Table of Contents Table of Contents .......................................................... 1 Introduction ................................................................... 8 NBG Code.................................................. 11 Programmer and Software........................... 11 Indications and Contraindications.............................12 Indications for Closed Loop Stimulation ........ 12 General Indications..................................... 13 General Contraindications..........
DOO Mode ..................................................28 Triggered Pacing .........................................29 DDT/A Mode, DDT/V Mode...........................29 VDI Mode....................................................30 OFF Mode...................................................30 Magnet Effect ..............................................30 Summary of the Functions and Timing Intervals of the Modes ...............................................32 Timing Functions ...................
Lead Configuration ......................................50 Continuous Measurement and Recording of Lead Impedance..................................................50 Automatic Lead Check................................. 51 Amplitude Control (ACC)...............................52 ACC Status .................................................57 Lead Detection and Auto-Initialization ............58 Antitachycardia Functions..........................................63 Upper Tracking Rate ....................
Maximum Activity Rate.................................87 Rate Decrease.............................................87 Sensor Simulation .......................................88 Rate Fading – Rate Smoothing ......................89 IEGM Recordings.........................................................92 Types of IEGM Recordings ............................93 Diagnostic Memory Functions (Statistics)................96 Overview.....................................................
Storing Follow-up Data ...............................118 Position Indicator for the Programming Wand ...............................................................118 Handling and Implantation ......................................119 Sterilization and Storage ............................119 Opening the Sterile Container......................120 Connecting the Leads.................................120 Follow-up Basics .......................................................124 Battery Status .........
Explantation..............................................141 Technical Data ..........................................................142 Pacing Modes ...........................................142 Home Monitoring — Programmable Parameters ...............................................................142 Home Monitoring – Non-Programmable Parameters/Value Ranges ..........................142 Pulse and Timing Parameters .....................144 Rate Adaptation.........................................
Index...........................................................................
Introduction Introduction Cylos is a line of pacemakers that may be used for all indications of bradycardic arrhythmias. There are three pacemakers in the Cylos product group. There are single- and dual-chamber pacemakers that achieve physiological rate adaptation using Closed Loop Stimulation,1 and a third pacemaker that permits external monitoring via a Home Monitoring feature.2 The myocardium contracts differently under different states of load.
Introduction All the systems have extensive features that allow quick diagnosis and delivery of safe therapy for cases of bradycardic arrhythmia. The guided follow-up functions have been largely automated. Initialization and optimization of Closed Loop Stimulation is also automated. This saves the physician time and eliminates problems in verifying and adjusting the pacemaker. Even during implantation, the implant can detect any connected leads – one of the key aspects of Auto-initialization.
Introduction • Innovative rate hysteresis promotes the patient’s own cardiac rhythm and avoids unnecessary overdrive pacing. • AV hysteresis features support intrinsic conduction and hence the natural contraction process. • The night program adjusts the pacing rate to the reduced metabolic needs of the patient while resting at night. • The regular automatic lead impedance check triggers the switch from a bipolar to unipolar pacing mode when values outside the normal range occur.
Introduction • Automatic functions and the storage of follow-up data in the implant simplify and accelerate the follow-up process. Note: This technical manual describes all the features of the Cylos line of pacemakers. A special note of any features that apply only to specific Cylos models will be made in the text or margins.
Indications and Contraindications Indications and Contraindications Indications for Closed Loop Stimulation Closed Loop Stimulation uses ventricular sense (Vs) and ventricular pace (Vp) events in calculating the pacing rate. The indications for Closed Loop Stimulation are summarized in the following: — Patients with intermittent AV conduction disorders or intact AV conduction. The algorithm is based on an AV hysteresis that can be turned off for patients with high-degree AV blocks.
Indications and Contraindications General Indications The following conditions are regarded as general indications for pacemaker implantation when they occur together with symptoms such as syncope, dizziness, reduced physical capacity, or disorientation: • Sinus node arrest and symptomatic bradycardia with or without an AV conduction disorder. • Intermittent or complete AV block. • Brady-/tachycardia syndrome or other symptoms of sick sinus syndrome that result in symptomatic bradycardia.
Indications and Contraindications The functions "Automatic Mode Conversion" and "Mode Switching" in connection with the pacing modes DDD(R) and VDD(R) are useful in cases of paroxysmal atrial tachyarrhythmia to interrupt any atrial synchronization of ventricular pulses during the phases of atrial tachyarrhythmia. The DDD(R) mode with Mode Conversion is an alternative to the DDI(R) or DVI(R) mode in this case.
Indications and Contraindications • If slow retrograde conduction is encountered after ventricular pacing, a longer atrial refractory period and/or a shorter AV delay may have to be programmed to prevent pacemaker-mediated tachycardia. Programming DDI, DVI, or VVI modes is rarely required in these instances. • If elevated rates above the basic rate are not well tolerated by the patient (e.g.
Home Monitoring Home Monitoring Introduction Cylos DR-T With BIOTRONIK's Home Monitoring function, patients can be treated even more effectively. All Home Monitoring implants are equipped with a small transmitter and are designated by the letter "T," e.g., Cylos DRT and Lumos DR-T. The Home Monitoring function has no effect on any functions and features of the basic implant, such as pacing and sensing functions, preset parameters, or memory functions.
Home Monitoring The patient's implant data are sent to the patient device at regular intervals. With Home Monitoring, the distance between the implant and the patient device should not be less than 20 centimeters (8 inches) and not more than two meters (6 feet). The implant can send three different types of messages: trend messages, event messages and patient messages (for pacemakers only). For more information about the message types, see "Types of Implant Messages," on page 17.
Home Monitoring On event reports, the title tells you which event triggered that Cardio Report, e.g., Event report – ERI detected. Programmer You must set up the Home Monitoring function in the programmer and register with the BIOTRONIK Customer Service Center. For more information about activating Home Monitoring on the programmer, see the manual of your programmer. For information about signing up for Home Monitoring, see the manual for the BIOTRONIK Home Monitoring® Service.
Home Monitoring Event M essage When the implant detects certain cardiac and technical events, an event message is sent to the patient device. For each implant, you decide what kinds of events will trigger a message. You can go to the Home Monitoring Service Center on the Internet and configure whether you also want to receive event reports for these events. Certain events, e.g., when the battery reaches ERI, can never be omitted.
Home Monitoring Monitoring Interval 1 day When you activate the Home Monitoring function, the (daily) interval of the trend message transmission is automatically activated. Transmission Time of the Periodic Report Between 0:00 (12:00 a.m.) and 23:50 (11:50 p.m.) For the trend message, program a time between 0:00 (12:00 a.m.) and 23:50 (11:50 p.m.). Selecting a time between 0:00 (12:00 a.m.) and 4:00 (4:00 a.m.) is recommended as that is a time when the patient is usually asleep.
Home Monitoring Prerequisites The technical prerequisites for access to Cardio Reports are described in the manual for the BIOTRONIK Home Monitoring® Service. Indications and Contraindications The known indications and contraindications for pacemakers and ICDs are applicable regardless of Home Monitoring. There is no absolute indication for the use of the Home Monitoring Service Center.
Pacing Types – Modes Pacing Types – Modes Closed Loop M odes Valid for Cylos DR and Cylos VR Cylos achieves physiologic rate adaptation using Closed Loop Stimulation. Closed Loop Modes work the same way as non-rateadaptive modes. The only difference is that the basic rate is increased when Cylos senses that the patient is under stress. Closed Loop modes are identified by the designation "CLS.
Pacing Types – Modes Overdrive Modes Overdrive modes reduce the probability of atrial tachycardias. In this case, the pacing rate always lies slightly above the intrinsic atrial heart rate. Preventive overdrive is available in modes DDD(R)+, DDT/(R)A+, DDT/V(R)+, AAI(R)+ and AAT(R)+. For a detailed functional description, see the "Preventive Overdrive Pacing" section.
Pacing Types – Modes Figure 1: AV-sequential pacing in DDD mode without an intrinsic event In the case of an atrial sensed or paced event, the AV delay starts together with the basic interval. If a ventricular sensed event does not occur within the AV delay, ventricular pacing is triggered at the end of the AV delay. If ventricular sensing (V S) occurs within the AV delay, the ventricular pulse delivery (VP) is inhibited.
