Q-tag CLm doc family Type: doc / doc L / doc LR / doc D

Q-tag CLm doc family Type: doc / doc L / doc LR / doc D Q-tag CLm doc The clever one Q-tag CLm doc LR The profitable one Q-tag CLm doc L The durable one Q-tag CLm doc D The cool one To monitor your transport and storage (singel use) To monitor your transport and for multipe use (restartable) To monitor your transport and storage (data logger) To monitor dry ice pacckages (dry ice) 1) OPERATION MANUAL (EN) 1-28

Table of Contents State of delivery 1) Display explanation 3 2) State of delivery / Sleep Mode 4 3) Gathering information prior activation 4 3.1) Reading out CID-/ serial number 7 Activation Process 4) Activation of a Q-tag CLm doc family 8 5) Start delay 9 6) Add a marker 9 Recording 7) Temperature recording 10 8) Display indication during temperature recording 11 After Recording / Stop Mode 9) End of temperature recording / STOP Mode 12 10) Reading display after device has been stopped 13 11) Gathering information after activation 13 of the device or in STOP Mode 12) Technical specifiacations 14 13) Error messages 17 Data read out 14) Connection the device with a computer 18 14.1) Generating a PDF file 19 14.2) Generating an ASCII file 21 14.3) Remove device from an USB port 21 14.4) Verifying process 22 14.5) Verification of the PDF-file 24 14.6) Verification of the ASCII-file 25 14.7) Verification open directory 26 15) Important Information 27 2

Introduction to the Q-tag CLm doc family The Q-tag CLm doc family monitors reliably and precisely various temperature-profiles. It indicates the current date and time and provides a visual indication of ALARMS on the display. Details about ALARM events may be obtained upon pressing the INFO-BUTTON and / or via a down-loaded report achieved through the USB connection with a computer. 1) Display explanation English 1 OK ( ) or ALARM (X) indicator 2 Individual ALARM indicators (T) 3 Operating indicator (running indicator) 4 START Indicator (start date and time) 5 Time Expired indicator (allowed recording time exceeded, optional) 6 OFF indicator (STOP date and time) 7 Duration display (DAY/h and h/min) and temperature display 8 Time display (duration and temperature display in Sleep mode) 9 Date display (details of ALARM settings in Sleep mode) DAY h START TIME EXP c h MIN OFF 3 back to menu

2) State of delivery / Sleep Mode Q-tag CLm doc devices will be shipped in the Sleep Mode. In this mode the display is blank. This is the state of delivery of the device. It is the lowest current consumption state of a device of the Q-tag CLm doc family. The device is not activated and no data is recorded (see also point: 1 State of delivery / Sleep Mode 3) Gathering information prior to device activation (in Sleep Mode) Diverse information can be read out after the INFO-BUTTON has been pressed 3 times in one second. After 1 minutes the device goes back into Sleep Mode; the display is blank again. 1 st Display test: all segments activated DAY c h h MIN START TIME EXP OFF 2 nd Time and date of test result of production testing back to menu 4

3 rd Start delay time English START 4 th Current time, date and ambient temperature c 5 th Temperature, time limits and ALARM type S > single event HI > high limit Time>h 01 00 MIN Explaination: Alarm occours if the limit of 44.9 C exceeds 1 hour at one time. h MIN 6 th* Temperature, time limits and ALARM type C > cumulative event HI > high limit Time>h 10 00 MIN Explaination: Alarm occours if the limit of 29.9 C exceeds 10 hours in total of the individual exceedances. h MIN 5 back to menu

7 th* Temperature, time limits and ALARM type S single event LO lo limit -0.4 C Time h 01 00 MIN Explaination: Alarm occours if the limit of -0.4 C is undercut by 1 hour at one time. h MIN 8 th* Temperature, time limits and ALARM type C cumulative event LO lo limit -0.4 C Time h 01 40 MIN Explaination: Alarm occours if the limit of -1.4 C is undercut by 1h 40 min. in totoalt of he individual exceedances. h MIN 9 th* Temperature, time limits and ALARM type S single event Hi high limit Time h 00 10 MIN Explaination: Alarm occours if the limit of 8.9 C exceeds 1 minute at one time. h MIN 10 th Time expiry (max running time in days) DAY *(only indicated if factory preset, otherwise skipped) back to menu 6

