Saadat Dena 350 User manual

SAADAT Co.
Service Manual
Electrocardiograph
D00720-V4
Dena 350

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

Contents Service Manual –Dena 350
Contents
Chapter 1. Introduction
1
Chapter 2. Theory of operation
10
Chapter 3. Technical specification of system
12
Chapter 4. Installation
15
Chapter 5. Programming Instruction
16
Chapter 6. Test,Calibration and Upgrade procedures
17

Chapter 1. Introduction Service Manual –Dena 350
1
Chapter 1. Introduction
1.1 About this manual
This service manual contains technical information about system for qualified service personnel
to troubleshoot, maintain and repair the Electrocardiograph Dena 350.
This Electrocardiograph Dena 350 is produced in POOYANDEGAN RAH SAADAT Co.
So when you want to service these systems, you should refer to this manual but if you want to
know about system settings and get more information about using them, you should refertothe
operator’s manual.
This manual is intended to help detecting troubles and trouble shooting of the
Electrocardiograph to the board level.
It is not permitted to service the printed circuit boards of system.
1.2 Warnings
Dena 350 Electrocardiograph is intended for clinical application
with Operation only granted to appropriate medical staff.
The device warranty is void if warranty labels were removed by
unauthorized persons.
Do not touch patient, table which device is placed on or the
equipment during patient defibrillation.
Every servicing or changing internal parts of system must be
performed by qualified technician of POOYANDEGAN RAH
SAADAT Co.
These systems are not suitable for use in environments containing
flammable anesthetic gases which combined with air, oxygen or
nitrogen oxide.

Chapter 1. Introduction Service Manual –Dena 350
2
1.3 General information
Dena 350 is a small, light-weight and portable Electrocardiograph usable in all areas due to
portability and battery function capability. It has a 5 inch TFT color LCD with touch screen and
built-in recorder.
1.3.1 Top Panel
Recorder: to load recording paper and print ECG signals.
Recorder Release Button: to open the recorder door.
Device Membrane: to control the system operation.
LCD Screen: ECG waveform, patient information, messages, etc. are contents displayed on
the LCD.
Figure 1-1 Electrocardiograph Dena 350 Top Panel
Avoid disinfecting of device and its LCD with liquid and
flammable materials.
If you want to use device with patient defibrillator simultaneously,
use patient cables approved by company (with internal resistor of
10kΩ, 3W at least) and do not use other cables

Chapter 1. Introduction Service Manual –Dena 350
3
▪LCD Screen
Electrocardiograph has a color TFT LCD screen. 12-lead ECG waveform, Heart Rate value,
Patient ID, Date and Time, system operating status and error messages are displayed on the
screen.
The screen is divided into four areas: Header Area, Waveform Area / Menu Area,Systemic
Message Area and soft keys area.
Figure 1-2 Electrocardiograph LCD Screen

Chapter 1. Introduction Service Manual –Dena 350
4
▪Control Panel and Keys
Electrocardiograph is designed so that the operator is able to control it through some keys and a
touch LCD 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 re-print previous record .
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 record ECG signals. Press again to stop the recording.
9- Reset :
Press to reset filters and bring signals back to the main screen.
10-Mode:
Press to select recording mode.
11- Right Arrow :
Press to move cursor to the right in some menus.
12- Down Arrow :
Press to move cursor to the down in some menus
13- Up Arrow :
Press to move cursor to the up in some menus
14- Enter:
Press to enter software menus or select menus options.
15- Left Arrow :
Press to move cursor to the left in some menus
16- Menu/Home:
Press to access Main Menu or return to main page.

Chapter 1. Introduction Service Manual –Dena 350
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Figure 1-3 Electrocardiograph Control Panel and Keys
▪Indicators
There are two indicators for power and battery on the top panel. The green indicator lights up,
when the device is plugged in (17in Figure 1-3). Depending on remaining charge of battery,
battery indicator can be green, orange or red when the battery is fully-charged, half-charged or
almost empty, respectively. (18in Figure 1-3).
17-AC indicator:
This LED lights on when AC power is plugged in
18- Battery indicator:
Battery indicator can change color according to battery status

Chapter 1. Introduction Service Manual –Dena 350
6
1.3.2 Bottom Panel
Bottom view of device is shown in Figure 1-4.
1- Speaker outlet
2- Battery container
Figure 1-4 Bottom Panel
1.3.3 Rear Panel
There are the following sockets on the rear panel of the main unit (Figure 1-5).
1- Equipotential grounding terminal for connecting to the grounding system of hospital.
2- Power Supply jack: 100-240 VAC, 60 VA 50/60 Hz.
Figure 1-5 Rear Panel
1.3.4 Right Panel
The following parts are on the right side of the main unit:
1- USB Device port for transmitting data to PC
2- RJ-45 Socket (future capability)
3- USB Host port for upgrading main firmware
4- SD Card Socket for saving data corresponding to recorded signals on the SD Card

