User Manual
Table Of Contents
- Enticos 4/8
- Table of Contents
- 1 Product Description
- 2 General Safety Instructions
- 3 Implantation
- Implantation Procedure
- Having parts ready
- Keeping an external defibrillator ready
- Unpacking the device
- Checking parts
- Implantation site
- Overview: Implanting
- Avoid damage to the header
- Preventing short circuits in the header
- Keeping distance between leads
- Connecting the lead connector to the device
- Applying the programming head
- Establishing wandless telemetry
- Auto-initialization
- Behavior during auto- initialization
- Precautionary Measures while Programming
- Checking the device system
- Performing standard tests and monitoring the patient
- Do not interrupt wandless telemetry during a treatment
- Cancelling telemetry
- Avoiding critical parameter settings
- Manually setting lead polarity
- Setting sensing
- Setting the sensitivity
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive left ventricular pacing
- If an ICD is implanted at the same time, do not permit unipolar pacing
- Recognizing lead failure
- Consider power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- 5 Technical Data
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.
SSRDDRHF
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