Safety Directives; Accessories; Definitions - C2Dx 0295-001-000 Manuel

0295-001-072 Rev-1

Safety Directives

WARNINGS:
▪ Before using this equipment, or any component compatible with
this equipment, read and understand the instructions for use. Pay
particular attention to safety information. Become familiar with the
equipment before use.
▪ Only healthcare professionals trained and experienced in the use
of this medical device should operate this equipment.
▪ The healthcare professional performing any procedure is
responsible for determining the appropriateness of this equipment
and the specific technique used for each patient. C2Dx, as
a manufacturer, does not recommend surgical procedure or
technique.
▪ Upon initial receipt and before each use, inspect each component
for damage. DO NOT use any equipment if damage is apparent.
▪ Upon initial receipt and before each use, clean the equipment as
indicated. See the Cleaning section.
▪ The Pressure Monitor must remain dry. If liquid is spilled on the
unit, the pressure reading may no longer be accurate.
Discontinue use and return to C2Dx for service.
▪ DO NOT use this equipment in areas in which flammable
anesthetics or flammable agents are mixed with air, oxygen or
nitrous oxide.
▪ Take special precautions regarding electromagnetic compatibility
(EMC) when using this medical electrical equipment. Install
and place the equipment into service according to the EMC
information contained in this manual. Portable and mobile radio
frequency (RF) communications can affect the function of the
equipment.
▪ ALWAYS operate the equipment within the specified environmental
condition values. See the Specifications section. The reading of
compartment pressure by the C2Dx Pressure Monitor System
is relative to atmospheric pressure. It may vary versus an
absolute pressure reading, which depends on the atmospheric
pressure at the time the reading is taken. Readings should not
be taken in environments with changing atmospheric pressure
such as aircraft, hyperbaric chambers or any vehicle undergoing
noticeable changes in elevation.
▪ Schedule to check the accuracy of the Pressure Monitor per
hospital protocol or at least once a year. To test the accuracy,
see the Calibration Verification section.
www.c2dxinc.com

Accessories

WARNINGS:
▪ Use only C2Dx-approved accessories. Other accessories may
result in increased emissions or decreased immunity of the
system.
▪ DO NOT modify any equipment without the authorization of the
manufacturer.
▪ DO NOT reuse, reprocess, or repackage a device that is intended
for single use only.
- A single use device may not withstand chemical, chemical
vapor, or high temperature sterilization reprocessing.
- Design features may make cleaning difficult.
- Reuse may create a contamination risk and compromise
structural integrity resulting in operational failure.
- Critical product information may be lost during repackaging.
Failure to comply may lead to infection or cross infection and
result in patient and/or healthcare staff injury.
This section identifies equipment that may be purchased to replace
consumed, worn, or damaged equipment. Optional equipment may
also be purchased to aid in operation.
The following C2Dx-approved accessories are sold separately:
DESCRIPTION
Side-Ported Needle, 18 GA x 2.4 inch (6.1 cm)
3 mL NaCl Fill/Syringe
Sterile, sodium chloride injection USP 0.9%. A
vehicle, solvent, or diluent for parenterals.
Battery Door
Housing Cover
Storage Case
9 V Alkaline Battery
NOTE: For a complete list of accessories, contact your C2Dx sales
representative or call C2Dx customer service. Outside the US,
contact your nearest C2Dx subsidiary.

Definitions

The symbols located on the equipment and/or labeling are defined
in this section or in the Symbol Definition Chart. See the Symbol
Definition Chart supplied with the equipment.
SYMBOL DEFINITION
| Power on
○
Power off
Press this button to reset the indicator to a "00"
ZERO
value.
Millimeters of mercury (unit of pressure
mmHg
measurement)
EN
REF
0295-003-000
0295-005-000
0295-001-004
0295-001-005
0295-008-000
0295-009-000
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