READER USER MANUAL
Contents
1. Ree mee eee ete E 34 Introduction Intended Use The PROFILE V MEDTOX Scan Drugs of Abuse Test System consists of the PROFILE V MEDTOX Scar Test Devices and the MEDTOX Scar Reader The PROFILE V MEDTOX Scarf Test Devices are one step immunochromatographic tests for the rapid qualitative detection of one or more of the following in human urine Amphetamine Barbiturates Benzodiazepines Buprenorphine Cocaine Methadone Methamphetamine Opiates Oxycodone Phencyclidine Propoxyphene THC Cannabinoids and Tricyclic Antidepressants or their metabolites The PROFILE V MEDTOX Scar Test Devices can only be used with the MEDTOXScan Reader The MEDTOXScan Reader is an instrument used to interpret and report the results of the PROFILE V MEDTOXScan Test Device The PROFILE V MEDTOX Scan Test Devices cannot be visually read The PROFILE V MEDTOX Scan Drugs of Abuse Test System is for in vitro diagnostic use and is intended for prescription use only It is not intended for use in point of care settings The PROFILE V MEDTOX Scar Drugs of Abuse Test System detects drug classes at the following cutoff concentrations AMP Amphetamine d Amphetamine 500 ng mL 100 ng mL OPI Opiates Morphine BAR Barbiturates Butalbital 200 ng mL BZO Benzodiazepines Nordiazepam 150 ng mL OXY Oxycodone Oxycodone 100 ng mL BUP Buprenorphine Buprenorphine 10 ng mL PCP Phencyclidine Phencyclidine 25 ng mL COC C2. Scan POS or NEG barcode from pouch for Specimen ID and press OK or manually enter Test results print out when QC Test device scan is complete Repeat steps 3 7 with second device The Negative device has six lines on each strip Oc PR O Verify that test results are reported correctly see partial example printouts below 28 All results are POS for the QCPOSCTRL All results are NEG for the QONEGCTRL device device Test Sample ID QCPOSCTRL Test Sample ID QONEGCTRL TCTRL1 VALID 5111 POS 5172 POS 5113 5 5114 POS POS TCTRL1 VALID 5111 NEG 5172 NEG S1T3 NEG 5114 NEG NEG 10 If the test results are all POS for the positive QC Test device and all NEG for the negative QC Test device the MEDTOXScan Reader is reporting results correctly Resume normal operation 11 the test results do not match expected then follow the flowchart to determine appropriate next steps which may include replacing the QC Test devices cleaning the sensor or calling Technical Support Cleaning Cassette Procedure A MEDTOXScan Cleaning Cassette is required for this procedure Contact MEDTOX for resupply This procedure is appropriate if you get incorrect results running the QC Test devices or if the MEDTOXScan Reader displays the CONTAMINATED SENSOR error message It is effective for cleaning contamination such as dirt dust or sample accumulated on the contact imaging sensor CIS 1 DISC
3. SEUD nnkan r r a r 12 IDotaul Sells a nee emer ner eee me RE e ME MEE ME 15 9 OND 16 e M 16 vm T 17 FF LIE FAC SUITS COTON 20 SS MM IM EMEN IM Md D MEM M M ML MIU 21 m mmm 25 Qualy t 26 26 Maintenance and 27 Routine Maintenance ee etti psu ERE ae 27 S el T 27 Troubleshooting Flowchart Using QC Test nnne 28 OC Test Devices Procedure acsi koe LIEU LER E ELE Li EE 28 Cleaning Cassete PIOGGdbll a aaa bouis tenes 29 Auto Contamination DETECT ON 30 Error MOSSaOOS 31 Service MOMMA Ol 33 PEU era E E 33 Append dee 34 Warnings Precautions and Limitations s Dicite 34 EIS GI ri Me sie E T 34 FCS Glas SIN OU CS i sa aioe C 34
4. View NEG Use Up and Down Navigation Keys t gt to select View NEG from the menu and press OK Key to display the list of all tests currently stored in the MEDTOXScan Reader that have only negative results Up and Down Navigation Keys Allow user to scroll through the tests OK Key Select the highlighted test the list and display the results Cancel Key Return to the Recall Results menu Print NEG Data This selection prints in numerical format all records currently stored in the MEDTOX Scar Reader containing only negative results Use Up and Down Navigation Keys to select Print NEG Data and press OK Key Print NEG Results This selection prints in POS NEG format all records currently stored in the MEDTOXScar Reader containing only negative results Use Up and Down Navigation Keys 10 select Print NEG Results and press OK Key 3 Cancel Key Cancel any printing operation Tip The Print Results options generate a printout that shows records with the test names and the POS NEG result for each test This is the default printout format The Print Data options generate a printout that shows records with the test names and the POS NEG result for each test as well as the threshold values and numeric test line data 23 The following options are available only with proper Network Setup The reader software will communicate with a middle ware server developed by a third party vendor usin
5. Contact MEDTOX Technical Support if you need any additional help at 1 800 832 3244 27 Troubleshooting Flowchart Using QC Test Devices MEDTOXScan Reader displays CONTAMINATED SENSOR f MEDTOX Scan Reader Troubleshooting Error Message Run Scan Test Device and MEDTOXScan Negative OC Test Device off Reader Follow Cleaning Cassette procedure Turn Reader back on Qc Test device damaged or dirty Yes Both Pass Welcome screen is displayed cleanings completed 4 Reader is NA QC Test detecting positive dies Device and negative Replace or call results properly TS Do not Report results report results Call Tech Support m Re run MEDTOXScan positive and TS negative Test Devices QC Test Devices Procedure 1 Set up and power on the MEDTOX Scar Reader 2 Remove devices from storage pouch The Positive device has one line on each strip Visually examine the devices to be sure the strips in the device window are clean free of dust fingerprints smudges or discoloration yellowing and undamaged scratched torn or bent Do not add sample to the sample wells of the QC Test Devices Place device in MEDTOX Scar Reader tray and close At the prompt enter test device Lot Number and press Enter User ID and press
6. 3244 Printed in USA 2010 MEDTOX Diagnostics Inc All rights reserved P N 102005 Rev 5 10
