NanoEnTek Frend system User Manual Download Page 1

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System

User

manual

Summary of Contents for Frend system

Page 2: ...at any time please contact NanoEnTek Inc customer support Tel 82 2 6220 7940 Fax 82 2 6220 7721 E mail sales nanoentek com 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 Read me first ...

Page 3: ...code chip and associated cartridge Software keys Setup FRENDTM System setup procedure Operation FRENDTM System operating procedure FRENDTM System data management Maintenance FRENDTM System maintenance Cleaning and storage Troubleshooting General specification normal environmental conditions Customer support information 2 4 18 4 5 6 7 8 9 10 11 12 13 14 15 18 19 26 19 26 27 37 27 33 34 37 38 56 38 ...

Page 4: ...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 signing for the shipment since your signature indicates receip...

Page 5: ...able reagent cartridge The FRENDTM 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 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 Introduction Int...

Page 6: ...igned to accommodate the FREND 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 Introduction Intended use ...

Page 7: ...n 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 Product components Introduction Main body Q C Cartridge Quick manual Adaptor Power cord Q C Code chip USB drive Mobile printer Q C Pouch User manual Pipettor Optional Optional System Q C Pouch Components 1 x Q C Cartridge 1 x Q C Code...

Page 8: ... symbols and always use the equipment in a safe manner Introduction Safety symbols abbreviations Definition Warning or caution Biohazard Class I laser product Manufactured by Authorized representative in the european community Lot number In vitro diagnostic medical device Catalogue number Symbol CLASS 1 LASER PRODUCT ...

Page 9: ...be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local authorities The correct disposal of your old appliance will help prevent potential negative consequences for the environment and human health For more detailed information about disposal of your old appliance please contact local distributor waste disposal service...

Page 10: ...t code chips 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 Do not insert any foreign materials into the air vent or the speaker Always set the main switch to the off position before connecting the power cord to the wall outlet When unpluggin...

Page 11: ...veitcarefullyandgently 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 General safety warnings Introduction Local regulations governing the disposal of materials containing bio hazardous materials must be observed It is in the responsibi...

Page 12: ...rd or the plug 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 an industrial environment In the docu 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...

Page 13: ...ply Use to connect to a USB drive Use to connect to a PC manufacturer or supplier only Location for the insertion of Q C or cartridge code chip Connection for an optional mobile printer FRENDTM System description Introduction Name Cartridge slot Screen Ventilation Speaker Power switch Power supply port USB H USB D Code chip slot Serial port Cartridge slot Ventilation Power switch Power supply port...

Page 14: ...hanics and optics of the FREND System Definition The cartridge code chip is specific for a given analyte and lot of reagent It contains information on calibration and calculation of results using readings from the FRENDTM reagent cartridge The cartridge contains reagents and microstructures to support a lateral flow assay where analytes of interest form immune complexes while the specimen is movin...

Page 15: ...ion Button designation TEST DATA SETUP Purpose 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 Initiates a test sequence for an analyte using that analyte specific cartridge ...

Page 16: ...d the production date of the instrument Allows for software updates Allows entry of the user name Move to the main screen HOME Allows user to check the information on the Q C or the cartridge code chip Allows the user to check the cartridge ID and its associated lot number Location to adjust the time and date for the FRENDTM system ...

Page 17: ...ater identify the data Search files or data Home button Move to the main screen Viewtheinformationoftheselectedfileordata Print the detailed data using the optional printer if it is connected to the system Software keys Introduction Backup a selected set of data to the connected USB drive ...

Page 18: ...iece of data Display the selected data Backup all the saved data to the connected USB drive Delete all the saved data confirmation required Select data by moving one location at a time Select data by moving one page at a time Software keys Introduction ...

Page 19: ...at the plug location If it is the appropriate adaptor plug the adaptor into the FRENDTM System and the AC power cord into the wall socket Warning If you use an incorrect adaptor the FRENDTM 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 5 While the system is booting up this image will appear 6 Check the main sc...

