CardioTécnica RG6 Series User manual

User Manual
Electrocardiograph RG6XX
Versión1.0

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Version 1.0 - CardioTecnica SRL
Tabla of Contents
0
Parte I Introduction 4
................................................................................................................................... 41 About this manual
.......................................................................................................................................................... 4Responsible Organization
.......................................................................................................................................................... 4User
.......................................................................................................................................................... 4Patient
.......................................................................................................................................................... 4Maker
.......................................................................................................................................................... 4Representative
.......................................................................................................................................................... 5Technical service
................................................................................................................................... 52 Expected use
................................................................................................................................... 53 Restrictions
................................................................................................................................... 64 Function and Purpose of the Electrocardiograph
................................................................................................................................... 65 Symbology Used
................................................................................................................................... 86 Environmental conditions
................................................................................................................................... 87 General Warnings and Precautions
................................................................................................................................... 108 Warranty
Parte II RG6XX Electrocardiograph 11
................................................................................................................................... 111 General description
.......................................................................................................................................................... 11Parts Applicable to the Patient
................................................................................................................................... 122 Family's description
................................................................................................................................... 133 Unpacking
................................................................................................................................... 134 Useful life
................................................................................................................................... 135 Final disposal of waste
................................................................................................................................... 146 Unit Description
.......................................................................................................................................................... 16Keyboard
......................................................................................................................................................... 16On / Off
......................................................................................................................................................... 16Navigation Keys
......................................................................................................................................................... 16Shortcut Keys
.......................................................................................................................................................... 16Printing machine
.......................................................................................................................................................... 16Screen
.......................................................................................................................................................... 16Connectors
......................................................................................................................................................... 17Mains Pow er Input
......................................................................................................................................................... 17Earth Connector
......................................................................................................................................................... 17Data Communication Port - RS232
......................................................................................................................................................... 17Signal Output Connector
......................................................................................................................................................... 18SD card / USB port
......................................................................................................................................................... 18Imput Patient Circuit
.......................................................................................................................................................... 18Fixation piece
.......................................................................................................................................................... 18Installation
Parte III Generalities 20

User Manual - Electrocardiograph line RG6XX2
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................................................................................................................................... 201 Use of Defibrillators
................................................................................................................................... 212 Color TFT display
................................................................................................................................... 213 Battery Operation
................................................................................................................................... 224 Use of Paper
................................................................................................................................... 235 System Messages
................................................................................................................................... 246 Measurements
.......................................................................................................................................................... 24Measurements of a Heartbeat
Parte IV ECG setup 25
................................................................................................................................... 251 Keyboard Functions
.......................................................................................................................................................... 25On / Off
.......................................................................................................................................................... 25Right Arrow
.......................................................................................................................................................... 25Left arrow
.......................................................................................................................................................... 25Manual / Automatic / Rhythm
.......................................................................................................................................................... 26Amplitude
.......................................................................................................................................................... 26Mv / Copy
.......................................................................................................................................................... 26Paper Advance
.......................................................................................................................................................... 26File
.......................................................................................................................................................... 26Navigation Keys
................................................................................................................................... 262 Menús
.......................................................................................................................................................... 27Setting
......................................................................................................................................................... 27Date and Time
......................................................................................................................................................... 27Print
......................................................................................................................................................... 28Communication
......................................................................................................................................................... 28System
......................................................................................................................................................... 29Test Equipment
.......................................................................................................................................................... 29Freeze
.......................................................................................................................................................... 29Patient
.......................................................................................................................................................... 30Working mode
.......................................................................................................................................................... 31Memory File
.......................................................................................................................................................... 33Manual / Automatic / Rhythm
.......................................................................................................................................................... 33To print
Parte V User Mode 34
................................................................................................................................... 341 Loading paper
................................................................................................................................... 352 Patient Connection
................................................................................................................................... 373 Conducting the Study
.......................................................................................................................................................... 37Turning on the Equipment
.......................................................................................................................................................... 38Manual Mode
.......................................................................................................................................................... 38Automatic mode
.......................................................................................................................................................... 39Rhythm Mode
.......................................................................................................................................................... 40Equipment Shutdown
Parte VI Accessories 41
................................................................................................................................... 411 Patient Cable
................................................................................................................................... 422 Ground wire
................................................................................................................................... 423 Mains Power Cable

