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User’s Manual

Heart Screen 60 G

Simultaneous 12-channel ECG device with 60mm wide


3-channel built-in printer and LCD

R-2531-2-I
HeartScreen 60G User’s Manual

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: (36-1) 460-9222
www.innomed.hu
innomed@innomed.hu

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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

3.1.1. Connections on the rear of the device

ECG input Serial port Charging adapter connection

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

Paper bin cover Cover open Display Battery charge indicator

INNOMED HS60G

1 3 4

1
5 6 7

8
9 0

Power on / off Printer output Keys

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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

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 Automatic recording and storage from all groups.
(STO)
Making rhythm analysis One-channel rhythm curve storage.
(ARR)
Making analysis Making 12-channel averaged QRS, numeric data
(ANL) table, storing 16s rhythm curve from one channel.
Menu operation Handling records stored in the device and
settings.
Including:
Catalog Used to handle stored records and their data.
(Menu/Catalog)
Settings Used to perform device basic settings.
(Menu/Settings)
Alarm Set alarm when heart frequency lower or upper
(Menu/Alarm) limit values are reached.
Identifier Ensures patient identifier entry.
(Menu/Identifier)

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HeartScreen 60G User’s Manual

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 ± 8 mVp


Frequency run 0.05 Hz…150 Hz +0,-3 dB
Voltage measurement relative error ± 3%
0,5 - 8 mVpp
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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HeartScreen 60G User’s Manual

3.2.7. Digitizing properties

Data acquisition 12 leads, simultaneous


Sampling frequency 1000 Hz / channel
A/D resolution 13 bit
Referring to ± 8 mV signal range 2.5 µV / bit
Stored signal resolution 500 Hz 10 µV / bit
Serial line resolution during on-line ECG 500 Hz 10 µV / bit
transfer

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 1.2kg
charger

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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

4. HeartScreen 60G components

The device package can contain the following parts in the best configuration:
• 1 pc HeartScreen 60G device
• 1 pc Mains charger: PSS-22U-150 or HES22-150160LF type
• 1 pc User’s manual
• 1 pc CD or floppy disk with Innobase for Windows program (optional)
• 1 pc Innobase for Windows device software module (optional)
• 1 pc Innobase for Windows ECG based management program user’s manual
(optional)
• 1 pc device carrying case
• 1 pc defibrillator protected patient cable: KPACDR or
KPACDL
• 1 pc 4-lead patient cable for rhythm analysis: KPAC4
• 4 pcs limb quick-electrodes (clip-on)
• 6 pcs chest suction electrodes
• 1 pc electrode gel 260g
• 1 pc SIO cable : SIO01
• 1 pc 58 mm wide printer paper with grid

Other devices that may be connected to the device:


• 1 PC-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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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

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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HeartScreen 60G User’s Manual

5.2. Battery related activities

The device measures the battery charge state and indicates low charge state with
a battery 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.

INNOMED HS60G

Battery low symbol


(Only during turned
on!)

1 3 4 Battery charge
indicator
1
5 6 7

8
9 0

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HeartScreen 60G User’s Manual

6. Using the device

6.1. Short overview of main functions

Functions Keys
Basic functions
1
5
Lead selection
8

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


STO
Storage (STO) program selection
(SW key)
RTM
Rhythm curve storage (RTM)
selection 3
(SW key)
ANL
Analysis selection
4
(SW key)
Printing stored records
Accessing menu item 1
then
8 1
Selecting record
or 5

Printing record 0
9
or

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HeartScreen 60G User’s Manual

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

Lead Speed (mm/s) Filter 1/3-channel


printing

Sensitivity

Pulse value

Battery low
indicator

Programs

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HeartScreen 60G User’s Manual

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.