Page 20: ...the Date Time button on the setup screen 9 Set the local date and time 10 After setting the date and time press the OK button to return to the setup screen 11 Press the USER button on the setup screen FRENDTM System setup procedure Setup 2012 AM 00 00 01 01 ...

Page 21: ...reen 13 Insert the Q C Code chip into the code chip slot in the direction of the arrow 14 Press the Code Chip button on the setup screen FRENDTM System setup procedure Setup Caution 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 ...

Page 22: ...d 16 When the Q C Code chip installation is complete press the OK button to go to the setup screen 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 FRENDTM System setup procedure Setup ...

Page 23: ...the Q C Code chip installation is complete press the OK button to go to the setup screen 20 After all settings are done press the button and move to the main screen 21 Press the TEST button on the main screen FRENDTM System setup procedure Setup ...

Page 24: ...e insertion 23 The Q C check that the instrument is operating correctly will complete automatically and the Q C Cartridge will be expelled Please wait patiently The system automatically checks three steps while reading Step1 Laser power Step2 Laser alignment Step3 Calculate ratio FRENDTM System setup procedure Setup ...

Page 25: ...e steps are displayed There will be three Passes if the system is properly operating 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 button and move to the main screen 26 Remove the Q C Cartridge FRENDTM System setup procedure Setup ...

Page 26: ... the Q C Code chip 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 FRENDTM System setup is complete FRENDTM System setup procedure Setup ...

Page 27: ...e software boots 3 Check the main screen FRENDTM System operating procedure Operation Power switch PSA 000000 Caution Please double check the direction of the cartridge code chip before insertion Each cartridge box contains one analyte and lot specific cartridge code chip The code chip works for all cartridges in the same box ...

Page 28: ... Press the Code Chip button on the setup screen 7 The information in the cartridge is automatically saved 8 If the cartridge code chip installation is complete press the OK button to go to the setup screen FRENDTM System operating procedure Operation ...

Page 29: ...e code chip If the cartridge code chip installation is complete press the OK button to go to the setup screen 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 button and move to the main screen FRENDTM System operating procedure Operation ...

Page 30: ...ID on the sticker of the cartridge inject into the inlet of the cartridge using a calibrated micro pipette and disposable tip the volume of serum or plasma specified in the package insert sheet for the analyte being measured 14 Press the TEST button on the main screen and the system moves to the Patient ID screen automatically FRENDTM System operating procedure Operation Caution Please be careful ...

Page 31: ...the Patient ID and press the ENTER button 16 Insert the cartridge into the cartridge slot FRENDTM System operating procedure Operation Caution Please check the direction of the cartridge before insertion And also check if the insertion is complete ...

Page 32: ... System starts to record the fluorescent readings 19 When the test is done the cartridge is expelled and the results are displayed FRENDTM System operating procedure Operation Caution Do not turn off the FREND System while there is a cartridge in the system This is a common cause of malfunction ...

Page 33: ...esults will be printed out 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 The results are stored automatically If the DATA button on the main screen is pressed more information is visible FRENDTM System operating procedure Operation ...

Page 34: ...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 If you click the search box on the top left it will be switched into the input window Click the Enter button after entering the Patient ID on the input window FRENDTM System data management Operation ...

Page 35: ...e DATA screen to complete the search Result confirmation After selecting the data click the result button to check the results Print 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 Printer should be purchased separately FRENDTM System data management Operation ...

Page 36: ...USB H port on the back of the device If you want to receive the backup only for a selected data click the green Select button in the center after selecting the data If you want to receive the backup for all of the data click the green All button in the upper center FRENDTM System data management Operation Caution Confirm the USB drive version 1 1 other formats will not work ...

Page 37: ...to delete only a selected data click the black Select button after selecting the data and the selected data will be deleted If you want to delete all of the data click the black all button and all of the data will be deleted FRENDTM System data management Operation ...

Page 38: ...use using the Q C Cartridge and the Q C code chip to specifically test the optics If 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 The FREND System checklist 1 Laser power 2 Laser alignment 3 Calculate ratio FRENDTM System maintenance Maintenance Q C Pouch Q C Cartrid...

