E60VGA IU 03-2009 90408 in English

ELECTROCARDIOGRAPH
E60VGA
20 12,5 50 Hz
3x4 Manual
mm/mV mm/s 35 Hz
II
III
E 60VGA
5 V1 V4
I aVR V5
10 12,5 aVL V2
3 II V6
50 Hz Man V3
20 25 II I aVF
6
Auto 50 12 Aut
25 Hz o
Rytm 1 23
mm/mV
mm/s 35 Hz
0297
User’s Manual
03/2009
FARUM S.A.
Address: 03-301 Warsaw, 74 Jagiellońska Street, Poland
Reception: (+48 22) 811 14 11 Sales Department (+48 22) 811 06 79
Fax. (+48 22) 811 40 59 Phone./Fax: (+48 22) 811 19 22
www.farum.pl Showroom: (+48 22) 811 28 42
E60VGA Electrocardiograph
User`s Manual
CONTENTS
1. INTRODUCTION .............................................................................................................................................3
1.1 HOW TO USE THE USER’S MANUAL? ..........................................................................................................4
1.3 INFORMATION AND INSTRUCTIONS FOR SAFE USE.......................................................................................5
2. STRUCTURE OF THE ELECTROCARDIOGRAPH ..............................................................................7
Figure 1. Structure of the electrocardiograph............................................................................................... 7
Figure 2. External sockets view. .................................................................................................................. 8
3. DESCRIPTION OF SYMBOLS AND FUNCTIONS OF THE ELECTROCARDIOGRAPH ..............9
Figure 3. Foil keyboard................................................................................................................................ 9
Figure 4. Foil with drawing of electrodes connection.................................................................................. 9
4. TURNING THE ELECTROCARDIOGRAPH ON AND PREPARATION FOR EXAMINATION..12
4.1 INSTALLATION .........................................................................................................................................12
4.2 CONNECTING THE PATENT CABLE ............................................................................................................13
4.3 PREPARING FOR EXAMINATION ................................................................................................................13
Figure 5. Standard location of the electrodes ............................................................................................. 14
4.4 CONNECTING ECG TO THE MONITOR .......................................................................................................14
Figure 6. Connecting ECG to the monitor ................................................................................................. 15
4.4.1. Main view, electrode test mode ...........................................................................................................15
4.5 SETTING THE SPEED, SENSITIVITY AND FILTERS .......................................................................................16
4.5. SETTING UP THE REGISTRATION PARAMETERS .............................................................................................17
4.5.1. ECG Configuration Icons. .............................................................................................................17
4.5.3. Printout Format Selection. ...................................................................................................................18
4.6 OPERATING THE RECORDER, CHANGING THE ROLL OF PAPER ...................................................................19
Figure 7. Mounting the roll of paper onto the handle................................................................................. 19
5. RECORDING THE ECG TESTING.........................................................................................................20
5.1 RECORDING IN THE MAN (MANUAL) MODE ............................................................................................20
5.2 RECORDING IN THE AUTO (AUTOMATIC) MODE......................................................................................20
5.3 ANALYSIS ................................................................................................................................................21
5.4 MEASUREMENTS AND ANALYSIS OF THE HART BEAT RHYTHM .................................................................22
6. TRANSMISSION OF DATA INTO THE COMPUTER .........................................................................23
Fig. 8. PC - ECG Wiring Diagram............................................................................................................. 23
7. AUTOTEST .................................................................................................................................................24
8. OPERATING, STORAGE AND PERIODICAL MAINTENANCE ......................................................25
8.1 CHECKING, MAINTENANCE AND SAFETY TESTS ........................................................................................26
9. RECYCLING AND DISPOSAL .............................................................................................................27
10. ELECTROMAGNETIC COMPATIBILITY .....................................................................................28
11. TECHNICAL SPECIFICATIONS ......................................................................................................30
STANDARD ACCESSORIES: ..................................................................................................................................32
User`s Manual
1. Introduction
The Electrocardiograph E60VGA is intended for heart muscle testing in hospitals, clinics,
emergency service and private doctor’s rooms.
The Electrocardiograph E60VGA with external and internal, battery operated power
source are to be used in routine diagnostics of the heart muscle and for the 3, 6, and 12-
channel data recording of the action variables according to the widely used output
systems: Einthoven’s, Goldberger’s, Wilson’s.
The Electrocardiograph allows for the following:
- manual or automatic recording of the ECG signal
- automatic regulation of the location of the zero line inside the recording channel,
- automatic elimination of crawling of the zero line,
- automatic choice of recording sensitivity,
- digital filtration of external disturbances,
- digital filtration of disturbances occurring on the level of the patient muscles,
- signalization about disconnected electrodes,
- signalization about lack of paper or that the recorder is not closed,
- performance of 3 min II recording in order to create a characterization of the frequency of
the heart beat rhythm,
- measurements of the R-R line,
- cooperation with a computer through the inline connector RS 232,
- storage of the last test - test archiving
- repeated printout of the performed test,
- analysis of the recorded ECG signal and printout of the measurement results,
- 2 hours of continuous work for printout in AUTO mode (without analysis), when the
apparatus is powered by an internal battery.
The Electrocardiograph E60VGA is constructed and produced in full in the X-ray and
Medical Equipment manufacturer FARUM S.A., in accordance with the Directive about
Medical Equipment number 93/42/EEC and the ISO 9001:2000 and ISO 13485:2003
quality markers. It fulfills all the requirements of the PN-EN 60601-1:1999, PN-EN
60601-1-1:2002, PN-EN 60601-2-25:2004, PN-EN 60601-1-2:2002, PN-EN 60601-1-
4:2006, PN-EN ISO 14971:2004 standards.
It is produced under first class safety (I class), in the safety level of CF.
The patient is separated by an electro isolating barrier, which ensures the highest level of
safety and has a special protector against defibrillation impulses.
User Manual: edition 03/2009 date 07.04.2009, Electrocardiograph E60VGA