7. any additional help at 1 800 832 3244 30 Error Messages Part Number Not Recognized This error appears if the device code cannot be read by the internal scanner or is not recognized The device code may be related to a new test type or the printed bar code may be damaged The correct device code can be entered the same way as the Specimen ID Press OK Key to continue once the code has been entered If the code is recognized by the MEDTOXScan Reader the test procedure will resume and the User ID screen will appear 11 15 56 05 i ERROR AU Fart Humber Recognized A device was detected but the barcode PRESS OF TO CONTINUE Update Needed This error will appear if the device barcode is not found in the database Pressing OK Key will return the interface to the welcome screen and cancel the test 11 15 Os 16 05 Ww UPDATE NEEDED J The device iz not found in database Firmware updates are needed Refe PRESS OF TO CONTINUE Contaminated Sensor This error will appear when the MEDTOX Scan Reader determines that the contact imaging sensor CIS is contaminated Pressing OK Key will return the interface to the welcome screen and cancel the test Follow the Cleaning Cassette Procedure to clean the contaminated sensor 1115 AM 03 16 05 m ERROR F CONTAMINATED SENSOR Ferform cleaning H procedure PRESS OF TO QUIT Network Error messages similar to those above are dis
8. setup is terminated and only the Set Ethernet Network menu option is listed on screen Applying configuration When the Ethernet is set to ON and the IP source is set to DHCP an error message DHCP failed to obtain an IP address will appear if the MEDTOXScan Reader is not physically connected to a network Press OK Key to continue If the Ethernet is set to ON and the IP source is set to DHCP the Network Menu lists the following options Set Ethernet Set Server IP Set Server Port IP Source as shown below 11 15 1 5 02 Set Ethernet Set Serwer IF Set Server Part IF Source Set Server IP Use Up and Down Navigation Keys to select Set Server IP and press OK Key Enter the server IP address and press OK Key when done 11 15 3 16 05 Set Server Qo QQ Set Server Port Use Up and Down Navigation Keys to select Set Server Port and press OK Key Enter the Port number of the server and press OK Key when done 11 15 3 16 05 Set Server Port Poa IP Source This network menu allows the user to choose one of two protocols DHCP and Static that provides the MEDTOX Scar Reader its IP address Dynamic Host Configuration DHCP protocol allocates IP addresses dynamically while the Static protocol option allows the user to manually configure each reader with the required information Use Up and Down Navigation Keys to select IP S
9. suspect that the Header or test device is not working properly 5 if you have had a repeated unexpected test result or 6 if you suspect that the test devices have been stored improperly External quality control materials are available from MEDTOX and other commercial sources Should control results indicate a problem with the PROFILE V MEDTOXScan Drugs of Abuse Test oystem please follow the instructions in the Troubleshooting Section below External quality control materials are available from MEDTOX Contact MEDTOX at 1 800 832 3244 for further information Calibration The MEDTOX Scar Reader is calibrated and verified before shipping to the customer No calibration is required of the operator Reader calibration cannot be changed by users in the field 26 Maintenance and Troubleshooting Routine Maintenance amp Cleaning No maintenance other than periodic external cleaning is required of the operator MEDTOX recommends using isopropyl alcohol wipes to clean the outside of the MEDTOXScan Reader and the device drawer Do not immerse the reader in water or other liquids If service or maintenance is required the MEDTOX Scan Reader should be sent to the manufacturer The MEDTOX Scan Reader has been designed to provide you with reliable and worry free service If for any reason you have a problem with your equipment please call MEDTOX Technical Support at 1 800 832 3244 Troubleshooting Use the QC Test devices provided w
10. 6 05 Set IP Address QO OG gogo Set Netmask Use Up and Down Navigation Keys to select Set Netmask and press OK Key Enter the Netmask of the Reader and press OK Key when done 11 15 3 16 05 Set Hetmask 299 299 299 000 Set Gateway Use Up and Down Navigation Keys to select Set Gateway and press OK Key Enter the IP address of the subnet s gateway and press OK Key when done 11 15 3 16 05 set Gateway Qo Default Settings The following table lists the default settings for each of the User Defined Options Default value Set Time Date None Set Contrast 25 5 bars set Beeper Volume 70 14 bars Set Backlight Timeout On Operation Power On Plug the power cord cable connector of 12V AC Adapter into the rear of the MEDTOXScan Reader Connect the AC power cord to the inlet of the AC Adapter Insert the power cord plug into a standard wall outlet Turn on the power with the power switch located on the rear of the reader This startup screen indicates that MEDTOX Scan Reader is powered up NOTE It usually takes 1 to 2 minutes to load the operating system The startup screen will remain on until the system 15 fully loaded The device drawer needs to be closed for initialization The MEDTOXScan Reader goes through a brief initialization process The progress bar indicates that the MEDTOX Scar Reader is running system checks and is
11. 60Hz 0 3A Keypad Alphanumeric with special function keys 18 total Display LCD screen Environmental Temperature 5 C 40 C Humidity 10 RH 90 RH Location Dry clean flat horizontal surface indoors away from direct sunlight Memory Capacity 1000 Records Miscellaneous External Bar Code Scanner rapid entry of numeric User Patient or Lot ID numbers External Thermal Printer Test Device Specifications Test device specific information is provided in the product insert accompanying the MEDTOX Scar Drugs of Abuse Test System Device kit The MEDTOXScan Reader analyzes immunoassay test devices manufactured only by MEDTOX Diagnostics Inc Set Up Installation Refer to the Product Overview illustration to see the locations of various cable and cord connections on the MEDTOX Scar Reader MEDTOX Scar READER 1 Plug in the cable connector of 12V AC Adapter to the Power Jack on back of MEDTOXScan READER 2 Connect AC power cord to the inlet of the AC Adapter 3 Insert AC power cord plug into an electrical outlet NOTE Save the original foam padded box to return the MEDTOXScan Reader for service MEDTOX Scar PRINTER optional CT S280 Printer Plug cable connector of printer AC adapter to power jack on back of PRINTER Connect printer AC power cord to inlet of printer AC adapter Insert printer power cord plug into an electrical outlet Attach 9 pin end of printer cable to Bottom Connector P
