(Draft) Cardiac Airbag / Cardiac Airbag-T Family of Implantable Cardioverter Defibrillators and Software Cartridge for TMS 1000 PLUS and EPR 1000 PLUS Technical Manual
X-ray Identification Cardiac Airbag/Cardiac Airbag-T Implantable Cardioverter Defibrillator Inside the housing, top left-hand side: EI X-Ray identification • Year of manufacture C AUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. 2003 BIOTRONIK, Inc., all rights reserved.
Cardiac Airbag Technical Manual i Contents 1. General...........................................................................1 1.1 System Description....................................................1 1.2 Indications and Usage ...............................................2 1.3 Contraindications .......................................................2 1.4 Warnings and Precautions.........................................3 1.4.1 Sterilization, Storage, and Handling ..................3 1.4.
ii Cardiac Airbag Technical Manual 2.3 Tachyarrhythmia Redetection ....................................28 2.3.1 VT Redetection ..................................................28 2.3.2 VF Redetection ..................................................28 2.3.3 Tachyarrhythmia Termination ............................28 2.4 Tachyarrhythmia Therapy ..........................................28 2.4.1 Shock Therapy...................................................29 2.5 Bradycardia Therapy .......................
Cardiac Airbag Technical Manual iii 5.6 Blind Plug Connection ...............................................55 5.7 Program the ICD........................................................56 5.8 Implant the ICD ..........................................................56 5.9 Suggested Cardiac Airbag Implant Procedure ..........57 6. Follow-up Procedures ..................................................68 6.1 General Considerations .............................................68 6.
iv Cardiac Airbag Technical Manual Cardiac Airbag Specifications Battery Voltage: 6.3 Volts Maximum Shock Energy: 30 joules Defibrillation Lead Ports Two DF-1 (3.2 mm) Pacing Lead Ports One IS-1 (3.
Cardiac Airbag Technical Manual 1 1. General 1.1 System Description The Cardiac Airbag family of Implantable Cardioverter Defibrillators (ICDs) detects and treats ventricular tachyarrhythmias as well as provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician’s assessment of a patient’s condition and the performance of the implanted device.
2 Cardiac Airbag Technical Manual The Cardiac Airbag and Cardiac Airbag-T have two DF-1 defibrillation / cardioversion and one IS-1 pacing/sensing header ports. IS-1 refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit [Reference ISO 5841-3:1992]. DF-1 refers to the international standard for defibrillation lead connectors [Reference ISO 11318:1993].
Cardiac Airbag Technical Manual 3 1.4 Warnings and Precautions ATP (Anti-Tachycardia Pacing) – The Cardiac Airbag ICD does not provide ATP therapy. Do not implant this ICD in patients with documented ventricular tachycardias unless high energy defibrillation is desired for treatment of the ventricular arrhythmia. MRI (Magnetic Resonance Imaging) - Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient.
4 Cardiac Airbag Technical Manual Storage (temperature) - Store the device between 5° to 55°C (41° - 131° F) because temperatures outside this range could damage the device. Storage (magnets) - To avoid damage to the device, store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference (EMI).
Cardiac Airbag Technical Manual 5 Magnets - Positioning of a magnet or the programming wand over the ICD will suspend tachycardia detection and treatment. The minimum magnet strength required to suspend tachycardia treatment is 1.8 mT. When the magnet strength decreases to less than 1 mT, the reed contact is reopened. Pacemaker/ICD Interaction - In situations where an ICD and a pacemaker are implanted in the same patient, interaction testing should be completed.
6 Cardiac Airbag Technical Manual Shock Impedance - If the shock impedance is less than twentyfive ohms, reposition the lead system to allow a greater distance between the electrodes. Never implant the device with a lead system that has measured shock impedance as less than twenty-five ohms. Damage to the device may result. Programming Wand - Throughout the EP Test session, the programming wand must be positioned and remain directly over the device.
Cardiac Airbag Technical Manual 7 Kinking Leads - Do not kink leads. This may cause additional stress on the leads that can result in damage to the lead. Liquid Immersion - Do not immerse leads in mineral oil, silicone oil, or any other liquid. Short Circuit - Ensure that none of the lead electrodes are in contact (a short circuit) during delivery of shock therapy as this may cause current to bypass the heart or cause damage to the ICD system.