User`s Manual
1.1 How to use the User’s Manual?
To ensure a proper and safe operation of the electrocardiograph, as well as to be able to fully
benefit from all the functions of the electrocardiograph every potential user must carefully and
thoroughly read the instructions given in the User’s Manual.
This symbol signifies the user’s duty to carefully read instructions given in a
particular point in the User’s Manual, pertaining to the topic discussed, as well
as all the warnings about any possible dangers arising for the patient and the
personnel operating the electrocardiograph.
This symbol warns about the necessity of applying special safety precautions
and the user’s duty to carefully read instructions given in a particular point of the
User’s Manual.
This symbol signifies important cautions and instructions, for example, those
cautioning against damaging the electrocardiograph or its components.
Operating the electrocardiograph in accordance with instructions marked with

this symbol makes the operation of the electrocardiograph easier.
The set up of this User’s Manual allows for familiarization oneself with the proper ways of
operation of the electrocardiograph, as well as its functions in time and on the level depending
on the reader’s abilities and amount of knowledge about operation of such instruments.
More information may be obtained at the following address:

FARUM S.A. –74 Jagiellonska Street, 03-301 Warsaw, e-mail: sales@farum.com.pl,
phone: (+48 22) 811 38 67, phone/ fax: (+48 22) 811 28 42.
1.2 Place and conditions of operation
The Electrocardiograph E60VGA is constructed in accordance with the European directives

about electromagnetic compatibility. No emission of electrocardiograph disturbances, which
may influence and damage radio and telecommunication transmissions is ensured, and also
the apparatus is protected against any disturbances emitted by any other systems or
equipment. However, in order to protect the electrocardiograph against negative influences of
other equipment on the electrocardiograph, the following rules need to be done:
- not use cellular telephones in the close proximity of the electrocardiograph,
- locate the electrocardiograph as far away from any electrical wiring and any other electric
power sources as possible. The EKG signal may be disturbed if the electrocardiograph is
located in the proximity of any sources of high voltage;
- do not locate the electrocardiograph near any other diagnostic or therapeutic apparatus (e.g.
x-ray apparatus, ultrasound, etc.), which can cause disturbances and distortion of the EKG
signal;
- if it is impossible to locate the electrocardiograph away from any apparatus and equipment
emitting electromagnetic impulses shut all those off while performing the EKG reading.
To avoid any external environment influences on the ECG test results you should:
- always perform the test in room temperatures between 20 and 25°C; this will prevent
the feeling of cold in the patient, which could cause vibrations of the muscles,
User`s Manual
- always perform the test powering the electrocardiograph from the batteries (internal power
source); disconnect the external power source cable from the power source.
1.3 Information and instructions for safe use
The electrocardiograph should be operated by qualified and experienced medical

personnel.
- Always use the electrocardiograph according with the instructions and precautions given in the
User’s Manual.
- The electrocardiograph is equipped with the standard set of accessories. To ensure safety and
compliance with the Directive about Medical Equipment number 93/42/EEC always use only
original additional accessories accepted and approved by the manufacturer.
- The apparatus is equipped with a thermal writing head, which allows for maximum quality and
precision of the test recording on paper. To avoid frequent and expensive repairs and renovations
always use only original paper accepted and approved by the manufacturer. The manufacturer
will not be held responsible for damage caused by the usage of inappropriate paper.
- The electrocardiograph is adapted to work on mobile trolley produced by FARUM S.A. (with
arm for patient cable, equipped with two castors with brakes, the apparatus is fastened to the
trolley with the knob) – optional equipment.
- The electrocardiograph should be carried or transported to the patient in a special bag the
production of FARUM S.A. - optional equipment.
- Do not subject the apparatus to any heavy blows or shaking.
- Never allow any liquids inside the apparatus. If such occurs you must immediately bring the
apparatus to our technical service department in order to test its functionality.
- Always check if the voltage of the power source complies with that described on the information
label located on the apparatus.
- If you are using this electrocardiograph in connection with other apparatus always check that: all
connections comply with the safety regulations; all apparatus connected falls under the same
safety regulations. Lack of compliance with the safety regulations may cause bodily harm to the
patient connected to the apparatus, as well as the person operating the electrocardiograph. If it is
difficult for you to obtain information required to analyze the risks connected with each
individual connection contact the manufacturer, or refrain from using such connections.
- If you are using other apparatus connected directly or indirectly to the patient always check all
the risks, which may be caused by the sum of all the variables transmitted through the patient.
- The electrocardiograph is protected against defibrillation in compliance with the standards and
norms PN-EN 60601-2-25:2004; to ensure proper transmission of the signal always use only the
original electrodes accepted and approved by FARUM SA.
- Do not allow any contact of the apparatus with extreme temperatures, excessive dirt or dust, or
very salty and humid climates; always behave in compliance with the instructions about the
environment conditions given.
- If the system of the apparatus “crashes” or “freezes” (the apparatus does not respond to the
commands given from the keyboard) press the on/off button or ,if this does not help, press the
button number 9 (reset button) shows in figure 1, which is located on the right side of the
apparatus cover in the cover hole.(using for example the plug of patient cable)
- Before starting the examinations check visually the technical state of the apparatus. Contact with
FARUM SA or with Authorized Service of the producer in all cases of finding of damage or
improper functioning of the apparatus. Contact the Authorized Technical Service Department in
every case of improper operation of the electrocardiograph.
User`s Manual
- To ensure a long usage of the apparatus it is important to periodically have it checked by the
Authorized Technical Service Department of the producer according to point 8 of this User’s
Manual.
- The electrocardiograph cannot be operated when using surgical

equipment of high frequencies.
- Do not use this electrocardiograph for monitoring the heart beat during
any operations.
- Do not use this electrocardiograph in the presence of anesthetics or

flammable gasses and fumes.
- All medical equipment should be used only by qualified and

