FREND User Manual
Contents
1. The cartridge should be inserted into the equipment within the stipulated time The instrument should be used in a clean environment Biohazard e Ensure the sample is not contaminated by any foreign material or contain fibrin clots e Human samples and controls should be considered potentially infectious Introduction Location to insert or remove the FREND cartridge Show the operating status and results Pathway to dissipate internal heat to the outside FREND Sys tem Cartridge slot description Screen Ventilation Speaker Operational instructions and warning indicators Power switch Power on off Power supply port Power supply USB H Use to connect to a USB drive USB D Use to connect to a PC manufacturer or supplier only Code chip slot Location for the insertion of Q C or cartridge code chip Serial port Connection for an optional mobile printer Screen Power supply port Speaker USB D Ventilation Cartridge slot Power switch Serial port USB H Code chip slot 13 FREND System 2012 NanoEnTek Inc Introduction The function Product Definition 9 090 00009 Q C Code chi The chi taining information for the of the code ae ee proper functioning of the Q C Cartridge chip and Q C Cartridge The cartridge used to che2. car tridge in which a quantitative in vitro measurement of specific antigens in human serum or plasma are made to be used as an aid in the clinical management of patients When the FREND System is received open the shipping box and Product carefully check the package contents Note that the Q C designation components is used in terms of hardware verification of performance not quality control of the actual testing process for any analytes Note also that the mobile printer is included only if it was specifically ordered C nc OT Main body Adaptor Power cord Q C Pouch ee a Q C Cartridge Q C Code chip User manual ee QC Code chip User Marval TA Ep IT Gaririage MMT IIT IMI IATL ab ezine Bo Quick manual USB drive Quick Manual SHAE yy ae lel Optional m Optional Pipettor Mobile printer PSA Plus 30 uL TSH 35 uL 7 FREND System 2012 NanoEnTek Inc Safety The following symbols are found on the FREND System and in the manual and package inserts Study the meanings of the symbols and symbols amp always use the equipment in a safe manner abbreviations Definition Warning or caution Biohazard CLASS 1 LASER PRODUCT Class laser product Manufactured by Authorized representative in the european community Lot number In vitro diagnostic medical devi
3. cartridge slot v D E E amp Q C Caution Please check the direction of the Q C Cartridge before insertion 41 FREND System 2012 NanoEnTek Inc Maintenance FREND System maintenance 13 Wait until the test is done automatically Running Test Please Wait _ e The system automatically checks three steps while reading Step1 Laser power Step2 Laser alignment Step3 Calculate ratio 14 When the test is done the Q C Cartridge is ejected and the results from each of the three steps are displayed You will see three Passes if the system is properly operating Quality Control Result Date Time 2014 2 19 10 9 Stepi Laser Power Pass Step2 Laser Alignment Pass Step3 Calculate Ratio Pass Caution If you do not pass all tests try again 11 14 But if you do not pass again please contact the Customer support 42 Maintenance FREND System maintenance 15 Press a button and move to the main screen Quality Control Result Date Time 2014 2 19 10 9 Stepi Laser Power Pass Step2 Laser Alignment Pass Step3 Calculate Ratio Pass Q C Pass 16 Remove the Q C Cartridge Q c Cartridge Caution y A D eeee Press the Q C Code chip first to remove the Q C Code chip ae code chip 111011 The FREND System check is complete 43 FREND System 2012 NanoEnTe
4. inserted completely Restart and insert cartridge Evan Cartridge Insert Alert e Re insert the cartridge completely After insertion check to make sure the cartridge is properly and completely inserted EMCI 03 The cartridge is inserted in the opposite direction Restart and insert cartridge EMCLO3 Cartridge Insert Alert e Re insert the cartridge correctly After insertion check to make sure the cartridge is properly and correctly inserted 45 FREND System 2012 NanoEnTek Inc Maintenance Trouble shooting Cartridge insertion issues EMCI 04 The cartridge is inserted upside down Check the insert direction then restart Cartridge Insert Alert e Re insert the cartridge correctly After insertion check to make sure the cartridge is properly and completely inserted Barcode issues EMBR 01 The barcode printed on the cartridge may have been damaged so the reader is unable to interpret the code correctly Restart with new cartridge ERROR CODE 5 EMBR 01 Barcode Scanning Alert e Remove the damaged cartridge from the system Load a new cartridge with sample and reinsert the cartridge into the cartridge slot Discard the damaged cartridge EMBR 02 The barcode information related to the cartridge lot number printed on the cartridge is not readable by the system reader Enter the cartridge lot number in the manual mode EMBR 02 Barcode Scanning Alert e Manually enter the lot number of the cartri
