User Manual Holter MMC10L - MMC10D - English

Juramento 5841-(1431) Bs. As. Argentina-Tel.4572-7004-Fax:(5411) 4572-0045 – info@cardiovex.com.
ar –
www.cardiovex.com.ar
MUC-HOLTERVEX/E 11-08 1 of 53
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 the 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
Juramento 5841-(1431) Bs. As. Argentina-Tel.4572-7004-Fax:(5411) 4572-0045 – info@cardiovex.com.ar –

Intented use 4
Use instructions 4
Symbols 5
Warnings and precautions 7
Warnings 7
Precautions 7
Introduction 8
Characteristics 8
Recorder illustrations 9
Functioning 10
Patient preparation 11
Patient preparation for the Holter procedure 11
Preparation to place the electrodes on the patient 11
Service policy 14
Maintenance 15
Cleaning the recorder and the patient’s cable 15
Recorder inspection 15
Checking the recorder 15
Storage of the recorder 16
Elimination of the equipment 16
Technical specifications 17
Regulations 17
Accessories 18
Information on electromagnetic emissions and immunity 19
Solving problems 22
Limited warranty 23
Minimum system requirements 24
Software installation 24
System configuration 25
Starting the recording 28
Acquiring data from a recording 28
Studies organizer 30
Data processing 31
Data editing 32
Frequency variability 44

Intented use
Cardiovex Holter in its models MMC10D and MMC10L is an ambulatory System of electrocardiography
Monitoring with three independent channels. The registered ECG measurements are stored in a solid state
memory card SD continuously during 24 hours. In the MMC10D model, the quality of the signal and the
state of the battery and the memory are shown on the graphic LCD display, while in the MMC10L model it is
done through a sequence of lights with a LED. Once the data is registered, the card containing the
information is extracted from the recorder and connected to the reader device, where the data is transferred
to a computer for its analysis with the CardioVex Holter program; the device is now available for a new
study. The software automatically classifies the recorded beats, then the physician must verify this and
make the necessary corrections. The software allows the user to reclassify beats and/or delete false beats
so as to carry out an automatic detection of arrhythmias. The physician makes a diagnostic for the patient
according to the results of the analysis. Finally a report is obtained which can be printed. The CardioVex
Holter system has been designed to be used exclusively by medical personnel. The results provided by the
software must be analyzed considering the patient's medical condition. The diagnosis and treatment of the
patient, according to the interpretation of the results obtained with the system, are the responsibility of the
medical personnel only. The CardioVex Holter system has not been designed for children who weigh less
than 10 kg. Its use will not produce adverse effects on the patient or the medical personnel.
Use instructions
The CardioVex Holter System has been designed to obtain, in ambulatory form, ECG signals from the
patients. The patients are people with 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 doctors 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 pacemaker
• Regulation of anti-arrhythmic medicines
• Evaluation of a patient after suffering a myocardium infarction
• Family precedents of cardiac problems

MUC-HOLTERVEX/C 11-07 4 of 53
Symbols
Warning. Read carefully
Precaution / Notices. Read carefully
Attention: see Use instructions
Applicable part BF Type
Class II device
Product not designed to be used with children with weight under 10 kg
Manufacturer data:
VECCSA S.A.
Juramento 5841 (C1431CLA) Buenos Aires – Argentina
Technical Director: Daniel Taboh
Authorized European Community representative:

ADRIANA SILVIA PERSICO
C/ ENRIQUE IV N° 28 A 2° DER.
35500 ARRECIFE LANZAROTE - PCIA. DE LAS PALMAS
Polarity of the battery. Use alkaline AA batteries
Temperature range. (See Technical specifications).

