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QynetiQ Enterprise - User Manual 1.5 (EN) PDF
QynetiQ Enterprise - User Manual 1.5 (EN) PDF
User Manual
Version 1.5 (EN)
Copyright notice
Copyright © 2012 Fysicon B.V. and/or one of its subsidiaries.
All Rights Reserved.
Use of this documentation and related software is governed by a license agreement. This
documentation and related software contain confidential, proprietary and trade secret information
of Fysicon and are protected under Dutch and international copyright and other intellectual property
laws. Use, disclosure, reproduction, modification, distribution, or storage in a retrieval system in any
form or by any means is prohibited without the prior express written permission of Fysicon. This
documentation and related software are subject to change without notice.
Publication date
December 2012
Corporate addresses
Fysicon BV
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands
Tel: +31 412 653333
Fax: +31 412 653330
email: info@fysicon.com
0044
Fysicon BV
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands
2. QynetiQ™Enterprise ............................................................................................................... 12
2.1 Display of “Live” signals ............................................................................................................... 13
6.15 ST analysis.................................................................................................................................. 88
9. Alarms...................................................................................................................................104
9.1 ALARM PRIORITY TABLE part 1 .................................................................................................. 105
housing of the monitors and sockets available for the user to connect probes, cables and to
control the monitors,
way of controlling basic parts of monitors,
information about safe monitors usage,
installation and preparation monitors to work,
essential actions of monitors’ operation,
general rules of monitors’ maintenance.
patient’s physiological parameters, important for the patient’s life and a treatment process,
characteristic parameters of the patient’s treatment process, important for the process
controlling.
The monitors of the QynetiQ™ product line include stationary and remote monitors, used as bedside
monitors.
The QynetiQ™Advanced and the QynetiQ™Care monitor are intended to be used inside buildings in
care units at the patient bedside, a diagnostic stand or in a catheterization room. The QynetiQ™
Enterprise is intended to be used in a cardiac catheterization room, as it incorporates also extensive
reporting tools. The QynetiQ™ Enterprise system can be integrated with FlexPAXS®, this
configuration is called; The QynetiQ™ Cardio Vascular Information System.
The QynetiQ™ Monitors are modular. A type and number of monitored parameters may be
configured according to user’s requirements. A list of available monitoring modules includes:
electrocardiogram – from limb and pre-cordial leads with possibility of ECG analysis,
respiration – using reographic method,
blood pressure – using invasive method,
arterial blood pressure – using non-invasive method,
oximetry – using photometric method,
carbon dioxide concentration –inspired and expired air using mainstream and side stream
method,
temperature – monitored in chosen points of patient’s body with a possibility of measuring a
difference between temperatures,
cardiac output – using the thermo dilution method.
The QynetiQ™ product line is a state-of-the-art solution for your monitoring requirements.
This product line consists of stationary monitors, which may work with various parameters
configurations, what allows patient monitoring during complex procedures and at the hospital ward.
QynetiQ™ Care
QynetiQ™ Advanced
QynetiQ™ Advanced+
QynetiQ™ Enterprise
Thanks to the newest construction and the technology, the QynetiQ™ product line has a compact
and light structure, which allows an easy installation at a hospital bedside, a diagnostic stand, an
operating table or in a cardiac catheter lab. The housing of all monitors is made of materials, which
ensure safety during their usage and easy to maintain and to clean.
The QynetiQ™ Enterprise system can be integrated with FlexPAXS®, this configuration is called; The
QynetiQ™ Cardio Vascular Information System.
Fig. 2.01
The Display’s – High resolution LCD TFT screens, which are able to present waveforms,
digital values of all measured parameters, reports, etc.
The Front-end – This Front-end has a universal cavity with a special shape, which facilitates
placing up to 7 parametermodules in the right position. The modules can be easily removed
from the monitor by the user and placed in one of the other modular monitors of the
QynetiQ™ product line. The modules are automatically identified by the monitor’s software
and the monitor automatically configures itself for work with a newly inserted module.
A Power Unit – The Power Unit is situated in the machine room of a catheter lab, and is the
power source of the Front-end and the monitor(s). It incorporates an Isolated Power supply.
CAUTION!
To remove any of the modules; Press the button, located at the bottom of every module (Fig. 2.02),
and gently pull the module towards yourself in order to remove the module from the
QynetiQ™Front-end’s cavity.Gently insert the module into the QynetiQ™Front-end’s cavity and
press the module, so it is connected to a socket placed on the back wall of the cavity, in order to
start the module to work.
Communication and
power connector
Parameter socket
Fig. 2.02
It is possible to display up to 18 waveforms together with digital values. Two examples are shown on
the next page; 12 Lead ECG together with the numerical values of IBP, SpO2 and NiBP (figure 2.03),
and a standard setup in a cardiac catheterization lab; 3 Lead ECG with 2 IBP Channels, SpO2 and
Respiration and of course the numerical with digital values of other parameters (sample figure 2.04).
The QynetiQ™Enterprise system is standard equipped with 19” color LCD TFTscreens, which is
prepared for safe usage by a special insulation of the power supply.
CAUTION:
Only a special bracket delivered by the manufacturer may be used for the installation of the Front-
end on tableside.
The displays of the QynetiQ™Enterprise system must be powered only from the Power Unit. It is
not allowed to supply the power to the display of the stationary monitors from a different source.
CAUTION:
It is up to the end-used which parameters modules will be installed. This must be defined before
the monitor is ordered. Additional modules can be re-ordered at any time.
The QynetiQ™Enterprise system has easy to remove, independent parameter modules in the shape
of rectangular cubes. Every module is placed in a separate plastic housing, which may be moved to
another QynetiQ™ monitor. An input socket for connecting the sensors and cables is placed on the
front panel of every measuring module.
Fig. 2.05
WARNING!
The modules may be freely installed depending on the user’s requirements. Except of the ECG
module which needs to be installed in the first slot.
The system accepts up to 2 IBP modules, with a maximum of 4 IBP channels.
Fig. 2.06
The following connections are situated on the back panel of the QynetiQ™Power Unit (Fig. 2.07):
2
3
1 5
Fig.207
Fig. 208
WARNING!
A short main power failure may turn the monitor off and when the main power is present again,
the QynetiQ™Enterprise application will starts up again and after a few second the vital signs will
be monitored again (screen setup is a default configuration).It is highly recommended to use an
UPS (uninterruptible Power Supply), in case of often, short power failures.
The PC-unit which takes care of reporting calculations and the storage of samples will be up and
running within a couple of minutes.
Fig. 2.09
Fig. 2.10
The central area (Fig. 2.11) is intended to presentation of waveforms and digital values of
monitored parameters. Including:
dynamic waveforms presented in a form of graphical curves displayed from the left to the
right side of the screen,
measuring modules windows present digital values of specific parameters of the monitored
patient’s biological parameters,
Fig. 2.11
Lower toolbar,
- waveform sweep speed;
- comment bar
WARNING!
Visual information is presented also outside the monitor’s display in a form of LED indicators,
which shows states of monitor’s work.
“~” green light indicator – informs about connecting the monitor to the mains.
“I” green light indicator– informs about switching the monitor on (the screen should start
displaying the first screen after about 20 seconds after the lamp starts to shine).
The Vital signs monitoring will start almost immediately and the PC Unit is ready when it prompt to
fill in the Username and Password (fig. 3.1).
Fig. 3.1
After three attempts, the account will be blocked and you need to contact the system administrator.
A precise technical control and the exchange of parts that concern the safety of monitor and/or it
usage must be made, if the monitors are used longer than 10 years.
This chapter includes general information crucial for the safety usage of QynetiQ™Enterprise
monitors.
Additionally, notices, special symbols placed at the housing of the monitor and warnings important
for safe usage and operation of the monitor are described in this chapter.
CAUTION:
Disposable parts must not be used twice and should be disposed according to the local regulations.
Only accessories manufactured or recommended by Fysicon must be used in order to ensure
patient’s safety.
The monitor is a device, which may be used only for monitoring of one patient at the time.
WARNING!
The user responsible for monitor’s maintenance should perform a procedure, which checks
the correctness of the monitor’s functionality by checking the messages and statuses displayed on
the screen, once per week. The monitor’s equipment, extension cables, leadwires and probes
should be also inspected.
It is necessary to perform a temporary manufacturer’s check-up of all important monitor’s
functions at least once per year or more frequently, whenever functionality of the monitor is
questionable.
WARNING!
The user must inform manufacturer or manufacturer’s representative in case of any medical
incident:
Manufacturer: Fysicon
Hoogheuvelstraat 114,
5349 BA Oss, the Netherlands
phone: +31 412 65 33 33
fax: +31 412 65 33 30
e-mail: support@fysicon.com
Familiarize with the safety recommendations concerning the power supply and safety of
usage of other devices, in case of connecting them to the QynetiQEnterprise monitor, to
ensure safety of the monitors’ functionality.
