Operator Manual Version 2.
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M™ Rapid Detection Reader Table of Contents Table of Contents Warnings and Precautions........................................................................................................1 Summary of Warnings and Precautions................................................................................... 2 Introduction ...............................................................................................................................3 Overview..............................................
3M™ Rapid Detection Reader Table of Contents Login.................................................................................................................................21 File....................................................................................................................................22 About ................................................................................................................................23 Edit Settings.......................................
3M™ Rapid Detection Reader Table of Contents Power On Self Test Message / IQC Messages .......................................................................39 Test Run Messages ...............................................................................................................39 Lot Card Messages ................................................................................................................41 Settings Messages...................................................................
3M™ Rapid Detection Reader Warnings and Precautions Warnings and Precautions Read all contents of this manual prior to use. The following symbols are used on the 3M Rapid Detection Reader, related components and accessories, or in the text of this user manual: WARNING! Indicates a hazardous situation, which if not avoided, could result in death or injury, e.g., fire, electrical shock or explosion. WARNING! Hazardous Voltage CAUTION.
3M™ Rapid Detection Reader Warnings and Precautions Summary of Warnings and Precautions The 3M Rapid Detection Reader and its related devices and accessories are designed to provide safe and reliable service when used according to the instructions provided in this Operator Manual. The following warnings and precautions should be followed in order to avoid unsafe actions with the 3M Rapid Detection Reader that could potentially result in personal injury or device damage.
3M™ Rapid Detection Reader Introduction Introduction Overview The 3M Rapid Detection Reader is a rapid immunochromatographic system for performing in vitro diagnostic analyses. The 3M Rapid Detection Reader is comprised of the 3M Rapid Detection Control Module (CM) and the 3M Rapid Detection Test Module (TM). Each Test Module has two ports. Up to three Test Modules are connected to each Control Module providing the user the ability to test 1-6 samples simultaneously.
3M™ Rapid Detection Reader Unpacking and Setup Unpacking and Setup Inspect all components carefully. If any damage is visible, notify the carrier and your distributor or 3M to arrange for repair or replacement.
3M™ Rapid Detection Reader Unpacking and Setup Item Description Barcode Scanner Omni-directional, hands-free barcode scanner with cradle for entering Operator and Patient/Sample ID. The barcode scanner is shipped in the correct configuration and is ready for use after connecting to the CM via USB. Symbol Technologies Inc. model LS9208. Additional information available at www.symbol.com, 1.800.653.5350 or 1.631.738.2400.
3M™ Rapid Detection Reader Unpacking and Setup Figure 1.
3M™ Rapid Detection Reader Unpacking and Setup Figure 1a.
3M™ Rapid Detection Reader 3M Rapid Detection Reader (MODULES) 3M Rapid Detection Reader (MODULES) Figure 2. 3M Rapid Detection Reader Features - Front View Control Module Touch Screen Display Lot Card Insertion Slot Test Module (3 max) Port LEDs Test Cartridge Ports Turning on the 3M Rapid Detection Reader The power On/Off switch is located on the rear panel of the CM (Figure 1).
3M™ Rapid Detection Reader 3M Rapid Detection Reader (MODULES) Display Icons The left hand column of the screen displays an icon for each available port. Touching these icons leads to a full screen display of the status of that port. The lower left corner of the display screen, below the port icons, displays LQC, Printer and Communication warning icons. The meaning of the displayed icons is as follows: Icon Meaning Figure 4.
3M™ Rapid Detection Reader Performing an Assay Performing an Assay WARNING! To reduce risk to the operator: • Observe local protocols and appropriate precautions in the collection, handling, and disposal of specimens. CAUTION. • When entering data via the CM touch screen (e.g., Sample/Patient/User ID), enter characters one at a time as failure to do so may result in erroneous data entry.
3M™ Rapid Detection Reader Performing an Assay NOTE: The message Lot # XXX Not Found, Insert Lot Card or Cancel will be displayed if a Test Cartridge is inserted and the Lot Card data is not stored in the CM. The Lot Card must be inserted within 40 seconds or the assay will be aborted. Touch OK to return to the Home screen. 1. Touch Run Assay. If prompted, enter Operator ID and/or Password (Figure 6) using either the touch screen or the barcode scanner. To accept the displayed information, touch Accept.
