Page 3 - Table of Contents
3M™ Rapid Detection Reader Table of Contents i Table of Contents Warnings and Precautions........................................................................................................1 Summary of W arnings and Precautions........................................................................
Page 4 - ii
3M™ Rapid Detection Reader Table of Contents ii Login .................................................................................................................................21 File.................................................................................................................
Page 5 - iii
3M™ Rapid Detection Reader Table of Contents iii Power On Self Test Message / IQC Messages .......................................................................39 Test Run Messages ...............................................................................................................39 Lot...
Page 6 - Warnings and Precautions; Read all contents of this manual prior to use.
3M™ Rapid Detection Reader Warnings and Precautions 1 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 situat...
Page 7 - Summary of W arnings and Precautions; To reduce the risk associated with hazardous voltage:; Unplug the 3M Rapid Detection Reader before cleaning.; To reduce the risk associated with incorrect results:
3M™ Rapid Detection Reader Warnings and Precautions 2 Summary of W arnings 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 w...
Page 8 - Introduction; Overview; in vitro; Intended Use
3M™ Rapid Detection Reader Introduction 3 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 ...
Page 9 - Unpacking and Setup; M Rapid Detection Reader Components; M RAPID DETECTION Control Module; Optional Accessories; Printer
3M™ Rapid Detection Reader Unpacking and Setup 4 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 Components Item Description 3M RAPID DETECTION Control Module...
Page 10 - Barcode Scanner; M Rapid Detection Reader Setup; The 3M Rapid Detection Reader is comprised of:; M RAPID DETECTION Reader Configuration Utility Software (RCU); CD allows customized settings for the 3M Rapid Detection Reader; Power supply and interconnect cable; Remove dust protection stickers from TM ports
3M™ Rapid Detection Reader Unpacking and Setup 5 Item Description Barcode Scanner Catalog # 3967 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 ...
Page 11 - , 2, or 3 TMs can be connected to each CM
3M™ Rapid Detection Reader Unpacking and Setup 6 Figure 1. 3M Rapid Detection Reader - Rear View Showing Connectors and Power Switch NOTE: • 1, 2, or 3 TMs can be connected to each CM • TMs can be stacked • CM can be placed on top of the TM • Do not place anything on top of the CM. CAUTION. Do not s...
Page 13 - Figure 2. 3M Rapid Detection Reader Features - Front View; Turning on the 3M Rapid Detection Reader; Home
3M™ Rapid Detection Reader 3M Rapid Detection Reader (MODULES) 8 3M Rapid Detection Reader (MODULES) Figure 2. 3M Rapid Detection Reader Features - Front View Turning on the 3M Rapid Detection Reader The power On/Off switch is located on the rear panel of the CM (Figure 1). When the power is switche...
Page 14 - Display Icons; Port Identification Nomenclature
3M™ Rapid Detection Reader 3M Rapid Detection Reader (MODULES) 9 Display Icons The left hand column of the screen displays an icon for each av ailable 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 ico...
Page 15 - Performing an Assay; Using Lot Cards
3M™ Rapid Detection Reader Performing an Assay 10 Performing an Assay WARNING! To reduce risk to the operator: • Observ e 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/...
Page 17 - Running Quality Control
3M™ Rapid Detection Reader Running Quality Control 12 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 result...
Page 18 - LQC Icons
3M™ Rapid Detection Reader Running Quality Control 13 Do not use excessiv e 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 sa...
Page 19 - Running IQC; screen is displayed
3M™ Rapid Detection Reader Running Quality Control 14 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 interv als. IQC takes less than 1 minute to complete. When IQC is initiated, the appro...
Page 20 - Working with Results and Logs; Viewing Saved Results; Viewing Saved Logs
3M™ Rapid Detection Reader Working with Results and Logs 15 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). W hen the CM database is full, the oldest result is ov er-written. Dual analyte assay results ...
Page 21 - Searching Results; Searching Logs
3M™ Rapid Detection Reader Working with Results and Logs 16 be displayed. To view the details of a particular event, touch the event, and then touch View . 2. To return to the ev ent list, touch Events List . Searching Results Result Type Search Options Assay Operator Name Sample/Patient ID Assay Na...
Page 22 - Manually Transferring / Printing Results or Logs
3M™ Rapid Detection Reader Working with Results and Logs 17 Manually Transferring / Printing Results or Logs Results (assay, patient or IQC) that hav e 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 m...
Page 23 - Managing Settings; Accessing the Settings Menus
3M™ Rapid Detection Reader Managing Settings 18 Managing Settings The 3M Rapid Detection Reader can be operated immediately after set-up using the pre-programmed default settings. Each Reader also has customizable features which can be configured to enhance its functionality and data management capa...
Page 24 - Assay; New Assay Lockout; LQC; Hide Numeric LQC Results
3M™ Rapid Detection Reader Managing Settings 19 Settings: View Tabs Tab Screen Assay 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...
Page 25 - continued; Timer; Edit through RCU only.
3M™ Rapid Detection Reader Managing Settings 20 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 b...
Page 27 - Login; Login Requirements; File; Network Settings
3M™ Rapid Detection Reader Managing Settings 22 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 r...
Page 28 - About
3M™ Rapid Detection Reader Managing Settings 23 Settings: View Tabs Tab Screen About Purpose: This tab displays the details the Serial Number, software and hardware v ersions of the 3M Rapid Detection Reader System. This information will assist in discussions with Technical Support. Figure 27. Setti...