8 Cardiac Airbag Technical Manual Resuscitation Availability - Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing should the patient require external rescue. Safe Program – Within the EP Test screen, pressing the “Safe Program” key on the programmer head does not immediately send the safe program to the ICD.
Cardiac Airbag Technical Manual 9 1.4.6 Hospital and Medical Hazards Electromagnetic interference (EMI) signals present in hospital and medical environments may affect the function of any ICD or pacemaker. The ICD is designed to selectively filter out EMI noise. However, due to the variety of EMI signals, absolute protection from EMI is not possible with this or any other ICD. The ICD system should have detection and therapy disabled prior to performing any of the following medical procedures.
10 Cardiac Airbag Technical Manual External Defibrillation - The device is protected against energy normally encountered from external defibrillation. However, any implanted device may be damaged by external defibrillation procedures. In addition, external defibrillation may also result in permanent myocardial damage at the electrode-tissue interface as well as temporary or permanent elevated pacing thresholds.
Cardiac Airbag Technical Manual 11 1.4.7 Home and Occupational Hazards Patients should be directed to avoid devices that generate strong electromagnetic interference (EMI) or magnetic fields. EMI could cause device malfunction or damage resulting in non-detection or delivery of unneeded therapy. Moving away from the source or turning it off will usually allow the ICD to return to its normal mode of operation.
12 Cardiac Airbag Technical Manual Based on results to date, adverse effects resulting from interactions between cellular telephones and implanted ICDs have been transitory. The potential adverse effects could include inhibition or delivery of additional therapies. If electromagnetic interference (EMI) emitting from a telephone does adversely affect an implanted ICD, moving the telephone away from the immediate vicinity of the ICD should restore normal operation.
Cardiac Airbag Technical Manual 13 1.5 Adverse Events 1.5.
14 Cardiac Airbag Technical Manual Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD system that may include the following: • Dependency • Depression • Fear of premature battery depletion • Fear of shocking while conscious • Fear that shocking capability may be lost • Imagined shocking (phantom shock) There may be other risks associated with this device that are currently unforeseeable. 1.5.
Cardiac Airbag Technical Manual 15 Two ICDs were explanted during the trial. One was secondary to the patient being unable to tolerate further testing required by the clinical protocol. The other was secondary to a systemic infection; the patient was subsequently implanted with another device. Table 1 provides a summary of the adverse events that were reported during the clinical study regardless of whether or not the event was related to the ICD system.
16 Cardiac Airbag Technical Manual Event High DFT’s Minor stroke Renal failure Required additional drug therapy ICD/lead connection ICD therapy during lead connection Non-sustained VT Non-conversion of arrhythmia of real-time Interpretation markers Reconfirmation algorithm # of pts with AEs 1 1 1 1 % of pts with AEs 0.6% 0.6% 0.6% 0.6% # of AEs 2 1 1 1 AE/ ptyrs 0.02 0.01 0.01 0.01 1 1 0.6% 0.6% 1 1 0.01 0.01 1 1 1 0.6% 0.6% 0.6% 1 1 1 0.01 0.01 0.01 1 0.6% 1 0.01 1.
Cardiac Airbag Technical Manual 17 1.6 Clinical Studies N OTE : The Phylax XM ICD is an earlier generation of BIOTRONIK devices. The Cardiac Airbag family is based upon the Phylax XM and other BIOTRONIK ICDs (i.e., Belos VR and Belos VR-T). This clinical study was performed on the Phylax XM and Phylax 06 ICDs, which are earlier versions of the Cardiac Airbag ICD.
18 Cardiac Airbag Technical Manual 1.6.2 Methods The multicenter clinical investigation was designed to validate the safety and effectiveness of the ICD system to detect and treat monomorphic ventricular tachycardia (MVT), polymorphic ventricular tachycardia (PVT), ventricular fibrillation (VF), and bradycardia.
