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ramp reader manual

1. Operator s Manual RAM P Reader iii 1 0 INTRODUCTION 1 4 Overview The RAMP System is a rapid quantitative immunochromatographic system for performing in vitro diagnostic analyses on a variety of analytes The System can be used for various applications from use in a clinical setting point of care central or STAT laboratory to use for onsite screening of environmental samples The System is comprised of the RAMP Reader Reader and various RAMP Assay Test kits Kits Optional accessories include a barcode wand printer and cabling required to connect the Reader to a computer printer or another Reader Calibration and expiration information for Kits are input to the Reader through Lot Cards enclosed with the Kits The Reader only accepts Kits that are designed specifically for use with this instrument To perform a test the operator prepares the appropriate sample according to the analyte specific Package Insert places an aliquot of the sample into the sample well of the Test Cartridge and inserts the Test Cartridge into the Reader Once the cartridge has been inserted no further intervention is required A barcode on the bottom of the cartridge is read to determine the Kit lot number Information loaded with the Lot Card identifies lot specific parameters and expiration date This ensures that an expired cartridge is not used Analysis time is analyte specific and typically less than 20 minutes per sample Resu
2. Turn off Reader Plug in AC Adapter Charger When Reader is turned back on RUN OPTIONS Menu is displayed only after the battery voltage is sufficient for operation NOTE 24hours of continuous charging is required to completely charge battery Tests may be run during charging Operator s Manual RAMP Reader 37 Troubleshooting Guide LCD Message Cause Action RUN TEST Enter OW BATTERY Message accompanied by intermittent chirp During Power On Self Test IQC RUN OPTIONS or RUN LQC EXIT prompt Reader detects low battery voltage From 1 to 4 tests remain before Reader will cease operation due to a fully discharged battery Plug in AC Adapter Charger NOTE 24hours of continuous charging is required to completely charge battery Tests may be run during charging OPTICS FAULT CONSULT MANUAL The lower line of the message alternates between CONSULT MANUAL and PRESS KEY TO PROCEED Critical Failure see note An optics failure was detected during Power On Self Test or IQC Press any key to return to the RUN OPTIONS or RUN LQC EXIT prompt Contact Technical Support READER CALIBR FAULT CONSULT MANUAL Critical Failure see note A checksum mismatch was detected in Reader calibration data during Power On Self Test or IQC Contact Technical Support for re calibration servicing REMOVE CARTRIDGE A Test Cartridge
3. 1 DISABLE ID amp PIN 2 ENABLE ID ONLY 3 ENABLE ID amp PIN Press Enter to select the displayed option Press Options to return to the system Menu without changing the current setting 2 6 5 Edit User ID P I N The Edit User ID P I N option allows the supervisor to modify User IDs and P I N s The Reader will store 250 User IDs of up to 20 alphanumeric characters The defaults for the User IDs are USEROO1 through to USER250 Each operator can be assigned a P I N consisting of 1 5 numeric digits From the SYSTEM Menu press A or WV until 4 EDIT USER ID PIN is displayed Press Enter The screen displays the currently selected User ID SELECT USER ID USEROO1 To select another User ID use A or V until the desired User ID is displayed Press Enter to edit the User ID EDIT USER ID Operator s Manual RAM P Reader 28 RAMPO System Operation Enter the User ID using the keypad or optional barcode wand A maximum of 20 alphanumeric characters can be input for the User ID When finished editing press Enter to store the displayed User ID To accept the ID without editing press Options or Enter with nothing typed The screen advances to the EDIT P I N prompt EDIT P I N 00000 whe ale ale ale ale ale ale ale ale ale ale ale ale ale ale EEEE Type in new P I N and press Enter to accept To accept the P I N without editing press Options or Enter with nothing typed The screen returns t
4. NOTE If only one result is stored the Reader will display OUTPUT LAST TEST RESULT SELECTED RESULTS defaults to the last two results Press A or W until the number of results to be output is displayed then press Enter The screen will display SENDING RESULTS followed by OUTPUT COMPLETED The Reader s LCD Display should now read Clear Memory Yes or No Use A or V to choose your desired result Choosing YES will delete all information and is irreversible CLEAR MEMORY gt YES NO NOTE Do not clear memory until results have successfully been transferred to the computer and confirmed Press Enter Operator s Manual RAM P Reader 52 Appendix B Step 15 Once the data has transferred as illustrated below exit from this screen by selecting File and Exit from the drop down menu or double clicking on the X at the top right of the screen ramp HyperTerminal iol Es File Edit View Cal Transfer Help Response Biomedical Corp RAMP Reader S N 88038 Version 1 88 ID JO USER J RESULT finthrax POSITIUE DATE lov 2882 27 N z MB1234 EXP 08 Rug 2005 END OF DATA Zi Connected 0 00 12 Auto detect S500 8 N 1 SCROLL CAPS NUM Capture Print echo After exiting the above screen another screen may appear see below If this screen does appear click Yes HyperTerminal x You are currently connected e Are you sure you want to disconnect now
5. RAMP READY WHEN YOU ARE OPERATOR S MANUAL RAMP Reader E lt z lt 2 x O 5 TT o O Response Biomedical Corporation TOSSINTRODUCTION c bert ne YEY LEN ME ee EPI ETERNI Ita 1 PME OUO P ELE 1 1 2 Interided IJse 3 uidet i EO ERES eb tated deen CER e ba tad pa Do d e M br MAN M 1 1 3 How the RAMP System Works tette ttt tet 3 14 RAMP System Comporients E deba beo sedat y i qe 5 140 RAMP Re AA O e he hod ae ded iium 5 1 4 2 RAMP Assay Test Kit Components sssssssessseeeeeene enne 5 1 43 ACCO SS DONO San ica eo di odii e d b a bee ke PR GAP EH S alii dates 6 1 5 Warnings and Precautions 4 2544 54 yl 2ala ad sl n dikani nano k a nano nemen 6 1 5 1 Symbols and Definitions ail 45 448 rit siiaa x n 24k RAAEN 204kk ah y h kuna sana y sa k y 6 1 5 2 Summary of Warnings and Precautions sssssssseeee em emen 6 1 6 Unpacking and Installation eee ter nein ee aka Eka k Aka nik ak asla a xwedan Ek ac aw k ka 6 1 6 1 Unpack Ngo o ate eoe em am ees RA A 6 1 6 2 RAMPO Reader Contents ore eate erem teg d aei iR E EP DR TERR 7 1 6 3 Optional Accessories oOnten lS kk aka k kk A kk mne nnns 7 1 6 4 Installation teorie E enda emu 7 1 6 5 Initial Start p x cu DD cette dado 7 1 6 6 Optional Accessories oooococi nnncconionicocinnnacornnnnna nin 7 20D RAMP SYSTEM OPERATION a UU 10 2 4 Keypad Functhon an
6. Step 16 Import the file into Excel Operator s Manual RAMP Reader 53 Appendix B Open Excel and click File Open Ensure that Files of type field at the bottom of the screen has ALL FILES highlighted Find the file named during Step 11 capture txt Highlight and click Open A 21xi Look in WINDOWS C amp axe Tools archive Documents and Settings History EES amp Dio My Documents My Documents r Desktop amp Favorites File name Poo p 0 T My Network Lo b az Open Places Files of typi Jar Files Cancel Step 17 The following screen will appear Ensure Delimited is selected click Finish Text Import Wizard Step 1 of 3 2 x The Text Wizard has determined that your data is Delimited IF this is correct choose Next or choose the data type that best describes your data iginal data type Choose the file type that best describes your data Del d Characters such as commas or tabs separate each field C Fixed width Fields are aligned in columns with spaces between each field Start import at row zi File origin windows ANSI J Preview of file C Program Files Accessories HyperT CAPTURE TXT RAMP Reader S N 80055 ersion 2 00 Print or Save as necessary Operator s Manual RAMP Reader 54 APPENDIX C Warranty Response Biomedical s express and implied warranties including implied warranties of m
7. Pressing Enter when DISABLE is selected will disable the INFO LINE no content stored and return to the SYSTEM SETTINGS Menu ENTER INFO LINE 1 Each line can contain 20 alphanumeric characters Use the keypad to enter the desired content for the selected information line and then press Enter to save the changes and return to SYSTEM MENU Press Options to delete the last entered character When no character is input pressing Options or Enter will return the Reader to the SYSTEM MENU without any changes Example printouts are shown below with 2 additional lines of information Figure 2 4 Sample Results Printout with custom information Example RAMP Reader S N XXXXX Version X XX CITY LABS NETWORK PATHOLOGY ID RB123 USER USER1 RESULT Myo 61 7 ng mL DATE 25 Jun 2009 TIME 19 19 LOT Mxxxxx EXP 30 Jun 2010 END OF DATA 2 6 7 Transfer Users This option allows transfer of User ID and User P I N data from one Reader source Reader to another receiving Reader Connect source Reader to receiving Reader using a Reader to Reader cable available from Response Biomedical see Appendix D Ensure the receiving Reader is powered on and the RUN OPTIONS prompt is displayed From the source Reader SYSTEM SETTINGS Menu press A or Y until 6 TRANSFER USERS is displayed Press Enter to begin download During transfer the source Reader displays the following screen SENDING USERS Operator s Manu
8. SET LQC TIMER to set interval from 1 31 days 0 RESET LQC TIMER to set the LQC timer countdown TEST COUNTERS maintains a record of the number of Sample IQC and LQC tests that the instrument has performed 12 CONNECTIVITY to allow the transfer of data to an external system 13 EXIT MENU to return to RUN OPTIONS screen 2 6 1 Accessing the SYSTEM SETTINGS Menu Press Options and scroll to the 5 SYSTEM SETTINGS prompt from the OPTIONS Menu Press Enter to select If the Master P I N feature is enabled Section 2 6 2 access to the SYSTEM Menu requires input of a P I N at this prompt ENTER MASTER P I N whe ale ale ale ale ale ale ale ale ale ale ale ale ale BE FE FE FE FE TE TE TS FS TEE FS FS FS When the correct Master P I N is entered full access to the SYSTEM Menu is permitted By default the Master P I N is disabled If no P I N is entered the screen reverts to the OPTIONS menu If an incorrect P I N is entered a P I N IS INCORRECT message is displayed Pressing any key will display the following gt RE ENTER P I N OVERRIDE P I N Press Enter to re enter correct P I N or press W and Enter to select the P I N override feature The following prompt is displayed CONTACT TECH SUPPORT WITH PERMIT XXXXX Operator s Manual RAM P Reader 26 RAMPO System Operation NOTE Please contact Technical Support Appendix D Be sure the Reader is accessible and the screen wi
9. 6 3 Setting the System CIOCK xa 544 s xaa d la aka Pk n ta dka i ka kan xay kar AAAA d RE raan NA ENEA aih 27 2 6 4 Enable User IOP LN m 28 2 6 5 Edit User ID P EIN iita tre d n NE WE eu Eka Eh ET eod a Z ra sen Ree eee 28 2 6 6 Print Settings eterne KERAN ERK ku ceu det RF KAR Kek e et d k kahn Ee av Van dos 29 2 06 74 Transfer USES cata w M w A Ze kak dk wd ke aa E eeu aces 31 2 6 8 Erase Mona Cn once cueste SN uec tere de ted deter cte pair tes ies 32 2 6 9 Set QGO TITIQE cado tt red ees 33 2 640 SetL QC Timer eris tree edet vetet C ga a er quels 33 2 06 11 Reset LOC Timer io aida 34 2 90 12 TeSt COUntelrs oe E ivan et dasha NM utis cia era aes 35 2 04439 Connectivity MM KN ados 35 20 14 Exits MOM as e ME MA arde head DIMA rs 35 Table of Contents Operator s Manual RAM P Reader i 3 0 MANTENAN CE ETUR RETURNS 36 Bit OVeOIVIQW Xe YO N e etm edt tabi dee de dd e tenes 36 3 2 Cleaning and Decontamination deoise rasede iarain aAa aE nano ke Taka l ke narrar rara 36 Battery Ca a mei Rede iit betreut ad terea 36 A40 C XIROUBE ESHOOTING GUIDE tee fen ette tee ete eI RAEE 37 4 1 Power On Self Test Messages IQC Messages ssssseem mme 37 4 2 Lot Card Barcode MeSSa4ge8 xxxk keka nnnn nc cnn nan kk AA KA KAKA AA AA WAK AWA HAAA KA K KA WAA KAR 39 4 3 Transport Messages is nian aira aa a aaar aa ee aa aa a a a are 40 44 Test Run Mess