3M™ Rapid Detection Reader Running Quality Control Running Quality Control Two types of quality control test records are stored by the 3M Rapid Detection Reader: • LQC (Liquid Quality Control) - external surrogate sample test results. • IQC (Internal Quality Control) - self-diagnostic test results including a check of the power supply voltage, system memory, cartridge transport system, cartridge barcode sensor, LED function, and incubator function for heated assays. Running LQC 1.
3M™ Rapid Detection Reader Running Quality Control Do not use excessive force when inserting the Test Cartridge. The TM will guide the Cartridge into place. Once the Cartridge Inserted message clears, the previous screen is displayed and the active port icon shows a timer that counts up until sample flow is detected, then counts down until the assay is complete. NOTE: Touching Run Assay or Run LQC will start another assay/LQC and the test sequence will begin again using a different available port.
3M™ Rapid Detection Reader Running Quality Control Running IQC IQC runs automatically every time the 3M Rapid Detection Reader is turned on. IQC can also be initiated manually or configured to run at predefined intervals. IQC takes less than 1 minute to complete. When IQC is initiated, the appropriate tests are performed on each port in each attached TM. IQC verifies the power supply voltage, system memory, cartridge transport system, LED function and incubator function for heated assays.
3M™ Rapid Detection Reader Working with Results and Logs Working with Results and Logs The 3M Rapid Detection Reader can store up to 900 results (300 assay results, 300 LQC results and 300 IQC results). When the CM database is full, the oldest result is over-written. Dual analyte assay results are stored as two separate patient records. IQC results are stored separately for each individual test port. In manual transfer mode only (i.e.
3M™ Rapid Detection Reader Working with Results and Logs be displayed. To view the details of a particular event, touch the event, and then touch View. 2. To return to the event list, touch Events List. Searching Results Result Type Search Options Assay Operator Name Sample/Patient ID Assay Name LQC Operator Name Control ID Assay Name IQC Operator Name Port 1. From the Assay (or IQC or LQC) Results screen, touch Search to open the Search Assay Results screen (Figure 17). Figure 17.
3M™ Rapid Detection Reader Working with Results and Logs Manually Transferring / Printing Results or Logs Results (assay, patient or IQC) that have been selected on the Results screen can be transferred to a printer, USB flash drive or to a network. It is important to note that the user should manually delete the results from the Reader after manual transfer or they will be transferred again, unless a specific range of results is selected when the next manual transfer is performed.
3M™ Rapid Detection Reader Managing Settings Managing Settings The 3M Rapid Detection Reader can be operated immediately after set-up using the preprogrammed default settings. Each Reader also has customizable features which can be configured to enhance its functionality and data management capability. Customizable features include LQC timer, Operator ID and password, and data transfer options (USB, print, network). Some of these features can be configured in the CM Settings menu.
3M™ Rapid Detection Reader Managing Settings Settings: View Tabs Tab Screen Assay Figure 21. Settings: View Assay Tab Edit through RCU only. Sample/Patient ID Purpose: Define the field name as Patient ID or Sample ID. Default: Patient ID. String length can be set from 1 to 18. Default: Min Length 1, Max Length 18. New Assay Lockout Purpose: Define ability of operators to perform assays not in the assay list. The assay list is displayed on the LQC-Assay List screen (Figure 9). Set as either Yes or No.
3M™ Rapid Detection Reader Managing Settings Settings: View Tabs Tab Screen LQC continued Max Failures Before Lockout Purpose: Define the number of LQC failures allowed before the assay is Locked Out when LQC Timer is set in RCU. LQC Failure count is reset upon successful completion of LQC. Can be set from 1-9. Default: 9. Control ID Purpose: Define control IDs. Default: Min length 1, Max length 18. Figure 23.
