User Manual - Alere Technologies GmbH
Contents
1. The image is needed to analyse the test run 1 Only shown in User R amp D mode 17 5 1 Data Export Result data export can be performed directly out of the ARRAYMATE Archive mode or out of the Windows mode which can be started within Administrator mode NOTE Only authorised Users are able to export data out of the Archive mode Authorised Users of the ARRAYMATE are to be determined by the Administrator via Windows User roles Export within User mode Enter Archive mode and select run to be exported by right mouse click In the popup you can select Export Run A new window opens enabling to enter a different name for the selected run Type in individual name and press ok A popup asking for entering the directory where the exported data are to be stored opens up Enter new directory and press ok Test run including all individual tests will be renamed and stored at the selected directory Export within User R amp D mode Enter Archive mode and select run to be exported by right mouse click In the popup you can select Export Run Export Run Reports Edit Run Delete Run In case you want to rename the individual test run select Edit Run A new window opens enabling to enter a different name for the selected run Type in individual name and press ok A popup asking for entering the directory where the exported data are to be stored opens up Enter new directory and press ok Test run including all ind2. ARRAYMATE Operating Manual Version 2 1 Alere Technologies 2013 ai Table of Contents 1 1 sch 2 2 2 3 3 1 a2 3 3 4 1 4 2 4 3 4 4 5 1 7 1 72 7 3 rO UCHOM EE 3 ergeet pie aa a EE e aTa ENAA aR AVEA 3 SaO Or aO eee E E E E EE E e 4 D portant Operation e 4 12 Tee EE 5 WeSC MMC AIS DCC CANONS ege 6 INS EAU e EEN 7 UG KV ANG EE 7 GEES 7 SE 9 ee ee ee A en E a ee ee eee ae er ee 8 image Recording amp AE 10 ei ING RE E 10 L ad Disposables cee czacecucnsaaserescadinceuscetvacsetescauzcenspasntysmuscescooutoedsaeasesvedkcnmescuentesvan econcneaesnnoeenceseasncacuace 12 oe EE 15 EE 16 Rico Merci ner he hence ET enn ee eh eee ee ee ee ee ee ee ee ere cer ee 16 OE DON GE 18 E OPRANO ME 19 ADENA eebe 19 ArrayMate Interface Board EE 19 ER e E 19 E E 19 Di The ARRAYMATE is designed for the rapid and reliable analysis of diagnostic tests in the array platforms ArrayTubes AT and ArrayStrips AS Two replaceable racks provided with the machine enable detection and analysis of either up to 96 ArrayStrips or 1 to 6 ArrayTube tests in one analysis run Detection and analysis of AT or AS array images represent the final step within a multiparameter test in the array platforms At the end of the experimental lab procedure comprising steps like sample preparation amp target labelling assay reaction on array chip e g hybridisation and precipitation staining the ARRAYMATE reader comes into operati
3. H20 etc Avoid disinfection If disinfection is necessary use alcohol based disinfectants Do not expose to disinfectant for a longer period of time than necessary for disinfection and rinse with pure water thereafter 7 3 Contact Alere Technologies GmbH Lobstedter Str 103 105 D 07749 Jena Phone 49 36 41 3111 0 Fax 49 36 41 3111 120 www alere technologies com 19 sch Decontamination Certificate Institute Name amp Address Instrument Serial No infectious sample material It has not been used in an invasive procedure The instrument has been cleaned and decontaminated in preparation for W This instrument has not been in contact with blood other body fluids or any inspection service or repair The decontamination procedure is as outlined below The instrument could not be contaminated The natures of risk and safety precautions to be adopted are as follows 20
4. Only trained and authorised personnel are allowed to use the ARRAYMATE CLONDIAG is not responsible for any injury or damage caused by improper use of the ARRAYMATE reader Please read the following safety notes carefully to avoid any misuse Conformity ARRAYMATE complies with the requirements EN 61326 1 and EN 61326 2 6 Electrical Power The reader is licensed for an operating voltage of 100 240 V AC 50 60 Hz The right environment Before starting to work with the reader ensure that the temperature of the reader has reached room temperature in order to avoid condensation collecting within the reader The reader needs a safe and stable standing position Protect the reader against humidity and direct sunlight For optimal application in combination with ArrayStrip AS and ArrayTube AT assay conditions operate ARRAYMATE at surrounding room temperatures between 15 and 30 C 59 86 F Avoid any vibration during reader operation Cleaning and Maintenance For ARRAYMATE cleaning with a dry soft cloth is usually sufficient If required the device can be additionally cleaned by using a mild detergent In case of using a liquid detergent disconnect power supply before cleaning Do not clean inside the device If you assume that dust has collected inside the optical system please contact the customer service Only devices cleared with a decontamination certificate see appendix will be accepted for inspe
