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User Manual - BC Group International Inc.

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1. 51 SENSITIVITY ken itla eer e ie a et c d a ed 53 REFRACTORY PERIOD TES td e ees 55 PRINT MENU SOBEEN 57 PLAYBACK LAST PULSE SCREEN 59 MESSAGES VEA VOI 61 so Ser Ment Best ma LM ecc coh ot ottico 63 POWER UP SETTINGS kc ieaie 64 AUTO SEQUENCE FUNG TION 65 VIEW MODE iiio nio Eu E EQ UR D EEG EE Gio GEO REIP 67 aibi BL GIE EPOR tr Cr ply RP ONUS PT RUP TOR CN 71 PROGRAMMING AUTO 80 MANDBAEBEVISKONS exo dk ku 91 LIMITED WARRANTY cessa ccc i leak ete ara ant ava ndn 91 SPECIFICATIONS nico acf taint einen bane canas vereint n aded cb 92 T M 98 This User Manual covers the following units e DA 2006 DA 2006P WARNING USERS The DA 2006 Series Analyzers are for use by skilled technical personnel only WARNING USE The DA 2006 Series Analyzers are intended for testing only and they should never be used in diagnostics treatment or any other capacity where they would come in contact with a patient WARNING MODIFICATIONS The DA 2006 Series Analyzers are intended for use within the published specifications Any appl
2. T RESULT Joules Stats Charge Timer Will Begin in 75 volte SUE Or d Cancelio Exit L 3 Amps Amp 0 5 rb hal mS When the timer reaches zero a beep will sound and the charge timer will begin counting up The following is an example of the count up timer CONFIGURATION r MT 1 n a Joules Status Re Charge Timer Running 75 Vult ECG 30E 9 3 Seconds 1 4 Amps Detib hen Charged Am 0 5 rhe 27 The DUT should be discharged as soon as it becomes charged When the DUT is discharged the timer will automatically stop The display will show the results of the Defibrillator pulse analysis as well as the time required to charge the DUT COMFIGURATIOM TEST RESULTS EMM etree 213 7 Joules Status Ready for Defib Peak s 1347 5 Volts Peak 27 0 Amps eae Timer 6 5 Ser esults At any time the CANCEL key can be depressed to end the timer and return to the MAIN SCREEN 28 PRINT HEADER The DA 2006 provides a header for recording test data as well as the results of each pulse that is discharged into the unit Test results are immediately sent to the printer port as soon as the data is available The header is sent by pressing the key from the MAIN SCREEN The status line of the configuration section will indicate that the header has been sent to the printer COMFIGURATIOM TE
3. Biometiic UNIT BC GROUP INTERNATIONAL INC DEFIBRILLATOR ANALYZERS DA 2006 DA 2006P W PACER ANALYZER USER MANUAL BC BIOMEDICAL DA 2006 SERIES TABLE OF CONTENTS WARNINGS CAUTIONS INGQIEIGES 2 oec iii DESGRIP TION m 1 VOOM sedi eS 7 DEFIBRILLATOR ANALYZER teuren utter setate genou isch dde 15 MAIN SCREEN 15 ECG WAVEFORMS SCREEN LA GA KR 22 PLAYBACK EAST PULSE SOGREEN itt ein a een een 25 START CHARGE TIMER SGHEEN ri rra ro Reha rro eo rh Era 27 PRINT HEADER a 29 SELF TEST WAVEFORM xi e xr 31 RUNNING A DEFIBRILLATION TEST 32 INTRODUC TION scii ices tanen ei ci aen ret 32 DEFIBRILLATION TEST teure tede 34 CARBIOVEHRHSION TES T 37 41 SHOCK ADVISORY ALGORITHM 43 TRANSCUTANEOUS PACEMAKER ANALYZER 45 PACE MAIN SCREEN sists eich wa vette aa aa ee a se ah 45 PACER MODE SETUP SCREEN
4. 2 25 2007 41AM This section configures the ECG Performance sequence when the ECG Performance Test option is set to YES for a Defibrillator Test The ECG sequence consists of up to 10 steps Each step consists of a selected waveform group Disabled NSR AED Arrhythmia or Performance output waveform and output amplitude There is only one ECG sequence for all 50 Auto Sequence tests To use less than 10 steps set the ECG output group of the next step after the last to Disabled 90 MANUAL REVISIONS Revision Program Revisions Made Rev 01 DT7395CA Preliminary Manual Rev 02 DT7395CA Miscellaneous Editing Updates Rev 03 DT7395CA Pictures Updated Rev 04 DT7395CD Accessories Added Rev 05 DT7395CF Added Pacer Graphing Auto Sequences Rev 06 DT7395CF Miscellaneous Editing Updates Rev 07 DT7395CG Added minimum pacemaker pulse width Rev 08 DT7395CG CE page and Miscellaneous Edits Rev 09 DT7395CG Miscellaneous Edits Rev 10 DT7395CG Added Indications for Use Rev 11 DT7395CG Updated Manual Format Misc Edits LIMITED WARRANTY WARRANTY 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 MERC
5. International High Level Output A high level ECG output signal 200x Amplitude Setting is available on the RCA jack located on the rear of the unit RS 232 Serial Port A female 9 pin D Sub connector is provided for the connection of the unit to a PC This link can be used for either remote interfacing or flash downloading of software upgrades Parallel Port A female 25 pin D Sub connector is provided for the connection of a printer via a Centronics parallel interface Oscilloscope Output A BNC connector is provided to connect an oscilloscope to the unit This output provides an attenuated version of the input signal Power Switch A rocker switch is provided on the rear of the unit to turn the power on and off Battery The unit utilizes two 9 Volt Alkaline Batteries in the bottom battery compartments When the unit detects LOW BATTERY condition 1096 Battery Life a warning window will appear once per minute to alert the user AC Adaptor The unit has a 2 1 mm jack for powering the unit with an AC Adaptor Note The AC Adaptor does not charge the batteries DEFIBRILLATOR ANALYZER MAIN SCREEN When the DA 2006 is first powered up the Defibrillator Analyzer MAIN SCREEN will be displayed This screen shows the current CONFIGURATION the TEST RESULTS and the available FUNCTION KEYS All defibrillator tests are run from the MAIN SCREEN When the unit detects an input of greater than 100 Volts on the
6. Sens Pads 0 71 mw Load 50 ohm ETG 0 09 mY Moise Mone Faced RF ms Wave 40 mS Sauare Sensed mS PACE MODE SENSITIVITY REFRACTORY TOGGLE MORE SETUP TEST PERIOD TEST ITEXT RESULTS KEV 54 REFRACTORY PERIOD TEST For on demand pacemakers the pacemaker should ignore any ECG activity after a pacer pulse for a specific period of time This time period is known as the Refractory Period The Paced Refractory Period is the time after the pacemaker pulse that ECG activity is ignored If an ECG pulse is present inside the refractory period it is ignored If an ECG pulse is detected outside of the refractory period the pacemaker will re synchronize to the sensed ECG pulse For each sensed ECG pulse there is a second refractory period This is known as the Sensed Refractory Period It is the period of time after the sensed ECG pulse that ECG activity is ignored The Refractory Period Test may be initiated by pressing the key from the PACE MAIN SCREEN WARNING This section is provided as a guide to familiarize the user with the DA 2006P It is not intended to provide the necessary test sequence for every Pacemaker The user must consult the manufacturer s manual for each DUT to determine the correct test procedure to follow While the Refractory Period test is running the display will indicate the progress of the test COMP pi U NOTE Itis important that the pulse rate do
7. 60 INPUT OVERLOAD The Warning Input Overload Check Range message can display during Defibrillator testing The range should be checked to see if it should be changed to High Range for the current Joule setting COMFIGURATION TEST RESULT Low Range 50 1 i Status Ready for Defib ECG Disabled Lupin Range 5 ECG PLATERCK START PRINT WAVEFORM LAST PULSE ICHREGE TIMER HEADER NO PULSE DA 2006P Only The Test Cancelled No Pulse for 3 seconds message can display during Refractory or Sensitivity Pacer testing The settings should be checked and the test rerun TET OE LTE Pace D0 Test Cancelled Load 10 Mo Pulse for 3 seconds 10 0 mS Moise Mar Check Settings and retry m Wave 40 Or Press Cancelto Exit 10 0 mJ RETRY CANCEL 61 SENSITIVITY TOO HIGH DA 2006P Only The Test Cancelled DUT Sensitivity too high message can display during Pacer testing This happens when the Pacemaker does not detect the pulse generated by the DA 2006P It could be that it is connected improperly or set to Async mode This can occur during either the Sensitivity or Refractory test modes TEST Moise Reduce Sens and retry 0 0 m Wave Or Press Cancelto Exit D O m RETRY CANCEL LOW BATTERY This message indicates that the batteries are low and should be replaced CONFIGURATION TEST RESULT High Ranse 0 0 Joules Status Plea LOVY
8. 160 BPM POLYFOCAL VENTRICULAR TACHYCARDIA 140 BPM POLYFOCAL VENTRICULAR TACHYCARDIA 160 BPM SUPRAVENTRICULAR TACHYCARDIA 90 BPM TRANSCUTANEOUS PACER ANALYZER DA 2006P The unit can test external transcutaneous pacemakers It has a wide variety of loads and can measure the Pacer Pulse Demand Sensitivity and Refractory Periods Pacing and Sensing e LOAD e RANGE 50 100 150 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 2100 2200 2300 e PULSE e PULSE CURRENT 4 TO 300 mA 100 ohm load e RATE 30 TO 800 ppm e WIDTH 0 6 to 80 ms e DEMAND SENSITIVITY e WAVEFORMS e SELECTIONS SQUARE TRIANGLE HAVERSINE e WIDTH 10 25 40 100 200 ms e ECG e AMPLITUDE OUT 0to 4 mV PACER INPUT 50 TO 400 e AMPLITUDE OUT 0to 10mV 500 e RATE IN 30to 100 ppm e PACER INPUT 500 TO 2300 amp OPEN e AMPLITUDE OUT 0 to 100 mV e RATE IN 30to 100 ppm e DEFIBRILLATOR PLATES AMPLITUDE OUT 0 to 10 mV RATE IN 30 100 ppm e REFRACTORY PERIOD e PACING 20 to 500 ms e SENSING 20 to 500 ms 50 60 HZ INTERFERENCE TEST SIGNAL e ECG OUTPUT 0 0 4 0 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 mV PACER INPUT 50 OHM 0 1 2 3 4 5 6 7 8 9 10 mV PACER INPUT 100 OHM 0 2 4 6 8 10 12 14 16 18 20 mV e PACER INPUT 150 OHM 0 3 6 9 12 15 18 21 24 27 30 mV e PACER INPUT 200 OHM 0 4 8 12 16 20 24 28 32 36
9. Noise Waveform NOTE Since Pacemaker pulses are normally continuous the test data must be printed manually via the Print Menu NOTE Printing the header also resets the test number printed on the data sheet 58 PLAYBACK LAST PULSE SCREEN The DA 2006P can display a graphical representation of the last pulse This screen may be accessed by pressing the key from the PACE MAIN SCREEN The playback allows the user to view the Pacemaker pulse in a time expanded form Samples are stored internally at 0 1 ms intervals The PLAYBACK LAST PULSE SCREEN shows these samples expanded by a time factor of 200 In playback mode the samples are shown on the display and sent out the ECG leads Defibrillator Plates and the High Level output The following is a sample of the waveform that is shown in the display PLAYEACE PLAYERCE FIRST 202 IEHTIRE 100 m EXIT The scale shown on the screen is automatically adjusted to provide the maximum resolution available The key can be used to pause the screen at any point while a pulse is being played back This key replaces the key when a pulse is being played back The key can be used to play continue the waveform if it has been paused This key replaces the key 59 The key starts a playback of only the first 20 ms of the waveform The TS key starts a playback of the entire 100 ms of the waveform At any time the EXIT key or key can be depressed to return to the MAIN SCREEN
