B. Braun VenaTech RETRIEVABLE, Instructions For Use Manual

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2
IMPORTANT
Introducer system for use with the VenaTech® RETRIEVABLE Vena Cava Filter System for temporary or permanent filtration
of the Inferior Vena Cava.
STERILE and non-pyrogenic. Sterilized using Ethylene Oxide. FOR SINGLE USE ONLY. The device
and its accessories are not reusable nor designed to be re-used. Any re-use would definitely compromise the performance
and safety of the device. After use, the VenaTech® RETRIEVABLE, Brachial Introducer System and accessories may be a
potential biohazard. Handle and dispose of in accordance with the current medical practice and applicable laws and/or
regulations.
COMPONENTS MAY NOT BE CLEANED OR RE-STERILIZED . Store at room temperature. Avoid freezing and
excessive heat. Do not remove from unit carton until ready for use.
Opening the sterile packaging:
Check that the sterile packaging is undamaged before opening. Confirm the date of sterile expiration on the labeling. Never
use an introducer system which has exceeded its sterile expiration date. To maintain sterility, all normal aseptic room sterile
procedures should be followed.
VenaTech® RETRIEVABLE
Brachial Introducer System
(Antecubital)
Reference: 04415160
B. Braun Medical
204, avenue du Maréchal Juin - BP 331
92107 Boulogne Cedex - FRANCE
Information: Fax: 33 5 49 52 88 77
Symbols Glossary
Please refer to the Symbols in these Instructions For Use
Fig. 1 Brachial approach
Fig. 2 Contents of the kit
Fig. 3 Caution, consult accompanying documents
Fig. 4 Recommended Vena Cava Diameter
Fig. 5 Use by date
Fig. 6 Lot number
Fig. 7 Catalogue number
Fig. 8 Sterilized using ethylene oxide
Fig. 9 Manufacturer
Fig. 10 Do not re-use
Fig. 11 Do not resterilize
Fig. 12 Do not use if package is damaged
Fig. 13 Keep away from rain
Device Description
The VenaTech® RETRIEVABLE Brachial Introducer System (Antecubital) must be used with a Venatech®
RETRIEVABLE Vena Cava filter only.
The VenaTech® RETRIEVABLE Brachial Introducer System (Antecubital) includes a 101 cm long (37.8”) sheath,
designed to be used during the implantation of a VenaTech® RETRIEVABLE Vena Cava Filter via the brachial
approach (Antecubital).
System contents
- 7F Introducer sheath with hemostasis valve and side port tubing (Fig. A)
- 7F Dilator (Fig. B)
- Short Pusher (Fig. C)
- Long Pusher (Fig. D)
- PTFE coated “J” guide-wire, 1800 mm in length, 0.035” (0.89 mm) in diameter (Fig. E)
Introducer Sheath Dilator Short Pusher Long Pusher
Total length (mm) 1010 1087 183 1057
Usable length (mm) 960 1048 146 1020
Internal diameter (mm) 2.43 1.00 NA NA
External diameter (mm) 3.10 2.33 2.33 2.30
For an implantation of a VenaTech® RETRIEVABLE, Vena Cava Filter System via the brachial approach
(Antecubital), it is mandatory to use the above mentioned accessories, instead of the accessories available in the
VenaTech® RETRIEVABLE, Vena Cava Filter System.
The only items that must be used from the VenaTech® RETRIEVABLE, Vena Cava Filter System
(Ref. 04435150) are the following :
s&ILTERINITSCARTRIDGE
s#ARTRIDGECRADLE
s)NSTRUCTIONS&OR5SE*5'5,!2OR35"#,!6)!.APPROACHES
)
Important Information
Instructions For Use
This medical device is to be used when implantation via the brachial approach has been selected by
physicians who have experience with the technical and clinical requirements of Vena Cava Filter implantation.
0LEASEREFERTOTHE6ENA4ECHš2ETRIEVABLE)NSTRUCTIONS&OR5SEBOOKLETDEDICATEDTOTHE*5'5,!2OR35"#,!6)!.
approaches for ( Reference:04435150 ) :
- Instructions For Use
- Use of the device
- Implantation period
- Warning
- Filter placement in case of pregnancy
- Secondary Catheterization
- Indications / contraindications
- Potential adverse events
- Implantation procedure
Implantation approach:
This Introducer System is designed for insertion via the brachial approach (Antecubital).
If needed, this introducer system can be used to insert the filter via the right internal jugular vein or the left
or right subclavian veins.
Warnings:
- Other approaches (particularly the left internal jugular vein, the right or left external jugular veins) should
not be attempted.
- During the insertion of the dilator into the sheath, ensure that they are in the same axis, to avoid any potential
dilator kink / dilator tip damage.
Preparation of the patient:
Stretch the arm of the patient 90 degrees from the long axis of the spinal column. This will allow placement of
the introducer in the axis of the subclavian vein.
During the implantation via the brachial approach (Antecubital) the filter cartridge must be inserted in
the JUGULAR position into the cartridge cradle.
Filter diameter :
The diameter of the Vena Cava, as evaluated during cavography, must be 14mm and 28 mm from an AP
projection when corrected for magnification. In cases in which measurement is accomplished using Computed
Tomography (CT), the section with the largest diameter should be used.