Schiller CARDIOVIT CS-104 User manual

User Guide
CARDIOVIT CS-104
Art. no.: 2.511335 Rev. a *2.511335*

Sales and Service Information
The SCHILLER sales and service centre network is worldwide.
For the address of your local distributor, contact your nearest SCHILLER
subsidiary. In case of difficulty a complete list of all distributors and subsidiaries
is provided on our Internet site:
http://www.schiller.ch
Sales information can also be obtained from:
[e-mail]
Manufacturer
SCHILLER AG Phone: [phone]
Altgasse 68 Fax: [phone]
CH-6341 Baar, Switzerland
Article no.: 2.511335 Rev. a
Issue date: 3.5.2019

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User Guide
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
Contents
1Safety Notes ..................................................13
1.1 Intended Use ................................................................................. 13
1.2 Indication for Use........................................................................... 13
1.3 Optional Use.................................................................................. 13
1.4 Characterisation of Users .............................................................. 13
1.5 Characterisation of Patients .......................................................... 13
1.6 Contraindications........................................................................... 14
1.7 Responsibility of the User ............................................................. 14
1.8 Organisational Measures............................................................... 14
1.9 Safety Facilities ............................................................................. 14
1.10 Safety-Conscious Operation.......................................................... 15
1.11 Trolley Installations - Transporting & Placement ........................... 15
1.12 Maintenance .................................................................................. 16
1.13 Operation with other Devices ........................................................ 16
1.14 Extra Precautions for Spirometry................................................... 17
1.15 Electrical and Power Source Related ............................................ 17
1.16 Network Security ........................................................................... 18
1.17 Terms of Warranty......................................................................... 18
1.18 Additional Statements.................................................................... 19
1.19 Safety Symbols and Pictograms.................................................... 20
1.19.1 Symbols Used in this Document ............................................................... 20
1.19.2 Symbols Found on the Device and Recorder ........................................... 20
2Introduction ..................................................23
2.1 Overview........................................................................................ 23
2.2 Configurations ............................................................................... 24
2.2.1 CARDIOVIT CS-104 ................................................................................. 24
2.2.2 CARDIOVIT CS-104 System .................................................................... 24
2.2.3 CARDIOVIT CS-104 Spiro........................................................................ 24
2.3 Options and Features .................................................................... 24
2.4 Installation ..................................................................................... 25
2.5 Networking Overview..................................................................... 26
2.6 ECG Recorders ............................................................................. 26
2.6.1 MS-12 USB ECG Recorder....................................................................... 27
2.6.2 MS-12 blue ECG Recorder ....................................................................... 27
2.6.3 FT-1 Streamer........................................................................................... 28

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Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
2.7 Switching On/Off and Opening the Program ................................ 29
2.7.1 CARDIOVIT CS-104 System (Trolley) ...................................................... 29
2.7.2 PC Based Installations.............................................................................. 29
2.8 Power Supply................................................................................ 30
2.8.1 CARDIOVIT CS-104 (Trolley)................................................................... 30
2.8.2 CARDIOVIT CS-104 Resting and CS-104 Spiro (PC Based)................... 30
2.8.3 Power Supply for ECG Recorders ............................................................ 30
2.8.4 Isolating the Mains Supply........................................................................ 30
2.9 Location ........................................................................................ 30
2.10 Locking the Wheels of the Trolley................................................. 31
2.11 System and ECG Settings ............................................................ 31
3Software Overview ....................................... 32
3.1 Login............................................................................................. 32
3.2 Workflow Screens and Main Menu ............................................... 33
3.3 Home Screen................................................................................ 33
3.3.1 Main Menu ................................................................................................ 34
3.4 Screen Layout............................................................................... 35
3.4.1 Side Bar and Bottom (Main) Icons............................................................ 36
3.4.2 Defining the Tables................................................................................... 36
3.4.3 Changing the Column Order..................................................................... 36
3.4.4 Sorting Columns ....................................................................................... 36
3.5 Selecting / Displaying the Recording Device ................................ 37
3.6 Connection with the Server (if Networked) ................................... 37
3.6.1 Offline........................................................................................................ 38
3.7 Recordings.................................................................................... 39
3.7.1 Types of Recording................................................................................... 39
3.7.2 Opening a Recording................................................................................ 39
3.8 Display Configuration.................................................................... 40
3.8.1 Home Screen and Main Menu Options..................................................... 41
3.9 Recording and Patient Search...................................................... 41
3.9.1 Search Options ......................................................................................... 42
3.9.2 Search Results.......................................................................................... 42
3.9.3 Extra Search Options for Worklist (Filter Worklist).................................... 42
3.9.4 Barcode Reader........................................................................................ 43
3.10 Patient Data .................................................................................. 43
3.10.1 Entering / Editing Patient Data.................................................................. 43
3.10.2 Visit Data................................................................................................... 44
3.11 Recording-Specific Data ............................................................... 45