12. MEDIOX READER USER MANUAL Intentionally left blank Intentionally left blank Contents BUC OCLC OI a aoa oe ecg cs eee ce ce cate cece sce cece ence cece cece c 1 AME IG OG teen susan seen rM EN 1 Product VSN SW icc kc ach sci ac rts ated ated 3 TO TT TEES 5 SDOCHIO SUL use ui ctu ioter tese Ecoles itum oues actin me oec cde A 5 Fue 6 6 About MEDTOX SCAN Reddi decals 6 Setting User defined Options c ccccscceccsececeseesceneccsesescecesceeecceuseseseescueescouaessseeescenscouaessaeessoeeeeceaeesoes 7 RS 7 ONU RE TRE 7 DOU siccam RE 8 Del BQCRIOnI TIITIGOLUE existe acea unie Dein E E E A A E 8 RESUS BEED oi M 8 STAO FIIN sirene a a a 9 Set AUIOXHOOCDIO aa a a a eade E E E EA 9 SEA UO A E E E A IIE 9 TALS FNRI O a CON Em A E a 10 Se ESUS r 10 Copy Aesulis t SD Memory T a Satie oa spayed ea 11
13. ONNECT the MEDTOXScan Reader from the power supply 2 Prepare the MEDTOX Scan Cleaning Cassette by rinsing under running tap water Apply one drop of mild liquid hand soap detergent to the pad Rinse thoroughly to remove any soap remnants 3 Remove excess water by blotting Cleaning Cassette pad on paper towels 4 Place moist cleaning cassette in MEDTOXScan Reader drawer While holding down the Eject button slowly move the drawer in and out 10 times Use the tape tail attached to the Cleaning Cassette to the drawer out while holding down the Eject button 5 f visible dirt is observed on the Cleaning Cassette pad wash rinse and blot the Cleaning Cassette again Place the Cleaning Cassette in the drawer of the MEDTOX Scar Reader and repeat Step 4 6 When finished cleaning the CIS remove the Cleaning Cassette from the MEDTOX Scar Reader drawer 7 Re connect power supply and power on the MEDTOXScan Reader 8 If the Welcome screen appears then run the QC Test devices to confirm that any contamination has been removed from the sensor and the MEDTOX Scan Reader is functioning properly 9 If the CONTAMINATED SENSOR error message displays again after the first cleaning procedure repeat steps 1 7 10 If the MEDTOX Scan Reader still displays the error message after the Cleaning Cassette procedure has been conducted twice call Technical Support 29 Auto Contamination Detection The MEDTOX Scan Reader
14. Send the reader back to MEDTOX as soon as possible 33 Appendix Warnings Precautions and Limitations 1 Operate the MEDTOX Scan Reader on level dry surface away from direct sunlight and bright light sources Do not move the reader while a test is in progress 2 Do not immerse the MEDTOX Scan Reader or components Printer Scanner etc in any liquid 3 Wipe spills off the device before placing the cassette in the reader tray Do not apply sticky adhesive labels to cassettes This may contaminate the sensor and interfere with reading test results 4 Do not drop hit or place objects on top of the MEDTOXScan Reader or components 5 Do not open or tamper with the components Only MEDTOX authorized personnel may service repair the components 6 Use only the AC DC power adapter provided with the MEDTOXScan Reader to power the reader 7 Keep the components clean and serviceable to assure continued reliability and performance 8 The MEDTOXScan Reader system is designed to be used only with PROFILE V MEDTOX Scan Test Devices 9 Refer to the Printer User Manual and Scanner Quick Start Guide for instructions and cautions before using these components Disclaimers MEDTOX is not responsible for outcomes due to misuse of the components resulting in damages to personnel or property which will be the responsibility of the end user Use of the equipment in a manner not specified by the manufacturer may impair the protection prov
15. X Scan Cleaning Cassette effectively removed any contamination Principles of Operation The MEDTOX Scarf Reader accepts the PROFILE V MEDTOX Scar Test Devices which are designed specifically for use with the MEDTOXScan Reader Please refer to the PROFILE V MEDTOX Scar Drugs of Abuse Test System insert PROFILE V MEDTOXScar Test Devices are qualitative immunochromatographic lateral flow devices The MEDTOXScan Reader scans the device and utilizes a full color contact imaging sensor CIS to capture relative line intensities Software algorithms and barcodes are used to identify the type of device to be read the analyte s associated with the device and whether the presence or absence of a line is associated with a negative or positive result The PROFILE V MEDTOX Scan Test Devices can be inserted into the MEDTOXScan Reader as soon as the patient sample is added to the device The MEDTOXScan Reader times the reaction providing results after the required time has elapsed The results of the scans will be printed automatically or may be displayed on the MEDTOX Scan Reader screen According to good laboratory practice the laboratory should follow the package insert instructions for performing the test and follow government regulations for the running of QC material to ensure the accuracy and reliability of the instrument prior to use Product Overview LCD Display Membrane Keypad Drawer Eject Drawer Pow
16. a 1 5 02 Set Times Date Set Contrast Set Beeper Volume Set Timing Set Time Date Use Up and Down Navigation Keys to select Set Time Date from the menu and press OK Key 3 Use numeric keypad to enter time and Up and Down Navigation Keys to toggle between AM PM Press OK Key when done 11 15 03 16 05 Enter Time The Enter Date screen appears Use numeric keypad to enter date Press OK Key when done Set Contrast Use Up and Down Navigation Keys to select Set Contrast from menu and press OK Key Use Up and Down or Right and Left of the Navigation Keys to increase or decrease contrast Press OK Key when done 11 15 03 16 05 Contrast Set Beeper Volume Use Up and Down Navigation Keys to select Set Beeper Volume from menu and press OK Key 3 Use Up and Down or Right and Left of the Navigation Keys to increase or decrease volume Press OK Key when done 11 15 03 16 05 Set Beeper Set Backlight Timeout Use Up and Down Navigation Keys to select Set Backlight Timeout from menu and press OK Key 3 Use Up and Down or Right and Left Navigation Keys to increase or decrease time Press OK Key when done 11 15 03 16 05 Set Backlight Timeout Set Results Beep Use Up and Down Navigation Keys to select Set Results Beep from menu and
