or even an automotive/vehicle power adapter (see chap-

ter 6.1). This provides the user with various options to

ensure an uninterrupted power supply during transport.

Sensors within the transportation compartment of the de-

vice 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 con-

nectivity to the Cellbox App.

3. INTENDED USE

3.1 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 auto-

matically 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:

• 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

3.2 Restrictions on the Use of this Device

This device is intended for Research Use

Only (RUO).

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 Inter-

national Carriage of Dangerous Goods by Road, appli-

cable as from 01.01.2015) as well as Class 3.6.2 of

the IATA (International Air Transport Association - Dan-

gerous Goods Regulations, applicable as from

01.01.2021).

Use of the device for any purpose other than the in-

tended purpose described in section 3 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, mate-

rials and substances that pose a risk of exploding, burst-

ing 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.

4. SAFETY INSTRUCTIONS

The device may only be operated in a good

working order. When the user identifies any irreg-

ularities, disturbances or damage before

or during the operation of the device, it should immedi-

ately be decommissioned. After decommissioning the

device, the user should contact the manufacturer.

The device may not be rebuilt, modified or al-

tered in any way without the authorization of

the manufacturer. In the event of any unauthor-

ized modification or alteration, the declaration of con-

formity is declared invalid and the device must be de-

commissioned.

During the transport of unsuitable goods, the

possibility exists that toxic vapors or explosive

fumes may be formed. This may cause the de-

vice 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 vapors or explosive fumes when

heated (also see section 3. Intended Use).

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 quanti-

ties 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 compo-

nents must only be performed by the manufacturer.

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 CDI in well

ventilated areas when filled with dry ice.

Due to the sublimation of dry ice an

increase of the CO2 concentration can ensue.

Depending on the CO2concentration 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.

5. SCOPE OF DELIVERY, FEATURES AND DE-

VICE OVERVIEW

5.1 Scope of Delivery

Besides the Cellbox Flight CDI the following

items are included in the scope of delivery:

• 1 multi-well holder

• 3 spacers for multi-well holder

• Power adapter for operation of the device or for

charging the battery packs

• Car adapter

• Technical Manual (Online)

• Power plugs with wall socket compatibility for

the EU, Japan, UK, USA, Switzerland and Australia.

5.2 Features

The Cellbox Flight CDI has the following features:

• Protective environment for the temporary stor-

age and transport of cells and culture media

within a variety of cell culture vessels.

• Mechanical protection of goods when the de-

vice is carried or transported in a vehicle, train,

ship or airplane.

• Simple-to-use touch screen interface for the

operation of the device.

• Incubation range 3°C above ambient

temperature and programmable be-

tween 28°C and 38°C.

• Programmable CO2 concentration between

0% and 18%.

• Display that is updated with the internal

CO2concentration and temperature in

real-time.

• The Cellbox logs the history of the internal

temperature, CO2concentration, remaining CO2in the

dry ice compartment as well as its set values for tem-

perature and CO2.

• Bluetooth connection for communication with smart

devices.

• Cellbox App for data export and graphical presenta-

tion of logged environmental conditions.

5.3 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

5.4 Display Elements

The touch screen of the Cellbox Flight CDI displays the

conditions inside the incubation chamber and allows the

user to adjust temperature, CO2 concentration and reset

the elapsed time and remaining CO2.

The Cellbox Homescreen becomes visible when the de-

vice is switched on. The following is displayed:

• Current temperature in the incubation chamber in °C

• Preset temperature in incubation chamber (user-de-

fined) in °C

• Current CO2level in the incubation chamber in %

• Preset CO2level (user-defined) in %

• Elapsed time in hh:mm:ss

• Bluetooth toggle on/off

• CO2dry ice level in %

• Battery level in %

Tap the respective field to enter its sub menu.

Setup – Temperature

Use the keypad to define the preset temperature

in the incubation chamber. A value in the range of

28.0°C to 38.0°C is possible and can be defined in in-

crements of 0.1°C. Use the “<” key to correct your entry.

Confirm your entry with “OK” (green field).

The user is returned to the Homescreen. Tap “ ” to re-

turn to the Homescreen without modifying the preset

value.

If a value lower than 28.0°C or higher than 38.0°C is en-

tered and confirmed, the system will automatically default

to the closest minimum or maximum temperature.

It is strongly recommended that the initial heating

of the incubation chamber is performed with the

Cellbox connected to a wall power socket to re-

serve the fully charged batteries for transport. Depending

on the ambient temperature the initial heating stage can

take up to 45 minutes.