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Parte VII Maintenance 43
................................................................................................................................... 431 General care
................................................................................................................................... 432 Cleaning and disinfection
................................................................................................................................... 443 Error Messages
................................................................................................................................... 454 Reviews to be performed by the operator
................................................................................................................................... 455 Periodic Safety Reviews
................................................................................................................................... 466 Preventive Maintenance
................................................................................................................................... 467 Corrective maintenance
................................................................................................................................... 468 Problem solving
.......................................................................................................................................................... 46Patient Cable Problems
.......................................................................................................................................................... 47Printer Problems
.......................................................................................................................................................... 48Problems with the keyboard
.......................................................................................................................................................... 48Alternating Current Interference
.......................................................................................................................................................... 49EMG interference
.......................................................................................................................................................... 49Baseline Deviation
.......................................................................................................................................................... 50Electrocardiograph Won't Turn On
.......................................................................................................................................................... 51Incorrect Results
Parte VIII Technical specifications 52
................................................................................................................................... 521 Performance Specifications
................................................................................................................................... 542 Maker
Index 0

User Manual - Electrocardiograph line RG6XX4
Version 1.0 - CardioTecnica SRL
1 Introduction
1. Introduction
ALERT: It is the duty of the Responsible Organization and the User to Read and
Understand this Manual before using the RG6XX Electrocardiograph for the first
time, mainly the Safety chapter.
1.1 About this manual
This document, the RG6XX Electrocardiograph User Manual, is an integral part of the product
and should be kept with the equipment.
The use of this manual is a fundamental requirement to guarantee the functionality and safety
of the equipment.
The RG6XX Electrocardiograph User Manual is intended for Responsible Organizations and
Users, describes the use of the RG6XX Electrocardiographs, and contains detailed
information about their performance, specifications and operation.
The institutions and people mentioned in this manual are:
1.1.1 Responsible Organization
Institution or Health Professional, owner of the RG6XX Electrocardiograph, responsible for the
administration of use, conservation and maintenance.
1.1.2 User
Healthcare professional who operates the RG6XX Electrocardiograph, electrically connects
the patient and records the ECGs.
1.1.3 Patient
Person who connects to the patient circuit of the RG6XX Electrocardiograph to record the
ECG.
1.1.4 Maker
Maker:
CARDIOTÉCNICA SRL -
Av. Reservistas Argentinos 443
Ciudad Autónoma de Buenos Aires - Código Postal C1408AII
Buenos Aires - Argentina.
Tel/Fax: (5411) 4643-9436 / (5411) 4643-9482
Web: cardiotecnica.com.ar
E-mail: info@cardiotecnica.com.ar; ventas@cardiotecnica.com.ar
1.1.5 Representative
Company or Person who, with a representation contract with Cardiotécnica SRL, markets
and distributes the RG6XX Electrocardiographs.

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1.1.6 Technical service
Company or Trained Person, with authorization from Cardiotécnica SRL, to carry out repairs
on the RG6XX Electrocardiographs.
1.2 Expected use
The Electrocardiographs manufactured by CardioTécnica are electromedical equipment
designed to carry out complementary studies for the clinical diagnosis of cardiac conditions,
capable of recording the action potentials of the cardiac tissue, one patient at a time, using a
patient cable.
It has been designed to be used in neonatal, pediatric and adult patients in hospitals, hospital-
type centers. The use of the equipment is intended for health professionals or institutions.
Electrocardiographs must be operated In person and attended by health professionals
trained in the operation of electrocardiographs, with the supervision of a specialist in
cardiology.
Connected exclusively to the electrical network installation of class 2A medical
environments, in accordance with Regulation 90364-7-710 of the AEA, or the IEC 60364-7-
710 standard; or battery.
Supported on flat, stable surfaces with an inclination of less than 5º.
The air of the environment of use of the device:
must be free of anesthetic gases,
must be free of flammable gases,
must not be enriched with oxygen,
it must have a temperature between 10ºC and 40ºC,
must have a non-condensing relative humidity between 25% and 95%,
It must have an atmospheric pressure between 700hPa and 1060hPa.
1.3 Restrictions
The RG6XX Electrocardiographs must be used in a stable position, properly supported on a
flat horizontal surface.
They are not designed to be used:
as a patient monitor,
as devices with category AP or APG,
in environments with flammable anesthetic mixtures with air,
in environments with flammable anesthetic mixtures with oxygen,
in environments with flammable anesthetic mixtures with nitrous oxide,
connected to more than one patient simultaneously,
with other devices with electrical connection on the patient,
in the vicinity of MRI or CT equipment.
There is no risk or restriction on the use of the RG6XX Electrocardiographs in patients with
pacemakers or other implanted stimulators.

