User Manual CardioVex Holter
User Manual CardioVex Holter
User Manual CardioVex Holter
ar
MUC-HOLTERVEX/E 11-08 1 of 51
Copyright 2007 CardioVex. All rights reserved. It is forbidden the reproduction or copy, in any way, of this
manual or its parts without the permission of CardioVex.
CardioVex does not take any responsibility for personal injuries or for the illegal or inadequate use of this
product, which could be caused by its use in conditions that are not according to the instructions, warnings,
or the statement of use published in this manual.
CardioVex, MMC10L and MMC10D are commercial labels of Veccsa S.A.
SD is a commercial label of Toshiba.
The software of this product is Copyright 2006 of CardioVex or its suppliers. All rights reserved. The
software is protected by the legislation of intellectual property of the United States of America and by
dispositions of international treaties that apply worldwide. By virtue of the mentioned legislation, the owner
of the license is authorized to use the copy of t he software provided with the product in the foreseen way for
the functioning of the product in which it is integrated. The software cannot be copied, technically inverted,
dismantled or reduced, in any way, to a form perceptible by human being. It is not a sale of the software or
of a copy of it; all rights, titles and property of the software remain being property of CardioVex or its
suppliers.
For information on any CardioVex product, contact CardioVex's Centre of technical assistance.
VECCSA S.A.
Juramento 5841
(C1431CLA) Buenos Aires
Argentina
Tel.: (5411) 4572-7004
Fax: (5411) 4572-0045
www.veccsa.com
www.cardiovex.com.ar
Use instructions
The CardioVex Holter System has been designed to obtain, in ambulatory form, ECG signals from the
patients. The patients are people wi th possible or already detected coronary problems. This
electrocardiograph for ambulatory use and its system of associated analysis can be used with any patient,
regardless of gender or age.
The procedure of the Holter recorder is one of the many tools do ctors use to detect rhythmic anomalies in
the ECG, both infrequent and caused by his normal activity. The indications of the Holter recorder are listed
as follows:
• Arrhythmias
• Thoracic pain
• Idiopathic syndrome
• Dyspnea
• Palpitations
• Evaluations of a pacemak er
• Regulation of anti-arrhythmic medicines
• Evaluation of a patient after suffering a myocardium infarction
• Family precedents of cardiac problems
Class II device
Manufacturer data:
VECCSA S.A.
Juramento 5841 (C1431CLA) Buenos Aires – Argentina
Technical Director: Daniel Taboh
Fragile, crystal
Serial number
Fulfils or exceeds the stipulations of the Council Directors 93/42/CE in relation to the
sanitary products, Class IIa
Warnings
The warnings in this manual identify situations or pr actices which, if not corrected or stopped immediately,
can produce injuries, diseases or even the patient's death.
WARNING Safety — Remove the electrodes, the leads and the recorder from the patient
before using a defibrillator.
WARNING Safety — The conducting parts of the electrodes and their corresponding
connectors of type BF or CF pieces applied to the patient, included the neutral electrode,
must not be in contact with other conducting pieces, included the ground connection.
WARNING There is a possible danger when various equipments are interconnected to the
patient, caused by the sum of leak currents.
WARNING Safety — Always check the recorder and its accessories before using it.
WARNING Safety — The equipments and peripheral accessorie s in touch with the patient
must comply with all the safety and electromagnetic compatibility (EMC) requirements, as
well as the applicable regulations.
WARNING Fire risk — Use alkaline AA batteries when replacing the batteries. Observe
polarity.
Precautions
The precaution warnings of this manual identify sit uations or practices that, if not corrected or stopped
immediately, could cause a failure in the equipment, damages to it or loss of data.
Precaution DO NOT use acetone, ether, freon, substances derived from oil or other
solvents to clean the recorde r.
Precaution DO NOT let the battery contacts or the electrode wires be in touch with water
or soup.
Precaution DO NOT submerge the recorder or the wires, and do not sterilize with
autoclave or steam cleaning.
Characteristics
All models:
Are light and small so as to be comfortable for the patient.
Have an “events bottom” tha t the patient can press to indicate events they consider important.
