USER MANUAL
Contents
1. lhe dala ie fe mevicah E 20 SET UP USER ACCOUNT In the program SET UP CHANGE ADVANCED USER ACCOUNT USER ACCOUNT Select the user Modify the User Account MODIFY ACCOUNT Type in Busse Password confirm Click on E MAIL ACCOUNT and the set up menu will come up Inthe set up menu select POPS settings followed by SMTP settings and add your e mail information Click on OK to confirm Click on MODIFY 13 IMPORT EXPORT OF DATA File Setup Window Add Test 4 Change Change Display Resolution puso ey Print Exit Change Address Language Name EME J Test Cutoff 56 Mode Measurement Paths Sample ID User account User Account Administrator user confirm Active Administrator Add test Change donor data Comments Aclive Delete reading Delete donor Dutgoing Mail Server SMTP F vourserver com Reading export Port 25 Reading import i Reading validation login None Measurement amp ccount Printout Sample ID modify Password Service modul Your email ourname yourserver com Open measurement donor data y EMAIL ACCOUNT _POP3 settings SMTP settings 21 IMPORT EXPORT OF DATA Nano Checker 710 13 IMPORT EXPORT OF DATA SET UP POP3 Active check box Incomin2. In the program MENU BAR NEW READING Select the donor to be deleted Click DELETE You may use the search option to find the donor when entering the first types of their name or date of a saved measurement in the input window CONFIRMATION The selected donor data will be deleted permanently and cannot be recovered Click YES to confirm Note The donor data and test results are no longer available Click No to cancel 19 DELETING A DONOR 11 DELETING A DONOR AL e u x gn st nw org Lat hone CELY Don DOE EH 22 08 1965 Street State Cancel HAHODITECH CHECKER A472 fo amp e sre af Yes aL 308 HAHODITECH CHECKER POLARE SUE X No X No wf Yes Nano Checker 710 12 DELETING A READING LOAD A DONOR Explorer Load Donor In the program MENU BAR LOAD DONOR Select the donor DELETING READINGS fe Jip piia Load the reading to be deleted Right click on the result area Click CONFIRMATION selected reading will be permanently deleted Click YES to confirm the data is no longer available Click No to cancel Nano Checker 710 Umar Arminii L224 Donor eire Pim Mame DOE JOHN 121219608 ID HAHODITECH CHECKER 3 4 CERE EE i
3. Name ID Py Enter System Key me orol EM KEY 9324947648660 45851 7 3 433333354032 lt lt Back Continue gt gt sw we are depicted in eee le eee uH ARE RR 8 the Test Explorer Window vL Wc 1 AMI 21 v70 UK AML 3 1 v65 UK AMI 3 1 v70 UK AMI CK MB v65 UK AMI CK MB v70 UK AMI Myo v65 UK AMI Myo v70 UK AMI Tnl v65 UK AMI v70 UK DAT 5B v65 UK DAT v65 UK DAT BM v65 UK Single v65 UK Single BAR v65 UK Single BUP v65 UK Single 20 v65 UK Single COC v65 UK Single KET v65 UK Single MET v65 UK Single OPI 2000 v65 UK Single OPI 300 v65 UK Single OXY v65 UK Single PCP v65 UK ADDING A NEW TEST 12 13 7 ADDING A NEW TEST The installation may take a few moments Drug Screen Report Test After completion of the AMI 2 1 v 0 UK installation a test report is E AMI CK MB v65 UK depicted for all installed tests AMI CK MB v65 UK AMI Myo v65 UK AMI Myo v70 UK AMI v65 UK AMI Tnl v70 UK DAT 5B v65 UK Click OK DAT 5M v65 UK DAT 6M v65 UK Single AMP v65 UK Single BAR v65 UK Single v65 UK Single B20 v65 UK Single v65 UK Single KET v65 UK Single MET v65 UK Single OPI 2000 v65 UK Single OPI 300 65 UK Single OXY v65 UK Single PCP v65 UK ADDING A NEW TEST Nano Checker 710 8 ADDING A DONOR ADDING A DONOR In the program MENU BAR ww NEW READING to confirm
4. DAT v65 UK Single AMP v65 UK Single BAR v65 UK Single BUP v65 UK Single 20 v65 UK Single COC v65 UK F Single v65 UK Single MET v65 UK O Single 2000 v65 UK Single OPI 300 v65 UK O Single OXY v65 UK Single PCP v65 UK Single PPX v65 UK O Single TCA v65 UK O Single THC v65 UK YTO OCR LIK PERFORMING A MEASUREMENT 16 10 PERFORMING A MEASUREMENT CAMERA PREVIEW Preview AMI 2 1v65 UK X Cancel 1 In the program Accept the picture with CONTINUE or disregard with CANCEL LEICHT LL BELLE E PICTURE ACCEPTANCE EY 4 0 on Boe amp on The results appear on the screen E L t after a few moments e Analyzed test strip Sample CK MEI e Densitometric evaluation Pile ae e Calculated values 17 PERFORMING A MEASUREMENT Nano Checker 710 10 PERFORMING A MEASUREMENT t CURRENT MEASUREMENT er Boe im K _ DOE JOHN Dog 12 12 1968 D After the measurement the software shows e Results of Tests e Test Evaluation PRIOR MEASUREMENT e Headings which were saved or archived can be recalled by clicking the entry in the list 1 i DG 20 08 Nano Checker 710 PERFORMING A MEASUREMENT 18 DELETING A DONOR
