abiss CYRENE Instrucciones De Uso página 14

EVALUATION OF THE DEVICE
ABISS asks doctors or medical staff to inform the company of any complication that follows the use of
this device, and to return any explanted components or devices. To ensure safe handling when sending
or receiving the devices, ABISS requests that the latter be decontaminated prior to dispatch.
DESCRIPTION AND CHARACTERISTICS OF THE CYRENE SLING
The sling is a sterile, implantable, single-use medical device with the following technical characteristics:
- Monofi lament woven polypropylene, non-resorbable
- Mean thickness : 0.0005 m
- Mean grammage: 0.899 g/m
- Diameter of the threads: 0.15 mm
- Size of the principal pores in mm:
* 1.31 x 0.44
* 1.62 x 1.02
- Mean porosity: 85%
- Resistance to rupture > 55 N
- Mean elongation to rupture: 58%
- Mean elongation under 10 N: 8%
Values currently measured may undergo slight variations due the limits of manufacturing procedures.
Without infl uencing the function of the device.
The tests were performed in accordance with the norm NF S 94-801 "Vaginal reinforcement implant for
stress urinary incontinence and / or pelvic organ prolapse repair surgery through vaginal approach –
preclinical and clinical tests" (Dec. 2007).
CYRENE y versiones premium INSTRUCCIONES DE USO ES
¡ IMPORTANTE !
El objetivo de estas instrucciones es servir de ayuda para la utilización de la cinta protésica no reab-
sorbible. No se trata de un documento de referencia para el establecimiento de indicaciones y técnicas
de suspensión uretral.
Puede ponerse en contacto con el representante de la empresa para obtener información adicional.
ANTES DE UTILIZAR ESTE IMPLANTE, LEA ATENTAMENTE LA INFORMACIÓN SIGUIENTE EN
SU TOTALIDAD.
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