Inventra 7 Iperia 5/7 Itrevia 5/7 Product Description Intended Medical Use Intended use Inventra/Iperia/Itrevia are parts of a familiy of implantable cardioverter-defibrillators (ICDs). Primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing.
System Overview Indications Inventra/Iperia/Itrevia can treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation. Generally approved differential diagnostics methods, indications, and recommendations for ICD therapy apply to BIOTRONIK devices. See the guidelines of cardiology associations for guidance.
Connector port RV SVC Lead Configuration connector DF-1 Shock coil DF-1 Shock coil RA (R)V LV IS-1 IS-1 IS-1 Bipolar Bipolar Unipolar, bipolar Implantation site Device type Right ventricle Superior vena cava Atrium (Right) ventricle Left ventricle VR, DX, DR, HF VR, DX, DR, HF DF4/IS4/IS-1 lead connection The device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment: HF QP DX, DR, HF VR, DX, DR, HF HF DF4-LLHH
Programmer Implantation and follow-up are performed with BIOTRONIK's portable programmer: There is one with integrated RF telemetry and one with a separate SafeSync Module. The programmer is used during implantation to transfer the current device program to the device. The pacing thresholds can be determined and all tests can be performed during in-office follow-up.
BIOTRONIK Home Monitoring® In addition to effective pacing therapy, BIOTRONIK provides a complete therapy management system: • With Home Monitoring, diagnostic and therapeutic information as well as technical data are automatically sent to a stationary or mobile transmitter via an antenna in the device header. The data are encrypted and sent from the transmitter to the BIOTRONIK Service Center via the cellular phone network. • The received data are deciphered and evaluated.
Order numbers for Inventra with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Order numbers for Itrevia with DF-1/IS-1, DF4/IS-1 or DF4/IS4/IS-1 connection Not all device types are available in every country: Itrevia 5 Itrevia 7 Inventra 7 DF-1/IS-1 DF4/IS-1 DF4/IS4 DF-1/IS-1 DF4/IS-1 DF4/IS4 393058 393059 — 393040 393041 — VR-T VR-T DX 393055 — — 393037 — — DR-T 392417 392422 — 392412 392426 — HF-T 393066 393064 — 3930
Therapeutic and Diagnostic Functions Package contents The storage package includes the following: • Sterile packaging with device • Serial number label • Patient ID card • Warranty booklet Note: Technical manuals are available either printed in the storage package or digitally in the internet.
Antibradycardia pacing and CRT • Innovative rate hystereses, automatic sensor functions, and a night program promote the patient's intrinsic rhythm, avoid overdrive pacing, and facilitate adaptation of the device to the individual needs of the patient. • Thresholds: atrial as well as ventricular pacing thresholds are automatically determined in the device.
2 General Safety Instructions Sterile packaging The device and screwdriver are packaged in two separately sealed blisters. The inner blister is also sterile on the outside so that it can be transferred in a sterile state during implantation. Single use only The device and screwdriver are intended for single use only. • Do not use the device if the package is damaged. • The device must not be resterilized and reused.
Possible Risks Possible technical failures Technical failure of a device system cannot be entirely ruled out.
3 Radiation therapy The use of radiation therapy must be avoided due to possible damage to the device and the resulting impaired functional safety. If this type of therapy is to be used anyway, prior risk/benefit analysis is absolutely necessary. The complexity of influencing factors such as different sources of radiation, a variety of devices and therapy conditions makes it impossible to issue directives that guarantee radiation therapy without an impact on the device.
Unpacking the device Preventing unintentional shock delivery W WARNING W WARNING Inadequate therapy due to defective device If an unpacked device is dropped on a hard surface during handling, electronic parts could be damaged. • Use a replacement device. • Return the damaged device to BIOTRONIK. Shock delivery with activated ICD There is a risk of unintended shock delivery when handling an activated ICD.
Connecting the lead connector to the device 1 2 3 4 5 6 7 8 Disconnect stylets and stylet guides. DF-1/IS-1 connection: • Connect the DF-1 connector for the right-ventricular shock coil to RV. • Connect the DF-1 connector for the supraventricular shock coil to SVC. Or connect a subcutaneous array to SVC. DF4/IS-1 or DF4/IS4 connection: • Connect the DF4 connector to RV DF-1/IS-1 connection: • Connect the bipolar IS-1 lead connector for the atrium to RA.
Precautionary Measures while Programming Applying the programming head The programming head (PGH) features a diagram of the device. This is used to assist in positioning the head to ensure proper telemetry. • Make sure the PGH is positioned correctly. Performing standard tests and monitoring the patient Critical conditions can occur for the patient even during standard tests due to inadequate parameter settings or interrupted telemetry. • Ensure sufficient patient care even during tests.
Avoiding critical parameter settings No modes and parameter combinations that pose a risk to the patient should be set. • Prior to setting rate adaptation, determine the patient's capacity for strain. • Check compatibility and effectiveness of parameter combinations after making settings. Preventing conduction of atrial tachycardia BIOTRONIK devices feature several functions to prevent conduction of atrial tachycardia to the ventricle(s): • Set mode switching for indicated patients.
Magnet Response Avoiding risks in the case of exclusive LV pacing Lead dislodgement in the case of exclusive left ventricular pacing could pose the following risks: loss of ventricular pacing and ATP therapy, induction of atrial arrhythmias. • Consider sensing and pacing parameters with reference to loss of therapy. • Exclusive LV pacing is not recommended for patients who depend on the device. • Please note that active capture control is not available.