10. up values 64 AUTO SEQUENCE FUNCTION The DA 2006 Series allows the user run up to 50 pre programmed sequences of tests Auto Sequences The tests are configured with an easy to use PC program Each test can be configured to test Defibrillator Transcutaneous Pacemaker or both For programming Auto Sequences see the Auto Sequence Programming section Once configured the tests are then downloaded to the DA 2006 unit through the RS232 serial interface The AUTO SEQUENCE SCREEN is accessed using the key Use arrows to find 43LifePak 6S Auto Sequence ifePak 7 Sequence BR ILiftePak SP Defib and Pacer FALifePak In this menu the keys are used to select the desired test The IE key can be used to enter the VIEW MODE which will allow the user to view the program ed test options of the selected test The FUN will run the selected test and enter the RUN MODE which will step the technician through the programmed test as well as identify whether each step has passed or failed based upon AUTO SEQUENCES LifePak 4 5 LifePak 6 LifePak 6S LifePak 8P LifePak 9P LifePak 9PM LifePak 10 LifePak 10P LifePak 10PM HP 78660A HP XLPM Nihon Kohden 7000 Laerdal HS 2000 Marquette 1500PM Zoll PD 2000 Zoll M Series DSW Zoll AED Plus Blank Tests 20 50 the pre programmed test limits that are part of each Auto Sequence 65 The following table shows the possibl
11. America Volt s Volt s Direct Current viii 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 NOTICE 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 2006 Series User Manual Copyright 2012 www bcgroupintl com Made in the USA 08 12 Rev 11 This Page Intentionally Left Blank BC BIOMEDICAL DA 2006 SERIES DEFIBRILLATOR ANALYZER The Model DA 2006 Series is a microprocessor based instrument family that is used in the testing of defibrillators They measure the energy output and provide information about the defibrillation pulse They are used on manual semi automatic and automatic defibrillators with monophasic or biphasic outputs The DA 2006P model additionally provides a Transcutaneous Pacemak
12. Async Mode Test Yes x Rate 60 ppm Load 100 Ohms e TO ph Th mo m o Demand Mode Tests 0 to End Do Demand Mode Test ves Hate race Load ppm Ohms Output Waveform Step1 50 700 gt 40 mS Square Step2 0 Defib v 10 mS Square Step3 0 Defib 10 mS Square Step4 0 Defib 10mS Square Steps 0 Defib v 10 mS Square Refractory Mode Test Do Refractory Mode Test No Pacer Test Details Each of the potential tests and test details for the Pacer are displayed for configuration For ease of programming individual steps can be deleted or added and individual tests can be included or not included Insert and Delete Steps Buttons These buttons will open the Insert Steps Screen or the Delete Steps Screen 86 Copy Sequence Screen This function allows the user to quickly configure similar Auto Sequences Simply select the source and target test sequences press OK and the target sequence will be overwritten with the configuration from the source sequence configuration The Cancel button will exit the window without modifying any configuration settings Select Source Select Target Sequence Sequence Zoll M Series DSW Zoll AED Plus Blank Test 20 Blank Test 20 Blank Test 21 Blank Test 21 Blank Test 22 Blank Test 22 Blank Test 23 Blank Test 24 Blank Test 24 Bla
13. VIEW MODE are determined by the Auto Sequence selected on the AUTO SEQUENCE SCREEN and its configuration as defined with the PC program The following screens are examples of what could be shown in the VIEW MODE if all test options are selected NOTE If any particular test option is disabled using the PC Program it will not be shown in the VIEW MODE DEFIBRILLATOR ENERGY TESTS Test Settings COMFIGURATIDE RESULTS LifePak Eneray Test 1 0 0 J Set Defibrillator for 2 Joules 0 0 View CINFIGURRTIDN TEST RESULTS 0 0 J LifePak Defib Eneray Limits 15 15 0 0 iew TEST RESULTE 0 0 J LifePak i ECG fib tor Enersy Tests ves View DEFIBRILLATOR MAXIMUM ENERGY TESTS COMFIGURATID LifePak cha Time Set Defibrillator for 360 Joules View CONFIGURATIO LifePak Eneray Limits 336 382 Joules View Mode LifePak Set Defibrilator for 100 Joules View Mode LifePak Crdvran Limits Cardioversion Limit 12 12 View 68 DEFIBRILLATOR ECG PERFORMANCE TEST COMFIGURATID RESULTS LifePak EC Perf 1 ECG Performance Waveforms ves View NOTE The individual selected waveforms are not displayed in the VIEW MODE PACEMAKER PULSE AND AMPLITUDE TESTS DA 2006P Only b RESULTS LifePak pom Set Pacemaker for 40rem 200m m View Load
14. at any time Function Keys There are five e keys that are used to provide general operational control The functions of the keys vary depending on the current screen The section of the screen just above the key indicates its current meaning NOTE Only functions that are available to the user will be visible at any given time COMFIGURATION RESULTS mida ts Eee Coers 100 0 Joules Status Ready for Defib Peak 805 0 Volts Peak 15 1 Amps LI OF Or 1 0mv 22 ms ECG START PRINT LAST PULSE CHARGE TIMER HEADER Sample Function Key Labeling ECG Waveforms The microprocessor sends the waveforms to a Digital to Analog converter that generates an accurate analog representation The waveforms are then sent through a resistor network developing the appropriate signals on the output terminals Universal Patient Lead Connectors The 10 Universal Patient Lead Connectors allow for 12 lead ECG simulations AHA and IEC color coded labels are located on the face of the unit to aid in connecting the corresponding U S and International Patient Leads AHA Label IEC Label RA R Right Arm LA L Left Arm Right Leg RL N reference or ground LL F Left Leg V Leads V1 V6 V1 C1 U S and Canada V2 C2 also referred to as pericardial V3 C3 precordial or unipolar chest leads V4 C4 V5 C5 V6 C6 Chest Leads C1 C6
15. be prosecuted to the maximum extent possible under law System Info 82 FILE CONTROL The file control section allows the user to Load and Save Auto Sequence files greatly expanding the number of pre programmed sequences from 50 to virtually unlimited The user also uses the File Control section to Load and Store Auto Sequences on the DA 2006 P AutoSequence Filename C Program Files BC Biomedical DA 2006 Series AutoS equence Programmer T esting amp utosequence s Open Save AutoSequence Read AutoS equence Download amp utoSequence AutoSequence File to File from DA 2006 P to DA 2006 P Dropdown List This list shows the history of files that have recently been used This provides quick access for switching between common Auto Sequence files Open Auto Sequence File This button brings up the standard Windows Open File dialog box It is used to load an existing configuration file Save Auto Sequence to File This button brings up the standard Windows Save File dialog box It is used to save the current configuration to a file for future reference Read Auto Sequence from DA 2006 P This button is used to load the configuration currently stored in the DA 2006 P Download Auto Sequence to DA 2006 P This button is used to send the configured Auto Sequence to the DA 2006 P where it is stored in non volatile flash memory 83 SEQUENCE SELECTION Select Sequence to Edit Nihon Kohden 7000 L
16. for wear and should be serviced if any parts are in question NOTICE INDICATIONS FOR USE The DA 2006 and DA 2006P Analyzers are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output The DA 2006 tests defibrillators while the DA 2006P additionally tests transcutaneous pacemakers C c NOTICE CE C c The DA 2006 Series Analyzers bear the C mark Based on the following testing standards ELECTROMAGNETIC COMPATIBILITY DIRECTIVE EMC Directive 89 336 EEC and 2004 108 EC as amended by 92 31 EEC 93 68 EEC and Directive 91 263 EEC TTE SES EN 61326 1 1997 A1 1998 A2 2001 A3 2003 Electrical equipment for measurement control and laboratory use EMC requirements This equipment has been type tested by an independent accredited testing laboratory and compliance was demonstrated to the above standard to the extent applicable EMISSIONS Radiated and Line Conducted Emissions EN 61000 3 2 Harmonic Current Emissions EN 61000 3 3 Voltage Fluctuation and Flicker IMMUNITY CLASS C EN 61000 4 2 Electrostatic Discharge EN 61000 4 3 Radiated Electric Field Immunity EN 61000 4 4 Electrical Fast Transients Bursts EN 61000 4 5 Surge Voltage EN 61000 4 6 Conducted Disturbance EN 61000 4 11 Voltage Dips and Short Interrupts LOW VOLTAGE DIRECTIVE EC Directive 73 23 EC EN 61010 1 2001 Safety requi
17. may be changed using the key NOTE This line also allows for the selection of the Pacer Analyzer that is an option available in the DA 2006P model The key will toggle to Pacer to put the unit into the Pacemaker Analyzer mode See Pacemaker Analyzer section for more information STATUS This line provides information about the current status of the analyzer ECG This line displays the selection that is active on the ECG terminals This setting may be changed in the ECG WAVEFORMS screen AMP This line displays the amplitude that has been selected for the ECG terminals This setting may be changed in the ECG WAVEFORMS screen 17 TEST RESULTS The TEST RESULTS section of the MAIN SCREEN displays the results of the last pulse It will continue to be displayed until the power is turned off another test is run or the range is changed RESULT Enerev 603 7 Joules Peak v 3555 0 Volts Peak 71 3 Amps Delay 1205 mS NOTE The unit automatically starts a test when it sees a voltage greater than 100 Volts on the Defibrillator Plates 20 Volts in Low Range NOTE Test results are immediately sent to the printer port as soon as the data is available ENERGY This line displays the total energy of the last pulse PEAK V This line displays the peak voltage of the last pulse PEAK I This line displays the peak current of the last pulse DELAY This line normally displays the delay from the pea
