user manual
Contents
1. 05 4 1 Monitoring and electrode control 00 00000 2 28 05 4 2 Starting and ending a resting ECG 28 05 4 3 Editing options during the recording Drocess 29 05 4 4 Online ECG pormntng 0 000 29 06 Working with the evaluation 07 06 1 Opening the evaluaton aaaeeeaa ccc cece cence 30 06 2 Resting ECG evaluation 06 2 1 Screen pages within an evaluation 00 0 32 06 2 2 Comparing several evaluations from one patient 33 06 2 3 Note on navigation in the evaluation 000 33 06 2 4 Overview of evaluation pages 0 eee 34 06 3 Writing UDerenort 0000 e nee 42 06 4 Ending the evaluaton 00ers 43 Product Information 07 1 Technical data and system requirements aaaaaaaeaaaaanaaa 44 07 2 Manufacturer declaration on EMC Electromagnetic Compatibility according to IEC 60601 1 2 2007 000 0 46 07 3 EC Declaration of Conformity EE 49 07 4 Shutdown storage and transport 51 ART ne EE 51 07 6 Keyboard navigation and ehortcuts 0c 52 01 Introduction Ai SH 01 1 Symbols on the device Device conforms with the standards and guidelines of the EU Observe the Operating Manual Separate collection of electrical and electronic equipment do not dispose with domestic waste Protection class classification of medical electrical equipment according to IEC 60601 1 type BF defibrillation protected 01 2 Intended use seca CT 320 321 is2. 1060 hPa approx 160 85 25 mm L W H approx 300 g approx 1050 mm extremities approx 700 mm chest Safety class Il seca CT 320 Safety class Ill seca CT 321 Class lla z Type BF defibrillation protected not intracardiac l IEC 60601 1 IEC 60601 2 25 IEC 60601 2 51 Does not apply to Bluetooth devices System requirements Operating system PC Hardware amp ports Windows XP x64 Windows Vista x64 Windows 7 x64 Windows Server 2003 x64 Windows Server 2008 x64 Windows Server 2008 R2 Older versions are not supported The PC hardware must meet the minimum requirements of the operating system used seca cardio 150 requires additional RAM 256 MB Ensure that there is enough free hard disk space for the seca cardio 150 evaluations File size of the evaluations Resting ECG approx 200 KB approx 10 sec ECG DVD or CD ROM drive USB port 45 Product information 07 2 Manufacturer declaration on EMC Electromagnetic Compatibility according to IEC 60601 1 2 2007 Cable lengths of the patient leads and the USB cables Patient leads seca CT 320 321 approx 1050 mm amp 700 mm USB cable seca CT 320 321 approx 2500 mm Manufacturer s Declaration electromagnetic emissions The seca CT 320 321 ECG device is designed for operation in the electromagnetic environment stated below The customer or user of seca CT 320 321 should make sure that it is used in such an environme
3. a SE A TTF Zeg Comparison Q Measurement ECG Overview Options Print End d 2 Settings for the Print button Under Examination Resting ECG Settings General Workflow in the Workflow Default area you can define whether the extended print menu should be displayed when the Print button is clicked standard setting or whether printing should be conducted automatically according to the standard print settings option Default printout without any ad ditional settings being made The standard print setting for resting ECG can be found under Examination Resting ECG Settings Print Default Click on Save to apply your changes 34 Elements on the ECG start page Options for ECG display d Mouse functions for detailed viewing and measuring of the ECG signal Zoom Analysis Measure HR Calliper Mark Further evaluation pages gt Button for printing the evaluation 2 Button for closing the evaluation If the Measurement view is set as the start page the same operating and navigation elements can be found there r to The start page of the evaluation can be set under Examination Resting ECG Settings General Workflow in the Workflow Show evaluation area cardio Examination Resting ECG Mouse x Zoom A Main filter HR 5 Channel v 12 Channel a mm
4. 799 800 Ni gt i Confirm Comparison Measurement ECG Overview Options Print End Extended ECG start page with additional content In the Options menu select Report to show the additional contents Measured values Measurement HR curve and ST Trends can also be displayed instead of the report User seca pamm L Hate Mustermann 0 10 1960 51 Y cardio Examination Resting ECG Evaluation of 29 02 2012 14 44 v Mouse e Zoom M Be C E E DEIER e Eo e Be Ee E EE E E EE EE EE EE Eo ga Hn KEE EE REES SEET md yyy E Comparison Measurement ECG Options Gel Print End Select ECG Evaluation gt ECG Overview Overview of complete ECG as 2 channel ECG strip display 36 seca User seca m L Cardio Examination Resting ECG Evaluation of 29 02 2012 14 44 HR Channel 12 Channel a mm m ei 20 a mm s v 100 Mouse v Zoom a Main filter 00 01 00 02 00 03 Comparison Measurement ECG Options Ge Print End Select ECG evaluation mouse function Zoom double click on ECG Magnified display of a channel By double clicking on the ECG again all or the set channels are displayed again User seca w m x cardio Mouse functions Measure HR Resting ECG Examination HR 75 Channel 12 Channel al mmm 7 ID a mm s 7 50 a
