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1. Loss of Communication with Printer When communication 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 If this occurs 1 2 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 unable to communicate with the SQ 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 Apply a pulse generator magnet to the SQ RX device to elicit beeper tones Remove the magnet and re attempt communication 65 Q TECH PROGRAMMER COMPLIANCE STATEMENTS COMPLIANCE STATEMENTS Federal Communications Commission FCC US This transmitt
2. Table 4 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 x 8kV air ceramic tile If floors are covered IEC 61000 4 2 with synthetic material then the relative humidity should be at least 30 Electrical Fast 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that Transient Burst 1 kV for input output lines 1 kV for input output lines of a typical commercial or hospital IEC 61000 4 4 environment Surge 1kV line s to line s x 1kV line s to line s Mains power quality should be that of a IEC 61000 4 5 2 kV line s to earth 2 kV line s to earth typical commercial or hospital environment Voltage Dips Short 596 U 295 dip in Uj for 0 5 cycles 596 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 V 6096 dip in Un for 5 cycles typical commercial or hospital environment variations on power 70 U 30 dip in Un or 25 cycles 70 U 30 dip in Uj for 25 cycles If the user of the Q TECH Model 3200 suppl
3. 5000 pA Wand BF Safety Features Defibrillator protection to 5000 V 400 J 71 Q TECH PROGRAMMER DEFINITION OF PACKAGE LABEL SYMBOLS Table 11 Packaging Symbols Q TECH Programmer Symbol Specification 72 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 Conformit Europ enne Product fully complies with European Directive AIMD 90 385 EEC Keep Dry Ship and store in a dry place Electrostatic Discharge Identifies a connector not tested for immunity to electrostatic discharge Power plug Storage location of power cord 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 Reference Number Catalog number Door open Open the flap Q TECH PROGRAMMER DEFINITION OF PACKAGE LABEL SYMBOLS Table 12 Packaging Symbols Q TECH Programmer Wand Symbol Specification Symbol Specification Non Sterile
4. The Automatic Setup screen appears Figure 23 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 Automatic Setup O w Patient Name Therapy 70 LI 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 lt 130bpm prior to continuing Figure 23 Automatic Setup screen 5 Once started the Automatic Setup will Perform the shock electrode integrity check to measure electrode impedance Figure 24 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 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 33 Q TECH PROGRAMMER OPERATION Automatic Setup 3 x Patient Name Therapy 70 LI Figure 24 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 6 The Automatic Setup Sensing Optimization screen will be displayed The programmer will
5. Up to 44 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 for each Untreated Episode e Pre episode S ECG 44 seconds of pre episode S ECG e 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 after a patient session is ended It is recommended that afinal report be printed immediately following the implant procedure There are three patient reports Summary Report Captured S ECG Report Episode Reports To print patient reports from either an Online or Offline session 1 Select the Main Menu button to display the Main Menu screen 2 Select the Print Reports button 45 Q TECH PROGRAMMER OPERATION 3 Select the desired report type A 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
6. 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 lonizing 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 To minimize the risks of ionizing radiation Shield the SQ RX Pulse Generator with a 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 SQ RX Pulse Generator If required avoid direct flow of the pulse waves near the site of the implanted SQ RX Pulse Generator 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 SQ RX Pulse Generator and electrode The programmer is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Q TE
7. slider bars to set the desired zone configuration The Shock Zone is programmable between 170 and 250 bpm in steps of 10 bpm TheConditional Shock Zone 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 Shock Zone and Conditional Shock Zone maintain at least a 10 bpm difference between the two zones If the Conditional Shock Zone slider yellow is dragged over the Shock Zone slider red the two sliders will merge to create a single Shock Zone 6 If post shock pacing is desired slide the Post Shock Pacing switch to the On position Post shock bradycardia pacing occurs at a non programmable rate of 50 bpm for up to 30 seconds Pacing is inhibited if the intrinsic rate is greater than 50 bpm 7 Select the Program button to apply the changes and program the SO RX device A screen will appear to confirm that the SQ RX device settings were programmed Figure 30 If the SQ RX device does not accept the SO RX device programming a Program Device alert screen will appear Select the Try Again button to return to the Device Settings screen 37 Q TECH PROGRAMMER OPERATION Device Settings Y L n Therapy On 670 LJ Settings were successfully programmed to the device EE i Hu Figure 30 Confirmation of programming 8 Once programming is confirmed s
8. 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 fa spontaneous episode occurs during a patient s follow up session while the SO RX device is wirelessly communicating with the programmer the episode will not be stored To view stored episodes 1 Select the Main Menu button 2 Select the Follow Up button 3 Select the Captured and Stored Episodes S ECG icon from the Navigation Bar 4 Select the Episodes option to access the episodes pick list 5 Select an episode treated or untreated from the list Figure 35 The selected episode will be downloaded from the SO RX device and displayed Episodes Therapy On Description Date 004 Untreated Episode 04 30 2009 003 Untreated Episode 04 30 2009 002 Treated Episode 77 Ohms 04 30 2009 001 Treated Episode 77 Ohms 04 30 2009 A Episodes _ Captured Figure 35 Stored Episodes screen scrollable list Q TECH PROGRAMMER OPERATION 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 The following details are available for each episode Treated Episodes Up to 128 seconds of S ECG data is stored for each Treated Episode e Pre episode S ECG
