Innomed Medical Heart Screen 60 G User manual

R-2531-2-I
User’s Manual
Heart Screen 60 G
Simultaneous 12-channel ECG device with 60mm wide
3-channel built-in printer and LCD

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This manual is for devices with software versions 1.00 and above.
Innomed Medical Inc. reserves the right for unannounced modifications concerning
further device development.
Copying this manual in whole or in part is only allowed with our written consent.
All product names and logos are copyrighted properties of their respective owners.
All rights reserved!
Budapest, 01.27.2005.
Device manufactured and distributed by:
Innomed Medical
Medical Developing and Manufacturing Inc.
H-1146 Budapest, Szabó József utca 12.
(36-1) 460-9200 Fax: [phone]

www.innomed.hu

[e-mail]

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Table of contents
1. FIELD OF APPLICATION..........................................................................................................................5
2. WARNINGS...................................................................................................................................................6
2.1. SAFETY ....................................................................................................................................................6
3. DEVICE DESIGN AND TECHNICAL PARAMETERS ..........................................................................7
3.1. DESIGN ....................................................................................................................................................7
3.1.1. Connections on the rear of the device............................................................................................8
3.1.2. Device front panel..........................................................................................................................8
3.2. TECHNICAL PARAMETERS ........................................................................................................................9
3.2.1. General ..........................................................................................................................................9
3.2.2. Mains and power supply ................................................................................................................9
3.2.3. Safety............................................................................................................................................10
3.2.4. Operating modes..........................................................................................................................10
3.2.5. Lead groups .................................................................................................................................11
3.2.6. ECG amplifier..............................................................................................................................11
3.2.7. Digitizing properties ....................................................................................................................12
3.2.8. Printing and display properties ...................................................................................................12
3.2.9. SIO parameters ............................................................................................................................12
3.2.10. Mechanical (informative) data.....................................................................................................12
3.2.11. Pacemaker pulse detection...........................................................................................................13
3.2.12. Checking electrode and amplifier operation................................................................................13
4. HEARTSCREEN 60G COMPONENTS ...................................................................................................14
5. INSTALLATION.........................................................................................................................................15
5.1. INSTALLING THE PRINTER,LOADING PAPER............................................................................................15
5.2. BATTERY RELATED ACTIVITIES ..............................................................................................................17
6. USING THE DEVICE.................................................................................................................................18
6.1. SHORT OVERVIEW OF MAIN FUNCTIONS .................................................................................................18
6.2. MONITORING .........................................................................................................................................19
6.2.1. Baseline filter effect .....................................................................................................................20
6.2.2. Setting automatic blocking, filter .................................................................................................20
6.2.3. Displaying pacemaker signal.......................................................................................................21
6.2.4. QRS sound....................................................................................................................................21
6.2.5. Backlight, automatic shutdown....................................................................................................21
6.3. FUNCTIONS IN MONITORING OPERATING MODE ......................................................................................22
6.3.1. Lead selection ..............................................................................................................................22
6.3.2. Sensitivity setting .........................................................................................................................22
6.3.3. Speed setting ................................................................................................................................22
6.3.4. Filter setting.................................................................................................................................22
6.3.5. Manual amplifier blocking...........................................................................................................23
6.3.6. Starting manual printing..............................................................................................................23
6.3.7. Starting automatic printing..........................................................................................................24
6.3.8. Selecting and starting programs..................................................................................................25
6.3.9. Device settings and accessing stored records..............................................................................25
6.4. RECORD STORAGE –THE “STO” STORAGE PROGRAM............................................................................26
6.4.1. Program execution.......................................................................................................................26
6.4.2. Aborting a program .....................................................................................................................26
6.5. RHYTHM CURVE STORAGE –THE “RTM” PROGRAM .............................................................................27
6.5.1. Program execution.......................................................................................................................27
6.5.2. Aborting the program ..................................................................................................................27
6.6. PERFORMING ANALYSIS –THE “ANL” PROGRAM ..................................................................................28
6.6.1. Program execution.......................................................................................................................29
6.6.2. Running the program ...................................................................................................................29