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HeartScreen 60G User’s Manual

6.2.3. Displaying pacemaker signal

The device has a pacemaker detector, which recognizes the presence of pacemaker
signal in the ECG. In this case the letter ‘P’ appears in the bottom left corner of the
display. In case of a pacemaker signal the device places a marker on all channels
indicating the position of the pacemaker beat. This marker is visible on both the
display and the printout:

PACEMAKER

PACEMAKER
Markers

6.2.4. QRS sound

If QRS sound is turned on in the SETTINGS menu, the device emits a sound when
detecting R waves.
The QRS sound is also generated according to the slightly delayed displayed curve.

6.2.5. Backlight, automatic shutdown

The device display has backlight. The backlight turns on when the device is turned
on or when any button is pressed. If the device is not used for approx. 40 seconds,
the backlight turns off.
If none of the buttons are used for 5 minutes, the device turns off after emitting 5
short sounds. This function can be turned on and off in the
MENU/SETTINGS/OTHER/QRS SOUND menu. If the HeartScreen 60G is used connected
to a computer and there is data transfer over the serial line (monitoring, data transfer,
etc.) this function is off.

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HeartScreen 60G User’s Manual

6.3. Functions in monitoring operating mode

6.3.1. Lead selection

8 1
Use the and 5 buttons. The selected lead also indicates a group, when
printing this group (3 channels) is printed. The group that contains the lead displayed
on the screen is active. Available lead groups:
Standard leads Cabrera leads
• I, II, III aVL, I, aVR
• aVR, aVL, aVF II, aVF, III
• V1, V2, V3 V1, V2, V3
• V4, V5, V6 V4,V5,V6

6.3.2. Sensitivity setting

Use the button. Available values:


• x 1/4 - 0.25 cm/mV
• x 1/2 - 0.5 cm/mV
• x1 - 1 cm/mV
• x2 - 2 cm/mV

6.3.3. Speed setting

Use the 7 button. Available values:


• 5 mm/s
• 25 mm/s
• 50 mm/s

6.3.4. Filter setting

Use the 6
button. Available states:
• Only mains filter on display:
• Only muscle filter on display:
• Mains and muscle filter on display:
• Filters off on display: no indication.

The above set values are visible in the top row of the display.
(Note: the baseline filter state cannot be set or modified here, but in the
MENU/SETTINGS/FILTERS/BASELINE menu item).

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HeartScreen 60G User’s Manual

6.3.5. Manual amplifier blocking

Use the button. Pressing this button blocks the ECG amplifier, resets the
baselines that moved due to noise or inappropriately placed electrodes.
Meanwhile either the word “BLOCK” in inverse, or the word “Wait…” in normal
appears in the middle of the display, followed by monitoring.

Blocking is only available during monitoring, and is off during storing and analysis
creation.

6.3.6. Starting manual printing

Use the 9 button. Pressing this button starts on-line printing. The on-line printing
properties (speed, sensitivity and filter state) are the same as the current monitoring
ones. The lead group (3 channels) with the lead indicated on the display, is printed.
If pre-delay (Menu/Settings/Programs/Printing/Pre-delay) has been set, the 2
seconds prior to pushing the button is also printed. This way you can print signal
already displayed.
During monitoring you can change
• lead groups,
• speed,
• and sensitivity.
In this case printing is restarted with the calibration signal. If you turn the filters on
during printing, printing restarts with a new header and the changed settings.
The record header always contains the
• patient ID,
• date and time of printing,
• paper speed,
• sensitivity, and
• filter settings,
• device type and software version number.

The automatic patient ID is only incremented by one when starting storing or


! the analysis program, but not when printing.

The header is followed by a 300ms long, 1mV amplitude calibrating signal.


The curve of the 3 channels only appears after these.
During printing the current heart rate (HR) is printed at the bottom of the paper every
10 seconds.

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HeartScreen 60G User’s Manual

During printing the printed heart frequency is the calculated average heart
! frequency for the 10 seconds prior to printing, so it may differ slightly from
what can be measured on the printout.

Printing is not on-line. Besides the delay caused by the filters, the actual speed as
the paper leaves the printer:
• @ 5mm/s: approx. 5 mm/s
• @ 25 mm/s: approx. 25 mm/s
• @ 50 mm/s: approx. 25 mm/s

Press the 9 and 0 buttons to stop printing.


