Saadat Dena 350 User manual

SAADAT Co.
User Manual
Dena
Electrocardiograph
D00718-4.2
Dena 350

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]
Cell: [phone]
Fax: [phone]
Legal responsible: Trionara Technologies AB
Laxfiskevägen 6
433 38 Partille, Sweden
Tel: [phone]
Fax: [phone]
Web site: www.saadatco.com
Email: [email protected]

Contents
Table of Contents
Manual Purpose
I
Explanations of the used expressions in this Manual
II
Explanations of the symbols in the Manual and device
III
Section 1 General Warnings…………………………………………………....
1
General Warnings………………………………………………………………...
2
Section 2 System Configuration………………………………………………..
5
General …………….……………………………………………………………..
6
System Description……………………………………………………………....
7
ECG Electrodes Connection…………………………………………………….
16
Section 3 Device Setting…………………………………………………………
21
General …………….……………………………………………………………..
21
Main Menu………………………………………………………………………..
22
System Setting Menu……………………………………………………………..
22
User Setting Menu………………………………………………………………..
25
Section 4 Patient Information………………………………………………….
28
Section 5 Data Management…………………………………………………....
32
General …………….……………………………………………………………..
32
Memory Menu……………………………………………………………..…......
32
Section 6 Recording Operation……………………………………….………..
34
General …………….……………………………………………………………..
34
Recording Type………………………………………………………..…………
35
Copy Mode……………………………………………………………..………...
37
Recorder Paper………………………………………………………..………….
37
Recorder Cleaning …………………………………………………..………….
40
Section 7 Patient Safety…………………………………………....……………
41
Section 8 Getting Started……………………………………………….….…...
43
Section 9 Technical Specifications………………………………………..….....
44
Section 10 Care and Cleaning (PM)……………………………………………
46
System Check………………………………………………………….….……...
46
Cleaning………………………………………………………………..…...…….
47
Disinfection……………………………………………………….………………
48
Section 11 Troubleshooting ………………………...…………….……………
50
Appendix I-Accessories
52
Appendix II-List of System parameters
53
Appendix III-Error Messages
56
Appendix IV-EMC
58

Manual Purpose
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 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
D00718-4.2

Explanations of the used expressions in this Manual
II
Explanations of the used expressions 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.

Explanations of the symbols in the Manual and device
III
Explanations of the symbols in the Manual and device
Definition
Symbol
Consult user manual of the monitor and pay attention
to the warnings and cautions.
For protection against defibrillator, use only
manufacturer recommended accessories.
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.
The equipment shall be disposed of in an
environmentally-friendly manner.
Equipotential grounding system.
AC power supply
SD port
SD
Serial number
SN
Manufacture date
Manufacturer information
European community representative
USB port

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

Chapter 1. General Warnings
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 operator must check that 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 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.
Equipment is not suitable for use in the presence of a flammable
anesthetic mixture.

Chapter 1. General Warnings
3
The electrocardiograph and devices connected to it should form
an equipotential body to ensure effective grounding.
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.
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 .
To prevent electric shock, connect the protection earth wire of
electrocardiograph device.
Electrocardiograph needs to be installed and put into service
according to the EMC information provided in the APPENDIX IV .
Do not touch the patient, bed or devices nearby during
defibrillation.
Electrocardiograph software is designed in a way that hazards
arising from errors in the software programmed are minimized.

Chapter 1. General Warnings
4
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 and turn on the
system after at least 30 minutes.
.
Clean the gel from limb electrodes and chest electrodes after
using them.
Entering any conductive sharp objects into device ports may
cause danger.
Unplug the system after being completely charged.
If you want to use device with patient defibrillator
simultaneously, use patient cables approved by manufacturer (with
internal resistor of 10kΩ, 3W at least) and do not use other cables

Chapter 2. System Configuration
5
Chapter 2. System Configuration
Dena350 electrocardiograph system is capable of:
_Displaying 12-lead ECG waveform
_Displaying Rhythm-lead waveform separately on the screen
_3-channel waveform recording
_Data storage in Internal and External memory
_Displaying and printing stored data

Chapter 2. System Configuration
6
2- 1 General Information
System is equipped with 5 inch color TFT, touch screen, recorder and built-in battery.
Dena350 is a small, light-weight and portable Electrocardiograph device and can be used
anywhere.
Environment:
5~40º C
Temperature working
-25 ~60º C
Temperature of Transport and
Storage
20~90 %
Humidity
-200 to 3500m
Altitude
100-240 VAC
60VA, 50/60 Hz
Power Supply
Product Lifetime:
Since electric parts have lifetime of 10 years and recommended calibration interval of the device
is 1 year and its mandatory calibration interval is 2 years, the expected lifetime of the device is
10 years.
Intended use:
Dena350 is an Electrocardiograph that integrates ECG module, Recorder module, display screen
and power supply in one device. Compactness, lightweight, portability of this system facilitates
transportation.
DENA350 is applicable to variety of ages ranging from neonates to adults in all medical awards
by skilled medical staff for diagnostic purpose.