Pacing Types – Modes Figure 3 and Table 1 summarize the timing intervals initiated by sensing or pacing. The table distinguishes between pacing at the end of the AV delay (VP) or pacing at the end of the AV safety delay (V SP) and between sensing within the AV delay (V S) or sensing outside the AV delay (VES).
Pacing Types – Modes Timing Interval Event Ap As (Dynamic) AV Delay • • AV Safety Delay • Interference Interval (A) Vp Vsp Vs VES • • • Interference Interval (V) Blanking Period (A) • • • Blanking Period (V) • • • Table 1: Timing intervals initiated by pace and sense events in DDD and DDI modes (Vsp = ventricular safety pacing) DDI Mode In contrast to the DDD mode, the basic interval in the DDI mode does not start with a P wave, but rather with ventricular sensed or paced event
Pacing Types – Modes Figure 5: Inhibition of atrial pacing in DDI mode by an atrial sensed event occurring within the VA interval. The atrial refractory period restarts at the end of the VA interval. DVI Mode The DVI mode is based on the DDI mode. In contrast to the latter, atrial sensing does not occur in DVI mode. Therefore, atrial pacing is forced at the end of the VA delay. Ventricular sensing within the VA interval inhibits both the atrial and the ventricular pulse.
Pacing Types – Modes Figure 6: Prevention of pacemaker-mediated tachycardia in VDD mode AAI Mode, VVI Mode The AAI and VVI single-chamber pacing modes are used for atrial or ventricular demand pacing. In each case, pacing and sensing only occur in either the atrium (AAI) or the ventricle (VVI). The basic interval is started by a sense or pace event. If there is a sense event before the end of the basic interval, pulse delivery is inhibited.
Pacing Types – Modes Triggered Pacing Triggered pacing modes correspond to the respective demand modes, the difference being that detection of an atrial/ventricular event outside the refractory period does not cause pulse inhibition, but rather triggers immediate pulse delivery to the respective chamber.
Pacing Types – Modes VDI Mode The VDI mode is derived from the VVI mode. In contrast to the latter, the VDI mode allows intra-atrial events to be recorded. The timing corresponds to the VVI mode, however. The VDI mode is designed for measuring retrograde conduction with the IEGM and/or the marker function.
— — — — — — — — — — Pacing Types – Modes Recording of statistics Mode switching Automatic lead check AV hysteresis and rate hysteresis Rate adaptation Overdrive PMT protection VES lock-in termination Active capture control (ACC) Rate fading Automatic Magnet Effect During the first 10 cycles after magnet application the pacemaker paces asynchronously at 90 ppm (at 80 ppm upon reaching the replacement indication).
Pacing Types – Modes Summary of the Functions and Timing Intervals of the Modes Table 2 summarizes the functions and time intervals that apply to the various demand pacing modes. Not included are rate-adaptive parameters and parameters that can be programmed in all pacing modes. The sensitivity can always be programmed during pulse inhibition and/or pulse triggering.
Pacing Types – Modes AV scan hysteresis • AV safety delay • Sense compensation • V blanking period • Wenckebach possible • • • • • • • • • • • • • • • • • • • • Table 2: Functions and timing intervals of the different pacing modes • = present A = atrium, atrial V = ventricle, ventricular A p = atrial pace event As = atrial sense event Vp = ventricular pace event Vs = ventricular sense event VVT VVI AAT AAI VDI VDT VDD DVT DVI DDI/T DDI DDT/V DDT/A Pacing Modes DD
Timing Functions Timing Functions Basic Rate The basic rate is the rate at which the pacemaker delivers pulses in the absence of a spontaneous rhythm or if sensing is deactivated. The corresponding interval is called the "basic interval" - the interval between two pacing pulses. In the atrial-controlled modes, the basic interval is started by an atrial event. In the atrial-controlled dual-chamber modes, the basic interval is also started by a ventricular extrasystole.
Timing Functions Figure 7: Basic rate and rate hysteresis in DDD mode In pacing modes DDD(R), DDT(R)/A, DDT(R)/V, DDT(R), VDD(R), VDT(R), AAT(R), and AAI(R) the hysteresis interval starts with an atrial sense event. In the modes DDI(R), VVI(R), VVT(R) and VDI(R) it starts with a ventricular sense event. In modes DDD(R), DDT(R)/A, DDT(R)/V, DDT(R), VDD(R) and VDT(R) it also starts with a ventricular extrasystole. The rate hysteresis is specified as the difference from the basic rate.
Timing Functions Figure 8: Repetitive rate hysteresis An existing spontaneous rhythm is thus once again able to inhibit the pacemaker. This prevents any worsening of the hemodynamics, as might otherwise occur in modes such as VVI pacing. The pacemaker supports and stabilizes the spontaneous atrial rhythm in DDD or DDDR modes. This prevents the undesirable suppression of the spontaneous rhythm through overdrive, especially during periods of rest.
Timing Functions If scan hysteresis is activated, the pacemaker will reduce the pacing rate temporarily to the hysteresis rate after every 180 consecutive atrial paced events. The number of scan intervals can be programmed (See Figure 9). Figure 9: Scan rate hysteresis If no intrinsic event is detected during the scan intervals, pacing at the basic rate is resumed (at the sensor rate in rate-adaptive mode). Scanning for a spontaneous rhythm is repeated after an additional 180 cycles.
Timing Functions Basic Rate: Increased value, for example 90 ppm Rate Hysteresis: Such that the hysteresis rate at rest is always lower than the intrinsic rhythm (e.g., -50) Scan Rate Hysteresis: Enabled, with the number of cycles set according to the patient's condition Repetitive rate hysteresis Enabled, with a low number of cycles This programming will inhibit the pacemaker until bradycardia episodes occur.
Timing Functions The beginning and end of the night, as well as the basic night rate, can be programmed. At the beginning of the night period, the basic rate and the hysteresis rate are gradually reduced to the night values. If rate adaptation is enabled, the sensor threshold during the night is increased by one increment (less sensitive). This prevents undesirable rate increases – even in patients who do not sleep soundly. After the night has ended, the pacemaker resumes its daytime pacing values.
Timing Functions Dynamic AV Delay Valid for Cylos DR and Cylos DR-T The AV delay defines the period of time between an atrial event and the subsequent ventricular stimulus. The "dynamic" AV delay lets you optimize the AV delay for five different atrial rate ranges. The AV delay selected for this rate is then effective depending on the current atrial rate (the A-A interval). The dynamic AV delay is valid after atrial detection and after sensor-driven atrial pacing.
Timing Functions Rate range AV delay (in ms) for programming the dynamic AV delay to Low Medium High Basic rate (for non- 180 rate-adaptive modes) 180 180 Less than 70 ppm 180 180 180 70 - 90 ppm 170 160 150 91 -110 ppm 160 140 120 111 - 130 ppm 150 120 100 Over 130 ppm 140 100 75 Table 3: Dynamic AV delays The dynamic AV delay serves to prevent pacemaker-mediated tachycardias and supraventricular tachycardias. See also the "Antitachycardia Functions" section.
Timing Functions AV Repetitive Hysteresis In AV repetitive hysteresis, the AV delay is also extended by the defined hysteresis value after the sensing of an intrinsic ventricular event. In contrast to normal AV hysteresis, once the ventricular pace event occurs, the long AV delay remains intact for a programmed number of cycles. If intrinsic activity occurs during one of these repetitive cycles, the long AV delay remains intact.
Timing Functions Negative AV Hysteresis Purpose In individual cases it can be necessary to promote ventricular pacing and allow the least possible amount of conductions of the atrial sinus rhythm. This can be especially necessary for patients with hypertrophic obstructive cardiomyopathy (HOCM). Description With a sensed ventricular event (Vs), the function decreases the AV delay and thereby promotes ventricular pacing.