5. required by the regulations under which your site operates The equipment itself and the electronic accessories must be dis posed of according to the regulations for the disposal of electronic components Be sure to understand what the rules at your site are 11 FREND System 2012 NanoEnTek Inc Do not attempt to disassemble modify the equipment Do not insert foreign objects into the equipment and insert only Na noEntTek Inc provided cartridges Do not handle the equipment or the power cord with wet hands Do not move tilt jar or shake the equipment when it is in operation Do not store the equipment in direct sunlight high low temperatures or high humidity Do not throw drop hit or push the equipment Do not touch the equipment or the plug during an active thunder and or lightning storm Do not touch the LCD panel with sharp objects Do not use the equipment if it has any damaged parts including the power cord or the plug e There is a risk of explosion if the instru ment battery is replaced with an incorrect type Class A equipment is intended for use in Warning an industrial environment In the docu or caution mentation for the user a statement shall be included drawing attention to the fact that there may be potential difficulties in ensuring electromagnetic compatibility in other environments due to conducted as well as radiated electromagnetic distur bances from the instrument itself
6. will be required to correct the interference at his own expense General safety warnings Before using the equipment read this manual and be certain you thoroughly understand it s contents Please follow the instructions in this manual to assure proper opera tion of the equipment When not in use unplug the equipment from the electrical outlet Perform regular maintenance checks on the main body of the instru ment Inspect all components After long term storage take extra care to be sure the equipment operates correctly Avoid handling or storing liquid on or near the equipment Do not open the machine at any time while it is operating or when it is plugged in to the wall outlet Keep the instrument away from open flames and or smoke When moving the equipment unplug itand move it carefully and gently The instrument should be placed on a flat and stable surface Refer to this manual for handling and or maintenance Keep the equipment including the cable and the plug out of reach of children Disposal management Local regulations governing the disposal of materials containing bio hazardous materials must be observed It is in the responsibility of the user to arrange for the proper disposal of these items All instrument parts which may be contaminated with potentially infectious materials must be disinfected by suitable validated pro cedures autoclaving chemical treatment prior to disposal if this is
7. 12 15 11 44 2011 12 13 10 43 2011 12 12 09 42 2011 12 10 08 41 2011 12 08 08 00 2011 12 06 12 35 2011 12 05 08 15 If the printer is connected click the Print button to print the result If you Click the List button it will return to the DATA screen e Printer should be purchased separately 35 FREND System 2012 NanoEnTek Inc Operation FREND Click DATA buttons on the main screen to check search delete the test data and perform your backup System data management Data backup Connect the USB drive that will receive the data backup to a USB H port on the back of the device Caution Confirm the USB drive version 1 1 other formats will not work NANOENTEK 2011 12 15 11 44 ABC 2011 12 13 10 43 BIO 2011 12 12 09 42 CDAC 2011 12 10 08 41 AAA 2011 12 08 08 00 BBB 2011 12 06 12 35 ccc 2011 12 05 08 15 If you want to receive the backup only for a selected data click the green Select button in the center after selecting the data NANOENTEK 2011 12 15 11 44 ABC 2011 12 13 10 43 BIO 2011 12 12 09 42 CDAC 2011 12 10 08 41 AAA 2011 12 08 08 00 BBB 2011 12 06 12 35 ccc 2011 12 05 08 15 If you want to receive the backup for all of the data click the green All button in the upper center 36 Operation FREND Data deletion System data management gt NANOENTEK 2011 12 15 11 44 ABC 2011 12 13 10 43 BIO 2011 12 12 09 4
8. 2 CDAC 2011 12 10 08 41 AAA 2011 12 08 08 00 BBB 2011 12 06 12 35 ccc 2011 12 05 08 15 If you want to delete only a selected data click the black Select button after selecting the data and the selected data will be deleted 2011 12 15 11 44 2011 12 13 10 43 2011 12 12 09 42 2011 12 10 08 41 2011 12 08 08 00 2011 12 06 12 35 2011 12 05 08 15 If you want to delete all of the data click the black all button and all of the data will be deleted 37 FREND System 2012 NanoEnTek Inc Maintenance FREND System maintenance The FREND System checks To assure reliable and accurate test results please check the following e Observe the external appearance and screen of the FREND Sys tem every time you use the device e Check the signal input part of the FREND System once a month regardless of the device use using the Q C Cartridge and the Q C code chip to specifically test the optics e f there are any problems found in the results after the checkup stop using the device immediately and contact the supplier s customer support The FREND System maintenance supplies Q C Pouch Q C Cartridge Q C Code chip FREND Syste FREND System Q C Code chip Components far dcvus 11100 ub The FREND System checklist 1 Laser power 2 Laser alignment 3 Calculate ratio 38 Maintenance FREND System mainten