18. or low Back Light Key STERNUM 1 5 Light Touch Keys for turning on for Dynamic and off the gt functions backlight These keys are Kd labeled in the bottom portion of d the screen and change function A based on operating m mode Large Defib Plates Fixed 50 ohm input load for Defibrillator testing This section looks at the layout of a DA 2006P and gives descriptions of the elements that are present 10 Universal LCD Graphical Display Patient Lead Shows Parameters for Test Connectors Data and Waveforms Range Key Back Light Key for selecting for turning on f Defib input and off the range high or backlight low and pace mode Pacemaker Input Jack ert 4 5 Light Touch Keys optional for Dynamic 4 functions 2 h 50 2300 ohms l These keys are labeled in the bottom portion of the screen and change function based on operating mode Large Defib Plates Fixed 50 ohm input load for Defibrillator testing and Pacer Input This section looks at the layout of the back and gives descriptions of the elements that are present Oscilloscope output BNC connector nA Hi LeveL for easy n viewing of input waveforms AC Adaptor High Level Serial Port Parallel Port 2 1 mm Jack ECG output Female 9 Pin Female 25 Pin RCA Jack D Sub D Sub Connector Connector NOTE The DA 2006 and the DA 2006P offer
19. peak voltage of 1000 Volts or less the unit may be changed to the Low Range Defibrillator mode using the E key 37 4 Select the desired ECG Waveform and Amplitude to be tested from the choices on the ECG WAVEFORM SCREEN NOTE The selected waveform must contain a QRS complex 5 Set the Defibrillator to Synchronized Cardioversion mode 6 Place the Defibrillator Paddles on the DA 2006 contact plates The APEX is on the right and the STERNUM is on the left NOTE Reversing the paddles will not cause any damage to the unit or error in the energy reading However it will cause the polarity of the oscilloscope output and the playback waveform to be inverted 7 Holding the paddles firmly in place charge the Defibrillator and discharge it into the DA 2006 WARNING Observe all precautions noted by the Defibrillator Manufacturer when using the Defibrillator 38 8 The DA 2006 will automatically sense the voltage rise across the internal 50 ohm load and begin taking readings After the sampling is done 100 ms the unit will compute and display the results a The power pulse is available at the oscilloscope output in real time at 200 1 signal attenuation when in low range and 1000 1 signal attenuation when in high range b After the computation the pulse is automatically played back at a 200 1 time base expansion 200 times slower on both the ECG leads and the Paddle plates The signal level is 1 mV per 1
20. the same features with the DA 2006P having the addition of a Transcutaneous Pacemaker Analyzer function See Pacemaker Analyzer section for more details General Operation The unit is controlled by 7 light touch keys They allow the user to move around within the displayed parameters select the desired options choose a specific category and control the setup for the unit When a key is depressed there is an audio click when it is accepted or a razz tone if the key is invalid A large LCD graphics display with backlight provides the user with information about the current status of the device configuration options test results and more The display identifies the function of each key on a dynamic basis As the operation mode changes the key functions change to suit the operating mode Range Key The key scrolls through the ranges of the DA 2006 Series analyzers Depressing the key will allow the user to select between High Defibrillator Range 1000J max Low Defibrillator Range 50J max and with the DA 2006P Pacemaker Range The default mode on power up is High Defibrillator Range Backlight Key The Graphic LCD display may be viewed with or without the backlight Depressing any key will activate the backlight However since the backlight will drain the battery if left on it will automatically shut off after a user programmable delay when running on battery power The key is provided to toggle the backlight on or off
21. will be lost even if they are from a test that passed 75 PACEMAKER ASYNCHRONOUS MODE TEST DA 2006P Only COMFIGURATIOM LifePak Set Pacer to Async Mode 7 nnm Press Capture Test Readings COMFIGURATIOM TEST RESULT LifePak Pacer amp svnc T Set Pacer to Async Mode Orpern Showin Captured Readines Load Test Passed Auto Advancing in 3 PRINT GET HELI RESULTS READING NOTE If the test fails or new readings are desired the Get New Readings Key can be used to replace the current readings The current readings will be lost even if they are from a test that passed 76 PACEMAKER DEMAND MODE TESTS DA 2006P Only COMFIGURATIOM LifePak Pacer Dmnd 1 Set Pacer to Demand Mode 5pm Press Start for Sensitivity test Sens Pada 0 00 m 0 00 mv HEST PRINT TEST RESULT LifePak Sensitivity Test Running m Set Pacer Press Star Please Wait Sens Padal Or Press Cancel to Exit COMFIGURATION LifePak Pacer Dmnd 1 Set Pacer to Demand Mode 50pm Showing Captured Readings Sens Pada 4 66 ECG O65 PRINT GET HELI RESULTS READING NOTE If the test fails or new readings are desired the Get New Readings Key can be used to replace the current readings The current readings will be lost even if they are from a test that passed 77 PACEMAKER REFRACTORY TEST DA 2006P Only COMFIGURAT
22. will be manually y controlled by backlight key Autosequence Sets the delay between Auto Sequence 1 20 Timer tests when the test passes Displays current life of the batteries At 5 5 100 Battery Life a warning screen will appear At 10 the Read O nly unit will power down automatically Selects the values that will be used when Default Last powerin wih the unit is first turned on It is also used to Custom p Set the Custom Defaults if used See Set Custom Power Up Settings Defaults Software Displays current software program Read Only 63 POWER UP SETTINGS The DA 2006 Series allows the user to tailor the settings that the unit will have on Power Up The Power Up With parameter in the System Setup Menu allows for the selection of either Default or Custom selections DEFAULT If this option is selected the following settings will be used every time the unit is turned on Range Defib High Range mode ECG Output Disabled Pacemaker Load 100 ohm Pacemaker Noise Waveform None Pacemaker Output Waveform 40 ms Square wave CUSTOM If this option is selected the user may save a unique set of default parameters and the unit will recall them every time the power is turned on SET CURRENT AS CUSTOM The user simply configures the unit to the desired default conditions selects this option and presses EMTER The current configuration is then saved as the Custom Power
23. 000 Volts on Lead 1 c Atthe same time the test results are sent to the printer 9 The Status line will change to indicate the various steps as they are being done 10 At the end of the process the results are continuously displayed in the Test Results section of the MAIN SCREEN They will remain there until another test is performed the range is changed or the power is turned off NOTE Special note should be made of the Delay xxx msec line in the results This will show the delay between the peak of the R wave and the start of the Pulse 39 The user may repeat the playback of the waveform at any time by changing to the PLAYBACK LAST PULSE SCREEN using the key In this screen the pulse may be viewed in 20 msec segments and paused for review NOTE The pulse is sent to the ECG and Paddle outputs at the same time itis being displayed on the screen 40 CHARGE TIME TEST The charging time of a Defibrillator is nothing more than a measurement of the time required for the Defibrillator to charge It is used to test the battery charging circuitry and capacitor The DA 2006 provides a simple way to start and stop the timer It also records the results WARNING This section is provided as a guide to familiarize the user with the DA 2006 Series It is not intended to provide the necessary test sequence for every Defibrillator The user must consult the manufacturer s manual for each DUT to determine the correct test pr
24. 40 mV PACER INPUT 300 OHM 0 6 12 18 24 30 36 42 48 54 60 mV PACER INPUT 400 OHM 0 8 16 24 32 40 48 56 64 72 80 mV e PACER INPUT 2 500 OHM 0 10 20 30 40 50 60 70 80 90 100 mV DEFIBRILLATOR PLATES 0 1 2 3 4 5 6 7 8 9 10 mV INPUT CIRCUITRY PROTECTION e INPUT CIRCUITRY IS PROTECTED AGAINST DAMAGE IN THE EVENT OF AN ACCIDENTAL DEFIBRILLATOR DISCHARGE INTO THE PACEMAKER TEST INPUT TERMINALS BC20 00432 BC20 21103 or BC20 21101 BC20 00427 BC20 30108 BC20 41341 BC20 41339 BC20 00420 BC20 00421 BC20 00423 BC20 00424 BC20 00425 BC20 00426 STANDARD ACCESSORIES INTERNAL PADDLE ADAPTERS 2 adapters AC ADAPTOR USA Version AC ADAPTOR Euro Version PLASTIC ELECTRODE PLATES 2 plates OPTIONAL ACCESSORIES BC BIOMEDICAL SOFT SIDED CARRYING CASE RS 232 COMMUNICATIONS CABLE DB 9M to DB 9F USB TO RS 232 ADAPTER USB A TO DB 9M PHYSIO CONTROL DEFIB PACE TEST CABLE MARQUETTE DEFIB PACE TEST CABLE ZOLL DEFIB PACE TEST CABLE PHYSIO CONTROL PACE ONLY TEST CABLE ZOLL PACE ONLY TEST CABLE HP AGILENT LAERDAL AAMI DEFIB PACE TEST CABLE LAYOUT This section looks at the layout of a DA 2006 and gives descriptions of the elements that are present LCD Graphical Display Shows Parameters for Test Data and Waveforms 10 Universal Patient Lead Connectors RA R LA Range Key for selecting Defib input range high
25. 400 1500 1600 1700 1800 TEST LOAD 1900 2000 2100 2200 2300 Q AGGUBASY 50 to 1300 Q 196 1400 to 2300 1 596 RANGE 4 to 300 mA 100 Q load ACCURACY 5 or 0 5 mA whichever is greater 50 600 Q 300 mA 700 Q 286 mA 800 Q 250 mA 900 Q 222 mA 1000 Q 200 mA 1100 Q 182 mA 1200 Q 167 mA PULSE CURRENT PME 1400 0 143 mA 1500 Q 133 mA 1600 Q 125 mA 1700 Q 118 mA 1800 Q 111 mA 1900 Q 105 mA 2000 Q 100 mA 2100 Q 95 mA 2200 Q 91 mA 2300 Q 87 mA 94 TRANSCUTANEOUS PACEMAKER ANALYZER continued RANGE 30 to 800 ppm PULSE RATE ACCURACY t 196 or 2 ppm whichever is greater RANGE 0 6 to 80 ms PULSE WIDTH ACCURACY 196 or 0 3 ms whichever is greater VARIABLE 200 V LOAD INPUT FIXED LOAD 15V INPUT 0 15V 10 24 1 AMPLITUDE OSCILLOSCOPE ATTENUATION 15 60 V 41 1 MAX OUTPUT 200 V WAVEFORMS Square Triangle Haversine WIDTH 10 25 40 100 200 ms ECG OUTPUT 0 to 4 mV PACER INPUT 50 TO 400 OHMS X OUTPUT AMPLITUDE PACER INPUT 500 TO 2300 0 to 100 mV OHMS amp OPEN DEFIBRILLATOR PLATES to 10 mV ECG OUTPUT 40 uV DEMAND SENSITIVITY PACER INPUT 50 TO 400 40 uV OUTPUT om RESOLUTION PACER INPUT 500 TO 2300 1 mV OHMS amp OPEN DEFIBRILLATOR PLATES ied OUTPUT R ACCURACY Sen ECG OUTPUT N A D