10. B Step 6 If the screen shown below appears select OK with the mouse If this screen does not appear proceed to Step 7 Phone and Modem Options 2x Dialing Rules la The list below displays the locations you have specified Select the BS location from which you are dialing Locations O My Location 604 Step 7 Enter RAMP or choose a connection name in the box and select an icon as highlighted below click OK Connection Description ax M S New Connection Enter a name and choose an icon for the connection Name Cancel Operator s Manual RAMP Reader 48 Appendix B Step 8 Choose the appropriate COM port below COM port1 or COM port2 refer to Step 1 where this selection was made or COM port 3 if using a laptop that does not have a serial port Click OK le 5I5 alel Connect To Step 9 The following screen will appear The five settings need to be changed to those shown below Click OK once the settings are modified COM1 Properties e ce c Operator s Manual RAMP Reader 49 Appendix B Step 10 The following diagram illustrates the screen that will appear Select Transfer from the menu and from the drop down menu click Capture Text T RAMP HyperTerminal m x File Edi View Call Transfer Help Du gl 3 SendFie Receive File Capture Text Send Text File Capture to P
11. Cartridge Barcode to recover data BARCODE UNREADABLE PRESS KEY TO PROCEED If re scanning Barcode fails a second time see above message barcode lot information may be entered manually Follow on screen instructions to enter lot number using keypad CARTRIDGE EXPIRED EJECTING CARTRIDGE Cartridge is from an expired lot Remove cartridge Do not use cartridges from this lot The screen returns to the RUN OPTIONS Menu DATA SAVE ERROR CONSULT MANUAL Data from Lot Card was not correctly saved in the Reader s memory Remove Lot Card then re insert ENTRY IS INCORRECT CONSULT MANUAL The lower line of the message alternates between CONSULT MANUAL and PRESS KEY TO PROCEED Lot number information entered was not in correct format After pressing a key operator will be prompted to enter lot number again First character must be M second character must be 0 zero INCORRECT LOT CARD CONSULT MANUAL The wrong Lot Card was inserted at the above screen The test is aborted and cartridge ejected Locate the correct Lot Card for kit T Repeat Test with a fresh set of components INSERT LOT CARD FOR LOT Mxxxxx NOTE If not correct Lot Card press Options to abort Cartridge Reader cannot find matching Lot information stored in memory corresponding to Lot specified on Cartridge Barcode Insert specified Lot Card If Lot Card is not inserted within 5 m
12. Data from an expired lot is not copied into the Reader s memory Operator s Manual RAM P Reader 13 RAMPO System Operation 2 4 Running an Assay 2 4 4 Entering User ID If the User ID option is enabled the following screen is displayed after pressing Enter at the RUN OPTIONS prompt SELECT USER ID ENTER USER ID If the User ID option is disabled this screen does not appear and the test proceeds to Sample ID entry after pressing Enter Section 2 4 2 NOTE The default for the User ID option is ENABLED For information on how to enable disable the User ID via the SYSTEM SETTINGS Menu see Section 2 6 4 When the gt cursor is pointing to the SELECT USER ID prompt press Enter The following prompt is displayed SELECT USER ID USEROO1 Use the A or V keys to display the appropriate User ID and press Enter to select The Reader then progresses to the ENTER SAMPLE ID Section 2 4 3 The Reader provides up to 250 USER ID s of up to 20 characters each The default entries for User ID s are USERO01 USEROO2 through to USER250 To edit the User ID s see Section 2 6 5 To return to the SELECT USER ID ENTER USER ID screen without selecting a displayed User ID press Options To enter a User ID from the keypad press V to move the gt cursor to ENTER USER ID and press Enter The following screen is displayed ENTER USER ID Use the keypad to enter up to 20 alphanumeric characters
13. Input Port on the back panel of the Reader Figure 1 2 and plug into an AC outlet It requires 24 hours to fully charge the battery but it can be used for testing while it is charging NOTE Do not connect or disconnect the Reader from an AC outlet while a test is in progress Operator s Manual RAM P Reader 6 Introduction 1 6 5 Initial Start up The power button is located on the back panel of the Reader Figure 1 2 When the power is turned on the Reader performs a Power On Self Test POST to ensure the system is operating within certain pre set parameters The POST includes calibration verification optical system verification real time clock test transport movement test and a battery test if the Reader is operating on the battery at the time of the POST If the measured battery voltage is low a warning message appears on the LCD along with an audible alarm If this occurs the Reader should be plugged into an AC outlet using the supplied Adapter NOTE A fully charged battery will allow approximately 100 tests to be run before re charging is required In the event that a Reader is left on for 24 hours the battery may run low It takes approximately 24 hours to fully recharge the battery however the Reader may be operated with the AC Adapter during battery recharging Refer to Section 3 3 for recommended battery care NOTE Ensure that the battery is sufficiently charged or that the Reader is connected to an AC outlet prio
14. Manual RAM P Reader 5 Introduction 1 6 Unpacking and Installation 1 6 1 Unpacking The Reader and or optional accessories are packed in a foam cushioned container for maximum protection during shipment If the shipping container is damaged inspect the Reader as it is unpacked If the Reader is damaged notify the carrier and your distributor or Response Biomedical Corporation to arrange for immediate repair or replacement Retain the shipping container and all packaging material for repackaging To unpack the Reader remove the top foam insert and carefully lift out the Reader Place the Reader on a dry clean level surface Remove the AC Adapter and Power Cord and check the label to confirm country specific voltage requirements Remove remaining contents and compare with the packing slip or list below If any of the contents are missing contact your distributor or Response Biomedical Corporation Customer Service Appendix D 1 6 2 RAMPOQO Reader Contents Quantity Instrument 1 RAMP Reader 1 Reader AC Adapter with adaptable plug region specific 1 Reader Operator s Manual 1 6 3 Optional Accessories Contents Quantity Optional Accessories 1 Printer with associated accessories 1 Barcode Wand 1 Computer Connection Cable 1 Reader to Reader Cable 1 6 4 Installation The Reader should be plugged in prior to use in order to charge the battery Connect the AC Adapter to the
15. Press Enter to display the IQC Counter IQC COUNTER COUNT NUMBER Press Enter to display Reset Counters prompt RESET COUNTERS Press Enter to select NO If the Counters are to be reset press W to move the cursor to select the YES option NOTE Resetting the Counters will reset all the counters Sample LQC and IQC to 0 2 6 13 Connectivity Data can be transferred to a computer via the RS232 port on the Reader See Appendix B for details on this data transfer 2 6 14 Exit Menu Selecting this option from the SYSTEM Menu returns the Reader to the RUN OPTIONS prompt From SYSTEM SETTINGS Menu press A or W and Enter to select 13 EXIT SYSTEM MENU and return to the RUN OPTIONS screen Once the SYSTEM Menu is exited the Master P I N is required for re access unless the Master P I N is disabled set to O0000 Operator s Manual RAM P Reader 35 3 0 MAINTENANCE 3 1 Overview The Reader does not require routine maintenance other than occasional cleaning of external surfaces A CAUTION The instrument contains no operator serviceable components Replacement of the custom built battery pack must only be performed by authorized service technicians 3 2 Cleaning and Decontamination A WARNING Unplug and power off the Reader before cleaning A WARNING Do not immerse the Reader in water To clean and decontaminate the Reader wipe down the exterior surfaces of the Reader using a soft cloth cont
16. RE SCAN TRANSPORT ERROR RE CALIBRATING HOME Followed by TEST IS REJECTED PRESS KEY TO PROCEED Mechanical fault in transport mechanism is detected after scan repeated See above message After the TRANSPORT ERROR RECALIBRATING HOME message this message is displayed along with two short beeps Reader re initializes transport mechanism Next error message see below is displayed Automatically performed by the Reader Press any key on the keypad to continue Contact Technical Support Operator s Manual RAM P Reader 40 4 4 Test Run Messages Troubleshooting Guide LCD Message Data Print Out Cause Action Message CARTRIDGE ERROR CTG ERROR May be due to Cartridge is automatically CONSULT MANUAL ejected Cartridge not pushed completely to The lower line of the the back of the insertion port of the Remove cartridge message alternates Reader between CONSULT Please contact Response MANUAL and Error may be due to a defect in the Biomedical Technical REMOVE cartridge Support and report the CARTRIDGE problem TRepeat Test with a fresh set of components HIGH BACKGROUND HRB May be due to Cartridge is automatically SEE PACKAGE ejected INSERT Interfering substances in sample Remove cartridge The lower line of the message alternates Operator should refer to between SEE the analyte specific PACKAGE INSERT Package Insert for further an
17. The screen limits the number of characters to a maximum of 20 Alternatively use the optional Barcode Wand to enter the User ID If the Barcode Wand is attached a loud beep will sound when the ENTER USER ID prompt is displayed Press Enter to accept the information entered by the keypad or Barcode Wand This will link the User ID to the Sample ID entered in the next step If there no characters entered pressing Options returns the screen to the SELECT USER ID menu Operator s Manual RAM P Reader 14 RAMPO System Operation 2 4 3 Entering User P I N User Lock out Mode P I N Enabled If the User ID and P I N options are enabled the following screen is displayed after pressing Enter to select the appropriate User ID ENTER USER P I N whe ste ale ale ale ale ale ale ale ale ale ale ale ale ale EEKE If the User P I N option is disabled this screen does not appear and the Reader progresses to ENTER SAMPLE ID screen Section 2 4 3 NOTE The default for the User P I N option is DISABLED For information on how to enable disable the User P I N via the SYSTEM SETTINGS Menu see Section 2 6 4 Use the keypad to enter the numeric User P I N required and press Enter The following screen is displayed briefly VERIFYING P I N PLEASE WAIT If the User P I N is recognized the Reader progresses to the ENTER SAMPLE ID screen Section 2 4 3 If the User P I N is not recognized the
