USER`S MANUAL

MOCA203
V2
with Unity Software
Hemodynamic Monitoring System
USER’S MANUAL
Version 2
V2
MOCA203
User’s Manual
Manufactured by:
LiDCO Ltd
16 Orsman Road
London N1 5QJ UK
LiDCOrapid User’s Manual
Software V2.0
This device is covered by one or more of the following patents:
US Pat 006071244; WO9724982; other patents applied for.
This device bears the mark in accordance with the provisions of the Directive 93/42/EEC of June 14, 1993, concerning
medical devices.
Caution: (USA) Federal Law restricts this device to sale by or on the order of a physician.
All LiDCO devices are intended for use by qualified medical personnel only.
Carefully read all manuals that are provided with your device before use.
Printed in the United Kingdom.
All rights are reserved. LiDCO Ltd. reserves the right to alter the products described in this manual at any time without
notice. No part of this manual may be reproduced, copied, translated or transmitted in any form or by any means without
the prior written permission of LiDCO. Information provided in this manual is intended to be accurate and reliable.
However, LiDCO assumes no responsibility for use of this manual, nor for any infringements upon the rights of third
parties which may result from such use. All brand and product names mentioned herein are trademarks or registered
trademarks of their respective holders.
This device is subject to the EU Directive 2002/96/EC (WEEE). It is not registered for use in private households, and may
not be disposed of at municipal collection points for waste electrical and electronic equipment. LiDCO Ltd has authorized
a firm to dispose of this device in the proper manner. For more detailed information, please contact your local LiDCO Ltd
organization.
Copyright Notice
• LiDCO, LiDCOunity and PulseCO are trademarks of LiDCO Ltd. This document is copyrighted, 2007-2012, by LiDCO
Ltd.
• Bispectral Index, BIS and the BIS logo design, BISx and the BISx logo design, BIS Ready and the BIS Ready logo
design and Zipprep are registered trademarks of Nellcor Puritan Bennett LLC. For more information on BIS products,
visit www.covidien.com
• CNAP is a trademark of CNSystems.
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Version 2
MOCA203
V2
With Unity Software
Safety and Maintenance
1. Read these safety instructions carefully.
2. Keep this User's Manual for later reference.
3. All cautions and warnings on the equipment should
be noted.
4. Make sure the voltage of the power source is correct
before connecting the equipment to the power outlet.
5. Use only the power supply unit supplied with the
equipment. To avoid the risk of electric shock, this
monitor must be connected to a mains supply with
protective earth.
6. Use only the correct adapter for the power supply
unit to suit the power source.
7. The power outlet socket must be located near the
monitor and must be easily accessible. Position the
power cord so that people cannot step on it. Do not
place anything over the power cord.
8. Disconnect this equipment from any power outlet
socket before cleaning. Use a damp cloth. Do not
use liquid or spray detergents for cleaning directly
onto the monitor.
16. Never open the equipment. For safety reasons, the
equipment should be opened only by LiDCO certified
service personnel.
17. If one of the following situations arises, get the
equipment checked by service personnel:
a. The power cord, or power supply unit, or other
cable is damaged.
b. Liquid has penetrated into the equipment.
c. The equipment has been exposed to moisture.
d. The system does not work well, or you cannot get
it to work according to the User's Manual.
e. The equipment has been dropped and damaged.
f. The equipment has obvious signs of breakage.
18. DO NOT LEAVE THIS EQUIPMENT IN AN
UNCONTROLLED ENVIRONMENT WHERE THE
STORAGE TEMPERATURE IS BELOW -20° C (-4° F)
OR ABOVE 60° C (140° F). THIS MAY DAMAGE THE
EQUIPMENT.
9. Keep this equipment away from humidity.
10. Never pour any liquid into an opening. This may
cause fire or electrical shock.
11. The openings on the enclosure are for air convection.
Protect the equipment from overheating. DO NOT
COVER THE OPENINGS.
12. Put this monitor on a reliable surface during
installation. Dropping it or letting it fall may cause
damage. The Monitor should be mounted on the
LiDCO desktop stand, or a dedicated roll stand, or
an engineered support to provide stability during use.
Follow the instructions supplied with the mounting
arrangement to ensure correct fitting.
13. If the equipment is not used for a long time,
disconnect the Monitor and the power supply unit
from the power source to avoid damage by transient
over-voltage.
14. No modification to this equipment is allowed.
15. There are no user or service personnel replaceable
parts.
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Safety and Maintenance
BISx Warnings:
BISx Cautions
DUE TO ELEVATED SURFACE TEMPERATURE, DO NOT
PLACE BISx IN PROLONGED DIRECT CONTACT WITH
PATIENT’S SKIN, AS IT MAY CAUSE DISCOMFORT.
Do not autoclave the BISx. Autoclaving will seriously
damage this component.
THE CONDUCTIVE PARTS OF ELECTRODES OR
SENSOR AND CONNECTORS SHOULD NOT CONTACT
OTHER CONDUCTIVE PARTS, INCLUDING EARTH.
TO REDUCE THE HAZARD OF BURNS DURING USE OF
HIGH FREQUENCY SURGICAL EQUIPMENT, THE
SENSOR OR ELECTRODES SHOULD NOT BE LOCATED
BETWEEN THE SURGICAL SITE AND THE ELECTROSURGICAL UNIT RETURN ELECTRODE.
TO REDUCE THE HAZARD OF BURNS DURING USE OF
BRAIN STIMULATING DEVICES (e.g., TRANSCRANIAL
ELECTRICAL MOTOR EVOKED POTENTIAL), PLACE
STIMULATING ELECTRODES AS FAR AS POSSIBLE
FROM THE BIS SENSOR AND MAKE CERTAIN THAT
SENSOR IS PLACED ACCORDING TO PACKAGE
INSTRUCTIONS.
THE SENSOR MUST NOT BE LOCATED BETWEEN
DEFIBRILLATOR PADS WHEN A DEFIBRILLATOR IS
USED ON A PATIENT CONNECTED TO THE BIS VISTA
SYSTEM.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION,
THE PATIENT INTERFACE CABLE (PIC) MUST BE
CAREFULLY PLACED AND SECURED.
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Do not open BISx for any reason. The seal to prevent
liquids from entering the BISx may be damaged if opened.
Service or repairs must be performed only by qualified
biomedical technicians.
Continuous impedance checking may need to be disabled
if the 1 nanoampere 128Hz impedance check signal
interferes with other equipment (e.g., evoked potential
monitors).
The sound pressure level at the operator's position
according to IEC 704-1:1982 is no more than 70dB(A).
Only connect the LiDCOrapid to other equipment or data
networks that are certified to IEC 60601-1 or locally
equivalent safety standards.
Although compliant with the applicable EMC requirements
this equipment may still be affected by, and may still affect
other equipment. If interference is occurring, the user is
encouraged to try to correct the interference by one of the
following measures:
•
Repositioning either equipment to reorient and/or
increase the separation between the equipment
•
Connect the equipment to a power outlet on a circuit
different from that to which the other equipment is
connected
•
Consult an experienced technician for help.
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Version 2
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V2
With Unity Software
List of Symbols
Symbol
Meaning
Symbol
DC Power
Meaning
Locate over artery (e.g. Brachial)
CE Mark
SN
Serial Number
UL Mark
REF
Reference Number
Potential RF Source
Equipotential
ETL Mark
Hot Surface
Read Operators Manual (old)
Manufacturing Date
Press
Read Operators Manual
Classification Type B, Class I
Classification Type BF, Defib Proof
Classification Type CF, Defib Proof
Warning
WEEE Regulations symbol for disposal
of Electronic Equipment
Latex Free
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User’s Manual
Table of Contents
1.0 Introduction / Overview ............................................1
4.7 Patient Details Screen ......................................26
1.1 Standard Hemodynamic Monitoring ..................2
4.8 Operation ........................................................29
1.2 Functional Hemodynamic Monitoring ................3
4.8.1 Overview of LiDCOrapid Screen ....................29
2.0 Quick Start ..............................................................4
4.8.2 Navigating the Screen ..................................30
2.1 LiDCOrapid ........................................................4
4.8.3 Hemodynamic Monitoring Display ................31
2.2 BIS ....................................................................6
4.8.4 Event Response Display................................33
2.3 CNAP ................................................................7
4.8.5 Dynamic Preload Responsiveness Display ....35
3.0 Intended Use/Contra-Indications/Warnings ..............8
4.9 Configuration of LiDCOrapid Screen ................37
3.1 Intended Use ....................................................8
4.9.1 Hemodynamic Trend: ....................................38
3.2 Contraindications ..............................................8
4.9.2 Event Response: ..........................................38
3.3 Warnings – LiDCOrapid......................................9
4.9.3 Dynamic Preload Responsiveness Parameters:
..............................................................................38
3.4 Warnings – BIS ................................................11
3.5 Warnings – CNAP ............................................11
3.6 Cautions ..........................................................12
4.0 Monitor Operation ..................................................14
4.1 Setup ..............................................................14
4.1.1 LiDCOrapid Equipment Setup ......................14
4.1.2 Starting the Monitor ......................................14
4.2 Connecting the LiDCOrapid to the Primary Patient
Monitor ..................................................................15
4.2.1 Option 1: Direct Analog Input (POC Model Only)
..............................................................................15
4.2.2 Option 2/3: LiDCO BP Module ......................15
4.2.3 LiDCO BPM Channel Selection ....................16
4.2.4 Zeroing Channel 1 ........................................17
4.2.5 Beat Detector Threshold ..............................17
4.3 BIS Monitoring Equipment and Setup ..............19
4.4 CNAP Module Equipment and Setup ..............20
4.5 Welcome Screen and Module Navigation ........23
4.5.1 Adding or Removing Modules after the Session
Starts ....................................................................23
4.5.2 LiDCOrapid ..................................................24
4.5.3 BIS................................................................24
4.5.4 CNAP Module ..............................................24
4.6 LiDCOsmart ....................................................25
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4.10 LiDCOrapid Calibration ..................................39
5.0 Bispectral Index and EEG monitoring ....................40
5.1 Overview ..........................................................40
5.2 Warnings..........................................................42
5.2 1 General ........................................................42
5.2.2 Precautions ..................................................42
5.2.3 Patient Preparation........................................43
5.3 Hardware Setup: Connecting the BISx Pod......44
5.3.1 Connect the BISx Pod to the monitor............44
5.3.2 Secure the BISx Pod ....................................45
5.3.3 BIS Setup ....................................................45
5.4 BIS Configuration Menu Options ......................46
5.4.1 Configuration Menu ......................................46
5.5 Sensor Check ..................................................47
6.0 CNAP Operation ....................................................49
6.1 Overview ..........................................................49
6.2 Warnings..........................................................50
6.3 Hardware Setup: Connecting the CNAP Module ..
..............................................................................52
6.3.1 Hardware Connections..................................52
6.3.2 Patient Setup (connection) ............................52
6.4 CNAP Operation ..............................................53
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6.4.1 Starting the Measurement ............................53
9.7 Service Mode ..................................................92
6.5 Main LiDCO CNAP Module Measurement and ....
Display Screen ......................................................56
9.8 Parameters ......................................................93
6.6 CNAP Configuration Menu Options ..................58
6.6.1 CNAP Calibration Interval ..............................58
6.6.2 Alarms ..........................................................59
7.0 Combined Display and Common Features ............60
7.1 LiDCOrapid and BIS ........................................60
7.2 LiDCOrapid and CNAP ....................................61
7.3 BIS and CNAP ................................................62
7.4 LiDCOrapid, BIS and CNAP ............................63
7.5 Event Marking ..................................................64
7.6 Event History....................................................65
7.7 History Screen ................................................66
7.8 Chart Screen....................................................67
8.0 Alarms, Safety, Cleaning and Maintenance ............68
8.1 Alarms ............................................................68
8.2 Safety Instructions, Cleaning, Maintenance ......69
8.2.1 Safety Requirements ....................................69
8.2.2 Cleaning and Disinfection Instructions ..........70
9.8.1 Rapid ............................................................93
9.8.2 BIS................................................................94
9.8.3 CNAP Parameters ........................................94
9.9 Technical Specifications ..................................95
9.9.1 Rapid Monitor ..............................................95
9.9.2 Power Supply Unit (POC-125 only)................96
9.9.3 LiDCOsmart Card..........................................96
9.9.4 Blood Pressure Module and Components ....96
9.9.5 BISx ..............................................................97
9.9.6 BISx EEG Specifications................................98
9.9.7 CNAP Module Specifications ........................98
9.10 Electrical Safety and EMC ............................101
9.11 Standards ....................................................107
9.12 Monitor Connectors Layout..........................107
9.13 Mounting Details ..........................................108
9.13.1 LiDCOrapid ..............................................108
9.13.2 LiDCOrapid and BP Module ......................109
8.2.3 Maintenance or Service ................................71
9.13.3 LiDCOrapid and the CNAP Module Mounting
Options ................................................................110
8.3 Troubleshooting LiDCOrapid ............................72
10.0 References ..........................................................113
8.4 BIS Technical Alarms and Status Messages ....74
8.5 CNAP Alarms and Status Messages ................79
8.5.1 Summary ......................................................79
8.5.2 CNAP Alert Types Overview ..........................79
8.5.3 Detailed Listing of CNAP Alerts ....................80
9.0 Appendices............................................................84
9.1 Demonstration ................................................84
9.2 Data Download ................................................85
9.3 Data Output ....................................................87
9.3.1 Serial Data Configuration ..............................87
9.3.2 TCP/IP Configuration ....................................88
9.4 Date/Time ........................................................89
9.5 Language ........................................................90
9.6 Software Upgrade ............................................91
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1.0 Introduction / Overview
The display of natural groupings of parameters provides clearer and more integrated information about the patient’s
hemodynamic status. The LiDCOrapid provides new platform-based software, Unity, that allows for the addition of new
parameters or different methods of displaying existing parameters.
At the core of the monitor is the established LiDCOrapid technology, which is a minimally invasive hemodynamic monitor
that derives nominal stroke volume and heart rate from the patient's existing arterial pressure waveform using the
PulseCO algorithm. The LiDCOrapid Monitor is designed to be simple to interpret, quick to set-up and provides an
effective way of managing the hemodynamics of surgical or any hemodynamically unstable patient requiring fluid and
drug support.
The beat – to – beat parameters displayed by the LiDCOrapid allow the acute care physician to get immediate feedback
on a patient’s fluid and hemodynamic status. Optimising fluid and drugs in the perioperative period to specific goals is
called GDM (Goal Directed Management) and has been associated with decreased complications and length of hospital
stay.1
The LiDCOrapid is the first multiparameter hemodynamic monitor specifically designed for use in the highly demanding
conditions encountered in the operative room. The LiDCOrapid is now available with an optional module (BIS) for noninvasive monitoring of the patient’s EEG signal. The BIS (Covidien, USA) technology can now be connected to the
LiDCOrapid Monitor. This provides the ability to monitor the state of the brain based on acquisition and processing of
EEG signals. The BIS system processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS,
which may be used as an aid in monitoring the effects of certain anesthetic agents. It use may be associated with a
reduction in the incidence of awareness with recall in adults during general anesthesia and sedation.
BIS technology monitors the state of the brain through acquisition of EEG signals, and may provide insight into the
patient-specific effects of anesthesia on the brain. (ref. B1) BIS is a consciousness monitoring technology proven in
rigorous prospective clinical studies to help clinicians reduce the incidence of awareness in adults with recall by
approximately 80%. (ref. B2). Prospective, randomized studies have shown reductions in the use of certain primary
anesthetic agents when titrated to the BIS Index. (ref. B3) Prospective randomized studies have shown that when
anesthetic agents were titrated to the BIS Index, patients woke up faster, were extubated sooner, and were more
oriented on arrival at the post anesthesia care unit, compared to standard methods of practice (ref. B4).
LiDCOrapid is also has an optional module for continuous non-invasive arterial blood pressure monitoring (CNAP,
CNSystems, Austria). The CNAP technology can now be directly connected to the LiDCOrapid in order to display arterial
blood pressure waveform data. The LiDCO CNAP Module uses established CNAP technology to obtain the arterial blood
pressure waveform continuously and non-invasively for patients that are not otherwise indicated for invasive arterial blood
pressure monitoring.
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1.1 Standard Hemodynamic Monitoring
The LiDCOrapid is a combination of both standard and functional hemodynamic monitoring.
The standard monitoring portion is comprised of two trend display periods and associated numeric values of
hemodynamic parameters. The parameters are combined in a natural grouping to facilitate ease of interpretation.
The upper trend shows the Blood Pressure (Systolic, Mean and Diastolic) with the Heart Rate. The lower trend is
normally set to display Stroke Volume. This can be configured to alternatively display Cardiac Output or Systemic
Vascular Resistance. The values displayed in the lower trend are nominal unless the monitor is calibrated with a known
value for Cardiac Output.
Figure 2: Rapid Trend Screen
The two display periods are designed to show both an acute change and the data covering the full procedure. The acute
change portion is shown to the left of the numeric display and is set to a fixed scale of 2 minutes. This provides an early
warning of significant changes in the displayed parameters so that appropriate interventions may be considered without
delay. The full procedure trend display is shown to the left of the acute change. This window will display all data and
automatically rescale the time axis as more data is collected (maximum window size is 8hrs). The full procedure trend
display provides a complete picture of changes and is useful in examining long term increases or decreases as well as
change from start for the hemodynamic parameters.
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1.2 Functional Hemodynamic Monitoring
The functional monitoring portion is comprised of two different sets of display (See Figure 3) that provide both a
predictive indication of fluid responsiveness and the ability to assess changes in hemodynamic parameters as a result of
interventions such as fluid boluses, vasoactive drugs or inotropes. All the data are derived via continuous beat-to-beat
Pulse Pressure and Stroke Volume analysis.
The event response display is used to monitor the change in a hemodynamic parameter after an intervention (e.g. fluid
challenge or change in drug therapy). The display is designed to calculate a % change from baseline and plot this every
20 seconds. This allows for a clear understanding of the actual hemodynamic response to the intervention.
