Integra LifeSciences Codman ICP EXPRESS Manual De Instrucciones página 7

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 (catalog no. 82-6635). 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 can 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 3 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
(EO) 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. Contact
your local Integra LifeSciences sales representative for full details.
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.
If the integrity of the protective earthing system is in doubt, operate the ICP EXPRESS
Monitor from its internal battery.
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 use of electrosurgical equipment (e.g., Monopolar, Bipolar, Diathermy) can cause
damage to the Codman Microsensor and/or ICP EXPRESS Monitor. This could lead to
permanent or temporary disabling of either device.
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.
PRECAUTIONS
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.
Connect Patient Monitor Interface connector to certified patient monitors.
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 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 cannot be properly zeroed to the ICP EXPRESS
Monitor. Consult with appropriate technical personnel.
Discontinue use if the patient monitor cannot 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.
The Codman Microsensor must be zeroed at atmospheric pressure, prior to
implantation.
The Codman Microsensor transducer tip must remain wet during the zeroing process.
Do not submerge the tip of the Codman Microsensor or ventricular catheter vertically
in a cup of sterile water or saline during the zeroing process. Doing so will impose
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