Integra NeuroSciences LICOX CMP User manual
LICOX® CMP
Brain Oxygen Monitoring System
Operations Manual
.
Distributed by:
Integra NeuroSciences
311 Enterprise Drive, Plainsboro, New Jersey 08536 USA
Tel.: 800-654-2873
Outside the US: 609-275-0500, Fax: 609-275-5363
www.Integra-NeuroSciences.com
Manufacturer:
GMS - Gesellschaft für Medizinische Sondentechnik mbH
Dorfstraße 2, D-24247 Kiel-Mielkendorf, Fed. Rep. Germany
Tel +49(0)4347 7051 0, FAX +49(0)4347 705129, e-mail:gmsmbh@aol.com
Contents
1 Introduction ..................................................................................................................... 3
2 Indications for Use .......................................................................................................... 3
3 Important Notes ...............................................................................................................3
Device Classifications and Standards .....................................................................................3
Warning Instructions................................................................................................................4
4 Oxygen Sampling Method .............................................................................................. 5
5 Operation and Display .................................................................................................... 7
Front Panel of the LICOX CMP Monitor .................................................................................. 7
Rear Panel of the LICOX CMP Monitor ...................................................................................8
Handle of the LICOX CMP Monitor .........................................................................................8
The LCD Display .....................................................................................................................8
Explanation of the Symbols on the Front and Rear Panel ..................................................... 10
6 Components of the LICOX CMP System ..................................................................... 11
Instruments, Cables and Accessories ...................................................................................11
Optional accessories used in displaying the measured data with other monitoring systems 11
Disposable Catheter Probe and Bolt .....................................................................................12
Temperature catheter microprobes .......................................................................................15
7 Explanation of the Symbols on the Packaging of Sensors and Accessories.......... 16
8 System Set Up ............................................................................................................... 17
Assembly ...............................................................................................................................17
Functional Check of the System ............................................................................................17
Connecting the LICOX CMP to other Devices ....................................................................... 18
9 Measuring pbtO2............................................................................................................. 18
Checks Prior to Monitoring ....................................................................................................18
Connecting the Probe/Starting the Measurement/Temperature Compensation .................... 18
Data Recording .....................................................................................................................19
Plausibility Check ..................................................................................................................20
Checking probe zero after removal from patient ................................................................... 21
Sensor Implantation Technique .............................................................................................21
Troubleshooting.....................................................................................................................22
Problems due to instrument malfunction ...............................................................................22
Fault in operation ................................................................................................................... 23
Risks to the patient ................................................................................................................23
Artifact ...................................................................................................................................25
10 Cleaning, Disinfection, Sterilization and Disposal ................................................... 26
The Instrument ......................................................................................................................26
The Cables ............................................................................................................................26
Probes and Other Disposables .............................................................................................26
Disposal of Probes and Disposable Accessories ..................................................................27
11 Maintenance................................................................................................................. 28
Periodic Checks to be Carried Out by the User.....................................................................28
12 Technical Specifications ............................................................................................ 30
LICOX CMP Instrument .........................................................................................................30
Appendix ........................................................................................................................... 32
Terms of Sale .................................................................................................................... 33
Integra NeuroSciences Limited Warranty ...................................................................... 34
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1 Introduction
The LICOX CMP instrument is used for continuous determination of oxygen partial pressure (pbtO2) in cerebral spinal fluid and brain tissue. Minimally invasive catheter micro-
probes are implanted directly into brain tissue and are connected to the CMP monitor
via an electrical cable. Tissue temperature can also be continuously measured and
used for temperature compensation of p
sensing catheter is used.
In clinical use however, the LICOX CMP instrument can not be used for blood gas
monitoring.
measurements, if a separate temperature
btO2
The catheter employs an electrochemical (polarographic)
ing. The temperature catheter employs a (type K) thermocouple.
Due to its smart card technology, minimal time and effort is required to calibrate the
system before use. Calibration data is stored on a smart card supplied with each catheter. When the smart card is inserted into the LICOX CMP instrument, the system calibrates automatically and is ready for use. Oxygen catheters may be disconnected during use and re-connected to any CMP monitor, as long as the catheter and it’s smart
card are connected to the same CMP monitor. A catheter implanted in the ER can be reconnected to a second CMP unit located in the ICU or elsewhere.