9. Check 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 its internal 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 not know the national regulations in your country please contact your Cameron Health Boston Scientific representative If IEC EN 62353 is a required 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 10 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 Cameron Health Boston Scientific representative or the customer service department for instructions and return packaging Do not
10. EMV REI e RE HEID DECLARATIONS TABLES Declaration Electromagnetic Emission sssssscsssecsssecsseccessecsseecssscessscesseecsueccsscceseceesceessecesncessneeeseeeess 67 Declaration Electromagnetic Immunity Part 1 eese netten teen ttnntttentttns 67 Declaration Electromagnetic Immunity Part 2 etes gee RR ee RR eek ee RR ees 68 Recommended Separation Distances ccsessssscsesssescsesssssssesssesssecssesssessseessessssessessassssessseessessaeesseesneessees 69 EMI RFI Enforrmiatiori GE EE EE eoe 69 SPECIFICATIONS Product GUID RE OR N 70 Specifications aran mimmaini mmimmmmmmmmmmmmmmmm mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmi 70 Nominal SpecificatioRs 5 e ER anmain in dette seer 71 DEFINITION OF PACKAGE LABEL SYMBOLS Packaging Symbols Q TECH ProgramMet ssscsssssssscssescessecsnsecsnseesnscessecesseecnseccssccessecssnecssncessneeesseeess 72 Packaging Symbols Q TECH Programmer Wand gesek seek gee RR gegee Gee RR tentent ee RR ee 73 WARRANTY ETE DIN OR OE cc 74 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
11. Used to indicate the LOT Lot number Batch code ede nore 73 Q TECH PROGRAMMER WARRANTY Warranty Cameron Health Boston Scientific Inc offers a 2 year limited warranty on the Q TECH Programmer to the user or using facility Please contact your Cameron Health Boston Scientific 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 Boston Scientific organization 74 gel rac Came Health Cameron Health Inc Guidant Europe NV SA Boston Scientific 4100 Hamline Avenue North Green Square St Paul MN 55112 5798 USA Lambroekstraat 5D 1831 Diegem Belgium 1 800 CARDIAC 227 3422 1 800 CARDIAC 227 3422 0344 1 651 582 4000 1 651 582 4000 2013 www cameronhealth com www cameronhealth com PN 104749 004 en 2013 09
12. at the 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 a lengthened rhythm detection period Consistent tachy T markers indicate that tachyarrhythmia detection is occurring and that capacitor charging is imminent If a high degree of amplitude variation is noted during the arrhythmia a slight delay may be expected prior to capacitor charging or shock delivery 41 Q TECH PROGRAMMER OPERATION 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 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 complexes If other markers are noted use the Manual Setup process to evaluate other sensin
13. audible tones Q TECH PROGRAMMER OPERATION 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 Figure 45 2 Select the Test button to perform the electrode integrity test AT Measure Impedance Therapy On 70 ua Press the Test button to check the Device Impedance Figure 45 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 are three available sensing vectors that can be manually selected e 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 SO RX device Alternate Sensing from the distal sensing electrode ring to the proximal sensing electrode ring on the subcutaneous electrode 55 Q TECH PROGRAMMER OPERATION The gain setting adjusts the sensed S ECG signal sensitivity It may be manually selected via the Select Gain slider switch Figure 46 Manual Setup T
14. dispose of the programmer in the trash or at electronics recycling facilities 63 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 printer is 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 enabled 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 a printer was not set 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 64 Q TECH PROGRAMMER TROUBLESHOOTING
15. in active communication with an SO RX pulse generator and no user activity 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 LCD touch screen The screen can be adjusted to the desired viewing angle by using the kick stand located on the back of the programmer All interaction with the programmer is conducted using the fingers to touch the appropriate areas on the screen Scroll on screen lists by sliding a finger up and down the list Figure 3 An on screen keyboard is presented whenever text entry is required c Boston Scientific Figure 3 Scrolling on screen lists 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 a non sterile device DO NOT STERILIZE the wand or the programmer The wand must be contained in a sterile barrier before use in the sterile field Q TECH PROGRAMMER OPERATION To connect the wand to the programmer slide the wa
16. integrity either at implant or as warranted by patient condition A manual shock may be administered with the S ICD detection zone s either ON or OFF Manual Shock Test Therapy Set Shock Energy Joules gt 10 15 20 25 30 35 40 45 50 55 OE 75 80 Shock Polarity Figure 52 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 arrhythmia 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 SQ RX device memory 61 Q TECH PROGRAMMER 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 can override the use of the magnet as long as the 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 wireless communication between the SQ RX device and the programmer Charging the Programmer Wh
17. to a supply mains with protective earth e 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 or a damaged programmer Q TECH PROGRAMMER GENERAL DESCRIPTION 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 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 monitor medical electrical equipment in the vicinity when using the programmer The presence of other equipment 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 refer to the Troubleshooting section of this manual If the programmer is used near other medical or office equipmen