Follow-up with BIOTRONIK Home Monitoring® Monitoring using the Home Monitoring function does not serve to replace regular inoffice appointments with the physician required for other medical reasons. Follow-up supported by Home Monitoring can be used to functionally replace in-office follow-up under the following conditions: • The patient was informed that the physician must be contacted despite use of the Home Monitoring function if symptoms worsen or if new symptoms arise.
Explantation and Device Replacement W CAUTION Explantation • Interrogate the device status. • Deactivate VT and VF therapies prior to explantation. • Remove the leads from the header. Do not simply cut them loose. • Use state-of-the-art techniques to remove the device and, if necessary, the leads. Temporally limited therapy If ERI occurs shortly after follow-up and is only detected during the subsequent follow-up, then the remaining service time can be much less than 3 months. • Replace device soon.
4 Parameters Timing: AV delay Range of values Standard AV dynamics Low; Medium; High; Fixed; (Individual) Low x x x N.n. ms Either automatic: AV delay after pacing + sense compensation Or: N.n. ms N.n. bpm N.n. bpm OFF; N.n. ms OFF; Positive; Negative; IRSplus OFF; Positive; Negative N.n.
Timing: Ventricular pacing Upper rate Atrial upper rate N.n. bpm OFF; N.n. bpm N.n. bpm N.n. bpm Parameter Range of values Standard Intervention rate Onset criterion Resolution criterion Modification of basic rate Mode OFF; N.n. bpm N.n. N.n. bpm N.n. x x x x x x OFF; N.n. bpm After mode VDD(R): VDI(R) After mode DDD(R): DDI(R) N.n. bpm VDI DDI x x x x x x x x OFF; N.n. bpm N.n. min N.n. bpm N.n.
Pacing: Ventricular capture control Timing: Rate adaptation via accelerometer Maximum sensor rate Sensor gain N.n. bpm AUTO; Very low; Low; Medium; High; Very high Very low; Low; Medium; High; Very high N.n. bpm/cycle N.n. bpm/cycle 160 bpm Medium Medium x x x x Rate increase Rate decrease Range of values Standard x x x x x x x x Ventricular capture control Threshold test start OFF; ATM; ON N.n. V x x x x x x x x Minimum amplitude Safety margin N.n. V N.n. V ATM ATM: N.n.V ON: N.n. V N.n.
Tachycardia LV lead configuration with IS4 Pacing polarity LV (IS4) LV1 tip ->LV2 ring LV1 tip -> LV4 ring LV1 tip -> RV coil LV1 tip -> ICD LV2 ring -> LV1 tip LV2 ring -> LV4 ring LV2 ring -> RV coil LV3 ring -> LV2 ring LV3 ring -> LV4 ring LV3 ring -> RV coil LV4 ring -> LV2 ring LV4 ring -> RV coil LV1 tip -> LV2 ring LV2 ring -> LV3 ring LV3 ring -> LV4 ring LV1 tip -> ICD LV2 tip -> ICD LV3 tip -> ICD LV4 tip -> ICD LV1 tip >LV2 ring MRI program Valid for devices with ProMRI®: Parameter Range of
N.n. ms Therapy: Shock x x x x x x OFF Parameter Range of values Standard Therapy Rate Duration Backup Stimulation Mode OFF; HF burst N.n. Hz N.n. s OFF; N.n. bpm OFF; V00 OFF N.n. Hz N.n.
Range of values Standard VR DX DR HF Diagnostics Upper threshold duration after detection Upper threshold duration after pacing Lower threshold RV T-wave suppression after pacing Minimum threshold A Minimum threshold RV Minimum threshold LV N.n. ms VFS: N.n. ms N.n. ms x x x x The following can be set: Parameter N.n. ms N.n.% OFF x x x x x x x x N.n. mV N.n. mV N.n. mV N.n. mV N.n. mV N.n. mV x x x x x x x x OFF; ON; Advanced ON OFF; ON When Home Monitoring OFF: OFF; N.n.
5 Technical Data Factory settings • Arrhythmia zones VT1, VT2, VF: OFF • Antibradycardia pacing: OFF • Home Monitoring: OFF Mechanical Characteristics Housing Devices with a DF-1/IS-1, DF4/IS-1 or DF4/IS4 header: Type Connector port W x H x D in mm Volume cm3 VR DX DR HF HF QP DF-1 DF4 DF-1 — DF-1 DF4 DF-1 DF4 DF4/IS4 Telemetry data • Nominal carrier frequency: 403.6 MHz • Maximum power of transmission: < 25 µW (-16 dBm) Mass g 65 x 55 x 12.5 65 x 52 x 12.5 65 x 55 x 12.
tions are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. • This device will be registered with Federal Communications Commission under the following number: FCC ID: QRITACH70 ATP amplitude A burst was measured at 500 Ω, an amplitude of 7.5 V (tolerance ±1.5 V), pulse width of 1.
Battery Data Battery characteristics The following data is provided by the manufacturers: Manufacturer GREATBATCH, INC. Clarence, NY 14031 Battery type GB 2992 Battery ID number shown on the 3 programmer Device type Battery voltage at ERI Charge time at BOS Charge time at ERI Usable capacity until ERI Usable capacity until EOS VR, (DX), DR, HF 2.5 V 10 s 12 s 1590 mAh 1730 mAh • Capacitor reforming is performed N.n. times per year and therefore at least N.n.
Legend for the Label TP2 Compatibility with telemetry protocol, version 2 of BIOTRONIK Home Monitoring Label on the package The label icons symbolize the following: Manufacturing date Use by Temperature limit Order number Serial number Product identification number Dangerous voltages! CE mark Contents Follow the instructions for use Device: NBG code and compatible leads Example Factory settings for therapy: OFF Example Screwdriver Examples of DF-1/IS-1 or DF4/IS-1 header 2 Sterilized with et
