Cameron Health CHI1010 SQ-RX Model 1010 User Manual 102098 004 rev a qxp

Cameron Health, Inc. SQ-RX Model 1010 102098 004 rev a qxp

User Manual

SQ-RX™PULSE GENERATORA COMPONENT OF THE S-ICD®SYSTEM USER’S MANUALMODEL 1010102098 004 rev a.qxp 12/2/2008 7:43 AM Page 1
Copyright©2008 Cameron Health, Inc., San Clemente, CA USAAll 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 writtendocumentation may not be copied or distributed without Cameron Health, Inc. authorization. Cameron Health, Inc.905 Calle AmanecerSuite 300San Clemente, CA 92673USATel: 1 949 498 5630Free: 1 877 SICD 4111 877 742 3411Fax: 1 949 498 5932URL: www.cameronhealth.comCameron Health BVWorld Trade CenterNieuwe Stationsstraat 106811 KS ArnhemThe NetherlandsTel: 31 26 3550260Free: 800 SICD 4 YOU800 7423 4 968Fax: 31 26 3550269URL: www.cameronhealth.com102098 004 rev a.qxp 12/2/2008 7:43 AM Page 2
Table of ContentsGeneral Description 5Description 5Indications for Use 5Contraindications 5Warnings and Cautions 5General 5SQ-RX Pulse Generator Packaging 6Storage and Handling 6Implant and Programming 6Explanting the System 7Use of Other Medical Therapies/Diagnostic Procedures 7Electromagnetic Interference (EMI) Outside of the Hospital Environment 8Potential Adverse Events 8Clinical Studies 10Results 11Observed Adverse Events 13Patient Screening 14Operation 17General 17Modes of Operation 17Shelf Mode 17Therapy On Mode 17Therapy Off Mode 17Sensing Configuration and Gain Selection 18Sensing and Tachyarrhythmia Detection 18Detection Phase 18Certification Phase 18Decision Phase 19Therapy Zones 19Analysis in the Therapy Zones 19Charge Confirmation 20Therapy Delivery 21Smart Charge 21Redetection 21Shock Waveform and Polarity 21Post-Shock Bradycardia Pacing Therapy 22Manual and Rescue Shock Delivery 22Additional Features of the S-ICD System 22102098 004 rev a.qxp 12/2/2008 7:43 AM Page 3
Magnet Application 22Auto Capacitor Reformation 22Internal Waning System (Beeper Control) 23Arrhythmia Induction 23System Diagnostics 23Storing and Analyzing Data 24Patient Data 25S-ICD System Magnet Model 4520 26Using the SQ-RX Pulse Generator 27Implanting the S-ICD System 27Creating the Device Pocket 27Implanting the Q-TRAK Subcutaneous Electrode 28Connecting the Electrode to the Device 31Setting Up the SQ-RX Pulse Generator 33Post Implant Follow-Up Procedures 34Explanting the S-ICD System 34Federal Communications Commission (FCC) Compliance 35Additional Information 36Specifications 36Definitions of Package Label Symbols 41Appendix 42S-ICD System and Pacemaker Interaction 42Limited Warranty 43Table of Contents (Continued)102098 004 rev a.qxp 12/2/2008 7:43 AM Page 4
DescriptionThe SQ-RX Pulse Generator (the “device”) is a component of the Cameron Health S-ICDSystem, which is prescribed for patients when cardiac arrhythmia management is warranted.Implanted with the Q-TRAK Subcutaneous Electrode (the “electrode”), the device detectscardiac activity and provides defibrillation therapy.Indications for UseThe S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias.ContraindicationsThe S-ICD System is contraindicated for patients with symptomatic bradycardia, incessantventricular tachycardia and patients with documented spontaneous, frequently recurringventricular tachycardia that is reliably terminated with anti-tachycardia pacing.Unipolar pacemakers are contraindicated for use with the S-ICD System.Warnings and CautionsBefore using the S-ICD System, read and follow all warnings and cautions provided in thismanual.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.All Cameron Health implantable components are designed for use with the Cameron HealthS-ICD System only. Connection of any S-ICD System components to any other ICD system willresult in failure to deliver life saving defibrillation therapy. General• External defibrillation equipment should be available for immediate use during theimplantation procedure and follow-up.• Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detectionand therapy response. Removing the magnet resumes arrhythmia detection andtherapy response. Refer to the S-ICD System Magnet Model 4520 section.• Battery depletion will eventually cause the SQ-RX Pulse Generator to stopfunctioning. Defibrillation and excessive numbers of charging cycles shorten thebattery longevity.5SQ-RX PULSE GENERATOR GENERAL DESCRIPTION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 5
SQ-RX Pulse Generator PackagingThe device has been sterilized with ethylene oxide gas and is packaged in a sterile containerthat is suitable for use in the operating field. Store in a clean, dry area. Each packagecontains the following:• One SQ-RX Pulse Generator Model 1010 • One Bi-Directional Torque Wrench • SQ-RX Pulse Generator Model 1010 User’s ManualBefore opening any package, visually inspect the sterile packaging to ensure the contents arenot contaminated or been previously used. Do not use if any of the following conditions exist:• Tears or punctures in the packaging• “Use By” date has expired• Evidence of damage exists• Sterile package is dropped from a height of 24 in/61 cm or greaterReturn the product to Cameron Health if any of these conditions exist. Contact your localCameron Health representative or Customer Service Department for instructions and returnpackaging.Storage and Handling• Store the S-ICD System components in a clean, dry area away from magnets or anyother electromagnetic interference source that could cause damage to the device. • Do not expose the S-ICD System to temperatures outside the recommended storagetemperatures indicated on the device package. • Do not modify, cut, kink, crush, stretch or otherwise damage any component of the S-ICD System. Impairment to the S-ICD System may result in an inappropriate shockor failure to deliver therapy to the patient.Implant and Programming• Use only the electrode insertion tool to tunnel.• Suture only those areas indicated in the implant procedure. • Do not place a suture directly on the electrode body.• Use appropriate anchoring techniques as described in the implant procedure toprevent S-ICD System dislodgement and/or migration. Dislodgement and/ormigration of the S-ICD System may result in an inappropriate shock or failure todeliver therapy to the patient.• Use only the Q-TECH Programmer (the “programmer”) and appropriate software forcommunicating with and programming the device. 6SQ-RX PULSE GENERATOR GENERAL DESCRIPTION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 6