3.1) Reading out CID-/ serial number Before activation press and hold the INFO-BUTTON for 3 seconds. The CID number (Cofiguration ID) is shown for 10 seconds, after that the serial number is displayed for 10 seconds. Then the display goes back into sleep mode. OFF CID (Configuration Identification Number) English Serial Number After activation (start logging) both numbers cannot be read out through the device anymore. After stopping the CID- and serial number can be read out through the PDF file with a computer. PDF creation time stamp (20170307, 07:52) Run counter (for CLm doc LR devices only) Serial Number CID (Configuration Identification Number) 7 back to menu

4) Activation of a Q-tag CLm doc family device Q-tag CLm doc devices can be started as follows: (The start option must be filled out in the evaluation sheet when ordering) Option A) Option B) Option C) Option D) Option E) Press the START button for at least 3 seconds After re-activation with the software easy go* and disconnecting the device from the USB interface. After a pre-configured date and time with the software easy go CLm doc L CLm doc LR CLm doc D CLm doc L CLm doc LR CLm doc L CLm doc LR After a pre-configured date and CLm doc L time with the software easy go. CLm doc LR Breaking off the START CLm doc break-tab START/STOP brack-tab Expiry date: Please always verify the expiry date prior using any device (see: Expiry Code Explanation) Important: Before a re-activation of a Q-tag CLm doc LR device you must connect device to a USB port, please read out the recorded data otherwise the recorded data will be lost! START OFF The device cannot be restarted until it has been connected to a USB port on a computer. Read out your recorded before a restart. Active recording: is shown by the (OK symbol) and the flashing dot on the LCD. Q-tag easy go software download: www.berlinger.com back to menu 8

5) Start delay (optional) If a start delay has been preset, the device starts recording the START temperature after the completion of the start delay time. The start delay time is displayed by the flashing START and the remaining time of the countdown. Stopping the device during the start period is not possible. English 6) Add a marker In order to mark a special event like a start of a destination A or an arrival of a destination B with a time stamp (M1, M2, etc.) on the PDF, press the info button 3 times in a row. When setting the first marker 1 will be shown at the display for 3 seconds, after that the information disappears. For the next marker 2 is shown on the screen and so on and so forth. Up to 255 markers can be set during the lifetime period. Important: for the CLm doc LR 255 markers can be set per running cycle. 9 back to menu

7) Temperature recording / Placing the device The activated monitor must be placed immediately in its predetermined location. It is recommended to place the device as close to the supervised goods as possible. This is an important prerequisite to ensure the temperatures observed by the device are as close to the product temperature as possible. Importamt: It is recommended to precondition the device to the desired mean temperature for about 30 minutes before use, especially if no start delay time has been programmed. This is to insure against false readings during start up. back to menu 10

8) Display indication during temperature recording A (OK symbol) is indicated during normal operation as long as no ALARMs have been recorded. English OK Display This (OK symbol) will be replaced by a (ALARM symbol) as soon as any ALARM has been triggered. ALARM Display Additional arrows are shown in the left display area to indicate which limit has been exceeded. The operating indicator is flashing. ALARM Display with 3 parameter exceedances. 11 back to menu

9) End of temperature recording / STOP Mode The device may be stopped if the recording shall be finished, e.g. if a shipment has reached its final destination. To do so the STOP button must be pressed for at least 3 seconds. OFF For the Q-tag CLm doc only the plastic USB cover has to be pushed down and up in order to break off the STOP-tab. The display indicates OFF and the flashing dot disappears. OFF Important: All other indicators such as (OK symbol) or (ALARM symbol) and individual ALARM arrows remain stable for at least 3 months. Display recoding has been stopped back to menu 12

10) Reading the display after the device has been stopped OK display The monitored goods have not been exposed to temperature and time conditions outside the preset ALARM parameters. OFF English ALARM display The monitored goods have been exposed to temperature and time conditions outside the preset ALARM parameters. OFF Important: The ALARM indication cannot be cancelled nor reset. 11) Gathering information after activation of the device or in STOP Mode To avoid missreadings (e.g. caused by hand temperature), the device interrupts its recording if and as soon as the INFO-BUTTON is pressed for 3 seconds. Reading and recording will automatically resume after 10 minutes without any button pressing. On page 16 the information indicated on the LCD screen upon successive pressing of the INFO-BUTTON after activation or in STOP Mode is explained. 13 back to menu