Chapter 1. Introduction Service Manual –Dena 350
7
Figure 1-6 Right Side Panel
1.3.5 Left Panel
The following parts are on the left side of the main unit:
1- Recorder release button
2- Connector of ECG cable
Figure 1-7 Left Side Panel

Chapter 1. Introduction Service Manual –Dena 350
8
1.4 Explanations of the symbols in the Manual and device
Definition
Symbol
Serial number
Manufacture date
Manufacturer information
Consult user manual of the DENA system and pay
attention to the warnings and cautions.
Recyclable
Indicates that the instrument is CF type equipment
according to IEC 60-601-1. The module with this
symbol contains a Type CF defibrillation proof applied
part which provides a high degree of protection against
shock, and is usable during defibrillation.
Symbol for "CAUTION"
Equipotential grounding system.
AC power supply
100-240 VAC
60 VA 50/60 Hz
USB port
SD port
SD

Chapter 1. Introduction Service Manual –Dena 350
9
1.5Factory Setting Menu
Press Main/menu and enter to Main/menu window. Select the Factory Settings Menu from
System Settings Menu and enter it by the means of entering factory code.
FACTORY CODE
abc
Now you can:
- Calibrate Touch.
-Active Demo mode.
-Formatinternal memory.
- Adjust backlight

Chapter 3. Technical specifications of system Service Manual –Dena 350
10
Chapter 2.Theory of operation
2.1 Different Parts
The system is composed of following parts:
•Motherboard
•LED Indicators and membrane
•LCD and Touch Screen
•Power Board
•Battery Charger board
•Analog Board
•Recorder Mechanism
•Interface Board
2.1.1 Motherboard
This part of system is identified as "DMY”.
This part consists of main processor, system power supply, LCD controller, Touch Screen driver,
internal flash memory, recorder motor driver and parts related to recorder thermal head.
In Dena 350, main processes are performed by microcontroller on the mainboard. Received data
from Analog Board are processed and at the end, become ready for recording and displaying.
System continuously checks inputs (membrane and touch screen) and in each page, if correct
input received, responses appropriately. In automatic records, Microcontroller saves data on
selected memory (internal flash or SD card) as well as sending commands to thermal head.
Microcontroller is transmitting data to LCD controller continuously.
System power supply is located on motherboard. This part provides necessary voltages for
system by the regulators which mounted on the board.
2.1.2 LED Indicator and membrane keypad
Membrane is an input part of the system which is scanned by microcontroller. User can control
system through this part. LED indicators on the membrane show status of selected power supply
to user.
2.1.3 LCD and Touch Screen
Display screen used in Dena 350 is a 5 inch TFT LCD with resolution of 800 × 480 pixels. On
this LCD, a resistive touch screen is mounted which is one of the system inputs. This part is
controlled by microcontroller.

Chapter 3. Technical specifications of system Service Manual –Dena 350
11
2.1.4 Power board
The power board performs AC/DC conversion in order to charge battery andsupply system
power. This board has medical label and its input and output are isolated above 4000Vac. This
board starts its functionality when connected to power line and continue its function as long as
remains connected to power line.
2.1.5 Battery Charger board
This board provides motherboard power with battery or power board. If power cable is
connected, the board charges battery (if necessary) with smart battery charger IC mounted on it.
In addition, this board is capable of transmitting data corresponding to battery remaining
capacity to motherboard.
2.1.6 Analog Board
This board is capable of acquiring, basic filtering and amplification of input signals from patient.
Also, this board converts analog signal to digital data with resolution of 16 bits.Another task of
this board is detection and removal of Pace signals before amplification. For this purpose, Pace
signals are attenuated as much as possible and then, a comparator circuit is used for pace
detection. Occurrence of pace is reported to motherboard through transmitted data. Also, board
can report disconnecting of lead or leads to the motherboard. For the safety of patient, an
isolation line (with isolation up to 4KVAC) is implemented.
2.1.7 Recorder Mechanism
Recorder mechanism has to print ECG signals on thermal paper. This mechanism consists of a
thermal head, a motor, and a paper holder frame. The motor has different speeds defined in the
systemand rotates bythe help of pulses sent by its driver and its power supply which is mounted
on the motherboard and as a result of motor force transmission with the help of gearboxes in the
mechanism, paper is fed out of mechanism. Furthermore, a thermal head is placed into the
mechanism which gets its commands from microcontroller and the data related to signals or texts
is loaded on it synchronous with each motor step.By activation/deactivation of dots on the head,
printing on the paper is performed.
2.1.8 Interface Board
Interface board handles communications with defined peripherals of the system. Defined ports of
the system are as below:
- SD Card Port which provides connection of SD Card to the board and stores data on SD Card.
Type: SD Card or Micro SD Card with Micro to SD adaptor, Size: 2 –4 Gigabyte.
- USB Device Port which sends ECG raw data to the PC software.
- USB Host Port which is used for upgrading firmware.
- RJ-45 Port which is dedicated for connecting to local networks and is optional and for future
use.

