BIOTRONIK Selectra Catheters Manuel Technique page 7

Storage
The upper temperature limit for storing the product is 55°C.
Packaging and sterility
The Selectra guiding catheter is delivered in a blister with a lid. This blister is
placed in two sterile bags so that the inside bag and the blister are also sterile on
the outside. Ethylene oxide is used for sterilization purposes.
The sterile bags with the blister are packaged in a box that bears 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 damages prior to
opening.
2 If it is suspected that the sterile packaging has been opened or damaged,
return the product to BIOTRONIK.
Scope of delivery
• 1 guiding catheter (sterile)
• 1 dilator (sterile) - for the outer catheter only
• 1 technical manual (non-sterile)
Opening the packaging
In a non-sterile area:
• Remove the sterile bag from the box and open it.
In a sterile area:
• Remove and open the inner sterile bag.
• Remove and open the blister.
Use and handling of the catheters
Use of the Selectra guiding catheter in combination with other implantation
accessories and a suitable CS lead is described in the manuals for the
Selectra accessory kit and the lead.
Caution: Rinse thoroughly before use.
- Avoid excessive sliding friction on the interior wall of the catheter
• Before use, rinse with sufficient physiological NaCl solution to activate the
hydrophilic inner coating of the catheter.
In addition, this prevents air from being trapped.
Disclaimer
BIOTRONIK's Selectra CS lead introducer system (including all available
accessories), used in conjunction with devices for implantation in the coronary
sinus, has been qualified, manufactured, and tested according to proven and
accepted standards and procedures. Nonetheless, the physician must be aware
that the accessories may easily be damaged through improper handling or use.
Except as set forth in BIOTRONIK's limited warranty, BIOTRONIK makes no
expressed or implied warranties for its accessories.
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