The LICOX CMP data can be displayed in the following ways:
• The LICOX CMP instrument can be used as a simple stand alone
monitor with digital display of the pbtO2 values.
• The oxygen pressure and temperature data measured by the LICOX system may
also be sent to patient monitors, e.g. Hewlett Packard, Marquette, etc., for display,
storage and processing. This is accomplished by the use of the LICOX LML interface
device and cables.
micro-cell for oxygen sens-
2 Indications for Use
The LICOX Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating
the perfusion status of cerebral tissue local to sensor placement. LICOX System values
are relative within an individual, and should not be used as the sole basis for decisions
as to diagnosis or therapy. It is intended to provide data additional to that obtained by
current clinical practice in cases where hypoxia or ischemia are a concern.
3 Important Notes
Device Classifications and Standards
This instrument has been designed for constant use.
Electrical safety meets EN 60601-1 (including amendments 1 and 2), Type CF.
Immunity from electromagnetic disturbance meets IEC 801 including ext. No. 2, 3, 4, 5.
Maximum electromagnetic emission meets EN 55011, Group 1, Class B.
3
Warning Instructions
Failure to observe one or more of the following warnings could compromise the safety of
the patient or result in measurement errors. This also applies to warnings that are issued at other locations throughout this operation manual; sections in which reference is
made to dangers or to possible operating errors are marked in this document with an
index-finger symbol "
a The LICOX CMP instrument may only be used per the “Indications for
Use” section of this document.
b The LICOX CMP instrument may only be used when device mainte
nance has been carried out.
c The use of excessive force on the instrument may seriously damage it;
the same applies to the cable and to the sensor. All mechanical fea
tures of the LICOX system can be operated without the use of exces
sive force.
d The housing of the unit and/or the wall power supply must not be opened.
Units must be returned to the manufacturer for repair and service.
e Only original LICOX parts may be used with or on the instrument. This
applies in particular to all pbtO2 probes, probe cables, analog
transmission cables and the power supply.
":
f The instrument, the power supply and the cable connectors must be
protected against moisture and wetness.
g The instrument must be switched off before cables are connected or
disconnected at the rear of the device.
h Probe cables (or extension probe cables) with damaged isolation
jacketing must not be used. Connector contacts must be cleaned after
coming into contact with saline solutions or body fluid. Measurement
error can occur if these recommendations are not observed.
i Probe extension cables may not be used when their connectors are wet
or damp. Measurement errors can occur if this recommendation is not
observed.
j The potential equalisation plug at the rear of the device must be
connected to the hospital grounding system, when available.
k The anesthetic gas halothene disturbs measurement with all types of
polarographic pbtO2 probes. After an initial exposure time of 5 to 20
min., the displayed pbtO2 value is overestimated; this effect is usually
reversible. However, other common anesthetic gases such as nitrous
oxide (N2O), enflurane and isoflurane can be used without impairing
the accuracy of the measurement.
l Strong electrical interference (e.g. during cauterization) can cause a
disturbance of the measurement that outlasts the interference by a few
seconds.
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m The device has not been designed for use in areas where there is a risk
of explosion.
n Only use the prescribed cleaning agents and methods when cleaning
and disinfecting the instrument and the cable.
o Disposable probes and accessories are for single use only.
p In hyperbaric medicine, the instrument may be used in an air-filled (not
enriched with O
!) pressure chamber up to a pressure of 3 bar. The
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power supply (low voltage DC) is connected through the wall of the
chamber from the outside using suitable connectors. On precisely speci
fied demand, a custom-made cable can be obtained from the manufac
turer, or the manufacturer of the pressure chamber. This authorization
to use the LICOX CMP in a pressure chamber does not extend to
connected devices. It is, however, generally recommended as a sim
pler technical solution for measurement during Hyperbaric Oxygenation
(HBO), that the LICOX CMP instrument is set up outside the chamber
and that the probe signals be transmitted via bi-polar electrical bush
ings. A description of the technical details can be obtained from the
manufacturer upon request.
q The measurement error can exceed the defined limits when the cath
eter is continuously operated for more than 5 days.
r Facilities for neurosurgical treatment of an intracranial bleed must be
available in the hospital.
s Accessory equipment connected to the analogue and digital interfaces
must be certified according to the respective UL standards (UL2601 for
medical equipment). Furthermore all configurations shall comply with
the system standard UL2601. Anyone who connects additional equip
ment to the signal input part or signal output part configures a medical
system, and is therefore responsible that the system complies with the
requirements of the systems standard IEC60601-1. If in doubt consult
the technical service department.