26. 50 2 LifePak Pacer Rate 10 Ame 10 View TEST RESULT LifePak Pacer A amp zvnc pom Set Pacer Async Mode 0 0 m view Load SO 2 69 PACEMAKER DEMAND MODE TESTS DA 2006P Only COMFIGURATID TEST RESULT LifePak Pacer Dmnd 1 pom Set Pacer to Demand Mode 5mm 0 0 m view Load 50 2 PACEMAKER REFRACTORY TEST DA 2006P Only h RESULTS LifePak Pacer Refract pom Pacemaker Refractory Test na m View Load SO 2 OF SEQUENCE 70 The RUN MODE allows the user to run the test configuration The screens that are displayed in the RUN MODE are determined by the Auto Sequence selected on the AUTO SEQUENCE SCREEN and its configuration as defined with the PC program Running an Auto Sequence will provide a consistent guided procedure for testing equipment This is a semi automated process that will provide immediate feedback to the user if the DUT passes or fails individual tests A programmable timer is provided to automatically progress through the test when a given test passes This timer is set in the Auto Sequence Timer parameter in the SYSTEM SETUP SCREEN NOTE If any particular test option is disabled using the PC Program it will not be shown in the RUN MODE NOTE Some tests like Performance Waveforms do not have quantitative analyses and therefore require the user to manually progr
27. AYBACK e OUTPUT LEAD 1 amp PLATES e GRAPHICS SCREEN 200 1 Time Base Expansion SYNC TIME MEASUREMENTS e TIMING WINDOW Starts at peak of each R wave e TEST WAVEFORMS All waveform simulations available CHARGE TIME MEASUREMENT From 0 1 to 99 9 sec ECG FUNCTIONS The unit can produce a wide variety of ECG simulations The user simply selects the parameters that match the desired output RATE 30 40 45 60 80 90 100 120 140 160 180 200 220 240 260 280 300 BPM e AMPLITUDE 0 50 1 0 1 5 2 0 mV Lead II ECG PERFORMANCE FUNCTIONS The unit can generate Sine Square Triangular and Pulse waveforms with adjustable amplitudes for performance testing e SINE 0 1 0 2 0 5 5 10 40 50 60 100 Hz e SQUARE 0 125 2 Hz e TRIANGLE 2 2 5 Hz e PULSE 30 60 120 BPM 60 ms WIDTH AMPLITUDE 0 5 1 0 1 5 2 0 mV Lead 11 ARRHYTHMIA FUNCTIONS The unit can simulate 12 different arrhythmias VENTRICULAR FIBRILLATION ATRIAL FIBRILLATION SECOND DEGREE A V BLOCK RIGHT BUNDLE BRANCH BLOCK PREMATURE ATRIAL CONTRACTION EARLY PVC STANDARD PVC R ON T PVC MULTIFOCAL PVC BIGEMINY RUN OF 5 PVC VENTRICULAR TACHYCARDIA SHOCK ADVISORY TESTS The unit can simulate 8 different waveforms to test the shock algorithm of advanced defibrillators ASYSTOLE COARSE VENTRICULAR FIBRILLATION FINE VENTRICULAR FIBRILLATION MULTIFOCAL VENTRICULAR TACHYCARDIA 140 BPM MULTIFOCAL VENTRICULAR TACHYCARDIA
28. BATTERY nn volts ECG Dizabl 7 Life Remaining 0 0 Amps START PRINT WAVEFORM LAST PULSE ICHREGE TIMER HEADER EXITING AUTO SEQUENCE TESTING The Exit Auto Sequence Test All Data Will be Lost message will display in the Auto Sequencing Mode when EXIT pushed If the data is needed it should be printed prior to exiting TEST RESULT LifePak Exit AutoSequence Test 0 ppm setPacem All Data Lost 0 0 ms Press Star Are You Sure 0 0 mA Pace RP 0 0 mJ 62 SYSTEM SETUP The SYSTEM SETUP SCREEN allows for the configuration of the system settings The settings can be selected using 4 to highlight the parameter and using SELECT to allow the editing of the parameter The 4 keys are used to edit the setting then EMTER is used to accept the new setting CANCEL key be used to return to the configuration screen without making a new selection The EXIT key is used to return to the MAIN SCREEN System Setup More Backlisht Timed sec 3 Autaseauence Timer 1 17 Battery Life Power up with Defaultz b ad SELECT ERIT The following is a brief description of the parameters and the available range of settings Parameter_ Range Off Always off 1 20 sec The elapsed time after which the Backlight Timed backlight will automatically turn off eis 52 a Always On The backlight
29. Defibrillator Plates 20 Volts in Low Range it will automatically begin a test The default configuration is the High Range Defibrillator mode This mode allows for a waveform of up to 1000 Joules to be analyzed The following is a sample screen for this mode COMFIGURATIOM RESULTS mii a Cera 100 0 Joules Status Ready for Defib Peak 805 0 volts 5 Peak 15 1 Amps LI OF Om Lll 1 0m Delas 32 ms PLAYEACE START PRIMT WAUEFORMS LAST PULSE ICHARGE TIMER HEADER The E key may be used to toggle the unit to the Low Range Defibrillator mode This mode allows for waveforms up to 50 Joules to be analyzed The Defibrillator Analyzer works the same in both ranges The lower range simply provides for a higher resolution for pulses with smaller amplitudes The following is a sample screen for this mode COMFIGURATIOM RESULTS Low Rianse SO hla a y 20 4 Joules Status Ready for Defib Peak s 357 5 Yolts Peak 7 4 Armes 394 mS NOTE The key will also put the DA 2006P into the Transcutaneous Pacemaker Analyzer mode See Pacemaker Analyzer section for more information CONFIGURATION The CONFIGURATION section of the MAIN SCREEN displays the current setup of the unit eee Bane Rea for Defib ECG 30 BPM Ame 0 5 mw RANGE The first line displays the range value for the pulse It may be either 1000 Joules or 50 Joules max This setting
30. EASUREMENTS TEST WAVEFORMS available DELAY TIME ACCURACY 1ms 92 PATIENT SIMULATOR 30 40 45 60 80 90 100 120 140 160 180 200 Een 220 240 260 280 300 BPM SINE 0 1 0 2 0 5 5 10 40 50 ECG WAVEFORM RATES 60 100 Hz SQUARE 0 125 2 000 Hz TRIANGLE 2 000 2 500 Hz PULSE WAVE 30 60 120 BPM 60 ms width AMPLITUDE 0 5 1 0 1 5 2 0 mV Lead II RATE 1 ACCURACY AMPLITUDE 2 Lead Il OUTPUT 200 times Amplitude HIGH LEVEL ACCURACY 5 QRS DURATION 80 ms LEAD TO LEAD 10000 IMPEDANCE ECG ARRHYTHMIA SELECTIONS Ventricular Fibrillation Atrial Fibrillation Second Degree A V Block Right Bundle Branch Block Premature Atrial Contraction PVC Early PVC Standard PVCRonT Multifocal PVC Bigeminy Run of 5PVCs Ventricular Tachycardia 93 PATIENT SIMULATOR continued ECG SHOCK ADVISORY ALGORITHM TEST SELECTIONS Asystole Coarse Ventricular Fibrillation Fine Ventricular Fibrillation Multifocal Ventricular Tachycardia 140 BPM Multifocal Ventricular Tachycardia 160 BPM Polyfocal Ventricular Tachycardia 140 BPM Polyfocal Ventricular Tachycardia 160 BPM SupraVentricular Tachycardia 90 BPM TRANSCUTANEOUS PACEMAKER ANALYZER LOAD VALUES 50 100 150 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1
31. EFIBRILLATOR PLATES 30 to 100 ppm PACING 20 to 500 ms REFRACTOR PERIOD SENSING 20 to 500 ms ACCURACY 2ms 95 TRANSCUTANEOUS PACEMAKER ANALYZER continued ECG OUTPUT 0 0 4 0 8 1 2 1 6 2 0 2 4 2 8 3 2 3 6 4 0 mV 0 1 2 3 4 5 6 90 Q 7 8 9 10 mV 0 2 4 6 8 10 1000 12 14 16 18 20 mV 0 3 6 9 12 15 1500 18 21 24 27 30 mV 0 4 8 12 16 20 50 60 HZ Uus AD MAS pane INTERFERENCE TEST PACER INPUT 200 24 28 32 36 40 SIGNAL 1nd 0 6 12 18 24 3000 30 36 42 48 54 60 0 8 16 24 32 4000 40 48 56 64 72 80 mV 0 10 20 30 40 25000 50 60 70 80 90 100 mV DEFIBRILLATOR PLATES 0 1 2 3 4 5 6 7 8 9 10 mV PHYSICAL amp ENVIRONMENTAL DISPLAY LCD Graphical 240 X 64 Pixels Backlit Royalite R59 CONSTRUCTION ENCLOSURE UL Flame Rating 94 V 0 OVERLAY Lexan Back printed SIZE 4 10 x 9 77 x 10 65 Inches 104 1 x 248 2 x 270 5 mm WEIGHT 5 0 Lbs s 2 27 kg OPERATING RANGE 15 to 40 59 to 104 F STORAGE RANGE 20 to 65 C 4 to 149 F 96 ELECTRICAL 9V Alkaline Battery 2 Required ANSI NEDA 1604 Alkaline or equivalent 9 to 10 VDC gt 200 mA AC ADAPTOR bdo BC20 21103 USA Version BC20 21101 Euro Version BAUD 115200 DATA BITS 8 START BITS 1 RS 232 COMMUNICATIONS PIDE PARITY None HANDSHAKING No
32. ELF TEST WAVEFORM This key sends an internal test pulse to the unit allowing for the display of the results to give an indication that the system is working properly DA 2006 SETUP This key brings up the SYSTEM CONFIGURATION SCREEN which allows for adjusting the various system configuration parameters 21 ECG WAVEFORMS SCREEN The DA 2006 ECG output can be connected in 3 5 or 12 lead configurations Pressing the key from the MAIN SCREEN will allow the user to configure the waveform that is used for the ECG output The following is a sample of the ECG waveform configuration screen ECG GROUP WAVEFORM Disabled None NSR 30 40 45 60 80 90 100 120 140 160 180 200 220 240 260 280 300 BPM AED Asystole Coarse Vfib Fine Vfib Multifocal Vtach 140 Multifocal Vtach 160 Polyfocal Vtach 140 Polyfocal Vtach 160 SupraVent Tach 90 Arrhythmias Vfib Afib Second Deg Block RBBB PAC PVC Early PVC STD PVCRon T MF PVC Bigeminy Run of 5 PVC Vtach Performance 0 125 2 Hz Square 2 2 5 Hz Triangle 0 1 0 2 0 5 5 10 40 5 0 60 100 Hz Sine 30 60 120 BPM Pulse Waveform Mone Amplitude Leadl 0 70m Lead ll 1 0rn y AMPLITUDE Lead 0 35 mV Lead 1 0 5 mV Lead 0 70 mV Lead Il 1 0 mV Lead 1 05 mV Lead Il 1 5 mV Lead 1 40 mV Lead II 2 0 mV 22 T
33. EQUENCE TESTING CAPABLE OF STORING 50 CUSTOM TEST SEQUENCES DA 2006P ADDS PACEMAKER OPTION e 26 SELECTABLE INTERNAL LOADS FULL PULSE ANALYSIS DEMAND SENSITIVITY TEST REFRACTORY PERIOD TESTS 50 60 Hz INTERFERENCE TEST SIGNALS INPUT TERMINALS AND CIRCUITRY PROTECTED AGAINST ACCIDENTAL DEFIBRILLATOR DISCHARGE INTO PACEMAKER TEST TERMINALS ENERGY OUTPUT MEASUREMENT GENERAL The unit measures the energy in the output pulse of both monophasic and biphasic defibrillators PULSE TYPE Monophasic or Biphasic LOAD RESISTANCE 50 1 non inductive 1 uH DISPLAY RESOLUTION 0 1 Joules MEASUREMENT TIME WINDOW 100 ms ABSOLUTE MAX PEAK VOLTAGE 6000 Volts CARDIOVERSION DELAY 0 to 6000 ms CARDIOVERSION RESOLUTION 0 1 ms ENERGY OUTPUT MEASUREMENT HIGH RANGE The high range allows for a large pulse with high voltage and current VOLTAGE lt 5000 Volts MAX CURRENT 100 Amps MAX ENERGY 1000 Joules TRIGGER LEVEL 100 Volts PLAYBACK AMPLITUDE 1 mV 1000 V Lead I TEST PULSE 125 Joules 20 ENERGY OUTPUT MEASUREMENT LOW RANGE The low range allows greater resolution on smaller pulses VOLTAGE 1000 Volts MAX CURRENT 20 Amps MAX ENERGY 50 Joules TRIGGER LEVEL 20 Volts PLAYBACK AMPLITUDE 1 mV 1000 V Lead TEST PULSE 5 Joules 2096 ENERGY OUTPUT MEASUREMENT OTHER OSCILLOSCOPE OUTPUT e HIGH MEASUREMENT RANGE 1000 1 amplitude attenuated e LOW MEASUREMENT RANGE 200 1 amplitude attenuated WAVEFORM PL
34. GGLE TEST RESULTS This key toggles the test result section to view the first 4 lines or the second 4 lines of data MORE KEYS These keys toggle between the Primary and Secondary Function Keys PRINT MENU This key enters the PRINT SCREEN that allows the printing of the header or the test data 49 PLAYBACK LAST PULSE This key enters the PLAYBACK LAST PULSE screen where a graphical representation of the last pulse may be viewed and sent out AUTO SEQUENCES This key brings up the AUTO SEQUENCE MENU which is used to view or run the Auto Sequences stored in the unit DA 2006 SETUP This key brings up the SYSTEM CONFIGURATION SCREEN which allows for adjusting the various system configuration parameters 50 PACER MODE SETUP SCREEN The DA 2006P can be configured to run a large number of tests under various load conditions This screen is used to configure the unit for these tests The pacemaker configuration screen is accessed by pressing the key from the PACE MAIN SCREEN In this screen the user can select the desired Load the output Noise waveform the Sensitivity Test waveform and the Pacemaker Pulse Filter The following is a sample of the Pacemaker configuration screen Load 100 ohm Noise Mane Wave 40 mS Sauare Pacemaker Pulse Filter 0 0 mS ww CHOICES EXIT Defib Plates Input 500 50 ohm 100 ohm 150 ohm 200 ohm 200 ohm 300 ohm 400 ohm 500 ohm 600 ohm 700 ohm WAVEFORM PULSE FIL