MUC-HOLTERVEX/D 04-10 5 of 53
Keep dry. (See Technical specifications).
This side up.
Fragile, crystal
Serial number
Keep away from direct sunlight
Fulfils or exceeds the stipulations of the Council Directors 93/42/CE in relation to the
sanitary products, Class IIa

Warnings and precautions
Familiarize with these warnings. In this manual you will also find specific warnings and precautions.
Warnings
The warnings in this manual identify situations or practices which, if not corrected or stopped immediately,
can produce injuries, diseases or even the patient's death.
WARNING Safety — In patients with a pacemaker, keep a minimum distance of 15 cm

between the recorder and the pacemaker. If you suspect the recorder is interfering with the
pacemaker, immediately turn off the recorder and attend the patient as needed.
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 accessories in touch with the patient
must comply with all the safety and electromagnetic compatibility (EMC) requirements, as
well as the applicable regulations.
WARNING Safety — Throw away the electrodes after using them.
WARNING Explosion risk — Do not use in presence of combinations of flammable

anaesthetics with air, oxygen or nitrous oxide.
WARNING Fire risk — Use alkaline AA batteries when replacing the batteries. Observe
polarity.
Precautions
The precaution warnings of this manual identify situations 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 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.

Introduction
This manual is destined to medical professionals familiarized with the monitoring of patients with cardiac
diseases. They will have to read and understand this manual and all the additional information provided with
the ambulatory ECG and the corresponding options or accessories before:
 using the CardioVex Holter Recorder for clinical purposes;

 installing, configuring, solving problems or repairing the recorder.
Characteristics
All models:
 Are light and small so as to be comfortable for the patient.
 Have an “events bottom” that 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.

Recorder illustrations
MMC10L
Recorder
LCD Display
MMC10D
Recorder
SD card
reader
SD memory
card
Figure 1

Functioning
To start a test
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.
1. Prepare the patient as indicated in the “Patient preparation” section.
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).
4. Insert the new AA alkaline battery (LR 6). Observe polarity.
5. Place the battery lid back on the recorder and press the button until the LED turns off.
6. Press the button of EVENT to initiate the functioning of the recorder
MMC10L — 4 different phases (sequences) of the LED will occur:

PHASE 1: The green LED turns on 4 times intermittently during 2 seconds. This phase corresponds to the
test done by the recorder to check that the SD memory has been correctly installed in the corresponding
slot.
PHASE 2: Signal check on channel 1. Turns on the yellow LED intermittently at the rhythm of the QRS
complex detected on channel 1. This phase lasts about 4 seconds. Then comes a 2 seconds pause.
PHASE 3: Signal check on channel 2. Turns on the green LED intermittently at the rhythm of the QRS
complex detected on channel 2. This phase lasts about 4 seconds. Then comes a 2 seconds pause.
PHASE 4: Signal check on channel 3. Turns on the yellow LED intermittently at the rhythm of the QRS
complex detected on channel 3. This phase lasts about 4 seconds.
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 will 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 case 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 recorder will turn off or remove the battery lid from the recorder.
WARNING Throw away the electrodes after using them.

Transfer of data to the workstation
1. Remove the SD memory card from the recorder.

2. Insert the memory card in the SD card reader and connect it to the USB port in
the PC.
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).
Preparation to place the electrodes on the patient
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.
To prepare the patient and place the electrodes
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.
6. Connect the electrodes to the wires before attaching them to the patient's skin.
7. Fasten all the wires. Form a loop of 2.5 to 5 cm of diameter with each wire, place them
about 5 cm from each sensor, and tape them to the skin (see Figure 3). This will reduce the movements
that can cause signal artefacts.
Figure 3. Tension loop of the electrode wires
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.
Table 1. Placement of 7 leads.
Lead Colour Place

CHANNEL 1+ Red Forth intercostal space, to the left of the sternum
CHANNEL 1- White Right clavicle, in the midclavicular line
CHANNEL 2 + Brown Fifth intercostal space, to the left of the midclavicular line
CHANNEL 2- Black Left clavicle, lateral to the sternum
CHANNEL 3+ Orange Sixth intercostal space, on the midaxilliary line
CHANNEL 3- Blue Left clavicle, to the left of the midclavicular line
NEUTRAL Green Last rib on the right side of the thorax
Figure 4. Placement of 7 leads (all models).