9. C vp FREND System User manual Nano nTek Read me first Thank you for purchasing the FREND System Please take a few minutes to read this user manual If you have any questions at any time please contact NanoEnTek Inc customer support Tel 82 2 6220 7940 Fax 82 2 6220 7721 E mail sales nanoentek com FREND System F10 SN Electrical input 12V 3 33A ee NanoEntTek Inc HQ Tel 82 2 6220 7940 Manufactured by 12F 5 Digital ro 26 gil Guro gu Seoul 152 740 Korea NanoEnTek USA Inc Tel 1 925 225 0108 1 888 988 0108 Toll free 5627 Stoneridge Drive Suite 304 Pleasanton CA 94588 USA MT Promedt Consulting GmbH 66106 Altenhofstrasse 80 66386 St Ingbert Germany This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation MADE IN KOREA sales nanoentek com www nanoentekinc com US Branch This manual is considered a necessary part of the equipment It must be available for the operator to use at the bench as well as for the indi vidual responsible for instrument maintenance Table of contents Read me first 2 Introduction 4 18 Warranty 4 Introduction 5 Intended use 6 Product components 7 Symbols and abbreviations 8 9 Safety pre
10. NTEK PSA 1 87 ng mL e A maximum of 3 code chips per item can be installed Any cartridge whose lot number matches that of any one of the three code chips lot numbers can be used 11 Press the a button and move to the main screen 29 FREND System 2012 NanoEnTek Inc Operation FREND System operating procedure 12 Prepare the cartridge and patient samples 302501 bo 13 0140 reve e For patient samples collect 2 4 mL of blood in a 5 mL tube Spin the tube in a centrifuge and collect the serum or plasma 13 After writing the patient information or ID on the sticker of the cartridge inject sample into the inlet of the cartridge using a calibrated micro pipette and disposable tip Refer to the package insert for specific sample volume Caution Please be careful not to overfill and not to make bubbles 14 Press the TEST button on the main screen and the system moves to the Patient ID screen automatically 30 Operation 15 Type the Patient ID User ID and Order and press the Enter button To start a test press the OK button FREND System operating procedure f you setted the Entry Requiremnts as optional on General setting screen press the OK button to skip this step 16 Insert the cartridge into the cartridge slot bs 13 01 10 i a Caution Please check the direction of the cartridge before insertio
11. OME Introduction Software Data screen keys et Backup NANOENTEK 2011 12 15 2011 12 13 2011 1212 2011 12 10 2011 12 08 2011 12 06 2011 12 05 Enter the file name to later identify the data Search files or data Home button Move to the main screen View the information of the selected file or data Print the detailed data using the optional printer if it is connected to the system Backup a selected set of data to the connected USB drive 17 FREND System 2012 NanoEnTek Inc Introduction Software keys Data screen NANOENTEK ABC BIO CDAC AAA BBB CCC 2011 12 15 2011 12 13 2011 12 12 2011 12 10 2011 12 08 2011 12 06 2011 12 05 Backup all the saved data to the connected USB drive Delete all the saved data confirmation required Delete one selected piece of data Select data by moving one location at a time aa 1 Select data by moving one page ata time Display the selected data Setup FREND System setup procedure 1 Carefully examine the box for damage Remove all components of the FREND System from the box 2 Plug the power cord into the adaptor GBecsl oe 3 Carefully examine the adaptor i and make certain it is compatible with the power at the plug location If it is the appropriate adap
12. ance 1 Turn the power switch to the ON position ON OFF 00 12V USB H Asa Ee Power switch 2 Insert the Q C Code chip into the code chip slot in the direction of the arrow Caution Please check the direction of the code chip before insertion The Q C Pouch contains one Q C Code chip The Q C Code chip works with 00 Q C Cartridges pee 3 Check the main screen and press the setup button on main screen TEST DATA SHTU 4 Press the code chip button on the setup screen 39 FREND System 2012 NanoEnTek Inc Maintenance FREND 5 The Information on the Q C Cartridge is automatically saved System maintenance New QC code installed 6 When the Q C Code chip installation is complete press the OK button to go to the setup screen ep 7 Press the item button on the setup screen 8 Check the Q C Cartridge lot number the installation date of the Q C Code chip and the expiration date of cartridge Lot 303272 303003 303771 153050 111012 Expiration Date 2013 8 27 2014 6 2 2015 6 5 2016 12 17 9 If the Q C Code chip installation is complete press the OK button to go to the setup screen 40 Maintenance FREND 10 After all settings are edited press the a button and move to Sys tem the main screen maintenance 11 Press the test button on the main screen 12 Insert the Q C Cartridge into the