5. Content of report dialogue Report module Hidden Enabled Comment Hidden A Enahlad Automatic report text End 42 06 3 Writing the report The report is opened by right clicking on the evaluation interface In the context menu select Report Enter your data in the white text field If the Add report option is active in the system set tings on page Examination Settings Resting ECG Diagnostic Report an automatic report is already present in the text field When you click on Confirm your input is saved and the evalu ation gets the Confirmed status see End dia logue In the event that your report text is not yet com plete but you want to save it nevertheless with out reaching Confirmed status reset the evalu ation Confirmed status in the End dialogue Text modules for writing reports On the page Examination Resting ECG Set tings Diagnostic Report text modules for writing a report can be created e A total of four groups with up to eight text modules can be stored The text modules are called in the Report dia logue using keyboard commands F5 to F12 A report module can be created from normal text as well as variables When using a report module in the Report dialogue the actual value from the evaluation is used instead of the vari able and is automatically inserted in the report text The structure of a variable
6. Mouse vy Measure HR a Main filter 00 01 00 02 00 03 00 04 00 05 00 06 fe Ss E Tk Comparison Measurement ECG Overview Options e Print End The selection list Mouse top right above the ECG contains besides Zoom the Analysis Measure HR Calliper and Mark mouse functions 6 Working with the evaluation Evaluation pages in the Measurement area seca cardi O User Examination Resting ECG Evaluation of 29 02 2012 14 44 HR 5 Channel 12 Channel a mmm ei 10 a mme el 50 Mouse el Caliper a Main filter I i aVR Vi v4 T r de ECH ae ENF be tu AS A HH jN ST 0 11 ST 0 12 ST 0 14 ST 0 14 2011 J 0 13 J 0 15 J 0 15 ij II aVL V2 V5 H HHNH HEE HN if y ST 0 14 ST 0 04 ST 0 03 ST 0 12 J 0 14 J 0 04 J 0 04 1 0 13 li f III aVF v3 ve E aban aft tease tase SHE SAH eS AH ae ST 0 03 ST 0 08 ST 0 08 ST 0 10 J 0 03 J 0 09 J 0 08 J 0 10 Comparison ECG Measurement Single Complex Options a Print End Select ECG Evaluation gt Measurement Averaged complexes of all channels In the Options menu you can display the ST values for the averaged complexes seca Under Examination Resting ECG Settings
7. eg GL 800 Irement ECG Overview Resting ECG mm s E KA SEN GEES Mustermann Franz v 50 a Cancel peri ee m PHHH IST SES EH 800 Options em 43 Product information 44A 07 1 Technical data and system requirements Technical data of seca CT 320 321 Frequency response Accuracy Time constant Sampling rate A D converter Input impedance Amplitude quantification CMRR Impedance measurement Defibrillation protection Voltage supply Energy consumption IT connection Software additional functions seca cardio 150 Operating conditions Transport and storage conditions Size Weight Patient leads Classification 0 05 500 Hz lt 1 5 3 2 sec 1 0ms 1000 Hz for extremities and chest wall 0 25ms 4000 Hz for pacemaker 24 bit gt 50 MQ 0 3 uV bit gt 70 dB At all electrode leads not N with automatic quality indication Electrical strength 5000 V Recovery time after defibrillation lt 10s USB devices USB cable BT devices Rechargeable lithium ion battery Max 2 5 watt during recording USB cable length 2 50 m or Bluetooth range up to 80 m depending on ambient conditions Power filter muscle filter AD filter Anti drift pacemaker recognition Temperature 10 C 40 C Air humidity 25 95 rH Air pressure 700 1060 hPa Temperature 20 C 45 C Air humidity 25 95 rH Air pressure 700
8. 12 kanaals PC ECG apparaat O aparelho de ECG para PC de 12 canais H ovokeun HKT 12 kavaAiwv H Y 12 kanalovy PC EKG p stroj 12 kanaliga EKG arvutiseade A 12 csatorn s sz m t g pes EKG k sz l k 12 kan lu EKG datoram piesledzama ierice 12 kanalu datora EKG ierice 12 kanatowy komputerowy aparat EKG 12 kanalna PC EKG naprava 12 kanalovy PC EKG pr stroj 12 Kanal PC EKG Cihaz seca 321 07 4 Shutdown storage and transport Putting out of operation and storage Clean and disinfect seca CT 320 321 and its components before putting it out of operation Make sure that the storage location is dust free dry and away from direct sunlight After a long period of non operation seca CT 320 321 may only be used again if a technical safety check has been carried out by your authorised seca dealer Transport Clean and disinfect seca CT 320 321 and its components before transport Use the original packaging for transport This is a sensitive piece of elec tronic equipment If the original packaging is not available pack the device in a way that it is protected against collision humidity and dust The device must comply with the operating conditions when it is put into operation again e g operating temperature see 07 1 Technical Data Ambient conditions for storage and transport Temperature 20 45 C Air humidity 25 95 rH Air pressure 700 1060 hPa 07 5 Disposal The device and all its compo
9. Chest wall standard according to Wilson V1 C1 red V2 C2 yellow v3 C3 green V4 C4 brown v5 C5 back v6 C6 purple Extremities R red L yellow F green N black 4 intercostal space at the right sternal border 4 Intercostal space at the left sternal border On the left on the 5th rib between C2 and C4 5 Intercostal space on the left midclavicular line On the left on the anterior axillary line on the level of C4 On the left on the midaxillary on the level of C4 Right arm Left arm Left leg Right leg 25 05 Carrying out an examination User Patient Examination Resting ECG 2 User Patient Examination New Resting ECG Show Evaluation Show Comparison Assign Evaluation Settings 26 05 3 First work steps in seca cardio 150 Note on the procedure The steps necessary to record and evaluate ECG data in seca cardio 150 are shown without a surgery IT system or HIS connection Program start calling the ECG Start seca cardio 150 and log on with your user name and password if required Click on Examination Resting ECG New Resting ECG e Selecting the patient Select a patient for the examination Enter the patient s name or the first letter of their name into the input fields of the patient search screen EN Select the patient from the list below the input fields and confirm your selection by clicking the S
