Phase-3 vPad XSC for User Manual
Contents
1. Additional charges for damage and or missing parts and accessories will be applied to all returns Products which are not in as new and resalable condition are not eligible for credit return and will be returned to the customer at their expense Certification This instrument was thoroughly tested and inspected and found to meet DSI s manufacturing specifications when it was shipped from the factory Calibration measurements are traceable to the National Research Council of Canada NRC and or the National Institute of Standards and Technology NIST Devices for which there are no NRC NIST calibration standards are measured against in house performance standards using accepted test procedures Page i Warranty Warranty and Product Support Datrend Systems Inc DSI warrants this instrument to be free from defects in materials and workmanship under normal use and service for 90 days from the date of original purchase During the warranty period DSI will at our option either repair or replace defects in materials and workmanship at no charge provided the product is returned shipping duty brokerage and taxes prepaid to DSI Any and all transportation charges incurred are the responsibility of the purchaser and are not included within this warranty This warranty extends only to the original purchaser and does not cover damage from abuse neglect accident or misuse or as the result of service or modification by other than DSI INNO EVENT SHA2. PC using a text editor Once a new Checklist has been written it can be imported to vPad Check through a USB flash drive or directly from the PC Further information on Checklists and vPL including a full list of vPL keywords is provided in the vPad Check Operating Manual which can be opened with the Datrend Docs app Overview Chapter 1 Page 2 vPad XSC for Phase 3 USER MANUAL 2 Connection and Setup Verify DIP switches on the Interface unit are set appropriately for your application for a wired setup all three DIP switches are set to the OFF position for a wireless setup all DIP switches are ON For a wired setup connect the DB9 serial port of the Interface to the DB9 serial port of Phase 3 using the null modem serial cable P N 3140 400 provided with the Interface For a wireless setup connect the Bluetooth module P N 7050 028 to the DB9 serial port of Phase 3 Power up Phase 3 and select REMOTE mode from the main menu For a wireless system Phase 3 will apply power to the Bluetooth module and the module will then be initialized Connect the XBUS port on the Interface to the XBUS port on the vPad safety analyzer using the RJ12 cable P N 3140 069 provided with the Interface Note that the two XBUS ports on the Interface are interchangeable This enables several vPad XSC interfaces of different types to be chained in series if necessary Once connected to the vPad safety analyzer the Power indicator on
3. Checklist may start a pacer sensitivity test through a vPL statement similar to the following xtest Wait Then verify sensitivity result PSNS For the this statement PSN commands Phase 3 to immediately begin generating pacer triggers and S is a placeholder which may also be L Assuming that the pacer sensitivity limit is set to default the Interface automatically assigns a PASS result if measured sensitivity is less than 2000 uV In the case of a PASS the Test Report would contain an entry similar to the following Task Wait Then verify sensitivity test result Data Pacer Sensitivity Test Pacer Pulse Rate 70 1 PPM Sensitivity Min uV Max 2000 uV Result 1100 uV Result PASS A placeholder appears in the test data whenever a limit is not applicable such as the minimum sensitivity when limit is set to max or the limit is not enabled Operation Chapter 3 Page 25 vPad XSC for Phase 3 USER MANUAL Operation Chapter 3 Page 26 vPad XSC for Phase 3 USER MANUAL Chapter 4 Calibration and Maintenance Calibration of vPad XSC for Phase 3 is not required For service assistance contact Datrend for a Return Materials Authorization RMA number and the location of the nearest Service Facility Datrend Systems Inc 130 4020 Viking Way Richmond BC CANADA V6V 2L4 Tel 800 667 6557 North America Only or 604 291 7747 Fax 604 294 2355 e mail custom
4. E DATREND Systems Inc vPad XSC Automation Interface for Phase 3 Defibrillator Analyzer User Manual vPad XSC Automation Interface for Phase 3 Defibrillator Analyzer User Manual 2014 Datrend Systems Inc 130 4020 Viking Way Richmond BC CANADA V6V 2L4 Tel 800 667 6557 North America Only or 604 291 7747 Fax 604 294 2355 e mail customerservice datrend com 23 DATREND Systems Inc To order this manual use Part Number 6100 089 m Revision Histoty Revision Description Date A Initial Release 2014 Nov 26 Copyright Datrend Systems Inc DSI agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications If you would like other reproductions or distributions submit a written request to Datrend Systems Inc Unpacking and Inspection Follow standard receiving practices upon receipt of the instrument Check the shipping carton for damage If damage is found stop unpacking the instrument Notify the freight carrier and ask for an agent to be present while the instrument is unpacked There are no special unpacking instructions but be careful not to damage the instrument when unpacking it Inspect the instrument for physical damage such as bent or broken parts dents or scratches Claims Our routine method of shipment is via common carrier Upon delivery if physical damage is found retain