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User Guide
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
4Recording an ECG ........................................46
4.1 Placing the Electrodes................................................................... 46
4.1.1 Electrode Identification and Colour Code.................................................. 46
4.1.2 Basics........................................................................................................ 47
4.1.3 Standard 12-lead....................................................................................... 48
4.1.4 Exercise ECG............................................................................................ 49
4.1.5 Right Precordial (C4r) ............................................................................... 50
4.1.6 Balanced ................................................................................................... 51
4.1.7 Left Posterior C7-C9 ................................................................................. 52
4.1.8 Nehb Leads............................................................................................... 53
4.1.9 Paediatric .................................................................................................. 54
4.1.10 Right Precordials (C3r-C6r)....................................................................... 55
4.1.11 Standard with C4r ..................................................................................... 56
4.1.12 Frank Leads X, Y, Z .................................................................................. 57
4.2 Entering a Recording Screen ........................................................ 58
4.2.1 From the Patient Search Screen............................................................... 58
4.2.2 From the Recorder Screen........................................................................ 59
4.3 Hookup Screen, Electrode Placement and Check ........................ 60
4.4 Electrode Check ............................................................................ 61
4.4.1 Quality Indication on the ECG Trace......................................................... 61
4.4.2 Electrode Placement................................................................................. 61
4.5 Standard or Cabrera Lead Sequence............................................ 62
4.5.1 Selecting the Lead Configuration.............................................................. 62
4.6 Display Layout and Speed and Amplitude..................................... 62
4.7 Pacemaker Detection .................................................................... 62
4.8 Filter............................................................................................... 63
4.9 Blood Pressure .............................................................................. 63
4.10 Saving a Recording ....................................................................... 64
4.11 Discarding a Recording ................................................................. 64
5Resting ECG Recording ...............................65
5.1 Procedure ...................................................................................... 65
5.1.1 ETM Sport (Option)................................................................................... 66
6Rhythm ECG Recording ..............................67
6.1 Procedure ...................................................................................... 67
6.1.1 Arrhythmia (option).................................................................................... 68
6.2 Events............................................................................................ 69
6.2.1 Manual Events .......................................................................................... 69
6.3 At the End of a Rhythm Recording ................................................ 69

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Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
7Exercise ECG Recording ............................ 70
7.1 Safety Notes ................................................................................. 70
7.2 Emergency Stop ........................................................................... 70
7.3 Settings to Check Before Taking an Exercise Test ...................... 71
7.3.1 Ergo Device and BP unit........................................................................... 71
7.3.2 Protocols................................................................................................... 71
7.3.3 Default J-point, Target HR Calculation ..................................................... 72
7.4 Exercise Test Procedure .............................................................. 72
7.4.1 Starting an Exercise Test.......................................................................... 73
7.5 During the Test ............................................................................. 75
7.5.1 Test Control Buttons ................................................................................. 76
7.5.2 Information and Settings Panel................................................................. 76
7.5.3 Trend Graphs............................................................................................ 78
7.5.4 Blood Pressure ......................................................................................... 78
7.5.5 SpO2......................................................................................................... 78
7.5.6 Arrhythmia (option) ................................................................................... 79
7.5.7 RPE........................................................................................................... 79
7.5.8 Events....................................................................................................... 79
7.5.9 Treadmill (Speed and Elevation) Control.................................................. 80
7.5.10 Bicycle (Load) Control............................................................................... 80
7.6 Ending the Test............................................................................. 80
8ECG Recording Analysis ............................ 82
8.1 General Analysis Settings and Options ........................................ 82
8.1.1 Saving after Editing................................................................................... 82
8.1.2 Reports - Printing a Recording or Generating a PDF File......................... 83
8.1.3 Direct Print or PDF Generation................................................................. 83
8.1.4 Rejecting a Recording............................................................................... 84
8.2 Resting ECG Recordings.............................................................. 85
8.2.1 Data Views and Functions ........................................................................ 85
8.2.2 ECG Filter ................................................................................................. 86
8.2.3 ECG Measurements ................................................................................. 86
8.2.4 Zoom......................................................................................................... 86
8.2.5 Amplitude and Speed................................................................................ 86
8.2.6 Changing the Rhythm leads (Rhythm and Average Views)...................... 87
8.2.7 Measurement Table.................................................................................. 87
8.2.8 RR Intervals .............................................................................................. 87
8.2.9 Changing the Global Measurement Points ............................................... 88
8.2.10 Measurement Interval and Heart Rate...................................................... 89
8.2.11 Interpretation............................................................................................. 90
8.2.12 ETM Sport Option ..................................................................................... 90
8.2.13 LVH........................................................................................................... 92
8.2.14 Vector Cardiogram.................................................................................... 94
8.2.15 Full Visual Comparison............................................................................. 95
8.3 Resting Rhythm Recordings ......................................................... 96
8.3.1 Rhythm Screens View............................................................................... 96
8.3.2 Full Disclosure View.................................................................................. 97
8.3.3 Events....................................................................................................... 97
8.3.4 Events View .............................................................................................. 98

