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.