- The worlds most advanced thermal solution for goods requiring temperature control Operating manual Content 1 1.1 1.2 2 3 3.1 3.2 3.2 4 5 5.1 5.2 6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 7 8 9 General Information Identification of manufacterer.......................................................................................................................... Scope of delivery...................................................................................................................................................... 3 3 4 Representation of safety notes 5 Notes for the customer Purpose of the operating manual.................................................................................................................. Liability and warranty coverage...................................................................................................................... Copyright...................................................................................................................................................................... 6 6 6 6 Basic safety instructions 7 Description of the device 8 8 Functional description.......................................................................................................................................... 9 Design and components..................................................................................................................................... Comissioning and operation Intended use and foreseeable misuse...................................................................................................... Tips for saving energy.......................................................................................................................................... General LED / display functions..................................................................................................................... General button functions................................................................................................................................... Connecting / switching on NelumBox..................................................................................................... Opening / closing NelumBox........................................................................................................................ Emergency release............................................................................................................................ 6.6.1 Transporting and storing NelumBox........................................................................................................ Switching temperature profiles..................................................................................................................... Running on power supply................................................................................................................................. Switching batteries............................................................................................................................................... 10 10 11 11 11 12 13 14 14 15 17 18 Cleaning and care Troubleshooting and disposal Technical data 10 Declaration of Conformity 20 21 22 23 1 General Information Thank you for choosing NelumBox!
In order to ensure a quick commissioning, it is necessary for you to thoroughly read and follow the subsequent notes and descriptions. 1.1 Identification of manufacterer Name of manufacturer:
Street:
Town:
Telephone:
E-mail:
Website:
Tec4med Lifescience GmbH Otto-Hesse-Strae 19 | T9 64293 Darmstadt
+49 (0) 6151 - 360 37 00 info@tec4med.com www.tec4med.com 3 1.2 Scope of delivery Quantity 1x 2x Designation NelumBox Li-Ion Battery 1x Power Supply 100 - 240 V AC 1x RFID card 1x 1x 1x Docking-Station 100 - 240 V AC (optional) Replaceable NIST calibrated Pt-100 temperature sensor RFID token (optional) Before putting the unit into operation, check that all parts be-
longing to the scope of delivery are present. 4 2 Representation of safety notes DANGER!
This symbol signifies imminent dan-
ger for the life and health of persons. WARNING!
This symbol signifies potential risks to property and/or the environment. FACTS!
indicates important This symbol facts and especially useful items of information. Tips for saving energy. No spray water. Electronic equipment may not be disposed of with household waste. Environmentally hazardous. 5 3 Notes for the customer 3.1 Purpose of the operating manual This operating manual contains important information for safe, correct and economical operation of the device. Observing the instructions will help to avoid dangers, reduce repair and increase the reliability and prolong the service life of the device. Danger!
Please keep the manual for future use. 3.2 Liability and warranty coverage All information in this manual are provided to the best of our knowl-
edge, on the basis of our experience and findings to date. The original version of this manual was drawn up in the German lan-
guage and its technical correctness checked by our company. The translation into the customers national language/the contractual lan-
guage has been carried out by a recognised translation agency. This manual has been drafted with the utmost care. Should you nev-
ertheless establish any gaps and/or errors, please notify us at the abovestated address. Your suggestions for improvements will assist us in designing a user-friendly manual. 3.3 Copyright All rights are expressly reserved. This manual may not be duplicated or its contents divulged to third parties in any form whatsoever without our written consent. 6 4 Basic safety instructions A basic prerequisite for safe handling and trouble-free operation of this device is acquaintance with the basic safety instructions. It is not per-
mitted to use the device for a purpose other than that stipulated by the manufacturer. Keep children away from the device at all times!
