CardioTécnica RG6 Series User manual

User Manual
Electrocardiograph RG6XX
Versión1.0

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Version 1.0 - CardioTecnica SRL
Tabla of Contents
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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
Version 1.0 - CardioTecnica SRL
................................................................................................................................... 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: [phone]
Web: cardiotecnica.com.ar
E-mail: [e-mail]; [e-mail]
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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Version 1.0 - CardioTecnica SRL
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
Version 1.0 - CardioTecnica SRL
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.

Introduction 7
Version 1.0 - CardioTecnica SRL
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.

User Manual - Electrocardiograph line RG6XX8
Version 1.0 - CardioTecnica SRL
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

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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.