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q-tech™ programmer - user`s manual

1. Table 6 Declaration Electromagnetic Immunity Part 2 The Q TECH Model 3200 programmer is intended for use in the electromagnetic environment specified below The customer or the user of the Q TECH Model 3200 should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Conducted RF 3 Vrms Portable and mobile RF communications equipment should be used no closer IEC 61000 4 6 150 kHz to to any part of the Q TECH Model 3200 programmer including cables than the 80 MHz recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF 3V m IEC 61000 4 3 80 Mhz to Recommended Separation Distance 2 5 GHz ds EIVA 150 KHz to 80 MHz 1 d WP 80 MHz to 800 MHz y d Le IN 800 MHz to 2 5 GHz where P isthe maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters asdetermined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occut in the vicinity of equipment marked with the following symbol gt Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and
2. PROGRAMMER OPERATION Programmer Software Version To view the programmer s software version 1 Select About Programmer on the Programmer Settings screen The Programmer Software Version information screen appears Figure 13 About Programmer S N NN SEE EER Programmer Software Version X XX X Figure 13 Programmer Software Version information screen 2 This screen displays the current version of the programmer software Select the Continue button to return to the Programmer Settings screen Note Thepatientprinted report contains the programmer software version Modes of Operation for the Q TECH Programmer Online Behavior The programmers interface vari s according to whether the programmer is Online actively communicating or Offline not communicating with a selected SO RX device 24 Q TECH PROGRAMMER OPERATION An Online session begins when the programmer establishes a telemetry link with a specific SQ RX device A yellow alert screen is displayed if the telemetry signal is lost between the programmer and the SQ RX device for more than five seconds during active communication This may occur if the wand is moved out of the telemetry communications range or if noise or interfering objects inhibit communication Programming commands including Rescue Shocks will not be available until telemetry is reestablished Telemetry reconnection may occur automatically within one minute when the SO RX device
3. 5 Select and drag the calipers to viewcdetails 6 Selectthe Continue button to return tothe Captured S ECG list screen Utilities Menu 56 The programmer Utilities menu provides access to additional SO RX device features These include Acquire Reference S ECG Capture All Sense Vectors Beeper Control Manual Setup and Smart Charge To access the Utilitiesmenu during an Online session 1 Selectthe Main Menu icon to display the Main Menu screen 2 Select the Utilities button The Utilities screen appears Figure 45 Q TECH PROGRAMMER OPERATION Utilities P Patient Name Therapy On Figure 45 Utilities screen Acquire Reference S ECG To acquire amanual Reference S ECG 1 From the Utilities screen accessible from the Main Menu screen select the Acquire Reference S ECG button to access the Acquire Reference S ECG screen 2 Select Continue to acquire a Reference S EGG The programmer will begin acquiring the Reference S ECG A message will appear requesting that the patient remain still Figure 46 The reference S ECG ORS template is recorded and stored in the SQ RX device 3 Select the Continue b tton to complete the process and return to the Utilities screen The Cancel button can be used at any timeto end S ECG acguisition and return to the Utilities screen 57 Q TECH PROGRAMMER OPERATION Acquire Reference S ECG Patient Name Therapy On This process may take up to one minute during
4. seoste eee eee eee soog se Ee see ge a narro EP EA eene sene tens ease Ee EG 7 PatttagingmS ON ee N Nen NI pee e enn em Ne eene 7 Programmer Controls and Connections Charging the Programmer 7 Ur ww oO Navigation Screen Header Navigation Bar Restarting the Programmer ERR CL Configuring the Q TECH Programmer sssessoe sesde see ee ee Ge GE Ge GE Ge GE GE sss ee Gee sno 16 Configuring Programmer Settings ED be see RR gese RR gee gee Rea eek Rea BRek ee notis no eek ee 16 Date and Time Format Ne E Va N N N 18 Time de AE ER ETE ME OE anao 19 OPERATION continued Language Preference RR 21 Printer Selection es ie EN I inertes o EE ER cpi RE be LUE 21 Programmer Software Version users sees gesek eek ttennnnttnnnnt nentes nto ttt ee Rea RR ee RR ee Re RR ees 24 Modes of Operation for the Q TECH Programmer eese cese ae Ge EG EE EG Ge ee 24 Online Behavior once eom Maie i det os sede kende ee eant danse oe Gn Hen iere 24 OfflineBehavior Ad ONE SA NE test ici rece Ede dee deretur ton een Ge dek ee e Re gets 25 Modes of Operation for the SQ RX Device 1 ese EA EA EA GE GE GR EE 26 Shelf Mode NN a Ael eg OA essens se ee ee ae ee eg Gegee 26 Therap amp n MIRS Jee dd M EEN AE 26 Thefapy Off Mode 4 25 WARE NONE ON AE EN 26 Programming the SQ RX Device at Implantes see esse tese sesse se ee sege ae ee ge ep nenas oe Ge ee ee 32
5. MRI scanning can damage the SO RX Pulse G nerator and cause patient injury Electrical interference or noise from sources such as electrosurgical and monitoring equipmentcan interfere with the communication between the programmer and SQ RX Pulse Generator or cause inappropriate therapy lf interference occurs move and reposition the programmer or wand away from the source of the interference lonizing radiation therapy such as radioactive cobalt linear accelerators and betatrons may adversely affectthe S ICD System operation Therapeutic ionizing radiation cannot be immediately detected however it can damage the electroniccomponents of the SO RX Pulse Generator To minimize the risks of ionizing radiation Shield the SQ RX Pulse Generator witha radiation resistant material regardless of the distance between the SO RX Pulse Generator and the radiation beam Do not project the radiation port directly at the SO RX Pulse Generator Evaluate the S ICD System operation after each radiation treatment Lithotripsy and other therapeutic forms of ultrasound can damage the SO RX Pulse Generator If required avoid direct flow of the pulse waves nearthe site of the implanted SO RX Pulse Generator Q TECH PROGRAMMER GENERAL DESCRIPTION Use caution during ablation procedures Program the S ICD System to Therapy Off Keep the current path electrode tip to ground as far away as possible from the implanted SO RX Pulse Generator and ele
6. Programmer components include Model 3200 Programmer with pre loaded software Model 3203 Telemetry Wand External power supply and AC power cord Visually inspectthe packaging to ensure the contents are complete Do not use if there is evidence of damage In case of damage return the product to Cameron Health Boston Scientific Contact your local representative or the Cameron Health Boston Scientific customer service department for instructions and return packaging Programmer Controls and Connections Volume control N Power button Telemetry wand connector port External power supply port N microSD slot for technical support use Figure 1 Controlsand external connections Q TECH PROGRAMMER OPERATION Charging the Programmer The programmer is primarily intended to be op rated while connected to the AC powered external power supply but may also be operated ombattery power provided that the internal battery is adequately charged The programmer is recharged whenever it is connected to the AC powered external power supply When not in use it is recommended that the programmer remain connected to the external power supply in order to maintain an adequate battery charge Note Current session data may be lost if a 45 minute period of inactivity occurs during an active telemetry session and the programmer is not connected to AC power Typical charge time for a fully discharged battery is 5 hours However
7. SQ RX Device Software Version Captured S ECG Report To print a Captured S ECG report 1 Select the Captured S ECG Report option from the Print Reports screen Figure 37 A listof the captured S ECG strips is displayed Figure 38 Select the Captured S ECG s to be printed A checkmark appearsnext to the selected Captured S ECG ex Select Captured S ECG Reports Oe E patient name Therapy On Description c NEN ee SE a a l Captured S ECG Alternate 1X 03 58 41 PM oan aa 9 EE Captured S ECG Secondary 1X d 03 58 21 PM ee mr ERES MEUSE Captured S ECG Primary 1X 03 58 02 PM Figure 38 Captured S ECG selection screen scrollable Q TECH PROGRAMMER OPERATION 3 Select Continue to return to the Print Reports screen 4 Select the Print button to print the selected report 5 Select the Cancel button to return to the previously accessed screen Episodes Report To print an Episode Report 1 Select the Episodes Reportoption on the Print Reports screen Figure 37 2 The Episode Listscreen appears showing a list of the stored episodes Figure 39 Select the episode s to be printed A checkmark appears next to the selected episode s Note Inorderto beavailable for printing episodesmust have been individually selected and viewed from the Stored Episodes Screen Figure 36 AN Select Episode Reports i Patient Name Therapy On Description Date mm ums SE 003 Un
8. be changed with each session To configure the programmer settings 1 Select the Programmer Settings button on the Startup screen Figure 6 to display the Programmer Settings screen Figure 7 uu gt Programmer Settings ghost fie Stored Patient Sessions S ICD System Came Figure 6 Startup screen Q TECH PROGRAMMER OPERATION Programmer Settings Figure 7 Programmer Settings screen 2 Select the corresponding line to access each setting Thesettingsthat can be configured include Date and time format Time zone Language Printer Q TECH PROGRAMMER OPERATION Date and Time Format To set the date and time format 1 Select Set Date and Time Format on the Programmer Settings screen Figure 7 The Date and Time Settings screen appears Figure 8 2 Select the desired date format 3 Select the Save button to save the changes and return to the Programmer Settings screen or select Cancel to return tothe Programmer Settings screen without saving the changes Date and Time Settings 9 gt gt 1 WV AA em ON FC om Figure 8 Date and Time Settings screen Q TECH PROGRAMMER OPERATION Time Zone The SQ RX device includes an electronic filter intended to minimize electromagnetic interference This filter should be set according to the electrical power line frequency used in the country or region where the patient resides The SQ RX device line fre
9. by patient condition A manual shock may be administered with the S ICD detection zone s either ON or OFF CEN Manual Shock Test i Patient Name Therapy Set Shock Energy Joules gt 40 45 50 55 eo v 75 Shock Polarity Figure 56 Manual shock S ICD System Magnet Model 4520 Model 4520 Magnet the magnet is a nonsterile accessory used to inhibit the delivery of therapy from the SQ RX device Apply the magnet flat against the skin directly over the implanted SQ RX device for a minimum of one 1 second to suspend arrhythimia detection Removal of the magnet will return the SQ RX device to normal operation If the magnet is applied during an episode the episode will not be stored in the SO RX device memory 67 Q TECH PROGRAMMER OPERATION MAINTENANCE Other behaviors of magnet application Inhibit shock therapy delivery Terminate post shock pacing therapy Prohibit arrhythmia induction testing Activate the SQ RX device s beeper with each detected QRS complex for 60 seconds Note Note A programmer commanded Rescue Shock cari override the use of the magnet as long asthe magnet was in place prior to the initiation of the programming command If the magnet is applied after the initial command the Rescue Shock will be terminated Magnet application does not affect wirelesscommunication between the SQ RX device and the programmer MAINTENANCE 68 Charging the Programmer When