Figure 3: Rapid Trend Screen
The preload responsiveness variables display provides either Stroke Volume Variation or Pulse Pressure Variation
information as a long term trend and a short term trend of Delta SV (or PP). Both trends have a defined zone (shaded in
green) that indicates the currently accepted cut-off for potential fluid responsiveness. SVV tends to predict fluid
responsiveness when the values are consistently above 10%2. PPV tends to predict fluid responsiveness when the
values are consistently above 13%3. The long term trend is adjustable between 10 and 60 minutes and provides an easy
to interpret picture of the value and general trend in these parameters. As the values and trend go above the 'green
zone' it becomes more likely that the patient will respond to fluid administration. The short term trend (Delta SV/PP)
covers a 30s period and can be used in a similar manner. As the amplitude of the wave increases beyond the 'green
zone' with each ventilator cycle, it becomes more likely that the patient will respond to fluid administration. It is also
possible to interpret the stability of the SVV/PPV data. A numeric value for heart rate variation (HRV) is provided.
A numeric display is also provided for ease of data recording.
The combination of preload responsiveness variables and event response displays, in combination with other clinical
signs, provides the opportunity provides the opportunity for the user to anticipate any necessary interventions to
anticipate the necessary intervention and to observe the patients actual hemodynamic response.
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2.0 Quick Start
Unity Software allows for selection of the available modules from the Welcome Screen. When a module is
available for selection it is shaded blue. When a module is selected it is shaded green and a green tick
button appears in the centre. If a module is not connected or available it is greyed out and not selectable.
2.1 LiDCOrapid
Connect Cables and Switch ON (Figures 4 and 5)
1. Connect the power cable to the monitor and an appropriate power socket
2. Switch on the monitor via the power switch on the bottom
3. Connect the appropriate blood pressure cable to the LiDCOrapid Monitor and to the primary monitor.
CAUTION: When connecting or disconnecting cables grasp the connector housing and NOT the cable itself
ON/OFF
Signal From Monitor
(1 Volt = 100mmHg)
Power Input
Figure 4: POC-125/127 connection illustration
Figure 5: DTP-1201 connection illustration
Insert the LiDCOsmart Card (Figure 6)
1. Obtain a new LiDCOsmart card when starting a new patient.
2. Orient the LiDCOsmart card so that LiDCOrapid can be read and the arrow
points to the monitor.
3. Insert the card into the reader – the gold chip should be facing you
4. When complete the Welcome Screen will indicate the LiDCOrapid is available for
selection
Figure 6: LiDCOsmart
5. Press the Rapid section to select LiDCOrapid, and press the tick to begin. The Patient Details Screen will be
displayed next.
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Patient Details Entry Screen
1. Enter the Patient’s identification number, age, height, weight and gender.
2. Open the module selection tray and press the green tick to start LiDCOrapid.
Open the Module
Tray and Press the
Green Tick to start
LiDCOrapid
Figure 7: Patient Details Screen
Rapid Setup Screen – Confirm blood pressure waveform
1. Observe the blood pressure waveform matches the primary monitor.
2. Check the values for Systolic, Mean, Diastolic Blood Pressure and Heart Rate are within 5% of the primary monitor’s
displayed values.
Figure 8: Rapid Config Screen
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2.2 BIS
Note – BIS does not require a smartcard.
1. Connect the BISx Pod to the monitor.
• Plug the BISx Monitor Interface Cable into a USB port on the LiDCOrapid.
2. Connect the Patient Interface Cable (PIC) to the BISx Pod.
• Attach the 10-pin connector from the PIC to the BISx Pod.
3. Connect the BIS sensor to the PIC.
4. Press the BIS section of the module tray to select BIS, and press the tick to begin. The Patient Details Screen will be
displayed next.
Patient Details Entry Screen
1. Enter the Patient’s identification number, age, height, weight, type and gender.
2. Press the green tick button to accept all entries.
3. Open the module selection tray and press the green tick to start BIS.
NOTE: Before starting BIS monitoring, ensure that the sensor is connected properly and has passed impedance check.
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2.3 CNAP
NOTE: CNAP requires a smartcard for use with the LiDCOrapid.
Connect the CNAP Module to the LiDCOrapid (refer to Appendix 9.13.3)
• Connect the CNAP Module to the Cuff Controller
• Select and attach the Finger Cuff to the patient and the Cuff Controller
• Select and attach the NBP Arm cuff to the patient and to the CNAP Module
Figure 9 : CNAP Patient Connection
• Insert a LiDCOrapid CNAP smartcard
• Select CNAP from the Welcome Screen and press the green tick
• Enter the Patient details including Type: Adult or Pediatric
• Press the Green Tick to confirm the data entered
• Select the Module tray and press the Green tick to begin
The CNAP is ready for use when it has completed initializing and the patients fingers are in the finger cuffs.
The CNAP start button will turn from grey to green to indicate the CNAP is ready for use.
Press the CNAP Start button to begin the measurement.
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3.0 Intended Use/Contra-Indications/Warnings
3.1 Intended Use
The LiDCOrapid Hemodynamic Monitoring System is intended for use for the measurement of blood pressure, cardiac
output and associated hemodynamic parameters in adult patients.
When connected to the BIS Module: intended for monitoring the state of the brain by data acquisition of EEG signals and
may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide
anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during
general anesthesia and sedation.
When connected to the CNAP Module: intended for the non invasive continuous measurement and display of blood
pressure including the blood pressure waveform and beat-to-beat numeric values of systolic, diastolic and mean
pressure.
Suitable Patients and Locations of use
LiDCOrapid: Adult patients requiring cardiovascular monitoring who have peripheral arterial pressure monitoring
– Medical & Surgical ICU’s – Operating Suites – Step Down / High Dependency Units
– Trauma / A&E (ER) Departments – Coronary Intensive Care Units – Cardiac Catheter Laboratories
BIS: Adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the
brain by data acquisition of EEG signals.
CNAP: Adult and pediatric patients from the age of 4 years, and is to be operated by medical professional staff in
hospitals, clinical institutions, medical practices and outpatient settings.
3.2 Contraindications
The following patients are contraindicated for use with the LiDCOrapid Hemodynamic Monitor:
• Patients with aortic valve regurgitation
• Patients being treated with an intra-aortic balloon pump (IABP)
• Patients with highly damped peripheral arterial lines
• Patients with peripheral arterial vasoconstriction
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3.3 Warnings – LiDCOrapid
WARNING:
LiDCOrapid Monitor is for use in conjunction with a Primary Vital Signs Monitor.
DO NOT USE THE LIDCORAPID HEMODYNAMIC MONITOR WITH THE PATIENT TYPES LISTED ABOVE – THE
PERFORMANCE OF THE DEVICE MAY BE SIGNIFICANTLY COMPROMISED IN SUCH PATIENTS. BEFORE USE OF
THE LIDCORAPID HEMODYNAMIC MONITOR FAMILIARIZE YOURSELF WITH THE FULL LIST OF INDICATIONS,
CONTRAINDICATIONS AND WARNINGS.
WARNING:
PRODUCT INSTRUCTIONS AND TRAINING - BEFORE USE OF THE LIDCORAPID MONITOR SYSTEM PLEASE
ENSURE THAT YOU HAVE BEEN TRAINED IN THE USE OF THE SYSTEM AND FAMILIARIZE YOURSELF WITH THE:
- CONTRAINDICATIONS & WARNINGS – OPERATING INSTRUCTIONS – SECTION 4
WARNINGS – LIDCORAPID HEMODYNAMIC MONITOR INITIAL CHECKS OF PATIENT PATHOLOGY AND PERIPHERAL
ARTERY CONDITION
• BEFORE USE, CHECK THE PATIENT NOTES FOR THE PRESENCE OF AORTIC VALVE REGURGITATION. THE
LIDCORAPID HEMODYNAMIC MONITOR MAY BE INACCURATE IN SUCH PATIENTS.
• SEVERE PERIPHERAL ARTERIAL VASOCONSTRICTION/ VASOSPASM MAY NEGATIVELY AFFECT THE ARTERIAL
PRESSURE WAVEFORM AND THEREFORE THE ACCURACY OF THE LIDCORAPID HEMODYNAMIC MONITOR SUCH EVENTS MAY OCCUR IN SEVERE PERIPHERAL VASCULAR DISEASE, EXTREMES OF VASOPRESSOR
DRUG ADMINISTRATION AND HYPOTHERMIC PATIENTS.
OTHER WARNINGS
• ON SET-UP AND DURING USE OF THE LIDCORAPID HEMODYNAMIC MONITOR ALWAYS CROSS-CHECK TO THE
PRESSURE PARAMETERS AND HEART RATE DISPLAYED BY HOST MONITOR. THE FOLLOWING PARAMETERS:
HEART RATE, SYSTOLIC, DIASTOLIC AND MEAN PRESSURES SHOULD ALL BE WITHIN 5% OF THE VALUES
DISPLAYED BY THE HOST/PRIMARY MONITOR. PAY ATTENTION TO THE HEART RATE AND, IF NECESSARY,
ADJUST THE THRESHOLD FOR DETECTING THE BEAT IN ORDER TO ADJUST THE RATE - SEE SECTION 4.2.5.
• DYNAMIC PRELOAD RESPONSE VARIABLES (E.G. SVV OR PPV) ARE ONLY VALID IN PATIENTS WITH CLOSED
CHESTS ON FULL MODE CONTROL VENTILATION.
• DYNAMIC PRELOAD RESPONSE VARIABLES (E.G. SVV OR PPV) ARE UNRELIABLE IN PATIENTS WITH
SIGNIFICANT ARRHYTHMIA. THE LIDCORAPID WILL ALERT WHEN HEART RATE VARIATION EXCEEDS 10%.
• ALWAYS USE THE CORRECT LIDCORAPID HEMODYNAMIC MONITOR CABLE ASSEMBLY FOR CONNECTION TO
THE PRIMARY MONITOR. LIDCO LTD HAS A LIST OF COMPATIBLE MONITOR CABLE ASSEMBLIES.
• THE SCALING FACTOR ESTIMATE CANNOT BE AS PRECISE AS AN INDEPENDENT CALIBRATION OF THE
PULSECO ALGORITHM WITH A WELL PERFORMED INDICATOR DILUTION MEASUREMENT.
• THE ESTIMATE USED HAS BOUNDARY CONDITIONS SIMILAR TO ANY DEVICE USING A NOMOGRAM-BASED
APPROACH TO ESTIMATE PHYSICAL CHARACTERISTICS. INDIVIDUAL PATIENT HISTORY MAY INCLUDE A
VARIETY OF POTENTIALLY CONFOUNDING CONDITIONS SUCH AS CHRONIC HYPERTENSION,
ARTERIOSCLEROSIS AND/OR DIABETES, WHICH MAY ALTER AORTIC CAPACITANCE.
• CARE SHOULD BE TAKEN WHEN USING THE LIDCORAPID IN PATIENTS WITH SEVERE PERIPHERAL
VASOCONSTRICTION DUE TO PRE-EXISTING DISEASE OR AS A RESULT OF VASOACTIVE DRUG TREATMENT. IN
THESE CASES THE RADIAL ARTERY PRESSURE MAY BE SUBSTANTIALLY DIFFERENT TO THE CENTRAL
AORTIC PRESSURE.
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• THE SCALING FACTOR ESTIMATE IS DERIVED FROM IN VIVO RADIAL ARTERY DATA AND MAY BE LESS
ACCURATE IN PATIENTS WITH FEMORAL ARTERIAL CATHETERS11.
• ALWAYS SHUT DOWN THE MONITOR BEFORE USING IT ON A DIFFERENT PATIENT. THIS WILL AVOID THE
POSSIBILITY THAT INCORRECT SET-UP PARAMETERS AND/OR CALIBRATION FACTORS ARE USED IN THE
CALCULATION OF THE NEW PATIENT’S HEMODYNAMICS.
• THE CENTRAL VENOUS/RIGHT ATRIAL PRESSURE IS MANUALLY ENTERED ON THE LIDCORAPID SCREEN –
ALWAYS CHECK THAT THE CORRECT VENOUS FILLING PRESSURE IS BEING USED FOR THE CALCULATION OF
THE SYSTEMIC VASCULAR RESISTANCE/INDEX.
• LIDCORAPID HEMODYNAMIC MONITOR IS NOT REQUIRED TO BE DIRECTLY CONNECTED TO THE PATIENT
APPLIED PART (PRESSURE TRANSDUCER). THE DATA PROCESSED IS THE ISOLATED PRESSURE ANALOG
OUTPUT FROM AN APPROVED PATIENT MONITOR.
• THE LIDCORAPID HEMODYNAMIC MONITOR SHOULD NOT BE CONNECTED TO ANY ELECTRICAL EQUIPMENT
THAT IS NOT COMPLIANT WITH IEC 60601-1 (OR EQUIVALENT) ELECTRICAL SAFETY AND EMC STANDARDS.
MAKE SURE THE LIDCORAPID MONITOR IS SECURELY MOUNTED, AND THAT ALL CORDS AND ACCESSORY
CABLES ARE APPROPRIATELY ARRANGED TO MINIMIZE THE RISK OF INJURY TO PATIENTS, USERS OR THE
EQUIPMENT.
DO NOT EXPOSE THE LIDCORAPID MONITOR TO EXTREME TEMPERATURES.
DO NOT OBSTRUCT THE LIDCORAPID MONITOR VENTILATION OPENINGS.
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3.4 Warnings – BIS
DUE TO ELEVATED SURFACE TEMPERATURE, DO NOT PLACE BISx IN PROLONGED DIRECT CONTACT WITH
PATIENT’S SKIN, AS IT MAY CAUSE DISCOMFORT.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSOR AND CONNECTORS SHOULD NOT CONTACT OTHER
CONDUCTIVE PARTS, INCLUDING EARTH.
TO REDUCE THE HAZARD OF BURNS DURING USE OF HIGH FREQUENCY SURGICAL EQUIPMENT, THE SENSOR
OR ELECTRODES SHOULD NOT BE LOCATED BETWEEN THE SURGICAL SITE AND THE ELECTRO-SURGICAL UNIT
RETURN ELECTRODE.
TO REDUCE THE HAZARD OF BURNS DURING USE OF BRAIN STIMULATING DEVICES (e.g., TRANSCRANIAL
ELECTRICAL MOTOR EVOKED POTENTIAL), PLACE STIMULATING ELECTRODES AS FAR AS POSSIBLE FROM THE
BIS SENSOR AND MAKE CERTAIN THAT SENSOR IS PLACED ACCORDING TO PACKAGE INSTRUCTIONS.
THE BIS SENSOR MUST NOT BE LOCATED BETWEEN DEFIBRILLATOR PADS WHEN A DEFIBRILLATOR IS USED ON
A PATIENT CONNECTED TO THE BIS.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT.
INTERFACE CABLE (PIC) MUST BE CAREFULLY PLACED AND SECURED.
3.5 Warnings – CNAP
TO AVOID THE POSSIBILITY OF OCCLUDING BLOOD FLOW IN THE FINGER DO NOT USE A FINGER CUFF THAT IS
TOO SMALL FOR THE PATIENT'S FINGERS . USE THE CUFF CONTROLLER TO ESTIMATE THE CORRECT SIZE. THE
DUAL FINGER CUFF SHOULD SLIDE ON AND OFF THE FINGER WITHOUT RESISTANCE OR EFFORT. THE PATIENT'S
FINGER MAY SWELL IN SIZE IF PERIPHERAL ODEMA OCCURS. IF IN DOUBT USE THE NEXT LARGER SIZE OF CUFF.
DO NOT CONNECT THE MODULE’S AIR CONNECTORS TO AN INTRAVASCULAR SYSTEM.
DO NOT USE THE OSCILLOMETRIC CUFF ON PATIENTS WITH VASCULAR PROSTHESES.
REGULARLY INSPECT THE PATIENT’S MONITORED ARM AND HAND TO PREVENT PROLONGED IMPAIRMENT OF
BLOOD CIRCULATION DURING PRESSURE MEASUREMENTS. DISCONTINUE MONITORING AND REMOVE ALL AIR
CONNECTORS IF THERE IS ANY CONCERN ABOUT BLOOD CIRCULATION. DURING REGULAR USE THE PRESSURE
IN THE FINGER CUFF WILL BE THE SAME AS THE ARTERIAL PRESSURE AND THEREFORE CAUSE GREATER THAN
NORMAL VENOUS PRESSURE. AS A RESULT VENOUS CONGESTION IN THE MEASURED FINGER MAY BE
OBSERVED. THIS WILL VARY DEPENDING ON SKIN TEMPERATURE, THICKNESS, PATIENT AGE, AND NORMAL
PERFUSION. THE EFFECT IS EXPECTED, IS NOT HARMFUL AND SHOULD QUICKLY SUBSIDE AFTER DISCONTINUING
THE MEASUREMENT.
USE ONLY LIDCO APPROVED DEVICES WITH THE MODULE; DO NOT USE WITH ANY THIRD PARTY
MANUFACTURED DEVICES.
USE THE MODULE ONLY ON ONE PATIENT AT A TIME.
THE LIDCO CNAP MODULE IS NOT TO BE USED WITHOUT ADDITIONAL ECG MONITORING FOR INDEPENDENT
PATIENT MONITORING OF THE HEART RATE.
IF THE MONITORED HAND IS NOT VISIBLE THEN PAY PARTICULAR ATTENTION TO THE QUALITY OF THE BLOOD
PRESSURE WAVEFORM DISPLAYED ON THE MONITOR SCREEN. DECREASES IN PULSATILITY, PULSE PRESSURE
COULD BE THE RESULT OF MOVEMENT OF THE CUFF, OR TISSUE SWELLING LOCAL TO THE MEASUREMENT
SITE. IN SUCH CASES RE EXAMINATION OF THE HAND AND SENSOR FIT AND POSITIONING IS RECOMMENDED.
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3.6 Cautions
General
Do not autoclave any of the components. Autoclaving will seriously damage the components.