Timing Functions Sense Compensation For hemodynamic reasons, it is desirable to maintain a constant period between an atrial and a ventricular contraction and to adjust it to physiologic conditions. To this end, sense compensation can be used to shorten the AV delay after atrial sensing. You can program values of -15 to -120 ms for the sense compensation. In this case, the AV delay after atrial sensing is shorter than it would be following atrial pacing according to the value you have set.
Timing Functions Note: It is recommended that the lowest possible values be selected, so that ventricular/atrial sensing is ensured for the period during which ventricular/atrial intrinsic rhythm may occur. Note: It is also recommended that the selected values be high enough to prevent undesired sensing of pacing in the other chamber. This is possible with high atrial/ventricular pulse energies and/or high ventricular/atrial sensitivities.
Timing Functions Figure 10: Ventricular blanking period and the AV safety delay If AV sequential pacing is observed with an AV delay corresponding to the AV safety delay, this may be evidence of ventricular crosstalk (recognition of atrial pulse delivery). In order to avoid crosstalk, you can define a lower atrial pulse energy, a lower ventricular sensitivity (assigning it a higher numerical value), and/or a longer ventricular blanking period.
Timing Functions Depending on whether interference is sensed in either the atrium or the ventricle, the following pacing modes will be used for the duration of the interference: Mode Interference During EMI in the Atrium Ventricle Atrium and ventricle DDD-CLS DVI-CLS DAD-CLS DOO(R) DDD(R)(+) DVI(R) DAD(R)(+) DOO(R) DDI(R) DVI(R) DAI(R) DOO(R) DVI(R) VDD(R) DOO(R) VVI(R) VAT(R) VVI-CLS VOO(R) VVI(R) VOO(R) VOO(R) AAI(R)(+) AOO(R) DDT(R) DVT(R) DAT(R)(+) DOO(R) DDT(R)/A(+)
Mode Timing Functions Interference During EMI in the Atrium Ventricle Atrium and ventricle AAI(R) AOO(R) DDT(R) DVT(R) DAT(R) DOO(R) DDT(R)/A DVD(R) DAT(R) DOO(R) DDT(R)/V DVT(R) DAD(R) DOO(R) DDI/T(R) DVT(R) DAT(R) DOO(R) DVT(R) DOO(R) VDT(R) VVT(R) VAT(R) VOO(R) VDI(R) VVI(R) VOO(R) VOO(R) VVT(R) AAT(R) VOO(R) AOO(R) Table 6: Interference modes
Pacing and Sensing Functions Pacing and Sensing Functions Pulse Amplitude and Pulse Width In dual-chamber systems, the pulse amplitude and the pulse width are independently programmable for the atrium and the ventricle. The BIOTRONIK PAC ("Pulse Amplitude Control") system keeps all pulse amplitudes below 8.4 V constant during the entire service time of the pacemaker. This means that the pacing safety margin is maintained even when the battery voltage drops.
Pacing and Sensing Functions Lead Configuration In a unipolar configuration, the negative pole (the cathode) is situated in the heart, while the positive pole (the anode) is formed by the housing of the pacemaker. In a bipolar configuration, both poles of the leads are situated in the heart. The pacemakers allow you to program separate lead polarities for pacing and sensing.
Pacing and Sensing Functions To this end, up to 4 stimuli of 4.8 V are triggered every 1.5 hours in order to be able to determine the impedance under defined conditions. If an amplitude higher than 4.8 V is set, the measurement is conducted with the preset amplitude. Impedances between 200-3000 Ohm are considered. Automatic Lead Check When this function is activated, the lead impedance is automatically measured with every pace.
Pacing and Sensing Functions Amplitude Control (ACC) Purpose The amplitude control function (Active Capture Control - ACC) does the following: • Continuously monitors for effective ventricular pacing • Periodically determines the ventricular pacing threshold • Verifies the stimulus response The advantage for the patient is that pacing remains effective even when there are changes in threshold.
Pacing and Sensing Functions Description — — — — — The device measures with a constant, maximum pacing amplitude for a duration of 5 cycles. The AV delay is shortened to 50 ms after pace and to 15 ms after sense. After another 5 cycles, a second pulse is delivered with the same amplitude 100 ms after the effective pace. This pace reaches refractory tissue and thus does not evoke a stimulus response. This makes it possible to determine the sole polarization artifacts of the lead.
— — — Pacing and Sensing Functions The incremental decrease of the pacing amplitude continues until loss of capture is measured (meaning the pace is ineffective). The last effective pacing amplitude that is measured is accepted and saved. After the first ineffective pace is detected, either the AV delay (for atrial-controlled pacing) or the basic rate (for ventricularcontrolled pacing) is changed with the subsequent pace.
Pacing and Sensing Functions Pacing in Single-Chamber Pacemakers In order to ensure pacing in single-chamber pacemakers during signal analysis and threshold verification, the device paces at a rate that is 10 ppm higher than the intrinsic rate. Programmable Parameters Amplitude Control ACC ON; OFF; A TM The "minimum ventricular amplitude" and "maximum ventricular amplitude" parameters prevent a certain value of the ventricular amplitude from being exceeded or undershot.
Pacing and Sensing Functions Options for the ACC Function The following options are available for the amplitude control function: Active capture control (ACC) ON; OFF; A TM ON This option activates all sub-functions: The pacing threshold is monitored and recorded, and the pacing energy is continuously adapted.
Pacing and Sensing Functions ACC Status It is possible to display information via the status of the Active Capture Control (ACC) function. The following statuses are possible: — OK — OFF; the following is displayed: "---------" — Deactivated — Unconfirmed — High pacing threshold OK Shows that the ACC and ATM functions are activated and operating properly. OFF Shows that ACC and ATM have been deactivated by the user.
Pacing and Sensing Functions Lead Detection and Auto-Initialization Lead Detection Purpose The lead detection function allows the implant to recognize the connected leads as early as during implantation. This is also the basis for being able to activate the auto-initialization function. When the connected leads have been successfully detected, the pacing and sensing polarities are automatically set. This depends on the type of leads connected (be they unipolar or bipolar).
Pacing and Sensing Functions If the impedance lies outside of this range, the implant switches to unipolar pacing. A unipolar lead is then confirmed. Any sense event occurring during the phase for recognizing lead polarity triggers a stimulus in the same chamber. This allows the impedance to be measured. The Confirmation Phase After successful lead detection and detection of the lead polarity, an implantation confirmation time of 30 minutes is started.
Pacing and Sensing Functions select lead polarity implantation confirmation 30 min.
Pacing and Sensing Functions CLS Standby Mode CLS Standby Mode is where, after auto-initialization, Closed Loop Stimulation is fully installed but deactivated. When the implant is interrogated for the first time, Closed Loop Stimulation can be activated. The CLS Standby Mode entails the following: — Closed Loop Stimulation has been installed, but is deactivated. — Until CLS is activated, the implant will pace at the basic rate.
Pacing and Sensing Functions Note: The auto-initialization function can only be accessed before implantation. After the pacemaker has been implanted and the auto-initialization function has been run, this parameter is no longer displayed on the Parameters screen. Note: If the implant is interrogated while autoinitialization is still running, the programmer will show a message indicating this.
Antitachycardia Functions Antitachycardia Functions Overview of antitachycardia functions: • Upper tracking rate • Tachycardia mode • Tachycardia response - mode conversion and - mode switching • PMT management • Preventive overdrive pacing • VES Lock-in Protection Upper Tracking Rate In atrial-controlled dual-chamber modes, the upper tracking rate, along with the atrial refractory period, determines the maximum P-wavetriggered ventricular rate.
Antitachycardia Functions Tachycardia Mode The resulting tachycardia mode (either 2:1 or Wenckebach) is automatically displayed, depending on the combination of selected parameters. A response similar to Wenckebach block (the WRL mode) results if the selected upper tracking rate is lower than the rate corresponding to the atrial refractory period.
Antitachycardia Functions The extended AV delay in the WRL mode and the associated desynchronization of the atrium and ventricle increase the likelihood of detecting retrograde P waves. This should especially be considered if the dynamic AV delay is to be used for preventing or terminating (pacemaker-mediated) reentry tachycardia, since the WRL mode deactivates the dynamic AV delay when the upper rate is exceeded. (See also PMT Management.
