Important Information; Description; Indications; Contraindications - Depuy Synthes CODMAN NEURO DirectLink ICP Module Betriebsanleitung

ENGLISH

IMPORTANT INFORMATION

Please Read Before Use
DirectLink™ ICP Module
(REF 82-6828)

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 Codman Neuro Representative to order the appropriate
cable.
A 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 Codman Neuro 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.

List of Symbols

The following symbols may be present on the product, the product
package/label, or in this manual.
Prescription device only (USA)
ARROW BUTTON for calibrating patient monitor
ZERO BUTTON for zeroing ICP sensor prior
to implantation
Patient Monitor output connector
Extension Cable input connector
Electrostatic sensitive devices
Follow instructions for use
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