Do not open any of the components for any reason. The seal to prevent liquids from entering the BISx may be damaged
if opened.
Service or repairs must be performed only by qualified biomedical technicians.
BIS
The BISx system has been designed to operate with a BIS sensor. Use of other electrodes is not recommended.
Continuous impedance checking may need to be disabled if the 1 nanoampere 128Hz impedance check signal interferes
with other equipment (e.g., evoked potential monitors).
Considerations when using Electro-Convulsive Therapy (ECT) equipment during BIS monitoring: Place ECT electrodes as
far as possible from the BIS sensor to minimize the effect of interference. Certain ECT equipment may interfere with the
proper function of the BIS monitoring system. Check for compatibility of equipment during patient setup.
Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC sensor connector can interfere with PIC
performance.
Service or repairs must be performed only by qualified biomedical technicians.
When connecting or disconnecting BISx, take care not to touch the exposed contacts of either connector. Damage due
to electrostatic discharge may result.
CNAP
The LiDCO CNAP Module is a Safety Extra-Low Voltage device and meets the requirements of IEC 60601-1. The input
ports are type BF and protected from defibrillation.
According to IEC 601-2-30/EN 60601-2-30, non-invasive blood pressure measurement is fit for use during electrosurgery as well as during discharge of a cardiac defibrillator.
Do not compress the air hoses or reduce their diameter in any way as this may impair the measuring signal quality.
Do not allow liquid ingress into the Module. In the event this occurs, the Module must be inspected by a qualified
technician before use.
The Module must be stored properly: Do not bend the cables or hoses or coil them tightly as this may result in damage.
Any damaged cables or hoses should be replaced immediately.
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Blood Pressure
Never start a measurement without a finger in each finger cuff.
Remove all objects (e.g. rings) from the fingers before measuring.
Usually the index and middle fingers are best suited for the finger cuffs as their phalanges are longest.
Ensure that the CNAP double finger cuff is applied to the patient’s hand such that the cables run along the back of the
patient’s hand and the labelling can be read.
If no continuous blood pressure waveform is displayed within a few minutes, it is probably due to an insufficient blood
flow in the fingers. First try an alternate pair of fingers or if possible, use fingers on the other hand.
In rare cases, the device may be unable to detect a continuous blood pressure signal. This is usually caused by a
vasopathy. Improving circulation by warming the hand may resolve this problem.
Limitations: In certain cases a continuous blood pressure measurement is not reliable and/or possible:
• Weak signal shown via the Perfusion Index indicator (Low PI <1)
• Reduced peripheral blood flow (e.g. peripheral shock, hypothermia extreme centralization, extreme hypothermia)
• Arterial vascular diseases (arteriosclerosis, Raynaud’s syndrome, endarteritis obliternans, collagenosis, extremely
advanced vascular diseases (PAOD).
NON-INVASIVE BLOOD PRESSURE CUFF LIMITATIONS:
Under the following conditions there may be a decrease in accuracy of the oscillometric blood pressure measurement:
• Weak pulse
• Arrhythmia
• Patient movement artefacts
• Tremor artefacts
• Respiratory artefacts
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4.0 Monitor Operation
4.1 Setup
4.1.1 LiDCOrapid Equipment Setup
MOUNTING RECOMMENDATIONS:
Securely mount the LiDCOrapid Monitor according to your institution’s practices. Optional mounting accessories can be
purchased from LiDCO and approved medical equipment suppliers. Contact your local LiDCO representative for
recommendations on alternative mounting options.
Refer to Appendix 9 for details on mounting the LiDCOrapid Monitor.
CONNECTING THE POWER SUPPLY:
After the monitor is securely mounted, attach the power cord supplied with the monitor at the back and connect it to a
hospital-grade power outlet. The LiDCOrapid power supply automatically adjusts for power voltages from 100 to 240
VAC and converts the input voltage to 24VDC for supply to the monitor (POC model only). Refer to Appendix 9 for further
illustrations.
WARNING:
Do not use extension cords or multiple socket devices to connect power to the monitor. Do not use any other
detachable power cords other than the power cord provided.
NOTE:
The LiDCOrapid Hemodynamic Monitor does not have a mouse or keyboard. All user interactions are mediated through
the touch sensitive screen.
4.1.2 Starting the Monitor
The monitor will automatically switch on when power is applied. If this does not happen, then switch on the power using
the ON/OFF switch located near to the power cable. The power switch is not latching and will return to the original
position. The monitor will complete its start-up routine and display the Welcome Screen.
Switch off the power by removing the power cord from the mains supply or by pressing and holding the ON/OFF switch
for 5 seconds.
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4.2 Connecting the LiDCOrapid to the Primary Patient Monitor
4.2.1 Option 1: Direct Analog Input (POC Model Only)
The LiDCOrapid Hemodynamic Monitor is designed to interface with standard patient monitors that provide an analog arterial
pressure waveform output. LiDCO Ltd or your local distributor can provide a list of compatible patient monitors / modules
together with the appropriate cable assembly to connect to the patient monitor analog pressure out.
4.2.2 Option 2/3: LiDCO BP Module
• The BP Module (BPM) allows the arterial blood pressure waveform to be accessed directly via a standard invasive blood
pressure transducer when connected to a patient monitor.
• The BP Module is used when it is difficult or not possible to access the arterial blood pressure waveform via a standard
analog output from the patient monitor.
• The BP Module will accept a standard analog output from the patient monitor.
Figure 10: BPM Channel 1 and Channel 2 cable connection
WARNING:
It is important that the primary blood pressure monitor is correctly zeroed and any analog output is calibrated. Check that the
pressure display on the monitor is the same as the pressure displayed on the LiDCOrapid Screen.
CONTRAINDICATIONS: None
PRECAUTIONS:
Check the BPM cable and module before use.
Do not use in the event of damage.
When connecting cables do not try to force, instead align them and gently connect.
Insert and remove cables using the connector. Use the mark to align connectors.
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4.2.3 LiDCO BPM Channel Selection
Channel Selection is required on first use of the BP Module. The selected channel becomes
the default for future use. Channel selection is required again only if the cable input channel is
changed.
• Press to display the channel selection window. (see below)
Figure 12: BP Channel Select window
• Available BP waveforms will display in black. Only one channel can be selected at a time.
Choose the channel that matches the cable connection by pressing the radio button.
The selected waveform will display in red in the associated window. Values for Systolic, Mean and Diastolic arterial
pressure, and heart rate will display beneath each window.
• Channel 1: IBP Transducer – BP Module
• Note: Channel 1 must be zero’ed before pressure and heart rate values will display
• Channel 2: Analog BP Waveform – BP Module
• Channel 3: Analog BP Waveform – LiDCO Monitor (POC Model only)
• Confirm the Pressures and Heart Rate match the Patient Monitor
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4.2.4 Zeroing Channel 1
Press to zero the pressure on Channel 1
• When the Patient Monitor is zero’ed, press the green tick to return to the previous screen
Figure 14: Zero BPM Ch 1 window
4.2.5 Beat Detector Threshold
The Beat Detector Threshold is used to correct for large differences in heart rate (HR) caused by
unusual blood pressure waveforms. If the HR displayed on the Patient Monitor is approximately double
(2X) the LiDCOrapid HR, then lower the beat detector threshold until the values are equivalent. If the HR
displayed on the Patient Monitor is approximately half (½) the LiDCOrapid HR, then raise the beat
detector threshold until the values are equivalent.
Press the icon to display the interactive screen shown below. Observe the HR and adjust using the arrow buttons until
equivalent, press the green tick to accept the new value. Press the red X button to cancel any changes since the last
change.
Figure 16: Beat Detector Threshold window
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NOTE:
• Patients with a pronounced diastolic pressure ‘bounce’ can cause the LiDCOrapid Hemodynamic Monitor to double
trigger the heart rate. The Beat Detector Threshold should be increased as above.
• Patients experiencing bigemini instability will, on occasion, cause the LiDCOrapid Hemodynamic Monitor to underestimate the heart rate. Decrease the threshold to obtain the correct heart rate
LIDCO BPM CHANNEL CONNECTIONS:
Channel 1 Connection (refer to Figure 10):
IBP Transducer Input
1. Connect the USB cable between the LiDCOrapid Monitor and BPM. The BPM serial number should be displayed in
the upper right corner.
2. Connect the transducer specific BPM cable to the BPM. Channel 1 should now be selectable.
3. Connect BPM cable to Patient Monitor cable.
4. Connect BPM cable to IBP Transducer cable.
Channel 2 Connection (refer to Figure 10):
Analog Input to BPM
1. Connect the USB cable between LiDCOrapid Monitor and BPM
2. Connect analog output cable from patient monitor to BPM
Channel 3 Connection (refer to Figure 5)
Analog Input to LiDCO monitor (POC only)
Connect analog output cable from patient monitor to the analog input on the monitor
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4.3 BIS Monitoring Equipment and Setup
Figure 17: BISx puck, MIC and PIC
The BIS VISTA Monitoring System consists of the following basic components:
• BISx (P/N 186-0195-SF)
• Patient Interface Cable (PIC) (P/N 175-0046)
• BIS Sensor
Quattro, Extend or Pediatric (supplied separately)
• Monitor Interface Cable (MIC) (P/N BIS 175-0075)
The BISx receives, filters, and processes patient EEG signals. It is located close to the patient’s head where the EEG
signal is less subject to interference from other medical equipment.
The BISx is shown in Figure 17 above. Its long flexible Monitor Interface Cable (MIC) connects to the LiDCOrapid Monitor
via a USB connector. The Patient Interface Cable (PIC) connects the BIS sensor to the BISx.
The attachment clip on the BISx is used to secure it in a convenient location near the patient's head.
Sensors are sold separately. For a list of available sensors please contact Covidien or your local distributor (refer to
www.lidco.com for contact details).
WARNING:
DUE TO ELEVATED SURFACE TEMPERATURE, DO NOT PLACE BISx IN PROLONGED DIRECT CONTACT WITH
PATIENT’S SKIN, AS IT MAY CAUSE DISCOMFORT.
CAUTION:
Do not open BISx for any reason. The seal to prevent liquids from entering the BISx may be damaged if opened. Service
or repairs must be performed only by Covidien qualified biomedical technicians.
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4.4 CNAP Module Equipment and Setup
LiDCO CNAP Module
1. CNAP Cuff Controller Cable Port
2. NBP cuff connector via pneumatic tube
1
2
Figure 18: CNAP Module Cuff Connector Ports
3. 12 – 24 VDC input
4. 12 - 24 VDC Output
5. USB
5
3
4
Figure 19: CNAP Module Interface Connectors
Power Supply
The LiDCO CNAP Module is powered by a 12 – 24 VDC
external power supply from an external power adapter or
the monitor.
Caution: Do not use any power supply accessories with
the Module except those authorised by LIDCO.
Double Finger Cuff
The CNAP double finger cuff comes in three sizes, each
marked by a different colour.
Size
Diameter (mm)
Colour
L
24-28
Dark Red
M
18-24
Dark Blue
S
10-18
Light Blue
Figure 20: CNAP Finger Cuffs
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1. CNAP Cuff Controller
2. Cuff Controller Fixation Strap
1
3. Cuff Controller Cradle
4. CNAP Cable
The CNAP Cuff Controller connects the CNAP double
finger cuff and the module via the CNAP cable. The
connectors for the CNAP are colour coded and keyed to
avoid incorrect connection
3
• The graphic on the top of the CNAP Cuff Controller can
be used to assist selection of the correct double finger
cuff size.
Figure 21: CNAP Cuff Controller
4
To avoid the possibility of occluding blood flow in the
finger do not use a finger cuff that is too small for the
patient's fingers. Use the cuff controller to estimate the
correct size. The dual finger cuff should slide on and off
the finger without resistance or effort. The patient's finger
may swell in size if peripheral odema occurs. If in doubt
use the next larger size of cuff.
• The CNAP Cuff Controller Fixation Strap is fastened to
the patient’s forearm by means of the CNAP Cuff
Controller Fixation Strap with a Velcro fastener.
Figure 22: CNAP Cuff Controller Cable
• The Cradle for the CNAP Cuff Controller connects the
CNAP Cuff Controller Fixation Strap mechanically to the
CNAP Cuff Controller.
• The CNAP Cuff Controller should be positioned to
ensure that there is no tension on the double finger cuff
that could cause it to rotate or move off of the
measurement location.
NBP Cuff and pneumatic cable
The NBP cuffs are intended for oscillometric blood
pressure measurement and are available in four sizes:
Size Arm
Figure 23: NIBP Cuffs and Cable
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Circumference (cm)
Child
12–19
Small Adult
17–25
Adult
23–33
Large Adult
31–40
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Patient Setup:
CNAP Setup
a) Choose the correct CNAP double finger cuff size by
means of the graphic on the CNAP Cuff Controller. If a
patient's finger size is between two cuff sizes, choose
the larger cuff.
To avoid the possibility of occluding blood flow in the
finger do not use a finger cuff that is too small for the
patient's fingers. Use the cuff controller to estimate the
correct size. The dual finger cuff should slide on and off
the finger without resistance or effort. The patient's finger
may swell in size if peripheral odema occurs. If in doubt
use the next larger size of cuff.
b) Assemble the CNAP hardware by connecting the
CNAP double finger cuff, the CNAP Cuff Controller, the
CNAP cable with the LiDCO CNAP Module. All plugs
and connectors are designed so as to make it
impossible to switch them accidentally.
c) Attach the CNAP hardware to the patient: The CNAP
double finger cuff is placed on the proximal joints of
the index and middle fingers. Ensure that the cuff
cables run along the outside of the patient's arm.
Figure 24: CNAP Setup on Patient
d) Fasten the CNAP Cuff Controller to the patient's
forearm by means of the fixing cuff (with a Velcro
fastener) and make sure that the hand with the CNAP
double finger cuff is placed at heart level (see Figure 24).
Note: ensure the CNAP Cuff Controller is in the middle of
the cradle to allow for some movement. There should be
no tension or pressure between the CNAP Cuff Controller
and the finger cuff.
NBP Setup
a) Make sure that only NBP cuffs authorized by LiDCO
are used and that you apply the correct size to the
patient (Child, Small Adult, Adult, Large Adult).
Figure 25: NBP Cuff Connection
WARNING:
Please be aware that CNAP finger cuffs as well as CNAP
Cuff Controller needs to be setup without tension. The
fixation of CNAP Cuff Controller is to be setup centrally.
This obviates tension during a measurement due to
movement of the patient which can affect the CNAP
measurement significantly.
b) Place the blood pressure cuff on the patient's upper
arm, preferably contra laterally, at heart level. The
marker on the NBP cuff should be directly above the
brachial artery (see Figure 25).
c) If possible, do not wrap the cuff over the patient’s
clothing. The cuff should fit snugly to the patient’s arm
for maximum oscillometric signal quality.
d) Connect the NBP cuff with the NBP air connector on
the patient side of the CNAP Module.
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4.5 Welcome Screen and Module Navigation
Figure 26: Welcome Screen – Rapid selected
The Welcome Screen is the entry point to initiate patient monitoring with the LiDCOrapid.
The Welcome Screen displays a circle with segments showing individual modules that may be connected to the monitor
(e.g. BIS, CNAP). The graphic display for each module is greyed out until it is connected, then it changes colour to blue.
A module that is blue can now be selected for use by touching inside the segment area. Once selected, it will change the
segment colour from blue to green.
When at least one module is selected the central accept (tick) icon will change from grey to green. Touching the tick icon
will start the monitoring session.
4.5.1 Adding or Removing Modules after the Session Starts
It is possible to add or remove modules after a monitoring session starts by simply plugging or unplugging
them from the USB port. Module availability and selection is shown by selecting the Welcome Icon tray in
the upper right corner of all screens. This icon expands into a tray to show the available modules and to
allow selection/deselection of those available modules in the same way that the Welcome Screen
functions. Each combination of modules results in a specific screen layout (refer to Combination Screens).
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The purpose of this feature is to allow the introduction or removal of devices as required, or to change the trend display.
It also allows a monitoring session to start prior to having all equipment ready for use.
Important points to remember:
Selection of a module may require additional information to be entered to allow the module to start or function. An
advisory alert will be issued to remind the user of what is required. Further, the display screen will adjust to the new
combination of modules.
Disconnection of a module will result in a loss of data from that module until it is reconnected. An advisory alert will be
issued to remind the user if a module is removed.
4.5.2 LiDCOrapid
Insert a new or previously used LiDCOsmart card to begin. The LiDCOrapid will indicate ‘connected’ status and display
the card status). Select LiDCOrapid by pressing the LiDCOrapid section of the display. Press the green tick when ready
to begin.
The Welcome Screen will indicate that the LiDCOsmart is new or has been previously used.
A new LiDCOsmart will start the monitoring session on the Patient Data Entry Screen.
A previously used card will have all the patient details automatically entered.
Note: It is important that previously used cards are not used on patients other than indicated on the card. The patient
details will differ and will result in a poor estimation of stroke volume and cardiac output.
The Welcome Screen will indicate if the LiDCOsmart is not valid (e.g. expired, damaged) or missing, and a valid
LiDCOsmart will be required.
4.5.3 BIS
Attach the BISx Pod to the LiDCOrapid Monitor via the USB port to begin. The BIS area will indicate connected status.
Select BIS by pressing the BIS section of the display. Press the green tick when ready to begin.
4.5.4 CNAP Module
Attach the CNAP module to the LiDCOrapid Monitor via the USB port, insert a LiDCOsmart CNAP Card and connect the
power supply to begin. The CNAP area will indicate connected status. Select CNAP by pressing the CNAP section of the
display. Press the green tick when ready to begin.
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4.6 LiDCOsmart
The LiDCOsmart card is used to access the LiDCOrapid’s Advanced Hemodynamic parameters. The LiDCOsmart is a
single patient use card. When a valid LiDCOsmart is inserted, the LiDCOrapid will indicate it is now connected. When a
valid LiDCOsmart CNAP card is inserted, the CNAP module will be available as well. If the LiDCOrapid was used
previously the Welcome Screen will indicate the card is Used in the alert notice bar.
