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POC coordinators can standardize test procedures, enforce QC protocols, control access privileges, define operator recertification requirements, and more. Diabetes: Featured Topics Learn about how in-office HbA1c testing can improve diabetes decision-making and patient outcomes, all while helping lead to a healthier life. Chronic Disease Management Help assess the appropriate care pathway for patients with or at risk of chronic diseases.Clin Chem 2010;56(1):44. Diabetes Care 1999;22:1785-9. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details. I would like to be contacted by a Siemens representative. I would like to receive e-mails from Siemens Healthineers I hereby consent to the processing of my above given personal data by the Siemens Healthineers company referred to under Corporate Information and for the purpose described above. Further information concerning the processing of your data can be found in the Data Privacy Policy. I am aware that I can partially or completely revoke this consent at any time for the future. Patient satisfaction with point-of-care laboratory testing: report of a quality improvement program in an ambulatory practice of an academic medical center. Clinica Chimica Acta. 2013;424:8-11. 2 Schnell, et al. Impact of HbA1c testing at point of care on diabetes management. Journal of Diabetes Science and Technology. 2017;11(3):611-17. 3 Petersen J, et al. Effect of point-of-care on maintenance of glycemic control as measured by A1C. Chronic Disease Management Help assess the appropriate care pathway for patients with or at risk of chronic diseases. http://www.elmor.com.pl/userfiles/ford-expedition-owner-manual-1998.xml honda cb400 super four service manual pdf, honda cb400 super four workshop manual pdf, honda cb400 super four workshop manual download, honda cb400 super four service manual download, honda cb400 super four service manual download free, honda cb400 super four service manual download pdf, honda cb400 super four service manual download online, honda cb400 super four service manual download 2017. Educational Resources Point-of-care resources at your fingertips Next References Clin Chem 2010;56(1):44. Diabetes Care 1999;22:1785-9. Due to regulatory reasons their future availability cannot be guaranteed. Meet lab-quality testing standards with an analyzer that speeds and simplifies diabetes tests and delivers accurate, clinically relevant results shown to improve decision-making, patient compliance, and outcomes.Fast, actionable test results enable you to determine the effectiveness of a treatment plan, make therapeutic adjustments with confidence, and be more certain whether patients are complying with your recommendations.Reagents, controls, and consumables may be available. Service contracts may be available Once the user has seen at least one product this snippet will be visible. Meet lab-quality testing standards with an analyzer that speeds and simplifies diabetes tests and delivers accurate, clinically relevant results shown to improve decision-making, patient compliance, and outcomes.Fast, actionable test results enable you to determine the effectiveness of a treatment plan, make therapeutic adjustments with confidence, and be more certain whether patients are complying with your recommendations.This advanced point-of-care analyzer makes consultations easier by monitoring glycemic control and diabetes complications. Users can meet lab-quality testing standards with this analyzer. It speeds and simplifies diabetes tests and delivers accurate, clinically relevant results to improve decision-making, patient compliance, and outcomes. Self-contained cartridges facilitate easy walkaway operation after sample loading, with no sample or reagent preparation. The device also comes with a bar-code scanner which minimizes transcription errors and generates an audible alert to confirm a successful scan. Maintenance requirements are minimal and automatic reminders alert when maintenance is due. http://rizecanreklam.com/images/ford-expedition-online-manual.xml Reliable lab equipment suppliers offer leasing plans and reagent rental agreements for this analyzer, both great options for labs with budget constraints. With the increasing incidence of Type 2 diabetes, the volume of HbA1c testing conducted byclinical laboratories has increased dramatically in recent times. Numerous point-of-care analyzers are available in the market today for fast and reliable HbA1c testing. The DCA Vantage Analyzer simplifies diabetes testing, delivering accurate, clinically relevant results during