10. enabled automatically when an untreated ventricular arrhythmia episode is recorded To reset the Smart Charge feature 1 From the Utilities screen accessiblefrom th Main Menu screen select the SmartCharge button The Reset Smart Charge screen appears Figure 52 63 Q TECH PROGRAMMER OPERATION a Reset SMART Charge P Patient Name Therapy On SMART Charge automatically extends detection following non sustained arrhythmias p A SE A SMART Charge has been extended by 1 01 seconds Reset SMART Charge Figure 52 Reset Smart Chargescreen Select the Reset button to reset the Smart Charge to zero or press Cancel to return to the Utilities Menu without resetting the Smart Charge A confirmation window willappear with the message Smart Charge successfully reset Press the Continue button to returmto the Utilities screen Q TECH PROGRAMMER OPERATION Additional Programmer Functions Rescue Shock The Rescue Shock icon is availablein the navigation bar on the programmer display when the SQ RX device Setup Process is complete and an SO RX device is actively communicating with the programmer During active communication a maximum 80 J rescue shock can be delivered upon programmer command To deliver a rescue shock 1 Select the red Rescue Icon at the top of the programmer screen The Rescue Shock screen appears Figure 53 GE Rescue Shock fe Patient Name Therapy Off Seiect SHOC
11. episodes Figure 36 e Total number of untreated episodes since the lastfollow up session Remaining SQ RX device battery life Viewing Stored Episodes The SQ RX device stores up to 25 treated and 20 untreated tachycardia episodes which can be viewed during a patient s follow up session When the maximum number of episodes is exceeded the most recent episode replaces the oldest stored episode however the first treated episode will not be overwritten Note Ifaspontaneous episode occurs during a patient s follow up session while the SO RX device is wirelessly communicating with the programmer the episode will not bestored Q TECH PROGRAMMER OPERATION To view stored episodes 1 N eU N Select the Main Menu icon Select the Follow Up button Select the Captured and Stored Episodes S ECG icon from the Navigation Bar Select the Episodes option to access the Episodes screen Select an episode treated or untreated from the list Figure 36 The selected episode will be downloaded from the SO RX device and displayed In order to beavailable for printing episodes must be individually selected and viewed from the Stored Episodes Screen Figure 36 E Episodes ea Patient Name Therapy On Description 004 Untreated Episode h 04 30 2009 aM P BEC gt 003 Untreated Episode NDIUENDUGIRANGOCSURCSREEEUEMGNEENNM EE EE N 002 Treated Episode 77 Ohms 04 30 2009 4
12. indicator Screen title Rescue shock icon Q TECH PROGRAMMER OPERATION Navigation Bar The Navigation Bar is the primary method for navigating the Online programmer screens The bar is located along the top edge of the programmer screen and chosen screens appear with their selection icon highlighted Table 1 displays a list of the programmer icons and their corresponding descriptions Restarting the Programmer The programmer s operating system is self monitoring and is generally able to sense many system error conditions and automatically initiate a restart sequence in response Follow the on screen instructions to complete the programmer initiated restart sequence The programmer may need to be manually restarted if ex You cannot exit a screen Theoperating system stops resporiding A manualrestart is accomplishedby pressing and holding the power button until the system shutdown menu appears on the screen Select Restart from the popup and confirm by pressing OK If the programmer does not respond to a restart process contact your C meron Health Boston Scientific representative or the customer service department for assistance Q TECH PROGRAMMER OPERATION Table 1 con descriptions Main Menu Icon Automatic Setup Icon Device Settings Icon Device Status lcon open folder and dosed folder Patient View Icon Captured and Stored Episodes S ECG Icon Induction Test Icon Manual Shock Icon Ba
13. initiated between the SO RX device and the programmer a full energy capacitor reformation is automatically performed and the SO RX device is prepared for set up Once the SQ RX device is taken out of Shelf mode it cannot be reprogrammed back into Shelf mode Therapy On Mode The Therapy On mode is the primary operating mode of the SQ RX device allowing automatic detection of and response to ventricular tachyarrhythmias Note The SO RX devicemust be programmed out of Shelf mode before being programmed to Therapy On Therapy Off Mode The Therapy Off mode disables automatic therapy delivery and nables manual control of shock delivery Programmable parameters may be viewed and adjusted via the programmer Also the subcutaneous el ctrogram S ECG may be displayed or printed The SO RX device automatically defaults to Therapy Off moderwhen the SO RX device is taken out of Shelf mode Note Manual and rescue shock therapy are available oncethe initial Setup process is complete 26 Q TECH PROGRAMMER OPERATION Connecting and Disconnecting from the SQ RX Device This section provides the information necessary for selecting connecting to and disconnecting from the SO RX device Scanning For SQ RX Devices 1 Select the Scan For Devices button on the Startup Screen Figure 14 The Device List screen appears after the Scan Progress Bar displayed during the scanning process Select the Cancel button at any time to end the
14. more time may be required if the programmer is in use while being recharged The Battery Status indicatordocated on the upper right corner of the screen displays the status of the main battery power when the unit is in use Allfour barsare illuminated green The battery is 10096 charged Three bars are illuminated green The battery is 7596 charged Two bars are illuminated yellow The battery is 50 charged One baris illuminated red The battery is 25 charged The programmer displays one of the following alert screens as battery power gets progressively lower Programmer Battery Low Programmer Battery Critical Out Of Power To charge the programmer 1 Connect the external power supply cable to the programmer Figure 2 2 Plug the external power Supply cord into an AC power outlet Q TECH PROGRAMMER OPERATION External power supply port Ls Figure 2 Connectingthe external power supply Using the O TECH Programmer Turning the Programmer On The programmer power button is located inthe recessabove and behind the left corner of the screen Press and hold the button until the display screen is active Figure 3 Q TECH PROGRAMMER OPERATION Power On Off Volume Control Figure 3 Turning theprogrammer On Off and changing the volume level Note Ifthe programmer cannot be turned on while it is connected to AC power via the external power supply first unplug the external power supply
15. scanning process o lt gt Programmer Settings Boston Stored Patient Sessions S ICD System Camezon Health Figure 14 Startup screen 27 Q TECH PROGRAMMER OPERATION 2 When the scanning process is complete a list of all SO RX devices detected up to 16 will be displayed on the Device List Figure 15 The SQ RX devices that are in Shelf mode will be displayed as Not Implanted Any SQ RX devices that were previously taken out of Shelf modezare displayed either as Implanted or with the stored patient name Device List Patient Name Mode Serial Ray O Se A IMPLANTED 1010 123456 Figure 15 Device List screen scrollable list 3 Ifthe desired SQ RX device is not listed select the Scan Again button to re initiate the scanning process Select the Cancel button to return to the Startup screen Note Referto the Inability to Communicate with the SO RX Device section for further assistance 28 Q TECH PROGRAMMER OPERATION Connecting to the SQ RX Device From the Device List screen select the desired SQ RX device to initiate the communication session Note Regardless of how many SQ RX deVices are located by a scan the user must select an SQ RX device from thelist to begin active communication Connecting to an SQ RX Device in Shelf Mode 1 When the SO RX device selection is made the programmer connects to the selected SO RX device Awindow will appear indicat
16. the Continue button to display the next Induction Test screen Note Ensure that noise markers N are not present on the S ECG prior to induction The presence of noise markers may delay detection and therapy delivery 6 Select and hold th Hold To Induce button for the desired duration Figure 34 Induction Test Patient Name Therapy Or Hold io Induce Figure 34 Induction Test screen 43 Q TECH PROGRAMMER OPERATION 44 The following functions occur during the test The S ICD System induces ventricular fibrillation using 200 mA alternating current AC at 50 Hz Induction continues until the Hold To Induce button is released up to a maximum of 10 seconds per attempt Note If necessary theinduction can be terminated by disconnecting the wand fromthe programmer Arrhythmia detection and the Live S ECG are suspended during AC induction Once the Induction button is released the programmer displays the patient s rhythm Upon detection and confirmation of an induced arrhythmia the S ICD System automatically deliversa shockat the programmed energy output and polarity Note Whenever the programmer isin active communication with an SO RX device charging of the pulse generatorin preparation for delivering a shock wh ther commanded or in response to a detected arrhythmia is indicated by an audible notification The notification continues until the shock is delivered or aborted If the sh
17. to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power oftransmitter 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 55 VP d BEP y For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m caribe estimated using the equation applicable to the frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 17At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 8 EMI RFI Information Programmer to pulse generator Specification Medical Implant Communications Service MICS Frequency 403 5 MHz Effective Isotropic Radiated Power 22 3 pW Bandwidth 300 KHz 75 Q TECH PROGRAMMER SPECIFICATIONS Table 9 Product Guidelines Battery pack type 4000 mAh 3 7 voltlithium ion battery pack Charge time Approximately 5 hours Power Supply Input 100 240 VAC 50 60 Hz 0 5A Output 5 5 VDC 3 64A Power 20 W Manufacturer Model Elpac Power Systems MWA020005A gebie SO soe SOLD ees ED O Temperature 15 Eto 38 C 10 C to 4 55 C 59 F to 100 F 41