The LiDCOrapid has a predefined period of use that is printed on the card. The LiDCOsmart use period begins when
patient details have been entered and monitoring begins. For 12 hour cards, once the period has elapsed, the card
becomes expired. If this happens while in use, monitoring will continue for a further 96 hours. Once the expired card is
removed from the monitor for more than 15 minutes, or the monitor is shutdown for more than 5 minutes that
LiDCOsmart card can no longer be used.
How to insert the Card:
Avoid heat,
scratching, moisture
or bending
Figure 28: Avoid damage to IC contacts
Figure 27: Insert Smartcard POC-125/127
WARNING:
The LiDCOsmart must be fully inserted into the card reader. If the card is not recognised, remove and reinsert.
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4.7 Patient Details Screen
Enter Patient Information in the blue highlighted boxes for a new Patient. If resuming a previous patient these boxes will
be automatically filled in and cannot be altered. Touch the box to reveal in input keypad. Missing Entries will be
highlighted in red. Values outside valid ranges will generate a valid range above to the entry box.
Figure 29: Patient Details Screen
To start the monitoring session, open the device tray icon and press the green tick.
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Press to start
Press to close tray
The blood pressure (BP) waveform can be checked on the Rapid Setup Screen by selecting the Configure BP Graph. It
will appear as soon as the cable is connected between the LiDCOrapid and the Patient Monitor’s BP signal. The values
for pressure and heart rate will appear within 30 seconds.
The LiDCOrapid reports values for stoke volume (SV) and cardiac output (CO) that are based on the PulseCO algorithm
scaled to the patients’ specific characteristics. The PulseCO calibration factor reflects the patient-specific maximum
aortic capacitance and will generally remain constant over short periods of time. The PulseCO algorithm has been
demonstrated to trend without the need for recalibration in numerous studies for up to 24 hours 5-10, 12.
The LiDCOrapid uses a nomogram-based estimate of the patient specific scaling factor. This was developed using in vivo
calibration data from post surgical patients with radial arterial blood pressure waveform data. The nomogram estimate
was then validated in an independent cohort of medical ICU patients giving a good correlation (r2=0.77), no bias and
acceptable limits of agreement (+/-26%) when compared with indicator dilution based calibration.
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WARNINGS:
• The calibration factor estimate cannot be as precise as an independent calibration of the PulseCO algorithm with a
well performed indicator dilution measurement.
• The estimate used has boundary conditions similar to any device using a nomogram-based approach to estimate
physical characteristics. Individual patient history may include a variety of potentially confounding conditions such as
chronic hypertension, arteriosclerosis and/or diabetes, which may alter aortic capacitance.
• Care should be taken when using the LiDCOrapid in patients with severe peripheral vasoconstriction due to preexisting disease or as a result of vasoactive drug treatment. In these cases the radial artery pressure may be
substantially different to the central aortic pressure.
• The scaling factor estimate is derived from in vivo radial artery data and may be less accurate in patients with femoral
arterial catheters11.
Press the Navigate button to display a sub-menu:
Press this button to go to the History Screen (See Section 7.7)
Press this button to go to the Chart Screen (See Section 7.8)
Press the CO button to calibrate the monitor (see Section 4.10)
Press to adjust for incorrect HR display (See Section 4.2.5)
Press the Camera button to take a screen shot
Press the Exit button to shutdown the LiDCOrapid
Figure 39: Configure Screen Navigate Menu
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4.8 Operation
4.8.1 Overview of LiDCOrapid Screen
Figure 40: LiDCOrapid Trend Screen
The main Monitoring Screen is a single ‘heads up’ display that combines both standard and functional hemodynamic
monitoring. In this way the user can see both long term and short term trends in key parameters such as BP, HR and SV.
Dynamic preload responsiveness parameters SVV or PPV, give predicted fluid responsiveness assessment. Functional
hemodynamic change in parameters such as SV or CO via Event Response provides immediate feedback on
interventions.
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4.8.2 Navigating the Screen
Press the Navigate icon to reveal a submenu
Figure 41: Trend Screen Navigate Menu
Press to return to the Patient Details and Device Configuration Screens
Press this button to go to the History Screen (See Section 7.7)
Press this button to go to the Chart Screen (See Section 7.8)
Press the CO button to calibrate the monitor (see Section 4.10)
Press to adjust for incorrect HR display (See Section 4.2.5)
Press to enter an event (7.5)
Press to display the Event List (7.6)
Press to capture the screen as a JPG file
Press to shutdown the LiDCOrapid Monitor
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4.8.3 Hemodynamic Monitoring Display
The LiDCOrapid provides standard hemodynamic parameters of blood pressure and heart rate in a unique trend display
that allows both long term and short term views. In addition, using the PulseCO blood pressure waveform analysis
algorithm, the monitor also displays nominal stroke volume.
The long term display contains the entire case up to a maximum of 24 hours. The time axis automatically adjusts scale to
provide the highest resolution possible for the duration of the case. This display provides a complete overview of the
case with the ability to identify trends and also where targets were met. A marker line can be placed on the Lower Trend
Screen to mark a baseline or set a target.
The short term or acute display shows data over a fixed 2 minute period. This provides an easy way to observe
immediate changes and give an early warning for more immediate response.
The scale of the axis can be adjusted by pressing on the magnifying glass icon next to the axis and using the
increase/decrease buttons. The time axis is set to Autoscale (default). As the case progresses the time axis will
adjust the display to show all data. Touch the increase/decrease buttons to remove Autoscale, or untick the box.
Axis and Target line adjustment window
For SV, CO and SVR, a target or marker line can be added by touching on the target icon
and enabling the adjustment control
Figure 48: Target line setpoint
The location of the line can be adjusted by using the increase/decrease buttons.
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When events are marked, they are displayed on both the short and long term trend displays of the blood pressure and
heart rate trend.
Figure 49: MAP & HR Trend
The display of numeric data to the right can be averaged over periods of 10, 20 or 30 seconds. This is adjusted in the
Rapid Configuration Screen.
A toggle switch allows
selection of nominal stroke
volume or cardiac output.
Figure 50: Selector switch
The nominal stroke volume and cardiac output is scaled to the patients’ demographic information using a nomogram
based estimate of the patient specific scaling factor (see 4.8.1).
Figure 51: Hemodynamic pull down
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Press this icon to select two of the three variables:
CO, SV and SVR for display as numeric and graphical trend values.
Figure 52: Hemodynamic Parameter Choices
Press to temporarily change the variable on the hemodynamic numeric display between absolute and index.
4.8.4 Event Response Display
Figure 54: Event response
The Event Response Display is used to track changes in a hemodynamic parameter as a result of a therapeutic
intervention. Simply press the green 'play' button to start and the display will show the relative change in the parameter
both graphically and numerically, at regular intervals over a period of up to 40 minutes. Press the red 'stop' button when
complete. To reset the start, simply press the green 'restart' button and the display will clear and start over again.
The default parameter for display is Stroke Volume and the display/averaging interval is 10 seconds. These can be
changed by using the Configuration Screen (see section 4.9). Alternately press the parameter name to switch between
Cardiac Output, Mean Arterial Pressure, Heart Rate or Systemic Vascular Resistance.
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Press to Change the parameter displayed in the Event Response window.
Figure 56: Event Response Parameter Menu
When an event is started, restarted or stopped, an event is automatically selected. If not required, this event can be
cancelled by selecting the red X. The event information is entered as normal to keep a record of the intervention. Other
events can still be entered when the event response is running. (see 7.5)
Press to switch between alternate displays
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4.8.5 Dynamic Preload Responsiveness Display
Figure 59: Preload Responsive Trend
The Dynamic Preload Responsiveness Display is used to assess the likely response of a patient to a fluid challenge. Data
is displayed both graphically and numerically on this screen for ease of use.
WARNING: Dynamic Preload response variables (e.g. SVV or PPV) are only valid in patients with closed chests on full
mode control ventilation.
WARNING: Dynamic Preload response variables (e.g. SVV or PPV) are unreliable in patients with significant arrhythmia.
The LiDCOrapid will alert when heart rate variation exceeds 10%.
Figure 60: SVV Trend
The display is made up of two independent graphical trends.
The first is a trend of either the Stroke Volume Variation (SVV) or the Pulse Pressure Variation (PPV) over a 10 minute
period, adjustable to 60 minutes.
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Figure 61: Delta SV Trend
The second, Delta SV (or PP), is a short term trend of the change in stroke volume (or pulse pressure) normalised to the
current mean stroke volume (or pulse pressure). This results in a percentage value that oscillates around a baseline of 0.
The numeric value of SVV (or PPV) is displayed along with the heart rate variation. When the HRV exceeds 10% the SVV
(or PPV) is considered unreliable. The background of the HRV display will change to yellow and the Trend of the dynamic
preload responsiveness display will indicate unreliable data by substituting a yellow line for each affected data point.
Figure 62: Numeric SVV HRV display
Press this button to switch the display to PPV.
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4.9 Configuration of LiDCOrapid Screen
The LiDCOrapid Screen can be configured to adjust the display of hemodynamic parameter trends.
Figure 63: LiDCOrapid Configuration
Press the configuration button to make changes to the display.
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4.9.1 Hemodynamic Trend:
Parameters can be displayed as either absolute or indexed to body surface area
The averaging period for numeric display can be chosen from: Never, 10, 20 (default) or 30 seconds
CVP value can be entered for a more precise calculation of SVR
4.9.2 Event Response:
Stroke Volume (default) can be replaced with any of the selected parameters: CO, MAP, HR or SVR
4.9.3 Dynamic Preload Responsiveness Parameters:
SVV (default) or PPV
SVV target zone limit: 10% (default) range 5 – 25%
PPV target zone limit: 13% (default) range 5 – 25%
Press to select the arterial blood pressure waveform input source
Figure 64: BPM Channel Select
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4.10 LiDCOrapid Calibration
Press the CO Entry button to display the window for calibration
Enter the value for CO in the Measured CO box and press the Equalize Button to generate a calibration factor. Press the
Green tick to accept the calibration or press the Red X to cancel.
Figure 65: Rapid Calibration Window
The LiDCOrapid can be calibrated by entering a known value for Cardiac Output (CO) or Calibration Factor (CF). It is
important that calibration is carried out in a hemodynamically stable period with minimal variation in blood pressure or
heart rate. The entry of the cardiac output should be done in a timely manner to avoid introducing a bias due to a change
in the patient's condition.
PRE-CALIBRATION CHECK LIST
The performance of the LiDCOrapid Hemodynamic Monitor may be compromised in the following patients:
• Patients with aortic valve regurgitation
• Patients being treated with an intra-aortic balloon pump (IABP)
• Patients with highly damped peripheral arterial lines
• Patients with peripheral arterial vasoconstriction
WARNING:
Do not use the LiDCOrapid Hemodynamic Monitor with the patient types listed above – the performance of the device
may be significantly compromised in such patients. Before use of the LiDCOrapid Hemodynamic Monitor familiarize
yourself with the full list of indications, contraindications and warnings concerning calibration as shown in this manual.
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5.0 Bispectral Index and EEG monitoring
5.1 Overview
The Bispectral Index (BIS) is designed to monitor the hypnotic state of the brain based on acquisition and processing of
EEG signals. The BISx pod processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS,
which correlates with the patient's level of hypnosis. The BIS may be used as an aid in monitoring the effects of certain
anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of
the incidence of awareness with recall in adults during general anesthesia and sedation.
A sensor placed on the patient’s head transmits EEG signals to the BISx pod. The BISx Pod filters the data, analyzes it
for artefact and processes it using digital signal processing techniques, then sends the data to the monitor for display.
The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order
to provide easier pattern recognition of changes over time during the recording. The monitor can be configured to display
the following BIS related information:
Figure 66: BIS Trend Screen
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• Bispectral Index (BIS) – a two-digit value ranging from 0 to 100 that represents the patient's level of consciousness,
where 100 = awake and 0 = flatline EEG.
• The BIS number is invalidated (displayed as dashes) when the SQI is less than 15 and is displayed as a hollow
number when the SQI is less than 50.
• A vertically oriented alarm limits bar graph – The High and Low BIS alarm limits are user configurable from the BIS
Configuration menu. These limits are displayed as a green coloured area on the BIS Trend.
• An Electromyograph (EMG) Indicator – The EMG bar graph displays the power (in decibels) in the frequency range
70–110 Hz. This frequency range contains power from muscle activity (i.e., electromyography or “EMG”) as well as
power from other high-frequency artefacts. When the graph is low, it indicates that EMG activity is low, which is
desirable. High levels of EMG may bias the BIS number high. BIS monitoring conditions are optimal when the
bar is empty.
• 1 bar represents power in the 30-38 range
• 2 bars represent power in the 39-47 range
• 3 bars represent power in the 48-55 range
• 4 bars represent power greater than 55.
• A Signal Quality Indicator (SQI) – The SQI bar graph is an indication of the quality of the EEG signal that is received
and processed into onscreen data. Signal quality is optimal when all 6 bars are green.
• A Suppression Ratio (SR) Number – The Suppression Ratio (SR) is a calculated parameter designed to indicate when
an isoelectric (flatline) condition may exist. Suppression ratio is the percentage of time over the last 63-second period
that the signal is considered to be in the suppressed state. For example: SR=11 (isoelectric over 11% of the last 63
second review).
• A Burst Count (BC) – Only available when a BIS Extend Sensor is in use, the Burst Count is an alternative method of
quantifying suppression, reported as the number of EEG bursts per minute. The Burst Count displays only when the
Signal Quality Indicator (SQI) is greater than 15 and the Suppression Ratio (SR) is greater than 5.
A RAW EEG WAVEFORM
Filtered electroencephalogram (EEG) waveforms are displayed above the BIS trend graph with a sweep rate of 25
millimeters per second and a scale of 25 microvolts (1 channel) or 50 microvolts (2 channels) per division. One or two
channels of EEG may be displayed in this area. EEG filters can be turned off, if desired.
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5.2 Warnings
5.2 1 General
• This LiDCOrapid Monitor uses a modular device in deriving the Bispectral Index (BIS) supplied by Covidien. It is
important to recognize that this index is derived using solely that company's proprietary technology. It is
recommended that clinicians have reviewed applicable information on its utility and/or risks in published articles and
literature/web site information from Covidien, or contact that company itself if they have clinical-based BIS questions
relating to this module portion of the LiDCOrapid Monitor. Failure to do so could potentially result in the incorrect
administration of anesthetic agents and/or other potential complications of anesthesia or sedation. LiDCO recommend
that clinicians also review the following practice advisory (that includes a section on BIS monitoring): The American
Society of Anesthesiologists, Practice Advisory for Intra-operative Awareness and Brain Function Monitoring
(Anesthesiology 2006;104:847-64). Clinicians are also recommended to maintain current knowledge of FDA or other
federal-based regulatory, practice or research information on BIS and related topics.
• Operation of the BISx in magnetic resonance imaging (MRI) environments is not currently supported.
• Surgeons using electorcautery scalpel must ensure scalpel does not come into contact with BIS sensor, to avoid
serious patient injury.
• To reduce the hazard of burn in the high-frequency surgical neutral electrode connection, the sensor should not be
located between the surgical site and the electro-surgical unit return electrode.
5.2.2 Precautions
• Clinical judgement should always be used when interpreting the BIS in conjunction with other available clinical signs.
Reliance on the BIS alone for intraoperative anesthetic or sedative management is not recommended.
• Artefacts and poor signal quality may lead to inappropriate BIS values. Potential artefacts may be caused by poor skin
contact (high impedance), muscle activity or rigidity, head and body motion, sustained eye movements, improper
sensor placement and unusual or excessive electrical interference.
• BIS values should be interpreted cautiously in patients with known neurological disorders, those taking other
psychoactive medications and in children below the age of one.
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5.2.3 Patient Preparation
• In accordance with the instructions included on the sensor packaging, prepare the sensor site and place the BIS
sensor on the patient.
• CAUTION: The BISx has been designed to operate with a BIS sensor. The sensor is a silver/silver chloride electrode
array that utilizes Covidien’s patented Zipprep technology and uses a proprietary connector. Use of other electrodes is
not recommended.
• WARNING: The conductive parts of BIS electrodes or sensor and connectors, including the neutral electrode, should
not contact other conductive parts, including earth.
• WARNING: To reduce the hazard of burns in the high-frequency surgical neutral electrode connection, the BIS sensor
or electrodes should not be located between the surgical site and the electro-surgical unit return electrode.
• WARNING: The BIS sensor must not be located between defibrillator pads when a defibrillator is used on a patient
connected to the BISx pod.
• WARNING: To minimize the risk of patient strangulation, the BIS Patient Interface Cable (PIC) must be carefully placed
and secured.
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5.3 Hardware Setup: Connecting the BISx Pod
Patient Interface Cable (PIC)
BISx Pod
Monitor Interface Cable (MIC)
Figure 67: BIS System with sensor
5.3.1 Connect the BISx Pod to the monitor
• Plug the BISx Monitor Interface Cable (MIC) into a USB port (see
Appendix 9.12) connector on the LiDCOrapid Monitor.
Connect the Patient Interface Cable (PIC) to the BISx Pod
Attach the 10-pin connector from the PIC to the BISx Pod.
• The connector is designed with a keyway that ensures proper pin
alignment. To disconnect the PIC, grasp the connector housing
and pull firmly. DO NOT pull the cable.
• An automatic Sensor Impedance Check is initiated each time a
BIS sensor is connected to the sensor cable.
Figure 68: BIS USB connector to Rapid
monitor
• All signal status messages and alarms are suppressed for 60
seconds after a Sensor Impedance Check has ended. This allows
time for signal quality to recover.
WARNINGS:
• When placing the pod, assure adequate ventilation/heat
dissipation and avoid direct contact of the patient with the pod’s
exterior surface
Figure 69: BIS Sensor attached to PIC
• To avoid electric shock, inspect all cables before use. Do not spill fluids on connectors, electrodes or electrode cables.