experienced medical personnel, which due to their training and
experience is able to ensure proper and safe operation of this
apparatus. A person operating this apparatus must carefully and
thoroughly read the User’s Manual and familiarize themselves with the
apparatus before the first operation!
- All data retained from automatic interpretation programs or other

diagnostic tools should be passed on to the cardiologist to analyze and
verify.
- The electrocardiograph is equipped with a RS232 interface for the

transmission of the ECG signal data to personal computer. Such
transmissions can be operated only by qualified and experienced
medical personnel, which due to their training and experience is able to
ensure proper and safe operation of such.
- FARUM SA is responsible for the safe and proper operation of the electrocardiograph only
when:
o all modifications and repairs were performed by the FARUM S.A. or and Authorized
Service Department of the manufacturer;
o voltage in the building complies with that required;
o the apparatus is exploited in compliance with the instructions and precautions given in the
User’s Manual;
o all basic and additional accessories used with the apparatus have been accepted and
approved by the FARUM S.A.
User`s Manual
2. Structure of the electrocardiograph
9 2 11
RESET
5
®
4
S.A. E60VGA
1
5 V1 V4
I aVR V5
10 12,5 3 II aVL V2
50 Hz Man V3 V6
20 25 III aVF
6
Auto 50 12 Auto
1 2 3
mm/mV 25 Hz Rytm
mm/s 35 Hz
RS-232 VGA
10 8 6 7
Figure 1. Structure of the electrocardiograph
The following components are included in the E60VGA Electrocardiographs, shown in

figure 1:
1 - foil keyboard, divided into the control section (right side) and the part of setting
configuration (left side), shown in figure 3;
2 - thermal head recorder;
3 - mains plug-in socket;
4 - green indicator of connecting the apparatus to the mains and yellow indicator of
battery uncharged
5 - patient cable outlet;
6 - RS 232 interface to the PC;
7 – VGA interface to the monitor;
8 - lever to open the record table;
9 - reset button;
10 – grounding socket/potential equalization;
11 - electric insolating covers;
User`s Manual
VGA RS-232
VGA interface –
RS232 interface –
monitor signal
communication with the PC
output
Figure 2. External sockets view.

User`s Manual
3. Description of symbols and functions of the electrocardiograph

Keyboard - description
5 V1 V4
I aVR V5
10 12,5 aVL V2
3 II V6
50 Hz Man V3
20 25 III aVF
6
Auto 50 12 Auto
1 2 3
mm/mV 25 Hz Rytm
mm/s 35 Hz
Figure 3. Foil keyboard
Diode signalling
disconnected electrode
E 60
Figure 4. Foil with drawing of electrodes connection

User`s Manual
Setting of the parameters is signalled by lighting of the proper diode.
Setting the registration sensitivity

5 5, 10, 20 mm/mV,
10
20 Auto – automatic sensitivity matching
Auto
- switch for the sensitivity of the record, rewinder. Button is inactive during the
mm/mV
electrocardiograph work in modes: AUTO, COPY PC, RHYTHM.
- switch for the printer speed, rewinder.
12,5 Available speed 12,5mm/s, 25mm/s, 50mm/s
25
50
Button is inactive during the electrocardiograph work in modes: AUTO, COPY
mm/s
PC, RHYHTM.
Setting of the filters:

50 Hz
Mains filter 50 Hz
25 Hz
35 Hz
Muscle interference filter 25 or 35 Hz
Change of the quantity of printing channels.

3
6
12
Choose of working mode:

Man Man – manual work mode
Auto
Auto – automatic registration 5 seconds.
Rytm
Rhythm – rhythm test, registration 3 minutes.
Diode signalling
connection of the
apparatus to power
supply
Turn on/turn off of the

apparatus
Diode signalling
discharged battery
User`s Manual
While working without a power supply, the flashing diode signals that the battery is
discharged and it is necessity to connect it to the external power source and perform a
complete battery charge, as it is described in point 4.1.
- STOP button. After pressing the button STOP the apparatus always return to
the same settings as before the test began.
activation of the print out (START).
I aVR V1 V4
II aVL V2 V5
III aVF V3 V6
- switches for the choice of the leads for the MAN
recording
After choosing the desired group of the leads, the apparatus will be switched over into manual
working mode MAN.
1 2 3
- measurement tests performed in the AUTO or RHYTHM modes.
- copy of the last examination record

User`s Manual
4. Turning the electrocardiograph on and preparation for

examination
4.1 Installation
The electrocardiograph should be connected to the outlet of the external power source of
90÷240V 50 Hz, with the grounding bolt using the cable equipped with the apparatus.
Power supply
ON/OFF button
indicator
Battery charding
indicator
If the yellow LED diode lights up, it signalizes that the internal power source (battery) is
uncharged.
In case the level of energy in the accumulator is not sufficient and unables the proper
functioning of the apparatus a sound signal is going to be generated five times and afterwards
the apparatus will turn off. Further usage of the apparatus is going to be possible only after
plugging it into the alternating current mains.
If the battery discharges to a point when a proper ECG recording cannot be performed the
apparatus will not turn on if it’s not connected to an external power source. You must then
connect it to an external power supply and perform a complete, 16-hour battery charge
(during that time the apparatus should be turned off).
The average lifespan of the battery is approximately 500 full discharge / charge cycles.
An apparatus, which is on and left without activate the registration turn off automatically after
5 minutes
If the internal power source (battery) is discharged excessively it can cause

the apparatus not to turn, and a loss of all electrocardiograph data saved in
the electrocardiograph archive. In such case the apparatus must be connected
to an external power source and after about 1 min if the apparatus will not
turn on and the button, located on the right side of the electrocardiograph
cover must be reset pressed (using, for example, the bolt on the patient cable
plug).
Do not remove any used batteries on your own! If the batteries must be
changed immediately contact the authorized Technical Service of FARUM
S.A.
Press the button to turn the apparatus on.

