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User Manual - BC Group International Inc.
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1. A UNIT OF BC GROUP INTERNATIONAL INC DEFIBRILLATOR ANALYZER CALIBRATION STANDARD Belibrilistor Analyzer calibration Inierface m Module Analyzer Calibration Standara DA CS 06 USER MANUAL BC BIOMEDICAL DA CS 06 TABLE OF CONTENTS WARNINGS CAUTIONS NOTICES sau anne aan u DESCRIPTION ee een 1 Ar OUT ee een 2 CALIBRATION VERIFICATION 3 MAIN SCREEN 3 MENU RIE ns 4 MENU N ses reset 5 NEST SETUP near 6 TOLERANCBADJIUSTMENT susana 7 TEIL nara LAU 7 CONTRAGEBULTO NS m T 8 AUTO SCALING 9 MANUAL 10 WIN BR VARAS 10 SPECIFICATION een se een 11 NOTE uae 12 WARNING USERS The DA 2006 Series Analyzers are for use by skilled technical personnel only WARNING USE The DA CS 06 is intended for calibration of Defibrillator Analyzers only and should never be used in diagnostics treatment or any other capacity where they would come in contact with a patient WARNING CONNECTIONS All connections to patients must be removed before connecting the DUT to the Calibration Standard A serious hazard may occur if the patient is connected when testing with the Analyzer or Calibration Standard Do not connect any leads
2. view Display Option This option drops down the Display Option List Display Options Print Options Print Option This option drops down the Print Option List Display Options List Show Waveform This option determines whether the waveform graph is shown on the screen Allow Datapoint View This option determines whether the user can view the individual voltage readings measured by the A D converter Print Options List View Print Detailed Test Results This option determines if Display Options gt the report printout contains just a Pass Fail or if it Print Options Fi Print Detailed Test Results d th C lib t D t DUT D Technician Fan also INCIU es e allDrator Data ala Print DataPoints Tolerance Limits and Error miit 2 r Print Waveform This option determines if the waveform plot is included in the report printout Print Datapoints This option determines if the individual A D datapoints are included in the report printout TEST SETUP The Test Setup part of the Main Screen is used to enter all of the information about the DUT as well as the user and calibrator being used All of the fields that have a drop down arrow maintain a history of entries As data is entered it is compared to any entry previously used If a new entry is made it is added to the history list for quick future reference See the Menu File section for clearing the list histor
3. from the patient directly to the DUT NOTICE DISCLAIMER BC GROUP INTERNATIONAL INC WILL NOT BE RESPONSIBLE FOR ANY INJURIES SUSTAINED DUE TO UNAUTHORIZED EQUIPMENT MODIFICATIONS OR APPLICATION OF EQUIPMENT OUTSIDE OF THE PUBLISHED INTENDED USE AND SPECIFICATIONS NOTICE DISCLAIMER BC GROUP INTERNATIONAL INC RESERVES THE RIGHT TO MAKE CHANGES TO ITS PRODUCTS OR SPECIFICATIONS AT ANY TIME WITHOUT NOTICE IN ORDER TO IMPROVE THE DESIGN OR PERFORMANCE AND TO SUPPLY THE BEST POSSIBLE PRODUCT THE INFORMATION IN THIS MANUAL HAS BEEN CAREFULLY CHECKED AND IS BELIEVED TO BE ACCURATE HOWEVER NO RESPONSIBILITY IS ASSUMED FOR INACCURACIES CONTACT INFORMATION BC BIOMEDICAL BC GROUP INTERNATIONAL INC 3081 ELM POINT INDUSTRIAL DRIVE ST CHARLES MO 63301 USA 1 800 242 8428 1 314 638 3800 www bcgroupintl com sales bcgroupintl com DA CS 06 User Manual Copyright 2012 www bcgroupintl com Made in the USA 08 12 Rev 04 This Page Intentionally Left Blank BC BIOMEDICAL DA CS 06 DEFIBRILLATOR ANALYZER CALIBRATION STANDARD The Model DA CS 06 is a sophisticated calibration standard system for Defibrillator Analyzers It consists of a Standard an Interface Module and a PC based Software Interface The following are highlights of some of the main features e WORKS WITH DEFIBRILLATOR ANALYZERS FROM ALL MANUFACTURERS USES ANALYZER LOAD FOR MAXIMUM ACCURACY 16 BIT RESOLUTION 10 000 SAMPLES PC BASED DI
4. GITAL INTEGRATOR FULL NIST TRACEABILITY CALIBRATION IS MAINTAINED IN THE HARDWARE NOT THE SOFIWARE FOR EASE OF RECALIBRATION e SINCE VERIFICATION IS DONE BY COMPARISON ANY DEFIB SOURCE MAY BE USED TO GENERATE INPUT LAYOUT This section looks at the layout of the DA CS 06 and gives descriptions of the elements that are present and shows how they should be connected Sample Defibrillator NOTE A specific Defibrillator is not necessary to verify the calibration of a Calibration Verification Software Defibrillator Analyzer to the PC based program for control presented Standard and display of results to verify a This is a sample of a Defibrillator Analyzer falls within typical source the presented Standard Calibration Standard Interface Module Plugs into DUT Input Jacks BC DA Connects via a BNC cable 2006 Series Analyzer pictured to the Calibration Standard Connects to Interface Module using and via a USB cable to the BNC cable PC running the Calibration Verification Software CALIBRATION VERIFICATION SOFTWARE MAIN SCREEN OVERVIEW The following is a general overview of the main operating screen Each part of this Main Screen is described in full detail later in this section Test Setup Used to identify the Device Under Test DUT for reference purposes This data is included on printouts and in the saved data files Test Hesults Used to display the resul
