Lead Placement; Appendix; Technical Data; Disclaimer - BIOTRONIK Sentus ProMRI OTW BP L Manuel Technique

Lead Placement

Depending on the implantation site and patient's anatomy, the lead may be longer than
required to connect the active device and position the lead in the heart.
In this case, we recommend placing the excess lead length around the active device in
loose loops.
Schematic diagram: Placing the lead around the active device
W CAUTION
Damage to the lead as a result of mechanical overstress
When positioning the lead, make sure it is not knotted, twisted or bent.
W CAUTION
Damage to the lead as a result of mechanical overstress
If the active device is implanted underneath the pectoral muscle, ensure that no parts
of the lead lie between the housing of the device and the ribs.
Otherwise local pressure and abrasion can damage the lead insulation.

4 Appendix

Technical Data

Sketch
Sentus (ProMRI) OTW BP L: Schematic diagram
Sentus (ProMRI) OTW BP S: Schematic diagram
Model versions
Lead in the version: ...-75
Overall length 77 cm
Distance between tip and 1st ring electrode 21 mm
Lead connector
Design
Suitable for active devices with an IS-1 connector
Labeling
Material of contacts (connector pin and contact ring)
Tip electrode
Outer diameter 1.6 mm
Surface (size) 5 mm 2
Material Platinum/iridium alloy
Surface (material and structure) Iridium, fractal
en • English
Ring electrodes
Outer diameter
Surface (size)
Material
Surface (material and structure)
Fixation
Principle
Length of the pre-formed
helix
Sentus OTW (ProMRI) BP S
Principle
Lead body
Material of insulation
Anti-friction coating
Material
Thickness
Coated area
Outer diameter
Conductor to tip electrode and ring
electrode
Architecture (structure)
Material of the wire
MP35N is a registered trademark for a particular cobalt-chromium-nickel alloy.
Conductor resistance (wire)
Conductor to tip electrode
Pacing impedance
Pacing impedance according to EN 45502-2-1 or EN 45502-2-2
Steroid
Active ingredient
Quantity
Steroid carrier
Stylets
Accessories for leads in the version:
Usable length of the stylet
Diameter at the handle
Technical details for the stylets:
Designation Diameter
S 75-K OTW Max. 0.36 mm
...-85 ...-95
S 85-K OTW
S 95-K OTW
87 cm 97 cm
S 75-G OTW Max. 0.36 mm
S 85-G OTW
S 95-G OTW
IS-1, bipolar
Guide wire
Guide wire
IS-1 BI (LV)
Recommended model
Stainless steel
Recommended CS guiding catheter
Internal diameter
Recommended model
Note: The Selectra accessory kit is required for proper use of the catheters.
1.6 mm
2
8 mm
Platinum/iridium alloy
Iridium, fractal
Pre-shaped S-curve of the distal area
Approx. 6 cm
Silicone thread between the tip electrode and the
distal ring electrode
Silicone
Polyurethane
0.1 mm
From 4.4 cm behind the tip to the connector
1.6 mm
Coil
Coradial coil made of 2 x 2 parallel wires
Each wire is electrically insulated.
MP35N-DFT
0.08 Ω/cm
Two out of the five wires from the coil lead
to the tip electrode.
600 to 1200 Ω
Dexamethasone acetate
0.5 mg
Silicone rubber
...-75 ...-85 ...-95
783 mm 883 mm 983 mm
3.5 mm
Color coding 
Stiffness Diameter of
ball tip (stylet handle)
Medium 0.48 mm Green
Soft 0.48 mm Purple
PTCA guide wire, max. diameter: 0.36 mm (0.014")
Streamer Polymer Wire ES/XT, Vision Wire
5 F
Selectra CS guiding catheter (inner and outer guiding
catheter)
5
Package contents
In the sterile packaging:
• Lead with premounted stylet
• Lead fixation sleeve, 5 F, made of silicone rubber, premounted on the lead, may
contain titanium dioxide
• Vein lifter
• Additional stylets
In box (non-sterile):
• Either: Technical manual (printed)
Or: Supplement with information on how to download the technical manual as
a PDF file from the Internet
Storage conditions
Permissible storage temperature range 5 - 55°C
Permissible storage period 2 years

Disclaimer

Conditions of use and requirements
Implantable BIOTRONIK 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.
Risks and possible complications
Problems or failures that occur during or after lead implantation can have many
causes, including the following:
• Medical complications
• Foreign body rejection phenomena
• Fibrosis
• Lead dislodgement
• Erosion
• Migration through body tissue
• Insulation defect
Risk of damage
Despite meticulous care in development, material selection, production, and final
inspection prior to delivery, leads can be easily damaged in the event of improper
handling or use.
Limitation of liability
BIOTRONIK does not guarantee that the following events will not occur:
• Lead malfunctions or failures
• Immune response of the body against lead implantation
• Medical complications (including myocardial perforation) during lead implantation
or as a consequence of implanting the lead
The same applies to implantation and lead accessories by BIOTRONIK.
Burden of proof for defective goods
The state of the product at the time of sale is critical for any product returns.
No liability is assumed for any defects not immediately detected upon receipt of the
goods.
Responsibility for complications and consequential damage
The buyer/user bears the entire risk associated with the use of the lead.
BIOTRONIK shall not be liable for any loss, damage, or injury of any nature, whether
direct, indirect, or consequential, that may occur in connection with the leads and
accessories or their use.
BIOTRONIK 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 costs for
consequential damages.
Final clause
No one is authorized to hold BIOTRONIK liable for any statement or warranty deviating
from the above.