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Schiller CARDIOVIT FT-1 User Manual

Electrocardiograph for contract research organization
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ELECTROCARDIOGRAPH FOR CONTRACT RESEARCH
CRO
ORGANIZATION
User Guide
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April 4, 2025

Is there a Japanese manual for Cardiovit FT-1 CRO?

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Summary of Contents for Schiller CARDIOVIT FT-1

  • Page 1 ELECTROCARDIOGRAPH FOR CONTRACT RESEARCH ORGANIZATION User Guide only...
  • Page 2 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...
  • Page 3 Safety Symbols and Pictograms ..........13 1.10.1 Symbols used in this document ..............13 1.10.2 Symbols used on the deviceSymbols used on the device ......14 Introduction ..........15 Main Components of the CARDIOVIT FT-1 ....... 15 2.1.1 Standard....................16 2.1.2 Options......................
  • Page 4 CARDIOVIT FT-1 Placing the electrodes ......... 29 Basics ..................29 Electrode Identification and Color Code ........30 Standard 10-lead resting ECG ........... 31 4.3.1 Electrode placement for standard leads ........... 31 Balanced..................32 Paediatric..................33 Right precordials (C3r-C6r)............34 Standard with C4r ............... 35 Left posterior C7-C9 ..............
  • Page 5 CARDIOVIT FT-1 User Guide ECG....................61 7.3.1 Leads & cable ................... 61 7.3.2 Filters ......................61 7.3.3 Manual printout ..................61 7.3.4 Views & layouts..................62 7.3.5 Print formats....................63 7.3.6 Additional leads..................63 Connectivity ................. 64 7.4.1 Update server.................... 64 7.4.2...
  • Page 6 CARDIOVIT FT-1 Technical Data ..........83 11.1 Device ..................83 11.2 ECG ....................85 11.3 Safety Standards ................ 86 11.4 WLAN information ..............86 11.5 EMC information ................. 87 11.5.1 Electromagnetic emissions ..............87 11.5.2 Immunity ....................87 11.5.3 Emissions equipment and systems............88 11.5.4 Immunity to proximity fields from RF wireless communications equipment...
  • Page 7  The CARDIOVIT FT-1 is intended to be used by trained operators under supervision of a licensed healthcare practitioner. Patient target group  The CARDIOVIT FT-1 is intended to be used for adult and paediatric patients.  There are no restrictions regarding height, weight, gender or ethnicity of the patients.
  • Page 8 Context of use  The CARDIOVIT FT-1 is intended for indoor use in healthcare facilities.  The CARDIOVIT FT-1 needs to be operated according to the technical data (see Technical Data). – The CARDIOVIT FT-1 is portable. The CARDIOVIT FT-1 is transportable by means of a trolley (optional).
  • Page 9 The device must be serviced 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.
  • Page 10  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 FT-1.
  • Page 11 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 12  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.
  • Page 13 Safety Notes CARDIOVIT FT-1 User Guide Safety Symbols and Pictograms 1.10 1.10 Safety Symbols and Pictograms 1.10.1 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 manual.
  • Page 14 The CARDIOVIT FT-1 radiates high-frequency electromagnetic energy and can dis- turb other devices if not installed and operated in accordance with the user guide. CARDIOVIT FT-1 However, there is no guarantee that no interference can occur in certain installations. If the CARDIOVIT FT-1 causes interferences, these can be de- termined by switching the device off/on or by transmitting/not transmitting ECG data.
  • Page 15 Main Components of the CARDIOVIT FT-1 2 Introduction The SCHILLER CARDIOVIT FT-1 is a 12-channel ECG unit designed to record, display, and measure resting ECGs. The multi-touch screen allows easy and intuitive operation to efficiently enter patient data, record ECGs and adjust device settings.
  • Page 16 Introduction Connections CARDIOVIT FT-1 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 layout • Measurements • Full disclosure of all 12 channels •...
  • Page 17 Introduction CARDIOVIT FT-1 User Guide Display Display The display will vary according to the task being carried out. In all screens, however, the top, bottom and right areas always display the same category of information. Example for a typical subject data view:...
  • Page 18 Introduction Multi-Touch Screen Operation CARDIOVIT FT-1 Multi-Touch Screen Operation The touch-sensitive areas of the screen are located as follows:  Select protocol, enter subject data or “Lookup Subject from previous visits with the screening  Open/close the number. main menu ...