Page 39: ... the arrow 3 Check the main screen and press the setup button on main screen 4 Press the code chip button on the setup screen FRENDTM System maintenance Maintenance Power switch Q C Code chip 000000 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 Q C Cartridges ...

Page 40: ...lete press the OK button to go to the setup screen 7 Press the item button on the setup screen 8 Check the Q C Cartridge lot number and the installation date of the Q C Code chip 9 If the Q C Code chip installation is complete press the OK button to go to the setup screen FRENDTM System maintenance Maintenance ...

Page 41: ...re edited press the button and move to the main screen 11 Press the test button on the main screen 12 Insert the Q C Cartridge into the cartridge slot FRENDTM System maintenance Maintenance Caution Please check the direction of the Q C Cartridge before insertion ...

Page 42: ...p3 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 FRENDTM System maintenance Maintenance Caution If you do not pass all tests try again 11 14 But if you do not pass again please contact the Customer support ...

Page 43: ...5 Press button and move to the main screen 16 Remove the Q C Cartridge 17 Remove the Q C Code chip The FRENDTM System check is complete FRENDTM System maintenance Maintenance Caution Press the Q C Code chip first to remove the Q C Code chip ...

Page 44: ...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...

Page 45: ...rectly After insertion check to make sure the cartridge is properly and completely inserted EMCI 02 The cartridge is not inserted correctly Re insert the cartridge correctly After insertion check to make sure the cartridge is properly and completely inserted EMCI 03 The cartridge is not inserted correctly Re insert the cartridge correctly After insertion check to make sure the cartridge is properl...

Page 46: ... reader is unable to interpret the code correctly 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 Manually enter the lot number of the cartridge using the keyp...

Page 47: ...ot 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 to be sure the USB drive is the version 1 1 required for the FRENDTM System and that the USB drive is connected properly to the USB H port If after trying a sec...

Page 48: ... 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 FRENDTM System to store the data has been exceeded Back up the data stored in the FRENDTM System to a version 1 1 USB drive Then delete the data stored in the FRENDTM...

Page 49: ...d remove the code chip from the system locate another code chip from the same lot number and restart the code chip installation process If the problem continues contact customer support EMCC 02 The FRENDTM System does not recognize the code chip Restart the code chip installation process If the problem persists locate another code chip from the same lot number and restart the code chip installatio...

Page 50: ...riginal 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 system detected readings in the cartridge during analysis that were abnormal so a result could not be calculated 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 diffe...

Page 51: ...s repeated try a sample from a different source different patient If the problem still continues contact customer support EMTF 04 The lateral flow of the sample within the cartridge is incomplete 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 p...

Page 52: ...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 incomplete 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 ...

Page 53: ... 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 Update issues EMUF 01 There is no executable file FREND exe on the USB drive Save the executable file FREND exe transfer it to the USB drive and then retry the update process Trouble s...

Page 54: ... exe on the USB drive Save the executable file FRENDUPDATE exe transfer it to the USB drive and then retry the update process NOTE In addition to the above for any reason if the instrument does not work please turn off and turn on again Trouble shooting Maintenance ...

Page 55: ...ght Interface Print width Printing speed AC100 240 V 1 7 A 50 60 Hz DC 12 V 3 33 A 240mmx260mmx175mm WxLxH 9 4inchX10 2inchX6 9inch 3 Kg 6 6 lbs IPX0 Class I 7 0 inches diagonal dimension 800 x 480 TFT LCD 75 mm x 103 mm x 44 3 mm 237 g Serial RS232C 2 inch 48 mm 50 mm sec Do not place unit in the direct sun Position the unit in a well ventilated area Place the unit on a flat dry and smooth surfac...

Page 56: ...t This product is sold all over the world Customer support services vary for each geographical region When the FRENDTM 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...

Page 57: ...88 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 SK Medical Beijing Co Ltd 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 Email sales nanoentek com Website www nanoentekinc com NESMU F10 002EN V 0 6 System ...

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