18. 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 48 57 Q TECH PROGRAMMER OPERATION 58 p Reset SMART Charge e n Therapy On LEONE LJ SMART Charge automatically extends detection following non sustained arrhythmias SMART Charge has been extended by 1 01 seconds Reset SMART Charge ci ee oe oo N Figure 48 Reset Smart Charge screen 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 will appear with the message Smart Charge successfully reset Press the Continue button to return to the Utilities screen Q TECH PROGRAMMER OPERATION Additional Programmer Functions Rescue Shock The Rescue Shock button is 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 Shock screen appears Figure 49 Rescue Shock L Therapy Off Y 225 E S
19. CH PROGRAMMER GENERAL DESCRIPTION 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 EMI or static magnetic field source 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 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 patients 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 e Acceleration induction of atrial
20. Electrode Insertion Tool 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 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 in patients who do not have symptomatic bradycardia incessant ventricular tachycardia or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti tachycardia pacing 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 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
21. OGRAMMER DECLARATIONS TABLES Table 6 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 to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz of transmitter d NP d BSWP V For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency ofthe transmitter where p is the maximum output power rating ofthe transmitter in watts W according to the transmitter manufacturer Note 1 At 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 7 EMI RFI Infor
22. Printed Report Date SO RX Device Model Serial Number Electrode Model Serial Number Implant Date 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 SQ RX Device Integrity Check if applicable Programmer Software Version SQ RX Device Software Version To print a summary report select the Summary Report button on the Print Reports screen Q TECH PROGRAMMER OPERATION 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 to the Cap tured S ECG s to be printed A checkmark appears next to the selected Captured S ECG Figure 36 Print Reports Therapy On Default Printer Figure 36 Selecting Captured S ECG 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 47 Q TECH PROGRAMMER OPERATION Episodes Report To print an Episode Report 1 Select the Episodes Report button on the Print Reports pick list screen The Episode List screen appears showing a list of the stored episodes Figure 37 Select the button next to th
23. Q TECH PROGRAMMER A COMPONENT OF THE S ICD SYSTEM USER S MANUAL 3200 Boston Scientific Programmer Settings Stored Patient Sessions S ICD System Came Health Copyright 2013 Boston Scientific or its affiliates All rights reserved Limited Software License and Equipment Use S ICD SQ RX and Q TRAK are all registered trademarks of Cameron Health Inc 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 gl rac Cameron Health Inc Guidant Europe NV SA Boston Scientific 4100 Hamline Avenue North Green Square St Paul MN 55112 5798 USA Lambroekstraat 5D 1831 Diegem Belgium 1 800 CARDIAC 227 3422 1 800 CARDIAC 227 3422 1 651 582 4000 1 651 582 4000 www cameronhealth com www cameronhealth com TABLE OF CONTENTS GENERAL DESCRIPTION DesEriptiON eee IIT EE 1 Indications for Use ede esee betae a eoru ava aes aa eese oes e de aoa eere Enea cepa Gee oe ose Ue ee bae eg s Ree de aa ige 1 CoritraindicatiOns ss ES eee eto o ee sto eoa coast GEE EE Ve Des eo Ge sper Ea cola GE SG Uo a ee s ae aea GE EDE Gee 1 Programmer Warnings and Cautions sees ee ee GE Ge GE EE eene etas etos EG teas eno sets Gee 1 sac immmmmmmmmmm mmmmrmrmrmmrmrmrmrmmmmmmmmmmrmmrmmmmmmrmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmrmrmmrmmmmmmmmmmmmmmmmciykymH 1 Electrostatic D
24. RATION continued Modes of Operation for the Q TECH Programmer eee e eee ee Ge Ge eene EG EG EG Ee 21 Online Behavior Offline Behavior Modes of Operation for the SQ RX Device scsssscssssssssssscsssssssssscssssssssssscsssessssssscesssssoess 23 Shelf Mode aere rerit ata Therapy On Mode Therapy Off Mode RE EE EE N AREA HE as 23 Programming the SQ RX Device at Implant eee cesse eene eene EG EE GE Ge Se Ge Ee 29 Entering Electrode Information Creating the Patient Charte eter ete ceti enne e hee etarki Automatic Setup sss Programming Therapy Parameters Defibrillation Testing Performing an SQ RX Follow up EG eene eere eene enean EG EG Ee tense inset ese Ge teu 42 Sensing Configuration and Automatic Setup eese teen teen ee eek eek ee 42 Viewing SQ RX Device Status Jeter tesi ti GESE ERG GE ionieni iiae iesea qe eke ee 42 Viewing Stored Episodes EE restet reise erae be E n ATN a 44 Printing Reports from the Programmer ese see eene Ee eaten EG esteso sinas tese Ge Ee 45 Printing ReDOLts EE ence a n OE eH ecrit rte deep on ax Summary Report x nee tee e RU ED Pee ID URSUS bene A RET GE SURE AERE RECHNER Captured S ECG Report Episodes Report S ECG Features p m S ECG Rhythm Strip Marketsin niin a a a TE as S ECG Scale S
25. 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 Gain or Sweep Speed Scale bars as desired Figure 39 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 S ECG Display Settings Therapy On 70 LJ Full Range 1 2 Range 1 4 Range 1 8 Range Km LCH Sweep Speed 12 5mm sec 25mm ES 50mm sec SN oe MG Figure 39 Adjusting Gain and Sweep Speed Note Amplitude settings and display speed adjustments on scrolling real time S ECG and Captured S ECGs affect the display screen settings only and have no impact on the SO RX device settings for sensing 50 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 e 8 5 seconds 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 olde
26. SO RX device A yellow alert screen is displayed if the telemetry signal is lost between the programmer and the SO RX device for more than five seconds during active communication This may occur if the 21 Q TECH PROGRAMMER OPERATION 22 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 SQ RX device and wand are within telemetry range Note Whenever the programmer is in active communication with an SO RX device charging of the pulse generator in preparation for delivering a shock whether commanded or in 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 to 15 patient sessions When the 16th session occurs the programmer will automatically replace the oldest stored session with the new data A stored session includes the followi
