CDx Reader Part No

Transcription

1 Xpress Pathogen Detection System User Manual CDx Reader Part No Copyright 2015 Pathogen Systems, Inc., Broomfield, CO USA

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3 Table of Contents Introduction... 1 Warranty... 1 Important Safety Instructions... 2 Basic Operation... 4 Basic Operation Power up... 5 Basic Operation Select Reader Function... 7 Basic Operation Select Test... 8 Basic Operation Sample Description Basic Operation Testing Basic Operation Multiple BioCassettes Basic Operation Results Basic Operation Abort Test Basic Operation Power down Advanced Operation Advanced Operation Printer and Network Advanced Operation Setup Advanced Operation USB Flash Drive Product Information, Storage, and Shelf Life Safety Information Technical Assistance Specifications Certificate of Analysis Sample... 22

4 Introduction Thank you for purchasing the CDx Reader. The CDx Reader is an AOAC approved platform technology for the detection of pathogenic targets using a liquid crystal based BioCassette. It allows up to 5 samples to be tested simultaneously, and each sample can be tested for multiple pathogens. Using proprietary BioCassettes for the safe delivery of samples and Antibody Kits for superior target selectivity and specificity, the CDx Reader provides unsurpassed reliability and speed for pathogen detection. The CDx Reader also provides maximum flexibility for testing both small and large sample applications without the need of highly trained technicians. This user manual is divided into two basic sections based on the complexity of the operation. For most installations, the Basic Operation will be sufficient. This section describes the general operation of the CDx Reader, including how to use the 4.3 color touch screen, wireless keyboard and mouse pad and general operation of the CDx Reader. Advanced Operation will detail how to utilize the USB port for direct printing of your Certificates of Analysis and software updates. Included with the purchase of your CDx Reader is installation and training by a certified Customer Service provider. However, should you unpack your CDx Reader, please be careful. This instrument is susceptible to damage from dropping or the placement of heavy objects on top. Save the original package and all enclosed packing material in case the unit requires factory service. Damage due to shipping in cartons other than the original package is not covered under the warranty. Any modifications or improper use of the CDx Reader will void the warranty. Please read all information and instructions concerning this system before using. Contact Crystal Diagnostics with questions or concerns about the CDx Reader. We are happy to assist you with any problems you may be experiencing. If you are unsure of any aspect of your installation or operation, please call Customer Service. Warranty Crystal Diagnostics, Ltd. (CDx) warrants this product to be free from defects in materials and workmanship for a period of one year from the date of purchase, or CDx will repair, or at its option, replace the defective product. Any implied warranty arising from the sale of the product including implied warranties of merchantability and fitness for the purpose are limited to the warranty stated above. CDx shall not be responsible for losses or damages or expenses, whether direct, consequential or incidental arising from the use of or the inability to use this product. Some states do not allow limitations on how long the implied warranty lasts or the exclusion or limitation or incidental or consequential damages, so the above limitations and exclusions may not apply to you. This warranty gives you specific legal rights, and you may have other rights, which may vary from state to state. 1 UM0001DOC 1.00

5 Important Safety Instructions Read this User Manual. Keep this User Manual. Heed all Warnings. Follow all Instructions. Do not use this Instrument near Water. Clean only with a Dry Cloth. The lightning flash with arrowhead symbol, within an equilateral triangle, is intended to alert you to the presence of uninsulated "dangerous voltage" within the product's enclosure that may be of sufficient magnitude to constitute a risk of electrical shock to persons. The exclamation point within an equilateral triangle is intended to alert you to the presence of important operating and maintenance (servicing) instructions in the literature accompanying the instrument. Do not block any Ventilation Openings. Must be installed by a Certified Representative. Do not move unit near any heat sources such as radiators, heat registers, stoves or other apparatus that produce significant heat. Do not defeat the safety purpose of the grounding type plug. A grounding type plug has two blades and a third grounding prong. The third prong is provided for your safety. If the provided plug does not fit into your outlet, consult an electrician for replacement of the obsolete outlet. Protect the power cord from being walked on or pinched particularly at plugs, convenience receptacles, and the point where it exits from the instrument. Only use attachments/accessories specified by the manufacturer. Unplug this apparatus during lightning storms or when unused for long periods of time. Refer all servicing to qualified service personnel. Servicing is required when the apparatus has been damaged in any way, such as power supply cord or plug is damaged, liquid has been spilled or objects have fallen into the instrument, the instrument has been exposed to rain or moisture, does not operate normally, door fails to close or has been dropped. CAUTION RISK OF ELECTRICAL SHOCK DO NOT OPEN CAUTION: DO NOT REMOVE COVER. NO USER SERVICEABLE PARTS INSIDE. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL. UM0001DOC

