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Q-TECH Programmer User`s Manual

1. Recommended separation distances between portable and mobile RF communications equipment and the Q TECH Model 2020 programmer power of the communications equipment The Q TECH Model 2020 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 2020 programmer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Q TECH Model 2020 programmer as recommended below according to the maximum output Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz m to 800 MHz Separation distance according to frequency of transmitter 800 MHz to 2 5 GHz E a EHS d ESME a WP V1 E1 E1 0 01 0 117 0 117 0 233 0 1 0 360 0 369 0 369 1 1 17 1 17 1 17 10 3 69 3 69 7 38 100 1h7 HT 23 3 transmitter manufacturer people Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies For transmitters rated at a maximum output power not listed above the recommended separatiom distance d in metres m can be 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 Note 2 These guidelines may not apply in all situations El
2. If this occurs 1 Select be Try Again button to reconnect to the printer Verify that the selected printer has a Cameron Health approved wireless adapter inserted in the programmer 2 Move the programmer closer to the printer 3 Move am 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 unable to communicate with the SQ RX device follow the steps below 1 Attempt to reposition tlie wand 2 Select Scan For Devices from the Main Menu or select Sean Again from the Device List screen to locatethe desired device 3 Move any equipment and associated cables that may be interfering with RF communication Q TECH PROGRAMMER COMPLIANCE STATEMENTS Federal Communications Commission FCC Compliance This transmitter is authorized by rule under the Medical Implant Communications Service part 95 of the FCC Rules and must not cause harmful interference to stations operating in the 400 150 406 00 MHz band in the Meteorological Aids i e transmitters and receivers used to communicate weather data the Meteorological Satellite or the Earth Exploration Satellite Services and must accept interference that may be caused by such aide including interference that may cause undesired operation This transmitter shall be used only in accordance with the FOC Rules governing the Medical Implant Communications Service Analog and digital voice communication
3. green The battery is 100 charged Three bars are illuminated green The battery is 75 charged Two bars are illuminated yellow The battery Ta DON charged One baris illuminated flashing red The battery is 25 charged The programmer displays one of the following alert screens as battery power gets progressively lower e Programmer Battery Low Programmer Battery Critical e Out Of Power To charge the programmer 1 Ensure that the main battery pack is inserted into the programmer 2 Connect the AC adapter power cord to the programmer 3 Insert the power cord into an AC power outlet Using the Q TECH Programmer Turning the Programmer On The programmer can usually bestarted by simply opening the programmer lid If the programmer does not start press the ESC On Off key in the upper left corner of the keyboard Figure 4 ESC On Off Figure 4 Turning the programmer On Off Q TECH PROGRAMMER OPERATION Placing the Programmer in Suspend Mode The programmer has a Suspend Mode which is activated automatically to conserve power When this mode is in effect the display will be blank The programmer enters Suspend Mode whenever e The programmer is inactive for 15 minutes The Power Off keys FN and ESC On Off are pressed The touch screen display is closed e The Power Off button is selected fromthe Main Menu If the programmer enters Suspend Mode during active communication with the SQ RX device the
4. ICD systeem Une version traduite du guide d utilisation du programmateur TECHTM est disponible sur demande Pour en obtenir un exemplaire contactez votre repr sentant local Cameron Health ou le service clients de Cameron Health Remarque Avant d implanter programmer ou effectuer des op rations de suivi sur un Syst me S ICD les professionnels de la m decine doivent lire tous Tes manuels d utilisation bersetzungen der Gebrauchsanleitung des Q TECHTM Programmierger ts sind verf gbar Entsprechende Exemplare sind bei Ihrem Cameron Health Vertreter oder bei der Kundendienstabteilung von Cameron Health erh ltlich Hinweis Das medizinische Fachpersonal sollte vor der Implantierung oder Programmierung des S ICD Systems bzw vor der Durchf hrung einer Nachsorgeuntersuchung alle Gebrauchsanleitungen gr ndlich lesen Il manuale d uso del Programmatore Q TECH disponibile in pi lingue Per riceverne una copia nella propria lingua contattare il proprio rappresentante o il servizio clienti di Cameron Health locale Nota si raccomanda ai medici la consultazione dei manuali d uso pertinenti prima di procedere all impianto alla programmazione o al monitoraggio del sistema S ICD Est o dispon veis vers es traduzidas do manual do utilizador do programador Q TECH M Para obter um exemplar contacte o seu representante local ou o departamento de apoio ao cliente da Cameron Health Observac o os profissionais cl nicos
5. Packaging Symbols Definition Symbol Definition Type BF Applied Part Symbol Indicates connection of Type BF applied part ed Manufacturer Identification of manufacturer rr 8 Ka m U Limitation European Community Represented Authorized Representative in the EU community Storage Temperature Product is stored with temperature limitations Me gt AJ Er Part Number Component number Hazardous Voltage Caution dangerous Voltage Pi Do Not Dispose Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations Radio Radio frequency ES m H Reference Number Finished goods stock number Instructions Consult instructions before use Serial Number Serial number of the SQ RX device Risk Of Shock Indicates the risk of electric shock C N MO Ss Confornmit Europ enne Product fully omplies with European Directive AIMD 90 385 EEC Fragile Handle with Care Transport and store with care Power Plug Identifies the storage place Keep Dry Ship and store itva dry place Flap Open Identifies control to open lid or flap Date Of Manufacture Date on which the SQ RX device was manufactured Electrostatic Discharge Identifies the potentialof a sudden flow of electric current through a material that isnormally an insulator Packaging
6. S ECG_and markers will reflect the temporary selections for evaluation purposes 4 There are three available sensing vectors that cap be manually selected Primary Sensing from the proximal electrode ring on the subcutaneous electrode to the surface of the active SQ RX device e Secondary Sensing from the distal sensing electrode ring on the subcutaneous electrode to the surface of the active SQ RX device Alternate Sensing from the distal sensing electrode ring to the proximal sensing electrode ring on the subcutaneous electrode The gain setting adjusts the sensed S ECG signal sensitivity It may be manually selected via the Select Gain toggle button Figure 49 Therapy On Figure 49 Gain adjustment 45 Q TECH PROGRAMMER OPERATION e 1x Gain 4 mV should be selected when the signal amplitude is large enough to cause clipping when the 2x gain is selected 2x Gain 2 mV should be selected when the signal amplitude is small enough to allow use of a more sensitive setting without causing clipping of the captured signal The 2x gain selection amplifies the signal twice as much as the 1x gain selection To program the manually selected sense configuration 1 Select the Program button to save th sense vector and gain settings 2 The Acquire Reference S ECG process is automatically enabled during the Manual Setup Process Select the Continue button to acquire a reference S ECG A c nfirmation screen will appear wh
7. SQ 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 SQ RX device must be programmed out of Shelf mode before being programmed to Therapy On Therapy Off Mode The Therapy Off mode disables automatic therapy delivery and enables manual control of shock delivery Programmable parameters may be viewed and adjusted via the programmer Also the subcutaneous electrogram S ECG may be displayed or printed The SQ RX device automatically defaults to Therapy Off mode when the SQ RX device is taken out of Shelf mode Note Manual and rescue shock therapy are available once the initial Setup process is complete Connecting and Disconnecting from the SQ RX Device This section provides the information necess ry for selecting connecting to and disconnecting from the SQ RX device Scanning For Devices 1 Select the Scan For Devices button on the Startup Screen Figure 16 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 scanning process Figure 16 The Scan for Devices button is on the Startup screen 23 Q TECH PROGRAMMER OPERATION 2 When the scanning process is complete a list of all C
8. Used t enclose and protect product for distribution Product Drawing Used for visual identification Wand an electronic accessory that can read coded data i b v Batteries AAA replaceable alkaline batteries Literature Included in packaging FCC ID SDYCHI2020 Federal Communications Commission Identifier serial number Q TECH PROGRAMMER WARRANTY Cameron Health Q TECH Programmer Warranty Cameron Health Inc offers a full lifetime warranty on the Q TECH Programmer to the user or using facility Please contact your local Cameron Health office or local representative for details The warranty on the Q TECH Programmer does not extend to any product that has been tampered with altered or repaired by any person other than an employee of Cameron Health organization Service 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 Customer Service or your local Cameron Health Representative for a Return Authorization number Disclaimer Every effort has been made o make the materialin the Q TECH Programmer User s Manual complete accurate and up to date Cameron Health reserves the right to make changes without notice and shall not be responsible for any damages inc
