Chapter 1. Introduction; Product Description; Declaration Of Conformity; General Warnings And Cautions - DePuy Mitek FMS solo Bedienungsanleitung

Chapter 1. Introduction

1.1. Product description

Irrigation system.
The fms solo is an advanced, and user friendly
®
irrigation system that uses patented technology to
improve visualization and lower cost.
Flow compensation.
The fms solo communicates with your current
®
shaver, improving visualization by activating the
�Flow compensator� cycle while the shaver is
in rotation.
Pressure cycle red pedal.
One of the most critical aspects of arthroscopy is
visualization. The field of view is often obstructed
by blood and debris. To alleviate this problem the
fms solo has a pressure cycle. By stepping on the
®
red foot pedal you will activate a timed cycle of
increased pressure to control bleeding. Once the
cycle is completed, the fms solo
original configuration.

1.2. Declaration of conformity

We, at fms group declare under our sole
responsibility that the product fms solo
conformity according to CE 93/42 EEC Medical
Device Directive. This product is manufactured in
an ISO 9001:2000/13485 facility.

1.. General warnings and cautions

It is recommended that hospital personnel read
this manual before operating, cleaning or sterilizing
this product and its accessories. Failure to follow
these instructions may result in potential injury and
damage or malfunction of the equipment.
The manufacturer and licensed seller of this
device do not accept any liability for direct or
consequential damage or injury caused by improper
use of disposables other than FMS products. Any
alterations to this device, repair from an unlicensed
service center, or use of non-FMS disposables,
will return to its
®
will void CE marking, FMS warranty and product
liability coverage.
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is in
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