Place the cables in a distance from the patient’s neck to prevent patient’s strangulation.
Make sure that the conductor parts of the electrodes and other conductors do not touch
other conductors including grounding connection.
The monitor must be immediately disconnected from the patient and the mains in case of
pouring a liquid on the monitor. The person responsible for monitor’s maintenance must
check if the monitor did not become damaged before it is turned on again.
The user must pay special attention to using monitor in the presence of flammable
anesthetic gases.
Special attention for safety of a patient should be paid during defibrillation. The monitor is
technically protected against the defibrillator impulse. A defibrillator is a serious danger for
QynetiQ™ Enterprise – User Manual (Version 1.5) 21
the patient as well as the user because of the high voltage (up to 5 kV) needed for the
defibrillation. The defibrillator paddles should not be placed on top of ECG electrodes and/or
leadwires.
The monitor is protected against defibrillator shocks and high frequency disturbances.
Only cables recommended by Fysicon must be used in order to ensure safety during the
defibrillation.
Do not touch the monitor during the defibrillation, because it may cause a serious injury.
The monitor is protected against pacemakers and ICD’s.
The monitor’s housing must not be opened. The monitor must not be repaired by the user in
case of its improper work, because the user may be exposed to an electrical shock.
It is not necessary to shut down the monitor during a position change of a parameter module
of the QynetiQEnterprise system or moving a module to or from another QynetiQ Care,
Advanced or Enterprise monitor. The monitor is protected against unstable states caused by
inserting and removing the modules from the monitor.
In case of falling down or applying a mechanical shock to the monitor, it is necessary to
perform safety and functionality tests. The tests should be done by a manufacturer’s service
representative
The improper room ventilation, where the monitor works, may cause the monitor’s failure
and make the monitoring difficult. Do not place any objects at the monitor, which would
cause worsening of the heat exchange.
CAUTION:
The manufacturer is not responsible for any damage of the monitor caused by improper room
ventilation, improper or a damaged power supply and or a faulty installation performed by any
other than the manufacturer or its local representative.
The monitor must be used by qualified and trained medical personnel only,
WARNING!
The institution is responsible for the technical condition/installation of the 230 VAC mains circuit.
It is necessary to submit a statement, which concerns compliance of the mains circuit with Class I of
safety regulations, before the installation of the monitor.
The power circuit, which the monitor is connected to, should be checked at least once a year and a
proper written document as prove should be included into the building documentation.
~ If the green lamp shines over this informs that the QynetiQ™Power
Unit monitor is connected to Mains (230VAC)
The system must be installed and fixed securely by using the provide brackets in a secure and
reliable way. The provided wall-bracket protects the system from accidentally falling down.
Connection to a 3-wired 230 VAC power network should be made under supervision of the
qualified personnel.
CAUTION!
Plug the power supply cord of the Power Unit into the 230 VAC wall socket (with protection of a
grounding connection) and switch the power on using the switch placed at the back of the
QynetiQ™Front-end, the PC-Unit and on the Power Unit (Fig. 2.07 en Fig. 2.08).
Turn on the monitor with an on/off switch (Fig.2.08). The Live- screen should start displaying
after around a couple of second after switching the monitor on.
Plug the cables and probes into the monitor’s sockets.
Check the functional correctness of every measuring circuit and read the messages displayed on
the monitor screen.
As far as the QynetiQ™Enterprise monitor is concerned, all necessary parameter modules should be
installed in the front panel cavity before the start of monitoring a patient.
Only good quality ECG electrodes should be used for ECG monitoring
Usage time of the disposable ECG electrodes is limited and should not exceed 24 hours.
Electrode gel should be wet, not dry, what means that the electrode is still proper to use
Metal electrode contacts should be made of a good material. They should “shine”, because it
means that they are good quality electrodes. It guarantees low impedance between an electrode
and a cable clip for the ECG signal.
Electrodes must be adhered on a clean patient’s skin (skin must not be cleaned with a high
percentage alcohol, because it may cause drying out of the skin and makes the contact between
the ECG electrode worse).
If the amplitude of the ECG signal is very low (less than 0.5 mV), it is recommended to rub the
skin with a special dedicated for this action, rough material, or lotion or changing the placement
of an electrode.
Electrodes must not be applied to a hairy chest of a patient. Hair should be removed before
placing the electrodes on the patient skin.
ECG signal amplitude must be higher than 5 mm for the sensitivity 10 mm/mV.
If the patient’s respiration is monitored, red and yellow electrodes should be adhered as far from
each otheras possible (even under patient’s armpits, if the respiration amplitude is low). The user
may also change pairsof electrodes (used for respiration measurement).
NIBP cuff must be placed tightly on a patient arm (so only two fingers may be shoved in with
difficulty between the cuff and the arm). Check also the marks on the cuff, to determine the
correct cuff-size.
NIBP measurement may be not comfortable for a patient because of a compressing the arm.
That is why frequency of the measurements should be selected individually for a patient and
according to necessary medical requirements.
NIBP cuff’s hose, which connects the monitor with a cuff, may not be bend across all its length.
Pay attention to it especially, when a patient’s arm is bend.
The NIBP cuff should not be placed at the patient’s are where some constant injections are done.
If the NIBP cuff is placed on the same patient arm as the SpO2 probe, then a temporarily weak
pulse waveform and lower oxygen saturation may be observed at the monitor’s screen.
NIBP measurement must not be started, if the cuff is not placed on a patient arm because the
cuff may become damaged. This situation may occur, if the automatic measuring mode is active.
When the automatic mode is not longer required, it should be disabled. The cuff should be taken
off, rollup, and tighten with the Velcro.
WARNING!
All used disposable or reusable accessories must be original and recommended by the Fysicon,
because usage of not original parts may cause incorrect measurements and damage of the
measuring module.
In the following chapters we will refer to a control screen and a live screen:
Control screen: The screen on which you will control the system, fill in your report, create
samples etc.
Live screen: The screen on which you will see your waveforms live (as ECG, IBP, SpO2
etc). This is the same screen as you will find in the monitoring boom in the
cathlab.
Log in
1. Double click the QynetiQ™ icon on your desktop
2. Log in with your username and password
Fig. 5.1
3. In this phase (fig. 5.1) it is impossible to create a new patient: the “new patient” button is not
available
4. Fill in: bb. Press enter or click the search button. No results will show
5. The “new patient” button is now available. Click the “new patient” button
6. Fill in the new patientdemographics
Fig. 5.2
7. Press the “angio” button in the button bar or choose it from the “Procedures All” list (by
clicking on the Procedures All button)(Fig 5.2)
8. Choose “new procedure”. Click yes when asked: Are you sure to save your changes?
Log in
1. Double click the QynetiQ™ icon on your desktop
2. Log in with your username and password
Fig. 5.3
3. Fill in (a part of) the last name of the patient you created before (fig. 5.3). Press enter or click
“search”
4. Double click to open the patient
Log in
1. Double click the QynetiQ™ icon on your desktop
2. Log in with your username and password
Fig 5.4
3. Fill in (a part of) the last name of the patient you created before (fig. 5.4). Press enter or click
“search”
4. Double click to open the patient
Fig. 5.5
5. Click the procedure you want to open in the hospitalizations & procedures list (fig 5.5).
6. QynetiQ™ will start displaying messages:
Procedure is starting…
Procedure in progress…
7. Open the QynetiQ™ tab which you will find under the button “Next” (right top corner of your
screen, below the yellow close button). From here you can view the samples and the full
disclosure of this procedure. See chapter 7. Sample review and 8. Full disclosure.
8. Close the application by clicking the yellow “close” button in the top right corner of your
screen.
Fig5.6
Fig 6.1
Unfolding boxes
In the procedure control page you will see several boxes (Fig 6.1). By default only a few boxes are
opened/unfolded. In this case the ECG box, the IBP box and the condition boxes are unfolded by
default.
To unfold each box; press the arrows on the right top corner of the box. The box will then unfold. (fig
6.2)
Fig. 6.2
WARNING!
It is recommended, that the signal on the monitor’s screen should have no less than 5 mm of
height (for the sensitivity 10 mm/mV) with the clearly visible QRS complex. If the amplitude of the
patient’s ECG signal is low, the placing of the ECG electrodes should be changed into order to
assure the higher amplitude.
The ECG cable must not hang out of the bed because the cable may become damaged.
If one set of disposable electrodes are used over 24 hours, the ECG signal can be incorrect.
The ECG cable should not beplaced next to the patient’s head because it may cause patient’s
strangulation.
If the user encounters problems with ECG monitoring (e.g. problems with Heart Rate calculation),
it is recommended to change the ECG averaging mode to “Short”.
