Device-Inherent Dangers - Stryker 150 Handbuch

Purpose of the Device
US
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
CAUTION
6
3.2

Device-inherent Dangers

Fluid irrigation pumps used in Arthroscopy may cause fluid extravasation into
the surrounding tissue. In severe cases, the resulting oedema may result in a
serious 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.
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,
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
replace the expertise of the surgeon.
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
refer to the descriptions of various warnings described in this manual.
This product contains Diethylhexylphthalate (DEHP), which is classified as toxic
to reproduction according to the EU Directive 67/54/8EEC 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.
Reprocessing of sterile disposable products
Infection hazard for patients and/or users and impairment of product
functionality due to reuse. Risk of injury, illness or death due to contamination
and/or impaired functionality of the product! Do not reprocess the product.
The device is only intended for use with flexible fluid containers. Do not use glass
containers as they might break. Fluid cannot flow quickly enough due to the
vacuum being generated inside of the bottle. Risk of implosion.
Set up the device in such a way as to allow for easy monitoring of the display values,
device functions, and access to the control elements.
Position the device such that it is easy to operate and disconnect.
Endoscope
The device may only be connected with endoscopes designed for and featuring the
technical specification permitting such a combined use. Any utilized endoscopes