5. Limit In this next example the vPL statement sets the defib charge time limit to a maximum of 12 seconds xctrl Setting charge time limit to max 12 sec lim2 max 12 For this statement 2 immediately following the Lim command specifies the limit is for charge time max specifies limit type as maximum the only allowable type for charge time 12 is the maximum value 12 seconds In this case the Lim command does not include a param 2 since it is not required Operation Chapter 3 Page 8 vPad XSC for Phase 3 USER MANUAL Limits persist until modified by a xctr1 statement There is no need to set a defib energy limit for a charge time test if it has previously been set for a debrillator energy test 3 2 1 3 Example 3 Setting Pacemaker Pulse Current Limit The following vPL statement sets pacer pulse current limit to a target with tolerance in mA xctrl Setting pulse current tol to 3mA lim4 target 3 units For this statement 4 immediately following the Lim command specifies the limit is for pacer current target specifies the limit type as a target with tolerance as opposed to a min max range 3 is the tolerance value 3 and units sets the tolerance type as a number of milliamps as opposed percent The target value referred to above is not included with the limit but is specified in the vPL statement that executes the pacer pulse test itself 3 2 1 4 Example 4 Setting Pacem
6. Width ms 4 13 4 13 Result PASS The above example result is for a biphasic defibrillator waveform Pulsed biphasic waveform reports are similar though they include phase frequency Hz and duty cycle 7o measurements instead of phase delay and tilt Operation Chapter 3 Page 16 15 vPad XSC for Phase 3 USER MANUAL 3 3 2 Defibrillator Charge Time Test To perform a defibrillator charge time test use a vPL statement of the form xtest lt instr gt DCH lt fmt gt lt targ gt where lt instr gt isan instruction to be displayed to the user while the charge time test is in progress DCH is the command to measure defib charge time lt fmt gt can be either S or L as there is only one test result format and lt targ gt isan optional energy target in joules for automatic pass fail assessment cc 29 Note the comma separating the required parameters from the optional target energy 3 3 2 1 Example 9 Measuring Defibrillator Charge Time A Checklist may start a defibrillator charge time test with a target of 100 joules through a vPL statement similar to the following xtest Charge when Phase3 beeps then discharge DCHS 100 For this statement DCH commands Phase 3 to initiate a charge time test S is a placeholder which may be either S or L and 100 is the optional target energy J Assuming that defib energy and charge time limits are set to defaults the Inte
7. be displayed to the user while the refractory test is in progress PRF is the command to measure pacer refractory period and lt fmt gt can be either S or L as there is only one test result format Phase 3 measures two pulse characteristics for this test the paced refractory period PRP and the sensed refractory period SRP Since the only limit types allowed for both measurements are min max and range no target is needed in the xtest statement Results are automatically passed or failed after pacer PRP and SRP limits have been enabled 3 4 2 1 Example 12 Measuring Pacemaker Refractory Period A Checklist may start a pacemaker refractory test with automatic pass fail through vPL statements similar to the following xctrl Setting PRP limit 200 to 500ms lim8 range 200 500 xctrl Setting SRP limit max 300ms lim9 max 300 xtest Wait Then verify refractory test result PRFS For the above xtest statement PRF commands Phase 3 to immediately begin testing the pacer refractory period and S is a placeholder which may also be L Since the PRP limit and SRP limit are enabled prior to running the test the Interface automatically assigns a PASS result if the PRP is between 200 ms and 500 ms and SRP is less than 300 ms For the case of a PASS the Test Report will contain an entry similar to the following Operation Chapter 3 Page 22 vPad XSC for Phase 3 USER MANUAL Tas
8. the Interface should light up to show that it is now ready for operation Installation Chapter 2 Page 3 vPad XSC for Phase 3 USER MANUAL Installation Chapter 2 Page 4 vPad XSC for Phase 3 USER MANUAL Chapter 3 Checklist Programming A Checklist contains operator prompts and machine instructions for conducting an automated maintenance and inspection sequence To create or edit a Checklist with a vp extension you may use any text editor that works with plain text x7 files A sample Checklists to control Phase 3 through the Interface are provided with the vPad Check installation A Checklist that controls 4ase 3 may consist of at least three types of instructions initialization configuration and test 3 1 Initialization Before attempting to send commands to Phase 3 a Checklist must first initialize the connection For example the vPL statement xopen Phase 3 P 15 causes the Interface to attempt handshaking with Phase 3 The character P in uppercase is an identifier which represents the vPad XSCTM for Phase 3 the P is mandatory and enables vPad Check to address commands to the Phase 3 Interface specifically The value 5 sets a delay time in seconds after which the data connection is checked before proceeding with subsequent Checklist steps this value can be reduced to 2 if a wired connection is in use Phase 3 is simply a description of the device under control by the