18. and printing sample results If the LOC timer reaches zero and the Reader is displaying the RUN OPTIONS screen the display will change to LQC NEEDED PRESS KEY TO PROCEED 2 6 11 Reset LQC Timer Resetting the LOC Timer starts a new countdown to the specified time interval From SYSTEM Menu press A or W until 10 RESET LQC TIMER is displayed Press Enter to select this option The Reader displays the following prompt along with a double beep RESET TIMER gt YES NO Press Enter to select YES The LQC Timer is reset to the specified interval and is confirmed by two short beeps The following prompt is displayed for 2 seconds and the screen returns to the SYSTEM Menu LQC TIMER HAS BEEN RESET Operator s Manual RAMP Reader 34 RAMP System Operation NOTE The RESET LQC TIMER option does not allow the operator to disable the LQC Timer In order to turn the LQC Timer off the steps outlined in Section 2 6 10 should be followed 2 6 12 Test Counters The TEST COUNTERS option maintains a record of the number of Sample IQC and LQC tests that the instrument has performed The counters can be viewed and reset From SYSTEM Menu press A or V until 11 TEST COUNTERS is displayed Press Enter to select this option The Reader displays the following prompt example sample test numbers SAMPLE COUNTER COUNT NUMBER 13212 Press Enter to display the LQC Counter LQC COUNTER COUNT NUMBER
19. become a potential biohazard If a spill occurs disinfect external surfaces only using a soft cloth containing a solution of 0 596 bleach 7096 isopropyl alcohol or 7096 ethanol Use appropriate precautions in the collection handling and disposal of specimens including diluted specimens and Test Kit contents as these items are potential biohazards Refer to analyte specific package insert for instructions Dispose of instrument and accessories in accordance with federal state and local requirements for potential biohazards WARNING Reduce the risk associated with inaccurate results Keep movement of the Reader to a minimum while an assay is in process however sitting the Reader in an idling or moving vehicle should not inhibit the development of a test CAUTION Reduce the risk of instrument or accessory damage Do not spill sample near the Reader cartridge port or on the outside of a cartridge Liquid contact with electrical components inside the Reader may damage the Reader If a spill enters the cartridge port power off the device immediately to prevent damage and no not power on until any spill is dry Do not touch the gold contact pads on the Lot Cards Store Lot Cards in the anti static pouches provided Use only Response Biomedical supplied or recommended accessories with the Reader DO NOT connect the barcode wand to Reader while the Reader is turned ON Doing so may result in damage to the barcode wand Operator s
20. currently selected option Whenever the OPTIONS Menu and associated functions are used the keypad is limited to using the A V Options and Enter keys All other character keys are inactive except when required for Editing User ID User P I N Master P I N and adding printout information Operator s Manual RAM P Reader 10 RAMP System Operation Figure 2 1 RAMP Reader Keypad LCD Display Alphanumeric Keys Down W Key Up A Key Function Keys Operator s Manual RAMP Reader 11 RAMPO System Operation 2 2 RUN OPTIONS Menu When the Reader is turned on it initially performs a Power On Self Test and displays the following animation on the display for one second while emitting two short beeps The following message scrolls across the screen from right to left and remains displayed for a few seconds X XX corresponds to the software version RAMP READER RS aha ala ala 2 98 8 WWW Version X XX NOTE If errors are found during the Power On Self Test see Section 4 1 for detail When the Reader is ready for operation the RUN OPTIONS Menu is displayed RUN TEST Enter OPTIONS Options At this point the following actions may be performed e Inserta Lot Card to upload lot information Section 2 3 e Run an Assay Section 2 4 e Access the OPTIONS menu Section 2 5 NOTE If a critical system failure is found during the Power On Self Test or during IQC the Reader wil
21. displayed When the character of choice has been selected press a different key other than the key initially pressed to enter the character The blank cursor will then move one character position to the right and display the new character Press Enter to accept the displayed character string and proceed to the next step Alternatively a two second pause after the desired character is selected will automatically enter the character and move the blank cursor one space to the right This provides a means of entering multiple characters on the same key NOTE When keying in a P I N only the numerical character for each key 0 9 can be selected Press Options to erase and move the cursor one step to the left This provides a backspace or correction function Press Options again to erase the displayed character and move the cursor one more step to the left Pressing a new character key will overwrite the displayed character above the cursor If either Options or Enter key is pressed when no characters are shown on the display this step is aborted and the operator is returned to the RUN OPTIONS Menu The character keys ABC 1 and GHI 3 also function as the up A and down keys respectively allowing the operator to scroll through the OPTIONS menu or move the displayed gt cursor to select specific options Holding down the A or W key causes the display to scroll through the available choices The gt cursor points to the
22. is detected in the Reader during the Power On Self Test or IQC Remove Test Cartridge Reader displays the RUN OPTIONS Menu If no Cartridge is present this error may be caused by a bright light shining on the Reader Shade Reader to see if this corrects the error REMOVE LOT CARD A Lot Card is detected during Power On Self Test or IQC Remove Lot Card Reader displays RUN OPTIONS Menu SERVICE REQUIRED PRESS KEY TO PROCEED Critical Failure was detected during Power On Self Test or IQC Access to running samples and LQC is blocked Press any key to return to the RUN OPTIONS or RUN LQC EXIT prompt Contact Technical Support Results in memory can still be viewed printed or downloaded Critical Failure detected during Power On Self Test or IQC Leads to SERVICE REQUIRED message and access to running test samples and LQC is blocked The results in memory can still be viewed printed or downloaded Operator s Manual RAM P Reader 38 4 2 Lot Card Barcode Messages Troubleshooting Guide Repeat Test Using the same whole blood sample follow the testing procedure in the analyte specific Package Insert beginning at the SAMPLE PREPARATION section A new Sample Buffer Vial Assay Tip and Test Cartridge must be used LCD Message Cause Action BARCODE DATA ERROR RE SCANNING BARCODE Reader detects an error in reading Barcode Reader automatically re scans
23. one of the three printing options 1 DO NOT PRINT default the user is not prompted to print after an assay is run Results may be printed when viewing results at a later date 2 PROMPT USER the user is prompted to print each result after running an assay When prompted use A or V to select YES or NO and press Enter If YES is selected the Reader will send the current result to a printer 3 AUTO PRINT each assay result will be printed automatically after running an assay followed by OUTPUT COMPLETE The screen then displays the sample results 2 6 6 2 Adding custom information to results printout From the PRINT SETTINGS menu press V and Enter to select 2 ADD INFORMATION l PRINT OPTION gt 2 ADD INFORMATION The following is displayed gt 1 INFO LINE 1 2 INFO LINE 2 Use A or V to select the line to edit and press Enter The current content of the selected line is displayed HIT ENTER TO MODIFY ABC LABORATORY NOTE If Info Line is disabled holding no content the following is displayed HIT ENTER TO MODIFY LINE 1 IS DISABLED When Enter is pressed the following is displayed Press Options to return to the SYSTEM MENU INFO LINE 1 gt ENABLE DISABLE Operator s Manual RAMP Reader 30 RAMP System Operation Use A or V to select ENABLE or DISABLE Pressing Enter when ENABLE is selected will display the INFO LINE input screen
24. via an AC adapter 1 4 2 RAMP Assay Test Kit Components The Kits are used in conjunction with the Reader to detect the concentration of analyte in an aqueous sample There are several components associated with the Kits including a Lot Card and applicable sample handling supplies For more information on the Kit components operation and sample handling for the assay refer to the analyte specific Package Insert NOTE The Reader is only designed to be used with Kits manufactured by Response Biomedical Corporation 1 4 3 Accessories There are a number of optional accessories that can be purchased for use with the RAMP System All items are available from Response Biomedical Please contact your local distributor or Response Biomedical Customer Service Appendix D if you require any of the following accessories 1 4 3 1 Printer A printer can be connected to the Reader via the RS 232 serial port on the back panel and is used to create a hard copy of the assay results The recommended printer is the Citizen iDP 3110 1 4 3 2 Barcode Wand A barcode wand can be connected to the Reader via the back panel and used to enter sample identification or operator identification into the Reader instead of using the Reader keypad The barcode wand is capable of reading UPC Codabar EAN ISBN or similar barcode information 1 4 3 3 Computer Connections Appendix A and Appendix B provide the detailed instructions for enabling assay results to be o
25. ETTINGS Menu Operator s Manual RAMP Reader 32 RAMP System Operation If Enter is pressed to select a specific memory that has no results stored the following display is shown MEMORY PREVIOUSLY ERASED PUSH A KEY The display returns to the SELECT RESULT TYPE Menu 2 6 9 Set IQC Timer The Set IQC TIMER option allows the setting of the interval at which the Reader will automatically run IQC testing The default setting for the IQC timer is disabled NOTE The IQC will only run at the RUN OPTIONS or RUN LQC EXIT prompt From the SYSTEM Menu press A or V until 8 SET IQC TIMER is displayed Press Enter to select this option The following prompt is displayed which is the system default SET IQC TIMER IQC TIMER IS OFF To initiate the IQC TIMER INTERVAL press A or V until the desired IQC interval is displayed The range of IQC Timer Interval is 1 24 hours SET IQC TIMER TO XX HOURS Once the IQC interval is selected press Enter to return to the SYSTEM Menu NOTE If Options is pressed instead of Enter the changes to the IQC interval will not be accepted and the screen returns to the SYSTEM Menu To turn the IQC Timer off press A or Y until the message IQC TIMER IS OFF is displayed If an IQC Interval has been set the Reader begins a countdown timer Once the timer reaches zero the IQC will run automatically at the next available opportunity IQC will only run if the Reade
26. THER PERSON FOR ANY DAMAGES LOSSES COSTS EXPENSES OR OTHER LIABILITIES WHATSOEVER AND REGARDLESS OF THE FORM OF ACTION IN CONTRACT TORT OR PURSUANT TO STATUTE THEN RESPONSE S AGGREGATE LIABILITY TO ALL SUCH PERSONS WILL BE LIMITED TO AN AMOUNT EQUAL TO THE PURCHASE PRICE PAID FOR RAMP The exclusion of certain conditions and warranties and the limitation of certain liabilities is prohibited in some jurisdictions so these limitations and exclusions may not apply to some purchasers This limited warranty is governed solely by the laws of the Province of British Columbia Canada and applicable federal laws of Canada excluding any rules of private international law or the conflict of Operator s Manual RAMP Reader 55 Appendix C laws which would lead to the application of any other laws and the courts of British Columbia Canada shall have exclusive jurisdiction over any claims relating to this limited warranty This document is in the English language In the event this document is translated into any other language and any inconsistency or contradiction in meaning or interpretation results wherefrom the English language version shall prevail and be controlling as between Response and the purchaser RECALL POLICY Recalls are actions taken by Response Biomedical Corporation Response to remove a certain serial or lot numbers of products from the market and replace them Recalls may be conducted on Response s own initiative or by