Antitachycardia Functions Tachycardia Behavior Cylos offers a choice of two algorithms that effectively suppress atrial tachycardia from being conducted to the ventricle. At the start of a tachycardic episode, the pacemaker automatically switches from an atrial-controlled to a ventricular-controlled mode.
Antitachycardia Functions Figure 13: In DDD mode without mode conversion (shown in upper graphic), every second P wave triggers a ventricular pace during an atrial tachycardia. In the DDD mode with mode conversion (shown in the lower graphic), an atrial sensed event occurring in the atrial refractory period restarts the atrial refractory period without the basic interval being restarted. This results in DVI response for the duration of the atrial tachycardia.
Antitachycardia Functions Mode Switching with X/Z-out-of-8 Algorithm This X/Z-out-of-8 algorithm can be used to program activation and deactivation criteria. This prevents, for example, unnecessary mode oscillations in the case of atrial extrasystoles or unstable atrial signals. In addition, this algorithm can be employed to determine the speed at which a de- and resynchronization of ventricular depolarization takes place. This intervention rate can be programmed within a range from 100… (10)...
Antitachycardia Functions Basic Rate during Mode Switching It is possible to set a higher basic rate during mode switching, in order to lessen undesirable hemodynamic conditions during mode switching. This basic rate can be programmed to a higher value than the standard basic rate, which leads to a slight increase of the cardiac output. Programmable parameters: Basic Rate during Mode Switching +5...(5)...
Antitachycardia Functions The implant behavior thus resembles a 2:1 block. The implant paces in the ventricle at a rate that corresponds to one-half of the atrial rate. At very high atrial rates, this can produce high ventricular rates that are physiologically unsuitable. Example: If atrial flutter at a rate of 280 bpm takes place, then the pacemaker paces with a ventricular rate of 140 ppm.
Antitachycardia Functions Confirmation of 2:1 Lock-In Detection of a 2:1 situation is determined as follows: — The AV delay is lengthened for one cycle by a maximum of 300 ms, in order to confirm the 2:1 lock-in situation. In this manner, events that previously fell within the blanking period are detected by the implant as atrial refractory events. At the same time, the minimum PVARP function is activated for the time of the AV delay extension.
Antitachycardia Functions PMT Prevention Pacemaker-mediated tachycardia is generally triggered by ventricle depolarization that is out of synchrony with atrial depolarization, e.g., as would be the case in ventricular extrasystoles (VES). The tachycardia is maintained retrogradely by VA conduction coming from the ventricle depolarization due to pacing and antegradely by P-wavetriggered ventricular pacing.
Antitachycardia Functions An atrial refractory period extension might be necessary in the case of a short atrial refractory period in conjunction with a long VA conduction period in order to prevent the triggering of a PMT by asynchronous ventricular depolarizations. PMT Protection Pacemaker-mediated tachycardias can also be caused by artifacts and atrial extrasystoles. In such cases, the PMT protection algorithm provides functions for both reliable detection as well as termination of PMTs.
Antitachycardia Functions If these two conditions are met, the pacemaker automatically extends or shortens the AV delay by a defined value. If the resulting Vp-A s interval remains constant, the PMT is considered confirmed. The algorithm for terminating the PMT is automatically started. Note: In cases where a low upper tracking rate and long AV delays have been programmed, pacing rates slightly above the UTR may occur for a few cycles.
Antitachycardia Functions Incremental Rate Increase and Decrease Each time an atrial event is sensed, the pacing rate is increased by a programmable increment (see Figure 15). This overdrive increment can be set to either low (approx. 4 ppm), medium (approx. 8 ppm), or high (approx. 12 ppm). If the intrinsic rate does not continue to rise after a programmable number of cycles (the overdrive pacing plateau), the overdrive pacing rate is reduced in increments of 1 ppm.
Antitachycardia Functions Figure 16: Incremental rate reduction with preventive overdrive pacing Safety Function of the Algorithm Preventive overdrive pacing provides various safety functions which are, for example, effective for high atrial rates: • When the programmed maximum overdrive rate (MOR) is exceeded, such as in the case of atrial tachycardias, then the algorithm is automatically deactivated. Should the rate fall below the MOR, the overdrive algorithm is reactivated.
Caution! Antitachycardia Functions When programming the DDD(R)+ overdrive mode, you should check whether a pacemaker-mediated tachycardia could be triggered on the basis of the selected pacemaker program, and whether atrial overdrive pacing might then develop. If this is the case, we recommend programming the maximum overdrive rate (MOR) for the atrial overdrive to a value which is lower than the expected rate of the pacemaker-mediated tachycardia.
Rate Adaptation Rate Adaptation Cylos uses two completely separate principles for rate adaptation: • Rate adaptation by an accelerometer • Physiologic rate adaptation using Closed Loop Stimulation The programmable rate-adaptive modes fall into the following categories: Rate Adaptation Closed Loop Stimulation Accelerometer-based physiological rate adaptation activity modes atrial overdrive pacing DDD-CLS VVI-CLS DDDR DDIR DDITR DDTR DDTRA DDTRV DVIR DVTR VDDR VDTR VDIR VVIR VVTR V00R AAIR AATR A0
Rate Adaptation The pacemakers are equipped with an accelerometer that is integrated into the hybrid circuit. This sensor produces an electric signal that is constantly processed by analog and digital signal facilities. If a rateadaptive mode is programmed, then this effects an adjusted increase of the basic rate, depending on the exertion level of the patient. With the sensor being integrated in the hybrid circuit, it is not sensitive to static pressure on the pacemaker housing.
Rate Adaptation The pacemaker evaluates the dynamics of the myocardial contraction quickly after ventricular contraction. Impedance is measured via a ventricular lead and is largely dependent on the specific conductivity of a small volume of tissue surrounding the electrode tip. Changes in impedance are characteristic of ventricular contraction and are directly proportional to heart stress.
Rate Adaptation Individually Adjusting CLS Parameters The following parameters can be individually adjusted with the “extended CLS settings”: • The required V P • The CLS dynamics • Dynamic runaway protection The Required V P In the DDD CLS mode, the default setting includes AV hysteresis to support existing adequate intrinsic conduction. For patients with inadequate or non-existing intrinsic conduction, it may be necessary to turn off AV hysteresis. To do this, turn on the parameter [required V P].
Rate Adaptation Dynamic Runaway Protection This parameter sets the pacing rate attainable during rest to a programmable value,1 for example 20 ppm, above the preset basic rate. This suppresses any non-specific rate fluctuations at rest without limiting the rate adaptation under mental stress. In cases where runaway protection is not clinically appropriate, this feature can be turned off.
Rate Adaptation Sensor Gain The sensor gain designates the factor by which the electric signal of the sensor is amplified before subsequent signal processing occurs. The programmable sensor gain permits adaptation of the desired rate adaptation to the individually variable signal strengths. The optimum setting is achieved when the desired maximum pacing rate is attained during exertion (see Figure 17).
Rate Adaptation Figure 17: Impact of sensor gain on rate adaptation Automatic Sensor Gain The manually programmable sensor gain is supplemented by an automatic sensor gain function. When the function is enabled, the pacemaker continuously checks whether sensor gain optimally corresponds to the patient's needs and makes adjustments as necessary. The "automatic sensor gain" function checks daily whether 90% of the set "maximum sensor rate" (MSR) has been reached for a total of 90 seconds.
Rate Adaptation Figure 18: Automatic adjustment of sensor gain with a 7:1 algorithm Sensor Threshold The minimum strength of the signals used for rate adaptation is determined with the programmable sensor threshold. Sensor signals below this threshold do not affect rate adaptation (see Figure 19). Through the programmable sensor threshold, a stable rate at rest of the patient can be achieved by ignoring low-amplitude signals that have no relevance for increased levels of physical exertion.
Rate Adaptation Figure 19: Only signals above the programmed threshold influence the rate adaptation Rate Increase The rate increase parameter determines the maximum speed by which the pacing rate rises if the sensor signal indicates increasing exertion (see Figure 20). When the rate of increase is set to 2 ppm per cycle, the rate increases from 60 ppm to 150 ppm in 45 cycles, for example.
