WHO PQS-Code E006/016. Q-tag CLm doc USB Multi- Limit Temperature Indicator

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1 WHO PQS-Code E006/016 Q-tag CLm doc USB Multi- Limit Temperature Indicator

2 Q-tag CLm doc management by excursion via USB Start it. Dock it. Pack it. Send it. File it. ERP-System Excel Data Management Reporting System Local file server Smartview data management software

3 The Q-tag CLm doc is a reliable support for your valuable temperature-sensitive products. USB interface for easy read-out of the data without additional installation of software Individual alarms programmed to customer specifications Precise date and time display for all events Displays minimum and maximum temperature extremes Cumulative duration of the overrun for each alarm limit Calculation of MKT and average temperature Immediate and easy decision-making thanks to easily comprehensible OK/alarm display Detailled PDF report with additional temperature graph User-friendly, reliable and as highly precise as a Swiss watch The break-off tab makes it clear that the device is activated Accurate measurement of temperature and time - NIST/ILAC traceable FDA regulation 21 CFR Part 11 compliant Cost effective

4 Q-tag CLm doc - your benefits Reading data without software via USB As soon as the Q-tag CLm doc is connected via USB to a PC or Mac, it creates a PDF and an ASCII file. Thanks to the electronic signature the raw data can be verified and are FDA regulation 21 CFR Part 11 compliant. Fast and user-friendly! Management and storing of documents The ACII and PDF files generated in the device can be ed to the sender of goods for proof of quality, storage and analysis. The files may be converted or directly imported into existing internal report formats or ERP systems in place. The temperature information can be assigned directly to shipments and products automatically. Easy and simple solution! Individual alarm programming Up to 5 different temperature and time alarms can be set between -25 C and +50 C. These are individually adapted to product or customer requirements. Customized control! Display of the extreme temperatures and duration of excursions The significance of any temperature limit violation can be seen at a glance, even if an alarm is not triggered yet. During use, extreme temperatures and time out of temperature can be observed for each limit. All relevant information is available at any time. Appropriate measures can be initiated immediately. Ready at all times! Date and time display The Q-tag CLm doc irrevocably shows the exact time and date of the occurrence that a limit is exceeded. Traceability of an alarm event is conviniently available at any time by pressing the INFO button, so that important conclusions concerning accountability are made immediately. Intelligent descision tool! Accurate measurement of temperature and time The Q-tag CLm doc is a highly accurate electronic temperature monitor. It is 100% calibrated and has a measuring accuracy of ± 0.5 C. The temperature measurements are made every minute over the entire monitoring time. Even if an alarm limit has been exceeded and the Q-tag CLm doc already indicates an alarm, it accumulates all additional temperature limit violations and shows the total time on the display. A built-in quartz crystal is responsible for accurate timekeeping. NIST/ILAC traceable temperature accuracy! Efficient and Economical Despite all its diverse information and high quality standards, the Q-tag CLm doc is a very cost-effective system. No further software costs and reports can be adapted to any existing format including your own ERP system. By establishing appropriate alarm parameters in the device, users avoid false alarms that are common with simple, temperature only alarm limits. Saving significant time by reducing excursion report writing. Reduce operating costs!

5 The display clear and tamper-proof OFF status (inactive) OK ( ) or Alarm (X) indicator Individual alarm indicators Operating indicator (running indicator) START Indicator (start date and time) OFF indicator (stop date and time) Duration display (DAY/h and h/min) and temperature display Time display (duration and temperature display in Sleep mode) OK status (active) 5 Time Expired indicator (allowed recording time exceeded, optional) 9 Date display (details of alarm settings in Sleep mode) ALARM status (stopped)

6 Sample displays of the Q-tag CLm doc Pressing the Info button allows various relevant values and information to be read from the Q-tag CLm doc. These are then shown clearly on the display. Below is some of the information that the Q-tag CLm doc can display: Display during INACTIVE state using the Info button For example used as a quality check of random samples during in-bound inspection. Without activating the device for use the alarm program and other information is automatically displayed on the screen: Date, time and ambient temperature, alarm settings, the preset start delay time etc. (example shows: 27 March 2011, 13:40, current temperature 25.3 C). Display during ACTIVE state - using the Info button even during active measuring mode Start date and time are displayed. (Example: Q-tag CLm doc was started on 2 March 2011 at 9:40)

7 Display of measured extreme temperatures Measured extreme temperatures (min/max), with the corresponding event date and time, are indicated precisely. Precise statements on the extent and cause of the excess temperature can be made easily without calculations (Example: the lowest measured temperature occurred on at 1:50 am and was -0.9 C). Display of an alarm event Alarm events are indicated with the precise date and time as well as the total duration that the alarm occurred. This important information is the basis for decisions on the future use of the monitored products (Example: on 17 March 2011 at 23:40, the alarm limit was observed to be +25 C for 30 minutes; overall, the duration of the cumulative time out of temperature was 3 hours and 47 minutes). Display of the duration of the overrun, even before an alarm has been triggered Even if the alarm limit is not triggered yet, the Q-tag CLm doc displays the observed duration while the temperature was too low or too high. This informs the user that the Q-tag CLm doc observed temperatures beyond the required limit, but the alarm time was not exceeded. Supplementary information as to how long the product being monitored was not in the required temperature range is thus available. (Example: the unit displays the temperature during monitoring was observed to be above 25 C for 0 hours and 7 minutes. An alarm was not triggered because the duration would have to be longer than 30 minutes as programmed).