7SQ-RX PULSE GENERATOR GENERAL DESCRIPTION• Verify the device is in Shelf mode or Therapy Off to prevent the delivery of unwantedshocks to the patient or the person handling the device during the implantprocedure.Explanting the System• To avoid inadvertent shock discharges, program the device to Therapy Off duringdevice explantation or postmortem procedures.• Remove the device from a deceased patient prior to cremation. The device batterymay explode when exposed to extreme temperatures. Use of Other Medical Therapies/Diagnostic Procedures• External defibrillation or cardioversion may damage the implanted SQ-RX PulseGenerator. Current flow through the SQ-RX Pulse Generator may be minimized byavoiding the placement of defibrillation paddles directly over the device.• Do not expose a patient with an implanted S-ICD System to diathermy. Theinteraction of diathermy therapy with an implanted SQ-RX Pulse Generator candamage the SQ-RX Pulse Generator and cause patient injury.• Do not expose the patient to MRI scanning. MRI scanning can damage the SQ-RXPulse Generator and cause patient injury.• Electrical interference or “noise” from sources such as electrosurgical andmonitoring equipment can interfere with the communication between theprogrammer and the SQ-RX Pulse Generator or cause inappropriate therapy. Ifinterference occurs, move the programmer away from the source of the interference.• Ionizing radiation therapy, such as radioactive cobalt, linear accelerators, andbetatrons, may adversely affect the S-ICD System operation. Therapeutic ionizingradiation may not be immediately detected; however, it can damage the electroniccomponents of the SQ-RX Pulse Generator. Follow these conditions to minimize therisks 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 theradiation beam.§Do not project the radiation port directly at the SQ-RX Pulse Generator.§Always evaluate the S-ICD System operation following each radiationtreatment.• Lithotripsy and other therapeutic forms of ultrasound may damage the SQ-RX PulseGenerator. If required, avoid direct flow of the pulse waves near the site of theimplanted device.• 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 theimplanted SQ-RX Pulse Generator and electrode.102098 004 rev a.qxp 12/2/2008 7:43 AM Page 7
8SQ-RX PULSE GENERATOR GENERAL DESCRIPTIONElectromagnetic Interference (EMI) Outside of the Hospital Environment Exposure to Electromagnetic Interference (EMI) or Static Magnetic Field sources maysuspend tachyarrhythmia detection and cause temporary inhibition of therapy delivery. EMImay also trigger delivery of a shock in the absence of a tachyarrhythmia. Automatic sensingand detection of tachyarrhythmias will resume when the patient moves away from the EMI orstatic magnetic field source.To minimize the risk, advise patients to avoid sources of EMI or static magnetic fields havingstrengths >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 securityPatients should seek medical guidance from their physician before entering an area where aposted sign prohibits patients with an implantable cardioverter defibrillator or pacemaker.Potential Adverse EventsPotential adverse events related to implantation of the S-ICD System may include, but arenot limited to, the following:• Acceleration of arrhythmia• Allergic reaction• Bleeding• Conductor fracture• Cyst formation• Death • Electrode dislodgement• Electrode insulation failure• Electrode deformation and/or breakage• Erosion/extrusion• Improper electrode connection to the device• Inappropriate shock delivery102098 004 rev a.qxp 12/2/2008 7:43 AM Page 8
• Infection• Hematoma• Hemothorax• Keloid formation • Migration or dislodgement• Muscle stimulation• Nerve damage• Pneumothorax• Postoperative discomfort• Potential mortality due to inability to defibrillate or pace• Premature battery depletion• Random component failures• Tissue necrosis• Ventricular arrhythmiaIf any adverse events occur, invasive corrective action and/or S-ICD System modification orremoval may be required.Patients who receive an S-ICD System may develop psychological disorders that include, butare not limited to, the following:• Depression• Fear of shocks• Phantom shocks9SQ-RX PULSE GENERATOR GENERAL DESCRIPTION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 9
Clinical Studies10SQ-RX PULSE GENERATOR GENERAL DESCRIPTION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 10
Results11SQ-RX PULSE GENERATOR GENERAL DESCRIPTION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 11
Results12SQ-RX PULSE GENERATOR GENERAL DESCRIPTION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 12
Observed Adverse Events13SQ-RX PULSE GENERATOR GENERAL DESCRIPTION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 13
14SQ-RX PULSE GENERATORInstructions for using the screening tool:1. Place standard ECG skin electrodes according to Figure 2. This will simulate the threesensing vectors used by the device.• Electrode LL should be placed in a lateral location, at the 5th intercostal space alongthe mid-axillary line.• Electrode LA should be placed 1 cm to the left of the patient’s xiphoid.• Electrode RA should be placed 14 cm superior to the LA electrode, 1 cm left lateral ofthe sternal margin.SQ-RX PULSE GENERATOR GENERAL DESCRIPTIONFigure 1: Patient Screening ToolFigure 2: Placement of ECG LeadsPatient ScreeningThe patient screening tool (Figure 1) is a customized measurement tool made of transparentplastic printed with colored profiles. The profiles are designed to ensure appropriate deviceperformance by identifying signal characteristics that may lead to unsatisfactory detectionoutcomes for a patient before implant.The patient screening tool can be obtained from any Cameron Health representative or bycalling the Customer Service Department.102098 004 rev a.qxp 12/2/2008 7:43 AM Page 14
15SQ-RX PULSE GENERATOR2. Record 10 - 20 seconds of ECG using a sweep speed of 25 mm/sec and ECG gain between5 - 20 mm/mV (use the largest ECG gain that does not result in clipping).3. Record ECG signals in at least two postures: (1) Supine and (2) Standing. 4. Select a representative QRS complex from the first sense vector. Note: If multiple morphologies are noted (e.g., bigeminy, pacing, etc.), all morphologiesshould be tested as described below before the vector is deemed acceptable. 5. Select the colored profile from the Patient Screening Tool that best matches theamplitude of the QRS from Step 4. The QRS peak must fall within the window boundedby the dotted line and the peak of the colored profile (Figure 3). For biphasic signals, thelarger peak should be used to determine the appropriate colored profile. Note: ECG gains > 20 mm/mV are not permitted. If when printed at the maximum 20mm/mV gain the QRS peak does not reach the minimum boundary (dotted line) of thesmallest colored profile, the vector should be deemed unacceptable.6. Align the left edge of the selected colored profile with the onset of the QRS complex andthe horizontal line with the complex’s isoelectric baseline.7. If the entire QRS complex and trailing T-wave are contained within the colored profile,the vector/posture combination is deemed acceptable. If any portion of the QRS complexor trailing T-wave extends above or below the colored profile, the sense vector is deemedunacceptable (Figure 4).SQ-RX PULSE GENERATOR GENERAL DESCRIPTIONFigure 3: Determine colored profile for QRS amplitudeFigure 4: QRS profile selection102098 004 rev a.qxp 12/2/2008 7:43 AM Page 15