27. ader or print or delete individual results 3 RUN INTERNAL QC to initiate a non scheduled Internal QC test 4 RUN LIQUID QC to run a Liquid QC test 5 SYSTEM SETTINGS to enable or disable the optional settings that can be protected with a Master P I N see Section 2 6 2 6 EXIT OPTIONS to exit OPTIONS and return to the RUN OPTIONS Menu Press Options from the RUN OPTIONS Menu to access these various options Press A or Y until the desired option is displayed then press Enter to select the specified option Pressing Options will switch the display back to the RUN OPTIONS Menu 2 5 1 Output Results To send test results to the optional printer or a computer perform the following steps Ensure that the printer or computer is connected via the RS 232 serial port and that it is turned on Appendix A From the RUN OPTIONS Menu select Options by pressing Options Operator s Manual RAM P Reader 19 RAMPO System Operation Press Enter to select 1 OUTPUT RESULTS The screen displays the following prompt SELECT RESULT TYPE l SAMPLE RESULTS The three result types available to select are 1 Sample Results 2 LQC Results 3 IQC Results Press A or WV until the desired option is displayed Pressing Options will switch the display back to the OPTIONS Menu Press Enter to select the specified option The screen displays the following prompt gt ALL RESULTS SELECTED RESULTS To o
28. ages eee IDEE ica 41 4 5 General Messages menhear cedi a a aa aa iia eed n ka one de dd cede 43 5 0 READER SPECIFICATIONS o in 44 APPENDIXA 054a TAE eden eder ore dee aa D n 45 Connecting the RAMP Reader to Accessories ssssetettee tette 45 Printer Computer Connections sssssssssssssesseseeeeeeneerere nennen KAK kK A KA KA nnn nennen KA sre KA KA KA 45 Reader to Reader Connections ui EEE kek kaka kk kk kk kk ka KA KAKA KA KA KAK KA KA KA KA KA KA KA KA A KA 45 Barcode Wand Connections 2 ccccccceceeeecccce cece Eke keke keka kk kk kaka kaka KA KA KA KA KA KA KA KA KAK KA KA KA KA KA KA KA KA AK AA 45 APPENDIX Bi eere ete EI EI D PI EIE E REYE seers ba sara nebe re EIER REIP MEI P RIDE 46 Sending Data from the RAMP Reader to a A ween rol a an da eka deena 46 ABPENDLXC SS eee M RETE E EE RE D EE E ER EU EIE 55 Warranty M EEE 55 APPENDDGBD S uei UIN III ETE 58 Contact AAA o teet edet adt OE 58 Response Biomedical Customer Service Ek ener 58 Response Biomedical Technical Support esses ener enne 58 European Authorized Representative ssssssssssssssssesese eene Enana rE ka KAKA KA KAKA KA RR KI 58 Operator s Manual RAM P Reader ii Revision History Revision DM SW Effective Date Summary of Changes ersion 1 0 3 20 3 21 December 2010 um di of generic RAMP Operators
29. aining a solution of 0 5 bleach 70 isopropyl alcohol 70 ethanol or a non organic disinfectant containing not more than 0 5 bleach Do not spray the Reader with disinfectant or attempt to clean any internal parts or surfaces Any spills should be cleaned away before inserting a cartridge into the Reader If the Reader should require servicing or replacement it must be decontaminated per above instructions prior to repackaging and shipping 3 3 Battery Care The service life of the internal custom battery pack depends on the amount of time the Reader is run on the battery If battery operation is kept to a minimum and complete battery discharge is avoided the battery pack should not require servicing over the lifetime of the instrument If battery operation is frequent and continuous however the battery pack may need replacement within the Reader s lifetime To maximize battery performance the Reader should always be recharged optimally for 24 hours when the Low Battery indicator first appears The Reader may be operated with the AC Adapter during battery recharging The user may choose to recharge the battery before reaching full discharge This is called topping up the charge While this can be done it will reduce the service life of the battery and will temporarily reduce battery capacity A deep discharge is recommended after several top up charges to restore full battery capacity A CAUTION Complete battery discharge should be a
30. al RAM P Reader 31 RAMP System Operation During transfer the receiving Reader displays the following screen RECEIVING USERS After completion the following screen is displayed USER ID PIN DATA RECEIVED amp STORED Upon completion of download source Reader returns to TRANSFER USERS option screen If the receiving Reader is not properly connected the source Reader briefly displays an error screen RECEIVING READER IS NOT RESPONDING The source Reader then returns to the 6 TRANSFER USERS screen 2 6 8 Erase Memory Results can be erased from the Reader memory from the Output Results option This selection removes all stored results of the selected result type From the SYSTEM SETTINGS Menu press A or V until 7 ERASE MEMORY is displayed Press Enter and the RESULT TYPE Menu is displayed There are 3 available result types 1 SAMPLE RESULTS 2 LQC RESULTS 3 IQC RESULTS To remove the results from memory press A or V until the appropriate result type is displayed Press Enter The display shows the following prompt CLEAR MEMORY gt YES NO To remove these results from the memory press Enter to select YES The operator is asked to confirm this request by the following prompt ARE YOU SURE gt YES NO Press Enter to confirm results deletion The MEMORY HAS BEEN CLEARED message with the result type is displayed for 2 seconds and the screen returns to the SYSTEM S
31. caused by misuse neglect unauthorized attempts to open repair or modify RAMP use of RAMP with accessories or other products that are not authorized by Response attempts to use a RAMP kit or components past their explicit Use by dating or any cause other than the intended normal use of RAMP Non warranty work is charged at the standard repair rate or replaced products price effective at the time RAMP is returned to Response All repairs include a complete functional test using factory test fixtures EXCLUSIONS TO THE FULL EXTENT ALLOWED BY LAW THIS LIMITED WARRANTY IS THE PURCHASER S SOLE AND EXCLUSIVE REMEDY AND NO OTHER WARRANTIES CONDITIONS OR GUARANTEES OF ANY KIND SHALL APPLY WHETHER STATUTORY WRITTEN ORAL EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES CONDITIONS OR GUARANTEES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE PERFORMANCE QUALITY OR DURABILITY ALL OF WHICH ARE DISCLAIMED IN NO EVENT WILL RESPONSE BE LIABLE FOR ANY SPECIAL EXTRAORDINARY INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF DATA LOST PROFITS LOSS OF OPPORTUNITY BUSINESS INTERRUPTION PERSONAL INJURY OR DEATH OR ANY OTHER LOSS ARISING OUT OF RELATING TO OR IN CONNECTION WITH RAMP EVEN IF RESPONSE IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES LIABILITY LIMITATIONS IF AS A RESULT OF OR IN CONNECTION WITH ANY USE OF RAMP RESPONSE BECOMES LIABLE TO THE PURCHASER OR ANY O
32. city is 500 tests When number of tests exceeds this limit oldest test is overwritten If required print out or download data to prevent loss of data then erase memory REMOVE CARTRIDGE THEN REPEAT TEST Message is displayed along with a click after the TEST IS REJECTED PRESS KEY TO PROCEED message and any key on the keypad is pressed The screen returns to the RUN OPTIONS Menu If error persists contact Technical Support T Repeat Test with a fresh set of components TRANSFERRING DATA PLEASE WAIT The Reader is transferring data to an external system If the Reader is not being used with an external system disable the CONNECTIVITY option in SYSTEM SETTINGS see Section 2 6 13 WARNING LQC DUE PRESS KEY TO PROCEED Message is displayed at the VIEW RESULTS option as a sample result is viewed or printed out with sample result at OUTPUT RESULTS The warning indicates that the sample was run after the LOC Timer had expired Run LQC see Section 2 5 4 Reset LQC Timer see Section 2 6 10 If at any time further assistance is required contact your distributor or Response Biomedical see Appendix D Operator s Manual RAM P Reader 43 5 0 READER SPECIFICATIONS Dimensions Weight Power Requirements Pollution Degree Installation Category RAMP Battery External Connections Operating Temperature Range Operating Humidity Range Storage Humidity Range S
33. d REMOVE instructions CARTRIDGE TRepeat Test with a fresh set of components LOW SIGNAL LOW SIGNAL May be due to Cartridge is automatically CONSULT MANUAL ejected while alarm The lower line of the message alternates between CONSULT MANUAL and REMOVE CARTRIDGE Insufficient sample being transferred to cartridge Insufficient mixing of sample message is displayed Remove cartridge Operator should refer to the analyte specific Package Insert for further instructions T Repeat Test with a fresh set of components Operator s Manual RAM P Reader 41 Troubleshooting Guide LCD Message Data Print Out Message Cause Action SAMPLING ERROR 1 SEE INSTRUCTIONS The lower line of the message alternates between SEE INSTRUCTIONS and REMOVE CARTRIDGE SAMP ERROR 1 Sample flow occurred before the cartridge was inserted into the Reader This may be due to A delay of more than 30 seconds between sample addition to cartridge and insertion of the cartridge into the Reader except WNV assay Insertion of a used cartridge Re insertion of a cartridge that has been previously rejected by Reader Cartridge is automatically ejected Remove Cartridge Operator should refer to the analyte specific Package Insert for further instructions TRepeat Test with fresh set of components SAMPLING ERROR 2 SEE INSTRUCTIONS The lower line of
34. d Section 2 6 6 and the screen returns to the RUN OPTIONS prompt 2 5 5 System Settings The Reader provides built in User Lock out capability such that Systems Settings require a Master P I N The default setting is Master P I N disabled To access the SYSTEM SETTINGS Menu from the RUN OPTIONS Menu select Options and press A or W until 5 SYSTEM SETTINGS is displayed See Section 2 6 for details on using the SYSTEMS SETTINGS Menu 2 5 6 Exiting OPTIONS Menu To exit from the OPTIONS Menu press Options A or W until 6 EXIT OPTIONS is displayed Press Enter to select this option or press Options to return to the RUN OPTIONS Menu Operator s Manual RAM P Reader 25 RAMPO System Operation 2 6 Using the SYSTEM SETTINGS Menu The SYSTEM SETTINGS Menu allows controlled access to the following system settings SET MASTER P I N to edit the Master PIN 2 SET CLOCK to adjust the date and time 3 DISABLE ID amp P I N to enable or disable the User ID PIN option 4 EDIT USER ID P I N to review and edit the User ID PIN 5 PRINT SETTINGS allows for printing of the results after each test and the ability to include two additional lines of information on the printout 6 TRANSFER USERS to download User ID PIN data to another RAMP Reader 7 ERASE MEMORY to delete test results stored in the Reader memories i e Sample LQC and IQC SET IQC TIMER to set interval from 1 24 hours 9
35. d Use ete Da ge et cat e TERRE A vance cascade ener b dar 10 2 2 RUN OPTIONSM HRU teet iiri n bi aren b D ka y ide kad e d b n l d rami aet edad 12 2 9 USING LOU Cards tet EE eee db e dee rage KENA E ME e dpt edge 12 2 4 RUNNING a ASS Y aee pe D ertt ee t HEGE a te ertt db ia aad 14 2 4 1 Entering User ID teet ih toi egestate Coe cite Her k a ae eC pe ene 14 2 4 2 Entering User P I N User Lock out Mode P I N Enabled 15 2 4 3 Entering Sample ID 2 3 tinte tat ten ot Ltd eoe beber cba 15 2 4 4 Ins rting a Cartridge y 30545151 sen arek Pee b e HIR E db K ke Med ERR cated 16 2 59 Using the OPTIONS Menu ith eee eb eR Eee b Pb k Gu Heka E eek eb 19 2 5 1 Output Results m tete ette Phe ct liene Nd db otitis 19 2 5 2 Miew Results ON 22 2 5 3 Run Internal Quality Control IQC sssee emm 24 2 5 4 Run Liquid Quality Control LOQ i Ass eee dkan salla kay sk nennen emere 25 2 5 5 Sylen SOUINGS Lm 25 2 5 6 Exiting OPTIONS Menu cceecccceteeseceeeeseeeeteeeeeeeeeeneeeceeeaeeeeeeaaeseseegeeeseseneeeteneeaeess 25 2 6 Using the SYSTEM SETTINGS Menu 2 0 2 cece eeneee eee ee kk kaka aka ak kk AA k AA Ak AA AA AA AWA 26 2 6 1 Accessing the SYSTEM SETTINGS MenU ii EEE kk ek kk KA kk ke 26 2 6 2 Set Master PLN g s43x5455122ar454x5a tddi nya E aw y ka n Xuya n ZE ye G n e aa Ewa eka 27 2