18. was not performed Figure 18 4 Select the Continue button tond the patient session and return to the Startup Menu screen or select Cancel to remain online and return to the Main Menu screen 30 Q TECH PROGRAMMER OPERATION End Session Patient Name Therapy On is NOT complete is NOT valid Select Continue to disconnect from the device Figure 18 Session incomplete message Note Oncethe Continue button is selected the session is stored and communication isterminated Note Atelemetry session must be terminated using the End Session process as described in steps 1 through 4 above in order for data obtained during that session to besaved If the programmer is powered off during a session either automatically or manually session data will not besaved Note In order to confirm that Automatic Therapy is programmed On upon disconnection always use the End ession process and reviewall displayed warning messages 31 Q TECH PROGRAMMER OPERATION Programming the SQ RX Device at Implant This section provides the information necessary for programming the SO RX device during an implant setting Entering Electrode Information The programmer maintains information onthe implanted electrode To record this information for a patient s new or replacement electrode 1 Select the MainMenu icon 2 Select the Implant button 3 Select the Automatic Setup icon in the Navigation Bar The Automatic
19. which the patient should remain still Figure 46 The patient should remain still while the Reference S ECGds acquired Capture All Sense Vectors The Capture All Sense Vectors button on the Utilitiesscreen configurestemporary programmer settings that allow you to capture S ECGs generated from each of the three sense vectors Primary Secondary and Alternate This process takes approximately one minute The programmer returns to itsoriginal settings configuration after all S ECGs have been captured To capture the three sense vectors 1 From the Utilities screen accessiblefrom the Main Menu screen select the Capture All Sense Vectors button 2 The Capturing 12 Second S ECG screen will appearand display the status of the sense vector capture process Figure 47 58 Q TECH PROGRAMMER OPERATION Capturing 12 Second S ECG D Patient Name Therapy On Capturing S ECG please wait Primary Figure 47 Capture all sense vectors Once captured the three S ECGs can be viewed by following the steps outlined in Toviewa previously captured S ECG on page 56 Beeper Control The SO RX device has an internal alert system that emits an audible beeping tone when an alert condition occurs Alert conditions may include Elective Replacement Indicator ERI End of Life EOL electrodeimpedance out of range prolonged charge times failed Device Integrity Check and irregular battery depletion Beeper Control allows a
20. 4 F to 4 131 F Relative humidity 5 to 93 maximunrat 40 C 5 to 93 maximum at 40 C non condensing non condensing Atmospheric pressure 50 kPa to 106 kPa 50 kPato 106 kPa 7 252 psito 15 374 psi 7 252 psi to 15 374 psi Table 10 Specifications Dimensions 24 0 cm x 12 7 m x 2 6 cm Width x Depth x Height 94 in x 5 0 inx 1 0 in Standard Screen Display WVGA 1024x 600 pixels 16M TFT 76 Q TECH PROGRAMMER SPECIFICATIONS Table 11 Nominal Specifications Characteristic Electrical Safety Testing IEC 60601 1 2005 ANSI AAMI ES60601 1 2005 allowed values Electrical Safety Testing IEC 62353 2008 allowed values Earthbond testing Groundbond testing 300 m including power cable not exceeding 3 meters Equipment leakage direct method 500 pA Patientleakage current direct method 5000 pA Wand BF Safety Features Defibrillator protection to 5000 V 400 J 77 Q TECH PROGRAMMER DEFINITION OF PACKAGE LABEL SYMBOLS Table 12 Packaging Symbols Q TECH Programmer 78 Symbol Specification Type BF Applied Part Symbol Indicates connection of Type BF applied part European Community Representative Authorized representative in the EU community Part Number Component number Do Not Dispose Do not dispose of in trash Serial Number Serial number of the programmer Keep Dry Ship and store ina dry place Electrostatic Discharge Identifies a con
21. Entering Electrode Infortmation esse sesse sg eene ee deer e ttes enn nennt tttennnttnnnns Creating the Patient Ghart GaN NNN N oes NN dee ee nn NENN eg ee seek ee ee ee A tomatic Setup 2 Programming Therapy Parameters DefsRrilation T sting dd Dee Quee PNG N ee NN osse NM DR see De Performing an SQ RX Follow up sesse esse se esse esse se ee sg de oe ee ER etae sene ee oge ee Ge ee 45 Sensing Configurationrand Automatic Setup ass see gee See eg See een Sae ee ee ee 45 Viewing SQ RX Device StatUS eeuse ee see ae es eek een be een oen ga he ee ee eg Dee RR ee Rae eek ee 45 Viewing Stored N oda de ee ee tS Ks yt NON gee N ee 46 Printing Reports from the Programmer sreseessessoesedk sesde ese Seg dek see soe De eon ee Ge eaae Ge Ge ee ee 48 Printing Reports Summary Report Captured S ECG Rep rt es 4 N ese tL NN ee ee ek Gee ee ERA RA 50 Episodes Report 4 sees AN 0 e Rossen ML Deense ee RR Oak oak OER RR 51 HT GO N EN N NE EE Sososorcoecoecoeceeccoeceecoecoecooeceeeoesoeesoeoeee 52 S ECG Rhythm Strip Markers AA N N N OE tts notte notti tts notion ones 52 S ECG Scale Settings NEO RN ned dede ER agi 54 Capture and View S ECG Strips i sdlesssnasesiadesdeeccsscccsscccsuccessecessecsssecensecsnscessscesuscesusecssccesseecsueessneceseee 55 Utilities pee Acauire Reference S ECG Capture All Sense Vectors N eee eee eeent tentent ntt natia ttt to tta ttis etos t
22. Guidelines EE EA ER N OE EG 76 SPECI et lie IN Qr 76 Nominal Specifications Ry ee GQereesesssssssssssssssnssscnseccessecansccnnssesnscessscessscensscensscenssesaneccaneceanscensesenseeets 77 DEFINITION OF PACKAGE LABEL SYMBOLS Packaging Symbols Q TECH Programme r sssesscsssssccssssecsssscessssecssscccesssceesnscecsnssscessscessnseecenseceesnsessne 78 Packaging Symbols O TECH Programmer Wand eterne nnne nnn tennnnttnnnns 79 WARRANTY Limited WarMNty CM OT es C A ec Qe ee Geek 80 Q TECH PROGRAMMER GENERAL DESCRIPTION Description The Q TECH Programmer the programmer Model 3200 is a component of the Cameron Health Boston Scientific S ICD System which is prescribed for patients when cardiac arrhythmia management is warranted The other components of the S ICD System include the SQ RX Pulse Generator the SQ RX device Q TRAK Subcutaneous Electrode electrode and the Q GUIDE Subcutaneous Electrode Insertion Tool EIT The programmer is a non sterile non implantable tablet computer controlled by a graphic user interface GUI displayed Oma touchscreen The pr grammer is powered by either AC line power or an internal lithium ion battery pack The programmer uses a connected RF telemetry wand to communicate wirelessly with the SO RX device to enable adjustment of programmable settings as well as collection of data The S ICD System is designed for ease of use and simplic
23. K to deiiver maximum energy rescue shock Figure 53 Rescue Shock screen 2 Select the Shock button to begin charging the SO RX device fora Rescue shock A red background screen with the word Charging will appear Figure 54 Selecting the Abort button will prevent delivery of a rescue shock and will return to the Device Settings screen 65 Q TECH PROGRAMMER OPERATION Rescue Shock Patient Name Therapy Off Charging Figure 54 Abort Rescue Shock 3 A confirmation screen willappear with notification that the shock was delivered successfully along with the corresponding shockimpedance Figure 55 Rescue Shock Patient Name Therapy Off Shock delivered shock impedance 75 Ohms Figure 55 Confirmation of Rescue Shock delivery 66 Q TECH PROGRAMMER OPERATION If for any reason the shock could not be delivered a red background screen will appear with a message stating The Shock could not be delivered Note Inthe event telemetry is lost SQ RX device commands including Rescue Shocks will not be available until telemetry is reestablished Manual shock Manual Shock allows the user to deliverna synchronizedshock during a sinus rhythm an atrial rhythm or a ventricular rhythm The shock energy level is user configured in the 10 to 80 joule range Figure 56 Manual shock may also be utilized ata low energy to assess system impedance integrity either at implant or as warranted
24. Q TECH PROGRAMMER A COMPONENT OF THE S ICD SYSTEM USER S MANUAL 3200 Boston Scientific mmm Came Health Copyright 2014 Boston Scientific or its affiliates All rights reserved Limited Software License and Equipment Use S ICD SQ RX and O TRAK are all registered trademarks of Cameron Health Inc Q GUIDE and Q TECH are all trademarks of Cameron Health Inc Bluetooth is a trademark or registered trademark of Bluetooth SIG Inc microSD is a trademark or registered trademark of SD 3C LLC Manuals or other writtendocumentation may not be copied ordistributed without Cameron Health Inc authorization This literature is intended for use by professionals trained or experienced in device implant and or follow up procedures TABLE OF CONTENTS GENERAL DESCRIPTION Description RARE GE GE EG EG GE GE GE GE GE Ge 1 Indications for Use D ERE oes kg Neser EE EE EE EE EE EE ER EE EE EE EE EE ee 1 Intended Use iS ie NEE ANN ee Ee Gee DE Ge A GR UU a OP EVER goe de eN Ee bed 1 S cC TDI ETT T ERU DER JEDE D aD QV dq E AEE EAEE 1 Programmer Warnings and Cautions 5 e ede eerte see ee Ge Se ont ise Re ee ee etos ense Gee Ge ee eae 1 ENE MERE AND RA S AEA N AES EN Tm 1 Use of Other Medical Therapies Diagnostic Procedures Electromagnetic Interference EMI Outside the Hospital Pronn m Potential Adverse Events OPERATION Setup of the Q TECH Programmer
25. Setup screen appears Figure 19 4 Select Set Electrode ID button A Automatic Setup e Patient Name Therapy Figure 19 Select the SetElectrode ID button to enter electrode information Note ECG and heart rate information is notpresent on the Automatic Setup and Electrode ID setup screens untilthe electrode has been connected to the SO RX device 5 Enter the electrode model and serial number Figure 20 32 Q TECH PROGRAMMER OPERATION Electrode ID Setup Patient Name Therapy Please enter the electrode model and serial number before pressing program AC Mua EE Figure 20 Entering electrode information Select the Program button to save the information A confirmation screen will appear during communication with the SO RX device Figure 21 Select Cancel to cancel information storage and return to the Automatic Setup screen Communication in progress Figure 21 Confirmation screen showing communication in progress Q TECH PROGRAMMER OPERATION Creating the Patient Chart This chart contains reference information for the patient To set up the patient chart 1 Select the Main Menu icon on the Navigation Bar 2 Select the Implant button Figure 22 Main Menu Online Patient Name impfant Follow Up Print Reports End Session Utilities Patient Test Figure 22 Select thelmplant button to createa patient chart 3 Selectthe Patient View icon t
