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.