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Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
8.4 Exercise ECG ................................................................................ 99
8.4.1 Summary................................................................................................... 99
8.4.2 Editing the Results in the Step Table...................................................... 102
8.4.3 ST Measuring J point .............................................................................. 102
8.4.4 Average View.......................................................................................... 103
8.4.5 Rhythm View - Continuous (Single Lead Rhythm).................................. 105
8.4.6 Rhythm View - Full Disclosure ................................................................ 106
8.4.7 Rhythm View - Step ................................................................................ 107
8.4.8 Step Averages......................................................................................... 108
8.4.9 Step Measurements................................................................................ 108
8.4.10 ST Table View......................................................................................... 109
8.4.11 ST Trend View ........................................................................................ 109
9Worklist .......................................................110
9.1 What is a Worklist........................................................................ 110
9.2 The Worklist Screen .................................................................... 110
9.3 Downloading Work Items............................................................. 111
9.3.1 Worklist Entries ....................................................................................... 111
9.4 Performing a Worklist Item .......................................................... 112
10 Importing and Exporting Recordings .......113
10.1 Importing Recordings .................................................................. 113
10.2 Exporting Recordings .................................................................. 114
10.2.1 Log File ................................................................................................... 115
11 System Settings .........................................116
11.1 Overview...................................................................................... 116
11.1.1 Settings Search....................................................................................... 116
11.1.2 Setting Types .......................................................................................... 117
11.1.3 Elevating a User or Device Setting ......................................................... 117
11.1.4 Changing the User Password ................................................................. 118
11.1.5 Importing /Exporting System Settings..................................................... 118
11.2 General........................................................................................ 119
11.2.1 Station..................................................................................................... 119
11.2.2 Font Size................................................................................................. 119
11.2.3 Screen Resolution................................................................................... 119
11.2.4 Layout ..................................................................................................... 120
11.2.5 Recording Selector.................................................................................. 120
11.2.6 Workflow ................................................................................................. 120
11.2.7 Custom Fields ......................................................................................... 120
11.2.8 Medication............................................................................................... 121
11.2.9 Simulation Data....................................................................................... 121
11.2.10 Recorder View......................................................................................... 121