the patient visit to help physicians and nurses improve patient decision-making and diabetic patient compliance. This analyzer supports lab managers with its ease of use, powerful functionality, versatile data management, and reporting options to suit different test environments and workloads. The device provides fast results for HbA1c from a whole blood sample in six minutes, minimizing the need for follow-up visits. The unit also detects Albumin, Creatinine, and Albumin-to-Creatinine (A:C) ratio from a urine specimen in 7 minutes to report a quantitative protein status with automatic creatinine adjustment. This unit's bar-code scanner minimizes transcription errors, and generates an audible alert to confirm a successful scan. Customized alerts, reports, and audit trails ensure peace of mind. In May 2018, Siemens Healthineers and Hill-Rom had signed a co-marketing agreement to provide a suite of point-of-care diagnostic instruments that will enable primary healthcare providers in the U.S. to bridge gaps in diabetes care and satisfy value-based quality measures in a single office visit.Our collection of point-of-care analyzers features the Siemens DCA Vantage, a reliable diabetes system that delivers accurate clinically relevant HbA1c and A:C ratio results proven to improve decision-making, patient compliance, and treatment outcomes. http://www.familyreunionapp.com/family/events/driver-parallel-lines-manual This user-friendly device delivers lab-quality performance and is ideal to monitor glycemic control and detect early kidney disease in various environments such as the physician office and point-of-care coordinated sites in hospitals and multisite practices. Self-contained cartridges facilitate easy, walk away operation after sample loading. Flexible result recording options and patient trending graphs greatly improve decision making. Once the user has seen at least one product this snippet will be visible. Learn More. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results At HbA1c levels of 5.1 and 11.2, total coefficients of variation (CV) for the In2it were 4.9 and 3.3, respectively, and for the DCA Vantage were 1.7 to 1.8 and 3.7 to 5.5 depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5 for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly. Keywords: HbA1c, point of care, regulation Introduction Hemoglobin A1c (HbA1c), reflecting mean glycemia, is used as a risk parameter for diabetic complications and as a quality assurance indicator for the quality of diabetes care. Point-of-care (POC) instruments for HbA1c are widely used in the world for the measurement of HbA1c. The rapidity of obtaining a result can increase clinical effectiveness and contribute to improved outcomes for patients, but it is imperative that the result provided by the device is accurate and reliable. A faster result is only safe if it is an accurate result. Point-of-care instruments for HbA1c provide relatively quick results and minimize patient inconvenience. The bias of these instruments was compared with three certified International ederation of Clinical International Federation of Clinical Chemistry (IFCC) and or National Glycohemoglobin or National Glycohemoglobin Standardization Program (NGSP) secondary reference measurement procedures, which were calibrated with secondary reference material with assigned IFCC and derived NGSP values and with the mean of the three methods. Moreover, instruments were tested on differences obtained with capillary blood versus venous blood by nurse practitioners at a diabetes care center. Methods The evaluation consisted of an analytical part by the laboratory and an end-user evaluation by nurse practitioners at a diabetes care center investigating user-friendliness and differences between capillary and venous blood. To check overall calibration and bias, the mean of duplicates of POC instruments in the EP-9 procedure was compared to the mean of the three reference measurements procedures. An informed consent was obtained from all patients prior to blood collection in accordance with the local ethical committee. Approximately 90 of the measurements was done by two different nurse practitioners, whereas the other 10 was done by three different nurse practitioners. The nurse practitioners were asked about user-friendliness, advantages, and disadvantages of the different POC analyzers. Statistics Computations were performed using EP Evaluator Release 8 (David G. Rhoads Associates, PA). 