9. devem ler atentamente todos os manuais do utilizador antes de implementar programar ou realizar um acompanhamento do sistema S ICD Dostupn su prelo en verzie uz vatelskej pr rucky pre program tor Q TECH Pre z skanie k pie kontaktujte svojho miestneho reprezentanta spolo nosti Cameron Health alebo oddelenie z kazn ckeho Servisu Pozor Zdravotn cki profesiondli by si mali prestudovat vsetky uZivatelsk prirucky pred zavedenim programovan m uskutocnen m a sledovan m na syst me S ICD EI Manual del usuario del Programador O TECHTM est disponible en diversas versiones traducidas Para obtener un ejemplar comun quese con el representante local o el Departamento de Servicio al Cliente de Cameron Nota Los profesionales m dicos deben examinar todos los manuales del usuario antes de implantar o programar el Sistema S ICD o realizar un procedimiento de seguimiento Oversatta versioner av Q TECH Anv ndarhandbok fof programmeringsenheten finns att fa Ta kontakt med lokal representant f r Cameron Health f r att erh lla en kopia Anm Samtliga anv ndarhandb cker ska genomg s v medicinsk h lsov rdspersonal f re implantation programmering eller utf rande av n gon uppf ljning pa S ICD systemet m Cameron Health Inc Cameron Health BV San Clemente CA 92673 6811 KS Arnhem USA The Netherlands Q TECH PROGRAMMER A COMPONENT OF THE S ICD SYSTEM USER S MANUAL Model 2020 Copyright 2
10. information storage and return to the Automatic Setup screen 27 Q TECH PROGRAMMER OPERATION Therapy On Patient Name GEEET Please enter the c octrode model and serial number betore pressing program Figure 23 Confirmation screen showing communicationin progress Create the Patient Chart This chart contains reference information for the patient To set up the patient chart 1 Select the Main Menu button on the Navigation Bar 2 Select the Implant button Figure 24 Therapy Un Tapis d d 4 Follow Up EE End Session Figure 24 Select the Implant button to create a patient chart 28 Q TECH PROGRAMMER OPERATION 3 Select the Patient View button to access the Patient Menu screen 4 The SQ RX device model and serial numbers appear on the first line of 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 25 Using the keyboard enter the following patient information Patient Name up to 25 characters Physician Name up to 25 characters Physician Information up to 25 characters Notes up to 100 characters Therapy On Patient View Device Modest implant Date Patient Name N Figure 25 Entering information into the patient chart Note The Notes field will automatically wrap the text with the presence of a space between any characters within the first line 5 Select the Save bu
11. pack charge supply is low The user can remove and replace the two AAA alkaline batteries as needed To install or replace the two internal batteries 1 Place the programmer in Suspend Mode by holding down the FN and ESC On Off keys simultaneously 2 Open the battery compartment Figure 3 The backup battery cover is located on the top left of the keyboard Angle the programmer screen forward to provide access to the cover Apply downward pressure to the center of the battery cover and slide it toward the front of the programmer Angle display slightly Backup Battery Cover forward eer o d Sy Figure 3 Inserting backup batteries Q TECH PROGRAMMER OPERATION 3 Remove the depleted AAA alkaline batteries 4 Insert two AAA batteries observing the polarity indication 5 Close the battery compartment by sliding the cover over the top of the batteries while applying downward pressure to the center of the cover Charging the Programmer The programmer is primarily intended to be AC powered but can also be operated on battery power provided that the internal batteries are adequately charged The main battery pack is recharged automatically whenever the programmer is powered using the AC adapter A battery pack is fully charged within 4 hours The Battery Status indicator located on the upper right corner of the screendisplays the status of the main battery power when the unit is in use All four bars are illuminated
12. prepare this device for implant Mode Serial P Sts N D e mae n Figure 18 Device Identification screen Note The Device Identification screen is visible only while eonmecting to an SQ RX device in Shelf mode 3 The SQ RX device model and serial numbers are automatically acquired and displayed during the initial scanning process Select Continue to remove the SQ RX device from Shelf mode and prepare forimplantation or select Cancel to return to the Device List sereen Ending a Patient Session To end an Online patient session and return the programmer to Wa Offline operation mode 1 Select the Main Menu button on the Navigation Bar The Main Menu screen appears 2 Select the End Session button Figure 19 Follow e Print Report Tend Season M PauentTet Figure 19 Select the End Session button to end a patient session 25 26 Q TECH PROGRAMMER OPERATION 3 A warning message will be displayed to the user if any of the following conditions exists Automatic Therapy is programmed to Off Reference S ECG has not been acquired Automatic Setup or Optimization has not been completed This message is typically displayed following the implant procedure as Setup Optimization was not performed Figure 20 Therapy On Patient Name CS Eng Session CG KI is NOT complete is NOT valid Select Coutinue to disconnect from the device Figure 20 Session incomplete message 4 Sele
13. to Therapy Off Keep the current path electrode tip to ground as far away as possible from th implanted SQ RX Pulse Generator and electrode The programmer isnot suitable for use in the presence of aflammable 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 a shock in the absence of a tachycardia Automatic sensing and detection of tachycardias will resume when the patient moves away from the EMLor static magnetic field source e To minimize the risk advise patients to avoid sources of EMI or static magnetic fields having strengths of gt 10 gauss or 1 mTesla Sources of EMI include but are not limited to High voltage power lines Arc welding equipment Electrical smelting furnaces Large radio frequency transmitters such as radar Alternators on running engines in automobiles Communications equipment such as high power radio transmitters Q TECH PROGRAMMER GENERAL DESCRIPTION Sources of strong static magnetic fields may include the following Industrial transformers and motors Large stereo speakers Magnetic wands such as those used for airport security Patients should seek medical guidance from their physician before entering an area where a posted sign prohibits pati
14. 010 Cameron Health Inc San Clemente CA USA All rights reserved Limited Software License and Equipment Use S ICD is a registered trademark of Cameron Health Inc SQ RX Q TRAK Q GUIDE and Q TECH are all trademarks of Cameron Health Inc Manuals or other written documentation may not be copied or distributed without Cameron Health Inc authorization Cameron Health Inc 905 Calle Amanecer Suite 300 San Clemente CA 92673 USA Tel 1 949 498 5630 Free 1 877 SICD 411 1877 142 3411 Fax 1949 498 5932 URL www cameronhealth com Cameron Health BV World Trade Center Nieuwe Stationsstraat 10 6811 KS Arnhem The Netherlands Tel 81 26 3550260 Free 4800 SICD 4 YOU 800 7423 4 968 Fax 381 26 3550269 URL www cameronhealth com Table of Contents General Description Description Indications for Use Contraindications Programmer Warnings and Gautions General Batteries Electrostatic Discharge ESD S ICD System Warnings and Cautions General Use of Other Medical Therapies Diagnostic Procedures Electromagnetic Interference EMI Outside the Hospital Environment Potential Adverse Events Operation Setup of the Q TECH Programmer Packaging Inserting the Main Battery Pack Inserting the Backup Batteries Charging the Programmer Using the Q TECH Programmer Turning the Programmer On Placing the Programmer in Suspend Mode Using the Programmer TouchScreen Stylus Keyboard Using the Wand Navigation
15. 6 47 47 48 Table of Contents Continued Programmer Maintenance Cleaning and Maintenance Programmer End of Life Possible Problems and Solutions Inability to Print No Printer Available Loss of Communication with Printer Inability to Communicate with the GO RX Device Compliance Statements FCC EMI RFI Declaration Tables Declaration Electromagnetic Emissions Declaration Electromagnetic Immunity Part T Declaration Electromagnetic Immunity Part 2 Recommended Separation Distances Specifications Product Guidelines Specifications Definitions of Package Label Symbols Warranty Cameron Health Q TECH Programmer Warranty Service Disclaimer 49 49 49 50 50 50 50 50 51 51 51 52 52 52 53 54 55 55 55 56 57 57 57 57 Q TECH PROGRAMMER GENERAL DESCRIPTION Description The Q TECH Programmer the programmer Model 2020 is a component of the Cameron Health 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 the electrode and the Q GUIDE Subcutaneous Electrode Insertion Tool the EIT The programmer communicates wirelessly with the SQ RX device to enable adjustment of programmable settings and data collection The S ICD System is designed for ease of use and simplicity of patient management The S ICD System has
