Saadat Dena User manual

SAADAT Co.
User Manual
Dena
Electrocardiograph
D00912-4.2
Dena 650 (Linux)(

POOYANDEGAN RAH SAADAT CO.
No. 4, 1st East St., Ettehad Blvd., Damavand St., TEHRAN, IRAN
Post box: 1658916599
Tel: [phone]
Fax: [phone]
Customer Services:
Tel: [phone]
Fax: [phone]
Cell: [phone]
Legal responsible:
Trionara Technologies AB
Laxfiskevägen 6
433 38 Partille, Sweden
E-Mail: [e-mail]
Tel: [phone]
Fax: [phone]
Web site: www.saadatco.com
Email: [e-mail]

Contents
Manual Purpose .......................................................................................................................... I
Symbols.....................................................................................................................................II
General warnings......................................................................................................................III
Patient’s safety........................................................................................................................VII
Grounding..............................................................................................................................VIII
1) Introduction ..........................................................................................................................1
General ...................................................................................................................................2
Features...................................................................................................................................2
Signal recovery accuracy.........................................................................................................2
Environment ...........................................................................................................................2
Intended Use...........................................................................................................................3
Getting started.........................................................................................................................3
Top Panel................................................................................................................................5
Display Screen........................................................................................................................5
Header Area:.......................................................................................................................6
Waveform/ Menu Area:.......................................................................................................6
Message Area:.....................................................................................................................6
Touch screen keys...................................................................................................................7
Control Panel ..........................................................................................................................7
Indicators................................................................................................................................9
Bottom panel...........................................................................................................................9
Rear panel.............................................................................................................................10
Side panel .............................................................................................................................10
Built-in Battery .....................................................................................................................10
2) General settings...................................................................................................................13
General .................................................................................................................................14
Main Menu ...........................................................................................................................14
Print Mode Menu ..................................................................................................................15
Recorder Setting Menu..........................................................................................................16
Filters Menu..........................................................................................................................17
About Menu..........................................................................................................................20
User Setting Menu ................................................................................................................20
Setting Menu.........................................................................................................................21
3) Patient information.............................................................................................................27
Patient Data Entry.................................................................................................................28
4) Preparation .........................................................................................................................31
Patient preparation ................................................................................................................32

ECG Electrodes Connection..................................................................................................32
Connection of the Limb Electrodes........................................................................................33
Connection of the Chest Electrodes.......................................................................................34
Lead Placement Diagram ......................................................................................................36
Recorder paper......................................................................................................................36
Paper loading ........................................................................................................................37
Information printed on the recorder paper..............................................................................39
Recorder Cleaning.................................................................................................................40
5) Recording operation ...........................................................................................................41
General .................................................................................................................................42
Recording Type.....................................................................................................................42
Manual Recording.............................................................................................................42
Automatic Recording ........................................................................................................43
Rhythm Recording ............................................................................................................44
Periodic Recording................................................................................................................44
6) ECG analysis and measurement.........................................................................................47
Reported parameters in Global ..............................................................................................48
Reported parameters in Details..............................................................................................48
7) Data Management .............................................................................................................51
General .................................................................................................................................52
Archive Menu .......................................................................................................................52
Export Menu.........................................................................................................................54
Upgrade ................................................................................................................................55
Online data transfer to PC .....................................................................................................55
8) Care and Cleaning ............................................................................................................57
System Check .......................................................................................................................58
Cleaning................................................................................................................................58
Disinfection...........................................................................................................................60
Maintenance..........................................................................................................................62
Preventive Maintenance (PM) Checklist................................................................................63
9) Troubleshooting and Error messages ................................................................................65
Troubleshooting ....................................................................................................................66
Error messages......................................................................................................................68
10) Technical specifications ..................................................................................................71
Appendix 1: Accessories .........................................................................................................75
Appendix 2: System parameters.............................................................................................77
Appendix 3: Electro-magnetic compliance (EMC)................................................................81
Appendix 4: The GLASGOW program.................................................................................87

I
Manual Purpose
This manual provides the instructions necessary to operate Electrocardiograph device based on its
intended use. Observance of this manual is a prerequisite for proper operation and ensures patient
and operatorsafety. Ifyou have any question about the device, please contactour customer service.
Intended Audience
This manual is provided for the clinical medical professionals. Clinical medical professionals are
expected to have working knowledge of medical terminology and procedures as required for the
device operation.
Explanations of the used expressions in this Manual
WARNING
A WARNING symbol advises against certain actions or situations that could result in personal injury
or equipment damage.
A NOTE symbol provides useful information and recommendations about device function.
Version Information
This manual has a version number. The version number changes whenever the manual is revised
due to software or technical specification changes. The version information of this manual is as
follows:
Release date
Version number
July 2020
D00912-V4.2