Information about the system's state: LED (MMC10L) or LCD screen (MMC10D).
Secure Digital extractable memory card where the ECG is stored during a minimum of 24 hours, and
for the transfer of the ECG data.
Work with 1 (one) alkaline AA battery.
Have extractable electrode wires.
MMC10D:
The LCD window shows the ECG curve to guarantee the correct connection of the electrodes.
Shows the time.
Indicates when the battery charge is not enough to complete the recording.
Indicates if the memory contains a previous study.
Indicates errors in the memory.
MMC10L
Recorder
LCD
Display
MMC10D
Recorder
SD card
reader
SD memory
card
Figure 1
WARNING Before using it each time, check the wire and the electrode wires
connected to the patient, the LED or the LCD display and the enclosure
of the recorder to see if there are any fissures or fractures. See the
“Maintenance” section for more information.
2. Remove the battery lid from the recorder (see “Recorder illustrations”).
3. Insert the Secure Digital card in the recorder's Secure Digital port, located on the inferior part of the
device (see Figure 1).
5. Place the battery lid back on the recorder and press the button until the LED turns off.
Finally the LED stays on blinking intermittently until the battery is withdrawn. If the LED blinks yellow (with
any sequence), see “Solving problems”.
MMC10D — The recorder will show an initial screen, the LCD screen w ill show the present date and time,
and the recorder's serial number. The recorder turns on the SD memory and starts the channels test
monitoring the ECG signal, a few seconds each channel to verify that the electrodes are correctly
connected. The display also indicates if the battery charge is right and if the memory has a previous study
or errors. If it does not show the time and shows an error code, see “Solving problems”.
7. Put the recorder inside the carrying case. Place the recorder with the carrying c ase on the patient.
8. Write down the start time, date and information about the patient on the patient's diary.
To turn off the recorder (if it has not turned off automatically) it is necessary to to press the button of
EVENTS during 2 seconds and the recor der will turn off or remove the battery lid from the recorder.
Patient preparation
Patient preparation for the Holter procedure
During the appointment, tell the patient the following:
Not to remove the electrodes or disconnect the wires.
Not to wet or shower while the recording process lasts.
To attend the appointment with loose, comfortable clothes (shirt and trousers or blouse and skirt
rather than one-piece suits).
WARNING Safety — During the placing and removal of the recorder, leave free an area of
1.5 m around the patient.
WARNING Safety — Do not connect external devices to the recorder. The electrode wires
must only be connected to the recorder.
WARNING Safety — Keep the recorder and the patient's cable clean, specially the
components that are in touch with the patient.
WARNING The conducting parts of the electrodes and the associated connectors for the
applicable BF type parts, including the neutral electrode, must not be in touch with other
conducting parts, including the ground.
Precaution Check that the accessories that are to be used have not expired.
Precaution Always check that you are using the right electrode positioning for the
configuration of the selected wires.
Precaution The ECG electrodes could cause irritations to the skin. Examine the patient's
skin to see whether he presents signs of irritation or inflammation and, if he does, do not
place the electrodes on the affected areas.
Try to make the patient feels comfortable. The patient preparation is important for a correct Holter
procedure.
1. Describe the procedure to the patient.
2. Prepare the spots where you will place the electrodes. See Figure 4 on page 12, Placement of the
electrodes.
3. If necessary, shave the area where the electrodes are going to be placed.
4. Clean the spots of application of electrodes with alcohol.
5. Let the spots of application of electrodes dry.
Physician’s tasks
Explain to the patient:
the recording procedure;
how to record information on the patient's diary;
how to use the event button;
that he must avoid the contact with water.
Connector
Conector
HOLTER
HOLTER Cable Porta Electrodo
Electrode wire
R
If the product does not work correctly, or if it needs parts replaced or technical assistance, contact the
CardioVex's nearest technical assistance Centre. You will find the telephone numbers on page 2.
Before contacting CardioVex, try to reproduce the problem and check all the accessories to make sure they
are not causing the problem. When making the call, have the following information ready:
Name of the product, model number and full description of the problem.
Serial number of the product.
Name, address and phone number of y our centre.
In the case of off warranty reparations or requests for spare parts, a credit card number.