Fig. 6.5
Fig. 6.7
Fig. 6.6
Averaging:
Choosing “Long”, “Medium” or “Short” averaging mode for HR calculation. Default setting: Medium.
Fig. 6.8
Fig. 6.9
WARNING!
If the user encounters problems with ECG monitoring (e.g. problems with Heart Rate calculation),
it is recommended to change the ECG averaging mode to “Short”.
ECG cable unplugged Displayed, when the ECG cable is not connected to the monitor.
Bad contact of Displayed, when the electrode is disconnected from a patient or a cable
or the high level of interferences is present.
No ECG module Displayed, when the module is not connected to the monitor.
No communication to Displayed, if the monitor cannot communicate with the module after it
was initialized.
WARNING!
The cable should be inspected, if it is clean and has no mechanical defects, before using it.
Below mentioned you will find the available cables and lead wires. The items marked with an asterisk
* are supplied with the ECG module.
In the next step the algorithm of the arrhythmia analysis makes the qualification to one of the
following types of arrhythmia:
Asystole lack of QRS complex for time longer than 3.5 seconds
Pause lack of QRS complex for time longer than 2.5 seconds
Bradycardia decreasing of the HR value to less than 40 bpm (this limit can be changed in the
arrhythmia analysis Menu)
WARNING!
The arrhythmia analysis is turned off after switching the monitor off. It can be turned on again after
switching the monitor on in the arrhythmia analysis Menu.
After enabling the arrhythmia analysis, a screen which is divided into more than ten horizontal
channels is displayed. Every channel is reserved for one type of arrhythmia. When arrhythmia is
detected by the algorithm, a small vertical line is displayed. Every type of arrhythmia has reserved its
own type of color.
WARNING!
Correct analysis’ results depend on proper supervision of correct and not disturbed ECG signal
monitoring. Controlling of electrodes’ contacts is very important. It is recommended to use only
disposable electrodes as for Holter monitoring. If electrodes are inaccurately or improperly adhered,
increasing of interferences is signaled. A level of interferences (called “Signal noise”) is available at
the second channel from the bottom, above the “Irregular HR” channel. If the interferences value
exceeds 20 %, it means that analysis results could not be appropriate, because interference disturbs
the ECG signal very much.In this situation, checking of electrodes’ adhering and placing of the ECG
cable endings is recommended. Fixing of the ECG cables endings could be made using an adhesive
tape about 5 cm away from the electrodes.
Alarms are presented in red colors at the upper toolbar and are labeled as follows: Alert “Asy” for
Asystole, “Pau” for Pauze, VF/VT or “Brd” for Bradycardia. In order to acknowledge one of the above
alerts, the user should press the blinking red field and the acoustic and visual signalization should be
stopped.
WARNING!
Icon informs about disabling the arrhythmia alerts and it is displayed in the left upper corner
of the screen.
QynetiQ™ Enterprise – User Manual (Version 1.5) 39
6.2.3 Maintenance and cleaning
The information about maintenance and cleaning of accessories used for the arrhythmia analysis is
described in 6.1.5 concerning the ECG module.
Changes of pressure in the measuring place are transformed by an electronic system and then
displayed on the monitor’s screen as a dynamic pressure waveform in a scale chosen by the user.
Digital values, which describe three kinds of pressure: systolic, diastolic and average, are displayed in
the IBP window.
The measuring system enables monitoring of the high pressure e.g. arterial and the low pressure e.g.
a blocked pulmonary artery. Thebandwidth of the measuring system enables also precise monitoring
of shape changes of a pressure waveform. Thanks to very precise measuring sensors, it is possible to
obtain very accurate pressure values and true shapes of monitored waveforms.
CAUTION:
The IBP cable connector is mechanically coded what prevents connecting the cable into other than
IBP socket. Pay attention not to connect or disconnect the cable using too much force because the
cable may become damaged.
3. Fix the IBP transducer to a tripod or stand at height, which corresponds to the place of the
IBP measurement at patient (e.g. right atrium).
4. Set the range of the displayed IBP waveform to maximum at the Menu IBP.
5. Connect the IBP transducer to one end of the sample line and saline to the second.
40 QynetiQ™ Enterprise – User Manual (Version 1.5)
6. Fix the saline container at the tripod or stand so a pressure, which allow filling in the
measuring circuit, will be present.
7. Connection of the IBP sensor to the patient should be performed in three steps.
Step 1 – filling the IBP sensor with the saline (Fig. C1.35).
Step 2 – filling the IBP sample line with the saline (Fig. C1.36).
Step 3 – preparation of the IBP sensor to the measurement (See 6.3.2.3).
8. Set the alert limits for the measured parameters.
9. Set the name of the IBP channel, which corresponds to the place of measurement.
10. Set the type of the averaging of the IBP values.
11. Optionally allow displaying the mean IBP value IMP at the field of the IBP digital values.
12. Optionally allow displaying pulse rate IPR derived from the IBP waveform.
WARNING!
The measuring system should be cleaned with a blood anti-coagulation agent, if the invasive blood
pressure is monitored for a long time. A frequency of periodic cleaning may be chosen by a doctor,
according to his practice. It should be done at least once for 2 hours of the IBP monitoring.
Special attention should be paid to the tightness of the measuring circuit because leakage will affect
the accuracy of the measurement.
Every two or three hours the tightness of the measuring should be checked, and zeroing of the
measuring circuit should be performed if necessary.
WARNING!
There must not be air bubbles in the sensor’s chamber because it will cause inaccuracy in the
measured pressure values.
C. Release the tabs after the measuring changer is fully filled with the saline and perform
zeroing of the IBP channel the sensor is connected to. Zeroing can be performed after going
into the IBP Menu, choosing “Zeroing” button and pressing “Channel 1 zeroing” or “Channel
2 zeroing” depending of the currently used channel.
D. Press the tabs of the IBP sensor so the saline will fill the measuring chamber of the sensor.
WARNING!
There must not be air bubbles in the sensor’s chamber because it will cause inaccuracy in the
measured pressure values.
E. Release the tabs after the measuring changer is fully filled with the saline and perform
zeroing of the IBP channel the sensor is connected to. Zeroing can be performed after going
into the IBP Menu, choosing “Zeroing” button and pressing “Channel 1 zeroing” or “Channel
2 zeroing” depending of the currently used channel.
WARNING!
Zeroing can be performed only when the valve arm is in position 1.
CAUTION:
There must not be air bubbles in the sample line and the sensor’s inlet because it will cause
inaccuracy in the measured pressure values.
Fig. 6.12
Fig. 6.13
Fig. 6.14
Fig. 6.15
A label can also be changed afterwards in the sample review page (see chapter 5.4.2 Sample review)
Fig. 6.16
Fig. 6.17
On top of the QynetiQ™ control screen you will find the QynetiQ™ toolbar, by clicking on the QynetiQ
button you can select the Zero All option as well.
Fig. 6.17a
Fig. 6.17b
Fig. 6.18
From here you can change the grid color and thickness by choosing the color and thickness from the
dropdown list. You can also add grid subscales by choosing the desired subscale from the dropdown
list.
When you select ‘Description’, the IBP labels will show on the live screen as well as the scale
numbers. When the box has a blue edge, it means that the description is on.
IBP sensor unplugged Displayed, when the IBP sensor is not connected to the IBP extension
cable or if theIBP extension cable is not connected to the monitor.
No IBP module Displayed, when the IBP module is not connected to the monitor.
Channel 1 (or 2) zeroing Displayed while zeroing each of the IBP channels.
No communication to IBP Displayed when there is no communication to the IBP module after
module the module initialization.
CAUTION:
Do not immerse the IBP extension cable plugs and/or cable in any liquid.
The IBP extension cable must not be exposed to ultraviolet radiation.
The cable should be inspected, if it is clean and do not have any mechanical defects, before using it.
All disposables must not be reused.
ATTENTION:
The serial number of the monitor should be included in the order.
Below mentioned you will find the available cables. The items marked with an asterisk * are supplied
with the IBP module.
Fig. 6.19
6.5 Presets
Fig. 6.20
Predefined preset
Here you can switch to a predefined preset by choosing the preset from the dropdown list, for
example ‘CoronaryAngiogram_2IBP’. In this list you will find predefined system presets and presets
you created.
Fig. 6.21
If you have set your ECG settings and IBP settings and you would like to have these settings saved as
a preset, you can give in a name and click ‘Save user preset’. The preset is now saved and you can
pick the preset from the dropdown list anytime.
Fig. 6.22
It is possible to set one single timer or two timers at once. There can be chosen for one or two count
up timer(s) or one or two countdown timer(s) or one count down timer and one count up timer.