Rate Adaptation Maximum Activity Rate Regardless of the sensed amplitude of the sensor signal, the pacing rate will not exceed the programmed maximum activity rate (see Figure 21). The programmed value applies only to the maximum pacing rate during sensor-controlled operation and is independent of the upper tracking rate. Figure 21: Maximum activity rate Note: In the DDIR and DVIR modes, lower maximum sensor rates result than those indicated here, depending on the selected AV delay.
Rate Adaptation Setting the decrease speed to 0.5 ppm per cycle means that the rate decreases from 150 ppm to 60 ppm in 180 cycles, for example. In the modes DDIR and DVIR, the rate decrease is slightly slower than indicated here (partly depending on the programmed AV delay). The programmed rate decrease setting applies only to the decrease in pacing rate during sensor-driven operation and does not affect the pacing rate during atrial-controlled ventricular pacing.
Rate Adaptation Thus, sensor information is available prior to the activation of the rate adaptation, which can be used to evaluate the sensor response (see also the "Sensor Histogram" and "Activity Chart" sections under "Diagnostic Memory Functions"). Note: In the sensor simulation, you can only select sensor threshold values that are greater than those used in the permanent program.
Rate Adaptation After four consecutive A S, the target rate for the backup rate is calculated from the current atrial sensing rate minus 10 ppm. AES and AP set the target rate to the value of the basic/sensor rate. Figure 24: Controlled rate fading after a sudden incident of tachycardia If atrial tachycardia occur suddenly triggering a mode switch, the target rate is set to either the sensor or basic rate.
Rate Adaptation Figure 25: Updating the backup rate (rate fading), P=pacing, S=sinus rhythm Four consecutive intrinsic sense events are necessary to activate rate fading. Individual sense events do not affect rate fading. Backup Rate Rate that the pacemaker uses to pace when there is a sudden rate decrease. This can be a maximum of 10 ppm less than the intrinsic rate and follows the target rate with an increase of 1,2,4, or 8 ppm per cycle, or 0.1...
IEGM Recordings IEGM Recordings Purpose This function makes it possible to automatically record the progression of intracardiac events. These recordings are made between follow-ups and provide diagnostic information about the origin of the tachycardia, especially the time just prior to a tachycardia episode. Description When the preset criteria are satisfied, the IEGM recordings are automatically started and data are recorded for up to 10 seconds.
IEGM Recordings When all 20 IEGM memories are full, the device searches for disk space that is not protected and will record the following: • The oldest recording for the ventricular rate • The oldest recording, triggered by magnet application • The oldest recordings for mode switching, a high atrial rate and PMT termination When the maximum number of entries is exceeded, then the oldest recordings are overwritten (meaning there is a loop memory principle in place for each recording type).
IEGM Recordings IEGM Recording during Mode Switching This type is initiated by mode switching. The parameters can only be set in the Mode Switching function. Note: Do not activate IEGM recording for high atrial rates and for mode switching at the same time. IEGM Recording during High Ventricular Rates This type is initiated by high ventricular rates and ventricular tachycardias.
IEGM Recordings IEGM Recording during PMT Termination (PMT) This type starts a recording at the end of a PMT. The PMT protection function must be activated beforehand, however. Displaying IEGM Recordings After the list of IEGM recordings has been selected, the desired IEGM recording is selected and interrogated. The data are read from the implant and displayed in the associated window as a graph.
Diagnostic Memory Functions (Statistics) Diagnostic Memory Functions (Statistics) Overview The diagnostic memory functions are divided into the following five groups of statistics that in turn contain various subgroups.
Diagnostic Memory Functions (Statistics) Description of Displays The contents of the diagnostic memory are displayed as a combined text/graphical image, with the following display options: — Event counters — Histograms — Trends Event counters are displayed as bar charts showing the event totals expressed as a percentage. Histograms count the frequency of events in different time or rate intervals (e. g., how many events have occurred in the 160-169 ppm range).
Diagnostic Memory Functions (Statistics) Timing Statistics Timing Events The display of the event counter varies depending on the kind of pacing. In addition to the graphic display, absolute values of the event counter are displayed.
Diagnostic Memory Functions (Statistics) Ventricular extrasystoles are counted both as VES as well as ventricular sense events. Special Events The following events can be recorded: — Successful AV scan hysteresis — Overdrive safety switch-off — Mode switching counter — PMT termination — VES lock-in protection Note: All event counter data are transmitted to the programmer and evaluated there, but not all events are displayed in detail on the programmer.
Diagnostic Memory Functions (Statistics) In the A/V rate trend, the heart rate in ppm is recorded in the upper chart, and the percentage distribution of the pacing rate is recorded in the lower chart. The ventricular curve for the heart rate as well as for the pacing rate is indicated by a thicker line than the atrial curve. Far-Field Histogram The frequency of events that fall within the far-field interval is recorded.
Diagnostic Memory Functions (Statistics) Arrhythmia Statistics The pacemaker monitors the cardiac rhythm and characterizes it according to the following classification criteria: — SR (sinus rhythm) — ST-A T range (sinus tachycardia/atrial tachycardia) — Afl/AF range (atrial flutter/atrial fibrillation) Arrhythmia detection does not occur at any individual interval, but rather within arrhythmia ranges with suitable criteria. These criteria are described below.
Diagnostic Memory Functions (Statistics) The tachy event trend is automatically started by activating the mode switching function. The memory contents are deleted and the memory function is restarted with every permanent programming and every restart of the mode switching function. It is not possible to manually switch off the tachy event trends while the mode switching function is activated. The beginning and end times of the tachycardias are saved with a resolution of 2 seconds.
Diagnostic Memory Functions (Statistics) Figure 26: AES/AT classification Atrial sense events that occur within the AESW are classified as AES. The AESW timing is triggered under the following conditions: — — — The AESW starts at the end of the AARP until the requirement for atrial prematurity is met. The requirement for atrial prematurity can be programmed within the range of 5...(5)...50%. The atrial prematurity is the percentage of the last four PP intervals.
Diagnostic Memory Functions (Statistics) Figure 27: Arrhythmia detection The diagnostically relevant arrhythmia ranges can be set as follows: — ST/A T range between 80...(10)...200 ppm — Afl/AF range between 100...(10)...400 ppm In addition to the arrhythmia ranges, other criteria must be fulfilled: — Activation criteria — Atrial rate stability — Sudden rate increase Note: All classifications are exclusively for diagnostic purposes, i.e.
Diagnostic Memory Functions (Statistics) AES Trend In the AES trend, the sequence of atrial extrasystoles per minute is displayed in the form of a line chart. The AES trend is a rolling longterm trend with a recording time of 180 days and a resolution of 24 hours. 0-100 AES/min. are displayed. In addition, individual AES, couplets, triplets, the shortest Ax-AES interval, and the maximum number of AES per hour are displayed. AES Versus Atrial Rate The display of the AES vs.
Diagnostic Memory Functions (Statistics) Hence it is recommended that you ensure that stable atrial sensing exists prior to the activation of the VES analysis. If the atrial lead is bipolar, bipolar sensing should be considered. The event counters of the VES classification are subdivided into three percentage classes: — 0 - 25% — 25 - 50% — 50% In addition, individual VES, couplets, triplets, runs, tachycardias and the maximum number of VES per hour are displayed.
Diagnostic Memory Functions (Statistics) Sensor Statistics The sensor statistics contain the recording of the rate trend and sensor trend. A setting of [12 min/fixed] integrates the sensor optimization. Rate / Sensor Trend The rate / sensor trend is displayed in the form of a line graph containing the length of the time intervals and the trend data. The permanent sensor parameters can be edited at the setting [12 min/fixed]. The edited sensor parameters are simulated and displayed as a trend.