Printing also stops if automatic blocking is performed or the length of the recording
has reached the factory set maximum limit for paper save reasons. This maximum
length:
• @ 5mm/s: approx. 200 seconds, or 1000mm
• @ 25 mm/s: approx. 90 seconds, or 2250mm
• @ 50 mm/s: approx. 50 seconds, or 2500mm

6.3.7. Starting automatic printing

Use the 0 button. The device creates an adjustable length recording from the
standard 12 leads, in other words from all 4 standard ECG lead groups in the
following order:
• I, II, III
• aVR, aVL, aVF
• V1, V2, V3
• V4, V5, V6
The on-line printing properties (speed, sensitivity and filter state) are the same as the
current monitoring ones.
The automatic printer header is the same as the one created for manual printing.
However, the calibrating signal is only printed before the first group.
The leads are printed in groups of three, but of course the signal acquisition is
performed simultaneously for all groups.
The length of the recording can be set to 2, 4 or 6 seconds in the
MENU/SETTINGS/PROGRAMS/PRINTING/AUTO LENGTH menu.
If pre-delay (SETTINGS/PROGRAMS/PRINTING/PRE-DELAY) has been turned on, the 2
seconds prior to the push of the button is also printed. This way you can print signal

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HeartScreen 60G User’s Manual

already on the display (in case of the 2 seconds long auto length this means that only
2 seconds prior to print start is printed).

Printing stops only by pushing the 9 or 0 button, or when the 12 channels


have been printed.

6.3.8. Selecting and starting programs

During monitoring you can start different programs. Depending on configuration, the
names of the available programs appear on the display above the yellow keys
( , 3
, 4 ).

These can be the following:


• STO storage
• RTM rhythm curve storage
• ANL analysis creation
The following sections contain details on the programs; use the appropriate yellow
key to start the program.

6.3.9. Device settings and accessing stored records

Press the 1 button to enter the device settings and stored records menu.
Handling stored records and device settings are covered in later sections.

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6.4. Record storage – the “STO” storage program

This program creates an adjustable length recording from the 12 ECG leads, which is
stored unconditionally. 4, 6 or 8-second long record can be created from the ECG
leads.
The storage parameters can be set in the following menu: MENU/SETTINGS/ STORAGE.
If pre-delay (’Menu/Settings/ Printing/Pre-delay’) has been set, the 2 seconds prior to
the button-push is also stored. This way you can store the signal already displayed
on the display.
When using the KPAC4 four-lead cable, leads V1…V6 may not be selected, they are
not printed or stored. The type of the cable is automatically recognized by the device.

6.4.1. Program execution

When starting the program, its name and a counter indicating the number of seconds
until the end of the data acquisition required for the program.
During program execution the possible rhythm curve from the selected lead and the
rhythm analysis result is stored.
When the counter reaches 0 the program performs further data processing. The
device assigns the record an automatic identifier. The identifier format is AUTO xxxx,
where xxxx is an increasing ordinal. The identifier can be modified later. This is
followed by the catalog where the new record is displayed inverse.
After this you can view the record and the related data as described in the Handling
stored records section or return to monitoring.

6.4.2. Aborting a program

Press the 1 button or the STO key again to stop the program.

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6.5. Rhythm curve storage – the “RTM” program

This examination does not require the chest leads, so it is recommended to short
these, for example by connecting them to the R lead. When using chest electrodes,
unstable chest electrode contact during a several-minute long examination may
cause problems, causing automatic blocking.
When using the KPAC4 four-lead cable, leads V1…V6 may not be selected, they are
not printed or stored.
For a monitored lead select a limb lead, for example II.
Before starting the program, make sure there is paper in the device.
During monitoring pressing the “RTM” key executes the selected program.

For the device to correctly define the heart frequency, stable ECG signal
! must be visible on the display at least 2 seconds prior to storage.