Timer 1 is default a countdown timer and Timer 2 is default a count up timer. (The on button behind
‘count up’ has a blue edge)
If you press the ‘on’ button behind count up (for both timers) you can change from count up to count
down and vice versa.
6.7 Alerts
Fig. 6.23
The input circuit of the respiration path – similarly as in the ECG path – is galvanic insulated from the
rest of the device to ensure a full protection for the patient and the user. The same electrodes are
used as during the ECG monitoring. Changes of the breast impedance between two electrodes are
presented in form of a waveform on the monitor’s screen. One of two pairs of electrodes is used for
the respiration detection:
RA (red) with LA (yellow),
RA (red) with LL (green).
Respiration rate is derived by the analysis of the respiration waveform. One of the most important
parameters, besides respiration rate monitoring, especially during neonatal monitoring, is apnea
supervision. Delay time before Apnea alarm initialization may be set in the respiration menu
depending on requirements for the patient.
WARNING!
The red-yellow pair of electrodes should be adhered at the furthest distance from each other.
It is recommended to set highest possible respiration signal amplitude on the monitor’s screen.
If the respiration signal amplitude is low even after setting the highest amplitude, the user should
try changing the pair of electrodes from the standard red-yellow (RA-LA) to red-green (RA-LL) pair
in the respiration Menu.
In case of a very low signal’s amplitude, the electrodes should be adhered even under the patient’s
armpits.
Fig. 6.24
ECG cable unplugged Displayed when the ECG cable is not connected to the monitor.
No contact of electrodes Displayed when a disposable electrode is disconnected, the ECG cable
and/or leads are damaged.
Bad contact of electrodes Displayed when an electrode or electrodes is either not adhered
properlyor has a badcontact with the patient’s chest.
No respiration module Displayed when the ECG module is not connected to the monitor.
No communication to Displayed when there is no communication to the ECG module after
respiration module the moduleinitialization.
To ensure protection, the measuring system of the pulse oximeter is galvanic insulated from the
patients and the user.
The pulse oximetry module ensures the continuous measurement and supervision of the oxygen
content in the arterial blood. It also ensures the continuous monitoring of the peripheral pulse rate.
The measurement is based on monitoring of the light (660 nm and 940 nm) transmission through the
vascularized tissue (e.g. the finger) and deriving the light absorption, what informs about SpO2 value.
The known phenomenon of changing of the blood color together with changing of the oxygen
content in the blood is used during the measurement of the blood oxygenation. The sensor placed
e.g. on the finger (transmitter) transmits the light beam to the receiver through the finger. The signal
detected in the receiver is analyzed by the electronic system and the algorithm calculates the oxygen
saturation.
2. Place the sensor in the chosen for measurement site e.g. at patient’s finger (Fig. 6.27) or at
patient’s ear in position a) or b) (Fig. 6.28).
WARNING!
Place the sensor in a position, which will assure that the sensor windows are against each other,
while a patient’s tissue is being tested and secure its position.
The sensor should be place in a way, which will not worsen the blood circulation because it will
cause incorrect measurement of SpO2 and pulse rate.
Reusable sensors may be used on the same site for maximum 4 hours, provided the site is
inspected routinely to ensure skin integrity and correct positioning. Because individual skin
condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change
the sensor site more frequently with some patients.
3. Connect the sensor to the extension cable and then the extension cable plug to the SpO2
socket in the monitor.
4. Pulse waveform the SpO2 value and pulse rate value will be displayed at the monitor’s screen
within a few seconds.
WARNING!
If a message “Pulse detection” is displayed at the monitor’s screen for a long time, it is suggested to
change the sensor’s site.
5. Set the alert limits for the SpO2 and Pulse rate.
6. Set the averaging time for SpO2 measurement.
CAUTION:
Failure to apply the sensor properly may cause incorrect measurements. Any pressure that limitsthe
blood flow in the extremities testing causes that the measurements are wrong.
If an NIBP cuff is placed at the same extremity as the pulse oximetry sensor, then during the NIBP
measurement there can be a temporary pause in the SpO2 measurement. The pulse oximeter will
measure the oxygen saturation again when the cuff pressure falls below the diastolic pressure.
In order to start the SpO2measurement as soon as possible, place the sensor at the patient before
connecting the sensor into the monitor’s SpO2socket.
Using the sensor in the presence of bright lights may result in inaccurate measurements. In such
cases, cover the sensor site with an opaque material.
Reusable sensors must be moved to a new site at least every 4 hours. Because individual skin
condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change
the sensor site more frequently with some patients. If skin integrity changes, move the sensor to
52 QynetiQ™ Enterprise – User Manual (Version 1.5)
another site.
Use only that wraps designed for use with this sensor. Do not use tape. Use of additional tape or
various other types of wraps can cause skin damage.
Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented cream, may
lead to inaccurate measurements.
It is recommended to use “Y” sensors for neonates monitoring. Special wraps and tapes allow quick
and reliable fixing at the patient’s body.
Excessive motion may compromise performance. In such cases, try to keep the patient still, or
change the sensor site to one with less motion.
When the sensor is wrapped too tightly or supplemental tape is applied, venous pulsations may lead
to inaccurate saturation measurements.
As with all medical equipment, carefully route cables to reduce the possibility of patient
entanglement or strangulation.
Do not use the sensor or other oximetry sensors during MRI scanning. Conducted current may cause
burns. Also, the sensor may affect the MRI image, and the MRI unit may affect the accuracy of
oximetry measurements.
Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
If the pulse oximetry sensor is not used for monitoring but the monitor is switched on, it is suggested
to unplug it from the monitor’s socket because it will extend the life of the sensor.
It is recommended to place the “Y” sensors as shown at the figure Fig. 6.29.
Fig. 6.29
It is recommended to fix the yoke part of the “Y” sensor using an adhesive tape, so the sensor’s
endings or not stretched or moved during the monitoring, because it will cause problem with
continuous oxygen saturation measurement and a message “Pulse detection” may be displayed
frequently.
Fig. 6.30
SpO2 probe unplugged Displayed when the SpO2 sensor is not connected to the monitor.
Probe of patient Displayed when the sensor is not placed on the measuring site or it has
partly slipped off.
Searching for pulse Displayed directly after placing the sensor on the measuring site or
whenbiginterferences are present.
Selftest error Displayed when the sensor is damaged. Please contact the Fysicon
Support.
No SpO2 module Displayed when the module is not connected to the monitor
No communication to SpO2 Displayed when there is no communication to SpO2 module after the
module module initialization.
CAUTION:
All disposables must not be reused.
CAUTION:
1. Saturate a clean, dry gauze pad with cleaning solution. Wipe all surfaces of the sensor and
cable with this gauze pad.
2. Saturate other clean, dry gauze pad with sterile or distilled water. Wipe all surfaces of the
sensor with this gauze pad.
3. Dry the sensor and cable by wiping all surfaces with a clean, dry gauze pad.
CAUTION:
Do not sterilize by irradiation, steam, or ethylene oxide. Such sterilization will damage the sensor.
1. Place the sensor in the cleaning solution, such that the sensor head(s) and desired length of
cable are completely immersed.
CAUTION:
Do not immerse the connector end of the cable as this may damaged the sensor.
CAUTION:
Using excessive force when removing the disposable wrap may damage the sensor.
CAUTION:
In order to avoid damaging the “Y” sensor, remove the sensor before cleaning both parts.
In order to remove the “Y” sensor from the clip, press rear tabs of the clip and delicately slide out the
sensor heads. Do not pull the head cable while removing the head from the clip.
The clip should be cleaned after its every usage.
In order to clean the clip, it should be wiped and immersed (for 10 minutes) in is isopropyl alcohol
(70%). If the clip is immersed, then it should be washed with water and dry it out before the next
usage.
QynetiQ™ Enterprise – User Manual (Version 1.5) 55
CAUTION:
Do not sterilize by irradiation, steam, or ethylene oxide. Such sterilization will damage the sensor.
Fig. 6.31
The clip should be disposed in case the force of the clip’s spring is lowered because it will cause
movingthe “Y” sensor in the place of measurement. This may affect performance or accuracy.
ATTENTION:
The serial number of the monitor and module should be included in your request.
Below mentioned you will find the available cables, probes and accessories. The items marked with
an asterisk * are supplied with the SpO2 module.
Measuring values are displayed as digital values and trends, similarly to the other parameters.
WARNING!
The measured temperature values are stabilized within about 3 minutes.
The probe must not press the blood vessel.
Use only water-based crèmes for introduction a central probe.
Introduction of the probe may induce nose bleeding.
Use disposable protective sheets during rectal applications.
Different parts of the body may differ significantly in temperature. Monitoring temperature from
two different sites, e.g. esophagus and extremity, provides indirect information on the blood flow.
Fig. 6.33
The measurement in the esophagus should be made below the forth esophagus’ part.