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6.6.3. Aborting the program ..................................................................................................................29
6.7. USING THE MENU SYSTEM .....................................................................................................................30
6.7.1. Entering the menu........................................................................................................................30
6.7.2. Moving in the sub-menus .............................................................................................................30
6.7.3. Parameter modification ...............................................................................................................30
6.7.4. Branching possibilities in the menu system..................................................................................31
6.8. HANDLING STORED RECORDS (CATALOG)..............................................................................................32
6.8.1. Deleting a record .........................................................................................................................32
6.8.2. Printing all the data of a record ..................................................................................................33
6.8.3. Displaying stored records............................................................................................................33
6.8.3.1. Normal storage, “STO” record display................................................................................................... 33
6.8.3.2. Handling rhythm record.......................................................................................................................... 34
6.8.3.3. Handling analysis results ........................................................................................................................ 34
6.8.3.4. Modifying the identifier.......................................................................................................................... 35
6.9. DEVICE SETTINGS (SETTINGS) ................................................................................................................36
6.9.1. Printing ........................................................................................................................................36
6.9.2. Storage.........................................................................................................................................37
6.9.3. Date, time.....................................................................................................................................37
6.9.4. Language .....................................................................................................................................38
6.9.5. Filters...........................................................................................................................................39
6.9.6. Others...........................................................................................................................................39
6.10. COMPUTER CONNECTION .......................................................................................................................40
7. SHIPPING AND STORAGE REQUIREMENTS ....................................................................................40
8. PACKAGING ..............................................................................................................................................40
9. MAINTENANCE, CLEANING .................................................................................................................41
9.1. MAINTENANCE ......................................................................................................................................41
9.2. CLEANING,DISINFECTING ......................................................................................................................41

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1. Field of application
The HeartScreen 60G is a battery operated, modern 12-channel electrocardiograph
used to measure and graphically record the heart’s bioelectric potential when
examining the human heart and circulatory system. The device has a 12-channel
amplifier and ECG signal-processing unit. The built-in printer is 3-channel. The
3-channel on-line data transfer on the serial line insures the 3-channel on-line
monitoring on the PC.
Operation of the device is simple, selecting the basic functions and the pre-edited
record modes, and creating and storing the records need but a few button presses.
Dedicated buttons can control the main functions, and the device returns the settings
in the top row of the display.
Even in its basic configuration the device can be connected to a computer. On-line
display of the selected 3 channels and record storage is possible on the PC’s large
display. Besides the date and exact time, the patient code identify the records stored
in the HeartScreen 60G.
The ECG management program, running under the Windows operating system,
performs archiving and is useable with other INNOMED manufactured devices.
The ECG can be operated only by trained staff of the hospital or clinic!
The HeartScreen 60G is available with the following services and configurations:
•Basic version
3-channel recording in manual or automatic mode, 12-channel record storage,
with built-in clock and battery pack.
•Expanded version
All the services of the basic version with built-in analysis program.
•ECG management program
Optional with the above versions.
IBM-PC based archiving program system. Can be used for on-line ECG
monitoring, ECG and analysis storage, search and display. The program runs
under the Windows operating system.

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2. Warnings
2.1. Safety
For safe operation, always follow these warnings!
The HeartScreen 60G is a safety class I. ECG device (CF). The device mains
cable may only be plugged into a grounded outlet. Covering the charging
adapter is FORBIDDEN!
Change a fuse or open the power supply only after it has been disconnected
from the mains. Only qualified personnel can perform repairs.
If the mains plug is damaged or faulty, the grounding is not satisfactory; the
device may only be operated from batteries!
Only use fuse type indicated in the device manual.
The device can be used only with the charger supplied by Innomed Medical
Inc.
In case of completely discharged batteries, the device has to be charged for
at least 1 hour. Only after this can a record be made safely.
It is advised to use the device with paper suggested by the manufacturer, as
this is the only way the printer head lifetime can be guaranteed.
Only the electrodes may be connected to the patient, the use of other
grounding is FORBIDDEN!
When connecting the device into a measurement system, take care that only
appropriately isolated and IEC601 approved devices may be connected
together and that the patient cannot touch any mains connected devices.
If the device is used connected to a computer, make sure that the patient
cannot get closer than 1.5m to the computer, or that the computer is
operated from an isolating transformer.
The device’s defibrillator protection is only guaranteed with one of the
following manufacturer recommended defibrillator protected cables.
Cable type: KPACDR or
KPACDL
For environmental protection reasons, keep in mind the following!
When changing batteries, store the used or damaged batteries in a place marked for
the storage of dangerous waste (NiMh rechargeable batteries).
!
!
!
!
!
!
!
!
!
!
!