17. a time NOTE If fewer than 10 records exist the left right keys will advance to the first or last record Print Data This selection prints in numerical format all records currently stored in the MEDTOX Scar Reader Use Up and Down Navigation Keys to select Print Data from the menu and press OK Key Print Results This selection prints in POS NEG format all records currently stored in the MEDTOX Scar Reader Use Up and Down Navigation Keys to select Print Results from the menu and press OK Key Cancel Key Cancel any printing operation View POS Use Up and Down Navigation Keys to select View POS from the menu and press OK Key to display the list of all tests currently stored in the MEDTOX Scar Reader that have positive results Use keypad Up and Down Navigation Keys OK Key and Cancel Key as described under View All above POS O3 25 1211 0 TA PO 5395 192 MA ooo 992 22 Print POS Data This selection prints in numerical format all tests with positive results currently stored in the MEDTOXScan Reader Use Up and Down Navigation Keys to select Print POS Data and press OK Key 3 Print POS Results This selection prints in POS NEG format all tests with positive results currently stored in the MEDTOXScan Reader Use Up and Down Navigation Keys to select Print POS Results and press OK Key C Cancel Key Cancel any printing operation
18. acro box in the spreadsheet Results data from the SD card will be automatically imported formatted and highlighted in the spreadsheet Save the MEDTOX Scan Results Excel spreadsheet under a different name so that the template can used again to copy another data file without having to overwrite the last file that was copied Network Setup In order to access the Network menu a password is required This is to prevent non authorized users from changing the network settings Contact MEDTOX Technical Support to obtain a password The reader software will communicate with a middle ware server developed by a third party vendor using a local area network over Ethernet Data is transmitted using TCP standard protocol The middle ware server provides an interface from the MEDTOXScan Reader to a laboratory information system Use Up and Down Navigation Keys to select Network from Setup menu and press OK Key Enter the Network password and press OK Key when done 11 15 05 16 05 Enter Password A Set Ethernet option appears Press the OK Key 3 Set Ethernet Use Up and Down or Right and Left Navigation Keys to toggle between Ethernet On or Off Press OK Key when done 11 15 AM 03 16 03 T Ethernet iz ON Use LeftiRight to toggle Press OF to accept If the Ethernet status is changed OFF ON Applying configuration appears on screen If the Ethernet is set to OFF the Network
19. er Switch USB Connector Power Jack Ethernet Network Connector Top Connector Bar code scanner Bottom Connector Printer Keypad Overview 11 15 05 16 05 T Welcome fT Entry Keypad allows for easy entry of numeric or alphanumeric specimen and operator identificatian Cancel takes the interface back ore operation OK accepts a selected 4 Way Navigation keys allow for selection and cursor movement Menu key brings up the main menu screen A Z toggles the interface between numeric and alphanumeric entry Eject releases the drawer and allows test devices to be inserted or removed Box Contents MEDTOXScan Reader e 12V AC Adapter Power Cord e User Manual e Quick Set Up Guide Essential accessories packaged separately contact MEDTOX Diagnostics for replacements MEDTOXScan QC Test Devices MEDTOXScan Cleaning Cassette MiniPet pipettor Optional accessories packaged separately contact MEDTOX Diagnostics e Thermal Printer e Bar Code Scanner Supplies packaged separately contact MEDTOX Diagnostics PROFILE V MEDTOXScar Test Devices e Thermal Printer Paper e SD Memory Card Specifications Physical Size 3 5 x 5 5 x 8 H x W x D 86mm x 128mm W x 192mm D Weight 1 2 pounds 0 6kg Electrical input 12V DC at 1 A supplied by AC DC converter Electrical supply AC 100 240V 50Hz
20. g a local area network over Ethernet The middle ware server provides an interface from the MEDTOXScan Reader to a laboratory information system Send Unsent Records This selection on the Recall Results menu sends all records that haven t already been sent to the server 11 15 03 16 05 Uploading Send All Records This selection on the Recall Results menu sends all records currently stored in the Reader to the server 11 15 03 16 05 Uploading COUT Send Record This option is located on the View Results screen together with Done Prt Result and Prt Data scrollable selections This menu selection will send the currently displayed record to the server 11 15 03 16 05 Uploading An error screen will alert the user to any problems during the record transmission across the network 11 15 02 16 05 2 UPLOAD ERROR W Test results Upload was unsuccessful Connection to was not found Refers PRESS OF TO CONTINUE 24 Clear History User can clear stored scan data from Clear History on the main menu Press the Menu Key to see the main menu Use Up and Down Navigation Keys to select Clear History and press OK Key 3 Clear All History User can clear all stored scan data Use Up and Down Navigation Keys to select Clear All History from menu and press OK Key 11 15 AM 95 15 05 Clear All History Clear Older T
21. han Follow the instruction on the screen to clear history by pressing OK Key or to cancel action by pressing Cancel Key 3 NOTE To Clear History requires confirmation on a second pop up screen This action will permanently remove all results from the MEDTOXScan Reader memory There is no recovery capability 11 15 AM 93 16 05 Dm Clear History n Press C to cancel clearing test history PRESS OF TO CONTINUE Clear Older Than User can clear stored scan data older than a specified date and time Use Up and Down Navigation Keys select Clear Older Than from menu and press OK Key Use the keypad to enter the time and date at the prompts All records older than the time and date entered will be deleted from the MEDTOXScar Reader Follow the instruction on the screen to clear history by pressing OK Key or to cancel action by pressing Cancel Key 3 Tip If the maximum number of records is reached and Auto Erase mode is turned on the MEDTOXScan Reader will automatically overwrite the oldest history record with the new record when a scan is performed If Auto Erase mode is turned off the user will be prompted to take action after the maximum is reached if no recoras are deleted then the oldest record will be overwritten on the next scan 25 Quality Control The purpose of quality control is to ensure accuracy and reliability of results and to detect errors MEDTOX recommends a Quality C