The turning on the apparatus is signalized by an acoustic signal and lighting of the diode of
each setting which describes the initial state.
User`s Manual
If there is no more paper in the printer, or if the printer is “open,” the functional keyboard is
12,5
25
50
mm/s
blocked and diodes which are placed in the field of speed choosing signal those state
by flashing.
Pressing each button of functional keyboard and finishing the RHYTHM (3 minutes)
registration are signalling by sound signal.
4.2 Connecting the patent cable
The electrocardiograph is equipped with a patient cable for 10 electrodes, which is to be

connected to the patient cable socket (located on the side wall of the apparatus, figure 1,
position 5), it is protected against disconnection with two screws.
4.3 Preparing for examination
The standard set includes 4 limb electrodes and 6 suction electrodes for the heart area.
The limb electrodes are placed on the signal receiving spots on the arms and legs of the
patient.
In case there is no contact or the electrodes have not been connected, electrode symbols will
flash .
Additionally lack of the contact or disconnected electrodes, may be signalized by flashing
electrode symbol on the monitor display, as follows:
R - red electrode – red plug, C1 electrode - red and white plug,
L - yellow electrode - yellow plug, C2 electrode - yellow and white plug,
F - green electrode – green plug, C3 electrode - green and white plug,
N - black electrode – black plug, C4 electrode - brown and white plug,
C5 electrode - black and white plug,
C6 electrode - purple and white plug,
The electrodes should be connected in compliance with general methods connecting

them to the patient output plugs. Before connecting the electrodes to the patient each
connection spot on the patient’s skin should be wiped with water. In a case where the
patient’s top layer of skin creates difficult testing conditions, connection spot on the
patient’s skin should be washed by alcohol, any hair should be removed and special
electrode gels should be used to maximally improve the quality of the recording..
User`s Manual
Standard location of the electrodes:

C1 (V1) – (under the fourth rib, along the
right line),
C2 (V2) – (under the fourth rib, along the
R L left line),
C1 C2 C3 (V3) – (on the fifth rib, between V2 and
C3 C6 V4),
C4 (V4) – (under the fifth rib, on the left
C5
side of middle-clavicle line),
C4 C5 (V5) – (on the left inner groin, on the
same level as V4),
C6 (V6) – (on the left middle groin, on the
same level as V4),
Limb electrodes: usually a few
N F centimetres above the ankles and wrists.
Figure 5. Standard location of the electrodes
Attention: If during the examination Electrode N is open, the system will print final
report only; this will help saving the paper.
It is very important to notice the following when performing the ECG recording:
- that the patient and transmitting electrodes are not touching any other persons
or transmitting objects, even if such are grounded;
- that the heart electrodes are not touching each other;
- that the patient cable is placed far from the power source cable and that they
are not intercrossing;
because such can cause severe disturbances or interrupt the recording.
4.4 Connecting ECG to the monitor
Connecting monitor enables getting additional function of the apparatus like graphical
preview of disconnected electrodes, ECG signals view etc.
ECG will be functioning properly including all the basic functions also in the case, when the
monitor is disconnected.
It is recommended to connect monitor to the apparatus before turning both devices on..
Turn on the energy supply of the apparatus.

Turn on the energy supply of the computer screen through the separating transformator
bought at FARUM S.A.
User`s Manual
Precautions and alerts:

The apparatus and the screen have to be plugged in to the same feed batten. It is forbidden to
support equipment from the set from different sources of support.
Feed batten can't be situated on the flor.
The equipment, that does not belong to the set (another equipment), shouldn’t be connected to
the feed batten.
The maximum permitted loading (bourden) of the feed batten should not exceed 100W.
The screen which is (employ) in the set should be prepared to power supply with voltage from
100V to 240V.
The cable plug of the monitor should be connected to the VGA socket on the rear side of the
apparatus in the way shown below
VGA socket in the

ECG
VGA RS-232
Plug connecting
Monitor cable
Transformer
separating
Figure 6. Connecting ECG to the monitor
Parameters of monitor view:

Resolution: 640x480 (VGA)
Refresh frequency: 50Hz
It is recommended to use 14” or 15” LCD monitor. Using the old CRT monitors is also
possible, but because of preset frequency (50Hz) the view may flash.
4.4.1. Main view, electrode test mode
Attention: If the monitor has not been plugged, the lack of connection of the
electrodes of the patient cable have not been connected or disconnection of the
electrode is present, electrode symbols will flash in the aparatus
User`s Manual
20
mm/mV
12,5
mm/s
50 Hz
35 Hz
3x4 TEST Directly after turning the apparatus on (producer’s
logo view) apparatus gets to the main view and
works in the electrodes test mode enabling simple
R
L identification of improper contact of the
F
N electrodes.
C1
C2
C3
C4
C5
C6
20 12,5 50 Hz
3x4 TEST
mm/mV mm/s 35 Hz
R
L
F Electrodes contact pointers. Lack of
N
C1
the contact or improper contact of the
C2 electrode with the patent is signalized
C3
C4 by the corresponding electrode
C5
C6
pointer flashing and the audible
signal. Disconnection of the patient
cable is signalized by the N electrode
flashing only.
It is possible to perform the simplified examinations to the limb outputs only.
4.5 Setting the speed, sensitivity and filters
Settings of the sensitivity, speed and filters can be changed by pressing the following buttons:
Sensitivity - mm/mV,
Speed - mm/s,
Filter 50 Hz - ON / OFF,
Filter 35 Hz or 25 Hz - ON / OFF
Turning on of the settings is signalized by LED diodes which are placed in the field of chosen
settings.
User`s Manual
4.5. Setting up the registration parameters
In the top part of the display actual apparatus settings are displayed.
Part of the screen with

apparatus current settings
20 12,5 50 Hz
3x4 Manual
mm/mV mm/s 35 Hz
Cecha: 1 mV
I
II
Chart field
Channel mark III
4.5.1. ECG Configuration Icons.
Recording modes;
ECG amplitude - Immediate real-time printout (MAN)
signal [mV]: - Automatic (AUTO)
5; 10; 20; - Rhythm examination (RHYTHM)
AUTO
Paper feed rate, ECG Filters: Printout format
signal scale [mm/s]: 25, 35, 50 Hz MAN: 3 channels
12.5 ; 25 ; 50 AUTO: 4x3 ; 2x6 ; 1x12
RHYTHM: 6 or 12 lines (IInd channel)
The impact of mains-generated interferences may be reduced down to a minimum: press

down "50 Hz" key which will switch on the mains filter.
Where the patient displays muscular tremor which may considerably reduce the recording
quality, use "25 Hz" or "35 Hz" filters in order to eliminate such interferences. The
phenomenon of muscular tremor may originate from patient's excessive cool down, improper
placement of the patient or condition (cleanness) of the electrodes.
User`s Manual
4.5.3. Printout Format Selection.
Available Printout Formats Recording Mode