  • Page 19 Introduction CARDIOVIT FT-1 User Guide Multi-Touch Screen Operation  Prepare ECG recording – Determine electrode positions and apply electrodes – Check the signal quality  Visual indication of pacemaker pulses is switched off and needs to be manually activated in the ECG preview.
  • Page 20 Connection panel CARDIOVIT FT-1 Connection panel  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. 2.5.1 Back panel (1) Power input 15 VDC (2) Potential equalisation stud.
  • Page 21 • Do not allow the unit to come into contact with acidic vapours or liquids. • The CARDIOVIT FT-1 must not be placed in the vicinity of X-ray or diathermy units, large transformers or electric motors.
  • Page 22 Operation Switching on / off CARDIOVIT FT-1 Switching on / off  The unit is switched on and off with the On / Off key. Power supply 3.3.1 Mains and battery indicators The unit can either be operated from the mains supply or from the built-in rechargeable battery.
  • Page 23 Operation CARDIOVIT FT-1 User Guide System and ECG settings System and ECG settings The CARIOVIT FT-1 CRO has limited access (password protected) to System and ECG settings. The settings are predefined or if server access is available the configuration can be downloaded via the Menu>Configuration update button.
  • Page 24 Operation System and ECG settings CARDIOVIT FT-1 3.4.2 Access to System ECG settings System/ECG settings (password admin) Maintenance menu only for production and service (password-protected) Download CRO configuration from server (e.g Protocol, Study site#, Visite code) • The system settings (time, date, device ID etc.) and other general settings are de-...
  • Page 25 • Certain glues can react with the paper. Therefore, do not use glue to attach the printout onto a mounting sheet. SCHILLER can only guarantee perfect printouts when original SCHILLER chart paper or chart paper of the same quality is used.
  • Page 26 Operation Subject details/ recording data CARDIOVIT FT-1 Subject details/ recording data In the subject details data screen, new data can be entered and previously entered data can be edited if the recording wasn’t accepted before. If you want to enter subject data once the recording has been performed (and before it has been accepted), you can jump to the subject data screen, enter the data and use the Review key to jump back to Step 3 to accept (save) the recording.
  • Page 27 Operation CARDIOVIT FT-1 User Guide Subject details/ recording data Subject data Protocol Select protocol (Predefined by the Contract Research Organisation) Study site number Automatically defined when protocol is selected Screening number Enter screening number (maximum 50 characters). This number is also used for further visits to be able to for stored subject data with this number.
  • Page 28 *Barcode reader* • Only the Barcode reader type Symbol Model LS 2208, from Symbol Tech N.Y. has been tested for the Schiller devices. • Barcode scanner configuration: see document 2.510721.  If a the barcode reader is attached, scan the barcode code to enter data into the...
  • Page 29 A minimal resistance between skin and electrode is required to obtain the best ECG signal and ensure the highest quality ECG recording. Therefore, please note the following points: Only use electrodes that are recommended by Schiller AG (see accessories) Before using disposable electrodes, check that the expiration date has not yet passed.
  • Page 30 Placing the electrodes Electrode Identification and Color Code CARDIOVIT FT-1 Electrode Identification and Color Code The electrode color codes in the following sections correspond to Code 1 (IEC) for the graphics and to Code 2 (AHA) in the tables IEC label...
  • Page 31 Placing the electrodes CARDIOVIT FT-1 User Guide Standard 10-lead resting ECG Standard 10-lead resting ECG C1 Red C2 Yellow C3 Green C4 Brown C5 Black C6 Violet R Red L Yellow N Black F Green 4.3.1 Electrode placement for standard leads...
  • Page 32 Placing the electrodes Balanced CARDIOVIT FT-1 Balanced C7 (C4 brown) C8 (C5 black) C9 (C6 purple) C4r (C3 green) C3r (C2 yellow) C1 Red L Yellow R Red F Green N Black Balanced, 10-wire cable IEC label AHA label Electrode placement...
  • Page 33 Placing the electrodes CARDIOVIT FT-1 User Guide Paediatric Paediatric C2 Yellow C7 Red C3r Green C5 Black C6 Purple C4r Brown L Yellow R Red N Black F Green IEC label AHA label Electrode placement C4r white / brown V4 brown / blue ...
  • Page 34 Placing the electrodes Right precordials (C3r-C6r) CARDIOVIT FT-1 Right precordials (C3r-C6r) Since the treatment of an infarction might depend on the influence of the right ventricle, it is suggested to perform additional recordings with right precordial leads in the case of an acute infarction of the right ventricle's inferior wall (Circulation 2007).