3M™ Rapid Detection Reader Managing Settings Settings: View Tabs Tab Screen Timer continued NOTE: Only new results that have not been previously transferred are transferred during an upload. Data is not deleted from CM upon transfer. When the CM database is full, the oldest result is over-written. NOTE: It is important that the upload interval be set to ensure data capture and transfer prior to records being overwritten. Auto IQC Interval Edit on CM and through RCU.
3M™ Rapid Detection Reader Managing Settings Settings: View Tabs Tab Screen Login continued Login Requirements Purpose: Define login requirements independently for Operators and Supervisors requiring None, ID and Password, ID only or Password only. If None, an Operator ID cannot be entered when running assays. Default: Operators – None, Supervisors – ID and Password. Privilege Requirements Purpose: Defines the access privileges for each level user. All Operators: Operators and Supervisors have access.
3M™ Rapid Detection Reader Managing Settings Settings: View Tabs Tab Screen About Figure 27. Settings: View About Tab Purpose: This tab displays the details the Serial Number, software and hardware versions of the 3M Rapid Detection Reader System. This information will assist in discussions with Technical Support.
3M™ Rapid Detection Reader Managing Settings Edit Settings From the Main Menu select Settings. Only a Supervisor, when in the default systems configuration, can access the Settings menu. (Refer to Access the Settings Menus for additional information.) Touch Edit Settings on the Settings menu, and use the tabs to select those settings to be changed. On all the Settings: Edit dialogs: • Use the touch screen or dropdown lists to enter/select the desired settings. • Touch Save to save your settings.
3M™ Rapid Detection Reader Managing Settings Settings: Edit Tabs Tab Screen Date/Time Figure 30. Settings: Edit Date/Time Tab Edit on CM. Can only edit through RCU if NTP is enabled. Purpose: Set the current date and time for the 3M Rapid Detection Reader. If in Auto transfer Mode, the 3M Rapid Detection Reader date and time may be synchronized with the NTP server. The date format in the Reader is variable. To Change: 1.
3M™ Rapid Detection Reader Managing Settings Settings: Edit Tabs Tab Screen Misc. continued Sound Edit on CM. Cannot edit through RCU. Test: Touch to hear indicator. On: The audio indicator is ON and sounds at the completion of an assay and when a USB device is connected or disconnected. Off: The audio indicator is OFF. Default: On There is no volume adjustment feature.
3M™ Rapid Detection Reader Managing Settings 2. From the Settings menu (Figure 20), touch Edit Operators. The Settings: Operators screen will open (Figure 34). Figure 35. Settings: Operator Detail A complete list of all operators authorized to use the device with Display Name and Operator Type is displayed. The 3M Rapid Detection Reader will store a maximum of 600 operators.
3M™ Rapid Detection Reader Managing Settings Expire: Date that operator’s permission to use the 3M Rapid Detection Reader expires. Operator will be locked out after that date. Disable expiration feature by leaving the field blank. 2. Use the € arrow to select the desired Operator Type: Supervisor or Operator. 3. Touch Accept. (The Next button changes to Accept.) 4. An entry verification screen appears. Select Confirm to add the operator information or Cancel to reject.
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) Editing Settings Using the Reader Configuration Utility (RCU) Overview The Reader Configuration Utility (RCU) allows the user to set up Readers according to the needs of their institution. The RCU stores this setup information in a set of Reader configuration files. Each Group of one or more Readers has its own directory containing a set of configuration files that define how the Readers in that Group operate.
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) To change the default login Figure 39. Reader Configuration System Settings: Settings 1. Select the Settings menu to open the Reader Configuration: System Settings screen (Figure 39). 2. Under Reader Configuration Utility Accounts, change the User ID, Account Name and Password. 3. Be certain that the Privilege level remains as Full Access. To save your settings select File > Save.
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 3. Enter the Web server directory. Contact the local IT administrator for the appropriate Web server directory. 4. Save your settings by selecting File > Save from the menu. No additional setup is required to access configuration files on a network shared drive. Accessing Configuration Files A Group is defined as a common configuration shared by multiple Readers. As many Groups as necessary can be defined.