5. manual and record the reading value on the calibration recording sheet 4 Analysis the reading result following as the recording book the calculated average value should be in the range of acceptable deviation described on the calibration card and provided QC record 5 If the average value is out of range of acceptable deviation restart the reader and repeat step 2 and 4 Still the value is not acceptable contact your local customer service agent or the manufacturer 30 MAINTENANCE amp CALIBRATION Nano Checker 710 CLIA wa ved on For more information please contact CLlAwaived Inc at TEL 858 481 5031 FREE 888 882 7739 E MAIL info cliawaived com wes www cliawaived com Distributed by CLIAwaived Inc San Diego
6. measurements of the control function Optical densities are converted to the value of analyte concentration Figure 1 shows a signal slope generated by the NANO CHECKER 710 The measurement of the reflected density allows calculating the concentration of analyte in the tested specimen based on the predetermined slope Signal RR 710 1 reflected density 1 Figure 1 During the testing routine the standard approved AMI tests are selected for reading See section 8 Adding a test The tests cover the product and scope of use of the NANO CHECKER 710 provided by the manufacturer The 710 should only be used for measurements evaluation of tests manufactured by the original equipment supplier The manufacturer and distributor disclaims all warranties expressed or implied if a user attempts to use the 710 to record the results of a test not covered under Scope of Use Furthermore the manufacturer and or distributor shall not be held liable for any damages including but not limited to incidental consequential or special damages arising out of the user attempting to use the 710 to record the results of a test not covered under Scope of Use Correct capture and results of the tests are only possible when the test used has been handled according to the package insert GENERAL Nano Checker 710 2 EQUIPMENT SUPPLIED CONTENTS IMPORTAN
7. the message Mame BROWN MARY automatically from the screen Format PDF Yours sincerely RECEIVING E MAIL BROWN MARY TEST File Edit Wie Tools Message Help Open the NANO CHECKER ee amp og D 710 Software t Reply Reply Forward Print Delete Previous From Your e mail 21 October 2004 02 25 BROWN MARY TEST a f the attach ment is a P D F Attach 1000092 77 PAT 350 KB or Excel file double click to open the file Name BROWN MARY If the attachment is a PAT file click Te and drag the file into the NANO CHECKER 710 program The Yours sincerely results will open Nano Checker 710 IMPORT EXPORT OF DATA 24 DATA TRANSFER DATA TRANSFER In the program MENU BAR IMPORT EXPORT gt Select directory gt Enter file name Click on SAVE to save the file IMPORT EXPORT OF DATA 13 IMPORT EXPORT OF DATA All donor data including saved results can be exported or imported to and from any destination on the local drive or onto a network Results can be exchanged between different NANO CHECKER 710 systems Fie Setup Window Help Reading ei gt Mame KING 7788553 Donor Sample 1 TS Dateiname Dateityp Rapid Reader FILE BCD Abbrechen E Nano Checker 710 13 IMPORT EXPORT
8. 409 0722 Website WAAL com e mail infaceinanoeditech com Cost Center Humber Optional information regarding QC QA may be added here Reader ID refers to the serial number of the NANO CHECKER 710 27 SET UP Nano Checker 710 15 PRINTING AN ASSAY REPORT PREVIEW PRINTOUT You can activate the preview and printout by using the icon Print in the respective window PREVIEW NANODITECH CHECKER Rel 515 User Administrator AMI 3 1 v70 UK 11 06 2 B Eile Setup Window Help In the program ee Reading e Load Donor axe Name DOE JOHN DOB 12 12 1968 0 result is shown in the window USING THE ICON 15 32 41 END Ut 15 31 04 PRINT PREVIEW Printout pet mee Ee Y O In the program Assay Report printout is shown in the mE window Administered USING THE ICON PRINT PRINTOUT AMM 3 1 v70 Nano Checker 710 PRINTING AN ASSAY REPORT 28 16 TROUBLE SHOOTING Symptom Mp oo Message An attempt to import a file The file is already on the PC Target and source that is already on the PC equal when importing Image of test strip The test cassette was not Insert the test strip cassette properly seems off centre or inserted accurately into the holder slope the reading Image of test strip he holder was not Insert holder completely seems very light or inserted entirely Ret
