Schiller CARDIOVIT AT-1 G2 User Manual
1
11
CARDIOVIT
AT-1 G2
User guide
Art. no.: 2.511235 Rev.: d *2.511235*
Address Headquarters
SCHILLER AG Phone: +41 (0) 41 766 42 42
Altgasse 68 Fax: +41 (0) 41 761 08 80
CH-6341 Baar, Switzerland E-mail: sales@schiller.ch
Web:www.schiller.ch
Sales and Service Information
The SCHILLER sales and service centre network is world-wide. Contact your nearest
SCHILLER subsidiary to obtain the address of your local distributor. In case of difficulty,
a complete list of all distributors and subsidiaries is provided on our internet site:
www.schiller.ch
Sales information can also be obtained from:
sales@schiller.ch
The CARDIOVIT AT-1 G2 bears the CE-0123 mark (Notified Body TÜV-SÜD Produkte Service
GmbH, Ridlerstr. 65, 80339 Munich, Germany), indicating its compliance with the essential requirements of the Annex I of the Medical Device Directive 93/42/EE regarding safety, functionality and
labelling. The requirements apply to patients, users and third persons who come into contact with
this device within the scope of its intended use.
Article no.: 2.511235 Rev.: d
Issue date: 28.03.18
Based on DE vers. b
SW > 1.1.0
User guide
Art. no.: 2.511235 Rev.: d
Contents
Page 3
CARDIOVIT AT-1 G2
Table of Contents
1 Safety notes ..............................................7
1.1 Intended Use ........................................................................ 7
1.2 Indications for use................................................................ 7
1.3 Contra-indication .................................................................. 7
1.4 Responsibility of the User ................................................... 7
1.5 Organisational Measures..................................................... 8
1.6 Safety-conscious Operation................................................ 8
1.7 Safety facilities ..................................................................... 8
1.8 Operation with other Devices .............................................. 9
1.9 Maintenance.......................................................................... 9
1.10 Terms of warranty .............................................................. 10
1.11 Symbols and Pictograms................................................... 11
1.11.1 Symbols used in this document ....................................................... 11
1.11.2 Symbols used on the device ............................................................ 12
2 Overview ................................................. 13
2.1 Main Components of the CARDIOVIT AT-1 G2 ................ 13
2.1.1 Standard........................................................................................... 13
2.1.2 Options............................................................................................. 13
2.2 Keyboard ............................................................................. 14
2.2.1 Description of keys........................................................................... 14
2.3 Display................................................................................. 15
3 Operation ................................................ 16
3.1 Initial operation ................................................................... 16
3.1.1 Location............................................................................................ 16
3.2 Connections........................................................................ 16
3.2.1 Back panel ....................................................................................... 16
3.2.2 Right-hand side panel...................................................................... 17
3.2.3 Connection of external cable assemblies......................................... 17
3.2.4 Potential equalisation....................................................................... 17
3.3 Switching on / off................................................................ 18
3.4 Power supply ...................................................................... 18
3.4.1 Mains and battery indicators ............................................................ 18
3.4.2 Isolating from the mains ................................................................... 18
3.5 Changing the Printing Paper ............................................. 19
3.6 System and ECG settings.................................................. 20
Art. no.: 2.511235 Rev.: d
Contents
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CARDIOVIT AT-1 G2
4 Electrode placement ...............................21
4.1 Basics .................................................................................. 21
4.2 Electrode Identification and Colour Code ........................ 22
4.3 Resting ECG with 10-lead patient cable ........................... 23
4.3.1 Electrode placement for standard leads .......................................... 23
4.4 Standard with C4r for CCAA recordings .......................... 24
4.5 Skin/Electrode Resistance................................................. 25
4.5.1 Electrode and patient cable check................................................... 25
4.6 Lead sequence/lead view................................................... 26
4.6.1 Setting Standard or Cabrera lead sequence.................................... 26
5 Patient data .............................................27
6 Resting ECG ............................................29
6.1 Resting ECG - Procedural Flow Diagram ......................... 30
6.2 Automatic resting ECG recording..................................... 31
6.2.1 Printout............................................................................................. 32
6.3 Manual Rhythm Printout .................................................... 33
6.3.1 Starting manual printout................................................................... 33
6.4 Changing the ECG display................................................. 34
6.4.1 Display............................................................................................. 34
6.4.2 Myogram filter.................................................................................. 34
6.4.3 Other filters ...................................................................................... 34
7 Culprit Coronary Artery Algorithm ........35
7.1 Introduction......................................................................... 35
7.1.1 Culprit Artery Algorithm Decision Overview..................................... 36
7.1.2 Starting the CCAA analysis.............................................................. 37
7.1.3 CCAA information on print preview/printout..................................... 38