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) To open an Individual Configuration File Figure 41. Open Default Configuration If only one configuration file requires modification, for example, when updating Operator Lists, there is no need to open all the Group files, just the file to be changed (in this example, userlist.opl). To do this, click on File > Open, and then select Defaults..., Network... or USB Device....
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) Identifying Readers through the RCU The RCU uses Reader information files to identify the Readers installed within an institution. Once a Reader has been identified, the RCU may be used to change Reader specific settings. Non-networked Environment A USB flash drive is used to transfer Reader settings between the Reader and the RCU.
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) Importing Files Device settings, including Operator Lists from the RCU or another 3M Rapid Detection Reader, can be imported using the USB flash drive. 1. From the Settings menu (Figure 20), touch Import Configuration. The Settings: Import Configuration screen opens (Figure 43). Figure 43. Settings: Import Configuration 2. Insert the USB flash drive into an available USB port. 3.
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) Deleting Results The 3M Rapid Detection Reader can store up to 900 results (300 patient, 300 LQC and 300 IQC) and 500 events (log file entries). When the CM database is full, the oldest result is over-written. In Manual Transfer mode only (i.e.
3M™ Rapid Detection Reader Maintenance Maintenance WARNING! To reduce the risk associated with hazardous voltage: • Unplug the 3M Rapid Detection Reader before cleaning. • Do not disassemble the 3M Rapid Detection Reader or any of its related components and accessories. The instrument contains no operator-serviceable components. • Do not immerse any of the 3M Rapid Detection Reader components in any liquid.
3M™ Rapid Detection Reader Maintenance If the 3M Rapid Detection Reader requires repair or replacement, it must be disinfected prior to repackaging and shipping. Upgrading Device Software In the event there are enhancements made to the 3M™ Rapid Detection Reader software, upgrades will be available through a USB Flash Drive. Attach the drive containing the latest software to the CM and follow the instructions provided with the USB and those below. 1.
3M™ Rapid Detection Reader Troubleshooting Troubleshooting The following information is to be used to diagnose and resolve general errors and error messages displayed by the CM. If additional assistance is needed, please contact 3M Health Care Helpline. 3M Health Care Helpline - 1-800-228-3957 Outside the U.S.A. and Canada, contact your local 3M subsidiary. Restoring the Supervisor Operator ID / Password By default, only a Supervisor with a correct ID and password can access the Settings menu.
3M™ Rapid Detection Reader Troubleshooting Power On Self Test Message / IQC Messages Message Cause Action No Available Ports. IQC Failed To Start. Ports are disabled. All ports are disabled. Switch the CM off and switch back on. If problem persists contact Technical Support to report the problem. Test Run Messages To display the error message, before removing the cartridge, touch the red port icon for detailed information about the failure.
3M™ Rapid Detection Reader Troubleshooting Test Run Messages – indicated by red port icon Port Display Error Message Cause (s) Action Fail Sample Error 2 Sample flow has not been detected. The Test Cartridge is ejected. Insufficient sample added to the Test Cartridge. Remove and dispose of appropriately. Clogged sample pad. Repeat the assay with a fresh set of components. If problem persists contact Technical Support to report the problem. Failure to use supplied assay tip.
3M™ Rapid Detection Reader Troubleshooting Test Run Messages Message / Symptom Cause Action Barcode Error Aborting Assay The 3M Rapid Detection Reader was unable to read the barcode on the Test Cartridge. Repeat assay using a fresh set of components. No Ports Available, Assays in Progress All ports are in use by other assays. Touch OK to return to the main menu and wait until an assay is complete before attempting to run another test.
3M™ Rapid Detection Reader Troubleshooting Settings Messages Message Cause Action Access denied. Try again. The user does not have the login permissions necessary to access selected function. Confirm correct login details and try again. Assay List Size Exceeded. The list of assays permitted is full. No further additions can be made. Delete existing assays from the assay list (Refer to RCU online help). The maximum number of assay entries allowed is 200. Assay Locked, Aborting.
