Saadat Dena 1210 User manual

User Manual
Electrocardiograph
DENA 1210
SAADAT Co.
D00948-5

POOYANDEGAN RAH SAADAT Co.
Address: 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:
Address: Trionara Technologies AB
Polygonvägen 21. 18766. Täby. Sweden
E-Mail: [e-mail]
Tel: [phone]
Web site: www.saadatco.com
Email: [e-mail]

Contents
Manual Purpose ......................................................................................................................... I
Symbols.....................................................................................................................................II
Patient’s safety.........................................................................................................................III
1) Introduction........................................................................................................................1
Device description .................................................................................................................2
Intended use...........................................................................................................................2
Features..................................................................................................................................2
Get started..............................................................................................................................3
Top panel ...............................................................................................................................4
Display screen....................................................................................................................4
Control panel......................................................................................................................6
Recorder.............................................................................................................................8
Bottom panel........................................................................................................................11
Rear panel ............................................................................................................................12
Side panel.............................................................................................................................12
2) System settings.................................................................................................................13
General information.............................................................................................................14
Recording Mode menu.........................................................................................................15
Rec. Setting menu................................................................................................................17
Filter menu...........................................................................................................................18
User Setting menu................................................................................................................20
Patient Information ..............................................................................................................21
Setting menu ........................................................................................................................23
3) Patient preparation...........................................................................................................29
Actions before recording......................................................................................................30
ECG electrodes connection..................................................................................................30
Connection of the Limb electrodes......................................................................................31
Connection of the Chest Electrodes.....................................................................................31
Detection of electrode disconnection...................................................................................32
Color codes and Labels of electrodes ..................................................................................33
Lead placement diagram......................................................................................................34
4) Recording Operation........................................................................................................35
Recording Types..................................................................................................................36
Manual Recording............................................................................................................36
Automatic Recording.......................................................................................................36
Rhythm Recording...........................................................................................................37

Periodic Recording...............................................................................................................38
5) ECG analysis and measurement.......................................................................................39
General information.............................................................................................................40
Reported parameters in Global mode ..................................................................................40
Heart Axis........................................................................................................................41
QTc parameter .................................................................................................................41
Reported parameters in Details mode..................................................................................42
6) Data management.............................................................................................................45
General information.............................................................................................................46
Archive menu.......................................................................................................................46
Transfer menu......................................................................................................................48
Online data transfer to PC....................................................................................................49
7) Care and Cleaning............................................................................................................51
System check .......................................................................................................................52
Maintenance.........................................................................................................................53
Cleaning & Disinfection......................................................................................................54
External surfaces of the device........................................................................................54
Display screen..................................................................................................................54
Recorder...........................................................................................................................55
Accessories ......................................................................................................................55
Preventive Maintenance.......................................................................................................57
8) Troubleshooting and Error messages...............................................................................59
Troubleshooting...................................................................................................................60
Error messages.....................................................................................................................62
9) Technical specifications...................................................................................................65
Appendix 1: Accessories..........................................................................................................69
Appendix 2: System parameters ..............................................................................................71
Appendix 3: Electro-magnetic compliance..............................................................................75
Appendix 4: The GLASGOW program...................................................................................81

I
Manual Purpose
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.
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.
Note
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
Sep. 2022
D00948-V5

II
Symbols
Symbol
Description
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.
100-240 VAC
120 VA
50/60 Hz
AC power supply
3A fast fuse
USB port (Host)
USB port (Device)
Network port (LAN)
S/N
Serial number
Manufacture date
Manufacturer information
European community representative
Equipotential grounding system.