36. earing all letters or numbers also returns the screen to the RUN OPTIONS Menu Once the Sample ID has been accepted and entered the system proceeds to the ADD SAMPLE THEN INSERT CARTRIDGE prompt Section 2 4 4 2 4 4 Inserting a Cartridge After accepting a Sample ID the Reader activates an internal barcode detector and prompts the operator to ADD SAMPLE THEN INSERT CARTRIDGE NOTE The Reader will remain on this screen for 5 minutes or until a cartridge is inserted If the sample is not available at this time or if the test is to be aborted press Options to return to the RUN OPTIONS Menu Prepare a cartridge with sample following the procedure described in the appropriate Assay Package Insert Insert the cartridge into the Cartridge Insertion Port Figure 2 2A by gently pushing the cartridge until firm resistance is felt Figure 2 2B Do not attempt to force the cartridge all the way into the slot The Reader will automatically guide the cartridge while reading the barcode graphic on the bottom The barcode contains the assay lot number and graphic markings to indicate to the Reader that the cartridge has been correctly inserted Operator s Manual RAM P Reader 16 RAMPO System Operation Figure 2 2 Inserting a Test Cartridge 2 2A 2 2B A CAUTION To prevent damage to internal components of the Reader it is important to prevent excess sample from getting onto the cartridge or spilling out of the sample well C
37. echnical Support at 1 866 525 RAMP Step 1 Connect the RS232 port DB 9 Extension Cable F F purchased from Response Biomedical to the Reader and to the COM port on the rear panel of the CPU back of a personal computer Take note of the COM port selected since it will be required in a later step If using a laptop there may not be a serial port In this situation a USB to RS 232 adapter must be purchased and installed prior to use This adapter will plug into a USB port on the laptop and allow the RS 232 cable to be plugged in NOTE The COM port will be COM 3 NOTE A new HyperTerminal connection must be created at each upload Step 2 Switch on Reader Step 3 Using the computer mouse click Start at the bottom left hand corner of the screen Select Programs from the menu then select Accessories Communications and then the HyperTerminal folder see picture below New Office Document E Open Office Document Accesso E BBD DialUp Networking E 3 Entertainment gt E SS e Microsoft Office Tools A Internet Tools Y Intemet Connection Wizard WinZip E3 Norton AntiVirus Corporate Edition Z5 System Tools gt NetMeeting 13 Online Services 2 Address Book Ey Phone Dialer gt nj Calculator gt E Imaging Ed Favorites e Acrobat Reader 5 0 e Notepad d Intemet Explorer Mj Paint a Documents 1 Microsoft Access E Synchronize altings 3 Microsoft Excel WordPad KS Microsof
38. erchantability and fitness are conditioned upon observance of Response Biomedical s published directions with respect to the use of Response s products Under no circumstances whatsoever shall Response Biomedical Corporation be liable for any indirect or consequential damages Response Biomedical Corporation Response warrants to the original purchaser that the RAMP amp System and all accessories provided with the RAMP System collectively RAMP will be free from defects in material and workmanship for the lesser of one 1 year from the date of the original purchase from Response or an authorized reseller or the Use by date provided on kits and components This limited warranty is non transferable If RAMP is defective during the warranty period the purchaser s sole and exclusive remedy and Response s sole obligation will be to at Response s option repair or replace RAMP Repaired or replaced products or parts may be new or reconditioned and are subject to this limited warranty through the end of the original warranty period To obtain warranty service the purchaser must contact Response during the warranty period provide Response with a dated proof of original purchase and ship RAMP to Response in its original or equivalent packaging after receiving an authorization notice in writing from Response The purchaser is responsible for shipping costs to Response This warranty does not apply if the defect or malfunction in RAMP was
39. following screen is displayed P I N IS INCORRECT PRESS KEY TO PROCEED Press any key to restore the screen to the RUN OPTIONS prompt Press Enter to retry or consult supervisor 2 4 3 Entering Sample ID After the USER ID and or P I N is entered if enabled a beep is emitted and the following prompt is displayed ENTER SAMPLE ID NOTE If the USER ID is disabled the above prompt will be displayed after pressing Enter from the initial RUN OPTIONS screen Operator s Manual RAM P Reader 15 RAMP System Operation A Sample ID of up to 20 alphanumeric characters can be input using the letter number and space keys Section 2 1 ENTER SAMPLE ID R When all characters have been entered press Enter to store the displayed Sample ID into memory If a letter or number has been inadvertently entered press Options to clear the entry Alternatively the optional Barcode Wand may be used to enter the Sample ID If the Barcode Wand is attached a loud beep will sound when the ENTER SAMPLE ID prompt is displayed Swipe the Barcode Wand across the barcoded information in either direction A beep will sound if the Swipe is successful Accept the displayed information by pressing Enter To erase the entry press Options NOTE If the Reader is operating on the internal battery and a Sample ID is not entered within 30 seconds the screen returns to the RUN OPTIONS Menu Pressing Options or Enter after cl
40. heduled to run automatically at intervals during a 24 hour period Section 2 6 9 In addition a manual IQC test can be performed at any time by performing the following steps From the RUN OPTIONS Menu select Options and press A or W until 3 RUN INTERNAL QC is displayed Press Enter to select The test takes just a few seconds during which the following screen is displayed CONDUCTING IQC PLEASE WAIT Upon completion of IQC the screen returns to the OPTIONS Menu If an error occurs refer to Section 4 1 NOTE A manual IQC does not affect the IQC timer settings Operator s Manual RAM P Reader 24 RAMP System Operation 2 5 4 Run Liquid Quality Control LQC External liquid quality control reagents are available for clinical RAMP Assays To conduct an LQC test perform the following steps From the RUN OPTIONS Menu select Options and press A or W until 4 RUN LIQUID QC is displayed Press Enter The following screen is displayed RUN LQC ENTER EXIT OPTIONS Press Enter to select Run LQC feature If User ID or P I N is enabled the test will progress as described in Section 2 4 2 Then the display will prompt for a Sample ID Enter a sample ID and press Enter the following screen is shown ADD SAMPLE THEN INSERT CARTRIDGE Perform the LQC test following LOC and Assay package insert instructions After completion of a successful LQC assay relevant print messages are displaye
41. ight carrier s requirements Response will pay the shipping charges for the product exchange Contamination For Biodefense Readers Response will replace at no charge any Biodefense Reader that was used to run a test for a bioterrorism agent that showed a positive result This result must have been confirmed in writing by the local government laboratory using accepted methods It will be the responsibility of the customer to properly and safely dispose of the contaminated reader Note This policy does not apply if live agents are purposefully being used as part of a demonstration or evaluation Operator s Manual RAM P Reader 57 APPENDIX D Contact Information Response Biomedical Customer Service 1 888 591 5577 North America only Tel 1 604 456 6010 Fax 1 604 456 6066 Response Biomedical Technical Support 1 866 525 RAMP 525 7267 North America only Tel 1 604 219 6119 Fax 1 604 456 6066 Email techsupport responsebio com Response Biomedical Corporation 1781 75th Avenue West Vancouver British Columbia Canada V6P 6P2 www responsebio com RAMP is a Registered Trademark of Response Biomedical Corporation European Authorized Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 0 70 345 8570 Fax 31 0 70 346 7299 R1519 Rev1 0 December 2010 Operator s Manual RAMP Reader 58
42. inutes the test is aborted and the cartridge is ejected LOT CARD EXPIRED REMOVE LOT CARD The Lot Card contains data for an expired test lot Remove Lot Card to clear error message Do not use Test Cartridges from this lot Operator s Manual RAM P Reader 39 Troubleshooting Guide LCD Message Cause Action LOT CARD READ ERROR REMOVE LOT CARD Lot Card data is corrupted due to electrical fault or poor contact between Lot Card and Reader slot Remove Lot Card then re insert PROHIBITED TEST REMOVE LOT CARD Test is not compatible with this Reader Contact Technical Support REMOVE CARTRIDGE THEN RE INSERT Barcode sensor does not detect barcode correctly Ensure cartridge is properly inserted The Reader waits until operator removes cartridge then displays RE INSERT CARTRIDGE When cartridge is properly inserted Reader displays TEST IN PROGRESS READING BARCODE TIMEOUT DISCARD TEST HIT A KEY Either cartridge or Lot Card was not inserted within 5 minutes Insert correct Lot Card T Repeat Test with a fresh set of components 4 3 Transport Messages LCD Message Cause Action SCANNING ERROR ATTEMPTING RE SCAN A mechanical problem with the transport mechanism is detected during scanning phase of the test Reader automatically attempts a repeat of scan Screen displays the message TEST Myo
43. l lock out the operator from running samples or Liquid Quality Control LQC Pressing Enter at either the RUN OPTIONS or RUN LQC EXIT prompts will display this message SERVICE REQUIRED PRESS KEY TO PROCEED Press any key to return to the menu The OPTIONS Menu is still accessible to output print or view results 2 3 Using Lot Cards Each Kit includes a Lot Card that is individually packaged in an anti static pouch The Lot Card provides information including lot specific data and the expiration Use by date of each Kit Use the Lot Card to input the specific lot information into the Reader before using the Cartridges This step is only required once prior to the use of a new lot Operator s Manual RAM P Reader 12 RAMPO System Operation To load the lot information hold the Lot Card by the label with the arrow text facing up then insert the Lot Card with the arrow pointing toward the Reader contact end first into the slot located under the keypad on the front of the Reader Figure 1 1 A CAUTION Do not touch the gold contact pads on the Lot Card The Lot Card must be inserted before the accompanying new Kit lot can be used If the Lot Card is not inserted prior to running the first cartridge for a new lot the operator will be prompted to insert the appropriate Lot Card Section 4 2 Refer to the following steps for loading Lot Card information At the RUN OPTIONS Menu prompt insert the Lot Card After the Lot Ca