9. 2 As Seba delta 5 St Initialization meere es ord goa Oe a Seu Ue ba EN Seek petes us 5 3 2 Gonubalion cure eger ota RR Re 6 3 2 1 Setting Limits and Tolerances 0 00 ccc eee eee ee 6 3 2 1 1 Example 1 Setting a Defibrillator Energy Limit 8 3 2 1 2 Example 2 Setting Defibrillator Charge Time Limit 8 3 2 1 3 Example 3 Setting Pacemaker Pulse Current Limit 9 3 2 1 4 Example 4 Setting Pacemaker Sensitivity Limit 9 3 2 1 5 Example 5 Disabling a Limit 0002s 10 3 2 2 Resetting Limits to Defaults 22i 204m H ee RR HH RR a aaa 11 32 3 EG Gy SIMUlatlan es meer 12 3 2 3 1 Example 6 Configuring ECG Simulation 12 3 2 4 Pacemaker Test Load 0 cc eee eee 13 3 2 4 1 Example 7 Configuring Pacemaker Test Load 13 33 Defibrillator Tests ida aehan naeh mecs Gane ae 14 3 3 1 Defibrillator Energy Test RR gt 15 3 3 1 1 Example 8 Measuring Defibrillator Energy 15 3 3 2 Defibrillator Charge Time Test llle 17 3 3 2 1 Example 9 Measuring Defibrillator Charge Time 17 3 3 3 Defibrillator Sync Delay Cardioversion Test 00 00 18 3 3 3 1 Example 10 Measuring Defibrillator Sync Delay 18 34 gt Pacemaker Tests nu este tico e Hier 19 3 4 1 Pacemaker Pulse Test cess shi deed E Re doen dox Gene ee 19 3 4 1 1 Example 11 Me
10. 3 2 3 1 Example 6 Configuring ECG Simulation The following vPL statement configures Phase 3 s ECG simulator xctrl Setting ECG to Fine VFIB ECGDK21 For this statement ECG is the Phase 3 remote command for ECG simulation DK is the wave code for Fine Ventricular Fibrillation 2 sets simulation amplitude to x2 scale and 1 indicates that the simulator should return to normal sinus rhythm after a defibrillator discharge This type of statement would typically precede a statement that tests defibrillator energy or other aspect of defibrillator performance A carriage return character lt CR gt or Nr as specified in the Phase 3 Operating Manual is not necessary in a vPL statement as the Interface handles such formatting automatically Operation Chapter 3 Page 12 vPad XSC for Phase 3 USER MANUAL 3 2 4 Pacemaker Test Load Most pacemaker manufacturers specify the load resistance at which their device should be tested Mase 3 has a variable load bank for a wide range of pacemaker test requirements vPL statements that configure pacer loads are of the form xctrl lt info gt PLD lt code gt where lt info gt isa description of the selected load which is briefly displayed to the user and lt code gt is the unique identifier for a particular pacer load For a full list of pacer load codes refer to Chapter 5 Remote Control Pacer Load Select Command in Phase 3 Operating Manual 3 2 4 1 Example 7 Conf
11. Interface and this may be modified to a different description if desired For a complete explanation of the xopen statement refer to the vPad Check Operating Manual When vPad Check encounters this statement it will interrogate the Interface and notify the operator whether initialization was successful If handshaking succeeds the Online indicator will light up on the Interface unit If not the operator should verify connections and power then retry the initialization Operation Chapter 3 Page 5 vPad XSC for Phase 3 USER MANUAL 3 2 Configuration As an optional function the Interface has the ability to automatically assign a pass fail result for measurement data obtained from ase 3 Configuration statements can set limits for automatic pass fail assessment as well as to change Phase 3 settings for defibrillator and pacemaker tests In a Checklist pass fail limits and Phase 3 settings are configured with xct r1 statements For more information on the xctr1 statement refer to the vPad Check Operating Manual 3 2 1 Setting Limits and Tolerances The Interface supports the following Phase 3 test functions defibrillator energy defibrillator charge time defibrillator sync delay catdioversion pacer pulse pacer refractory period pacer noise immunity pacer sensitivity When automatically assigning a pass or fail each test utilizes one or more pass fail limits which are stored in the Interface
12. LL DATREND SYSTEMS INC BE LIABLE FOR CONSEQUENTIAL DAMAGES No warranty shall apply when damage is caused by any of the following e Power failure surges or spikes e Damage in transit or when moving the instrument e Improper power supply such as low voltage incorrect voltage defective wiring or inadequate fuses e Accident alteration abuse or misuse of the instrument e Fire water damage theft war riot hostility acts of God such as hurricanes floods etc Only serialized products those items bearing a distinct DSI serial number tag are covered under this warranty PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY Items such as cables and non serialized modules are not covered under this warranty This warranty gives you specific legal rights and you may have other rights which vary from province to province state to state or country to country This warranty is limited to repairing the instrument to DSI s specifications When you return an instrument to DSI for service repair or calibration we recommend shipment using the original shipping foam and container If the original packing materials are not available we recommend the following guide for repackaging e Use a double walled carton of sufficient strength for the weight being shipped e Use heavy paper or cardboard to protect all instrument surfaces Use non abrasive material around all projecting parts e Use at least four i