6 WARNING To reduce risk of fire or electric shock, do not expose the CDx Reader to extreme heat, extreme cold, moisture or water. This instrument should not be used near water for example, near sinks, washbasins, etc. Do not allow foreign objects to get into the enclosure. If the unit is exposed to moisture, or a foreign object gets into the enclosure, immediately disconnect the power cord from the wall. Take the unit to a qualified service person for inspection and the necessary repairs. The CDx Reader operates off power sources 100 to 240 VAC. It may also be operated at 50/60 Hz line frequency. The unit is autosensing for power configuration. The instrument should be situated so that its location or position does not interfere with its proper ventilation. For example, the appliance should not be situated on towels or similar surface that may block the ventilation openings, or placed in an enclosed or semi enclosed area, such as a shelving unit or cabinet, that may impede the flow of air through the ventilation openings. Care should be taken so that objects or liquids do not fall on or inside the instrument. The CDx Reader is designed for table top usage only. The CDx Reader must be placed on a fixed, level surface strong enough to support its weight. Connect the CDx Reader to the power outlet only with the supplied 3 prong grounded power supply cord or an exact equivalent. The cable should be connected to a properly grounded 3 conductor wall outlet. Do not modify the supplied cable in any way. Extension cords must be rated for adequate current. Power cord for countries other than North America are not included, but can be made available if requested. Do not route the power cord where it can be crushed, pinched, bent at severe angles, exposed to heat, or damaged in any way. If the cord shows any sign of wear or damage, immediately stop using it and obtain a proper replacement from a qualified service agency or from the Crystal Diagnostics Customer Service department. If the CDx Reader shows signs of improper operation, or if it has been dropped or damaged in any way, immediately disconnect the power cord from the power outlet. Contact Crystal Diagnostics Customer Service department and speak to a qualified Service Technician to determine if the instrument requires repair. DECLARATION OF CONFORMITY 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 ISTRUMENT MUST ACCEPT ANY INTERFERRENCE RECEIVED, INCLUDING INTERFERENCE THAT MAY CAUSE UNDESIRED OPERATION. ANY CHANGE OR MODIFICATION TO THIS INSTRUMENT WITHOUT PERMISSION OF CRYSTAL DIAGNOSTICS MAY VOID THE USER S AUTHORITY TO OPERATE THIS INSTRUMENT. 3 UM0001DOC 1.00

7 Basic Operation Included with the purchase of your CDx Reader is the installation and setup of your system and a brief but comprehensive training. Most of the features of your instrument will be reviewed during the training process. Refer to the user manual or contact CDx Customer Service should you have further questions once training is completed. A valuable feature of the CDx Reader is its ability for remote communications, thus allowing the instrument to upgrade its internal software, test reports, print to a local printer, as well as provide remote diagnostics. These functions are accomplished via its Ethernet, USB (optional) or WiFi connection. During setup, your CDx Customer Service Representative will optimize your instrument to make full use of these functions, pending local service and equipment availability. During normal operations and after completion of each pathogen test, a Certificate of Analysis (COA) can be sent as a PDF to multiple designated representatives with valid addresses. Once an address is provided and programmed, a test COA will be sent and verified as part of the training. An example of the COA can be viewed on Page 22. Additionally, your CDx Reader has the ability to print the COA locally (optional) via the USB or Ethernet port. For a list of compatible printers, refer to Advanced Operation Printer Setup. As part of the setup of your instrument, a wireless keyboard with mouse pad will be paired with your CDx Reader. If you have multiple CDx Readers installed, each reader will have its own keyboard paired specifically to that instrument. The keyboard allows for optional textual descriptions to be added for testing. The keyboard is NOT required to operate the CDx Reader. Should a keyboard become damaged or inoperative, contact CDx Technical Support for assistance. When using the CDx Reader, you will be queried for different input selections on the 4.3 color liquid crystal display (LCD). Your selections can be made using the keyboard, the mouse pad on the keyboard or the touch screen on the LCD. To use the keyboard to make your selection, simultaneously press Alt and the character underlined (typically the first character) within that selection field. Alternatively, you may use the arrow or Tab keys to move to the desired selection or input field and press Enter. To use the mouse pad to make your selection, slide your finger over the surface of the mouse pad and a cursor will move accordingly on the LCD. Once you have positioned the cursor over the desired field or button, press the LEFT key switch below the mouse pad to select. To use the touch screen to make your selection, touch the surface of the LCD with your finger at the location of the desired field or button. UM0001DOC

