Atos Medical Provox GuideWire, Instructions For Use Manual

Page: 10 / 116

10
spontaneously. Patients on anti-coagulant therapy, however, should
be carefully evaluated for the risk of hemorrhage prior to secondary
puncture and prosthesis placement.
Rupture of the tracheoesophageal tissue –
In case of a rupture
of the TE tissue the TE puncture procedure should be abandoned
and the rupture should be sutured immediately. TE puncture should
only be repeated after proper healing of the tissues.
The Provox GuideWire gets stuck inside the esophagus –
If
the Provox GuideWire gets stuck inside the esophagus, do not
use excessive force. Attempts to pull out a stuck GuideWire may
cause tissue damage and/or breaking the GuideWire. The device
has to be retrieved with an endoscope.
2. Instructions for use
2.1 Preparation
Check the integrity of the sterile package. Do not use the product
if the package is damaged or opened.
2.2 Operating instruction
2.2.1 Primary puncture placement (Fig 2):
1. Insert the Provox Pharynx Protector in the open pharynx
(Fig 2.1).
2. Use the Provox Trocar with Cannula to create a TE-puncture
(about 8-10 mm from the edge of the tracheostoma) (Fig 2.2).
3. Remove the Trocar after the puncture, while leaving the
Trocar Cannula in place (Fig 2.3).
4. Introduce the Provox GuideWire in anteroposterior direction
through the opening of the Trocar Cannula.
The connector of the GuideWire appears out of the upper opening
of the Pharynx Protector, which then can be removed (Fig 2.4).
CAUTION:
Do not attach the voice prosthesis when the Pharynx
Protector is in place, since the voice prosthesis can get stuck.
5. The safety strap of the voice prosthesis of the proper model,
diameter and size is attached and secured to the GuideWire
connector. The Trocar Cannula is removed from the puncture
opening and is pulled back.
Careful traction on the GuideWire will bring the strap of the
prosthesis into the TE-puncture. The voice prosthesis is carefully
rotated into position with two non-toothed hemostats firmly
holding the tracheal flange (Fig 2.5).
CAUTION:
Do not pull the voice prosthesis in place with the
GuideWire.
6. When the voice prosthesis is correctly positioned, the safety
strap is cut off while still attached to the GuideWire and the voice
prosthesis is turned so that the part where the safety strap was
attached points downwards into the trachea. The laryngectomy
procedure can then be completed (Fig 2.6).
2.2.2 Secondary puncture placement (Fig 3):
1. Insert a rigid endoscope (or equivalent instrument) into the
esophagus (Fig 3.1).
2. Use the Provox Trocar with Cannula to create a TE-puncture
(about 8-10 mm from the edge of the tracheostoma) (Fig 3.2).
3. Remove the Trocar after the puncture, while leaving the
Trocar Cannula in place (Fig 3.3).
4. Introduce the Provox GuideWire through the Trocar Cannula.
The GuideWire is pushed upwards through the scope until it is
stopped by the Stopper at the end of the Cannula. The endoscope
can then be removed (Fig 3.4).
CAUTION: Do not attach the voice prosthesis when the endoscope
is in place, since the voice prosthesis can get stuck.
5. The safety strap of the voice prosthesis of the proper model,
diameter and size is attached and secured to the GuideWire
connector. The Trocar Cannula is removed from the puncture
opening and is pulled back.
Unregistered
copy