ThermoSecure medical equipment GmbH

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1 ThermoSecure medical equipment GmbH Thermosecure GmbH. Richmodstr 6 D Cologne Germany Tel:+ 49(0) Fax:+ 49(0) info@thermosecure.de Manual for active thermosystems Release No. Software The software supplied with the product has been tested with the specific product serial number. The software version is indicated on the main menu screen after starting. Be aware that an update is not required if your product operates correctly. If you have questions for updates please send an to info@thermosecure.de. 1.2 Name and Address of Producer, Supplier or Reseller Producer s data Thermosecure medical equipment GmbH. Richmodstrasse 6 D Cologne/ Germany (Europe) Tel : +49 (221) or +49 (2203) Fax : +49 (221) or +49 (2203) info@thermosecure. de Visit our Homepage for details Supplier, Reseller International distribution is done through selected local agent partners

1.3 Operating Functions 1 2 3 4 5 6 7 8 9 10 11 12 13 Box Function Controls All box functions and settings may be operated by marked colour keys.

Box Function Display Status of function setting may be controlled by the liquid crystal display (LCD) and light emitting diodes (LEDs). 1. USB Port 2.

2 1.3 Operating Functions Box Function Controls All box functions and settings may be operated by marked colour keys. The keys are protected against dirt and splash water. Box Function Display Status of function setting may be controlled by the liquid crystal display (LCD) and light emitting diodes (LEDs). 1. USB Port 2. LCD 3. Function Key 4. Function Key 5. Increase Key 6. Print Key 7. Logger Key 8. ON/OFF Key 9. Function Key 10. Function Key 11. Function Key 12. Menu Key 13. Decrease Key Please note: The cover lid of the USB Port can by opened by being pushed slightly forward.

1.3.1 Keys Functions Key Names Colour Function Key Picture Menu

Setting of scanning interval time in minutes Logger White Activates

offline Print White Prints a status and error log for the active

Stops session logging process and switches LCD off 2.

User-definable keys to adjust fixed temperatures Function Key Red/

White/ Blue User-definable keys to adjust fixed temperatures

temperatures If the key is not pressed well it doesn t sound and the

Note: It may be required to press a key twice for triggering the

3 1.3.1 Keys Functions Key Names Colour Function Key Picture Menu White 1. Setting of target temperature in degrees Celsius 2. Setting of scanning interval time in minutes Logger White Activates status and error logging to computer memory while box is online or offline Print White Prints a status and error log for the active session ON/OFF White 1. Stops session logging process and switches LCD off 2. Switches box and LCD on when switched off Function Key Red User-definable keys to adjust fixed temperatures Function Key Red/ White User-definable keys to adjust fixed temperatures Function Key White/ Blue User-definable keys to adjust fixed temperatures Function Key Blue/ White User-definable keys to adjust fixed temperatures Function Key Blue User-definable keys to adjust fixed temperatures If the key is not pressed well it doesn t sound and the requested operation will not be performed. Note: It may be required to press a key twice for triggering the desired function which is due to the electronic status check taking place every few seconds and not accepting an input during the time.

4 ThermoSecure medical equipment GmbH Thermosecure GmbH. Richmodstr 6 D Cologne Germany Tel:+ 49(0) Fax:+ 49(0) info@thermosecure.de Operating the keys Purpose Step Activity Display Note Switching the box on 1 Press key ON/OFF LCD switches on and shows 2 lines Works only if box is connected to mains and backup battery is loaded Switching the box off 1 Press key ON/OFF LCD switches to Standby Terminates active logging session and switches box off Selecting A) Target temperature B) Measuring rate Note Box must be switched on 1 Press key Menu 2 nd line shows Temperature n.n C n.n or nn are numeric substitute symbols for the displayed value. 2 Press key or to set requested temperature 2 nd line shows changing temperature values 3 Press key Menu 2 nd line display changes to Interval nn MINUTES 4 Press key or to set requested temperature 2 nd line displays changing measuring rates in minutes Disconnect box from power cable plug for offline use (after LOGGER was started) Connect box to power cable plug for online use Every button should be pressed for 3 seconds 1, 3, 5, 10, 15 or 30 minutes may be selected Start data logging 1 Press key Logger LCD shows START LOGGING The data logger records changes deviations beyond ±0,4 C only (differences report) Stop data logging 1 Press key ON/OFF + LOGGER LCD switches to Standby Terminates active logging session and switches box off Print protocol 1 Press key Print Not applicable Printout reports differences to preset parameters, when lid was opened, starting and ending time of logged session. May be used for intermediate or final report. Final report requires switching the box off and on again.