9. Export Change Address Language Test Cutoff Mode Measur Paths Sample ID User account USER ACCOUNT wn with Name and Active Status YES NO see below USER STATUS Active status YES The user is able to start the program e Active status NO The user is notable to start th program User Account Administrator Nano Checker 710 USER ADMINISTRATION ICONS 5 USER ADMINISTRATION The options of the user administration are accessible by using the following 4 Modify User Account Changes the functions of a user profile icons Add User Account Adds a new user profile Delete User Account Deletes an old user profile Close User Account Leaves the user administration Password 2222 01 confirm Jw Pv User or Modify User is Administrator activated then a window for Add test Change donor data Comments Delete reading Delete donor Reading export Reading import Reading validation Measurement Printout Sample ID modity changing the user profile appears USER ADMINISTRATION Nano Checker 710 5 USER ADMINISTRATION OPTIONS DESCRIPTIONS User Name of the user Allowed characters A Z a 2 0 9 Password Type in password Allowed characters A Z a 2 0 9 Password confirm Type in password Allowed characters Z 2 0 9 v the user is able to start the program Administrator Only the program adm
10. N 3 TECHNICAL SPECIFICATIONS otorage Settings International Norm This system can be used according to the conditions of FCC Part 15 B CISPR 11 and CISPR 22 European Norm This system can be used according to the conditions of EN 61326 1997 A 1 1998 Class B for emission and absorption 16 5 x 32 3 x 17 5 cm H x W x L 2 25 kg DC 12 V 5A Maximum 60 Watt Storage temperature should not be under 32 F 0 C and not over 122 F 40 C Operating temperature of the instrument should not be under 50 F 10 C and not over 104 F 40 C The instrument should not be exposed to direct sunlight The factory installed basic settings are factory installed The NANO CHECKER 710 software is factory installed Operating system Windows XP or Vista Hard disk space 40 GB Touch Screen The NANO CHECKER 710 is a touch screen instrument Please do not use any sharp objects to touch the screen TECHNICAL SPECIFICATIONS Nano Checker 710 4 INTEGRATED PC SWITCHING ON AND OFF e on off button is on the rear right side of the NANO CHECKER 710 e n order to switch the NANO CHECKER 710 on or off press the silver button on the back side of the NANO CHECKER 710 shortly HANDLING You will find a stick for touching the screen in the carton There are four USB ports built in the NANO CHECKER 710 so that you can connect printer keyboard 5 0 POWER SUPPLY Plug the power outlet
11. OF DATA RESULTS MANAGEMENT Users can record donor information donor name DOB test used test results All data is stored in Microsoft Excel allowing review analysis and charting of data In the program MENU BAR Vv REPORT Select report today week month customized Select report type file e mail Click on CONTINUE If the selected report type is File this will be automatically saved in C Rapid Export DATA BACKUP IMPORTANT It is recommended that all data is backed up on a regular basis to an external storage system e g CD CDRW DVD External Hard Drive USB stick etc Nano Checker 710 Select Report Info Labell Start Time Day 1 2 3 4 5 Week 3 4 508 14 15 16 17 18 19 20 D Month 2 Customized 28 293 30 Type amm File _ EXCEL multi rey E mail Progress G Exportfile CARAPIDYEXPORTI IMPORT EXPORT OF DATA 26 14 SET UP SETTINGS J X Add Test oc The SET UP option allows you to change Display Resolution PE mpowExpon ax determine several settings see page sun 13 ADDRESS N Street T Clarke Drive City Cranbury The address of the location performing the testing is entered This address will appear at the top of all reports State MJ FIP 085 2 Country USA Tel 609 409 0700 FA 609
12. T Nano Checker 710 1 NANO CHECKER 710 instrument Instruction Manual Brief Instructions Note Should any piece of equipment be missing or damaged contact your local distributor Read this manual prior to first use Follow the instructions The software is factory installed and the NANO CHECKER 710 is ready to use when it is delivered Use touch screen pen and or mouse Distributor and manufacturer are not responsible for any damage occurring due to misuse or improper handling of software or hardware disclaims all warranties express or implied including any implied warranty of merchantability or fitness for a particular purpose and the limit of s liability on account of any breach of any express warranty under this agreement will be limited to replacement of the product or the purchase price of the product as will determine Without limiting the foregoing shall not be liable for incidental special or consequential damages arising out of any product defect failure to include all components listed or breach of warranty See the license provisions for further details page 30 If you have any questions concerning handling of software or hardware contact your distributor by phone fax or e mail EQUIPMENT SUPPLIED INTERNATIONAL amp EUROPEAN NORM DIMENSIONS WEIGHT PHYSICAL DATA POWER CONSUMPTION ENVIRONMENTAL STORAGE OPERATING TEMPERATURE BASIC SETTINGS PRECAUTIO
