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1 site monitoring Kit 1 User Manual Site Monitoring Kit User Manual we prove it.

2 2 site monitoring Kit Content 1. Introduction 3 2. Content of the Site Monitoring Kit 4 3. Preparation 6 1. Positioning of the alarm bracket 6 2. Positioning of the temperature probe 6 3. Alarm bracket settings 7 4. Settings of the alarm behavior 8 5. Preparation of the refrigerator 8 4. Installation 9 Installation of the flexible flat cable probe 9 Installation of the thermal damper 10 Installation of the alarm bracket 10 Functional check 11 Mount TemperatureLog Start of operation and monitoring In case of alarm Create PDF report TemperatureLog Display codes / Troubleshooting Battery warning and exchange After use Connection of an external alarm device 19

3 site monitoring Kit 3 1. Introduction With the Site Monitoring Kit, ELPRO provides a clever, easy-to-install temperature monitoring system including alerting for remote laboratory cabinets and refrigerators / freezers. The autonomous Site Monitoring Kit offers a reliable 24 / 7 alerting, and observes compliance with the regulations of GMP and FDA 21 CFR Part 11. The Site Monitoring Kit consists of the following hardware: - LIBERO PDF Logger Te1-N that automatically creates a PDF report upon connection to a USB port of a computer. A temperature probe with a thin flexible ribbon cable which adapts perfectly to the gaskets of any laboratory cabinet and enables an installation by the user. - A thermal damper to avoid false alarms - A battery-operated alarm bracket, which provides an audible and visual alarm signal. Optionally, the alarm can be routed to an external alarming system. If required, the LIBERO PDF report can be analyzed and documented in detail by means of the elproviewer software.

4 4 site monitoring Kit 2. Content of the Site Monitoring Kit A Certificate 1-point calibration certificate for the entire system B TemperatureLog Notepad for weekly function check and monthly protocol attachment A C LIBERO Te1-N Data logger with display and preset alarm conditions D Alarm Bracket Full functionality for audible and visual alarming (LED, buzzer, silent button) incl. internal relay for connection to external system B E Flexible flat cable probe Probe length of 153 cm, 17 cm are flexible ribbon cable F Thermal Damper and Cable Manager Delays thermal reaction time (TAU 90) by 35 minutes in order to avoid any false alarms due to frequent door openings (equivalent to the use of a glycol bottle).

5 site monitoring Kit 5 E F D C

6 6 site monitoring Kit 3. Preparation Before installing the Site Monitoring Kit, the following items should be considered: 1. Positioning of the alarm bracket A Option Option A B on the door of the cabinet on the side of the cabinet B Make sure that the cable length for the selected positioning is sufficient. Do not place the entire kit within the cabinet! 1 2. Positioning of the temperature probe There are 3 possibilities to mount the temperature probe inside the cabinet. It should be as close as possible to the products to reflect temperatures to which products are exposed Use the hook to hang it to the middle refrigerator grid shelf Use the adhesive tape to attach it underneath the middle refrigerator glass shelf Use the adhesive tape to attach it to the side wall 3

7 site monitoring Kit 7 3. Alarm bracket settings The alarm bracket offers various settings for alarm notification. Before mounting the alarm bracket, check the factory settings and if applicable change them by means of the DIP switches. «Silent» period When pressing the «Silent» button, the audio alarm will be suppressed for 30 minutes or 2 hours. «Missing data logger» The alarm bracket can trigger an alarm if the data logger is missing from the bracket for more than 30 minutes. Buzzer volume The audio alarm has 2 volume levels. DIP switches 1 to 4 Turn buzzer ON / OFF The audio alarm can be turned off or on. The alarm LED is always active. DIP Switch Settings OFF ON Factory settings 1 Silent period / 30 min 2 h OFF suppression of audio alarm 2 Missing data logger OFF 30 min ON 3 Buzzer volume Low High OFF 4 Buzzer OFF ON ON

8 8 site monitoring Kit 4. Settings of the alarm behavior 5. Preparation of the refrigerator LIBERO Te1-N is delivered with a standard refrigerator profile, see sample report in kit. It is ready for immediate use. If other settings are required, these can be changed with the liberoconfig software. It is downloadable free of charge from Important: In order to reach best possible adhesive strength, the cabinet should be warmed up to room temperature, cleaned and dried before any parts are mounted.