8 PDF export ...............................................39
8.1 Data integrity ...................................................................... 39
8.2 Export procedure................................................................ 39
8.2.1 Deleting ECG data stored on the device.......................................... 39
9 General and System Settings ................40
9.1 System settings .................................................................. 40
9.2 ECG ...................................................................................... 41
9.2.1 Leads & cable.................................................................................. 41
9.2.2 Filters & formulas............................................................................. 41
9.2.3 Display............................................................................................. 41
9.2.4 Print formats..................................................................................... 42
9.2.5 Interpretation.................................................................................... 42
9.2.6 PDF formats..................................................................................... 42
9.3 System ................................................................................. 43
9.3.1 Settings............................................................................................ 43
9.3.2 Info................................................................................................... 43
User guide
Art. no.: 2.511235 Rev.: d
Contents
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CARDIOVIT AT-1 G2
10 Maintenance ............................................44
10.1 Visual inspection ................................................................ 44
10.2 Cleaning the casing and cables ........................................ 45
10.2.1 Cleaning the patient cable................................................................ 46
10.2.2 Admissible detergents...................................................................... 46
10.2.3 Non-admissible detergents .............................................................. 46
10.3 Disinfection ......................................................................... 47
10.3.1 Admissible disinfectants................................................................... 47
10.3.2 Non-admissible disinfectants ........................................................... 47
10.4 Cleaning the print head...................................................... 47
10.5 Battery ................................................................................. 48
10.5.1 Charging the battery......................................................................... 48
10.5.2 Battery disposal................................................................................ 48
10.6 Inspection Report ............................................................... 49
10.6.1 Lifed-item replacement every 3 - 5 years......................................... 50
10.7 Accessories and disposables ........................................... 51
11 Trouble Shooting .................................... 52
11.1 Possible problems.............................................................. 52
11.2 Preventing electromagnetic interferences....................... 54
11.2.1 Measures to prevent electromagnetic interferences ........................ 55
12 Technical Data ........................................ 56
12.1 Device .................................................................................. 56
12.2 ECG...................................................................................... 57
12.3 Safety Standards ................................................................ 58
13 Index ........................................................ 59
Art. no.: 2.511235 Rev.: d
Contents
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CARDIOVIT AT-1 G2
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Art. no.: 2.511235 Rev.: d
Safety notes 1
User guide Intended Use 1.1
CARDIOVIT AT-1 G2
1 Safety notes
1.1 Intended Use
1.2 Indications for use
1.3 Contra-indication
1.4 Responsibility of the User
F
The CARDIOVIT AT-1 G2 is a 12-lead ECG device intended to be used by trained
medical professionals in healthcare facilities for cardiological diagnosis in adult
and paediatric patients.
ECG analysis is complemented with algorithms that provide measurement
results, data, graphic presentation and interpretation for review by the user.
The CARDIOVIT AT-1 G2 is a 12-lead ECG device intended to acquire ECG
signals from body surface electrodes and record, analyze, display and print
ECGs for cardiological diagnosis in adult and paediatric patients.
The unit is not intended for:
• sterile use.
• use in potentially explosive areas or in the presence of flammable gases such as
anaesthetic agents.
• direct cardiac application.
• use in an MRI suite.
The CARDIOVIT AT-1 G2 must only be used by qualified medical personnel.
The numerical and graphical results and any interpretation given must be
examined with respect to the overall clinical condition of the patient and the
general recorded data quality.
The responsibilities of the personnel for the operation and maintenance of the
device must be specified.
Ensure that the personnel have read and understood this user guide. In particular
this section safety notes must be read and understood.
Damaged or missing components must be replaced immediately.
The safety, reliability and performance of the device can only be guaranteed
when the maintenance intervals as stated in the section Maintenance are
observed.
1 Safety notes
1.5 Organisational Measures
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CARDIOVIT AT-1 G2
Art. no.: 2.511235 Rev.: d
1.5 Organisational Measures
1.6 Safety-conscious Operation
1.7 Safety facilities
Before using the device, ensure that a medical product representative has
explained its functions as well as the safety requirements.
Keep this user guide in an accessible place for reference purposes. Make sure
that it is always complete and legible.
Observe the operating and maintenance instructions.
These operating instructions do not override any statutory or local regulations, or
procedures for occupational safety and environmental protection.
Only operate the device in accordance with the specified technical data.
The device is CF classified. It is defibrillation protected only when the
SCHILLER original patient cable is used. However, as a safety precaution and if
possible, remove the electrodes before defibrillation.
