Table Des Matières; Introduction; Indications For Use; Contraindications - C2Dx 0295-001-000 Manuel

EN
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . .2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . .2
Description. . . . . . . . . . . . . . . . . . . . . . . . . . . .2
For Use With . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Safety Directives . . . . . . . . . . . . . . . . . . . . . . . . .3
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Quick Pressure Monitor Set . . . . . . . . . . . . . . . . . .4
Indwelling Slit Catheter . . . . . . . . . . . . . . . . . . . .5
Suggested Set-Up for the Pressure Monitor with Indwelling Slit
Catheter Set . . . . . . . . . . . . . . . . . . . . . . . . .6
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . .7
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Recommended Equipment and Materials . . . . . . . . . . . .8
To Wipe Down the Equipment . . . . . . . . . . . . . . . . .8
Testing and Maintenance . . . . . . . . . . . . . . . . . . . . .8
Battery Replacement . . . . . . . . . . . . . . . . . . . . .8
Calibration Verification . . . . . . . . . . . . . . . . . . . . .8
Storage and Handling. . . . . . . . . . . . . . . . . . . . . . .9
Disposal/Recycle . . . . . . . . . . . . . . . . . . . . . . . . .9
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 10

Introduction

This instructions for use manual contains information intended to
ensure the safe, effective, and compliant use of your product. This
manual is intended for in-service trainers, physicians, nurses, surgical
technologists, and biomedical equipment technicians. Keep and
consult this reference manual during the life of the product.
The following conventions are used in this manual:
▪ A WARNING highlights a safety-related issue. ALWAYS comply
with this information to prevent patient and/or healthcare staff
injury.
▪ A CAUTION highlights a product reliability issue. ALWAYS comply
with this information to prevent product damage.
▪ A NOTE supplements and/or clarifies procedural information.
For additional information, including safety information, in-service
training, or current literature, contact your C2Dx sales representative
or call C2Dx customer service. Outside the US, contact your nearest
C2Dx subsidiary.
2

Indications For Use

The C2Dx Intra-Compartmental Pressure Monitor System is intended
to measure compartmental pressures to aid in the diagnosis of
compartmental syndrome. Compartmental syndrome is defined as
a condition in which the circulation and function of tissues within
a closed space are compromised by increased pressure within the
space. Excessive pressure must be relieved in order to prevent
muscle and nerve necrosis, which lead to permanent loss of function
and limb contracture.

Contraindications

None known.

Description

The Intra-Compartmental Pressure Monitor System is a hand-held,
portable pressure monitor system specifically designed to measure
tissue fluid pressures.
As an interpretive tool, the Intra-Compartmental Pressure Monitor
System should be used along with other clinical indicators to aid the
surgeon in the diagnosis of compartmental syndrome.

For Use With

This section identifies components intended to be used with the
equipment to obtain a safe combination. The Intra-Compartmental
Pressure Monitor System consists of three major components:
DESCRIPTION
Pressure Monitor and Battery
Quick Pressure Monitor Set
Sterile, disposable set includes a syringe pre-
filled with saline, a side-ported needle, and a
diaphragm chamber to maintain a sterile fluid
pathway.
Indwelling Slit Catheter Set
Sterile, disposable set used for continuous
pressure monitoring; set includes a slit catheter,
a break-away needle, and extension tubing.
NOTE: The Quick Pressure Monitor Set (REF
0295-002-000) is required to use the Indwelling
Slit Catheter Set.
0295-001-072 Rev-1
REF
0295-001-000
0295-002-000
0295-006-000
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