13. cautions 10 General safety warnings 11 12 FREND System description 13 The function of the code chip and associated cartridge 14 Software keys 15 18 Setup 19 26 FREND System setup procedure 19 26 Operation 27 37 FREND System operating procedure 27 33 FREND System data management 34 37 Maintenance 38 57 FREND System maintenance 38 43 Cleaning and storage 44 Troubleshooting 45 55 General specification normal environmental conditions 56 Customer support information 57 3 FREND System 2012 NanoEnTek Inc Introduction Warranty NanoEntTek Inc warranties the original purchaser for one 1 year from the date of its initial purchase that this equipment and other devices sold by one of its authorized representatives will function as specified NanoEnTek Inc and its representatives shall be relieved of any liability under this warranty if the product is not used in accordance with the manufacturer s instructions altered in any way not specified by Na noEnTek Inc not regularly maintained used with equipment not ap proved by NanoEnTek Inc or used for purposes for which it was not designed This warranty does not apply to damages incurred during the initial shipment of the instrument and associated auxiliary materials Any damages incurred on initial shipment are to be reported immediately to the freight carrier for the settlement of the claim Please examine the equipment carefully for any damage before signin
14. ce Jag felipe Catalogue number Symbol Definition Disposal of your old appliance 1 When this crossed out wheeled bin symbol is attached to a product it means the product is covered by the european directive 2012 19 EU 2 All electrical and electronic products should be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local authorities 3 The correct disposal of your old appliance will help prevent potential negative consequences for the environment and human health 4 For more detailed information about disposal of your old appliance please contact local distributor waste disposal service or call the number listed in the manual FREND System 2012 NanoEnTek Inc Safety precautions Thoroughly read all instructions before attempting to operate this equip ment Pay particular attention to all safety precautions The following guidelines must be observed during every phase of operation Break ing these rules may be dangerous illegal or affect performance of the equipment and or invalidate the equipment approval and or warranty In order to avoid instrument damage or personal harm read this manual carefully and follow the instructions given e Always ensure that the power supply input voltage matches the volt age available in your location e This machine is air cooled so its surface becomes warm during operation Wh
15. ck the associated mechanics and optics of the FREND cartridge system Analyte code The cartridge code chip is specific for chip a given analyte and lot of reagent It contains information on calibration and calculation of results using readings from the FREND reagent cartridge Analyte cartridge The cartridge contains reagents and microstructures to support a lateral flow assay where analytes of interest form immune complexes while the specimen is moving and being separated Ratio between test zone and reference zone is calculated Introduction Software Main screen keys Initiates a test Sequence for an analyte using that analyte specific cartridge Check and search results Back up the data and transfer the data to a USB drive Set up the FREND System parameters specific for the site and operator 15 FREND System 2012 NanoEnTek Inc Introduction Software keys Setup screen Allows user to check the information on the Q C or the cartridge code chip Allows the user to check the serial number software or firmware version and the production date of the instrument Allows the user to check the cartridge ID and its associated lot number Allows for software updates Location to adjust the time and date for the FREND system Allows entry requirements and Lab ID Move to the main screen H
16. dge using the keypad The lot number is printed directly above the barcode on the cartridge 46 Maintenance Trouble shooting Barcode issues EMBR 03 The lot number entered for the cartridge does not match the lot number on the code chip Cartridge lot number should correspond to code chip number Enter correct cartridge lot number EMBR 03 Incorrect Barcode Info e Carefully enter the lot number of the cartridge again If the same message is repeated check the lot number on the installed code chip If code chip and cartridge lots do not match change either code chip or cartridge so they are the same lot number and retry loading the cartridge Data backup issues EMDB 01 The USB drive version is not correct or the USB drive is not properly connected to the FREND System In addition the USB drive or USB H port has somehow been damaged Check the USB version or if the USB is connected to the USB port firmly EMDB 01 Unrecognizable USB e Check to be sure the USB drive is the version 1 1 required for the FREND System and that the USB drive is connected properly to the USB H port If after trying a second time with the same USB drive the error message is repeated try a new USB drive version 1 1 If the problem persists contact customer support for assistance 47 FREND System 2012 NanoEnTek Inc Maintenance Trouble shooting Data backup issues EMDB 02 A problem has been d