10. Diagnostic Calculation can be set if the QTc duration is to be calculated according User to Bazett preset or Fridericia Save your input cardio Examination Resting ECG Evaluation of 29 02 2012 14 44 Heart Rate Axis Position Duration ms Average value 75 QRS axis 53 QRS 101 Average R R ms 800 P Axis 32 P 95 T Axis 40 PQ 157 QT 363 QTc 406 104 QTc disp 71 Amplitude mvV Duration ms P Q R S R Ss T J ST Q R S R S I 0 13 0 06 1 37 0 27 0 27 0 11 0 11 I 19 59 23 zen II 0 14 0 08 2 28 0 52 bie bie 0 37 0 14 0 14 II 16 59 26 III 0 03 1 02 0 30 ees San 0 11 0 03 0 03 III 12 59 30 SS aVR 0 13 0 07 1 82 0 38 0 32 0 13 0 12 aVR 17 59 25 aVL 0 07 0 10 0 32 0 07 0 10 0 04 0 04 aVL 36 50 15 aVF 0 08 0 05 1 64 0 41 0 23 0 09 0 08 aVF 15 58 28 vi 0 15 52s 0 08 2 09 0 44 0 37 0 15 0 14 Vi beet 17 59 25 V2 0 54 0 13 0 09 0 04 0 03 V2 74 27 Ke V3 0 09 0 04 1 03 0 21 bie 0 20 0 08 0 08 V3 18 59 24 V4 0 15 0 08 2 06 0 43 0 36 0 15 0 14 V4 17 58 26 v5 0 13 0 06 1 72 0 35 0 31 0 13 0 12 v5 17 59 25 V6 0 41 0 05 1 39 0 28 0 25 0 10 0 10 V6 17 59 25 zen Comparison ECG All Complexes Single Complex Options Print End Select ECG Evaluation gt Measurement gt Measurement Tabular display of all measure
11. according to previously defined print settings for analysed ECG 29 06 Working with the evaluation Reference between End dialogue and search screen In order to make proper use of the search screen the correct examinati on status must be defined in the End dialogue when closing an examination Example An examination can only be found in the search screen with the preference confirmed No when the evalua tion status Confirmed is NOT selected in the End dialogue 30 06 1 Opening the evaluation seca cardio 150 offers different options to open an evaluation e g via the evaluation search or the main menu of the respective examination Opening an evaluation via the evaluation search Click with the right mouse button on the Patient button This opens the evaluation search In the Examinations area enter what type of evaluation you are searching for e g Resting ECG In the Properties area you can define more search criteria If you set the confirmed preference to No you will receive a list of all the evaluations which have not yet been confirmed a type of to do list To start the search click on Search Evaluation or activate Search auto matically option This option triggers an automatic search in your data base whenever the search criteria are changed The right part of the screen displays a list of all the evaluations which cor respond to the activated search criteria To
12. differ from the diagonal of the diagram 40 Comparison pages comparison of different evaluations User cardio Examination Channel v 12 Channel a mmf m sei 10 a HF 29 02 2012 14 43 73 00 01 II f A A III J inname a a Eech Rei aVR Se NS Se et Evaluation ECG Measurement Report Resting ECG mm s v 50 HF 29 02 2012 14 44 US EX 00 01 Print The Comparison button is deactivated light grey if no End further evaluations of the patient are available Select ECG Evaluation gt Comparison gt ECG The current evaluation is compared with a further evaluation the selection lists above the ECG offer further evaluations for comparison With the Report button the reports can be directly compared to each other User cardio Resting ECG Mustermann Franz Evaluation of 29 02 2012 14 44 v Examination Channel Limb a mmf m sei 10 a mm s ei 50 a 29 02 2012 14 43 v 29 02 2012 14 44 29 02 2012 15 47 29 02 2012 16 26 v HOH E ANHA Er AEN ca kr IO Wd kr HR 75 QT 363 HR 75 QT 363 HR 75 QT 363 HR 75 QT 363 PQ 157 QTcB 406 PQ 157 QTcB 406 PQ 157 QTcB 406 PQ 157 QTcB 406 QRS 10
13. electromagnetic sources in the immediate vicinity of the seca CT 320 321 may result in recording errors e g HF electrosurgical devices mobile phones induction furnaces The device must not be operated simultaneously with HF surgical equipment The device must be protected against the ingress of moisture dust or dirt and also against mechanical impacts such as damage due to dropping or transit damage Safety instructions Patient safety Safety distances of devices to the patient Without medical protective devices for example medical protector the PC and all the non medical devices connected to the system e g the monitor and printer must be set up and used at a distance of at least 1 5 m to the patient unit see the orange area in the figure as leakage currents can occur When coupled with other devices make sure that there is no danger due to the accumulation of leakage currents During routine maintenance work to non medical devices connected to the system the patient must not be touched risk of electric shock Make sure that the electrode contacts do not come into contact with other conductive parts All results of automatic analysis and the resulting unconfirmed reports pro duced by the system must be considered as suggestions only For diag nosis and therapy purposes it is essential that the results are checked and assessed by a qualified physician seca CT 321 Bluetooth rechargeable lithium
14. for input and output wires 1 kV push pull voltage 2 kV push push voltage lt 5 Ur for 0 5 period gt 95 drop 40 Ur for 5 periods 60 drop 70 Ur for 25 periods 30 drop lt 5 Ur for 5s gt 95 drop 3 A m Compliance Level 6 kV contact discharge 8 kV air discharge Not applicable Not applicable Not applicable 3 A m Electromagnetic Environment Guidelines Floors should be made of wood or concrete or be equipped with ceramic tiles If the floor is provided with synthetic material the relative air humidity must be at least 30 The quality of the supply voltage should correspond to the one of a typical business or Clinical environment The quality of the supply voltage should correspond to the one of a typical business or Clinical environment The quality of the supply voltage should corres pond to the one of a typical business or clinical environment If the user of seca CT 320 321 requires continued function even if interruptions in the energy supply occur it is recommended to supply seca CT 320 321 from an interruption free power supply Magnetic fields with net frequency should correspond to the typical values as they can be found in the business and clinical environment COMMENT U is the net AC voltage before applying the test levels 46 Manufacturer s Declaration electromagnetic emissions The seca CT 320 321 ECG device is designed for operation in