To request for spare parts, the number or numbers of the part or parts needed.
If the product requires technical assistance, you should first of all cal l CardioVex's nearest technical
assistance centre. A representative will help you identify the problem and will try to solve it on the phone, to
avoid unnecessary returns.
If you need to return articles for servicing, follow these recommended instructions to pack them:
Remove all the wires, sensor and accessories (as necessary) before, unless you think they might be
related to the problem.
If possible, use the shipping box or the original packaging.
It is recommended to insure all the returned articles. T he claims for loss or damage of the product will have
to be presented by the sender.
Precaution DO NOT use acetone, ether, freon, substances derived from oil or other
solvents to clean the recorder.
Precaution DO NOT let the battery contacts or the electrode wires be in touch with water
or soup.
Precaution DO NOT submerge the recorder or the wires, and do not sterilize with
autoclave or steam cleaning.
Cleaning instructions
o Remove the battery and close the battery lid.
o Clean the exterior of the Holter recorder and the accessories with a wet cloth. Use a soft
detergent diluted in water.
Recorder inspection
WARNING Always check the cable, the elect rode wires, the LED or the LCD screen and
the enclosure of the recorder to see if there are any fissures or fractures before using it.
1. Check the cable and the electrode wires, the LED or the LCD screen and the
enclosure.
2. Make sure that the patient's cable is fully inserted.
Length 76.25 mm
Width 83.50 mm
Height 17.60 mm
Weight (batteries and
200 g
patient's cable included)
Table 3. Functioning
Regulations
International Electrotechnical Commission
Table 6. Accessories
Connection: USB
Type of Port USB 1.1 or 2.0
SD Card Reader
Type of Memory: SD
System Windows 2000 SP4, XP SP1, SP2
Requeriments: or VISTA
Type of Extension A to A
USB Extension Maximun Voltage 30 V
Length: 1,80 m
Radiofrequency emissions Group 2 The CardioVex Holter recorder emits electromagnetic energy to
CISPR 11 carry out the function it has been designed for. The electronic
equipment in the area could be affected .
Radiofrequency emissions Class B The CardioVex Holter recorder is suitable to be used in any kind of
CISPR 11 location, including domestic locations. The recorder does not
include a connection to the public low voltage supply network.
Harmonics emissions Not applicable
IEC 61000-3-2
Tension fluctuations/intermittent Not applicable
emissions IEC 61000-3-3
Electromagnetic immunity
The Holter recorder has been designed to be used in the electromagnetic environment indicated as follows.
It is the client's or the user's responsibility to ensure the environment is according to the requirements.
Immunity test Test level ICE 60601 Conformity level Electromagnetic environment - Guide
Electrostatic ±6 kV contact ±6 kV contact The floor must be wood, cement or ceramic. On
discharge (ESD) IEC ±8 kV air ±8 kV air floors made of synthetic materials, the relative
61000-4-2 humidity must be 30% minimum
Conformity
Immunity test Test IEC 60601 Electromagnetic environment - Guide
level
Conducted 3 Vrms 3 Vrms The mobile and portable communication
radiofrequency 150 kHz to 80 MHz systems based on transmission by
IEC 61000-4-6 radiofrequency must be used at a distance
from the Holter recorder and the cables that
Irradiated 3V/m 3 V/m is not less than the recommended separation
radiofrequency 80 MHz to 2.5 GHz distance, calculated from the equation
IEC 61000-4-3 applicable to the transmitter 's frequency.
Note 1: at 80 MHz and 800 MHz the superior frequency range is applied.
Note 2: these directives might not be applicable in all situations. The electromagnetic propagation is
affected by the absorption and the reflection of structures, objects and people.
a The field intensities generated by static transmitters, as well as the base units for radiophones (mobile /
wireless) and radiomobile earth stations, ham radio operators, AM and FM radio and TV can not be
precisely predicted from a theoretical point of view.