See Section 8.2.2, Cleaning
• Avoid accidental contact between electrodes and other conductive parts.
• To minimise the risk of patient strangulation, the BIS sensor cable must be carefully placed and secured.
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5.3.2 Secure the BISx Pod
Using the BISx clamp, secure the BISx Module to a convenient location near the patient’s head (e.g. IV pole, bed rail or
bedsheet), ensuring that both the clamp and the module are not in direct contact with any part of the patient’s body.
CAUTION: Proper placement of the BISx pod is on an IV pole, bed rail, or clipped to a bedsheet.
WARNING: Ensure against prolonged contact between the patient’s skin and the BISx Pod. The heat that may be
generated could cause discomfort.
CAUTION: Do not open the BISx Pod for any reason. The seal to prevent liquids from entering the module may be
damaged if opened. Service or repairs must be performed by qualified biomedical technicians only.
5.3.3 BIS Setup
NOTE: Before starting BIS monitoring, ensure that the sensor is connected properly and has passed impedance check.
To access the BIS Configuration menu
ii. Click on the navigation icon
iii. Click on the configuration icon
iv. Click on BIS
The BIS setup menu is displayed.
Figure 70: BIS Configuration Screen
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5.4 BIS Configuration Menu Options
5.4.1 Configuration Menu
Target Range
To aid in patient management, a target range of desired BIS values may be set. When the Target Range is activated, the
selected range displays on the BIS Trend Graph. The monitor will notify the user when the patient’s BIS value is outside
of the intended range by flashing yellow. The Target Range menu has two steps:
1. Activating the Target Range feature so that the range displays on the BIS Trend Graph.
2. Setting a Target Range of desired BIS upper and lower limit values.
There are three preset target ranges:
Custom
OR
ICU
Target BIS Range
40 to 60
40 to 60
40 to 80
Secondary Variable
None
EMG
EMG
EEG
Channel 1
Channel 1
Channel 1
BIS Smoothing
15 seconds
30 seconds
30 seconds
Filtering
On
On
On
Quick Reference Table:
Menu Item
Description
Available Settings
Target Range
High and Low BIS limits
High: 5 – 95
Low: 0 – 90
Default Target Range
Predetermined settings for
specific environments
Custom: 40 TO 60
CU : 40 TO 80
OR : 40 TO 60
BIS smoothing rate
Averaging for BIS
10, 15 (def) or 30sec
Filter
Applies filter to EEG
On (def) or OFF
Secondary Variable
Set second BIS parameter
(Config Screen)
Choices: None (def), EMG, SQI,
Suppression Ratio, or Bursts/min
EEG Channels
Display of EEG Channel 1 or 2
1 Channel (def) or 2 Channel
Suppression Ratio (SR)
% of time over last 63 seconds
that isoelectric conditions existed
Burst Count
Number of EEG ‘bursts’
per minute
Displayed with Extend Mode Sensor;
not displayed if SR <5% or SQI <15%
Sensor Check
Opens sensor check page
See below
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5.5 Sensor Check
Figure 71: BIS Sensor Check display and button
The Sensor Check tests the impedance of each electrode on the BIS sensor to verify that it is within an acceptable range
for monitoring. A Sensor Check is initiated automatically when the sensor and PIC are connected to the BISx. It may also
be initiated by the user by pressing the touch key. The message, “Sensor Check in Progress” appears. When the sensor
successfully passes the test, the Main Screen displays and monitoring begins.
Figure 72: BIS Sensor Check display
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If the sensor does not immediately pass the test, or if the user has manually initiated the test, the Sensor Check Screen
displays (Fig 72). This screen shows the sensor with each electrode numbered. Colours indicate the status of each
electrode:
• Hollow circle – No status is available. The electrode label will appear after a few seconds.
• Green circle with Checkmark – The electrode impedance is within the acceptable range. When all circles are green,
monitoring can begin.
• Red blinking circle with ‘X’ – The electrode impedance is not within the acceptable range. Press the edges of the
sensor to ensure adhesion and then press each circle for 5 seconds to ensure proper contact. Check all connections.
If the problem persists, remove sensor, clean skin thoroughly, and reapply sensor or apply new sensor in accordance
with instructions on the sensor packaging.
• Gray circle with Question Mark – The electrode impedance cannot be determined due to electrical interference
(noise) from another source. Monitoring will not commence until the source of the noise has been removed and all
electrodes have passed the sensor check.
If the user has requested the Sensor Check and all electrodes pass the test, the circles return to their original display
colour (green). If user action is required, messages in the message region of the screen issue instructions.
The monitor continues updating the values until all impedance values are acceptable. The cancel key allows
the user to exit the screen before the test has completed, however, the Sensor Check impedance test must
be successfully completed before normal processing resumes.
In this display, the impedance value for each electrode, in kilo ohms, appears on the screen along with its status:
PASS – An electrode passes if the impedance for that electrode is less than 7.5 kilo ohms. The ground electrode
(electrode #2) must be less than 30 kilo ohms to pass.
HIGH – An electrode is labeled “HIGH” if its impedance value is above 7.5 kilo ohms (30 kilo ohms for the ground
electrode). As long as the combined impedance of electrodes #1 and #3 and the combined impedance of electrodes #1
and #4 are less than 15 kilo ohms, and the ground electrode is less than 30 kilo ohms, the sensor check will be
considered successful.
NOISE – If the signal from the electrode goes beyond the measurable range, the label “NOISE” displays.
POOR CONTACT – If the impedance check indicates that the electrode is not in contact with the patient, the label
“POOR CONTACT” displays.
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6.0 CNAP Operation
6.1 Overview
CNAP – Continuous Non-Invasive Arterial Blood Pressure – is a non-invasive method for measuring the continuous blood
pressure waveform in adult and pediatric patients from the age of 4 years.
A patient's blood pressure waveform is recorded by the CNAP Module by means of a double finger cuff with an
integrated IR light sensor and air chambers. The measured IR signal – similar to a pulse oximeter – helps to measure the
blood volume in the finger, which is kept constant by means of CNAP: beat to beat a counter pressure in the finger cuff is
built up, which fluctuates between the systolic and diastolic blood pressure.
Counter pressure
ControlSystem
Constant finger volume
Figure 73: CNAP Technology Graphic
A NBP cuff (oscillometric blood pressure measurement), measures absolute blood pressure values which are used to
calibrate the relative blood pressure in the finger, thus ensuring absolute accuracy. The NBP cuff can be placed on the
patient's upper arm either on the same or on the other arm as the CNAP double finger cuff. NBP measurement is
essential to ensure absolute accuracy of the recorded blood pressure values.
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6.2 Warnings
CAUTION:
The accuracy of the CNAP measurement depends on the accuracy of the accompanying NBP measurement, which is
particularly important during calibrations or before interventions.
The clinician should be aware that there may be lateral differences in blood pressure. The CNAP device does not
compensate for lateral blood pressure differences that may occur in some patients.
Make sure that no movement artefacts occur during measurement, especially during and until approx. 2 min. after
measurement initialization.
Powerful light sources (e.g. cameras with flashlight) may affect the CNAP measurement and cause artefacts.
Movements of the patient, which result in changes of position of the CNAP double finger cuff regarding heart level, will
have immediate influence on the absolute values of blood pressure readings. To compensate these physical effects
(hydrostatic height), recalibrate the CNAP measurement by triggering a single NBP measurement.
CAUTION:
Do not use CNAP and NBP in patients with vascular prostheses in the arm.
Check the patient's hand for warmth prior to using the CNAP module. Cold temperatures may affect CNAP
performance. If no perfusion index is detected during use then the module cannot be used.
CNAP is designed for the concurrent measurement of only one patient at a time.
The CNAP blood pressure waveform is calibrated by means of oscillometric NBP measurement. If the accuracy of the
NBP measurement is affected by artefacts (weak pulse, irregular pulse, artefacts from patient movement or tremor, or
respiratory artefacts), this may also affect and reduce the accuracy of values measured by the CNAP Module.
The use of some surgical devices might cause interference and reduce the quality of CNAP recordings.
Never connect the device's air connectors to an intravascular system!
TO AVOID THE POSSIBILITY OF OCCLUDING BLOOD FLOW IN THE FINGER DO NOT USE A FINGER CUFF THAT
IS TOO SMALL FOR THE PATIENT'S FINGERS . USE THE CUFF CONTROLLER TO ESTIMATE THE CORRECT SIZE.
THE DUAL FINGER CUFF SHOULD SLIDE ON AND OFF THE FINGER WITHOUT RESISTANCE OR EFFORT. THE
PATIENT'S FINGER MAY SWELL IN SIZE IF PERIPHERAL ODEMA OCCURS. IF IN DOUBT USE THE NEXT LARGER
SIZE OF CUFF.
Regularly inspect the patient’s hand during measurement to avoid possible lasting damages caused by prolonged
impairment of the patient's blood circulation! In case of any signs of total arterial compression in a finger during
measurement, immediately discontinue the measurement process by pressing Stop
on the CNAP control
panel or by pressing on the Notification bar.
If the monitored hand is not visible then pay particular attention to the quality of the blood pressure waveform displayed
on the monitor screen. Decreases in pulsatility, pulse pressure could be the result of movement of the cuff, or tissue
swelling local to the measurement site. In such cases re examination of the hand and sensor fit and positioning is
recommended.
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Pain or strong feelings of discomfort are in no way normal and are not a part of CNAP measurements! Should a patient
report any of these feelings, stop the measurement process immediately!
Before connecting any cables to a patient, visually inspect all components for damages or wear. Any faulty parts are to
be replaced immediately.
Check the correct positioning of the CNAP double finger cuff regularly during measurement. Make sure that the cuff is
not positioned on the finger joints.
NOTE:
Avoid compressing the air hoses or reducing their diameter in any way (e.g. by bending the cables) as this could impair
the quality of the CNAP measurement. To avoid mechanical damage to the CNAP finger cuff, remove all objects (e.g.
rings) from the patient’s fingers before measuring.
WARNING:
The operating environment for CNAP hardware has to comply with the directions regarding ambient temperature, relative
humidity and atmospheric pressure.
Take care to ensure regular and sufficient air circulation around the CNAP Module by placing the device accordingly (e.g.
do not cover it with sheets or blankets).
In some cases, CNAP measurement is not suitable
• Weak signal shown via the Perfusion Index indicator (Low PI <1)
• Reduced peripheral blood flow (e.g. peripheral shock, hypothermia extreme centralization, extreme hypothermia)
• Arterial vascular diseases (arteriosclerosis, Raynaud’s syndrome, endarteritis obliternans, collagenosis, extremely
advanced vascular diseases (PAOD).
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6.3 Hardware Setup: Connecting the CNAP Module
NOTE:
Place the CNAP double finger cuff on the index and the middle finger of a patient. In rare cases – if necessary – the
CNAP double finger cuff may also be placed on the middle and the ring finger. Thumb and little fingers are not suited for
CNAP blood pressure measurement.
The use of a too big or too small CNAP double finger cuff may result in faulty blood pressure recordings.
6.3.1 Hardware Connections
The LiDCO CNAP Module is connected to the LiDCOrapid via two cables
The power cable which is a 12-24V DC input and
The USB cable, type ‘A’ to ‘B’ via a type ‘B’ connector on the module and a type ‘A’ connector on the monitor.
NOTE:
The CNAP module requires power and communication via the LiDCOrapid V2 monitor in order to measure and display
blood pressure.
6.3.2 Patient Setup (connection)
Preparation for a measurement (refer to chapter 4.4 – Patient setup):
Choose the correct size of a CNAP double finger cuff by means of the graphics on the top of the CNAP Cuff Controller.
Assemble the CNAP hardware by connecting the CNAP double finger cuff, the CNAP Cuff Controller, the CNAP cable
and the CNAP Module. All the plugs and connectors are designed so as to make it impossible to switch them
accidentally.
Attach the CNAP hardware to the patient: The CNAP double finger cuff is placed on the proximal joints of the index and
middle fingers. Make sure that the cuff cables run along the upper side of the patient's arm. Ensure the finger cuff slides
on and off the patient's fingers easily.
Fasten the CNAP Cuff Controller to the patient's forearm by means of the Fixation Strap using the Velcro fastner and
make sure that the hand with the CNAP double finger cuff is placed at heart level).
Place the NBP blood pressure cuff on the patient's upper arm (calibration for CNAP) contralaterally, or, if necessary, on
the same arm as the double finger cuff.
As soon as you have selected the patient type in the Patient Details Screen, the CNAP measurement is ready to start.
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6.4 CNAP Operation
6.4.1 Starting the Measurement
1. Press the
(start) button located in the CNAP Control panel to begin.
NOTE:
A stat measurement of blood pressure can be performed using the arm cuff prior to starting the CNAP if required.
CAUTION:
At any time during the calibration or after the start of the measurement, it is possible to stop the CNAP by pressing either
the Stop button adjacent to the CNAP waveform display, or the emergency stop button located on the Notification bar.
2. Perfusion Index
The CNAP control panel will display the Perfusion Index at the start of a measurement. This is displayed until a finger
waveform has been identified and the calibration to the arm cuff (NBP) is ready to begin.
The Perfusion Index (PI) describes the signal quality of perfusion in the finger artery in the CNAP cuff on a scale from 0
(no signal) to 6 (very good signal). The currently found PI is shown on the screen as a yellow bar. The maximum value
that has been found during this calibration phase is marked with a green rectangle in the bar graph.
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Patients with poor peripheral blood circulation can be identified by means of a very low PI ≤ 1. A red bar at the first
position in the bar graph is displayed.
If the PI is ≤ 1, the CNAP measurement will not complete.
Such a case involves the risk of a CNAP interruption due to insufficient peripheral circulation, i.e., in the course of
measurement it could fail temporarily or completely. The red rectangle will disappear if a PI > 1 is found.
3. NBP – Arm Cuff Calibration
The CNAP measurement requires calibration to an arterial blood pressure measured from a large artery near the heart
(e.g. brachial).
3.1 NBP – Automatic NBP Calibration
NBP (Non-Invasive Blood Pressure) uses the oscillometric method to determine a patient's blood pressure on a noncontinuous basis. To achieve this, the NBP module is integrated into the CNAP Module. Blood pressure measurement is
conducted by means of a NBP cuff (available in 4 sizes) which is placed around the patient's upper arm (brachial artery)
and connected to the CNAP Module. For measurement purposes, the pressure in the NBP cuff is controlled by the NBP
module. The cuff pressure is first increased above systolic blood pressure and decreased step by step. The pulsations in
the NBP cuff provide the basis for deriving the blood pressure values Systolic and Diastolic.
3.2 Manual NBP Calibration
The user can enter NBP values manually to complete the
calibration. This option is selected on the CNAP Config screen
(sect 6.6). When required the monitor will issue an alert, both
visual and audible, and open a window to allow Systolic, Mean
and Diastolic values to be entered (see figure to right).
CAUTION:
At any time during the calibration or after the start of the measurement, it is possible to stop the CNAP by pressing either
the Stop button adjacent to the CNAP waveform display, or the emergency stop button located on the Notification bar.
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During the NBP measurement, the CNAP control panel will indicate the pressure in the arm cuff as shown above. Once
complete the values of Systolic and Diastolic pressure from the NBP measurement are displayed in brackets beneath the
continuous values.
4. CNAP Timer for Finger Change and CNAP Controls
There is a user specified time interval between each finger measurement that can last for 5 to 60 minutes (refer to CNAP
configuration). In the CNAP control panel, a timer is used to display the time remaining until the next change of finger.
The timer starts after the calibration is complete and remains visible while the CNAP measurement is being displayed.
When the CNAP automatically changes the finger, the new finger is calibrated to the previous blood pressure values.
The user can request a change of finger at any time, except during a NBP measurement. A change of finger
request will automatically result in a new NBP calibration.
Prior to CNAP Measurement the user can request a NBP measurement for display only. During a CNAP
measurement the user can request a NBP measurement at any time. The NBP values will be used to
recalibrate the CNAP measurement.
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6.5 Main LiDCO CNAP Module Measurement and Display
Screen
Figure 86: CNAP Trend
• Description of sections during operation
a. Trend
The CNAP trends are provided as standard hemodynamic parameters of blood pressure and heart rate. The trend
can be adjusted to display intervals from 30 minutes to 8hours, and the scale of the display can be adjusted from
100 to 300mmHg.
The scale of the axis can be adjusted by pressing on the axis and using the slide to select the preferred
settings.
When events are marked, they are displayed on trend displays of the blood pressure and heart rate trend.
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b. Numeric Values
The display of numeric data to the right can be averaged over periods of 10, 20 or 30 seconds. This is can be
adjusted in the Configuration Screen.
c. Waveform
The Blood pressure waveform is displayed as a trend over a 6 second window. The y-axis scale is fixed at a range
of 0-300mmHg.
d. CNAP Control Panel
The CNAP Control Panel displays different information and control buttons depending on the measurement mode
(refer to section 4.4 for more detail):
i. Pre-measurement
1. Start button
ii. During CNAP Calibration
1. Stop button and Perfusion index
2. Stop Button and NPB cuff pressure
iii. During CNAP Measurement
1. Stop Button
2. Manual Finger Change button
3. Manual NBP button
4. Timer to next automatic finger change
• Measurement Stop
a. Routine
i. Press stop button to stop the CNAP measurement.
ii. Press the stop button to stop the NIBP measurement, when in process. This will not stop CNAP. Pressing the
stop button again will stop the CNAP.
b. Emergency CNAP/NIBP stop
i. Press this button, located on the Alert bar, to stop the NBP and CNAP measurement at any time.
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6.6 CNAP Configuration Menu Options
Figure 87: CNAP Config Screen
6.6.1 CNAP Calibration Interval
The CNAP Calibration Interval controls the automatic change from one finger to the other. This interval can be set
between 5 and 60 minutes, at 5 minute increments.
Note: Automatic finger change will calibrate the new finger to the previous values of Systolic and Diastolic pressure.
