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Introduction

 

Operator’s Manual, RAMP

®

  Reader

 

Instructions for Uses for 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. 

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. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Содержание RAMP READER

Страница 1: ...UR TECHNICAL SUPPORT Tel 1 866 525 7267 toll free Tel 1 604 219 6119 int l Email techsupport responsebio com RESPONSE CORPORATE OFFICE Tel 1 888 591 5577 toll free Tel 1 604 456 6010 int l Email custo...

Страница 2: ...ing Lot Cards 12 2 4 Running an Assay 14 2 4 1 Entering User ID 14 2 4 2 Entering User P I N User Lock out Mode P I N Enabled 15 2 4 3 Entering Sample ID 15 2 4 4 Inserting a Cartridge 16 2 5 Using th...

Страница 3: ...CATIONS 45 APPENDIX A 47 Connecting the RAMP Reader to Accessories 47 Printer Computer Connections 47 Reader to Reader Connections 47 Barcode Wand Connections 47 APPENDIX B 48 User Agreement and Warra...

Страница 4: ...ge is not used Analysis time is analyte specific and averages 15 minutes across Assays Test dependent Results may be viewed on the Reader LCD screen and or output to a printer or computer Operator inp...

Страница 5: ...r 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 expiratio...

Страница 6: ...th the RAMP System All items are available from Response Biomedical Please contact your local distributor or Response Biomedical Customer Service Appendix C if you require any of the following accesso...

Страница 7: ...y Off power supply Reader Warnings and Precautions Symbols and Definitions Read all contents of this manual prior to use The following symbols are used on the RAMP Reader related components and access...

Страница 8: ...rtridge as they become a po If a spill occurs disinfect external surfaces only using a soft cloth containing a solution of 0 5 bleach 70 isopropyl alcohol or 70 ethanol Use appropriate precautions in...

Страница 9: ...ents 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 C 1 6 2 RAMP Reader Conten...

Страница 10: ...care that the battery is sufficiently charged or that the Reader is connected to an AC outlet prior to performing a test Do not connect or disconnect the Reader from an AC outlet once the test has st...

Страница 11: ...Operator s Manual RAMP Reader Reader Figure 1 1 RAMP Reader Introduction 8...

Страница 12: ...Operator s Manual RAMP Reader Figure Reader Figure 1 2 RAMP Reader Rear Panel View Introduction 9...

Страница 13: ...s 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...

Страница 14: ...Operator s Manual RAMP Reader RAMP System Operation Reader Figure 2 1 RAMP Reader Keypad System Operation 11...

Страница 15: ...n 2 4 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 will lock out the operator from running samples or Liquid Qu...

Страница 16: ...S Menu prompt insert the Lot Card After the Lot Card is inserted a beep is emitted and the screen displays the following message When the Lot Card is accepted indicating that the Lot information has b...

Страница 17: ...0 USER ID s of up to 20 characters each The default entries for User ID s are USER001 USER002 through to USER250 To edit the User ID s see Section 2 6 5 To return to the SELECT USER ID ENTER USER ID s...

Страница 18: ...e keypad to enter the numeric User P I N required and press Enter The following screen is displayed briefly If the User P I N is recognized the Reader progresses to the ENTER SAMPLE ID screen Section...

Страница 19: ...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 Insertin...

Страница 20: ...lowing 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 abort the test and require another test...

Страница 21: ...s 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 th...

Страница 22: ...ropriate institutional practices 2 5 Using the OPTIONS Menu The following functions are available through the OPTIONS Menu 1 OUTPUT RESULTS to send results to a printer or computer using the serial po...

Страница 23: ...er see example below and the following message is displayed To output only selected results press to choose Selected Results Press Enter The following message is displayed NOTE If only one result is s...

Страница 24: ...om 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...

Страница 25: ...e 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 fo...

Страница 26: ...e Result list Press Enter to display the following prompt Use or and Enter to select desired option If User Lock out mode is disabled Section 2 4 2 the following prompt is displayed NOTE Within the VI...

Страница 27: ...QC can be scheduled 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 OP...

Страница 28: ...following LQC and Assay package insert instructions After completion of a successful LQC assay relevant print messages are displayed Section 2 6 6 and the screen returns to the RUN OPTIONS prompt 2 5...

Страница 29: ...s 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 ENABLE SOUND to disable enable the alert s...

Страница 30: ...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 Th...

Страница 31: ...in the second line For example if both ID and P I N are disabled the following is displayed To change the ID P I N function press or until the desired option is displayed The options are 1 DISABLE ID...

Страница 32: ...following screen is displayed 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 a...

Страница 33: ...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...

Страница 34: ...printouts are shown below with 2 additional lines of information Figure 2 4 Sample Results Printout with custom information Example 2 6 7 Transfer Users This option allows transfer of User ID and User...

Страница 35: ...e From the SYSTEM SETTINGS Menu press or 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 RES...

Страница 36: ...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 or until t...

Страница 37: ...a countdown timer When the timer reaches zero any subsequent sample result will be flagged with the message WARNING LQC OVERDUE on both viewing and printing sample results If the LQC timer reaches zer...

Страница 38: ...Press Enter to display the LQC Counter Press Enter to display the IQC Counter Press Enter to display Reset Counters prompt Press Enter to select NO If the Counters are to be reset press to move the c...

Страница 39: ...turns the Reader to the RUN OPTIONS prompt From SYSTEM SETTINGS Menu press or and Enter to select 14 EXIT SYSTEM MENU and return to the RUN OPTIONS screen Once the SYSTEM Menu is exited the Master P I...

Страница 40: ...decontaminate the Reader wipe down the exterior surfaces of the Reader using a soft containing a solution of 0 5 bleach 70 isopropyl alcohol 70 ethanol or a non disinfectant containing not more than...

Страница 41: ...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 Crit...

Страница 42: ...h 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 is detected in the Reader during the...

Страница 43: ...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 PR...

Страница 44: ...ther Cartridge or Lot Card was not inserted within 5 minutes Insert correct Lot Card Repeat Test with a fresh set of components 4 3 Transport Messages LCD Message Cause Action SCANNING ERROR ATTEMPTIN...

Страница 45: ...ROUND SEE PACKAGE INSERT The lower line of the message alternates between SEE PACKAGE INSERT and REMOVE CARTRIDGE HRB May be due to Interfering substances in sample Cartridge is automatically ejected...

Страница 46: ...ejected by Reader Cartridge is automatically ejected Remove Cartridge Operator should refer to the Test Kit Instructions for Use for further instructions Repeat Test with fresh set of components SAMPL...

Страница 47: ...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...

Страница 48: ...sing Storage Transport Humidity Range 20 90 relative humidity non condensing Storage Transport Temperature Range 10 50 C 14 122 F Operating Storage Altitude 2000m Keypad 10 character alphanumeric keys...

Страница 49: ...nment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communication...

Страница 50: ...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...

Страница 51: ...ectly of the error as soon as possible but not later than 30 days from the Date of Receipt the Exchange Period Exchanges for Wrong Shipped Items are handled in accordance with the Exchange Policy note...

Страница 52: ...TENT 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 O...

Страница 53: ...nformation in RAMP or the Software except to the extent that such restrictions are prohibited by applicable law ii modify or adapt or otherwise make error corrections to RAMP or the Software or create...

Страница 54: ...rth America only Tel 1 604 219 6119 International E mail techsupport responsebio com Response Biomedical Corporation 1781 75th Avenue West Vancouver British Columbia Canada V6P 6P2 www responsebio com...

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