35. HANTABILITY 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 OPTION OF BC GROUP INTERNATIONAL INC THE REFUND OF THE PURCHASE PRICE P MANUALS BCGroup DA 2006_UM_Rev_11 doc 91 SPECIFICATIONS ENERGY OUTPUT MEASUREMENT METHOD Monophasic or Biphasic LOAD RESISTANCE 50 1 Non Inductive lt 1 DISPLAY RESOLUTION 0 1 J MEASUREMENT TIME WINDOW eg ABSOLUTE MAX PEAK VOLTAGE eon PULSE WIDTH 100 ms CHARGE TIME MEASUREMENT ae HIGH RANGE LOW RANGE VOLTAGE lt 5000 V lt 1000 V CURRENT lt 100A lt 20A ENERGY lt 1000 J lt 50 100 2J lt 20J 0 4J ACCURACY 100J 2 of reading gt 20 2 of reading TRIGGER LEVEL 100 V 20 V PLAYBACK AMPLITUDE 1 mV 1000 V Lead 1 1 mV 1000 V Lead 1 TEST PULSE 125 J 2096 5 J 2096 OSCILLOSCOPE OUTPUT ATTENUATION BUD id DELAY 0 to 6000 ms CARDIOVERSION RESOLUTION 0 1 ms ACCURACY 2 OUTPUT LEAD amp PLATES WAVEFORM PLAYBACK Ti SCREEN 200 1 Time Base Expansion TIMING WINDOW Starts at 51 each R SYNC TIME All waveform simulations M
36. ION RESULT LifePak Pacer Refract Set Pacemaker to Demand Press Start for Refractory test Pace RP me Sense Orns EMD OF PRINT TEST SEQUENCE RESULTS LifePak SP Refractory Test Running 81000 Set Pacerr Press Star Please Wait Pace RP Cr Press Cancel to Exit CONFIGURATION LifePak Pacer Refract Set Pacemaker to Demand Mode Showings Captured Readines PaceRP 284m amp SensRP 290 gt EHD OF PRINT TEST GET MEL SEQUENCE RESULTS READING NOTE If the test fails or new readings are desired the Get New Readings Key can be used to replace the current readings The current readings will be lost even if they are from a test that passed 78 EXITING AUTO SEQUENCE TESTING MESSAGE The Exit Auto Sequence Test All Data Will be Lost message will display in the Auto Sequencing Mode when EXIT 5 pushed If the data is needed it should be printed prior to exiting TEST RESULT LifePak Exit AutoSequence Test ppm Set Data will be Lost 0 0 ms 2 0 0 mA Are You Sure DO mJ 79 PROGRAMMING AUTO SEQUENCES Auto Sequences are programmed with an easy to use PC interface This section shows how to use the Auto Sequence configuration software NOTE In the Auto Sequence PC interface the DA 2006 Series is noted as DA 2006 P SPLASH SCREEN The Splash Screen identifies the version of the program This screen will be displayed for 5 seconds or until the
37. ST RESULTS Enere 213 7 Joules Status Printing Header Peak wv 1347 5 vnlt Peak 27 0 Amps Ll 0 70 LI 1 0m Cha Time 6 5 Sec PLAYBACK START PRINT WAWEFORM LAST PULSE ICHARGE TIMER HEADER 29 The following is the print header and sample data that are used for the Defibrillator Analyzer mode BC Biomedical DA 2006 Defibrillator Analyzer DA 2006 Serial Number Dut Manufacturer Dut Model Dut Serial Number Technician Location Comments Test Data Ecg Defib Dut DA 2006 Measurements Test Wave Load Setting Energy Voltage Current Dely ChgT 1 0 mv 50 112 57 1085 0V 21 7A NOTE Printing the header also resets the test number printed on the data sheet NOTE In the test results the user must manually write the power setting of the DUT 30 SELF TEST WAVEFORM The DA 2006 has built in test waveforms that will give an indication that the system is working properly The Self Test Waveform may be sent by pressing the from the MAIN SCREEN After the waveform has been sent the results will be reflected in the test results section of the MAIN SCREEN and the PLAYBACK LAST PULSE SCREEN The Self Test Waveform is not calibrated but will provide a waveform that is approximately 125 Joules when configured for the High Rang
38. TE Not all ASCII characters are valid and will be ignored Copy Sequence Button This button opens the Copy Sequence Screen that allows the user to quickly configure similar test sequences Test Mode Selections These selections allow each test to be configured as a Defibrillator Only a Pacer Only or a Defib amp Pacer test Configure Test Buttons These buttons are used to alternate between defib and pacer test configuration windows Defibrillator Test Details Each of the potential tests and test details for the Defibrillator are displayed for configuration For ease of programming individual steps can be deleted or added and individual tests can be included or not included Insert and Delete Steps Buttons These buttons will open the Insert Steps Screen or the Delete Steps Screen 85 Edit Sequence Name 20 chars max SPM Copy Sequence Select Test Mode C Defibrillator Only C PacerOnly 6 Defib amp Pacer Configure Defibrillator Test Configure Pacer Test Pulse Mode Tests 0 ppm to End Step 1 J 60 ppm Step 2 150 ppm Step 3 170 ppm Step 4 160 ppm Step 5 140 ppm Step 130 ppm Step 120 ppm Step 8 110 ppm Step 3 100 ppm Step 10 S0 ppm Step 11 80 ppm Step 12 70 ppm Step 13 60 ppm Step 14 50 ppm Step 15 40 ppm Step 15 60 ppm Step 17 60 ppm Step 18 60 ppm Step 19 60 ppm Step 20 ppm Insert Step Delete Step Rate Tol 10 amp mpTol 10 Async Mode Test Do
39. TER 0 0 2 0 ms 10 mV 50 Hz 9 mV 50 Hz 8 mV 50 Hz 7 mV 50 Hz 10 ms Square 25 ms Square 40 ms Square 100 ms Square 800 ohm 900 ohm 1000 ohm 1100 ohm 1200 ohm 1300 ohm 1400 ohm 1500 ohm 1600 ohm 1700 ohm 1800 ohm 1900 ohm 2000 ohm 2100 ohm 2200 ohm 2300 ohm Open 6 mV 50 Hz 5 mV 50 Hz 4 mV 50 Hz 3 mV 50 Hz 2 mV 50 Hz 1 mV 50 Hz NONE 1 mV 60 Hz 2 60 Hz 3 mV 60 Hz 4 mV 60 Hz 5 mV 60 Hz 6 mV 60 Hz 7 mV 60 Hz 8 mV 60 Hz 9 mV 60 Hz 10 mV 60 Hz 51 200 ms Square 10 ms Triangle 25 ms Triangle 40 ms Triangle 100 ms Triangle 200 ms Triangle 10 ms SSQ 25 ms SSQ 40 ms SSQ 100 ms SSQ 200 ms SSQ These settings can be selected using 4 to highlight the parameter and using to open drop down menu of all the options for the highlighted parameter Moise Pacere BEER ENTER CANCEL Use PX 4 to scroll to the desired option Then EMTER used to accept the new setting The CAMCEL key be used to return to the Pacemaker configuration screen without making a new selection The EXIT key is used to return to the PACE MAIN SCREEN PACEMAKER PULSE FILTER This filter eliminates noise pulses from being detected as pacemaker pulses Any pulses that have a width less than the Pacemaker Pulse Filter setting will be ignored When set to 0 0 the filter is disabled When the filter is ON an indicator will show FILTER ON in the main pa
40. aerdal HS 2000 Blank Test 45 This section shows a list of all of the names of the Auto Sequences It is used to select an individual sequence for configuration Once selected the configuration window will change to display the settings for the selected sequence 84 SEQUENCE CONFIGURATION The sequence configuration window displays all of the configuration settings for each Auto Sequence This sample screen shows a defib test configuration Edit Sequence Name 20 chars max LitePak 4 Sequence Select Test Made Defibrillator Only Pacer Only Defib amp Pacer Configure Defibrillator Test Configure Racer Test Joules Joules Joules Joules Joules Joules o Joules Step 10 Joules Step 11 8 Joules Step 12 8 Joules Step 13 Joules Step 14 Joules Step 15 8 Joules Stepi amp 0 Joules Step 17 0 Joules Step 18 58 Joules Step 18 o Joules Step 20 Joules Insert Step Delete Step Tolerance 15 15 Max Energy Test Do Max Energy Test ves Max Energy 450 Joules High Limit 480 Joules Low Limit 418 Joules Charge 08 Seconds Cardioversion Test Do Cardioversion Test ves Step 1 100 Joules Step 2 100 Joules Step 3 100 Joules Energy Limit 10 10 Delay Limit 30 mS ECG Performance Test Do Performance Test Yes X Sequence Name This name can be any string of up to 20 standard ASCII characters NO
41. ature Ventricular Contraction NSR of 80 BPM with periodic left focus premature ventricular beats with 3396 premature timing PVC Type 1 9 NSR Continuous PVC Std Standard Type 1 Premature Ventricular Contraction NSR of 80 BPM with periodic left focus premature ventricular beats with 20 premature timing PVC Type 1 9 NSR Continuous PVC RonT R on T Type 1 Premature Ventricular Contraction NSR of 80 BPM with periodic left focus premature ventricular beats with 6596 premature timing placing R on the previous T PVC Type 1 9 NSR Continuous Multifocal PVCS Multifocal Premature Ventricular Contraction NSR of 80 BPM with Type 1 and Type 2 PVCs PVC Type 1 2 NSR PVC Type 2 2 NSR Continuous Bigeminy Bigeminal Rhythm NSR of 80 BPM with every other beat a Type 1 PVC Continuous Run of 5 PVCs Run of 5 Premature Ventricular Contractions NSR of 80 BPM with periodic group of 5 Type 1 PVCs b PVC Type 1 36 NSR Continuous Vent Tach Ventricular Tachycardia 160 BPM No P wave Beats similar to Type 1 PVC Continuous 24 PLAYBACK LAST PULSE SCREEN The DA 2006 can display a graphical representation of the last pulse This screen may be accessed by pressing the key from the Defibrillator Analyzer MAIN SCREEN The playback allows the user to view the Defibrillator pulse in a time expanded form Samples are stored internally at 0 1 ms inter
42. aximum energy levels 32 The energy contained in a pulse is determined mathematically based on the fact that the energy is defined as the integral of the power curve The following formulas describe the basic computation Power V R Energy E dt VIR V at R This computation is implemented digitally by taking timed samples of the voltage every 100 usec for 100 msec 1000 readings Each value is then squared and divided by the resistance 50 ohms The sum of these 1000 values times 10 is then the Energy in Joules Watt Seconds contained in the pulse 33 DEFIBRILLATION TEST The setup for a Defibrillation Test is dependent on the physical hardware involved For the sake of this example we will assume a standard defibrillator with 5 lead ECG NOTICE PERFORMING TESTS REFER TO DUT MANUFACTURER S SERVICE MANUAL FOR TEST PROCEDURES AND MEASUREMENT LIMITS 1 Connect ECG leads to the corresponding universal connector on the DA 2006 The connectors are marked with both the AHA and International color codes 2 Turn on the DA 2006 3 The unit will come up in the High Range Defibrillator mode This range is used for normal adult testing NOTE If it is desirable to run a test at 50 Joules or less with a peak voltage of 1000 Volts or less the unit may be changed to the Low Range Defibrillator mode using the key 4 Select Ventricular Fibrillation from the ECG WAVEFORM SCREEN wi