Page 29 - Edit Settings; Timers
3M™ Rapid Detection Reader Managing Settings 24 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 Menu s for additional information.) Touch Edit Settings on the Settings menu, a...
Page 30 - Language; Manual / Auto Transfer Mode
3M™ Rapid Detection Reader Managing Settings 25 Settings: Edit Tabs Tab Screen Date/Time 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 syn...
Page 31 - Restoring Defaults
3M™ Rapid Detection Reader Managing Settings 26 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: Th...
Page 32 - Adding/Modifying an Operator
3M™ Rapid Detection Reader Managing Settings 27 2. From the Settings menu (Figure 20), touch Edit Operators . The Settings: Operators screen will open (Figure 34). A complete list of all operators authorized to use the device with Display Name and Operator Type is displayed. The 3M Rapid Detection R...
Page 33 - Searching for an Individual Operator
3M™ Rapid Detection Reader Managing Settings 28 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 : Superviso...
Page 34 - Editing Settings Using the Reader Configuration Utility (RCU); Save As; Installation; NOTE; Getting Started
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 29 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...
Page 35 - Emergency Password Reset Mechanism; Setting Up a USB Flash Drive
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 30 To change the default login 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 a...
Page 36 - Accessing Configuration Files; MUST
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 31 3. Enter the Web serv er directory. Contact the local IT administrator for the appropriate Web serv er directory. 4. Sav e your settings by selecting File > Save from the menu. No additional setup is requi...
Page 37 - Setting Up Communications Between RCU and Readers; Files
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 32 To open an Individual Configuration File 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 chan...
Page 38 - Identifying Readers through the RCU; Non-networked Environment
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 33 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 speci...
Page 39 - Importing Files
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 34 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 Conf...
Page 40 - Deleting Results
3M™ Rapid Detection Reader Editing Settings Using the Reader Configuration Utility (RCU) 35 Deleting Results The 3M Rapid Detection Reader can store up to 900 results (300 patient, 300 LQC and 300 IQC) and 500 ev ents (log file entries). When the CM database is full, the oldest result is over-writte...
Page 41 - Maintenance; Exterior Cleaning; To reduce the risk of instrument or accessory damage:; Clean external surfaces only.
3M™ Rapid Detection Reader Maintenance 36 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...
Page 42 - Upgrading Device Software
3M™ Rapid Detection Reader Maintenance 37 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 availab...
Page 43 - Troubleshooting; Restoring the Supervisor Operator ID / Password; General
3M™ Rapid Detection Reader Troubleshooting 38 Troubleshooting The following information is to be used to diagnose and resolv e 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 O...
Page 44 - Power On Self Test Message / IQC Messages; To display the error message, before removing the cartridge; Test Run Messages; – indicated by red port icon; CTG
3M™ Rapid Detection Reader Troubleshooting 39 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....
Page 45 - Fail; Timed Out
3M™ Rapid Detection Reader Troubleshooting 40 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. Insufficient sample added to the Test Cartridge. Clogged sample pad. Failure to use supplied assay tip. Insu...
Page 46 - OK; Lot Card Messages; Lot Card Error, Reinsert
3M™ Rapid Detection Reader Troubleshooting 41 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 por...
Page 47 - Settings Messages; Assay List Size Exceeded.
3M™ Rapid Detection Reader Troubleshooting 42 Settings Messages Message Cause Action Access denied. Try again. The user does not hav e 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 f...
Page 48 - User Expired, Try Again; LQC Related Messages; LQC Overdue, Assays Locked
3M™ Rapid Detection Reader Troubleshooting 43 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. LQC Related Messages Message Cause Action LQC Lockout. Ejecting. LQC is ov ...
Page 49 - Warnings and Confirmation Requests; Cancel if not intended.; Printer Errors; Technologies· Ribbon:
3M™ Rapid Detection Reader Troubleshooting 44 Warnings and Confirmation Requests Message Cause Action ! All Databases Will Be Erased Back up files at Settings: Export Configuration System will restart following this procedure Request was made to upgrade software or reset system to default settings. ...
Page 50 - Printer light does not turn on; Printer is not receiving power.; Communications Errors; Transfer Error; USB Device Errors; Remove additional printer.
3M™ Rapid Detection Reader Troubleshooting 45 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 t...
Page 52 - Specifications
3M™ Rapid Detection Reader Specifications 47 Specifications CAUTION. Possible device damage and warranty invalidation. Changes or modifications to this equipment, not expressly approv ed by the manufacturer could v oid the warranty. TM Specifications Model Name 3M 3968 Dimensions 185mm D x 195mm W x...
Page 53 - Supported USB Devices; Operating temperature; UL/IEC 60529 - Degrees of protection provided by enclosures.
3M™ Rapid Detection Reader Specifications 48 CM Specifications Supported USB Devices Label printer: Zebra ® TLP 2824 Generic USB flash driv e 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 -...
Page 54 - Index; See
3M™ Rapid Detection Reader Index 49 Index 3M RAPID DETECTION READER Overview and Product Description.......... 3 System Components .............................. 5 Access Access Denied Message ...................... 42 Access Privilege Requirements ............ 22 Configuration File Access Method .....
