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YM303i Mediana
YM303i Mediana
Operator s Manual
L09521 Revision 02
Note
The information in this manal applies to YM303i 3channel resting ECG system. Due to
continuing product innovation, specifications in this manual are subject to change without
notice.
Warranty
The information contained in this document is subject to change without notice. MEDIANA
Co., Ltd. makes no warranty of any kind with regard to this material, including, but not limited
to, the implied warranties or merchantability and fitness for a particular purpose. MEDIANA
shall not be liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this material.
Revision History
The document part number and revision number indicate its current edition. The revision
number changes when a new edition is printed in accordance with the version of the
documentation. Minor corrections and upgrades which are incorporated at reprint do not
cause the revision number to change. The document part number changes when extensive
technical changes are incorporated.
Supplier
MEDIANA CO., Ltd.
132, Donghwagongdan-ro, Munmak-eup,
Wonju-si, Gangwon-do, Korea
Tel: (+82) 70-7092-9967 Fax: (+82) 33-742-5483
4.3 Storing............................................................................................................... 68
4.3.1 Storing thermal paper ............................................................................................... 68
Keep dry: This symbol means that the product avoid expose
in rain or wet environment during it is transported and
stored.
Getting start
Warning:
To avoid injury or harm, read all operating instructions in this manual and
safety information in chapter1. Important Product Information.
Caution:
The YM303i is intended to be used in a hospital and hospital facilities
environment by trained medical personnel.
Power button
Keypad
Cover open
button
Patient cable
connector Ventilation hole
Bottom
view
Tilt feet
Rubber feet
Product label
2.2.3 Keypad
The buttons of YM303i have more than one function. There is
an example button 1 works as number 1 at text input situation
and gain hotkey at home screen.
4 Number 4
5 Number 5
*
G mode Hotkey for change grouping of ECG waveform
displayed on LCD screen
6 Number 6
*
C mode Hotkey for change channel of grouped ECG
waveform displayed on LCD screen
7 Number 7
*
Save Hotkey for last acquisition data save
8 Number 8
*
Copy Hotkey for extra report printing of last recorded ECG at
automatic mode.
9 Number 9
*
File Hotkey for ECG data management.
l. Manual(1EA)
2.5 Installation
Install the YM303i in place where avoid humidity, high temperature, dust in
the air, salt or sulfuric material and avoid the unventilated place or the direct
sunlight.
Connect provided AC power cable with the YM303i.
All leads has label as shown in figure 2-6. Match the electrodes and the leads
as shown in figure 2-6 and label difference between IEC and AHA shown in
Table 2-4. If the connection is wrong it may makes bad effect on signal or
result.
Operating
3.1 Screens
At this chapter it will be described major screens of the YM303i and its
functions.
K
L
M
N
O
A
B
C D E F G H I
Figure 3-3 The Home screen
1) Turn on YM303i
Press the POWER button to turn on the YM303i. If already turned on
press the ESC button to show the home screen.
Caution: Do not print more than 30min in the manual mode. It may result
in break down or reduction of life time of the device.
The Figure 3-4 shows Configuration menu and submenu of YM303i. Move the
cursor on items using Up cursor key or Down cursor key, and press the ENTER
button to open the submenu.
Figure 3-4 The Menu Screen of YM303i(Up: main configuration menu, Down
submenu)
Gain Select the input gain rate. Selectable options are 5, 10 or 20mm/mV
*If the report format is selected as 6x2, the gain is fixed as 5mm/mV.
Tip
If press the Gain button at Home Screen, it will be switched input
gain among 5, 10, and 20mm/mV without enter the configuration
menu.
If press the Speed button at Home Screen, it will be switched print
speed among 5, 10, 25, 50 mm/s without enter the configuration
menu.
Report format The YM303i has 5 different styles of report formats. The report
styles are identified by ECG waveform matrix. The automatic report includes
interpretation result and detail result.
*Display format and Print format are independent at Automatic mode.
2+R 12 Lead ECG waveform prints in 2x6 and a rhythm lead added
Interpretation This option selects the interpretation report print or not. Yes for
print, No for not print interpretation result.
Tip
If press the Filter button at home screen, filter adjust window will be
opened.
No. of Copy This option is select how many extra copies will be printed.