43. cemaker screen COMFIGURATION TEST RESULTS FILTER OM Pace DO NOT DEFIB Fate perm Load SO ohm Width 0 0 mS Moize Mone Ame 0 0 m Wave 40 mS Sauare Energy 0 0 md PACE MODE SEMSITINITY REFRACTORY TOGGLE MORE SETUP PERIOD TEXT KEYS 52 SENSITIVITY TEST The Sensitivity Test is used to determine the smallest waveform that the pacemaker can detect For this test the selected waveform is generated outside of the refractory period of the pacemaker The DA 2006P uses a successive approximation approach to determine the smallest output waveform that can be detected by the pacemaker The Sensitivity Test may be initiated by pressing the key from the PACE MAIN SCREEN WARNING This section is provided as a guide to familiarize the user with the DA 2006P It is not intended to provide the necessary test sequence for every Pacemaker The user must consult the manufacturer s manual for each DUT to determine the correct test procedure to follow While this test is running the following display will show the progress of the test CORP pi U Wave 40 Or Press Cancel to Exit At any time the CAMCEL key can be depressed to stop the test and return to the PACE MAIN SCREEN 53 At the end of the test the display will show the pacemaker amplitude sensitivity at the Pacer Terminals and the ECG Terminals COMFIGURATIOM TEST RESULTS MD LO
44. d Il 1 0 mV ha ECG Output Group Performance d ECG Output Waveform Triangle 2 Hz ECG Output Amplitude Lead Il 1 0 mv had ECG Output Group Normal Sinus Rhythm fsal ECG Output Waveform 80 BPM E ECG Output Amplitude Lead Il 1 0 mV Ide Com Port being used Sequence Configuration Task Use this section to configure each Auto Seauence test Indicator 81 Progress 2 25 2007 3394M Today s Date PROGRAM MENU DA 2006 AutoSequence Progr File Help Save AutoSequence to File Load AutoSequence File Clear Filename History Exit The program menu contains shortcuts to file operations as well as program version information From the File Menu you can Save or Load Auto Sequences as well as Clear the History of files that were used You can also Exit the program from this menu The Help Menu provides access to program version information shown Ele Help ET below x AutoSequence Programmer for DA 2006 P Version 1 15 This utility is used to configure amp utoSequence routines for the DA 2006 P Series of Defibrillator Analyzers Copyright 2006 BC Biomedical 314 638 3800 www bcgroupintl com Warning This program is protected by Copywright Law and International Treaties Unauthorized reproduction or distribution of this program or any portion of it may result in severe civil and criminal penalties and will
45. e and 5 Joules when configured for the Low Range The following is an example of the MAIN SCREEN with the results of the Self Test Waveform COMFIGURATIOM RESULTS ee 108 7 Joules Status Ready for Defib Peak wv 1080 0 Volts ECG Disabled Peak 21 6 Amps AUTO SELF TEST DA 2O06 SEQUENCES WAVEFORM SETUP The following is an example of the PLAYBACK LAST PULSE SCREEN showing a graphical representation of the Self Test Waveform 00 1200 PLRYEREK PLRYEREK FIRST Des ENTIRE mias 31 RUNNING A DEFIBRILLATOR TEST WARNING CONNECTIONS All connections to patients must be removed before connecting the DUT to the DA 2006 Series Analyzers A serious hazard may occur if the patient is connected when testing with the Analyzer Do not connect any leads from the patient directly to the Analyzer or DUT INTRODUCTION The DA 2006 will analyze the pulse output of a monophasic or biphasic defibrillator The primary measure of the output is the Energy that it contains Other information deals with the maximum voltage and current as well as the pulse timing with respect to the R wave The human body has characteristic impedance that may vary but 50 ohms is used for comparative defibrillator testing The DA 2006 has a large internal 50 ohm non inductive high power resistor to simulate a human body It is sized to safely and reliably accept repeated pulses at the m
46. e test sequence with the details and options that can be selected using the PC program Test Description Fields Options Defibrillator Test Sequence eee 1 20 Joules Defib Energy Tests discharge energy Energy Level Limits 0 99 VFIB ECG Output i m Maximum Energy for detipaliaion to Shad Energy Level Limits xxx Joules Test fountain energy MES Allowed Charge ime Measures Cardioversion 1 3 xxx Joules Caldlevelsion Test Delay Energy Level Limits 0 99 Up to 10 E Performan ibri CG Performance Tests defibrillator Waveform Outputs x Waveform Group Test ECG input x Waveform and Amplitudes Lead II mV Pacemaker Test Sequence DA 2006P Only Pulse Rate xxx ppm Pulse Amplitude and xx mA Load settings xxx ohms Limits for 8 Rate and Amplitude dt METER Asynchronous Test Asynchronous Mode Pulse Rate and ppm Load xxx ohms Measures Pacemaker Demand Mode Tests Sensitivity at Pacemaker Pulse Rate xxx ppm Pads ECG leads Load and xxx ohms Output Waveform x Waveform Measures Paced Refractory Test Refractory Period Do Test yes no Sensed Refractory Period Pulse Measures Pacemaker Rate and Amplitude Pulse Rate and Tests Amplitude 66 VIEW MODE The VIEW MODE allows the user to look at the test configuration Each test setting will be shown as well as the test limits that identify a valid or invalid test result The screens that are displayed in the
47. ep 20 0 Joules DK Cancel OK Cancel Pressing OK here would shift steps 4 19 Pressing OK here would shift steps 6 20 up down by one step and insert a blank step at by one step and insert a blank step at step step 4 20 88 Pacer Examples i Delete Autosequence Step Annio ERERREEEEPEEEEEPPPPE recerererseeceeet ete amp amp amp amp amp O amp amp amp amp amp w Insert Autosequence Step FECPEPPEEREEEEEEPEEE amp amp amp amp amp amp amp amp amp amp amp amp amp amp amp amp amp Pressing OK here would shift steps 6 20 up by one step and insert a blank step at step Pressing OK here would shift steps 4 19 down by one step and insert a blank step at 89 ECG CONFIGURATION SECTION ECG Performance Test Sequence Step 1 ECG Output Group AED ECG Output Waveform Asystole ECG Output Amplitude Lead Il 1 0 mY Step 2 ECG Output Group Performance bd ECG Output Waveform Square 2Hz ECG Output Amplitude Lead II 1 0 mv Step 3 ECG Output Group Performance 7 ECG Output Waveform Triangle 2Hz ECG Output Amplitude Lead Il 1 0 mv x Step 4 ECG Output Group Normal Sinus Rhythm ECG Output Waveform x ECG Output Amplitude Lead Il 1 0 mv Step 5 Dam Remi
48. er analysis function It measures and displays pacer pulse information as well as performing Refractory Period Sensitivity and Immunity testing All models have a built in 50 human body simulation load as well as 12 lead ECG with arrhythmias and performance waveforms Additionally they have a Parallel Printer port a RS 232 serial communications port oscilloscope output high level ECG output as well as provision for an AC adaptor The DA 2006 Series makes viewing and selecting the desired waveforms and test data quick and intuitive with all operational information being available on the 240 by 64 pixel graphic display allowing for easy maneuvering through parameters and scrolling through available options The following are highlights of some of the main features DA 2006 Basic Features e SIMPLE TO OPERATE GRAPHICS DISPLAY WITH SIMULTANEOUS DETAILED STATUS OF PARAMETERS AND SCROLLING CONTROL OF OPTIONS ON SCREEN VIEWING OF DEFIBRILLATOR AND PACEMAKER WAVEFORMS DROP DOWN CHOICE SCREENS LIST ALL OPTIONS FOR PARAMETERS MONOPHASIC AND BIPHASIC COMPATIBLE 5000 V 1000 JOULE CAPACITY HIGH AND LOW RANGES CARDIOVERSION DELAY MEASUREMENT CHARGE TIME MEASUREMENT WAVEFORM STORAGE AND PLAYBACK 10 UNIVERSAL PATIENT LEAD CONNECTORS POWERED BY 9 VOLT BATTERY OR OPTIONAL AC ADAPTOR LOW BATTERY INDICATOR DISPLAY BACKLIGHT PARALLEL PORT FOR PRINTING FULL REMOTE OPERATION VIA RS 232 FLASH PROGRAMMABLE FOR UPGRADES 1 AUTO S
49. es not change for the duration of the Refractory Test 55 At any time the C4NCEL key be depressed to stop the test and return to the PACE MAIN SCREEN When the test is completed the display will update with the Paced Refractory Period and Sensed Refractory Period in the Test Results COMFIGURATIOM TEST RESULTS ee LOR Oe Fada 0 71 mw Load SO ohm Sens ECG 0 09 roy Moise Mone Paced RP 245 gt Wave 40 mS Sauare Sensed RP 200 gt REFRACTORY Inaa TEST PERIOD TEST ITEXT RESULTS KEV 56 PRINT MENU SCREEN The DA 2006P allows the user to print the latest Pacemaker Analysis data or a header The PRINT MENU SCREEN is accessed by pressing the key from the PACE MAIN SCREEN The following is an example of the print menu screen What would you like ta print PRINT PRINT TET HEADER RESULT The header is sent by pressing the key The test data is sent by pressing the PRINT TET key The CANCEL key can be depressed to return to the PACE MAIN SCREEN 57 The following is the print header and sample data that are used for the Pacemaker Analyzer mode BC Biomedical DA 2006P Transcutaneous Pacemaker Analyzer DA 2006 Serial Number Dut Manufacturer Dut Model Dut Serial Number Technician Location Comments LOAD SETTING DA 2006P Measurements Output Output Rate Width Ampl Enrg S Pads S ECG Test
50. ess through the test The following sample screen shows the common elements present during the RUN MODE Instructions Selected Current Test Results Exit Key for Settings Auto Sequence Test Step exits RUN MODE and Actions NOTE All CINFIGURRTIDN TEST RESULTS 2 0 LifePak Enererz Test 1 Data will be Set Defibrillator for 2 Joules lost when Test Results When Ready this key is P est Passed Suto Advancing 2 assed Last MENT PRINT TEST EXIT used Failed x STEP STEP RESULTS Special Action Key Last Step Key Next Step Key Print Key Capture Readings for returning to for advancing for printing all Get New Readings the last step to the next step results to printer Start 71 The following screens may be shown in the RUN MODE if all test options are selected DEFIBRILLATOR ENERGY TESTS COMFIGURATIOM LifePak Eneray Test Set Defibrillator for 2 Joules Discharge When Ready PRINT RESULTS COMFIGURATIOM LifePak Eneray Tes Set Defibrillator for 2 Joules Discharge When Ready Test Passed Suto Advancing in 2 PRINT RESULTS CONFIGURATION TEST RESULTS 2 1 J LifePak Eneray Tes Set Defibrillator for 2 Joules 183 0 Y Discharge When Ready Test Failed Retry if desired PRINT RESULTS 72 DEFIBRILLATOR MAXIMUM ENERGY TESTS COMFIGURATIOM LifePak Set Defibrilator for 360 Joules Press Start Timer Whe