22. hasing an SD card any capacity from 32MB to 2GB and any speed grade of SD card can be used NOTE All SD cards must be formatted with the FAT32 file system format before they will work in the MEDTOXScan Reader Please consult your computer manual or IT department for further information about formatting SD cards on your computer C Insert SD memory card into the SD card slot Make sure that the SD 4 card is pressed firmly in place This is indicated by clicking sound Proper orientation of SD Then use the Up and Down Navigation Keys to select Copy Results to SD from the menu and press the OK Key The currently stored results will be copied to the SD card When the copy is complete the Setup menu will be displayed and the SD card can be removed Copying Results Please wait SD Memory Card Transfer of Results History Files to the PC Follow the instructions above to copy results history files from the MEDTOXScan Reader onto an SD memory card Once again note that the SD card must be formatted as a FAT32 File System Call MEDTOX Technical Support 1 800 832 3244 to obtain a Microsoft Excel spreadsheet template MEDTOXScan Reader Results for importing test results from the SD card Insert the SD memory card into an SD card reader connected to a PC or directly into an SD card slot ona PC Open the Excel spreadsheet template and click on the Import m
23. ided by the equipment FCC Class A Notice This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference 2 This device must accept any interference received including interference that may cause undesired operation NOTE This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if it is not installed and used in accordance with the instruction manual it may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at the user s expense Modifications not expressly approved by the manufacturer could void the user s authority to operate the equipment under FCC rules Safety Certificate This device complies with requirements of UL 61010 1 2004 CAN CSA C22 2 No 61010 1 2004 for electrical safety and mechanical safety 34 MEDIOX Reader Manufactured for MEDTOX Diagnostics Inc 1238 Anthony Road Burlington North Carolina 27215 www medtox com Technical Support amp Supplies 800 832
24. ith the MEDTOX Scar Reader to detect errors associated with the MEDTOX Scar Reader and a contaminated color contact imaging sensor CIS and to verify that the CIS cleaning procedure using the MEDTOX Scar Cleaning Cassette effectively removed any contamination dirt dust or sample The QC Test Devices function as an optical performance system check for the MEDTOX Scar Reader only not for the PROFILE V MEDTOX Scan Drugs of Abuse Test System and are not intended to replace the need for the external controls The QC Test Devices have been designed to simulate the end points that are generated in the PROFILE V MEDTOXScan Test Device when external positive and negative QC controls are run The QC Test Devices consist of artificial control lines and test lines negative or artificial control lines and no test lines positive printed on a membrane and placed in the PROFILE V MEDTOX Scar plastic housing The QC Test Devices are not intended to evaluate all components of the test system from specimen preparation through generation of results They are intended to function as a troubleshooting device to determine that the MEDTOX Scar Reader is functioning correctly You should run the QC Test devices 1 if you suspect the MEDTOX Scan Reader is not functioning properly or 2 if you suspect the CIS is dirty or 3 if the MEDTOXScan Reader has been dropped or damaged Refer to the Cleaning Cassette Procedure for details on the cleaning procedure
25. mation All service will be performed by MEDTOX authorized personnel at a MEDTOX authorized facility This will normally require a return of the component to MEDTOX per the Return Procedure To provide flexibility and support MEDTOX Scar Reader software upgrades may be required in the future These can be performed by the user MEDTOX will send the user a memory card that will be placed in the SD memory card slot on the back of the MEDTOXScan Reader The user will follow any on screen prompts if required to complete the upgrade Return Procedure NOTE All components returned to MEDTOX Diagnostics Inc must have a RETURN MATERIAL AUTHORIZATION RMA number assigned prior to returning e Call MEDTOX Technical Support or your sales representative at 1 800 832 3244 if you have difficulty with the MEDTOX Scar Reader If Technical Support determines the reader should be returned you will be provided an RMA number and further instructions MEDTOX will normally send a replacement reader immediately after a return has been authorized Return the malfunctioning reader to MEDTOX Pack the MEDTOX Scan Reader in the original foam padded box along with the 12V AC Adapter Power Cord Returns must come back in the original box If you do not have the original box please let us know Do not mark on the box Place the reader box in appropriate outer shipping container Mark the RMA number on the shipping documents and the outer shipping container
26. not yet ready to test 11 15 HM 4 16 85 Initializing A welcome screen appears when the MEDTOX Scan Reader is ready Run Test The welcome screen indicates that the MEDTOXScan Reader is ready to accept a device and initiate a new test 11 15 AM 05 16 059 T Welcome INSERT DEVICE BEGIN MENU FOR OPTIONS ONLY PROFILE V MEDTOX Scar Test Devices can be used with the MEDTOX Scar Reader Tip Follow the directions included with PROFILE V MEDTOXScan Test Devices to insure their correct use Do not attach any type of adhesive label to the device as this may interfere with reading test results Wipe spills off the surface of the device before inserting in the reader to avoid contaminating the sensor 1 Insert Device Press the Eject button to open the device drawer Place the device with sample in the drawer and push to close Once a test device is inserted a progress bar will indicate that the MEDTOX Scar Reader is detecting the specific device type This process will take 3 5 seconds If a test device is not recognized an error message will prompt for further actions WARNING Do not eject test device while MEDTOXScan Reader is scanning 11 15 93 16 05 Detecting Device DO NOT EJECT DEVICE 2 Enter Lot Number Once device detection is complete the Enter Lot Number screen appears The test device Lot Number is entered using the MEDTOX Scan Reader keypad or optional barcode scanner See ne