If, when starting the program, there is not enough free memory to store the result, the
program does not start and the following warning message appears on the display:
Not enough free memory!
Press the key!
The message disappears when pressing the key and the device returns to
monitoring operating mode. In this case, to make new records, delete some records
from the catalog.

6.5.1. Program execution

A counter appears on the display when starting the program, indicating the number
of seconds remaining until the end of data acquisition required for the program.
During program execution the rhythm curve from the monitored lead is stored.
When the counter reached 0, data acquisition stops. The device assigns the record
an automatic identifier. The identifier format is AUTO xxxx, where xxxx is an
increasing ordinal. The identifier can be modified later. This is followed by the catalog
where the new record is displayed inverse.
You can now view the record and the related data as described in the Handling
stored records section, or you can return to monitoring.

6.5.2. Aborting the program

Press the 1 button or the RTM key again to stop the program.

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6.6. Performing analysis – the “ANL” program

The analysis program collects a 16 seconds long section from the 12 ECG channels,
performs R wave averaging, amplitude and time parameter calculations, and stores
the following data:
• a typical averaged QRS cycle from all 12 channels;
• analysis data from all 12 channels;
• a 16 seconds long 1-channel rhythm record.
The 12 typical – so-called averaged QRS – complexes are only evaluated based on
the typical beats, the non-characteristic QRS’s are filtered. Their length is always
880ms.

The device can only make analysis in the 45 – 175 heart frequency range.
!

If the pre-delay (SETTINGS/PROGRAMS/PRINTING/PRE-DELAY) is turned on, the 2


seconds before the button is pressed is also analyzed and part of the stored ECG
section. This way you can analyze and store signal already on the display.
Analysis data
• heart-rate;
• QRS length in ms;
• P-Q distance in ms;
• Q-T distance in ms;
• Q-Tc distance in ms;
• P-wave angle in degrees;
• QRS angle in degrees;
• T-wave angle in degrees;
• P+ amplitude, positive and P-, negative P-wave in mV, separate for the 12
channels;
• Q-wave amplitude, separate for all 12 channels;
• R and R’-wave amplitude, separate for all 12 channels;
• S-wave amplitude, separate for all 12 channels;
• S-T level in mV, separate for all 12 channels;
• T+ amplitude, positive and T-, negative T-wave, separate for all 12 channels;
• Qd, Q-wave length in ms, separate for all 12 channels.

For the device to exactly define the heart frequency, there must be stable
! ECG signal on the display for at least 2 seconds prior to pushing the button.

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6.6.1. Program execution

Press the ‘ANL’ button during monitoring to start the analysis program.
If there is not enough free memory to store the result when starting the program, it is
not started and the following appears on the display:
Not enough free memory!
Press the key!
This message disappears when the key is pressed and the device returns to
monitoring mode. In this case you have to delete a few records from the catalog, only
then can you store further records.

6.6.2. Running the program

A counter appears on the display when starting the program, indicating the number
of seconds remaining until the end of data acquisition required for the program.
When the program starts, the device turns the mains and noise filters off (if they were
on). The baseline filter state is unchanged. The device does not turn the filters back
on after program execution.
If the device finds less than 6 beats in the 16 seconds long data collection, it displays
the following message:
Not enough recognizable beats!
Press the key!
If the device finds more than 45 beats in the 16 seconds long data collection, it
displays the following message:
Heart frequency too high!
Press the key!
The device does not create an analysis in either case, but it does perform data
storage.
In case of pacemaker signal the device creates the analysis, but there may
! be inconsistencies in the numeric data due to morphological differences.

When the counter reaches 0, the program performs more data processing after data
collection. The device assigns an automatic ID to the record. Its format is AUTO
xxxx, where xxxx indicates increasing numbers. This ID can be modified later. This is
followed by a catalog, indicating the new record in inverse.
Now you can view the record and its data according the instructions in the Handling
stored data section, or you can return to monitoring.

6.6.3. Aborting the program

Press the 1 button or the ANL key again to stop the program.