User Manual - Electrocardiograph line RG6XX6
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1.4 Function and Purpose of the Electrocardiograph
Electrocardiography detects and graphs the electrical potentials generated by the cells of the
heart tissue; that precede and give rise to the systolic and diastolic mechanical activity of the
heart.
Cardiac electrical activity generates weak ionic currents physiologically conducted to the
surface of the skin, where they are sensed with contact electrodes, at different points on the
body surface.
The sensed cardiac signals vary between 100µV and 5mV, and are amplified and conditioned
to represent them temporarily on a Cartesian graph called an electrocardiogram or ECG.
The particularities of the waveform of the cardiac electrical signal represented in the ECG
depend on the sensing point and the adopted reference.
The ECG allows the cardiology specialist to detect anomalies in the cardiac signal waveform,
correlate them with possible pathologies, and, with complementary tests, confirm them by
analyzing characteristic symptoms and signs, to establish a clinical diagnosis and an
associated treatment.
1.5 Symbology Used
Symbol
Reference
Indicates protective earth.
IEC 60417-5019 symbol.
Alert signal that indicates the need to refer to the reading of the instructions
that accompany the equipment. ISO 7000-0434A symbol.
Applicable part type CF protected against defibrillation.
IEC 60417-5336 symbol.
Symbol that indicates that waste must be collected in a different way. Symbol
of Directive 2002/96 / CE.
Symbol that indicates that the manual should be read before operating the
equipment. ISO 7010-M002 symbol.
Serial number.
Lot Number
Keep dry
Degree of Protection provided for the enclosure.
DC.

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Symbol
Reference
Alternating current.
USB port
Signal output
Produced by
Date of production
Standby (On / Off Key)
Lead Selector, Left and Right
Record Paper Advance
Work Mode Selector
Amplitude selector
Access to Internal Memory
Calibration Signal
Copy function of the Last Study
Menu Navigation Controls
Internal Battery Operation Indication
Indication of Equipment Charging the Internal Battery
Indicates that the SD Card is inserted, a cross indicates its absence.
It indicates the connection with the PC, with a cross indicates the lack of
connection.

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1.6 Environmental conditions
The RG6XX Electrocardiographs must be transported, stored and used respecting the
following environmental conditions:
Characteristics:
Functioning
Transportation and Storage
Temperature
5ºC a +40ºC
-10ºC a +70ºC
RH
25% a 95% (not condensed)
10% a 95% (not condensed)
Atmospheric pressure
700hPa a 1060hPa
500hPa a 1060hPa
Maximum stowage
No weight on equipment
5 Units
The RG6XX Electrocardiographs must be connected exclusively to the electrical network
installation of class 2A medical environments, in accordance with the AEA Regulation 90364-
7-710, or the IEC 60364-7-710 standard; or used on battery.
The RG6XX Electrocardiographs comply with the immunity and interference requirements
required by the IEC60601-1-2 standards with the modifications provided in the IEC60601-2-
25.
WARNING:
The equipment must not be used if the transport or storage requirements indicated on the
packaging and in this manual have not been observed.
The RG6XX Electrocardiographs
They are not suitable for surgery in MRI or CT settings.
They are not suitable for working with anesthetic gases. They are not AP or APG category.
They should not be used in environments with a risk of explosion.
In the room of use there must be extinguishers for fire of electrical origin.
1.7 General Warnings and Precautions
The RG6XX Electrocardiographs must not be disposed of with household waste; They must
be treated as electronic waste and respect the applicable legislation.
The batteries of the RG6XX electrocardiographs must be treated as electronic waste and
respect the applicable legislation. If they are disposed of improperly, they pollute the
environment.
Connectors and accessible conductive parts of the equipment should not be improperly
connected.
Do not connect the patient, directly or indirectly, to the equipment's protective earth input.
The RG6XX Electrocardiographs are not designed to be used in conjunction with other
electrically connected equipment on the patient. The electrical connection of the patient
simultaneously with other equipment must be evaluated and authorized by a technical
manager.
Only the models of patient cables recommended by Cardiotécnica SRL, listed in the
accessories chapter, should be used. The use of inappropriate patient cables can