8 Basic Operation Power up To power up the CDx Reader the first time, you must first turn on the primary power switch located on the rear of the instrument. Once the primary power switch is on, press the Stand by power button located on the front of the instrument. This button is the principal means for turning the CDx Reader on and off. Additional stand by operations will be described later in the manual. Warning: In case of emergency, you should immediately power off the CDx Reader using the primary power switch located on the rear of the instrument. The CDx Reader is a sophisticated instrument with considerable computing power. As such, Crystal Diagnostics has taken great care in verifying the unit s health and operation. Additionally, the CDx Reader will update its software via its Ethernet connection or USB port as revisions become available. Updates might include new pathogenic target selections, feature enhancements, or revised algorithms for increased detection sensitivity. Once the primary power has been switched on, followed by depressing the Stand by power, the CDx Reader s initial power up (boot) screen will appear within a few seconds. The progress bar at the bottom indicates the status and takes approximately 60 seconds to complete. During the initial boot process, the CDx Reader will conduct an internal hardware test, verify network communication and perform its initial calibration. After testing and calibration, the CDx Reader will begin a cooling down process. The internal temperature of the instrument is maintained at approximately 17 C. This is the ideal temperature for the liquid crystal biosensor to provide optimal results. For additional details on the science behind the pathogen detection process, visit the Crystal Diagnostics web site 5 UM0001DOC 1.00

9 The initial cooling down period takes approximately 15 minutes. This time will vary as it is dependent on the ambient temperature and humidity of the room in which it is located. Once the initial cool down is completed, the unit will maintain the required temperature until turned off. UM0001DOC

10 Basic Operation Select Reader Function After initial power up or the completion of a test, you will be prompted to select how the CDx Reader will manage time and temperature of a sample filled BioCassette. There are three functions of operation, allowing for the greatest amount of flexibility. The functions are divided into two areas: running a test with an External Cooler (incubator) and without. A typical test, when pre cooling the BioCassette and sample mix, takes approximately 10 minutes. When the CDx Reader is providing cooling internally, a typical test takes approximately 20 minutes. With External Cooler To achieve expedited throughput, use the CDx Reader in conjunction with an optional incubator. The incubator typically supplied with the system is the Heratherm IMC18 Microbiological Incubator and is set to 17 C, similar to the temperature maintained by the CDx Reader. This allows for pre cooling of the sample filled BioCassette prior to placing it in the instrument. Pre cooling the BioCassette and sample mix saves time by eliminating the need for the CDx Reader to perform the cooling operation, allowing it to skip directly to imaging the samples. If testing requires the use of two BioCassettes per test (discussed later in the manual) and you are using the External Cooler, you have two options: you can either have the CDx Reader begin testing the first BioCassette immediately by selecting From Mini Env (20/10 minute test), which requires immediately moving the BioCassette directly from the CDx Mini Controlled Environment to the instrument, while holding the second BioCassette in the incubator until the instrument is ready, or you can select Pre Cooled (10 minute test) and process both BioCassettes by first placing them in the incubator for at least 10 minutes, and then into the CDx Reader. Without Cooler Attention: For proper results when using an incubator to pre cool, the sample filled BioCassette must remain in the incubator for a minimum of 10 minutes. Additionally, to minimize the effect of the ambient room temperature, be swift when transferring the BioCassette from the incubator to the instrument. If you are not using an optional incubator, select Without Cooler (20 minute test). This is the standard process for the CDx Reader. When directed, you will transfer the target BioCassette from the CDx Mini Controlled Environment to the instrument. The instrument will begin the cool down process of the BioCassette and sample mix, followed by imaging. The total processing time is approximately 20 minutes. 7 UM0001DOC 1.00