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6.7. Using the menu system

6.7.1. Entering the menu

Press the 1 button to enter the menu. This places you in the main menu. The top
of the menu contains four items:
• Catalog
• Settings
• Alarm
• Identifiers
The bottom line of the menu system shows the device software version.

6.7.2. Moving in the sub-menus

1 8
Use the ‘arrow up / down’ ( 5 / ) buttons to move in the menu.
If there is a ’>’ sign at the end of a menu item, it indicates that there is a sub-menu,

which can be accessed with the ’right arrow’ ( ).

Use the ‘left arrow’ ( ) key to return from a sub-menu.

Press the 1 key to return from the main menu, or from any submenu, to
monitoring mode.

6.7.3. Parameter modification

If there is no ‘>’ sign at the end of a line, then it is not a sub-menu, but a parameter
that can be modified.

In this case press the ‘right arrow’ ( ) key to modify the parameter, except when
setting the date, which we will be talk about later.

You can return with the ‘left arrow’ ( ) key.

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6.7.4. Branching possibilities in the menu system

Stored Pac1
record
Record
identifiers Pac2 display

Pac..n
Catalog>

Settings> AUTO length: 4 s (2,4,6,8 s)


Printing> Pre-delay: 0s (2s)
Alarm> Prog+print: on /off

12-lead ECG: 4 s (4,6,8 s)


Identifier> Storage> Rhythm time: 1m (20s1,,3,5,10m)

MM,DD,YYYY
Date, time> 2004.01.01
7:23:22
Wednesday

Magyar,English,Deutch,Francais,
Language> Espanol,Italiano,Pycckuu,Polski
MM,DD,YYYY (sorrend!)

Mains: 50Hz /60Hz


Filters> Baseline: on /off

QRS sound: on /off


Other> Shutdown: 5 minutes /none
Lead: standard /cabrera
Erase memory

Alarm: off /on


Upper limit: 120 (60...140)
Lower limit: 40 (30...55)

Enter identifier

Notice:
• Settings in bold indicate default values used after memory is deleted.
• Values in italics indicate possible values.

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6.8. Handling stored records (Catalog)

Press the ‘arrow right’ ( ) key to enter the catalog from the main menu.
The catalog shows the records with the following information:
• identifier,
• patient ID,
• record date and time.
The catalog format is the following:
Number of stored records
Record
identifier

Patient ID
Record date
and time

The display shows at most 3 records simultaneously. If there are more than 3
1 8
records, use the ‘arrow up / down’ ( 5 / ) keys to display more records.
The currently selected record is displayed in inverse.

6.8.1. Deleting a record

1 8

Use the 5
and keys to select the record to be deleted, then press to

delete. To confirm, press the key; if you changed your mind, press the key.

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6.8.2. Printing all the data of a record

Pressing the 9 or 0 key prints all the data.


Pressing any of the two buttons again stops printing.

6.8.3. Displaying stored records

6.8.3.1. Normal storage, “STO” record display

1 8
Select the stored record in the “Catalog” menu with the 5
/ keys, then press

the , keys to display the stored curve.


During display you have the following options:

• stored curve speed setting (with the 7


key)

• sensitivity setting (with the key)

• filter switching (with the 6


key)
8 1

• lead selection (with the / 5


keys)

Since the displayed record may be longer than what fits on the display, you can
freely scroll the record with the right / left arrow, multi-function yellow soft keys. The
bottom row of the display shows the beginning and end time of the displayed section.

Press the 9
key to print the displayed channel’s group.

During printing the stored and printed heart frequency is the calculated
! average heart frequency of the 10 seconds prior to the key being pressed, so
it may differ a little from what can be measured on the printout.

The displayed channels’ lead group (3 channels) is printed.


The printing properties (speed, sensitivity and filter states) are the same as those of
the current curve display properties.
Press the key to print all 12 channels’ stored curves in groups of 3 channels.
The printout format is the same as described for manual and automatic printing.

Press the 1 key to return to the previous menu level.