15. m e 10 a mm s ei 50 a print op 01 00 02 00 03 Q Export I LC Blood Pressure II il Qevents urv III d F Tou Delete ECG aVR So Reanalysis aVL KEEN Q auto Report aVF OS Filter C ADO Anti Drift vi H TT no filter V2 V3 V4 V5 Display Om Pacemaker 800 O O anti aliasing V 799 Options Comparison Measurement ECG Overview Print m a Content in the Options menu So Oe 00060 G e e Print menu for temporary changes to the print settings Button for exporting the evaluation e g Excel PDF e mail DICOM Manual blood pressure input F9 key Trend graphic for displaying events in the ECG e g VPB Tables and graphics for Heart Rate Variability e g SDNN5 ANN5 pNN5O rMSSD PSD Deletion of ECG outside the marked sections New analysis of ECG signal for resetting manual changes in the ECG additions to the report remain Automatic creation of a new report after manual changes have been made in the ECG recording Anti drift filter for compensating fluctuations in the zero line Deactivation of all filters display of raw data Fade in and fade out of additional content in the right half of the screen e g HR curve and ST trend averaged complexes and report or measurement table Fade in and out of pacemaker spikes Graphic flatt
16. the electromagnetic environment stated below The customer or user of seca CT 320 321 should make sure that it is used in such an environment Immunity Tests IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines Portable and mobile radio sets should not be used at a closer distance to the device includ ing the leads than the recommended protective distance which is determined according to the equation of transmitting frequency Recommended protective distance Conducted HF transients 3 Veffective value U4 V d 3 5 U4 VP IEC 61000 4 6 d 3 5 E VP 80 MHz to 800 MHz d 7 E VP 800 MHz to 2 5 GHz Radiated HF transients 3 V m 10 V m with P as the nominal power of the transmitter in according to 80 MHz to 2 5 GHz watt W according to the indications of the trans mitter manufacturer and d as the recommended IEC 61000 4 3 protective distance in meters m According to an examination on site a the field strength of stationary radio transmitters should be inferior to the compliance level b with regard to all frequencies In the vicinity of devices carrying the following symbol interferences are possible Dol COMMENT 1 With 80 Hz and 800 MHz the higher frequency range is valid COMMENT 2 These guidelines may not apply in every case The propagation of electromagnetic variables is influ enced by absorptions and reflections of buildings objects and people a The field strength of stationary
17. the interface selection list Click on the Save button at bottom left System Database Export System Connection Import 4 gt Device 1 i s medical band custo connect Email dl Device setting for the workstation Device a ECG a Interface Autom BT COM search v seca ct 32x Test Vd Then select Examination Settings Connection i s medical band Acti vate the Microsoft Stack option click on Save and then on Open to the left of Microsoft Stack The message Interface is enabled appears Switch on seca CT 321 and click on the Search button The i s medi cal band search dialogue appears Restart the search if the device is not found repeat the process several times if necessary Select the desired device and click on Confirm The previously selected device is displayed in the table on the i s medical band page Save your input User seca om xX seca Patient Leesch CES Examination z System z Database Export System Connection Import 41 gt Device i s medical band custo connect Email jm gt Interface ena Status DLL Version HW Version BT Version SDK Version Kensigton MSI Widcomm jE 4 0 9 Microsoft Stack E end Interface is enabled 4 4 0 0 6 1 7600 1638 6 1 7600 1638 6 1 7600 16385 Connected Devices Settings Name Serial number Interface Workstation
18. 0 and Windows Vista To ensure the smooth installation of the supplied Bluetooth USB sticks in WINDOWS XP the full installation of the current seca cardio 150 version not the update must be carried out from the CD even if another version of seca cardio 150 is already installed Otherwise the operating system will need to be accessed manually The seca cardio 150 installation must be completed before connecting the Bluetooth USB stick to the PC For WINDOWS 7 no subsequent installation of seca cardio 150 or additional access is required as the Bluetooth USB stick is already known in the operating system Overview Bluetooth installation 4 Install the Bluetooth interface in seca cardio 150 5 Allocate the device for examination see 03 4 3 Device settings for resting ECG A description of work steps 1 to 3 can be found in the Quick guide for in stalling Bluetooth devices in seca cardio 150 This Quick Guide is located on your seca cardio 150 CD IMPORTANT Before continuing with the configuration of the Bluetooth interface in seca cardio 150 make sure that the Bluetooth USB stick is correctly connected and the power supply to the ECG device is guaranteed 19 Description of device initial operation 20 Installing the BT interface in seca cardio 150 Start seca cardio 150 Select Examination Settings Connection Device Select ECG seca CT 32x in the device selection list and Autom BT COM search em