27. a name for the new printer or select Cancel to select a different printer Default Printer Figure 10 Use the on screen 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 11 Printer Setup Printer setup successfully complete Figure 11 Printer Setup confirmation screen 20 Q TECH 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 12 About Programmer Programmer Software Version X XX X Figure 12 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 Thepatient printed report contains the programmer software version Modes of Operation for the Q 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 SO RX device An Online session begins when the programmer establishes a telemetry link with a specific
28. al and rescue shock therapy are available once the initial Setup process is complete 23 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 SQ RX device Scanning For SQ RX Devices 1 Select the Scan For Devices button on the Startup Screen Figure 13 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 D li 2 Programmer Settings Des Stored Patient Sessions S ICD System Cameron Health Figure 13 Startup screen 24 Q TECH PROGRAMMER OPERATION When the scanning process is complete a list of all SQ RX devices detected up to 16 will be displayed on the Device List Figure 14 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 Device List Patient Name Model Serial ID IMPLANTED 1010 123456 Figure 14 Device List screen scrollable list If the 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 Refer to the Inability to Communicate with the SQ RX Device secti
29. approved printers can be used with the programmer To select the printer to be used with the programmer 1 Ensure the printer is on and as applicable the wireless function is enabled or the wireless adapter is in the printer s USB port Q TECH PROGRAMMER OPERATION Select Printer Setup on the Programmer Settings screen A previously configured printer becomes 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 programmer is currently scanning for printers Select the printer of choice Figure 9 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 If a printer was selected during another session the Printer Setup screen is displayed Printer Setup Printer Name Printer Serial Number h470 Figure 9 Printer Selection screen Once the scan is complete the Printer Selection screen appears Figure 9 Note Refer to Troubleshooting section for printer problems Select the desired printer name and enter the name using the on screen keyboard up to 15 characters A unique printer identifier should appear with the printer selection Figure 10 19 Q TECH PROGRAMMER OPERATION Printer Setup Enter
30. ate format 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 Date and Time Settings m gt Figure 7 Date and Time Settings screen 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 time zone selec tion screen appears Figure 8 2 Select the country time zone button for the zone in which the programmer will be used A checkmark will appear in the selected button The SQ RX device line frequency of 50 Hz or 60 Hz is automatically programmed based on the country time zone selected Q TECH PROGRAMMER OPERATION Set Time Zone Figure 8 Time Zone selection screen scrollable list 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 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 Only Cameron Health Boston Scientific
31. del 3203 Telemetry Wand External power supply and AC power cord Visually inspect the 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 Charging the Programmer The programmer is primarily intended to be operated while connected to the AC powered external power supply but may also be operated on battery 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 Typical charge time for a fully discharged battery is 5 hours However more time may be required if the programmer is in use while being recharged The Battery Status indicator located on the upper right corner of the screen displays the status of the main battery power when the unit is in use All four bars are illuminated green The battery is 100 charged Three bars are illuminated green The battery is 75 charged Two bars are illuminated yellow The battery is 50 charged One bar is illuminated red The battery is 25 charged Q TECH PROGRAMMER OPERATION The p
32. 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 25 Automatic Setup w Therapy 70 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 25 Automatic Setup screen 34 Q TECH PROGRAMMER OPERATION Select the Continue button to finish the Automatic Setup process A confirmation screen will appear when Automatic Setup is complete Figure 26 Automatic Setup O w Therapy 70 Automatic Setup completed successfully Figure 26 Confirmation of successful Automatic Setup Following the optional optimization process the Acquire Reference S ECG screen is displayed Figure 27 Select the Continue button to acquire a reference S ECG Acquire Reference S ECG O Pd Therapy 70 The following procedure will significantly improve rhythm discrimination and requires acquisition of a reference S ECG This process will take less than one minute Select Continue if the displayed S ECG is acceptable Figure 27 Acquire Reference S ECG screen 35 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 remai
33. e episode s to be printed A checkmark appears next to the selected episode s Select Episode Reports L 5 Therapy On 60 Gms Description Date 003 Untreated Episode 04 30 2009 002 Treated Episode 77 Ohms 04 30 2009 Figure 37 Stored Episode List screen scrollable 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 Note In order to be available for printing episodes must be individually downloaded from the Stored Episodes Screen Figure 35 48 Q TECH PROGRAMMER OPERATION 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 the S ECG Markers on Programmer Display Screens and Printed Reports table Table 2 and an example is shown in the Sample ECG Markers illustration Figure 38 Table 2 S ECG Markers on Programmer Display Screens and Printed Reports EEN EN ha 3 ai mam Marker present on printed report but not on programmer display screen EE N EE EE EE EE EE EE EE Figure 38 Sample ECG markers 49 Q TECH PROGRAMMER OPERATION S ECG Scale Settings To adjust the real time