16. 6 Induction Test sereen 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 amaximum of Il seconds per attempt 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 35 Q TECH PROGRAMMER OPERATION Upon detection and confirmation of an induced arrhythmia the S ICD System automatically delivers a shock at the programmed energy output and polarity Ifthe shock fails to convert the arrhythmia re detection occurs and subsequent shocks are delivered at the SQ RX device s maximum energy output 80 J Note The SQ RX device can deliver a maximum of five shocks per episode At any time an 80 J rescue shock can be delivered by pressing the Rescue Shock button 7 At any time prior to therapy delivery the programmed energy may be aborted by selecting the red Abort button 8 Select the Exit button to exit the induction process and return to the Main Menu screen Performing an SQ RX Follow up Sensing Configuration and Automatic Setup It is not necessary to perform Automatic Setup at each follow op 1f 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 pector
17. N Therapy On Patient Name Select Episode Reports Description Figure 40 Stored Episode List screen 2 Select Continue to return to the Print Reports pick list screen 3 Select the Print button to print the selected report 4 Select Oe Cancel button to return to the previously accessed screen S ECG Features The programmer provides the capability to view adjust and capture 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 Table 2 and an example is shown in Figure 41 Table 2 ECG Rhythm Strip Markers Display Printed Description MarkerScreen Reports Charging C X v Sensed Beat S M Y Noisy Beat N Y d Paced Beat P v y Tachy Detection T Y Y Discard Beat Y A Figure Al Sample S ECG markers Shock E Y Y Return to NSR sep i d 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 window The S ECG Settings screen is displayed 2 Select and drag the Gain or 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 devices with an SQ RX device gain setting of x1 and t
18. Q TECH Programmer Model 2020 Information Sheet Translated versions of the Q TECHTM Programmer user s manual can be downloaded from the Cameron Health website at www cameronhealth com or available from your local Cameron Health Representative or Customer Service Department Note Medical professionals should review the user s manual before implanting programming or performing a follow up on the S ICD System K dispozici jsou p elo en verze P ru ky uzivatele program toru O TECHTM V tisk z sk te od m stn ho z stupce spole nosti Cameron Health nebo z odd len Customer Service Dep rtment Pozn mka P ed implantac programovdnim nebo kontrolnim w erten syst mu S ICD se musej zdravotn ci sezn mit se v emi P ru kami pro u ivatele Oversatte versioner af brugervejledningen ti O TECHTM Programmer er tilg ngelige Kontakt den lokale Cameron Health repr sentant eller kundeservice for at anskaffe en Kopi Bem rk Professionelle inden for sundhedssektoren ber gennemg alle brugervejledninger fer implantation programmering eller udf relse af kontrol p S ICD systemet Vertaalde versies van de Q TECH Programmer zijn beschikbaar Om een kopie te krijgen dient u contact op te met de plaatselijke vertegenwoordiger van Cameron Health of de afdeling Klantendienst NB Medische professionelen dienen alle gebruikshandleidingen door te nemen v r het implanteren programmeren of uitvoeren van een follow up op het S
19. Screen Header Navigation Bar Reset the Programmer Configuring the Q TECH Programmer Configuring Programmer Settings Date and Time Format Time Zone Language Preference Printer Selection Programmer Software Version cO OO OO ON N N DADARAO 10 10 10 11 12 12 12 18 18 18 14 14 14 15 15 17 17 17 18 18 19 19 21 Table of Contents Continued Modes of Operation for the TECH Programmer Online Behavior Offline Behavior Stored Patient Sessions Modes of Operation for the SQ RX Device Shelf Mode Therapy On Mode Therapy Off Mode Connecting and Disconnecting from the SQ RX Device Scanning For Devices Connecting to the SQ RX Device Ending Patient Session Programming the SU RX Device at Implant Entering Electrode Information Create the Patient Chart Automatic Setup Programming Therapy Parameters Defibrillation Testing Performing an SQ RX Follow up Sensing Configuration nd Automatic Setup Viewing Device Status Viewing Stored Episodes Printing Reports from the Programmer Printing Reports Summary Report Captured S ECG Report Episodes Report S ECG Features S ECG Rhythm Strip Markers S ECG Scale Settings Capture and View S ECG Strips Utilities Menu Acquire Reference S ECG Beeper Control Manual Setup Smart Charge Additional Programmer Functions Rescue Shock Magnet Use 22 22 22 22 22 23 23 23 23 23 24 25 26 26 28 20 32 34 36 36 36 37 38 38 38 39 39 40 40 41 41 42 43 44 44 4
20. 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 ventricular tachyarrhythmias Contraindications The S ICD System is contraindicated for patients with symptomatic bradycardia incessant ventricular tachycardia and patients with documented spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti tachycardia pacing Unipolar pacemakers are contraindieated 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 To avoid risk of electric shock the programmer must only be connected to a supply mains with protective earth Mains isolation is achieved by disconnecting the AC or DC connector of the power supply Do not position the programmer sothat it is difficult to disconnect the power connections e The US power cordis for connection to 110 VAC supply mains All other power cordsare for connection to 230 VAC supply mains 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
21. al exercise Sensing performance during high rate exercises can also be performed Acceptable sensing will yield S markers synchronous to all QRS complexes 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 be taken when selecting Automatic Setup If an update to the reference S ECG is desired due to a change in the patient s resting ECG followthe Acquire Reference S ECG instructions found on page 43 Viewing Device Status Once communication isestablished the programmer displays the Device Status screen with information regarding the current episodes and battery status of the SQ RX device To view this information 1 Select the Main Menu button 2 Select the Follow Up button 3 Select the Device Status button on the Navigation Bar 4 The Device Status screen will appear showing an overview of all SQ RX device activity since the last communication session Figure 37 Therapy OR 36 Figure 87 Device Status sereen Q TECH PROGRAMMER OPERATION The Device Status overview reports Date of the last follow up session Total number of shocks delivered since the last follow up session Total number of treated episodes since the last follow up session e Total number of untreated episodes since the last follow up session Remaining SQ RX device battery life Vi
22. ameron Health SQ RX devices detected up to 15 will be displayed on the Device List Figure 17 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 mode are displayed either as Implanted or with the stored patient name Mam 3 Device L ist Patient Name Model Serial a an 9 e Figure 17 Device List sereen 3 1f the desired SQ RX device isnot listed select the Scan Again button tore initiate the scanning process Select the Cancel but ton to return tothe Main Menu screen Note Refer to the Inability to Communicate withthe SQ RX Device section for further assistance Connecting to the SQ RX Device 1 From the Device List screen select the desired SQ RX device to initiate the communication session Note Regardlessof how many 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 SQ RX device selection is made the programmer connects to the selected SQ RX device A window will appear indicating connection is in process The Cancel button ca be selected_at any time to end the connection and return to the Device List screen 2 Once communication is established with the SQ RX device the Device Identification screen appears Figure 18 24 Q TECH PROGRAMMER OPERATION Device Identification Select Continue to
23. available on the programmer display when the SQ RX device Setup Process is complete and an SQ 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 Button at the top of the programmer screen The Rescue Sh ck screen appears Figure 52 Therapy On Ham Select SHOCK to deliver maximum energy rescue shock Figure 52 Rescue Shock screen 47 Q TECH PROGRAMMER OPERATION 2 Select the Shock button to begin charging the SQ RX device for a Rescue shock A red background screen with the word Charging will appear Alternatively selecting the Abort button will prevent delivery of a rescue shock and will return to the Device Settings screen The shock can be aborted by selecting the Abort button 3 A confirmation screen will appear with notification that the shock was delivered successfully along with the corresponding shock impedance Figure 53 Therapy On use Pmi Shock delivered shock impedance 75 Ohms Figure 58 Confirmation of Rescue Shock delivery If for any reason the shock could not be delivered red background screen will appear with a message stating The Shock could not be delivered Note In the event telemetry is lost SO KX device commands including Rescue Shocks will not be available until telemetry is reestablished S ICD Syste