Do not touch the unit during defibrillation.
To ensure patient safety, none of the electrodes including the neutral electrode,
nor the patient or any person with simultaneous patient contact, must come in
contact with conductive parts, even when these are earthed.
Immediately report any changes that impair safety (including operating
behaviour) to the responsible person.
Do not place any liquids on the unit. If liquid is spilled on the device, immediately
disconnect the device from the mains and wipe it. The device must be checked
before reusing.
Only connect the original SCHILLER patient cable to the patient socket.
If the patient cable should become defective after defibrillation, an electrode
becomes displaced, or an electrode resistance is too high, a lead-off indication is
displayed in the upper right part of the screen (see section 4.5.1 Electrode and
patient cable check, page 25).
Only use accessories and disposables recommended or supplied by SCHILLER.
The use of third-party accessories (including disposables) may result in injury,
inaccurate information due to electromagnetic interferences and/or damage to
the device.
Operating the device without the correctly rated fuse or with defective cables
constitutes a danger to life! Therefore:
– Do not operate the unit if the earth connection is suspect or if the mains lead,
the power supply unit or the device is damaged or suspected of being damaged.
– Damaged cable connections and connectors must be replaced immediately.
– Electrical safety devices, such as fuses, must not be modified.
– Fuses must only be replaced with the same type and rating as the original.
©
Page 9
Art. no.: 2.511235 Rev.: d
Safety notes 1
User guide Operation with other Devices 1.8
CARDIOVIT AT-1 G2
1.8 Operation with other Devices
1.9 Maintenance
Accessories connected to the analogue and/or digital interfaces must be certified
according to the corresponding IEC standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment).
Furthermore, all configurations shall comply with the valid version of IEC/EN
60601-1. Everyone who connects additional equipment to the signal input part or
signal output part configures a medical system and is therefore responsible that
the system complies with the requirements of the valid version of IEC/EN 60601-
1. If in doubt, contact the technical service department or your local
representative.
Any other equipment used with the patient must use the same common earth as
the CARDIOVIT AT-1 G2.
Special care must be exercised when the unit is used with high-frequency
equipment. Use the special high frequency SCHILLER patient cable to avoid
possible signal interference during ECG acquisition. However, the stimulation
units should only be used at a sufficient distance from the electrodes and both
devices must be connected to the same potential equalisation. If in doubt, the
patient should be disconnected from the device.
There is no danger for patients with a pacemaker.
There is no danger when using this unit simultaneously with electrical stimulation
equipment.
If the patient cable should become defective after defibrillation, a lead-off
indication is displayed on the screen (see page 25).
Portable communication devices, HF radios and devices labelled with the
symbol (non-ionic electromagnetic radiation) can affect the operation of this
device (page 54).
Danger of electric shock. Do not open the device. There are no serviceable parts
inside. Servicing must only be performed by qualified technicians authorised by
SCHILLER.
Before cleaning and to isolate the mains power supply, switch the monitor off and
disconnect it from the mains by removing the plug.
Do not use high-temperature sterilisation processes (such as autoclaving). Do
not use e-beam or gamma radiation sterilisation.
Do not use aggressive or abrasive cleaners.
Do not, under any circumstances, immerse the unit or cable assemblies in liquid.
1 Safety notes
1.10 Terms of warranty
Page 10
CARDIOVIT AT-1 G2
Art. no.: 2.511235 Rev.: d
1.10 Terms of warranty
Your SCHILLER CARDIOVIT AT-1 G2 is warranted against defects in material and
manufacture, as stated in the Terms and Conditions. Excluded from this warranty is
damage resulting from negligence or improper use. The warranty entitles to free
replacement of the defective part. Any liability for subsequent damage is excluded.
The warranty is void if unauthorised or unqualified persons attempt to make repairs.
In case the device is defective, send it to your local SCHILLER representative or
directly to the manufacturer. The manufacturer can only be held responsible for the
safety, reliability and performance of the apparatus if:
• assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by the manufacturer, and
• the SCHILLER device and approved attached equipment is used in accordance
with the manufacturer's instructions, and
• the maintenance intervals as stated in the section Maintenance are observed.
There are no express or implied warranties which extend beyond the warranties
hereinabove set forth. SCHILLER makes no warranty of merchantability or fitness for
a particular purpose with respect to the product or parts thereof.
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Art. no.: 2.511235 Rev.: d
Safety notes 1
User guide Symbols and Pictograms 1.11
CARDIOVIT AT-1 G2
1.11 Symbols and Pictograms
1.11.1 Symbols used in this document
The safety level is classified according to ISO 3864-2. The following overview shows
the safety symbols and pictograms used in this user guide.