Cardiac Airbag Technical Manual 19 Table 2: Clinical Study Results Description Study Group [95% CI] 95.8% (496/518) Tachyarrhythmia Conversion Rate1 [93.6%, 97.3%] Induced Spontaneous Total Sudden Cardiac Death Survival (at one year) Complication Rate (per total number of patients) Appropriate Sensing and Pacing Rate2 99.7% (1540/1544) [99.3%, 99.9%] 98.7% (2036/2062) [98.2%, 99.2%] 100.0% (39/39) [91.0%, 100.0%] 5.2% (8/154) [2.3%, 10.0%] 98.0% (703/717) [96.8%, 98.9%] 1.
20 Cardiac Airbag Technical Manual 1.7 Patient Selection and Treatment 1.7.1 Individualization of Treatment • • • Determine whether the expected device benefits outweigh the possibility of early device replacement for patients whose ventricular tachyarrhythmias require frequent shocks. Determine if the device and programmable options are appropriate for patients with drug-resistant supraventricular tachyarrhythmias (SVTs), because drug-resistant SVTs can initiate unwanted device therapy.
Cardiac Airbag Technical Manual 21 Persons administering CPR may experience the presence of voltage on the patient’s body surface (tingling) when the patient’s ICD system delivers a shock. A patient manual is available for the patient, patient’s relatives, and other interested people. Discuss the information in the manual with concerned individuals both before and after pulse generator implantation so they are fully familiar with operation of the device.
22 Cardiac Airbag Technical Manual 2. Device Features The Cardiac Airbag family feature set is presented under the following sub-headings: Sensing, Tachyarrhythmia Detection, Tachyarrhythmia Redetection, Tachyarrhythmia Therapy, Bradycardia Therapy, and Special Features. The features apply to all members of the Cardiac Airbag family except where specifically referenced differently. 2.
Cardiac Airbag Technical Manual 23 Setting Standard Enhanced T Wave Suppression Table 3: Sensitivity Settings Definition for Use This setting is recommended for most patients, especially for those with measured R-wave amplitude of ≥3 mV. This setting offers suppression of T-wave oversensing. This mode should not to be used on patients with the following conditions: • Sinus rhythms with small signal amplitudes, R-waves <4 mV • Enhanced VF Sensitivity Free VF with highly fluctuating signal amplitudes.
24 Cardiac Airbag Technical Manual Figure 1. Automatic Sensitivity Control with Standard Setting Figure 1 provides an illustration of Automatic Sensitivity Control with the sensitivity programmed to Standard. The tracked R – wave is measured to be 6.0 mV following the sensed refractory period the UT is set to 3.0 mV. After the T-wave discrimination period, the threshold is further reduced to 1.5 mV. Both the Upper and Lower Thresholds decay over time, but the Minimum Threshold is never violated.
Cardiac Airbag Technical Manual 25 E N H AN C E D T - W AV E S U P P R E S S I O N - The Enhanced T-Wave Suppression setting is specifically designed to avoid double counting of each QRS-T complex during normal sinus rhythms. Two adjustments are made to ASC with this setting: • • • High pass filtering is increased to reduce low frequency signal components such as T-waves and respiratory artifacts. The UT is increased to 75% of the measured R-wave.
26 Cardiac Airbag Technical Manual 2.2.1 VF Classifications Detection of ventricular fibrillation (VF) utilizes a nonprogrammable X out of Y criterion. If X number of intervals within the sliding window (defined by Y) are shorter than the programmed VF rate interval in ms (> in bpm), VF is detected. After fibrillation is detected, the programmed therapy sequence for VF is initiated.
Cardiac Airbag Technical Manual 27 2.2.4 Onset and Stability In addition to the standard tachycardia detection parameters previously described, the VT Monitoring Zone incorporates two additional detection enhancements: Onset and Stability. Both Onset and Stability are preset to standard values and are not programmable for the VT Monitoring Zone. 2.2.4.1 Onset The Onset function provides an additional discrimination test that must be satisfied before a VT tachyarrhythmia can be declared.
28 Cardiac Airbag Technical Manual 2.3 Tachyarrhythmia Redetection The Cardiac Airbag ICDs incorporate settings for determining if tachyarrhythmias remain after therapy has been delivered. The redetection routine allows the ICDs to determine whether further therapy is required when the initial therapy was unsuccessful in terminating the arrhythmia. Tachyarrhythmia redetection criteria are based on cardiac cycle length and number of intervals.