3M™ Rapid Detection Reader Troubleshooting Settings Messages Message Cause Action User Expired, Try Again User certification has expired or the details were entered incorrectly. Re-enter Operator ID or contact Supervisor. Message Cause Action LQC Lockout. Ejecting. LQC is overdue for this assay and no overrides are available. LQC must be run and passed, or a Full Access User can reset the LQC timer and/or overrides for this assay in Reader Settings on the RCU. Invalid Control. Ejecting.
3M™ Rapid Detection Reader Troubleshooting Warnings and Confirmation Requests Message Cause Action ! All Databases Will Be Erased Request was made to upgrade software or reset system to default settings. Cancel if not intended. Back up files at Settings: Export Configuration Before performing this operation all databases should be backed up using Export Configuration System will restart following this procedure ! All Results Will Be Deleted Request was made to delete all results.
3M™ Rapid Detection Reader Troubleshooting Printer Errors Message / Symptom Cause Action Printer light does not turn on Printer is not receiving power. Refer to Printer Manual. Check system power; ensure power supply is connected. Ensure that switch on bottom right side of the printer is turned to the ON position. If problem persists contact Technical Support to report the problem. Message Cause Action Transfer Error Network communications error, or error writing to USB flash Drive.
3M™ Rapid Detection Reader Troubleshooting USB Device Errors Message Cause Action Unrecognized USB Drive Attached, Remove Device A USB drive without a valid partition table is inserted into the CM.
3M™ Rapid Detection Reader Specifications Specifications CAUTION. Possible device damage and warranty invalidation. Changes or modifications to this equipment, not expressly approved by the manufacturer could void the warranty. TM Specifications Model Name 3M 3968 Dimensions 185mm D x 195mm W x 96mm H Weight 1.
3M™ Rapid Detection Reader Specifications CM Specifications Supported USB Devices Label printer: Zebra® TLP 2824 Generic USB flash drive Barcode scanner: Symbol Technologies LS9208. Display 640 x 480 pixels, 5.7~6.5 “ diag (14.48~16.51 cm diag). TM / CM Specifications Operating temperature 15 - 30º C (59 - 86º F) Storage temperature -10 - 50º C (14 - 122º F) Operating Humidity 20 – 90% relative humidity, non-condensing.
3M™ Rapid Detection Reader Index Index Ribbon Part Number .............................. 4 3M RAPID DETECTION READER Overview and Product Description.......... 3 System Components.............................. 5 Barcode Scanner Connecting to Control Module................ 5 Description ............................................ 5 Manufacturer Contact Information .......... 5 Operator Input ....................................... 3 Optional Accessories ..........................
3M™ Rapid Detection Reader Index Editing Settings.....................................18 Editing Settings on Control Module .......18 Power Switch Location........................... 8 Rear View .............................................. 5 Restoring Supervisor Operator ID / Password ......................................... 38 Setting Operator Login On.................... 26 Setup ..................................................... 5 Specifications.......................................
3M™ Rapid Detection Reader Index Messages .............................................43 Results, Pass/Fail vs. Numeric..............19 Running................................................12 Status Screen .......................................13 Viewing/Printing Saved Results.............15 Warnings Icons...................................... 9 Troubleshooting ................................... 39 Viewing/Printing Saved Results............ 15 Labels Rear Panel Labels and Descriptions.......
3M™ Rapid Detection Reader Index Printer Settings .....................................21 Setting Date/Time Format .....................25 Setting Up Communication Between RCU and Readers .....................................32 Password Overriding a Lost Password ................. 38 Restoring Supervisor Password ........... 38 Patient ID Editing Settings.................................... 19 RCU (Reader Configuration Utility) Installation ............................................
3M™ Rapid Detection Reader Index Settings Menu Screen ............................. 18 Touch Screen Display Location................................................. 8 Settings Menus Accessing ............................................ 18 Transferring Manually Transferring Results...............17 Setup Reader Components Setup .................... 5 Troubleshooting Communication Errors ..........................45 IQC Messages......................................39 Lot Card Messages, Issues.......