MAN: ECG signal recording in real time. The user may
I aVR V1 V4
II
directly adjust the amplitude, paper feeding rate as well as
aVL V2 V5
III aVF V3 V6 lead groups. The system will record 3 channels from a
selected group of leads. Recording will continue until the
user presses down "Stop" key or the paper roll runs out.
Format: 4x3
I aVR V1 V4
II aVL V2 V5
III aVF V3 V6
AUTO: 12-channel automatic recording mode. Within 10

Format: 2x6 seconds the system will record the ECG signals from 10
I V1 electrodes (12 channels) in Einthoven, Goldberg, and
II V2 Wilson configuration. The examination will be saved to the
III V3
aVR V4
built-in memory which ensures further ECG analyses,
aVL V5 printout of copies or transmission of the results to PC.
aVF V6
Simplified AUTO investigation:

Format: 1x12 The user may select connection of R, L, F, and N limb
I electrodes only. In such a case the system will record the
II
III signals from channels I, II, III, aVR, aVL, and aVF.
aVR
aVL
aVF
V1
V2
V3
V4
V5
V6
Format: 6 lines
0’00 ... RHYTHM: Rhythm examination.
0’30 ...
1’00 ... Within 3 minutes the system will record the signal from
II channel II and save it to the built-in memory. This type of
1’30 ...
2’00 ... investigation ensures determination of statistical
2’30 ... distribution of HR (R-R distance) and printout of a
histogram.
Format: 12 lines
0’00 ...
0’15 ...
0’30 ...
0’45 ...
1’00 ...
II 1’15 ...
1’30 ...
1’45 ...
2’00 ...
2’15 ...
2’30 ...
2’45 ...
User`s Manual
4.6 Operating the recorder, changing the roll of paper
Before beginning any recording the roll of paper should be placed into the recorder and the
recorder should be loaded in the way that the printed side of the paper is touching the thermal
head with its scale. After closing the recorder table and choosing the lead it is possible to
begin the recording.
After all the paper has been used the recorder will stop and the diodes which are placed in the
chosen speed field are signalling this state by flashing.
In order to change the roll of paper push the lever of the recorder table latch. This will cause
the table to open up and will allow access to the recorder where the empty roll of paper is
located.
Table of the recorder is not fix immovable to the apparatus – it is necessary to treat
with care so as not to cause any damage, for example by dropping.
Place the new roll of paper into the recorder, pullout the end of the paper from the recorder in
the record, placing it symmetrically to the bosses on the external surface of the recorder table,
and, through pressing the table, close the record.
After changing the roll of paper the apparatus is again ready to operate.
Remember that the high quality of the print out can only be ensured if you
are using original recording paper which was bought in FARUM S.A.
Figure 4 shows how to mount the roll of paper onto the handle.
MOUNTING Lever to open the

THE ROLL OF record table
PAPER
Figure 7. Mounting the roll of paper onto the handle

User`s Manual
5. Recording the ECG testing

5.1 Recording in the MAN (Manual) mode
After turning on the apparatus and choosing the desired output group from the foil keyboard
(figure 3) the diode MAN light, which is placed in field of working modes.
After pressing the button the recording and printout will begin. The printout
in 3 channels will include:
- coding of the output and the calibration impulse,
- recording of the chosen output group along with the printout consisting of the following
information: MAN, measuring sensitivity, speed of paper intake, description of active
filters 35 Hz (25 Hz) and 50 Hz.
Changing the output group, sensitivity settings and the speed, as well as activation
and deactivation of filters while the recording is in progress will cause a printout of
a new information sheet.
The recording is terminated by pressing the button.
5.2 Recording in the AUTO (Automatic) mode
Choosing the AUTO mode is possible by switching over the button of choose of registration
modes (rewinding) and the AUTO diode will be lighted.
Man
Diode signalling the

Auto
choose of AUTO Rytm
Lever for change
working mode of choose of the
registration mode
In similar way it is choosing the recording format (3, 6, 12 channels), the output group of
speed settings, sensitivity settings and filters settings.
After pressing the button (START) the speed, sensitivity and filters buttons will be
blocked and AUTO diode will start flashing what symbolize the registration test.
After 5 seconds of collecting data of the ECG signal a printout in the following format will
begin:
• 3 channel recording – 4 groups each 3 leads
• 6 channel recording – 2 groups each 6 leads
• 12 channel recording – 1 group each 12 leads
After the outputs are printed a report with the following information is printed:
- HR, R-R measurements results,
- Medicines used: dotting area with the place for writing of used medicines
and the others.
User`s Manual
The Apparatus automatically remember the last test. It enables to make the later copy of the
test and the following button can be pressed on the apparatus:
- STOP - terminates the test
- START – repeated recording
1 2 3
- ANALIZA – creation of an analysis report
- KOPIA – creation of a copy
and it is possible to create multiple printouts copy of the last test also after switching on and
after the next switching off the apparatus.
CAUTION: In order to save paper if the N electrodes will not be connected when
performing a recording the report of „Electrode disconnected” will be
printed.
5.3 Analysis
After the printout is finished in the AUTO (automatic) mode the following button will be
pressed:
- STOP - terminates the test
1 2 3