Diagnostic Memory Functions (Statistics) Activity Chart The activity chart on the programmer is divided into three ranges: "MAR" (maximum activity rate), "Activity", and "No Activity." The activity range indicates the time in which the sensor was active, but not with the maximum sensor rate. All values are expressed as percentages. Sensing Statistics P-Wave Trend This is where the course of sensitivity in the atrium is displayed. The Pwave trend is displayed in the form of a line chart.
Diagnostic Memory Functions (Statistics) Pacing Statistics Ventricular (Pacing) Amplitude Trend The ventricular (pacing) amplitude trend is a long-term trend that records values in the range of 0.0 to 10 V with a recording duration of 180 days. Ventricular Threshold Trend The ventricular threshold trend is a long-term trend that records values in the range of 0.0 to 8 V with a recording duration of 180 days.
— — Diagnostic Memory Functions (Statistics) Long-term trend with a recording time of 180 days and a resolution of 24 hours Short-term trend with a recording time of 33 hours and a resolution of 1.5 hours The thicker line represents the ventricular impedance curve, the thinner line the atrial impedance curve.
Follow-up Options Follow-up Options The pacemaker is equipped with an extensive array of automatic functions that greatly simplify the adjustment and monitoring of the pacing system and reduce the time required for follow-up examinations.
Follow-up Options The IEGM is transmitted together with the atrial and ventricular markers for sensing, pacing, and sensing within the refractory period. The IEGM, markers, and surface ECG can be displayed directly on the programmer screen, printed by the programmer printer, or output to an external ECG recorder. IEGM Recordings Purpose The recording of intracardiac information over a short period of time before a tachycardia phase provides valuable details about the arrhythmogenesis of tachycardia.
Follow-up Options Note: Program the magnet effect to [synchronous] when you want the patient to do IEGM recording. Caution! Due to the compression and reconstruction processes that the signals undergo, the IEGM recordings are not suitable for direct morphologic analyses. If you have activated the "patienttriggered IEGM recording" function, please tell the patient how to use the magnet to trigger an IEGM recording.
Follow-up Options Rate and Sensor Trend The rate trend is a real-time trend, whereas the sensor trend is a simulated trend. Sensor Trend with Rate Forecasting Valid for Cylos The pacemaker can record the sensor rate curve over a period of 12 minutes to optimize sensor rate settings. The resolution is four seconds. Recording stops automatically after 12 minutes.
Follow-up Options Automatic Threshold Test in the Ventricle The prerequisites for an automatic threshold test in the ventricle are as follows: • Ventricular rate 100 bpm • Adequate signal quality • The implant is not set to mode switching P/R-Wave Test A P/R-wave test is available for measuring the amplitude of spontaneous events during follow-up examinations. This test measures the minimum, mean, and maximum amplitude values over several cycles.
Follow-up Options Through its external pulse control function, the pacemaker can be used as an "implanted electrophysiologic laboratory" for non-invasive programmed stimulation (NIPS) and for terminating tachycardia. The maximum pacing rate is 800 ppm for single-chamber operation (corresponding to a minimum coupling interval of 75 ms).
Follow-up Options Temporary program activation facilitates a quicker and safer follow-up. All test programs that could be hazardous to the patient should only be activated temporarily. If a dangerous situation arises, the permanent program can be reactivated immediately by removing the programming wand.
Follow-up Options Patient Data Memory Individual patient data can be stored in the pacemaker. This data includes the patient's name, patient code, symptoms, etiology, ECG indication, implantation date, and lead polarity. The extent and type of the stored data depends on the programmer software module being used. Storing Follow-up Data Purpose This function allows you to store up to 4 follow-ups in the implant.
Handling and Implantation Handling and Implantation Sterilization and Storage The pacemaker and its accessories have been sterilized with ethylene oxide gas. To guarantee sterility, the container should be checked for damage before opening. If resterilization becomes necessary, contact your local BIOTRONIK representative. The pacemaker is shipped in a cardboard box equipped with a quality control seal and an information label.
Handling and Implantation Opening the Sterile Container Caution! Use only the BIOTRONIK screwdriver to connect and loosen the screw in the connector block. If you need to exchange a lead, order another sterile screwdriver from BIOTRONIK. For protection against mechanical jolting during transportation and to preserve sterility, the pacemaker is packaged in two plastic containers, one within the other. Each one is separately sealed and then sterilized with ethylene oxide.
Handling and Implantation If you cannot insert the lead connector completely, it may be that the setscrew is projecting into the hole for insertion on the screw block. Turn the setscrew counterclockwise with a screwdriver far enough to allow you to insert the lead connector completely. Caution! To prevent cross threading, do not back the setscrew all the way out of the threaded hole. Leave the screwdriver in the slot of the setscrew as you insert the lead.
Handling and Implantation Connecting Cylos DR/DR-T with an IS-1 Connector Insert the lead connector into the connector receptacle without bending the lead until the connector pin becomes visible behind the set screw block. A: Using the screwdriver included, pierce the slot of the silicone plug vertically and insert the blade of the screwdriver into the setscrew. B: Tighten setscrew with the enclosed screwdriver clockwise until the torque becomes limited (you will hear a crackling sound).
Handling and Implantation Connecting Cylos VR with an IS-1 Connector Insert the lead connector into the connector receptacle without bending the lead until the connector pin becomes visible behind the setscrew block. A: Using the screwdriver included, pierce the slot of the silicone plug vertically and insert the blade of the screwdriver into the setscrew. B: Tighten setscrew with the enclosed screwdriver clockwise until the torque becomes limited (you will hear a crackling sound).
Handling and Implantation Follow-up Basics Follow-up lets you check the pacing system and optimize settings. The likelihood of an electronic defect or a premature battery depletion is extremely low. Pacing system malfunctions attributed to other causes such as threshold increase are considerably more probable. In most instances, they can be corrected by reprogramming the pacemaker.
Handling and Implantation If the pacing rate only decreases when a magnet is applied, then the replacement indication has not yet been reached but may be expected shortly. The replacement indication will also be displayed by the programmer when interrogating the pacemaker and will appear in a data printout. For a detailed description of the replacement indication and the expected service times, please refer to the section entitled "Replacement Indication.
Handling and Implantation Sensing Functions A measuring function for the P- and R-wave amplitudes is available for testing the sensing function. This test measures the minimum, mean, and maximum amplitude values over several cycles. An optional realtime printout contains an amplitude annotation of the measured value in each individual cycle. Additionally, the pacemaker provides an intracardiac electrogram with marker signals.
Handling and Implantation A measuring test is available for verifying the retrograde conduction time. See also the "Follow-up Options" section. If retrograde conduction is present, the measured times should be nearly identical. If the measured conduction times vary significantly, this may be due to unstable atrial sensing or the absence of conduction.
Handling and Implantation Sensor Gain The sensor gain controls the change in pacing rate for a certain change in workload detected by the sensor. An exercise test (such as walking) is recommended in order to achieve a rate response proportional to workload by optimizing the sensor gain. If the pacing rate is too high for the specific amount of workload, the sensor gain should be reduced. If the pacing rate is too low, a higher gain setting should be selected.
Handling and Implantation Note: Values can only be selected for the sensor threshold that are greater than those used in the permanent program. Battery, Pulse and Lead Data Battery, pulse and lead data can be obtained non-invasively by means of analog telemetry. These data contain important information about the status of the pacing system. Therefore, they should be documented at each follow-up examination.
Replacement Indication Replacement Indication The length of the period from beginning of service (BOS) until replacement indication (ERI) is reached depends on several factors. These include battery capacity, lead impedance, pacing program, pacing to inhibition ratio, and the properties of the pacemaker circuit. Expected Time Until ERI In the course of the follow-up, the pacemaker displays the expected value up until ERI, based on the permanent program.
Replacement Indication Magnet Effect cycles 1-10 after magnet application after 10th cycle automatic asynchronous with 80 ppm synchronous with basic rate reduced by 4.5 - 11% a) asynchronous asynchronous with 80 ppm asynchronous with 80 ppm synchronous synchronous with basic rate synchronous with basic rate reduced by 4.5 – 11% a) reduced by 4.
