Promedon ANCORIS POP Instructions D'utilisation page 3

ANCORIS POP Repair System components are designed and intended for
SINGLE use only. Therefore, DO NOT REUSE or RE-STERILIZE, since this could
decrease the performance of the device and increase the likelihood of
cross-contamination.
It is advisable that patients avoid heavy lifting, strenuous exercise (cycling,
running, etc.) and sexual intercourse at least during the first four weeks after
surgery. The doctor determines when it is appropriate to resume her normal
activities.
The patient should contact the surgeon immediately in the event of:
• Dysuria
• Vaginal pain
• Fever
• Serous, bloody or purulent secretions
• Hemorrhages or other problems
PRECAUTIONS
The implant must not be handled with pointed, serrated, or sharp objects
since any damage, or tearing can cause subsequent complications.
Maximum precautions must be taken to avoid contamination.
Avoid excessive tension on the implant during insertion.
Maximum precautionary measures must be taken when attaching the TAS
to the insertion guide and in order to avoid exerting pressure in the wrong
direction during TAS insertion. See "Surgical procedure" section below.
Handling and Storage Precautions
ANCORIS POP Repair System is provided sterile and pyrogen-free. It comes
packaged in a cardboard box containing a blister pack. The blister pack holds
the Retractable Insertion Guide, the Knot pusher with its protective tube,
and the Dispenser Unit in which are placed the circle surgical eye needle and
the three Tissue Anchoring Systems. IF THE BLISTER PACK IS DAMAGED, DO
NOT IMPLANT.
Operating room conditions must meet hospital, administrative, or local
government requirements.
After use, discard the product and packaging according to hospital,
administrative, or local government requirements.
STORAGE
ANCORIS POP Repair System should be stored under the following
conditions:
TEMPERATURE: Room temperature
DO NOT USE AFTER THE EXPIRATION DATE SPECIFIED ON THE PACKAGING.
MAGNETIC RESONANCE (MR) ENVIRONMENT
The implant does not affect and is not affected by magnetic resonance (MR)
environments.
POSSIBLE COMPLICATIONS
The patient and/or her representatives should be fully informed of the
procedure and give consent. The surgeon should discuss with the patient
and/or her representatives the possible complications associated with the
surgery, anesthesia and device prior surgery.
The implant may cause complications related to each patient's specific
degree of intolerance to any foreign material implanted in the body. Some
complications may require removal of the implant.
Some patients may experience vaginal pain during the initial post-operative
period. Treatment with ANALGESICS and ANTI-INFLAMMATORY DRUGS may
be sufficient to relieve pain.
Other complications reported with this or other similar implants include:
• Infection
• Adhesion formation
• Vaginal pain, discomfort, irritation
• Purulent, serous or bloody discharge
• Inflammation
• Injuries to blood vessels or nerves
• Presence of vaginal fistula
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