Cardiac Airbag Technical Manual 29 2.4.1 Shock Therapy The Cardiac Airbag ICDs offer shock therapy only for the VF rate classifications. Up to 8 shocks are available for the VF zone for each episode detected. The first defibrillation shock in the therapy sequence is delivered with confirmation (while the capacitors are being charged). The first shock energy is programmable to 20 or 30 joules and is delivered following confirmation of the arrhythmia.
30 Cardiac Airbag Technical Manual Synchronization - A synchronization window is started at the end of the charging period. During this window, the device will attempt to synchronize the shock therapy to an R-wave. If no Rwave is detected, the shock will be delivered asynchronously at the end of the synchronization period. 2.4.1.3 Shock Waveform All shocks utilize a standard biphasic waveform. The waveform starts at the calculated voltage, based on the programmed energy level.
Cardiac Airbag Technical Manual 31 2.5 Bradycardia Therapy The Cardiac Airbag ICDs have programmable bradycardia and post-shock bradycardia pacing functions. The post-shock bradycardia parameters are preset to a higher rate and output values following a delivered shock, without compromising the longevity of the ICD for patients who require chronic bradycardia pacing. The post-shock values are presented in the following subsections after the chronic bradycardia support values. 2.5.
32 Cardiac Airbag Technical Manual 2.5.4 Gain and Threshold The Gain defines how much the sensor signal is amplified before it is used by the rate adaptive algorithm. The Gain is programmed so the maximum desired pacing rate during exercise occurs at a maximum exertion level. The Gain is preset to 4 when programmed to the VVIR mode. The Sensor Threshold defines the lowest sensor output that initiates a change in the pacing rate and all motion below this threshold is ignored by the algorithm.
Cardiac Airbag Technical Manual 33 2.5.8 Pulse Width The Pulse Width parameter defines the duration of the pacing pulses. The pulse width is independently set for normal and post-shock bradycardia pacing. 2.5.9 Noise Response The Cardiac Airbag ICD’s response to detected noise is to deliver asynchronous pacing in ventricular channel. 2.5.10 Post Shock Pacing Separately, bradycardia pacing support is available with the ICD following shock therapy delivery.
34 Cardiac Airbag Technical Manual 2.6.1.1 Transmission of Information The implant transmits information with a small transmitter, which has a range of about 2 meters. The transmissions are activated by the detection of an arrhythmia episode, as programmed. The types of transmissions are discussed in Section 2.6.1.4. The minimal distance between the implant and the patient device must be 15 cm. 2.6.1.
Cardiac Airbag Technical Manual 35 Figure 3: Example of Patient Device with Charging Stand (CardioMessenger) 2.6.1.3 Cardio Report The implant’s information is digitally formatted by the BIOTRONIK Service Center and processed into a concise report called a Cardio Report. The Cardio Report is titled depending on the type of event transmission. This Cardio Report contains current and previous implant data. The Cardio Report is sent to the attending physician via fax. All reports use the same report format.
36 Cardiac Airbag Technical Manual To ensure successful transmission of the patient data, the Cardiac Airbag-T is programmed to send up to 10 repetitive transmissions of identical data at an hourly time interval. Event Report - When certain cardiac and technical events are detected by the implant, a report transmission is automatically triggered. This is described as an “event message”.
Cardiac Airbag Technical Manual 37 Leads • Pace impedance (ventricular) • Shock impedance • Date of impedance measurements Device Status Summary • Status • Remarks 2.6.2 Real-time IEGM Transmission The pulse generators provide real time transmission of the unfiltered intracardiac electrogram (IEGM) to the programmer. IEGMs from the proximal shock coil (SVC) and ventricle can be simultaneously recorded with a bandwidth of 0.5 to 200 Hz.
38 Cardiac Airbag Technical Manual An automatic or manually initiated capacitor reform fully charges the capacitors and then allows the capacitors to drain off through the internal circuitry of the ICD. No shock will be delivered to the patient. Throughout the reformation process the ICD will provide bradycardia pacing support and tachyarrhythmia sensing and detection as programmed. If a tachyarrhythmia is detected during capacitor reformation, the process is aborted and therapy is available if required.