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

Chapter 2. System Configuration
8
Display Screen
Dena350 is equipped with a TFT color screen. All 12-lead ECG waveform, HR value, Patient ID,
Date and Time, system and battery operating status, error and informative messages are displayed
on the screen. The screen is divided into three areas: Header area (Figure 2-2) Waveform / Menu
area (Figure 2-2), Messages area (Figure 2-2).
Figure 2-2 Display Screen
Header Area:
The Header Area is at the top of the screen. The parameters displayed in Header Area are heart
rate, current date and time and system operating status.This information is displayed on the
screen throughout the system operation.
The HR value is measured and updated per second.
Waveform/ Menu Area:
Rhythm-lead or 12-lead ECG waveforms are displayed on the screen and their arrangement
could 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:

Chapter 2. System Configuration
9
All electrodes connection is checked continuously by the system and in case of improper
connection, the related message will appear in this area in red.
2- Informative and system error messages area (Figure 2-2).
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 Control Panel for details.
Do not touch the screen with sharp objects.

Chapter 2. System Configuration
10
Control Panel
Dena350 is designed in such a way that user can easily perform operations by using keys and
touch screen.
1-On/Off:Press to turn on or off the device.
2-Sens: Use to adjust the amplitude of ECG waveform on the screen and recording paper.
3- Copy:Press to print the last recorded data.
4-Speed:Use to adjust the recording speed.
5-Calib:Press to record a 1mv calibration signal.
6-◄Lead: Press to select previous lead (s).
7-Lead►: Press to select next lead (s).
8-Start/Stop:Press to start/stop ECG recording.
9- Reset:Use to reset Drift filter and restoring signals quickly to the screen.
10-Mode: Use to select recording mode.
11-Arrow Keys:Use to scroll between menus.
12- Enter: Press to enter software menus or select menus options.
13- Menu: Press to access Main Menu.
Figure 2-3 Control Panel

Chapter 2. System Configuration
11
Indicators
The POWER switch (On/Off) is located on the control panel (in Figure 2-3-
1
). There are two
indicators for power and battery on the control panel. The green power indicator lights up when
the device is powered on (in Figure 2-3-
14
).
The battery indicator Turns into green when the battery is fully charged, yellow when it is half
charged, otherwise it is red. (in Figure 2-3-
15
).
14-AC indicator: This LED lights on when AC power is plugged in
15- Battery indicator: Battery indicator can change color according to battery status
Before using the electrocardiograph, check function of all keys
and make sure that it is in proper working order.

Chapter 2. System Configuration
12
2-2-2-Bottom Panel
Figure 2-4 Bottom Panel
Speaker outlet
Battery Compartment: For loading the battery.
2-2-3-Peripheral Connectors
Figure 2-5 Rear Panel
Equipotential grounding terminal.
Power Supply jack: 100-240 VAC,2- 0.8 A 50/60 Hz.

Chapter 2. System Configuration
13
The following connectors are located at the left side of the device:
Figure 2-6 Side Panel\Left
Recorder Release Button: to open the recorder door.
Connector of ECG cable
The following connectors are located at the right side of the device:
Figure 2-7 Side Panel\right
USB Device connector: for transferring data to pc software.
RJ-45 connector: Future capability (optional).
USB Host: For upgrading firmware by qualified operator.
Slot for SD Card : for saving recorded ecg signal data on SD card.

Chapter 2. System Configuration
14
2-2-4-Built-in Battery
Electrocardiograph is equipped with a rechargeable battery. The battery will charge
automatically once you connect the system to the AC INPUT (whether the device is on or
off).When the battery is fully discharged, it takes about 4 hours to charge it again.Afully-charged
battery allows an operating time of minimum 8 hours.
Symbol in the Header Area indicates the battery charge capacity, in which the color part
represents the remaining battery charge. This symbol is only displayed when the AC INPUT is
not plugged in. The status of the battery charging is also shown by the battery indicator on the
control panel.
When the battery indicator is solid green, the battery is fully charged. When the battery is
charging, the AC indicator is on and battery indicator is off.
When the battery is depleted in less than 2 hour, it needs to be
replaced. Please call customer service for the battery replacement.
.
Use only the manufacturer recommended batteries. Other
batteries may result in fire.Using unapproved battery will void the
device warranty.
Charge and discharge of the battery is calculated by the battery
specification, 11.1 V-4300 mAh -Li Pol.
.
The electrocardiograph will turn off automatically if the battery
power is too low. When the electric power is going out, the message
"BATTERY LOW" will be displayed.