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Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
11.3 Regional...................................................................................... 122
11.3.1 Date and Time Format............................................................................ 122
11.3.2 Language and System............................................................................ 122
11.3.3 Units........................................................................................................ 122
11.3.4 Patient ID System ................................................................................... 122
11.4 Connectivity ................................................................................ 123
11.4.1 SCHILLER Server................................................................................... 123
11.4.2 SCHILLER Update Server (SUS) ........................................................... 123
11.5 Import / Export ............................................................................ 125
11.5.1 Import...................................................................................................... 125
11.5.2 Export...................................................................................................... 125
11.5.3 GDT /SEMA2 .......................................................................................... 126
11.6 Interpretation............................................................................... 127
11.6.1 General ................................................................................................... 127
11.6.2 Default Acronyms.................................................................................... 127
11.6.3 Custom Acronyms................................................................................... 127
11.6.4 Templates ............................................................................................... 127
11.7 Search ........................................................................................ 128
11.7.1 Quick Search .......................................................................................... 128
11.7.2 Limit ........................................................................................................ 128
11.8 Security....................................................................................... 128
11.8.1 Lock (Auto User Logout)......................................................................... 128
11.8.2 Single Sign On........................................................................................ 128
11.9 Licenses...................................................................................... 129
11.10 Reports ....................................................................................... 129
11.10.1 General (Company information).............................................................. 129
11.10.2 Header .................................................................................................... 129
11.10.3 Printer ..................................................................................................... 129
11.10.4 PDF......................................................................................................... 130
11.10.5 Formats................................................................................................... 131
11.10.6 Combine Reports.................................................................................... 131
11.11 ECG............................................................................................ 132
11.11.1 General ................................................................................................... 132
11.11.2 Power Line.............................................................................................. 132
11.11.3 Display Filter ........................................................................................... 132
11.11.4 Analyser View ......................................................................................... 132
11.11.5 Print Output and PDF Output.................................................................. 132
11.12 Resting ECG............................................................................... 133
11.12.1 Scale ....................................................................................................... 133
11.13 Rhythm ECG............................................................................... 133
11.13.1 General (Rhythm Length) ....................................................................... 133
11.13.2 Scale ....................................................................................................... 133
11.13.3 Events..................................................................................................... 133
11.14 Exercise ECG ............................................................................. 133
11.14.1 General ................................................................................................... 133
11.14.2 Recorder ................................................................................................. 133
11.14.3 Scale ....................................................................................................... 134
11.14.4 Events..................................................................................................... 134
11.14.5 Ergo Devices........................................................................................... 134
11.14.6 Protocols ................................................................................................. 135
11.14.7 Protocol Editor ........................................................................................ 135
11.15 Spirometry .................................................................................. 136

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User Guide
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
12 User Management ......................................137
12.1 Defining the Privileges for a User Role........................................ 138
12.2 Defining a New User.................................................................... 138
12.3 Deleting or Editing a User............................................................ 138
13 ECG Recorders ...........................................139
13.1 MS-12 blue .................................................................................. 139
13.1.1 Control Button ......................................................................................... 139
13.1.2 Switching the Unit On.............................................................................. 139
13.1.3 Switching the Unit Off.............................................................................. 139
13.1.4 Switching Off from the Main Menu.......................................................... 139
13.1.5 Switching off from the Electrode (recording) ECG Screen...................... 140
13.1.6 Display .................................................................................................... 140
13.1.7 Electrode Screen..................................................................................... 141
13.1.8 Bluetooth Screen..................................................................................... 142
13.1.9 Pairing..................................................................................................... 142
13.1.10 Deleting Paired Connections................................................................... 142
13.1.11 Power Supply.......................................................................................... 142
13.1.12 Battery Capacity...................................................................................... 143
13.1.13 Changing the Batteries............................................................................ 143
13.1.14 MS-12 blue Bluetooth Pairing Procedure................................................ 144
13.1.15 Pairing the unit with the PC..................................................................... 144
13.2 MS-12 USB Recorder.................................................................. 146
13.2.1 Function Button....................................................................................... 146
13.3 FT-1 Streamer ............................................................................. 147
14 Cleaning and Disinfection .........................148
14.1 Before Cleaning........................................................................... 148
14.2 Cleaning Interval.......................................................................... 149
14.3 Cleaning / Disinfecting................................................................. 149
14.4 Cleaning Cable Assemblies......................................................... 150
14.5 Cleaning Solutions....................................................................... 150
14.5.1 Construction Material .............................................................................. 150
14.5.2 Approved Cleaning Solutions.................................................................. 150
14.5.3 Cleaning Materials that Must Not be Used.............................................. 151
14.6 Disinfection .................................................................................. 151
14.6.1 Approved Disinfectants ........................................................................... 151
14.6.2 Recommended........................................................................................ 151
14.6.3 Non-admissible Disinfectants.................................................................. 152