Esophagus Nasopharynx
Fig. 6.34
The measurement in the anus should be made, when the measuring probe’s end passes the
sphincter. We recommend using the disposable protection covers PC1 (Fig. 6.35)
Fig. 6.35
Fig. 6.36
Temperature sensor Displayed, when the temperature sensor is not connected to the
unplugged monitor.
No temperature module Displayed, when the temperature module is not connected to the
monitor.
ATTENTION:
The serial number of the monitor should be included in the order.
Below mentioned you will find the available probes and accessories. The items marked with an
asterisk * are supplied with the Temp module.
The measurement is made during deflation of the air from a cuff, after it is filled with the air to the
pressure that exceeds the systolic pressure for about 30 mm Hg. If the algorithm could not measure
the blood pressure, then a new measurement is initiated with new initial parameters (e.g. upper
pressure is set to a higher value). The values of the systolic, diastolic and average pressure are
displayed in the NIBP window after the measurement is accomplished. The module managing
software has a built-in protection against damaging including overpressure protection: > 300 mmHg
– for adults and > 150 mmHg – for neonates.
WARNING!
The patient should be relaxed and calm before performing a NIBP measurement. Even a small effort
(making a few steps) or a situation, when patient is upset may cause increasing of the patient’s
pressure.
CAUTION:
The cuff’s size should be appropriately chosen according to the size of the patient’s arm. Using
an improper size of the cuff may cause incorrect measurement.
3. Place the NIBP cuff at the patient forearm in a position shown at figure 6.37 so an arrow
drawn at the cuff is directed to the artery. The cuff should be placed about 2 cm about the
arm.
4. The arm should not be moved during the measurement.
5. Connect the air hose of the cuff with the NIBP extension hose and then the extension hose
with the monitor’s socket marked with “NIBP” label. The connections are made by quick-
connectors which enable quick and reliable pneumatic connections and easy disconnection.
6. Choose a working modus (adults or neonates), set a proper pressure level for the first
measurement and set required alert limits.
7. Optionally set the automatic NIBP measurement. It allows automatic initialization of
measurement after a specific time interval.
CAUTION:
The incorrectly installed cuff on the patient’s arm may be a source of improper results of the
patient’s blood pressure measurement.
Make sure that the hose between the monitor and the cuff is not bent.
The cuff must be wrapped after finishing the automatic measurement because the cuff may
become thorn apart, if the compressor is started.
“NIBP measurement” text and the current value of the air pressure in the cuff is displayed in an NIBP
window. An initial analysis of parameters is made during filling the cuff with the air in order to define
the initial conditions for the measuring algorithm. When the pressure reaches a required level, the
compressor stops working and a procedure of the pressure detection is started. The pressure in the
cuff will be deflated in steps.
If the systolic pressure is not detected (e.g. the upper cuff pressure was too low or a dynamic
pressure signal is too weak) the measurement will be repeated with the higher initial pressure (about
30 mmHg higher) or with a more amplified dynamic pressure signal.
If the “Stop NIBP” button is pressed during the measurement, the measurement will be terminated.
Fig. 6.38
Mode select
Choosing the working mode depending on a monitored patient
(Adult or neonates).
NiBP measurement break Displayed when the NiBP measurement is terminated using the
“Stop NiBP” button in the lower toolbar.
No cuff Displayed during the NiBP measurement, while the cuff is not
connected to the module.
Kinked hose Displayed when the module detects an incorrect air flow in the
hose between the patient’s cuff and the monitor.
Out of range Displayed when the patient’s pressure is out of the measuring
range of the NIBPmodule.
NiBP module failure Displayed when the NIBP module does not responds to monitor’s
commands.
No NiBP module Displayed when the module is not connected to the monitor.
No communication to NiBP Displayed when there is no communication to NIBP module after the module
module
For disinfecting use a solution, such as Enzol, Cideyzene, Cidex, Sporicidin, Isopropyl alcohol (70%),
Ethanol (70%), wipe or spray the BP cuff and allow standing for approximately one minute. Than
wipe a cloth moistened in water and dry.
CAUTION:
If the blood pressure cuff has been grossly contaminated with blood or other bodily fluids, it should
be discarded.
If the cuff is submerged in the cleaning or disinfecting solution, the fittings should be capped to
prevent the liquid from getting inside the cuff.
The liquid should not come into the pumping circuit because it may cause damaging of the module.
All disposable or single patient use cuffs should not be reused.
Below mentioned you will find the available cuffs and accessories. The items marked with an asterisk
* are supplied with the NiBP module.
The CO measurement is realized using the time analysis of the thermal indicator concentration
changes in circulating blood. The measuring method of the module is based on impulse injection of
specified volume of injection solution (3 or 5 or 10 cc saline with determined temperature) through
Swan-Ganz catheter directly into the right atria and the analysis of the temperature changes in the
pulmonary artery (PA) trunk recorded with the thermistor of the same Swan-Ganz catheter. The
value of each individual CO measurement in the session is calculated basing on areaof surface under
the curve of recorded temporary temperature changes.
CAUTION:
Injection solution, which will be injected to Swan-Ganz catheter, must be sterile. That is why it is
not acceptable to introduce non-sterile elastic temperature probe to a container with a sterile
injection solution which is used for injections through the Swan-Ganz catheter.
In clinical practice the CO, the parameter used for patient’s hemodynamic status examination, is
calculated as a mean value of a few individual measurements collected in one session. The
measurements in a single session typically are performed directly one after another. The CO module
allows CO calculating as the mean value in the session of from 1 up to 6 individual measurements. It
is possible to edit each individual measurement in the session by marking doubtful measurements
and making new measurements instead of the marked ones. The maximum session capacity is 6
individual CO measurements. If the number of individual measurements is prolonged and exceeds 6
measurements, each new measurement will replace the oldest one or a marked as doubtful one.
Such a replacement needs to be confirmed by the user.
The CO value in resting conditions at healthy man hearts in within a range from 4 to 8 l/min and it is
strongly dependent from patient's body weight and height. Therefore the more significant usage has
a calculation of the standardized cardiac output, related to patient's body surface area (BSA), and
called the Cardiac Index (CI). The QynetiQ™ monitors realize the automatic CI calculation by dividing
the CO value by BSA. The only condition necessary for that is that the patient's and height and weight
were earlier introduced in the patient's data screen. The monitors present both results
simultaneously as standard: the pure CO value as well as standardized CI index.
The average value of CO and CI appointed in session along with results of individual measurements in
the session could be recorded in memory the monitor for a trend analysis of parameters changes.
These values could to be also utilizing for computation of the hemodynamic calculations of patient
circulation system by Hemodynamic Calculations software. The Hemodynamic Calculation software is
a data acquisition tool offered as option in the monitor.
In case of temporary break of measuring session and exit from CO module screen, the module allows
continuation of the broken session. It is the user’s responsibility to verify the examination conditions
(the patient hemodynamic status, injection solution temperature, etc.) and make the decision either
the broken session could be continued or the next session with new measurements should be started
from the beginning.
CAUTION:
The usage of the Swan-Ganz thermo dilution catheters recommended by the monitor’s
manufacturer is crucial for proper CO module work and accurate cardiac output estimation.
To CO module
socket
Swan-Ganz catheter
Thermistor connector
Reference
temperature
sensor
connector
Fig. 6.39
3. Connect the connector of Swan-Ganz catheter with the socket of the CO module interface
cable. The thermistor has been already properly introduced into patient vascular system for
the cardiac output examination using thermo dilution technique.
WARNING!
The proper localization of Swan-Ganz catheter thermistor in the trunk of pulmonary artery as well
as setting the outlet of injection port directly in right atria is crucial for accurate cardiac output
estimation.
4. Prepare the sterile injection solution with proper temperature for CO examination and the
additional container with non-sterile solution about identical temperature like sterile
injection solution prepared for examination. The additional container with non-sterile
solution will be used for measurement of reference injection temperature.
WARNING!
The difference between temperatures of injection solution (delivered during examination through
the Swan-Ganz into the right heart) and the reference injection solution (non-sterile in additional
5. Introduce the external temperature probe, used for measuring the temperature of the
injection solution, properly into the middle of additional container with non-sterile reference
injection solution, and protect its stable position.
6. Go into the Menu CO in order to start managing the CO module.
7. Press “Measurement” button in the CO menu (in the mode dropdown list). See figure6.40
8. If CO measurement has been already performed or has been paused a message asking if the
user wants to start a new session or continue the previous session will be displayed. Choose
the appropriate option.
WARNING!
The continuation of earlier paused session makes the sense only then when the essential change of
conditions of CO examination did not occur - the patient's status, the catheter placement, and
temperatures of both: blood and injection solution.
WARNING!
An improper CC value causes a fundamental error in CO value estimation and consequentially in the
CI value.
