6
Product Description
System Overview
System Overview
Device family
This device family consists of single-chamber, dual-chamber and triple-chamber
devices with or without Home Monitoring. Not all device types are available in every
country.
The following device variants are available:
Device
The device's housing is made of biocompatible titanium, welded from the outside
and therefore 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.
Lead connections
BIOTRONIK provides pacemakers with headers for different standardized lead
connections:
•
IS-1
•
IS-1/IS4
Note:
Suitable leads must comply with the norms:
Note:
The device and leads have to match.
Note:
Use only adapters approved by BIOTRONIK for leads with different connec-
tions.
IS-1
The device labeling provides information pertaining to the connection assignment:
Device type
Variant with
Home Monitoring
Variant without
Home Monitoring
Single-chamber Enticos 8 SR-T
Enticos 4 S, Enticos 4 SR
Dual-chamber
Enticos 8 DR-T
Enticos 4 D, Enticos 4 DR
Triple-chamber
Enticos 8 HF-T, Enticos 8 HF-T QP —
•
A device's IS-1 connector port must only be used for connecting leads with
an IS-1 connector that conform to ISO 5841-3.
•
A device's IS4 connector port must only be used for connecting leads with
an IS4 connector that conform to ISO 27186.
•
Only quadripolar leads must be connected to the IS4 connector on device
type HF QP with IS4.
•
If you have any questions concerning the compatibility of other manufacturers'
leads, please contact BIOTRONIK.
S
SR
D
DR
HF
Connector
port
Lead
connector
Configuration
Implantation site Device type
A/RA
IS-1
Unipolar, bipolar
Atrium
D, DR, HF
V/RV
IS-1
Unipolar, bipolar
Right ventricle
S, SR, D, DR, HF
LV
IS-1
Unipolar, bipolar
Left ventricle
HF