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3. Device design and technical parameters
3.1. Design
The HeartScreen 60G electronics is based on a base board. The printer unit and the
LCD are mounted to the upper part of the device. A designed lower and upper plastic
cover insures the device’s aesthetic appearance.
The device contains the following parts:
•Amplifier unit with isolated input.
•Processor unit, controlling the device.
•Special battery-pack, supplying power to the device.
•Power supply and charging circuit.
•Keyboard.
•Display unit.
•Printer unit.
•Insulated serial line for standard and safe PC connection.
•External mains power supply for battery charging.
The HeartScreen 60G contains a printing unit that does not require any maintenance
and whose lifetime may be considered unlimited. The LCD insures 1-channel display,
used to check the ECG signal quality. Its value is not diagnostic.

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3.1.1. Connections on the rear of the device
The patient cable connection and the RS232 serial line connection used to connect
to a PC are located on the device rear.
3.1.2. Device front panel
ECG input Serial port Charging adapter connection
Paper bin cover Cover open
Printer output
Power on / off
6
7
1
9
0
INNOMED
HS60G
1
3
4
8
5
Battery charge indicatorDisplay
Keys

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3.2. Technical parameters
Classification according to EC directives: 2a
Applied standards: IEC 601-2-25 functional
AAMI EC11 functional
IEC 62D functional
IEC 601-1 safety
EN 60601-1-2 EMC
IEC 68-2-6 mechanical vibration
IEC 68-2-29 mechanical shock
93/42/EEC medical directive
3.2.1. General
Reference temperature range 0... +40 °C
Operating temperature range 0... +45 °C
20… 95% humidity
(without condensation)
Shipping / storage temperature range -20 ... +55 °C
Operating area dry, confined space
3.2.2. Mains and power supply
Mains voltage 110V – 230V +10% / -15%
Mains frequency 50 / 60 Hz
Current consumption 0.3-0.6A
Battery type 8-piece NiMh battery-pack with at
least 1500mAh capacity
10V voltage
Battery charging current (informative) 1.2A, controlled, intelligent quick-
charge
Battery charging time 30-minute periodic ECG curve
printing or 6-hour monitoring
(only basic functions are
operational)

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3.2.3. Safety
Safety class I.
Patient protection (with PC connection) CF
3.2.4. Operating modes
Monitoring 1-channel ECG monitoring on the LCD from any
lead.
Including:
Manual printing Manual recording from any lead group on 3
channels.
Automatic printing Adjustable length automatic printing from the 12
standard ECG leads in 4 x 3 channel groups.
Record storage
(STO)
Automatic recording and storage from all groups.
Making rhythm analysis
(ARR)
One-channel rhythm curve storage.
Making analysis
(ANL)
Making 12-channel averaged QRS, numeric data
table, storing 16s rhythm curve from one channel.
Menu operation Handling records stored in the device and
settings.
Including:
Catalog
(Menu/Catalog)
Used to handle stored records and their data.
Settings
(Menu/Settings)
Used to perform device basic settings.
Alarm
(Menu/Alarm)
Set alarm when heart frequency lower or upper
limit values are reached.
Identifier
(Menu/Identifier)
Ensures patient identifier entry.

