Promedon ARGUS Gebrauchsanweisung Seite 2

INSTRUCTIONS FOR USE
DESCRIPTION
ARGUS, ARGUS T and ARGUS ONE Adjustable System have been designed to
treat male stress urinary incontinence.
ARGUS and ARGUS ONE are permanent implants with two
polydimethylsiloxane elastomer fixation arms made up of two regions, a lower
smooth circular region and an upper region with multiple conical subunits,
and a central radiopaque pad made of the same elastomer foam. This pad
supports the bulbar urethra producing its coaptation passively and during
stress. The system includes one pair of radiopaque rings (washers), also made
of polydimethylsiloxane elastomer, which are placed in the fixation arms to
adjust (tighten and loosen) the implant.
ARGUS (KIT-M-01b)
• 1 ARGUS Implant + 2 adjustment rings (washers) (Code: S-42M-AFhL), made
of biocompatible synthetic materials.
• Needles (Code: DPN-MA): These surgical instruments have been designed
for device implantation through retropubic approach and are disposable. The
kit includes 2 needles and 2 handles.
• Ring (washer) positioners (Code: P-02-A): These surgical instruments have
been designed to adjust the implant during surgery and, if necessary, to adjust
the implant post surgery. The kit includes 2 disposable positioners.*
• Adjustment rings (washers) (Code: AR-M): The kit includes 2 extra
radiopaque rings (washers), made of biocompatible synthetic materials.
• Ruler (Code: R-PU): The kit includes a ruler to measure the retrograde
pressure adjustment during implantation, for reference.
ARGUS ONE (KIT-MOL-01)
• 1 ARGUS ONE L Implant + 2 adjustment rings (washers) (Code:S-42M-
AFhOL), made of biocompatible synthetic materials.
• Needles (Code: DPN-MA): These surgical instruments have been designed
for device implantation through retropubic approach and are disposable. The
kit includes 2 needles and 2 handles.
• Needles (Code: DPN-HHA): These surgical instruments have been designed
for device implantation through transobturator approach and are disposable.
The kit includes 2 needles and 2 handles.
• Ring (washer) positioners (Code:P-02-A): These surgical instruments have
been designed to adjust the implant during surgery and, if necessary, to adjust
the implant post surgery. The kit includes 2 disposable positioners.*
• Adjustment rings (washers) (Code: AR-M): The kit includes 2 extra
radiopaque rings (washers), made of biocompatible synthetic materials.
• Ruler (Code: R-PU): The kit includes a ruler to measure the retrograde
pressure adjustment during implantation, for reference.
ARGUS T is a permanent implant with two polydimethylsiloxane elastomer
fixation arms made up of multiple conical subunits and a central radiopaque
pad made of the same elastomer foam. This pad supports the bulbar urethra
producing its coaptation passively and during stress. The system includes one
pair of radiopaque rings (washers) made of polydimethylsiloxane elastomer,
which are placed in the fixation arms to adjust (tighten and loosen) the
implant.
ARGUS T (KIT-MT-01)
• 1 ARGUS T Implant + 2 adjustment rings (washers) (Code: S-42M-AFhT),
made of biocompatible synthetic materials.
• Needles (Code: DPN-HHA): These surgical instruments have been designed
for device implantation through transobturator approach and are disposable.
The kit includes 2 needles and 2 handles.
• Ring (washer) positioners (Code:P-02-A): These surgical instruments have
been designed to adjust the implant during surgery and, if necessary, to adjust
the implant post surgery. The kit includes 2 disposable positioners.*
• Adjustment rings (washers) (Code: AR-M): The kit includes 2 extra
radiopaque rings (washers), made of biocompatible synthetic materials.
• Ruler (Code: R-PU): The kit includes a ruler to measure the retrograde
pressure adjustment during implantation, for reference.
*NOTE: In all cases only one ring (washer) positioner is needed for the implant
procedure. Keep the other ring (washer) positioner in a safe place and in its
double pouch packaging to maintain sterility. It will be used in case a post
surgery adjustment is needed.
All kit components, EXCEPT for the ruler, are provided sterile and ready for
use.