1 2 3
After pressing button and after 5 seconds the following will be performed:
- a printout of standardized outputs with the vertical markers showing the beginning and the
end of each break will be created
- a printout of calculated time parameters will be created
- a printout of calculated amplitude will be created
- stop the print out and the following button will be pressed:
- STOP – terminates the test

1 2 3
CAUTION: In a case of appearing of big disturbances in the examined ECG signal or in

presence of a pacemaker, the measuring will not be performed. On the paper there
will be printed the message: “Analysis failed”.
User`s Manual
In case of detection by the apparatus the impulses of pacemaker (or appearing a big periodic
disturbances, the analysis will not be done. However, on screen of the apparatus appear the
statement:
Analysis failed
Pacemaker is detected
CAUTION! ECG research, in which can appear the pacemaker impulses, it has to done when
the filters 25, 35, 50 Hz are turn on. Turning on in apparatus the filters 25, 35, 50
Hz, it cause deformity and filtration the impulses of the pacemaker, what the
reason it what they can not be seen in printout.
5.4 Measurements and analysis of the hart beat rhythm
Choosing the RHYTHM mode is possible by switching over the button of choose of
registration modes (rewinding) till the RHYTHM diode will be lighted.
Man
Diode which Lever to change
signalling the Auto
the registration
Rytm
RHYTHM choose choose mode
working mode
After inputting the patient identification data (not mandatory) and pressing the (start)
button the speed, sensitivity and filters buttons will become blocked and
RHYTHM diode will start flicker, what signals the data acquisition.
After the 3-minute recording of the II output a printout of the measured contractions in the 6-
channel format will be created and the following button will be pressed:
:
- STOP – terminates the test
1 2 3
- ANALIZA – creation of an analysis (measurement) report
- KOPIA – creation of a copy of the record
1 2 3
After pressing the (analysis) button the following calculations will be printed out:
R-R interval parameters and a histogram of time trends of the recorded test will be created.
User`s Manual
6. Transmission of data into the computer

Sockets used for connection of the outer devices.
The Apparatus has a socket used for PC connecting by RS 232 interface (figure. 1 point 6).
The functions built into the apparatus enable transmission of the ECG signal data
to a personal computer in compliance with the RS232 standard. This connection
can be operated only by qualified personnel whose training and experience
assures safe and proper use of the apparatus.
The PC must be loaded with the E600Win program delivered by the producer of the apparatus
to enable such transmission. The program enables archiving of data after the recording in
AUTO (automatic) or RHYTHM modes is finished.
Required PC parameters:
Minimal hardware requirements:
- The processor: compatible with Pentium 400 MHz,
- Memory: 256 MB RAM,
- Resolution: 256 colours, 800x600 dpi,
- Windows 95
During the examination the apparatus must not be connected to the PC.
PC
Connection inside of the apparatus
PC
RS 232
Lead for communication

Lead for protection and equalization
of the apparatus with PC
of potentials. Colour: yellow/green.
Figure 8. PC - ECG Wiring Diagram.

User`s Manual
7. Autotest
The “Autotest” function allows the user to turn on the automatic testing and checking of the
apparatus functions operation.
Testing of the apparatus is activated upon pressing and holding the measurement button for 3
seconds after turning on the apparatus.
The triangular line on the width of the paper will be printed.
The test of the apparatus will be made and in case of proper working the symbol will be
printed.
In case of mistakes and damages will be appeared the symbol will be printed.
It means that the apparatus should be given to the service.
CAUTION! After making the autotest of the apparatus press the

STOP button before starting the tests.
User`s Manual
8. Operating, storage and periodical maintenance

The apparatus is to be used in quarters not in danger of any explosions, fires and
influence of gases and caustic fumes. Do not store or use the apparatus in dusty, wet or
steamy conditions.
Avoid heating of the Apparatus by direct sunlight or other means of heat.
Avoid storing and operating the apparatus in the close proximity of X-ray apparatus,
diathermy apparatus, large transformers or engines.
Before cleaning the apparatus always remember to disconnect from the power source.
Never clean the apparatus using a cleaning detergent or sterilize it using boiling / hot
water, steam or hot air.
The apparatus may be externally cleaned using a solution of water and a mild
detergent with a soft cloth.
After each use of the apparatus the electrodes should be cleaned using the solution of
water and soap. You must check if the sucker of the suction electrode is completely
dry. Sterilization can also be performed using the ethylene oxide or, for example,
Alhydex, Vygon.
The patient cable should not be subjected to any heavy pressure. While disconnecting
the outputs you must always hold the plugs, not the cable. The cables should be placed
in a way that they would not cause any persons to trip over them or any carts wheeling
them over.
If sterilization is required it should be performed using only gas, never steam. In order
to disinfect the cable should be wiped with a soft cloth dampened with one of the
following detergents: Inicidin GG, Amocid, Lysoformin, Alhydex.
The longevity of the apparatus is seven (7) years on condition that maintenance and annual
technical safety tests of the apparatus will be done
Storage and transport conditions:
Storage of the apparatus:

Temperature: min: 0 ºC max: 60 ºC
Relative humidity: min: 10% max: 95% (without condensation)
Transport of the apparatus:

Temperature: min: -20 ºC max: 60 °C
Relative humidity: min:10% max: 95% (without condensation)
Caution: If the apparatus was transported in temperature lower than 0°C, after getting out it
from packing, it is needed to warm it to the working temperature (10 °C ÷ 40°C)
before connecting the apparatus to the mains or switching on it using starting
button. That time depends on freezing grade of the apparatus and it could be
approximately from one to few hours. After that time it is needed to full recharge of
the battery according to point 4.1 of the User`s Manual.
User`s Manual
If the storage time of the apparatus is longer than one month, it is needed to
recharge the battery according to point 4.1 of the User`s Manual after each month
of storage.
8.1 Checking, maintenance and safety tests
Type of intervention Frequency