17. en installing the equipment on the countertop always leave a space of more than 10 cm 4 inches around the instrument in all directions e Leave adequate distance between the back of the instrument and the wall to allow the operation of the on and off power switch This location must also be accessible to load the Q C Code chip and the test code chips e Do not insert metallic objects into the FREND System as this could result in an electrical shock personal injury and equipment damage insert only qualified and authorized devices supplied by NanoEnTek Inc e Do not insert any foreign materials into the air vent or the speaker e Always set the main switch to the off position before connecting the power cord to the wall outlet e When unplugging the power cord be certain to turn the main switch off then unplug the power cord NOTE This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio commu nications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user
18. erface Serial RS232C Print width 2 inch 48 mm Printing speed 50 mm sec e Do not place unit in the direct sun e Position the unit in a well ventilated area e Place the unit on a flat dry and smooth surface with sufficient ventilation area around the unit e Operating condition Temperature 15 30 C Humidity 10 80 e Storage condition Temperature 15 30 C Humidity 10 80 56 Customer support information All materials in this manual are protected by korean and international copyright laws They cannot be reproduced translated published or distributed without the permission of the copyright owner Every effort has been made to avoid errors in text and diagrams How ever NanoEnTek Inc assumes no responsibility for any unintentional errors which may appear in this publication Information and specifica tions contained in this document are subject to change at any time without prior notice For the most up to date information contact Na noEntTek Inc s customer support This product is sold all over the world Customer support services vary for each geographical region When the FREND System is shipped information will be included that lists the appropriate telephone num bers fax numbers and email addresses from which support for your geographical region can be most readily obtained The information in this manual has been carefully reviewed and has been found t
19. ete Restart test with new cartridge ERI EMTF 06 Incomplete Cartridge Flow e Load the sample into a new cartridge and restart the test If the same error message is displayed centrifuge the sample to remove particulate matter and fibrin clots and retry with a new cartridge If the problem persists try a different sample If the problem still continues contact customer support 52 Maintenance Trouble shooting Test result issues cont EMTF 07 Time out error Restart test with new cartridge EMTF 07 Incomplete Cartridge Flow e Load the sample into a new cartridge and restart the test If the same error message is displayed centrifuge the sample to remove particulate matter and fibrin clots and retry with a new cartridge If the problem persists try a different sample If the problem still continues contact customer support EMTF 08 The cartridge has passed the expiration date The valide date of cartridge is expired Restart with the cartridge containing the new lot EMTF 08 Expired Cartridge e Load the sample into a new cartridge which does not pass the expiration date and restart the test If the cartridge does not pass the expiration date check to make sure if date setting is correct on Date amp Time screen 53 FREND System 2012 NanoEnTek Inc Maintenance Trouble Update issues shooting EMUF 01 There is no executable file FREND exe on the USB drive Re
20. etected when attempting to transfer data from the FREND System to the USB drive Check the USB is connected to the USB port firmly EMDB 02 File Transmission Alert e Check to be sure the USB drive is the version 1 1 required for the FREND system and that the USB drive is connected properly to the USB H port If after trying a second time with the same USB drive the error message is repeated try a new USB drive version 1 1 If the problem persists contact customer support for assistance Data save issues EMDS 01 The storage capacity of the FREND System to store the data has been exceeded Back up the data with USB and then delete the data in the storage EMDS 01 Data Storage is Full e Back up the data stored in the FREND System to a version 1 1 USB drive Then delete the data stored in the FREND System so space is again available on the system 48 Maintenance Trouble shooting Code chip install issues EMCC 01 The code chip is not inserted properly the code chip has somehow been damaged or the FREND System does not recognize the code chip Check for proper installation of code chip then restart code chip installation process EMCC 01 Code Chip Reading Alert e Check that the code chip is installed properly If it appears to be properly installed remove the code chip from the system locate another code chip from the same lot number and restart the code chip installation proce