Introduction 9
Version 1.0 - CardioTecnica SRL
compromise patient safety.
The defibrillation protection of the RG6XX electrocardiographs is integrated into the patient
cable. In the event of defibrillation, the device must be manually re-started to record the
patient's ECG.
The Responsible Organization must manage the maintenance of the RG6XX
Electrocardiographs, complying with the requirements determined by Cardiotécnica SRL,
indicated in this manual.
Maintenance of the RG6XX Electrocardiographs must only be carried out by personnel with
written authorization issued by Cardiotécnica SRL.
The equipment must be operated exclusively by health professionals specialized in
electrocardiography, under the supervision of a doctor specializing in cardiology.
In the event of external electromagnetic interference, it may happen that the display restarts,
but the equipment will continue to operate without user intervention, or the display turns off so
the operator must restart the equipment. When the equipment is restarted there is no risk to
the patient or the user.
PRECAUTIONS:
Do not loosen the cabinet screws, or disassemble the equipment using other methods;
There are dangerous voltages inside the equipment.
Use only the recommended grounded power cord.
Do not use adapters, slippers or any bypass device in the electrical power supply of the
equipment.
Do not spill liquids on the equipment, immerse it, get it wet, or expose it to abrasive
atmospheres or sunlight.
Do not touch, press, scratch or damage the surfaces of the equipment with hard objects.
Check the proper state of integrity of the connection cables (patient cable, derivations,
transmission, power supply, ground connection) before using the equipment.
Keep equipment and accessories clean and disinfected.
Periodically check the operation.
Carry out annual preventive maintenance (verification, adjustments and calibration),
through the official technical service. Since the safety and reliable operation of the
electrocardiograph are important, maintenance is vital.
If it is necessary to electrically connect a patient to more than one equipment, a technical
manager must evaluate and authorize the operation of the complete system, analyzing the
new particular risks of the system, analyzing the recognized risks specific to each
equipment, and respecting the IEC60601-1 standards. and IEC60601-1-1. Bear in mind that
the total patient leakage current of the system is not the direct (algebraic) sum of the
leakage currents particular to each equipment.
Place the electrodes in the correct position, on the skin, without contact with mucous
membranes, body fluids, injured tissue, oil, villi or dirt.
IMPORTANT
The information presented on the equipment display is for guidance only. All measurements
and analyzes must be performed on paper printing.