- checking and cleaning of thermoprint head once in 3 months
- checking of keyboard once a year
- cleaning of paper container once a year
- checking of patient’s cable and electrodes once a year
- safety test once a year
Checking thermoprint head
Thermo print head SHALL BE cleaned with switched off apparatus. Correct frequency of
cleaning ensures long time of printing and its correctness.
Proceed as follows:
remove the shield of the paper container
clean the heat points of the thermoprint head with the small piece of cotton-wool
saturated with spirit, regarding not to touch the head with hand or with other
thing!
Every 12 months the apparatus should be given a safety test performed by the FARUM
S.A. Technical Service Department or Authorized Service of the producer.
The test should include the following:
- thorough overview of the apparatus,
- thorough overview of the components,
- test of the safety grounding, test of the isolation,
- measurement (analysis) of the current flow,
- checking of all the functions of the apparatus.
The results of the tests should be attached to the documentation pertaining to the apparatus.
All repairs can be performed only by FARUM S.A. Service or by Authorized Service of the
producer.
User`s Manual
9. Recycling and disposal

This product is an electronic unit subjected to the Act of used electric and electronic devices
of 29th July 2005, in accordance with the European Directives 2002/95/CE – 2002/96/CE –
2003/108/CE. The apparatus cannot be disposed of in the territory of European Union as
urban waste. It must be returned to the place where used electric and electronic devices are
collected or must be returned to the manufacturer or distributor from whom it was purchased.
This disposal operation does not entail any extra costs for the user. Scrapping operation does
not charge the user of any additional costs.
For extra-European markets comply with the laws in force considering that the product
contains:
- Battery
- Lead
- Electronic units
- Ferroalloys, aluminium and copper
- ABS
User`s Manual
10. Electromagnetic compatibility

Estimation criteria of proper activity:
A criterion: Apparatus should act according to its intended use during and after
finishing the tests. It is not allowed any worse activity or looses the function
below action level described by the producer, in condition when the apparatus is
used appropriately.
B criterion: Apparatus should act according to its intended use after the tests.
However, it is allowed level reduction during test. It is not allow changing the
activity condition or loosing storage data.
Kind of measurement Relevant standard Result

Conducted emission PN-EN 55011:2001+A2 Positive
measurement
B class
Radiated emission PN-EN 55011:2001+A2 Positive
B class
Current harmonics emission PN-EN 61000-3-2:2002+A2 Positive
A class
Voltage fluctuations and PN – EN 61000-3- Positive
flicker emission 3:2002+A2
Summary of immunity tests.

Kind of Test method used Result Recommendations
measurement
Electrostatic PN-EN 60601-1- Positive It is recommended that
discharge immunity 2:2002 floors in space were made
test (ESD) PN-EN 61000-4- of wood, concrete or
2:1999+A2 ceramic. It is not
recommend synthetic
covering.
Radiated, radio- PN-EN 60601-1- Positive
frequency, 2:2002
electromagnetic field PN-EN 61000-4-
immunity test 3:2003+A1
Electrical Fast PN-EN 60601-1- Positive Quantity of power supply
transients immunity 2:2002 should be the same as it is
PN-EN 61000-4- used in typical medical
4:2005 devices or other hospital
devices.
Surges immunity PN-EN 60601-1- Positive As mentioned above
User`s Manual
2:2002
PN-EN 61000-4-
5:1998+A1
Conducted RF PN-EN 60601-1- Positive The best quality of
immunity 2:2002 registered test could be
PN-EN 61000-4- reached by disconnection,
6:1999+A1 during registration, power
supply and using internal
accumulator.
Magnetic field PN-EN 60601-1- Positive It is not allowed to use
immunity 2:2002 devices which generate
PN-EN 61000-4- magnetic field during test
8:1998+A1 in view of possibility of
increase interference level
visible in printout.
Voltage dips, PN-EN 60601-1- Positive Apparatus is equipped
interruptions 2:2002 with internal accumulator
immunity tests PN-EN 61000-4- which ensue continuity of
11:2005 activity.
Magnetic field resistance with power supply frequency according to PN-EN

61000-4-8:1998+A1.
Frequency Magnetic field Dwell time at Performance Performance
strength single frequency criterion criterion tested
required
50 Hz 3 A/m 10 s A A
Conduct disturbances resistance induced by radio frequency field

according to PN-EN 61000-4-6:1999+A1.
Ports/line Frequency Disturbance Modulati Dwell time Perform Performa
s tested range s voltage on at single ance nce
(level) parameter frequency criterion criterion
s required tested
AC mains 0,15 – 80 3 VRMS AM 80% 3s A A
MHz (130 dBµV) 10 Hz
step 1% sinus
User`s Manual
11. Technical specifications

Dimension (length/depth/height 295 x225x65
Environmental conditions:
- duty Ambient temperature: from + 10oC to +40oC
Humidity: from 25% to 75% (without condensation)
Atmospheric pressure: from 700 hPa to 1060 hPa
- transport and storage Ambient temperature: from 0 ºC to + 60 °C (from -20 °C to
0 ºC till 24h),
Humidity: from 10% to 95% (without condensation)
Atmospheric pressure: from 700 to 1060 hPa
Safety classification I
Level of protection CF
Power supply unit AC mains 90 ÷ 240 V 50Hz
battery NiMH 12 VDC 2,5 Ah
Working time with battery 2 hours of continuous work for printing out of the
supply examination in AUTO mode (without analysis) with
following parameters:
Sensitivity 10 mm/mV
Printing speed 25 mm/s
Channels 6
Power input ≤ 20 VA
ECG signal registration 12 standard leads
Protection against
defibrillation provided, inside
ECG amplifier:
Input impedance >100 MΩ
CMRR >100dB
Registration band 0,05 ÷ 150Hz
A/C converter 12 bits
Frequency sampling 800 Hz/channel
Maximal level of constant ±300 mV
voltage
Time constant ≥ 3,2 s
Measurement sensitivity 5; 10; 20 mm/mV or AUTO
Paper intake speed 12,5; 25; 50 mm/s
Working modes Manual (3 leads choice)
Automatic:
Basic test and RHYTHM
Signal memory 5 s in AUTO mode and 3 minutes in RHYTHM mode
Pacemaker recognition AUTO and RHYTHM modes – automatic recognition
In MAN mode the impulses are visible in EKG record
after turning on the filters 25/35/50 Hz
Filfil demands of IEC 60601-2-51:2003
Software of the apparatus:

