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Table of Contents
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Device Variants and NBG Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Possible Medical Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Possible Technical Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Possible Electromagnetic Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Possible Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Prior to Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Indications and Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Ambient Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Sterility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Preparing the Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implanting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connecting Pacemaker Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Precautionary Measures while Programming . . . . . . . . . . . . . . . . . . . . . . . . . . 10
After Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Follow-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Notes for the Physician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Timing: Triple-Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Pacing and Sensing: Triple-Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Preset programs: Triple-Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Tolerances of Parameter Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Battery Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
1 Product
Description
Intended Medical Use
Intended use
Evia 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 pace-
maker is a symptomatic therapy with the following objective:
• Compensation of bradycardia by atrial, ventricular, or AV sequential pacing
• Resynchronization of ventricular chamber contraction via biventricular 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 Evia family. BIOTRONIK Home Monitoring
®
enables
physicians to perform therapy management at 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
Evia HF and Evia HF-T are triple-chamber devices and belong to the Evia family. Not all
device types are available in every country.
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