11 Basic Operation Select Test Once the Reader Function has been selected, you will then select the pathogen target test and number of samples to be tested, followed by Ok. The pathogen target test selected, e.g., (S) Salmonella, can be changed by first selecting the pull down list (clicking anywhere within the selection bar), followed by choosing the desired pathogen target. This can be changed any time prior to clicking Ok. The next selection identifies how many samples will be tested simultaneously, e.g., 3 Samples (2 cassettes). The number of samples in combination with the type of antibody target selected dictates the number of BioCassettes required (1, 2 or 3). The chart below will assist you in determining which combination works best for your application. 1 Single Panel Antibody Multi Panel Antibody 1st BioCassette 2nd BioCassette 1st BioCassette 2nd BioCassette 3rd BioCassette Samples Legend: = Negative Control Legend: = Negative Control = Target Antibody = Panel A Multi Panel Alternate 1st BioCassette = Panel B UM0001DOC

12 A general rule when testing a single sample, a single BioCassette is used. Refer to the specific Antibody Kit protocol you are using for additional BioCassette loading procedures. If additional testing will be conducted using the same configuration, you can save your settings by selecting Set as Default. The next time this menu is displayed, those settings will be pre set. Once you have chosen your test target pathogen and number of samples to be tested, select Ok. 9 UM0001DOC 1.00

13 Basic Operation Sample Description After completing Select Test, you may add a description to each of the samples to be tested (up to 80 characters). Additionally, you may add a general description in the Notes field (also up to 80 characters). Any text added for sample descriptions or to the Notes field, will be included on the Certificate of Analysis document, both ed and printed locally (optional). Sample descriptions may be unique, e.g., Sample 1: 283 Lot Code , Sample 2: 283 Lot Code , and Sample 3: 283 Lot Code Once you have entered the desired text description for each of the samples to be tested and the text in the Notes field, select Ok. If for any reason you need to modify the selection on the previous screen, you may select the Back button to make the necessary corrections. UM0001DOC

14 Basic Operation Testing After the test descriptions are added, the CDx Reader will eject the tray for the BioCassette. Warning: Never prevent the tray from ejecting, obstruct the motion of the tray, push on the tray or attempt to assist the tray mechanism. Doing so may cause critical damage to the instrument. Once the tray is fully extended, place the first BioCassette in the tray with the numbers on the BioCassette facing towards you. Depending on the number of samples selected and the target specified, additional BioCassettes may be required (after the initial BioCassette is complete). Once the BioCassette is seated flat in the tray, select Ok. Again, if for any reason you need to modify the selection on the previous screen, you may select the Back button to make the necessary corrections. Caution: Avoid extended periods of time where the instrument door is in the open position. Keeping the instrument door closed will allow the CDx Reader to better maintain its internal temperature. After selecting Ok, the CDx Reader will retract the tray. 11 UM0001DOC 1.00

15 Once the tray has fully retracted, the CDx Reader will begin the testing process. If the BioCassette was pre cooled, the testing process will take approximately 10 minutes. If the BioCassette was NOT pre cooled, the process will take approximately 20 minutes. The process to test the samples within the BioCassette is based on the disruption of the liquid crystal matrix. Once the CDx Reader identifies alignment of the liquid crystal matrix within the BioCassette, the instrument will begin imaging the individual cells. If antigens within the sample being imaged have bound to the antibody covered microspheres, an aggregate will form and a distortion will be created exceeding a critical diameter (3 5 microns) in the aligned liquid crystal matrix. A disruption is a positive. No disruption is a negative. After the CDx Reader has completed imaging the FIRST BioCassette, the data is processed and analyzed. The instrument turns the images into data points it can manipulate. As part of the evaluation, the instrument compares the baseline data (the negative sample) against the target sample. This comparison determines if the sample being tested is positive or negative for the target pathogen. If only one BioCassette is required, skip to the Basic Operation Results section of the manual. UM0001DOC