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6.6.2 Alarms
Physiological Alarms are available for Systolic, Mean and Diastolic pressures. The default values are shown in the table
below for both Adult and Pediatric patients.
i. Alarms On/Off
Physiological alarms can be set to on or off by using the tick box. When physiological alarms are on they create an
audible alert automatically when exceeded by either the CNAP or NBP measurements.
ii. Alarm Limits Settings
Alarms limits can be changed for both Adult and Pediatric patients at any time.
Adult limits if Adult is chosen as patient type
mmHg
Lower
Lower limit
Default
Upper
Lower
Upper limit
Default
Upper
Sys
40
90
255
45
140
260
Mean
35
60
250
40
110
255
Dia
30
50
245
35
90
250
Pediatric limits if Pediatric is chosen and patient type
59
mmHg
Lower
Lower limit
Default
Upper
Lower
Upper limit
Default
Upper
Sys
40
70
175
45
120
180
Mean
35
50
170
40
90
175
Dia
30
40
165
35
70
170
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7.0 Combined Display and Common Features
7.1 LiDCOrapid and BIS
Figure 88: LiDCOrapid and BIS combined display
When both the LiDCOrapid and the BIS modules are selected for use in a monitoring session a combined screen is the
default display.
The Rapid + BIS combined display maintains features of each individual display while allowing additional data to be
displayed simultaneously.
The Hemodynamic section is identical to the Rapid alone display. The BIS trend and numeric data are also similar with
indications for SQI and EMG available as well as a second trend variable.
Event Response and Preload Response displays are combined into a single smaller co-display. The functions remain
identical.
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Press to alternate with the EEG or blood pressure waveform display
Figure 89: Bis trend display options
7.2 LiDCOrapid and CNAP
Figure 90: Rapid + CNAP Screen
When both the LiDCOrapid and the CNAP modules are selected for use in a monitoring session a combined screen is
the default display.
The Rapid + CNAP combined display maintains features of each individual display while allowing additional data to be
displayed simultaneously. The key difference is the control panel for the Blood Pressure which is designed to control the
CNAP Module.
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7.3 BIS and CNAP
When both the CNAP and the BIS modules are selected for use in a monitoring session a combined screen is the default
display.
The CNAP + BIS combined display maintains features of each individual display while allowing additional data to be
displayed simultaneously.
The Hemodynamic section is identical to the CNAP alone display. The BIS trend and numeric data are also similar with
indications for SQI and EMG available as well as a second trend variable. EEG data is displayed as well.
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7.4 LiDCOrapid, BIS and CNAP
Figure 92: Rapid + BIS + CNAP
When both the LiDCOrapid the CNAP and the BIS modules are selected for use in a monitoring session a combined
screen is the default display.
The Rapid + CNAP + BIS combined display maintains features of each individual display while allowing additional data to
be displayed simultaneously.
The Hemodynamic section is identical to the Rapid alone display. The BIS trend and numeric data are also similar with
indications for SQI and EMG available as well as a second trend variable.
Event Response and Preload Response displays are combined into a single smaller co-display. The functions remain
identical.
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7.5 Event Marking
Events can be marked at any time during the use of the LiDCOrapid. A flag is placed on the hemodynamic or BIS
monitoring display with the event number. Each event can be individually annotated. Standard event types are listed and
additional information can be entered as well. A full list of events is available for review at any time.
Press to display the submenu and choose
to mark an event
Use the following window to annotate the event:
Figure 93: Event Entry Screen
Choose an Event and Characteristic from the pull down options menu.
Touch the white box to add additional information in the Notes field.
Press the ‘green’ tick when complete.
Press the ‘red’ X to cancel the event.
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7.6 Event History
Press this button to display a list of events as shown below
Figure 94: Event History Window
Editing Events
Press this button to edit the specific event details
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7.7 History Screen
Press this button to display the Trend History Screen
The History Screen can be used to look back over up to 24hrs of hemodynamic and/or BIS data, including preload
response parameters SVV, PPV and HRV. Absolute or index values are displayed based on the Configuration Screen
settings.
Figure 96: History Screen
LiDCOrapid Parameters available:
CO (CI), SV (SVI), SVR (SVRI), MAP, HR, SVV, PPV, HRV
BIS Parameters available:
BIS, EMG, SQI, SR (if selected)
Touch the magnifying glass to adjust the vertical or horizontal (time) scale
Touch to display a target window for CO, SV or SVR
BIS, SVV and PPV targets are displayed based on the Configuration Screen settings
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7.8 Chart Screen
Press this button to display a Chart of numeric data for up to 24 hours.
The Chart Screen allows for numeric data display to assist in recording values for routine clinical charts as well as general
review. The Chart Screen displays all the LiDCOrapid hemodynamic and BIS parameters, including absolute and index
values, in seven (7) columns. Data are available for up to the past 24 hours.
The Earliest data is the
oldest data available
Patient
Information
The Latest data is the most
recent data available.
Figure 97: Chart Screen
Data Navigation:
Press to move
by one column
The period between each displayed time point. The interval choices
are 5 (default), 15 and 30 minutes or 1, 2 and 4 hours
by one page
to start of data
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The time period for data averaging at each time point. The data can be
averaged for periods of 10, 30 (default) or 60 seconds.
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8.0 Alarms, Safety, Cleaning and Maintenance
Figure 98: Alarms Display
8.1 Alarms
i. Alarm Description/Categories
• There are 2 categories of alarm
a. Advisory: white text on a blue background,
This alarm text remains until acknowledged or the alarm condition is removed.
b. Serious: black text on a flashing yellow background,
i. This alarm continues to flash until it has been acknowledged.
ii. Alarm text remains until the alarm condition is removed.
ii. Alarm Display and Control
• All alarms are displayed in the common notification bar when they occur.
• The highest priority alarm is displayed when there is more than one alarm activated.
• Alarms of the same priority are ordered in the following manner:
a. By the time they occurred, with the most recent at the top, and
b. Whether they have been acknowledged, with unacknowledged alarms at the top of the list.
c. When there are multiple alarms the highest priority alarms will rotate every 15 seconds until acknowledged
or removed.
iii. Alarm Acknowledgement
• Alarms are acknowledged by touching the alarm.
• Audible alarms can be silenced by touching the speaker icon.
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8.2 Safety Instructions, Cleaning, Maintenance
8.2.1 Safety Requirements
Safety Instructions (see also inside front cover)
• Always refer to this LiDCOrapid Hemodynamic Monitor User’s Manual.
• Disconnect the LiDCOrapid Hemodynamic Monitor and the power supply unit from the voltage supply when not being
used.
• Check the power supply voltage is suitable for use with the LiDCOrapid Hemodynamic Monitor before connecting the
equipment to the power outlet.
• Disconnect this equipment from any AC outlet before cleaning. Use a damp cloth and do not use liquids or spray
detergents for cleaning.
• When disconnecting a cable, pull on the connector not the cable itself.
• Do not attempt to remove the back cover of the LiDCOrapid Hemodynamic Monitor, any modules or open the power
supply unit as you will be exposed to an electric shock hazard. This operation should only be performed by LiDCO Ltd
certified service personnel.
• To avoid the risk of electric shock, or permanent damage to the product, do not expose any of the LiDCOrapid
Hemodynamic Monitor, power supply unit components or modules to rain, liquids or excessive moisture.
• Consult qualified service personnel if the LiDCOrapid Hemodynamic Monitor or any associated module does not
operate normally, the power supply unit or power cord is damaged or moisture/liquid has penetrated the product.
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8.2.2 Cleaning and Disinfection Instructions
Clean any spillage of blood or solutions on either the monitor or modules as soon as possible. Dampen the towel with
detergent and lukewarm water to aid in cleaning. Use lint-free absorbent towels for spill cleanups.
WARNING:
WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS OCCURS, RE-TEST LEAKAGE CURRENT
BEFORE FURTHER USE.
Recommended cleaning materials and methods are shown below:
• To clean: Wipe with a cloth moistened with warm water or a soap solution.
• Do not allow liquid to enter the monitor or any connectors.
• Do not immerse any components in liquid.
• Do not let residues of detergents or disinfectants air-dry on any parts of the device. Wipe them off with a cloth moist
with water, then dry the instruments with a clean cloth.
• Never use scouring agents, bleaching agents, or abrasive detergents.
• After cleaning, wipe connector ends with alcohol and allow to dry completely. Residual moisture inside a connector
may affect performance.
• Dry thoroughly with a lint-free cloth.
To disinfect: Wipe with a lint-free absorbent towels moistened with a dilute alcohol, 10% bleach solution,
gluteraldehyde-based disinfectant or a commercial disinfectant.
CAUTION:
• Disinfectant agents: Never mix different kinds of disinfecting solutions (e.g. bleaching agents and ammonia), as this
might result in the production of dangerous gases.
• Internal hospital regulations: Disinfect the product in accordance with your own hospital regulations in order to avoid
long-term damage of any kind.
CAUTION:
Do not autoclave the monitor, modules or any of the components. Autoclaving will seriously damage this product.
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8.2.3 Maintenance or Service
The following maintenance is recommended for the LiDCOrapid Hemodynamic Monitor
Annual electrical safety check in accordance with hospital protocol
Acceptable service/repair of the BISx Module in the field is limited to:
• Replacement of the Monitor Interface Cable (MIC)
• Replacement of the Patient Interface Cable (PIC)
Replacing the PIC and MIC cables is an important routine maintenance action which will improve the reliability of the BIS
monitoring system.
CNAP Module maintenance includes an annual safety inspection to be performed by LiDCO certified service personnel:
Functional technical inspection and check to determine if the unit is in calibration
Safety test including leakage current measurement acc. IEC 60601-1
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8.3 Troubleshooting LiDCOrapid
Description
Possible Causes and Corrective Measures
Setup Screen
Cannot access the LiDCOrapid Screen
• Data must be filled into the fields: Patient’s ID, Height,
Weight and Age before accessing the LiDCOrapid Screen
Enter data in boxes
Press ‘Rapid’ button
Set-Up Procedure
Difference of greater than 5% between
parameters displayed on primary Monitor
and those shown on the BP Window
of the LiDCOrapid
• BP Cable not connected to patient monitor
and/or at the LiDCOrapid ADC connection
Check connections
• Patient Monitor analog output is not to the LiDCOrapid
Hemodynamic Monitor
ADC Specification of 100 mmHg = 1 volt
Check analog pressure output specification of Monitor or
Module used
No BP Waveform is observed on any channel
• Check all cable connections
• For Channel 2 zero the Patient Monitor IBP waveform
No values are displayed for Channel 1
Check all cable connections
Zero Fail: Signal Varying
Zero Fail: Offset too large
Channel 1 must be zero’ed before values will display
No BP waveform or values
are displayed for Channel 2
Check cable connections
No cable for Channel 2
Contact your LiDCO representative to obtain a cable
Specify the Make/Model of your Patient Monitor
The BPM is compliant with the applicable
EMC requirements. It may still be affected by
and/or affect other equipment.
If interference occurs:
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between the equipment. Connect the equipment
to a power outlet on a different circuit
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LiDCOSmart Card
Description
Possible Causes and Corrective Measures
Smartcard is not recognised or Invalid Smartcard
Wrong card or inserted incorrectly
Check card is a LiDCOsmart and is oriented facing
the user with the chip-end entering the monitor first
(see section 4.6)
Card has expired and can no longer be used
Replace card with a new LiDCOsmart
Data Download
Buttons Not Active
Download does not complete
• USB device is not attached
• USB device is full
• USB device is not compatible
Check USB device is attached
Try a different USB device
Serial Data Interface
Data does not appear on Philips Monitor
Data does not appear on Interfacing Monitor
• Vuelink Enabled not selected for Serial Link
Select Vuelink in Engineering Screen, Data
Communications, then restart monitor
• LiDCOserial Enabled not selected Serial Link
Select LiDCOserial in Engineering Screen, Data
Communications, then restart monitor
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8.4 BIS Technical Alarms and Status Messages
Status Messages:
Possible Causes:
Corrective Actions:
Connect BISx
1. BISx disconnected.
2. Defective BISx cable.
3. Defective BISx.
4. Defective monitor.
1. Connect BISx. Verify all cable
connections.
2. Inspect/repair cable at
connector end.
3. Replace the BISx.
4. Replace monitor.
Press electrode(s) x, y
Temporarily unable to measure
electrode(s) x, y
[ 13 ]
1. Sensor is not fully in contact
with patient’s skin.
2. Incorrect sensor application.
3. Defective PIC.
4. Defective BISx.
1. Press electrode indicated on the
screen.
2. Read Instructions on sensor
package to ensure correct sensor
placement.
3. Replace the PIC.
4. Replace BISx.
Sensor Disconnected/Connect
sensor or PIC
[ 14 ]
1. Disconnected sensor.
2. Poor or contaminated
connection between sensor and
PIC.
3. Disconnected PIC.
4. Defective PIC.
5. Defective BISx.
1. Connect the sensor.
2. Connect/clean connection
between sensor and PIC.
3. Connect the PIC.
4. Replace the PIC.
5. Replace the BISx.
Last Sensor Check Failed /
Restart sensor check or
reconnect sensor
[ 16 ]
1. At least one element of sensor
has too high impedance, and EXIT
pressed (before sensor check
completes).
2. Incorrect sensor application.
3. Poor sensor connection.
4. Defective PIC.
5. Defective BISx.
1. Verify Sensor Check passes.
2. Read Instructions on sensor
package and reapply sensor.
3. Check sensor connection.
4. Replace the PIC.
5. Replace the BISx.
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Status Messages:
Possible Causes:
Corrective Actions:
Excessive Artefact Detected in
Signal
[ 27 ]
1. Artefact, such as those
generated by motion or
eyeblinks, is causing loss of EEG
recognition.
2. EMG Bar indicates electrical
activity that may be interfering
with EEG recognition.
3. PIC is defective.
4. BISx is defective.
Note: This message may occur
as the results of artefact (nonEEG signal) such as those
generated from motion (patient
movement or eye blinks)
or
the presence of electrocautery,
warming blankets, or other
devices.
1. If ARTEFACT label appears
above the EEG waveform box,
attempt to identify and eliminate
artefact source.
2. If EMG bar is illuminated,
attempt to determine and eliminate
cause.
3. Verify Sensor Check passes. If
not, replace PIC.
4. Replace BISx.
The Signal Quality is less than half
of the level desirable for optimal
monitoring conditions.
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Status Messages:
Possible Causes:
Corrective Actions:
Data unavailable due
to poor signal quality
[ 28 ]
The signal quality is too low to
accurately calculate a BIS
value. The BIS value and other
trend variables that are
adversely affected by artefact
are not displayed.
1. If ARTEFACT label appears
above the EEG waveform box,
attempt to identify and eliminate
artefact source.
1. Artefact, such as those
generated by motion or eye
blinks, is causing loss of EEG
recognition.
2. EMG Bar indicates electrical
activity that may be interfering
with EEG recognition.
2. If EMG bar is illuminated,
attempt to determine and
eliminate cause.
3. Verify Sensor Check passes. If
not, replace PIC.
4. Replace BISx.
3. PIC is defective.
4. BISx is defective.
Note: This message may occur
as the results of artefact (nonEEG signal) such as those
generated from motion (patient
movement or eye blinks)
or
the presence of electrocautery,
warming blankets, or other
devices.
BIS Out of Target Range
Low – [ 29 ]
High – [ 30 ]
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The BIS has fallen outside
the target range set by the
user.
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1. Check patient.
2. Take note of BIS at limit set by
user.
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Status Messages:
Possible Causes:
Corrective Actions:
Isoelectric EEG
Detected
[ 31 ]
No discernible EEG activity
is detected for sixty-three
seconds; SR=100.
Note: This message
notifies user of a flatline
EEG. This is a normal
condition when Sensor
Simulator or Test Sensor is
connected.
If unintended:
1. Check patient vital signs,
dosage, etc.
2. Check leads for proper
connection and possible
shorts.
3. Verify Sensor Check passes.
4. Verify DSC Self-test passes.
5. Verify PIC. Use Test Sensor or
Sensor Simulator and Sensor
Check.
Replace with
compatible sensor
[ 83 ]
The sensor is not
compatible with the monitor
configuration.
Replace sensor.
Sensor Ground Fault
[ 92 ] (negative)
[ 93 ] (positive)
Problem is detected relating
to sensor ground element.
1. Disconnect and examine
sensor connection. Clean
any contamination present.
2. Replace sensor if necessary.
3. Replace PIC.
4. Replace BISx.
Sensor Overcurrent
[ 94 ]
Sensor is using too much
current.
1. Disconnect and examine sensor
connection. Clean any
contamination.
2. Replace sensor if necessary.
3. Replace PIC.
4. Replace BISx.
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Status Messages:
Possible Causes:
Corrective Actions:
No more Uses for this
Sensor
[ 95 ]
Sensor has been connected
and disconnected too many
times.
Replace the sensor.
Reinsert sensor firmly
[ 96 ]
1. Poor or contaminated
connection between
sensor and PIC.
1. Connect/clean connection
between sensor and PIC.
2. Replace the PIC.
2. Defective PIC.
3. Replace the BISx.
3. Defective BISx.
Sensor used for over
24 hours
[ 109 ]
Unrecoverable BISx
error
[ 517 ]
Replace PIC. Possible
PIC problem.
[ 548 ]
Sensor was attached to system
for more than 24 hours.
Replace sensor.
(See Message 1000).
1. Defective PIC.
1. Test another PIC with Sensor
Simulator.
2. Defective Sensor Simulator.
2. If failure persists, replace
simulator and retest.
Possible PIC problem.
Check cable using
Sensor Simulator
[ 549 ]
Defective PIC.
Unrecoverable BISx
Error /BISx initialization
error
[ 1000-1999 ]
1. Poor connection between
BISx monitor cable and monitor.
1. Test PIC using Sensor
Simulator or Test Sensor.
