PACEMAKER System Speciflcation - SQRL - Home

1 PACEMAKER System SpecificationCopyrightc 2007 Boston ScientificJanuary 3, 2007 DISCLAIMER: This document is provided for academic purposes only,specifically demonstration of formal methodologies and engineering Scientific disclaims any use of information contained herein for anyproduct whatsoever, disclaims safety, disclaims efficacy, and disclaims fitness forpurpose. Any person or entity who uses this document for anything assumescomplete responsibility for its to copy is granted, provided the copyright declaration and thisdisclaimer are direct any comments or questions System Specification2 Contents1 Scope .. Acronyms .. 52 System System Overview .. System Components .. Device Overview .. Device Controller-Monitor (DCM) Overview .. Lead System Overview .. Indications and Contraindications .. User Characteristics and Operational Environment.

2 Hospitals/Physician Users .. Device Usage with Other Equipment .. System Operational Life Phases .. Pre-Implant Phase .. Implant .. Predischarge Follow-up .. Routine Follow-up .. Ambulatory .. Explant .. Disposal .. 123 System Model Type .. Device Controller-Monitor (DCM) .. DCM User Languages .. DCM User Interface .. DCM Utility Functions .. Printed Reports .. Strip Chart Recording Support .. DCM-PG Telemetry .. Lead Support .. Pacing Pulse .. Pulse Amplitude .. Pulse Width .. Rate Sensing .. Sensitivity Adjustment .. Bradycardia Operating Modes .. No Response To Sensing (O) .. Triggered Response To Sensing (T) .. Inhibited Response To Sensing (I) .. Tracked Response To Sensing (D) .. Bradycardia States .. 17 PACEMAKER System Permanent State .. Temporary Bradycardia Pacing.

3 Pace-Now State .. Magnet State .. Power-On Reset (POR) State .. Magnet Test .. Implant Data .. 194 Measured Data .. P and R Wave Measurements .. Lead Impedance Measurement .. Battery Status .. Threshold Test .. Bradycardia History .. Rate Histograms .. Rate Trending .. Recording Duration and Time Stamp .. Sensor Trending .. Real-time Electrograms .. Electrogram Viewing .. Real-time Electrogram Event Marker Annotations .. Atrial Markers: AS AP AT TN .. Ventricular Markers: VS VP PVC TN .. Marker Modifiers: () -Hy -Sr .. Augmentation Markers: ATR-Dur ATR-FB ATR-End PVP Faults and Error Handling .. Faults .. Errors .. 275 Bradycardia Lower Rate Limit (LRL) .. Upper Rate Limit (URL) .. Atrial-Ventricular (AV) Delay .. Paced AV Delay .. Sensed AV Delay .. Dynamic AV Delay.

4 Sensed AV Delay Offset .. Refractory Periods .. Ventricular Refractory Period (VRP) .. Atrial Refractory Period (ARP) .. Post Ventricular Atrial Refractory Period (PVARP) .. Extended PVARP .. Refractory During AV Interval .. Noise Response .. Atrial Tachycardia Response (ATR) .. 31 PACEMAKER System Atrial Tachycardia Detection .. ATR Duration .. ATR Fallback .. Rate-Adaptive Pacing .. Maximum Sensor Rate (MSR) .. Activity Threshold .. Response Factor .. Reaction Time .. Recovery Time .. Hysteresis Pacing .. Rate Smoothing .. 33A Programmable Parameters34B Measured Parameters35 List of Tables1 Model Type and Lead Port .. 132 Bradycardia Operating Modes .. 173 Battery Status and Therapy Availability .. 224 Intervals Associated with Histogrammed Events .. 235 Event Marker Annotations.

5 256 Programmable Parameters for Bradycardia Therapy Modes .. 287 Programmable Parameters .. 348 Measured Parameters .. 35 PACEMAKER System Specification51 IntroductionThis System Specification for PACEMAKER defines the functions and operat-ing characteristics, identifies the System environmental performance parameters,and characterizes anticipated uses of the ScopeThis document identifies the functions that the System must perform and pro-vides a description of these functions and their primary AcronymsAPAtrial PaceASAtrial SenseARP Atrial Refractory PeriodATR Atrial Tachycardia ResponseAVAtrial-to-VentricularBOL Beginning Of (battery) LifeBPM Beats Per MinuteccCardiac Cycle(s)CCIC ardiac Cycle IntervalDCM Device Controller-MonitorECG Electrocardiogram, external heart signalsEGM Electrogram, internal heart signalsEOL End Of (battery) LifeEPElectrophysiology, electrophysiologistERN Elective Replacement NearERT Elective Replacement TimeHRL Hysteresis Rate LimitICD Implantable Cardio-DefibrillatorIS-1 Industry Standard lead type 1 LRL Lower Rate LimitMSR Maximum Sensor RateNSR Normal Sinus RhythmOROperating RoomPGPulse GeneratorPOR Power-On ResetPMT PACEMAKER -Mediated Tachycardiappm Pulses Per MinutePVARP Post-Ventricular Atrial Refractory PeriodPVC Premature Ventricular ContractionSIRS ensor Indicated RateSRD Sustained Rate DurationURL Upper Rate LimitVPVentricular PacePACEMAKER System Specification6 VSVentricular SenseVRP Ventricular Refractory PeriodPACEMAKER System Specification72 System System OverviewThis PACEMAKER System Specification describes the PACEMAKER -specificprogramming application and pulse generator (PG).