8. Test all vectors in each posture.9. A patient should be considered suitable for implant if at least one sense vector isdeemed acceptable for all tested postures (Figure 5).16SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR GENERAL DESCRIPTIONFigure 5: Acceptance of one sense vector102098 004 rev a.qxp 12/2/2008 7:43 AM Page 16
GeneralThe S-ICD System is designed for ease of use and simplicity of patient management. Thearrhythmia detection system employs up to two rate zones, and the device has a singleautomatic response to a detected ventricular tachyarrhythmia – a nonprogrammable,maximum-energy, biphasic shock of 80 J. The device has a number of automatic functionsdesigned to reduce the amount of time required for implantation, initial programming andpatient follow-up. Modes of OperationThe device has three modes of operation:• Shelf • Therapy On• Therapy OffShelf ModeThe Shelf mode is a low power consumption state intended for storage only. Whencommunication is initiated between the device and the programmer, a full-energy capacitorreformation is performed and the device is prepared for set-up. Once the device is taken outof Shelf mode, it cannot be reprogrammed back into Shelf mode.Therapy On ModeThe Therapy On mode is the primary operating mode of the device, allowing automaticdetection of and response to ventricular tachyarrhythmias. All device features are active. Note: The device must be programmed out of Shelf mode before being programmed toTherapy On..Therapy Off ModeThe Therapy Off mode disables automatic therapy delivery and enables manual control ofshock delivery. Programmable parameters may be viewed and adjusted via the programmer.Also, the subcutaneous electrogram (S-ECG) may be displayed or printed. The device automatically defaults to Therapy Off when taken out of Shelf mode.Note: Manual and rescue shock therapy are available only after the initial Setupprocess is complete. Refer to the Q-TECH Programmer User’s Manual for details..17SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR OPERATION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 17
Sensing Configuration and Gain SelectionDuring the Automatic Setup process, the device automatically selects an optimal sensingvector based on an analysis of cardiac signal amplitude and signal-to-noise ratio. Thisanalysis is performed on the three available vectors:• Primary: Sensing from the proximal electrode ring on the electrode to the active surface of the device.• Secondary: Sensing from the distal sensing electrode ring on the electrode to the active surface of the device.• Alternate: Sensing from the distal sensing electrode ring to the proximal sensing electrode ring on the electrode.The sensing vector can also be selected manually. The Q-TECH Programmer User’s Manualprovides instructions for sensing vector selection.The device automatically selects an appropriate gain setting during the Automatic Setupprocess. The gain can also be manually selected, as further explained in the Q-TECHProgrammer User’s Manual. There are two gain settings:• 1x Gain (±4 mV): Selected when the signal amplitude is clipped at the 2x gainsetting.• 2x Gain (±2 mV): Selected when the signal amplitude is not clipped at this setting.Sensing and Tachyarrhythmia DetectionThe device is designed to prevent inappropriate therapy delivery as a result of noise sensingor multiple counting of individual cardiac cycles. This is accomplished by an automaticanalysis of sensed signals, which includes event detection, certification and decision phases. Detection PhaseDuring the Detection Phase, the device uses a detection threshold to identify sensed events.The detection threshold is automatically adjusted continuously using amplitudes of recentlydetected electrical events. In addition, detection parameters are modified to increasesensitivity when rapid rates are detected. Events detected during the Detection Phase arepassed on to the Certification Phase.Certification PhaseThe Certification Phase examines the detections and classifies them as certified cardiacevents or as suspect events. Certified events are used to ensure that an accurate heart rate ispassed to the Decision Phase. A suspect event can be one whose pattern and/or timingindicates the signal is caused by noise, such as a muscle artifact or some other extraneoussignal. Events are also marked as suspect if they appear to derive from double or tripledetections of single cardiac events. The device is designed to identify and correct multipledetections of wide QRS complexes and/or erroneous detections of a T-wave. 18SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR OPERATION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 18
19SQ-RX PULSE GENERATORDecision PhaseThe Decision Phase examines all certified events and continuously calculates a running fourR-to-R interval average (4 RR average). The 4 RR average is used throughout the analysis asan indicator of the heart rate. Therapy ZonesThe device allows the selection of rate thresholds that define a Shock Zone and an optionalConditional Shock Zone. In the Shock Zone, rate is the only criterion used to determine if arhythm will be treated with a shock. The Conditional Shock Zone has additionaldiscriminators used to determine if a shock is warranted to treat an arrhythmia. The Shock Zone is programmable from 170 - 250 bpm in increments of 10 bpm. TheConditional Shock Zone must be lower than the Shock Zone, with a range of 170 - 240 bpm inincrements of 10 bpm. Graphically, the use of a Shock Zone and Conditional Shock Zone is shown in Figure 6.The device declares a Tachycardia when the 4RR average enters either therapy zone. Once a Tachycardia is declared, the 4RR average must become longer (in ms) than thelowest rate zone, plus 40 ms for 24 cycles for the device to consider the episode to haveended. In the Shock Zone, treatable arrhythmias are determined by rate alone.Analysis in the Conditional Shock ZoneIn contrast, rate and morphology are analyzed in the Conditional Shock Zone. TheConditional Shock Zone is designed to discriminate between treatable and other high-rateevents such as atrial fibrillation, sinus tachycardia and other supraventricular tachycardias.SQ-RX PULSE GENERATOR OPERATIONFigure 6: Shock Zone Rate Detection Diagram102098 004 rev a.qxp 12/2/2008 7:43 AM Page 19
20SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR OPERATIONA normal sinus rhythm template (NSR Template) is formed during device initialization. ThisNSR template is used during analysis in the Conditional Shock Zone to identify treatablearrhythmias. In addition to morphology comparison with the NSR template, othermorphologic analysis is used to identify polymorphic rhythms. Morphology and QRS width areused to identify monomorphic arrhythmias such as ventricular tachycardia. If the ConditionalShock Zone is enabled, then an arrhythmia is found to be treatable according to the decisiontree shown in Figure 7.For some patients, a NSR Template may not be formed during device initialization as a resultof variability in their cardiac signal at resting heart rates. For such patients, the device usesbeat-to-beat morphology and QRS width analysis for arrhythmia discrimination.Charge ConfirmationThe device must charge the internal capacitors before shock delivery. Confirmation of theongoing presence of a tachyarrhythmia requires monitoring a moving widow of the 24 mostrecent intervals defined by certified events. Charge confirmation employs an X (treatableinterval) out of Y (total intervals in the window) strategy to accomplish this. If 18 of the 24most recent intervals are found to be treatable, the device begins to analyze rhythmpersistence. Persistence analysis requires the X out of Y condition be maintained orexceeded for at least two consecutive intervals; however, this value may be increased as aresult of Smart Charge, as explained below.Capacitor charging is initiated when the following three conditions are met:1. X of Y criterion met2. Persistence requirement is met3. The last two certified intervals are in the treatable zone.Figure 7: Decision tree for determining treatable arrhythmias in the Conditional Shock Zone102098 004 rev a.qxp 12/2/2008 7:43 AM Page 20
21SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR OPERATIONTherapy DeliveryRhythm analysis continues throughout the capacitor charging process. Capacitor charging isaborted if the 4 RR average interval becomes longer (in ms) than the lowest rate zone, plus40 ms for 24 intervals. When this occurs, an untreated episode is declared and a SmartCharge extension is incremented, as explained below.Capacitor charging continues until the capacitor has reached its target voltage, at whichtime reconfirmation is performed. Reconfirmation requires the last three consecutivedetected intervals (regardless of whether the intervals are certified or suspect) to be fasterthan the lowest therapy zone.Reconfirmation is always performed and shock delivery is non-committed untilreconfirmation is complete. Once the criteria for reconfirmation is met, the shock isdelivered.Smart ChargeSmart Charge is a feature that automatically increases the Persistence requirement by threeintervals each time an untreated episode is declared, up to a maximum of five extensions.Thus, after an untreated episode, the requirement to start capacitor charging becomes morestringent. The Smart Charge extension value can be reset to its nominal value (zeroextensions) using the programmer. The Smart Charge feature cannot be disabled, though itis not used for the second and later shocks that occur during any given episode.RedetectionA blanking period is enabled following delivery of a high-voltage shock. After delivery of thefirst shock, up to four additional shocks will be delivered if the episode does not terminate.Rhythm analysis for delivering shocks 2 - 5 generally follows the detection steps describedabove, with the following exceptions: 1. Following the first shock delivery, the X/Y criterion is modified to require 14 treatableintervals in the last 24 (14/24), rather than 18. 2. The Persistence Factor is always set to two intervals (i.e., not modified by the SmartCharge feature).Shock Waveform and PolarityThe shock waveform is biphasic, with a fixed tilt of 50%. The shock is delivered synchronouslyunless a 1000 ms time out expires without an event being detected for synchronization, atwhich time the shock is delivered in an asynchronous manner.The device is designed to automatically select the appropriate polarity for therapy. Both102098 004 rev a.qxp 12/2/2008 7:43 AM Page 21
standard and reversed polarity shocks are available. If a shock fails to convert the arrhythmiaand subsequent shocks are required, polarity is automatically reversed for each successiveshock. The polarity of the successful shock is then retained as the starting polarity for futureepisodes. Polarity can also be selected during the Induction and Manual Shock process tofacilitate device-based testing.Post-Shock Bradycardia Pacing TherapyThe device provides optional post-shock, on-demand bradycardia pacing therapy. Whenenabled via the programmer, bradycardia pacing occurs at a non-programmable rate of 50bpm for up to 30 seconds. The pacing output is fixed at 200 mA, and uses a 15-ms biphasicwaveform. Pacing is inhibited if the intrinsic rate is greater than 50 bpm. In addition, post-shock pacingis terminated if a tachyarrhythmia is detected or a magnet is placed over the device duringthe post-shock pacing period.Manual and Rescue Shock DeliveryUpon programmer command, the device can deliver manual and rescue shocks. Manualshocks are programmable from 10 to 80 J delivered energy in 5 J steps. Rescue shocks arenon-programmable, delivering the maximum output of 80 J.Note: The Rescue Shock will NOT be inhibited with magnet application.Additional Features of the S-ICD SystemThis section presents descriptions of several additional features available in the S-ICDSystem.Magnet ApplicationApplication of the S-ICD System Magnet over the device will:• Suspend arrhythmia detection • Inhibit shock therapy delivery except for a programmer-commanded Rescue Shock • Terminate post-shock pacing therapy • Prohibit arrhythmia induction testing• Activate the device’s beeper with each detected QRS complex for 60 secondsNote: Magnet application does not affect wireless communication between the deviceand the programmer.Auto Capacitor ReformationThe device automatically performs a full-energy (80 J) capacitor reformation when taken outof Shelf mode and every four months until the device reaches End of Life (EOL). The energy22SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR OPERATION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 22
23SQ-RX PULSE GENERATORoutput and reformation time interval are non-programmable.The Auto Capacitor Reformation interval is reset after any 80 J capacitor charge is deliveredor aborted.Internal Warning System – Beeper ControlThe device has an internal warning system (beeper) that emits an audible tone to alert thepatient to certain device conditions that require prompt consultation with the physician.These conditions include:• Elective Replacement Indicator (ERI)• Electrode impedance out of range• Prolonged charge times• Failed Device Integrity CheckThis internal warning system is automatically activated at time of implant. Once triggered,the beeper sounds for 16 seconds every nine hours until the trigger condition has beenresolved. If the triggering condition reoccurs, then the tones will once again alert the patientto consult the physician. The beeper can be disabled via the programmer once ERI isreached.Note: The beeper also sounds with each certified QRS complex when a magnet ispositioned over the device. Arrhythmia InductionThe device facilitates testing by providing the capability to induce a ventriculartachyarrhythmia. Via the programmer, the implanted system can deliver a 200 mA output at afrequency of 50 Hz. The maximum length of stimulation is 10 seconds.Note: Induction requires that the device be programmed to Therapy On.System DiagnosticsThe S-ICD System automatically performs a diagnostic check at scheduled intervals.Electrode ImpedanceElectrode impedance is measured each time a shock is delivered. In addition, a leadelectrode integrity test is performed once a week. The shock impedance values are storedand displayed in the episode data and summary report.Note: If the device is taken out of Shelf mode, but not implanted, the internalwarning system will be activated due to the weekly automatic measurements ofimpedance. Device beeping due to this mechanism is normal behavior.Device Integrity CheckThe Device Integrity Check is automatically performed daily by the implanted system, andSQ-RX PULSE GENERATOR OPERATION102098 004 rev a.qxp 12/2/2008 7:43 AM Page 23
24SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR OPERATIONalso each time the programmer links to an implanted device. This test scans for any unusualconditions in the device, and if any are detected, the system provides a notification either viathe device’s internal warning system or on the programmer screen.Battery MonitoringThe device automatically monitors battery status to provide notice of impending batterydepletion. Two indicators are provided via messages on the programmer, each activated bydeclining battery voltage. ERI is also signaled by activation of the device’s beeper.• Elective Replacement Indicator (ERI): When the ERI is detected, the device willprovide therapy for at least three months, if no more than five maximum energycharges/shocks occur. The patient should be scheduled for replacement of thedevice.• End of Life (EOL): When the EOL indicator is detected, the device should bereplaced immediately. Therapy may not be available when EOL is declared.Storing and Analyzing DataThe device stores S-ECGs for up to 24 treated and 20 untreated tachyarrhythmia episodes.The number of treated episodes, untreated episodes, and the therapy shocks delivered sincethe last follow-up procedure and initial implant are recorded and stored. Through wirelesscommunication with the programmer, the stored data is retrieved for analysis and reportprintouts.Note: Episodes that occur during communication with the programmer will not bestored.Treated EpisodesUp to 128 seconds of S-ECG data is stored for each treated episode:• First Shock: 44 seconds of pre-episode, up to 24 seconds of pre-shock, up to 12seconds of postshock S-ECG.• Subsequent Shocks: A minimum of 6 seconds of pre-shock and up to 6 seconds post-shock S-ECG.Untreated EpisodesFor untreated episodes, 44 seconds of pre-episode and up to 24 seconds of episode S-ECG arestored. A return to normal sinus rhythm during an untreated episode halts S-ECG storage.102098 004 rev a.qxp 12/2/2008 7:43 AM Page 24
25SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR OPERATIONCaptured S-ECGThe S-ECG can be captured in real time on rhythm strips when the device is actively linkedvia wireless telemetry to the programmer. Up to five 12-second recordings of S-ECG can bestored.S-ECG Rhythm Strip MarkersThe system provides S-ECG annotations to identify specific events during a recorded episode.These markers are shown in Table 1; sample annotations are shown for the programmerdisplay (Figure 8) and the printed reports (Figure 9).Patient DataThe device can store the following patient data, which can be retrieved and updated throughthe programmer:• Patient’s name• Physician’s name and contact information• Device and electrode identification information (model and serial numbers) andimplant date• Notes up to 50 charactersTable 1: S-ECG Rhythm Strip MarkersDescription MarkerDisplayScreenPrinted ReportsCharging CX3Sensed Beat S3 3Noisy Beat N3 3Paced Beat P3 3Tachy Detection T3 3Discard Beat •3 3Shock 3 3Return to NSR X3Figure 8: Display Screen MarkersFigure 9: Printed Report Markers102098 004 rev a.qxp 12/2/2008 7:43 AM Page 25
26SQ-RX PULSE GENERATORS-ICD System Magnet Model 4520The Cameron Health magnet is a nonsterile accessory used to inhibit the delivery of therapyfrom the device. Placing the magnet against the skin directly over the implanted device(Figure 10) will temporarily inhibit rhythm detection, abort high-voltage capacitor chargingand post-shock pacing. Removal of the magnet will return the device to normal operation. Ifthe magnet is applied during an episode, the episode will not be stored in the device memory.SQ-RX PULSE GENERATOR OPERATIONFigure 10: Magnet Model 4520MagnetPlacementPP102098 004 rev a.qxp 12/2/2008 7:43 AM Page 26
27SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATORThis section presents the information necessary for implanting and testing the S-ICD System,including:• Implanting the SQ-RX Pulse Generator (the “device”)• Implanting the Q-TRAK Subcutaneous Electrode (the “electrode”) using theQ-GUIDE Subcutaneous Electrode Insertion Tool (the “EIT”)• Setting up and testing the device using the Q-TECH Programmer (the“programmer”). Refer to the Q-TECH Programmer User’s Manual for additionalinformation.Implanting the S-ICD SystemThe device and electrode are implanted subcutaneously in the left thoracic region (Figure11). The EIT is used to create the subcutaneous tunnel in which the the electrode isinserted. Creating the Device PocketThe device is implanted in the left lateral thoracic region. To create the device pocket, makean incision such that the device can be placed in the vicinity of the left 5th and 6thintercostal spaces and near the mid-axillary line (Figure 12). This can be accomplished bymaking an incision along the inframammary crease.Figure 12: Creating the device pocketFigure 11: Placement of the S-ICD System102098 004 rev a.qxp 12/2/2008 7:44 AM Page 27
28SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATORImplanting the Q-TRAK Subcutaneous ElectrodeThere are two methods for implanting the electrode, referred to as the “Pull/Pull” and the“Pull/Push” techniques. The electrode tunneling is facilitated by the use of the Q-GUIDEmodel 4010 and/or 4020 Subcutaneous Electrode Insertion Tool.Pull/Pull Implant1. Make a small (approximately 1 cm) lateral incision 1 - 2 cm to the left and 1 cm superiorto the xiphoid2. Insert the distal tip of the EIT at the xiphoid incision and tunnel laterally until the distaltip emerges at the device pocket (Tunnel 1).Note: The EIT is malleable and can be curved to match the patient’s anatomical profile.3. Using conventional suture material, tie the distal end of the electrode to the EITcreating a loop knot that allows for free motion of both tips (Figure 13).4. With the electrode attached, carefully pull the EIT back through the tunnel to thexiphoid incision until the electrode emerges (Figure 14).Note: Do not use surgical instruments to advance the electrode.Figure 14: Tunneling the electrode to the xiphoid incisionFigure 13: Connecting distal end of electrode to the EITII102098 004 rev a.qxp 12/2/2008 7:44 AM Page 28
29SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATOR5. Once the distal tip of the electrode is pulled through the tunnel, cut and discard thesuture loop that connects the electrode to the EIT.6. Make a second incision approximately 14 cm superior to the xiphoid incision andapproximately 2 cm to the left of the sternal midline.7. Insert the distal tip of the EIT into the new incision and tunnel subcutaneously in thecaudad direction to the lower xiphoid incision (Tunnel 2, Figure 15). 8. Using conventional suture material, tie the distal end of the electrode to the EIT,creating a loop knot that allows for free motion of both tips.9. With the electrode attached, carefully pull the EIT back through the tunnel until theelectrode’s distal tip emerges at the upper sternal incision. The electrode should beparallel to the sternum, approximately 2 cm to the left of the sternal midline.10. Cut and discard the suture material. 11. Using conventional suture material, anchor the electrode through the anchor hole at thedistal tip to the subcutaneous tissue to prevent possible device migration (Figure 16). Note: If there is excess electrode body at the xiphoid incision, pull it through the tunnelto the device pocket.Figure 15: Tunneling in the caudad directionFigure 16: Anchoring the distal electrode tipII102098 004 rev a.qxp 12/2/2008 7:44 AM Page 29
30SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATOR12. Optional: Secure a suture sleeve to the electrode at least 1 cm away from the proximalsensing electrode using the pre-formed grooves. Verify that the suture sleeve is stablewith no slippage by grasping the suture sleeve with the fingers and trying to move theelectrode in either direction. Anchor the electrode by suturing the suture sleeve to thesubcutaneous tissue at the xiphoid incision (Figure 17).13. To dispose of the EIT, return the used product to the original package, then dispose in abiohazard container.Pull/Push Implant1. Make a small (approximately 1 cm) lateral incision 1 - 2 cm to the left and 1 cm superiorto the xiphoid.2. Insert the distal tip of the EIT at the xiphoid incision and tunnel laterally until the distaltip emerges at the device pocket (Tunnel 1).Note: The EIT is malleable and can be curved to match the patient’s anatomicalprofile.3. Using conventional suture material, tie the distal end of the electrode to the EIT,creating a loop knot that allows for free motion of both tips (Figure 13).4. With the electrode attached, carefully pull the EIT back through the tunnel to thexiphoid incision until the electrode emerges (Figure 14).Note: Do not use surgical instruments to advance the electrode.5. Once the distal tip of the electrode is pulled through the tunnel, cut and discard thesuture loop that connects the electrode to the EIT.6. Place a 12 French peel-away introducer sheath over the Model 4020 EIT’s shaft andsecure to the luer-lock ring.Figure 17: Secure the electrode with a suture sleeve at the xiphoid incisionI102098 004 rev a.qxp 12/2/2008 7:44 AM Page 30
31SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATOR7. Starting at the xiphoid incision, create a cephalad tunnel (Tunnel 2) approximately 2 cmto the left of the sternal midline (Figure 18).8. Once the EIT is fully inserted in Tunnel 2, unlock the sheath from the luer-lock hub.Carefully withdraw the EIT while leaving the sheath in place.9. Insert the distal tip of the electrode into the sheath and push through until theelectrode’s distal tip is in the desired location, approximately 14 cm superior to thexiphoid incision.10. Stabilize the electrode’s position during sheath removal by applying manual pressureover the electrode’s distal tip. Grasp the tabs of the sheath and split while maintainingthe implanted electrode position.11. Secure a suture sleeve to the electrode at least 1 cm away from the proximal sensingelectrode. Verify that the suture sleeve is stable with no slippage by grasping the suturesleeve with the fingers and trying to move the electrode in either direction. Anchor theelectrode by suturing the suture sleeve to the subcutaneous tissue at the xiphoid incision(Figure 17).12. Optional: Make a second incision at the point where the electrode distal tip anchor holeresides. Using conventional suture material, anchor the distal tip of the electrodethrough the anchor hole to the subcutaneous tissue to prevent possible device migration(Figure 16). 13. To dispose of the EIT, return the used product to the original package, then dispose in abiohazard container.Connecting the Electrode to the DeviceNote: Avoid allowing blood or other body fluids to enter the connector port in thedevice header. If blood or other body fluids inadvertently enter the connector port, flushwith sterile water.Note: Do not implant the device if the set screw seal plug appears to be damaged.Figure 18: Creating a cephalad tunnel parallel to the sternal line usingthe EIT & 12 Fr sheathII102098 004 rev a.qxp 12/2/2008 7:44 AM Page 31
1. Insert the proximal end of the electrode into the connector port until it will no longeradvance.Note: Do not use surgical instruments to advance the electrode.2. Ensure that the electrode pin is protruding past the innermost connector ring in theconnector cavity (Figure 19). 3. Use the torque wrench to tighten the set screw in a clockwise motion (Figure 20). Thetorque wrench is designed to apply the proper amount of force to the set screw. Tightenthe set screw until the wrench ratchet clicks.Note: When connecting the electrode to the device, use only the tools provided in thedevice tray. Failure to use the supplied tools may result in damage to the set screw.Retain the tools until all testing procedures are complete and the device is implanted.4. Gently tug on the electrode body to confirm a secure connection.5. Insert the device into the subcutaneous pocket, with any excess electrode placedunderneath the device.32SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATORFigure 19: Proper position for inserted electrode pinFigure 20: Using torque wrench to tighten set screwI102098 004 rev a.qxp 12/2/2008 7:44 AM Page 32
6. Anchor the device to subcutaneous tissue to prevent possible migration usingconventional suture material. A suture hole is provided in the header for this purpose(Figure 21).7. Refer to the Q-TECH Programmer User’s Manual for set-up instructions and/or inductiontesting.Note: Initial set-up is recommended at implant.8. After device set-up, close all incisions using standard suture protocol (Figure 22).Setting Up the SQ-RX Pulse Generator A brief Setup process must be completed before the device can deliver manual or automatictherapy. This process can be performed automatically or manually during the implantprocedure, although Automatic Setup is recommended.During Setup, the system automatically:• Confirms entry of the subcutaneous electrode model and serial numbers• Measures the shock electrode impedance• Optimizes the sense electrode configuration• Optimizes the gain selection• Provides an option to acquire a reference NSR templateInstructions for completing this process can be found in the Q-TECH Programmer User’sManual.33SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATORFigure 21: Anchoring the device using header suture holesFigure 22: System placement after closure of all incisions102098 004 rev a.qxp 12/2/2008 7:44 AM Page 33