2. Replace PIC.
2. Defective BISx.
1. Follow on-screen instructions. If
necessary, power OFF and unplug
power cord to shut down monitor
completely. Then plug in and restart monitor.
3. Defective monitor.
2. Replace the BISx.
3. Replace the monitor.
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8.5 CNAP Alarms and Status Message
8.5.1 Summary
The CNAP issues five (5) different types of Message or Alert to the user: Status messages, Physiological Alerts, Critical
Alerts, Fatal Alerts and Arm Cuff Alerts. All of these will appear in the Alert Bar, and certain ones will issue an audible
notification as well. When a Critical Alert occurs, the CNAP Module will indicate to ‘Disconnect and Reconnect the CNAP
Cuff Controller’. If a Fatal Alert occurs, the CNAP Module will indicate to ‘Disconnect and Reconnect the USB cable’.
8.5.2 CNAP Alert Types Overview
8.5.2.1 Status Messages
The CNAP Module will issue status messages to indicate what is happening with the setup or measurement. The most
common are
‘CNAP Initializing’ when it is first connected,
‘CNAP Put Fingers In Cuff’ when initializing is complete and
‘CNAP Ready’ when fingers are in cuffs and it is ready to start.
These messages can be acknowledged or they will disappear as the CNAP changes to a new operation step. These
status messages do not result in an audible notification.
8.5.2.2 Physiological Alerts
The LiDCOrapidV2 has the option to monitor CNAP Systolic, MAP and Diastolic pressures against a set of user defined limits
for High and Low values (refer to 6.6.2). These alert settings are located in the CNAP Configuration screen. The alerts
can be turned on or off, and the High/Low limits for each pressure can be adjusted individually. There are different limits
for Adult and Pediatric patients. These alerts will issue an audible notification as well as a flashing notice in the Alert Bar.
8.5.2.3 Critical CNAP Alerts
The CNAP Module will issue a Critical Alert when there is a fault related to the measurement function. These can include,
for example: air leaks or poor connections, or faulty finger cuffs. When a Critical Alert is issued, it will be accompanied by
a unique message describing the fault and a common message indicating that the user must disconnect and reconnect
the CNAP Cuff Controller in order to proceed.
8.5.2.4 Fatal CNAP Alerts
The CNAP Module will issue a Fatal Alert when there is a system fault. This is a less common, but more severe system
fault. The fault can be cleared by disconnecting and reconnecting the USB cable between the CNAP and the LiDCOrapid.
8.5.2.5 Arm Cuff Alerts
The CNAP Module will issue alerts when the NIBP Arm Cuff has a fault. The most common would be NIBP leakage ( e.g.
tube not connected) or NIBP terminated (e.g. user presses stop). These are cleared the next time the NIBP is
successfully used.
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8.5.3 Detailed Listing of CNAP Alerts
Status Messages
Message
Condition/Cause
Actions
CNAP Module USB Cable
Disconnected
USB cable disconnected
Reconnect USB Cable
CNAP Ready
Ready to begin measurement
None
CNAP Cuff Controller
Disconnected
NA
Connect Cuff Controller
CNAP Finger Cuff Disconnected
NA
Connect Finger Cuff
CNAP Initializing
CNAP Starting Up
None
CNAP Put Fingers in Cuff
CNAP waiting for patient
None
CNAP Cuff Near End of Life
Finger Cuff total use time is high
Replace finger cuff soon
CNAP Calibration with NIBP
Waiting for Arm Cuff measurement
to complete
None
CNAP Ringing
Faulty cuff controller
check cable connections
replace cuff controller
CNAP - Check Power Supply
Power has been removed
Check cable connections
Check that mains power is on
CNAP Calibration: Manually
Enter NIBP Values
Waiting for NIBP Values
Enter Sys/MAP/Dia values from
Patient Monitor
Message
Condition/Cause
Actions
Sys/MAP/Dia is High or Low
Physiological values is
above upper limit or
below lower limit
Check Patient and treat as
necessary
Check/adjust alarm limits
Check cable and connections
Replace cuff or cable if necessary.
Physiological
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Critical
Message
Condition/Cause
• CNAP ERROR - Disconnect and
Reconnect Cuff Controller
Critical Alerts issued;
will accompany all Critical Alerts
• CNAP Fault - Reservoir Pressure
Air Leak in System
• CNAP Zero Offset Controller Fault
Faulty Cuff Controller
• CNAP Fault - Initial Pressure
Actions
Check all connections between
CNAP Module, Cuff Controller
and Finger Cuff
Disconnect and Reconnect
Cuff Controller
• CNAP Fault - Pump/Tubing/Valve
Leaky
Replace Cuff Controller
• CNAP: Cuff Cannot Deflate/Blocked
Replace Finger Cuff
• CNAP Fault - Blocked Or Leaky Valve
• CNAP Fault - Left Cuff Leak
• CNAP Fault - Right Cuff Leak
• Finger Light Amplitude
Check size/fit of finger cuff
• CNAP Cuff Fault - Light Sensor Left
Finger Cuff fit is too loose on
finger
• CNAP Cuff Fault - Light Sensor Right
Faulty Finger Cuff
Disconnect and Reconnect
Cuff Controller
Incompatible Cuff Controller or
Finger Cuff
Replace Cuff Controller or
Finger Cuff
• CNAP Check Cuff - Ambient Light
Replace Finger Cuff
• CNAP Check Cuff - Low Light Signal
• CNAP Invalid Cuff Controller
• CNAP Invalid Finger Cuff
• CNAP Cuff Fault Expired
• CNAP Cuff Fault - Memory
Finger Cuff has reached use
limit
Faulty Finger Cuff
• CNAP Check Arm Cuff - Timeout On
Calibration
• Watchdog Error disconnect/reconnect cuff controller
NIBP Measurement or External
NIBP Values not obtained
within 3 minutes
Disconnect and Reconnect
Cuff Controller
System Fault
Disconnect and Reconnect
Cuff Controller
• CNAP Power Supply
Repeat measurement
If problem persists, return
CNAP Module, cuff controller,
cable and finger cuffs.
• CNAP Temperature Exceeded
• Cuff Pressure Exceeded
• SCIA Watchdog Overflow
• SCIB Watchdog Overflow
• CNAP Controller Non-volatile Memory
Fault
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Fatal Alerts
Message
Condition/Cause
Actions
• CNAP Fault - Module Auto
Reset
Fatal Alert issued
Disconnect and Reconnect USB
cable between CNAP Module and
Monitor
• CNAP Coprocessor Fault
Faulty CNAP Module
Will Accompany all Fatal Alerts
• CNAP Memory Overflow
Disconnect and Reconnect USB
cable
If problem persists contact LiDCO
representative.
• CNAP Reset
• CNAP Temperature Sensor
Fault
• CNAP EEPROM Fault
• CNAP Cuff Inflation Timeout
• CNAP Fault ADC
• CNAP Failure - Cuff
Overpressure Left
Faulty Pressure Control
• CNAP Failure - Cuff
Overpressure Right
Disconnect and Reconnect USB
cable
If problem persists contact LiDCO
representative.
• CNAP Failure - Reservoir
Overpressure
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Arm Cuff Alerts
Message
Condition/Cause
Actions
• NIBP: Weak Or No Signal Check Arm Cuff
Kinked or Blocked tubing
Check connections and tubing
Arm Cuff too large or too small
Check arm cuff size
Arm Cuff not near to brachial artery
Check location of arm cuff on
patient
• NIBP Leakage
Tubing disconnected or connectors
not fully attached to plugs
Check connections and tubing
• NIBP Terminated
User or System as issued a Stop
• NIBP Safety Timeout
Faulty CNAP Module
• NIBP: Artefact - Check Arm
Cuff
• NIBP Blocked Line
• NIBP Out of Range BP Value
• NIBP Overpressure
• NIBP Hardware Fault
If problem persists contact LiDCO
representative.
• NIBP Autozero Failure
• NIBP Transducer Failure
• NIBP ADC Failure
• NIBP Calibration Failure
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9.0 Appendices
The LiDCOrapid allows for configuration of the monitor, downloading of data files and a demonstration mode. This is
accessed from the Welcome Screen by pressing the configuration button. These screens have three main purposes
Demonstration
Data Download
Configuration Functions
9.1 Demonstration
Figure 99: Demonstration Data Screen
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i. Select each module for demonstration and a file or files will appear in the section below. Demonstration mode allows
the user to playback one of several waveforms into the LiDCOrapid.
Note that the monitor will display an alert message when a demonstration waveform is being displayed. In this mode,
the normal blood pressure signal input is ignored.
ii. The following waveforms are available in demonstration mode:
• Fluid Responsive
• Fluid Challenge
• Inotrope
• Stable
• High Heart Rate
• Post Fluid Challenge
9.2 Data Download
Figure 100: Data Download Screen
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i. The LiDCOrapid stores patient data for up to 6 months. The data download feature allows patient files to be
downloaded either as LiDCOview files (*.LVU) or for the specific files to be downloaded separately. All data is
downloaded to USB drives which must be inserted before a download can occur. The files are organised according to
the patient ID field. The patient's name is not included in any of the data files.
ii. The Download Screen allows easy navigation of the available data by collecting all files with the associated patient ID
'folder'. In the lower window all the associated files are displayed.
iii. To download data
1. Attach a USB device and ensure it is acceptable
2. Select the Patient ID
3. Select the specific file in the lower window and press the 'File Download' button.
iv. The display can be sorted by each category by touching the category. The default is by Session ID.
Figure 100a
v. A summary of all Patient ID's can be created and downloaded to USB for auditing purposes by pressing
.
1. Insert USB
2. Press
3. File Name : Patient_ID_List_(Serial Number)_DateTTime.csv
vi. Delete all Patient Data by pressing
green tick to confirm and delete.
. A confirmation window will appear (fig 100d). Type YES and press the
NOTE: DATA CANNOT BE RECOVERED AFTER IT IS DELETED
Figure 100d
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9.3 Data Output
9.3.1 Serial Data Configuration
Connect 9-pin D-type cable to COM1 port
Data Output: CO/CI, SV/SVI, SVR/SVRI, PPV, SVV, HRV, Sys/MAP/Dia and BIS/EMG/SQI/BC/SR
Figure 101: LiDCOserial Data Output Config
• LiDCOrapid has two serial data output formats:
a. IntelliBridge or Vuelink (for Philips Monitors)
i. Configurable data output frequency
b. LiDCO serial (using RS232)
i. Configurable data output frequency
ii. Configurable data averaging periods
iii. Configurable RS232 port settings (default)
1. Baud Rate: 57600
2. Data Bits: 8
3. Stop Bits: none
4. Parity: 1
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9.3.2 TCP/IP Configuration
Figure 102: TCP/IP Configuration
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9.4 Date/Time
Select the year, month, day hour and minute from the pull down menu. Select the green tick button to accept or the red
X button to cancel any changes.
Figure 103: Set Date/Time
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9.5 Language
Select a language by touching the radio button next to the language name. Select the green tick button to accept or the
red X button to cancel any changes. A change will require the monitor to restart.
Figure 104: Set Language
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9.6 Software Upgrade
The LiDCOrapid software can be upgraded via a USB flash drive. LiDCO will issue the new software and passwords to
allow monitors to be upgraded. It is not possible to modify the software without these specific drives, software and
password. Separate instructions will accompany each upgrade.
Figure 105: Software Upgrade Screen
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9.7 Service Mode
The Service mode provides access for global configuration changes and equipment servicing and calibration. This mode
is restricted by special smartcard and password authentication to authorised LiDCO representatives.
Figure 106: Service Mode NIBP Calibration
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9.8 Parameters
9.8.1 Rapid
Variable Name
Description
Display Range
Cardiac Output (CO)
(Index)
The product of stroke volume and heart rate.
The CO is the amount of blood pumped by
heart over a minute.
0 – 30 l/min
(l/min/m2)
Stroke Volume (SV)
(Index)
The amount of blood ejected by the heart in
a given beat; updated beat-by-beat based
on the PulseCO pulse power analysis
algorithm.
1-500ml (ml/m2)
Sys/MAP/Dia Pressure
The Systolic, Mean Arterial and Diastolic
pressures derived from the arterial blood
pressure waveform.
0 – 240 mmHg
Heart Rate (HR)
The number of beats per minute of the heart.
0-220 bpm
Systemic Vascular
Resistance (Index)
The quotient of pressure and cardiac output.
SVR reflects the resistance to flow and is
calculated as the quotient of pressure and
cardiac output.
50 - 60,000 dyn s /cm5
(dyn s m2 /cm5)
Stroke Volume Variation
SVV
The maximum SV minus the minimum SV
divided by the mean SV across at least one
respiratory cycle (10 seconds).
Values below 10% indicate the patient is
unlikely to respond to fluids values above 10%
indicate the patient will respond to fluids.
0-100%
Pulse Pressure Variation
(PPV)
The maximum PP minus the minimum PP
divided by the mean PP across at least one
respiratory cycle (10 seconds).
Values below 10% indicate the patient is
unlikely to respond to fluids values above 10%
indicate the patient will respond to fluids.
0-100%
Heart Rate Variation (HRV)
The standard deviation in heart rate over a
respiratory cycle (10 sec) divided by the mean
HR. Values above 10% will not display the SVV
or PPV.
0-100%
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9.8.2 BIS
Variable Name
Description
Display Range
Bispectral Index
(BIS)
The output from a multivariate discriminate
analysis that quantifies the overall bispectral
properties (frequency, power, and phase)
throughout the entire frequency range.
0 – 100
Signal Quality
Indicator (SQI)
A measure of the signal quality for the EEG
channel source(s) that is calculated based
on impedance data, artefact, and other
variables.
Not affected by Suppression Ratio.
0 – 100
15 points per bar
EMG
The absolute power in the 70-110 Hz range.
The power value is reported in dB with respect
to 0.0001μV2. All the artefact detection is
turned off for this variable.
30 – 80 dB Trend
30 – 55 dB Bar Graph
Suppression Ratio
(SR)
The percentage of epochs in the past 63
seconds in which the EEG signal is considered
suppressed.
0 – 100 %
Burst Count
The number of EEG bursts per minute, where
a “burst” is defined as a short period of EEG
activity preceded and followed by periods of
inactivity (suppression).
0 – 20
Description
Display Range
Sys/MAP/Dia Pressure
The Systolic, Mean Arterial and Diastolic
pressures derived from the arterial blood
pressure waveform.
0 – 240 mmHg
Heart Rate (HR)
The number of beats per minute of the heart.
0-220 bpm
9.8.3 CNAP Parameters
Variable Name
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9.9 Technical Specifications
9.9.1 LiDCOrapid Monitor
Monitor – HM 8101
Platform:
POC-125
DTP-1201
Weight:
4.8kg
4.75kg
Dimensions:
350 x 290 x 90mm
310 x 260 x 80mm
Input:
24VDC
100-250 VAC 50-60 Hz
Power Consumption:
50w
60w
Display:
12" Colour LCD
12" Colour LCD
User Interface:
Touchscreen
Touchscreen
External Connections:
Power input
Analog Blood Pressure Input
File Download
Power input
Power output 12VDC, 11W
File Download
Operating Conditions:
10-40 °C
30-75% RH noncondensing
700-1060hPa
10-40 °C
30-75% RH noncondensing
700-1060hPa
Storage Conditions:
-20-50 °C
-20-50 °C
10-95% RH noncondensing
10-95% RH noncondensing
Equipment Classification
SELV (IEC60601-1)
Class I
For Continuous Use
For Continuous Use
Not Protected against water ingress
Not for use in the presence of flammable gases
Fitted with a 3V, 195mA lithium battery. Only to be replaced by qualified service personnel. Dispose of the old
battery in a safe manner that complies with applicable laws.
Analog IBP Input Signal Specification:
Scaling
1V/100mmHg
Range
0-2.5 VDC (0-250mmhg)
Accuracy
± 3% full scale
Signal to noise
> -55dB
Internal ADC Card Specification:
95
NA, uses LiDCO BP Module
Resolution
12 bit
Accuracy
0.01% ± bit
Stability > 0.5% full scale
over 4 hours
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9.9.2 Power Supply Unit (POC-125 only)
Power Supply Unit: POC-125 PSU PCM80P524
Input:
100-250 VAC 50-60 Hz
Output:
24VDC
Equipment Classification
Class 1 (IEC 601)
9.9.3 LiDCOsmart Card
LiDCOsmart Card
Type
Microprocessor-integrated chip
Size (WxLxT)
Nominal 86 x 54 x 0.76 (7816-1)
Memory
1Kb minimum
9.9.4 LiDCO Blood Pressure Module and components
Dimensions (H x W x L)
Overall
35 x 207 x115 mm
Mounting plate
4 x 120 x 105 mm
Weight
300g
BPM interface cable length
3m
USB Cable, A to B
30 cm
Compatible transducers sensitivity
5uV/Ve/mmHg
Analog input specification
1V=100mmHg, 0-2.5VDC, 0V offset.
Accuracy
+/-3% of full scale
Power (USB)
5VDC, 500mA max
Operating Conditions
10-40 °C 30-75% RH
Storage Conditions
0-40 °C 20-90% RH
Not protected against water ingress
Type CF applied part. F-type isolated (floating) patient part providing a high degree of protection against shock
and is suitable for use during defibrillation. Defibrillation recovery <5 seconds.
The BPM is not Category AP or Category APG and should not be used in the vicinity of a flammable anaesthetic
mixture with air or oxygen or nitrous oxide.