24. battery IEC 61000 4 11 60 dip in Ur 60 dip in Ur for 5 cycles for 5 cycles 70 Up VO Ur 80 dip in Ur 80 dip in Ur for 25 cycles for 25 cycles lt 5 Ur lt 5 Uy gt 95 dip in Ur gt 95 dip in Ur for 5 sec for 5 sec Power Frequency 3 Am 3 A m Power frequency magnetic fields should be at levels characteristic of a typical 50 60 Hz Magnetic Fields IEC 61000 4 8 location in a typical commercial or hospital environment 52 NOTE Ur is the a c mains voltage prior to application of the test level Q TECH PROGRAMMER DECLARATIONS Table 6 Declaration Electromagnetic Immunity Part 2 The TECH Model 2020 programmer is intended for use in the electromagnetic environment specified below The customer or the user of the TECH Model 2020 should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Level Electromagnetic Environment Guidance Test Level Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment should be used no closer IEC 61000 4 6 150 kHz to Lo am part of the Q TECH Model 2020 programmer including cables than the 80 MHz recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Radiated RF 3 V m 3 V m IEC 61000 4 3 80 Mhz to 2 5 GHz 4 ENF V4 where P is the maximum output power rating of the transmitter in watts W according t
25. ber Implant Date Therapy Parameters Programmed Gain Settings and Sensing Configuration Q TECH PROGRAMMER OPERATION Initial Shock Polarity Configuration Episode Summary Since Last Follow Up and Since Initial Implant Battery Status Subcutaneous Electrode Impedance Measurement Device Integrity Check if applicable Programmer Software Version To view and print a summary report sel ct the Summary Report button on the Select Episode S ECG Report screen Captured S ECG Report To print a Captured S ECG report 1 Select the Captured S ECG Report button from the Print Reports pick list screen A list of the captured S ECG strips is displayed Select the button next tothe Captured S ECG s to be printed A green checkmark appears next to the selected Captured S ECG Figure 39 G Therapy On Patient Name D Print Reports Figure 39 Selecting Captured SCG Reports for printing 2 Select Continue to return to the Print Reports pick list screen 3 Select the Print button to print the selected report 4 Select the Cancel button to return to the previously accessed screen Episodes Report To print an Episode Report 1 Select the Episodes Report button on the Print Reports pickdist screen The Episode List screen appears showing a list of the stored episodes Figure 40 Select the button next to the episode s to be printed A green checkmark appears next to the selected episode s 39 Q TECH PROGRAMMER OPERATIO
26. cess induction screen Manual Shock Button Allows user to access the manual shock screen open hand and closed hand Battery amp Telemetry Left side of the meter allows user to view the programmer s battery status Meter The right side of the meter allows viewing of telemetry signal Capture S ECG Allows user to capture a live ECG S ECG Display Allows user to modify the zoom and sweep speed on the live S ECG Settings Heart Rate Icon Allows user to view current heart rate Rescue Button Allows user to administer shock from any programmer screen Toggle Switch Allows user to turn functions on or off Q TECH PROGRAMMER OPERATION Reset the Programmer Periodically the programmer may need to be reset if You cannot exit a screen The operating system stops responding You are unable to turn the programmer On using the ESC On Off keys e You see a red alert screen instructing you Lo press CTL ALT DEL The programmer can be reset by pressing and holding CTL ALT DEL for 5 seconds If the programmer does not respond to the reset process contact your local Cameron Health representative or Customer Service Department for assistance 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 date and time format time zone language and printer Once these settings are
27. configured during the initial setup process they will become the default parameters and will not normally need to be changed with each session Note If power loss occurs and the battery is depleted these settings will need to be reconfigured To configure the programmer settings 1 Select the Programmer Settings button on the Startup screen Figure 7 to display the Programmer Settings screen Figure 8 F Programmer Settings ER Set Date and Time Format EER BEER HEER EE im M Printer setup MI About Programmer Figure 7 Startup screen Figure 8 Programmer Settings screen 2 Select the corresponding line to access each setting The settings that 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 9 The Date and Time Settings screen appears Figure 10 Date and Time Settings Programmer Settings Figure 9 Programmer Settings screen Figure 10 Date and Time Settings screen 2 Select the desired date format 3 Select the Automatically Adjust for Daylight Savings Time button to initiate the daylight savings option A green checkmark will appear when this feature is active 4 Select the Save button to save the changes and return to the Programmer Settings screen or select Cancel to return to the Programmer Setting
28. ct Continue to acquire a Reference S ECG The programmer will begirracquiring the Reference S ECG A message will appear requesting that the patient remain still Figure 46 The reference S ECG QRS template is recorded and stored in the SQ RX device Select the Continue button to complete the process and return to the Utilities screen The Cancel button can be used at any time to end S ECG acquisition and return to the Utilities screen Therapy Un 70 Bes L52 Pu D GEREG Acquire Reference S ECG RW This process may take un to one minute during which the patient should remain still Figure 46 The patient should remain still while the Reference S ECG is acquired 43 Q TECH PROGRAMMER OPERATION Beeper Control The SQ 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 subcutaneous electrode impedance out of range prolonged charge times and failed Device Integrity Check Beeper Control allows activation or suppression of the beeper Once an alert condition is triggered audible tones beep for 16 seconds every nine hours until the alert condition is resolved Beeper Control is automatically enabled when the SQ RX device is taken out of Shelf mode To reset the Beeper Control Note The Beeper Control display screen is enabled only when an alert condition occurs If an alert condition is activate
29. ct the Continue button to end the patient session and return to the Startup Men screen or select Cancel to remain online and return tothe Main Menu screen Note Once the Continue button ds selected the sessiondis stored Am be SQ RX device and communication is terminated Note Inorder to confirm that Automatic Therapy is programmed On upon disconnection always use the End Session process and review all displayed warning messages Programming the SQ RX Device at Implant This section provides the information necessary for programming the SQ RX device during an implant setting Entering Electrode Information The programmer maintains information on the implanted electrode To record is information for a patient s new or replacement electrode 1 Select the Main Menu button 2 Select the Implant button 3 Select the Automatic Setup button in the Navigation Bar 4 Select Set Electrode ID button Figure 21 Q TECH PROGRAMMER OPERATION Therapy Off L5 Pui Automatic Setup Figure 21 Select the Set Electrode ID button to enter electrode information 5 Enter the electrode model and serial number Figure 22 Therapy OFF Piease enter the electrode model and serial number before pressing program rU AAN AR Figure 22 Entering electrode information 6 Select the Program button to save the information A confirmation screen will appear during communication with the SQ RX device Figure 23 Select Cancel to cancel
30. d a notification screen will appear upon connection 1 Select the Main Menu button to display the Main Menu 2 Select the Utilities button to display the Utilities Menu 3 Select the Beeper Control button 4 Select the Reset Beeper button to suspend audible beeping tones triggered by an alert condition Figure 47 If the alert condition is not corrected the audible beeping tones will be reactivated during the next automatic S ICD System self check Therapy On Select Reset Beeper to stop the beeper for the current device alert Figure 47 Resetting the Beeper 5 The disable Beeper feature is enabled when ERI is reached or EOL 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 audible tones Manual Setup Manual Setup enables the user to perform the electrode integrity test and select the electrode sensing configuration and gain setting in the SQ RX device 1 From the Utilities Menu select the Manual Setup button The Impedance Test screen appears 2 Select the Test button to perform the electrode integrity test Figure 48 44 Q TECH PROGRAMMER OPERATION Therapy On Measure Impedance Figure 48 Impedance test sereen 3 Select Continue to proceed or select Test to retry The sensing configuration can be evaluated by t mporarily activating any of the vectors or gain settings Th Live
31. d the wand with an isopropyl alcohol moistened cloth 4 Dry the programmer immediately to remove residue Programmer End of Life The programmer and accessories are designed to provide years of service under typical use To dispose of return or exchange a programmer contact your local Cameron Health representative or Customer Service Department for instructions and return packaging 49 50 Q TECH PROGRAMMER POSSIBLE PROBLEMS AND SOLUTIONS This section presents potential programmer issues and the possible solutions to resolve them Contact your local Cameron Health Representative or Customer Service Department for additional assistance Inability to Print If unable to print follow the steps below 1 Ensure that the printer is turned On and at 1 contains paper and a sufficient ink supply 2 Check printer feed for paper jam 3 Ensure the wireless printer card is inserted into the programmer 4 Ensure the wireless printer card is inserted into the printer No Printer Available The No Printer Available screen will appear if a printer was not set up Select the Try Again button or refer to the Printer Selection section for instructions Loss of Communication with Printer When communication between the programmer and the printer fail 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