Figure 5. Electrode wires.
Connector
C o n e c to r
HO LTE R C a b le P o r ta E le c tr o d o
R
HOLTER Electrode wire

Service policy
CardioVex must do or approve of all the reparations of warranted products. The unauthorized reparations
annul the warranty. Moreover, the reparations of products, regardless whether they have a warranty or not,
must be done by certified personnel of CardioVex's technical assistance service exclusively.
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 your 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 call 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. The claims for loss or damage of the product will have
to be presented by the sender.

Maintenance
Cleaning the recorder and the patient’s cable
WARNING Keep the recorder and the patient's cable clean, specially the components that
are in touch with the patient.
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.
o Dry them with a clean, soft cloth or paper towels.
o Reconnect the patient's cable to the recorder.
o Before using it each time, clean the patient's cable as described.
Recorder inspection
WARNING Always check the cable, the electrode 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.
Before carrying out a Holter procedure:
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.
Checking the recorder

When you revise the recorder or suspect there is a problem, carry out the following
test procedures:
1. Check that the recorder is working correctly by using an ECG simulator to obtain a
standard ECG signal level of known intensity.
2. Transfer the ECG data to the workstation and verify that the shape is normal, with the
right intensity and without any distortions or excessive noise.

Storage of the recorder
Remove the battery before storing the recorder. Take into account the environmental conditions for the
storage. See the “Technical specifications” section.
Elimination of the equipment

Discard the recorder and its accessories according to the local legislations.
Follow the national regulations on recycling or the recycling policy of your centre to guarantee the adequate
elimination of the recorder and its accessories. If you wish to obtain more information on recycling, call the
Agency for the protection of the local environment.

Technical specifications
Any deviation from the range of specifications indicated as follows can cause a decrease in the performance
of the device.
Table 2. Characteristics of the Holter recorder
Characteristic MMC10L and MMC10D
Length 76.25 mm
Width 83.50 mm
Height 17.60 mm
Weight (batteries and
200 g
patient's cable included)
Table 3. Functioning
Power supply AA alkaline battery

Recording period 24 continuous hours minimum
Storage capacity SD card of 128 Megabytes minimum
Battery duration 24 hours minimum
A/D real bits resolution 8 bits
Frequency response 0.05 Hz to 100 Hz
Sampling rate 250 Hz (both models)
Table 4. Environmental specifications
Functioning temperature 0°C to 45°C

Storage temperature 0°C to 60 °C
Functioning humidity 0% to 95%, nocondensation
Storage humidity 0% to 95%, no condensation
Atmospheric pressure 700 to 1060 mb.
Table 5. Device classification
MDD 93/42 Class IIa

IEC type Class II BF type applicable part
Regulations
International Electrotechnical Commission
IEC/EN 60601-1: 2006 CEI/IEC 60601-2-47: 2006 EN 980: 2003

IEC/EN 60601-1-2: 2001 IEC/EN 60601-1-4: 2000 ISO 13485: 2003
ISO 9001: 2000

Accessories
To request for accessories, call CardioVex's technical assistance centre on the numbers listed on page 2.
Its recommended to use accessories with similar characteristics described in the Table 6.
The used accessories will have to be validated by marked CE.
Table 6. Accessories
Type of Connection: Socket to Snap

Electrode Length: 60 cm
Wire
Red, White, Brown, Black, Orange,
Colors:
Blue y Green
Type of Memory: SD(Secure Digital)
Memory Card Capacity: 1 Gb
Voltaje of operation: 3,3 V
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