6 The PACEMAKER systemsupports the following needs of patients that require bradycardia pacing support: Implantation Ambulatory Follow-up ExplantationThe PACEMAKER System : Provides dual chamber, rate adaptive bradycardia pacing support Provides historical data on device performance Provides user diagnostics through brady analysis functionsThe bradycardia analysis functions permit the following pacing measurementsand tests to be performed: Lead impedance Pacing threshold P and R wave measurement Battery status Temporary brady pacing Motion sensor System ComponentsThe PACEMAKER System consists of three major components: Device (also called the pulse generator or PG) Device Controller-Monitor (DCM) and associated software LeadsA standard cardiac donut magnet is a minor System System Device OverviewThe device monitors and regulates a patient s heart device detects and provides therapy for bradycardia device provides programmable, single- and dual-chamber, rate-adaptivepacing, both permanent and adaptive rate modes, an accelerometer is used to measure physical activityresulting in a sensor indicated rate for pacing the device is programmed and interrogated via bi-directional telemetry fromthe Device Controller-Monitor (DCM).

7 This allows the physician to change theoperating mode or parameters of the device non-invasively after device provides the following history data: Sensor output data Atrial and ventricular rate device, in conjunction with the DCM, provides diagnostic features in-cluding: Real time telemetry markers EGMs P and R wave measurements Lead impedance Battery status Device Controller-Monitor (DCM) OverviewThe Device Controller-Monitor (DCM) is the primary implant, pre-dischargeEP support, and follow-up device for the PACEMAKER System . The DCMis capable of being used both in the OR, physician s office, and the EP DCM communicates with the PG using a communication protocol andsupporting hardware. The DCM consists of the following: A hardware platform PACEMAKER application softwareThe DCM has the following and interrogate a delivery of Pace-Now and show diagnostics (history) and lead signal measurement and show sensor history and trending System visible and audible indications of communication between the DCMand device, including beeping and LED s for alerting the operator to and show multi-channel monitoring including surface electrocar-diogram and telemetered signals ( EGM, annotated event markers) reports and strip battery to external strip-chart cursor positioning and button windows for display of text and the date and Lead System OverviewThe lead System implanted in the patient allows the device to sense intrinsic ac-tivity of the heart s electrical signals and delivers pacing therapy to the patient leads are connected to the PG via its header.

8 All IS-1 bipolar leads Indications and ContraindicationsThe PACEMAKER System is indicated for patients exhibiting chronotropic in-competence and who would benefit by increased pacing rates concurrent withphysical activity. Generally accepted indications for long-term cardiac pacinginclude, but are not limited to, sick sinus syndrome; chronic sinus arrhythmias,including sinus bradycardia, sinus arrest, and sinoatrial (S-A) block; second-and third-degree AV block; bradycardia-tachycardia syndrome; bundle branchblock; and carotid sinus who demonstrate hemodynamic improvement from atrioventricularsynchrony should be considered for one of the dual-chamber or atrial pacingmodes. Dual-chamber modes are specifically indicated for treatment of conduc-tion disorders that require restoration of rate and of atrioventricular synchrony,including varying degrees of AV block; low cardiac output or congestive heartfailure related to bradycardia; and certain of the PACEMAKER pulse generator in DDDR and VDDR modes maybe contraindicated (1) in patients with chronic atrial tachyrhythmias (atrialfibrillation or flutter), which may trigger ventricular pacing, or (2) in the pres-ence of slow retrograde conduction that induces PACEMAKER -mediated tachycar-dia (PMT) which cannot be controlled by reprogramming selective parametervalues.

9 In DDDR, DDIR, and AAIR modes, atrial pacing may be ineffectivein the presence of chronic atrial fibrillation or flutter or an atrium that doesPACEMAKER System Specification10not respond to electrical stimulation. In addition, the presence of clinically sig-nificant conduction disturbances may contraindicate the use of atrial pacing is contraindicated for patients with an implanted cardioverterdefibrillator (ICD) because it may cause unwanted initiation or inhibition ofICD User Characteristics and Operational EnvironmentPatients with arrhythmias may be users of portions of the System such as Hospitals/Physician UsersThe PACEMAKER device and leads are implanted by physicians and hospitalstaff with varying degrees of experience. Follow-up of the patients is typicallyperformed by nurses or technicians under the supervision of a following Device Usage with Other EquipmentThe device functions with the following equipment: The ECG monitors.

10 The device meets industry standards for electrical safety. The device func-tions with the following ancillary equipment present in ORs and EP labs whichcan be sources of EMI or direct energy interference: A fluoroscope. Anesthesia machines. Patient water blankets. Electrocautery devices. External defibrillators. Blood pressure monitors. Pulse System Operational Life PhasesThe System s life cycle is shown below. Each phase in the cycle is described inmore detail System Specification11 Pre-Implant Implant Follow-up Ambulatory Explant Disposal -----NominalSettingsPhysicianSelectedSet tingsPhysicianSelectedSettings123456 Figure 1: PACEMAKER Life Pre-Implant PhaseThe System is manufactured using good manufacturing practices as specifiedby the FDA and other appropriate regulatory bodies. During manufacturing,nominal settings for the PG are ImplantDuring implant, the PACEMAKER device is placed into the patient.