Patient’s safety
III
Patient’s safety
Introduction
The DENA 1210 electrocardiograph device 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.
Grounding
To protect the patient and hospital personnel, the electrocardiograph system must be grounded.
The DENA 1210 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.
Equipotential Grounding
Protection class I instruments are already included in the protective grounding (protective
earth) system of the room by way of grounding contacts in the power plug. For internal
examinations on the heart or the brain, the electrocardiograph must have a separate connection
to the equipotential grounding system. One end of the equipotential grounding cable (potential
equalization conductor) is connected to the equipotential grounding terminal on the rear panel
of the device and the other end to one point of the equipotential grounding system. The
equipotential grounding system is for the safety function of the protective grounding conductor
if ever there is a break in the protective grounding system. Examinations in or on the heart (or
brain) should only be carried out in medically used rooms incorporating an equipotential
grounding system. Check each time before use that the instrument is in perfect working order.
Warning
•Dena 1210 electrocardiograph is intended to be used only by qualified medical staff.
•Before using the Dena 1210 electrocardiograph, read the user manual and its
accessories thoroughly.
•Dena 1210 electrocardiograph is intended for use only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and symptoms.
•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 and devices connected to it should form an equipotential
body to ensure effective grounding.

Patient’s safety
IV
•Before using the Dena 1210 electrocardiograph, the operator must ensure the safety
and correct operation of the device and its accessories. (Device calibration date must
be valid).
•Do not touch the patient, bed or devices nearby during defibrillation.
•Disposable electrodes are recommended when using electroshock and electrosurgery
with an electrocardiograph.
•When defibrillator is used, the signals may be disturbed for a few seconds, after
which the device will continue to operate normally.
•For people who have a pacemaker, be sure to enable the pacemaker detection feature
on the device.
•The physician shall consider all known side effects when using the Dena 1210
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 connect devices that are not part of the Dena 1210 electrocardiograph.
•Do not expose DENA 1210 near any local heating item such as the direct radiation.
•It is possible to increase leakage current when touching the patient and connected
devices, or when several systems as well as DENA 1210 are connected to the patient
simultaneously.
•Due to the possibility of explosion, the equipment is not suitable for use in the
presence of a flammable anaesthetic mixture or in oxygen-rich places.
•To protect patient against the electrical shock hazards, DENA 1210 needs to be
connected to grounded power receptacle.
•The location of the device shall be such that when necessary, the plug of the device
can be easily disconnected from the electrical outlet.
•If any liquid is spilled on the system or accessories, immediately turn off the system
and wipe up it by a soft cloth. If water seeps into the device, it should be inspected
by trained personnel before reuse.
•Electric and magnetic fields cause the device to malfunction. The Dena 1210
electrocardiograph must be installed and serviced in accordance with the information
in Appendix 3 Electromagnetic Compatibility (EMC).
•To prevent EMC effect on DENA 1210, 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.
•Do not use DENA 1210 during X-ray and Magnetic Resonance imaging. Induced
current could potentially cause burns and may affect the accuracy of DENA 1210
measurements. DENA 1210 may also adversely affect MRI and X-ray images.

Patient’s safety
V
Note
•Before connecting the device to the power supply, make sure that the voltage and
frequency match the specifications of the device.
•The environment in which the device is used must be free from vibration, dust,
corrosive and flammable gases, high temperature and humidity.
•The device is designed to work well at temperatures between 5 and 40 degrees
Celsius. When the ambient temperature exceeds this range, it adversely affects the
measurement accuracy of the device and may damage electrical circuits.
•The Dena 1210 electrocardiograph software is designed in such a way that minimize
the risk of software errors.
•According to the frequency band up to 150 Hz and the sampling rate of 1000 samples
per second, the accuracy of signal reconstruction in Dena 1210 electrocardiograph is
in accordance with the requirements of IEC 60601-2-25.