User Manual - Electrocardiograph line RG6XX10
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1.8 Warranty
Cardiotécnica SRL assumes, before the warranty holder, the economic costs of repair or
exchange due to defects or manufacturing faults of the RG6XX Electrocardiographs.
The warranty has a validity period of 12 months from the date of delivery of the equipment, it
is non-transferable and does not cover costs for damages or lost profits.
The warranty holder is the Responsible Organization (institution or health professional) that
purchases the RG6XX Electrocardiograph through authorized representatives or the
manufacturer.
The warranty is not valid if:
the recommendations in this manual were not followed,
the inscription label and / or the serial number are altered,
the warranty certificate card available at the end of this manual was not completed and sent
to the authorized service center,
Or when the failure or defect is a consequence of:
A use other than the intended use detailed in this manual.
Accidents, negligence, abuse or improper use of the equipment.
Incorrect installation of the equipment.
An incorrect connection with other equipment.
Repairs, modifications or alterations made without written and signed authorization by the
Manufacturer.
To make use of this guarantee, the Responsible Organization (institution or health
professional) must:
Contact the manufacturer to report the defect or failure.
Request written and signed authorization from the manufacturer.
Coordinate the shipment of the equipment with the manufacturer.
Send the device in its original packaging, freight and taxes paid at origin.
If you require our professional service, contact:
CARDIOTECNICA S.R.L.
Av. Reservistas Argentinos 443 - C.A.B.A.
Buenos Aires - Argentina - (C1408AII)
TE/FAX (5411) 4643-9436 / (5411) 4643-9482
E-MAIL: fabrica@cardiotecnica.com.ar
ventas@cardiotecnica.com.ar

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2 RG6XX Electrocardiograph
2.1 General description
The Electrocardiographs manufactured by CardioTécnica are electromedical equipment
designed to carry out complementary studies for the clinical diagnosis of cardiac conditions,
capable of recording the action potentials of the cardiac tissue, one patient at a time, using a
patient cable.
They should not be used as a patient monitor.
The RG6XX Family of Electrocardiographs are units with internal rechargeable batteries,
which record 12 leads of cardiac electrical activity, and present them with direct printing on
thermal paper, in several simultaneous channels, using a high definition thermal matrix
printer.
The applicable part is type CF with defibrillation protection. The patient connection circuit has
an electrical isolation greater than 3KV with respect to the low voltage electronic stage.
The different keyboard options allow you to manage all the use and configuration menus.
Menus, configuration parameters, device operating status, and the heart signal being
recorded are displayed on the screen.
In the models with memory storage for records it is possible to save the data of 250 studies
and recall them later.
The data connection port allows log information to be transmitted to the PC.
The electrocardiographs meet the immunity and interference requirements required by the
IEC60601-1-2 standards with the modifications provided in the IEC60601-2-25.
WARNING: Electrocardiographs are NOT designed to be used in conjunction with other
electrically connected equipment on the patient. The electrical connection of the patient
simultaneously with other equipment must be evaluated and authorized by a technical
manager.
WARNING: The defibrillation protection of the RG6XX Electrocardiographs is integrated into
the patient cable. In the event of defibrillation, the device must be manually re-started to
record the patient's ECG.
2.1.1 Parts Applicable to the Patient
The equipment has applicable parts, namely:
Patient Cable with all ten leads. Of these, 4 are connected to Limb Electrode and the other 6
to Suction Electrodes.
Patient Cable

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Limb Electrodes
Suction Electrodes
2.2 Family's description
RG-603: Electrocardiograph up to 3 channels with 50mm thermal printer, 4.3 "TFT graphic
display with touch screen, storage memory for records and port for connection to PC.
RG-601 PC: Electrocardiograph with storage memory for records and port for connection to
PC.
RG-601 PC Ergo: Electrocardiograph with storage memory for records, Ergometry Module
and port for connection to PC.
RG-606: 6-channel electrocardiograph with 80mm thermal printer, 4.3 "TFT graphic display
with touch screen, storage memory for records and port for connection to PC.
The RG-603 and RG-606 print on 50 and 80mm paper respectively. All records include study
date and time, print speed, amplitude, activated filters, heart rate, and printed lead. If the
option has been configured, print the patient's data, these must be edited from the keyboard
that appears on the screen.