51. etup of the unit CONFIGURATION Pace O00 MOT DEFIE Load 500 ohm Noise Mone Wave 40 mS Sauare LOAD This line displays the selected load This setting may be changed in the PACE MODE SETUP screen The load choice determines what impedance is used at the pacemaker input as well as whether the unit uses the Pacer Input Terminals or the Defibrillator Plate Input Terminals NOISE This line displays the selected noise output This setting may be changed in the PACE MODE SETUP screen WAVE This line displays the selected output waveform This setting may be changed in the PACE MODE SETUP screen The selected waveform is the output to the pacer on the ECG Terminals Pacer Terminals and Defibrillator Plate Terminals 46 TEST RESULTS The TEST RESULTS section of the PACE MAIN SCREEN displays the results of the last test It will continue to be displayed until the power is turned off or another test is run The Test Results section of the PACE MAIN SCREEN contains eight lines of data that can be toggled to view the first 4 lines or the second 4 lines by pressing the key RESULT Rate Width 19 9 mS Amp 82 3 m Energy 32 0 mJ RESULT Sens Pads 1 52 mw Sens Ec 0 21 mw Paced 270 ms Sensed RP gr mS RATE This line displays the rate of the pacemaker pulse that is present at the selected load WIDTH This line displays the width of the pacemaker pulse that is p
52. he ECG Group Waveform and Amplitude can be selected using highlight the parameter and using CHOICES to open a drop down menu of all the options for the highlighted parameter Disabled ECG Sinus Rhythm Waveform Advanced Electronic Defib Amplitude H ENTER CANCEL Use scroll to the desired option Then used to accept the new setting CANCEL key can be used to return to the ECG waveform configuration screen without making a new selection The EXIT key is used to return to the MAIN SCREEN 23 The following is a brief description of how the DA 2006 simulates the available arrhythmias Abbreviation Arrhythmia Description Irregular waveform with no real Fib Eibrilation 2 R R interval and low Continuous Absence of P wave irregular P R Atrial Fib Atrial Fibrillation interval rate and a high level signal Continuous 274 Deg Heart Block Second Degree Heart Block 80 BPM with increasing P R interval for four beats 160 220 400 470 ms followed by a P wave without a QRS Continuous Rt Bundle Branch Block Right Bundle Branch Block 80 BPM with Normal P wave and P R interval but wider QRS complexes Continuous PAC Premature Atrial Contraction NSR of 80 BPM with Periodic Abnormal 2596 early P waves PAC 7 NSR Continuous PVC Early Early Type 1 Prem
53. ication beyond these specifications or any unauthorized user modifications may result in hazards or improper operation WARNING CONNECTIONS All connections to patients must be removed before connecting the DUT to the DA 2006 Series Analyzers A serious hazard may occur if the patient is connected when testing with the Analyzer Do not connect any leads from the patient directly to the Analyzer or DUT WARNING LIQUIDS Do not submerge or spill liquids on the DA 2006 Series Analyzers Do not operate the Analyzer if it may have been exposed to fluid CAUTION CLEANING Do not immerse The Analyzer should be cleaned by wiping gently with a damp lint free cloth A mild detergent can be used if desired CAUTION AC ADAPTOR Unplug the AC Adaptor before cleaning the surface of the DA 2006 Series Analyzers CAUTION SERVICE The DA 2006 Series Analyzers are intended to be serviced only by authorized service personnel Troubleshooting and service procedures should only be performed by qualified technical personnel CAUTION ENVIRONMENT Exposure to environmental conditions outside the specifications can adversely affect the performance and accuracy of the DA 2006 Series Analyzer If the Analyzer is outside the Operating Specifications allow it to acclimate to specified conditions for at least 30 minutes before attempting to operate it CAUTION INSPECTION The DA 2006 Series Analyzers should be inspected before each use
54. ifePak 6 LifePak 6S LifePak 7 LifePak 8P LifePak 9P LifePak SPM LifePak 10 LifePak 10P LifePak 10PM HP 786604 HP XLPM Nihon Kohden 7000 Laerdal HS 2000 Marquette 1500PM Zoll PD2000 lank Test 24 lank Test 25 lank Test 26 lank Test 27 lank Test 28 lank Test 29 lank Test 30 lank Test 31 lank Test 32 lank Test 33 lank Test 34 lank Test 35 lank Test 36 lank Test 37 lank Test 38 lank Test 39 lank Test 40 lank Test 41 lank Test 42 lank Test 43 lank Test 44 lank Test 45 Edit Sequence Name LifePak 4 Select Test Mode Defibrillator Only 20 chars max Copy Sequence C PacerOnly Defib amp Pacer Configure Pacer Test Configure Defibrillator Test ECG Output Group AED ECG Output Waveform Asystole ECG Output Amplitude Lead Il 1 0 mV Energy Level Test 0 to End Step 1 Joules Step 2 5 Joules Step 3 Joules Step 4 100 Joules Step 5 200 Joules Step 6 300 Joules Step 7 400 Joules Step 8 450 Joules Step 9 9 Joules Step10 0 Joules Step 11 loo Joules Step 12 9 Joules Step 13 v Joules Step 14 Joules Step 15 8 Joules Step 16 loo Joules Step17 0 Joules Step 18 9 Joules Step 19 lo Joules Step 20 8 Joules Insert Step Delete Step Tolerance 15 15 92 V Fib Output During Step 2 Step 3 Step 4 ECG Output Group Performance ECG Output Waveform Square 2 Hz E ECG Output Amplitude Lea
55. illator to the various waveforms 44 TRANSCUTANEOUS PACEMAKER ANALYZER The DA 2006P can analyze pacemaker pulses as well as determine Refractory periods and Sensitivity levels of on demand pacemakers For maximum versatility the DA 2006P has 26 internally selectable pacemaker loads ranging from 50 ohms to 2300 ohms The DA 2006P can also test the noise immunity of the DUT by generating a 50 or 60 Hz noise waveform with amplitude up to 100 mV For sensitivity testing the DA 2006P can output a Square Triangle or Haversine waveform with widths ranging from 10ms to 200ms The input circuitry of the DA 2006P is protected against damage in the case of an accidental defibrillator discharge into the Pacemaker Input terminals The key is used to change to the Pacemaker Analyzer mode PACE MAIN SCREEN The Pacemaker Analyzer MAIN SCREEN shows the current CONFIGURATION the TEST RESULTS and the available FUNCTION KEYS The following is a sample of the PACE MAIN SCREEN COMFIGURATIOM RESULTS Pace D0 DEFIB mpm Load SO ohm Width 38 8 5 Moize Mone 19 2 Wave 40 mS Sauare Energy NOTE The Test Results section of the MAIN SCREEN contains eight lines of data that can be toggled to view the first 4 lines or the second 4 lines See TEST RESULTS section of manual for more information 45 CONFIGURATION The CONFIGURATION section of the PACE MAIN SCREEN displays the current s
56. k of the R wave until the start of the Defib Energy pulse The line is replaced by the CHARGE TIME if this test has been run see START CHARGE TIMER SCREEN for more information CHG TIME This line displays if the Charge Timer has been run It shows the time required to charge the Device Under Test DUT This test is started with the key FUNCTION KEYS The FUNCTION KEYS section of the MAIN SCREEN displays the current functions of the keys found below the display These keys allow for navigation to supporting screens and initiation of specific features PLRVEREE START PRINT HORE i pg WAVEFORMS LaST PULSE CHREGETIMERI HEADER KEYS _ Primary Function Keys MORE AUTO SELF TEST 09 2005 A EEE secitences CHEF ORM SETUP _ Secondary Function Keys ECG WAVEFORMS This key enters the ECG WAVEFORMS screen where all ECG parameters are set PLAYBACK LAST PULSE This key enters the PLAYBACK LAST PULSE screen where a graphical representation of the last pulse may be viewed and sent out START CHARGE TIMER This key brings up the CHARGE TIMER screen and starts the pre warn timer It is used to test the charge time for the defibrillator PRINT HEADER This key sends the Report Header to the printer MORE KEYS These keys toggle between the Primary and Secondary Function Keys 20 AUTO SEQUENCES This key brings up the AUTO SEQUENCE MENU which is used to view or run the Auto Sequences stored in the unit S
57. n Ready LifePak Set Defibri Press Star COMFIGURATION TE RESULTE LifePak 337 54 Set Defibri 2470 0 Press Star 49 44 Test FailectL 21 65 COHFIGURATIOH LifePak MaxE Cha Time Set Defibrilator for 360 Joules Press Start Timer When Ready Test Passed Suto Advancing in 3 PRINT TEST START RESULTE CHARGE TIMER 73 PRINT TEST RESULTS COMFIGURATIOM LifePak Crdvren Test Set Defibrilator for 100 Joules Discharse Sync Made When PRINT TEST RESULTS Waveform DEFIBRILLATOR ECG PERFORMANCE TEST COMFIGURATION RESULTS LifePak ECG Perf Al heck ECG Performance Waveforms On Defib Triangle Wave 2 Hz Lead 0 Or Leadll1 0m PRINT TEST RESULTS NOTE Some tests like Performance Waveforms do not have quantitative analyses and therefore require the user to manually progress through the test 74 PACEMAKER PULSE AND AMPLITUDE TESTS DA 2006P COMFIGURATION LifePak Pacer Test 1 Set Pacemaker for 40 20m Press Capture to Test Readings PRINT RESULTS COMFIGURATIOM TEST RESULT LifePak Pacer Test 1 41 ppm Set Pacemaker for 40 20m Showin Captured Load Test Passed Auto Advancing in 2 SOc HEST PRINT TEET GET HELI RESULTS READING NOTE If the test fails or new readings are desired the Get New Readings Key can be used to replace the current readings The current readings
58. ne CONNECTIONS Female DB 9 PARALLEL PRINTER PORT CONNECTIONS Female DB 25 97 NOTES 98 7 BC Group 77 YOUR ONE STOP Bici ENG 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 2006 Series User Manual 08 12 Rev 11 Copyright 2012 Made in the USA
59. nk Test 25 Blank Test 25 Blank Test 26 Blank Test 26 Blank Test 27 Blank Test 27 Blank Test 28 Blank Test 28 Blank Test 29 Blank Test 29 Blank Test 30 Blank Test 30 87 Insert Step and Deleting Step Screens The insert and delete functions allow the user to quickly modify an existing test configuration Deleting a step will move all of the tests following the deleted test up by one step and clear the final step Inserting a step will shift all following steps down by one step and clear the selected step location Defibrillator Examples x E Select Where to Insert the Step Select the Step to Delete C Step1 10 Joules C 10 Joules C Stp2 25 Joules C Stp2 25 Joules C Step3 50 Joules C Step3 5 Joules 4 100 Joules C Step 4 100 Joules C Stp5 200 Joules Step5 200 Joules C Steps 300 Joules C Steps 300 Joules 400 Joules C Step 400 Joules C Steps 450 Joules C Steps 450 Joules C Step9 0 Joules C 5 9 Joules Step 10 0 Joules C 10 0 Joules C Step11 0 Joules C Step11 0 Joules 12 0 Joules Step12 0 Joules C Step13 0 Joules 13 0 Joules C 14 0 Joules C 14 Joules C Step15 Joules C 15 Joules C Step 16 0 Joules Step 16 0 Joules C Step17 0 Joules C Step17 Joules C 18 0 Joules C 18 Joules 19 0 Joules Step 19 0 Joules C Step 20 0 Joules St