Cardiac Airbag Technical Manual 39 2.6.5 System Status Various device parameters can be monitored through the Status section of the programmer screen. (See Figure 4) Displayed data includes ICD information, charge circuit parameters, capacitor reformation data, battery status, and lead information.
40 Cardiac Airbag Technical Manual Figure 4. System Status 2.6.6 Holter Memory Important information is available within the Holter memory. The Holter memory has a preset configuration to provide the most critical information to the physician. 2.6.6.1 Episode List The ICD stores essential diagnostic data about tachyarrhythmia episodes that may be used to optimize tachyarrhythmia detection and therapy parameters. This diagnostic data includes a therapy history and stored intracardiac electrograms.
Cardiac Airbag Technical Manual 41 Figure 5.
42 Cardiac Airbag Technical Manual Figure 6. Stored IEGM 2.6.7 Arrhythmia Induction Features The Cardiac Airbag ICD offers two arrhythmia induction methods for non-invasive EP testing. These include the following: HF Burst Induction This feature consists of a large number of pulses delivered in rapid succession over a period of several seconds. The frequency of the pulses and the duration of the burst are defined by the user.
Cardiac Airbag Technical Manual 43 2.6.8 Manual Shock The Cardiac Airbag ICD can deliver a manual shock on demand through a programmer command in the EP test menu. To deliver a shock, place the wand over the device and select the Start Shock button. A confirmation menu will appear and the shock command will be delivered upon selecting the OK button in this screen. After each manual shock, the EP test screen will display the shock energy, lead impedance and charge time. 2.6.
44 Cardiac Airbag Technical Manual 3. Software Features This section describes the features available with A-K00.0.U programmer software and the procedures necessary for interrogating and programming Cardiac Airbag ICDs. All references to Cardiac Airbag are also applicable to the Cardiac Airbag-T. Please refer to the TMS 1000PLUS or EPR 1000PLUS technical manuals for detailed descriptions of how to operate within the specific menus and windows. 3.
Cardiac Airbag Technical Manual 45 Figure 7. Follow-Up Assistant with measured values 3.1.1 Interrogate ICD without Follow-up To perform an interrogation without using the Follow-Up Assistant, select Skip Follow-Up Interrogate ICD. Once interrogation is completed all current programmed parameters are listed within the Parameter screen. 3.
46 Cardiac Airbag Technical Manual [Follow-Up] - The Follow-up Assistant (FAST) is into the programmer applications to provide a system guided follow-up. The “guided” follow-up developed to allow consistent and quick actions through a single command. incorporated user-defined function was by the user [Parameter] - The [Parameter] window serves for programming all parameters for sensing, detection and therapies.
Cardiac Airbag Technical Manual 47 [Emergency] - The [Emergency] function key is always present. Activating this key produces a screen display that turns ventricular tachyarrhythmia Detection ON and OFF, activates emergency bradycardia pacing parameters, or activates a programmer commanded shock. [Print] - This function key appears in the lower right side of the screen in windows with printing options. Activation of this key immediately prints the relevant data from the open window. 3.
48 Cardiac Airbag Technical Manual Figure 8.
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50 Cardiac Airbag Technical Manual 4. Sterilization and Storage The ICD is shipped in a storage box, equipped with a quality control seal and product information label. The label contains the model specifications, technical data, serial number, use before date, and sterilization and storage information. The ICD and its accessories have been sealed in a container and gas sterilized with ethylene oxide. To ensure sterility, the container should be checked for integrity prior to opening.
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52 Cardiac Airbag Technical Manual 5. Implant Procedure 5.1 Implant Preparation Prior to beginning the ICD implant procedure, ensure that all necessary equipment is available. The implant procedure requires the selected lead system (including sterile back-ups), the programmer with appropriate software, and the necessary cabling and accessories.
Cardiac Airbag Technical Manual 53 Refer to the appropriate lead system technical manual. 5.3 Opening the Sterile Container The Cardiac Airbag ICDs are packaged in two plastic containers, one within the other. Each is individually sealed and then sterilized with ethylene oxide. Due to the double packing, the outside of the inner container is sterile and can be removed using standard aseptic technique and placed on the sterile field.
