Saadat Dena 640 User manual

SAADAT Co.
User Manual
Dena
Electrocardiograph
D00850-0
Dena 640

POOYANDEGAN RAH SAADAT CO.
Address: No.4, East First St, Ettehad Blvd. Damavand St, TEHRAN, IRAN
Post box: 16765-965
Tel: [phone]
Fax: [phone]
Customer Services:
Tel: [phone]
Fax: [phone]
Cell: [phone]
Web site: www.saadatco.com
Email: [e-mail]

Table of Contents
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…………………………………………………….
15
Section 3 Device Setting…………………………………………………………
25
General …………….……………………………………………………………..
25
Main Menu………………………………………………………………………..
26
System Setting Menu……………………………………………………………..
26
User Setting Menu………………………………………………………………..
30
Section 4 Patient Information………………………………………………….
33
Section 5 Data Management…………………………………………………....
38
General …………….……………………………………………………………..
38
Memory Menu……………………………………………………………..…......
39
Section 6 Recording Operation……………………………………….………..
43
General …………….……………………………………………………………..
43
Recording Type………………………………………………………..…………
44
Copy Mode……………………………………………………………..………...
46
Recorder Paper………………………………………………………..………….
47
Section 7 Patient Safety…………………………………………....……………
51
Section 8 Getting Started……………………………………………….….…...
53
Section 9 Technical Specifications………………………………………..….....
55
Section 10 Care and Cleaning (PM)……………………………………………
59
System Check………………………………………………………….….……...
57
Cleaning………………………………………………………………..…...…….
68
Disinfection……………………………………………………….………………
59
Section 11 Troubleshooting ………………………...…………….……………
61
Appendix I-Accessories
63
Appendix II-List of System parameters
64
Appendix III- Error Messages
67
Appendix IV-EMC
70

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
April 2018
D00850-0

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.

III
Explanations of the symbols in the Manual and device
Definition
Symbol
Consult user manual of the DENA system 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 VAC60VA50/60 Hz
3A fast fuse
USB port
USB
SD port
SD
Serial number
S/N
Manufacture date
Manufacturer information

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 trained and authorized personnel by
manufacturer company.
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.
Always verify the beep sound when the system powers on. (For
more information, please refer to section 8)

3
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 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 sunlight.
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 programmed software 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 and turn on the
system again.
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
_Displaying Rhythm-lead waveform separately on the screen
_6-channel waveform recording
_Data storage in internal and external memories
_Displaying and printing stored data
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 3000m
Power Supply 100-240VAC, 50/60Hz
60 VA
Intended Use
Dena is an advanced electrocardiograph which is designed to record electrical signals of the heart
in six channels (10-wire) using a thermal printer 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.

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

8
2-1 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: Header area (Figure 2-2-
1
), Waveform /
Menu area , Lead error message area (Figure 2-2-
22
) , informative and system error messages
area (Figure 2-2-
3
) and touch keys area (Figure 2-2-
4
).
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, patient name/ ID, current date and time and system operating status. This information is
displayed on the screen throughout 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.

9
Waveform/ Menu Area:
Rhythm-lead or 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 continuously by the system and in case of improper
connection, the related message will appear in this area in red (Figure 2-2-
22
).
2- Informative and system error messages area (Figure 2-2-
3
).
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.

10
2-2 Control Panel
Dena is designed in such a way that user can easily perform operations using some keys and
touch screen.
1
Start/Stop
Press to start/stop ECG recording.
2
Arrow
Keys
Use to scroll between menus.
3
Menu
Press to access Main Menu.
4
Copy
Press to print the last recorded data
5
Calib
Press to record a 1mv calibration signal.
6
Speed
Use to adjust the recording speed.
7
Reset
Use to reset Drift filter and restore signals quickly to the screen.
8
Enter
Press to enter software menus or select menus options
9
Lead►
Press to select next lead(s).
10
◄Lead
Press to select previous lead (s).
11
Sens
Use to adjust the amplitude of ECG waveform on the screen and recording paper.
12
Mode
Use to select recording mode.
131313
Power
Press to turn on or off the device.

11
2-3 Indicators
The POWER switch (On/Off) is located on the control panel (
131313
in Figure 2-3). There are two
indicators for power on and batter‟s charge on the control panel.
The green power indicator lights up when the device is powered on (
15
in Figure 2-3).
The battery indicator illuminates green when the battery is fully charged otherwise it is orange.
(
14
in Figure 2-3).
Before using the electrocardiograph, check function of all keys
and make sure that it is in proper working order.
Figure 2-3 Control Panel

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
The following connector are located at the back side of the device:
Figure 2-5 Rear Panel
Power Supply: 100-240 VAC, 60 VA, 50/60 Hz
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
The following connectors are located at the right side of the device:
Figure 2-6 Side Panel
1-Connector of ECG cable
2-Programmer connector: it should only be used by the manufacturer trained and
authorized personnel.

14
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 5 hours to charge it again. A fully-charged battery
allows an operating time of minimum 8 hours.
Symbol in the Header Area indicates the battery charge capacity, in which the yellow 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. Orange indicator means
that the battery is being charged.
When the battery is depleted in less than 1 hour, it needs to be
replaced. Please call customer service for the battery replacement.
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.
Use only the manufacturer recommended batteries. Other
batteries may result in fire.