To assess the intensity in an electromagnetic environment generated by static RF transmitters, it would be
advisable to carry out an electromagnetic verification in situ. If the field intensity measured at the point
where the Holter recorder is used exceeds the RF applicable compatibility level previously indicated, the
recorder will have to be revised to make sure it is working correctly. If an anomalous behaviour is observed,
supplementary measures such as a change in orientation or in the position of the recorder might have to be
taken.
b For frequency ranges superior to 150 KHz – 80 MHz, the electromagnetic fields intensities must be
inferior to 3 V/m.
Recommended separation distan ces between mobile and portable RF communication devices and
the Holter recorder
The Holter recorder must be used in electromagnetic environments in which the irradiated RF interferences
are controlled. The client or the user of the Holter recorder can co ntribute to the prevention of
electromagnetic interferences by keeping a minimum distance between the mobile/portable RF
Juramento 5841-(1431) Bs. As. Argentina-Tel.4572-7004-Fax:(5411) 4572-0045 – [email protected] – www.cardiovex.com.ar
MUC-HOLTERVEX/E 11-08 20 of 51
communication device (transmitter) and the Holter recorder, as recommended as follows, calculating the
distance depending on the maximu m output power of the communication device.
For the transmitters with a maximum output power level not indicated in the table above, the recommended
distance of separation d in metres (m) can be determ ined using the equation applicable to the transmitter's
frequency, where P is the transmitter's maximum level of output power calculated in watts (W), according to
the transmitter's producer.
Note 1: at 80MHz and 800MHz the superior frequency range is app lied.
Note 2: these directives might not be applicable in all situations. The electromagnetic propagation is
affected by the absorption and the reflection of structures, objects and people.
CardioVex commercializes this product with the warranties expressed in the following paragraphs . These
warranties are only for the final user, as long as he has bought the product from CardioVex or authorized
distributors as a new product.
During a period of 1 year starting on the original delivery date to the customer, it is guaranteed that the
software and hardware components of the recorder have no functioning defects because of materials and
working force, and are in all the material aspects according to the description of the product contained in the
Use instructions and in the labels and broch ures included. CardioVex also warranties the accessories
provided (patient's cable included) during a period of 3 months. The warranty for the accessories acquired
separately through registered suppliers will be the responsibility of the registered supplie rs.
This warranty is valid only if (a) the whole equipment has been approved by CardioVex to be used with the
recorder and has been installed following the instructions provided by CardioVex or its authorized
distributors; (b) the product is correctly hand led in normal operating conditions, according to the regulation
and applicable safety requirements; (c) the substitutions and reparations are carried out according to the
instructions provided by CardioVex; (d) the CardioVex recorder and the software are u sed in a workstation;
(e) the product has not been configured, modified, adjusted or repaired by anybody else other than
CardioVex or people explicitly authorized by CardioVex, or according to the written instructions provided by
CardioVex; (f) the product was neither been incorrectly or negligently used, nor has it suffered an accident.
It is CardioVex's only and exclusive obligation, and the customer's only and exclusive solution under the
previously expressed warranties, the reparation or replacement, fr ee of charge, of a product notified to
CardioVex through the customer service, through the phone numbers listed on page 2. CardioVex will not
be in any way responsible for any damage, included, among others, the accidental ones, either resulting or
special.
There are no expressed or implicit warranties that extend the warranties mentioned in this document.
CardioVex does not offer any warranty of commercialization or adequation to a particular purpose.
If you wish to use an extra SD memory card remember it must have a minimum 128 Mb capacity.
NOT complying with these requirements can cause the malfunctioning of the software.
Software installation
To install the software, insert the CD in the corresponding unit and a menu like the one shown below will
appear:
You will have to communicate with the supplier of the software to request for a Registration Code that will
generate from the Registration Number appearing on the window above.
Once the software has been installed, if you have WINDOWS 98 you will need t o install drivers for the
memory card reader; for this, go back to the menu on the CD and select READER DRIVERS to proceed to
install the SD card reader drivers.
System configuration
Access the system configuration from the options menu on [Configure]. T o configure the institution and the
physician data access [Institution data...].
From a configuration window you can define the heading that will be printed on the pages of the report.
The [ECG gain...] option allows to adjust the ECG size either before entering the study into the system or
once it has already been analyzed.
With [Beat colours...] the user can select a colour for each type of beat.