Information on electromagnetic emissions and immunity
Electromagnetic emissions
The CardioVex Holter recorder has been designed to function on the electromagnetic environment specified
as follows. It is the client's or the user's responsibility to ensure the environment is according to the
requirements.
Electromagnetic radiation Conformity Electromagnetic environment - Guide

test
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
Fast transitory ±2 kV for electric power Not applicable

electric lines
currents/voltage ±1 kV for input/output
peaks IEC 61000-4-4 terminals
Overvoltage ±1 kV differential mode Not applicable

IEC 61000-4-5 ±2 kV common mode
Voltage drops, short <5% Ut Not applicable

interruptions and (>95% drop of Ut) during
voltage variations in0.5 cycles
the voltage network 40% Ut
supply. (60% drop of Ut) during
IEC 61000-4-11 5 cycles
70% Ut
(30% drop of Ut)
during 25 cycles
<5% Ut
(>95% drop of Ut) during
5 seconds
Magnetic field 50/60 3 A/m Not applicable
Hz frequency
IEC 61000-4-8
Note: UT is the CA network voltage measured before the test.

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.
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.
Recommended separation distance

d = (1.17)
d = (1.17) 80 MHz to 800 MHz
d = (2.33) 800 MHz to 2.5 GHz
where P is the maximum power output of the
transmitter expressed in watts (W) according
to the producer of the transmitter and d is the
recommended separation distance in meters
(m).
As determined by a study on electromagnetic
compatibility in situ (a), the field intensities of
the static RF transmitters must be inferior to
the conformity level in each frequency range
(b).
Interferences can occur near the equipments
marked with this symbol:
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 distances 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 contribute to the prevention of

electromagnetic interferences by keeping a minimum distance between the mobile/portable RF
communication device (transmitter) and the Holter recorder, as recommended as follows, calculating the
distance depending on the maximum output power of the communication device.
Separation distance according to the transmitter's frequency (m)

Transmitter's maximum output 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz
nominal power (W) d = (1.17) d = (1.17) d = (2.33)
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
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 determined 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 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.
WARNING In patients with pacemakers, keep a minimum distance of 15 centimetres

between the recorder and the pacemaker. Immediately turn off the recorder and give the
patient the necessary attention if you suspect the recorder id interfering with the
pacemaker.

Solving problems
If you detect functioning problems in the unit, consult the following tables.
Table 7. Errors in patient preparation
Error in patient preparation Probable cause and solution

Wrong skin preparation. Remove the sensors,
Absence of signal or low intensity signal in repeat the preparation, choose a new position
the ECG's preview of the MMC10D model (consult the connection procedure) and use new
electrodes
Table 8. Errors previous to the acquisition indicated by the LED (MMC10L)
Error Cause Solution

When connecting the
battery, the yellow LED
The SD memory is not correctly Remove the memory, verify it is
turns on intermittently 4
inserted or is right protected. not locked and insert it again.
times, then turns off and
does not turn on again.
After an intermittent LED
The battery is discharged or
sequence, the yellow Discard the battery and install a
does not have enough charge
LED stays on and does new one.
for 24 hours.
not turn off.
When connecting the Disconnect the battery and
battery, the green LED reconnect it. If after several tries
The memory was not formatted
turns on intermittently 4 the problem persists, insert the
by the recorder or it was not
times, but phase 2 of memory in the PC's reader and
possible to write the digital file
yellow – green erase it with the utility program
of the ECG signal.
alternation does not CardioVex Holter 3 or with
occur. Windows Explorer.
Table 9. Errors in the display (MMC10D)
Error Cause Solution

When connecting the
battery, an “Initializing The SD memory is not correctly Remove the memory, format it in
Error” message will formated. FAT.
appear on the display.

Limited warranty
Holter recorder MMC10L, MMC10D and accessories.
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 brochures 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 suppliers.
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 handled 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 used 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, free 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.

Minimum system requirements
To use the CardioVex Holter system you need:
A computer with Pentium II 500 Mhz or better

64 Mb RAM memory
SVGA 800x600 monitor or better
Laser or Ink jet printer
Windows 98, ME, 2000, XP or VISTA.
20 Gb free space on disc
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.
Analysis program characteristics:
 Simultaneous analysis of ECG arrhythmias on the three channels.

