Device-Inherent Dangers - Stryker Flosteady Manual De Instrucciones

Device Purpose
EN
8
3.2

Device-inherent Dangers

WARNING!
Fluid irrigation pumps used in Arthroscopy may cause fluid extravasation into
the surrounding tissue. In severe cases, the resulting oedema may result in a se-
rious adverse patient event which may include compartment syndrome or nerve
compromise. Should extravasation be observed, it is recommended to reduce
pressure settings and closely observe the excess fluid build up.
WARNING!
The nominal pressure of the described device can be preset to values described
in this manual. Select the optimum pressure based on the patient profile, includ-
ing but not limited to blood pressure, height, weight and age. The manufacturer
recommends pressure settings for different areas of application; however these
are suggestions only and are not intended to substitute or replace the expertise
of the surgeon.
WARNING!
In case of an overpressure situation when using Single Use Cassette Tubing, the
here described device is equipped with safety measures to assist in reducing the
overpressure. The pump may display warning signs and start turning the inflow
spindle backwards, in an attempt to decrease the intra-articular pressure by re-
moving fluid from the joint. Please refer to the descriptions of various warnings
described in this manual.
WARNING!
The FloSteady Arthroscopy Pump (Model 150) does not reduce pressure by rotat-
ing the roller wheel backwards when used with the Day Use Tubing if the actual
pressure exceeds the nominal pressure. To reduce the pressure in the joint, open
the outflow cannula/and or manipulate the joint to a stress-free position.
WARNING!
Disposable tube sets contain Diethylhexylphthalate (DEHP), which is classified as
toxic to reproduction according to the EU Directive 67/548/EEC on Classification
and Labelling of Dangerous Substances. DEHP may impair fertility, may cause
harm to unborn child, may excrete in breast milk. Therefore, this product must
not be used for unauthorized applications. When applied within the intended
use, the potential risk to pregnant or breastfeeding women as well as to children
resulting from the DEHP contained in this product is not critical. In regard to the
short exposure time and the physical characteristics the eventuality of critical
quantities of DEHP being dissolved from the tube sets is neglectable.
WARNING!
Reprocessing of sterile disposable products
Infection hazard for patients and/or users and impairment of product function-
ality due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product! Do not reprocess the product.