13. aker Sensitivity Limit Before executing a pacer sensitivity test a Checklist can set pass fail limits through following vPL statement xctrl Setting sensitivity limit 25 to 45uV limil1 range 25 45 For this statement 11 immediately following the Lim command specifies the limit is for pacer sensitivity range sets limit type as a min max range as opposed to a minimum or maximum only 25 is the minimum value 25 microvolts and 45 is the maximum value 45 microvolts No target is needed for range limits Measurement results are automatically assessed as long as limit is not set to none Operation Chapter 3 Page 9 vPad XSC for Phase 3 USER MANUAL 3 2 1 5 Example 5 Disabling a Limit Sometimes automatic assessment may not be desirable in which case a vPL statement similar to the following can be used to disable a particular limit For example xctrl Disabling pulse width limit lim6 none For this statement 6 immediately following the Lim command specifies the limit is for pacer pulse width none sets the limit to none disabling automatic pass fail Other parameters of the command are omitted because they are not necessary Once a limit has been disabled a target specified in a xtest statement will appear in the Test Record but the corresponding measurement value will not be passed or failed automatically Operation Chapter 3 Page 10 vPad XSC for Phase 3 USER MANUAL 3 2 2 Rese
14. all packing materials in their original condition and contact the carrier immediately to file a claim If the instrument is delivered in good physical condition but does not operate within specifications or if there are any other problems not caused by shipping damage please contact your local sales representative or DSI immediately Standard Terms and Conditions Refunds amp Credits Please note only serialized products products labelled with a distinct serial number and accessories are eligible for partial refund and or credit Non serialized parts and accessory items cables carrying cases auxiliary modules etc are not eligible for return or refund In order to receive a partial refund credit the product must not have been damaged and must be returned complete meaning all manuals cables accessories etc within 90 days of original purchase and in as new and resalable condition The Return Procedure must be followed Return Procedure Every product returned for refund credit must be accompanied by a Return Material Authorization RMA number obtained from Datrend Customer Service All items being returned must be sent prepaid freight duty brokerage and taxes to our factory location Restocking Charges Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 Products returned in excess of 30 days after purchase but prior to 90 days are subject to a minimum restocking fee of 2096
15. ason for breaking the Quality Seal You should break this seal only after you have received factory authorization Do not break the Quality Seal before you have contacted us Following these steps will help ensure that you will retain the original warranty on your instrument without interruption WARNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation Datrend Systems will not be responsible for any injuries sustained due to unauthorized equipment modifications DSI DISCLAIMS ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION THIS PRODUCT CONTAINS NO USER SERVICEABLE COMPONENTS UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES vPad vPad XSC vPad Check and Phase 3 are trademarks of Datrend Systems Inc Android is trademark of Google Inc Page iii Page iv vPad XSC for Phase 3 USER MANUAL Table of Contents TABLE OF CONTENTS 3215 12 its a AA IN APP V Oil EFE ER XE 1 1 1 Standard Accessories 0 0c cece ee 1 1 2 Optional Accessories nase Dare o Se RN OO a hoy d aut draws 1 1 9 Checklists and VP au rc an e QUE ee ede QU tuc Pe QUE aftra 2 2 CONNECTION AND SETUP a cc ace tha ata ato do oe in lor deu thee Bla o ra di do ra tae 3 3 CHECKLIST PROGRAMMING 2 2 22 2 222 12
16. asuring Pacemaker Pulse 20 3 4 2 Pacemaker Refractory Period Test 000 0 eee eee eee 22 3 4 2 1 Example 12 Measuring Pacemaker Refractory Period 22 3 4 3 Pacemaker Noise Immunity Test 0 0000 eee eee eee 24 3 4 3 1 Example 13 Measuring Pacemaker Noise Immunity 24 3 4 4 Pacemaker Sensitivity Test 0000 eee 25 3 4 4 1 Example 14 Measuring Pacemaker Sensitivity 25 4 CALIBRATION AND MAINTENANCE 000000 cece eee eee et eaee 27 Table of Contents Page v vPad XSC for Phase 3 USER MANUAL Table of Contents Page vi vPad XSC for Phase 3 USER MANUAL Chapter Ao 1 Overview vPad XSC for Phase 3 referred to as the Interface in this manual is an intelligent hardware interface which supports vPad electrical safety analyzers having the vPad Check software application App installed The Interface allows vPad Check to conduct automated maintenance and inspection sequences on defibrillators and transcutaneous pacemakers using the Phase 3 analyzer In addition to automated control of Phase 3 operation the vPad XSC provides automatic assessment of measurement results based on user defined limits test reports in summary or detailed format flexibility of workspace with the optional wireless Bluetooth module This manual provides guidance for users integrating vPad Check and vPad XSC for Phase 3 into ne