Print out of the copy Yes
Autotest of the apparatus Yes
User`s Manual
Signalisation of disconnected
Yes
electrodes
Co-operation with PC Use of one COM port
Available of archivization and A4 print out.
Work with the monitor Standard VGA socket,
Resolution: 640 x 480; Refresh frequency: 50Hz.
Observation of ECG signal on
Yes
PC monitor
Programme of ECG parameters
Yes
measurement (Analysis)
Histogram for RHYTHM test Yes
Digital muscle filter 35 Hz or 25Hz
Digital mains filter 50 Hz
Thermal head 104 mm, 8 points./mm
Thermoactive paper Width 110÷112 mm on roll of ∅ 54 mm
Serial interface RS-232 port
Keyboard functional
Quantity of channels 3 / 6 / 12
Screen: Graphical colour display, 640 x 480, 6.25 inch,
presenting 3, 6, 12 channels
Wright of the apparatus ~ 2 kg
Standards: PN-EN 60601-1:1999:

Electric appliances for medical applications. General safety
requirements.
PN-EN 60601-1-1:2002
Medical electrical equipment. General requirements for safety.
Supplementary standard: Safety requirements for medical electrical
systems.
PN-EN 60601-1-4:2006
Medical electrical equipment. - Part 1-4: General safety
requirements. - Supplementary standard: Programmable medical
electrical systems.
PN-EN 60601-2-25:2004
Electric appliances for medical applications. Part 2-25: Detailed
safety requirements applicable to electrocardiographic systems.
PN-EN 60601-1-2:2002 (U):
Electric appliances for medical applications. Part 1-2: General safety
requirements - Standard supplement: Electromagnetic
Compatibility. Requirements and Evaluation.
PN-EN ISO 14971:2007
Medical devices – Application of risk management to medical
devices.
Directive No. 93/42/EEC.
User`s Manual
Standard accessories:
1. Mains cable > 1,7 m

2. Patient cable type R01 3-R01-4316-500-1
3. Limb electrode R
4. Limb electrode L
5. Limb electrode F
6. Limb electrode N
7. Suction electrode 6 pieces
8. Separating transformator TS 90VA or TSOP 160/003M from Indel company
9. Thermoactive paper roll, width 110 mm length 38m (internal ∅ 19 / external ∅ 54)
User’s Manual
Warranty Certificate
Additional accessories:
10. Junction cable RS232 ~ 1.5÷2 m

11. Installation programme E600Win
12. ECG Gel
13. ECG carring bag 3-W01-6403-001-1
14. Trolley E61 3-E61-4115-073-4
15. Trolley E61 with arm for patient cable 3-E61-4115-073-4

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ELECTROCARDIOGRAPH

User Manual: edition 03/2009 date 07.04.2009, Electrocardiograph E60VGA

1.1 How to use the User’s Manual?

Operating the electrocardiograph in accordance with instructions marked with

More information may be obtained at the following address:

1.2 Place and conditions of operation

The Electrocardiograph E60VGA is constructed in accordance with the European directives

1.3 Information and instructions for safe use

The electrocardiograph should be operated by qualified and experienced medical

- The electrocardiograph cannot be operated when using surgical

- Do not use this electrocardiograph in the presence of anesthetics or

- All medical equipment should be used only by qualified and

- All data retained from automatic interpretation programs or other

- The electrocardiograph is equipped with a RS232 interface for the

2. Structure of the electrocardiograph

Figure 1. Structure of the electrocardiograph

The following components are included in the E60VGA Electrocardiographs, shown in

Figure 2. External sockets view.

3. Description of symbols and functions of the electrocardiograph

Figure 3. Foil keyboard

Figure 4. Foil with drawing of electrodes connection

Setting of the parameters is signalled by lighting of the proper diode.

Setting the registration sensitivity

Setting of the filters:

Change of the quantity of printing channels.

Choose of working mode:

Turn on/turn off of the

activation of the print out (START).

- measurement tests performed in the AUTO or RHYTHM modes.

- copy of the last examination record

4. Turning the electrocardiograph on and preparation for

If the internal power source (battery) is discharged excessively it can cause

Press the button to turn the apparatus on.

4.2 Connecting the patent cable

The electrocardiograph is equipped with a patient cable for 10 electrodes, which is to be

4.3 Preparing for examination

The electrodes should be connected in compliance with general methods connecting

Standard location of the electrodes:

Figure 5. Standard location of the electrodes

4.4 Connecting ECG to the monitor

Turn on the energy supply of the apparatus.

Precautions and alerts:

VGA socket in the

Figure 6. Connecting ECG to the monitor

Parameters of monitor view:

4.4.1. Main view, electrode test mode

It is possible to perform the simplified examinations to the limb outputs only.

4.5 Setting the speed, sensitivity and filters

4.5. Setting up the registration parameters

Part of the screen with

Channel mark III

4.5.1. ECG Configuration Icons.

The impact of mains-generated interferences may be reduced down to a minimum: press

4.5.3. Printout Format Selection.

Available Printout Formats Recording Mode

AUTO: 12-channel automatic recording mode. Within 10

Simplified AUTO investigation:

4.6 Operating the recorder, changing the roll of paper

MOUNTING Lever to open the

Figure 7. Mounting the roll of paper onto the handle

5. Recording the ECG testing

The recording is terminated by pressing the button.

5.2 Recording in the AUTO (Automatic) mode

Diode signalling the