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Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
15 Maintenance ............................................... 153
15.1 Visual Inspection......................................................................... 153
15.2 Basic Functional Check .............................................................. 153
15.3 Safety and Functional Checks .................................................... 154
15.4 Tests After Defibrillation.............................................................. 154
15.5 Decommissioning ....................................................................... 154
15.6 Disposal...................................................................................... 154
15.6.1 Electronic Parts....................................................................................... 154
15.6.2 Consumables.......................................................................................... 154
15.7 Inspection Report........................................................................ 155
15.7.1 Every Six Months.................................................................................... 155
15.7.2 Every 24 Months..................................................................................... 155
16 Trouble Shooting ....................................... 156
16.1 Error Messages .......................................................................... 156
17 Accessories and Disposables .................. 157
17.1 General....................................................................................... 157
17.2 MS-12 blue ................................................................................. 157
17.3 MS-12 USB................................................................................. 157
17.4 FT-1 ............................................................................................ 157
18 Technical Specification ............................. 158
18.1 CARDIOVIT CS-104 System ...................................................... 158
18.2 Requirements for PC Based Installations ................................... 159
18.2.1 CARDIOVIT CS-104 ............................................................................... 159
18.3 ECG Recorders .......................................................................... 159
18.3.1 MS-12 USB............................................................................................. 159
18.3.2 MS-12 blue.............................................................................................. 160
18.3.3 FT-1 Streamer......................................................................................... 160
18.4 ECG............................................................................................ 160
18.5 Standards ................................................................................... 161
18.6 Environmental Conditions........................................................... 161
18.7 Program Information................................................................... 161
18.8 Log Information........................................................................... 162
18.9 End of Life Disposal.................................................................... 162
18.10 Measures to Prevent Electromagnetic Interferences.................. 163

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User Guide
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
19 Annex - Installation ....................................164
19.1 Installations using the MS-12 USB .............................................. 164
19.2 Installation Notes and Requirements........................................... 164
19.3 Installation ................................................................................... 165
19.4 Exercise ECG and BP Unit.......................................................... 166
19.4.1 Procedure to Connect the USB-232 Serial Adapter................................ 166
19.4.2 USB to RS-232 Serial Adapter................................................................ 168
19.5 Connection Overview .................................................................. 169
20 Index ............................................................171

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Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104

Page 13
Safety Notes 1
User Guide Intended Use 1.1
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1 Safety Notes
1.1 Intended Use
The CARDIOVIT CS-104 is a 12-lead ECG and Spirometry (option) system
intended to be used by trained medical professionals in healthcare facilities for
cardiological diagnosis in adult and paediatric patients.
Analysis of the ECG and Spirometry is accomplished with algorithms that provide
measurements, data presentations, graphical presentations, and interpretations
for review by the user.
1.2 Indication for Use
The CARDIOVIT CS-104 is a 12-lead ECG device intended to acquire ECG
signals from body surface electrodes, and record, analyse and display ECGs for
cardiological diagnosis in adult and paediatric patients.
Using the optional spirometry module and the associated accessories, the
CARDIOVIT CS-104 is intended to record, analyse, display and print measures
and waveforms of pulmonary function tests for the diagnosis of lung diseases in
adult and pediatric patients able to understand the test instructions.
1.3 Optional Use
The following options can be sold with the CARDIOVIT CS-104:
– Exercise ECG (standard in some configurations)
– Arrhythmia detection: detection of arrhythmias during exercise tests and rest-
ing rhythm acquisition.
– Vector ECG: provides a 3-dimensional view on the electrical activity, and adds
value to the diagnostic of the hearts backside
– Spirometry Test: Indicated to assess patient's pulmonary health status and
evaluate symptoms, signs, or abnormal laboratory test results. The spirometry
module analyses flow/volume and volume/time waveforms recorded during
pulmonary function tests. (standard in some configurations)
1.4 Characterisation of Users
The CARDIOVIT CS-104 is intended to be used by trained medical professionals
or under direct supervision of a licensed health care practitioner, in hospitals,
clinics, physician offices and outreach centres.
1.5 Characterisation of Patients
The CARDIOVIT CS-104 is intended to be used for adult and paediatric patients.
The CARDIOVIT CS-104 is intended to be used as a spirometry system for adult
and paediatric patients able to understand test instructions