Never open the housing of the device. Repair work on the device may only be carried out by Tec4med LifeScience GmbH or by authorised workshops. Defective parts or components must only be replaced by parts ap-
proved of by Tec4med LifeScience GmbH. If the unit shows visible damage, it must not be put into operation. If the connecting cable of this unit is damaged, it must be replaced by the manufacturer or a similarly qualified person to avoid hazards. Repairs to this unit may only be carried out by qualified personnel. Improper repairs can pose considerable risks. Disconnect the unit from the power supply, before each cleaning and care; after each use. Medicines may only be stored in original packaging /
secondary packaging or suitable containers. Compare the voltage information on the nameplate with the available power supply. Connect the unit only as follows:
with the AC connection cable to the AC network. Never pull the plug out of the socket using the connection cable. Danger!
Danger!
Warning!
Danger!
The unit is not suitable for the transport of corrosive or solvent-containing substances. Warning!
The insulation of the unit contains flammable cyclopentane and requires a special disposal process. Dispose the unit properly at the end of its service life. 7 5 Description of the device 5.1 Functional description The unit is suitable for both mobile and stationary use. It can cool goods down to max. 28 C below ambient temperature or it can heat goods up to max. 65 C. In principle, NelumBox is designed for the temperature ranges 2-8 C, 15-25 C and 37 C. The unit is a wear-free Peltier cooling (thermoelectric cooling) device with heat dissipation by a fan. The use of the device can be car-
ried out at up to 80% outside air humidity. 8 5.1 Design and components 2 4 1 3 6 9 5 7 8 10 11 1 2 3 4 5 6 upper button display cooling grid lower button RFID sensor with green LED light hinged handle 7 8 9 10 11 cooling/ heating chamber door battery compartment DC connection power switch 9 6 Commissioning and operation Before commissioning, make sure that the supply cable and the plug are dry. If the unit shows visible damage, it must not be put into operation. Danger!
Do not use any electrical equipment inside the unit, unless the recommended by is this electrical equipment manufacturer. Do not place the unit near naked flames or other heat sources
(heating, strong sunlight, gas oven, heater, etc.). Danger of overheating! Always ensure that heat generated during operation can be sufficiently dissipated. Ensure that the unit is at a sufficient distance (at least 10 cm) from walls or objects so that the air can circulate. Do not use the unit in closed systems with a volume of less than 1 m3. Make sure that the ventilation openings are not covered. Do not fill the inner container with liquids or raw ice. Never immerse the unit in water. Protect the unit and the cables from heat and moisture. Avoid throwing or skidding the box or applying excessive external forces. Danger!
6.1 Inteded use and foresseable misuse NelumBox is suitable for cooling and heating medical drugs and samples. All materials used are safe for medication. NelumBox can be used and transported in the aircraft as hand lug-
gage. NelumBox may not be checked in as baggage and stored in the cargo hold (Li-Ion batteries). Please check whether the capacity of the unit meets the requirements of the medication you want to keep at the right temperature. Danger!
10 6.2 Tips for saving energy A fan inside the unit circulates the air inside the chamber, resulting in better cooling / heating performance. Choose a well-ventilated place protected from solar irradiation. Do not open the unit more often than necessary. Do not leave the unit open longer than necessary. Once attached to the power grid, NelumBox switches to AC-mode. In AC-mode, Nelumbox constantly keeps the temperature at the most efficient level to increase the runtime in mobile mode. Thus to increase runtime, keep NelumBox attached to the power grid as long as possible before using the device in mobile mode. 6.3 General LED / display functions After the selected temperature has been reached, the display turns off and the LED light is illuminated. The LED light will be on, as long as the display is off and Nelumbox is within the defined temperature range (without error messages). The display can be activated by pressing one of the buttons. If there is no activity for more than one minute, the display is turned off again (if Nelumbox is still within the defined temperature range). 6.4 General button functions The buttons can illuminate in the following colors:
Blue: NelumBox cools down, but has not reached the target temperature range. Red: NelumBox heats up, but has not reached the target temperature range. / Access via RFID denied. / Battery lower than 5%. / If the temperature deviates by more than +/-0.5C degrees, after reaching the target temperature range. Not illuminated:
NelumBox has reached the target temperature range. Green: Access via RFID granted. 11 Yellow: When attempting to open the door via button, but RFID is required. / Battery lower than 10%. / If the temperature deviates by up to +/-0.5C, after reaching the target temperature range. / Door is opened longer than 22 seconds. 6.5 Connecting/ switching on NelumBox Make sure that only items or goods that may be cooled or heated to the selected temperature are stored in the device. Warning!