 Simultaneous analysis of the ST segment on the three channels (decrement, increment, slope).
 24-hour tendency graphs on heart rate, ventricular incidents, supraventricular incidents, ST
segment for each channel and PR interval.
 R-R and ST histograms for each channel.
 Frequency variability.
 Tables with 24 hour summaries.
 Morphology editor.
 Validation of events and reclassification of all events.
 Report generator with preview.
 Storage of the Holter's recordings and the analyzed reports.
Software installation
To install the software, insert the CD in the corresponding unit and a menu like the one shown below will
appear:

Select SOFTWARE INSTALLATION to proceed to install the software in your computer. The installation
program crates a directory C:\Program files\CardioVexHolter3 where some directories will be created and
the necessary files for the operation of the system will be copied.
To start the system operation, double click the CardioVex Holter 3 icon created in the Desk.
You can also use the accesses created in the CardioVex Holter 3 folder on the Programs menu.
When starting the program for the first time, a window like the following 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 to 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]. To 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.

It is possible to select the logo that will be printed on the report. The logo's file must have a BMP extension
to be recognized by the system.
Then there are three text areas to write: Institution name, Department / service / physician and Additional
data.
In the [Recording source...] option, the recorder's type of connection to transfer the data can be specified.
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.

In [ECG leads...] the leads used in each channel can be specified.
With [Beat colours...] the user can select a colour for each type of beat.

The [Erase recorder memory...] option in the UTILITIES menu allows to erase the recorder's memory so it
can be used again.
Starting the recording

Start study
Start
1 - Place the recorder on the patient as shown in Figure 7.
2 - Insert a new battery (we recommend using one battery for each study for more safety). In the MMC10D
model the patient's ECG signal can be visualized on the display. This signal is not useful for diagnosis
purposes. In the MMC10L model a LED sequence can be visualized.
3 - The patient will have the recorder on registering the ECG during 24 hours.
4 - When he returns, disconnect the recorder from the patient and the battery.
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.
Acquiring data from a recording

Download process
The download process is started by clicking on the [File] option in the main menu and selecting [New
Study].

The system will open a window to write the patient's data. If the patient has already been analyzed, clicking
on [Find] he will be found and when selected, his information will appear on the screen. If the patient is new,
click on [New] and write down his data.
Next, the date and time of the recording and the study data are to be filled in.
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.

Once the download has finished the system will give the option of saving it or continue on to processing the
acquired data.
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.

Importing studies
To import CardioVex Holter 3 studies, go to [File], then to [Import] and select [Holter Recordings].
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:
 Filtering the signal

 Reversing polarity in any of the three channels
 Annulling channels
 Amplifying or attenuating the signal intensity

If you have made any change to the signal and want to apply it, press on “Save”. Finally, you have the
possibility of deciding the starting and ending time of the signal processing for the detection of beats and
arrhythmias. It is important to use this tool in the cases where the patient has disconnected the Holter's
electrodes before the 24 hours of recording are over.
Data Editing
Data Editing
The downloaded study editing is implemented through a navigation menu located on the upper part of the
screen.

Navigation Menu
The navigation menu is composed of a group of tools which are activated by clicking on them:
ECG
On the ECG display, the recording can be looked over with 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.

Beat Data
When you select a beat on the ECG display, the general information on the beat will appear on the right
side of the screen:
 Beat type (Normal, Ventricular, etc.).
 Time (hh:mm:ss).
 RR Interval.
 Average RR Interval in the last minute.
 Heart rate.
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 be 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.
And so will characteristic information on each channel:
Wave detection (Present QRS or the absent wave).

ST segment changes.
ST segment slope.
QRS level.
QRS interval.
QT interval.
PR interval.
NOTE: The grid on the screen is calibrated in 10 mm/mV and 25 mm/sec.

