Single cystoscopy

REF: 54758

Tubing systems for single use, non-invasive and non-active, which are used to administer fluids (such as water or physiological saline) into the patient’s body under a more or less constant pressure. This is done by means of an integrated section of peristaltic pump tubing. The systems are intended for use by healthcare professionals in a clinical environment.

INTENDED USE:
To be used as a channel for the removal of bodily fluids and secretions, surgical tissue debris, irrigation fluids and gases during surgical invasive procedures or via body openings or cavities.

INDICATIONS FOR USE
According to the professional judgement of the clinician, for any procedure where the surgical site or body cavity needs to be cleared of excess fluids to facilitate observation and/or to remove an obstruction.

INTENDED PATIENT
The intended patient population is not restricted and depends on the medical condition and other clinical considerations; the qualified medical professional must determine whether the medical device is suitable for the intended medical procedure.

Informatie

Product

PRODUCT FAMILY		Cystoscopy
DURATION OF USE		Short Term Use: ≥60min - ≤30days Within the time period the duration of use will be patient specific. This is at the discretion of the medical practitioner.
REGULATION		EU MDD 93/42/EEC
PRODUCT CLASSIFICATION		Class IIa Rule 2
PRODUCT INFORMATION		Cystoscopy System Single System Length Tube: ±175cm Diameter Tube: Ø4.8x6.8mm Length Silicone: ±13cm Diameter Silicone: Ø5x9mm Open/close

Material

MAIN MATERIALS		LDPE - ABS - Master White 11060 - PVC - PVC DEHT 803 - Silicone
LATEX		NO
PHTHALATES, CMR, ENDOCRINE DISRUPTING SUBSTANCES (≥ 0.1% w/w)		NO
PRESENCE OF ANIMAL ORIGIN SUBSTANCES		YES
STERILE or NON-STERILE		STERILE (1 cycle)
STERILISATION METHOD		EO
STERILISATION CYCLES ALLOWED		1 (in total)
SHELF LIFE		≤ 36 MONTHS