32. ds 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 for each Untreated Episode 44 seconds of pre episode S ECG Up to 84 seconds of tachycardia S ECG data Printing Reports from the Programmer Printing Reports Patient reports ean be printed before or after 3 patient session is ended It is recommended that final report be printed immediately following the implant procedure Ther are three patient reports Summary Report e Captured S ECG Report Episode Reports To print patient reports from eitheran Online or Offline session 1 Select the Main Menu button to display the Main Menu screen 2 Select the Print Reports button 3 Select the desired report type A green checkmark will appear next to the selected report Report types are described below 4 Select the Print button to print the selected reports 5 Select the Cancel button to return to the previously accessed screen Summary Report The Summary Report includes the following information Patient Name Date of Current Follow Up Date of Last Follow Up Printed Report Date Device Model Serial Number Subcutaneous Electrode Model Serial Num
33. e viewed via the 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 30 Q TECH PROGRAMMER OPERATION 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 6 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 by selecting the Skip button Figure 28 The device will now optimize detection instruct the patient to cit up then press Optimize wiien ready to continue if the patient is unable to change positions at this time press Skip to proceed EX Figure 28 Automatic Setup screen 7 Following the optional optimization process the Acquire Reference S ECG screen is displayed Figure 29 Select the Continue button to acquire a reference S ECG Therapy Off Ki GEO The following procedure will significantiy improve thythm discrimination and ires acquisition of a reference S EGG This proce ill take less han one minute Select Continue it the displayed S ECG is acceptabie Figure 29 Acquire Reference S ECG screen 31 Q TECH PROGRAMMER OPERATION 8 Once the Reference S ECG acquisition process begins a status screen a
34. e battery in combination with primary batteries such as dry cell batteries or batteries of different capacities or brands Immediately remove the battery from the programmer and stop use if the battery gives off an odor generates heat becomes discolored or deformed or in any way appears abnormal during use Do not continue charging the battery if it does not recharge within the specified charge time e If the battery should leak donot allow the contents to come into contact with the skin or ees If they do wash immediately with cold water and seek medical advice Do not store the battery in any location having temperatures outside the storage range 10 G t0 55 C 14 F to 131 F Exposure to high temperatures may cause the battery to overheat or ignite and may possibly reduce the performance and service life ofthe battery Batteries may be considered hazardous waste and are Lo be disposed of in accordance with the manufacturer s instructions deposited in theappropriate local battery recycling facility or returned to Cameron Health for proper disposal Keep batteries out of the reach of children Note If the programmer is not likely to be used for an extended period remove the main battery A resetof the Time Zone is required when the programmer returns to active communication Electrostatic Discharge ESD The programmer may be affected by ESD If ESD occurs and the programmer s functionality isaffected attempt to reset the p
35. e 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 indicator Screen title Rescue shock icon Navigation Bar The Navigation Bar ja the primary method for navigating the Online programmer screens The bar is located along the left side of the programmer screen and the corresponding screen appears with the selected icon highlighted Table 1 displays a list of the programmer icons and their corresponding descriptions 16 Q TECH PROGRAMMER OPERATION Table 1 Icon Descriptions Icon Description User Application Main Menu Button Allows user o returm to the main menu Auto Setup Button Allows user to access the auto setup menu Device Settings Button Allows user to access the SQ RX device settings ser en 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 closed folder life Patient View Button Allows user to access the patient chart screen Captured Episodes Allows user to access captured S ECG and stored episode screens S ECG Button Induction Test Button Allows user to ac
36. ectromagnetic propagation is affected by absorption and reflection from structures objects and Q TECH PROGRAMMER SPECIFICATIONS Table 8 Product Guidelines Component Requirement DC Power Battery Pack Type 2200 mAh 12 6 volt lithium ion battery pack Charge Time Approximately 4 hours Battery Capacity Gradually declines approximately 15 20 of initial capacity over 400 charge discharge cycles Storage Battery capacity declines with age storage End Of Life Battery capacity has declined 50 of battery packe initial capacity approximately 1000 charge discharge cycles Typical use is 4 years Back Up Batteries Two AAA alkaline batteries Power Supply Input 100 to 240 VAC 47 gt 63 Hz 0 7A Output I5VDC 1 6 Powers 24 W Manufacturer Model Elpac Power Systems MW2415 Environment Operating Storage Temperature 15 C to 488 C 10 C0 55 C 59 F to 100 F 14 Fo 131 F Relative Humidity 5 t093 maximum at A0 C 5 to 93 maximum at 40 C non condensing non condensing Table 9 Specifications Component Specification Dimensions 24 cm x 18 cmx4 0 cm Width x Depth x Height 9 8 in x 72 inx 1 4 in Weight 1 1 kg 3 0 lbs Includes 2200 mAh battery pack Standard Screen Display High Quality SVGA 600 x 800 pixels 16 bit color display with backlight stylus and touch screen sensitive 55 56 Q TECH PROGRAMMER DEFINITIONS OF PACKAGE LABEL SYMBOLS Table 10
37. en the captured reference S ECG is acquired Figure 50 ENT Reference SECG acquisition successful Figure 50 Captured Reference S ECG confirmation 3 Select the Continue button Smart Charge Through the Smart Charge feature the SQ RX device charge initiation sequence adapts to the occurrence of non sustained ventricular arrhythmia episodes by delaying capacitor charging This conserves battery longevity and may prevent unnecessary shocks for non sustained arrhythmias Smart Charge is enabled automatically when an untreated ventricular arrhythmia episode is recorded To reset the Smart Charge feature 1 Select the Main Menu button 2 Select the Utilities button on the Main Menu to display the Utilities Menu 3 Select the Smart Charge button The Reset Smart Charge screen appears Figure 51 46 Q TECH PROGRAMMER OPERATION Therapy On Ham SI Reset SMART Charge SMART Charge automatically extends detection following non sustained arrhythmias K SMART Charge has been extended by X 1 01 seconds gt Figure 51 Reset Smart Charge screen 4 Select e Reset button do reset he Smart Charge to zero or press Cancel to return tothe Utilities Menu without resetting the Smart Charge 5 A confirmation window will appear with the message Smart Charge successfully reset Press the Continue button to return to the Utilities screen Additional Programmer Functions Rescue Shock The Rescue Shock buttomis
38. ended for use in the electromagnetic environment specified below The customer or the user of the Q TECH Model 2020 should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Level Electromagnetic Environment Guidance Test Level Electrostatic Discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with ESD 8 kV air 8kVair synthetic material then the relative humidity should be at least 30 TEC 61000 4 2 Electrical Fast 2 kV for power 42 kV for power Mains power quality should be hat of a typical commercial or hospita Transient Burst supply lines supply lines environment TEC 61000 4 4 1 kV for LkV for input output lines input output lines Surge EzlkV 1 kV Mains power quality should be that of a typical commercial or hospita IEC 61000 4 5 line s to line s line s to line s environment 2 kV line s to 2 KV line s to earth earth Voltage Dips Short lt 5 Un lt 5 Ur Mains power quality should be that of a typical commercial or hospital environment interruptions and gt 95 dip in Ur gt 95 dip in Ur If the user of the Q TECH Model 2020 programmer requires continued operation voltage variations on for 0 5 cycles for 0 5 cycles during power mains interruptions it is recommended that the Q TECH Model 2020 power supply input lines 40 Ur 40 UT ptogrammer be powered from an uninterruptible power supply or a
39. ents with an implantable cardioverter defibrillator or pacemaker Potential Adverse Events Potential adverse events related to implantation of the S ICD System may include but are not limited to the following Acceleration of arrhythmia Allergic reaction Bleeding Conductorfracture Cyst formation Death Electrode dislodgement Electrode insulation failure Electrode deformation and or breakage Erosion extrusion Improper electrode connection to the device Inappropriate post shock pacing Inappropriate shock delivery Infection Hematoma Hemothorax Keloid formation Migration or dislodgement Potential morbidity due to inability to defibrillate and pace Muscle stimulation Nerve damage Pneumothorax Postoperative discomfort Premature battery depletion Random component failures Tissue necrosis Ventricular arrhythmia 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 Programmer components include Model 2020 Programmer with pre loaded software Touch screen stylus Lithium ion rechargeable battery e Non rechargeable alkaline AAA backup batteries Wireless printer card Cameron Health Programm