Chapter 1: Introduction
1
1)Introduction

Chapter 1: Introduction
2
Device description
DENA 1210 (ECG Recorder) is one of the most important, safest, and simplest medical devices
for measuring, displaying, storing, and recording cardiac signals to diagnose many heart
diseases.
Intended use
DENA 1210 can be used for adults, children and infants. This device is intended for trained
medical staff in all medical centers that have complied with the requirements of the medical
location, for diagnostic purposes.
Contraindications:
•DENA 1210 is not intended for home or MRI use.
•DENA 1210 is not a therapeutic device. The results provided by the device should be
evaluated based on the patient's clinical condition and these results cannot replace
routine examinations.
Features
•Color display and touch screen
•Lightweight and portable
•Works with rechargeable batteries or AC power
•Recording and displaying 12-lead ECG waveform
•Displaying Rhythm-lead waveform separately on the screen
•Up to 12-channel waveform recording
•Adjustable filter, gain, paper speed and recording mode
•Data storage in internal and external memories
•Displaying and recording stored data
•Data transfer via USB
•Connection and online data transfer to PC
•Upgrading the software via USB
•Dividing the paper space according to the signal amplitudes
•Signal analysis and diagnosing cardiovascular abnormalities –Measurement and
Interpretation
•Measurement of cardiac angles

Chapter 1: Introduction
3
Get started
1- Open the package and take out the DENA 1210 and accessories carefully. Keep the package
for possible future transportation or storage. If trolley is available, assemble it according to its
instruction and place the electrocardiograph on it properly.
•Check the device for any mechanical damage.
•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 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.
3- Power on the DENA 1210.
•Press the Power key to turn on the electrocardiograph.
4- Connect the patient cable. Connect all necessary accessories to patient and the DENA 1210.
Warning
•If any sign or error message is observed in DENA 1210 that may be due to its failure,
please do not use the device on the patient until the sign or error is eliminated.
In the following, the different parts of this device will be explained.

Chapter 1: Introduction
4
Top panel
Display screen: ECG waveforms, patient information, messages, etc. are displayed on
the screen. (more information follows).
Recorder Release Button: to open the recorder door.
Recorder: to load recording paper and record ECG waveforms.
Control panel: to control the system operation. (more information follows).
Display screen
2
3
4
1
Figure 1-1 DENA 1210 Top panel
Figure 1-2 DENA 1210 display screen (default)

Chapter 1: Introduction
5
DENA 1210 has a TFT color screen. The 12-wave ECG waveform, HR numerical value,
patient name and ID, date and time, device status and system messages are displayed on this
screen. The screen can be divided into three parts:
- Header area (figure 1-3-
1
),
- Menus and touch keys (figure 1-3-
22
), and
- Waveform and message area (figure 1-3-
3
).
Header Area
The upper section of the screen is called Header Area. The parameters displayed in this area
include the numerical value of the HR, time, date and operating conditions of the device. This
information is always displayed on the screen when the device is on. Touch keys to change the
display mode, access the settings and archive menus are also in this area. According to the
battery conditions during operation of the device, the corresponding symbol is displayed in the
Header Area.
It should be noted that the numerical value of HR is measured and updated in real-time.
Menus and touch keys
Using this section, you can easily change the recording settings. The function of each of the
keys in this section is similar to the equivalent key function on the device keyboard (control
panel). More details can be found in the System Settings chapter.
Waveform and message area
12-lead ECG waveforms or Rhythm lead waveforms are displayed on the screen. The name of
the lead is displayed on the area corresponding to the ECG waveform. In the lower right corner
of this section is the touch record key, which functions exactly like the Start / Stop key on the
keyboard. The green color of this key means that touching it starts recording. When recording,
Figure 1-3 DENA 1210 display screen (with messages)

Chapter 1: Introduction
6
the key turns red. When the word Stop is displayed on the key, touching it will stop recording.
When recording the signal in Rhythm mode, its color will be displayed in blue and, a counter
will appear inside the key. This key becomes inaccessible when entering menus or an error
message appears.
The Dena 1210 electrocardiograph constantly checks the connection of the electrodes and, if it
detects that the electrodes are not connected properly, displays a message in the signal drawing
area (such as lead V6 in Figure 1-3-
3
).
Device notification and error messages are displayed in yellow box at the bottom of this area.
Control panel
The Dena 1210 electrocardiograph is designed so that the operator can easily work with it using
several keys along with a touch screen. Figure 1-4 shows the functional keys and indicators of
the Dena 1210 electrocardiograph.
1
2
4
13
14
15
16
8
9
10
11
12
7
17
6
5
3
18
Figure 1-4 Functional keys and Indicators