5 1.3.3 LC Display The LCD is switched on with the box online being connected to a power supply. The LCD is switched off with the box offline being disconnected from a power supply LC Display with Data logging active The Display STANDBY is shown when the BCTS is connected with a power cable. 1 st line displays actual cabinet temperature actual date 2 nd line displays target temperature actual time LC Display with Data logging passive Display for selecting the target temperature. 2 nd line displays the target temperature. Display for selecting the Logging interval 2 nd line displays the target Logging interval Alarms An alarm is triggered with the box online with logging active when the actual box compartment temperature deviates from the target temperature. a critical temperature deviation lasts for more than 1 measuring cycle. A non-operating box doesn t trigger any alarm. The alarm signal is acoustic and optic: Acoustic alarm: Sounds rhythmic as long as the alarm stage persists Optic alarm: The red LED is lit as long as the alarm stage persists.

6 1.3.5 Data transmission The external data transmission module has a range of 50 meters and is used for current control of temperature inside the box (optional). Method Signal Status condition Signification Required (Re-)Action Optic red LED green LED yellow LED - activated temperature alarm immediately connect box to a mains power supply - deactivated temperature status ok none - activated Mains on none - deactivated Mains off none - activated connected none - deactivated disconnected control connection 1.4 Operating the Software Make sure that the supplied serial data cable is securely connected to the box interface and the correct interface of the computer. The cable MUST be connect to the box interface to avoid data transmission errors. Don t fix these screws too tight. Don t use any other data cable - data transmission may not work Software installation Note: The software works only with Windows XP. Copy the directory from the supplied CD to the desktop of your PC. Upon the initial insertion of the USB cable the installation assistant will start automatically. Choose the appropriate path to your desktop directory. The USB driver will be located and installed automatically. Now you can start your software by double-clicking the file TempLogger.exe. The program window Thermologger V1.0X that is now open allows you to determine the set-up for the recording of a particular transport.

1.4.2 Main Menu The main menu displays several options to be selected by the corresponding menu item number. ESC (Escape key) terminates the program.

7 1.4.2 Main Menu The main menu displays several options to be selected by the corresponding menu item number. ESC (Escape key) terminates the program. File: The menu item File is designated exclusively for storing records in an Excel-compatible format. You must first select a record under Logger/Reading in order to save the record. Logger: The Logger menu consists of Status, Settings, Transfer, Start and Reading. 1. Choosing Status allows you to view your rechargeable accumulator capacity for the logger and thermoprinter. The logger and printer operate on an accumulator that can be recharged with the included AC adapter (see below). 2. Under Settings you can determine the measurement time interval, the target temperature, min/max limits and the transport name of each recording session. It is essential that you give values for the first three categories. Activating the selection set logger using pc time you have the option to transfer the current time from your computer system to the logger 3. By selecting Transfer the settings are transferred to the logger and the confirmation window transfer successful is opened. 4. You can start the logger now by selecting Start. After selecting Start no further adjustment can be made to Settings. Change of settings blocked because logger running will be displayed in yellow if this is attempted.

1.4.3 0: Setting Target Temperature and scanning Interval 1. Put in the right time with the button set logger using PC time. 2. Choose a logging interval. 3. Select the target temperature in 1.

8 : Setting Target Temperature and scanning Interval 1. Put in the right time with the button set logger using PC time. 2. Choose a logging interval. 3. Select the target temperature in 1.0 C increments. 4. Put in a required transport note. 5. Select appointed temperatures. 6. Select a menu lock to save the settings Continue with selecting the scanning interval during which the temperature is to be verified. Enter the corresponding selection number for 1, 3, 5, 10, 15 or 30 minutes rate. Yet the practical logging allows for much longer data storage since error condition may not and will not be permanent.

1.4.4 1: Setting Date and Time Selecting time and date setting will set the thermobox computer to the system time and date of the PC connected. Therefore make sure that PC data are correct.

9 : Setting Date and Time Selecting time and date setting will set the thermobox computer to the system time and date of the PC connected. Therefore make sure that PC data are correct. For secure operation and to avoid manipulation the thermobox doesn t offer any direct possibility for setting time and date - this may only be done by computer link. This system setting option MUST be selected if the LC display of the box shows a wrong date like in the second line. A wrong date only appears if the box was offline too long from mains and the backup battery did switch off due to low capacity. By selecting the menu option time and date will be set automatically to PC values. No further input is required : Box reading out You may readout the logger at any time by selecting Reading provided the logger is connected to your PC via USB cable.

1.4.6 3: Box after reading out After reading out the Data logger of the thermobox appears a chart. At the left side under Records you can select a chart.