26. and wand are within telemetry range Note Whenever the programmer is in active communication with an SQ RX device charging of the pulse generator in preparation for delivering a shock whether commanded orin response to a detected arrhythmia is indicated by an audible notification The notification continues until the Shock is delivered or aborted Offline Behavior When the programmer is not actively communicating with an SQ RX device it is Offline During Offline sessions programmer settings can be accessed and stored patient sessions can be viewed and or printed Stored Patient Sessions During a patient follow up visit the programmer will retrieve data from the SQ RX device s memory The programmer can store up to50 patient sessions When the 51st session occurs the programmer willautomatically replace the oldeststored session with the new data A stored session includes the following information e Captured S ECG Reports e Episode History including any downloaded episodes e Patient Data Programmed Device Settings To view stored patient sessions 1 From the Startup screen select Stored Patient Sessions 2 Select the desired patient session 25 Q TECH PROGRAMMER OPERATION Modes of Operation for the SQ RX Device The SQ RX device has three modes of operation Shelf Therapy On Therapy Off Shelf Mode The Shelf mode is a low power consumption state intended for storage only When communication is
27. aul MN 55112 5798 USA Lambroekstraat 5D 1831 Diegem Belgium 0344 C 2013 1 800 CARDIAC 227 3422 1 800 CARDIAC 227 3422 1 651 582 4000 1 651 5824000 www cameronhealth com www cameronhealth com PN 104749 005 EU 2014 02
28. by selecting the Skip button Figure 26 Automatic Setup Patient Name Therapy The device will now optimize detection Instruct the patient to sit up then press Optimize when ready to continue If the patient is unable to change positions at this time press Skip to proceed Figure 26 Automatic Setup screen 37 Q TECH PROGRAMMER OPERATION 38 7 8 Select the Continue button to finish the Automatic Setup process A confirmation screen will appear when Automatic Setup is complete Figure 27 Automatic Setup D Patient Name Therapy Automatic Setup completed successfully Figure 27 Confirmation of successful Automatic Setup Following the optional optimization process th Acquire Reference S ECG screen is displayed Figure 28 Select the Continue button to acquire a reference S ECG Acquire Reference S ECG Patient Name Therapy The following procedure will significantly improve rhythm discrimination and requires acquisition of a reference S FCG This process will take less than one minute Select Continue if the displayed S ECG is acceptable a EE mH Figure 28 Acquire Reference S ECG screen Q TECH PROGRAMMER OPERATION 9 Once the Reference S ECG acquisition process begins a status screen appears The process may take up to one minute during which the patient should remain still During this process a template of the patient s baseline QRS complex is sto
29. cal Fast 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that Transient Burst 1kVfor input output lines YKV for input output lines of a typical commercial or hospital IEC 61000 4 4 environment Surge 1 kV line s to line s 1kV line s to line s Mains power quality should be that of a IEC 61000 4 5 2 kV line s to earth AKV line s to earth typical commercial or hospital environment Voltage Dips Short 596 U 295 dip in U for 0 5 cycles lt 5 U 295 dip in U for 0 5 cycles Mains power quality should be that of a interruptions and voltage 40 U 60 dip in U for 5 cycles 40 U 60 dip in U for 5 cycles typical commercial or hospital environment variations on power 70 U 30 dip in U ot 25 cycles 70 U 30 dipin U for 25 cycles Ifthe user of the Q TECH Model 3200 supply input lines lt 5 U gt 95 dip in Un for 5 sec lt 5 U 9596 dip in Un for 5 sec programmer requires continued operation IEC 61000 4 11 during power mains interruptions it is recommended that the Q TECH Model 3200 programmer be powered from an uninterruptible power supply or a battery Power Frequency 50 60 Power frequency magnetic fields should Hz Magnetic Fields be at levels characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level 73 Q TECH PROGRAMMER DECLARATIONS TABLES
30. cation between the programmer and the printer fails a Printing Error screen will appear with a message stating Error while printing reports Press Continue to try printing any remaining reports or Cancel to cancel the current print job 70 Q TECH PROGRAMMER TROUBLESHOOTING If this occurs Select the Try Again button to reconnect to the printer Verify that the selected printer has as applicable the wireless function enabled or a Cameron Health approved wireless adapter inserted in the left side of the printer Move the programmer closer to the printer Move any devices and the associated cables that may be interfering with the RF communication Inability to Communicate With the SQ RX Device If the programmer is unableto communicate with the SO RX device follow the steps below 1 2 Attempt to reposition the wand Select Scan For Devices from the Main Menu or select Scan Again from the Device List screen to locate the desired SO RX device Move any equipment and associated cables that may be interfering with RF communication If available attempt to communicate using a different S ICD System programmer and or wand Applya pulse generator magnet to the SO RX device to elicit beeper tones Remove the magnetand re attempt communication 71 Q TECH PROGRAMMER COMPLIANCE STATEMENTS COMPLIANCE STATEMENTS EMI RFI This equipment has been tested and found to comply with the applicable limi
31. ck Prior to each use you should perform a visual inspection and verify the following e Mechanical and functional integrity of the programmer cables and accessories Legibility and adherence of the programmer labels Startup screen appears a few seconds after you turn on the programmer The normal power up process verifies that the programmer has passed itsinternal checks and is ready for use Safety Measurements National regulations may require that the user manufacturer or manufacturer representative periodically perform and document safety tests of the programmer If such testing is required in your country follow the testing interval and extent of testing as regulated in your country If you do notknow the national regulations in your country please contact your Cameron Health Boston Scientific representative If IEC EN 62353 is arequired standard in your country but no specific testing or interval is specified it is recommended that you perform these safety tests using the direct method as specified in IEC EN 62353 at an interval of every 24 months Test values are shown in the Nominal Specifications table Table 11 Programmer End of Life The programmer and accessories are designed to provide years of service undertypical use To dispose of return or exchange a programmer contact your C meron Health Boston Scientific representative or the customer service department for instructions and return packaging Do not dis
32. cord fromthe programmer Press and hold the programmer power button until the display s reen is active Figure 3 AG power via the external power supply can then be reconnected Changing the Programmer Volume Level The volume level of programmer generated sounds may be temporarily adjusted using the volume control Figure 3 This level isautomatically reset when the programmer is restarted Placing the Programmer in Suspend Mode The programmer has a Suspend Mode which is activated automatically to conserve power The display will be blank when thismode is in effect The programmer enters Suspend Mode whenever The power button Figure 3 is momentarily pressed and released The programmer is not connected to the external power supply it is not in active communication with an SO RX pulse generator and no useractivity has occurred for 15 minutes Momentarily pressing the power button will resume normal operation Q TECH PROGRAMMER OPERATION Turning the Programmer Off There are two ways to turn the programmer off 1 Press and hold the power button Figure 2 until the System shutdown menu appears Select Power off from the popup and confirm by pressing OK 2 From the on screen Main Menu press the Power Off button and select OK at the confirmation prompt Using the Programmer Touch Screen The programmer is equipped with an LGD touch screen The screen can be adjusted to the desired viewing angle by using the kick s
33. ctivation or suppression of the beeper Once an alert conditionis triggered audible tones beep for 16 seconds every nine hours until the alert condition is resolved Beeper Control isautomatically enabled when the SQ RX device is taken out of Shelf mode To reset the Beeper Control Note Access to the Beeper Control display screen is enabled only when an alert condition occurs If an alert condition is activated a notification screen will appear upon connection 1 From the Utilities screen accessible from theMain Menu screen select the Beeper Control button 59 Q TECH PROGRAMMER OPERATION 2 3 Select the Reset Beeper button to suspend audible beeping tones triggered by an alert condition Figure 48 If the alert condition is not corrected the audible beeping tones will be reactivated during the next automatic S ICD System self check Set Beeper Function e Patient Name Therapy On Seiect Reset Beeper to stop the beeper for the current device alert Select Disable Beeper to disable the beeper warning for ali error conditions including FRI and EOL Figure 48 Resetting the Beeper The disableBeeper feature isenabled when ERI is reached or EOE occurs If desired select disable Beeper when ERI or EOL occurs Beeper tones are permanently disabled Note If beeper is disabled alert conditions will not trigger audibletones Manual Setup Manual Setup enables the user to perform the elec
34. ctrode The programmer is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Electromagnetic Interference EMI Outside the Hospital Environment Exposure to EMI or static magnetic fields may suspend tachycardia detection and possibly cause temporary inhibition of therapy delivery EMI may also trigger delivery of ashock in the absence of a tachycardia Automatic sensing and detection of tachycardias will resume when the patient moves away from the EMI or static magnetic field source To minimize the risk advise patients toavoid sources of EMI or static magnetic fields having strengths of 210 gauss or 1 mIesla Sources of EMI include but are not limited to High voltage power lines Arc weldingeduipment Electrical smelting furnaces Large radio frequency transmitters such as radar Alternators on running engines in automobiles Communications equipment such as high power radio transmitters Sources of Strong static magnetic fields may include the following Industrial transformers and motors Large ster o speakers Magnetic wands such as those used forairport security Patients should seek medical guidance from their physician before entering an area where a posted sign prohibits patients with an impl ntable cardioverter defibrillatorjor pacemaker Q TECH PROGRAMMER GENERAL DESCRIPTION Potential Adverse Events Pote
35. device Although the programmer may receive S ECG telemetry at greater distances programming should be performed with the wand placed over the SO RX device Q TECH PROGRAMMER OPERATION When telemetry loss occurs the display screen will turn yellow and a message will appear with the text Communication Loss to alert the user Reposition the wand to establish communication The programmer will display a screen informing the user if the SQ RX device is found and programming can continue Note f communication cannot bereestablished the session should be ended and restarted by scanning for the SQ RX device Navigation The programmer s graphic user interface GUI facilitates management and control of the S ICD System The Navigation Bar and on screen icons at the top of the screen allow the user to navigate programming software screens In addition a continuous subcutaneous electrocardiogram S ECG is displayed along the bottom of the screen during Online active communication with the SO RX device Screen Header When the programmer is Offline inactive communication the screen header displays the Battery Status Indicator When viewing Offline Stored Sessions the screen header displays Patient name Therapy On Off Battery status indicator When the programmer is online active communication the screen header displays Therapy On Off Patient name Patient heart rate Programmer Battery and Telemetry status
