CardioScreen - APC Cardiovascular

CardioScreen - APC Cardiovascular
®
CardioScreen
Non-Invasive Haemodynamic Monitoring-System
Operating Manual
of the measuring device
®
CardioScreen 1000
0118
Tel. 0 36 77 – 46 29 0
Fax 0 36 77 – 46 29 29
info@medis-de.com
http://www.medis-de.com
Medizinische Messtechnik GmbH
W.-v.-Siemens-Str. 8, D-98693 Ilmenau
Germany
© medis. Medizinische Messtechnik GmbH, Germany, Ilmenau, January 2006
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2
Table of contents
1
Introduction ............................................................................................... 5
1.1
Applications ........................................................................................ 5
1.2
Precautions and limitations ................................................................. 7
1.3
Safety instructions............................................................................... 7
1.4
Explanation of used symbols .............................................................. 9
2
Description of the device......................................................................... 10
2.1
Basic device ...................................................................................... 10
2.2
Patient cable ...................................................................................... 12
3
Commissioning of the device and preparing a measurement ............. 13
3.1
Commissioning of the device............................................................ 13
3.2
USB-driver installation ..................................................................... 14
3.3
Safety requirements........................................................................... 14
4
Maintenance, cleaning and disinfection ................................................ 16
4.1
Maintenance ...................................................................................... 16
4.2
Cleaning and disinfection.................................................................. 16
5
Technical Data......................................................................................... 17
6
Scope of delivery...................................................................................... 19
7
Medis Standard / Extended Warranty.................................................. 20
8
Troubleshooting ...................................................................................... 22
3
Before using the CardioScreen®-device read this manual carefully and completely to ensure that you operate the system correctly. When you set up the
device for the first time, check to see if it has suffered any damage during
transportation.
If you need additional information or if you have any technical, operational or
clinical question please contact the manufacturer. In the case of a request we
would ask you to inform us about the serial number of your device which you can
find on the type plate on the bottom side of the device.
You can contact us as follows:
E-mail support@medis-de.com
Phone + 49 - 36 77 - 46 29 - 0
Fax
+ 49 - 36 77 - 46 29 - 29
Mail
medis. Medizinische Messtechnik GmbH
Werner-von-Siemens-Str. 8
D - 98693 Ilmenau
Germany
You can find current information and software updates for your PC-software on
our home page:
http://www.medis-de.com.
The CardioScreen®-device works only computer supported with the niccomo
software. Please note also the manual of the software.
4
TM
1 Introduction
1.1
Applications
The CardioScreen®-device is used for non-invasive haemodynamic measurements
and monitoring of haemodynamic parameters using methods of impedance cardiography (ICG).
In impedance cardiography, pulse synchronous variations of the blood flow and
volume in the thoracic aorta are determined and used for calculating different
haemodynamic parameters. More specifically, with each beat of the heart, the
volume and velocity of blood in the aorta changes. This produces a change in the
electrical resistance (impedance) of the thorax to electrical alternating current. The
change in impedance over time can be used to calculate stroke volume and several
other important haemodynamic parameters. The CardioScreen®-device uses four
dual sensors, which are placed on the patient’s neck and thorax. The most upper
and lower gel pads of these sensors (the outer sensors) are used to apply a very
low constant and alternating current (1.5 mA, 86 kHz) which is imperceptible to
the patient. The other four gel pads are used to receive the applied current and
ECG signal.
Figure 1: Application of sensors
It is important to note that the ECG obtained and recorded by the ICG-patient cable is not a standard lead. It is, however, sufficient for monitoring rate and rhythm.
Different terms are used interchangeably when discussing impedance cardiography, electrical bioimpedance or thoracic electrical impedance (TEB). In this manual the term impedance cardiography or ICG is used.
5
Impedance cardiography allows the measurement of following parameters:
•
Thoracic fluid content (inverse to thoracic basic impedance)
•
Pre-ejection period,
•
Left ventricular ejection time,
•
Indexes of contractility: velocity index , acceleration index
•
Heart rate
Following parameters can be calculated:
•
Stroke volume, cardiac output
•
Heather index
•
Systolic time ratio
•
Systemic vascular resistance (requires blood pressure value)
•
Left cardiac work (requires blood pressure value)
With reference to body surface area the following indexed parameters can be calculated:
•
Stroke volume index, cardiac index
•
Systemic vascular resistance index
•
Left cardiac work index
The CardioScreen®-device can be used for following clinical applications:
•
Non-invasive monitoring of the above haemodynamic parameters including trend analysis
•
Determination and checking of the haemodynamic state of a patient including management of heart failure and hypertension therapy
•
Cardiologic diagnosis using haemodynamic parameters and waveform
shape analysis
•
Providing haemodynamic data that may facilitate pacemaker optimization
Additional information and a detailed description of the measuring method, the
parameters, the application of impedance cardiography, and its limitations are
given in the software manual.