Chapter 1: Introduction
7
Table 1-1 Functional keys and Indicators
①
This key is used to turn the device ON and OFF. Its indicator lights green
when the device is ON.
󰪧
Battery indicator (when the battery is fully charged it is green, otherwise
it is orange).
󰪨AC
Indicates the presence of AC power in the device.
󰪩Start/Stop
Pressing this key can record ECG signals, and pressing this key again
will stop recording.
󰪪Layout
Used to change the display mode of signals to full-screen or normal
mode.
󰪫Archive
Used to review stored data and recall records.
󰪬Settings
Used to access device settings.
󰪭Refresh
Used to reset the Drift filter and return signals quickly to the screen.
󰪮Calib.
Used to record 1mv calibration signal.
⑩Copy
Used to retrieve the last saved record.
⑪Speed
Used to set the recording speed.
󰪱Mode
Used to enter the recording mode selection menu.
⑬Gain
Used to set the amplitude of the ECG waveform on the main screen and
the record.
󰪳▲Lead
Used to select the next lead / group of leads.
⑮Lead▼
Used to select previous lead / group of leads.
⑯Menu
Pressing this key will return to the home screen.
󰪶Arrow keys
Used to move between menus.
⑱Enter
Used to enter menus or select the desired option.
Warning
•Before starting work with the Dena 1210 electrocardiograph, first check all the keys
and make sure that they work correctly.
•Do not use sharp objects to touch the screen.

Chapter 1: Introduction
8
Recorder
Warning
•Use only the record paper recommended by the manufacturer, otherwise the quality
of the record may be poor and the thermal head may be damaged.
•Only 210 mm heat-sensitive record paper should be used.
•The thermal head and its surroundings are very hot during and immediately after
recording, and touching it can cause injuries such as burns.
Paper placement
1. Press the recorder release button as shown below and open the recorder door.
2. Place the roll of paper obliquely on the bulging place and push it.

Chapter 1: Introduction
9
3. Place the other side of the paper roll in its proper place. Open the paper roll to leave some
of it out of the recorder.
4. Close the recorder door.
Warning
•Do not open the recorder while the recorder is operating. This can damage it.
•The paper comes out at a constant speed while the recorder is working. Pulling the
paper will damage the recorder.
•If the paper is jammed, do not pull it out by force. Open the recorder door and take
out the paper.

Chapter 1: Introduction
10
Note
•• If there is paper or foreign object on the sensor, it cannot work properly. Therefore,
if you see a foreign object on the sensor, remove it and clean the sensor.
•Be careful when loading the paper in the recorder. Avoid damaging the
thermosensitive print head. Do not touch thermosensitive print head.
•It is recommended to use papers with colored markings to warn of approaching
completion. The user must always make sure that the amount of paper is sufficient
before recording.
Information printed on the recorder paper
1- Recording time and date,
2- System settings:
•Recording type (Auto, Manual, Rhythm) and Status (Normal, Copy, Review,
Periodic), and Format.
•Recording time for each group of leads,
•Rhythm lead(s),
•Recording speed,
•Recording gain,
•Filters,
•Pace status,
•signal interpretation status,
•Power supply type (AC, Battery),
•Smart Record status
•Save status
3- Patient Info:
•Heart Rate numerical value,
•Patient’s name, ID, gender, height, weight, age and blood type,
•Physician name,
•Hospital/Ward Name,
4- Device Info:
•Manufacturer and device model,
•Software version.
Note
•The paper space is divided according to the size of the signals. It should be noted that
after connecting the cable, the patient should be given at least 4 seconds to calculate
these values and the space should be divided proportionally between the leads. This
feature is known as Smart Record and its activation / deactivation is determined by
the user and the selected status is displayed as Smart Record in the record header.
•If there is a DC offset and the Drift filter is off or there is a Pacemaker in the patient's
body and the device Pace option is off, the space may not be allocated properly.