Legend For The Label - sorin TILDA JT45 Manuel Technique

383376--C_GA_Tilda-TJT_mul.book Page 5 Monday, August 22, 2011 3:31 PM
Ring electrode
Surface (size) 2
25 mm
Material Pt/Ir
Surface, structure Iridium, fractal
Outer diameter (max. lead diameter) 2.2 mm (6.6 F)
Distance ring electrode to tip 15 mm
Lead body
TILDA T 53,
TILDA T 60
Conductor for lead tip (inner coil)
Design Coil made of 4 parallel wires
Coil outer diameter 0.7 mm
Wire diameter 0.11 mm
Conductor's impedance 1.1 Ohm/cm
Conductor to the ring electrode (outer coil)
Design Coil made of
4 parallel wires
Coil outer diameter 1.52 mm
Wire diameter 0.15 mm
Conductor's impedance 1.0 Ohm/cm
Coil material MP35N
(MP35N is a registered trademark for
a particular cobalt-chrome-nickel alloy)
Insulation material Silicone
Outer lead body diameter 2.1 mm (6.3 F)
Max. outer diameter (ring electrodes) 2.2 mm (6.6 F)
Storage conditions
Permissible storage temperature range 5 - 25 °C
(50 °C; max. 1 month)
Permissible storage duration 2 years

Legend for the Label

Symbol Meaning
Manufacturing date
Use by
Temperature limit
Order number
Serial number
Sterilized with ethylene oxide
Do not resterilize
2
STERILIZE
Do not reuse
Non-sterile
NON
STERILE
Follow the instructions for use
Contents
Do not use if packaging is damaged
en • English
Scope of Delivery
In the sterile packaging 1 pc.
Stylets (corresponding to the length of the lead):
• Model S 45-K (stiffness: medium, color coding
• Or model S 53-K (stiffness: medium, color coding
• Or model S 60-K (stiffness: medium, color coding
TILDA JT 45,
TILDA JT 53 1 pc.
2 pc.
1 pc.
1 pc.
1.1 Ohm/cm 1 pc.
In box (non-sterile) 1 pc.
Coil made of
Available accessories
6 parallel wires
Recommended product, intended use
Lead introducer (without guidewire)
0.45 Ohm/cm
Lead introducer (with guidewire)
Accessory kits for leads:
For TILDA JT 45
For TILDA T 53 and TILDA JT 53
For TILDA T 60
Disclaimer
Conditions of use and requirements
Implantable Sorin CRM leads (called 'leads' in the following) are sophisticated,
precision mechanical medical products.
They should be as thin and flexible as possible.
After implantation, they are subjected to great stress due to the mobilization of the
immune defense of the human organism.
Although they are designed to function reliably for many years under the given condi-
tions, their resilience and durability are limited.
Symbol Meaning
Manufacturer
Distributor
Endocardial lead with passive fixation
Endocardial, active fixation lead with
extendable and retractable screw
Unipolar IS-1 connector
Bipolar IS-1 connector
Unipolar DF-1 connector
Unipolar endocardial lead with tines
for passive fixation
Bipolar endocardial lead with tines for
passive fixation
Unipolar, endocardial, active fixation
lead with extendable and retractable
screw
Bipolar, endocardial, active fixation
lead with extendable and retractable
screw
Unipolar coronary sinus lead, fixation
using preformed tip
Bipolar coronary sinus lead, fixation
using preformed tip
Unipolar coronary sinus lead, fixation
in vessel using silicone thread
Risks and possible complications
Problems or failures that occur during or after lead implantation can have many rea-
TILDA T 53, TILDA T 60, TILDA JT 45,
sons.
TILDA JT 53 lead
For example:
• Medical complications
• Foreign body rejection phenomena
(handle): black/white)
• Fibrosis
• Displacement
(handle): blue/white)
• Erosion
• Migration through bodily tissue
(handle): green/white)
• Insulation defects
Premounted in the lead
Risk of damage
In sterile packaging
Despite meticulous care in development, component selection, production, and final
inspection prior to delivery, leads can be easily damaged by improper handling or use.
EFH-20 lead fixation sleeve
Limitation of liability
Vein lifter
Sorin CRM does not guarantee that
SG-BP stylet guide
• the lead will not malfunction or fail;
Technical manual
• the body will not reject the implanted lead;
• medical complications (including myocardial perforation) will not occur during lead
The same applies to Sorin CRM implantation and lead accessories.
Name, specification
Burden of proof for defective goods
7 F
The state of the product at the time of sale is critical for any product returns.
9 F
No liability is assumed for any defects not immediately detected upon receipt of the
goods.
P-KIT45
Responsibility for complications and consequential damage
P-KIT53
The buyer/user bears the entire risk associated with the use of the lead.
Sorin CRM shall not be liable for any loss, damage, or injury of any nature, whether
P-KIT60
direct, indirect, or consequential, that may occur in connection with the leads and
accessories or their use.
Specifically, Sorin CRM shall not reimburse the customer or a third party for any costs
incurred in connection with the use, malfunction, or failure of any lead or accessory,
including physician's fees, hospital expenses, medication costs, subsidiary costs, and
consequential damages.
Final clause
No one is authorized to bind Sorin CRM to any representation or warranty deviating
from the above.
Symbol Meaning
Bipolar coronary sinus lead; fixation
by electrically passive tip with
preshaped helix formation; two ring
electrodes for left atrial application
European approval mark
Maximum outer diameter
Minimum inner diameter
Maximum permissible guide wire
diameter
Total length
Surface and material of the indicated
lead
Recommended size of the lead intro-
ducer set
Stylets included, here: 1 stylet in the
lead, 1 additional stylet in the sterile
packaging
Lead fixation sleeve, premounted on
the lead inside the sterile packaging
5
implantation or as a consequence of implanting the lead.
Symbol Meaning
Fixation tool for active fixation lead
Marker clamp
Transfer sheath for leads with
PIN-lock PE lead connector (5 mm)
to connect to pacemakers with a
PEC socket (6 mm)
Torque tool for the guide wire
Teflon cannula for the hemostatic
valve
A Atrium
V Ventricle
LA Capabilities of the lead in the case of
left atrial application via the coronary
sinus
LV Capabilities of the lead in the case of
left ventricular application via the
coronary sinus
CS Coronary sinus
Pace Pacing
Sense Sensing
Shock Shock
DXA Dexamethasone acetate as steroid
eluant