Icp Express Monitor; Instruction Manual; Introduction; Warnings - Codman ICP EXPRESS Bedienungsanleitung

CODFR06058xx01v10.qxd 3/8/07

Introduction

This manual is intended to provide instructions on the proper use of the
ICP EXPRESS Monitor (Catalog No. 82-6634). It is the responsibility of the
user to ensure that any applicable regulations regarding the installation and
operation of the ICP EXPRESS Monitor are observed.
The ICP EXPRESS Monitor (see Figure 1) is intended to serve as an
interface between the CODMAN
compatible patient monitoring systems. When connected to a MicroSensor,
the ICP EXPRESS Monitor provides a continuous numeric display of the
mean, systolic and diastolic intracranial pressure. For detailed waveform
analysis the ICP EXPRESS Monitor generates an output signal that may
be interfaced directly to the pressure channel input on most patient
monitoring systems.
The ICP EXPRESS Monitor was designed for use wherever ICP monitoring
is appropriate, such as emergency rooms, operating rooms, and intensive
care units. The small profile and light weight of the ICP EXPRESS Monitor
make it ideal for monitoring ICP during patient transport, with or without
a separate transport monitor. The ICP EXPRESS Monitor operates
continuously on AC power, or for up to three hours on its own internal
rechargeable battery. Key features provided by the ICP EXPRESS
Monitor include:
• Digital display of mean, systolic, and diastolic ICP
• One-touch transducer zero function
• User programmable mean ICP alarms
• Compatibility with most patient monitoring systems for full ICP waveform
analysis and integration of ICP data with other patient information
• 0, 20 and 100 mmHg patient monitor reference signals
• Integral pole clamp
Included with the ICP EXPRESS Monitor is one ICP EXPRESS Cable
(Catalog No. 82-6636). The ICP EXPRESS Cable is used to connect the
MicroSensor to the ICP EXPRESS Monitor. During the transducer zeroing
process the ICP EXPRESS Monitor automatically stores the MicroSensor's
zero reference value in a non-volatile memory element embedded in the
ICP EXPRESS Cable. This feature allows the physician to transfer a patient
to another ICP EXPRESS unit without having to manually adjust the zero
reference value. The reusable ICP EXPRESS Cable can be sterilized by
ethylene oxide (EtO) gas. Refer to the Sterilization section for details.
CODMAN Patient Monitor Interface Cables are available separately for
connecting the ICP EXPRESS Monitor to a variety of compatible patient
monitoring systems. Inside the US, contact your local Codman sales
representative for full details. Outside the US, contact your local
Codman representative.

WARNINGS

Read the entire operating manual before attempting to operate this unit.
Do not attempt to bypass the grounding prong on the ICP EXPRESS
Monitor by using a three-prong to two-prong adapter. The unit must
be properly grounded to ensure operator and patient safety. Grounding
reliability can be achieved only when connected to a receptacle marked
"Hospital Only" or "Hospital Grade."
Explosion Hazard: Do not use in the presence of flammable materials
(i.e., anesthetics, solvents, cleaning agents and endogenous gases).
Electrical Shock Hazard: Do not remove side, front or rear panels. Send to
qualified personnel for servicing.
Disconnect the ICP EXPRESS Monitor from all external AC power sources
before changing fuses.
Patient connections are electrically isolated Type CF. Do not let patient
connections contact other conductive parts, including earth.
Routinely inspect all electrical plugs and connections. Do not use if damaged.
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® MicroSensor ICP Transducer and
Maintain strict sterile technique when connecting the ICP EXPRESS Cable
to the MicroSensor.
Medical electrical equipment needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put into
service according to the EMC information provided in this manual.
Portable and mobile radio frequency (RF) communications equipment can
affect medical electrical equipment.
The monitor should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the monitor should
be observed to verify normal operation in the configuration in which it will
be used.

CAUTIONS

Read all instructions included with the appropriate CODMAN MicroSensor
ICP Transducer Kit regarding proper operation prior to use.
Read all instructions provided with the external patient monitoring system
prior to use.
Patient leakage current is limited internally by the ICP EXPRESS
Monitor to less than 10 µA. However, additional leakage current can be
caused by other equipment used on the patient at the same time as the

ICP EXPRESS Monitor.

Use only the ICP EXPRESS Cable (Catalog No. 82-6636) to connect the
MicroSensor to the ICP EXPRESS Monitor.
Use only CODMAN MicroSensor ICP Transducers for intracranial
pressure measurements.
Use CODMAN Patient Monitor Interface Cables only with the patient
monitors for which they are specifically designed and designated.
Verify compatibility between the ICP EXPRESS Monitor and the external
patient monitor prior to use. Compatibility may be verified using the 0, 20 and
100 mmHg reference signals provided by the ICP EXPRESS Monitor.
Failure to verify compatibility between the ICP EXPRESS Monitor and the
patient monitor may result in inaccurate ICP readings on the patient monitor.
Discontinue use if the patient monitor can not be properly zeroed to the
ICP EXPRESS Monitor. Consult with appropriate technical personnel.
Discontinue use if the patient monitor can not be properly calibrated to the
ICP EXPRESS Monitor. Consult with appropriate technical personnel.
The signal processing algorithms used to detect and display physiological
pressure data may vary among patient monitors of different make and
model. Therefore, pressure data displayed by the ICP EXPRESS Monitor
may not always be consistent with the data displayed on an externally
connected patient monitor. Refer to the patient monitor manufacturer's
instruction manual for specific details regarding signal processing, calibration
and accuracy.
The MicroSensor must be zeroed at atmospheric pressure, prior
to implantation.
The MicroSensor transducer tip must remain wet during the zeroing process.
Do not submerge the tip of the MicroSensor or ventricular catheter vertically
in a cup of sterile water or saline during the zeroing process. Doing so will
impose pressure on the transducer diaphragm that is higher than
atmospheric zero, resulting in an inaccurate zero reference value.
The ICP EXPRESS Monitor transducer zero reference value setting should
only be adjusted manually if the displayed value differs from the value
recorded on the MicroSensor connector housing or the patient's chart.
The mean ICP alarms will reset to default values (LO: 0 mmHg;
HI: 20 mmHg) whenever the ICP EXPRESS Monitor power is turned OFF.
Do not autoclave the ICP EXPRESS Cable. Sterilize the
ICP EXPRESS Cable using Ethylene Oxide (EtO) gas only.
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