Events
The recorder has a button to register, parallel to the ECG signal, any event the patient wants to notify the
doctor about. The button is located on the front of the recorder as indicated in Figure 1.
After recording the patient's ECG for 24 hours, the next step is the transfer of data to the PC so it can be
processed.
Once the patient's data has been completed, the system is ready to start downloading the data from the
recorder.
Click on [OK] and the system will be ready to start downloading. Just click on [Start] and the recordings will
be transferred to the PC. A bar will show the download percentage.
Studies organizer
With this window the user can save the study in a compressed format (ZIP) for back -up purposes or to
transfer the recordings from one PC to another.
Data processing
Processing the data on the recording
Once the study has been acquired, you can carry out a pre -processing. This has the possibility of:
Data Editing
Data Editing
The downloaded study editing is implement ed through a navigation menu located on the upper part of the
screen.
ECG
On the ECG display, the recording can be looked over w ith the cursors or the keyboard ( ←, ↑, →, ↓, Re.
Page, Av. Page) and with the + and – keys you can expand or reduce the temporal scale.
The upper part of the ECG contains a bar with buttons that allow you to select the channel you want to
visualize.
On the same bar there is the possibility of selecting the time and defining the millivolts per cm scale.
The “Annotations” check box disables the visualization of the identified spots in each ECG complex.
The [Save event…] button allows to save the strip visualized on screen to be printed later.
A CF is associated to each beat, that results from averaging the RR of the previous 10 beats so
that:
the beat is not a pause (RR must be less than 2 seconds)
the beat is not premature (RR must b e more than 70% of the average RR)
the beat is not compensatory (RR must be less than 140% of the average RR)
When a beat has RR longer than a number of seconds determined by the user, it is considered a
pause. The default value is 2 seconds.
In this window, the user can adjust the Isoelectric Le vel, J Point and Measurement interval cursors for each
channel and so recalculate the ST segment measurement. Once the cursors have been adjusted, click on
[Start] and a bar will indicate the recalculated percentage.
The cardiac rhythm range and the range of shifting and/or inclination values during each episode are not
reported.
Morphologies
Here all the morphologies identified by the system in the study can be revised. The system divides the
morphologies in groups of classified, unclassified and deleted beats. The classified beats group contains the
normal, ventricular, supraventricular beats, and others.
The ECG display and the data of the selected beat can also be visualized.
When selecting, for example, a group of normal beats, the beats in the selected group will be shown on the
right panel.
1. Select a group and reclassify al l the beats associated to the respective grouping. (Select the group
and press the right button on the mouse).
2. Select a beat in a group and reclassify it. (Select a group and a beat and press the right button on
the mouse).
If you want to reclassify a group or a beat you have the option of deleting it or reassigning it to another
morphology. The deleted groups or beats will be assigned to the deleted beats group, where you have the
possibility of visualizing and reclassifying them in case you have made a mistake.
Arrhythmias
Here you can visualize the arrhythmias and select the type of arrhythmia, such as ventricular pairs,
ventricular runs, bigeminy #, trigeminy #, supraventricular pairs, supraventricular ru ns and pauses. Selecting
the type of arrhythmia on the right panel you can visualize at what time it occurred, and selecting the time
the system will automatically show the event on the ECG display.
Events
Here you can edit all the saved events to print them later.
PR Analysis
This window shows the tendency graphs for the PR interval in each channel.
Updating Results
This button is for updating the data reflected on the graphs and tables, in case changes have been made to
the classification.
However, the system has the option of updating the data automatically. This configuration is activated by
clicking on “Automatic updating of the data”, in the Configuring menu.
