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Product Description
Intended Medical Use
Intended use
Estella is a family of implantable pacemakers that may be implanted for all bradycardia
arrhythmia indications. The primary objective of the therapy consists of improving
patients' symptoms that can be clinically manifested.
The implantation of the pacemaker is a symptomatic therapy with the following
objective:
• Compensation of bradycardia by atrial, ventricular, or AV sequential pacing
Diagnosis and therapy forms
The cardiac rhythm is automatically monitored and bradycardia arrhythmias are
treated. All major therapeutic approaches from the field of cardiology and electro-
physiology are unified in the Estella family. BIOTRONIK Home Monitoring
physicians to perform therapy management any time.
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation of a device system. Only qualified medical specialists having the
special knowledge required for the proper use of implanted devices are permitted to
use them. If users do not possess this knowledge, they must be trained accordingly.
System Overview
Device family
Estella SR(-T) are single-chamber devices, Estella DR(-T) are double-chamber devices
and belong to the Evia family. Not all device types are available in every country.
Parts
The device system consists of the following parts:
• Device with connections for unipolar or bipolar sensing and pacing
• Suitable leads, adapters and approved accessories
• Programmer
• Current device programs
Device
The device's housing is made of biocompatible titanium, welded from outside and thus
hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle
area. The housing serves as an antipole in the case of unipolar lead configuration.
BIOTRONIK provides silicone-coated devices to avoid muscle twitching near the
implanted pacemaker in the case of unipolar pacing. The labeling provides information
about the device type and arrangement of the connections.
Leads
The leads are coated with biocompatible silicone. They can be flexibly maneuvered, are
stable long-term, and are equipped for active or passive fixation. They are implanted
using a lead introducer set. Some leads are coated with polyurethane to increase the
sliding properties of the lead. The coating of steroid-eluting leads reduces
inflammatory processes. The fractal design of the leads allows for low pacing
thresholds, high pacing impedance, and a low risk of oversensing.
Programmer
The portable programmer is used to transfer the current device program to the device.
In addition to this, the programmer is used for interrogation and storage of data from
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the device. It also acts as an ECG and IEGM monitor.
Note: It is not permitted to use the device's ECG display for diagnostic purposes
because it does not meet all requirements for diagnostic ECG devices
(IEC 60601-2-25).
The programmer communicates with the device via the programming head. It has a TFT
touch screen with a color display, on which the ECG, IEGM, markers and functions are
shown simultaneously.
The programmer has, among others, the following functions:
• Perform all tests during in-office follow-up
• Display and print real-time and saved IEGMs with annotated markers
• Determine the pacing threshold
BIOTRONIK Home Monitoring
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
• With Home Monitoring, diagnostic and therapeutic information and 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.
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