60. ocedure to follow 1 Turn on the DA 2006 2 The unit will come up in the High Range Defibrillator mode This range is used for normal adult testing 3 Set the Defibrillator to its maximum power setting 4 Depress the key 41 5 While the Pre Warning Countdown is running place the Defibrillator Paddles on the DA 2006 contact plates The APEX is on the right and the STERNUM is on the left NOTE Reversing the paddles will not cause any mage to the unit or error in the energy reading However it will cause the polarity of the oscilloscope output and the playback waveform to be inverted 6 Holding the paddles firmly in place wait until the Pre Warning Countdown equals zero and then immediately start charging the Defibrillator 7 As soon as the DUT is fully charged discharge it into the DA 2006 WARNING Observe all precautions noted by the Defibrillator Manufacturer when using the Defibrillator 8 At the end of the process the results are continuously displayed in the Test Results section of the MAIN SCREEN They will remain there until another test is performed the range is changed or the power is turned off NOTE The last line in the Test Results section of the screen will show Chg Time xxx x sec 42 SHOCK ADVISORY ALGORITHM TEST The Shock Advisory Algorithm Test works with the analysis and prompting functions on automatic and semiautomatic Defibrillators These circuits look a
61. rements for electrical equipment for measurement control and laboratory use General requirements This equipment has been type tested and compliance was demonstrated to the above standard to the extent applicable vi NOTICE SYMBOLS Symbol N Description Caution Consult Manual for Further Information Center Negative Hazardous Voltage Per European Council Directive 2002 95 EC do not dispose of this product as unsorted municipal waste IEC Measurement Category CAT equipment designed to protect against transients in equipment on circuits not directly connected to MAINS Under no circumstances should the terminals of the Analyzer be connected to any MAINS voltage vil NOTICE ABBREVIATIONS AAMI AHA A Amps ANSI ASCII ms mS msec mV NEDA Association for the Advancement of Medical Instrumentation American Heart Association Amperes American National Standards Institute American Standard Code for Information Interchange Beats Per Minute Celsius degree s Delta Time Change in Time Device Under Test Energy Electrocardiogram European Hertz International Electrotechnical Commission Joule s kilogram s pounds microampere s microhenry microvolt s microsecond s milliampere s millimeter s millisecond s millivolts National Electronic Distributors Association Ohm s Power pulse per minute Resistance ohms seconds United States of
62. resent at the selected load AMP This line displays the current of the pacemaker pulse that is present at the selected load 47 ENERGY This line displays the energy of the pacemaker pulse that is present at the selected load SENS PADS This line displays the sensitivity at the pads for the selected waveform during the last Sensitivity Test SENS ECG This line displays the sensitivity at the ECG leads for the selected waveform during the last Sensitivity Test PACED RP This line displays the paced refractory period detected at the selected load during the last Refractory Period Test SENSED RP This line displays the sensed refractory period detected at the selected load during the last Refractory Period Test 48 FUNCTION KEYS The FUNCTION KEYS section of the PACE MAIN SCREEN displays the current functions of the keys found below the display These keys allow for navigation to supporting screens and initiation of specific features MODE SENZITIHTY REFRACTORY TOGGLE MORE Da SETUP TEST PERIOD TEST ITEST RESULTS KEYS Primary Function Keys MORE PRIMT PLAYEARCK AUTO A 2006 i KEYS MHENU LAST SEQUENCES SETUP i Secondary Function Keys PACE MODE SETUP This key enters the PACE MODE SETUP SCREEN where all pace parameters are chosen SENSITIVITY TEST This key activates a Sensitivity Test REFRACTORY PERIOD TEST This key activates a Refractory Period Test TO
63. t ECG waveforms and prompt the user to Shock or Shock based on national and international guidelines The following table outlines these guidelines SHOCK ADVISORY ALGORITHM TEST ECG SIGNALS ACTION Asystole No Shock Supra Ventricular Tachycardia 90 BPM No Shock Polyfocal Ventricular Tachycardia 140 BPM No Shock Multifocal Ventricular Tachycardia 140 BPM No Shock Coarse Ventricular Fibrillation Shock Fine Ventricular Fibrillation Shock Polyfocal Ventricular Tachycardia 160 BPM Shock Multifocal Ventricular Tachycardia 160 BPM Shock WARNING This section is provided as a guide to familiarize the user with the DA 2006 Series It is not intended to provide the necessary test sequence for every Defibrillator The user must consult the manufacturer s manual for each DUT to determine the correct test procedure to follow 43 1 Connect ECG leads to the corresponding universal connector on the DA 2006 The connectors are marked with both the AHA and International color codes 2 Turn on the DA 2006 3 The unit will come up in the High Range Defibrillator mode This range is used for normal adult testing 4 Select the desired AED Waveform and Amplitude to be tested from the choices on the ECG WAVEFORM SCREEN 5 Set the Defibrillator to analyze the ECG waveform in the automatic or semiautomatic mode 6 Observe and record the response of the Defibr
64. th an amplitude of 1 mV This is necessary for most automatic defibrillators 5 Place the Defibrillator Paddles on the DA 2006 contact plates The APEX is on 34 the right and the STERNUM is on the left NOTE Reversing the paddles will not cause any damage to the unit or error in the energy reading However it will cause the polarity of the oscilloscope output and the playback waveform to be inverted 6 Holding the paddles firmly in place charge the Defibrillator and discharge it into the DA 2006 WARNING Observe all precautions noted by the Defibrillator Manufacturer when using the Defibrillator 7 The DA 2006 will automatically sense the voltage rise across the internal 50 ohm load and begin taking readings After the sampling is done 100 ms the unit will compute and display the results a The power pulse is available at the oscilloscope output in real time at 200 1 signal attenuation when in low range and 1000 1 signal attenuation when in high range b After the computation the pulse is automatically played back at a 200 1 time base expansion 200 times slower on both the ECG leads and the Paddle plates The signal level is 1 mV per 1000 Volts on Lead 1 c Atthe same time the test results are sent to the printer 35 8 The Status line will change to indicate the various steps as they are being done 9 At the end of the process the results are continuously displayed in the Test Results section of
65. the MAIN SCREEN They will remain there until another test is performed the range is changed or the power is turned off 10 The user may repeat the playback of the waveform at any time by changing to the PLAYBACK LAST PULSE SCREEN using the key In this screen the pulse may be viewed in 20 msec segments and paused for review NOTE The pulse is sent to the ECG and Paddle outputs at the same time itis being displayed on the screen 36 CARDIOVERSION TEST A Cardioversion Test is simply an energy test with special attention being given to the timing The DA 2006 continuously monitors for the R wave timing and displays if possible the delay between the R wave and the pulse In Cardioversion testing the Defibrillator is set to deliver a pulse based on a specific delay after the R wave WARNING This section is provided as a guide to familiarize the user with the DA 2006 Series It is not intended to provide the necessary test sequence for every Defibrillator The user must consult the manufacturer s manual for each DUT to determine the correct test procedure to follow 1 Connect ECG leads to the corresponding universal connector on the DA 2006 The connectors are marked with both the AHA and International color codes 2 Turn on the DA 2006 3 The unit will come up in the High Range Defibrillator mode This range is used for normal adult testing NOTE If it is desirable to run a test at 50 Joules or less with a
66. user presses a key or clicks the screen with the mouse XD lt 3 Qo ac a pao qa quuin Analyzer AutoSequence Programmer Warning This program is protected by Copywright Law and International Copyright 2006 Treaties Unauthorized reproduction or distribution of this program or any Biomedical portion of it may result in severe civil and criminal penalties and will be prosecuted to the maximum extent possible under law Version 1 15 Program Version 80 OVERVIEW The following is a general overview of the PC Interface used for Programming Auto Sequences Each part of this screen is described in full detail later in this section File Control This section is utilized to load save configuration files on the PC as well as ECG Sequence Programming Use this section to easily configure each step of the ECG Auto Sequence read write the auto configuration in the EXOSram menu Program Menu Bar DA 2006 P DA 2006 AutoSequei ce Programmer Ver 1 15 Sequence Selection Use this list to select which sequence to view edit File Help AutoSequence Filename C Program Files BC Biomedical DA4 2006 Series amp utoSequence Programmer T esting amp utosequence s Open Save AutoSequence Read AutoSequence Download AutoSequence AutoSequence File to File from DA 2006 P to DA 2006 P Select Sequence to Edit LifePak 4 LifePak 5 L
67. vals The PLAYBACK LAST PULSE SCREEN shows these samples expanded by a time factor of 200 In playback mode the samples are shown on the display and sent out the ECG leads Defibrillator Plates and the High Level output The following is a sample of the waveform that is shown in the display 1600 PLRYEREK PLAYEALE FIRST ENTIRE Dias The scale shown on the screen is automatically adjusted to provide the maximum resolution available The key can be used to pause the screen at any point while a pulse is being played back This key replaces the key when a pulse is being played back The key can be used to play continue the waveform if it has been paused This key replaces the key 25 The key starts a playback of only the first 20 ms of the waveform The key starts a playback of the entire 100 ms of the waveform At any time the EXIT key or can be depressed to return to the MAIN SCREEN 26 START CHARGE TIMER SCREEN A special timer has been incorporated into the DA 2006 to analyze the charging circuit of the Device Under Test DUT The START CHARGE TIMER SCREEN can be accessed by pressing the key from the MAIN SCREEN To synchronize the charge timer with the defibrillator charge time a Pre Warning Countdown period is started When the timer reaches zero the defibrillator charge should be initiated The following is an example of the countdown timer CONFIGURATION

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