1 Safety Notes
1.6 Contraindications
Page 14
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1.6 Contraindications
The CARDIOVIT CS-104 is not designed:
– for sterile use
– for use in areas where there is any danger of explosion or in the presence of
flammable gases such as anaesthetic agents
– for direct cardiac application
– for use in an MRI suite
– for outdoor use.
1.7 Responsibility of the User
The CARDIOVIT CS-104 with the MS-12 ECG Recorder or SpiroScout must only
be used by qualified physicians or trained 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.
Ensure that personnel have read and understood these operating instructions. In
particular this section safety notes must be read and understood.
The operator is responsible for compliance with all applicable accident prevention
regulations and safety regulations.
The safety, reliability and performance of the device can only be guaranteed
when the maintenance intervals as stated in the maintenance section are
observed.
1.8 Organisational Measures
Observe the operating and maintenance instructions. Keep all instructions in an
accessible place for reference when required. Make sure that they are always
complete and legible.
In addition to this user guide, legal and other binding regulations for the
prevention of accidents and for environment protection must be observed
1.9 Safety Facilities
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 15
Safety Notes 1
User Guide Safety-Conscious Operation 1.10
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1.10 Safety-Conscious Operation

©
The CARDIOVIT CS-104 is CF classified. It is defibrillation protected only
when the SCHILLER original patient cable is used. As a precaution however,
when possible remove the electrodes before defibrillation.
Ensure that the patient is informed about the procedure for stress testing and is
aware of the risks (for example, of falling on a running treadmill). Ensure the
patient is aware of the location and use of the emergency stop knob when using
a treadmill.
Do not touch the unit casing 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.
There is no danger when using the device for a patient with a pacemaker fitted.
However, data transmission modules could affect the pacemaker functionality.
To prevent a pacemaker malfunction, a distance of at least 25 cm must be kept
between the device and the pacemaker as soon as the Bluetooth module is
activated.
Do not place any liquids on the unit.
Only use the original SCHILLER patient cable and only use accessories and
disposables recommended or supplied by SCHILLER. Use of other than
recommended or supplied parts may result in injury, inaccurate information and/
or damage to the unit.
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.
 Precautions for Bluetooth pairing:
–ensure that no two sensor pairing processes are started simultaneously to pre-
vent incorrect pairing, and
– ensure that only one recorder is in range of the receiver during advertising/
pairing.
1.11 Trolley Installations - Transporting &
Placement
Be cautious when moving the Trolley. Quick stops, excessive forces and uneven
surfaces may cause the trolley to overturn thus risking the unit to fall to the
ground.
If the unit falls to the ground, turn the power off immediately and disconnect from
the mains. Contact a SCHILLER approved service centre. Continual use of the
unit can result in fire or electric shock.

1 Safety Notes
1.12 Maintenance
Page 16
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1.12 Maintenance
No serviceable parts inside the CARDIOVIT CS-104 nor the ECG Recorders or
SpiroScout. Refer servicing to a qualified technician authorised by SCHILLER
only.
Do not use high temperature sterilisation processes (such as autoclaving). Do not
use E-beam or gamma radiation sterilization.
Do not use solvent or abrasive cleaners on either the unit or cable assemblies.
Do not under any circumstances, immerse an ECG recorder, SpiroScout, or any
cable assembly in liquid.
1.13 Operation with other Devices
Accessory equipment connected must be certified according to the respective
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. Everybody 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 CS-104.
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.
This device can safely be used with pacemaker patients.
There is no danger when using this device simultaneously with electrical
stimulation equipment.
If the device is part of a medical system, only the original SCHILLER patient cable
must be used with, and connected to, the CARDIOVIT CS-104.
If the patient cable should become defective after defibrillation, a lead-off
indication is displayed on the screen.
Portable communication devices, HF radios and devices labelled with the
symbol (non-ionic electromagnetic radiation) can affect the operation of this
device (see para. 18.10, Measures to Prevent Electromagnetic Interferences,
page 163).