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1.2
Precautions and limitations
The CardioScreen®-device allows the examination of adult patients in a resting
position. The measured parameters can be used only if the ECG and ICG waveforms have sufficient signal quality and are without artefact. If the waveforms are
of questionable quality, display the “Waveforms” screen of the niccomo -software and ensure that the key reference markers on the waveforms are accurately
placed. Note the hints in the software manual.
TM
The method of impedance cardiography (ICG) is based on a theoretical model of
blood flow movement in the thorax (aorta). If the physiological and clinical conditions of the patient are not in accordance with the assumptions of the model, inaccuracies in the parameters may occur.
The following conditions may adversely affect the accuracy of ICG systems and
are relative contraindications for the use of ICG systems:
•
Septic shock
•
Aortic valve regurgitation and defect of septum
•
Severe aortic sclerosis, aortic prosthesis
•
Severe hypertension (MAP > 130 mmHg)
•
Tachycardia with a heart rate higher than 200 bpm
•
Patient heights below 120 cm (48″) or above 230 cm (90″)
•
Patient weights less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
•
Patient movement
•
Aortic balloon or aortic balloon pump
•
Simultaneous use of electrical cautery systems during surgical procedures
The CardioScreen® may be used to examine infants with limitations because of
insufficient comparable data. All measured values should be handled with care.
Especially absolute values are not sure; relative changes should be preferred.
1.3
Safety instructions
1.3.1
General information
According the Medical Device Directive (MDD) the CardioScreen®-device belongs to class IIa and, therefore, can be used for the monitoring of a patient if the
change of the measured parameters cannot cause immediate danger to the patient.
The Federal law requires that the CardioScreen®-device should be used only by or
on the order of a physician. Generally, all persons using the device must be qualified and understand the measuring method and the operation of the device.
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1.3.2
Safety instructions
The CardioScreen®-device may only be used with the delivered medial wall
power supply!
The CardioScreen®-device belongs to the application class BF (Body Floating).
Therefore, the sensors can be freely placed on the body surface, but a direct contact with the heart or vessels is not allowed.
The sensors should not have a direct contact to other electrically conductive materials.
Before monitoring patients with pacemakers, ensure that the function of the
pacemaker cannot be influenced by the measuring current used for impedance
cardiography. In the case of minute ventilation pacemakers the use of the CardioScreen®-device is not allowed if the minute ventilation function of the pacemaker
is activated.
If you monitor the patient when he is exposed to high-frequency current, please
consider that the ICG signals may be disturbed because of interferences.
The cables for impedance cardiography are protected against cardiac defibrillations.
Handle the patient cable and lead wires carefully and position them so that they do
not cross over each other or other cables or power cords to avoid signal interference.
The measuring unit should neither be placed on a surface, which emits heat nor
exposed to direct sunlight.
The device is not protected against splashing water. Therefore, do not operate in
bathrooms or other areas where water damage is possible.
The device is not protected against explosion. Therefore, users must not use the
device near any substances, which are flammable or combustible (for example,
anaesthetics, solvents, etc.).
To ensure that the measurement system functions safely, do not subject it to high
levels of humidity or to strong electrical or electromagnetic interference fields.
Only cables or components specified and allowed by the manufacturer should be
used to connect to the inputs and outputs of the device.
The measurement system must always be kept in safe and reliable working order
and must be checked regularly.
The device can only be used in combination with a PC. Therefore, the safety requirements in section 3.3 on page 14 must be consulted!
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1.4
Explanation of used symbols
Caution, consult accompanying documents!
Device type BF, Defibrillator-proofed
Insulation class II
USB-Connector
D.C. Voltage input 7.5V
9
2 Description of the device
2.1
Basic device
On the front side there is the green status indicator LED (1) located which gives
information about the device. This LED is active if:
the CardioScreen® is connected properly and the niccomo -software runs.
You may start a measurement.
TM
or:
the CardioScreen® is connected to the power supply, but the USB-cable is
not connected.
Also on the front side is the socket for the ICG patient cable (2) located. The use
of other cables is not allowed.
The patient cable is colour-coded as well mechanically coded. Please note that the
mentioned socket may only be connected to patient cables, which are made for the
CardioScreen®-device. All the plugs are self-locking. When the plug is inserted
the connection is secured and can be loosened by pulling the outer casing of the
plug. These cables can be disconnected only holding onto the outer casing of
the plug and pulling it out. Never attempt to rotate the plug while it is in the
socket.