34. elect SHOCK to deliver maximum energy rescue shock rn Figure 49 Rescue Shock screen 2 Select the Shock button to begin charging the SO RX device for a Rescue shock A red background screen with the word Charging will appear Figure 50 Selecting the Abort button will prevent delivery of a rescue shock and will return to the Device Settings screen 59 Q TECH PROGRAMMER OPERATION 60 3 Rescue Shock 3 L Therapy Off Y 225 E Charging rn Figure 50 Abort Rescue Shock A confirmation screen will appear with notification that the shock was delivered successfully along with the corresponding shock impedance Figure 51 Rescue Shock lt gt C Therapy Off 670 LJ Shock delivered shock impedance 75 Ohms Figure 51 Confirmation of Rescue Shock delivery Q TECH PROGRAMMER MAINTENANCE 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 deliver a synchronized shock 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 52 Manual shock may also be utilized at a low energy to assess system impedance
35. elect the Continue button to proceed to the next operation Note Ifany ofthe SO RX device settings are changed from the Device Settings screen and not subsequently programmed the Pending Program Changes screen will appear You may select Cancel to return to the Device Settings screen or select Continue to cancel all SO RX device setting changes 38 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 testing is recommended at implant to confirm the ability of the S ICD System to sense and convert VF Note Episode data associated with rescue shocks manual shocks and induction testing is not stored in the SQ RX device 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 button to setup the induction test Figure 31 Main Menu Online C 9 Therapy On V60 EJ Implant Follow Up Print Reports End Session Utilities Patient Test Figure 31 Select the Patient Test Button to access the Induction Test screen 39 Q TECH PROGRAMMER OPERATION 3 Select either standard STD or reverse REV polarity Figure 32 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 sa
36. en not in use it is recommended that the programmer remain connected to the external power supply This will ensure 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 programmer and wand To clean the programmer and wand as needed 1 2 3 62 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 Q TECH PROGRAMMER MAINTENANCE Service There are no user accessible or user serviceable parts or components in the programmer If any service repair or replacement of internal compontents 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 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
37. er is authorized by rule under the Medical Device Radiocommunication Service in 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 stations including interference that may cause undesired operation This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service Analog and digital voice communications 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 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 Cameron Health hereby declares that this transmitter is in compliance with the essential requirements and other relevant 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 inside front cover or back page of this manual EMI RFI This equipment has been tested and fo
38. ere P is the 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 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 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 reflection from structures objects and people a Field strengths from fixed transmitters such as 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 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 gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 68 Q TECH PR
39. ervice life Mishandling such as dropping or crushing could damage the programmer If you suspect damage to the programmer contact your Cameron Health Boston Scientific representative or the customer service department for instructions and return packaging The display on the programmer is made of glass or 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 Contact your Cameron Health Boston Scientific representative or the customer service department for assistance or a replacement part Electrostatic Discharge ESD The programmer may be affected by ESD If ESD occurs and the programmer s functionality is affected attempt to reset the programmer or contact your Cameron Health Boston Scientific representative or the customer service department for instructions Do not touch or connect the telemetry 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 components of the S ICD System with care at all times and maintain prope
40. ession 1 Select the Main Menu button to display the Main Menu screen 2 Select the Utilities button The Utilities screen appears Figure 42 Utilities Therapy On 70 Gm gt Figure 42 Utilities screen 52 Q TECH PROGRAMMER OPERATION Acquire Reference S ECG To acquire a manual Reference S ECG 1 Select the Acquire Reference S ECG button on the Utilities menu to access the Acquire Reference S ECG screen 2 Select Continue to acquire a Reference S ECG The programmer will begin acquiring the Reference S ECG A message will appear requesting that the patient remain still Figure 43 The reference S ECG QRS template is recorded and stored in the SQ RX device 3 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 Acquire Reference S ECG O Patient Name Therapy On 70 um This process may take up to one minute during which the patient should remain still Figure 43 The patient should remain still while the Reference S ECG is acquired 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 electrode impedance out of range prolonged charge times failed Device Integrity Check and irregular battery depl
41. etion Beeper Control allows activation or suppression of the beeper 53 Q TECH PROGRAMMER OPERATION 54 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 activated a notification screen will appear upon connection Select the Main Menu button to display the Main Menu Select the Utilities button to display the Utilities Menu Select the Beeper Control button Bep qe oc Select the Reset Beeper button to suspend audible beeping tones triggered by an alert condition Figure 44 If the alert condition is not corrected the audible beeping tones will be reactivated during the next automatic S ICD System self check p Set Beeper Function y Therapy On LEONE LJ Select Reset Beeper to stop the beeper for the current device alert Select Disable Beeper to disable the beeper warning for all error conditions including ERI and EOL ui oo NG Figure 44 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