  • Page 35 Placing the electrodes CARDIOVIT FT-1 User Guide Standard with C4r Standard with C4r ACC/AHA guidelines recommend examining patients suffering from a myocardial infarction with inferior ST elevation for possible RV ischaemia or RV infarction; this examination should be performed with a right precordial C4r lead.
  • Page 36 Placing the electrodes Left posterior C7-C9 CARDIOVIT FT-1 Left posterior C7-C9 If an acute coronary occlusion is strongly suspected, it is recommended to also register posterior chest wall leads (C7–C9) C4 Brown C7 (C1 Red) C5 Black C8 (C2 Yellow)
  • Page 37 Placing the electrodes CARDIOVIT FT-1 User Guide Nehb leads Nehb leads The Nehb leads are bipolar chest leads. They are of special interest for the diagnosis of changes in the posterior ventricle wall. Three leads are arranged in the form of a triangle, also called the “small cardiac triangle”.
  • Page 38 Placing the electrodes 4.10 Skin/Electrode Resistance CARDIOVIT FT-1 4.10 Skin/Electrode Resistance 4.10.1 Electrode and patient cable check The electrode check is part of step 2 before the start of an ECG recording. The following is checked and displayed: • Excessive noise (signal noise too high) –...
  • Page 39  Do not operate the unit if the earth connection is suspect or if the mains lead is damaged or suspected of being damaged.  If an external electronic device (e.g. a PC) is connected to the CARDIOVIT FT-1, use the potential equalisation stud for earth protection.
  • Page 40 Resting ECG Resting ECG - Procedural Flow Diagram CARDIOVIT FT-1 Resting ECG - Procedural Flow Diagram • Subject data Prepare the patient, connect the  Entering subject data or electrodes and switch on the device “Lookup Subject” data from previous visit with the screening number.
  • Page 41 Resting ECG CARDIOVIT FT-1 User Guide Automatic resting ECG recording Automatic resting ECG recording To take an automatic ECG recording, press the Auto key. After approx. 10 seconds, the recording is analyzed and the result displayed. The recording can be checked and saved and further printouts can be obtained in different formats.
  • Page 42 Resting ECG Automatic resting ECG recording CARDIOVIT FT-1 5.2.1 Printing, saving and transferring automatically This setting are predefined by the CRO and password protected. Menu > Settings > General> Workflow Activate Print after saving, Transmit after saving and Delete after transmission to automatically print and transmit a saved recording or to delete recordings after transmission.
  • Page 43 Resting ECG CARDIOVIT FT-1 User Guide Manual Rhythm Printout Manual Rhythm Printout Use this function to print a real-time ECG. The print parameters such as lead group, print speed and sensitivity can be changed by the user during the printout.
  • Page 44 Resting ECG Changing the ECG display CARDIOVIT FT-1 Changing the ECG display The ECG display is optimized for 2 columns with 6 leads each and cannot be changed. The amplitude and speed is fixed to 10 mm/mV and 25 mm/s, which corresponds to the default values for the display and thermal printer.
  • Page 45 Resting ECG CARDIOVIT FT-1 User Guide Changing the ECG display  When using the 25 Hz or 40 Hz filter, the displayed or printed ECG may not always fulfil the requirements for a diagnostic ECG. Page 45...
  • Page 46 Resting ECG Changing the ECG display CARDIOVIT FT-1 5.4.3 Other filters The following additional filters are available: Baseline filter The cut-off frequency for the baseline filter is based on IEC 60601-2-25 and cannot be changed. Notch filter This filter prevents recording interference due to mains frequency oscillation. If the filter is active, "AC 50 Hz"...
  • Page 47 Resting ECG CARDIOVIT FT-1 User Guide ECG settings ECG settings These settings are predefined by the CRO and password protected. When pressing the Menu key , the option Settings is displayed. The following table gives an overview of all the settings concerning the ECG acquisition: Patient cable Leads &...
  • Page 48 Resting ECG ECG settings CARDIOVIT FT-1 5.5.1 Leads & cable Menu Parameter Description / selection Patient cable IEC or AHA Leads & cable Lead sequence Standard or Cabrera • Standard 12 leads • Paediatric • Right precordials Default lead config.