27. o numeric entry mode Left and Right Navigation Keys Allow the user to move right to enter the next character and left to delete the last character entered Cancel key Cursor goes back to previous character in current data entry field OK Key Enter the completed Lot number User ID or Specimen ID number 5 Scanning The scanning screen will appear after the Specimen ID has been entered The timer at the bottom of the screen will indicate remaining time until the test is complete The timing is set to allow the test lines to fully develop in the reader and then scan the results Tip Do not eject the test device during scanning This may damage the reader Scanning can be canceled by pressing the Cancel key on the keypad when the scanning progress countdown screen is displayed This will cause the test to be terminated prior to the determination of results The test cannot be resumed and will have to be re run on a fresh test cassette When scanning is canceled a message 15 displayed to indicate that the scan is being aborted When scanning stops the device may be ejected 11 15 03 16 05 scanning M2 DO HOT EJECT DEVICE 6 Print Results If Auto Print mode is turned on the results will be printed directly to the printer when the test is complete and the View Results screen will appear If the Results Beep is turned on a beeping sound will indicate that the results are ready The View Results screen pro
28. ocaine Benzoylecgonine 150 ng mL 300 ng mL Norpropoxyphene MAMP Methamphetamine THC Cannabinoids d Methamphetamine eg ng ae 11 nor 9 carboxy A THO SERMONE MTD Methadone Methadone 200 ng mL ICA miei 300 ng mL esipramine Configurations of the PROFILE V MEDTOX Scan Test Devices may consist of any combination of the above listed drug analytes Test Devices will have an opiate cutoff of either 100 ng mL or 2000 ng mL Refer to specific product labeling for the combination of drug tests included on that test device THE PROFILE V MEDTOXScan DRUGS OF ABUSE TEST SYSTEM PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT GAS CHROMATOGRAPHY MASS SPECTROMETRY GC MS HIGH PERFORMANCE LIQUID CHROMATOGRAPHY HPLC OR LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY LC MS MS ARE THE PREFERRED CONFIRMATORY METHODS CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED The MEDTOX Scan Reader includes a Positive QC Test Device a Negative QC Test Device and a Cleaning Cassette The MEDTOXScan Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOX Scar Reader and a contaminated contact imaging sensor CIS and to verify that the CIS cleaning procedure using the MEDTO
29. omplete this operation you must Turn off the power switch located at reboot the MEDTOXScan Reader the rear of the MEDTOX Scan Reader Wait approx 10 sec and then switch power back on System failure Initialization has failed Unit needs Contact MEDTOX Technical Support service Attempting software Downgrading software versions is not Verify that the firmware upgrade on downgrade allowed Please check that the SD the SD card is higher than the S W card has the proper version of version listed on the About software and try again MEDTOXScan Reader screen Motor step error An internal motor error has been Contact MEDTOX Technical Support detected Press OK to re scan the cassette lf this error persists please return the Reader for service Print Error messages are displayed when the MEDTOXScan Reader detects a problem with printing The following table shows common print error messages Prblem Error ErorMessage Solution Solution No Printer Connected Communication with the printer was unsuccessful Please check that the 75 7 No Paper Roll or Paper The printer is out of paper Please install a fresh roll of paper and try printing Graphics Error The printer has reported an error while printing the graphics logo Please try HEU Dna m Other Printer Errors Test results printout was unsuccessful An error has been reported from the RUIT pene 32 Service Infor
30. ontrol Program for monitoring the performance of the PROFILE V MEDTOX Scar Test Devices and the MEDTOXScan Reader that uses a combination of internal controls and external controls Users should follow government regulations for the running of QC material Internal controls ensure that the test is working and that you are performing the test correctly A control line internal control is included on each PROFILE V MEDTOX Scar test strip Whether or not drug is present in the sample a line must form at the Control C position on the test strip to show that enough sample volume was used and that the reagents are migrating properly If a Control line does not form the test is invalid The Control line consists of immobilized anti mouse antibody that reacts with the antibody colloidal gold as it passes this region of the membrane Formation of a line detectable by the MEDTOX Scar Reader verifies the Control line antibody antigen reaction occurred External controls are urine based control materials that contain the drugs to be tested at concentrations above the cutoff positive control or contain no drug negative control Run external controls as if they were patient samples Refer to the instructions that accompany the external controls You should run external controls routinely or as needed for any of the following reasons 1 to practice the test with a known control 2 when you open a new lot of test devices 3 once a week 4 if you
31. ource and press OK Key Use Up and Down or Right and Left Navigation Keys t to toggle between DHCP and Static Press OK Key when done 11 13 23 16 05 T IF Source Currently Use Left Right toggle Press to accept If the IP Source is changed DHCP Static Applying configuration appears on screen Appling configuration When the Ethernet is set to ON and the IP source is set to DHCP an error message DHCP failed to obtain an IP address will appear if the MEDTOXScan Reader is not physically connected to a network Press OK Key to continue To use DHCP connect the MEDTOXScan Reader to the local area network If the Ethernet is set to ON and the IP source is set to Static the Network Menu lists the following new options Set IP address Set Netmask and Set Gateway The Set Ethernet Set Server IP Set Server Port IP Source menu options are the same as listed previously 11 15 AM Oc 260 IF Source Set IP Address Set Metmazk Set Gateway The Set IP address Set Netmask and Set Gateway menu options which appear only when the IP Source is set to Static need to be set manually by the user Contact your local Network Administrator to obtain the necessary information for each of these submenu parameters Set IP Address Use Up and Down Navigation Keys to select Set IP Address and press OK Key Enter the IP address of the Reader and press OK Key when done 11 15 3 1