5. for specification of disposable data matrix code 14 Immediately after disposable identification scanning reading of the ArrayStrip or ArrayTube arrays is starting Subsequent analysis of the recorded images will be automatically initiated and performed already during the imaging process 4 3 Image recording amp analysis Proceeding of the analysis process is visualised on the screen A fig 14 ArrayStrip image recording starts with most right strip here strip in row 12 and continues subsequently up and downward to the left side d Image calculate protocol NOTE In case of ArrayTube analysis identification scanning and image recording are performed in series for each ArrayTube i e first ArrayTube position will be approached for identification scanning and subsequent image recording then second one etc In case of ArrayStrip analysis at first all strip positions starting with row 1 are approached for identification scanning and only afterwards array image detection starts figs 13 and 14 This difference in reading progression is due to the geometrical arrangement of the individual camera systems for both data matrix scanning and array imaging When array image reading is finished the message Remove disposables appears and the shutter will open Remove disposables Now a new test run can be initiated or the recorded and analysed image data can be viewed ad edited in the Archive mode 4 4 S
6. initialisation procedure will start which may last a few minutes Venien 200 67 en CLONDIAG RR fig 6 initialisation screen with version number Pai 4 Image Recording amp Analysis After successful initialisation procedure the start screen as displayed in fig 7 appears The device is now ready for a new test run or for editing data of recorded and analysed tests within the ARRAYMATE Archive ad New Run e Archive eg we Power Button 3 0 fig 7 start screen of ARRAYMATE software 4 1 Start New Test Run Select button New Run in the upper left corner of the start screen fell out Run infos and chooses one detection mode in Experiment infos The reference name is required for the correct management of each ARRAYMATE test run and its storage within ARRAYMATE Archive NOTE One run consists of either 1 96 single tests in case of applying the ArrayStrip rack filled with 1 12 ArrayStrips or of 1 6 single tests in case of A applying the ArrayTube rack filled with 1 6 ArrayTubes z fig 8 Start Screen New Run 10 Experiment Infos Automatic During operation ARRAYMATE will automatically detection recognise the inserted rack and therefore the type of disposables to be analysed in the current run Both disposable racks are provided with an unique data matrix code enabling correct identification see fig 9 Worklist Exper A r ra y S t
7. r i p S Worklist ArrayStrips Use this mode to import a worklist of tests with ArrayStrips Wo rkl j st Worklist File LI 5 ArrayTubes In case individual test identification and specification is preset by an external lab software or LIMS test number and type can be imported in this mode If you want to write a worklist by yourself you can find a description in the kit manual Manual settings for ArrayStri ps Manual settings For ArrayStrips Use this mode to set manual parameters For tests with rrayStrips Specify number of tests 3 Specify assay Automatic detection This mode is only required if reading of the Manual rack data matrix code fails This can occur in settings for case of scratches or impurities on the data ArrayTubes matrix code of the racks Avoid accidental contaminations or scratches which may obliterate the code If disposable type identification frequently fails please inform CLONDIAG customer service 11 fig 9 ArrayTube rack labelled with data matrix code for rack identification 4 2 Load Disposables Now press Next button on the lower right corner of the window A screen appears asking to insert the disposables to be analysed At the same time the shutter of the ARRAYMATE is opening fig 10 ARRAYMATE with open shutter and rack fitting ready for inserting either ArrayStrip or ArrayTube rack Insert ArrayStrips For ArrayStrip test runs insert at first the requir