36. elect Sensing Location RE N MEETS A IT gt gt w Select Gain Origina 1X DI 2x ce SES Ae Figure 50 Gain adjustment e 1x Gain 4 mV 1x Gain should be selected when the signal amplitude is large enough to cause clipping when the 2x gain is selected 2XGain 2 mV 2x Gain should b selected when the signalamplitude is small enoughrto allow use of a moresensitive setting without causing clipping of the captured signal The 2x gain selection amplifies the signal twice asmuch asthe 1xgain selection To program them manually selected sense configuration 1 Select the Program button to save the sense vector and gain settings 2 The Acquire Reference S ECG process is automatically enabledduring the Manual Setup Process Select the Continue button to acquire a reference S ECG A confirmation screen will appear when the captured reference S ECG is acquired Figure 51 3 Select the Continue button 62 Q TECH PROGRAMMER OPERATION Acquire Reference S ECG Patient Name Therapy On Reference S ECG acquisition successful a Figure 51 Captured Reference S ECG confirmation Smart Charge Through the Smart Charge feature the SQ RX device charge initiation sequenceradapts to the occutrence of non s stained ventricular arrhythmia episodes by delaying capacitor charging This conserves battery longevityand may prevent unnecessary shocks for non sustained arrhythmias Smart Charge is
37. er time zone is selected If choosing an alternate time zone is required in order to achieve the correct line frequency filter it will be necessary to calculate the actual date times based on the difference between the local time zone and the selected time zone 20 Q TECH PROGRAMMER OPERATION Language Preference To set the language preference 1 Select Set Language on the Programmer Settings screen The Language Settings screen appears 2 Select the Save button to save the changes or select Cancel to return to the Programmer Settings screen without saving the changes If the language is changed the programmer will automatically restart and return to the Startup screen Printer Selection The programmer communicates with the printer wirelessly via Bluetooth technology Only Cameron Health Boston Scientific approved printers can be used with the programmer To select the printer tobe used with the programmer 1 Ensure the printer is on and as applicable the wireless function is enabled or the wireless adapter isindthe printer s USB port Select Printer Setup on the Programmer Settings s reen A previously configured printerbecomes the default printer and will be displayed at this time If a default printer has not already been selected and configured the programmer will scan the area to locate wireless printers A Scan Progress Bar will appear informing the user that the programmeris currently scanning for prin
38. eration Other equipment may interfere with the programmer even if that other equipment complies with the International Special Committee on Radio Interference CISPR emission requirements Use of non Cameron Health Boston Scientific approved accessories may result in increased emissions or decreased functionality of the programmerand may cause unintended operational behavior of the programmer No modification of the programmer is allowed Use only the Cameron Health Boston Scientific S ICD programmer and appropriate software to communicate with and program the SO RX Pulse Generator Do not discard the programmer in a fire incinerate or subject it to temperatures that exceed 100 C 212 F This could cause the programmer to explode Q TECH PROGRAMMER GENERAL DESCRIPTION e Do not disassemble or alter any parts of the programmer Donotimmerse the programmer in liquid of any kind If the programmer does get wet contact customer service for information about returning the programmer to Cameron Health Boston Scientific Do not attempt to dry the programmer in an oven microwave or dryer because this poses a risk of overheating or explosion Do not subject the programmer to temperatures outside of the 10 C to 55 C 14 F to 131 F storage range Exposure to high temperatures may cause the programmer to overheat or ignite and may possibly reduce its performance and service life e Mishandling such as dropping orcrush
39. from either an Online or Offline session 1 Select the Main Menu icon to display the Main Menu screen 2 Select the Print Reports button to display the Print Reports screen Figure 37 48 Q TECH PROGRAMMER OPERATION Print Reports a Patient Name Therapy On Default Printer FOOD SY Figure 37 Print Reports screen 3 Select the desired report type A checkmark will appear next to the selected report Reporttypes are described below 4 Select the Print button to print the selected report 5 Select the Cancel button to return to the previously accessed screen Summary Report To print a summary report selectthe SummaryReport option onthe Print Reports screen and press the Print button The report will print for either the current active session if the programmer is online or for the chosen stored session if the programmeris offline The Summary Reportincludes the following information Patient Name Date of Current Follow Up Date of Last Follow Up Printed Report Date SQ RX Device Model Serial Number Electrode Model Serial Number Implant Date 49 Q TECH PROGRAMMER OPERATION 50 Therapy Parameters Programmed Gain Settings and Sensing Configuration Initial Shock Polarity Configuration Episode Summary Since Last Follow Up and Since Initial Implant Battery Status Electrode Impedance Measurement SO RX Device Integrity Check if applicable Programmer Software Version
40. greater than 130 bpm select the Cancel button andrrefer to the instructions for Manual Setup Automatic Setup Patient Name Therapy The Automatic Setup process will tailor the S ICD to the patient s rhythm The patient will be required to lie at rest during this process Follow the on screen directions for guidance Please ensure the patient s heart rate is 130bpm prior to continuing Figure 24 Automatic Setup screen 5 Once started the Automatic Setup will Perform the shock electrode integrity check to measure electrode impedance Figure 25 Normal sub threshold impedance range is 400 Ohms Select the best sensing configuration The sense electrode configuration appears on the printed report and can be viewed viathe Manual Setup process Select the appropriate gain selection The selected sense gain appears on the Printed Report and can be viewed via the Manual Setup process 36 Q TECH PROGRAMMER OPERATION Automatic Setup F Patient Name Therapy A EI p 5 EED N Y DER Figure 25 Measuring electrode impedance The progress of the Automatic Setup process is shown in the status bar When each function is complete the arrow next to the function moves to a down position The Automatic Setup Sensing Optimization screen will be displayed The programmer will display a message requesting that the patient sit up however this process can be omitted during the implantation procedure
41. ing could damage the programmer If you suspect damage to the programmer contact your Cameron Health Boston Scientific representative or the customer service department for instructionsand return packaging The display omthe programm r is made of glassor acrylic and could break if the programmer is dropped or if it receives significant impact Do not use if screen is broken or cracked as this could cause injury Do not use the programmer adjacent to or stacked with other equipment If adjacent or stacked use is necessary check the programmer for norm l operation in that configuration c Contact your CameronHealth Boston Scientific representative or the customer service department for assistance or replacement part Electrostatic Discharge ESD The programmer may be affected by ESD If ESD occurs and the programmer s f nctionality is affected attempt to reset the programmer or contact your CameronHealth Boston Scientific representative or the c stomer service department for instructions Do not touch orconnectthe telemetry wand to the programmer unless ESD precautionary procedures are used S ICD System Warnings and Cautions Before using the S ICD System readrand follow all warnings and cautions provided in this manual Refer to the SQ RX Pulse Generator O TRAK Electrode or Q GUIDE Electrode Insertion Tool User s Manuals for information on implanting and explanting the S ICD System The S ICD System contains sterile
42. ing connection is in process 2 Once communication isestablished with the SQ RX device the Device Identification screen appears Figure 16 Device Identification Select Continue to prepare this device for implant Model o OREERT ENDE ON 1010 23456 Figure16 Device Identification screen Note The Device Identification screen is visible only while connecting to an SO RX device in Shelf mode 3 The SQ RX device model and serial numbers are automatically acquired and displayed during the initialscanning process Select Continue to remove the SQ RX device from Shelf mode and prepare forimplantation or select Cancel to return to the Device List screen 29 Q TECH PROGRAMMER OPERATION Ending a Patient Session To end an Online patient session and return the programmer to its Offline operation mode 1 Select the Main Menu icon on the Navigation Bar The Main Menu screen appears 2 Select the End Session button Figure 17 a Main Menu Online e Patient Name Therapy On impfant Follow Up Print Reports End Session Utilities Patient Test Figure 17 Main Menu screen 3 A warning message will be displayed to the userif any of the following conditions exists AutomaticTherapyis programmed to Off Reference S ECG has not been acquired Automatic Setup or Optimization hasnot been completed This message is typically displayed following the implant procedure as Setup Optimization
43. ity of patient management The S ICD System has a number of automatic functions designed to reduce the amount of time required for implantation initial programming and patient follow up Indications for Use The S ICD System is intended to provide defibrillation therapy for the treatment of life threatening ventriculat tachyarrhythmias in patients who do not have symptomatic bradycardia incessant ventricular tachycardia or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with antistachycardia pacing Intended Use The programmer is intended to communicate with the SO RX device The programmer software controls all SO RX device communication functions Contraindications Unipolar pacemakers are contraindicated for use with the S ICD System Programmer Warnings and Cautions General External defibrillation equipment should be available for immediate use during the implantation procedure and follow up Use the programmer only with the external power supply packaged with the programmer Using other accessories may cause damage to the programmer Q TECH PROGRAMMER GENERAL DESCRIPTION The US power cord is for connection to 110 VAC supply mains All other power cords are for connection to 230 VAC supply mains Outside North America use the supplied power cord that exactly matches your AC electrical outlet To avoid risk of electric shock the programmer must only be connected to a supply mains