Figure 2
Figure 2: Front view of the CardioScreen® 1000
(1) Status indicator LED
(2) Socket for the patient cable
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Figure 3
Figure 3: Back view of the CardioScreen® 1000
(3) Socket for the USB-interface
(4) Socket for the medical wall power supply
The connector 3 may only be connected to computers and must not be connected to other medical devices.
The device may only be used with the delivered medical wall power supply!
The type plate is located on the bottom side and lists important information about
the device, including the serial number of the device. The serial number will be
needed to obtain technical service assistance and warranty repairs.
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2.2
Patient cable
The patient cable is a small box, which includes a cable splitter (Figure 4) with
integrated electronics.
Figure 4
On the outside of the box two small LED's (green and orange) display the current
function of the patient cable, as indicated below:
LED
level
description of function
green and orange
off
the electronic part of the patient cable is not
connected with the power supply; cable is
disconnected or the device is switched off
green
flashes
patient cable is ready to use, but the
measurement has not started
green
on
measurement is running
orange
on
bad contact between sensors and patient: at least
one lead wire is disconnected or not properly
fixed; sensors are too dry (new sensors are
necessary)
orange
flashes
patient cable has power but the PC-software
cannot access the cable; PC-software has not
been started or is not ready for measurement
Table 1
The application of the sensors and the connection of ICG cable are detailed described in the software manual.
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3 Commissioning of the device and preparing
a measurement
3.1
Commissioning of the device
To place the CardioScreen®-device into operation carry out the following steps:
1. The device should be placed near the patient and fixed in such a way that
the device cannot fall down if someone pulls on the cables. Note that all
devices, which are placed in the patient environment of 1.5 m must meet
the needs the regulations of the MDD (see also section 3.3).
2. Connect the device with the mains supply and switch it on.
3. Connect the device with the computer using the USB-interface.
4. If the device is connected to the computer the first time, it may be possible
that you will be prompted to install the USB-driver (see section 3.2).
5. Connect the patient cables with the CardioScreen®-device and apply the
sensors to the patient. Please note the hints in the software manual. The
LED’s at the patient cable show the functional state (see Table 1).
6. Launch the niccomo -software. Choose as type of measurement “Impedance cardiography with cardioscreen 1000”. Before starting the measurement, the patient data must be entered. Please note also the hints in the
software manual.
TM
7. At the end of the measurement, go back to the patient data screen in the
niccomo -software and stop the measurement before switching off the device and removing the sensors from the patient.
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3.2
USB-driver installation
If the CardioScreen®-device is attached for the first time to a computer, then it is
recognized as new equipment and the “Found New Hardware Wizard” is started
(see Figure 5). Please put the provided software CD into your CD-ROM drive and
wait a few seconds, until the computer recognized the CD. Keep the selection
"software automatically install (recommended)", and press Next > .
Figure 5
Ignore the next dialogue by clicking onto Continue Anyway . Please wait, until
Windows copied necessary files and the message appears that the equipment is
ready for use now.
3.3
Safety requirements
The CardioScreen®-device may only be used with a medical wall power supply!
The CardioScreen®-device can only be used in combination with a PC or a notebook and a printer. Connecting these devices together constitutes a medical system device, which must be in accordance with the norm DIN-EN-60 601-1-1 (IEC
601-1-1).
For the compliance with these requirements the installer of the system is responsible.
The positioning of the system and its components regarding the patient is especially important. All devices, which are positioned in a distance less than 1.5 m
from the patient are treated as medical devices and must be in accordance with the
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requirements of medical systems. This is also valid for the computer and for connected printers. It must especially be ensured that the leakage current does not
exceed safety standards (also under failure conditions). This should be measured
and filed.
If the limits are exceeded special arrangements have to be taken. For instance, an
isolating transformer can be used or the computer can be positioned further from
the patient.
If a computer network should be connected, the safety requirements should especially carefully be considered, because the network may build an electrical connection (or an isolated connection with a lower isolation barrier than required) to
other devices.
Attention! This section deals only with some important aspects regarding the
safety of a medical electrical system and cannot be considered as a replacement of
the study of the DIN EN 60 601-1-1 (IEC 601-1-1).
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4 Maintenance, cleaning and disinfection
4.1
Maintenance
The CardioScreen®-device is a self-calibrating system so that external calibration
is not necessary. The proper function of the system can be checked using a special
signal generator (part no. N1101).