Replacement Indication Remaining Service Time after ERI The following tables show the mean1 and minimum2 values for the remaining service time between reaching the ERI (elective replacement indication) and magnet rate after reaching replacement indication EOS (end of service) for the standard program3 and a program with a higher pulse energy.4 The data are based on a lead impedance of 500 Ohms, 100% pacing and the data supplied by the battery manufacturer.
Cautionary Notes Cautionary Notes The pacemaker, the lead(s), and, if used, the lead extensions and adapters, become part of the artificial pacing system upon implantation. The functioning of the artificial pacing system depends on all these components, as well as the physiologic condition of the patient. The following notes are intended to emphasize some aspects that have been deemed especially important in the medical literature for evaluating and avoiding risks.
Cautionary Notes To avoid skeletal myopotentials interfering with pacemaker functioning, a lower sensitivity (a higher value), bipolar sensing, or a different pacing mode can be programmed, depending on the availability of these features. Electromagnetic Interference (EMI) Every implanted pacemaker can be affected by interference with signals that the pacemaker sees as intrinsic cardiac activity and/or that compromise measurements the pacemaker uses for rate adaptation.
Cautionary Notes If interference is expected to have clinically relevant consequences, the patient must be protected from the interference or its effects, e.g., through appropriate warnings or pacemaker reprogramming. Household Appliances Electrical household appliances (e.g., ranges, microwave ovens, radios, televisions, VCRs, electric shavers and toothbrushes) do not normally affect pacemaker operation if the appliances are in good condition and properly grounded and insulated.
Cautionary Notes Interference Due to Strong Electromagnetic Fields To assess the potential for interference, medical advice must be sought, especially in case of strong electromagnetic fields such as those stemming from the following: electric arc welders; electric melting furnaces; radio, radar, and television transmitters; power plants; exposed ignition systems (e.g.
Cautionary Notes Caution! Diathermy, transcutaneous nerve stimulation, magnetic resonance imaging, and electrocautery have been reported to interfere with electromyographic monitoring. Cardiac activity during any of these procedures should therefore be monitored by additionally taking the patient's peripheral pulse or blood pressure. Defibrillation The circuitry of BIOTRONIK pacemakers is protected against the energy normally induced by defibrillation.
Cautionary Notes Ultrasound Therapy and Diathermy As a rule, ultrasound therapy and diathermy are fundamentally contraindicated for pacemaker patients due to possible heat build-up in the implant. If a therapy must be performed, it should not be applied in the immediate vicinity of the pacemaker or the lead. The peripheral pulse of the patient should be continuously monitored during treatment. The pacemaker function and pacing threshold must be checked after the therapy.
Cautionary Notes After stimulation, the pacemaker function and pacing threshold must be checked. For home use, the electrode positioning and current strength settings must be such that the nerve stimulation does not interfere with pacemaker functioning. Magnetic Resonance Imaging (MRI) This diagnostic procedure is contraindicated for pacemaker patients, because a variety of complications may result, e.g.
Cautionary Notes Electrocautery Electrocautery should never be performed within 15 cm (6 inches) of an implanted pacemaker or lead because of the danger of inducing ventricular fibrillation and/or damaging the pacemaker. For transurethral electroresection of the prostate, placing the neutral electrode under the buttocks or around the upper thigh, but not in the thoracic area, is recommended. The pacemaker should be programmed to an asynchronous mode to avoid inhibition by interference signals.
Cautionary Notes Explantation Explanted pacemakers can be sent to the local BIOTRONIK representative for proper, environmentally friendly disposal. Before returning it, the explanted pacemaker should be cleaned with a sodium hypochlorite solution containing at least 1% chlorine and then thoroughly washed with water, if possible. The pacemaker should be explanted before a deceased pacemaker patient is cremated.
Technical Data Technical Data Pacing Modes Cylos DR DDD-CLS, VVI-CLS, DDDR, DDTR/A, DDTR/V, DDTR, DDIR, DDIR/T, DVIR, DVTR, D00R, VDDR, VDTR, VDIR, VVIR, VVTR, V00R, AAIR, AATR, A00R DDD, DDT/A, DDT/V, DDT, DDI, DDI/T, DVI, DVT, D00, VDD, VDT, VDI, VVI, VVT, V00, AAI, AAT, A00, OFF DDD(R) +, DDT/A(R) +, DDT/V(R)+ , AAI(R) +, AAT(R) + Cylos VR VVI-CLS, VVIR, VVTR, V00R, VVI, VVT, V00, OFF Valid for Cylos DR-T Home Monitoring is possible for the following modes: DDD(R) , DDT(R)/A, DDT(R)/V, DDT(R),
Technical Data Atrial Rhythms Mean Value AES 0; 1...(10); > 10; > 100 Number of Atrial Tachycardias (AT) 0; 1...(10); > 10; > 20 Number of Atrial Fibrillation (AF) 0; 1...(10); >10; > 20 Number of Atrial Flutter (AFl) 0; 1...(10); > 10; > 20 AV Synchrony (Ax Vx/Vx) 0; 3...(3)...100% Number of Tachycardia Episodes 0 ... (1)...10...(2)...60; > 60 Duration of Tachycardia Episodes 0; 3...(3) ...100% Ventricular Rhythms Mean Ven. Heart Rate < 50; 52; ...(2)...174; > 174 bpm Max. Ven.
Technical Data Active Capture Control (ACC) Status Amplitude Control (ACC) On; Off; Deactivated Ventricular Thresholds < 0.3; 0.3; 0.5;... (0.2) ... 4.7; 4.8 Pulse and Timing Parameters1 Cylos DR/DR-T Basic Rate a), b) 30 ... (1) ... 88 ... (2) ... 122 ... (3) ... 140 ... (5) ... 180 ppm Night Program Rate Hysteresis off; on a) Repetitive rate hysteresis off; -5 ... (5) ... -50 bpm off; 1 ... (1) ... 10 Scan rate hysteresis off; 1 ... (1) ...
Technical Data Cylos DR/DR-T Pulse amplitude A Pulse amplitude V 0.1 ...(0.1) ... 4.8 ... (0.6) ... 8.4 V 0.1 ... (0.1) ... 4.8 ... (0.2) ... 8.4 V Pulse width A Pulse width V 0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.5 ms 0.1; 0.2; 0.3; 0.4; 0.5; 0.75; 1.0; 1.5 ms Sensitivity A Sensitivity V 0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mV 0.5 ... (0.5) ... 7.5 mV Refractory period A Refractory period V 200 ... (25) ... 775 ms 170; 195; 220; 250; 300; 350; 400 ms Atrial refractory period extension 0 .
Technical Data
Technical Data Cylos DR/DR-T Scan Period Intervals; Times of Day Intervals every 0.1; 0.3; 1; 3; 6; 12; 24 hours Times of Day, the 1st/2nd Time of Day 0:00 to 24:00 hours Safety Margin 0.3...(0.1)...(0.5) ...(0.1)...1.
Technical Data Sensitivity A Sensitivity V 0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mV 0.5...(0.5)...7.5 mV Cylos VR Refractory period A Refractory period V 200 ... (25) ... 775 ms 170; 195; 220; 250; 300; 350; 400 ms Atrial Refractory Period Extension 0 ... (50) ... 350 ms Tachycardia Behavior Off, Mode Conversion, Mode Switching Mode conversion Off; On (in mode VDD(R)) Mode Switching Off; On (in mode VDD(R)) Intervention Rate 180...(10)...250 ppm X-out-of-8 Criterion 3...(1)...
Technical Data b) The values 30, 31, 32, 33, and 34 are for temporary settings only.
Technical Data Rate Adaptation Cylos DR/DR-T/VR Max. (sensor or) activity rate a) 80...(5)...180 ppm Sensor Gain auto; 1 ... 40 (in 32 steps) Automatic Sensor Gain Off; On Sensor Threshold Very Low; Low; Medium; High; Very High Rate Increase 1; 2; 4; 8 ppm/cycle Rate Decrease 0.1; 0.2; 0.5; 1.0 ppm/cycle Rate fading On; Off R Rate Increase 1; 2: 4; 8 ppm/cycle R Rate Decrease 0.1; 0.2; 0.5; 1.0; 1.