12) Technical specification of the Q-tag CLm doc family External dimensions (L x W x H) Q-tag CLm doc Q-tag CLm doc LR Q-tag CLm doc L Q-tag CLm doc D 95 x 54 x 12 mm 93 x 54 x 12 mm 93 x 54 x 12 mm 93 x 54 x 20 mm Size of LCD display 25 x 19 mm 25 x 19 mm 25 x 19 mm 25 x 19 mm Weight 40 g 40 g 40 g 54 g Warehouse conditions (device not activated) 0 C to +30 C / +32 F to +86 F Operating temperature -30 C to +60 C / -22 F to +140 F ALARM temperature range -25 C to +55 C, in 0.1 C increment/ -13 F to +131 F 0 C to +30 C / +32 F to +86 F -30 C to +60 C / -22 F to +140 F -25 C to +55 C, in 0.1 C increment/ -13 F to +131 F 0 C to +30 C / +32 F to +86 F -30 C to +60 C / -22 F to +140 F -25 C to +55 C, in 0.1 C increment/ -13 F to +131 F 0 C to +30 C / +32 F to +86 F -85 C to +30 C / ** -121 F to +86 F ** -80 C to +25 C / increment/ -112 F to +77 F ALARM limits Up to 5 individually programmable ALARM limits Up to 5 individually programmable ALARM limits Up to 5 individually programmable ALARM limits Up to 5 individually programmable ALARM limits English Temperature measurement interval Every minute Every minute Every minute Every minute Temperature log interval na * Adaptable 1 to 60 minutes Adaptable 1 to 60 minutes Adaptable 1 to 60 minutes Accuracy of temperature measurement +/- 0.5 C (-30 C to +60 C) +/- 0.9 F from -22 F to +140 F +/- 0.5 C (-30 C to +60 C) +/- 0.9 F from -22 F to +140 F +/- 0.5 C (-30 C to +60 C) +/- 0.9 F from -22 F to +140 F +/- 0.5 C (-30 C to +60 C), +/- 0.9 F from -22 F to +140 F, +/- 1.5 C (-85 C bis -30 C) Memory space 1 500 points (data selection) 38'000 points 38 000 points 38 000 points Protection class IP65 IP65 IP65 IP65 Working life Up to 2 years (1 year storage / 1 year useful life) Device STOPs working after 365 days. Up to 2 years (1 year storage / 1 year useful life) Device STOPs working after 365 days. Up to 2 years (1 year storage / 1 year useful life) Device STOPs working after 365 days. Up to 2 years (1 year and 11 month storage / 30 days useful life) Device STOPs working after 30 days. Battery life Up to 2 years Up to 2 years Up to 2 years Up to 2 years (30 days operation at -85 C) Activation Bend and break start tab Start button or per automatic start using configuration Start button or per automatic start using configuration with easy Start button with easy go software go software STOP Bend and break STOP tab STOP button or as per automatic STOP as per STOP button or as per automatic STOP as per defined time STOP button defined time Configuration Pre-set by Berlinger & Co. AG Pre-set by Berlinger & Co. AG or self-configuration Pre-set by Berlinger & Co. AG or self-configuration with easy go Pre-set by Berlinger & Co. AG with the easy go software software Software Format original document Free software for verifying the PDF and ASCII file PDF and ASCII file (can therefore also be read into many ERP systems) JAVA / The software checks the digital signature of the ASCII and PDF files. Complies with FDA regulations 21 CFR Part 11. Software complies with the GAMP 5 guidelines. PDF and ASCII file (can therefore also be read into many ERP systems) JAVA / The software checks the digital signature of the ASCII and PDF files. Complies with FDA regulations 21 CFR Part 11. Software complies with the GAMP 5 guidelines. PDF and ASCII file (can therefore also be read into many ERP systems) JAVA / The software checks the digital signature of the ASCII and PDF files. Complies with FDA regulations 21 CFR Part 11. Software complies with the GAMP 5 guidelines. Compatibility with Yes Yes Yes Yes smartview NIST/ILAC calibrationcertificate Yes Yes Yes Yes * Temp. Change +/-0.5 C ** PDF graph -90 C / -130 F to +25 C / +77 F visible. ASCII file records full temperature range. PDF and ASCII file (can therefore also be read into many ERP systems) JAVA / The software checks the digital signature of the ASCII and PDF files. Complies with FDA regulations 21 CFR Part 11. Software complies with the GAMP 5 guidelines. back to menu 14 15 back to menu