For a direct danger which could lead to severe personal injury or to death.
For a possibly dangerous situation which could lead to severe personal injury or to
death.
For a possibly dangerous situation that could lead to personal injury. This symbol is
also used to indicate possible damage to property.
For general safety notes as listed in this chapter.
For electrical hazards, warnings or precautionary measures when dealing with
electricity.
Note For possibly dangerous situations which could lead to damage to property or
system failure. Important or helpful user information.
Reference to other instructions.
1 Safety notes
1.11 Symbols and Pictograms
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CARDIOVIT AT-1 G2
Art. no.: 2.511235 Rev.: d
1.11.2 Symbols used on the device
Potential equalisation.
CF symbol. The device is classified safe for internal and external use. However, it is
only defibrillation protected when used with the original SCHILLER patient cable.
Manufacturer symbol, manufacturing date.
The device is IP20-classified and is not protected against the ingress of liquids. Keep
dry.
Symbol for the recognition of electrical and electronic equipment
Equipment/components and accessories no longer required must be disposed of in
a municipally approved collection point or recycling centre. Alternatively, you can return the equipment to your supplier or the manufacturer for disposal. Improper disposal can harm the environment and human health.
The unit/component can be recycled
0123
Notified Body TÜV-SÜD Produkte Service GmbH, Ridlerstr. 65, 80339 Munich, Germany
Attention: consult accompanying documents.
Consult the user guide.
Consult the Instruction for use.
Mains LED.
Battery charging LED (for details, see section 3.4.1 Mains and battery indicators,
page 18).
Page 13
Art. no.: 2.511235 Rev.: d
Overview 2
User guide Main Components of the CARDIOVIT AT-1 G2 2.1
CARDIOVIT AT-1 G2
2Overview
The SCHILLER CARDIOVIT AT-1 G2 is a 12-channel ECG unit designed to record,
display and measure resting ECGs. The display and keyboard enable easy and
intuitive operation to efficiently enter patient data, record ECGs and adjust device
settings.
The CARDIOVIT AT-1 G2 has the following features:
2.1 Main Components of the CARDIOVIT AT-1
G2
2.1.1 Standard
• Pacemaker detection
• Manual rhythm printout in real time (leads, speed and amplitude can be changed)
• Auto mode recording (10 seconds) with user-defined print formats
• Measurements
• Display of all 12 channels (4x3)
• Display of reversed electrodes
• Recording review
• PDF export to USB stick
2.1.2 Options
• Interpretation
• CCAA
Thermal printer and paper tray
On/Off key
LCD screen
Menu/navigation keys
Mains/battery status LED
Function keys
Setting keys
2Overview
2.2 Keyboard
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CARDIOVIT AT-1 G2
Art. no.: 2.511235 Rev.: d
2.2 Keyboard
2.2.1 Description of keys
Switching the device on/off
Starting an automatic resting ECG
Starting a manual resting ECG
For numerical input: delete (backspace )
• Stopping printout of an automatic/manual ECG
• Closing the menu
Entering patient information. If the key is pressed twice, the previous patient's data
is retrieved.
Printing an ECG from the Preview screen. Unless new patient data has been
entered, additional printouts (copies) can be generated.
Changing the myogram filter (Off, 25, 40 or 150 Hz). Once the recording is
completed, the filter is reset to the value programmed in the menu "Filter & formulas"
(see page page 41).
Setting the ECG chart speed and amplitude.
Menu/Enter key and Up/down keys ().
To enter a dot (.) or dash (-) as part of the patient ID, use the arrow keys ().
During numerical input, the numbers associated with the keys as well as Backspace
are automatically active.
Delete numerical
input
Numerical input
(.)
(-)
etc.
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Art. no.: 2.511235 Rev.: d
Overview 2
User guide Display 2.3
CARDIOVIT AT-1 G2
2.3 Display
The display will vary according to the task being carried out. In all screens, however,
the top and bottom areas always display the same category of information. Example
for a typical ECG view:
Menu display and navigation
12345
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25 mm/s 10 mm/mV LP 150Hz AC 50 Hz
I
II
III
60
/min
Patient number
Date and time
Heart rate
Leads:
Selection with up/down keys ()
Speed/amplitude
Myogram filter
Notch filter
Battery capacity/status
(green: mains operation, black: battery operation)
USB stick
Main menu
28.08.2016 17.58
next/previous select close
Filters & formulas >
ECG
Preview >
Print formats >
SYSTEM
Settings >
Info
Leads & cable >
Patient cable IEC or AHA
Signals Simultaneous
Lead sequence Cabrera
Print interpretation >
Menu/Enter key to open
main menu/parameter
change confirm
0..9 input confirm & close menu
Navigation help
(1)
(1)
(1)
(1)
Stop key to exit a sub-menu
(back) and to close the main
menu.