40. er wireless communication card with model 4510 telemetry wand e AC adapter power cord and power supply for battery charging Visually inspect the packaging to ensure the contents are complete Do not use if there is Evidence of damage or cracking Evidence of battery leakage or corrosion Return the product to Cameron Health if ang of these conditions exist Contact your local Cameron Health representative or Customer Service Department forinstructions and return packaging Inserting the Main Battery Pack The programmer is powered by a rechargeable lithium ion battery pack or through AC power with the AC adapter power cord Note If connected to AC power make sure the programmer is in Suspend Mode before insertion of the battery pack See Placing the Programmer in Suspend Mode section The main battery is located on the back of the programmer base To insert the main battery pack 1 Slide the battery so the outside latchis toward the rear of the programmer Figure 1 Main Battery Cover Figure 1 Madin battery cover Q TECH PROGRAMMER OPERATION 2 Insert the battery pack into place Figure 2 Figure 2 Inserting battery pack 3 Secure the battery pack with the slide cover by latching it in place Inserting the Backup Batteries Two internal AAA batteries serve as a backup power source for situations when the programmer is not Connected to an external power source the main battery pack is removed or the main battery
41. erapy with an implanted SQ RX Pulse Generator can damage the SQ RX Pulse Generator and cause patient injury Do not expose the patient to MRI scanning MRI scanning can damage the SQ RX Pulse Generator and cause patient injury Electricalinterference or noise from sources such as electrosurgical and monitoring equipment can interfere with the communication between the programmer and SQ RX Pulse Generator or cause inappropriate therapy If interference occurs move and reposition the programmer or wand away from the source of the interference Tonizing radiation therapy such as radioactive cobalt linear accelerators and betatrons may adversely affect the S ICD System operation Therapeutic ionizing radiation cannot be immediately detected however it can damage the electronic components of the SQ RX Pulse Generator Follow these conditions to minimize the risks of ionizing radiation Shield the SQ RX Pulse Generator with a radiation resistant material regardless of the distance between the SQ RX Pulse Generator and the radiation beam Do mot project the radiation port directly at the SQ RX Pulse Generator e Always evaluate the S ICD System operation following each radiation treatment Lithotripsy and other therapeutic forms of ultrasound can damage the SQ RX Pulse Generator If required avoid direct flow of the pulse waves near the site of the implanted SQ RX Pulse Generator Usecaution during ablation procedures Program the SACD System
42. ewing Stored Episodes The SQ RX device stores up to 24 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 If a spontaneous episode oecurs during a patient s follow up session while the SQ RX device is wirelessly communicating with the programmer the episode will notbe stored To view stored episodes 1 Select the Mam Meng button 2 Select the Follow Up button 3 Select Oe Captored amp Stored Episodes S ECG icon from the Navigation Bar 4 Select e Episodes toggle switch to access the episodes pick list 5 Select an episode treated or untreated from the list Figure 88 The selected Episodes screen appears Therapy On Patient Name Gum des s Untreated Episo Teen EI reated m Treated Episode 7 Ohms p i Figure 38 Stored Episodes screen 6 Each selected Episode screen also displays the programmed parameters and the stored S ECG data at the time of episode declaration 7 Select the Continue button to return to the Episodes pick list screen 37 38 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 to 44 secon
43. ier to be used in the sterile field To connect the wand to the programmer insert the wand Gable connector possessing a green label into the communication card connector port located on the side of the programmer also marked with a green label as shown in Figure 6 Figure 6 Connecting the wand To obtain optimal telemetry the wand should be placed directly over the implanted SQ RX device Although the programmer may receive S ECG telemetry at greater distances programming should be performed with the wand placed over the SQ RX device When telemetry loss occurs the display screen will turn yellow and amessage 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 device was found and programming can continue Note If communication cannot be reestablished 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 oval on screen buttons allow the user to navigate programming software screens In addition a continuous subcutaneous electrocardiogram S ECG is displayed along the bottom of the S reen during Online active communication with the SQ RX device Q TECH PROGRAMMER OPERATION Screen Header When the programmer is Offline inactive communication th
44. luding but not limited to consequential damages caused by reliance on the material presented including but not limited to typographical errors 57 Cameron Health Inc e lt 905 Calle Amanecer O nt QY Suite 300 Cie eN 10 A gt Cam C San Clemente CA 92673 AS an in S N aca 2 0 N Tel 1949 498 5630 el 1 63 Free 1 877 SICD 411 Free 800 S ES S 1 877 742 3411 dy 800 7423 4 Fax 1949 498 5932 Fax P ed C URL www cameronhealth com URL ND health com 2009
45. m Magnet Model 4520 The Cameron Health Magnet the magnet is anonsterile accessory used to inhibit the delivery of therapy from the device Apply the magnet flat against the skin directly over the implanted SQ RX device for a minimum of one 1 second tosuspend arrhythmia detection Removal of the magnet will return the device to normal operation If the magnet is applied during an episode the episode will not be stored in the device memory Other behaviors of magnet application Inhibit shock therapy delivery Terminate post shock pacing therapy Prohibit arrhythmia induction testing e Activate the device s beeper with each detected QRS complex for 60 seconds Note A programmer commanded Rescue Shock can override the use of the magnet as long as the magnet was in place prior to the initiation of the programming command If themagnet e applied after the initial command the Rescue Shock will be terminated Note Magnet application does not affect wireless communication between thedevice and the programmer 48 Q TECH PROGRAMMER MAINTENANCE Cleaning and Maintenance There are no user serviceable parts in the programmer system with the exception of the wand and batteries To clean the programmer and wand as needed 1 Turn the Programmer Off by pressing the FN key and the ESC On Off key simultaneously 2 Gently wipe the screen and keyboard with 3 soft clean dry cloth 3 Wipe the plastic portions of the programmer an
46. nal Shock Zone is programmable between T70 and 240 bpm in steps of 10 bpm Enhanced Detection Criteria are automatically enabled when the Conditional Shock Zone is programmed When programming both the Shock Zone and Conditional Shock Zone maintain at least a 10 bpm difference between the two zones If the Conditional Shock Zone slider yellow Gs dragged over th Shock Zone slider red the two sliders will merge to create a single Shock Zone 6 If post shock pacing is desired toggle the Post Shock Pacing button to On Post shock bradycardia pacing occurs at a non programmable rate of 50 bpm for op to 30 seconds Pacing is inhibited if the intrinsic rate is greater than 50 bpm 7 Select the Program button to permanently program the SQ RX deviee A screen will appear to confirm that the SQ RX device settings were programmed Figure 33 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 returmto the Device Settings screen 33 Q TECH PROGRAMMER OPERATION Therapy On EST Device Settings Settings were successfully programmed to the device Figure 88 Confirmation of programming 8 Once programming is confirmed select the Continue button to proceed to the next operation Note Tf any of the SQ RX device settings are changed from the Device Settings screen and not subsequently programmed the Pending Program Changes screen will appea
47. ng to the programmer s date and time setting Therapy On Patient Name Captured 12 Second S ECG d La w Se TR iv Figure 43 Select the Capture S ECG button Figure 44 Captured S ECG rhythm strip 2 Select and move the calipers across the S ECG strip to measure intervals as desired 3 Select the Continue button to return tothe previously accessed screen To view a previously Captured S ECG Select the Main Men button Select the Follow Up button Select the Captured amp Stored Episode S ECG button The Gaptured S ECG pick list screen appears Select one Captured S ECG from the list The Captured S ECG Details screen appears Select and drag the calipers to view details Select the Continue button to return to the Captured S ECG list screen aor WDE Utilities Menu The programmer Utilities menu provides access to additional SQ RX device features These inelude Acquire Reference S ECG Beeper Control Manual Setup and Smart Charge To access the Utilities menu during an Online session 1 Select the Main Menu button to display the Main Menn screen 2 Select the Utilities button The Utilities screen appears Figure 45 Q TECH PROGRAMMER OPERATION Therapy On Utilities Figure 45 Utilities sereen Acquire Reference S ECG To acquire a manual Reference S ECG 1 Select the Acquire Reference S ECG button on the Utilities menu t0 access the Acquire Reference S ECG screen 2 Sele