21. g for the shipment since your signature indicates receipt of undamaged equipment NanoEnTek Inc will not be responsible for any indirect incidental spe cial consequential or punitive damages or other losses including but not limited to damages to or losses of other properties or equipment NanoEnTek will not be responsible for personal injuries whether to the purchaser or others Introduction The principle of the FREND System e The FREND System is a portable automated FREND cartridge reader e The FREND System is based on quantitative immunoassay tech nology capable of quantifying single or multiple analytes by measur ing laser induced fluorescence in a single use disposable reagent cartridge e The FREND cartridge utilizes micro fluidics lateral flow technology where the analyte of interest in the sample forms immune complexes while moving through the fluidics pathway in the cartridge e The concentration of the analyte of interest in an unknown sample is calculated using the ratio of the fluorescent intensity of the test zone and the reference zone Laser Sample a O Le Result of reading sea ot RA Fluorescence intensity Test zone Control zone The principle of the fluorescence detection and calculation of the analyte con centration drawing from the manual FREND System 2012 NanoEnTek Inc Intended use The FREND System is designed to accommodate the FREND
22. k Inc Cleaning and storage Do not clean the FREND System with strong or caustic cleansing agents chemicals or cleansing tissues impregnated with chemicals Use a soft and dry cloth to clean the FREND System For safety reasons disconnect the power supply from the main out let and remove the power adapter equipment from the FREND System If you want to store for a lengthy period keep the FREND System covered in a dry place Do not expose the equipment to direct sunlight Recommended storage conditions are as follows Temperature 15 30 C Humidity 10 80 Store the equipment on a stable surface Avoid inclination vibration and impact Do not place the equipment near chemicals and or corrosive sub stances Keep the equipment cable and other accessories well organized Keep the equipment clean for the next use To move the equipment carefully pick it up and put it down gently to avoid impact Do not place heavy materials on top of the equipment Wrap or cover the equipment when in storage to protect from dust 44 Maintenance TM i i Trouble E FREND ie aneia please check the following efore you contact Customer Support shooting Cartridge insertion issues EMCI 01 The cartridge is not inserted Restart and insert cartridge Cartridge Insert Alert e Re insert the cartridge within 30 seconds after pressing OK button on TEST screen EMCI 02 The cartridge is not
23. n And also check if the insertion is complete 31 FREND System 2012 NanoEnTek Inc Operation FREND System operating procedure 17 Wait until the test is done automatically Processing 18 After the reaction is complete the FREND System starts to record the fluorescent readings Running Test Please Wait ss Caution Do not turn off the FREND System while there is a cartridge in the system This is a common cause of malfunction 19 When the test is done the cartridge is expelled and the results are displayed Date Time 2014 2 19 10 15 Patient ID KIM 04 User ID LEE 01 32 Operation FREND System operating procedure 20 If the FREND System is connected to an optional printer press the Print button and the results will be printed out Date Time 2014 2 19 10 15 Patient ID KIM 04 User ID LEE 01 Order 765 Lab ID NANOENTEK PSA 1 87 ng mL e Printers is optional and if needed should be purchased separately 21 The test is complete If another sample is to be run repeat again steps 12 19 e The results are stored automatically If the DATA button on the main screen is pressed more information is visible 33 FREND System 2012 NanoEnTek Inc Operation FREND Press the DATA button on the main screen to check search or delete the test data and perform data backup System data manageme
24. n the power switch to the ON position System operating B oT pen OF procedure 4p Power switch 2 The system will display this screen while the software boots 3 Check the main screen ON OFF DC 12V USBH USBD CODE SERIAL B Boo 2 op Please double check the direction of the cartridge code A chip before insertion Each cartridge box contains one PSA analyte and lot specific cartridge code chip The code chip works for all cartridges in the same box 000000 27 FREND System 2012 NanoEnTek Inc Operation FREND 5 Press the SETUP button on the main screen System operating procedure 7 The information in the cartridge is automatically saved New Code installed 8 If the cartridge code chip installation is complete press the OK button to go to the setup screen New QC code installed 28 Operation FREND System operating procedure 9 Press the Item button on the setup screen 10 Check the cartridge lot number and the installation date of the cartridge code chip If the cartridge code chip installation is complete press the OK button to go to the setup screen Install Date Expiration Date 2014 2 19 10 6 2013 8 27 2014 2 19 10 5 2014 6 2 2014 2 19 10 5 2014 2 17 17 23 2015 6 5 2014 3 7 13 51 2016 12 17 mmm 2 2 2 ull Date Time 2014 2 19 10 15 Patient ID KIM 04 User ID LEE O1 Order 765 Lab ID NANOE