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9.9.5 BISx
BISx Specifications:
BISx:
Weight:
10.0 oz (0.284 kg) including integral cable
Dimensions:
3.75 in diameter x 2.5 in thick
(9.5 cm x 6.3 cm)
Cable Length:
9 ft (2.7 m) Integral BISx Cable
4 ½ ft (1.4 m) from BISx to sensor connector
Analog to Digital Converter:
Noise-shaped sigma-delta
Sampling Rate:
16,384 samples/second
Resolution:
16 Bits at 256 samples/second
Input Impedance:
50 Mohms typical
Noise:
Common Mode Rejection:
(Isolation mode)
< 0.3 μV RMS (2.0 μV peak-to-peak); 0.25 Hz to 50 Hz
110 dB at 50/60 Hz to earth ground
Frequency/Bandwidth:
0.16 – 450 Hz
Equipment Classification
Class I, type BF, defib proof
Applied Part:
BIS Sensors (supplied separately)
Quattro:
Extend:
Pediatric:
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Operating Conditions:
10 – 40 C / 20 – 90% RH
Storage/Transport Conditions:
-20 to 60 C / 10 – 95% RH
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9.9.6 BISx EEG Specifications:
Epoch Duration:
2 seconds
Artefact Rejection:
Automatic
Input Amplifier Range
+/- 1 mV
EEG Scales: One channel display:
EEG Sweep Speed:
25 μV/div (+/- 50 μV full scale)
25 mm/sec
Computed Parameters:
Bispectral Index, Suppression Ratio, EMG, Signal Quality
Indicator, and Burst Count
User-defined Displays:
Trend and real-time EEG waveforms
Update Rate:
1 second for BIS number, 10 seconds for Trend
Filters:
ON (2 – 70 Hz with notch) or OFF (.25 – 100 Hz)
Mode:
Sensor automatically selects mode.
9.9.7 CNAP Module Specifications
Dimensions (H x W x L)
Overall
65 x 140 x 230 mm
Mounting points – VESA pitch
75 x 75 mm (2 faces)
Weight
800g
LEMO to miniDIN power cable
35 cm
USB Cable, A to B
30 cm
CNAP Main Board
Described below
NBP Board
Described below
Power (USB)
5VDC, 500mA max
Operating Conditions
10-40 °C 30-75% RH
Storage Conditions
0-40 °C 20-90% RH
Not protected against water ingress
type BF applied part. F-type isolated (floating) patient part providing a high degree of protection against shock
and is suitable for use during defibrillation.
The CNAP Module is not Category AP or Category APG and should not be used in the vicinity of a flammable
anaesthetic mixture with air or oxygen or nitrous oxide.
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CNAP - continuous non-invasive arterial pressure Main Board
99
Parameter classification
Sys, Dia, Mean [mmHg]
Heart Rate [bpm]
Measuring range
Sys: 40 - 250 mmHg (5.3 – 33.3 kPa)
Dia: 30 - 210 mmHg (4 - 28 kPa)
Mean:
35 - 230 mmHg (4 – 30.6 kPa)
Heart rate indication range
20-200 bpm
Accuracy
±5 mmHg (0.6 kPa)
Display resolution
1 mmHg (0.1 kPa)
Inflation pressure
Typ.: 120 mmHg (16 kPa)
Min.:
30 mmHg (4 kPa)
Max.:
300 ±10 mmHg (41.3 kPa ±1.3 kPa)
Excess pressure limit:
300 ±10 mmHg (40 kPa ±1.3 kPa)
Response time:
< 3 sec.
Deflation time:
< 15 sec.
Protection against electric shock
Type BF
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NBP – non-invasive blood pressure Board
Parameter classification
Sys, Dia [mmHg]
Measuring method
Oscillometric: diastolic value for phase 5 Korotkoff
Measuring range
Sys:
Dia:
ADULT 40 - 260 mmHg
PEDIATRIC 40 - 160 mmHg
ADULT 20 - 200 mmHg
PEDIATRIC 20 - 120 mmHg
Heart rate indication range
40-200 bpm
Inflation pressure at start
ADULT: 160 mmHg
PEDIATRIC: 120 mmHg
Clinical accuracy
Meets ANSI/AAMI SP10:1992 and 2002
Accuracy of pressure recording
± 3mmHg between 0 - 300 mmHg at operating
temperatures of 0 – 50°C
Calibration interval for pressure recording 12 months
Atmospheric pressure
No influence on accuracy of measurement
Measuring time
max. 130 s (ADULT)
Max. inflation time
50 s
Max. cuff pressure
300 mmHg
Automatic deflation after
180 s
Protection against electric shock
Type BF
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9.10 Electrical Safety and EMC
IEC 60601-1 Guidance and Manufacturer’s Declaration
The LiDCOrapid Hemodynamic Monitor System needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided below. Portable and mobile RF communications equipment can
affect the LiDCOrapid Hemodynamic Monitor System.
To assure compliance the LiDCOrapid Hemodynamic Monitor System should only be used with the following cables,
supplied by LiDCO:
Part Number
Description
Maximum length
CM32-001, CM-044
AC Power Cord
<3.0m
Li10705
LiDCO CNAP, DC Power
<1.0m
Li10xxx
PulseCO (LiDCOrapid) to Patient Blood Pressure Monitor
<3.0m
Li106xx
BPM Interface Cable
<4.0m
BIS 175-0075
BIS Monitor Interface Cable, USB
<4.0m
Li10739
USB Cable(s) (BP Module, CNAP Module)
<1.0m
Use of accessories and cables with the LiDCOrapid Hemodynamic Monitor System, other than those supplied by LiDCO,
may result in increased emissions or reduced immunity of the LiDCOrapid Hemodynamic Monitor System.
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Guidelines and manufacturer’s declaration – electromagnetic emissions
The LiDCOrapid is intended for use in an electromagnetic environment as specified below. The customer or operator of
the LiDCOrapid is to ensure it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidelines
RF emissions CISPR 11
Group 1
The LiDCOrapid uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Complies
Version 2
The LiDCOrapid system is suitable for use in all
establishments, other than domestic and those
directly connected to the public low voltage power
supply network that supplies buildings used for
domestic purposes.
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Guidelines and manufacturer’s declaration – electromagnetic immunity
The LiDCOrapid is intended for use in an electromagnetic environment as specified below. The customer or operator of
the LiDCOrapid is to ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Level of compliance
Electromagnetic
environment - guidelines
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wooden,
concrete or ceramic tile. If
floors are covered with
synthetic material, relative
humidity should be at
least 30%.
Electrical fast transient/
burst IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 2 kV for power
supply lines
Mains power supply quality
should be that of a typical
commercial or hospital
environment.
Surge IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
Mains power supply quality
should be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
< 5% UT
(> 95% dip in UT)
for 0.5 cycle 40% UT
(60% dip in UT
for 5 cycles 70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in UT)
for 5 sec
< 5% UT
(> 95% dip in UT)
for 0.5 cycle 40% UT
(60% dip in UT)
for 5 cycles 70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in UT)
for 5 sec
Mains power quality should
be that of a typical
commercial or hospital
environment. If the operator
of the LiDCOrapid requires
continued operation during
power mains interruptions,
it is recommended that the
LiDCOrapid be powered
from an uninterruptible
power supply or a battery.
Power frequency
(50 Hz/60 Hz) magnetic
field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
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Guidelines and manufacturer's declaration – electromagnetic immunity
The LiDCOrapid is intended for use in an electromagnetic environment as specified below. The customer or operator of
the LiDCOrapid is to ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Level of compliance
Electromagnetic
environment - guidelines
Portable and mobile RF
communication equipment should
be used no closer to any part of the
LiDCOrapid, including cables, than
the recommended separation
distance calculated from the
equation applicable to the frequency
of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 ➔ V1 in V
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 ➔ E1 in V/m
for 80 MHz to 800 MHz
for 800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance level in
each frequency range b.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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Guidelines and manufacturer's declaration – electromagnetic immunity
The LiDCOrapid is intended for use in an electromagnetic environment as specified below. The customer or operator of
the LiDCOrapid is to ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the
LiDCOrapid is used exceeds the applicable RF compliance level above, the LiDCOrapid
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the LiDCOrapid.
b
Above the frequency range 150 kHz to 80 MHz, field strengths should be less
than 1 V/m.
105
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Recommended separation distance between portable and mobile RF-communication
devices and the LiDCOrapid
The LiDCOrapid is intended for use in an electromagnetic environment with controlled RF disturbances. The customer or
operator of the LiDCOrapid can avoid electromagnetic disturbances by complying with the minimum distance between
portable or mobile RF-communication equipment (transmitter) and LiDCOrapid, depending on the power output of the
communication equipment as specified below.
Rated power output
of the transmitter W
Separation distance depending on the transmitting frequency m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters whose maximum rated power output values are not listed in the above list, the minimum distance can
be calculated depending on the transmitting frequency and rated power output by means of the respective formula,
whereas the maximum rated power output is P in watts (W) according to the specification of the manufacturer.
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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9.11 Standards
IEC 60601-1 Ed. 3.0 : 2005 Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance
– IEC 60601-1-30: 2000 (Non-invasive BP monitoring equipment)
– IEC 60601-2-26: 2012 (ElectroEncephaloGraphs)
9.12 Monitor Connectors Layout
POC-125/127
Bottom view of monitor
DTP-1201
Bottom view of monitor
1
2
Rear view of monitor
2 1
6
3
2 1
6
4
5
4 7
6
3
6
7
4 7
6
5
1. DC power
cable
input
4
5
2. On/off switch
3. BP signal input to ADC card
4. RS-232
5. VGA
6. USB ports
7. Ethernet
3
1. AC power cord input
2. On/off switch
3. DC output
4. RS-232
5. VGA
6. USB ports
7. Ethernet
4
Figure 107: a, b, c Connector Layout
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9.13 Mounting Details
9.13.1 LiDCOrapid
• Pole mount clamp
Use 4 off 10-32 x 5/16” FHMS
POC-125/127
DTP-1201
Use 4 off M4x12mm Pan Head Machine Screws
Use 4 off M4x10mm Pan Head Machine Screws
Figure 108: a, b, c Rapid + Pole/Rail Clamp or VES Plate
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9.13.2 LiDCOrapid and BP Module
POC-125/127
DTP-1201
• Pole/Rail Clamp
Use 4 off M4x20mm Pan Head Machine Screws
Use 4 off M4x12mm Pan Head Machine Screws
VESA Mounting
Use 4 off M4x20mm Pan Head Machine Screws
Use 4 off M4x16mm Pan Head Machine Screws
Figure 109: Rapid + BPM + Pole/Rail Clamp
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9.13.3 LiDCOrapid and the CNAP Module Mounting Options
POC-125/127
DTP-1201
Mounting Bracket to CNAP Module
to Finger Cuff Bracket
Mounting Bracket to CNAP Module
to Finger Cuff Bracket
6-off M4x10mm, countersunk
6 off M4x10mm countersunk
2-off M4x10mm, countersunk
2 off M4x10mm PHMS
Figure: 110: a, b CNAP Module bracket with and without BPM
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2 off M4x12mm PHMS
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POC-125/127
DTP-1201
• Pole/Rail Clamp
Use 4 off M4x25mm Pan Head Machine Screws
Use 4 off M4x16mm Pan Head Machine Screws
• VESA Mounting
Use 4 off M4x25mm Pan Head Machine Screws
Use 4 off M4x16mm Pan Head Machine Screws
Figure 109: Rapid + BPM + Pole/Rail Clamp
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Cable Connection Diagram
Warning: Connect only LiDCO supplied cables between the CNAP, PSU and Monitors
2
POC-125/127
1
3
1. Li10705, Cable Assembly, LiDCO CNAP, DC Power
2. Li10571, Cable Assembly, USB, A-B, 200mm
3. DC input to CNAP from POC-125 PSU PCM80PS24, PSU for POC-125
DTP-1201
1
2
3
4
1. Li10705, Cable Assembly, LiDCO CNAP, DC Power
2. Li10571, Cable Assembly, USB, A-B, 200mm
3. Li10739, Cable Assembly, USB, A-B, 300mm
4. AC power input to DTP-1201
Figure 112: Cable Connection
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10.0 References
1. Kemps H, Thijssen E, Schep G, Sleutjes B,De Vries
W, Hoogeveen A, Wijn P, Doevendans P. (2008)
Evaluation of two methods for continuous cardiac
output assessment during exercise in chronic heart
failure patients. Journal of Applied Physiology 105:
1822-1829
2. Mills E, Jonas M, Wolff C, O’Brien T (2010) PulseCO
consistency: variation in calibration factor over 24 and
48 hours. Poster presentation ISICEM, Brussels.
Critical Care 14(1), p101
3. Jonas M, Mills E, Wolff C, O’Brien T (2010) Effect of
cardiac arrhythmias on PulseCO calibration and
performance. Poster presentation ISICEM, Brussels.
Critical Care 14(1), p102
4. Green D, Paklet L (2010) Latest developments in perioperative monitoring of the high-risk major surgery
patient. International Journal of Surgery 8 90-99
5. Abdel-Galil K, Craske D, McCaul J (2010)
Optimisation of intraoperative haemodynamics: early
experience of its use in major head and neck surgery.
Brit Journal of Oral and Maxillofacial Surgery 48 (3)
189-191
6. Purushothaman B, O’Brien T, Green D (2010) The
Hemodynamic Effects of Anaesthetic Induction and
Their Correlation with Changes in Depth of
Anaesthesia. Proceedings of the 2010 Annual
Meeting of the ASA
7. Koff M, Richard K, Novak M, Canneson M, Dodds T
(2010) Elevated PPV Predict an increased Length of
Stay and Morbidity during High Risk Abdominal
Surgery. Proceedings of the 2010 Annual Meeting of
the ASA
8. Hadian M, Severyn D, Pinsky M (2010) The effects of
vasoactive drugs on pulse pressure and stroke
volume variation in postoperative ventilated patients.
Critical Care In press
9. Linton N, Linton R (2003) Haemodynamic response to
a small intravenous bolus injection of epinephrine in
cardiac surgical patients. European Journal of
Anaesthesiology 20: 298-304
10. Dyer RA, Piercy JL, Reed AR, Lombard CJ,
Schoeman LK, James MF (2008) Hemodynamic
changes associated with spinal anesthesia for
cesarean delivery in preeclampsia. Anesthesiology
Vol. 108, No. 5, 802 – 811
113
11. Jonas M, Fennell J, Brudney CS. (2008).
Haemodynamic optimsation of the surgical patient
revisited. Anaesthesia International, Spring 2008
Vol 2 No1
12. Archer T, Knape K, Liles D, Wheeler A, Carter B.
(2008). The hemodynamics of oxytocin and other
vasoactive agents during neuraxial anesthesia for
cesarean delivery: findings in six cases. Int. J.
Obstetric Anesthesia Vol. 17:3, 247-254.
13. Kim H, Hadian M, Severyn D, Pinsky M (2009). Crosscomparison of the trending accuracy of continuous
cardiac output measurement devices in postoperation
patients. Poster presentation ISICEM, Brussels.
Critical Care, 13(Suppl 1):P209doi:10.1186/cc7373
14. Dyer R, Reed A, van Dyk D, Arcache M, Hodges O,
Lombard C, Greenwood J, James M (2009)
Hemodynamic Effects of Ephedrine, Phenylephrine,
and the Coadministration of Phenylephrine with
Oxytocin during Spinal Anesthesia for Elective
Cesarean Delivery. Anesthesiology 111:753-65
15. Cecconi M, Monti G, Dawson D, Vamadan S,
Hamilton M, Della Rocca G, Grounds RM, Rhodes A
(2009) Dynamic Indices by PulseCO in post surgical
intensive care patients. Proceedings of the 2009
Annual Meeting of the ESICM
16. P Brass, E Mills. J Latza, J Peters, E Berendes.
LiDCOrapid and PICCOplus preload response
parameter validation study. 2011 doi:10.1186/cc9481
17. P Brass, E Mills. J Latza, J Peters, E Berendes.
Comparison of cardiac index: LiDCOrapid and
PICCOplus in the ICU. 2011 doi:10.1186/cc9482
18. P2.64 P D Santis, C Marano, F Cavallor, A Della’Anna,
P DE Santis, C Bonarrigo, C Falcone, C Sandroni.
Prediction of fluid responsiveness with the LiDCO
System. Journal List, 2011 doi:10.1186/cc9484
19. C Willars, A Dada, D Green, Functional
haemodynamic monitoring the relative merits of SVV,
SPV and PPV as measured by the LiDCOrapid in
predicting fluid responsiveness in high-risk surgical
patients. Poster presentation, 2011
doi:10.1186/cc9486
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Level of Conciousness BISTM Publications
B1: Gan T, Glass P, Windsor A, Payne F, Rosow C, Sebel
P, Manberg P. Bispectral index monitoring allows
faster emergence and improved recovery from
propofol, alfentanil, and nitrous oxide anesthesia. BIS
Utility Study Group. (1997) Anesthesiology, 87(4):808815.
B2. Myles P, Leslie K, McNeil J, Forbes A, Chan M.
Bispectral index monitoring to prevent awareness
during anaesthesia: the B-Aware randomised
controlled trial. (2004) Lancet. 363(9423):1757-1763.
B3. Ekman A, Lindholm M-L, Lennmarken C, Sandin R.
Reduction in the incidence of awareness using BIS
monitoring. (2004) Acta Anaesthesiol Scand.
48(1):20-26.
B4. Song D, Joshi G, White P. Titration of volatile
anesthestics using bispectral index facilities recovery
after ambulatory anesthesia. (1997) Anesthesiology,
87(4):842-848.
B5. Luginbühl M, Wüthrich S, Petersen-Felix S, Zbinden
AM, Schnider TW. Different benefit of bispectal index
(BIS) in desflurane and propofol anesthesia. Acta
Anaesthesiol Scand. 2003;47(2):165-173.
B6. Depth of anaesthesia monitors – Bispectral Index
(BIS), E-Entropy and Narcotrend-Compact M. Issued:
November 2012. NICE diagnostics guidance #6
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User’s Manual, LiDCOrapid, V2.05, English Li10788/6
www.redgraphic.co.uk 3616
User’s Manual
Registered Office, Sales, R&D and Production
LiDCO Limited 16 Orsman Road, London, N1 5QJ, UK
Telephone: +44 (0) 20 7749 1500 Fax: +44 (0) 20 7749 1501
Marketing LiDCO Limited
Unit M, South Cambridge Business Park, Babraham Road, Sawston, Cambridge, CB22 3JH, UK
For your local Distributor see www.lidco.com
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