ST Measurement
ST segment measurement
The ST segment analysis is done on the three ECG leads.
It reports on:
 Histogram with the ST segment changes for the 24 hours, for each channel
 Tendency graph for the average ST segment change per minute for the 24 hours, for each channel
 Amount of ST segment events in each hour and channel (either elevation or depression)
 Maximum elevation value in each hour and channel
 Maximum depression value in each hour and channel
The system initially carries out the analysis automatically, but the user can repeat it calibrating the
measuring points manually.
Pressing on [Study] and then on [Recalculate ST segment measurements], a window like the one below will
appear:

In this window, the user can adjust the Isoelectric Level, 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.
Compressed ECG
In the compressed ECG there is the Full Disclosure visualization, where the number of lines and the time
per line can be edited, as well as the channels you want to visualize.

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.

You can select a group to visualize the morphologies assigned by the system with the names Normal,
Ventricular, Supraventricular, Undetermined, etc. The undetermined group is formed by those that the
system could not identify as normal, ventricular, etc.
The unclassified beats group is formed by those that could not be grouped into any typical morphology.
You can either agree with the system's classification and leave it as it is or reclassify the beats in different
ways:
1. Select a group and reclassify all 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).

3. Select a beat from the ECG display strip and reclassify it. (Select the beat and press the right button
on the mouse).

4. Finally you can select several groups or beats in a group and reclassify them simultaneously by
selecting them with the mouse and holding the CONTROL or SHIFT keys pressed.
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 runs 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.

Average Beat
This window shows the average beat and allows to make measurements on it. For this, click on the cursor
you wish to move and drag it to the position you want it in.

Graphs
Here you can visualize the tendency graphs and the histograms for the 24 hours.
Events
Here you can edit all the saved events to print them later.

Conclusions
Here you can write down the conclusions drawn from the study, which will be printed on the report.
PR Analysis
This window shows the tendency graphs for the PR interval in each channel.

Report
This is the preview of the report that is to be printed.
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.

Frequency Variability
Introduction
The CardioVex Holter 3 system with Heart Rate Variability (HRV) analysis allows to examine the normal R-
R intervals with time and frequency domain and geometric methods. It also includes standard calculations,
SDNN (standard deviation of the NN intervals (SDNN), that is, the square root of variance), SDANN
(standard deviation of the average NN intervals), RMSSD (square root of the mean squared differences of
successive NN intervals), NN50 (the number of interval differences of successive NN intervals greater than
50 ms), pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals), Lorenz
graphs, triangular interpolation of the normal-normal (NN) beats interval histogram, HVR index, time
spectral estimation graphs and 3D.
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 markers 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), which 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 contains are explained,
in a summarized way.
Heart Rate Variability Analysis

The software only considers the RR intervals of which the beats are normal-normal. With this data, the
system builds the register of heart rate over time (tachometer). The quality of the HRV analysis depends on
the beat classification analysis, however, it is of great importance that the patient goes through all the
previous analysis of the Holter recorder.

Time domain analysis
With the navigation bar located on the bottom left side, you can visualize the different data you wish to
extract from the frequency variability analysis.
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.

Pressing on “Graphs [Time]” on the navigation menu you have the possibility of visualizing the statistical
graphs:
Histogram of all the NN intervals.
Histogram of the differences between intervals of all adjacent NN.
24 hours SDNN, RMSSD and pNN50 tendencies, for every hour.
Average NN tendencies on 5 min segments.
Average SDNN tendencies on 5 min segments.
Subsequently a detailed summary is presented on the meaning of statistical and geometrical indexes:
Statistical Measurements
Variable Units Description
SDNN msec. Standard deviation of all NN intervals, in a total record.
Standard deviation of the NN interval averages of 5 minute

SDANN msec.
segments, in a total record.
Square root of the mean squared differences of successive

RMSSD msec.
NN intervals
Averaged standard deviations of the NN intervals in 5 min

SDNN Index msec.
segments, in a total record.
Number of interval differences of successive NN intervals

NN50
greater than 50 msec.