9 site monitoring Kit 4. Installation Once the preparation is completed and all applicable settings have been chosen, the Site Monitoring Kit can be installed. Installation of the flexible flat cable probe Lead the cable between the door and housing of the cabinet. Mount the cable inside of the cabinet. - Clean and dry mounting surface - Remove the paper from the adhesive tape - Fix the adhesive tape by firmly pressing it against the inner refrigerator wall Mount the cable outside of the cabinet according to the chosen position of the alarm bracket. - Carefully close the door - Slightly pull the flexible flat cable to stretch it - Clean and dry mounting surface - Remove the paper from the adhesive tape - Fix the adhesive tape by firmly pressing 9

10 10 site monitoring Kit Installation of the thermal damper Before the thermal damper is mounted, A adjust the cable length and sort the extra cable length with the cable manager: A Unwind cable and slide temperature 1 probe as far as possible into the thermal B damper B Use the first hole to lock the cable and lead it to the back of the cable manager C Wind any extra cable around the cable C manager D Use the second and third hole 2 3 to hold cable tightly Place the thermal damper at the desired position. Installation of the alarm bracket Align the connector of the flexible flat cable and carefully plug it into the alarm bracket, tighten the silver lock nut. Use the adhesive tape to mount the alarm bracket and fix it by firmly pressing it against the refrigerator door or outside wall. D

11 site monitoring Kit 11 Functional check Plug LIBERO into the alarm bracket and perform the functional check: Press the «START / Transit» button for 3 seconds. Temperature value appears, functional check successfully performed. Transit C To end the test, press the «STOP / Arrived» button for 3 seconds, the temperature value disappears. Arrived If no temperature value appears: - Verify whether LIBERO is fully plugged into the alarm bracket - Verify whether the connection between the cable and the alarm bracket is correct - Display readings are explained in chapter 9 - Repeat test Mount TemperatureLog with the adhesive tape and proceed according to instructions in chapter 8. The installation is now completed. The Site Monitoring Kit is ready for use.

12 12 site monitoring Kit 5. Start of operation and monitoring Important: Before loading any material, cool down the cabinet. This may take several hours. In order to start the device, press the «START / Transit» button for 3 seconds. Make sure «Transit» appears in the display; this indicates the alarm conditions are active. Make sure that a temperature value appears in the display (current temperature). Transit C If a start delay has been configured, the display will show «dely» and the PDF logger will automatically start logging temperature after the set delay time has elapsed. If «n.c.» (not connected) is displayed, check installation and consult chapter 9. Transit C

13 13 site monitoring Kit 6. In case of alarm Alarming As soon as the configured alarm limits have been exceeded, the LIBERO display changes from OK to ALARM. The alarm bracket is triggered within 10 seconds. The red LED indicates the alarm (flashing light) The built-in buzzer gives an audible signal (beep) The internal relay closes or opens (NO / NC) and notifies an external alarm such as a telephone dialer (if connected). If the alarm cannot be immediately corrected, press the «Silent» button on the alarm bracket to suppress the audible alarm for 30 minutes (or 2 hours depending on DIP switch position). The red LED remains flashing until the alarm has been reset. Alarm reset and data logger evaluation - Re-establish storage temperature - Press «STOP / Arrived» button for 3 seconds to end the current monitoring period - Disconnect LIBERO from the alarm bracket - Generate the PDF report as described in chapter 7 - Start new monitoring period, see chapter 5