42. ettings Capture and View S ECG Strips Utilities Menu sesse sesse se Ge Ee Acquire Reference S ECG Beeper Control Manual Setup Smart Charge Additional Programmer Functions sessessoesosssosocssossosesosocssossoseoseoesssesoseessoesosesosossesssosesossse 59 RESCUE Shock sees eke e e Eie eene dese gesnede nege ke es ee erecto na 59 Manual shock recae ta ee e eg te AE EE Ge ties 61 S ICD System Magnet Model 4520 eterne nette nnn tts ettet ee eek eek ee 61 MAINTENANCE Charging the Prograrnriet er A c E A de RE ee 62 Cleaning the Programmaer seek ese ea a oge eh retento ettet notet nets ttt to ee stetit nonne 62 Esc AE AE RE EO AE EE N 63 Maihteriance Check siento eee eee aeter elect see ge 63 Safety Meas remetits cc e re bebe ER SR e RA dei rb taces ee d 63 Programmer End of Life sena n a e A 63 TROUBLESHOOTING Inability to Print No Printer Available Touch Screen Inactive while Connected to AC Power sesse sak RR oak ee ee RR Gee Roe Ge ea 64 Loss of Communication with Printer sesse sesse eee ttts Gee ek tetto ee RR tton tts R Re As 65 Inability to Communicate With the SQ RX Device sesse seen ese ee ae ER ee ee RR ee R Roe R RR 65 COMPLIANCE STATEMENTS Federal Communications Commission FCC US ee ee ee oe ee ee oe ee ee ee ee ee ee ee ee ee 66 1999 5 EC R amp TTE Directive
43. fety margin is recommended for defibrillation testing Fa Induction Test j y Therapy On 670 LJ Set Shock Energy Joules f 10 15 20 25 30 35 40 45 50 55 Ni IE 75 80 Shock Polarity AM o i ie Figure 32 Setting the desired first shock energy for defibrillation testing 5 Select 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 40 Q TECH PROGRAMMER OPERATION 6 Select and hold the Hold To Induce button for the desired duration Figure 33 p Induction Test C3 Therapy On 670 wis Hold To Induce Figure 33 Induction Test screen 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 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 delivers a shock at the programmed energy output and polarity e If the shock fails to convert the arrhythmia re detection occurs and subsequent shocks are delivered
44. firm by pressing OK If the programmer does not respond to a restart process contact your Cameron Health Boston Scientific Boston Scientific representative or the customer service department for assistance 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 date and 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 be changed with each session To configure the programmer settings 1 Select the Programmer Settings button on the Startup screen Figure 5 to display the Programmer Settings screen Figure 6 o Me A Programmer Settings gone Stored Patient Sessions S ICD System Cameron Health Figure 5 Startup screen Q TECH PROGRAMMER OPERATION Programmer Settings Figure 6 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 6 The Date and Time Settings screen appears Figure 7 2 Select the desired d
45. g 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 follow the Acquire Reference S ECG instructions Viewing SQ RX Device Status Once communication is established the programmer displays the Device Status screen with information regarding the current episodes and battery status of the SO RX device 42 Q TECH PROGRAMMER OPERATION To view this information 1 2 3 4 Select the Main Menu button Select the Follow Up button Select the Device Status button on the Navigation Bar The Device Status screen will appear showing an overview of all SQ RX device activity since the last communication session Figure 34 fa SA Device Status Since Last Follow Up E L n Therapy 70 04 28 2010 Figure 34 Device Status screen 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 Total number of untreated episodes since the last follow up session Remaining SQ RX device battery life 43 Q TECH PROGRAMMER OPERATION 44 Viewing Stored Episodes The SQ RX device stores up to 25 treated and 20 untreated tachycardia episodes which can be
46. herapy On Select Sensing Location Select Gain Original 1X 2x ANN ee Figure 46 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 e 2x Gain 2 mV 2x Gain 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 56 Q TECH PROGRAMMER OPERATION To program the 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 enabled during 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 47 3 Select the Continue button Acquire Reference S ECG e ha Therapy On Y70 LJ Reference S ECG acquisition successful Figure 47 Captured Reference S ECG confirmation 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
47. ischarge ESD sies ses eee se eei Ak GES ee be diet ee des se 3 S ICD System Warnings and Cautions 4 se ee ee GEE GEE EE GE Ge GEE EG Ge Ge ee Gee 3 ECC NOR 3 Use of Other Medical Therapies Diagnostic Procedures m Electromagnetic Interference EMI Outside the Hospital Environment 5D Potential Adverse EVENTS ee ee ee ee ee ee ee Ge ee ee ee oe oe ee ee ee ee ee ee ee ee ee oe oe ee ee ee ee ee ee soosis 5 OPERATION Setup of the Q TECH Programmer sscccsscsscscssscsccscscsecesscccecsesescscccsccccsesessscsccssecseserenesees 7 sel ale AR Ee OE ee a 7 Charging the gerek AE EE EE AE note 7 Using the Q TECH Programme ccccccssccsscscscsccssccscscsescccsccscccsesesesccssccsesssescesccssecsesesenceees Turning the Programmer On Placing the Programmer in Suspend Mode NEW EE EE EE EG ond ee ke ek ee RE ek Ge Ge RE N Ee ther ieee ek eg Screen Header Navigation Bar Restarting the Programmer Configuring the Q TECH Programmer ee eee eene ee eee EE tastes Ee Ge tenes ense Ge Gees Gee 15 Configuring Programmer Settings eee gee testet nate nott notti Gee RR ttes tton Geo eek 15 Date and Time Format Time PAIR A Language PrefereriCe eine orent ete eae eter eerte eec i Printer Selection sesse sees ese Programmer Software Version OPE
