Chapter 1. Introduction; Product Description; Indication For Use; General Warnings And Cautions - DePuy Mitek FMS SOLO Mode D'emploi

Chapter 1. Introduction

1.1. Product Description

Irrigation system.
The FMS SOLO is an advanced, lower cost
irrigation system that uses patented technology
to improve visualization and distension while
controlling pressure during arthroscopic surgery.
Flow compensation.
The FMS SOLO can recognize when a shaver is
in rotation and subsequently improve by activating
the "Flow compensator" cycle. Please contact
your DePuy Mitek representative for FMS Shaver
Interface products due to the variety of products
offered.
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
feature. 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 will return to its original
configuration.

1.2. General Warnings and Cautions

It is recommended that hospital personnel read
this manual before operating or cleaning 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, may void CE marking, FMS warranty
and product liability coverage.
109076-KIM Rev B.indd 9
The tube sets contain DEHP, a phthalate
chemical known to cause birth defects and other
reproductive harm, including in children and in
pregnant or nursing women.
Warning:
The FMS SOLO is a Class I Type B device
according to the Electrical Safety Standard EN
60601-1 for medical devices. Ensure that you are
using the correct interface cable when connecting
to another shaver. For more details, refer to
Interface Cable Instructions for Use. Contact your
DePuy Mitek Sales Representative to review
Shaver Interface Cable interface offerings.
The system may be affected by electromagnetic
interferences from other instruments. Verify that all
other instruments and appliances (associated or
not with the system) comply with the standard EN
60601-1-2 (EMC).
If the system continues to be affected, isolate it
from the offending instrument and connect to a
different mains outlet.

1.3. Indication for Use

The FMS SOLO Arthroscopic Fluid Management
System is indicated for use in a surgical setting by
personnel trained in arthroscopy.
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