9. The new screen will be displayed. Check the indications of the patient's blood temperature -
Tblood (measured by the Swan-Ganz catheter thermistor located in pulmonary artery) as
well as the temperature of injection solution Tinj (measured by the external temperature
probe in container with non-sterile reference injection solution). If temperatures are correct
the user can start the measurement.
WARNING!
The temperature of the injection solution that exceeds the proper temperature range for the
chosen computation constant causes the fundamental error in the CO value measurement and
consequentiallyin the CI value.
The difference between temperatures of injection solution (delivered during examination through
the Swan-Ganz into the right heart) and the reference injection solution (non-sterile in additional
container) is the reason of fundamental error introducing in CO individual measurement with this
technology.
Fig. 6.40
Select/deselect a CO measurement
When a measurement is performed, the results will show on the live screen and in the table on your
control screen (also in the cardiac output box). Under the column ‘Use’ you can select and deselect
the measurements you want to use. These measurements will be taken into calculations
CAUTION:
The CC value must be introduced before starting a new measurement session.
It is possible to change the CC value during the currently performed measurement session. However
the user should remember that every CC value is chosen taking into consideration specific condition
of the Cardiac Output measurement (type of Swan-Ganz catheter, volume and temperature of the
injection solution).
That is why changing of the CC value means that the condition of the Cardiac Output measurement
has been changed. In such a situation, the previous measurement in a session will be not correctly
computed comparing to the new measurements that will be performed after changing the CC value.
WARNING!
It is necessary to delete previous measurements, if the CC value has been changed during one
measurement session. Then the user may continue the session.
Ready for new The module is ready to begin with the next individual CO
measurement measurement
Inject now The command (followed by a sound signal) for the start of the
injection of the injectate.
Wait for new measurement The command of suspension of the module until finishing the
measurement and readiness for the beginning of the next one.
Too late injection The information that the injection of the solution (injectate) has
70 QynetiQ™ Enterprise – User Manual (Version 1.5)
begun too late – incorrect measurement.
Too quick curve drop The information about the incorrect shape of the blood temperature
changes during the measurement – incorrect measurement.
Too short measurement The information about too little time of measurement (the changes of
temperature after delivery of the injectate did not reduce within the
measurement time provided for the measurement – incorrect
measurement.
Tblood out of range The patient’s blood temperature is out of the range accepted fro CO
measurement. The accepted range of patient blood temperature
varies from 30oC - 40oC.
Tinj out of range The temperature of the injectate (solution) is out of range accepted
for CO measurement. The accepted range for the injectate varies
from -1oC - +30oC.
CO alert The COI value is out of the accepted range. The borders of alert
available for CO value are varied from 0 – 20 l/min.
CI alert The CI value is out of the accepted range. The borders of alert
available for CI value are varied from 0 – 20 l/min.
Disinfection:Use chemical disinfectants containing ethanol (70% - 80%), propanol (70% - 80%) or
aldehydes (2% - 4%).
ATTENTION:
The serial number of the monitor should be included in the order.
Below mentioned you will find the available probes and accessories. The items marked with an
asterisk * are supplied with the CO module.
014240601 CO Y-cable
QynetiQ™s CO module will co-operate with all Swan-Ganz catheters dedicated to thermo-dilution
measurements, compatible regarding electric features with catheters AHSC / Baxter (Rth: 14 kΩ ,
sensitivity: 510,52 Ω/ºC);
Fig. 6.41
Fig. 6.42
Create a sample
On top of the QynetiQ™ control screen you will find the QynetiQ™ toolbar:
Fig. 6.43
With these buttons you can create a sample (even while you’re filling in a report, because these
buttons are always available). When you press the QynetiQ™ button you will find more sample types:
Fig. 6.44
Choose the type of sample you want to make and then press the button. In the right bottom corner
of your control screen messages will appear:
Creating a sample…
Sample created successfully and ready to be viewed
The sample is now created and ready to be viewed in the sample review page (see chapter 7. Sample
review)
Fig. 6.45
Choose the type of sample you want to make and then press the button. In the right bottom corner
of your control screen messages will appear:
74 QynetiQ™ Enterprise – User Manual (Version 1.5)
Creating a sample…
Sample created successfully and ready to be viewed
The sample is now created and ready to be viewed in the sample review page (see chapter 7. Sample
review)
Fig. 6.46
Select which channel, and the source and destination. When you filled in all three, press OK. The
sample will now be created
Averaged samples
When the user creates a Pullback, Gradient or Merge sample, the medical specialist may find it
necessary to manipulate the average view of the sample for a more accurate calculation of the
gradient and/or valve areas.
In previous versions of our software (v1.5 and earlier), it was only possible to manipulate the full
view of these sample types, because any manipulations in the average view cannot be calculated
back to the original sample values. To make it possible for the user to manipulate the average view
of the samples, changes have been made in the new software version (v1.6) to produce two (2)
separate samples whenever a Pullback, Gradient or Merge sample is created and/or re-analyzed: a
full view sample and an average view sample. The table below lists the types of samples that
represent the full view and average view:
This document contains information about the changes implemented in the new software version,
and how the changes apply to each different sample type.
1. When the user requests a new Pullback sample, the system will produce two (2) samples:
When the entry “Full” is selected from the list, sample P1 is automatically selected and
displayed.
When the entry “Superimpose” is selected from the list, sample P2 is automatically selected
and displayed.
5. Please take note of this important point concerning re-analysis of these samples:
Re-analyze automatically updates
x
When a P1 sample is re-analyzed, a new version of the associated P2 sample is automatically
created. This is important as previous changes in the P2 sample will be overwritten.The user
must be advised to complete all manipulations of the P1 sample before manipulating the P2
sample
When a P2 sample is re-analyzed, the P1 sample is NOT updated because it is NOT possible to
calculate changes back to the original data.
76 QynetiQ™ Enterprise – User Manual (Version 1.5)
6. When viewing a P2 sample, it is not possible to change the ECG lead – this change must be made
in the original full view sample, i.e. P1
7. When viewing a P2 sample, only IBP1 and IBP2 channels are visible because the data represents
the superimposed view of a P1 (Pullback) sample.
Feature Comments
Move ECG wave (up/down) This feature is used for visual purposes only – no changes are
saved
Move IBP wave (left/right) It is now possible to move the IBP wave in the superimposed
view. During a re-analysis the gradient will be recalculated as
well as the subsequent valve calculations based on the
gradient.Note that it will only be possible to move the second
wave– the first wave must remain fixed, but the second wave
can be moved left/right.
Select/deselect gradient areas A new toolbox feature implemented for the Superimposed
(P2) sample – see next point for details
Using this feature will enable the user to select/deselect the gradient areas to include/exclude in
the calculations. Help text is shown in the sample display.
Note that when this toolbox feature is activated, the curve fitting type is automatically changed
from “Smooth” to “True” because the gradient areas shown on smoothed curves may be
different to the actual gradient areas.
When the toolbox feature is deactivated (e.g. when the sample is re-analyzed), the curve fitting
type is automatically changed back to its original setting.
1. When the user requests a new Gradient sample, the system will produce two (2) samples:
When viewing a G2 sample, the “View type” list contains only the entries “Full” and “Calculated
avg”.
When the entry “Full” is selected from the list, sample G1 is automatically selected and
displayed.
When the entry “Calculated avg” is selected from the list, sample G2 is automatically
selected and displayed.
X
When a G1 sample is re-analyzed, a new version of the associated G2 sample is automatically
created. This is important as previous changes in the G2 sample will be overwritten. The
user must be advised to complete all manipulations of the G1 sample before manipulating
the G2 sample
When a G2 sample is re-analyzed, the G1 sample is NOT updated because it is NOT possible
to calculate changes back to the original data.
6. When viewing a G2 sample, it is not possible to change the ECG lead – this change must be made
in the original full view sample, i.e. G1
Feature Comments
Move ECG wave (up/down) This feature is used for visual purposes only – no changes are
saved
Move IBP wave (left/right) It is now possible to move the IBP wave in the calculated
average view. During a re-analysis the gradient will be
recalculated as well as the subsequent valve calculations
based on the gradient.Note that it will only be possible to
move the second wave– the first wave must remain fixed, but
the second wave can be moved left/right.
Select/deselect gradient areas A new toolbox feature implemented for the Calculated
average (G2) sample – see next point for details
Using this feature will enable the user to select/deselect the gradient areas to include/exclude in
the calculations. Help text is shown in the sample display.
Note that when this toolbox feature is activated, the curve fitting type is automatically changed
from “Smooth” to “True” because the gradient areas shown on smoothed curves may be
different to the actual gradient areas.
When the toolbox feature is deactivated (e.g. when the sample is re-analyzed), the curve fitting
type is automatically changed back to its original setting.