48. mation Wireless Connection Frequency Bandwidth FCC Designation R amp TTE Class From Programmer Programmer Wireless Adapter 403 5 MHz lt 300 KHz CFR 47 Part 951 Class 1 and Device MICS Subclass 47 Printer Adapter 2 400 2 4835 GHz lt 1000 KHz Maximum CFR 47 Part 15 Class 2 Class B Subclass 21 69 Q TECH PROGRAMMER SPECIFICATIONS Table 8 Product Guidelines Battery pack type 4000 mAh 3 7 volt lithium 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 Temperature 15 C to 38 C 10 C to 55 C 59 F to 100 F 14 F to 131 F Relative humidity 5 to 93 maximum at 40 C 5 to 93 maximum at 40 C non condensing non condensing Atmospheric pressure 50 kPa to 106 kPa 50 kPa to 106 kPa 7 252 psi to 15 374 psi 7 252 psi to 15 374 psi Table 9 Specifications Dimensions 24 0 cm x 12 7 cm x 2 6 cm Width x Depth x Height 9 4inx5 0 in x 1 0 in Standard Screen Display WVGA 1024 x 600 pixels 16M TFT 70 Q TECH PROGRAMMER SPECIFICATIONS Table 10 Nominal Specifications Characteristic Electrical Safety Testing IEC 60601 1 2005 ANSI AAMI ES60601 1 2005 allowed values 500 pA Single Fault Condition SFC mains on applied parts ee ee eee Earthbond testing Groundbond testing Patient leakage current direct method lt
49. me Therapy On IINE LI Implant Follow Up Print Reports End Session Utilities Patient Test Figure 21 Select the Implant button to create a patient chart Select the Patient View icon to access the Patient View 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 22 Using the on screen keyboard enter the following patient information Patient Name up to 25 characters Doctor Name up to 25 characters e Doctor Info up to 25 characters Notes up to 100 characters 31 Q TECH PROGRAMMER OPERATION Patient View Patient Name Therapy On Figure 22 Patient Chart screen 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 button to update the SQ RX device with the patient information Note Failure to save the new patient information will result in loss of the entered data 32 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 button 2 Select the Implant button 3 Select the Auto Setup button on the Navigation Bar
50. n 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 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 Data from clinical testing of the S ICD System demonstrated a significant reduction in inappropriate therapy with the activation of the Conditional Shock Zone prior to hospital discharge 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 28 RA Device Settings FI Therapy 670 LJ SL m m mun Shock BPM 170 180 190 2 no EZ 240 250 Conditional Shock o as Therapy OFF Am Post Shock Pacing OFF y ui oo N Figure 28 Device Settings screen 36 Q TECH PROGRAMMER OPERATION 4 Select the On Off Therapy switch to set the desired therapy mode Figure 29 Device Settings au L OD Therapy On 70 1 Shock BPM 170 180 190 200 no EZ 240 250 he Conditional Shock CL od Therapy zc d ON Post Shock Pacing OFF y VEE Hau Figure 29 Setting the On Off Therapy switch 5 Select and drag the Conditional Shock Zone yellow and Shock Zone red
51. nd Session button Figure 16 Main Menu Online S Therapy On 60 ums Implant Follow Up Print Reports End Session Utilities Patient Test Figure 16 Main Menu screen 3 A warning message will be displayed to the user if any of the following conditions exists Automatic Therapy is programmed to Off e 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 17 4 Select the Continue button to end the patient session and return to the Startup Menu screen or select Cancel to remain online and return to the Main Menu screen 27 Q TECH PROGRAMMER OPERATION 28 End Session a x Patient Name Therapy On Y LI is NOT complete is NOT valid Select Continue to disconnect from the device Figure 17 Session incomplete message Note Once the Continue button is selected the session is stored and communication is terminated Note In order to confirm that Automatic Therapy is programmed On upon disconnection always use the End Session process and review all displayed warning messages Q TECH PROGRAMMER OPERATION 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 informa
52. nd cable connector over the communication connector port located on the rear edge of the programmer Figure 4 To disconnect the wand grasp the wand cable connector and gently pull it straight off the communication connector port Note Do not pull or yank on the cable to disconnect the wand from the programmer Such action could cause hidden damage to the cable A damaged cable might reduce wireless communication capabilities and require a replacement wand Figure 4 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 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 If communication cannot be reestablished the session should be ended and restarted by scanning for the SQ RX device Q TECH PROGRAMMER OPERATION 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 screen
53. ng 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 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 initiated between the SQ RX device and the programmer a full energy capacitor reformation is automatically performed and the 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 Manu
54. on for further assistance 25 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 the list 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 2 Once communication is established with the SQ RX device the Device Identification screen appears Figure 15 Device Identification Select Continue to prepare this device for implant Model Serial 123456 Figure 15 Device Identification screen Note The Device Identification screen is visible only while connecting to an SQ RX device in Shelf mode 3 The SO RX device model and serial numbers are automatically acquired and displayed during the initial scanning process Select Continue to remove the SO RX device from Shelf mode and prepare for implantation or select Cancel to return to the Device List screen 26 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 button on the Navigation Bar The Main Menu screen ap pears 2 Select the E
55. or e Bleeding ventricular arrhythmia 2 Cond ctorfract r Adverse reaction to induction testing Cyst formation e Allergic adverse reaction to system or Death medication e Delayed therapy delivery Q TECH PROGRAMMER GENERAL DESCRIPTION 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 Depression Fear of shocks 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 Phantom shocks Q TECH PROGRAMMER OPERATION Setup of the Q TECH Programmer Packaging Programmer components include Model 3200 Programmer with pre loaded software Mo