(2)
(2)
next/previous select back
+
(1)
Use the Up/down keys to scroll up or
down and select a sub-menu/setting
(3)
(3)
(3)
(2)
PDF export >
3Operation
3.1 Initial operation
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CARDIOVIT AT-1 G2
Art. no.: 2.511235 Rev.: d
3 Operation
3.1 Initial operation
3.1.1 Location
• Do not keep or operate the unit in a wet, moist or dusty environment. Avoid exposure to direct sunlight or heat from other sources.
• Do not allow the unit to come into contact with acidic vapours or liquids.
• The CARDIOVIT AT-1 G2 should not be placed in the vicinity of X-ray or diathermy
units, large transformers or electric motors.
3.2 Connections
3.2.1 Back panel
(1) Mains connection 100...240 VAC
(2) Potential equalisation stud. The potential equalisation stud is used to equalise
the ground potential of the unit to that of any nearby mains-powered equipment.
Use the hospital or building common ground for all mains-powered units.
(3) USB interface for USB memory stick.
(4) Kensington lock
Electrical shock hazard. Do not operate the unit if the earth connection is suspect
or if the power supply unit/mains lead is damaged or suspected of being
damaged.
All externally connected hardware must be approved by SCHILLER. Connection
of any hardware not approved by SCHILLER is at the owner‘s risk. Moreover, the
unit's warranty may become invalid.
Position the device so that the mains connection (1) is easily accessible at all
times.
2
1
3
4
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Art. no.: 2.511235 Rev.: d
Operation 3
User guide Connections 3.2
CARDIOVIT AT-1 G2
3.2.2 Right-hand side panel
3.2.3 Connection of external cable assemblies
1. Connect the mains cable to the mains.
3.2.4 Potential equalisation
ECG patient cable connector
The patient cable as well as the connector comply with the safety standard CF
, e.g. they are fully floating and isolated and defibrillation protected.
The unit is only CF rated and defibrillation protected if used with the original
SCHILER patient cable.
In order to prevent disturbance of the ECG signal caused by electromagnetic
interferences:
– only the original SCHILLER patient cable may be used.
– the patient cable needs to be screwed on to ensure a secure connection.
2. Connect the mains cable at the rear of the unit. The mains indicator LED is lit.
3. Leave the CARDIOVIT AT-1 G2 connected to the mains for 3 hours to fully charge
the battery.
4. Connect the potential equalisation cable.
5. Connect the patient cable (side panel).
The potential equalisation stud at the back of the unit is used to equalise the ground
potential of the CARDIOVIT AT-1 G2 to that of all mains-powered equipment in the
vicinity. Use the hospital or building common ground. A yellow/green ground cable is
supplied as an option (article number 2.310320).
Danger of triggering ventricular fibrillation! If the CARDIOVIT AT-1 G2 is used
together with devices that are designed for direct cardiac application, both
devices must be connected to the hospital/building common ground (potential
equalisation) to prevent equalising currents between different device potentials.
3Operation
3.3 Switching on / off
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CARDIOVIT AT-1 G2
Art. no.: 2.511235 Rev.: d
3.3 Switching on / off
3.4 Power supply
3.4.1 Mains and battery indicators
The unit can either be operated by the mains supply or by the built-in rechargeable
battery. Battery charging is indicated by the LED next to the battery symbol.
3.4.2 Isolating from the mains
To isolate the device from the mains supply, remove the mains plug from the external
power supply unit.
The unit is switched on and off with the On / Off key.
To switch the device off, confirm the dialogue by pressing the Enter key.
The device switches itself off automatically if it has not been used for 11 minutes. After
10 minutes, a dialogue is displayed in which switching off can be cancelled by
pressing .
Turn off device
Do you want to
switch off the
device?
YES
NO
(1) When the mains supply is connected, the mains LED is lit.
(2) The battery LED is blinking when the battery is being charged, and it is lit when
charging is complete.
During battery operation (no mains connected), both LEDs are off.
The status is indicated as follows:
• Battery LED is blinking: the battery is being charged.
• Battery LED is lit: the battery is fully charged.
Battery capacity/charging status on the LCD
• Symbol during mains operation
– Green symbol, filling: battery is being charged
– Green symbol: battery fully charged
• Symbol during battery operation
– Black symbol
– Black/red symbol: battery operation, capacity 25%
– Red symbol: battery empty
1
2
100%
75%
0%
50%
25%
Mains operation
Battery operation
100%
charging
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