19. 1 QTcF 391 QRS 101 QTcF 391 QRS 101 QTcF 391 QRS 104 QTcF 391 Axis 53 Axis 53 a Axis 53 T SH tt bin El KE Ke H Wd He Evaluation ECG e E HH ees SE Measurement Report So TIP additional display of measured values The display of measured values SHR in the averaged complexes can be activated in the settings This setting is available under L Examination Resting ECG PRH m Settings General ECG Print End In the Default settings for ECG area select the AVG complex comparison with measured Values option Select ECG evaluation gt Comparison gt Measurement Comparison of averaged complexes of several evaluations 41 Working with the evaluation d l LL mee E Tx 8 Meet ooo O II ial Resting ECG for Patient Mustermann Franz H Normal Sinus Rhythm Normal Type possible left ventricular Hypertrophy ST Lowering inanterolateral and inferolateral Leads Patient F5 Examination F9 A F6 Name F10 F amiji Ez Eili F8 F12 Hide Modules 800 800 800 800 User Patient Examination I Resting ECG v Print General Expo Report Calculation Personal report modules Category MA 1 a O Name Patient Function key x F6 a 5 Name Name Report module P_NAME P_VNAME Predefined report modules Shortcuts for export val Export values IW include units
20. G Evaluation of 29 02 2012 16 26 v Diagram 1 Histogram a kA Diagram 2 Table sA Number lof stages 7 Total 350 300 250 200 150 100 50 L L 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 ms Complete evaluation Complete evaluation D Total Number of RR total 454 Beats Number of RR total 454 Beats Number of RR analysed 452 Beats Number of RR analysed 452 Beats Averaged value 799 81 ms Averaged value 799 81 ms SDNN 0 40 ms SDNN 0 40 ms SDANN 0 00 ms SDANN 0 00 ms ASDNN 0 40 ms ASDNN 0 40 ms PNN50 0 00 PNN5O 0 00 Din RMSSD 0 62 ms RMSSD 0 62 ms ee HF e 0 01 a Ee HF 0 01 E Scatter Diagram Measurement ECG End Select ECG evaluation gt Options gt HRV Heart Rate Variability Using the Diagram 1 and Diagram 2 menus additional graphics for Heart Rate Variability can be opened cardio Examination Resting ECG Evaluation of 29 02 2012 16 26 v RR n 1 RR n 1 1200 1200 1000 j i 1000 800 oy s 800 600 600 400 400 200 200 200 400 600 800 1000 1200 RR ni 200 400 600 800 1000 1200 RR n Period D Total Period Total Number of RR total 454 Beats Number of RR total 454 Beats Number of RR analysed 452 Beats Number of RR analysed 452 L Beats HRY Trend Measurement ECG End Select ECG evaluation gt Options gt HRV gt Scatter diagram The more regular the heart rate the fewer the points which
21. a 12 channel PC ECG device which is designed for recording analysing and evaluating ECG recordings in medical practices and hospitals seca CT 320 321 is perfectly safe for patients with a pacemaker The ECG recording is not affected by pacemaker pulses seca CT 320 321 is not suitable for intracardiac use 01 3 Symbols used in this manual This Operating Manual uses the following symbols to indicate important information comments and tips ACTIONS THAT ARE PROHIBITED or not allowed under any circumstances WARNING used to indicate situations which if not avoided may result in personal injury and property damage NOTE provides important information which must be observed TIP contains practical information to assist you with your work Words highlighted in colour indicate buttons or click paths for the corresponding program point e g Examination Resting ECG Words highlighted 2 Safety instructions vvvv 02 1 General notes Strict compliance with the safety instructions protects against personal in jury and property damage during device operation This Operating Manual is designed to accompany the product and must be kept ready to hand close to the device As either the operator or user of this device you should have read and understood this Operating Manual in particular the safety instructions Laws and regulations applicable to the product This system is designed in accordance with Medical Device Directi
22. age the device Observe the manufacturer s specifications e g regarding dosage and contact times The device must never be immersed in liquids or cleaned with too much water The device must not be connected to a power source during cleaning and disinfection Surface cleaning Make sure that the exterior of the device is always aesthetic and clean Wipe the device using a damp cleaning cloth and a mild acid free clean ing agent or a suitable disinfectant Cleaning agents and disinfectants must not be sprayed directly on or into the device 04 2 Recommended cleaning agents and disinfectants Disinfectants All alcohol based disinfectants e g propanol ethanol approved for medical use 23 05 Carrying out an examination 24 05 1 Preparing the patient examination procedure Make sure that the ECG device is connected to the PC and the power supply to the device is guaranteed Check that your patient is lying comfortably and is not cold Shave clean and dry the electrode application points thoroughly Place the electrodes on the patient Connect the patient leads to the electrodes Start seca cardio 150 and click on Examination Resting ECG New Resting ECG select the patient for the examination and start the recording a precise description can be found in Chapter 05 2 The patient should not move or talk during the recording process 05 2 Electrode application d Le S