Post Implant Follow-Up ProceduresDuring a follow-up procedure, it is recommended that the location of the electrode beperiodically verified by palpation and or X-ray. When device communication with theprogrammer is established, the programmer automatically notifies the physician of anyunusual conditions. Refer to the Q-TECH Programmer User’s Manual for more information. Patient management and follow-up are at the discretion of the patient’s physician, but arerecommended at least once a year and should be more frequent when the device isapproaching end-of-life.Explanting the S-ICD SystemIf a device explant is required, observe the following guidelines:1. Use the programmer to ensure the device is programmed to Therapy Off.2. Use a sterile no. 2 wrench to disconnect the electrode from the device.3. Return the explanted device to Cameron Health, Inc. along with a completedExplant/Complication Reporting Form. Contact your local Cameron Healthrepresentative or Customer Service Department for instructions and return packaging.34SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR USING THE SQ-RX GENERATOR102098 004 rev a.qxp 12/2/2008 7:44 AM Page 34
Federal Communications Commission (FCC) ComplianceThis 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 inthe 400.150 - 406.00 MHz band in the Meteorological Aids (i.e., transmitters and receiversused to communicate weather data), the Meteorological Satellite, or the Earth ExplorationSatellite Services and must accept interference that may be caused by such aids, includinginterference that may cause undesired operation. This transmitter shall be used only inaccordance with the FCC Rules governing the Medical Implant Communications Service.Analog and digital voice communications are prohibited. Although this transmitter has beenapproved by the Federal Communications Commission, there is no guarantee that it will notreceive interference or that any particular transmission from this transmitter will be freefrom interference.FCC ID SDYCHI10101999/5/EC Compliance (R&TTE Directive)The S-ICD System contains radio equipment in the frequency range 402 MHz to 405 MHz forultra low power active medical implants. The radio equipment in the S-ICD System complieswith the applicable harmonized standards and essential requirements of the R&TTEDirective.35SQ-RX PULSE GENERATOR CCOOMMPPLLIIAANNCCEE102098 004 rev a.qxp 12/2/2008 7:44 AM Page 35
36SQ-RX PULSE GENERATORSpecificationsSpecifications provided at 37° C ± 3° C, and assume a 75W(± 1%) load unless noted otherwise. *Normal use is defined as three full-energy capacitor charges per year.Table 2: Physical CharacteristicsDimensions:Height x Width x Depth78.2 mm x 65.5 mm x 15.7 mmMass 145 gmVolume 69.9 ccLongevity Normal Use*: 5 years ERI to EOL 3 months therapy if no more than 5 maximum-energy charges/shocks occur.Radiopaque ID in Device Header CH1010SQ-RX Pulse Generator Storageand Shipping RangeTemp: 0° F or -18° C / +131° F or +55° CDefibrillation/Pace/Sense PortsCameron Health Proprietary Tripolar ConnectorPulse Generator Casing Material Hermetically Sealed Titanium, Coated With TitaniumNitrideConnector Block Header Implantation Grade PolymerBattery Lithium Manganese Dioxide SQ-RX PULSE GENERATOR ADDITIONAL INFORMATION102098 004 rev a.qxp 12/2/2008 7:44 AM Page 36
37SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR ADDITIONAL INFORMATIONTable 3: Programmable ParametersParameter Programmable Values Nominal(as shipped)Shock Zone 170 bpm - 250 bpm (steps of 10 bpm) 200 bpmConditionalShock ZoneOff, 170 bpm - 240 bpmIf On, at least 10 bpm less than Shock ZoneOffS-ICD System Therapy Off, Manual, Auto Therapy OffPost-shock Pacing On, Off OffSensing Configuration Primary: Proximal electrode ring to device.Secondary: Distal electrode ring to device.Alternate: Distal electrode ring to proximal electrode ring.PrimaryMax Sensing Range x1 (± 4 mV)x2 (± 2 mV)x1Manual Shock 10 - 80 J (in steps of 5 J) 80 JSmart Charge Resets to nominalPolarity Standard: Phase 1 Coil (+)Reverse: Phase 1 Coil (-)Table 4: Non-Programmable Parameters (Shock Therapy)Parameter ValueShock TherapyDelivered Energy 80 JShock Tilt (%) 50%Waveform Type BiphasicMaximum Number of Shocks per episode 5 shocksSync Time Out 1 secShock Sync Delay 60 msPost-Shock Blanking Period 1600 ms102098 004 rev a.qxp 12/2/2008 7:44 AM Page 37
38SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR ADDITIONAL INFORMATIONTable 5: Non-Programmable Parameters (Post-Shock Pacing)Parameter ValuePost-Shock PacingRate 50 ppmPacing Output 200 mAPulse Width 7.6 ms phase 1, 7.6 ms phase 2Waveform BiphasicPolarity (of the first phase) Standard Phase 1 Coil (+)Mode Inhibited PacingDuration 30 sPost-Pace Blanking Period/Refractory Period 550 ms (precedes refractory period)Runaway Protection 120 ppmTable 6: Non-Programmable Parameters (Detection/Rhythm Discrimination, FibrillationInduction, Shock Electrode, Capacitor Reform Schedule)Parameter ValueDetection/Rhythm DiscriminationX/Y for Initial Detection 18/24 intervalsX/Y for Redetection 14/24 intervalsConfirmation Before Shock 3 consecutive tachy intervalsRefractory Period Fast 160 ms, Slow 200 msFibrillation InductionFrequency 50 HzOutput 200 mATime out After Activation 10 sec102098 004 rev a.qxp 12/2/2008 7:44 AM Page 38
39SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR ADDITIONAL INFORMATIONTable 8: Magnet ResponseParameter ValueShelf Mode No ResponseTherapy On Arrhythmia detection and response are suspended. Beepersounds for 60 seconds to indicate sensing is occurring.*Therapy Off Beeper sounds for 60 seconds to indicate sensing isoccurring.*Table 7: Episode Data ParametersParameter ValueEpisode Data ParametersTreated Episodes 24 storedUntreated Episodes 20 storedMaximum Length per S-ECG Episode 128 secondsCaptured S-ECG Report 5 Captured S-ECG at 12 seconds each* Beeper Sounds – Beeper will sound for 60 seconds to indicate sensing is occurring or until the magnet isremoved, whichever occurs first.Capacitor Reform ScheduleAutomatic Capacitor Reformation Interval Approximately 4 months*Internal Warning SystemHigh Impedance > 400 OhmsMaximum Charge Time out 44 secondsTable 6: Continued* Reform can be delayed if capacitor was charged due to sustained/nonsustained arrhythmia in past 4 months102098 004 rev a.qxp 12/2/2008 7:44 AM Page 39
40SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR ADDITIONAL INFORMATIONSpecifications DescriptionShape CircularSize Approximate Diameter 2.7 in/7.0 cmThickness 0.5 in/1.3 cmContent Ferrous Alloys coated with epoxyField Strength 90 gauss minimum when measured at a distance of 1.5 in/3.8 cm from magnet surface.Table 10: Model 4520 S-ICD System Magnet SpecificationsPatient Information (Stored Data)Patient NamePhysician NamePhysician Contact InformationDevice Model NumberDevice Serial NumberElectrode Model NumberElectrode Serial NumberNotes up to 50 charactersTable 9: Stored Patient Information102098 004 rev a.qxp 12/2/2008 7:44 AM Page 40
41SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR ADDITIONAL INFORMATIONTable 11: Packaging SymbolsDefinitions of Package Label SymbolsSymbol Definition Symbol DefinitionISterilized by Ethylene OxideGas - Product is sterilized using ethylene oxide gas.NDate of Manufacture - Date on which the device was manufactured. Date shown as YYYY/MM/DD.PLimitation European CommunityRepresented - AuthorizedRepresentative in the EU community.HUse By - Use by the indicateddate. Date shown as YYYY/MM/DD.Part Number - Component number. lStorage Temperature - Productis stored with temperature limitations.gLot Number - Batch code. Hazardous Voltage - Caution -dangerous voltage.hReference Number - Finished goods stock number.Radio - Radio frequency.fSerial Number - Serial number of the device.Instructions - Consult instructions before use.Intended Use Symbol - In theUSA Federal Law restricts thedevice to sale by or on the order of a physician.Open Here - Symbol showing how to open the package.DNon-reusable - Single use only. Fragile: Handle with Care - Transport and store with care.MManufacturer - Place at which the device is manufactured. pKeep Dry - Ship and store in a dry place.Magnetic Field - To warn of a magnetic field.CReserved for CE markFCC ID SDYCHI1010 - Federal Communications Commission - Identifier serial number.102098 004 rev a.qxp 12/2/2008 7:44 AM Page 41
42SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR APPENDIXS-ICD System And Pacemaker InteractionInteraction between the S-ICD System and a temporary or permanent pacemaker ispossible and can interfere with the identification of tachyarrhythmias in several ways. • If the pacing pulse is detected, the S-ICD System may not adjust sensitivityappropriately, fail to sense a tachyarrhythmia episode and/or not delivertherapy.• Pacemaker sensing failure, lead dislodgment or failure to capture could resultin the sensing of two asynchronous sets of signals by the S-ICD System, causingthe rate measurement to be faster, and may result in delivery of unnecessaryshock therapy.• Conduction delay may cause the device to oversense the evoked QRS and T-waveresulting in unnecessary shock therapy.Pacemakers that employ impedance checks like MV sensors and unipolar pacemakersare contraindicated for use with the S-ICD System. This includes pacemakers thatrevert or reset to the unipolar pacing mode.The following test procedure aids in determining S-ICD System and pacemakerinteraction.Note: External defibrillation equipment should be available for immediate use duringthe implantation procedure as well as during testing and follow-up.Note: If implanting a pacemaker with an existing S-ICD System, program the S-ICDSystem to Therapy Off. During the testing procedure, program the pacemaker output to maximum andasynchronously pace in the pacing mode to which the pacemaker will be permanentlyprogrammed (e.g., DOO for most dual-chamber modes and VOO for single-chambermodes). 1. Follow the patient screening tool procedure to assure that the patient’s paced S-ECGsignal passes the criteria.2. Program the S-ICD System to Therapy On and complete the set-up procedure.3. Observe the S-ECG for any pacing artifacts. If any pacing artifacts are present and largerin amplitude than the R-wave, use of the S-ICD System is not recommended.4. Induce the tachyarrhythmia and observe the S-ECG markers to determine appropriatedetection and delivery of therapy.5. If inappropriate sensing is observed as a result of the device sensing the pacing artifact,reduce the pacemaker’s pacing output and retest. In addition, pacemaker operation may be affected by the S-ICD System therapy delivery. Thiscould alter the pacemaker’s programmed settings or damage the pacemaker. In this situation,102098 004 rev a.qxp 12/2/2008 7:44 AM Page 42
most pacemakers will conduct a memory check to determine if the parameters for safeoperation were affected. Further interrogation will determine if programmed pacemakerparameters are altered. Refer to the manufacturer’s pacemaker manual for implantationand explantation considerations.Limited WarrantyCameron Health, Inc. warrants to Purchaser, that for a period of five (5) years or sixty (60)months commencing with the date of implantation of the SQ-RX Pulse Generator (“theProduct”), that should the Product fail to function in accordance with Cameron Health, Inc.’spublished specifications, due to a defect in materials or workmanship, Cameron Health, Inc.will as Purchaser’s sole remedy and Cameron Health, Inc.’s sole liability:1. If within the three (3) year period, or 36 months, commencing with the date ofimplantation, Cameron Health, Inc. will provide a functionally comparablereplacement defibrillator at no charge.2. If after the three (3) year period from month 37 and until five (5) years or 60months from the date of implant, Cameron Health, Inc. will provide a credit tothe Purchaser for a replacement product in an amount equal to 50% of theoriginal purchase price reduced on a pro rata basis over this two year period.The prorated credit amount will be calculated on a monthly basis over thistwenty-four month period.In no event will any warranty credit issued hereunder exceed the original purchase price ofthe Product or the purchase price of the replacement Product.The Product is designed as a single use device and must not be resterilized. Anyresterilization voids the warranty.OTHER LIMITATIONS ON THE TERM OF THIS LIMITED WARRANTY ARE PROVIDED WITHTHE SALES DOCUMENTS AND ARE CONSIDERED AN INTEGRAL PART OF THIS LIMITEDWARRANTY, AS ARE THE WARNINGS CONTAINED IN THE PRODUCT LABELING. CONTACTYOUR LOCAL CAMERON HEALTH, INC. REPRESENTATIVE OR THE CAMERON HEALTH,INC. CUSTOMER SERVICE DEPARTMENT TO OBTAIN THIS INFORMATION AND TO OBTAININFORMATION ON HOW TO PROCESS A CLAIM UNDER THIS LIMITED WARRANTY.To qualify for this limited warranty, the following conditions must be met:•The Product must be implanted prior to the “USE BEFORE DATE” in conjunction with a Cameron Health, Inc. electrode.•The replaced Product must be returned to Cameron Health, Inc. within thirty (30) days after explant and shall be the property of Cameron Health, Inc.•The device must be clean and free from any bodily residue before returning.43SQ-RX PULSE GENERATORSQ-RX PULSE GENERATOR APPENDIX102098 004 rev a.qxp 12/2/2008 7:44 AM Page 43
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Cameron Health, Inc.905 Calle AmanecerSuite 300San Clemente, CA 92673USATel: 1 949 498 5630Free: 1 877 SICD 4111 877 742 3411Fax: 1 949 498 5932URL: www.cameronhealth.comCameron Health BVWorld Trade CenterNieuwe Stationsstraat 106811 KS ArnhemThe NetherlandsTel: 31 26 3550260Free: 800 SICD 4 YOU800 7423 4 968Fax: 31 26 3550269URL: www.cameronhealth.comPN 102098-004 Rev B 2008/09 102098 004 rev a.qxp 12/2/2008 7:44 AM Page 46

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