General Information; Contraindications - PFM Medical TiLOOP Notice D'utilisation

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Warnings
The instruments are delivered in an unsterilised condition and are to be cleaned, disin-
fected and sterilised before the first use and each use thereafter.
A careful inspection of the instruments is to be carried out before each use in order to
ensure that there are no defects. Do not use any damaged instruments.
When using instruments pay attention not to damage the mesh.
When using the instruments, ensure that the urethra, bladder, bowel and vessels are
not perforated and that no nerves are damaged. In case of injury immediate surgical
intervention is necessary.
The instruments must not be overstretched by twisting or levering, since this can lead
to damage or breakage of instrument parts.
In the event that the instruments are used on patients with Creutzfeldt-Jakob disease,
reuse is not recommended.
Precautions
• The physician should be experienced with the surgical procedures and techniques. The physician is
responsible for the use.
• The instruments are only to be prepared by persons with the required specialist knowledge and
training.
• Unrinsed areas caused by other instruments during preparation are to be avoided.
• Patients have to be observed with respect to signs of secondary hemorrhage.
• A cystoscopy is to be performed in order to ensure that the bladder has not been perforated during the
implantation.
• In the case of mesh implants that are fixed dorsally, the patient should be examined after surgery for
possible ureteral lesion/stenosis using appropriate resources (e.g. ultrasound).

General information

• If there is a mechanical cleaning option, this should be given preference over manual cleaning since
this is the best way of achieving a standardised procedure.
• Manufacturer specifications and recommendations are to be adhered to.
• Transport packaging etc. is to be removed before the instrument is treated.
• These Instructions for Use cannot replace training, care and the state of the art.
• The person carrying out the reprocessing is responsible for ensuring that the actual reprocessing
achieves the required results using the provided equipment, materials and staff at the reprocessing
facility. Validation and routine monitoring of the process are normally required for this.
• National regulations including preparation restrictions are to be observed.

Contraindications

• Do not use in infected, contaminated or inflamed areas.
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MK-E000620_09 / 2021-02-01