Total percentage of differences between adjacent NN
pNN50
intervals greater than 50 msec.
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 example 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 adjacent NN intervals greater than 50 msec.

RMSSD = Square root of the mean squared differences of successive NN intervals
Geometrical Measurements
TINN index msec. Triangular interpolation of the NN interval histogram.
The integral of the density distribution (that is, the number

HRV index msec. of all NN intervals) divided by the maximum of the density
distribution.
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 Cartesian 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).

Frequency domain Analysis
Pressing on “24 hs. table [freq.]” in the navigation menu you can visualize the spectral analysis of the
tachometer. The time table is presented as a summary of the power data in the different frequency ranges,
hour by hour for 24 hours and in sleep and vigil times.
Pressing on “Graphs [freq.]” in the navigation menu you can visualize the spectral and tendency graphs for
every hour:
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.
A detailed summary of the spectral indexes is shown below:

2
ULF msec /Hz Ultra low frequency power ≤ 0.003 Hz.
2
VLF msec /Hz Very low frequency power 0.003 - 0.04 Hz.
2
LF msec /Hz Low frequency power 0.04 - 0.15 Hz
2
HF msec /Hz High frequency power 0.15 - 0.4 Hz
2
Total power msec /Hz Total power approximately ≤ 0.4 Hz.
Normalized LF power
Norm. Lf
LF/(Total Power – VLF)x100
Normalized HF power
Norm. HF
HF/(Total Power – VLF)x100
LF/HF LF/HF relation

In long recordings (24 hs.) the power is decomposed in four bands:
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 parasympathetic 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.


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Juramento 5841-(1431) Bs. As. Argentina-Tel.4572-7004-Fax:(5411) 4572-0045 – info@cardiovex.com.

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Warning. Read carefully

Precaution / Notices. Read carefully

Attention: see Use instructions

Applicable part BF Type

Product not designed to be used with children with weight under 10 kg

Authorized European Community representative:

Polarity of the battery. Use alkaline AA batteries

Temperature range. (See Technical specifications).

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This side up.

Keep away from direct sunlight

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WARNING Safety — In patients with a pacemaker, keep a minimum distance of 15 cm

WARNING Safety — Throw away the electrodes after using them.

WARNING Explosion risk — Do not use in presence of combinations of flammable

Juramento 5841-(1431) Bs. As. Argentina-Tel.4572-7004-Fax:(5411) 4572-0045 – info@cardiovex.com.ar –

 using the CardioVex Holter Recorder for clinical purposes;

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1. Prepare the patient as indicated in the “Patient preparation” section.

4. Insert the new AA alkaline battery (LR 6). Observe polarity.

6. Press the button of EVENT to initiate the functioning of the recorder

MMC10L — 4 different phases (sequences) of the LED will occur:

WARNING Throw away the electrodes after using them.

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1. Remove the SD memory card from the recorder.

Preparation to place the electrodes on the patient

To prepare the patient and place the electrodes

Figure 3. Tension loop of the electrode wires

Table 1. Placement of 7 leads.

Lead Colour Place

Figure 4. Placement of 7 leads (all models).

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o Dry them with a clean, soft cloth or paper towels.

o Reconnect the patient's cable to the recorder.

o Before using it each time, clean the patient's cable as described.

Before carrying out a Holter procedure:

Checking the recorder

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Elimination of the equipment

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Table 2. Characteristics of the Holter recorder

Characteristic MMC10L and MMC10D

Power supply AA alkaline battery

Table 4. Environmental specifications

Functioning temperature 0°C to 45°C

Table 5. Device classification

MDD 93/42 Class IIa

IEC/EN 60601-1: 2006 CEI/IEC 60601-2-47: 2006 EN 980: 2003

ISO 9001: 2000

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Type of Connection: Socket to Snap

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