14 14 site monitoring Kit 7. Create PDF report In case of alarm or for monthly download, save and archive the PDF report. Perform activities of chapters 6 to 8 as fast as possible in order to avoid any monitoring gaps. Arrived C - Press «STOP/ Arrived» button for 3 seconds to end the current monitoring period. The temperature indication on the LIBERO display disappears. Disconnect the LIBERO from the alarm bracket. If the data logger is not reconnected after 30 minutes, an alarm for «missing data logger» is activated. Plug the LIBERO PDF Logger into the USB port of a computer. The display shows «PdF» Within 20 seconds, the PDF report will automatically generate (file may show in Windows Explorer) In case the PDF report does not appear automatically, navigate to the available computer drives (Windows «Start» button, choose «Computer») and open the «LIBERO» drive. - Copy or move (drag & drop) the PDF report to the appropriate folder. Arrived Arrived The LIBERO PDF report has all recorded data embedded into the PDF file. The recorded data can be analyzed further with elproviewer. - Before opening the PDF report, copy / move it to the desired folder. - Never save (save as...) the PDF report with a PDF editor program, as this can destroy the embedded data of the file. elproviewer software enables reading of the embedded data in the PDF report. Detailed analysis of the measurement data (zoom views, set marker points, create additional reports) is possible. elproviewer is downloadable free of charge from C

15 site monitoring Kit 15 PDF report A B C D E A B C Alarm Indicator: OK or ALARM Additional information: configurable by means of free liberoconfig software Device information: as e.g. data logger ID no, reported time base, remaining battery life, the chosen logging interval defines the number of days in memory D E Alarm statistics: for the last monitoring period results: the shown temperature curve and statistical data refer to the last monitoring period only, i.e. since the last restart

16 16 site monitoring Kit 8. TemperatureLog The self-adhesive notepad is mounted directly onto the refrigerator / freezer. It can be used as a weekly check signoff, serves as a guideline in case of an alarm, and can be attached to the PDF report as monthly protocol. Temperature should be checked frequently, but at least once every week. We recommend documenting the weekly checks with date and initials in the TemperatureLog. FILLED EXAMPLE Fill in TemperatureLog: - Logger ID - Expiry date of the calibration certificate - Company - Location - ID number / name of the cabinet - Shown temperature with date and initials

17 site monitoring Kit Display codes / Troubleshooting Code Meaning Recovery Action LIBERO is in start mode and not yet activated. No temperature logging takes place! Press «START / Transit» button for 3 seconds to start monitoring and activate the alarm conditions. Transit C Data logger is in TRANSIT mode. Temperature monitoring takes place. Normal case, no measures necessary. Transit C Data logger is in ALARM state. Temperature monitoring takes place. Temperature is or has been outside of the defined alarm ranges. Resolve failure. Establish PDF report. Arrived C PDF report is being created. After creating PDF report, reconnect LIBERO to the alarm bracket. Press «START / Transit» button for 3 seconds to restart LIBERO and reactivate the alarm conditions. Transit C LIBERO is not connected to the alarm bracket / temperature probe. Plug LIBERO into alarm bracket or check whether flexible flat cable probe is connected properly. If LIBERO is started, wait one logging interval for temperature to display. Transit C Sensor error due to defective temperature probe, no temperature data is being logged. Verify whether installation is still correct. Otherwise, please contact us by phone on or send us an to

18 18 site monitoring Kit 10. Battery warning and exchange The alarm bracket is self-sustaining and powered by internal batteries. The power is not supplied by the connected LIBERO PDF Logger. We recommend changing the batteries once every year or at the latest when the yellow «Bracket low battery» LED is lit. To exchange the batteries open the alarm bracket cover. Carefully remove the used batteries and exchange them with 3 new Alkaline AAA 1.5 V batteries. 11. After use - Remove batteries from the alarm bracket see above and dispose them of according to local procedures - Data logger, temperature probe and alarm bracket are disposed of as electronic waste

19 site monitoring Kit Connection of an external alarm device The alarm bracket has a built in alarm relay, which can trigger an external device (GSM interface or automatic telephone dialer) The relay contains a dry contact 3-way switch. As soon as the red LED is flashing, the relay contact changes to the «Alarm» position. The external alarm has to be connected to the internal terminals; it cannot be attached to the probe connector. Relay connection Maximum switching load: 42 VDC or VAC; 500 ma No alarm Alarm

20 LI6004E ELPRO-BUCHS AG Langäulistrasse Buchs SG Switzerland T For local representations see: Swiss Engineering

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