1. Current time, date and ambient temperature c 2. Temperature minimum with time and date of occurrence c 3. Temperature maximum with time and date of occurrence c 4.* Time, date and duration of 1st ALARM type h MIN 5.** Time, date and duration of 2nd occurrence of 1st ALARM type (max. 3 single events) h MIN 6.** Time, date and duration of 3rd occurrence of 1st ALARM type (max. 3 single events) DAY h 7.* Time, date and duration of 2nd ALARM type The information will be the same as 8.** Time, date and duration of 2nd occurrence of 2nd ALARM type (max. 3 single events) from point 4. to 6. refering to your individual alarm settings. 9.** Time, date and duration of 3rd occurrence of 2nd ALARM type (max. 3 single events) 10.* Time, date and duration of 3rd ALARM type The information will be the same as 11.** Time, date and duration of 2nd occurrence of 3rd ALARM type (max. 3 single events) 12.** Time, date and duration of 3rd occurrence of 3rd ALARM type (max. 3 single events) from point 4. to 6. refering to your individual alarm settings. 13.* 14.** Time, date and duration of 4th ALARM type Time, date and duration of 2nd occurrence of 4th ALARM type (max. 3 single events) The information will be the same as from point 4. to 6. refering to your individual alarm settings. 15.** Time, date and duration of 3rd occurrence of 4th ALARM type (max. 3 single events) back to menu 16

16.* Time, date and duration of 5th ALARM type The information will be the same as 17.** from point 4. to 6. refering to your Time, date and duration of 2nd occurrence of 5th ALARM type individual alarm settings. (max. 3 single events) 18.** Time, date and duration of 3rd occurrence of 5th ALARM type (max. 3 single events) 19. Transport time English 20. Start time and date (device activation) 21. Start time and date (device activation) START OFF *(only indicated if ALARM limit preset and range violations occurred, otherwise skipped) **(only indicated if ALARM limit preset as single event type and range violations occurred, otherwise skipped) 13) Error Messages An error message can only occur before or during the device activation. Wait until the device is recording (Page 8) before you put it into your shipment. If an error message like in the example occurs, do not use the device in any case! (Possible error notifications: Err01-Err17) Please contact the Berlinger support team immediately. E-mail: support@berlinger.com, Phone: +41 71 982 88 11 For any other purposes please contact our sales team. E-mai: info@berlinger.com, Phone: +41 71 982 88 11 17 back to menu

14) Connecting the device with a computer Plug in the device into any computer via USB-interface. Make sure the device is plugged in properly. The following window will appear: Wait sufficient time for the device to generate the ASCII and PDF files (approx. 10 seconds). Now choose the appropriate file generated by the Q-tag CLm doc device. Note: For this process no additional software is necessary. back to menu 18

14.1) PDF file - Sample of a PDF-file generated by a Q-tag CLm doc L Page 1: Information overview English 19 back to menu

Page 2: Temperature graph Page 3: Marker information back to menu 20

14.2) Sample of an ASCII-file generated by a Q-tag CLm doc L English 14.3) Remove device fromusb port For a proper USB-port disconnection of the device, please always use the safely remove hardware function on your PC/Mac. Do not disconnect the device before you receive the following message: Hardware can be removed now. The device CLM DOC (D:) can be removed from the computer now. 21 back to menu

14.4) Verifying process This process is to verify if the files created by a device of the Q-tag CLm doc family has been manipulated (meets the strict FDA CFR 21 Part 11 requirements). Download the software (Q-tag CLm doc verifier) from our website: www.berlinger.com under Software. Open the software (Double click on the Java icon) The follwoing window will appear: back to menu 22

Click on open file English Option 1: Select the files directly from the drive while the Q-tag CLm doc device CLM DOC is connected to your computer. Option 2: Select the files from the place where you saved them on your computer. 23 back to menu

