Page 2
PRODUCED BY An der Bahn 5 Englische Planke 8 22844 Norderstedt 20459 Hamburg Germany Germany T +49 40 226316410 T +49 40 226316410 cellbox-solutions.com office@cellbox-solutions.com...
Page 3
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.
TABLE OF CONTENT SAFEKEEPING OF THE MANUAL ........................8 DEVICE DESCRIPTION ............................8 LIST OF USED SYMBOLD ..........................8 INTENDED USE ..............................8 ................................... 8 URPOSE ........................8 ESTRICTIONS ON THE SE OF THIS EVICE SAFETY INSTRUCTIONS ........................... 9 PRODUCT SPECIFICATION ..........................9 ..............................
Bluetooth connectivity to the CELLBOX 2.0 – LIVE SAFEKEEPING OF THE MANUAL CELL SHIPPER App. The technical manual belongs to the Cellbox Flight 2.0 - LIST OF USED SYMBOLD 21 CFR Part 11 Data Security Software License - and must be downloaded digitally.
PRODUCT SPECIFICATION SAFETY INSTRUCTIONS Scope of Delivery Besides the Cellbox Flight 2.0 the following items are in- The device may only be operated in a good work- cluded in the scope of delivery: ing order. When the user identifies any irregularities, dis-...
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.
6.5.1.1 User Management Setup Internal actual temperature in °C • Internal set (user-defined) temperature in °C When you start the Cellbox 2.0 CFR for the first time you • Internal actual CO level in % will be asked to log in with the default information of the •...
Page 9
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). When information is entered and “Login”...
Page 10
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.
It is strongly recommended that the initial heating of the incubation chamber is performed with the Cellbox Flight 2.0 connected to a wall power socket to reserve the fully charged batteries for transport. Depending on...
6.5.5 Setup – Data Logging The Cellbox Flight 2.0 continuously logs data on the in- ternal storage drive when the device is turned on. Due to the continuous data stream feature, the Cellbox 2.0 of- fers two options for creating data logging episodes: The Cellbox 2.0 is now writing the continuous data...
Page 13
To stop the episode log, tap “Stop Episode Recording”. Tap “ ” to return to the Homescreen. Tap “ ” to return to the Homescreen. 6.5.5.3 Plot Episode 6.5.5.2 Historical Episode Creation In order to plot episodes in the plot menu, the episode must have been either created by “Immediate Episode Creation”...
Version, Battery Firmware Version and Bluetooth Firmware Version of the device. The service menu also To export data, install the “Cellbox 2.0 - LIVE CELL SHIP- shows the actual time, both in UTC and local time, as PER” - App on your smart device. Activate Bluetooth and...
The Software is now being shut down. Lastly press the Main power switch to The Cellbox is fitted with four lithium-Ion battery packs power off the Cellbox 2.0. that each have a capacity of 99.4Wh. These battery...
When only one light is blinking, the device needs to be connected to a power Open the Cellbox and gain access to the dry ice con- supply as soon as possible to ensure that incubation tainer by unscrewing the lid in an anti-clockwise motion conditions are maintained.
Use a small dry ice scoop or dry ice shovel to fill the Tap the CO dry ice timer window in the Cellbox dry ice container up so that the polystyrene lid can still Homescreen and reset the CO dry ice timer, as de- be easily placed on top of the dry ice.
To protect the contents of the Cellbox, the device should only be transported in an upright position. It is strongly recommended that the Cellbox, and more so the incubation chamber, remains closed during transport. The incubation chamber should only be...
IATA (International Air Transport Association - Dan- gerous Goods Regulations, applicable from 01.01.2021) the Cellbox has to be labelled to indicate that its operation requires dry ice for the conditioning of the internal environment as well as that the Cellbox is containing lithium-ion batteries.
Page 20
Labels on Cardboard Overpack / Cellbox during Ground and Flight Transport with dry ice CELLBOX FLIGHT 2.0 WITH DRY ICE ROAD (ADR) Labels on cardboard overpack UN 3481 label indicating the use of lithium-ion batteries with Cellbox Solution’s phone number in the indication field: +49...
Page 21
AIR (IATA) Labels on cardboard overpack UN 3481 label indicating the use of lithium-ion batteries with Cellbox Solution’s phone number in the indication field: +49 40 226316410 Please add amount of dry ice in kg as well as shippers and consignees’...
Page 22
CELLBOX FLIGHT 2.0 WITHOUT DRY ICE ROAD (ADR) Labels on cardboard overpack UN 3481 label indicating the use of lithium-ion batteries with Cellbox Solution’s phone number in the indication field: +49 40 226316410 Text on cardboard: UMVERPACKUNG / OVERPACK Information in transport documents (optional)
Page 23
II of PI967. This overview is intended as a guideline for the labelling of dangerous goods. Cellbox Solutions GmbH shall in no event be held liable for damages / unsuccessful transports resulting from inappropriate labelling. Please consult your speciality...
• ing. Affix the appropriate label(s) to the outer package, 535 mm x 380 mm x 340 mm either on the surface of the Cellbox 2.0, or on the carton (21.0“ x 15.0“ x 13.4“) overpack. Cellbox carton overpack dimensions: •...
13 CLEANING INSTRUCTIONS General Advice Clean the Cellbox before every use. Wear clean gloves for cleaning. Use an appropriate detergent (e.g., 70% aethanol or Bacillol® AF). Avoid spray disinfection. Immediate Measure Please remove any spills immediately. Regular Measure The outer surface of the device can be wiped clean with a dry cloth.
14 EC DECLARATION OF CONFORMITY Hereby, Cellbox Solutions GmbH declares that the radio equipment type Cellbox Flight 2.0 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://cellbox-solutions.com/downloads...
Page 27
An der Bahn 5 22844 Norderstedt I Germany Englische Planke 8 20459 Hamburg | Germany T +49 40 226316410 office@cellbox-solutions.com cellbox-solutions.com...