56. p 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 access the 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 shock from any programmer screen Allows user to select one of two options e g A or B 13 Q TECH PROGRAMMER OPERATION 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 You cannot exit a screen The operating system stops responding A manual restart is accomplished by pressing and holding the power button until the system shutdown menu appears on the screen Select Restart from the popup and con
57. r sterile technique General External defibrillation equipment should be available for immediate use during the implantation procedure and follow up Placing a magnet over the SQ RX Pulse Generator suspends arrhythmia detection and therapy response Removing the magnet resumes arrhythmia detection and therapy response 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 Q TECH PROGRAMMER GENERAL DESCRIPTION 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 or Anti 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 SO RX device or electrode e Cardio Pulmonary Resuscitation CPR may temporarily interfere with sensing and 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 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 Electrical interference or noise
58. rogrammer 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 1 External power supply port d Figure 1 Connecting the external power supply 2 Plug the external power supply cord into an AC power outlet Using the Q TECH Programmer Turning the Programmer On The programmer power button is located in the recess above and behind the left corner of the screen Press and hold the button until the display screen is active Figure 2 Q TECH PROGRAMMER OPERATION Power On 0ff Figure 2 Turning the programmer On Off 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 cord from the programmer Press and hold the programmer power button until the display screen is active Figure 2 AC power via the external power supply can then be reconnected 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 this mode is in effect The programmer enters Suspend Mode whenever The power button Figure 2 is momentarily pressed and released The programmer is not connected to the external power supply it is not
59. s In addition a continuous subcutaneous electrocardiogram S ECG is displayed along the bottom of the screen during Online active communication with the SQ 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 indicator Screen title Rescue shock icon 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 Q TECH PROGRAMMER OPERATION Table 1 con descriptions Main Menu Button Auto Setup Button Device Settings Button Device Status Button open folder and closed folder Patient View Button Captured and Stored Episodes S ECG Button Induction Test Button Manual Shock Button Battery amp Telemetry Meter Capture S ECG S ECG Display Settings Heart Rate Icon Option Selection Slider Switch Allows user to return to the main menu Allows user to access the auto setu
60. st previous recording is replaced with the new recording 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 40 The S ECG will scroll across the display screen Calipers appear below the Captured S ECG rhythm strip Figure 41 Each 12 second recording is date and time stamped according to the programmer s date and time setting Figure 40 Select the Capture S ECG button Captured 12 Second S ECG Patient Name Therapy On Y 70 sd SS pecus _ oe i Hu Figure 41 Captured S ECG rhythm strip 51 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 To view a previously Captured S ECG 1 Select the Main Menu button 2 Select the Follow Up button 3 Select the Captured and Stored Episode S ECG button The Captured S ECG pick list screen appears 4 Select one Captured S ECG from the list The Captured S ECG Details screen appears 5 Select and drag the calipers to view details 6 Select the Continue button to return to the Captured S ECG list screen Utilities Menu The programmer Utilities menu provides access to additional SQ RX device features These include Acquire Reference S ECG Beeper Control Manual Setup and Smart Charge To access the Utilities menu during an Online s
61. t 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 Interference CISPR emission requirements Use of non Cameron Health Boston Scientific approved accessories may result in increased emissions or decreased functionality of the programmer and 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 SQ 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 Do not disassemble or alter any parts of the programmer Do not immerse 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 Q TECH PROGRAMMER GENERAL DESCRIPTION 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 s
62. tion on the implanted electrode To record this 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 18 Automatic Setup Therapy Figure 18 Select the Set Electrode ID button to enter electrode information Note ECG and heart rate information is not present on the Automatic Setup and Electrode ID setup screens until the electrode has been connected to the SQ RX device 5 Enter the electrode model and serial number Figure 19 29 Q TECH PROGRAMMER OPERATION Electrode ID Setup Patient Name Therapy LENS LI Please enter the electrode model and serial number before pressing program Figure 19 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 20 Select Cancel to cancel information storage and return to the Automatic Setup screen Communication in progress Figure 20 Confirmation screen showing communication in progress 30 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 button on the Navigation Bar 2 Select the Implant button Figure 21 Main Menu Online j y Patient Na
63. und to comply with the applicable limits 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 Increase the separation between the devices Connect the equipment to an outlet on a different circuit Contact your Cameron Health Boston Scientific representative or customer service 66 Q TECH PROGRAMMER DECLARATIONS TABLES Table 3 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 SONA other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes
64. y input lines lt 5 U gt 95 dip in Un for 5 sec 596 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 67 Q TECH PROGRAMMER DECLARATIONS TABLES Table 5 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 ps to Recommended Separation Distance 2 5 GHz d BENP 150 KHz to 80 MHz 1 d BAND 80 MHz to 800 MHz 1 d EP 800 MHz to 2 5 GHz 1 wh

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