II
Symbols
Definition
Symbol
Consult user manual of the device and pay attention to
the warnings and cautions.
The device is IEC60601-1 type CF (Defibrillation proof
applied part) equipment. The units displaying this symbol
provide an F-type isolated (floating) patient applied part
with a high degree of protection against shock and is
suitable to use with defibrillator simultaneously.
For protection against defibrillator, use only manufacturer
recommended accessories.
The equipment shall be disposed of in an environmentally-
friendly manner.
AC power supply
100-240 VAC
60VA
50/60 Hz
3A fast fuse
USB port
USB
SD port
SD
Serial number
S/N
Manufacture date
Manufacturer information
European community representative

General warnings
III
General warnings
Please refer to this section for overall safety information.
Warning
Electrocardiograph system is intended to be used only by qualified medical staff.
Warning
Before use, carefully read this manual and directions for use of any accessories.
Warning
The electrocardiograph is intended for use only as an adjunct in patient assessment. It must
be used in conjunction with clinical signs and symptoms.
Warning
Do not use the electrocardiograph system during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns. The device may affect the MRI
image, and the MRI unit may affect the accuracy of device measurements.
Warning
There could be hazard of electrical shock by opening the system casing. All servicing and
future upgrading to this equipment must be carried out by personnel trained and authorized
by manufacturer.

General warnings
IV
Warning
The operator must check that the system and accessories function safely and see that it is
in proper working condition before being used (e.g. Date of the last calibration must be
valid).
Warning
Do not use cellular phone in the vicinity of this system. High level of electromagnetic
radiation emitted from such devices may result in strong interference with the
electrocardiograph performance.
Warning
Do not touch the patient, bed or devices nearby during defibrillation.
Warning
When defibrillator is used, the signals may be disturbed for a few seconds, after which the
device will continue to operate normally.
Warning
The physician shall consider all well-known side-effects when using the
electrocardiograph.
Warning
If any liquid is spilled on the system or accessories, immediately turn off the system and
wipe up it by a soft cloth.

General warnings
V
Warning
To prevent the environment pollution, the device and accessories (e.g. battery) shall be
disposed in accordance with national laws after their useful lives. Contact your
municipality to check where you can safely dispose of old batteries.
Warning
Do not expose the system near any local heating item such as the direct radiation.
Warning
It is possible to increase leakage current when several systems as well as
electrocardiograph are connected to the patient simultaneously.
Warning
Electrocardiograph software is designed in a way that hazards arising from errors in the
software programmed are minimized.
Warning
Do not connect items not specified as parts of the electrocardiograph system.
Warning
Equipment is not suitable for use in the presence of a flammable anaesthetic mixture.

General warnings
VI
Warning
To protect patient against the electrical shock hazards, the electrocardiograph device needs
to be connected to grounded power receptacle.
Warning
Electrocardiograph needs to be installed and put into service according to the EMC
information provided in the Appendix 3.
Warning
To prevent EMC effect on the electrocardiograph, it should not be used adjacent to or
stacked with other equipment and that if adjacent or stacked use is necessary, the system
should be checked for normal operation in the configuration in which it will be used.

VII
Patient’s safety
The electrocardiograph system is designed to comply with the international safety standards
requirements for medical electrical equipment. This device has floating input (isolated electricity)
and is protected against the effects of defibrillation. If correct electrodes are used in accordance
with the manufacturer instructions, the display screen will recover within 10 seconds after
defibrillation.
This symbol indicates that the device has CF type and Defibrillation Proof applied part according
to IEC60601-1. The modules with this symbol contain a CF-Type (Cardiac Float) and
Defibrillation Proofapplied part providing a high degree of protection against shock, and is usable
during defibrillation.
Follow the instructions below to ensure safety of the device installation.
The environment where the device will be used should be reasonably free from vibration, dust,
corrosive or explosive gases, extremes of temperature and humidity.
The electrocardiograph system is designed to operate under ambient temperatures between 5º C
and 40ºC. Ambient temperatures exceeding these limits could affect the accuracy of the device
and cause damage to the electrical circuits.
Warning
Do not touch the patient, bed or instrument during defibrillation.

VIII
Grounding
To protect the patient and hospital personnel, the electrocardiograph system must be grounded.
The device is equipped with a detachable 3-wire cable which grounds the instrument to the power
line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire
receptacle is not available, consult the hospital electricians. If there is any doubt regarding the
integrity of the protective grounding wire, the equipment should run on the battery.
Warning
Possible explosion hazard if the device is used in the presence of flammable anesthetic
agents.