44. m Changes screen will appear You may select Cancel to return to the Device Settings screen or select Continue to cancel all SQ RX device setting changes 41 Q TECH PROGRAMMER OPERATION Defibrillation Testing Once the SQ RX device is implanted and Automatic Therapy is programmed On defibrillation testing may be conducted Note Defibrillation testingisrecommended at implant to confirm the ability of the S ICD System to sense and convert VF Note Episode data associated withrescue shocks manual shocks and induction testing is not stored in the SO RX device To induce VF and test the S ICD System 1 Select the Main Menu icon on the Navigation Bar to access theMain Menu 2 Select the Patient Test button to setup theinduction test Figure 32 Main Menu Online Patient Name Implant Follow Up Print Reports End Session Utilities Patient Test Figure 32 Select the Patient Test Button to access the Induction Test screen 3 Select either standard STD or reverse REV polatity Figure 33 4 Select and drag the red marker to set the desired shock energy for the first delivered shock The shock energy may be programmed from 10 to 80 J A 15 J safety margin is recommended for defibrillation testing 42 Q TECH PROGRAMMER OPERATION GEN Induction Test P Patient Name Therapy On Set Shock Energy Joules Figure 33 Setting the desired first shock energy for defibrillationtesting 5 Select
45. mY Pap OA ae ANT ON NSS V 001 Treated Episode 77 Ohms 4 04 30 2009 v Episodes Captured Figure 36 Stored Episodes screen scrollable list Each selected episode screervalso displays the programmed parameters and the stored S ECG datavat the time of episode declaration Select the Continue button on the selected episodes screen to return to the Episodes screen 47 Q TECH PROGRAMMER OPERATION The following details are available for each episode Treated Episodes Up to 128 seconds of S ECG data is stored for each Treated Episode Pre episode S ECG Up to44 seconds e First shock Up to 24 seconds of pre shock S ECG and up to 12 seconds of post shock S ECG e Subsequent shocks 6 seconds of pre shock and 6 seconds post shock S ECG Untreated Episodes An Untreated Episode is defined as any high rate episode that spontaneously terminates during the charging process before a shock is delivered Up to 128 seconds of S ECG data is stored foreach Untreated Episode Pre episode S ECG 44 seconds of pre episode S ECG a Episode S ECG Up to 84 seconds of tachycardia S ECG data Printing Reports from the Programmer Printing Reports Patient reports can be printed before or aftera patient session is ended It isrecommended that a final report be printed immediately following the implant procedure There arethree patient reports Summary Report Captured S ECG Report Episode Reports To print patient reports
46. nds before activation of the Capture S ECG button 3 5 seconds after activation of the Capture S ECG button If an additional recording is required then the oldest previous recording is replaced with the new recording To capture a new S ECGrhythm strip 1 Select the Capture S ECG button located to the left of the Live S ECG window Figure 43 The S ECG will scroll across the display screen Calipers appear below the Captured S ECG rhythm strip Figure 44 Each 12 second recording is date and time stamped according to the programmer s date and time setting TERRE RE E Figure 43 Select the Capture S ECG button Captured 12 Second S ECG N Patient Name Therapy On EERDER UA ETE EE EE N 4 SO EE Figure 44 Captured S ECG rhythm strip 55 Q TECH PROGRAMMER OPERATION 2 Select and move the calipers across the S ECG strip to measure intervals as desired 3 Select the Continue button to return to the previously accessed screen It is also possible to capture S ECGSs corresponding to all three sense vectors Primary Secondary and Alternate by using the Capture All Sense Vectors button on the Utilities screen Figure 45 To view a previously captured S ECG 1 Select the Main Men icon 2 Select the Follow Up button 3 Select the Captured and Stored Episode S EGG icon The Captured S ECG screen appears 4 Select one Captured S ECG from the list The Captured S ECG Details screen appears
47. nector not tested for immunity to electrostatic discharge Reference Number Catalog number Conformit Europ enne Product fully complies with European Directive AIMD 90 385 EEC Symbol E ED Be as DEE ES me ee Manufacturer Name and address of the manufacturer Storage Temperature Product stored with temperature limitations Radio Non ionizing electromagnetic radiation Follow instructions for use Risk Of Shock Indicates the risk of electric shock Fragile Handle with Care Transport and Store with care Date of Manufacture Date programmer was manufactured Australian Sponsor Address Power plug Storage location of power cord Q TECH PROGRAMMER DEFINITION OF PACKAGE LABEL SYMBOLS Table 13 Packaging Symbols O TECH Programmer Wand Non Sterile Usedto indicate the product is not sterile Lot number Batch code 79 Q TECH PROGRAMMER WARRANTY Limited Warranty A limited warranty may apply to this programmer For warranty eligibility and to obtain a copy of the limited warranty contact Boston Scientific Cameron Health using the information on the back cover 80 Boston Scientific Australia Pty Ltd PO Box 322 Botany NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 ud ee eee Came Cameron Health Inc Guidant Europe NV SA ihe Health Boston Scientific 4100 Hamline Avenue North Green Square St P
48. not in use itis recommended that the programmer remain connected to the external power supply This willensure that the internal battery is adequately charged Cleaning the Programmer Keep the programmer away from dust and dirt Do not use harsh chemicals cleaning solvents or strong detergents to clean the programmerand wand To clean the programmer and wand asneeded 1 2 3 4 Service Turn the Programmer Off Gently wipe the programmer screen with a soft clean dry cloth Clean the programmer plastic case and the wand by wiping them with an isopropyl alcohol moistened cloth Dry the programmer immediately to remove residue There are no user accessible or user serviceable parts orcomponents in the programmer If any service repair or replacement of internal components is needed the programmer must be returned to Cameron Health Boston Scientific Contact your Cameron Health Boston Scientific Representative or the customer service department for instructions and return packaging Q TECH PROGRAMMER MAINTENANCE When requesting service please provide information concerning the nature of the failure and the manner in which the equipment was used when the failure occurred The model number and serial number should also be provided Before returning any products to the factory call Cameron Health Boston Scientific customer service or your local representative for a Return Authorization number Maintenance Che
49. ntial adverse events related to implantationof the S ICD System may include but are not limited to the following Acceleration induction of atrial or ventricular arrhythmia Adverse reaction to induction testing Allergic adverse reaction to system or medication Bleeding Conductor fracture Cyst formation Death Delayed therapy delivery Discomfort or prolonged healing of incision Electrode deformation and or breakage Electrode insulation failure Erosion extrusion Failure to deliver therapy Fever Hematoma Hemothorax Improper electrode connection to the pulse generator Inability to communicate with the pulse generator Inability to defibrillate or pace Inappropriate post shock pacing Inappropriate shock delivery Infection Keloid formation Migration or dislodgement Muscle stimulation Nerve damage Pneumothorax Post shock post pace discomfort Premature battery depletion Random component failures Stroke Subcutaneous emphysema Surgical revision or replacement of the system Syncope Tissue redness irritation numbness or necrosis If any adverse events occur invasive corrective action and or S ICD System modification or removal may be required Patients who receive an S ICD System may also develop psychological disorders that include but are not limited to the following Depression Fear of shocks Phantom shocks Q TECH PROGRAMMER OPERATION Setup of the Q TECH Programmer Packaging
50. o access the Patient View screen 4 The SO RX device model and serialnumbers appear on the first line cof the chart The electrode model and serial numbers appear on the second line of the chart The implant date appears on the third line of the chart Figure 23 Using the on screen keyboard enter the following patient information Patient Name up to 25 characters Doctor Name up to 25 characters Doctor Info up to 25 characters Notes up to 100 characters 34 Q TECH PROGRAMMER OPERATION GEN Patient View E Patient Name Therapy On FR KAN ma EEN EE WX NN GO TEM up to 100 characters d Figure 23 PatientChart screen Notes TheNotes field will automatically wrap the text with the presence of a space between any characters within the firstline Select the Save button to update the SO RX device with the patient information Note 5 Failure toisave thenew patient information will result jn loss of the entered data 35 Q TECH PROGRAMMER OPERATION Automatic Setup Before the SQ RX device can be activated it must go through an initial Automatic Setup Process at the time of the implant The Automatic Setup Process is initiated as follows 1 Select the Main Menu icon 2 Select the Implant b tton 3 Select the Automatic Setup icon on the navigation bar The Automatic Setup screen appears Figure 24 4 Select Continue if the patient s heart rate isless than 130 bpm For rates
51. ock fails to convert the arrhythmia re det ction occurs and subsequent shocks are delivered atthe SQ RX device s maximum energy output 80 J Note Following the release of the Hold To Induce button evaluate the sensing markers during the induced rhythm The S ICD System uses alengthened rhythm detection period Consistent tachy T markers indicate that tachyarrhythmia detection is occurring and that capacitor charging is imminent Ifa high degree of amplitude variation is noted during the arrhythmia a slight delay may be expected prior to capacitor charging or shock delivery Note TheSO RX device can deliver a maximum of five shocks per episode At any time an 80 Jrescue shock can be delivered by pressing the Rescue Shockicon At any time prior to therapy delivery the programmed energy may be aborted by selecting the red Abort button Select the Exit button to exit the induction process and return to the Main Menu screen Q TECH PROGRAMMER OPERATION Performing an SQ RX Follow up Sensing Configuration and Automatic Setup It is not necessary to perform Automatic Setup at each follow up If Automatic Setup is performed resulting in a vector change sensing should be reevaluated After the setup process is complete evaluate the streaming S ECG during a pectoral exercise Sensing performance during high rate exercises can also be performed Acceptable sensing will yield S markers synchronous to all QRS complexe