10 : Box after reading out After reading out the Data logger of the thermobox appears a chart. At the left side under Records you can select a chart. After a successful readout the window Records lists the recording sessions. By marking one of these records, it is possible via the menu item File to save the record. The logger stores all records until it reaches the maximum capacity of 30,000 total measurements. Each subsequent new data point will cause a simultaneous deletion of the next oldest data point according to the FIFO principle (first in, first out). Performing readout to your PC or thermoprinter does not erase that data in the logger. Furthermore, performing readout during an on-going recording session does not terminate the session. The record is displayed on your PC in graph and table form. The graph format is available only through your PC, not on the thermoprinter.

1.4.7 4: Battery Status Select the Button Logger and then the button Status. The logger and printer operate off a NiMh accumulator.

11 : Battery Status Select the Button Logger and then the button Status. The logger and printer operate off a NiMh accumulator. In recording mode, this has a lifetime 21 days, otherwise, in standby mode, 3 months. This accumulator must be recharged with the 9V charger included with the logger. The connection for the charger is over the control panel near the function keys. If the accumulator should ever become empty, the logger and printer switch over automatically to an emergency back-up Li cell battery. This back-up battery has a maximum lifetime of 18 months when not in use, otherwise 90 days. After 18 months, or when it has become discharged earlier due to use, it must be exchanged. You should not attempt to change either the accumulator or back-up battery yourself. These may be exchanged only by our service personnel (phone: 0049 (0) ). Please note that you can check the status of the accumulator and back-up battery with the function keys on the logger control panel or via your PC as described above.

12 1.5 Signals to regard Method Signal Status condition Signification Required (Re-)Action Acoustic digital sound rhythmic temperature alarm Optic red LED green LED - activated temperature alarm immediately connect box to a mains power supply immediately connect box to a mains power supply - deactivated temperature status ok none - activated Mains on none - deactivated Mains off none 1.6 Quick operating Guide Purpose Step Activity Switching the box on 1 Press key ON/OFF Switching the box off 1 Press key ON/OFF Selecting A) Target temperature B) Measuring rate Note Box must be switched on 1 Press key Menu 2 Press key or to set requested temperature 3 Press key Menu twice 4 Press key or to set measuring rate Start data logging 1 Press key Logger Stop data logging 1 Press key ON/OFF Print protocol 1 Press key Print Disconnect box from power cable plug for offline use (after LOGGER was started) Connect box to power cable plug for online use There is NO additional power switch!

13 1.7 Disinfection Before disinfecting take care to rapidly transfer the stored goods in time, and then switch off the box by pulling out the mains plug. If cleaning the BCTS is appropriate, clean ( page Fehler! Textmarke nicht definiert., Fehler! Verweisquelle konnte nicht gefunden werden., Fehler! Verweisquelle konnte nicht gefunden werden.) the interior before beginning disinfection. Only disinfect an emptied and defrosted box providing a dry interior surface. Best apply disinfection with a damp cloth. Only apply disinfecting agents with a ph value between 6 and 7, as silicones, rubbers, or PVCparts could change their colour and/or characteristics. DO NOT APPLY PRODUCTS THAT CONTAIN CHLORINE! Beware of the rapid loss in effect of oxides on metal surfaces. Do not allow the disinfecting agent to penetrate any locks, the electronic alarm system, the LCD, the battery supply system, any switches or the printer system! Avoid soaking the aeration grid of the BCTS compartment! Make sure the box has completely dried before putting to operation again.

14 1.8 Error Handling In case a box function does not operate as expected first check the manual whether the unexpected state may be acceptable, described or explained Error Search Function Problem What to do Box opening Box doesn t open Make sure the locks are not closed To ensure maximum insulation and due to slight low pressure in the box the wing doors may close very tight. Low pressure occurs when compartment air is cooled thus contracting the available air volume. Display Incorrect date Connect box to computer and reset date & time via software. A wrong date is displayed if the box was offline too long from mains and the backup battery did switch off due to low capacity. Operation Box LCD doesn t switch on Check whether cable is connected well to plugs on both endings. Check whether mains supply is available Check whether fuse of the box is good. FUSE (T, 10A, 250V) Printer No paper being printed Check for paper roll being empty Computer link No data communication Check serial cable for being connected well with interfaces of the box and the computer Box does not reach the target temperature Doors not closed Visually inspect rear doors If a function error cannot be solved contact the organisational unit in charge of service or the supplier.

IMPORTANT SAFETY INSTRUCTIONS SAVE THESE INSTRUCTIONS

IMPORTANT SAFETY INSTRUCTIONS IMPORTANT SAFETY INSTRUCTIONS SAVE THESE INSTRUCTIONS WARNING (SAVE THESE INSTRUCTIONS): This manual contains important instructions that should be followed during installation