  • Page 49 Resting ECG CARDIOVIT FT-1 User Guide ECG settings 5.5.4 Views & layouts In this menu, the views and layouts for the Preview, RECG review and Resting rhythms are defined. Preview RECG review Preview Menu Parameter Description Preview view order Select whether Hookup or Recorder is shown at the top...
  • Page 50 Resting ECG ECG settings CARDIOVIT FT-1 RECG review These settings apply to current resting ECG recordings and recordings from the memory. Therefore, saved ECGs can be displayed with different settings at any time. Preview RECG review Menu Parameter Description Adding/removing views, and defining their order: Review views and order rhythms, averages, results and measurements.
  • Page 51 Resting ECG CARDIOVIT FT-1 User Guide ECG settings 5.5.5 Print formats Menu View Visible Description On / Off Result Visible On / Off Measurements Visible Visible On /Off Layout 9 leads (Nehb) = 3x3+1 / 5/4 - 5s / 5/4 - 10s...
  • Page 52 Unless the user has the right to delete unsynchronized recordings. Approx. 350 resting ECGs can be stored on the CARDIOVIT FT-1. Recordings are stored manually after completion of the acquisition.
  • Page 53 Memory CARDIOVIT FT-1 User Guide Editing the Memory 6.2.1 Opening the print preview from the memory and printing a recording Depending on the settings in Menu > Settings > General > Workflow, the recording is printed automatically as soon as it has been saved.
  • Page 54 Memory Editing the Memory CARDIOVIT FT-1 6.2.2 Transmitting and deleting stored recordings Depending on the settings in Menu > Settings > General > Workflow, the recording is transmitted and deleted automatically as soon as it has been recorded. If automatic transmission is not activated, recordings can be transmitted as follows.
  • Page 55 General and system settings CARDIOVIT FT-1 User Guide System settings 7 General and system settings System settings When pressing the Menu key, the options Settings and Memory are displayed. The following table gives an overview of all the settings available.
  • Page 56 General and system settings System settings CARDIOVIT FT-1 Menu Settings Sub-menu • Info • Power management • Station • Update General (Page 66) • Manage licenses • Workflow • Printer • Barcode Page 56...
  • Page 57 General and system settings CARDIOVIT FT-1 User Guide System settings 7.1.1 Saving and restoring settings The settings are saved automatically. Import settings Select Import and Import target USB (device settings) and enter the desired file name to load the stored settings (e.g. default settings) from the USB to the device.
  • Page 58 General and system settings CARDIOVIT FT-1 7.2.1 CRO Configuration Setup of the server connection to download the device configuration from the CRO server. Menu Parameter Description / selection Hostname /Port CRO server host name and port CRO Config CRO Config Path...
  • Page 59 General and system settings CARDIOVIT FT-1 User Guide 7.2.3 Authentication Menu Parameter Description / selection • None No access control • Basic Access control mode Login when switching on the device and/or accessing the Settings Authentification and Memory menu requires a password •...
  • Page 60 General and system settings CARDIOVIT FT-1 7.2.4 Setting user name and password for access control  To prevent non-authorized users to access patient information, manipulate settings or the software, we strongly recommend changing the default password to a strong password according to the standard rules.
  • Page 61 General and system settings CARDIOVIT FT-1 User Guide The default settings are printed bold 7.3.1 Leads & cable Menu Parameter Description / selection Patient cable IEC or AHA Leads & cable Lead sequence Standard or Cabrera • Standard 12 leads •...
  • Page 62 General and system settings CARDIOVIT FT-1 7.3.4 Views & layouts In this menu, the views and layouts for the Preview, RECG review and Resting rhythms are defined. Preview RECG review Preview Menu Parameter Description Preview view order Select whether Hookup or Recorder is shown at the top...
  • Page 63 General and system settings CARDIOVIT FT-1 User Guide 7.3.5 Print formats Menu View Visible Description On / Off Result Visible On / Off Measurements Visible Visible On /Off Layout 9 leads (Nehb) = 3x3+1 / 5/4 - 5s / 5/4 - 10s...
  • Page 64 General and system settings Connectivity CARDIOVIT FT-1 Connectivity 7.4.1 Update server Menu Parameter Description / selection Host Schiller Update server Update server Port Port address and key Test connection 7.4.2 WLAN Menu Parameter Description / selection Wi-Fi enabled Active Not active SSID = Enter network name.
  • Page 65 General and system settings CARDIOVIT FT-1 User Guide Regional settings Regional settings Sub-menu Parameter Description / selection Date and time format Time zone Date and time setting Various Date/time  Key update time. The device must be restarted. Note: This setting can be done directly on the main screen (see Section 3.4.3 Time and date setting, page 24).