The measurement system must always be kept in safe and reliable working order
and should be checked regularly, at least once a year. The check should cover a
function test and the measurement of leakage currents (see DIN VDE 0751).
If you discover that the measurement system is faulty and/or unsafe (for example,
if any of the lines have insulation or breakage defects), repair the system and/or
replace faulty cables immediately.
Repairs may only be carried out by persons or workshops authorized to do so by
the manufacturer. Otherwise, general liability for improperly operating the measurement system and for injury, damage and consequential damage resulting therefrom will be passed on to the operator or to the persons or workshops that have
not been expressly authorized by the manufacturer.
4.2
Cleaning and disinfection
It is recommended to clean and to disinfect the device and its cables regularly.
Warning! Before cleaning or disinfecting the measuring unit, disconnect the unit
from the wall power supply by pulling it out of the wall socket.
Clean the unit and the cables with a soft cloth. Do not use any abrasive or corrosive substances. We recommend neutral cleaning agents or disinfecting substances,
like ethanol (70 – 80 %), propanol (70 – 80 %) or aldehyde (2 – 4 %).
Ensure that no disinfectant gets onto the contact points of the plugs and sockets,
and that no liquid seeps into the device.
Caution! Never gas-sterilize the patient cables. They are covered with a PVC
shroud that can react with the gas-sterilization procedure to form a highly toxic
ethyl nitrite.
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5 Technical Data
Power supply
medical wall power supply:
90 – 264 V AC, 50 / 60 Hz
Power input
<8W
Electrical safety
IEC 601-1 (EN 60 601-1)
MDD class IIa, insulation class II,
Classification for patient protection BF
Electromagnetic compatibility
DIN EN 55011 - class A
DIN EN 60601-1-2
Insulation voltage
Patient – Main supply: 4 kVeff ; 1 min; 50 Hz
Patient – Signal I/O: > 1.5 kVeff
Dimensions (W x H x D)
175 x 55 x 197 mm
Weight
approx. 0.5 kg
Signal I/O
USB interface
Operating conditions
Temperature
10 – 40 °C
Humidity
30 – 75 %
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Measuring channels
ICG (impedance cardiography)
Measuring principle Bioimpedance-plethysmography
defibrillator safe
Sensors
4 medis-ZTECTTM disposable sensors (solid gel)
Measuring current
1.5 mAeff ; 85 kHz; Sinus
Basic impedance
0 – 60 Ω; 0 – 5 Hz
Pulse wave
±1 Ω; 0.2 – 100 Hz
ECG (non-standard ECG over ICG-sensors)
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6 Scope of delivery
To the scope of delivery of the measuring system CardioScreen® 1000 the following components belong:
•
Measuring device CardioScreen® 1000
•
Medical wall power supply
•
USB cable
•
Patient cable
•
Operating manual for the measuring device
•
Software manual
•
Software-CD with the niccomo -software
TM
The necessary computer is not a component of the scope of delivery. Please consider the safety-relevant requirements in section 3.3 when connecting a computer.
If you have any question our support is at your disposal.
medis-ZTECTTM sensors can be ordered with the part number N1201.
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7 Medis Standard / Extended Warranty
Medis Medizinische Messtechnik GmbH („Medis“) warrants that the niccomo monitor or CardioScreen® ICG System („System“) and the System Software
(„Software“) shall be free from errors / defects in materials, workmanship, and
programming that cause the System not to function in accordance with the accompanying written specifications provided with the System at the time of installation. Medis will provide this Standard Warranty on each System for a period of
thirteen (13) months from the original Medis invoice date. This Standard Warranty shall exclude the System external patient cable(s) and (if applicable) the
external inflatable blood pressure cuff(s), hose(s) and sensors, which shall be covered under warranty for ninety (90) days from the original Medis invoice date.
Medis’ and/or its Distributors’ liability and obligation, and the End User’s sole
remedy shall be, at Medis’ option, to either repair or replace software and/or System or any part thereof. It is the responsibility of the End User to notify Medis or
Medis’ Distributor (if Medis requests the End User to notify its Distributor) by
telephone or in writing of any problem experienced by the End User within the
thirteen (13) month Standard Warranty Period and no later than thirty (30) days
after the expiration of the warranty period. This Standard Warranty does NOT
apply to dual sensors, fuses, ink cartridges or other consumable or disposable
items that are used in conjunction with the System.
TM
An Extended Warranty is available for sale, which provides the same warranty
coverage as the Standard Warranty in twelve (12) month increments. Under Extended Warranty, the System external patient cable(s) and (if applicable) external
inflatable blood pressure cuff(s) and hose(s) are not covered.