44. lean any spills before inserting the cartridge into the Reader NOTE For most assays it is important to IMMEDIATELY insert the cartridge into the Reader following sample addition If the cartridge is not inserted into the Reader within 30 seconds of sample addition the cartridge may be rejected and an error message displayed This will abort the test and require another test to be performed Section 4 4 If the Reader is unable to detect the cartridge a beep is emitted and the error message REMOVE CARTRIDGE THEN RE INSERT is displayed Section 4 4 When the inserted cartridge is detected the Reader automatically pulls the cartridge inside and displays the following TEST IN PROGRESS READING BARCODE Once the cartridge barcode is successfully read the Reader searches its memory for the corresponding lot specific data If the matching data cannot be found the operator is prompted to INSERT LOT CARD FOR LOT ZMxxxxx Section 4 2 If the Reader s memory contains the corresponding lot information for the cartridge a series of prompts indicating the progress of the analysis are displayed as shown in the following example of a Myoglobin test TEST Myo BEGINNING TEST TEST Myo RUNNING Running time is displayed as a count up timer until sample flow is detected Operator s Manual RAM P Reader 17 RAMP System Operation NOTE If sample flow is not detected within the time specified by the Lot Card the following
45. lts may be viewed on the Reader LCD display and or output to a printer or computer Operator input is accepted from the Reader s keypad or an optional barcode wand The RAMP System should only be used by trained personnel 1 2 Intended Use The RAMP Reader is a general use fluorometer that analyzes results produced by immunoassays manufactured by Response Biomedical 1 3 How the RAMP System Works Each disposable single use Test Cartridge houses an analyte specific immunochromatographic strip on which the Assay runs The RAMP System uses an internal calibrator incorporated into each test strip to compensate for test to test variations To perform an assay the operator transfers a sample into the sample well of a cartridge and inserts the cartridge into the Reader The sample is drawn by capillary action along the membrane Analyte present in the sample interacts and binds with the fluorescently labeled antibodies forming an antibody antigen complex The complexes and labeled antibodies are subsequently captured at the detection and internal standard zones When the reaction in the cartridge is complete the Reader scans the assay strip and detects fluorescence in the detection and the internal standard zones then by comparing fluorescence captured at the detection and internal standard zones converts this ratio RAMP Ratio into an analyte concentration using lot specific calibration data Refer to analyte specific package inserts fo
46. message is displayed with the bottom line alternating display with REMOVE CARTRIDGE Section 4 4 SAMPLING ERROR 2 SEE INSTRUCTIONS When the sample flow is detected within the proper time interval a double beep is emitted SAMPLE FLOW DETECTED is displayed followed by TEST Myo mm ss DEVELOPING 00 00 Development time is displayed as a countdown timer The time interval is analyte specific Once the development time countdown reaches 0 seconds the cartridge is scanned and the following message is displayed TEST Myo ee ale ale ale ale ale ale ale ale SCANNING VFS FS FS WE GE TS IS GS FS A WARNING To reduce the risk associated with inaccurate results keep movement of the Reader to a minimum while an assay is in process however sitting the Reader in an idling or moving vehicle should not inhibit the development of a test At the conclusion of the test the cartridge is ejected and should be removed from the Reader If auto print is selected the result will automatically be printed Section 2 6 6 The results and associated Sample ID are displayed as in the following example ID RB123 Myo 61 7 ng mL The top line alternates from Sample ID ID RB123 to PRESS ENTER to Cont every 2 seconds until either the Options or Enter is pressed To view the Test Date Time and Lot Identification press Options 23 Jun 2009 19 19 Lot MXXXXX The top line alternates from the Te
47. n Highlight the new folder by clicking on it once with the mouse Once highlighted right click the mouse and a menu will appear i Select Rename from the menu and New Folder will be highlighted Type in the desired name for this folder i e RAMP Now return to Step 11 and delete both the path and the text in the box and type in the drive and file name that was created above i e C RAMP capture txt Step 13 Select Start and a blank screen will appear as shown below g RAMP HyperTerminal lni xi Eile Edit View Cal Transfer Help Die 213 ls Connected 0 00 08 auto detect fauto detect Step 14 From the RAMP Reader Output Options follow the prompts on the LCD Display to send the data See Section 2 5 1 for detailed instructions From the RUN OPTIONS menu press Options until 1 OUTPUT RESULTS appears Operator s Manual RAM P Reader 51 Appendix B For RAMP Reader software v2 11 press Enter on the Reader to select this option The screen displays the following prompt gt ALL RESULTS SELECTED RESULTS For RAMP Reader versions 3 0 and higher press Enter on the next screen select the result type Using the arrow keys Sample Results LQC Results or QC Results can be selected Press Enter Choose either ALL RESULTS or down arrow key to choose SELECTED RESULTS The following prompt will appear if SELECTED RESULTS is chosen OUTPUT LAST 2 TEST RESULTS
48. nal Barcode Wand accessory ensure that it is properly connected to the Reader via the Barcode Wand connector port on the back panel PRIOR to turning the Reader on Failure to do so may result in damage to the Barcode Wand Operator s Manual RAM P Reader 7 Introduction Figure 1 1 RAMP Reader LCD Display 10 ABLES LENE amp 12 na Keypad Insertion Slot TeshGun do FRONT VIEW Insertion Port Carrying Handle Accessory Ports AC Adapter AC Adapter Label Model S N see figure 1 2 LED Port BACK VIEW Operator s Manual RAMP Reader 8 Introduction Figure 1 2 RAMP Reader Rear Panel View ON OFF Switch I esponse Biomedical Corp ON b e RS232 Printer Barcode Wand 15 18 VDC Input 1A max RS 232 Port Barcode Wand AC Adapter LED AC Adapter Port Printer Computer Reader to Reader Port lit when charging Operator s Manual RAMP Reader 9 2 0 RAMP SYSTEM OPERATION 2 4 Keypad Function and Use To interface with the RAMP System use the keypad Figure 2 1 when prompted by the Reader display The keypad consists of ten alphanumeric character keys and two function keys Options and Enter To input a specific letter or number press the key to scroll through the choices until the desired character is displayed For example to input the letter R press the key marked PQR 6 four times until the letter R is
49. ned on an error message is displayed and the screen automatically returns to the OPTIONS Menu Check to ensure the printer is turned on and properly connected Repeat the above steps After output is completed if User Lock out is disabled Section 2 4 2 the screen displays the following message CLEAR MEMORY gt YES NO To remove the type of results output from the memory i e sample IQC LQC press Enter to select Yes NOTE Pressing Enter erases all stored results from the specified memory The operator is asked to confirm this request If the Enter is pressed for the YES prompt all results stored in the specified memory are erased and a message specific to the database erased is displayed along with a double beep as seen below for SAMPLE MEMORY SAMPLE MEMORY HAS BEEN CLEARED After displaying this message for two seconds the screen returns to the Options Menu If the results are not to be erased from memory press V to move the cursor to the NO option Press either Enter or Options to return to the Options Menu The results in memory will not be erased Operator s Manual RAM P Reader 21 RAMP System Operation If there are no results stored in the Reader s memory the following is displayed with a long beep NO TEST RESULTS IN MEMORY PUSH A KEY Press any key to return to the SELECT RESULT TYPE Menu 2 5 2 View Results To review results from previous samples on screen without outpu
50. nter to select this option The following prompt is displayed DATE 20104 JUN 24 TIME 11 55 The arrows surrounding a field indicate the active edit field To edit the active field press A or V until the proper value is displayed When the value is correct press Options to move the editor to the next field When finished press Enter to return to the SYSTEM Menu Operator s Manual RAM P Reader 27 RAMP System Operation 2 6 4 Enable User ID P I N The Enable User ID option allows the Reader to store a User ID with each test result such that the User ID is included with the output of the sample or LQC result when sent to a computer or printer or when the result is viewed on the display screen The P I N function provides the capability of User Lock out NOTE The default setting is the ENABLE ID ONLY option where the User ID is enabled User P I N is disabled See Section 2 4 for details on how these settings affect the user interface To change this option perform the following steps From the SYSTEM Menu press A or WV until 3 ENABLE USR ID PIN is displayed Press Enter The SET ID P I N FUNCTION Menu is displayed The current setting can be viewed in the second line For example if both ID and P I N are disabled the following is displayed SET ID PIN FUNCTION l DISABLE ID amp PIN To change the ID P I N function press A or W until the desired option is displayed The options are
51. o SYSTEM Menu On entering a P I N the Reader checks for a duplicate P I N in memory while displaying the following screen CHECKING P I N PLEASE WAIT If the entered P I N does not match any in memory P I N IS OKAY is displayed and the Reader returns to the SYSTEM Menu If an identical P I N is already in memory the following screen is displayed ERROR DUPLICATE PIN INPUT DIFFERENT PIN The Reader then displays the EDIT P I N screen as shown above NOTE When operating on battery power if a new revised User ID is not entered within 30 seconds the screen advances to the EDIT P I N prompt as displayed above Press Enter to accept the information entered To cancel editing press Options repeatedly to remove all characters previously entered and return to the SYSTEM menu 2 6 6 Print Settings The Print Settings allow automatic printing of results after each test and the ability to include two additional lines of information with each printout such as institution and or department name From the SYSTEM Menu press A or V until 5 PRINT SETTINGS is displayed Press Enter to select this option the PRINT SETTINGS menu is displayed gt 1 PRINT OPTION 2 ADD INFORMATION 2 6 6 1 Print options after assay completion To change the print options select 1 PRINT OPTION and press Enter Operator s Manual RAM P Reader 29 RAMP System Operation Press A or W then Enter to select
52. ontact the local distributor s Technical Support Representatives as soon as possible but not later than 30 days from the date of purchase If a product is defective Response or the distributor will exchange it for the same item Replaced items will be shipped when the defective item is received and inspected by Response subject to in stock availability 3 The entire order is guaranteed to be correct In the case of wrong shipped items Response will exchange these items free of charge 4 Itis the customer s responsibility to open the package and inspect the items upon delivery Packages that appear to be damaged should be immediately reported to the freight carrier Damage due to shipping is the sole responsibility of the freight carrier and all claims are to be made by the customer directly with the carrier immediately upon recognizing a problem Shipping carriers may not honor late claims Response will not accept exchanges due to shipping damage Operator s Manual RAM P Reader 56 Appendix C Response will not accept any exchange claim due to incorrect operation of the products The original distributor must first contact Response to obtain authorization for the exchange Response will provide the instructions on how to ship the return Response will not accept shipments without a confirmed written authorization All the return items authorized for exchange must be in the original or equivalent packaging and in compliance with the fre
