Device-Inherent Dangers - Stryker Flosteady Handbuch

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 edema may result in a seri-
ous 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 these instructions for use. Select the optimum pressure based on the patient
profile, including 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 re-
place the expertise of the surgeon.
WARNING!
In case of an overpressure situation, 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 removing fluid from the joint. Please re-
fer to the descriptions of various warnings described in these instructions for
use.
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.
WARNING!
Instrument replacement when Auto calibration is used
Stop the device using the Start/Stop switch if replacing the instrument during
surgery. By next start, the device performs an Auto calibration for the new in-
strument