23. creen appears In this screen select the patient whose evaluation you want to open Enter the patient s name or the first letter of their name into the input fields of the patient search screen Select the patient from the list below the input fields and confirm your selection by clicking the Select Patient button You can also select the patient by double clicking on the corresponding name A list containing all the evaluations of the patient is then displayed Select the desired evaluation from the list and open it by means of a double click or via the Show Evaluation button 31 Working with the evaluation 06 2 Resting ECG evaluation 06 2 1 Screen pages within an evaluation The ECG evaluation is divided into two main areas ECG and Measure ment the ECG page is preset as the start page of the evaluation From the subpages of the two areas the main page of the other area can be accessed at any time Zoom Magnified display of a channel ECG overview Complete ECG mouse function zoom double click on ECG as 2 channel ECG strip display Start page ECG Complete ECG e g 12 channel display 1 Note on setting the start page The start page of the evaluation can be set under Examination Resting ECG Settings General Workflow in the Workflow show evaluation area Start page Measurement Averaged complexes of all channels Single complex Measurement Tabular display Ave
24. d components may only be connected to the PC after seca cardio 150 has been installed The required device drivers are in stalled using the seca cardio 150 standard setup or via targeted selection during the seca cardio 150 setup 03 4 1 ECG device with USB port Connecting the USB cable to the PC Connect the USB cable of the ECG device to the PC Power is supplied via the USB cable The Windows driver installation for the new hardware starts automatically Select the Find driver automatically option Use the Next and Finish buttons to control the installation process Setting up the interface in seca cardio 150 Start seca cardio 150 Select Examination Settings Connection Device en Select ECG seca CT 32x in the device selection list select USB in the interface selection list Click on the Save button at bottom left Selecting ECG device for resting ECG See section 03 4 3 Selecting ECG device for resting ECG seca User seca m X Patient caraio Examination dy System x Database Export System Connection Import 4 gt Device 1 i s medical band custo connect Email daada Device setting for the workstation Device ECG ZS seca ct 32x 2 Interface USB v Test 03 4 2 ECG device with Bluetooth connection Note on Bluetooth USB stick The supplied Bluetooth USB stick is supported by Windows XP and Windows 7 but not by Windows 200
25. d values 38 KE User seca cardio Resting ECG Examination HR Zb Channel ei 12 Channel a mm m ei 30 a mm s ei 100 a Mouse v Mark a 900 9 Se H H a Using the All button a all averaged complexes will e be shown on top of each other Vs highlighted light grey eg KR a gmg gnt grey aVL aVF Vi v2 AN yl T 4 Rass __ mv V3 it V4 V5 V6 All a a A yp E an a gt gt Auto J 60 302 Q R Ss R SI d ST Vector QRS P Li ms 17 59 25 mY 0 13 0 12 53 53 32 40 Comparison ECG Measurement All Complexes Options os Print End Select ECG Evaluation gt Measurement gt Single Complex Averaged complex of a channel and vector loop Further evaluation pages from the Options menu User seca Zale L Daten Mustermann J 10 1960 51 Y cardio Examination Trend v VPB OI a 150 3 100 2 i i ii TT 00 10 00 20 00 30 00 40 00 50 01 00 01 10 min HR 75 hannels ei V2 a el V4 al el V6 a mm m ei 10 a mm s 7 50 a Main filter 00 24 00 25 00 26 00 27 00 28 00 29 Measurement ECG Mark Delete Print End Select ECG evaluation gt Options gt Events If the red cursor in the top graphic is moved over an event mark orange line the corresponding ECG section will be displayed 39 Working with the evaluation seca User seca l X cardio Examination Resting EC
26. ecisely timed However the pulse width of the pacemaker is not calculated with the pacemaker detection in seca cardio 150 The device is not suitable for binding pacemaker checks In case of doubt use the device approved by the pacemaker manufacturer see the patient s pacemaker record 2 Safety instructions 10 we System and data security The device must only be used with the supplied seca software seca cardio 150 As the operator you are responsible for ensuring regular data backups patient databases evaluations etc and system backups We recom mend that you backup the data at the latest before new installations up dates and far reaching system configurations seca cardio 150 new installations updates and system configurations may only be performed by your authorised seca dealer Only change data generated in seca cardio 150 within seca cardio 150 itself and not in your EPR system Electronic Patient Record or your hos pital information system HIS seca does not accept any responsibility for any changes to data in your EPR system or your HIS which were made after the export from seca cardio 150 To ensure the safe operation of seca cardio 150 deactivate the screen saver and energy management options on your PC Set up your operating system in such a way to prevent the PC from being switched off either accidentally or automatically during the examination standby mode idle mode 02 4 Informatio
27. elect Patient o button You can also select the patient by double clicking on the correspond ing name New patient If the patient is not in your database click on the New patient button Enter the patient data The fields marked with an asterisk are manda tory Save the details to enter the patient in your database Mustermann All patients r l 10 10 1960 27 05 Carrying out an examination 05 4 Recording resting ECG 05 4 1 Monitoring and electrode control The patients ECG signal will be shown on the display but not recorded monitoring Work steps before the start Choose the type of lead standard left right Nehb Cabrera Check if all electrodes are attached optimally If there are red lines on the screen the contact between the skin and electrode s is insuf ficient and the corresponding electrodes need to be reattached For ECG devices with USB connection the Electrodes button provides you with a graphic representation of the signal quality of all electrodes Set the required filters Options menu Cl User seca The preset standard procedures seca aaa for automatic ECG and manual cardio a ___ IU Examination Resting ECG v recordings are described in this chapter S HR 75 Channel ml 12 Channel al mm mvV ial 10 Wil mm s ial 50 al Lead m Standard O These procedures can