t This equipment is not a bloodgas device .
u Disconnect the power supply from outlet to separate from main voltage
4 Oxygen Sampling Method
Relationship between oxygen pressure and oxygen content in biological media
Gases which are in contact with the surface of a liquid become physically dissolved in
the liquid. If the pressure, the composition and the temperature of the gas atmosphere
over the liquid remain constant over time, a stable equilibrium of diffusion is established
between the gas and the liquid. Ultimately, the pressure of the gas dissolved in the liquid
reaches the pressure of the gas above the liquid. The partial pressure of a gas dissolved
5
in a liquid is often expressed in units of mmHg, pressure units which correspond to the
pressure exerted by a column of mercury of a given height.
As partial pressure increases, the amount of gas that is dissolved in a particular volume
of liquid also increases. In other words: the higher the partial pressure of a gas in solution, the higher the concentration.
The pbtO2 value, a measure of cellular oxygen availability
The partial pressure of the oxygen physically dissolved in CSF or brain tissue corresponds to the availability of oxygen at the cellular level, since the cell membranes do
not represent a functionally variable O2 diffusion barrier and because the diffusion distance between the interstitial space and the mitochondria is short. Hence the pbtO
value reflects the balance between O2 supply and O2 demand of the oxidative energy
metabolism directly at the target of the complex oxygen transport. An increase in the
pbtO2 balance might be due to an increase in the oxygen transport rate to tissue or to a
decrease of the tissue oxygen consumption.
Temperature effect
The signal of a polarographic pbtO2 probe (the probe current) changes depending on
the temperature, even if the pbtO2 value in the environment remains constant. The change
in probe pbtO2 sensitivity with change in temperature is approximately 4% per degrees
centigrade. The probes zero signal (current with no oxygen present) does not depend
on temperature. The temperature sensitivity of the probe signal is compensated for
when the monitor calculates the pbtO2 value. Therefore the temperature of the pbtO
probe must be supplied to the LICOX CMP instrument. The temperature must be continuously measured by an additional LICOX temperature probe (recommended when
the tissue temperature is variable or unknown) or the tissue temperature must be supplied by adjusting a code switch on the front panel of the instrument. The second option
may be preferred when the patient‘s core temperature is continuously monitored, for
example by the use of a foley catheter with thermistor.
2
2
Microtrauma caused by catheter implantation
A local microtrauma results from the implantation of the p02 probe in the tissue. Tissue
is affected in a layer concentrically surrounding the catheter. Several hours after implantation the thickness of that layer is 70 µm to 500 µm.
The pbtO2 value measured corresponds to the mean value of the local pbtO2 levels at
the interface between the damaged tissue around the sensor and the surrounding undamaged tissue. Tissue lacking oxidative metabolism is transparent to the pbtO2 measurement. Therefore, the reading is predominantly determined by the pbtO2 in the undamaged tissue.
Immediately after implantation of the pbtO2 catheter, readings are influenced by the
developing microtrauma. This applies to the first 10 to 120 minutes after insertion. The
pbtO2 values displayed during this initial phase after implantation therefore do not provide relevant information about the oxygenation of the tissue.
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5 Operation and Display
Front Panel of the LICOX CMP Monitor
1 Slot for smart card
2 Blue socket for blue cable (REF: BC10PA), cable that connects the pbtO2 probe
3 Code switch for input of patient tissue temperature
4 Green socket for green cable (REF: BC10TA), cable that connects to tissue tem-
perature probe
5 LCD display. Measured data, instructions and error messages
Fig. 1: Front Panel of the LICOX CMP Monitor
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Rear Panel of the LICOX CMP Monitor
6 On/Off switch
7 Socket for connection of the LICOX main power supply (6.7 - 7.5 VDC), (REF: A10)
8 Analog pbtO2 signal output (0 to 10 V DC, 10 mV/mmHg)
9 Analog temperature signal output (0 to 10 V DC, 100 mV/°C)
10 LICOX bus socket
The analog signal output (No. 8 of Fig. 2) and bus socket (No. 10 of Fig. 2) may
be connected (by using the cable REF D11) to the LICOX monitor Link A for
p
11 Fuse (500 mA, slow-acting)
12 Potential equalisation plug
signal transfer to a bedside monitor. (See Directions for Use, REF: LML.1.)
btO2
Fig. 2: Rear Panel of the LICOX CMP Monitor
Handle of the LICOX CMP Monitor
13 By simultaneously pressing firmly on the buttons on both sides of the handle, the
handle is unlocked. It can then be rotated to a new position and again locked.