8. bes into the rack Ensure that tubes and tube lids are properly inserted as demonstrated in fig 12 fig 12a ArrayTubes correctly inserted fig 12b incorrectly placed ArrayTubes into ArrayTube rack ArrayTubes need to be open with tube lid connections placed into appropriate notches When rack incl disposables were successfully inserted press Next button on the lower right corner of the screen Shutter will close and the device starts data matrix code scanning to identify at first the selected disposable type and then number and assay of applied disposables Depending on the number of inserted disposables this process may last several seconds especially in the ArrayStrip reading mode 13 Proceeding of the scanning process is visualised on the screen fig 13 progress screen displaying status of number and type of identified Array Strips During identification scanning data matrix code of each applied ArrayStrips will be read and analysed Identified ArrayStrips with related assay type will be marked with the appropriate assay ID In the example ArrayStrips have been detected in rows 2 4 5 6 7 and 8 i e 6 ArrayStrips are to be analysed NOTE Data matrix code of each disposable includes the specific assay ID which determines procedure of the subsequent analysis If a code cannot be A read and analysed e g due to an assay ID not known by the system the test run will be aborted Please see also appendix A
9. ction and service In case shipping of an ARRAYMATE reader for inspection and service is required use original transportation box only Please contact ALERE customer service for detailed packing instructions 2 1 Important Operation Notes Do not place any object on the shutter to avoid blocking during operation Blocking of the automated shutter motor can lead to severe defects may result in loss of warranty rights Do not open the reader casing Any damage resulting from improper use will result in loss of warranty rights For transportation use only the original ARRAYMATE wrapping ARRAYMATE was designed for array image detection of ArrayStrips and ArrayTubes only Any other tubes vials or material must not be inserted into the reader Performance of the optical system is optimised for reading of ArrayStrips and ArrayTubes at dry stage Le after removal of detection solution in the final assay step Apply only ArrayStrips and ArrayTubes processed with non hazardous and non corrosive reagents and solutions The application of ArrayStrips and ArrayTubes in combination with hazardous or infectious material and reagents is in the full responsibility of the user Avoid any contamination of the inner parts of the reader with liquids The complete device incl PC unit is designed and approved to run with installed ARRAYMATE software only Do not install any other software and do not tamper with ARRAYMATE software t
10. ed amount of strips into ArrayStrip rack outside of device and only then position complete rack into rack fitting see fig 11a Slightly press ArrayStrips into rack to ensure proper hold Now position rack with inserted ArrayStrips into rack fitting by placing the two rack wholes onto the metallic guide pins of the rack fitting NOTE In case automatic detection mode was selected in the field for Experiment infos the ArrayStrip rack can be loaded individually e g empty rows between two strips are possible However in case the Manual settings for ArrayTubes mode was selected rack loading needs to be started with inserting first ArrayStrip into row 1 second ArrayStrip into row 2 etc No empty row between two strips is allowed see fig 11b 12 Alere Ww D Wu O N 8 9 10 11 12 Ir O mm o o WwW gt p LC EES fig lla ArrayStrip rack with inserted fig 11b if manual input of number of tests strips and rack wholes for position rack was selected rack loading needs to be into rack fitting Ensure correct insertion of performed in series starting with row 1 Strips by slightly pressing them into strip without empty rows in between frame In case of automatic detection mode empty rows between strips are possible Insert ArrayTubes For ArrayTube test runs position at first ArrayTube rack into rack fitting by placing rack wholes onto metallic guide pins see fig lla and insert then single tu
11. his includes also general software such as Microsoft Windows which has been specifically adapted to run with ARRAYMATE software Any installation or manipulation of the software may lead to malfunction of the system and is in the full responsibility of the customer user secure data storage system Hard disc capacity is limited and can be reached depending on frequency of operation No PC unit is completely secure against hardware failures like hard disk break down Result data output in form of hardcopies i e printouts and the performance of periodical data backups are strongly recommended A ARRAYMATE with incl integrated PC unit is not designed as permanent and 2 2 Sign description A important User manual LC Power on off button on the front AN Read the manual Type label SN Serial number Type label taal Manufacture date Type label onal Manufacturer Type label Ir Read this manual Type label European Conformity Type label 2 3 Technical Specifications Components ppo PC unit main board Kontron 986LCD M mITX processor Intel Core 2 Duo 2 16GHz T7400 disk space min 160 GB RAM 3 GB DDR2 RAM operating system MS Windows XP SP 3 external interfaces RS232 C ISUB D 9 pole VGA PS 2 mouse PS 2 keyboard USB 2 0 4x optional external interfaces EEE1394 10 100 1000 Bbps Ethernet Controller HD Audio amp AC97 compliant Environmental 15 C 30 C 59 86 F 10 C 55 C relative humidi