25. nt Data selection gt NANOENTEK 2011 12 15 11 44 ABC 2011 12 13 10 43 BIO 2011 12 12 09 42 CDAC 2011 12 10 08 41 v AAA 2011 12 08 08 00 BBB 2011 12 06 12 35 CCG 2011 12 05 08 15 Click the direction of the arrow button on the right to select the data moving one file moving one page The selected data is indicated by the arrow on the left side Search NANOENTEK 2011 12 15 11 44 ABC 2011 12 13 10 43 BIO 2011 12 12 09 42 CDAC 2011 12 10 08 41 AAA 2011 12 08 08 00 BBB 2011 12 06 12 35 ccc 2011 12 05 08 15 If you click the search box on the top left it will be switched into the input window Zz xic ivi BIN My Click the Enter button after entering the Patient ID on the input window 34 Operation FREND Once the input is complete it will return to the DATA screen Click the System d ata Search button in the top center of the DATA screen to complete the search management gt NANOENTEK 2011 12 15 11 44 ABC 2011 12 13 10 43 BIO 2011 12 12 09 42 CDAC 2011 12 10 08 41 AAA 2011 12 08 08 00 BBB 2011 12 06 12 35 ccc 2011 12 05 08 15 Result confirmation s NANOENTEK 2011 12 15 11 44 ABC 2011 12 13 10 43 BIO 2011 12 12 09 42 CDAC 2011 12 10 08 41 AAA 2011 12 08 08 00 BBB 2011 12 06 12 35 ccc 2011 12 05 08 15 After selecting the data click the result button to check the results Print 2011
26. o be as accurate However it may be changed by the copyright owner without prior consent or notification Copyright 2012 by NanoEnTek Inc All rights reserved Published in Korea Documentation NESMU F10 002EN V 0 7 Revision History V 0 0 Date Jan 2012 V 0 1 Date Dec 2012 V 0 2 Date Feb 2013 V 0 5 Date Jul 2013 V 0 6 Date Dec 2013 V 0 7 Date Mar 2014 57 FREND System 2012 NanoEnTek Inc FREND System NESMU F10 002EN V 0 7 Nano nflek NanoEnTek Inc HQ 12F 5 Digital ro 26 gil Guro gu Seoul 152 740 Korea Tel 82 2 6220 7940 Fax 82 2 6220 7721 Prats Ae eee ase anc es ee 5627 Stoneridge Drive Suite 304 Pleasanton CA 94588 USA Tel 1 925 225 0108 1 888 988 0108 Toll free Fax 1 925 225 0109 MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany Sic eon cs ee 26F SK tower No 6 Jia Jianguomenwai Avenue Chaoyang District Beijing 100022 P R China Tel 86 10 5920 7844 Fax 86 10 5920 5697 Website www nanoentekinc com
27. p screen 21 FREND System 2012 NanoEnTek Inc Setup FREND System setup procedure 15 The information on the Q C Cartridge is automatically saved New QC code installed 16 When the Q C Code chip installation is complete press the OK button to go to the setup screen Cx J 17 Press the Item button on the setup screen 18 Check the Q C Cartridge lot number and the installation date of the Q C Code chip Lot 303272 303003 303771 153050 111012 Install Date 2014 2 19 10 6 2014 2 19 10 5 2014 2 19 10 5 2014 2 17 17 23 2014 3 7 13 51 Expiration Date 2013 8 27 2014 6 2 2015 6 5 2016 12 17 fj 22 Setup FREND 19 If the Q C Code chip installation is complete press the OK button to go to the setup screen System setup procedure Lot Install Date Expiration Date 303272 2014 2 19 10 6 2013 8 27 303003 2014 2 19 10 5 2014 6 2 303771 2014 2 19 10 5 153050 2014 2 17 17 23 2015 6 5 111012 2014 3 7 13 51 2016 12 17 20 After all settings are done press the button and move to the main screen 23 FREND System 2012 NanoEnTek Inc Setup FREND 22 Insert the Q C Cartridge into the cartridge slot System setup procedure Caution Please check the direction of the Q C Cartridge before insertion 23 The Q C check that the instrument is operating correctly will complete automatically and the Q C Car
28. ss If the problem continues contact customer support EMCC 02 The FREND System does not recognize the code chip Restart code chip installation process EMCC 02 Code Chip Reading Alert e Restart the code chip installation process If the problem persists locate another code chip from the same lot number and restart the code chip installation process If the problem continues contact customer Support 49 FREND System 2012 NanoEnTek Inc Maintenance Trouble shooting Test result issues EMTF 01 The lot number of the inserted cartridge is different from the lot number of the installed code chip Cartridge lot number is different from code chip number Restart with new cartridge correspond ing to code chp or install new code chip corre sponding to cartridge EMTF 01 0180110 Code Chip e Check that the lot number printed on the cartridge is the same as the lot number on the code chip If not restart using a code chip and cartridge of the same lot number If the original set were the same lot number try a new code chip and cartridge pair in case either was damaged EMTF 02 Unable to output a test result because the reference signal is weaker than the baseline EMTF 02 Test Alert e Load the same sample into a new cartridge and load the cartridge into the system If the problem is repeated try a sample from a different source different patient If the problem continues contact c