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6.8.3.2. Handling rhythm record

1 8
After selecting it ( 5 / then ), the stored rhythm record is displayed the
following way:

It is possible to set the stored rhythm curve’s sensitivity. The 5mm/sec speed cannot
be changed.
The length of the rhythm record is according to the Settings/Storage/Rhythm time
menu item.
Since the displayed record may be longer than what fits on the display, you can
freely scroll the record with the right / left arrow, multi-function yellow soft keys. The
bottom row of the display shows the beginning and end time of the displayed section.
The printout sensitivity is the same as the sensitivity during rhythm curve display.

Press the 1 key to return to the previous menu level.

6.8.3.3. Handling analysis results

Since the analysis results cannot appear on the display, selecting this menu item
1 8
( 5 / then ) the program immediately offers to print, or you can return to

the previous menu level with the 1 key.

Pressing the 9 key prints the following:

• header
• QRS complexes’ typical average curves calculated from a 16s long curve,
• the curves’ amplitude and time parameters
After printing you are returned to the catalog.

In case of pacemaker signal the device creates only an analysis, which the
! pace impulse does not interfere with, but due to morphological differences
there may be inconsistencies in the numeric data.

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The amplitude and time parameters appearing on the printout:

6.8.3.4. Modifying the identifier

1 8
The following is visible after the identifier has been selected ( 5 / or ):

The first line contains the identifier. Its maximum length is 13 characters. Here you
can see the automatic identifier created by the device (Auto 0003)

Press the key to delete a character.

When you are done modifying the identifier, press the key to accept the changes
and return to the previous level.
If you would like to return to the previous level without saving the changes, press the

1 key.

If the ‘AUTO’ part at the beginning of the identifier has changed, it cannot be
! modified later, you will not be able to enter the Identifier menu.

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6.9. Device settings (settings)

To enter device settings, press the 1 key in monitoring mode, then select
1 8
Settings ( 5 / then ).
1 8

Move among the menu items the usual way ( 5


/ ) and select them ( ).

Return to the previous level with .

6.9.1. Printing

In this sub-menu you have the following options:


• AUTO length
• Pre-delay
• Prog+print
1 8

Entering the AUTO length sub-menu ( 5


/ then ) you can set the length of
the curves printed during automatic printing. The automatic length can be 2, 4, 6 or
8s.
In the AUTO length sub-menu you can turn the 2 seconds long pre-delay time on and
off, which is important when making automatic and manual printing.
In the Prog+print sub-menu you can turn immediate automatic printing after record
creation on or off. If “on”, the device prints the entire record after executing any
program.
1 8

Move among the menu items the usual way ( 5


/ ) or modify them ( ).

Return to the previous level: .

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6.9.2. Storage

1 8
Entering this sub-menu ( 5 / then ) lets you set the storage program
“STO” and rhythm storage program “RTM” parameters:
• 12 leads
• Rhythm time
In the 12 leads menu item you can set the length of the normal 12-channel “STO”
storage program, which can be 4, 6 or 8s.
In the Rhythm time sub-menu you can set the length of the one-channel rhythm
curve “RTM” program. The length of the rhythm record made during storage can be
20s, 1, 3, 5, 10 minutes.
1 8
Move among the menu items the usual way ( 5 / ) and modify them ( ).

Return to the previous level with .

6.9.3. Date, time

1 8
Selecting this sub-menu ( 5 / then ) you can set the built-in calendar and
clock. The following appears on the display:

Setting is as follows:

Select the parameter to be modified with the right arrow ( ).


The value of the parameter in inverse can be modified with the ‘arrow up/down’
1 8
( 5 / ) keys.

Press the 1 or ‘arrow left’ ( ) key to accept the changes and return to the
previous level.