5. ION OF BC GROUP INTERNATIONAL INC THE REFUND OF THE PURCHASE PRICE P Manuals BCGroup DA CS 06_UM Rev04 doc 10 SPECIFICATIONS Monophasic or Biphasic Waveforms METHOD Including Edmark Lown trapezoidal biphasic rectilinear biphasic truncated exponential etc DEFIBRILLATOR Defib Plates Banana Jack 4 6 Spacing Banana Plug 4 6 Spacing DUT Custom Interface available upon request INTERFACE MODULE TO CALIBRATION BNC 50 Q STANDARD USB B USB 2 0 Compatible POWER CONSUMPTION PHYSICAL amp ENVIRONMENTAL ENCLOSURES ee INTERFACE 6 8 x 4 8 x 1 5 Inches SIZE MODULE 172 7 x 121 9 x 38 1 mm CALIBRATION 8 7x4 3x 1 7 Inches STANDARD 221 0 x 109 2 x 43 2 mm WEIGHT CALIBRATION 1 Lbs 0 45 k STANDARD SUEDE TOT OPERATING RANGE 15 to 40 C 59 to 104 F STORAGE RANGE 20 to 65 4 to 149 F CONNECTIONS 11 NOTES Or ESTS ONE sus 1 BC GROUP INTERNATIONAL INC 3081 ELM POINT INDUSTRIAL DRIVE ST CHARLES MO 63301 USA 1 800 242 8428 1 314 638 3800 www bcgroupintl com sales bcgroupintl com DA CS 06 User Manual 08 12 Rev 4 Copyright 2012 Made in the USA
6. ge 2 Reading Joules Low 26 C Range 1000 Joules High Tolerance The test limits can be calculated as either of Range or of Reading Range If of Range is used the Range needs to be properly selected TEST RESULTS The Test Results part ofthe Main Screen contains the results of the latest pulse delivered to the defibrillator Test Results Cal brator Data DUT Data Tolerance Limits 1998 Joules 197 6 Joules 03 0 ta 195 5 Joules DUT Passad 1385 3 1380 1 14242 to 1368 4 Volts 7 0 Amps 27 7 Amps 0 4 to ero Amps DUT Failed Calibrator Data This data is automatically entered as the defibrillator pulse is analyzed by the calibrator NOTE In order for this data to be correct the DUT input impedance must be correct DUT Data This data is the readings taken by the DUT NOTE This information must be entered manually by the user Tolerance Limits This section shows the valid range of DUT Data based on the tolerances selected in the Test Setup section Error This section shows the error between the Calibrator Data and DUT Data based on the of Range or of Reading selection in the tolerance configuration DUT Passed Failed This section indicates whether the test Passed or Failed based on the tolerances selected in the Test Setup section CONTROL BUTTONS These buttons are used to control the operation of the program Sing
7. ies Setup A Customer Name Y Date 1 38 Technician Calibrator Standard DUT Manufacturer Test Reference DUT Madel DUT Senal Number Reading 50 Joules DUT Property 225 1000 Joules e High DUT Input Resistance Ohr Customer Name This field is used to enter the owner of the Device Under Test DUT Tolerance C Low Technician This field is used to enter the name of the person performing the test DUT Manufacturer This field is used identify the manufacturer of the DUT DUT Model This field is used to identify the model number of the DUT DUT Serial Number This field is used to identify the serial number of the DUT DUT Property Number This field is used for additional tracking numbers associated with the DUT DUT Input Resistance This field is used to enter the Input Resistance of the DUT NOTE This field must be updated with each DUT This is used for the power computation and will cause reading errors if it does not match the DUT input impedance Date This field is automatically updated when the program is opened Calibrator Standard Number This field is used to identify the calibrator that is being used for the test Test Reference Number his field is used for tracking the test data TOLERANCE ADJUSTMENT Tolerance han