9 Results Table 1 shows precision results of the EP-5 protocol. At HbA1c levels of 5.1 and 11.2, total coefficients of variation (CV) for the In2It were 4.9 and 3.3, respectively, and for the DCA Vantage were 1.7 to 1.8 and 3.7 to 5.5 depending on the lot number of the cartridges. Table 2 gives an overview of method comparison results achieved with the EP-9 protocol. The 95 confidence intervals (CI) at medical decision points (MDP) of 6 and 9 HbA1c, respectively, show that the In2it and the DCA Vantage were significantly deviant from any of the three reference methods.Open in a separate window Figure 1. (A) Scatter plot of the EP-9 protocol comparing the mean of the three secondary HbA1c reference methods (SRM) expressed in percentage HbA1c with the first lot number tested on the In2it from Bio-Rad. Blue dashed vertical lines represent MDP. Medical decision points were calculated with the EP evaluator. (B) Scatter plot of the EP-9 protocol comparing the mean of SRM expressed in percentage HbA1c with the second lot number tested on the In2it from Bio-Rad. Medical decision points were calculated with the EP evaluator. Open in a separate window Figure 2. (A) Scatter plot of the EP-9 protocol comparing the mean of the three secondary HbA1c reference methods (SRM) expressed in percentage HbA1c with the first lot number tested on the DCA Vantage from Siemens. Medical decision points were calculated with the EP evaluator. (B) Scatter plot of the EP-9 protocol comparing the mean of the SRM expressed in percentage HbA1c with the second lot number tested on the DCA Vantage from Siemens. Results from the DCA Vantage were not within the specifications of the manufacturer. The total CV at high HbA1c values was 5.5 ( Table 1 ). Differences between duplicates seen in the EP-9 protocol with the In2it were also unusual according to the manufacturer. Seven of the 40 samples showed a difference of more than 1.1 absolute at different HbA1c values (mean absolute differences between duplicates for the In2it were 0.52, DCA Vantage 0.21, Ultra 2 0.06, Tosoh G7 0.05, Tina-quant 0.08). To rule out particular problems with the lot number used, the EP-9 protocol for both methods was repeated with another lot number. Use of a second lot number diminished the mean difference in duplicates for the In2it from 0.52 to 0.27 absolute HbA1c percentage and remained the same for the DCA Vantage and the reference methods. No significant difference was found in both methods between capillary and venous blood. The noise produced by the In2it the first 3 minutes and the last minute of the run time was considered as inconvenient and disturbing by one nurse practitioner. Discussion Point-of-care HbA1c instruments are used more and more frequently. So far, the consequences of the introduction of these new types of instruments with their specific characteristics have not been discussed thoroughly in the literature. The evaluation of two types of POC instruments, the In2it and the DCA Vantage, is used here as an example to discuss several important consequences associated with the introduction of POC instruments in this field. Results of the evaluation of the In2it and the DCA Vantage showed that there is a lot number-dependent performance of both methods. The precision of the In2it expressed in total CV and standard error of estimates in the EP-9 is still a matter of concern. The second lot number showed better results. Unfortunately, one never knows if the precision of a particular lot number is acceptable because no duplicate measurements are run in daily life with POC instruments. The overall calibration of the second lot number for the In2it, as reflected in the overall bias, was acceptable between 6 and 9 HbA1c. Results from the first lot number were influenced by bad duplicates. Also, a recent evaluation of the DCA Vantage, the successor to the DCA 2000, showed a clear bias but was still considered to have acceptable imprecision and good agreement. 13 EP-9 results for the two lots of DCA reagents showed different regression lines. The results were too high (mean bias 0.27) for lot B and slightly low for lot A compared with the mean of the three reference methods and with the individual reference methods. The manufacturer may have overcompensated the calibration of the second lot number in response to results from the first lot number used in this study.The second lot number gave better results (total CV was 3.7). Apart from point-of-care instruments, interlaboratory variation is still a matter of concern and has stabilized at approximately 5. 