Page 17
Safety Notes 1
User Guide Extra Precautions for Spirometry 1.14
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1.14 Extra Precautions for Spirometry
In order to obtain correct predicted values and diagnosis, it is important that all
patient data is entered correctly. In particular gender, date of birth, ethnic, height
and weight must be entered.
The unit must be calibrated before the first pulmonary function test of the day and
after every significant temperature change.
False measurements can result when the sensor is not held vertically - ensure
that the sensor is held upright at all times.
The disposable mouthpiece of the SpiroScout sensor is designed for one-time
use to eliminate the danger of cross contamination - do not use the mouthpiece
for more than one patient . Do not attempt to clean the mouthpiece.
See the CARDIOVIT CS-104 Spiro User Guide for full safety precautions.
1.15 Electrical and Power Source Related
To avoid the risk of electric shock, this equipment must only be connected to a
mains supply with protective earth.
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
is damaged or suspected of being damaged.
– Damaged cable connections and connectors must be replaced immediately.
– The electrical safety devices, such as fuses, must not be altered.
Ruptured fuses must only be replaced with the same type and rating as the orig-
inal.
Only use power cords provided by the dealer to ensure safety and EMC compli-
ance.
The CARDIOVIT CS-104 unit must be connected to an approved power source
as shown on the specification label.
The power cords must not be damaged. Applied pressure, heat, and stress can
damage the power cord.
The power cords must be routed properly so as to help prevent people from step-
ping on the cords or the cords being run over by, for example, the trolley
Do not overload the mains outlet or extension cords. Electrical shocks or fires
may occur from overloading.
Do not touch the power source during a thunderstorm.
If your hands are wet, do not touch the plug.
Do not pull the power cord to remove it from the mains socket because this can
damage the cable. Use your thumb and index finger to grip the plug itself.

1 Safety Notes
1.16 Network Security
Page 18
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1.16 Network Security
It must be ensured that appropriate security measures are installed to protect the
transmission of data.
Security of the network is the sole responsibility of the network operator.
SCHILLER takes no responsibility for the configuration of Windows.
In order to guarantee the security of the network, Schiller AG recommends the
following:
–defining access authorisation for the configuration of the host system so that no
unauthorised alterations of the system are possible.
–installing the latest antivirus/firewall programs in order to prevent malware from
affecting the system
–regularly installing security and software updates
–apply “Risk management of IT-networks” according IEC 80001-1.
1.17 Terms of Warranty
Your SCHILLER CARDIOVIT CS-104 is warranted against defects in material and
manufacture, as stated in the general Terms and Conditions. Excluded from this
warranty is damage caused by an accident or as a result of improper handling. The
warranty entitles to free replacement of the defective part. Any liability for subsequent
damage is excluded. The warranty is void if unauthorized 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 device if:
• assembly operations, extensions, readjustments, modifications or repairs are car-
ried out by persons authorized by him, and
• the SCHILLER device and approved attached equipment is used in accordance
with the manufacturer's instructions, and
• the maintenance intervals as stated in this book 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.
SCHILLER assumes no liability for the loss of data saved on the computer or on the
device. The owner is solely responsible for the data backup.

Page 19
Safety Notes 1
User Guide Additional Statements 1.18
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1.18 Additional Statements
FCC statement
This equipment has been tested and found to comply with the limits for a class A
digital device, pursuant to both Part 15 of the FCC (Federal Communications
Commission) Rules and the radio interference regulations of the Canadian
Department of Communications. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with this instruction
manual, may cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in which case
the user will be required to correct the interference at his own expense.
This device contains FCC ID: Z64-WL180DBMOD
When using the WiFi networking option, operation of this equipment requires the prior
coordination with a frequency coordinator designated by the FCC for the Wireless
Medical Telemetry Service.
This device complies with Part 15 of the FCC rules. Operation is subject to the
following conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may
cause undesired operation.
Any changes or modifications to this equipment not expressly approved by
SCHILLER may cause harmful radio frequency interference and void your
authority to operate this equipment.
Within the 5150 to 5250 MHz band (5 GHz radio channels 34 to 48) the module
type cB-0941 is restricted to indoor operations to reduce any potential for harmful
interference to co-channel MSS operation.

1 Safety Notes
1.19 Safety Symbols and Pictograms
Page 20
Art. no.: 2.511335 Rev. a
CARDIOVIT CS-104
1.19 Safety Symbols and Pictograms
1.19.1 Symbols Used in this Document
The safety level is classified according to ANSI Z535.4. The following overview shows
the safety symbols and pictograms that may be used in the software or this handbook.
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 possibly dangerous situations 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.
Important or helpful user information or safety information.
1.19.2 Symbols Found on the Device and Recorder
Type Label
The following is a typical label found on the ECG recorder.
IP protection class
Type reference
and serial number
Manufacturing date
MS-12 USB
CARDIOVIT CS-104 Trolley Label
TYPE CARDIOVIT CS-104