Infiltration Tubing

REF: 45700

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		Flush
DURATION OF USE		Transient Use: Normally intended for continuous use for less than 60 minutes, but may be patient specific depending on the duration of the procedure.
REGULATION		EU MDD 93/42/EEC
PRODUCT CLASSIFICATION		Class IIa Rule 2
PRODUCT INFORMATION		Total Length Tubes: ±490cm Diameter Tubes: Ø3x4.1mm Length Silicone: ±16cm Diameter Silicone: Ø4.7x9.5mm Open/close

Material

MAIN MATERIALS		ABS - PP - LDPE - PE - Blue Colouring - PVDF homopolymer - PVC DEHT 553 - Silicone
LATEX		NO
PHTHALATES, CMR, ENDOCRINE DISRUPTING SUBSTANCES (≥ 0.1% w/w)		NO
PRESENCE OF ANIMAL ORIGIN SUBSTANCES		NO
STERILE or NON-STERILE		STERILE (1 cycle)
STERILISATION METHOD		EO
STERILISATION CYCLES ALLOWED		1 (in total)
SHELF LIFE		≤ 36 MONTHS