14 Holmes and colleagues 15 concluded that between-method variability is still a potential source of inaccuracy when HbA1c results are interpreted based on fixed clinical decision thresholds. This is especially the case when POC instruments and laboratory methods are used randomly in the same facility. Unfortunately, CLIA-waived POC instruments, which sustain part of the interlaboratory CV, are not obliged to join external quality schemes. The end users simply have to follow manufacturer's instructions and may therefore escape from the rules imposed on laboratory methods. 17 This is a so-called “hole in the dike.” At one end, proficiency testing criteria will be tightened (laboratory methods) and at the other end there will be no rules or very limited rules for CLIA-waived point-of-care instruments. The introduction of POC HbA1c instruments in the market will diminish the number of patient samples that are analyzed on one instrument; as a consequence, the Gaussian curve describing HbA1c results within a certain population is expected to get broader even if the performance of the new instruments will be the same as the HbA1c methods used in the laboratory. Point-of-care instruments increase the total number of analyzers per 1000 persons with diabetes. Therefore, interinstrument CV and intercartridge CV are extra sources of variability added to the total CV in comparison to a laboratory method. So far, the current CLSI evaluation protocols do not cover this phenomenon sufficiently. Results achieved by the NGSP and later on by the I CC working group for the standardization of HbA1c to decrease interlaboratory variability from 20 in 1993 to approximately 5 in 2008 should be supported by adjusting the CLIA-waived rules for HbA1c point-of-care instruments. Annual NGSP manufacturer certification should be done, and every laboratory instrument and every POC instrument should be obliged to join external quality schemes. Adequate actions (improve method or withdrawal from the market) must be administered if the performance of a laboratory and or point-of-care instrument is not acceptable. The manner in which quality controls are being handled may also need to be redefined. To run a quality control occasionally on POC instruments is adequate because it may tell something about the cartridge used but does not provide any guarantee for the next cartridge. However, the consequences of a bad cartridge may be less severe than a bad reagent in the laboratory (it may involve only one result on the POC instrument versus hundreds in the laboratory). Nevertheless, all POC instruments must be equipped with an electronic check on performance. Moreover, the cartridges need to be equipped with an internal HbA1c control. This may not only be true for POC HbA1c, but in general also applies for other POC tests using separate cartridges. In the end, evaluations of POC instruments must be done by end users. However, if manufacturers are capable of producing cartridges without cartridge-to-cartridge variability, the need for an internal quality control may be less important. To achieve this goal, standards need to be tightened at the level of manufacturers. Results presented here were obtained by the work of an experienced technician and are therefore likely the best results one can achieve analytically; EP-5 and EP-9 results obtained by less experienced end users may be less precise. Although the use of POC HbA1c instruments has some negative consequences that need to be addressed, it is also important to keep in mind that producing HbA1c results at the time of the patient's visit can improve patient care as well. Conclusion Performance results from the In2it and the DCA Vantage showed high variability and lot-dependent results. To maintain the interlaboratory CV of 5 for HbA1c, the rules for CLIA-waived point-of-care instruments should be revised. Acknowledgment We thank the nurse practitioners for the POC analyses at the diabetes care center. Abbreviations CAP College of American Pathologists CI confidence intervals CLIA Clinical Laboratory Improvement Amendments CLSI Clinical and Laboratory Standards Institute CV coefficients of variation HbA1c hemoglobin A1c HPLC high-performance liquid chromatography IFCC International Federation of Clinical Chemistry MDP medical decision points NGSP National Glycohemoglobin Standardization Program POC point of care References 1. Cagliero E, Levina EV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Effect of immediate haemoglobin A1c results on treatment decisions in office practice. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. CLSI, Wayne, PA: CLSI Document EP10-A; 1998. CLSI, Wayne, PA: NCCLS Document EP5-A; 1992. CLSI, Wayne, PA: CLSI Document EP9-A; 1995. Available from: www.dgrhoads.com. 10. Guercci B, Durain D, Leblanc H, Rouland JC, Passa P, Godeau T, Charbonnel B, Mathieu Daude JC, Boniface H, Monnier L, Dauchy F, Slama G, Drouin P. Multicentre evaluation of the DCA 2000 system system for measuring glycated hemoglobin. Arsie MP, Marchioro L, Lapolla A, Giacchetto GF, Bordin MR, Rizzotti P, Fedele D. Evaluation of diagnostic reliability of DCA 2000 for rapid and simple monitoring of HbA1c. Szymezak J, Leroy N, Lavalard E, Gillery P. Evaluation of the DCA Vantage analyzer for HbA1c assay. Analytic bias among certified methods for the measurement of hemoglobin a1c, a cause for concern. College of American Pathologists. IL: CAP: Northfield; 2008. CLIA requirements for waived tests. Available from:. Articles from Journal of Diabetes Science and Technology are provided here courtesy of Diabetes Technology Society. Albumin-to-Creatinine (A:C) ratio from a urine specimen in 7 minutes to reportPC via a USB flash drive to reduce manual logging and save time Minimal maintenance requirementsPOC coordinators can standardize test procedures,Customized alerts, reports, and audit trails ensure. DCA 2000, DCA, DCA Vantage, and RAPIDComm are trademarks of Siemens Healthcare Diagnostics. All other trademarks are the property of their respective owners. The following table describes how this manual is organized. If you want to... then refer to... BIOHAZARD Warning statements alert you to conditions that may cause personal injury. WARNING Caution statements alert you to conditions. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed using the DCA Vantage system are intended for in vitro diagnostic use. Messages, options, and requests for information display, and responses are made by selecting the appropriate key symbol on the screen. You can then insert the USB memory drive into another DCA Vantage system and restore the data to the new system. The DCA Vantage system does not support the connection of an NOTE: external computer keyboard or a mouse to enter data. The Home screen displays the time and date and the state of the system. It is the starting point for Patient and Control Test Sequences. After searching by patient ID, narrow the search Graph using a date range. The graph displays. You can print the graph to the external printer. DCA Vantage Operator’s Guide. Additional Settings Select Additional Settings from the System Settings screen to customize the system and add external devices. DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. This overwrites any current data on the system. DCA Vantage Operator’s Guide. Existing settings are overwritten.Do not place the DCA Vantage system on the same bench as a source of vibration.If you need to ship the system, the shipping carton provides the best protection against damage. External Connections Power Plug Power Switch Figure 6 External Connections and Power Connections DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. If no paper is available at the start of printing, the printer does not attempt to print. Software Setup After the system is properly installed, start the DCA Vantage system by toggling the power button to the On position.Configuring Connectivity If you are connecting the DCA Vantage system to a computer or LIS, you must choose the serial or Ethernet port before connecting to these external devices. Otherwise, the previous setting remain in effect. DCA Vantage Operator’s Guide. Otherwise, continue with step 4. 4. Select General 5. Select the down arrow 3 times. 6. Select Install Software DCA Vantage Operator’s Guide. You can add up to 1000 operators. Each Operator ID and access code must be unique. When system access is set to Fully Restricted or Restricted Plus, the operator enters his or her access code to continue. DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. Opening the Reagent Foil Package 1. Remove one foil package (containing a reagent cartridge) from storage. For more information, see Recommended Procedures for Handling Reagent Cartridges in the DCA Systems Reagent Kit package insert. DCA Vantage Operator’s Guide. Scissors can damage the reagent cartridge, the flexible plastic pull-tab on the cartridge, or the desiccant bag. Figure 7 Opening Reagent Cartridge Package 3. Remove the contents of the package. DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. Glass Capillary Absorbent Pad Latching Mechanism Figure 9 Capillary Holder DCA Vantage Operator’s Guide. Attempting to fill the capillary in this manner most often results in blood touching the capillary holder. If blood touches the capillary holder, discard the capillary holder. DCA Vantage Operator’s Guide. Repeat the procedure using a new capillary holder. 