16 Basic Operation Multiple BioCassettes If two or more BioCassettes are required for testing, you will be prompted to prepare for the next BioCassette. Press Ok when you are ready to insert the next BioCassette. After selecting Ok, the CDx Reader will again eject the tray. Once the tray is fully extended, remove the existing BioCassette and place the next BioCassette in the tray; the numbers on the BioCassette should be facing towards you. Warning: BioCassettes are single use ONLY and should be treated as biohazardous. Dispose of them properly after removal from the instrument. Once the BioCassette is seated flat in the tray, select Ok. Again, if for any reason you need to modify the selection on the previous screen, you may select the Back button to make the necessary corrections. After selecting Ok, the CDx Reader will retract the tray. DO NOT attempt to push the tray inward, as this may damage the instrument. 13 UM0001DOC 1.00

17 Once the tray has fully retracted, the CDx Reader will begin the testing process for the next BioCassette. Again, if the BioCassette was pre cooled (and this option was selected), the testing process will take approximately 10 minutes. If the BioCassette was NOT pre cooled, the process will take approximately 20 minutes. The test data will be processed once the CDx Reader has completed imaging the current BioCassette. The instrument turns the images into data points it can manipulate and further analyze. If an additional BioCassette is required once the CDx Reader has finished processing the current data, return back to the Basic Operation Multiple BioCassettes section of the manual. UM0001DOC

18 Basic Operation Results At his point the CDx Reader has completed imaging all of the required BioCassettes and the data has been processed. The results of the test will be displayed on the LCD as well as ed to the designated contacts in the form of a Certificate of Analysis (COA). If the optional printer is installed, a local copy of the COA will also be printed. A sample of a COA is located on page 22 and can be used for internal or external verification. Each sample will show one of three results (POSITIVE, NEGATIVE or RETEST) along with the description entered at the beginning of the testing process, e.g. Sample 1: Negative 283 Lot Code , Sample 2: Negative 283 Lot Code , and Sample 3: Negative 283 Lot Code POSITIVE The instrument identified a significantly higher signal to noise ratio as compared to the negative control. NEGATIVE The instrument identified a signal to noise ratio that was comparable to the negative control. RETEST The instrument identified an exceedingly high or extremely low signal to noise ratio as compared to the negative control. One potential cause might be improper BioCassette preparation. Refer to the specific Antibody Kit protocol for diagnostic information or contact a Technical Service Representative for assistance. Press Ok when you have completed logging the test results. At this point the test has concluded. The CDx Reader will prompt you to either select Ok and step you through the process for another test, or Back to review the data from the previous test. Warning Once Ok is selected, the data from the current test will no longer be available (although the will still contain the test results and the COA). 15 UM0001DOC 1.00

19 The CDx Reader will again eject the tray. Once tray is fully extended, remove the BioCassette from the tray and dispose of properly. Press Ok once the BioCassette has been removed and the CDx Reader will retract the tray. As soon as the tray has retracted fully, you will return to the initial screen allowing you to conduct an additional test; Basic Operation Select Reader Function. UM0001DOC

20 Basic Operation Abort Test At any time during the testing process you may abort a test. To do this, momentarily press and release the Stand by power button on the front of the instrument. When prompted, select Abort current test. The CDx Reader will return to the initial screen allowing you to start over. If you wish to continue the testing from the point of the interruption, select Ignore and continue running. The instrument will return to the point in the test from which it came. Attention: Attempting to abort the current test while the CDx Reader is imaging the BioCassette may cause a momentary delay in the instruments responsiveness. You will be able to make your selection once the instrument completes its task. If a test is aborted and a BioCassette remains inside the CDx Reader, you will have an opportunity to remove and dispose of it once the next test begins and the tray ejects. 17 UM0001DOC 1.00