12. hut Down To shut down user software and ARRAYMATE instrument click on Power button in lower left corner of ARRAYMATE start screen In case that the door is still open after shut down please start the device again It will be closing while initialise Then you can shut down the device again 5 Result data For viewing and editing result data and images enter Archive mode Select button Archive in the upper left corner of the start screen A directory with all test runs is listed in the left tree window 17 542 g t New Pun e 2008 03 25 17 59 05 AT OM E A AE A A G Power fig 13 Enter Archive mode for viewing editing and searching result data In the left tree window signed by the flag Browse a list of all ArrayStrip and ArrayTube test runs is displayed By clicking on one specific test run all single tests comprising to one run will be listed in the right window results results b raw data segmentation image test related array image can be viewed by selecting the individual flao 16 sue search Ue TEE D TOW GALE SOGENCaUON PRAJE PIJO pere 2 3 ARCHIVE a Now an mote cms A aureus Genotyping Kit Report 2010 02 16 15 00 49 i Er p z n kit ap i x e ep r For Investigational Use Only Not Intended for Use in Clinical Diagnostics 18 Sample ID 13ANR 70413 Experiment ID IANA 70613 S3EDBTES T1FT 47FA f01 FA 0 AIT Date of Result Mon Jan 21 16 36 13 2013 Assay Name tan DM ge Assa
13. ividual tests will be renamed and stored at the selected directory Export within Administrator mode ARRAYMATE needs to be started in the Administrator mode Type in Administrator password to enter Windows and then Windows explorer All data files generated by ARRAYMATE test runs are stored within the directory D archive_root name of test run Data export can be performed via one of the USB or the LAN interface accessible right rear side of the instrument see fig 3 18 Alere 6 Errorhandling Device doesn t start switch off the device backside switch wait some seconds and switch on again Door doesn t close correctly switch off the device backside switch close the door with hands do this only without power on the device switch on and restart normally Blue led don t stop blinking after switch on Contact Alere Technologies GmbH If you send back the device to repair please fill out the formular Decontamination Certificate on the end of this manual and send it to us 7 Appendix 7 1 ArrayMate Interface Board ARRAYMATE is provided with an extended interface and connector board on the right rear side see also fig 3 on page 8 RS232 C unused PS 2 keyboard PS 2 mouse unused VGA monitor USB 2 0 4x 1x USB mouse 3x free OD Oo Or OI fig 15 plug in 7 2 Care Instruction Clean with water or with mild detergent only Do not use aggressive chemicals like hypochlorite
14. on the staining reaction results in a test specific colorimetric pattern generated on the array chips which will be automatically detected and analysed by ARRAYMATE 1 Introduction NOTE The optical system and therefore performance of the device is optimised for reading of ArrayStrips and ArrayTubes at dry stage i e after removal of detection solution in the final assay step Please contact us for questions on optimised assay protocols The ArrayMate is intended to be used for research use only and not for in vitro diagnostic use 1 1 Instrument Overview Fig l ARRAYMATE with monitor keyboard mouse and disposable racks for exchange in the left image the ArrayTube rack is currently in use the ArrayStrip rack can be seen in front of the device Designed for automated detection and analysis ARRAYMATE is provided with a powerful integrated PC unit enabling the parallel performance of image detection and analysis In addition the complete system comprises external TFT screen keyboard and mouse for comfortable user interaction Both ArrayTube and ArrayStrip tests can be read and analysed with the ARRAYMATE instrument Depending on the applied platform the appropriate rack needs to be inserted into the device enabling reading of either ArrayStrip or ArrayTubes After opening the Shutter the trays can be easily exchanged 2 Safety Information The ARRAYMATE is designed for application in a laboratory environment
15. r monitor PS 2 serial USB and other interfaces 3 3 Start up For inserting either ArrayStrip or ArrayTube disposable rack the ARRAYMATE needs to be turned on Only then the shutter can be opened and a rack can be inserted Turn on the device by pressing at first the main power switch on the back side see fig 2 and then the power ON button on the front side of ARRAYMATE Power ON Status will be indicated by the blue LED right beside the power on button see fig 4 fig 4 System Power ON button and status LEDs blue LED indicating ON status of the system yellow LED indicating instrument error SS Init Run wmd E pror Alere Now turn on TFT screen by entering the related power button NOTE When starting TFT for the first time apply monitor button Auto adjust for one time for proper adjustment of the monitor screen The login screen will appear Windows ie begi Cack Your Ser name a fig 5 login screen The admin login password protection should be enabled for advanced ARRAYMATE service and data management operation only For standard user operation login the user mode This mode enables all standard reader operation like reading analysis and archive data editing The User R amp D mode password protection is an extension It shows more information than the user mode NOTE After login ARRAYMATE software will upload and an automated device