13. TYPE IN THE DONOR S DATA the donor s data into the form Click OK Now you can perform a reading on thi 1 To edit the data of an existing donor click Load donor change and type in the new data Nano Checker 710 ADDING A DONOR 14 9 PREPARING A MEASUREMENT 1 Insert the test cassette into the holder of the NANO CHECKER 710 2 Ensure the cassette is face up and inserted correctly as well as pressed down into the holder completely Do not touch the surface of the test 3 Push the test holder into the NANO CHECKER 710 The test holder must be inserted exactly and evenly into the NANO CHECKER 710 Make sure that the test holder is completely closed 15 PREPARING A MEASUREMENT Nano Checker 710 10 PERFORMING A MEASUREMENT SELECT DONOR In the program MENU BAR NEW READING Select a donor e Click ACCEPT You may use the search option to find the donor when entering the first types of their name or date of a saved measurement in the input window SELECT TEST In the program e Selecta TEST e Click CONTINUE Nano Checker 710 TEST Explorer NAT 2 BP N A A AME2 v70 UK A AMI 3 1 L1 AMI 3 1 70 UK 1 1 AMI CK MB vB5 UK L1 AMECK MB UK AMI Myo v65 UR L1 AMI Myo v70 UK DAMI Trl v65 UK F AMI Trl v70 UK M DAT v65 UK L1 DAT v65 UK F
14. USER MANUAL FOR Nano Checker 710 THE PI ONEER AND CONSI STENT INNOVATOR FOR IN VITRO DIAGNOSTICS E Read before initial operation Any questions call our technical support line TABLE OF CONTENTS Chapter 1 2 10 11 12 13 14 15 16 17 18 General Equipment supplied Technical specifications Storage Settings Integrated PC User administration Menu Bar Adding a new test Adding a donor Preparing Measurement Performing Measurement Deleting a donor Deleting a reading Import Export of Data Set up Printing an assay report Trouble shooting Maintenance and Calibration License conditions This manual complies with the Norm DIN EN 591 Intended only for use by qualified personnel Manual Version 0708 RR 0185 03 Nano Checker 710 TABLE OF CONTENTS Page 20 21 27 28 29 30 31 April 2009 PURPOSE PERFORMANCE FEATURES OUTPUT OF ANALYTICAL DATA SCOPE OF USE USER LIMITATIONS PRECAUTIONS 1 GENERAL The NANO CHECKER 710 is an instrument that evaluates the reflection or optical density of a biochemical reaction compared to the environmental background of the measurement sample The NANO CHECKER 710 can detect optical density signals of 0 2596 or greater When there is an optical density of 596 reproducibility of 0 2 96 optical density can be achieved Measurement values of the NANO CHECKER 710 are correlated linearly to the reflected density
15. g Mail Server Incoming Mail Server POP POP3 yourserver com enter your incoming mail Pot n oe icem conan Account type in account name Password Password type in password Click on OK to confirm SUE ach SET UP SMTP Settings DONOR Active check box uiis Outgoing Mail Server STF SMTP POEET ET COMI Outgoing Mail Server Port enter your outgoing mail Type login Simple Login server ise Simple Log E Port enter 25 Account account name Type login select Password sss Simple Login Cour email re Account type in account Password type password Add your e mail information Click on OK to confirm POPS settings SMTP 4 Click on EOAD DONOR Last Name First Name Click on ADD CHANGE DOB ds DATA DD MM YYYY Street e mail active Enter Add recipient e as m mail address es in TO ae CC and BCC 22 Country Group Nano Checker 710 IMPORT EXPORT OF DATA 22 13 IMPORT EXPORT OF DATA SENDING RESULTS Right click mouse ETC anywhere on the screen z uem qe Click on how the data is to be transmitted ASCII 23 IMPORT EXPORT OF DATA Nano Checker 710 13 IMPORT EXPORT OF DATA MESSAGE EDITOR Editor PDF Format In recipient s From our Name abe com To Your name in your message EC BCL Click on SEND to send Sends
16. inistrator can use all program functions inclusive of the user administration The user profile ADMINIS TRATOR cannot be deleted Add test Adds a new test by using the key number In the program SET UP ADD TEST Change donor data Changes the donor data or other data base information Adds comments to the single measurements Delete reading donor Deletes single measurements and or donor data Import export data Can import or export single measurements E mail capabilities Results may be transmitted via electronic mail or interfaced with a network Results management Sending or archiving of results in Excel format Reading validation Can validate single measurements Measurement Can perform reading measurement of donor samples Prints out the measurement results Sample ID modify Changes the sample ID numbers Open measurement donor data Archived data can be opened and retrieved from the data bank Nano Checker 710 USER ADMINISTRATION 10 6 MENU BAR Creates a new reading for an existing donor Loads a donor and previous readings Import Export Allows data transfer between NANO CHECKER 710s local drive or a network Allows preview of a printout and the option to print Adds a new test using the key number LANGUAGE ENGLISH SPANISH GERMAN Select ADVANCED Menu for technical support Change address Edits the information of the laboratory performing test Cascade Cascade Cascades all open wi