53. piry Use by date LOT MXXXXX EXP 15 Jun 2010 Press Enter to display the User ID that was recorded if enabled during the test USER ID USEROO1 NOTE If a User ID was not used for the selected Sample ID the screen is not displayed Pressing Options returns the screen to the Sample Result list Press Enter to display the following prompt PRINT RESULT NO YES Use A or V and Enter to select desired option If User Lock out mode is disabled Section 2 4 2 the following prompt is displayed DELETE RESULT NO YES NOTE Within the VIEW Menu deleting results does not create more memory space Deleting simply hides a result To make more memory space erase all results Section 2 6 8 Use A or V and Enter to select desired option If deleting result is selected the operator is asked to confirm this request by the following prompt ARE YOU SURE gt NO YES Operator s Manual RAMP Reader 23 RAMP System Operation Use A or V and Enter to select the desired option If YES is selected the following screen will be displayed RESULT HAS BEEN DELETED Upon completion the screen returns to the most recent sample result After the last result is deleted from the VIEW menu the following screen is displayed LAST RESULT DELETED Upon completion the screen returns to the OPTIONS Menu 2 5 3 Run Internal Quality Control IQC IQC can be sc
54. r is powered on and at either the RUN OPTIONS or RUN LQC EXIT prompt The Reader will indicate that IQC is being conducted as described in Section 2 5 3 2 6 10 Set LQC Timer The Set LQC TIMER option allows the setting of a timer in the Reader to automatically flag that LQC testing inspection is required The status of the LQC Timer is monitored during the Power On Self Test IQC and at the RUN TEST OPTIONS and RUN LQC EXIT prompts In order to activate this option perform the following steps Operator s Manual RAM P Reader 33 RAMPO System Operation From the SYSTEM Menu press A or WV until 9 SET LQC TIMER is displayed Press Enter The following prompt is displayed which is the system default SET LQC TIMER LQC TIMER IS OFF To initiate the LQC TIMER INTERVAL press A or Y until the desired LQC interval is displayed The range of the LQC Timer Interval is 1 31 days SET LQC TIMER TO XX DAYS Once the LQC interval is selected press Enter to return to the SYSTEM Menu NOTE If Options is pressed instead of Enter the changes to the LOC interval will not be accepted and the screen returns to the SYSTEM Menu To turn the LQC Timer off press A or V until the message LQC TIMER IS OFF is displayed If an LQC Interval has been set the Reader begins a countdown timer When the timer reaches zero any subsequent sample result will be flagged with the message WARNING LQC OVERDUE on both viewing
55. r more details The use of the RAMP Ratio significantly reduces variation due to sample operator and membrane differences The assay result is displayed on the Reader s LCD liquid crystal display following test development The result is stored and can be printed uploaded to a PC or deleted Operator s Manual RAMP Reader 1 Introduction Lot specific information for each Kit lot is entered using a pre programmed Lot Card included with each Kit Prior to running assays from a new Kit the Lot Card is inserted into a slot on the front of the Reader just below the keypad The Reader automatically uploads information including the lot number expiration Use by date and lot specific parameters for that Kit The Reader scans the barcode graphic on the bottom of the Cartridge This allows the Reader to use the barcode information to select the lot specific data stored in the non volatile memory of the instrument Built in Internal Quality Control IQC performs an automated test of all Reader analytical systems at start up and on a scheduled or operator determined basis to provide a record of proper Reader functionality Operator s Manual RAM P Reader 2 Introduction 1 4 How the RAMP System Works 1 4 1 RAMP Reader The Reader is a scanning fluorometer and data analysis system used for the measurement of fluorescence in various RAMP immunoassay applications Figure 1 1 The Reader can be operated on battery power or powered
56. r to performing a test Do not connect or disconnect the Reader from an AC outlet once the test has started The Reader can also function in an enhanced controlled manner by enabling the User Lock out function This requires the setting of a Master P I N which provides controlled access to the SYSTEM SETTINGS Menu Functions available through the SYSTEM SETTINGS Menu include changing the instrument clock setting and enabling User IDs and associated P I N s transferring operator data erasing data selecting print settings test counters erasing memory and setting QC timers The User Lock out mode ensures that only operators with a valid controlled P I N are allowed to run tests on the Reader To operate the Reader with User Lock out ensure the SYSTEM SETTINGS Menu has limited access by setting a Master P I N Section 2 6 2 and that a User ID and P I N are defined for each operator Section 2 6 4 NOTE Ensure that operators have read and understood the Operator s Manual and the analyte specific Package Insert before attempting to perform a test 1 6 6 Optional Accessories If using a printer connect it to the Reader via the RS 232 serial port on the back panel Figure 1 2 See Appendix A for printer compatibility information If the Reader is connected to a computer or another Reader ensure that the serial connection is properly secured See Appendix A for serial port compatibility information A CAUTION If using the optio
57. rd is inserted a beep is emitted and the screen displays the following message READING LOT CARD PLEASE WAIT When the Lot Card is accepted indicating that the Lot information has been successfully uploaded the following message is displayed LOT DATA VERIFIED SAVING DATA After the Lot Card data has been stored in memory the Reader beeps twice and prompts the operator with the following instruction REMOVE LOT CARD When the Lot Card is removed the Reader will beep once A CAUTION The Lot Card should be kept in the anti static pouch provided for safe storage and retained for the life of the Kit NOTE Lot Card information will only upload successfully if it is inserted when either the RUN OPTIONS or RUN LQC EXIT Menus are displayed The Reader will not acknowledge Lot Card insertion at any other time It is only necessary to insert the Lot Card once per Kit lot as the lot information is retained even when the Reader power is switched off The Reader can store data for up to 50 separate lot numbers When the memory is full the oldest data is overwritten when a new Lot Card is inserted If a Lot Card is defective or cannot be read the following message is displayed LOT CARD READ ERROR Section 4 2 The Reader verifies the expiry Use by date against its internal clock If the current date exceeds the expiry date the Reader emits an audible alarm and displays the error message LOT CARD EXPIRED Section 4 2
58. rinter Creates a file of all incoming text da Step 11 The screen below will appear RAMP HyperTerminal nml xj File Edit View Call Transfer Help Capture Text sl 4 Connected 0 00 39 Auto detect Auto detect SCROLL CAPS NUM Capture Print echo The default path is C Program Files Accessories HyperTerminal CAPTURE TXT for the test file This should automatically populate the file field If the path appears as indicated proceed to Step 13 If this path does not appear proceed to Step 12 Step 12 If the above path does not appear one must be created From Windows Explorer create a file folder in the C drive Follow the steps below to create this folder a Select Start at the left hand bottom corner of the Windows screen b Select Run from the menu c Inthe box that appears type explorer and select OK Operator s Manual RAMP Reader 50 Appendix B d From the left hand column select My Computer by clicking on it once the menu will expand e Select the C drive by clicking on it once f Inthe right hand column all files found in the C drive should have appeared Right click the mouse in a clear area of the column not on top of any file names A menu will appear g From the menu select New with the mouse and select Folder from the next menu that appears h A new folder entitled New Folder should now appear in the right hand colum
59. s e No Parity e 1 Stop Bit This output is designed to be compatible with small 40 character serial printers such as those available from Citizen Model iDP 3110 Dot Matrix Printer The serial output is also compatible with some other serial input printers and computer serial ports If connected to a printer the Reader uses the DTR line DB9 pin 4 as a handshaking signal If the connected device is a personal computer maintain the DTR or RTS line DB9 pin 7 in the active logic high state to receive data from the Reader Reader to Reader Connections A Reader to Reader cable is required to connect the Reader to another Reader when transferring User IDs and P I N s This cable can be purchased as an accessory from Response Biomedical Barcode Wand Connections An optional Barcode Wand may be connected to the Reader by plugging the Barcode Wand into the appropriate slot on the back of the Reader see Figure 1 2 A CAUTION Ensure the Reader is turned OFF PRIOR to connecting the Barcode Wand Failure to do so may cause irreversible damage to the Barcode Wand Operator s Manual RAMP Reader 45 APPENDIX B Sending Data from the RAMP Reader to a Computer For the following operating systems Windows 98 Windows 2000 amp XP NOTE Response Biomedical is providing these directions for assistance only and is not responsible for this software nor its suitability or function If there are specific concerns please consult with T
60. st Date Time 23 Jun 2009 19 19 to PRESS ENTER to Cont until either the Options or Enter is pressed To re display the Sample ID and test results press Options again When Enter is pressed the Reader will check that the used cartridge has been removed from the instrument If the Reader detects a cartridge a REMOVE CARTRIDGE prompt is displayed Operator s Manual RAM P Reader 18 RAMP System Operation To print results after each test is completed see Section 2 6 6 The Reader memory can store results for up to 500 tests Test results are stored in memory until erased using the SYSTEMS SETTINGS menu or until the memory is full at which time the oldest result is overwritten and the new result is stored When the number of test results in memory totals 480 or more the screen below is displayed Section 4 5 NOTE XXX TESTS IN MEMORY NOTE When an assay is aborted due to an error the test is stored in memory so that it can be viewed and or printed at a later date The error condition appears in the location where the result would normally be displayed or printed Dispose of the cartridges and test materials in accordance with appropriate institutional practices 2 5 Using the OPTIONS Menu The following functions are available through the OPTIONS Menu 1 QUTPUT RESULTS to send results to a printer or computer using the serial port 2 VIEW RESULTS to view results on the LCD display of the Re