32. played when the MEDTOXScan detects a problem with network set up or communication with the server The following table shows common Network error messages No Ethernet Cable DHCP failed to obtain an IP address Check cable connections and consult connected with your local computer Network Administrator Upload Error Test results upload was unsuccessful Check cable connections and Connection to PC was not found Network setup parameters Consult Refer to your user manual for more with your local computer Network information Administrator to confirm appropriate network settings 31 Hardware Software Error messages are displayed similar to those above when the MEDTOXScan Reader detects a problem with hardware or software functions The following table shows common error messages Initialization Failure The drawer is open Initialization has Close the MEDTOXScan Reader failed Please close the drawer to device drawer again Memory Full Results history memory is full Copy Transfer records to alternate storage results to SD card and clear the See Copy Results to SD Memory history file to prevent oldest result Card o Network Setup Select from being lost on next scan records to delete See Clear History Component error A fatal error occurred Restart the Turn off the power switch located at detected MEDTOXScar Reader the rear of the Reader Wait approx 10 sec and then switch power back on Restart required To c
33. press OK Key 3 Use Up and Down or Right and Left Navigation Keys gt toggle between Results Beep On and options Press the OK Key when done 11 15 AM 03 1605 T Results beep is OFF Use Left Right to toggle Press OK to accept Set Auto Print Use Up and Down Navigation Keys t gt to select Set Auto Print from menu and press OK Key Use Up and Down or Right and Left Navigation Keys to toggle between Auto Print On and Off options Press the OK Key when done 11 15 03 15 05 Auto Print mode disabled Use Left Right toggle Press OK to accept Set Auto Record Erase Use Up and Down Navigation Keys gt to select Set Auto Record Erase from menu and press OK Key Use Up and Down or Right and Left Navigation Keys to toggle between Auto Erase On and options Press the OK Key when done NOTE The Auto Record Erase function is applicable only when the MEDTOXScan Reader has 1000 stored records With this feature disabled a History full warning message will be displayed when the 1000 record is created and when the 1001 record is created the oldest record is automatically deleted and the History full warning is displayed When this feature is enabled the MEDTOXScan Reader will automatically delete the oldest record to make room for the 1001 record without displaying a warning screen 11 15 05 16 06 T Auto Record Erase enabled Use Left Right toggle P
34. ress to accept Set Auto Send Use Up and Down Navigation Keys to select Set Auto Send from menu and press OK Key 6 Use Up and Down or Right and Left Navigation Keys to toggle between Auto Send mode On and Off options Press the OK Key when done 11 15 03 16 05 T Auto Send mode disabled Lise Left Right to toggle Press OK to accept NOTE See Network Setup section to configure the MEDTOXScan Reader to send data to a local network With Network communication configured properly records may be sent to the network automatically as each scan is completed or manually from the View Results screen or Recall Results menu Update Firmware Use Up and Down Navigation Keys to select Update Firmware from menu and press OK Key 3 Follow the screen instruction to insert SD card to update firmware Press OK Key when done Please insert SO card Press OK to continue Set Results Type Use Up and Down Navigation Keys to select Set Results Type from menu and press OK Key 3 Use Up and Down or Right and Left Navigation Keys to toggle between POS NEG Results and Numerical Results display types Press the OK Key when done NOTE Results printouts will be the same type as the results display 11 15 03 16 05 T Results Use Left Right ta toggle Press OK to accept Copy Results to SD Memory Card SD cards are not included with MEDTOXScan Reader When purc
35. rinter on back of MEDTOXScan Reader Attach 25 pin end of printer cable into connector on back of PRINTER Secure connections MEDTOXScan BAR CODE SCANNER optional 152208 Barcode Scanning device 1 Attach end of BAR CODE SCANNER cable to Top Connector Bar code scanner on back of MEDTOXScan Reader and secure The Scanner is already programmed and ready for use with MEDTOXScar Reader Ace ni Deui Code 39 is the standard barcode for all data entry Do not reprogram If any issues occur scan the Set Defaults barcode in the Scanner quick start guide or at right to reset the Scanner to the appropriate settings for use with the MEDTOXScar Reader NOTE The Scanner gets power from the MEDTOXScan Reader not an electrical outlet NOTE Refer to the Printer User Manual and Scanner Quick Set Up for cautions and tips before using About MEDTOXScan Reader User can get product information from About MEDTOX Scan Reader on the main menu Use Up and Down Navigation Keys to select About MEDTOXScan Reader from menu and press OK Key 11 15 AM Q2 26 09 About 29060126 Version 2 6 5 Stored Records 51 Setting User defined Options User can define various options for the device by pressing the Menu Key and choosing Setup from main menu screen Use Up and Down Navigation Keys to select Setup and press OK Key Set Up option screen appears 11 15 er