Over the last years, the relation that exists between the functioning of the autonomic nervous system and
cardiovascular mortality has been recognized. This has motivated the search for quantitative mar kers of the
autonomic balance. The Heart Rate Variability (HRV) represents one of the most promising ones. The HRV
is defined as the variation that occurs in the time interval between consecutive beats and it has been
proposed that its behaviour depends on the autonomic modulation, as well as its implications on
cardiovascular mortality. To evaluate HRV, the tachometer (recording of cardiac frequency over time) is
analyzed. The study of HRV started about 30 years ago, and has gained more importance over the last 10
years. There are various methods to analyze HRV. The most accepted nowadays are the methods of
frequency domain (spectral analysis). The spectral analysis consists in decomposing the tachometer, which
assimilates a complex wave, in a way that the spectral components are obtained, and high frequency (HF)
components related to the tone parasympathetic are found, one with low frequency (LF), related to both
sympathetic and parasympathetic modulation, and another one with very low frequency (VLF), whic h has
not been related to the autonomic nervous system. The time domain methods are basically statistic and
evaluate variability with averages and standard deviations. They are the most well known ones, but appear
to have fewer advantages than the spectral methods. The HRV is correlated to physiological adaptations to
changes in the internal and external environments and the presence of diseases. In this manual, the main
methods of analysis in the frequency and time domains that the CardioVex Holter 3 conta ins are explained,
in a summarized way.
Pressing on “24 hs. table. [Time]” in the navigation menu you can visualize the statistic data extracted by
the system in two different formats. The first one is the time table that shows an hour by hour summary, for
the 24 hours, and in sleep and vigil times. The second format is the 24 hour summary shown on the top
right side.
Subsequently a detailed summary is presented on the meaning of statistical and geometrical indexes:
Statistical Measurements
Variable Units Description
Some examples of the way the indexes re calculated are shown below:
SDNN = Standard deviation of all NN intervals in a 24 hour record. Note that in the next example, the mean
is equivalent to 846 msec and the SDNN is 107. In simple terms, the standard deviation is a way of
representing the distribution of values around the mean.
SDANN = Standard deviation of the NN intervals averages of 5 min segments, in a 24 hour record. Note
that in the next exam ple the mean of 6 5 min segments is equivalent to 846 msec and the SADNN is 103
msec. It is the deviation of the middle value obtained from middle values, and so it is always inferior to the
SDNN.
SDNN index = Averaged standard deviations of the NN intervals in 5 min segments, in a 24 hour record.
pNN50 = Total percentage of differences between adjace nt NN intervals greater than 50 msec.
Geometrical Measurements
Variable Units Description
The calculation of the geometrical indexes starts in the construction of the NN intervals histogram. The
value of the HRV index is obtained dividing the area of the D integral (density distribution) by the maximum
height of the Y=D(X) histogram. The TINN index (Triangular interpolation of NN interval histogram) is
obtained by calculating the difference between M and N.
To establish the N and M parameters, a method is implemented of optimization by minimum squares
between the NN intervals histogram and the q(t) function, where q(t)=0 for t=N, t=M and q(X)=Y (see figure
bellow).
Lorenz Graphs
The Lorenz graph is a map of points on Cartesi an coordinates, where each point represents on the
horizontal axis (abscissa) the preceding normal RR interval and on the vertical axis (ordinate), the next
normal RR interval (see following figure).
Pressing on “Graphs [freq.]” in the navigation menu you can visualize the spectral and tendency graphs for
every hour:
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MUC-HOLTERVEX/E 11-08 49 of 51
One of the representations is the 3D graph of spectral estimation, where in axis (1) it represents the
frequency, in axis (2) is represents the time and in axis (3), the power.
1) High frequency (HF) band oscillating around 0.15 -0.4 Hz, that is 24 cycles/min. This corresponds to the
frequency variations related to the respiratory cycle (respiratory sinus arrhythmia) and is also accepted as a
marker of activity in the parasympatheti c system.
2) Low frequency (LF) band oscillating around 0.04 -0.15 Hz, that is 2.4 a 9 cycles/min., modulated by both
the sympathetic and parasympathetic systems with sympathetic domain in some specific situations which
are reflected as oscillations around the baroreceptive system.
3) The Very low frequency (VLF) band (0.003 to 0.04 Hz, that is 0.2 to 2.4 cycles/min.) depends on the
thermoregulation mechanisms and the renin -angiotensin system, whose regulation also affects the
sympathetic and parasympathetic system.
4) The ultra low frequency (ULF) band (< 0.003 Hz, that is < 0.2 cycles/min.) which corresponds in its
greatest part to the total variance; its physiological meaning has not been defined yet.