54 Cardiac Airbag Technical Manual 5.5 Lead to Device Connection The Cardiac Airbag ICDs have been designed and are recommended for use with a defibrillation lead systems having one IS-1 connector for ventricular sensing and pacing and up to two DF-1 connectors for delivery of shock therapy. Figure 9 depicts the configuration of the header ports on the Cardiac Airbag, where HV1 and HV2 are for DF-1 connectors, and V P/S is for IS-1 connectors. Figure 9.
Cardiac Airbag Technical Manual 55 Refer to the following steps when connecting the leads to the device. 1. Confirm that the setscrews are not protruding into the connector receptacles. To retract a setscrew, insert the enclosed torque wrench through the perforation in the self-sealing plug at an angle perpendicular to the lead connector until it is firmly placed in the setscrew. Rotate the wrench counterclockwise until the receptacle is clear of obstruction. 2.
56 Cardiac Airbag Technical Manual 1. Confirm that the setscrews are not protruding into the connector receptacles. To retract a setscrew, insert the enclosed torque wrench through the perforation in the self-sealing plug at an angle perpendicular to the lead connector until it is firmly placed in the setscrew. Rotate the wrench counterclockwise until the receptacle is clear of obstruction. 2.
Cardiac Airbag Technical Manual 57 Prior to surgically closing the pocket, the telemetry contact should be evaluated to help ensure chronic programmer communication. Close the device pocket using standard surgical technique. As the final step at device implant and each patient follow-up, the permanent program should be retransmitted to the ICD. Complete the Medical Device Registration Form provided with the ICD and return it to BIOTRONIK. 5.
58 Cardiac Airbag Technical Manual Figure 10. System Status Performing a manual capacitor reformation 1. Press Options button. 2. Select Start Formation (See Figure 11.) and then OK. 3. During charging, an ICD Charging meter is displayed in the ICD Status box. 4. Return to Status screen. 5. Verify the ICD Charge Time.
Cardiac Airbag Technical Manual 59 Figure 11. Manual Cap Reform Accessing the TMS 1000PLUS for lead and device-based testing 1. Press Options button. 2. In the Programmer area, press Implant List button to return to the main programmer screen. 3. Select TMS 1000 from the Implant List. Connecting the ventricular lead for testing 1. Connect the terminal pins of the ventricular lead to the appropriate port of the PK-44 Cable.
60 Cardiac Airbag Technical Manual Measuring R-wave Amplitude 1. Select Intracardiac Measurements 2. Press and hold the Record Data (See Figure 12) button to measure the R-wave amplitude. There is an audible tone when the ICD has detected a sensed R-wave. 3. In general, R-wave amplitudes should be greater than 5 mV. 4. Press Print to obtain a printout of the measurement. Figure 12.
Cardiac Airbag Technical Manual 61 Determining ventricular capture thresholds 1. Verify VVI mode is highlighted. 2. Set the Lower Rate at 5 to 10 ppm above the patient’s intrinsic rate. 3. Press Start Pacing to begin threshold testing at the displayed parameters. 4. Decrease Pulse Amplitudes (See Figure 13) until loss-of-capture occurs. 5. Press Stop Pacing to return to the patient’s intrinsic rhythm. Figure 13. Pacing Threshold Test 6. In general, ventricular pacing thresholds should be less than 1.0 V.
62 Cardiac Airbag Technical Manual Testing for diaphragmatic stimulation 1. Select 10.0 V in the Pulse Amplitude pop-up menu to test for diaphragmatic stimulation. 2. Press Start Pacing. 3. Check for diaphragmatic stimulation. 4. Press Stop Pacing to return to the patient’s intrinsic rhythm. Connecting the ICD to the leads 5. Verify VT/VF Detection is disabled. 6. Hand off the pre-programmed ICD to the implanting physician. 7.
Cardiac Airbag Technical Manual 63 Performing device-based testing measurements 1. Press Implant List button. 2. Place a sterile cover over the programming wand and instruct the implanting physician to position the wand over the device. 3. A green flashing light on the wand indicates good telemetry communication 4. Cardiac Airbag is automatically interrogated. 5. Press Start Follow-Up to automatically interrogate the device.