  • Page 66 Network host name Host name of the device (e.g. ft1) displayed in the network. Update software The check is performed on the Schiller update server. Therefore, an Check Schiller update server Ethernet/WLAN connection is required, including the necessary net- Update...
  • Page 67  Security of the network is the sole responsibility of the network operator.  SCHILLER AG takes no responsibility for the configuration of Windows.  In order to guarantee the security of the network, Schiller AG recommends the following: – isolating the FT-1 CRO network from other networks –...
  • Page 68 If Wifi is activated, the following symbols are displayed • Green symbol: connected to the Wifi network and the SCHILLER Server. • Black Symbol: connected to the network but no connection to the SCHILLER Server • Signal strength is displayed with bars.
  • Page 69 Maintenance work not described in this section may only be accomplished by a qualified technician authorized by SCHILLER AG. The following table indicates the intervals and responsibilities of the maintenance work required. Local regulations in your country may stipulate additional or different inspection intervals and tests.
  • Page 70  No kinks, abrasion or wear in any cable assembly.  Input/output connectors not damaged. In addition to the visual inspection, switch on the CARDIOVIT FT-1, toggle through the menu and check some functions randomly. In this way, you can check that: •...
  • Page 71 • Confirm that all connectors engage securely. The casing of the CARDIOVIT FT-1 and the cable assemblies can be cleaned with a cloth slightly moistened (not wet) on the surface only. If necessary, a domestic non- caustic cleaner or a 50 % alcohol solution can be used to remove grease stains and finger prints.
  • Page 72 Maintenance Cleaning the casing and cables CARDIOVIT FT-1 9.3.1 Cleaning the cable assembly 1. Before cleaning, inspect the cable for damage. Gently bend and flex all parts of the cable. Inspect for splits in the sheathing, damage or extreme wear, exposed wires or bent connectors.
  • Page 73 Maintenance CARDIOVIT FT-1 User Guide Disinfection Disinfection Disinfection removes certain bacteria and viruses. Please refer to the manufacturer's information. Use commercially available disinfectants intended for clinics, hospitals and medical practices. Disinfect the units in the same way as described for cleaning the units (previous page).
  • Page 74 Maintenance Battery CARDIOVIT FT-1 Battery • Make sure that the batteries remain charged during storage. If the device is not used for more than 3 to 4 months, the battery needs to be protected from deep dis- charge by recharging it; the ideal capacity is 50-80%. If a fully charged battery is stored for a long period of time, this may reduce its service life.
  • Page 75 Maintenance CARDIOVIT FT-1 User Guide Inspection Report Inspection Report  The user guide, especially chapter 9, must be read before the inspection.  Recommended inspection interval: Every 6 months Serial no.: ________________ Test Results Date Visual inspection ❒ ❒ ❒...
  • Page 76 CARDIOVIT FT-1 9.7.1 Lifed-item replacement every 3 - 5 years Inspection Results Replacement Internal battery  Replace Internal Accumulator if • Unit sent to SCHILLER service      operation falls substantially under centre for accumulator replace- one hour.
  • Page 77 • Old paper inserted.  Ensure that new SCHILLER paper is inserted.  Note that the CARDIOVIT FT-1 thermal paper is heat- and light- sensitive. If it is not stored in its original seal, stored in high temper- Printout fades, is not atures or is simply old, print quality can deteriorate.
  • Page 78  Press and hold the On/Off button for 10 seconds to force the device is blocked to switch off. Reconnect mains and switch on.  If the problem persists, call your local SCHILLER representative. Multi-touch screen • Excessive EMC interferences responds ...
  • Page 79 Trouble Shooting 10 CARDIOVIT FT-1 User Guide Preventing electromagnetic interferences 10.2 10.2 Preventing electromagnetic interferences The user can help avoid electromagnetic disturbances by keeping the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the FT-1. The distance depends on the output performance of the communication device, as indicated below.
  • Page 80 Trouble Shooting 10.2 Preventing electromagnetic interferences CARDIOVIT FT-1 10.2.1 Measures to prevent electromagnetic interferences The user can take the following measures to solve this problem: • Increase distance to the source of interference. • Turn the device to change the angle of radiation.