Setup – CO2Concentration

Use the keypad to define a preset CO2concentration be-

tween 0.0% and 18% in the incubation chamber. The tar-

get CO2concentration can be defined in increments of

0.1%. Use the “<” key to correct your entry. Confirm an

entry with “OK” (green field).

The user will be returned to the Homescreen. Tap “ ”

to return to the Homescreen without modifying the

preset value.

If a CO2concentration higher than 18% is entered and

confirmed, the system will automatically default to the

maximum value.

The initial CO2equilibration may take up to 15

minutes.

Setup – CO2 Dry Ice Timer

Reset the dry ice timer by tapping the green button to

confirm that the dry ice container has been refilled. The

timer will start to count backwards from 24 hours.

Tap “” to return to the Homescreen.

The remaining dry ice level is displayed by a

timer that counts backwards from 24 hours.

It is recommended to refill the dry ice

container before each transport. Re-

icing can also be performed more

frequently if needed.

When the timer reaches zero it is very likely that

there is little to no dry ice left to condition the transport

compartment.

During long transport periods the dry ice may

completely sublimate inside the container and be

replaced by gaseous CO2. Therefore, it is not

advised to open the dry ice compartment without re-icing

the device, because this could lead to a loss of the re-

maining gaseous CO2and compromise the incubation

functionality.

Be aware that leaving the transport compartment

opened for longer periods of time or increasing the

CO2concentration above 5% leads to faster sublimation

of dry ice which results in significant shorter runtimes.

Setup – Data Logging

The Data logging screen displays the elapsed time, in

hh:mm:ss, since the data logging function has been acti-

vated. To start a log, tap “start recording”, to stop a run-

ning log, tap “stop recording”.

After tapping “stop recording” the elapsed period of time

remains visible. The counter can be reset by tapping on

“reset time”.

The Cellbox can record up to 50 logs. The remaining log

counter is displayed in the upper right corner.

Once 50 log files have been recorded, the Cell-

box will be unable to record any further logs and

the user will be notified by a pop-up window.

To delete all records, tap the “delete all

records” button. A pop-up window will

be displayed in which the user needs to

confirm their command by tapping the “okay”

button. Take special note that all previously

recorded data logs will be irrevocably deleted by

pressing “okay”. Tap “cancel” to abort deleting

the records.

Tap “ ” to return to the Homescreen.

Setup - Energy Saving Mode

The battery management menu contains the settings for

Energy Saving Mode. This feature is necessary for any

transport exceeding 8 hours or when the device is left

unattended for a longer period of time. When the Cellbox

is in Energy Saving Mode, the cooling fans for the Peltier

elements are switched off which extends the battery run-

time of the device.

There are two options to choose from; Manual

Mode or Automatic Mode.

Automatic Mode

If Energy Saving Mode is set to “Auto”, the Cellbox will

automatically enter Energy Saving Mode when the tem-

perature difference between the set temperature and ac-

tual temperature is smaller than 1°C.

Activating the Automatic Energy Saving Mode allows the

Cellbox to optimize battery consumption by entering En-

ergy Saving Mode when required.

Manual Mode

If Energy Saving Mode is set to Manual, the user needs

to physically activate and deactivate the Energy Saving

Mode.

It is recommended to only activate the Energy Saving

Mode when the device is already pre-heated and the

Cellbox is about to be transported. If a Cellbox is left to

heat up the incubation chamber while Energy Saving

mode is activated, it will drastically increase the time re-

quired to equilibrate to the user defined temperature.

If Energy Saving Mode is active, either by man-

ual or automatic control, the fans for cooling the

Peltier elements are switched off, which also re-

sults in a lower noise level.

The actual status of the Energy Saving Mode is displayed

at the top of the Battery management menu.

Cellbox Solutions recommends activating Automatic En-

ergy Saving Mode for all transport applications.

Tap “ ” to return to the Home screen which will indicate

when Energy Saving Mode is turned on.

Data Export

To export data, install the Cellbox App on your smart de-

vice. Activate Bluetooth on your smart device and open

the Cellbox App.

Tap the Bluetooth button on the Cellbox Homescreen to

activate Bluetooth. If active, the Bluetooth symbol be-

comes blue. The Cellbox will attempt to pair with your

smart device via the Cellbox App. Once prompted, enter

the provided pin code to complete the pairing procedure:

Follow the on-screen instructions in the App to access

the data logs.

To learn more about the function of the Cellbox App,

please refer to our video tutorials and separate App In-

struction Manual accessible at:

www.cellbox-solutions.com &

www.cellbox-solutions.com/downloads

Only pair the Cellbox and the smart

device via the Cellbox App and not by

the smart device internal pairing

function.

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