52. onal Shock Zon is programmable between 170 and 240 bpm in steps of 10 bpm Enhanced detection criteria are automatically enabled when the Condi tional Shock Zone is programmed When programming both the ShockZone and Conditional Shock Zone maintain atleast a 10 bpm difference between the two zones If theConditional Shock Zone slider yellow is dragged over the ShockZone slider red the two sliders will merge to create a single Shock Zone If post shock pacing is desired slide the Post Shock Pacing switch to theOn position Post shock bradycardia pacing occurs at anon programmable rate of 50 bpm for up to 30 seconds Pacing is inhibited if the intrinsic rate is greater than 50 bpm Select the Program button to apply the changes and program the SO RX device A screen will appear to confirm that the SO RX device settings were programmed Figure 31 If the SQ RX device does not accept the SQ RX device programming a Program Device alert screen will appear Select the Try Again button to return to the Device Settings screen Q TECH PROGRAMMER OPERATION laa Device Settings a Patient Name Therapy On Settings were successfully programmed to the device Figure 31 Confirmation of programming Once programming is confirmed select the Continue button to proceed to the next operation Note If anyof the SQ RX device settings are changed from the Device Settings screen and not subsequently programmed thePending Progra
53. planted pulse generator and detection of touch screen presses are considered essential performance 72 Q TECH PROGRAMMER DECLARATIONS TABLES Table 4 Declaration Electromagnetic Emission The Q TECH Model 3200 programmer is intended for use in the electromagnetic environment specified below The customer or the user of the Q TECH Model 3200 should assure that it is used in such an environment RF Emissions CISPR 11 The Q TECH Model 3200 programmer uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Q TECH Model 3200 programmer is suitable for use in all establishments far other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Table 5 Declaration Electromagnetic Immunity Part 1 The Q TECH Model 3200 programmer is intended for use in the electromagnetic environment specified below The customer or the user of the Q TECH Model 3200 should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Level Electromagnetic Environment Test Level Guidance Electrostatic Discharge 6 kV contact 6 kV contact Floors should be wood concrete or ESD 8KV air 8kV air ceramictile If floors are covered IEC 61000 4 2 with synthetic material then the relative humidity should be at least 30 Electri
54. pose of the programmer in the trash orat electronics recycling facilities 69 Q TECH PROGRAMMER TROUBLESHOOTING TROUBLESHOOTING This section presents potential programmer issues and the possible solutions Of note restarting the programmer can often resolve many of the issues listed below The programmer can be restarted by pressing and holding the power button until the system shutdown menu appears and then choosing the Restart option Contact your Cameron Health Boston Scientific representative or the customer service department for additional assistance Inability to Print If unable to print follow the steps below 1 Ensure that the printeris turned On and that it contains paper and a sufficient ink supply 2 Check printer feed for paper jam 3 Ensure as applicable that the wireless function is enabl d on the printer or that the Cameron Health Boston Scientific approved wireless adapter is fully inserted into the left side of the printer No Printer Available The No Printer Available screen will appear if aprinterwas notset up Select the Try Again button or refer to the Printer Selection section for instructions Touch Screen Inactive while Connected to AC Power If the touch screen does not function while the programmer is connected AC power via the external power supply disconnect and reconnect the external power supply and restart the programmer Loss of Communication with Printer When communi
55. products for single use only Do not resterilize Handle the components of the S ICD System with care at all times and maintain proper sterile technique General External defibrillation equipment should be available for immediate use during the implantation procedure and follow up Q TECH PROGRAMMER GENERAL DESCRIPTION Placing a magnet over the SO RX Pulse Generator suspends arrhythmia detection and therapy response Removing the magnet resumes arrhythmia detection and therapy response Battery depletion will eventually cause the SO RX Pulse Generator to stop functioning Defibrillation and excessive numbers of charging cycles shorten the SO RX Pulse Generator s battery longevity The S ICD System has not been evaluated for pediatric use The S ICD System does not provide long term bradycardia pacing Cardiac Resynchronization Therapy CRT orAnti Tachycardia Pacing ATP Use of Other Medical Therapies Diagnostic Procedures External defibrillation or cardioversion may damage the S ICD System Avoid placing the defibrillation paddles directly over the SQ RX device orelectrode Cardio Pulmonary Resuscitation CPR may temporarily interfere with sensing nd may cause delay of therapy Do not expose a patient with an implanted S ICD System to diathermy The interaction of diathermy therapy with an implanted SO RX Pulse Generator can damage the SO RX Pulse Generator and cause patient injury Do not expose the patient to MRI scanning
56. quency filteris automatically programmed to either 50 Hz or 60 Hz based on the time zone selected Table 2 describes the relationship between line frequency and time zone selection in the programmer software Table 2 Electrical power line frequency associated with each available timezone option 8 00 Yukon Standard Time Canada 19 Q TECH PROGRAMMER OPERATION To set the time zone in which the programmer will be used 1 Select Set Time Zone on the Programmer Settings screen The time zone selec tion screen appears Figure 9 Set Time Zone ona at dat Ens O SEDAT O o A Ai ho ase M EEEE O SEEE O E m a OS E mym we dese Mma Mes n ens EE gt A MEER CARS TS TS T A TERRE N EE UR EE EE UC WE EE N n A EERO 99 O VOTESTV VAE T IP n Nn m PES ae VIE EEO AAR Figure 9 Time Zone Sselection screen scrollable list A Select the time zone button for the zone in which the programmer will be used A Checkmark will appearinthe selected button 3 Select the Save button to savethe changes and return to the Programmer Settings screen or select Cancel to ret rn tothe Programmer Settings screen without saving the changes If there is a mismatch between the local time zone and line frequency or if the local time zone is not available choose an alternate option that matches the ine frequency where the programmer is being used Note The date time displays and printouts willalign with whichev
57. r not available Marker present on printed report but not on programmer display screen Figure 41 Sample ECG markers 53 Q TECH PROGRAMMER OPERATION S ECG Scale Settings To adjust the real time S ECG amplitude and display speed scale settings 1 Select the S ECG Display Settings icon located to the right of the Live S ECG win dow The S ECG Settings screen is displayed 2 Select and drag the Gainyor Sweep Speed Scale bars as desired Figure 42 The S ECG scale will change according to the selected setting The gain setting controls the visual gain The programmer defaults to Full Range for SQ RX devices with a gain setting of x1 and to 1 2 Range for SQ RX devices with a gain setting of x2 The Sweep Speed slider controls the display speed of the scrolling Live S ECG The nominal sweep speed setting is 25 mm sec FIN S ECG Display Settings ae Patient Name Therapy On Full Range Range 1 8 Range 50mm sec Figure 42 Adjusting Gain ahd Sweep Speed Note Amplitude settingsand display speed adjustments on scrolling real time S ECG and Captured S ECGs affect the display screen settings only and have no impacton the SQ RX device settings for sensing 54 Q TECH PROGRAMMER OPERATION Capture and View S ECG Strips The programmer can display capture and store real time S ECG rhythm strips The programmer saves a maximum of fifteen 12 second Captured S ECG recordings comprised of 8 5 seco
58. red in the SQ RX device Select Cancel at any time to end Reference S ECG acquisition When acquisition is complete select the Continue button Programming Therapy Parameters Once Automatic Setup has been completed the SO RX device therapy parameters may be selected Note Datafrom clinical testing of the S ICD System demonstrated a significant reduction in inappropriate therapy with the activation of the Conditional ShockZone priorto hospital discharge To set the therapy parameters 1 Select the Main Menu icon on the Navigation Bar 2 Selectthe Implant button 3 Select the Device Settingsicon on the Navigation Bar to display the Device Settings Screen Figure 29 pe Device Settings Ok Patient Name Therapy EO BPM 170 180 190 2608 ae Conditional Shock SP se Therapy OFF D Post Shock Pacing OFF y Figure 29 Device Settings screen 4 Select the On Off Therapy switch to set the desired therapy mode Figure 30 39 Q TECH PROGRAMMER OPERATION 40 p Device Settings F Y Patient Name Therapy On lt gt A BPM 170 3180 190 200 210 230 240 250 Conditional Shock a Therapy R2 ON Post Shock Pacing OFF al Figure 30 Setting the On Off Therapy switch 5 Select and drag the Conditional Shock Zone yellow and Shock Zone red slider bars to set the desired zone configuration The Shock Zone is programmable between 170and 250 bpm in steps of 10 bpm The Conditi
59. reflection from structures objects and people a Field strengths from fixed transmitters such as base stations forradio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Q TECH Model 3200 is used exceeds the applicable RF compliance level above the Q TECH Model 3200 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Q TECH Model 3200 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 74 Q TECH PROGRAMMER DECLARATIONS TABLES Table 7 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Q TECH Model 3200 programmer The Q TECH Model 3200 programmer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Q TECH Model 3200 programmer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Q TECH Model 3200 programmer as recommended below according
60. s If other markers are noted use the Manual Setup process to evaluate other sensing configurations Note If Manual Setup was previously used to override a sensing configuration careful consideration should betaken when selecting Automatic Setup If an update to the reference S ECG is desired due to a change in the patient s resting ECG follow th Acquire Reference S ECG instructions Viewing SQ RX Device Status Once communication is establish d the programmer displays the Device Status screen with information regarding the current episodes and battery status of the SO RX device To view this information T 2 3 4 Select the Main Menu icon Select the Follow Up button Select the Device Status icon on the Navigation Bar The Device Status screen will appear showing anoverview of all SQ RX device activity since thedast communication session Figure 35 45 Q TECH PROGRAMMER OPERATION 46 GN Device Status Since Last Follow Up e Fi L iw Patient Name Therapy On 70 us SSA 04 28 2010 TEE T EES 1 O 0 9c wmv ra ma 100 Figure 35 Device Status screen The Device Status overview reports Dateof the last follow up session CTotal number of shocks delivered since the last follow up session Total numberof treated episodes since the last follow up session Note Choosing the View button in the Treated Episodes row allows navigation directly to thelist of stored