17. d representing the test to be executed by Phase 3 and targl gt targ2 gt are optional targets associated with automatic pass fail assessment of the measurement results separated by commas TAS AR AS The number of targets specified in the xtest statement depends on the test to be executed Automatic pass fail assessment is disabled if a required target has not been specified in the statement In this case a will appear in the Test Record report instead of a user defined target For a detailed description of the vPL xtest statement refer to vPad Check Operating Manual Operation Chapter 3 Page 14 vPad XSC for Phase 3 USER MANUAL 3 3 1 Defibrillator Energy Test To perform a defibrillator energy test use a vPL statement of the form xtest lt instr gt DE lt range gt lt fmt gt lt targ gt where lt instr gt isan instruction to be displayed to the user while the energy test is in progress DE is the command to measure defib energy lt range gt can be L for low range up to 50 joules or H for high up to 600 joules lt fmt gt can be S for short report format or L for long format and lt targ gt isan optional energy target in joules for automatic pass fail assessment cc 27 Note the comma separating the required parameters from the optional target energy 3 3 1 1 Example 8 Measuring Defibrillator Energy A Checklist may start a
18. defibrillator energy test with a target of 2 joules through a vPL statement similar to the following xtest Set energy to 2J and discharge defib now DELS 2 For this statement DEL commands Phase 3 to prepare for a low range discharge S instructs the Interface to prepare a short report and 2 is the optional target energy J Assuming the defib energy limit is set to its default value the Interface automatically assigns a PASS result if the energy measured is 2 J 15 For the case of a PASS the Test Report will contain an entry similar to the following Task Set energy to 2J and discharge defib now Data Defibrillator Energy Test Energy Limits 2 J 15 Energy 1 9 J Result PASS Operation Chapter 3 Page 15 vPad XSC for Phase 3 USER MANUAL Short reports contain only the essential measurements from the analyzed discharge If more details are needed a statement specifying the long format report can be used for example xtest Set energy to 2J and discharge defib now For the same measurement data as shown above for the short format the long format would appear in the Test Record as Task Set energy to 2J and discharge defib now Data Defibrillator Energy Test Energy Limits 2 J Total Energy 1 9J Wave Phase Delay 0 44 ms Tilt PHASE 1 PHASE 2 Phase Energy J 1 5 0 4 Peak Voltage V 190 93 Peak Current A 3 80 1 86 Avg Voltage V 136 66 Avg Current A 2 72 1 32 Pulse
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20. iguring Pacemaker Test Load The following vPL statement configures Phase 3 s pacer test load xctrl Setting pacer load to 600 ohms PLDL For this statement PLD is the Phase 3 remote command for pacer load select and L is the pacer load code for 600 ohms This type of statement would typically precede statements that test pacemaker performance The carriage return lt CR gt and r specified in Phase 3 Operating Manual is not necessary in a vPL statement as the Interface handles such formatting automatically Operation Chapter 3 Page 13 vPad XSC for Phase 3 USER MANUAL 3 3 Defibrillator Tests Once a Checklist has initialized communication with the Interface configured Mase 3 test settings and optionally prepared limits for automatic pass fail assessment vPad is ready to execute a range of defibrillator tests A typical Checklist will include prompts instructing the operator how to set up the defibrillator and Phase 3 followed by remote test statements While executing a test the Interface acts as an intermediary that relays commands to Mase 3 and reformats the numerical results into a form suitable for vPad Check and the Test Record vPL statements which trigger a remote test begin with the x test keyword in the form xtest lt instr gt lt cmd gt lt targi gt lt targ2 gt where instr gt isan instruction that is displayed to the user while the test is in progress cmd gt isa comman