The <Copy Print> mark will be located on the first page of extra report(s).
Tip
If press the Copy button at home screen, last printed report will be
printed.
*Automatic mode only. If power off the device, last printed report in
memory will be lost.
Speed This parameter sets the paper speed. If the speed value is big, print speed
will be fast.
Tip
If press the Gain button at Home Screen, it will be switched input
gain among 5, 10, and 20mm/mV without enter the configuration
menu.
If press the Speed button at Home Screen, it will be switched print
speed among 5, 10, 25, 50 mm/s without enter the configuration
menu.
Report format The manual operation mode has 4 types report formats, it is
selected using keypad.
Tip
If press the Filter button at home screen, filter adjust window will be
opened.
Write or Modify
Move the cursor to Select column using the left(◀) or right(▶) cursor button.
Press the number of list to write or modify using number pad and press the
ENTER button. It will move to the line of select and type the first name and
last name. First name and last name section is switched with the left(◀) or
right(▶) cursor button.
Delete
Move the cursor to Delete column using the left(◀) or right(▶) cursor button.
Press the number of list to delete using number pad and press the ENTER
button. It will be deleted.
Write or Modify
Move the cursor to Select column using the left(◀) or right(▶) cursor button.
Press the number of list to write or modify using number pad and press the
ENTER button. It will move to the line of select and type the first name and
last name. First name and last name section is switched with the left(◀) or
right(▶) cursor button.
Delete
Move the cursor to Delete column using the left(◀) or right(▶) cursor button.
Press the number of list to delete using number pad and press the ENTER
button. It will be deleted.
Cart No. When using multiple devices from multiple carts, each device can be
assigned a cart number.
Language When the cursor moved on Language parameter and press the ENTER
button it, will be shown up the selection box. Set the desired language with
number pad.
Date Move the cursor on Date field and set the current date with number pad.
Example> If today is 2010-08-26 and date format is yyyy-mm-dd,
Then type the flowing numbers using number pad
[Type] 2, 0, 1, 0, 0, 8, 2, 6
Time format Move the cursor on Time Format field and set the desired time
format with number pad.
Example1> If current time is 2:30pm and desired time format is [12h]
Then type the flowing numbers using number pad.
[Type] 1, 4
Example2> If current time is 2:30pm and desired time format is [24h]
Then type the flowing numbers using number pad.
[Type] 2
Units Move the cursor on Units field and select desire units.
Lead Label Move the cursor on Lead Label field and select desire labels.
High Pass filter Select cutoff frequency of the high pass filter.
Low Pass filter Select cutoff frequency of the low pass filter.
Tip
Press the Filter button to adjust high pass filer and low pass filter at
the home screen.
ECG Sample Acquisition This parameter is selecting the timing of ECG signal
acquisition beginning.
Pre-sample mode
If this parameter set to PRE, the pre-sampling buffer is enabled. It means a
report created with the ECG data acquitted before the RUN button pressed.
Post-sample mode
If this parameter set to POST, the pre-sampling buffer is disabled. It means
a report created with the ECG data acquitted after the RUN button pressed.
*This parameter applies to only Automatic mode.
Lead Fail Detection This function is detecting lead fail situation. It means bad
connection the device and the patient occurred. If lead fail is detect it will be
shown at the home screen of Lead fail indication section. (see the Home Screen,
p26)
Heart Rate Beep If this operation set to on the device will make a beep sound
when heart a peak detected.
Warning Beep If this operation set to on the device will make a beep sound when
warning situation occurred.
Print Setup Menu List If the cursor move to this filed and press the ENTER
button the device will print all setting value.
SD Card ECG List This parameter selects printing area of stored ECG list in SD
card.
1P: The most recent page will be printed.
1B: 1block(100 EA) of list form selected data will be printed.
The patient data menu is made for note the patient information. This information
will be printed on the report and saved with ECG data when save button pressed
or automatically saved at the Auto save mode.
