IsoFlex Lead Model 1944 - Lead, pacemaker, implantable, endocardial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Dostupné z:

Abbott Medical Australia Pty Ltd

Trieda:

Class III

Výrobca:

St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America

Terapeutické oblasti:

35223 - Lead, pacemaker, implantable, endocardial

Terapeutické indikácie:

IsoFlex leads are bipolar, steroid-eluting, passive-fixation implantable pacing leads with Optim insulation. IsoFlex Model 1944T leads can be placed in the right atrium. IsoFlex leads are designed for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Model 1944T) or ventricle (Model 1948T).

Stav Autorizácia:

A

Dátum Autorizácia:

2009-02-23

Príbalový leták

Passive-Fixation, Bipolar, Steroid-eluting,
Endocardial, Pacing Leads
SPECIFICATIONS
1948T (STRAIGHT)
1944T (J-SHAPED)
LENGTH (CM)
46, 52, 58
46, 52
LEAD INTRODUCER (minimum
recommended)
7 French
ELECTRODE CONFIGURATION:
Tip electrode
Ring electrode
semispherical shape, steroid coating
cylindrical
ELECTRODE SPACING:
Tip to ring electrode (mm)
12
10
CONNECTOR SIZE:
Sense/pace
IS-1
1
bipolar (3.2 mm)
1. St. Jude Medical IS-1 lead connectors are compatible with connector
cavities that conform to the international connector standard
ISO 5841-3.
LEAD BODY INSULATION
Optim
®2
with exterior Fast-Pass
®
coating
2. A silicone-polyurethane copolymer.
MATERIALS:
Conductors
Connectors
Suture sleeve
Tip and ring electrodes
Steroid-eluting plug
Stylet
MP35N
3
stainless steel
silicone rubber
titanium nitride-coated platinum-iridium alloy
silicone rubber with less than 1.0 mg dexamethasone sodium phosphate
stainless steel
3. MP35N is a trademark of SPS Technologies.
ELECTRODE SURFACE AREA (MM
2
):
Pacing tip
Pacing ring
3.5
16.0
ELECTRICAL RESISTANCE:
Tip to Connector Pin
Ring to Connector Ring
46 CM: 54
¬
52 CM: 60
¬
58 CM: 66
¬
46 CM: 74
¬
52 CM: 82
¬
58 CM: 90
¬
46 CM: 54
¬
52 CM: 60
¬
46 CM: 10
¬
52 CM: 12
¬
MAXIMUM DIAMETER (MM)
2.1
2.1
ACCESSORIES
Lead cap (3.2 mm)
Stylets
Stylet guide (funnel)
IsoFlex
®
Models 1944T, 1948T
46, 52, 58 cm
For indications, contraindications, warnings, and cautions,
see the accompanying manual.
November 2012
Art 60044244/A
SJM.COM
CARDIAC RHYTHM MANAGEMENT DIVISION
Stylet ring
Retainer
Suture sleeve
Vein lifter
STYLET COLOR CODE
KNOB COLOR
DESCRIPTION
DIAMETER
Green
Soft straight (20 mm taper)
0.014 in/0.35 mm
Yellow
Firm straight (20 mm taper)
0.015 in/0.38 mm
ACCESSORIES

Súhrn charakteristických

IsoFlex™
Model 1944
Model 1948
Passive-fixation
Bipolar
Steroid-eluting
Endocardial
Pacing leads
User's Manual
Unless otherwise noted, ™ indicates that the name is a trademark of,
or licensed to, St. Jude Medical or one of
its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are
trademarks and service marks of St. Jude
Medical, LLC and its related companies.
Pat. http://patents.sjm.com
© 2017 St. Jude Medical, LLC. All Rights Reserved.
1
Description
IsoFlex™ leads are bipolar, steroid-eluting, passive-fixation
implantable pacing leads with Optim™
insulation.
Certain IsoFlex lead lengths have been tested for use in the MRI
environment and are designated
MR Conditional. See MR Conditional Pacing System (page 2).
IsoFlex Model 1948 leads can be placed in either the right atrium or
the right ventricle. IsoFlex
Model 1944 leads can be placed in the right atrium.
IsoFlex Models 1944 and 1948 leads are insulated with Optim, a
silicone polyurethane copolymer.
Table 1. IsoFlex models and features
Model
Features
1944
J-shaped
Optim insulation
1948
Straight
Optim insulation
Additional features of all IsoFlex leads are:

Steroid Elution – An amount less than one milligram of dexamethasone
sodium phosphate
(DSP) is slowly released through the tip electrode upon contact with
body fluid. The drug is
intended to promote low chronic stimulation threshold by suppressing
the local inflammatory
response to a foreign body.

Fast Pass™ coating – The Optim outer insulation is coated to
create a highly lubricious
surface.
Note
IsoFlex low-polarization bipolar leads are compatible with the
AutoCapture™ pacing
system contained in St. Jude Medical pulse generators.
Indications/Intended Use
IsoFlex™ leads are designed for use in combination with a compatible
pulse generator to provide
permanent pacing and sensing in either the atrium or ventricle.
IsoFlex model 1948 is intended to
be placed in either the right atrium or the right ventricle. IsoFlex
model 1944 is intended to be
placed in the right atrium.
T