21. im defib energy 1 defib charge time delay 0 to 32000 ms 0 to 32000 ms ERE 7 0 to 999 percent only energy pacer paced 0 to 32000 S pacer pul rate width lse pacer pulse lse range period 0 to 32000 ms 0 to 32000 ms 0 to 32000 ms 0 to 32000 ms immunity 0 to 32000 uV 0 to 32000 LV pacer sensed refractory period Operation Chapter 3 Page 7 vPad XSC for Phase 3 USER MANUAL limit ID limit type param 1 param 2 TEST LIMIT ALLOWABLE VALUES in bold pacer 0 to 32000 uV 0 to 32000 LV 3 2 1 1 Example 1 Setting a Defibrillator Energy Limit To illustrate how the Lim command is used the consider following statement xctrl Setting defib energy tol to 10 limi target 10 percent For this statement 1 immediately following the Lim command specifies the limit is for defib energy target specifies the limit type as a target with tolerance as opposed to a min max range 10 is the tolerance value 10 and percent _ sets the tolerance type as a percentage as opposed to a number of joules units Note that this defib energy limit will be shared for all three defibrillator tests defibrillator energy charge time and sync delay The target value referred to above is not included with the limit but is specified in the vPL statement that executes the energy measurement itself 3 2 1 2 Example 2 Setting Defibrillator Charge Time
22. k Wait Then verify pacer refractory test result Data Pacer Refractory Test Pacer Rate 70 1 PPM Min Max Result Paced Refr ns 200 500 340 Sensed Refr ms 300 126 Result PASS A placeholder appears in the test data whenever a limit is not applicable for example a minimum SRP when the limit is set to max or when the limit has not been enabled Operation Chapter 3 Page 23 vPad XSC for Phase 3 USER MANUAL 3 4 3 Pacemaker Noise Immunity Test To perform a pacemaker noise immunity test use a vPL statement of the form xtest lt instr gt PN lt freq gt lt fmt gt where lt instr gt is an instruction to be displayed to the user while the immunity test is in progress PN is the command to measure noise immunity lt freq gt isthe noise frequency which can be A for 60 Hz or B for 50 Hz and lt fmt gt can be either S or L as there is only one test result format 55 c Since the only limit types allowed for pacer noise immunity limit are min max and range no target is needed in the xtest statement Results are automatically assessed as long as the limit is enabled 3 4 3 1 Example 13 Measuring Pacemaker Noise Immunity A Checklist may start a pacer noise immunity test through a vPL statement similar to the following xtest Wait Then verify noise test result PNAS For this statement PN commands Mase 3 to immediately begin sim
23. nches of tightly packed industrial approved shock absorbent material all around the instrument DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper packaging or handling All warranty claim shipments must be made on a prepaid basis freight duty brokerage and taxes No returns will be accepted without a Return Materials Authorization RMA number Please contact Datrend refer to Chapter 4 of this manual to obtain an RMA number and receive help with shipping customs documentation Page ii Warranty Disclaimer Should you elect to have your instrument serviced and or calibrated by someone other than Datrend Systems please be advised that the original warranty covering your product becomes void when the tamper resistant Quality Seal is removed or broken without proper factory authorization We strongly recommend therefore that you send your instrument to Datrend Systems for service and calibration especially during the original warranty period In all cases breaking the tamper resistant Quality Seal should be avoided at all cost as this seal is the key to your original instrument warranty In the event that the seal must be broken to gain internal access to the instrument e g in the case of a customer installed firmware upgrade you must first contact Datrend Systems at 1 800 667 6557 You will be required to provide us with the serial number for your instrument as well as a valid re
24. on to be displayed to the user while the pacer pulse test is in progress PP is the command for measuring pacer pulses lt meth gt isthe method for measuring the pulse current which can be A for average current L for leading edge T for trailing edge or P for peak value lt delay gt is the number of measurements to discard before capturing a final result which can be N for none ot a number from O to 99 and lt targ gt isaseties of optional targets for automatic pass fail assessment listed in the following ordet pulse current in milliamps pulse rate in pulse per minute pulse width in milliseconds pulse energy in microjoules default or explicitly specified with a mJ ot uJ suffix The method of measuring the pulse current meth gt depends on the waveform of the pacer pulse being measured while the delay gt parameter allows users to specify a number of pulse measurements to skip before a final measurement is recorded thereby giving the pacer time to stabilize its output before a pass fail test is applied Note the comma separating the required parameters from the optional target values In order to enable automatic assessment the statement must specify both the pulse current and the pulse rate target Pulse width and pulse energy measurements are assessed if targets are included and ignored if they are not Pulse energy targets are assumed to be in microjoule