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3.2.5. Lead groups
Standard or Cabrera Standard groups
The required lead may be set in the SETUP menu.
3.2.6. ECG amplifier
Input signal range ±8mVp
Frequency run 0.05 Hz…150 Hz +0,-3 dB
Voltage measurement relative error
0,5 - 8 mVpp
±3 %
Sensitivity 2.5, 5, 10, 20 mm/mV
Noise on input max. 20µVpp
Input impedance (informative) typ. 50 MOhm
CMRR min. 100 dB
DC tolerance min. ±320 mV DC
Pace-maker tolerance max. 700mV/2ms
Pace-maker detection min.2mV/0.5ms max.700mV/2ms
Time constant min. 3,2 sec
Patient leakage current max. 10 µA
Blocking automatic and manual
Calibrating signal (software generated) 1 mV / 300 ms
Muscle filter (digital) 35 Hz +0/-3 dB
Mains filter 50 / 60 Hz digital
50 Hz filter: 48,5 … 51,5 Hz
60 Hz filter: 59 … 61 Hz
Baseline filter (digital) below 0,3 Hz: full suppression
over 0,9 Hz: full transfer
Defibrillator tolerance max. 400 J, 5000 V
Only with defibrillator protected cable!

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3.2.7. Digitizing properties
Data acquisition 12 leads, simultaneous
Sampling frequency 1000 Hz / channel
A/D resolution 13 bit
Referring to ±8mV signal range 2.5 µV / bit
Stored signal resolution 500 Hz 10 µV / bit
Serial line resolution during on-line ECG
transfer
500 Hz 10 µV / bit
3.2.8. Printing and display properties
Printer head resolution In amplitude direction: 8 points / mm
On time axis: 8 or 16 points / mm
Paper speed 5, 25,50 mm / s
Paper width 58 mm +0; -1 mm
Paper roll outside diameter max. 50 mm
Printer lifetime 50.000 m
Paper change automatic feed
Display 64 x 128 points
3.2.9. SIO parameters
Serial I/O RS-232
Serial line services On-line monitoring from the 3 channels,
ECG curve archiving on the PC
3.2.10.Mechanical (informative) data
Size 250 x 150 x 70 mm
Device weight with battery pack and
charger
1.2kg

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3.2.11.Pacemaker pulse detection
When the device examines a patient with a pacemaker, it recognizes the pacemaker
signal within a set range according to technical data and displays them graphically on
the record. When making an analysis the presence of pacemaker is displayed in the
header, in certain cases ECG morphological deviations can disrupt wave recognition.
3.2.12.Checking electrode and amplifier operation
If the input side of the amplifier does not operate correctly or there is cable or
electrode problem, the device blocks automatically and initializes the filters. After
blocking it checks if the source of the problem still exists. If so, it repeats the blocking
and filter initialization.

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4. HeartScreen 60G components
The device package can contain the following parts in the best configuration:
•1pc HeartScreen 60G device
•1pc Mains charger: PSS-22U-150 or HES22-150160LF type
•1pc User’s manual
•1pc CD or floppy disk with Innobase for Windows program (optional)
•1pc Innobase for Windows device software module (optional)
•1pc Innobase for Windows ECG based management program user’s manual
(optional)
•1pc device carrying case
•1pc defibrillator protected patient cable: KPACDR or
KPACDL
•1pc 4-lead patient cable for rhythm analysis: KPAC4
•4pcs limb quick-electrodes (clip-on)
•6pcs chest suction electrodes
•1pc electrode gel 260g
•1pc SIO cable: SIO01
•1pc 58 mm wide printer paper with grid
Other devices that may be connected to the device:
•1PC-AT compatible computer. Minimum configuration: Pentium IV 1 GHz,
SVGA min. 17” monitor, 1024x768 resolution
(Note: the above list is not equivalent to the list of accessories shipped with the
device, this depends on the order.)

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5. Installation
The device is shipped in a carrying case, which contains the accessories and
manuals. Please follow these steps after unpacking the device.
Before turning the device on:
•Read the electrocardiograph’s manual and get to know the location and use of
the controls.
•Read and absolutely follow the contents of the Warnings chapter.
•Make sure that the device and its cables and connections are safe and sound.
•Connect the patient cable to the HeartScreen 60G.
•Connect the charging adapter to the device.
•Load the ECG device with printer paper according to the following.
5.1. Installing the printer, loading paper
Before first operation or if the device has run out of paper, a new roll has to be
loaded as follows:
1. Press the button indicated by the arrow and lift up the paper bin cover:
2. Place a new roll into the paper bin. Make sure that the paper runs off the roll
on the inside of the device, before the printer head.

