Rivacor 7 HF-T QP - Biventricular pacemaker/defibrillator

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Biotronik Australia Pty Ltd

Class:

AIMD

Manufactured by:

Biotronik SE & Co KG Woermannkehre 1, Berlin, D-12359 Germany

Therapeutic area:

47270 - Biventricular pacemaker/defibrillator

Therapeutic indications:

A triple chamber rate adaptive ICD, with IS4 port connecting a quadripolar LV lead, Home Monitoring functions, max. shock of 40J and DF4/IS4/IS-1 connector. Biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. Ellipsoid shape facilitates implanting in the pectoral muscle area. Connections for bipolar pacing, sensing, unipolar connections and shock delivery are in the header. MR conditional. Rivacor 7 HF-T QP belongs to a family of implantable cardioverter-defibrillators (ICDs). The 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. The implantation of an ICD is a symptomatic therapy with the following objectives: ?Termination of spontaneous ventricular fibrillation (VF) through shock delivery ?Termination of spontaneous ventricular tachycardia (VT

Authorization status:

A

Authorization date:

2019-03-18

Summary of Product characteristics

Rivacor ProMRI
Family of ICDs and CRT-Ds
Technical Manual
®
© 2019 BIOTRONIK, Inc., All rights reserved.
CAUTION
Federal (U.S.A.) law restricts this device to sale by,
or on the order of, a physician.
Rivacor ProMRI
®
Family of ICDs and CRT-Ds Technical Manual
Contents
Chapter 1: General
1
1.1 System Description
1
1.2 Indications for Use
3
1.3 Contraindications
3
1.4 Warnings and Precautions
3
1.4.1 Sterilization, Storage, and Handling
4
1.4.2 Device Implantation and Programming
5
1.4.3 Lead Evaluation and Connection
6
1.4.4 Follow‑up Testing
7
1.4.5 Pulse Generator Explant and Disposal
7
1.4.6 Hospital and Medical Hazards
7
1.4.7 Home and Occupational Hazards
8
1.4.8 Cellular Phones
8
1.4.9 Electronic Article Surveillance (EAS)
9
1.4.10 Home Appliances
9
1.4.11 Home Monitoring
9
1.5 Potential/Observed Effects of the Device on Health
10
1.5.1 Potential Adverse Events
10
1.6 Patient Selection and Treatment
11
1.6.1 Individualization of Treatment
11
1.6.2 Specific Patient Populations
12
1.7 Patient Counseling Information
12
1.8 Evaluating Prospective CRT‑D/ICD Patients
12
Chapter 2: Programmer
15
2.1 Device Programming
16
2.2 Master Switch Behavior
16
2.2.1 Enabled
16
2.2.2 Disabled
17
2.2.3 Temporarily Active
17
2.2.4 Temporarily Inactive
17
2.2.5 Pending
18
Rivacor ProMRI
®
Family of ICDs and CRT-Ds Technical Manual
2.3 RF Telemetry
18
2.3.1 Establishing RF Telemetry Contact
19
2.3.2 Economy Mode
20
2.3.3 Ending a Follow‑up Session
20
2.3.4 Switch between RF and Wand
21
2.3.5 Power Consumption Consideration
21
2.4 Programmer Functions
22
2.4.1 Far‑Field IEGM for Threshold Testing (Leadless ECG)
22
2.4.2 Real‑time IEGM Transmission
22
2.4.3 Additional Programmer Functions
25
2.4.3.1 Speed
26
2.4.3.2 ECG
26
2.4.3.3 Color scheme
26
2.4.3.4 AC Frequency
26
2.4.3.5 Gain
26
2.4.3.6 Overwrite / Continuous
26
2.4.3.7 Standard
26
2.4.3.8 Stores
26
2.4.4 Preferences
26
2.4.4.1 Follow‑up Preferences
26
2.4.4.2 Test Preferences
27
2.4.4.3 Print Preferences
28
2.4.4.4 System Preferences
30
2.4.4.5 Connectivity