Chapter 1: Introduction
1
1) Introduction

Chapter 1: Introduction
2
General
Dena is a small, light-weight and portable Electrocardiograph device. It is equipped with a color
TFT touch screen, recorder and built-in battery.
Features
Dena is applicable to adult and neonatal patients and capable of:
_Displaying 12-lead ECG waveform
_Displaying Rhythm-lead waveform separately on the screen
_Up to 6-channel waveform recording
_Data storage in internal and external memories
_Displaying and recording stored data
_Data transfer via USB
_Upgrading the software via USB
_Connection and online data transfer to PC
_Dividing the paper space according to the signal amplitudes
_Signal analysis and diagnosing cardiovascular abnormalities –Measurement and Interpretation
_Measurement of cardiac angles.
Signal recovery accuracy
With regard to maximum frequency bandwidth of 150 Hz and sampling rate of 1000 samples/s,
the signal recovery accuracy of Dena Electrocardiograph complies with the requirements ofIEC
60601-2-25 standard.
.
Environment
40~ 5 ◦c
Temperature (Working)
60 ~25- ◦c
Temperature ( Transport and Storage )
%90~20 (uncondensed)
Humidity
3500 ~200- m
Altitude
240~100 VAC, 60/50 Hz
60VA
Power Supply

Chapter 1: Introduction
3
Intended Use
Dena is an advanced electrocardiograph which is designed to record electrical signals of the heart
in up to six channels (10-wire) using a thermalprinter with adjustable filter, gain, speed, and mode.
This device is applicable to adults and neonates in all parts of the medical center and used by
healthcare professionals for diagnostic purposes.
Getting started
1- Open the package.
Open the package and take out the electrocardiograph and accessories carefully. Keep the
package for possible future transportation or storage.
■Check the device for any mechanical damage.
■Check existence of accessories and contents according the following checklist:
If there is any problem, contact the distributor immediately.
2- Connect the power cable to the device.
■Make sure the AC power supply complies with the following specification:
100-240 VAC, 50 /60Hz.
■Plug the power cable to the power supply socket of the device. Connect the other end of the
power cable to a grounded power receptacle.
1 unit
Electrocardiograph device
1 piece
Patient cable
1 roll
Recorder thermosensitive paper
Set of 4
Limb electrode (wrist electrode
clamping)
Set of 6
Chest electrode (suction bulb)
1 packet
Gel
1 piece
Power cable
1 copy
User manual
1 copy
Guarantee card
1 copy
Calibration certificate

Chapter 1: Introduction
4
Make sure that the battery indicator lights. If it does not light, check your local power supply
and power cable connection. If the problem still exists, contact the After sales services
department..
The battery needs to be charged after transportation or storage. If the power cable is not plugged
in before turning on the device, the device may not work properly because of insufficient power.
Connect the device to AC INPUT for about 8 hours while it is off.
3- Power on the electrocardiograph system.
Press Power key to turn on the electrocardiograph.
The battery must be recharged after a while to ensure adequate electricity reserve. To do so, you
only connect the system to AC power.
4- Connect the patient cable.
Connect all necessary accessories to patient and the electrocardiograph
Warning
If any sign or error message is observed in the device that may be due to its failure, please
do not use it on the patient.

Chapter 1: Introduction
5
Top Panel
Display Screen: ECG waveforms, patient information, messages, etc. are displayed on the
screen (See 1-1 for details).
Recorder Release Button: to open the recorder door.
Recorder: to load recording paper and record ECG waveforms.
Control panel: to control the system operation (See 1-1 for details).
Display Screen
Dena is equipped with a TFT color screen. All 12-lead ECG waveform, HR value, Patient name/ID,
Date and Time, system operating status, error and informative messages are displayed on the
screen. The screen is divided into four areas: informative and system error messages area (Figure
1-2-
1
), Header area (Figure 1-2-
22
), touch keys area (Figure 1-2-
3
), Waveform/ Menu area
and lead error message area (Figure 1-2-
4
).
Figure 1-1 Top panel

Chapter 1: Introduction
6
Header Area:
The Header Area is at the top of the screen. The heart rate, patient name/ ID, current date and time
and system operating status are displayed in this area. This information is displayed on the screen
during the system operation.
Symbol will appear in the Header Area only if the device runs on the battery.
The HR value is measured and updated per second.
Selecting each adjustable parameter from the main screen will call up a menu through which you
can set the parameter.
Waveform/ Menu Area:
Rhythm-lead or 12-lead ECG waveforms are displayed on the screen and their arrangement cannot
be changed.
ECG lead type is displayed in Waveform Area.
Message Area:
The message area is divided into two parts:
1Lead error message area:
Figure 1-2 Display screen

Chapter 1: Introduction
7
All electrodes connection is checked regularly by the system and in case of improper connection,
the related message will appear in this area in red (Figure 1-2-
4
).
2Informative and system error messages area (Figure 1-2-
1
).
The system messages are displayed in white background and red text.
(Refer to chapter 9 for the system messages).
Touch screen keys
The function of touch keys is the same as their corresponding hard keys on the control panel.
Refer to Control Panel for details.
Control Panel
Dena is designed in such a way that user can easily perform operations using some keys and
touch screen.
Warning
Do not touch the screen with sharp objects.
Figure 1-3 Control Panel