1. When the user uses the wizard to create a new Merge sample, the system will produce two (2)
samples:
When viewing a M2 sample, the “View type” list contains only the entries “Full” and “Calculated
avg”.
When the entry “Full” is selected from the list, sample M1 is automatically selected and
displayed.
When the entry “Calculated avg” is selected from the list, sample M2 is automatically
selected and displayed.
X
When a M1 sample is re-analyzed, a new version of the associated M2 sample is
automatically created. This is important as previous changes in the M2 sample will be
overwritten. The user must be advised to complete all manipulations of the M1 sample
before manipulating the M2 sample
When a M2 sample is re-analyzed, the M1 sample is NOT updated because it is NOT possible
to calculate changes back to the original data.
6. When viewing a M2 sample, it is not possible to change the ECG lead – this change must be made
in the original full view sample, i.e. M1
Feature Comments
Move ECG wave (up/down) This feature is used for visual purposes only – no changes are
saved
Move IBP wave (left/right) It is now possible to move the IBP wave in the calculated
average view. During a re-analysis the gradient will be
recalculated as well as the subsequent valve calculations
based on the gradient.Note that it will only be possible to
move the second wave– the first wave must remain fixed, but
the second wave can be moved left/right.
Select/deselect gradient areas A new toolbox feature implemented for the Calculated
average (M2) sample – see next point for details
Using this feature will enable the user to select/deselect the gradient areas to include/exclude in
the calculations. Help text is shown in the sample display.
Note that when this toolbox feature is activated, the curve fitting type is automatically changed
from “Smooth” to “True” because the gradient areas shown on smoothed curves may be
different to the actual gradient areas.
When the toolbox feature is deactivated (e.g. when the sample is re-analyzed), the curve fitting
type is automatically changed back to its original setting.
Two parameters are measured during the analysis: level, slope and they are labeled as follows:
Measurements are made automatically basing on the average QRS complex and chosen measuring
points:
ATTENTION:
The measuring points' placement depends on the morphology of the ECG waveform. To get the
reliable results the placement should be verified and corrected (if necessary). Every change of the
ECG amplitude begins the formation of a new average QRS complex model.
CAUTION:
Note that the measuring points are placed in standard positions but in some Holter systems, placing
of these points is different. In addition, for different ECG signal morphology, measuring points may
be changed and that is why the medical personnel should verify them. Default placing of the
measuring points may be changed in the ST menu.
There is a time required for averaging the QRS complex after enabling the ST analysis. The average
QRS complex is displayed on the left side of the ECG waveform.
Usually the averaging time is 10-20 seconds (depending on a current patient’s heart rate). During
this time, only the QRS complexes of the same class are analyzed in order to prepare an average QRS
complex. This adaptation process is started from the beginning, whenever the amplification of the
ECG waveform is changed.
Fig. 6.49
Bad contact of electrodes Displayed when an electrode or electrodes is either not adhered
properlyor has a badcontact with the patient’s chest.
No ST analysis module Displayed when the ECG module is not connected to the monitor.
No communication to Displayed when there is no communication to the ECG module after
ST analysis module the moduleinitialization.
6.16 FFR
6.16.1 Module description
The Fractional Flow Reserve (FFR) module works in conjunction with the IBP module. The FFR module
will calculate the ratio between maximal myocardial flow in a stenotic vessel and maximal myocardial
flow in the same vessel without stenosis. It accomplishes this by using data generated by two IBP
channels.
Fig. 6.51
Fig. 6.53
Fig. 6.54
However, if a FFR sample is taken in the full disclosure of a non-active procedure, the initial analysis
of the sample will fail. The sample itself will be created and can be viewed in the sample review tab.
To get a correct analysis the newly created sample will need to be reanalyzed. This is done by
selecting the sample in the sample review tab and opening the settings menu at the left side of the
screen. Select the two appropriate IBP channels and change their labels to Pa and Pd. Now press the
“Reanalyze” button in the quick access toolbar. The new FFR values will be displayed in the sample.
Fig. 6.56
(More information regarding the sample review tab and the reanalyze function can be found in
chapter 7)
Generate a report
When you finished your procedure, it is possible to create a report. To do, choose the type of report
you want to generate and then press that button in the reports toolbar:
Fig. 6.58
In the toolbar there will be a few shortcuts. To see more type of reports, press ‘Report all’. When you
chosen a type of report, that report will be opened in Microsoft Word©.
The sample review page can be viewed during an active procedure and when a previous performed
procedure is opened. During a review of a previous performed procedure, the sample review page
will show automatically when you opened the monitoring tab (the procedure control page is then not
available). If not, you can switch tabs by clicking them. When a page is opened, the name of the tab
will become blue:
Fig. 7.01
Fig. 7.02
Select the sample you want to view by clicking on the thumbnail
Fig. 7.03
To open a settings box, press the arrows on the left of the title:
Fig. 7.05
Fig. 7.06
Selecting/deselecting ECG channels
A highlighted button means that that ECG channel is selected and shown on the sample. Click the
button to select a channel. V1 –V6 can get a different name, choose the name from the dropdown
list.
Fig. 7.07
When you changed the lead and want to reanalyze the sample, press ‘Reanalyze’ on top of the
settings menu.
Fig. 7.08
Change the label of an IBP channel (pressure wave)
To change the label of an IBP wave, choose the correct label from the dropdown list (under ‘label’)
Display mean
To display the mean of a pressure on the sample, select the box under ‘mean’. When you deselect
the box again, the mean will no longer be visible on the sample
Fig. 7.09
Fig. 7.10
Fig. 7.11
Fig. 7.12
7.1.2.5 Toolbox
If you changed any of the above, it is necessary to reanalyze the sample. To do; press ‘Reanalyze’, on
top of the settings menu.
You will find the below mentioned options on top of the settings menu:
Reanalyze a sample
Reanalyze a sample by pressing ‘reanalyze’
Save a sample
Save a sample after you changed something by pressing ‘Save sample’
Delete a sample
Delete a sample by selecting the sample and pressing ‘Delete sample’
Print sample
Print the selected sample by pressing ‘Print sample’
Print ECG
Print the ECG by pressing ‘Print ECG’. Then choose the print format:
Fig. 7.14
Fig. 8.01
Fig. 8.02
Fig. 8.04
Fig. 8.05
Creating a sample…
Sample created successfully and ready to be viewed
The sample is now created and ready to be viewed in the sample review page (see chapter 5.4.2
Sample review)
When you created a sample, the place where you made the sample will be highlighted in blue now.
When you hover over that highlighted area, the sample data will be shown.
Fig. 8.06
Select which channel, and the source and destination. When you filled in all three, press OK. The
sample will now be created.
1-level alarm – alarms with the highest priority, which informs about a necessity of an immediate
action of the medical personnel (blinking red color).
2-level alarm – alarms with the medium priority, which informs about a necessity of a prompt action
of the medical personnel (blinking yellow color).
3-level alarm – alarms with the lowest priority, which informs about events of low importance or
only about patient’s discomfort (cyan color).
Description of all alarm groups are shown in the tables on the next pages.
WARNING!
Acoustic signaling of medical alarms may not be completely silenced in Menu Speaker.
Only Heart rate acoustic signaling may be completely silenced.
Cable
Low VF / VT High INOP Medium
Unplugged
No Bad contact of
Low Brady High Medium
Communication Electrodes
Bigeminy High
Trigeminy High
R on T High
VPBs High
SVEs High
AF High
Interferences High
Irr. HR High
Probe
∆T High DP High IBPD High Low
Off Patient
Sensor Probe Probe
High Overpressure High Low Medium
Unplugged Unplugged Unplugged
Excessive No No
No Module - Medium Low Low
Motion Communication Communication
No
Low
Communication
No Module Low
No
inCO₂ High CI High Low
Communication
Respiration Probe
High Low No Module Low
rate Unplugged
Measurement
Occlusion Medium Session Low
Message
No
No Water Trap Low Low
Communication
No
Low
Communication
No Module Low
CAUTION:
TheAlarm signalization described is based on the ECG module. The remaining parameters’ alarms
operate in a similar way. A little bit different operation concerns the arrhythmia analysis where
acoustic and optical signaling of Asystole, Pause, VF/VT and Bradycardia episodes are available.
Fig. 9.01
The user should press the red field ALARM HRat the main screen in order to acknowledge the
handling of the alarm. At this moment the red field and the acoustic signaling will be disabled but
the red HR value of the parameter, will still blink red.
WARNING!
In order to acknowledge the handling of the alarm, the user should press the blinking red field at the
upper toolbar, causing the acoustic signaling to be disabled. The red blinking of a value of a
parameter, which initiated the alarm signaling, will be stopped, when a cause of the alarm is
eliminated. If the cause of the alarm is not eliminated during 2 minutes, the acoustic signaling is
activated again.