8. le Trigger Continuous Trigger View Datapoints Save Result Print Results Single Trigger This button will initiate the sampling of the A D converter inputs 10 000 samples are buffered by the A D converter and scanned for a valid defibrillator pulse The A D converter will continuously scan the input until a pulse is detected When a valid pulse is detected it is analyzed and the A D converter stops reading the calibrator input NOTE It is possible for the Calibrator to miss a pulse if it occurs during the time that the samples are transferred from the calibrator to the PC NOTE If the pulse occurs too late in the sample buffer there will not be enough samples to properly analyze the pulse and the test will need to be repeated in which case an error message will be displayed Continuous Trigger This button configures the A D converter to not stop after detecting the defibrillator pulse It will continuously scan the A D input for further defibrillator pulses This can be useful when doing quick visual comparisons on the DUT The data can be entered printed and saved as normal however the PC will operate slowly due to the traffic on the USB View Datapoints This button will show all of the voltage readings taken by calibrator that were used in the pulse analysis NOTE This button may not always be available See the Menu View section for display options Save Results This button allows the user
9. onfiguration Clear List History mm Configuration This option opens the test configuration window Clear List History This option opens the clear list history window Exit This option exits the program Configuration Window This window is used to configure the Channel and Timing Parameters Physical Channel This field identifies the calibrator being used and must match the Device ID pz Configuration Channel Parameters Physical Channel ID ev Minimum value 1 1 0 Maximum Value vr 1 0 Minimum Value This is the minimum scaled voltage that the A D converter can read Maximum Value This is the maximum scaled voltage that the A D converter can read Timing Parameters Samples Channel 1 0000 Sample Rate Hz 1 0000 Save Cancel Samples Channel This is the number of datapoints collected from each read of the A D converter Sample Rate This is the number of samples taken per second Clear List History Window This box is used to erase the history of any drop down data entry boxes Clear List History select Dropdown List History to Clear DUT Manufacturer Check Al W DUTMadel UnCheck All Customer Name en Clear Checked Calibrator Standard Lancel MENUS VIEW View Menu This menu allows the user to select which program sections are visible to the user and which data is included in the report print outs
10. to save the data to an Excel spreadsheet NOTE All data will be saved even if it is not shown on the screen See the Menu View section for display options Print Results This button allows the user to print the collected data AUTO SCALING GRAPH The Waveform part of the Main Screen shows the pulse that was detected by the calibrator NOTE Only 1505 of data is used in the pulse analysis 1500 1000 500 Amplitude volts 500 1000 Time ms MANUAL REVISIONS Revision Revisions Made Rev 01 Origination Hev 02 Specification Method Updated Hev 03 Address Updated Pictures Edited Hev 04 Manual Format Updated Misc Edits LIMITED WARRANTY WARRANT Y BC GROUP INTERNATIONAL INC WARRANTS ITS NEW PRODUCTS TO BE FREE FROM DEFECTS IN MATERIALS AND WORKMANSHIP UNDER THE SERVICE FOR WHICH THEY ARE INTENDED THIS WARRANTY IS EFFECTIVE FOR TWELVE MONTHS FROM THE DATE OF SHIPMENT EXCLUSIONS THIS WARRANTY IS IN LIEU OF ANY OTHER WARRANTY EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANT ABILITY OR FITNESS FOR A PARTICULAR PURPOSE BC GROUP INTERNATIONAL INC IS NOT LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES NO PERSON OTHER THAN AN OFFICER IS AUTHORIZED TO GIVE ANY OTHER WARRANTY OR ASSUME ANY LIABILITY REMEDIES THE PURCHASER S SOLE AND EXCLUSIVE REMEDY SHALL BE 1 THE REPAIR OR REPLACEMENT OF DEFECTIVE PARTS OR PRODUCTS WITHOUT CHARGE 2 AT THE OPT
11. ts of the test NOTE The DUT data must be manually entered Menus File and View Used to configure the program and for data loading storing Amplitude olts Done Test Results Calibrator Data 199 4 Joules 1412 3 Volts 26 0 Amps Single Trigger Da Universal Calibration Verification Tool File View Setup Customer Name GE Medical Date 2n 3 2006 Ver le Technician Calibrator Standard 8 BC 5101 DUT Manufacturer BC Biomedical Test Reference 101 405 001 DUT Madel 2006 Tolerance DUT SerialNumber 11001 Reading DUT Property 551005 20 DUT Input Resistance 50 405 Ohms DUT Data Tolerance Limits 198 7 Joules 195 4 to 203 4 Joules DUT Passed 1408 8 Volts 27 9 Amps 27 4 to 20 6 Amps Continuous Trigger View Datapoints Save Results Print Results 1141 1112 EN 13841 to 1440 5 Volts DUT Failed Auto Scaling Graph Used to show the energy delivered to the DUT Tolerance Adjustment Used to modify the tolerance for DUT Pass Fail determination Control Buttons Used for quick access to common operations MENUS FILE File Menu Open This option allows you to view a previously stored test File View Save This option allows you to save the latest test data in a Microsoft Excel file for future reference Save Print Print This option prints the latest test data C
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