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9 Generated ASCII- and PDF/A document* When the Q-tag CLm doc is connected via USB to a PC or MAC, it creates a PDF/A* and an ASCII document with the temperature and time data measured. The clear PDF document includes a temperature graph and a summary page with information such as date/time of the alarm events, MKT, etc. All relevant data and results of temperatures monitored are available at a glance and can simply be sent via or saved electronically in a folder (see example right). In addition, the raw data (PDF or ASCII file) can be read into an existing ERP or other data management system directly and the process of archiving and tracking can be automated. Read-Out document of the Q-tag CLm doc Q-tag CLm doc Identification Number: BAAB00414_ Alarm status Alarm Transport duration Alarm Total number of measurements Alarm Configuration Status Date (dd.mm.yyyy) Time (GMT) Duration 1: Single Event above 45.0 C for 3min OK 2: Single Event above 25.0 C for 3min ALARM :33 58min 3: Single Event above 8.0 C for 1h ALARM :30 1h 15min 4: Accumulated below 2.0 C for 1h ALARM :52 2h 37min 5: Single Event below 0.0 C for 3min ALARM :56 2h 32min Log Result Temperature Date (dd.mm.yyyy) Time (GMT) Start date and time :59 Stop date and time :34 Highest temperature C :34 Lowest temperature C :46 MKT +5.0 C Average temperature +3.9 C Q-tag CLm doc is manufactured by Q-tag AG Switzerland 1/2 Read-Out document of the Q-tag CLm doc Q-tag CLm doc Identification Number: BAAB00414_ T The digital signature for both files (PDF and ASCII) can be verified with the assistance of free software, which confirms the data has been unaltered (FDA regulation 21 CFR Part 11 compliant) C C C C C +0.0 C C C C t *Password protected and printable only Q-tag CLm doc is manufactured by Q-tag AG Switzerland 2/2

10 Technical specifications of the Q-tag CLm doc Hardware External dimensions (L x W x H) Size of the LCD display Weight 55 x 95 x 10 mm 22 x 20 mm 40 g Storage condition (inactive) -30 C to +60 C -22 F to +140 F Operating temperature -30 C to +55 C -22 F to +131 F (Display visible) -10 C to +55 C +14 F to +131 F Alarm temperature range -30 C to +55 C, in 0.1 C increments -22 F to +131 F Alarm limits Alarm time Temperature measurement interval Accuracy of temperature measurement Measurement accuracy of the time Up to 5 individually programmable alarm limits 1 minute to 20 days Every minute +/- 0.5 C typ. (-5 C to 30 C), +/- 0.6 C (beyond this range) +/- 1.0 F typ. (+23 F to +86 F), +/- 1.1 F (beyond this range) +/- 30 minutes / year

11 Protection class Operating lifetime and shelf life Activation and stopping Manipulation IP64 Up to 365 days operating time expiry date printed on label Break-off tabs Q-tag CLm doc cannot be manipulated or reset without destroying it Software Format of the original document Free software for verifying PDF and ASCII file ASCII (it can also be imported by many ERP systems) JAVA / The software veryfies the digital Signature of the ASCII and PDF files. FDA regulation 21 CFR Part 11 compliant. Software is compliant with the requirements of GAMP 5. Q-tag is a registered trademark.

12 Freeze-tag Monitoring of the freezing point Q-tag Quad Multi-alarm shipping and storage temperature monitor feel safe with temperature monitoring systems from Berlinger Q-tag CLm Multi-alarm shipping and storage temperature monitor Q-tag CLm doc USB multi-alarm shipping temperature monitor Fridge-tag Storage temperature monitor Fridge-tag 2 Storage temperature monitor with USB port Berlinger & Co. AG Berlinger USA LLC Mitteldorfstrasse Millcreek Road. CH-9608 Ganterschwil P.O. Box 875 Switzerland Marietta, OH USA Q-tag 2/2R plus Shipping temperature monitor (single use / reusable) Online Data Management & Central Monitoring Solutions Tel. +41 (0) Fax +41 (0) info@berlinger.ch Tel Fax info@berlinger.ch