48. nicating with and programming the SQ RX Pulse Generator Contact your local Cameron Health representative or Customer Service Department for assistance or a replacement part Q TECH PROGRAMMER GENERAL DESCRIPTION Batteries The following warnings pertain to safe handling of the batteries and power supply used with the programmer To prevent the battery from leaking generating heat or exploding observe the following precautions Use the battery only with an approved Cameron Health power adapter Do not discard the battery in a fire incinerate or subject battery cells to temperatures that exceed 100 C 212 F This may result in harmful emissions or explosion The battery incorporates built in safety devices To ensure their proper function do not disassemble or alter any parts of the battery As a fire precaution do not use rechargeable AAA batteries Insert only alkaline AAA batteries into the programmer Do not short circuit the battery by directly connecting any of the exposed terminals with metal objects Do not transport or store the battery together with metal objects such as necklaces hairpins etc Do not use or leave the battery near a heat source such as a fire or heater Do not immerse the battery in water Do not crush puncture open dismantle or otherwise mechanically interfere with the batteries Do not directly solder the battery Do not put thebattery into a microwave or pressurized container Do not use th
49. o Half range for devices with an SQ RX device 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 Therapy On mmi 12 5mm I sec ee 50mm i sec sec Sweep Speed Figure 42 Adjusting Gain and Sweep Speed Note Amplitude settings and display speed adjustments on scrolling real time S ECG and Captured S EGGs affect the display screen settings only and have no impact onthe SQ RX device settings for Sensing Capture and View S ECG Strips The programmer can display capture and store real time S ECG rhythm strips The programmer saves 4 maximum of five 12 second Captured S ECGfecordings comprised of e 8 5 seconds before activation of the Capture S ECG button e 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 Note When the programmer goes Offline during a follow up session the previous 60 seconds of S ECG data are available for review in the Offline Stored Patient Sessions display 41 42 Q TECH PROGRAMMER OPERATION To capture a new S ECG rhythm 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 accordi
50. o the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following gt people 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 reflection from structures objects and Field strengths from fixed transmitters such s base stations for radio 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 th 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 2020 is used exceeds the applicable RF compliance level above the Q TEOH Model 2020 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 2020 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 53 54 Q TECH PROGRAMMER DECLARATIONS Table 7 Recommended Separation Distances
51. 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 ncrease the separation between the devices e Connect the equipment to an outlet on a different circuit e Contact your Cameron Health Representative or Cameron HealthCustomer Service 51 Q TECH PROGRAMMER DECLARATIONS Table 4 Declaration Electromagnetic Emissions The Q TECH Model 2020 programmer is intended for use in the electromagnetic environment specified below The customer or the user of the Q TECH Model 2020 should assure that it is used in such an environment Emissions Test Conipliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Q TECH Model 2020 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 RF Emissions CISPR 11 Class A The Q TECH Model 2020 programmer is suitable for use in all establishments other than domestic and those directly connected to the public low voltage Harmonic Emissions IEC 61000 3 2 Class A power supply network that supplies buildings used for domestic purposes Voltage Fluctuations Flicker Emissions Complies TEC 61000 3 3 Table 5 Declaration Electromagnetic Immunity Dart 1 The TECH Model 2020 programmer is int
52. of nearby equipment It may be necessary to take mitigation measures such as reorienting or relocating the programmer or shielding the location By design the programmer emits radio frequencies 403 5 MHz and 2 5 GHz This may interfere with nearby equipment Closely monitormedical electrical equipment in the vicinity when using the programmer The presence of other devices in the same frequency band 403 5 MHz for the SQ RX Pulse Generator and 2 5 GHz for the printer may interfere with communication If communication problems occur referto the Possible Problems and Solutions section of this manual Ifthe programmer is used near other medical or office equipment all equipment should be observed to verify normal operation Other equipment may interfere with the programmer even if that other equipment complies with the International Special Committee on Radio Interferenc CISPR emission requirements e Use of accessories other than those specified by Cameron Health may result in increased emissions or decreased functionality of the programmer and m y cause unintended operational behavior of the programmer Do not attempt to remove the wireless communication card or wireless printer card Use of non approved Cameron Health components will void the warranty and may ease unpredictable SQ RX Pulse Generator operation No modification of the programmer is allowed Use only the Cameron Health programmer and appropriate software for commu
53. ppears 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 stored in the SQ RX device Select Cancel at any time to end Reference S EOG acquisition H When acquisition is complete select the Continue button to finish the Automatic Setup process A confirmation screen will appear when Automatic Setup is complete Figure 30 Therapy Off TEST EE LH E Automati Re Automatic Setup completed successfully Figure 80 Confirmation of successful Automatic Setup Programming Therapy Parameters Once Automatic Setup has been completed the SQ RX device therapy parameters may be selected To set the therapy parameters 1 Select the Main Menu button on the Navigation Bar 2 Select the Implant button 3 Select the Device Settings button on the Navigation Bar to display the Device Settings screen Figure 31 180 190 200 210 220 23 4 Conditional Shock Post Shock Pacing 32 Figure 81 Device Settings screen O TECH PROGRAMMER OPERATION 4 Select the On Off Therapy switch to set the desired therapy mode Figure 32 Therapy On CECR Device Settings Figure 32 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 UO and 250 bpm in steps of 10 bpm The Conditio
54. programmer will scan the area to locate wireless printers A Scan Progress Bar will appear informing e user that the programmer is currently scanning for printers 3 Select the printer of choice Figure 12 If no printers are found a window willappear stating that there are no printers Select the Scan Again button or the Cancel button to stop the scanning process If print r was selected during another session the Printer Setup screen is displayed Q TECH PROGRAMMER OPERATION 4 Once the scan is complete the Printer Setup screen appears Figure 12 Note Refer to Possible Problems and Solutions for printer problems Printer Setup Printer Model Name Printer Serial Number Figure 12 Printer Selection screen 5 Selectthe desired printer name and enter e name using the keyboard up to 15 characters Aunigue printer identifier should appear with the printer selection Figure 13 Enter a name for the new printer or select Cancel to select a different printer Figure 13 Use the keyboard to enter a name for the selected printer 6 Select the Save button to save the changes and return to the Programmer Settings screen or select Cancel to return to the Programmer Settings screen without saving the changes A confirmation screen will appear when the printer setup is completed Figure 14 20 Q TECH PROGRAMMER OPERATION Printer Setup Printer setup successfully complete j Figure 14 Printe
55. r You may select Cancel to return to the Device Settings screen or select Continue to cancelall SQ RX device setting changes Defibrillation Testing Once the SQ RX device is implanted and Automatic Therapy is programmed On defibrillation testing may be conducted Note Defibrillation testing at the time of implantation isat the discretion of the physician To induce VF and test the S ICD System 1 Select the Programmer Main Menu button on the Navigation Bar to access the Main Menu 2 Select the Patient Test buttonto setup the ind ction test Figure 34 Therapy On m Impit Foiiow Up End session Q tities Patient Test 34 Figure 34 Select the Patient Test Button to access the Main Menu Q TECH PROGRAMMER OPERATION 3 Select either standard STD or reverse REV polarity 4 Select and drag the red marker to set the desired shock energy for the first delivered shock Figure 35 The shock energy may be programmed from 10 to 80 J Therapy On TEST M i Induction Test id N 1 1 20 25 3 35 40 45 SO 55 OT 75 ag n Set Shock Energy Joules Figure 35 Setting the desired first shock energy for defibrillation testing 5 Select the Continue button to display the Induction Test screen Note Episode data associated with rescue shocks manual shocks and induction testing is not stored in the SQ RX device 6 Select and hold e Hold To Induce button for the desired duration Figure 36 Figure 3