Chapter 3. Technical specifications of system Service Manual –Dena 350
12
Chapter 3. Technical specifications of system
3.1 Block Diagram
In the next pages, block diagram and relation between different parts are illustrated.
The system is made from two parts:
1. Back Panel
2. Front panel
In each panel, corresponding parts are mounted with some screws in specified places. In
back panel, power board and battery and battery charger board are assembled. In front
panel, LCD, recorder mechanism, analog board andmotherboard are assembled. Also,
membrane is mounted on the front panel. Figure 3-1 shows block diagram of device and
figure 3-2 shows system diagram of Dena 350.
Figure 3-1 Dena 350 Block Diagram
Motherboard
Display and Touch
screen
Analog board
Charger board
Power board
Recorder
mechanism
Interface
board
Membrane
Battery

Chapter 3. Technical specifications of system Service Manual –Dena 350
13
Figure 3-2 Dena 350 System Diagram
Earth
220 Vac
Serial
Data
Power
Serial Data
Parallel
Data
Power
Serial Data
Motor Pulse
Power
Board
Battery
Charger
board
Analog
board
Motherboard
Membrane and LED
Indicators
USB Device
SD Card
Touch
Screen
Display
Screen
Recorder mechanism

Chapter 3. Technical specifications of system Service Manual –Dena 350
14
3.2 Circuit diagrams & part lists
Last revision of circuit diagrams & part lists are available on master document in
POOYANDEGAN RAH SAADAT Co.
For more information, please contact with following email:
[email protected]

Chapter 4. Installation Service Manual –Dena 350
15
Chapter 4. Installation
4.1 System installation
1. Make sure the package is not damaged.
2. Take out the accessories package and make sure that the accessories are complete.
3. Install the proper trolley as it will be discussed on section 4.2.
4. Place the cable holder and plug AC-cable to system. Check the safety grounding
system.
5. Plug the system to AC-line and turn it on.
6. Unplug system. It must continue working (internal battery operation).
-Make sure that the battery indicator lights on. If it does not light, check your local power
supply and power cable connection. If the problem still exists, contact the local After Sale
Service.
- It is necessary to charge the battery completely before using, charge the battery for at
least 8 hours.
7. Test the system according to test III procedure and fill out test forms.
8. Fill out the warranty card.
4.2 Trolley installation
Open the trolley package and tight the separated parts together.
Use only trolley approved by POOYANDEGAN RAH SAADAT
Co.
Turn off system and unplug it before any installing operation.

Chapter 5. Programming Instruction Service Manual –Dena 350
16
Chapter 5. Programming Instruction
For programming Dena 350 Analog board and motherboard, “ST-Link” programmer is used.
For more info, please refer to “ST-Link” programmer section in programming instruction (code:
PP-W-05)

Chapter 6. Test, Calibration and Upgrade Service Manual –Dena 350
17
Chapter 6. Test, Calibration and Upgrade procedures
6.1 Equipment
ECG Simulator
6.2 Performance Test
6.2.1 Power On Test
1- Plug power cord on and press On/Off key so the device turns on. After one second, system
will boot and its logo will appear. After displaying main page, an alarm will be heard.
2- LED indicators of the battery will light on after main page was shown. If the charge of
battery is full, LED turns in green. If the charge of battery is half-full, LED color will become
orange and if battery is near empty, LED color will become red. If device is connected to AC
power line, battery indicator turns off and AC power indicator will light on.
3- Unplug device from AC power and turn it on. In this situation, battery indicator will be
displayed on the main page in order to specify amount of charge left on the battery.
4- Use all keys and go to different menus in order to make sure that functionality of all keys are
OK.
6.2.2 ECG functions
1- Connect the patient cable to dedicated connector on the left side of the device.
2- Attach ECG lead wires to the simulator.
3- Make sure that ECG signal and heart rate are displayed correctly.
4- Disconnect RA lead wire from simulator. “Check RA” should be displayed on the main page.
5- Re-connect RA lead wire to the simulator and disconnect LL lead wire from simulator.
6- “Check LL” should be displayed on the main page.
7- Re-connect LL lead wire to the simulator and disconnect V1 lead wire from simulator.
8- “Check C1” should be displayed on the main page.
6.2.3 Recorder functions
1- See if “Check Paper” alarm is shown, when paper is ran out.
2- Connect ECG simulator to the device and start recording by pressing “Start/Stop” key. Check
to see if texts and signals on the record were correct.