61. t Outlook Cx Eind r Microsoft PowerPoint e Help MS DOS Prompt J Windows Explorer v un iS630_730 V2 03 Microsoft Word 5 Dutlook Express 3 Roxio Easy CD Creator 5 3 Microcal Origin 6 0 fe Programs EEA Operator s Manual RAMP Reader 46 Appendix B Step 4 Once HyperTerminal is selected a screen as illustrated below will appear Select No with the mouse lf the following screen does not appear proceed to Step 5 Default Telnet Program 21x We recommend that you make HyperT erminal your default telnet program Do you want to do this I Don t ask me this question again Step 5 If the screen illustrated below appears fill in the boxes with the appropriate information and click OK For example What country region are you in now select the appropriate country from the drop down box and proceed to the next box If the screen below does not appear proceed to Step 6 Location Information 2 xl Before you can make any phone or modem connections Windows needs the following information about your current location What country region are you in now What area code or city code are you in now If you need to specify a carrier code what is it If you dial a number to access an outside line what is it The phone system at this location uses Tone dialing C Pulse dialing Cancel Operator s Manual RAM P Reader 47 Appendix
62. th the permit above is visible An override code will be provided by Technical Support Press Enter to enter the override code ENTER OVERRIDE CODE Me Me Me ale ale ale ale ale ale ale ale ale ale BE FE TE TE BSS BE BS FE FS FE FE OE NOTE Entering the override code does not reset the Master P I N but allows immediate access to the SYSTEM SETTINGS menu where the Master P I N can be reset If the Master P I N is not enabled all operators will have access to the SYSTEM SETTINGS menu 2 6 2 Set Master P I N The Reader can be set such that system settings or stored results are protected from unauthorized change or deletion From RUN OPTIONS Menu select Options and then press A or V until 5 SYSTEM SETTINGS is displayed Press Enter to access the SYSTEM Menu Press Enter at the screen to select 1 SET MASTER P I N The current P I N is displayed in the first line If the Master P I N has not been set 00000 is displayed The second line prompts the operator to enter a new P I N EDIT P I N 12345 whe ste ale ale ale ale ale ale ale ale ale ale ale ale ale EEEE Using the keypad type in a new P I N the P I N can be from 1 5 digits Press Enter to accept and reset the P I N NOTE To disable the Master P I N set the Master P I N to 00000 2 6 3 Setting the System Clock The clock displays a 24 hour format From the SYSTEM Menu press A or W until 2 SET CLOCK is displayed Press E
63. the message alternates between SEE INSTRUCTIONS and REMOVE CARTRIDGE SAMP ERROR 2 Sample flow not detected This may be due to Insufficient sample being transferred to the cartridge A clogged sample pad Failure to use supplied Assay Tip Insufficient mixing of sample Analyte levels significantly higher than the upper reported range Cartridge is automatically ejected Remove cartridge Operator should refer to the analyte specific Package Insert for further instructions t Repeat Test with a fresh set of components Operator s Manual RAM P Reader 42 4 5 General Messages Troubleshooting Guide LCD Message Cause Action kkkkkk ERROR kkkkkk SERIAL PORT OFF LINE Reader attempted to Output Results to printer and either printer was not attached correctly printer was not turned on or printer is OFF LINE Screen automatically returns to OPTIONS Menu Ensure printer is properly connected turned on and printer is ON LINE See printer s Operator s Manual for more information If printer is not connected or turned on do so and repeat the output request NO TEST RESULTS IN MEMORY PUSH A KEY The VIEW RESULTS or OUTPUT RESULTS option is selected and there are no test results stored in the memory Press any key and return to Options Menu NOTE XXX TESTS IN MEMORY 480 or more test results are stored in Reader s memory Reader memory capa
64. the request of a regulatory body 1 Response will inform the distributor of the necessary recall information in writing via email or fax 2 The distributor will take full responsibility for collecting all the products from their customers and for taking proper actions to discard destroy or send the products to Response designated destinations as instructed 3 Customers will receive free replacements from the distributor where purchased upon returning the recalled products 4 Only lot or serial numbers that fall within the recall information will be included in the recall 5 Response will replace the same quantity of returned recalled products free of charge Response is responsible solely for free replacement of recalled products and any other compensation to customers 7 Response may no longer repair or replace the recalled product if the customer fails to return the recalled products within the required period RETURN POLICY 1 All sales are final No returns will be accepted for any reason 2 Defective equipment will be replaced at no charge Please refer to the Exchange Policy for details EXCHANGE POLICY The exchange policy refers to new product and is in effect for 30 days after the customer receives the product 1 All exchanges are made through the distributor where purchased Response will not accept any exchange claims directly from customers 2 If the product is not functioning properly the customer should c
65. torage Temperature Range Operating Storage Altitude Keypad Display Complies With Noise Level 27 cm wide x 25 cm deep x 15 cm high 10 in wide x 10 in deep x 6 in high 2 1 kg 4 6 lbs 100 240 VAC 50 60 Hz 2 li Rechargeable Internal not operator serviceable RS 232 DB 9 male for serial communication Proprietary Mini DIN for barcode wand 5 40 C 41 104 F note 1 20 80 relative humidity non condensing 20 9096 relative humidity non condensing 10 50 C 14 122 F 2000m 10 character alphanumeric keys plus 2 special function keys 2 line by 20 character Liquid Crystal Display LCD IEC 61010 1 1990 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements IEC 60601 1 2 2001 Electromagnetic Compatibility Requirements for Medical Equipment Emissions Only CAN CSA 601 1 FCC CFR47 Part 15 B Does not emit sound level greater than 85 dB when running an assay Note 1 running assays Operator s Manual RAMP Reader Refers to Reader only Please refer to specific assay temperature specification when 44 APPENDIX A Connecting the RAMP Reader to Accessories Printer Computer Connections The Reader may be connected to a printer or computer for transferring data via the RS 232 serial output port on the back panel of the Reader Output configuration is as follows e 9600 baud e 8 data bit
66. tting to a computer or printer perform the following steps From the RUN OPTIONS Menu select Options then press A or Y and select 2 VIEW RESULTS Press Enter the screen displays the following Menu SELECT RESULT TYPE 1 SAMPLE RESULTS The three types of results available to select are 1 Sample Results 2 LQC Results 3 IQC Results Press A or WV until the desired result type is displayed Press Enter to select the specified option Pressing Options will switch the display back to the OPTIONS Menu Pressing Enter at 1 SAMPLE RESULTS displays the most recent sample result for example SAMPLE RESULT 713 ID RB123 Pressing Enter at 2 LQC RESULTS displays the most recent LOC result Pressing Enter at 3 IQC RESULTS displays the most recent IQC result If there are no sample results stored in the memory the following message is displayed accompanied by a long beep NO TEST RESULTS IN MEMORY PUSH A KEY The same sequence of steps applies to viewing SAMPLE LQC and IQC results The following illustrates the steps using a SAMPLE result To view a SAMPLE result select it using A or W and press Enter ID RB123 Myo 61 7 ng mL Operator s Manual RAMP Reader 22 RAMPO System Operation Press Enter again to display the sample result with date and time of the test Myo 61 7 ng mL 25 Jun 2009 19 19 Press Enter once more to display the Kit lot number with the ex
67. utput to a computer 1 4 3 4 Reader to Reader Cable By linking Readers together with the appropriate cables User ID user identification and P I N personal identification number information can be transferred to another Reader Appendix A provides more details Operator s Manual RAM P Reader 3 Introduction 1 5 Warnings and Precautions 1 5 4 Symbols and Definitions Read all contents of this manual prior to use The following symbols are used on the RAMP Reader related components and accessories or in the text of this user manual WARNING A Indicates a hazardous situation which if not avoided could result in death or injury e g fire electrical shock or explosion CAUTION Indicates a situation which if not avoided could result in damage to the device Consult Accompanying Documents On power supply O Off power supply Operator s Manual RAM P Reader 4 1 5 2 Introduction Summary of Warnings and Precautions Observe the following precautions when operating the RAMP System 1 5 2 1 A A 1 5 2 2 A A A 1 5 2 3 A 1 5 2 4 A E A WARNING Reduce the risk associated with hazardous voltage Unplug and power off the Reader before cleaning Do not immerse the Reader in water WARNING Reduce the risk associated with potentially infectious patient samples Do not spill sample on the Reader or the outside of a cartridge as they
68. utput all stored results press Enter All the results in the memory will be sent to the printer The results are sent to the computer or printer see example below and the following message is displayed SENDING RESULTS To output only selected results press W to choose Selected Results Press Enter The following message is displayed OUTPUT LAST 2 TEST RESULTS NOTE If only one result is stored the Reader will display OUTPUT LAST TEST RESULT The Reader defaults to outputting the last two test results Press A or W until the number of results to be output is displayed then press Enter Pressing Options will return the Reader to the OPTIONS MENU NOTE A maximum of 500 sample results 65 IQC results and 35 LQC results can be stored in memory The results are sent to the computer or printer see example below and the SENDING RESULTS message is displayed Operator s Manual RAM P Reader 20 RAMPO System Operation Figure 2 3 Sample Results Printout Example RAMP Reader S N XXXXX Version X XX ID RB123 USER USER1 RESULT Myo 61 7 ng mL DATE 25 Jun 2009 TIME 19 19 LOT MXxxxxx EXP 30 Jun 2010 END OF DATA When all results have completed printing the report indicates completion by printing the message END OF DATA at the bottom of the printout The following message is then displayed OUTPUT COMPLETED NOTE If the printer is not properly connected or if the printer is not tur
69. voided Operator s Manual RAMP Reader 36 4 0 TROUBLESHOOTING GUIDE When the Reader is unable to continue a specific task it will emit an audio alarm long beep unless otherwise stated and display a message Refer to the following list of messages when troubleshooting 4 1 If any Error persists call Technical Support Appendix D Power On Self Test Messages IQC Messages LCD Message Cause Action Blank Screen Battery is fully discharged Turn off Reader Charge battery fully for 24 hours CLOCK ERROR NOTIFY SUPERVISOR The lower line of the message alternates between NOTIFY SUPERVISOR and PRESS KEY TO PROCEED An internal clock failure was detected during Power On Self Test or IQC Press any key The clock is set to Jan 01 2030 Reset the clock in the System Settings Menu CTG TRANSPORT FAULT CONSULT MANUAL The lower line of the message alternates between CONSULT MANUAL and PRESS KEY TO PROCEED Critical Failure see note During Power On Self Test or IQC a failure was detected in transport stepper motor home sensor or transport mechanism is jammed Remove Test Cartridge if present Turn Reader off and then on again DEAD BATTERY PLUG IN CHARGER Message accompanied by audio alarm During the Power On Self Test IQC or at the RUN OPTIONS or RUN LQC EXIT prompt the Reader detects a battery that is fully discharged

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