17. into the socket Having pressed the silver button for switching on the NANO CHECKER 710 wait a few seconds The Reader software boots up automatically Nano Checker 710 INTEGRATED PC 5 USER ADMINISTRATION otart the software by clicking on the green ball H Reader MARJODITECH USER ADMINISTRATION The Nano Checker 710 offers a user administration option Each user has the option and flexibility to choose program functions that are allocated to individual users USER LOGIN After program start Type in user name Type in password e Click Continue SETUP CHANGE ADVANCED USER ACCOUNT MODIFY USER ACCOUNT proceed with login by using Login READER WAY D soe program starts by using the correct password and the settings that were defined by the user Note When the program is first started the administrator login password admin will be automatically assigned Type admin in lower case letters Recommendation Choose a new password after the first program starts Note Password is case sensitive 7 USER ADMINISTRATION Nano Checker 710 5 USER ADMINISTRATION In the program module user administration you can add modify and USER PROFILES delete a user account quickly and easily In the program SET UP CHANGE ADVANCED USER ACCOUNT File Setup Window Help Add Test pu J Change Change Display Resolution ort
18. ndowsa all open windows Cloe all windows Closes all open windows Show reading list Shows all open windows Modify account E E mailaccount account POPS settings active incoming mail server SMTP uaa CC active outgoing mail server BEEN Sending results Sends results Sends results by e mail e mail Message editor Offers the option to add additional recipients Sends the message automatically from the screen Led EJ e mail Opens the NANO CHECKER 710 software e mail attachments Opens results 3 Shows the contact details for technical support for 11 MENU BAR Nano Checker 710 7 ADDING A NEW TEST SYSTEM KEY NEW TEST In the program MENU BAR w SET UP ADD TEST In the program field to enter the system key appears Enter the new system key number if you are using a different NANO CHECKER 710 or another test strip holder Click CONTINUE In the program Click individual tests or panels to be utilized To select all tests click Select All To unselect all selected tests click Unselect All To convert all selected tests into non selected tests or convert all not selected tests into selected ones click Select Inverse ODER Click continue Nano Checker 710 Each test strip holder and NANO CHECKER 710 has its own system key File Setup Window Help Ji Load Donor DOB Change b Change Address
19. ry the reading overexposed Evaluation of the The wrong test cassette Insert correct test from the test list result is not or Select the correct test to be read the wrong test was the reading selected There is no visible of power Check the connection between the light inside the NANO CHECKER 710 and power NANO CHECKER outlet 710 device 17 MAINTENANCE amp CALIBRATION Cleaning of e Wipe the case by using ordinary Do not use acid agents or NANO laboratory detergents disinfectant or solvents CHECKER 710 alcohol e Use scratch free wipes Cleaning of e Wipe the entire test holder by using Do not use acid agents or test holder ordinary laboratory detergents solvents disinfectant or alcohol Use scratch free wipes Nano Checker 710 was calibrated by manufacture before shipping to customer However all customer should check the calibration status using calibration cards provided with Reader when install the reader and periodically recommend at least once per month The measurement protocol is follows 1 Check the serial number of the calibration card Printed on the pouch and backside of device and Reader Printed on the back side of monitor Numbers should be matched with each other 2 Open the calibration card pouch and take out the card from the pouch place the card device into the cassette holder of Nano Checker 710 3 Measure 5 times for each card following the user
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