28. ening of ECG signal 3 Note on Options menu The scope and content of the Options menu changes based on which page of the evaluation you are currently on e g on the Measurement page in the Options menu you can activate the display of ST values and set which marks should be displayed in the averaged complexes 4 Note on Heart Rate Variability For the heart rate variability to be displayed at least five minutes of ECG need to be recorded 35 06 Working with the evaluation Evaluation pages in the ECG area User seca d Lx Patient Mustermann Franz 10 10 1360 ol cardio Examination Resting ECG Evaluation of 29 02 2012 16 26 v HR 5 Channel ei 12 Channel a mm m ei 10 a mm s ei 50 a Mouse e Zoom a Main filter mm m sei 10 a mm s v 100 00 04 00 02 00 03 oojoaf Tt Da m GW IS H e Ss eg gt a aVR Cp ei H DS ESE v5 aVL fh d d V6 _ All a AA A EN D 8 E DEE EC Kc FC ops P PQ or Qr Axis E A r HNA EEA HH A PRE a MY E 101 95 157 363 406 53 v2 y Report Normal Sinus Rhythm o M Go En Ee maaca Normal Type possible left ventricular Hypertrophy ST Lowering inanterolateral and inferolateral V4 SS HHN HE aN ji HEAR See SE Eege V5 fea HE NEE REY oe ER HEEN V6 Vi CT PEAN ke le y 800 800 800
29. for a resting ECG see Examination 05 4 2 Starting and ending a resting ECG Resting ECG Settings Print Default Printout area Automatic ECG Auto Start button 2 Settings for Click on Auto Start to start the automatic recording The standard set manual recordings f f Under Examination ting for the duration of automatic recording is ten seconds After the ten Resting ECG Settings General f Workflow in the Workflowarea Seconds have elapsed the recording is automatically ended saved meas in the first block After record ing the procedures after the ured and printed out recording can be set Click on Save to apply changes Manual recording Start button or Enter key If you want to perform a recording without a time limitation e g because RE of suspected irregularities you have to activate the recording with Start At least 10 seconds of the ECG Click on End to close the recording Click on Confirm in the End dia signal must be recorded A recording cannot be ended logue to ensure that the recording is saved measured and displayed as before this time has elapsed Se an evaluation 28 05 4 3 Editing options during the recording process Marking ECG sections Automatic marking By clicking on the Mark button the last six seconds are automatically marked A dialogue appears for specifying saving and printing the marked part Manual marking By clicking o
30. ght in the Mouse menu By dragging the red cursor in the ECG you can mark ECG sections using the Mark mouse function A dialogue appears for specifying printing and saving the marked part With Continue you return to the normal view of the recording 05 4 4 Online ECG printing Click on Print A screen page of the ECG signal is printed from the point of clicking The printout contains 4 5 to 9 sec of the ECG signal depend ing on the display speed Tip Keyboard shortcut Change amplitude mm mV 3 TIP Text modules for specifying marked parts Use If a part is marked during the recording the Marking dialogue appears The marked parts will be automatically specified by pressing a previ ously configured text module button or the corresponding key e g F5 Configuring text modules Under Examination Rest ing ECG Settings General Marking the text modules can be configured for specify ing marked parts A name is assigned to the text module in the Name field This name later appears on the button for calling the text module In the Text module field enter the text which will later be used to specify the marked parts Save your input 4 Note on online printing Under Examination Resting ECG Settings Print Default you can define in the Online ECG printout area whether the ECG should be printed as it appears on the monitor or if online printing should be carried out
31. hancements repairs and other work to the device or system have been performed by an authorised seca dealer or seca and the Operating Manual has been observed during de vice operation 02 7 Warranty Our product philosophy is committed to providing you with faultless pro ducts which meet your expectations Should you have reason to complain we aim to rectify any defects immediately or provide a replacement deli very This does not include damage that can be attributed to usual wear and tear improper use unauthorised modification of parts and the use of violent force After the expiration of the warranty period only use original spare parts and accessories from seca This is the only way to ensure the safe and trouble free operation of your device Warranty periods seca CIT 32032 EE 12 months ECG electrodes ER without warranty 13 03 Description of device initial operation 03 1 Part names components for ECG recording IN O Medical Bluetooth seca CT 321 with Bluetooth connectivity Rechargeable lithium ion battery Charger with power supply unit Bluetooth USB stick Note about the electrodes For optimal results we recommend using high quality ECG electrodes and ECG preparation cream to prepare the electrode application points 14 seca CT 320 321 Length of patient cables CZE DEEN approx 1050 mm approx 700 mm 15 Description of device initial operation 03 2 Operation of seca CT 321 with Blue