14.5) Verification of the PDF-file Now open the PDF-file. When the file is in its original condition, the following window will appear: Note: File names are write-protected. The names may only be changed after downloading onto a computer. Changing is either possible directly on unopened files or via open and save commands with the Adobe Reader. Using other programs may cause loss of the digital signature. In case the file has been changed, the following error message will appear: back to menu 24

14.6) Verification of the ASCII-file Now open the ASCII-file. When the file is in its original condition, the following window will appear: English In case the file has been changed, the following error message will appear: Messages verifing a PDF file Digital signature (file was not manipulated) ( file was manipulated) Messages verifing an ASCII file Digital signature: (file was not manipulated) ( file was manipulated) Alarm status Transportation duration:* (no an ALARM has been detected (an ALARM has been detected The transport duration was in time The transport duration time was exceeded * If not set in the configuration, it is not shown in the verification result. 25 back to menu

14.7) Verification open directory Open the directory where you copied your files to. Following information will be shown All files OK? Directories scanned: 1 Files checked: 2 Files ignored: 0 Files with problems: 1 A click on Show details will bring the following information to the screen: The result shows that the PDF File is OK (green) and that an ALARM was triggered in the ASCII file. The files are not manipulated. In this case the ASCII file was manipulated. Signature invalid. The PDF file is OK. Due to this circumstances that a file was manipulated you can not read out the information, if there was an ALARM or not. More information about the Q-tag CLm doc family can be found under: www.berlinger.com back to menu 26

15) Important information Liability The manufacturer shall not be held liable: if the device was used beyond the manufacturer s given limitations. for any claims due to the improper storage and use of the device. for any problems with the temperature controlling and / or cooling unit. for the bad quality of any monitored goods. for incorrect readings if the device was used beyond its expiry date. Battery The devices of the Q-tag CLm doc family containing a lithium battery. Please pay strict attention to the following points: The housing of a Q-tag CLm doc family device must never be opened nor destroyed. Do never expose a device of the Q-tag CLm doc family to temperatures above the allowed range (fire, oven, micro waves, etc.). It may cause injuries. Always keep a device from the Q-tag CLm doc family out of the reach of children. The battery complies with IATA DGR Packaging Instruction 970 Section II and is therefore not considered as dangerous good Dispose or recycle the device from the Q-tag CLm doc family in accordance with the WEEE 2012/19/EU guidelines or your local regulations. The device may also be returned to the manu facturer for proper recycling. The end of the battery life is indicated by the expiry date printed on the label. Accuracy and proper function of the device cannot be assured beyond this date. English 27 back to menu

Useful life The devices can be used XXX days, but not longer than 365 day. It depends on the device type (see technical specifications) and on the condition that: The buttons are not pressed for very long time, e.g. if jammed between the goods in a shipment. Storage and operation of the device should remain inside the recommendations of the manufacturer, especially temperatures below 0 C or 32 F could have a negative influence for the operating lifetime of the battery. Attention All devices of the Q-tag CLm doc family monitor temperature exposures and not the product quality. Its purpose is to signal if product quality evaluation or testing is required. Subjet to change. Please note that all information in this document is correct at the time of publication. Due to our policy of continuous product development, we reserve the right to change this information without prior notice. Application area of the Q-tag CLm doc family device type technical data Q-tag CLm doc Q-tag CLm doc LR Usage International supply chain International or domestic supply chain/closed organisations Q-tag CLm doc L International or domestic supply chain Q-tag CLm doc D Temperature monitoring of frozen or dry ice shipments Sales markets Pharmaceutical, cosmetic, chemical and food industry, horticulture (plants) and distributors of perishable goods Pharmaceutical, cosmetic, chemical and food industry, health- care, horticulture (plants) and distributors of perishable goods Pharmaceutical, cosmetic, chemical and food industry, horticulture (plants) and distributors of perishable goods Pharmaceutical industry, clinical trials, animal-/ human healthcare, organ transplant (surgery) smartview X X X - easy go - X X - Berlinger & Co. AG Mitteldorfstrasse 2 9608 Ganterschwil Switzerland Tel. +41 71 982 88 11 Fax +41 71 982 88 39 info@berlinger.com www.berlinger.com back to menu 20170630_Release_5.2 28