En • English - BIOTRONIK Selectra Manuel Technique

en • English
About the Product
General considerations
Target group
This manual is intended for cardiologists, electrophysiologists and surgeons who are
familiar with and have practical experience with cardiac resynchronization therapy and
implantation of leads in the coronary venous system.
Description
BIOTRONIK's Selectra CS lead introducer system is a combination of guiding catheters
and implantation accessories used to facilitate access to the coronary venous system
for suitable leads and catheters.
Packaging units
It primarily consists of the accessory kit and various, individually available guiding
catheters with a nominal inner diameter of 7 F (outer guiding catheters) or 5 F (inner
guiding catheters).
Advantages for the user
Using the Selectra system has the following advantageous options:
• Quick probing of the coronary sinus
• Easy access to the coronary sinus
• Introduction of contrast media for angiography
• Easy and fast positioning and repositioning of the leads
Intended use
The Selectra accessory kit is used in conjunction with the CS lead introducer system to
facilitate lead implantation in the left side of the heart via the coronary sinus.
Contraindications
Use of the Selectra CS lead introducer system is contraindicated for the following:
• Patients with an existing or possible occlusion of the coronary vessels or unsuitable
anatomy of the coronary veins
• Patients with active systemic infection
Possible negative side effects
Possible complications are as follows:
• Allergic reactions to contrast media
• Hematoma
• Bleeding
• Infection
• Embolism
• Pneumothorax
• Cardiac tamponade
• Myocardial damage
• Venous or cardiac perforation
• Local tissue response, fibrotic tissue formation
• Damage to the heart valves
• Vascular occlusion
• Chronic nerve damage
Packaging, sterility, storage, and disposal
Sterile container
The Selectra accessory kit is delivered in a sterile container consisting of a blister 
with sealing paper. This blister is sterilely sealed and placed in a sterile bag, 
so that the outside of the blister is also sterile. Ethylene oxide is used for sterilization
purposes.
Outer box and labeling
The sterile bag with the blister is packaged in a box that has a quality control seal and a
product information label. The label lists the model type, technical data, use by date,
and information about sterility and storage of the package and content.
1 To ensure sterility, the container should be checked for damage prior to opening.
2 If it is suspected that the sterile packaging has been opened or damaged, return the
product to BIOTRONIK.
Storage
The permissible storage temperature ranges between 5 and 55°C.
If this temperature range or the use by date are exceeded, the documented properties
of the implantation accessories can no longer be warranted. This could result in tech-
nical failures.
Disposal
Used implantation accessories must be disposed of as medical waste in an environ-
mentally friendly and proper manner.
They do not contain material that requires further provisions.
Scope of delivery (package contents)
1) Torque tool for 
guide wires 
1
(0.36 mm = 0.014"
diameter)
2) Syringe with 
Luer lock connection
3) Guide wire in
3
protective tube
(Seldinger wire, 
0.89 mm diameter)
4
4) One-way valve (2 x)
5) One-way stopcock
(2 x)
6) Sealing cap (2 x) 5
7) Transvalvular
insertion tool (4 x)
6
8) Slitter tool (Selectra)
9) Technical manual 
(not depicted)
7
8
Fig. 1: Accessory kit contents
Specifications
Amount, designation Specification
1 slitter tool For leads with a diameter of between 4.6 and 5.8 F
Can cut up to 3 Selectra catheters
1 guide wire 
Length: 150 cm
(Seldinger wire) Material: stainless steel, teflon coated
Diameter: 0.89 mm
4 transvalvular insertion Inner diameter: 0.42 mm (1.26 F)
tools (TVI)
1 syringe
With Luer lock connection, volume: 12 cm
1 torque tool for  For guide wires with 0.36 mm diameter 
OTW guide wires (for OTW leads)
2 one-way valves For the side port, bidirectional, with Luer lock
internal and external thread. 
Opened by screwing in syringe
For the side port, with Luer lock internal and 
2 one-way stopcocks
external thread
2 sealing caps For the side port, with Luer lock inner thread
1 technical manual Outside the sterile container
Table 1: Scope of delivery and specifications
2
Basic Safety and Handling Instructions
Not for multiple usage
2
The Selectra implantation accessory kit is intended for single-use only.
Reuse of implantation accessories can result in infections, embolisms and damage to
the product.
Avoiding thrombosis
To inhibit blood clotting, BIOTRONIK recommends intravenously administering 
50-100 IU heparin per kg body weight if the patient is not otherwise anticoagulated. 
The heparin may be directly administered through the Selectra guiding catheter or a
different venous access point. In this case, please rinse with sufficient physiological
NaCl solution to guarantee that the heparin completely enters the patient's circulation.
Damaging the lead
Avoid damaging the lead with sharp-edged instruments - especially with the blade of
the slitter tool when removing the catheter.
Contrast media
Only use water soluble contrast media.
X-ray monitoring
Generally, perform the described implantation processes only under X-ray monitoring.
Damaged catheters
Do not use an (inner or outer) catheter showing any signs of damage.
Rinse catheter thoroughly before use!
The inner and outer Selectra guiding catheters must be rinsed thoroughly before use
(using a physiological NaCl solution), otherwise the hydrophilic inner coating of the
catheters, which significantly improves their gliding property, is not effective. 
This will also help to avoid trapping air in the catheters.
Using the transvalvular insertion tool
To prevent kinking, a transvalvular insertion tool (TVI) has to be used to guide a
0.36 mm OTW lead guide wire through the valve and into the guiding catheter.
Handling Instructions
Note: This technical manual does not claim to explain all the details of the implanta-
tion of a CS lead. This technical manual only deals with certain important aspects and
examples to illustrate the proper handling of the implantation accessories.
Opening the packaging
In a non-sterile area
Remove the sterile bag from the storage package and open it.
In a sterile area
Remove the sterile blister and open it by peeling the sealing paper off in direction of
the arrow.
Preparation
1 Choose the Selectra guiding catheter or a pairing of inner and outer catheters from
the product line that has the best dimensions and geometry for the patient's atrial
anatomy.
2 Please consult the technical manual included with the catheters.
3 Prior to use, all components must be thoroughly rinsed and, if possible, vented.
Repeat the rinsing procedure at regular intervals during the use of the implantation
accessories.
Note: Use a physiological NaCl solution for rinsing.
Note: The connection of a hemostatic valve is not required as all Selectra guiding
catheters have a hemostatic valve embedded in the handle.
3
4 The side port of the guiding catheter must be closed by fixating either the sealing
cap, the one-way stopcock, or the bidirectional check valve to the Luer lock connection.
This applies to inner as well as outer catheters.
Using the transvalvular insertion tool
To prevent kinking, a transvalvular insertion tool (TVI) has to be used to guide a
0.36 mm OTW lead guide wire through the valve and into the guiding catheter.
5 Insert the associated dilator into the (outside) guiding catheter. This causes the
catheter to straighten.
Note: Do not attempt to reshape the guiding catheter! It is preformed (except for curve
shapes Straight and Straight L) and resumes its curved shape after the dilator has been
removed.
Puncture
1 Connect a suitable puncturing cannula (inner diameter at least 1 mm = 18 G) to a
syringe body. Puncture the selected vein (e.g., subclavian vein, cephalic vein) at a
suitable site.
Caution! For patients with chronic lung disease, there is an increased risk of
pneumothorax!
2 To check the venous puncture, aspirate blood into the syringe.
3 Remove the syringe body. Leave the cannula in position.