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6.9.4. Language

1 8
Selecting this menu ( 5 / then ) lets you set the device language and date
format:

In the first row are the available languages. Text on the display and on the printouts
appear in the language set here. Currently the device supports 7 different languages.
These are, in order:
• Hungarian
• English
• German
• French
• Spanish
• Italian
• Russian
• Polish
In the second row you can set the date format. The date format changes with the
device language, since it automatically changes to the recommended format.
1 8
Move among the menu items the usual way ( 5 / ) and modify them ( ).

Return to the previous level with .

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6.9.5. Filters

1 8
Selecting this sub-menu ( 5 / then ) lets you enter the mains frequency for
mains filter operation. The mains frequency can be set to 50 and 60 Hz.
Furthermore, this is where you can turn the baseline filter on. The baseline filter
makes better-than-ever quality recordings possible by suppressing baseline
movement. The baseline filter insures during monitoring that
• low frequency noises on the electrodes,
• noises from patient breathing, and
• majority of the noises from patient movement
do not effect the ECG signal.
1 8
Move among the menu items the usual way ( 5 / ) and modify them ( ).

Return to the previous level with .

6.9.6. Others

1 8
Selecting this sub-menu ( 5 / then ) lets you turn the QRS sound and
automatic shutdown service on and off.
The automatic shutdown feature turns the device off after 5 minutes if none of the
controls have been operated and there was no connection with the PC.
1 8
Move among the menu items the usual way ( 5 / ) and select them ( ).

Return to the previous level with .

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6.10. Computer connection

The Innobase for Windows measurement data collection and database management
program can be purchased for the HeartScreen 60G. The program is used to
manage the patient database, store measurement results, monitor 3 channels,
display and evaluate measurement results. The program can be learned from its own
manual.
Connect the device to the PC serial port with the serial cable (included); turn the
device on and start Innobase for Windows on the PC. The program connects to the
device and from that point the PC is in control, all functions (sensitivity, speed, filter
state, monitoring, printing, starting programmed measurements, etc.) can be
performed there.

7. Shipping and storage requirements

In case of short-term storage, keep the electrocardiograph in a closed space, at


temperatures 0°C - 45°C and max. 80% relative humidity (meant at 25°C). The air in
the room cannot contain corrosion causing pollution.
If the above requirements cannot be met, the device must be stored in its original or
same quality packaging. Individual devices are shipped in a plastic carrying case
enclosed in a cardboard box with protective packaging.
If the electrocardiograph has not been in use for a long period – for example it was
stored at low temperatures –, keep it under normal operating conditions for at least 4
hours.
During shipping the device has to be placed in its original packaging – plastic
carrying case, cardboard box.

8. Packaging

The device is shipped in a carrying case, in which the device and its accessories are
placed together. The case may be used to carry the device around during use.
During operation make sure, that the accessories are always in their place and the
cable is not matted. Never force the case shut, it should close easily.

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9. Maintenance, cleaning

9.1. Maintenance

The HeartScreen 60G does not require any special maintenance, the number of
moving parts is minimal, thus is the chance of breakdown.
The device’s battery pack has to be changed every 4 years.
To preserve battery capacity it is recommended to format the battery at least semi-
annually. For this, drain the battery completely by disabling the automatic shutdown
feature (‘Settings/Others/Shutdown’), then fully charge the battery for 2.5 hours with
the device’s own charger.
Randomly pressing the control buttons does not cause failure.
It is advised to have the device checked and calibrated with the professional service
at periods specified in the warranty and service manual.
The device’s expected lifetime is 8 years.

9.2. Cleaning, disinfecting

Formaldehyde solution may be used to clean and disinfect the device. It may be
cleaned with a detergent wet cloth, and then disinfected with formaldehyde solution
by creating a continuous even layer and allowing it to dry. During cleaning take care
that no liquid gets inside the device and the paper bin. The electrodes may be
cleaned with alcohol or formaldehyde solution. The formaldehyde solution is a smelly
liquid that irritates the skin and mucous membrane, so it is suggested to perform the
cleaning in rubber gloves and afterwards air the room.
Making the formaldehyde solution: for 1000cm3 volume dilute 50 cm3 35-40%
formaldehyde solution in distilled water.

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