64 Cardiac Airbag Technical Manual DFT testing 1. Select method to induce ventricular fibrillation with the ICD: Shock on T wave or HF burst. 2. Press Print button to begin printing induction. 3. Press Start VT/VF Induction (See Figure 14) and OK to induce VF. 4. Observe the IEGM, markers, and ICD charging indicator on the programmer screen. Figure 14. VF Induction Test 5. After successful delivery of therapy, press Print to stop printing.
Cardiac Airbag Technical Manual 65 Figure 15. VF Induction Test 6. Read Shock Data is automatically updated with shock values. 7. Press Print to print out the DFT Test Screen. 8. Select Holter and review EGM to ensure proper sensing during VF. 9. Repeat induction process for a second therapy success or until the DFT is found. 10. After testing is complete, select VT/VF Detection to disable detection and prevent any inappropriate shocks during the remainder of the implantation procedure.
66 Cardiac Airbag Technical Manual Final Programming 1. Verify final programming of the following parameters: detection intervals, pacing, sensing, and therapy. 2. Select Transmit to permanently program final parameters. 3. Verify VT/VF Detection is Enabled. 4. Select Parameter button and press Interrogate then Print to print out final programming and system status.
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68 Cardiac Airbag Technical Manual 6. Follow-up Procedures 6.1 General Considerations An ICD follow-up serves to verify appropriate function of the ICD system, and to optimize the programmable parameter settings. In addition to evaluating the patient’s stored therapy history and electrograms, acute testing of sensing and pacing is recommended.
Cardiac Airbag Technical Manual 69 Starting Follow-Up Assistant 1. The software begins by displaying the Follow-Up Assistant screen. (See Figure 16) (To fully activate the Follow-Up Assistant program, ensure that all boxes are checked.) 2. Press Start Follow-Up, located in the lower left corner of the screen. This button begins the followup procedure by performing a complete interrogation of the ICD. Battery status, sensing, lead impedance, and episode counters are automatically verified. Figure 16.
70 Cardiac Airbag Technical Manual Determining the ventricular pacing threshold 17) 1. Enter Tests→Threshold (See Figure (automatic through Follow-up Assistant.) 2. Set Rate at 5 to 10 ppm above the patient’s intrinsic rate. 3. If desired, turn Print Test ON to run paper during testing. 4. Press Start Test to begin threshold testing at displayed parameters. 5. Decrease Test Amplitudes until loss-of-capture occurs. 6. Press Stop Test. (Permanently programmed pacing values are immediately restored.) 7.
Cardiac Airbag Technical Manual 71 Figure 17. Pacing Threshold Test Printing and analyzing detailed Holter data information 1. Press the Holter (See Figure 18) button to view episodes. 2. From the Episode List, select the episode EGM you wish to view and/or print. 3. Press Print to obtain a printed record of all events since implantation.
72 Cardiac Airbag Technical Manual Figure 18. Holter EGM Episode Verify system status 1. Press Follow-up button. 2. Check R Amplitudes (greater than 5 mV) 3. Verify Pacing Impedance values are within an acceptable range (300-1000Ω) 4. Verify Battery Status is OK. Verifying remaining shocks to ERI 1. Press Status button. (See Figure 19) 2. Review the date of last charge event, charge time, delivered energy, and shock impedance.
Cardiac Airbag Technical Manual 73 Figure 19. System Status 3. Verify remaining shocks to ERI by checking the level of the episode gauge. 4. ERI is reached when 3 treated VF episodes have occurred. 5. At ERI, contact your local BIOTRONIK representative. Making parameter changes and obtaining final printouts 1. Touch the parameter to be changed and select the new value from the pop-up menu. 2. Permanently program any changes by pressing Transmit. 3.
74 Cardiac Airbag Technical Manual 6.3 Longevity The service time of an ICD can vary based on several factors, including the number of charge sequences, programmed parameters, number of tachyarrhythmias detected, relative amount of bradycardia pacing required, pacing lead impedance, storage time, battery properties, and circuit operating characteristics. For the Cardiac Airbag ICD, there are two methods for reaching ERI.