21 Basic Operation Power down At any time, you may power down the CDx Reader. To do this, press and hold the Stand by power button on the front of the instrument for 7 seconds. The CDx Reader will power off and remain in stand by until the Stand by power button is pressed again. Alternatively, momentarily press and release the Stand by power button. When prompted, select Power off unit (will end running test). If you wish to continue the testing from the point of the interruption, select Ignore and continue running. The instrument will return to the point in the test from which it came. If the CDx Reader is powered off and a BioCassette remains inside the instrument, you will have an opportunity to remove and dispose of it once the CDx Reader is powered back on, a test begins and the tray ejects. UM0001DOC

22 Advanced Operation The CDx Reader has several advanced operations available, if factory enabled. These operations include printer and network configuration, setup and modify user addresses, update system software via a USB flash drive and backup instrument test data to a USB flash drive. To gain access you must first be at the Select Reader Function screen. Once at the correct screen, press Alt F10 on the wireless keyboard and the advanced operation menu will appear. Advanced Operation Printer and Network UPDATE PENDING Advanced Operation Setup UPDATE PENDING Advanced Operation USB Flash Drive UPDATE PENDING 19 UM0001DOC 1.00

23 Product Information, Storage, and Shelf Life The Crystal Diagnostics Xpress Antibody Kits have been optimized for the use of selective enrichment media for their associated targets. Use of enrichment media other than those stated may result in false detection of food background microflora. Liquid Antibody Kits should be stored in the refrigerator at 2 8 C. Lyophilized Antibody Kits can be stored at room temperature in their packing. All other materials should be kept at room temperature (20 25 C). Avoid temperature extremes from freezing or overheating. An expiration date and product code is located on the outside of the Antibody Kit as well as the individual components and should be adhered to strictly for accurate test results. Safety Information Antibody Kits are for human pathogens with a low infectious dose (pathogen ingestion of only a few cells can lead to severe illness). The use of gloves, protective clothing, and eye protection are recommended for all sample handling. Equipment and surfaces should be disinfected prior to testing, any time a spill, splash or suspected loss of sample have occurred, and again at test completion. Material Safety Data Sheets (MSDS) are available at and should be downloaded and read by all personnel using the materials. General class II biosafety practices should be followed throughout testing ( Biosafety in Microbiological and Biomedical Laboratories, US Department of Health and Human Services, Use of a class II laminar flow biosafety cabinet is recommended for processing when pathogens could be aerosolized. Warning: All materials used during testing (e.g., stomacher bags, tubes, gloves) should be treated as biohazard waste and disposed of properly in a biohazard receptacle and bag and destroyed using accepted methods. Technical Assistance Crystal Diagnostics Technical Support 1950 State Route 59, #200 Kent, OH 44242, USA p UM0001DOC

24 Specifications Electrical Input Voltage Range: VAC 50/60Hz Power Consumption: 45W Maximum Mechanical Dimensions: L19 x W13 x H13 ½ L24 ¾ x W13 x H13 ½ (cassette drawer extended) L24 x W24 x H24 (boxed) Weight 55 lbs. 59 lbs. (boxed) Connector Types Ethernet RJ 45 USB (optional) WiFi Antenna (qty. 2) Power Cord Connector EIC 320 (Power Cord for countries other than North America not included) Miscellaneous Detection: Antibody Based Liquid Crystal BioDetector (Disruption in an aligned liquid crystal matrix within the BioCassette caused by aggregation of antibody covered microspheres binding to the target antigen) 14.6 Megapixel HD Digital Imagers (qty. 5) Approximately 2 x 10 4 CFU/ml Detection Limit (target dependent) 3 5 micron Detection Size User Interface: 4.3 Color LCD Touch Screen Wireless Keyboard and Mouse Pad Web Browser (optional) Regulatory Certification: AOAC CE EN / IEC (pending) FCC Part Class B / EN55011A / CISPR 11A (pending) CSA / ESU (pending) 21 UM0001DOC 1.00

25 Certificate of Analysis Sample The COA includes your company name and address, CDx Reader serial number and software version information, date and time of test, test type (antibody target), test format (number of samples and BioCassettes), test results and notes. UM0001DOC

26 510 Compton St., Suite 106 Broomfield, CO 80020, USA p f Copyright 2015 Pathogen Systems, Inc., Broomfield, CO USA