25. r to the following xtest Set defib to sync mode and discharge now DSHQS 70 For this statement DSH commands Phase 3 to prepare for a high range sync ed discharge Q means delay is timed from the Q wave S is a placeholder which may be either S or L and 70 is the optional target energy J Assuming that defib energy and sync delay limits are set to defaults the Interface automatically assigns a PASS result if the energy measured is 70 J 15 and sync delay is between 20 ms and 65 ms For the case of a PASS the Test Report will contain an entry similar to the following Task Set defib to sync mode and discharge now Data Defibrillator Sync Delay Test Energy Limits 70 J 15 Energy 70 2 J Delay Limit Min 20 ms Max 65 ms Result 46 ms Result PASS Operation Chapter 3 Page 18 vPad XSC for Phase 3 USER MANUAL 3 4 Pacemaker Tests Once a Checklist has initialized communication with the Interface configured Phase 3 test settings and optionally prepared limits for automatic pass fail assessment vPad is ready to execute a range of pacemaker tests A typical Checklist will include prompts instructing the operator how to set up the pacer and Phase 3 followed by remote test statements 3 4 1 Pacemaker Pulse Test To perform a pacer pulse test use a vPL statement of the form xtest lt instr gt PP lt meth gt lt delay gt lt targ gt where lt instr gt isan instructi
26. rface automatically assigns a PASS result if the energy measured is 100 J 15 and charge time is less than 15 s For the case of a PASS the Test Report will contain an entry similar to the following Task Charge when Phase 3 beeps then discharge Data Defibrillator Charge Time Test Energy Limits 100 J 15 Energy 99 0 J Maximum Charge Time 15 s Result 8 7 S Result PASS Operation Chapter 3 Page 17 vPad XSC for Phase 3 USER MANUAL 3 3 3 Defibrillator Sync Delay Cardioversion Test To perform a defibrillator sync delay test use a vPL statement of the form xtest lt instr gt DS lt range gt lt ref gt lt fmt gt lt targ gt where lt instr gt isan instruction to be displayed to the user while the sync test is in progress DS is the command to measure defib sync delay X range gt can be L for low range up to 50 joules or H for high up to 600 joules lt ref gt canbe Q for Q wave sync reference or R for R wave lt fmt gt can be either S or L as there is only one test result format and lt targ gt isan optional energy target in joules for automatic pass fail assessment cc 27 Note the comma separating the required parameters from the optional target energy 3 3 3 1 Example 10 Measuring Defibrillator Sync Delay A Checklist may start a defibrillator sync delay test with a target of 70 joules through a vPL statement simila
27. rify pacer pulse test result PPLN 30 70 18 4000 the same measurement data would then appear in the Test Report as Task Wait Then verify pacer pulse test result Data Pacemaker Pulse Test Acceptable Limits Results Current 30 mA 10 29 8 mA Rate 70 PPM 2 PPM 70 1 PPM Width 18 ms 18 27 ms Energy 4000 uJ Ha 3906 uJ Result PASS Operation Chapter 3 Page 20 vPad XSC for Phase 3 USER MANUAL If pulse width limit and pulse energy limit had been enabled with these vPL statements xctrl Setting pulse width tol to 2ms lim6 target 2 units xctrl Setting pulse energy tol to 10 1lim7 target 10 percent before executing the pacer pulse test then the same measurement data would appear in the Test Report as Task Wait Then verify pacer pulse test result Data Pacemaker Pulse Test Acceptable Limits Results Current 30 mA 10 29 8 mA Rate 70 PPM 2 PPM 70 1 PPM Width 18 ms 2 ms 18 27 ms Energy 4000 uJ 10 3906 uJ Result PASS In the above example where all targets are specified and all limits are enabled then each one of the four measured values must be within limits for a PASS result Operation Chapter 3 Page 21 vPad XSC for Phase 3 USER MANUAL 3 4 2 Pacemaker Refractory Period Test To perform a pacemaker refractory test use a vPL statement of the form xtest lt instr gt PRF lt fmt gt where lt instr gt is an instruction to
28. s by default though users may choose to specify the unit of measure as either uJ or mJ Therefore 1000 1000uJ and 1mJ are equivalent energy tatget values Operation Chapter 3 Page 19 vPad XSC for Phase 3 USER MANUAL 3 4 1 1 Example 11 Measuring Pacemaker Pulse A Checklist may start a pacemaker pulse test through a vPL statement similar to the following xtest Wait Then verify pacer pulse test result PPLN 30 70 For this statement PP commands Phase 3 to begin analyzing pacer pulses L specifies the leading edge as the method of measuring peak current N means the Interface will report on the first pacer pulse detected 30 is the optional target pulse current mA and 70 is the optional target pulse rate PPM Assuming that pacer pulse current and rate limits are set to defaults the Interface automatically assigns a PASS result if the measured current is 20 mA 10 and pulse rate is 70 PPM 2 PPM For the case ofa PASS the Test Report will contain an entry similar to the following Task Wait Then verify pacer pulse test result Data Pacemaker Pulse Test Acceptable Limits Results Current 30 mA 10 29 8 mA Rate 70 PPM 2 PPM 70 1 PPM Width ms 18 27 ms Energy Se 3906 uJ Result PASS A placeholder appears in the test data whenever a target is not specified or a limit is not enabled If the xt est statement is modified to xtest Wait Then ve