Standard / Extended Warranty Coverage:
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•
Customer / Technical Support is available Monday through Friday, 8 a.m.
to 5 p.m. German Time, at +49 - 36 77 - 46 29 - 0.
•
Medis will repair or replace any components of the System that cause the
System to not function in accordance with the written materials provided
with the System at time of sale.
•
Medis will provide free shipping and freight charges for warranty repairs
performed at Medis or a Medis Authorized Service Centre.
•
Medis will provide subsequent operational software upgrade disks and installation instructions at no charge to the customer.
Standard / Extended Warranty Service is void if:
•
The System and/or Software has been maintained, repaired, modified or
altered by any person other than an authorized Medis representative or
without prior approval from an authorized Medis representative.
•
The System and/or Software has not been properly operated or maintained
in accordance with Medis’ then applicable written operating and maintenance manuals.
•
The configuration of the System and/or Software has been altered by, but
not limited to, the addition of any other computer software to the System.
•
The failure of the System and/or Software has resulted from accident,
abuse, or misapplication.
•
Note: There are no user-serviceable components in the niccomo -monitor
or CardioScreen® ICG system.
TM
All units must be returned to Medis or a Medis Authorized Service Centre for
repair or replacement.
Medis does not warrant (either expressed or implied) the correctness or validity of any output information or data provided by the System, including,
but not limited to, any information relating to any medical diagnosis/treatment or to the health and safety needs of patients. Medis does not
warrant that any output of the System will meet the standards or requirements of the End User’s medical practice. End User expressly acknowledges
that End User is solely responsible for verifying that any results produced by
the System are free from error and suitable for the applications for which
they are to be used.
Medis and its authorized Distributors shall not be liable for any special, incidental,
indirect or consequential damages arising out of the use of or inability to use the
System. Under no circumstances shall Medis and its Distributors’ liability under
this Limited Warranty exceed the purchase price of the System and/or Software
paid by the End User.
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8 Troubleshooting
The following overview serves for fast diagnosis and remedy of smaller problems.
If a problem should exist further, then contact, please, your dealer or the technical
support:
E-mail
Phone
Fax
Mail
support@medis-de.com.
+49 - 36 77 - 46 29 - 0
+49 - 36 77 - 46 29 - 29
medis. Medizinische Messtechnik GmbH
Werner-von-Siemens-Strasse 8
D-98693 Ilmenau
Germany
The status indicator LED (Figure 2, Pos. 1) is off.
If the CardioScreen®-device is connected, but not measurement takes place, the
status indicator LED is off.
If the niccomo -software runs and detected the CardioScreen®, the LED goes on.
Furthermore the LED is on if the CardioScreen® connected to the wall power supply but the USB cable is not connected.
TM
If the LED if off despite removed USB cable, examine please whether the medical
wall power supply is correctly attached.
A measurement cannot start because of the button Start in the niccomo software is disabled (grey).
TM
The niccomo -software did not find the CardioScreen®-device. Please check the
following points:
• Main mistake: The patient cable is not connected to the CardioScreen®.
Please guarantee that the locking plug snapped in!
• Please check if the examination type „Impedance cardiography with
cardioscreen 1000“ is selected in the niccomo -software.
• Check, if the USB cable is connected correctly.
• Remove the USB cable to test, if the status indicator LED goes on.
Otherwise the medical wall power supply is not connected or defective or
the CardioScreen®-device out of order.
• Is the USB driver correctly installed? Please look at the Windows device
manager to see if the “medis. Medical Device” is available (Figure 6).
Otherwise do the following: Insert the delivered CD into your CD-ROM
drive. Remove the USB-cable for a few seconds and re-connect it again.
Then Windows asks you to install drivers for a newfound hardware. Please
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follow the instructions in section 3.2 on page 14. If the installation of the
driver fails or if the hardware wizard does not appear, your USB adapter
might be not or wrongly configured or in the BIOS of the computer not
enabled.
Figure 6
The USB driver is already installed. Nevertheless Windows identifies the
Cardio Screen® 1000 as new equipment and requests you to install the driver.
Probably you disconnected the CardioScreen® from the computer and connected it
later again to another USB channel of your computer. It is normal that you are
requested to install the driver again. Even if you attach a further CardioScreen®,
Windows requests to install the driver again Please look at section 3.2 on page 14
to install the driver again.
23
The examination type „Impedance cardiography with cardioscreen 1000“ is
not available or can not be selected.
The serial number of the niccomo -software is wrong. Please click onto the button F5 Options in the patient data screen and compare the serial number in the
program with the serial number which is printed on the delivered software CD.
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