36. screen Cancel Key Cancel the printing operation Tip If Auto Print mode is turned on the results will be printed automatically as soon as the scan is complete The View Results screen will be displayed with the option to print if desired The Print Results option generates a printout that shows the test names and the POS NEG result for each test This is the default printout format The Print Data option generates a printout that shows the test names and the POS NEG result for each test as well as the threshold values and numeric test line data If the MEDTOX Scan Reader detects any problems with printing the interface will display a PRINT ERROR message to notify the user of the problem and steps to correct it Common error messages are listed in the Maintenance and Troubleshooting section 20 Recall Results User can review test results stored in the MEDTOXScan Reader Press the Menu Key to see the main menu Use Up and Down Navigation Keys to select Recall Results and press OK Key 3 11 15 03 16 05 Fecal Fesults Setup About Clear History Last Test Use Up and Down Navigation Keys t gt to select Last Test from the menu and press OK Key to display the results of the most recent completed test 11 15 AM 03 16 09 Last Test Wiew All Print Data Print Results The View Results screen appears a Lele VALID Prt Up and Down Na
37. software performs automatic contamination detection of the contact imaging sensor CIS without user intervention Automatic contamination detection is performed at startup and before each scan of a test device Startup Every time the MEDTOXScan Reader is powered up the automatic detection of sensor contamination is performed before a Welcome screen appears indicating that the MEDTOXScan Reader is ready for use If the sensor is contaminated normal operation is interrupted and a fatal error message is displayed If the sensor is clean at startup normal operation will continue Each scan Every time a test device is inserted in the MEDTOXScan Reader normal device detection is performed When the first strip is ready to be scanned automatic contamination detection is performed If the sensor is contaminated normal operation is interrupted and a fatal error message is displayed If the sensor is clean before a device is scanned normal operation will continue When a sensor is determined to be contaminated normal operation is interrupted and an error message is displayed 11 15 03 16 05 Dm ERROR CONTAMINATED SENSOR Perform cleaning H procedure PRESS TO QUIT The MEDTOXScar Reader will only resume normal operation when the contaminated sensor problem is adequately resolved Proceed with Cleaning Cassette Procedure in order to remove contamination from the sensor or contact MEDTOX Technical Support if you need
38. vides manual printing options at the bottom of the screen T View Results The View Results screen appears when the test is complete Use Navigation keys described below to review the results and print if desired ID CTRL Prt Result Up and Down Navigation Keys Allow the user to scroll through the results Left and Right Navigation Keys gt Allow the user to move through the option bar at the bottom of the screen Select Prt Result for the POS NEG results printing option or Prt Data to print numeric data Select Done to exit the View Results screen OK Key Press to initiate the highlighted option in the option bar Print Results When the optional printer is installed the user has the option to print the results of a completed test ID 92717 121 CTRL VALID THE Pos ert Left and Right Navigation Keys Allow the user to move through the option bar the bottom of the screen Select Prt Result for the POS NEG results printing option or Prt Data to print numeric data Select Done to exit the View Results screen OK Key Press to initiate the highlighted option in the option bar A status screen appears to notify the user that the request to print is received and being fulfilled 11 15 4 16 85 If the printing operation is successful the interface will return to the View Results
39. vigation Keys Allow the user to scroll through the results Left and Right Navigation Keys Allow the user to move through the option bar at the bottom of the screen Select Prt Result for the POS NEG results printing option or Prt Data to print numeric data Select Done to exit the View Results screen OK Key Press to initiate the highlighted option in the option bar Tip Store up to 1000 records in the MEDTOXScan Reader for ready recall If records must be stored for a longer period copy results to SD memory card and transfer to PC for storage If Network capability is available send records to your local network for storage Then clear history to continue using the unit If the maximum number of records is reached the MEDTOXScan Reader will automatically overwrite the oldest history record with the new record when the next scan is performed 21 View All Use Up and Down Navigation Keys to select View All from the menu and press OK Key to display the list of all test results currently stored in the MEDTOXScar Reader PAH ooo 4 PNOlo99 Up and Down Navigation Keys Allow the user to scroll through the tests OK Key Select the highlighted test in the list and display the results Cancel Key Return to the Recall Results menu FHolooz2 PHOT 1 PHO Left and Right Navigation Keys gt Allow the user to scroll through the test records 10 at
40. xt page for additional keypad explanation 11 15 92 15 05 Enter Lot Number EEE A z NOT EJECT DEVICE 3 Enter User ID Next the Enter User ID screen appears The User ID is entered using the MEDTOX Scan Reader keypad or optional barcode scanner x Ju ng Enter User ID oe 0 9 NOT EJECT DEVICE 4 Enter Specimen ID Once User ID is entered the Enter Specimen ID screen appears The Specimen ID is entered using the MEDTOXScan Reader keypad or optional barcode scanner Tip The PROFILE V MEDTOXScan Test Device Lot Number User ID and or Specimen ID number can be entered by using the optional bar code scanner to scan the information from a related document or label If the bar code scanner is configured to send a CR at the end of a barcode then the MEDTOXScan Reader will automatically advance to the next screen for data input 11 15 03 16 05 specimen ID mE 00 NOT EJECT DEVICE A Z key The default setting is for numeric entry Pressing the A Z key places the MEDTOXScan Reader in alohanumeric entry mode This allows the user to use the keypad to enter both letters and numbers as part of the User ID or Specimen ID For example when the MEDTOXScar Reader is in alphanumeric entry mode the user can press the 2 key to cycle through the letters A B and C and the number 2 Pressing the A Z key a second time returns the MEDTOXScan Reader t
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