29. start with update file in USB drive EMUF 01 Update file does not exist e Save the executable file FREND exe transfer it to the USB drive and then retry the update process EMUF 02 There is no executable file FRENDUPDATE exe on the USB drive Restart with update file in USB drive EURO Update file does not exist e Save the executable file FRENDUPDATE exe transfer it to the USB drive and then retry the update process 54 Maintenance No entry requirements Trouble resa shooting EMER 01 The entry requirements are not entered Invalid entry requirements Enter the valid entry requirements or check for your setting again ERROR CODE 5 EMER 01 Entry Requirement eEnter the Patient ID User ID and Order If you want not to enter the entry requirements change the setting on the General setting screen NOTE In addition to the above for any reason if the instrument does not work please turn off and turn on again 55 FREND System 2012 NanoEnTek Inc Maintenance General specification normal environmental conditions Voltage AC100 240 V Current 1 7A Frequency 50 60 Hz Voltage DC 12 V Current 3 33 A 240 mm x 260 mm x 175 mm W xL x H 9 4 inch X 10 2 inch X 6 9 inch 3 Kg 6 6 lbs IPXO Class Active screen size 7 0 inches diagonal dimension Pixel format 800 x 480 TFT LCD Size 75 mm x 103 mm x 44 3 mm Weight 237 g Int
30. tor plug the adaptor into the FREND System and the AC power cord into the wall socket Warning If you use an incorrect adaptor the FREND System may explode or start to burn If this happens it will no longer work properly anymore 4 Turn the power switch to the ON position Dc 12V ON OFF USBH USBD fal i Power switch 5 While the system is booting up this image will appear 6 Check the main screen TEST DATA 19 FREND System 2012 NanoEnTek Inc Setup FREND 7 Press the SETUP button on the main screen System setup procedure 10 After setting the date and time press the OK button to return to the setup screen Cx J 11 Press the General setting button on the setup screen 20 Setup FREND System setup procedure 12 Set the option of Entry Requirements and edit Lab ID Press the OK button to save the settings you specified Set Entry Requirements Patient ID Required User ID lt q Required Order lt Optional Lab ID NANOENTEK 13 Insert the Q C Code chip into the code chip slot in the direction of the arrow Caution a Please check the direction in which the Q C Code chip should be inserted before insertion The Q C Pouch contains one Q C Code chip which is used with the Q C Cartridge to do instrument validation boda chip 111011 14 Press the Code Chip button on the setu
31. tridge will be expelled Please wait patiently Running Test Please Wait _ e The system automatically checks three steps while reading Step1 Laser power Step2 Laser alignment Step3 Calculate ratio 24 Setup FREND 24 When the Q C check is done the Q C Cartridge automatically emerges and the results from all the three steps are displayed There System setup will be three Passes if the system is properly operating procedure Quality Control Result Date Time 2014 2 19 10 9 yotepl Laser Power Pass y Step 2 Laser Alignment Pass Step3 Calculate Ratio Pass 1 Caution If all tests do not pass try steps 21 24 again If the instrument does not pass all three steps please contact customer support via email 25 Press the a button and move to the main screen Quality Control Result Date Time 2014 2 19 10 9 Stepi Laser Power Pass Step2 Laser Alignment Pass Step3 Calculate Ratio Pass Q C Pass 26 Remove the Q C Cartridge E 2 a Q z i r Cartridge Q C 25 FREND System 2012 NanoEnTek Inc Setup FREND System setup procedure 27 Remove the Q C Code chip 111011 Caution Press the Q C Code chip into the slot slightly in order to release it and remove the Q C Code chip from the slot The FREND System setup is complete 26 Operation FREND 1 Tur
32. ustomer support 50 Maintenance Trouble shooting Test result issues cont EMTF 03 Unable to output a test result because the reference signal is stronger than the baseline EMTF 03 Test Alert e Load the same sample into a new cartridge and load the cartridge into the system If the problem is repeated try a sample from a different source different patient If the problem still continues contact customer support EMTF 04 The system cannot detect any signal e Load the sample into a new cartridge and restart the test If the same error message is displayed centrifuge the sample to remove particulate matter and fibrin clots and retry with a new cartridge If the problem persists try a different sample If the problem still continues contact customer support 51 FREND System 2012 NanoEnTek Inc Maintenance Trouble shooting Test result issues cont EMTF 05 The system detects more than four signals because the cartridge is damaged Restart test with new cartridge EMTF 05 Incomplete Cartridge Flow e Load the sample into a new cartridge and restart the test If the same error message is displayed centrifuge the sample to remove particulate matter and fibrin clots and retry with a new cartridge If the problem persists try a different sample If the problem still continues contact customer support EMTF 06 The lateral flow of the sample within the cartridge is incompl
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