56. r Setup confirmation screen 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 15 About Programmer Figure 15 Programmer Software Version information screen 2 This screen displays the current version of the programmer software Select the Back button to return to the Programmer Settings screen Note The patient printed report contains the programmer software version 21 22 Q TECH PROGRAMMER OPERATION Modes of Operation for the TECH Programmer Online Behavior The programmer s interface varies according to whether the programmer is Online actively communicating or Offline not communicating with a selected SQ RX device An Online session occurs when the programmer establishes a telemetry link with a specific SQ RX device Online and Offline display screens have a grey background appearance During active communication if the telemetry signal is lost between the programmer and the SQ RX device for more han Tue seconds a yellow alert sereen is displayed notifying the user 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 bejavailablewuntil telemetry is reestablished Telemetry reconnection may occur automatically within one minu
57. rogrammer or contact your local Cameron Health representative or Customer Service Department for instructions Do not touch or connect the Wand to the programmer unless ESD precautionary procedures are used S ICD System Warnings and Cautions Before using the S ICD System read and follow all warnings and cautions provided in this manual Refer to the SQ RX Pulse Generator Q 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 products for single use only Do not resterilize Handle the S ICD System with care at all times and maintain proper sterile technique Q TECH PROGRAMMER GENERAL DESCRIPTION General e Placing a magnet over the SQ RX Pulse Generator suspends arrhythmia detection and therapy response Removing the magnet resumes arrhythmia detection and therapy response e Battery depletion will eventually cause the SQ RX Pulse Generator to stop functioning Defibrillation and excessive numbers of charging cycles shorten the SQ RX Pulse Generator s battery longevity Use of Other Medical Therapies Diagnostic Procedures e External defibrillation or cardioversion may damage the implanted device Current flow through the SQ RX Pulse Generator may be minimized by avoiding the placement of defibrillation paddles directly over the device e Do not expose a patient with an implanted S IOD System to diathermy The interaction of diathermy th
58. s are prohibited Although this transmitter has been approved by the Federal Communications Commission there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference FCC ID SDYCHI2020 1999 5 EC Compliance R amp TTE Directive The S ICD System contains radio equipment in the frequency range 402 MHZ to 405 MHz for ultra low power active medical implants The radio equipment in the S ICD System complies with the applicable harmonized standards and essential requirements of the R amp TTE Directive For additional information contact Cameron Health Inc direct by the telephone numbers listed on the inside front cover or back page of this manual EMI RFI This equipment has been tested and found torcomply with the applicable limits for medical devices IEC 60601 1 2 or Active Implantable Medical Device Directive 90 385 EEC Table 3 EMI RFI Information Wireless Connection Frequency Bandwidth FCC Designation R amp TTE Class From Programmer Programmer Wireless 403 5 MHz 300 KHz CFR AT Part 951 Class 1 Adapter and Pulse MICS Subelass 47 Generator Printer Adapter 2 400 2 4835 GHz 1000 KHz Maximum CFR 47 Part 15 Class 2 Class B Subelass 21 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
59. s screen without saving the changes Time Zone To set the time zone in which the programmer will be used 1 Select Set Time Zone on the Programmer Settings screen The Set Time Zone screen appears 2 Select the country time zone button for the zone in which the programmer will be used A green checkmark will appear in the selected button Figure 11 The SQ RX device linefrequency of 50 Hz or 60 Hz is automatically programmed based on the country time zone selected 18 Q TECH PROGRAMMER OPERATION Set Time Zone Figure 11 Time Zone selection screen 3 Select the Save button to save the changes and return to the Programmer Settings screen or select Cancel to return to the Programmer Settings screen without saving the changes Language Preference To set the language preference LL Select Set Language on the Programmer Settings screen The Language Settings screen appears 2 Select the Sav button to save the changes and return to the Programmer Settings screen or select Cancel to return to the Programmer Settings screen without saving the changes Printer Selection To select the printer to be nsed with the programmer 1 Insert the wireless communication card into the printer s USB port 2 Select Printer Setup on the Programmer Settings screen A previously configured printer becomes the default printer and will be displayed at this tinte Tf a default printer has not already been selected and configured the
60. te when the OO RX device and wand are within telemetry range Upon disconnection caused by the loss of telemetry the last 60 seconds of S ECG can be viewed through the Captured S ECG programmer display screen Offline Behavior When the programmer is not actively communicating with an SU HX device it is Offline Stored patient sessions can be viewed and printed and programmer settings can be accessed during Offline sessions Offline screens have a grey background Stored Patient Sessions During patient follow up visit the programmer will retrieve data fromthe SQ RX device s memory The programmer can store up to 15 patient sessions When the 16th session occurs the programmer will automatically replace the oldest stored session with the new data Arstored session includes the following information e Captured S ECG Reports Episode History including any downloaded episodes Patient Data Programmed Device Settings To view stored patient sessions 1 From the Startup screen sel ect Stored Patient Sessions 2 Select the desired patient session Modes of Operation for the SQ RX Device The SQ RX device has three modes of operation Shelf e Therapy On e Therapy Off Q TECH PROGRAMMER OPERATION Shelf Mode The Shelf mode is a low power consumption state intended for storage only When communication is initiated between the SQ RX device and the programmer a full energy capacitor reformation is automatically performed and the
61. telemetry link will be disconnected However the programmer will maintain the current display screen and writes the ongoing session to memory Pressing the ESC On Off button or opening the touch screen from the folded down position ends S spend Mode operation Using the Programmer Touch Screen The programmer is equipped with an LCD touch screen By using the stylus and keyboard the user can select onscreen options and enter patient information Stylus The stylus is used to enter commands change parameters and navigate through the programmer screens Note Do not substitute any type of ink pen for the stylus this may cause a permanent stain and damage to the display screen To use the stylus 1 Push the square stylus eject button on the right side of the programmer base The stylus is ejected from the holder Figure 5 Power Connector Stylus Release Button Figure 5 Removing the stylus 2 Use the stylus to lightly tap the appropriate functions on the touch screen or press and hold the stylus to move a scroll bar 3 Push the stylus back into its holder when finished Q TECH PROGRAMMER OPERATION Keyboard The compact computer keyboard with 58 full size keys is used to enter text and numeric data Using the Wand Use only the Cameron Health Model 4510 wand the wand to communicate with the SQ RX device Note The wand is a non sterile device DO NOT STERILIZE The wand must be contained in a sterile barr
62. tton to update the SQ RX device with the patient information Note Failure to save the new patient information will result in Joss of the entered data Automatic Setup Before the SQ RX device can be activated it must go thro gh an initial Automatic Setup Process at the time of the implant The Automatic Setup Process is initiated as follows 1 Select the Main Menu button 2 Select the Implant button 3 Select the Auto Setup button on the Navigation Bar The Automatic Setup screen appears Figure 26 4 Select Continue if the patient s heart rate is less than 130 bpm For rates greater than 130 bpm select the Cancel button and refer to the instructions for Manual Setup 29 Q TECH PROGRAMMER OPERATION Therapy Of L2 REAL H Automatic Setup W The Automatic Setup process will tailor the SACD to the patients 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 lt 130bpm prior to continuing Figure 26 Automatic Setup screen 5 Once started the Automatic Setup will Perform the shock electrode integrity check Figure 27 to measure electrode impedance Normal sub threshold impedance range is 400 Ohms Therapy Off D Automatic Setup Figure 27 Measuring electrode impedance Select the best sensing configuration The sense electrode configuration appears on the printed report and can b

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