Place the unit on a firm base. Close the door. If the batteries are discharged or the batteries are not used, connect the unit to an AC power socket using the supplied AC power connection cable. Close the door. AC power socket power switch Press the power switch on the back of NelumBox to turn on the device. NelumBox welcomes a successful start-up with the NelumBox logo. The cooling unit now starts to heat or cool the interior to the previously set temperature. After powering up, the battery status and interior temperature of NelumBox immediately show up on the display. Before each trans-
port, make sure that all general conditions for the transport are safely observed!
The batteries can be charged by the Docking-Station. For more infor-
mation about that device read the RRC2054-2 manual or contact RRC power solutions GmbH. 12 6.6 Opening / closing NelumBox NelumBox is equipped with an electronic access control using RFID technology (optional). If the electronic lock is activated, the door can only be unlocked by RFID tokens/cards or via NFC. NelumBox can only be opened when switched on (exception: emer-
gency release; see chapter 6.4.1). To unlock NelumBox, hold the RFID token/card to designated area at the front of the device. Successfully unlocking NelumBox is confirmed by a green light on the buttons and via the display. The lock is unlocked by pulling either the upper or the lower button and by pulling the door. Prevented access is confirmed by the buttons glowing in red and on the display. If the electronic lock of NelumBox is not activated, simply open the device by pulling either the upper or the lower button and by pulling the door. If unlocking is prevented, do not attempt to open the door by force. This can lead to damage to the device. Warning!
If the unit is opened for more than 22 seconds, a warning signal sounds and the door lights begin to shine in yellow. The signal warns to quickly close Nelumboxs door to avoid exceeding the set temperature. If the alarm message is ignored, the signal increases in intensity. The display also prompts the user to close the door. Close the door by applying pressure to the front of NelumBox. Press on the area between the display and the hinged handle or on the LED to close the door. Do not press on the display and do not push any button while closing the door. After successfully closing the door, the audible signal, the lights and the warning on the display disappear. Warning!
13 6.6.1 Emergency release In cases of emergency, NelumBox can also be opened without power supply via cable / battery. In order to unlock NelumBox via the emergency release mechanism, push through the sealed opening and trigger the emergency button on the downside of NelumBox using a suitable device (e.g. a long pen). You can now open the door manually. 6.7 Transporting and storing NelumBox If the unit shows visible damage, it must not be put into operation. Danger of overheating! Always ensure that heat generated during operation can be sufficiently dissipated. Ensure that the unit is at a sufficient distance (at least 10 cm) from walls or objects so that the air can circulate. Do not use the unit in closed systems with a volume of less than 1 m3. Make sure that the ventilation openings are not covered. Protect the unit and the cables from heat and moisture. Avoid throwing or skidding the device or applying excessive external forces. The permissible maximum overall weight amounts to 15 kg. NelumBox can be put in operation horizontally and vertically. Danger!
