En - English - Codman DirectLink ICP Gebrauchsanleitung

Codman
®
DirectLink ICP Module
®
Instruction Manual
IMPORTANT:
Please read entire Instruction Manual before attempting to
operate this unit.
Description
The DirectLink ICP Module (see Figure 1) is a direct interface
®
to connect CODMAN MICROSENSOR® ICP Transducers to a
patient bedside monitor, allowing the user to
• Zero the ICP sensor
• Provide zero reference calibration signals to the patient
bedside monitor
• Transfer the ICP readings to the patient bedside monitor
for on-screen viewing and for data storage/processing
The module is powered through its connection to the patient
monitor. The use of a patient monitor interface cable is
required. Please consult Recommended Accessories and
Reordering Information or contact your Integra representative
to order the appropriate cable.
A 3 m long DirectLink ICP Extension Cable (catalog no. 82-
6840) is included with the module.
Notes:
The terms transducer and sensor are used interchangeably in
this manual.
The term ICP means intracranial pressure.
Indications
The intended use of the DirectLink Module is to enable the
connection of Codman intracranial pressure sensors to an available
invasive blood pressure input channel on select commercially
available third party patient bedside monitor systems.
Contraindications
There are no known contraindications at the present time.
User Profile
The DirectLink ICP Module is designed for use by trained
health care professionals in a hospital or critical care setting.
WARNINGS
The DirectLink Module and all associated cables are MR
Unsafe Do not bring the DirectLink Module or the cables into
the MR environment.
The DirectLink Module and associated cables should be
moved away from x-ray sources during CT or other x-ray
based imaging. Exposure to x-rays might damage the memory
function, which stores the transducer zero baseline.
Disconnect the DirectLink Module from the ICP sensor before
electrosurgery or use of a defibrillator. The ICP pressure
readings might be inaccurate when this equipment is used
simultaneously with radiofrequency (RF) electrosurgical
equipment or with a defibrillator.
Modification of the module is not permitted. Unauthorized
modifications to the module can cause a malfunction resulting
in serious patient injury.
To reduce the risk of damage to internal circuitry, do not
disassemble the module. Contact your Integra representative
for replacement, if needed.
Do not use the DirectLink Module with any transducers
(sensors), ICP sensor extension cables, or patient monitor
interface cables except those listed in Recommended
Accessories and Reordering Information.
Use the DirectLink Module only with patient monitors that
meet the specifications listed in Recommended External
Patient Monitor Specifications.
Follow the manual for the patient monitor when calibrating.
Follow the manual for the CODMAN MICROSENSOR ICP
Transducer. Follow aseptic technique when handling the
transducer.
PRECAUTIONS
Routinely inspect all connections: do not use if damaged.
The connectors for both the patient monitor interface cable
and the ICP extension cable must be properly aligned with the
receptacles on the DirectLink Module before pushing these
parts together. DO NOT twist the connector after pushing it in
part way. Twisting the connector in this manner will damage
the pins and can lead to product malfunction.
Once a transducer has been zeroed, its zero value will be
stored in DirectLink Module's memory. After a temporary
disconnection, the patient must be reconnected to the original
DirectLink Module that was used to zero the sensor prior
to implantation. Failure to reconnect to the original module
will result in loss of the transducer zero baseline, resulting in
inaccurate ICP measurements.
Exposure to electrostatic discharge (ESD) energy could damage
the transducer connected to this device. Please refer to
Electrostatic Discharge (ESD) Information.
Electrostatic Discharge (ESD) Information
CAUTION: Exposure to electrostatic discharge (ESD)
energy could damage the ICP transducer High levels
of ESD could damage the electronic components and
cause the transducer to be rendered inaccurate or
inoperable Take all precautions to reduce the buildup
of electrostatic charge during the use of this product
• Provide patient grounding; e.g., grounding straps on gurneys
• Avoid the use of materials that could generate ESD during
patient movement and transport; e.g., nylon transfer
boards with bedding
• Before touching the patient, caretakers should discharge
ESD buildup by touching a grounded metal surface, such as
a bed rail
It is recommended that all hospital personnel in contact with
these devices receive an explanation of the ESD symbol and
training in ESD precautionary procedures. Training should
include, at a minimum, an introduction to electrostatic
discharge, when and why it occurs, precautionary measure,
and the damage that can be done to electronic components if
touched by a user who is electrostatically charged.
• Avoid touching the transducer connector pins before
following ESD precautionary procedures.
• Avoid touching the transducer tip (sensing element) at
all times.
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