The similar rules of alarm signaling operation concern the other parameters available in the monitor
accept APNEA detection.
WARNING!
The values of alarm limits set by the user in the patient monitor are restored even after turning the
monitor off.
Alert settings,
QynetiQ™ Enterprise – User Manual (Version 1.5) 107
Alert suspension time.
A list of available alert limits in the monitor (except Apnea time and arrhythmia levels) is
shown in the first „Alert settings” tab. The user may change the whole list of alarms by
pressing “Select” button. After pressing this button there are 5 standard lists of alert limits
available:
List configurable by the user (“Set 1”, “Set 2”, “Set 3”),
Preconfigured factory list of alert limits (“factory”). Cannot be edited,
Automatic adjusted list of alert limits which are specifically set in accordance with currently
monitored parameters (“automatic”). In order to check the currently monitored parameters
and automatically set the limits the user should press “Set” button, which is available only
for this automatic list.
Every alert limit can be individually edited (except “factory” list) by pressing the field which it
concerns and then the upper or the lower value can be adjusted using “+” and “-” buttons.
After accomplishing the alert’s adjustments and choosing the list which should be currently active,
the user should press “Save” button.
In order to cancel all the changes that were currently made, the user should press “Cancel” button.
In this tab the user is able to set the time of the alerts suspension. There are two standard options; 1
or 2 minutes.
Off
upper lower
set 1
Select
Cancel Save
Fig. 9.02
* Parameter with “1” digit can be also present with digit “2” “3” or higher.
** “GAS” label is exchanged by first three letters of a name of a currently chosen anesthetic gas.
If there is no need to monitoring of one or more limits they can be turned off. Press a chosen alert
limit field and then press “Off” button. Chosen limits will not be monitored and numeric limits will be
replaced with dash. If such setting is saved, then an additional icon will be displayed in the alarm
mode field (Fig. 9.03).
Fig. 9.03
“Apnea time” parameter available in Respiration Menu, CO2 Menu, O2 Menu, Gas Menu is not
present in the list of alerts. In order to change the Apnea time the user should go into one of the
Menus mentioned above. The “Apnea time” can be set between 5 and 60 seconds or apnea
monitoring may be disabled. If Apnea detection is disable then a strikethrough label “APN” is
displayed in a digital values field of the Respiration module.
The second level technical alarm is signaled in an acoustic and optical way, which informs the user
about malfunctioning of a measuring circuit (e.g. an ECG electrode is not adhered to a patient,
patient’s finger has slipped off the SpO2 probe, measuring module became damaged etc.). Optical
signaling is presented as a yellow field at the upper toolbar with a text, which informs the parameter
which caused the alarm initiation (e.g. CO2, what means a failure of CO2 module). The acoustic
signalingof the technical alarm is presentedas a modulated sound.
The loudness of the technical alarm may be adjusted in the Speaker menu available in the Main
menu. Adjusting of the technical alarm loudness may be done after pressing “Alert loudness”.
The technical alarm signaling may be initiated by several reasons, which depend on the monitored
parameter.
The third level technical alarm is signaled in a visual way by displaying a cyan color field at the upper
toolbar with a text, which informs the parameter, which caused the alarm initiation. It is displayed to
inform the user about connecting the probes and cables to the monitor for the parameters installed
in the monitor.
Figure 9.04 shows a situation, when fields of alarms of the third (first field on the right side), the
second (first field on the left side) and the first priority level are displayed.
Fig. 9.04
WARNING!
Information about possible technical alarms is available in a chapter describing measuring
Alarm statuses may be changed by pressing the graphical figure until the sign, which concerns the
required status is displayed.
WARNING!
Disabling of the acoustic signalization of the alarms but especially complete disabling of all alarms
may be dangerous to a patient, because if a medical alarm should be initiated, the user of the
monitor may not be aware of a danger for the patient’s health. That is why these alarm statuses
should be set with full awareness of the medical personnel.
Setting of the alarm limits too wide may be dangerous to the monitored patient.
Fig. 10.1
Fig. 10.2
The key combinations for these shortcuts can be changed in the management console. To do so
please contact the system administrator.
The monitor should be properly shutdown, in order to store data that is gathered in the monitors
operating memory. The user should:
Press the “Quit” button,
A question will be displayed in the lower toolbar „Are you sure to quit?”
Choose the answer “Yes”.
After pressing the “Yes” button, a screen with a message “System is shutting down” will be
displayed. The user must not turn the monitor off in this moment!!! After a few seconds a black
screen with a message “You may turn off the monitor now” will be displayed and the QynetiQ™
Enterprise monitor should be switched off using the mechanical switch placed at the right side of the
monitor looking from the front of the monitor.
Fig. 10.01
WARNING!
The user may cause failures of the monitor, if the monitor is not properly shut down.
The monitor should be cleaned, tested and maintained in order to ensure its proper work.
The user should focus on the following matters during testing the monitor:
Visible mechanical damages. If the mechanical damage will be found by the user, then the
damaged part must be exchanged with a new one. Maintenance and repairs should
performed only by service engineers of Fysicon or its local representative authorized by
Fysicon,
Cables should be checked, if they are not damaged and plugs should be carefully observed, if
their pins are not broken or bend. Maintenance and repairs should performed only by
service engineers of Fysicon or its local representative authorized by Fysicon,
Isolation of all cables should be inspected and if a cable’s isolation shield is damaged, the
cable should
be exchanged. The user should contact the Fysicon representative in this matter.
The monitor should be cleaned in regular period of times. The housing of the monitor should be
cleaned with a wet, soft cloth. Use the following liquid for cleaning:
Water with a small quantity of soap.
The housing of the monitor’s display may be cleaned and disinfected using the agents and liquids
mentioned above.
The touch screen should be cleaned and disinfected using non aggressive 70% or 90% alcohols.
WARNING!
The monitor’s surface may become mat and even damaged, if the user does not follow the
suggestions mentioned here.
Do not use any disinfecting rays (beams) for disinfection of the patient monitor because the
monitor’s housing may become damaged.
Recycling should be made in accordance with the national and local regulations. Contact Fysicon’s
local representative for assistance.
The battery of the monitor should be disposed in accordance to local regulations concerning
dangerous materials after they are exploited. Batteries should be discharged before its disposing.
All disposable accessories of the monitor should be utilized in accordance with local hospital
regulations.
The package of the monitor should be recycled in accordance with the local regulations.
14.1 QynetiQ™Enterprise
Front-end
- Dimensions: 365 x 145 x 280 mm (without LCD display)
- Weight: 5.7 Kg
- Power supply: 20 V ± 10%
- Power consumption: < 45 VA
- Operating Temperature: 10 o – 40o C / 42 o - 104 o F
- Relative Humidity: < 85 % non condensing
- Safety Class: I, CF
- Safety requirements: MDD 93/42/EEC, EN 60601-1
Power Unit
- Dimensions: 365 x 145 x 280 mm (without LCD display)
- Weight: 11.2 Kg (without LCD display)
- Power supply: 240 V ± 10% 50/60 Hz
- Power consumption: <1100 VA
- Operating Temperature: 10 o – 40o C / 42 o - 104 o F
- Relative Humidity: < 85 % non condensing
- Safety Class: I,
- Safety requirements: MDD 93/42/EEC, EN 60601-1
Arrhythmia analysis
Based on the QRS Complex
- Sensitivity: 99.5%.
- Arrhythmia’s: Asystole; Pause; VF/VT; Bradycardia; STach; Bigeminy; Trigeminy;
VPC; VPC run; R on T; PSVC; AF and Missed beats.
Respiration
- Channels: 1
- Measuring method: Impedance
- Sampling frequency: 50 Hz
- Parameters: Respiration rate and Apnea
- Respiration rate: 0 – 150 / min
- Apnea recognition time: 5 – 60 sec
Arrhythmia analysis
Based on the QRS Complex
- Sensitivity: 99.5%.
- Arrhythmia’s: Asystole; Pause; VF/VT; Bradycardia; STach; Bigeminy; Trigeminy;
VPC; VPC run; R on T; PSVC; AF and Missed beats.
ST Analysis
Based on the average QRS Complex
- ST level: ± 1 mV.
- ST slope: ± 15 mV/s.
Respiration
- Channels: 1
- Measuring method: Impedance
- Sampling frequency: 50 Hz
- Parameters: Respiration rate and Apnea
- Respiration rate: 0 – 150 / min
- Apnea recognition time: 5 – 60 sec
Manufacturer’s service:
Fysicon B.V.
Hoogheuvelstraat 114
5349 BA Oss
The Netherlands
Tel: + 31 412 65 33 32
Fax: + 31 412 65 33 30
www: www.fysicon.com
@: support@fysicon.com
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