6. Inspect the glass capillary for the presence of bubbles. If bubbles are obvious, discard the capillary holder and repeat the procedure using a new capillary holder. DCA Vantage Operator’s Guide. Glass Capillary Reagent Cartridge Figure 13 Inserting Capillary Holder into a Reagent Cartridge DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. If no beep sounds, repeat procedure. Barcode track dot Figure 14 Scanning the Reagent Cartridge DCA Vantage Operator’s Guide. If you accidentally close the door before you pull the flexible plastic tab, NOTE: you have 5 seconds to reopen the door and pull the tab. DCA Vantage Operator’s Guide. If a scanned barcode has an odd number of characters, the symbology adds a leading zero, up to the maximum of 24 characters. To print manually, select. If the print button is not enabled, then the Print printer is disabled in Setup, or there is no paper. DCA Vantage Operator’s Guide. Result Description The serial number of the DCA Vantage System Serial Number system.For example, the system can report test results in IFCC standard or NGSP units, or both. DCA Vantage Operator’s Guide. This action releases (unlocks) the cartridge. Reagent Cartridge Release Button Figure 16 Removing the Reagent Cartridge DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. Starch Plug Figure 18 Filling the Capillary with Urine DCA Vantage Operator’s Guide. If sample loss is obvious, discard the capillary holder; then repeat the procedure using a new capillary holder. DCA Vantage Operator’s Guide. If bubbles are obvious, discard the capillary holder; then repeat the procedure using a new capillary holder. DCA Vantage Operator’s Guide. Do not dislodge the sample from the glass capillary or erroneous results may occur. Glass Capillary Reagent Cartridge Figure 20 Inserting the Capillary Holder into Reagent Cartridge DCA Vantage Operator’s Guide. NOTE: If no beep sounds, repeat the procedure. Barcode Track Dot Figure 21 Scanning the Reagent Cartridge DCA Vantage Operator’s Guide. The cartridge is designed to fit only one way into the system. Do not NOTE: force the cartridge into the system. Figure 22 Inserting Reagent Cartridge into System DCA Vantage Operator’s Guide. While a test is running, a display shows the time remaining and a Cancel button. If a test in progress is cancelled, you must discard the sample. To cancel a test, select Cancel. DCA Vantage Operator’s Guide. Result Description The serial number of the DCA Vantage System Serial Number system.In certain cases, no ratio is reported (---). DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. If System Access is set to Unrestricted, Restricted, or Restricted Plus, this screen does not display. The default security setting is set to NOTE: Off so that an access code is not required DCA Vantage Operator’s Guide. To use the search feature, this option is configured in System Settings, NOTE: Additional Settings. 1. From the Home screen, select Recall 2. From the Recall menu, select Patient Tests DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. NOTE: This screen displays only when both printers are configured and ready to print. 1. At the Patient Test Result screen, select Print The Printer Selection screen displays. DCA Vantage Operator’s Guide. Regardless of the printed report type setting, the system transmits the long-form report. DCA Vantage Operator’s Guide. To print a graph, you must have an external printer connected to the DCA Vantage system.Scanning the calibration card enters the information on the DCA Vantage system. 1. Locate the dot on the system next to the barcode track. Barcode track dot Figure 25 Scanning Hemoglobin A calibration card 6. To return to the Home screen, select DCA Vantage Operator’s Guide. DCA Vantage Operator’s Guide. Contact with the open end could result in a loss of sample. 10. Inspect the capillary holder for the presence of any bubbles. If bubbles are obvious, discard the capillary and repeat the collecting NOTE: procedure. DCA Vantage Operator’s Guide. Do not dislodge the sample in the glass capillary because erroneous results may occur. Figure 27 Capillary holder Reagent cartridge Figure 28 Inserting Capillary Holder into Reagent Cartridge DCA Vantage Operator’s Guide. If no beep sounds, repeat the scanning procedure. DCA Vantage Operator’s Guide. You can set the QC test reminder message to display only or display and require a QC test for selected control tests each time a patient test is run. To customize QC Reminders: 1. At the Home screen, select Menu 2. Select System Settings 3. Select Additional Settings 4. Select Control Tests 5.