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The LCD Display
Identification of parameters
pbtO2pbtO2 value (0.0 - 1999 mmHg), calculated from the probe current signal and
the compensation temperature
T
T
SET
mp
patient temperature (28 - 45 °C) set at code switch (No. 3 of Fig. 1)
temperature (0.0 - 46.0°C) measured by the LICOX thermocouple probe con-
nected to the monitor. In tissue, the thermocouple should be near the location
of the p
btO2
probe.
Messages on the LCD display
"please insert probe card"
Insert the smart card until it snaps into the chip card slot (No. 1 of Fig. 1). The gold
contact pads must point downwards. Push the card in the direction of the arrow labeled
on the card until the card snaps into place.
"card orientation wrong -> re-insert"
The smart card has been inserted incorrectly; turn the chip card over and re-insert it.
"please use probe no.: xxx"
Connect the probe with the serial number xxx that corresponds to the smart card connected to the CMP monitor. Or insert the smart card which corresponds to the probe
connected to the monitor.
"please connect dummy probe"
This message can only appear when the special smart card used for testing the instrument (REF: BC10R) has been inserted. The message requests that the "dummy probe"
be connected to the blue pbtO2 probe cable (REF: BC10PA). The temperature switch
must be set to 22°C and any thermocouple-temperature probe must be disconnected.
Error messages on the LCD display
"error no. x service required"
Error numbers 1 to 3 indicate that the instrument is no longer functional and must be
returned for repair. A short occurrence of error No. 4 after cardioversion or cauterization
or during use of an HF scalpel is normal. The instrument is no longer functional when
message no. 4 appears when there is no clearly definable source of the electrical noiseor when the probe cable is removed from the monitor.
"temperature is too low"
The measured temperature is below the lower limit of the operating range, 0°C.
"temperature is too high"
The measured temperature is above the upper limit of the operating range, 46°C.
"temperature is set too low"
The temperature set at the code switch (No. 3) is below the lower limit of the operating
range, 28°C.
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"temperature is set too high"
The temperature set at the code switch (No. 3) is above the upper limit of the operating
range, 45°C.
"probe or cable defective"
The pbtO2 probe pre-amplifier receives a signal that exceeds the probe current operating range. In most of these cases, there is a defect in the p
cable. This message, however, also occurs for a short time after connecting a p
probe which has been previously run, for example when a probe and smart card are
transfered from one monitor to another.
The following procedure is used to check whether or not there is a defect in the probe
cable: First, the pbtO2 probe should be disconnected from the cable. If the error message is not displayed, the probe is defective. If the error message remains, the probe
cable should be disconnected from the instrument. If the error message now disappears, then the probe cable is defective and must be replaced (REF: BC10PA). Note:
the contacts may be contaminated. If the error message is displayed even if no cable is
connected, then the CMP monitor is in need of repair or cleaning of the input connector
may be required.
probe or in the probe
btO2
btO2
Explanation of the Symbols on the Front and Rear Panel
Protected against electric shock. Type CF equipment per DIN EN 60601-
potential equalisation point for grounding
Caution: Consult accompanying documents
Instrument meets protection class II
~ AC voltage
DC voltage
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6 Components of the LICOX CMP System
Instruments, Cables and Accessories
Model No. Description
AC3 LICOX CMP instrument
Fig. 3: LICOX CMP Instrument
The following components are delivered with the LICOX CMP instrument (Model No.
AC3.1). Please check that all components are included on delivery.
A10 • LICOX wall connected power supply
BC10PA • pbtO2 probe cable (blue),
the cable is not suitable for sterilization in autoclave
BC10TA • temperature probe cable (green),
the cable is not suitable for sterilization in autoclave
BC10PV • extension cable for pbtO2 probe (blue) , sterilization in autoclave is pos-
sible
BC10TV • extension cable for the temperature probe (green), sterilization in auto-
clave is possible
BC10R • test equipment for the functional test of the device: test resistor for input
circuit and smart card to activate the diagnostic program
BC10S • test plug for the patient saftey test
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