Cardiac Airbag Technical Manual 75 In this table, it is assumed that the device delivers no shocks to treat ventricular tachyarrhythmias, however, automatic capacitor reformations are equally spaced on a quarterly (every 3 months) basis throughout the life of the ICD. Therefore, the table starts at a minimum of 4 shocks per year, because capacitor reformations are equivalent to shocks. The estimates associated with 0% pacing support assume the ICD is sensing an intrinsic sinus rhythm at a rate of 70 bpm.
76 Cardiac Airbag Technical Manual 6.3.2 Treated VF Episode ERI Method The Cardiac Airbag ICD is designed to treat a limited number (3) of spontaneous VF episodes prior to reaching ERI. Induced VF episodes via the BIOTRONIK programmer that receive shock therapy with the programmer wand in place do not increment against the 3 treated VF episode limit. Only spontaneous VF episodes that receive shock therapy increment the treated VF episode count.
Cardiac Airbag Technical Manual 77 Figure 21. Status at ERI Upon reaching ERI, the battery has enough energy left to continue monitoring for at least three months and to deliver a minimum of six high energy shocks. The estimates associated with duration of ERI assume the ICD is sensing an intrinsic sinus rhythm at a rate of 70 bpm. After this period the device is at EOS and should be explanted. Upon reaching EOS all tachyarrhythmia detection and therapy is disabled.
78 Cardiac Airbag Technical Manual 6.4 Explantation Explanted ICDs, lead systems, and accessories may not be reused. Please complete the appropriate out of service (OOS) form and return it to BIOTRONIK with the explanted devices. All explanted devices should be sent packaged in a bio-hazard container. These may be delivered to either the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal. Contact BIOTRONIK if you need assistance with returning explanted devices.
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80 Cardiac Airbag Technical Manual 7. Technical Specifications The following are the technical specifications for the Cardiac Airbag ICDs. The ranges are presented in the format: x…(y)…z where x = the lowest value, y = the increment, and z = the largest value. N OTE : Values depicted in gray are preset in the ICD and are not programmable values.
Cardiac Airbag Technical Manual 81 Parameters - Tachyarrhythmias Parameter Value Range Detection Parameters for VT Monitoring Zone Rate (VT Monitoring) OFF; 270…(10)…600 ms 100…222 bpm Interval Counter: Initial 16 Detection Interval Counter: Redetection 12 Onset 20 % (adaptive) Stability ±24 ms (absolute) Detection and Redetection Parameters for VF Zone Interval / Rate OFF; 200 …(10)…400 ms 150…300 bpm Number of X 8 Number of Y 12 Termination Detection 12 in 16 Shock Therapy Parameter Number of Shocks 1st S
82 Cardiac Airbag Technical Manual Bradycardia Therapy Parameter Value Range Mode VVI, VVIR, OVO (OFF) Rate 30…(5)…120 ppm Amplitude 0.2…(0.1)…6.2, 7.5 V Pulse Width 0.5, 1.0, 1.5 ms Maximum Sensor Rate 100, 125 ppm Sensor Gain 4 Sensor Threshold mean Rate Increase 2 ppm/s Rate Decrease 0.4 ppm/s Post-Shock Bradycardia Therapy Parameter Value Range Mode VVI Rate 70 ppm Amplitude 7.5 V Pulse Width 1.
Cardiac Airbag Technical Manual 83 Federal Communications Commission Disclosure The Belos-T ICD 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.
84 Cardiac Airbag Technical Manual
Cardiac Airbag Technical Manual 85 Appendix A Connector Compatibility Cardiac Airbag ICDs are indicated for use only with commercially available BIOTRONIK bipolar ICD lead systems or other lead systems with which it has been tested. The Cardiac Airbag family of ICDs is mechanically compatible with: • IS-1 sensing/pacing lead connectors • DF-1 defibrillation lead connectors. The Cardiac Airbag and Cardiac Airbag-T ICDs have a single IS-1 header port and two DF-1 header ports.
Distributed by: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by: M4088-A 3/03 BIOTRONIK GmbH & Co.
