IMPLANTED ELECTROCARDIOSTIMULATOR TWO-CHAMBERED
A dual-chamber implantable pacemaker (IPP) with an extended service life. An MRI-compatible dual-chamber implantable pacemaker allows patients with an implanted system to undergo 1.5T and 3T MRI scans without restrictions on the scanning area (including the heart area) or the duration of the MRI scan procedure, provided that the device is implanted with MRI-compatible electrodes and the manufacturer’s requirements for MRI scans are met.
Device: connectors: IS-1; weight: 14.2 g; volume: 29.2 cm3; dimensions: 58.8 mm x 44.5 mm x 7.5 mm.
Materials in contact with human body tissues: Titanium, polyurethane, silicone rubber
Body shape: Physiological.
Connector with color-coded port indicators.
High-capacity battery with technology that provides a service life of more than 15 years.
The device’s battery capacity is 1.6 Ah.
The estimated service life is 15.1 years under the following conditions: DDDR stimulation mode, 100% stimulation,
base frequency of 60 per minute, atrial and ventricular impulse duration of 0.4 ms, electrode impedance of 750
ohms, atrial/ventricular stimulus amplitude of 2.0 V; accelerometer is ON; multi-channel EEG recording is constantly ON.
Wireless telemetry and wireless ECG function.
Availability of functions: automatic measurement of stimulation thresholds and automatic change of stimulation parameters when thresholds change in all
chambers.
The function of frequency adaptation.
The device has two sensors: an accelerometer and a physiological sensor for minute ventilation.
The ability to mix data from two sensors to optimize frequency adaptation.
Function for adapting the AV interval to the heart rate.
Response function for AF/PT on the ventricles (ATR).
Function for smoothing the rhythm frequency up and down, independently programmable (Rate Smoothing Up/Down).
The function of responding to a sudden drop in the rhythm frequency (Sudden Brady Response).
Algorithm for reducing the percentage of unnecessary right ventricular stimulation AV Search + with search for native AV conduction.
Automatic implantation detection function.
Fully automatic post-implantation review (POST) function.
Automatic programming based on readings (IBP).
Режимы стимуляции: DDD(R); DDD; FREE(R); NULL; VDD (R); VDD; AAI(R); AAI; VVI(R); VVI; DOO; AOO; VOO; OFF.
The function of programming the MRI mode (MRI Protection Mode).
Function for programming the automatic exit of the device from the MRI mode (MRI Tim-out).
Stimulation parameters:
Stimulation amplitude of the PP, PG: Auto or Fix, 0.1 – 7.5 V.
Pulse width: 0.1-2.0 ms.
Automatic measurement of the amplitude and adjustment of the sensitivity thresholds for the PP, PG.
Sensitivity of the PP, PG: Auto (AGC) or Fix, 0.15-1.5 mV. Polarity of PP, PG stimulation – mono/bipolar.
Rhythm hysteresis function.
Maximum conduction frequency (MTR) – 50-185/min.
Maximum sensory frequency (MSR) – 50-185/min.
Maximum stimulation frequency (MPR) – 50-185/min.
Sound warning signals: during capacitor charging, when the electrode/device is damaged (when the electrode impedance exceeds the limits, when noise appears on the electrode, when the recommended battery replacement time is reached, and when the charging time exceeds the service life).
The diagnostic trend function provides an overview of the implanted system and the patient’s condition over the previous 12 months, with graphs that display long-term clinical trends in the patient’s condition and the performance of the device and electrodes, such as the frequency of arrhythmias, heart rate, and patient mobility.
Parameters for detecting tachyarrhythmia:
Detection of AF/TP: monitoring, detection frequency of 100-300 per minute.
Detection of VT: detection interval of 90-220 per minute.
Function for automatic detection and recording of VT episodes in the device’s memory, with the preservation of the ECG.
Algorithm for recognizing electromagnetic noise on the electrodes.
Algorithm for triggering an alarm when an electrode is damaged.
Function for switching the polarity of the electrodes (Safety Switch).
The battery technology with increased capacity extends the service life and expands the possibilities of using the device’s functions and algorithms: the estimated
service life is more than 15 years.
Atrial electrode: MRI-compatible up to 3T, IS-1 Vi connector; fixation is active, presence of a steroid, standard lengths of 45-59 cm, the distance from the tip to the ring is no more than 11 mm, and the diameter of the electrode body is less than 2 mm.
Ventricular electrode: MRI-compatible up to 3T, IS-1 Vi connector; active fixation, presence of a steroid, standard lengths of 45-59 cm, distance from the tip to the ring of no more than 11 mm, and a diameter of the electrode body of less than 2 mm.
Introducer, percutaneous, 2 pieces, size – 7 Fr