To prevent damage make sure the power supply is not Warning!
plugged in while using NelumBox vertically. horizontal operation vertical operation 14 6.8 Switching temperature profiles The control of the unit has a memory function: it remembers the se-
lected temperature range for each mode (2-8 C, 15-25 C, 37 C) once the device is shut off. The previously selected temperature range is set each time the unit is switched on. The selected temperature range is indicated by a white background at the top of the display. The basic settings are cold chain 2-8 C, ambient 15-25 C and incubation 37 C. Note that it may be intentional if the temperature range cannot be adjusted. The setting can be changed by authorized personnel or Tec4med. You can switch between the different temperature ranges by pressing the upper button for 3 seconds. Once the time is up, switching to the next temperature range is acknowledged by a short beep and by the display highlighting the next temperature range at the top of the display. To switch to the next range, it is required to press the upper button for 3 seconds again. 15 The heating process is indicated by a wave icon. The cooling process is indicated by a crystal icon. Once Nelumbox has reached the designated temperature range and leaves the area, a temperature warning occurs. Hereby, Nelumbox shows Temperature Warning (level 1) /
Temperature Alert (level 2), the buttons start to flash in yellow / red and a warning sound appears, increasing in intensity. The sound can be disabled by pressing one of the buttons. The temperature warning / alert occurs until the temperature moves back to its designated temperature range. Otherwise the warning remains. Only use NelumBox in the temperature profile of 2-8C up to a maximum outdoor temperature of 35C. Otherwise the desired temperature cannot be guaranteed. Warning!
16 6.9 Running on power supply NelumBox is operated via the included power supply with the respective country adapter (100 - 240 V AC). NelumBox indicates the state of charge independent of its charging level by the appearance of power plug icon in the battery symbol. If NelumBox is switched off, it is not possible to charge the batteries. Leave NelumBox switched on to charge the batteries. If there is no charging in progress, the battery status is displayed as a percentage. If NelumBox is supplied completely without inserted batteries and only with mains voltage, the battery indicator on the display disappears completely. Please note that in this condition, disconnecting the power supply will cause NelumBox to switch off immediately. For all intermediate states of battery level, the respective battery status is shown on the display. If the charge level is less than 10%, NelumBox displays the following warning. Also, the buttons start to flash in yellow and Nelumbox sends a beep every minute. Once the battery charge drops below 5%, NelumBox starts to beep every 10 seconds and the buttons start to flash in red. All cooling functions go to passive mode. In this case, please connect NelumBox to mains power immediately. 17 6.10 Switching batteries To operate Nelumbox properly, the system must either be powered by mains power or by charged batteries. If both batteries are removed at the same time without mains power, Nelumbox immediately swit-
ches off completely! Under certain circumstances, this may lead to damage to the loaded goods. Use Nelumbox only with batteries provided and approved by the manufacturer. The use of other types of batteries can lead to failure or severe damage to the device. Warning!
Warning!
To change the batteries, open the battery compartment and pull the respective battery out using the tab. (The batteries fit only in one direction.) Batteries can have a different charge level. If two batteries are inserted, the charge level shown on the display is always the average charge level of both batteries. 18 Nelumbox indicates the battery being due for change on the display by indicating either I or II within the changing icon. Please make sure to switch the correct battery. battery I battery II Do not change the batteries at the same time to maintain the function of the Nelumbox. First replace the first accumulator with a fully charged system before replacing the other accumulator with a fully charged system. To avoid failure when replacing the batteries, is recommended to replace the batteries as soon as they fall below a charge level of 10%. it Please note, that the batteries must be declared as UN3481 once being packed and delivered by mail. The declaration must state: Lithium ion batteries in compliance with Section II of PI966. Both batteries are fully IATA-compliant and can be carried as hand luggage. 19 7 Cleaning and care Always disconnect the unit from the power supply or remove the bat-
teries before cleaning and maintenance. Danger!
Never clean the unit under running water or in rinse water. Do not use strong cleaning agents or hard objects for cleaning, as these can da-
mage the device. Clean the inside and outside of the unit occasionally with a damp cloth. Make sure that the ventilation openings of the unit are free of dust and impurities so that the heat generated during operation can be dissipated and the unit is not damaged. Warning!
20 8 Troubleshooting and disposal Electronic equipment may not be disposed of with household waste!