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2.3 Unpacking
The RG6XX Electrocardiographs must be received with the original factory protective
packaging for transport and storage.
Before opening the packaging, check that the box is not open or damaged.
When unpacking the equipment, verify the existence of:
1 RG6XX Electrocardiograph.
1 Quick Use Guide.
1 Power cord.
1 10-wire patient cable.
4 Limb electrode holder forceps.
6 Precordial suction electrodes.
1 Roll of 50mm x 30m thermosensitive paper (RG603).
1 Roll of thermosensitive paper of 80mm x 30m (RG606).
1 Equipment bag.
When removing the items from the box, verify that the content is:
full, dry, and in good condition (no bumps, scratches or tears).
WARNING: The equipment must not be used if the transport or storage requirements
indicated on the packaging and in this manual have not been observed.
Keep the original packaging to use it in future transport, technical services, returns or
storage.
Fill in the warranty certificate card (available at the end of this manual) and send it to the
Authorized Service Center.
2.4 Useful life
The RG6XX Family Electrocardiographs manufactured by CardioTécnica have a stipulated
useful life of 5 years, as long as the conditions of use, transport and maintenance established
in this manual are respected.
2.5 Final disposal of waste
RG6XX Electrocardiographs and accessories must be disinfected before being discarded.
The batteries must be sent to the manufacturer, or collected by authorized institutions for the
collection and final disposal of batteries.
RG6XX Electrocardiographs and accessories should be considered and treated as electronic
waste. To dispose of them, the current local legislation must be respected.

User Manual - Electrocardiograph line RG6XX14
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2.6 Unit Description
The RG6XX Electrocardiographs are assembled on a plastic cabinet.
Front
Left side

RG6XX Electrocardiograph 15
Version 1.0 - CardioTecnica SRL
Right side
lower

User Manual - Electrocardiograph line RG6XX16
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2.6.1 Keyboard
The RG6XX EKG keyboard contains three sets of keys; the power keys, the menu navigation
keys, and the function keys.
2.6.1.1 On / Off
With the equipment off, pressing it turns on the equipment. If the equipment is on, press,
when releasing the button the equipment turns off. The display shows a Warning during
shutdown.
2.6.1.2 Navigation Keys
The navigation keys allow you to access the menus, modify the configuration options and
accept or cancel the changes.
2.6.1.3 Shortcut Keys
The function keys allow executing a device function immediately.
The available functions are:
Registration change between Manual mode, Automatic mode and Rhythm mode.
Amplitude change of the plotted signal.
Calibration signal printing on the register in Manual mode.
Access to memory studies
ECG signal recording start.
2.6.2 Printing machine
The RG-603 Electrocardiograph has a 50mm thermal head printer.
The RG-606 Electrocardiographs have a printer with an 80mm thermal head.
The RG-601PC RG-601 PC Ergo Electrocardiographs do not incorporate a printer.
The printing system of the RG6XX Electrocardiographs works with a resolution of 8 dots per
mm; It supports recording at speeds of 5mm / s, 10mm / s, 12.5mm / s, 25mm / s or 50mm /
s.
2.6.3 Screen
The RG-603 and RG-606 have a 4.3 "TFT graphic display with touch screen, while the RG-
601PC and RG601 PC Ergo do not have a display.
The RG6XX system of the Electrocardiographs allows to display, on screen, the navigation of
the menus, the configuration states, and the ECG signals.
IMPORTANT
The information presented on the equipment screen is for guidance only. All measurements
and analyzes must be carried out on paper printing.
2.6.4 Connectors
WARNING: The connectors and accessible conductive parts of the equipment must not be
improperly connected.
WARNING: Do not connect the patient, directly or indirectly, to the protective earth input of
the equipment.

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WARNING: The RG6XX Electrocardiographs are not designed to be used in conjunction with
other electrically connected equipment on the patient. The electrical connection of the patient
simultaneously with other equipment must be evaluated and authorized by a technical
manager.
2.6.4.1 Mains Power Input
The AC inlet is the connector base located on the left side of the equipment cabinet.
Connect the electrical network using the detachable power cable provided with the
equipment, or with an analogous cable recommended by CardioTécnica SRL.
The base of the connector must only be connected to a fixed socket, of an IT electrical
installation, of a class 2A medical use environment, in accordance with AEA Regulation
90364-7-710, or the IEC 60364-7-710 standard.
CAUTION: Do not place adapters between the detachable power cord and the fixed outlet of
the electrical installation.
2.6.4.2 Earth Connector
The protective ground connector is the tab located on the left side, next to the base of the
connector. It should only be used as a reinforcement of the protective earth connection of the
electrical installation.
Connect the end of the banana plug of the protective earth cable to the protective earth
connector of the equipment, and the crocodile tip of the other end to the protective earth of
the installation.
CAUTION: Do not connect the protective earth to ducts, faucets, etc. This connection should
be supervised by the technical manager of the IT installation.
CAUTION: Use only the protective earth cable optionally provided by CardioTecnica SRL.
2.6.4.3 Data Communication Port - RS232
RS232 Serial Port
The connection of the Electrocardiograph to a PC, through the serial port, allows, by installing
a specific software, to record and present on the PC screen, the studies stored in the internal
memory of the equipment.
CAUTION: The serial cable is not supplied with the equipment. Only use cables with the
characteristics indicated in the ACCESSORIES chapter.
CAUTION: Only connect the computer port to a serial port or through a Serial / USB adapter.
The connection of other devices (monitors, pendrive, headphones, etc.) can damage the
equipment and compromise electrical safety.
2.6.4.4 Signal Output Connector
This connector is reserved for future functions.