16. rument and equipment ensure that the temperature has reached room temperature in order to avoid condensation collecting within the device Remove protection belt 3 2 Setup left side of the Instrument Place the device in such a way that you reach the switch in the back of the device any time All other connectors and external interfaces are placed on the right rear side of the instrument as displayed in fig 2 and fig 3 For details on the interface connector board please refer to Appendix 6 2 Main power connector and POWER ON switch are situated on the back A Main POWER switch amp power supply cable inserted in appropriate line connector fig 2 back side of ARRAYMATE with POWER ON switch and type plate with serial number Connect provided power supply cable with the instrument s line connector on the back side of the device and plug it into a power socket WARNI NG The instrument must be only connected to power sockets with operating voltage written on type label ai Place TFT screen on top of the device as shown in fig 3 or alternatively besides ARRAYMATE Plug provided TFT power supply cable into appropriate power connector and VGA cable into VGA connector of connector board at the right side of ARRAYMATE Place mouse and keyboard in front of the device and plug into related PS2 and USB connectors of connector board on the right side of the instrument fig 3 right side with connector board fo
17. ty no relative humidity leading to condensation within device sunlight no direct sunlight method of disposal disposal by customer follow guidelines related to electronic devices for medical products ALERE accepts devices for disposal which have been sent back on the customer s expense with a signed decontamination certificate see certificate at the end of this document Physical ee dimensions width x depth x height 354 x 360 5 x 208 mm reader only weight 13 kg reader 5 6 kg monitor Supply 100 240 V AC 50 60 Hz 50 W typ protection system overcurrent overload short circuit protection 3 Aere Installation 3 1 Unpacking and Setup To unpack the ARRAYMATE device the transportation box needs to be in an upright position to open ARRAYMATE needs at least 600 x 700 x 600 mm w x d x h space and a safe and stable standing position at bench level Carefully lift and place the ARRAYMATE in position Heavy weight of approx 13 kg Inspect for any obvious sign of damage and report any damage immediately to CLONDIAG customer service Ensure free ventilation of the instrument Both ventilation slots on back and right instrument side must not be covered and require sufficient free space for air circulation Unpack ARRAYMATE equipment and TFT packed in a separate box Inspect for any obvious sign of damage and report any damage immediately to CLONDIAG customer service Before any further installation of inst
18. y ID 10248 Well Position 04 01 D Software Version 3013 01 15 Derice zatti staining control 0K TYPING SUMMARY Result MLIT clonal complex afiliation CC strain BISST IS AIRSAIL CREMRSA ARhne Besg EMESA stain syronymE New York Japan Clone USALM Canadian MRSA Irish ART AAR A MESA mech positive PVL mazativa REGULATORY GENES asri total megative ancessor geme resulator allele I asil total Positive sccessory gane rezuletor allele M Se total megative accessory geme regulator allele NI am total mepative antessory gene rezulstor allele TV METHICILLIN RESISTANCE GENOTYPE AND SCCmec TYPING E mec positive asltemate penicillin binding protein 2 defining MESA a fig 14 results of one test The flag result is designed for summarised and interpreted result presentations Depending on the assay type these presentations can consist of bar graph summaries result tables with diagnostic interpretation etc They usually can be setup only after assay validation and threshold determination and need to be programmed customised For further information please contact us The flag results b is an extension of results which includes more information Presented raw data depend on the individual IconoClust analysis script and can be adapted customised The segmentation image is generated only after successful image analysis by conoClust software representing successful grid and spot recognition
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