New patient Yes, No Pacemaker Yes, No
Patient ID 0-9(20 characters) Physician
Last name A-Z(20 characters) Technician
Fist name A-Z(20 characters) Room No. 0-9(4 digits)
Date of birth Medication1 No, digitalis, diuretics,
Sex male, female antidepress, steroids, nitrtes, ace,
Height 0-9(3 digits) cytostatics
Weight 0-9(3 digits) Medication2 No, digitalis, diuretics,
Race No, Caucasian, black, Asian, oriental, antidepress, steroids, nitrtes, ace,
Hispanic, native American, pacific Island, cytostatics
Hawaiian, Mongolian Comment1 A-Z(20 characters)
Comment2 A-Z(20 characters)
Tip
If the PATIENT button is pressed at home screen, it will be enter the
menu for patient data edit.
Figure 4-1. The paper ending mark (left: Roll type, right: Z-fold type)
NOTE Ending mark of the paper could be changed without notice.
NOTE The shafts are not for single use, do not throw
it away.
3) Release the paper and must be positioned
exactly on the cover roller, before the cover is
closed.
NOTE The shafts are not for single use, do not throw
it away.
3) Fold out the first page of paper to the right
and close the cover.
Caution: Use only MEDIANA Co., Ltd. supplied paper. If use other products
it may make poor quality printing or damage on the device.
Caution:
When cleaning the equipment, wipe it with sponge or something like
that wetted with soapy water and never use the detergent using
alcohol, ammonia or acetone as main ingredient.
4.3 Storing
2) Move the cursor on the Maintenance and press the ENTER button. When
password prompt shows up, enter the code 3031 .
2) All setting value of Automatic mode setup, Manual mode setup and System
setup will be lost during firmware update. Before firmware updating, please
print out setting value of the device.
*MENU>System Setup>Print Setup Menu List
3) Turn the YM303i off.
9) After firmware update complete turn off the device and remove the USB
memory device.
10) Turn the device on and set to default setting.
*Default Setting will be found at MENU > System Setup
Warning Due to the risk of electrical shock, do not open the cover of the
equipment unless absolutely necessary and disassembly of the machine
should be done only by a maintenance worker who has the license from
MEDIANA Co., Ltd.
Critical Error
Please Wait
Low Battery
Low Battery
Patient ID Error
Save Error
Save Error
Save Error
Date Error
Time Error
Figure Error
Password Error
Copy Error
Copy Error
Delete Error
No Data
Change Error
No Data
Send Error
No Data
Print Error
No Data
No Data
Pre-Sample Error
Display
Computerized Electrocardiograph
Writer
Thermal dot array
Type
(Voltage axis: 8dots/mm, Time axis: 16dots/mm)
Numbers of Traces 3 or 6 user-selectable
Physical
Dimension 311 X 242 X 85 (W x L x H) mm
Weight(without paper) Approximately 2.4kg
Environmental
Temperature range 10-45℃
Operating Conditions Humidity range 20%~95%(non-condensing)
Atmosphere Pressure: 700 to 1060 hPa
Temperature range -15~50℃
Storage/Transportation
Humidity range 20%~95%(non-condensing)
Condition
Atmosphere Pressure: 500 to 1060 hPa
Compliance
Classification Class I, Internally powered
Type of protection Type CF with defibrillation protection
Patient Leakage Current < 10㎂
Mode of operation Continuous
Degree of protection IPX 0
EU Directives for medical devices
(93/42/EEC as amended by 2007/47/EC)
ISO13485:2003 Medical devices - Quality management
systems - Requirements regulatory purposes
ISO14971:2007 Medical devices - Application of risk
management to medical devices
General IEC60601-1: 1988+A1:1991+A2:1995 General
requirements for Safety
IEC60601-1-4: 2000 General Requirements for safety -
Collateral standard: Programmable electrical medical
systems
ISO10993-1: 2003 Biological evaluation of medical devices
Part 1: Evaluation and testing
Warning: For best product performance and measurement accuracy, use only
accessories supplied or recommended by manufacturer. Use accessories according
to the manufacturer s directions for use and your facility s standards. The use of
accessories and cables other than those specified may result in increased emission
and/or decreased immunity of the YM303i electrocardiograph.
The YM303i Electrocardiograph is suitable for use in the specified electromagnetic environment.
The customer and/or user of the YM303i electrocardiograph should assure that it is used in an
electromagnetic environment as described below.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
YM303i electrocardiograph is used exceeds the applicable RF compliance level above, the YM303i
electrocardiograph should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the YM303i electrocardiograph.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.