Technical Data Parameters at Replacement Indication Basic Rate Programmed value minus 11% (minus 4.5 - 11% in modes DVI(R), DDI(R), DVT(R), and DDI/T(R), depending on the programmed AV delay) Magnet Rate 80 ppm for 10 cycles directly after magnet application (not so in synchronous magnet mode) Pulse Width Programmed values Pulse amplitudes – programmed values with ACC deactivated (Off) – last measured threshold + 1.
Technical Data Additional Functions Cylos DR/VR — — — — — — — — — — — — Automatic Amplitude Control (ACC) Automatic Initialization Automatic Lead and Polarity Detection IEGM Recordings Preventive Atrial Overdrive Pacing1 Tachycardia Behavior — Automatic Mode Conversion — X/Z-out-of-8 Mode Switching with 2:1-Lock-In Protection PMT Management VES Lock-in Protection Rate Fading Dual-channel IEGM with Event Markers AV Hysteresis — AV Scan and AV Repetitive Hysteresis — Negative AV Hysteresis Storage of
Technical Data Default Programs Cylos DR/DR-T Parameter/Function Factory Settings Standard Program Safe Program Mode DDD DDD VVI Basic rate 60 ppm 60 ppm 70 ppm Night program Off Off Off Rate hysteresis Off Off Off Repetitive rate hysteresis — — — Scan rate hysteresis — — — Upper tracking rate 130 ppm 130 ppm — Dynamic AV delay Low Low — AV hysteresis off off — Repetitive AV Hysteresis — — — AV Scan Hysteresis — — — Sense compensation -45 ms -45 ms — AV
Technical Data Parameter/Function Factory Settings Standard Program Safe Program Intervention Rate — 160 — Far-Field Blanking 56 ms 56 ms — Switch to — DDIR — Basic Rate during Mode Switching — + 10 — 2:1 Lock-in Protection off off — VES lock-in protection off off — Min. PVARP 235 ms 235 ms — Sensor Threshold — — — Sensor Gain — — — Autom. sensor gain — — — Rate Increase — — — Max.
Technical Data Rate hysteresis off -10 ppm Parameter/Function Factory Settings Standard Program off Safe Program — off — Scan rate hysteresis — off — Upper tracking rate 130 ppm 130 ppm — Dynamic AV Delay Low Low — AV hysteresis off off — AV Repetitive Hysteresis — — — AV Scan Hysteresis Repetitive rate hysteresis — — — Sense compensation — — — AV safety delay — — — Atrial blanking period 56 ms 56 ms — Magnet effect Auto Auto Auto Pulse amplitude V 3.
Technical Data Sensor Gain — 4 — Autom.
Technical Data Parameter/Function Factory Settings Standard Program Safe Program Rate Increase — 2 ppm/s — Max. Activity Rate — 120 ppm — Rate Decrease — 0.5 ppm/s — Rate Fading off off off RF Rate Increase — — — RF Rate Decrease — — — Pacing V unipolar unipolar unipolar Sensing A/V bipolar/ unipolar bipolar/ unipolar —/ unipolar PMT Management off on — VA Criterion — 380 ms — Autom.
Technical Data Electrical Data1 Cylos DR-T/DR/VR Circuit hybrid electronics with VLSI-CMOS chip Input impedance A Input impedance V > 10 kOhm > 10 kOhm Waveform biphasic, asymmetric Polarity cathodic Power consumption DR/DR-T D SLR BOS, inhibited 13 µA 13 µA 13 µA 21 µA BOS, 100% pacing 21 µA 21 µA Surface area of housing that is electrically conductive uncoated: coated: 32.8 cm 2 7.
c) Technical Data Anticipated service times taking all available data into consideration Mechanical Data Cylos DR Cylos DR-T Lead connection IS-1 (accepts unipolar and bipolar) Weight 26 g 27 g 3 Volume 10 cm Dimensions 6 x 42 x 51 mm Storage Conditions Relative Humidity max. 70% Temperature 5 ... 55 °C Pressure 0.7 ... 1.
Technical Data Projected Tolerances of Factory Settings1 Data according to EN 455002-2-1 Cylos DR/DR-T Basic rate Interference rate 60 ± 1.
Technical Data Cylos VR AV Delay Basic rate 70 ppm 70-90 ppm 91-110 ppm 111-130 ppm 130 ppm 180 180 160 140 120 100 +15/-5 +15/-5 +15/-5 +15/-5 +15/-5 +15/-5 ms ms ms ms ms ms Atrium Ventricle Pulse Amplitude maximum value EN 455002-2-1 mean value 3.6 +0.1/-0.7 3.3 +0.1/-0.7 Pulse width 0.42 ± 0.02 ms Sensitivity 15 ms sin2 40 ms sin2 0.2 + 0.05/-0.1 mV 2.5 ± 0.5 mV EN 455002-2-1 delta pulse 0.24 + 0.05/-0.1 mV 2.5 ± 0.
Technical Data Block Diagram for Cylos DR Figure 28: Block Diagram for Cylos DR
Technical Data Block Diagram for Cylos DR-T Figure 29: Block diagram for Cylos DR-T
Technical Data Block Diagram for Cylos VR Runaway protection Figure 30: Block Diagram for Cylos VR
Technical Data Federal Communications Commission Disclosure The CYLOS DR-T pacemaker is equipped with an RF transmitter for wireless communications. This transmitter is authorized by rule under the Medical Implant Communications Service (47 CFR Part 95) and must not cause harmful interference to stations operating in the 400.150 - 406.000 MHz band in the Meteorological Aids (i.e.
Technical Data Terms and Abbreviations AA Interatrial conduction time AESW Atrial extrasystole interval (atrial extrasystole window) ARP Atrial refractory period AUI Atrial upper interval AUR Atrial upper rate Autoshort Capacitor discharge time after pace AV Interval between an atrial action and the following ventricular action B Blanking BiA , BiV Biatrial, biventricular BI Basic interval BOS Beginning of service (for the implant) Cross-Triggering After atrial sensing events, pacing occur
Technical Data EOS End of pacemaker functioning (end of service) ERI Replacement indication (elective replacement indication) FFP Far-field protection Home Monitoring The implant data are made available to the treating physician via the cellular phone network and the Internet IAC Interatrial conduction time LA Left atrium LAESW Left atrial extrasystole safety window LV Left ventricle MAR Maximum activity rate (= sensor rate) MOR Maximum overdrive rate Mode Mode, pacing mode MSW Mode Switch
Technical Data RA Right atrium RAESW Right atrial extrasystole safety window Rate fading Rate smoothing. If the rate suddenly drops, e.g., upon the onset of bradycardia after a higher intrinsic rate.
Technical Data
Index Index A A/V rate trend......................................................... 98 A/V impedance trend ..........................................108 AAI mode ................................................................. 27 active capture control (ACC) .......................... 51-56 activity chart..........................................................107 AES classification.................................................101 AES coupling interval...........................................
Index D DDD mode ............................................................... 22 DDI mode................................................................. 25 DDT/A mode ........................................................... 28 DDT/V mode ........................................................... 28 default programs..................................................150 defibrillation, and interaction with pacemaker136 detection functions..........................................
Index H handling .................................................................118 household appliances..........................................134 high-frequency diathermy...................................137 home monitoring, parameters for .....................141 hyperbaric oxygen therapy .................................139 hysteresis AV hysteresis..................................................... 40 CLS and AV hysteresis..................................... 80 rate........................
Index DDT/V................................................................. 28 demand .............................................................. 28 DOO..................................................................... 27 DVI............................................................................ 26 OFF...................................................................... 29 overdrive...................................................... 22, 73 overview of (table) ..........................
Index pulse amplitude........................................................... 48 control, external...................................................9 data......................................................... 112, 128 parameters ......................................................143 width ................................................................... 48 PVARP, minimum................................................... 64 P-wave trend......................................................
Index automatic ..............................................................8 adjusting...........................................................127 sensor rate, maximum .......................................... 86 settings, factory, tolerances ...............................156 software, for programmer..................................... 10 statistics................................................................... 95 arrhythmia .......................................................