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3. Close the paper bin cover by hooking it from the paper roll side and and
snapping it on the printer head side.
4. Tear off the unneeded paper.
5. Print anything to make sure that the paper runs through the printer without
obstacles, and that the printer can feed the paper without force.

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5.2. Battery related activities
The device measures the battery charge state and indicates low charge state with
abattery symbol on the left side of the display.
•If there is no signal, battery charge state is acceptable.
•If the device cannot be turned on, the battery has to be charged for at least 2-3
minutes.
•The batteries may be charged continuously with the device charger adapter, no
damage happens, however it is suggested to stop charging overnight or when
supervision is not possible by unplugging from the mains.
•To preserve battery capacity it is recommended to format the battery at least
semi-annually.
To do this, completely discharge the battery by disabling the device’s automatic
shutdown feature (‘Settings/Other/Shutdown’), then charge the battery for at
least 2.5 hours with the device’s own charger.
•The “charge” indicator is located in the top right part of the HeartScreen 60G
keyboard under the battery symbol.
6
7
1
9
0
INNOMED
HS60G
1
3
4
8
5
Battery charge
indicator
Battery low symbol
(Only during turned
on!)

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6. Using the device
6.1. Short overview of main functions
Functions Keys
Basic functions
Lead selection
8
1
5
Sensitivity selection
Speed selection
7
Filter on / off
6
Manual blocking
Selection of the number of printed
channels (1 or 3): and
Printing
Manual printing
9
Automatic printing
0
Record storage, starting
Storage (STO) program selection
STO
(SW key)
Rhythm curve storage (RTM)
selection
RTM
3
(SW key)
Analysis selection
ANL
4
(SW key)
Printing stored records
Accessing menu item
1
then
Selecting record
8
or
1
5
Printing record
9
or
0

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6.2. Monitoring
After the device is turned on with the ON/OFF switch, if there are records stored, it
performs a memory test, indicated by the
Checking stored records...
message.
The device is automatically placed into monitoring mode, while in cases mentioned
later the
1
button must be used.
This is the device default, standard operating mode. A selected ECG channel is
visible on the display, with the current pulse, lead, speed, sensitivity and filter state.
The device indicates the names of the available programs on the display above the
yellow keys marked “2”, “3” and “4” ( ,
3
,
4
soft keys) and – if necessary –
warns you of low battery voltage.
Monitoring after turning on always starts with the same settings. These are the
following:
•Lead: II.
•Sensitivity: x1
•Speed: 25 mm/s
•Filters: off
•Program: STO storage
RTM rhythm analysis creation
ANL optional analysis creation
Display contents during monitoring
Programs
Sensitivity
Lead
Speed (mm/s)
Filter
1/3-channel
printing
Pulse value
Battery low
indicator

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6.2.1. Baseline filter effect
The baseline filter makes it possible to create better-than-ever quality recordings by
suppressing baseline wandering. The baseline filter insures during monitoring and
printing that
•polarization on the electrodes and slow contact potential change,
•noise from patient breathing, and
•noise from patient movement
does not effect the examined ECG signal.
The baseline filter causes an approx. 2.5 second signal delay, so this time has to be
waited out after blocking, or placing / moving the electrodes, for the recording to be
good quality.
During blocking the baseline filter is also reset to its default state, the word “Wait…”
appears on the display until the filter is set and the delay time is up. During this
period you can start printing, storing or the analysis program.
The baseline filter may be turned on and off in the Menu/Settings/Filters/Baseline:
menu item.
The delay remains even with the baseline filter off.
At pulse above 45, in case of normal width QRS complexes, the filter cannot
affect the ST level.
6.2.2. Setting automatic blocking, filter
If the amplifier input level is overdriven due to too much noise, high input electrode
potential or defibrillator use, automatic blocking happens, indicated by the word
“BLOCK”.
After this the filter initialization is indicated by the word “Wait...”
After blocking the device checks if the problem still exists. If so, it performs blocking
and filter initialization again.
In case of defibrillator use, the ECG curve can be monitored and printed 5 sec after
defibrillator shock.
!