29. s memory Limits are initialized to default values when power is applied to the Interface but may be modified through the lim command Modified limit settings do not persist once the Interface is disconnected from the vPad safety analyzer or the safety analyzer is powered off Limits are set as required during Checklist runtime Limit configuration statements in vPL are of the form xctrl lt info gt lim id gt lt type gt lt pl gt lt p2 gt where lt info gt isa description of the limit setting which is briefly displayed to the user lt id gt is an ID number 1 2 3 representing the limit to be set lt type gt isthe type of limit such as a target with tolerance or a min max range lt pl gt is the first pass fail threshold the effect of which depends on limit type and lt p2 gt is a second pass fail threshold which again depends on limit type Operation Chapter 3 Page 6 vPad XSC for Phase 3 USER MANUAL Table 1 lists the permitted values for the lim command Additionally any limit type can be set to none which disables automatic assessment for the affected test types If the Interface receives a limit configuration command with a disallowed limit type that particular limit will be disabled Note that the units of measurement are assumed when specifying a limit value TABLE 1 Allowed Values for Limit Configuration limit ID limit type param 1 param 2 l
30. tting Limits to Defaults The following vPL statement resets all limit settings to defaults xctrl lt info gt rslm where lt info gt isa descriptive message which is briefly displayed to the user Table 2 lists the limit default values which are assigned at power on of the Interface or in response to the rslm command as above TABLE 2 Default Limit Settings DEFAULT VALUES TEST LIMIT ID LIMIT TYPE SOUTIEN CR ree Lud E Xe IE ee ONDE TT See ae ee 2 puce cd E SIDE es dL st a me ed Bee uud 1 Be el eee ee ei qui ee 1 SE 1 Lose ue 4e 1394 Operation Chapter 3 Page 11 vPad XSC for Phase 3 USER MANUAL 3 2 3 ECG Simulation Phase 3 simulates ECG signals while conducting defibrillator and pacemaker tests A Checklist may select an ECG waveform through the Interface This is typically done prior to performing a defib or pacer test ECG configuration statements are of the form xctrl lt info gt ECG code gt lt scale gt lt mode gt where info gt isa description of the waveform which is briefly displayed to the user code gt isthe ECG waveform identifier scale gt isthe simulation amplitude scale and mode gt isthe mode of reaction to a defibrillator discharge TAS INAN For a full list of wave codes scales and modes refer to Chapter 5 Remote Control ECG Configuration Command in the Phase 3 Operating Manual supplied with the Phase 3 defibrillator and pacemaker analyzet
31. ulating ECG noise A sets the test noise to 60 Hz and S is a placeholder which may also be L Assuming that the pacer noise immunity limit has been set to default the Interface automatically assigns a PASS result if measured noise immunity is greater than 6000 pV In the case of a PASS the Test Report would contain an entry similar to the following Task Wait Then verify noise test result Data Pacer Noise Immunity Test Noise Freq 60 Hz Immunity Min 6000 uV Max UV Result 9000 uV Result PASS A placeholder appears in the test data whenever a limit is not applicable such as the maximum noise immunity when the limit is set to min or the limit is not enabled Operation Chapter 3 Page 24 vPad XSC for Phase 3 USER MANUAL 3 4 4 Pacemaker Sensitivity Test To perform a pacemaker sensitivity test use a vPL statement of the form xtest lt instr gt PSN lt fmt gt where lt instr gt is an instruction to be displayed to the user while the sensitivity test is in progress PSN is the command to measure pacer sensitivity and lt fmt gt can be either S or L as there is only one test result format 55 c Since the only limit types allowed for pacer sensitivity limit are min max and range no target is needed in the xtest statement Results are automatically assessed as long as the limit is enabled 3 4 4 1 Example 14 Measuring Pacemaker Sensitivity A
32. w and existing maintenance processes 1 1 Standard Accessories XSC Interface unit P N 7400 109 or 7400 110 RJ 12 cable P N 3140 069 for connection to XBUS of vPad safety analyzer DB9 null modem cable P N 3140 400 for connection to Phase 3 User Manual P N 6100 089 1 2 Optional Accessories Bluetooth wireless module P N 7050 028 For a complete list of available accessories visit www datrend com or contact Datrend Customer Service see Chapter 4 for contact details Overview Chapter 1 Page 1 vPad XSC for Phase 3 USER MANUAL 1 3 Checklists and vPL In vPad Check equipment maintenance and inspection procedutes are called Checklists A Checklist can contain a sequence of prompts for the operator as well as machine instructions to configure the vPad safety analyzer and to conduct other tests through a remote instrument In this case the remote instrument is a Mase 3 defibrillator and transcutaneous pacemaker analyzer In a Checklist prompts and machine instructions are written as statements in vPad Programming Language vPL A statement generally consists of a specific keyword followed by one or more parameters For example the statement xopen Phase 3 IP 5 initializes a data connection between the Interface and Phase 3 using the keyword xopen Other statements are responsible for configuring and initiating tests through Phase 3 Checklists can be written on the Android tablet or on a personal computer
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