General Information; Internal Parts; External Parts - Atrotech Atrostim PNS Anwenderhandbuch

Atrostim PNS
This manual is for the Atrostim Phrenic Nerve Stimulator (Atrostim PNS) V2.0.
It is valid for the following system components:

Internal parts

Component name
Implant Stimulator
Electrode
Electrode
Extension Lead
Extension Lead
Extension Lead
Shield Cap

External parts

Component name
Stimulus Controller
Programming Module
Module Cable
Energy Transfer Coil
Energy Transfer Cable
Battery Charger 12V
Battery Charger 9V
Battery
Battery
Accessories for United Kingdom
Component name
Battery Charger 12V
Battery Charger 9V
Clinician's Manual
The Clinician's Manual contains all information necessary for the clinical care of the patient.
User's Manual
The User's Manual contains cautions, system overview, implementation and technical description of the
Atrostim PNS system. Before using Atrostim PNS, please read the User's Manual.
Declaration of Conformity
The Atrostim PNS V2.0 is CE marked. CE-marking is based on the EC certificate issued by TÜV Product
Service GmbH, Munich, Germany (Notified body No. 0123). The Atrostim PNS V2.0 conforms with the
council directive 90/385/EEC relating to active implantable medical devices (AIMD). CE marking was
initially authorized 2002.
February 2012

General Information

Model name
RX 44-27-2 CL
TF 4A
TF 4BR
EL 1.5
EL 3
EL 4
SC
Model name
PX 244 L
PHS 240+
MC 52
TCL 27
PCL 80
NBE 12
BE 9
L12V
9V
Model name
NBUK 12
BUK 9
1
Version
V3.0
V2.1
V2.1
V1.1
V1.1
V1.1
V1.1
Version
V2.3
V2.1
V1.0
V1.0
V1.0
V1.0
-
V1.0
-
Version
V1.0
-
General Information