The insulation of the unit contains flammable cyclopentane and requi-
res a special disposal process. Dispose the unit properly at the end of its service life. The RRC-Li-Ion batteries are part of the GRS-battery system and can be returned at any GRS collecting point globally. Returning the batte-
ries is free of charge! For more information visit: www.grs-batterien. com/
Caution The battery used in this device may present a risk of fire or chemical burn if mistreated. Do not disassemble, heat above the maxi-
mum temperature limit of 45 C / 113 F, or incinerate. Replace battery with RRC 2054-2 only. Use of other battery may present a risk of fire or explosion. Dispose of used battery promptly. Keep away from children. Do not disassemble and do not dispose of in fire. The device and all its accessories must be disposed professionally by the manufacturer. Please also contact the manufacturer in the case of disruptions and emergencies. Tel.: +49 (0)6151 360 37 00 Email: help@tec4med.com Return to:
TEC4MED LifeScience GmbH, Otto-Hesse-Str. 19, T9, 64293 Darmstadt If the display shows an error code (E01 - E99) restart the box. If the error code does not disappear or if it returns, contact Tec4med or the source of supply / authorized retailer immediately. Danger!
Warning!
21 9 Technical data UDI 0 42 6063688 001X XXXXX1 FCC ID:
IC:
HVIN:
Voltage:
Power:
Current:
Weight:
W x L x H:
Net Volume:
IP:
Ambient temp. charging:
Ambient temp. battery mode:
Ambient relative humidity:
2AUKO-T4MNLMBXG 25600-T4MNLMBXG T4MNLMBXG 20 VDC 100 W 5 A 10,5 kg 353 x 360 x 225 mm 4,7 l IP20 Min. 0C/32F; max. 45C/113F Min. -10C/14F; max. 45C/113F Max. 80%
LABORATORY EQUIPMENT E505918 Scan code for service website. Tec4med LifeScience GmbH Otto-Hesse-Strae 19 64293 Darmstadt. Germany
+49 6151 360 37 00 2019 NelumBox is designed and assembled in Germany. 22 10 Declaration of Conformity Suppliers Declaration of Conformity Unique Identifier: NelumBox Party issuing Suppliers Declaration of Conformity:
TEC4MED LifeScience GmbH Otto-Hesse-Str. 19 Block T9 Darmstadt, Hessen 64293 Germany Telephone: +49(0)6151-360 37 00 Email: info@tec4med.com Website: www.tec4med.com Responsible Party U.S. Contact Information:
Mr. Gustaf Sandahl sgu@bito.dk Tel. +1 410 892 6658 BITO Storage Solutions US, Inc. 8314 Sherwick Ct 20794 Jessup (MD) Responsible Party Canada Contact Information:
Company Name: Celltech Labs Inc. Address: 21-364 Lougheed Road, Kelowna, BC V1X 7R8 Contact Name: Ben Hewson Telephone No.: (250) 765-7650 ext. 201 Email: IC-Rep@celltechlabs.com Innovation, Science and Economic Development Canada ICES-
003 Compliance Label: CAN ICES-3 (B)/NMB-3(B) This device complies with Industry Canadas license-exempt RSSs. Operation is subject to the following two conditions:
(1) This device may not cause interference; and
(2) This device must accept any interference, including interfer-
ence that may cause undesired operation of the device. 23 Le prsent appareil est conforme aux CNR dIndustrie Ca-
nada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes:
1) lappareil ne doit pas produire de brouillage;
2) lutilisateur de lappareil doit accepter tout brouillage radio-
lectrique subi, mme si le brouillage est susceptible den com-
promettre le fonctionnement. Antenna Information:
RFID antenna with five windings Total area: 25x25 mm NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equip-
ment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Connect the equipment into an outlet on a circuit different from Increase the separation between the equipment and receiver. that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause un-
desired operation. The Federal Communications Commission (FCC) warns the users that changes or modifications to the unit not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 24