61. tand located on the b ck of the programmer All interaction with the programmeris conducted using the fingers totouch the appropriate areas on the screen Scroll on screen lists by sliding a finger up and down the list Figure 4 An on screen keyboard is presented whenever text entry is required Boston Scientific 5 a oen mite sis v nd be OT oe I verder neat mee a els CA NJ Y I CRT Ny S Figure 4 crolling on screen lists Q TECH PROGRAMMER OPERATION Using the Wand Model 3203 wand the wand makes it possible for this programmer to communicate with the SQ RX device Note The wand is anon sterile device DO NOT STERILIZE the wand or the programmer Th wand must be contained in a sterile barrier before use in the sterile field To connect the wand to the programmer slide the wand cable connector overthe communication connector port located on the rear edge of the programmer Figure 5 To disconnect the wand grasp the wand cable connector and gently pullit straight off the communication connector port Note Donot pullor yank on the cable to disconnect the wand from the programmer Such action could cause hidden damage to the cable lA damaged cable might reduce wireless communication capabilities and require areplacement wand Figure 5 Connecting the wand To obtain optimal telemetry the wand should be placed directly over the implanted SO RX
62. ters Select the printer of choice Figure 10 If no printers are found a window will appear stating that there are no printers Select the Scan Again button or the Cancel button to return to the Programmer Settings screen 1f a printer was Selected during another session the Printer Setup screen is displayed 21 Q TECH PROGRAMMER OPERATION 22 Printer Setup O iio gt Printer Name Printer Serial Number Seo oS h470 Figure 10 Printer Selection screen Once the scan is complete the Printer Selection screen appears Figure 10 Note Refer to Troubleshooting section for printer problems Select the desired printername and enter the name using the on screen keyboard up to 15 characters A unique printer identifier should appear with the printer selection Figure 11 Q TECH PROGRAMMER OPERATION Printer Setup Enter a name for the new printer or select Cancel to select a different printer N AN N EE Default Printer Figure 11 Use the on screen keyboard to enter a name forthe selected printer Select the Save button toGave the changes and return to the ProgrammerSettings screen or select Cancelto return to the Programmer Settings screen without saving the changes A confirmation screen will appear when the printer setup is completed Figure 12 Printer Setup Printer setup successfully complete Figure 12 Printer Setup confirmation screen 23 Q TECH
63. to tttontttss ttt so tb sats Beeper Control A MA N OR EE ER N Manual Setup 9 or N er eee teer ite bee eror eR eei eee eiat Smart Charge Ns t NN reae e ie eiecit tuo Additional Programmer Functions Rescue Shock Manual shock S ICD System MagnetModel 4520 MAINTENANCE Chargiothe gegramRWqe O E S2 O ee AN ee ee o ee 68 Cleaning theProgrammer 5 ee ue N eterne nnne nennen grt lente ttes eek eek ee 68 SeN ice MO Mg ye Maintenance Check sees Safety Measurements RROGrAMENAT Enq sf ife A K N teqe Dorsser NOR Qu Ness 69 TROUBLESHOOTING aH ty die AF AE Nene ea ee A AE enfe AE 70 NO Printa Available Nee Ae Nene een NE enfe Mmpeccssssseseessesseeosedls 70 Touch Screen Inactive while Connected to AC Power eese ettteit ettet tenerent gts 70 Loss of Communication WwithPrinter t Lod E Inability to Communicate With the SQ RX Device COMPLIANCE STATEMENTS 1999 5 EC R amp TTE Directive ese ser se se LAR ee eg ee ee see oe Ge ee ee oe oe ee esee se ee ee ee ee ek ee 72 Essential Perform Qte OON ee Ed es ON ee IRR ON ee ee eene ee ene enge oe 72 DECLARATIONS TABLES Declaration Electromagnetic Emission ees seek Age seen eterne nnne nnne nennen ee Re RR ees Declaration Electromagnetic Immunity Part Declaration Electromagnetic Immunity Part 2 Recommended Separation Distances ka EMI RFI Information Programmer to pulse JerafDor SPECIFICATIONS Product
64. treated Episode 04 30 2009 ee ee 002 Treated Episode 77 Ohms d 04 30 2009 Figure 39 Stored Episode List screen scrollable 51 Q TECH PROGRAMMER OPERATION 3 Select Continue to return to the Print Reports screen Figure 40 Either 12 seconds or 44 seconds of pre episode S ECG data may be selected using the radio buttons below the Episode Reports row The default value for Episode Report Onset is 12 seconds Print Reports i Patient Name Therapy On emn Sh FS TERT Default Printer PETER EE CM EEN N I RS NEE N N A m S e AA AOD MANSY NANN m remm qm TEE EE NEP E N EET N EET n N NIE EI 4 Figure 40 Print Reports screen 4 Select the Print button to printthe selected report 5 Select the Cancel button to return to the previously accessed screen S ECG Features The programmer provides the capability toview adjust and capt re the streaming S ECG from the SQ RX device S ECG Rhythm Strip Markers The system provides annotations to identify specific events on the S ECG These markers are shown in the S ECG Markers on Programmer Display Screens and Printed Reports table Table 3 and an example is shown in the Sample ECG Markersillustration Figure 41 52 Q TECH PROGRAMMER OPERATION Table 3 S ECG Markers on Programmer Display Screens and Printed Reports Description Tachy Detection Be OY eS a SE Return to NSR Sy Episode data compressed o
65. trode integrity test and select the electrode sensing configuration and gain settingin the SQ RX device 1 2 60 From the Utilities screen accessible fromthe Main Menu screen select the Manual Setup button The Impedance lest screen appears Figure 49 Select the Test button to perform the electrode integrity test Q TECH PROGRAMMER OPERATION laa Measure Impedance P Patient Name Therapy On Press the Test button to check the Device Impedance Figure 49 Impedance test screen 3 Select Continue to proceed or select Test to retry The sensing configuration can be evaluated by temporarily activating any of the vectors or gain settings The Live S ECG and markers will reflect the temporary selections for evaluation purposes 4 There ate three availablesensing vectors that canbe manually selected cPrimary Sensing fromthe proximal electrode ring on the subcutaneous electrode to the surface of the active SO RX device Secondary Sensing fromthe distal sensing electrode ring on thesubcutaneous electrode to the surface of the active SO RX device Alternate Sensing from the distal sensing electrode ring tothe proximal sensing electrode ring on the subcutaneous electrode The gain setting adjuststhe sensed S ECG signal sensitivity It may be manually selected via the Select Gain slider switch Figure 50 61 Q TECH PROGRAMMER OPERATION Manual Setup Patient Name Therapy On S
66. ts for medical devices IEC 60601 1 2 2007 or Active Implantable Medical Device Directive 90 385 EEC Although this testing shows the device to provide reasonable protection against harmful interference in a typical medical installation there is no guarantee that interference will not occur in a particular installation If the device does cause harmful interference the user is encouraged to try and correct the interference by the following measures Reorient or relocate the device Increasethe separation between the devices Connect the equipment to an outlet on a differentcircuit Contact your Cameron He lth Boston Scientific representative or customer service 1999 5 EC R amp TTE Directive The ICD System contains radio equipment in the freguency range 402 MHz to 405 MHz for ultra low power active medical implants Cameron Health hereby declares that this transmitter is in compliance with the essential reguitements and otherrelevant provisions of Directive 1999 5 EC To obtain a full text Declaration of Conformity please contact Cameron Health Boston Scientific using the information given on the back cover of this manual Essential Performance In order for the Model 3200 Progr mmer to meet its intended use it must interrogate and maintain a communications link witha supported pulse generator as well as being able to appropriately detect touch screen button presses Therefore those functions that pertain to communications with the im
67. ttery amp Telemetry Meter Capture S ECG S ECG Display Settings Heart Rate Icon Rescue Shock Icon Option Selection Slider Switch Allows user to return to the main menu Allows user to access the automatic setup menu Allows user to access the SQ RX device settings screen Allows user to access the SQ RX device status screen User can view number of shocks delivered since the last update as well as the SQ RX device battery life Allows user to access the patient chart screen Allows user to access captured S ECG and stored episode screens Allows user to access induction screen Allows user to accessthe manual shock screen Left side of the meter allows user to view the programmer s battery status The right side of the meter allows viewing of telemetry signal Allows user to capture a live S ECG Allows user to modify the zoom and sweep speed on the live S ECG Allows user to view current heart rate Allows user to administer a rescue shock Allows userto select one of two options e g A or B 15 Q TECH PROGRAMMER OPERATION Configuring the Q TECH Programmer Configuring Programmer Settings The programmer should be configured before communication with an SQ RX device is attempted This includes setting the dateand time format time zone language and printer Once these settings are configured during the initial setup process they become the default parameters and will not normally need to
68. with protective earth Mains isolation is achieved by disconnecting the AC power cord Do not position the programmer or the external power supply in a manner that would make it difficult to disconnect that cord Never use a damaged external power supply ora damaged programmer The programmer is not waterproof or explosion proof and it cannot be sterilized Do not use it in the presence of flammable gas mixtures including anesthetic mixtures containing air oxygen or nitrous oxide Confirm that the programmer is in communication with the intended implanted SQ RX Pulse Generator The programmer is intended for use by healthcare professionals only The programmer may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such asteorienting or relocating the programmer or shielding thelocation By design the programmer emitsradio frequencies in the 403 5 MHz and 2 4 GHz bands This may interfere with nearby equipment Closely monitor medical electrical eguipment in the vicinity whenrusing the programmer The presence of other equipment in the same frequency bands 403 5 MHz for the SQ RX Pulse Generator arid 2 4 GHz for the printer may interfere with communication If communication problems occur refer to the Troubleshooting Secti ry f this manual If the programmer is used nearother medical or office equipment all equipment should be observed to verify normal op

q-tech™ programmer - user`s manual

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q-tech&trade; programmer - user`s manual

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q-tech™ programmer - user`s manual