Saadat Dena User manual

SAADAT Co.
User Manual
Dena
Electrocardiograph
D00948-V1
Dena 1210 (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]

II
Table of Contents
Section 1. General Warnings................................................................................................... 1
1.1 General Warnings:......................................................................................................... 2
Section 2. System Configuration.............................................................................................. 5
General..................................................................................................................................... 6
System Description................................................................................................................... 7
1. Top Panel............................................................................................................................. 7
1.1 Display Screen ................................................................................................................ 8
1.2 Control Panel.................................................................................................................10
1.3 Indicators.......................................................................................................................11
2. Bottom Panel.......................................................................................................................12
3. Connectors...........................................................................................................................12
4. Built-in Battery....................................................................................................................14
Section 3. Device Setting .........................................................................................................21
Section 4. Recording Operation..............................................................................................25
General....................................................................................................................................25
Recording Type.......................................................................................................................26
Manual Recording...............................................................................................................26
Automatic Recording ..........................................................................................................26
Recorder Paper.......................................................................................................................27
Paper loading ..........................................................................................................................27
Recorder Cleaning ..................................................................................................................30
Section 5. Patient Safety..........................................................................................................31
Grounding the electrocardiograph.........................................................................................32
Section 6. Getting Started.......................................................................................................33
Section 7. Technical Specifications.........................................................................................35
Section 8. Care and Cleaning (PM)............................................. Error! Bookmark not defined.
8.1 System Check ......................................................................... Error! Bookmark not defined.
8.2 Cleaning.................................................................................. Error! Bookmark not defined.
8.3 Disinfection............................................................................. Error! Bookmark not defined.
8.4 Preventive Maintenance (PM) Checklist............................... Error! Bookmark not defined.
Section 9. Troubleshooting .....................................................................................................46
APPENDIX I- Accessories......................................................................................................48
APPENDIX II- List of the System Parameters (Selections and Defaults) ............................49
APPENDIX III -Error Messages............................................................................................50
APPENDIX IV-EMC..............................................................................................................52

II
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 operator safety. If you have any question about the device, please contact our
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.
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
D00948-V1

II
Explanation of expressions used in this Manual
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.

III
Symbols
Definition
Symbol
Consult user manual of the monitor 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

1
Section 1. General Warnings
Please refer to this section for overall safety information.

2
1.1 General Warnings:
Electrocardiograph system is intended to be used only by
qualified medical staff.
Before use, carefully read this manual and directions for use of
any accessories.
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.
The electrocardiograph is intended for use only as an adjunct
in patient assessment. It must be used in conjunction with clinical
signs and symptoms.
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.

3
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).
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.
The physician shall consider all well-known side-effects when
using the electrocardiograph.
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.
Do not expose the system near any local heating item such as the
direct radiation.
When defibrillator is used, the signals may be disturbed for a few
seconds, after which the device will continue to operate normally.
Do not touch the patient, bed or devices nearby during
defibrillation.

4
It is possible to increase leakage current when several systems as
well as electrocardiograph are connected to the patient.
..simultaneously.
Do not connect items not specified as parts of the
electrocardiograph system.
Electrocardiograph software is designed in a way that hazards
arising from errors in the software programmed are minimized.
Electrocardiograph needs to be installed and put into service
according to the EMC information provided in the APPENDIX IV.
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.
If any liquid is spilled on the system or accessories, immediately
turn off the system and wipe up it by a soft cloth.
.
Equipment is not suitable for use in the presence of a flammable
anaesthetic mixture.
To protect patient against the electrical shock hazards, the
electrocardiograph device needs to be connected to grounded power
receptacle.

5
Section 2. System Configuration
Features:
Dena is applicable to adult and neonatal patients and capable of:
_Displaying 12-lead ECG waveform
_6-channel and 12- channel waveform recording
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 of IEC 60601-2-25
standard.
.

6
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.
Environment:
Temperature:
Working 5~40º C
Transport and Storage -25 ~60º C
Humidity 20~90 %
Altitude -200 to 3500m
Power Supply 100-240VAC, 50/60Hz
160 VA
Intended Use
Dena is an advanced electrocardiograph which is designed to record electrical signals of the heart
in maximum twelve channels (10-wire) using a thermal printer with adjustable filter, gain, speed,
and mode. This device is applicable to adults, pediatrics and neonates in all parts of the medical
centre and used by healthcare professionals for diagnostic purposes.

7
System Description
1. Top Panel
Figure 2-1 Top Panel
Display Screen: ECG waveforms, patient information, messages, etc are displayed on the
screen (See 1-1 for details).
Recorder: to load recording paper and record ECG waveforms.
Control panel: to control the system operation (See 1-2 for details).

8
1.1 Display Screen
Dena is equipped with a TFT color screen. All 12-lead ECG waveforms, HR value, Patient
name/ID, Date and Time, system operating status, error and informative messages are displayed
on the screen.
Figure 2-2 Display Screen
Header Area (inactive):
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.

9
Waveform/ Menu Area:
12-lead ECG waveforms are displayed on the screen and their arrangement can not be changed.
ECG lead type is displayed in Waveform Area.
Message Area:
The message area is divided into two parts:
1- Lead error message area:
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 2-2-
4
).
2- Informative and system error messages area (Figure 2-2-
1
).
The system messages are displayed in white background and red text.
(Refer to Appendix III 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 1-2 (Control Panel) for details.
Do not touch the screen with sharp objects.

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1.2 Control Panel
Dena is designed in such a way that user can easily perform operations using some keys and
touch screen.
①Menu
Press to access Main Menu.
②Lead▲
Press to select next lead(s).
③Copy
Press to record the last saved data
④Lead ▼
Press to select previous lead (s).
⑤Calib
Press to record a 1mv calibration signal.
⑥Speed
Use to adjust the recording speed.
⑦Reset
Use to reset Drift filter and restore signals quickly to the screen.
⑧Mode
Use to select recording mode.
⑨Start/Stop
Press to start/stop ECG recording.
⑩Sens
Use to adjust the amplitude of ECG waveform on the screen and recording
paper
⑪
Battery indicator
⑫
Press to turn on or off the device.
⑬ON
On/Off indicator
⑭Arrow Keys
Use to scroll between menus.
⑮Enter
Press to enter software menus or select menus options
Keyboard To input data

11
Figure 2-3 Control Panel
1.3 Indicators
The POWER switch (On/Off) is located on the control panel (Figure 2-3). There are three
indicators for power, device and battery on the control panel.
The device indicator lights up when the device is powered on (⑬in the figure 2-3). The power
indicator lights green when the device is plugged in (⑫in the figure 2-3).
The battery indicator illuminates green when the battery is fully charged; otherwise it is orange.
(⑪in the figure 2-3).
Before using the electrocardiograph, check function of all keys
and make sure that it is in proper working order.

12
2. Bottom Panel
Figure 2-4 Bottom Panel
Handhold: For transporting the device.
Battery Compartment: For loading the battery.
3A fast fuse
3. Connectors
Figure 2-5 Rear Panel
If the device is to be stored for a long period (more than 10
days), the fuse should be removed in order to prevent battery
discharge.

13
Power Supply: 100-240 VAC, 160 VA, 50/60 Hz
The following connectors are located at the right side of the device:
Connector of ECG cable
Network connector
Connector for PC connection
USB port for data export and software update
Figure 2-6 Side Panel