Important - Integra Codman ICP EXPRESS Manual De Instrucciones

Codman
®
ICP EXPRESS ® Monitor
Instruction Manual

IMPORTANT:

Please read entire Instruction Manual before attempting to operate this unit.
Introduction
This manual is intended to provide instructions on the proper use of the
ICP EXPRESS® Monitor (REF 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 Microsensor® ICP Transducer and compatible patient monitoring systems.
When connected to a Codman 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 is 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 3 m long ICP EXPRESS Cable (Catalog
No. 82-6636). The ICP EXPRESS Cable is used to connect the Codman Microsensor
to the ICP EXPRESS Monitor. During the transducer zeroing process the ICP EXPRESS
Monitor automatically stores the Codman 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 Integra representative for full details. Outside the US,
contact your local Integra 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."
Do not touch outer surfaces of monitor and patient simultaneously.
No modification of this equipment is allowed.
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. To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth.
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.
Maintain strict sterile technique when connecting the ICP EXPRESS Cable to the
Codman 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 must not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the monitor must be observed to verify normal
operation in the configuration in which it will be used.
The use of electrosurgical equipment (e.g., Monopolar, Bipolar, Diathermy) can cause
damage to the ICP Codman Microsensor and/or ICP EXPRESS Monitor. This could lead
to permanent or temporary disabling of either device.
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.
This device can be damaged by exposure to high levels of Electrostatic Discharge (ESD)
energy. Unusually high levels can damage the electronic components, which could
cause the unit or an attached sensor to be rendered inoperable. Take all precautions
to reduce the build-up of electrostatic energy during the use of this product. Provide
patient grounding at all times and avoid the use of materials that can generate ESD
during patient movement and transport (e.g., avoid the use of nylon transfer boards
and bedding; use grounding straps on gurneys, etc.).
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 Codman
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.
Connect the Patient Monitor Interface Cable connector to only certified patient
monitors.
Verify compatibility between the ICP EXPRESS Monitor and the external patient
monitor prior to use. Compatibility can 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 can 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 can 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.
2
EN – ENGLISH