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2.6.4.5 SD card / USB port
The use of the SD card and the USB port are reserved for the use of technical personnel.
2.6.4.6 Imput Patient Circuit
The patient circuit connector is a female DB15 plug, located on the right side of the
equipment.
The patient circuit connector has the compatible configuration, for the use of 10-electrode
patient cables, with protection against defibrillation and Connection Code No. 1 (usually
European), as established in the IEC-60601-2-51 Ed1 standard.
The isolation of the patient circuit is of the CF type, according to the specifications of the IEC-
60601-2-25 Ed1.1, and has an electrical isolation greater than 3KV with respect to the low
voltage electronic stage.
The patient circuit allows the patient to be connected, through the patient cable and the
electrodes provided with the equipment, to acquire the ECG signals.
WARNING: Only the patient cable models recommended by Cardiotécnica SRL, listed in the
accessories chapter, should be used. The use of inappropriate patient cables can
compromise patient safety.
2.6.5 Fixation piece
The RG6XX electrocardiographs have a insert at the bottom, with a 1/8 ”female thread of
6mm depth, which allows to fix the equipment cabinet to the work surface using a screw.
2.6.6 Installation
The RG6XX Electrocardiographs must be installed in a suitable enclosure, and on a work
surface that allows the operation of the equipment.
Before installing the RG6XX Electrocardiograph, it must be confirmed that the chosen
enclosure meets the environmental requirements for use established in the Environmental
Conditions heading of this manual.
The surface assigned to safely locate the RG6XX Electrocardiograph must be stable, flat,
support the weight of the equipment, have an inclination of no more than 5º and a minimum
surface area of ??0.25m x 0.35m.
It is recommended that the area assigned to install the equipment:
It has a comfortable surface for use, greater than the minimum specified, that allows to
support accessories and work elements,
has a suitable height for use (sitting in a chair; high bench or standing),
have a nearby electrical outlet to connect the power cord,
is at an adequate distance from the stretcher to connect the patient circuit,
is at a suitable distance from the PC,
allow access to the power and patient circuit connectors.
If it is necessary to tack the RG6XX Electrocardiograph, screw a 1/8 ”screw over the fixing
pad to secure the cabinet to the work surface.
After placing the RG6XX EKG machine on the work surface:
connect the detachable power cord to the connector base of the computer,

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connect the detachable power cable to the base of the fixed mains socket,
If it is necessary to reinforce the protective earth connection, request the intervention of the
technical manager of the IT electrical installation. The technical person responsible for the
installation must connect the banana plug of the protective earth cable to the protective
earth connector of the equipment, and the crocodile plug of the protective earth cable to the
assigned protective earth connector of the IT installation.
if you want to connect the equipment to the PC,
connect the DB15 male plug of the patient cable to the DB15 female connector of the
patient circuit and tighten the fixing screws.
place the thermal paper,
If the equipment does not turn on, with the supervision of the technical person in charge of the
medical equipment of the Responsible Organization, check again the network power
connections, protective earth, and USB port, and the status of the IT electrical network.
If the problem persists, contact the commercial representative of Cardiotécnica SRL, or the
authorized Technical Service.
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