  • Page 81 10.3 Accessories and disposables  Always use SCHILLER replacement parts and disposables, or products approved by SCHILLER. Failure to do so may endanger life and/or invalidate the warranty. Your local representative stocks all the disposables and accessories available for the CARDIOVIT FT-1.
  • Page 82 Trolley Art. no.: Label Article 2.101126 Trolley X1 with console for FT-1 Trolley X1 incl. basket and mounting bracket for CARDIOVIT FT-1 2.101118 Drawer for trolleys X1, X2, X3, X4 Drawer Basket translucent for trolleys X1, X2, 2.101119 Transparent basket...
  • Page 83 Technical Data 11 CARDIOVIT FT-1 User Guide Device 11.1 11 Technical Data 11.1 Device Dimensions 230 x 160 x 33 mm, approx. 1.1 kg incl. thermal paper Display • Multi-touch backlit LCD screen for graphic and alphanumeric representation • Resolution: 1200 x 768 dots, 8 “...
  • Page 84 Technical Data 11.1 Device CARDIOVIT FT-1 Ambient conditions Operating temperature • 10 to 40 °C Relative humidity • 15 to 95% (non-condensing) Pressure during operation • 700 to 1060 hPa Storage temperature • 5 to 50 °C Transport temperature •...
  • Page 85 Technical Data 11 CARDIOVIT FT-1 User Guide 11.2 11.2 Patient input Fully floating and isolated, defibrillation protected (only with original SCHILLER pa- tient cable) Lead configurations • Standard 12 leads • Paediatric • Right precordials • Standard C4r • Left posterior •...
  • Page 86 Technical Data 11.3 Safety Standards CARDIOVIT FT-1 11.3 Safety Standards Safety standard IEC/EN 60601-1 IEC/EN 60601-2-25 IEC/EN 60601-1-2 Protection class Device as a system: Class I in accordance with IEC/EN 60601-1 Conformity/classification CE/IIa in accordance with directive 93/42/EEC Protection This device is not designed for outdoor use (IP 20) 11.4...
  • Page 87 Technical Data 11 CARDIOVIT FT-1 User Guide EMC information 11.5 11.5 EMC information The unit meets the Collateral Standards of Electromagnetic compatibility – Require- ments and tests IEC/EN 60601-1-2 the limits and methods of measurement of elec- tromagnetic disturbance characteristics of industrial, scientific and medical radio fre- quency equipment.
  • Page 88 Technical Data 11.5 EMC information CARDIOVIT FT-1 11.5.3 Emissions equipment and systems Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic environment guidance Portable and mobile communications equipment should be used no closer to any part of this device, including cable, than the recommended...
  • Page 89 Technical Data 11 CARDIOVIT FT-1 User Guide EMC information 11.5 11.5.4 Immunity to proximity fields from RF wireless communications equipment Test max. Modulation Distance d Immunity Band frequency Service power P level [V/m] [MHz] [MHz] Pulse Various radio services (TETRA...
  • Page 90 Technical Data 11.6 Revision history CARDIOVIT FT-1 11.5.5 Recommended separation distances For fixed installed HF-Transmitters (z.B Radio und TV transmitters) the following minimum dis- tance to the transmitter can be calculated as follows:. Maximum Power Output Separation distance according frequency of the transmitter...
  • Page 91 Index 12 CARDIOVIT FT-1 User Guide 12 Index Accessories and disposables Operation – Overview ....... Address Headquarters Options ................ Baseline filter Potential equalisation .............. Battery Power supply ........Battery life ........Capacity ........... Charging time ......... Resting ECG ........
  • Page 92 Index CARDIOVIT FT-1 Page 92...
  • Page 93 Appendix - Symbols 13 Appendix - Symbols This appendix lists all general symbols that may be present on the device, label and accessories. Not all of those symbols are necessarily present on your device. This appendix has its own article number, which is independent of the user guide's article number.
  • Page 94 Appendix - Symbols CE marking, affirms its conformity with European standards Regulatory Compliance Mark for the Australian standards The device is recyclable Symbol for the recognition of electrical and electronic equipment. Device must not be disposed of in the household waste. Symbol for the recognition of a battery.
  • Page 95 Appendix - Symbols Keep dry (store in a dry location) Keep away from sunlight (protect from direct sunlight) Fragile, handle with care Transport upwards (this way up) Do not use hooks EIP = electronic information product (does not contain any toxic and hazardous substances or elements above the maximum concentra- tion values (product can be recycled and re-used).
  • Page 96 Appendix - Symbols Blank page...