32. i l i i V be changed in the ZS SE R DE H f k GH a ES SE SES seca cardio 150 settings ie A eS AN HEE DT E a EHEH AEAN HEEN i i i fy m Sit j HH SE ES H HHH i EHHH EEEE HEH j ere HHI 1 Settings for Ht d d E ea mae ue Auto start recordings aVR i NEEN EES SU SE af or automatic ECG 3 i HEE In seca cardio 150 select BEE G eren dn di A oe E S E Examination Resting ECG l Settings Gener al Workflow SNE J A EE a ee Blood Pressure ow EE The recording duration and El EE EE ar FEH N pocoo HEs HEHEHEH procedures after the recording E o H EE ll oo TN can be set in the oE k Automatic ECG area i E E EE Click on Save to apply changes P Spe r Main filt Print settings for EE ste S E automatic ECG The contents for a printout after me tA H H i i i EE an automatic ECG recording de z can be compiled at EA EE Lo EE DH a7 RRRRRRESRR RSR REES REES SS LINH HH LH t Examination Resting ECG E HEH SC rH HEE E Trend Qrs is es S ttings Print Automatic in the e a SE C QRS signal SC eee Printout Automatic ECG area ECG Moni oring ease cnec signal ain filter Start 2 Auto Start 0 Pause Electrodes Options Q Print End This setting is only required if the automatic ECG print pages should contain content other than the data already KE in the standard print settings
33. icians etc For users outside the Federal Republic of Germany the respective nati onal accident prevention measures regulations and requirements apply 02 3 Safety installations and safe working seca CT 320 321 must only be used in a technically perfect condition Regularly carry out a visual inspection of the device and the cables in particular the patient cable Only use accessories approved by seca The device is protected against defibrillation only in connection with the manufacturer s patient cable In the event of defibrillation take note of the manufacturers instructions regarding the safe and proper use of the defibrillator Defibrillation has an interfering effect on the ECG recording seca CT 320 321 has a recovery time of less than ten seconds Installation of the system Portable socket outlets must not be laid on the ground Portable multiple socket outlets which are supplied with the system are to be used only for supplying devices which are part of the system Additional portable multiple socket outlets lines and other equipment which are not part of the system must not be connected to the system When using a multiple socket outlet the maximum permitted load is 3200 VA Slots which are not used in the delivered system portable multiple socket outlets must be provided with covers Ambient conditions handling seca CT 320 321 is not suitable for use in rooms or areas with a risk of explosion Strong
34. ion battery Remove the rechargeable battery if the device is not used for a long period Only use the supplied charger to charge the rechargeable battery Do not expose the rechargeable battery to extreme temperatures fire and moisture Do not immerse the rechargeable battery in liquids Observe the operating and storage conditions Do not subject the rechargeable battery to strong shocks or drop it The recharge able battery must not be disassembled modified or short circuited Hygiene For cleaning and disinfection observe the legal requirements and the current state of technology Use only cleaning agents and disinfectants approved by seca for cleaning and disinfection Clean and disinfect your device in accordance with the specifications given in chapter 04 Hygiene Display of the ECG signal in seca cardio 150 lf electrodes become detached from the patient during an ECG recording or the electrode contact is too weak a red signal line will be displayed on the corresponding ECG channel in seca cardio 150 Below the ECG recording a hint will appear in red letters indicating which electrodes are concerned Reattach them The appearance of red signal lines in seca cardio 150 does not indicate that the patient has an asystole seca cardio 150 provides pacemaker detection Here the pacemaker pulse from the ECG signal in two channels at least is detected and then projected into the ECG recording as an artificial spike pr
35. is VARIABLE e g Heart Rate Resting HF_R The Short cuts for export values button provides you with a list containing all the available variables If the report modules should be shown in the Report dialogue make sure that the Enable option is activated Alternatively the text mod ules can be shown in the Report dialogue via the Show modules button There is also the option of entering a text or a user defined report text also as normal text and variables which will be automatically shown in each report The predefined text can be changed later in the Report dialogue Save your input 06 4 Ending the evaluation The evaluation is closed with the End button The end dialogue is opened The status of an examination can be changed berech Confirmed A confirmed evaluation can be reset to Not con firmed by deselecting the Confirmed option e g if reporting has not been completed Printed Indicates if the evaluation has been printed Locked After reporting has been completed by an au thorised person set the status of the evaluation to Locked After that the evaluation can still be viewed but no longer changed Click on Confirm to close the examination User annel LE j Examination 00 02 End a mm mv v 10 N 1 Status of Evaluation On confirmed On printed On locked Confirm Beer 800 S
36. n on EMC Electromagnetic Compatibility The use of other accessories other converters and leads than those in dicated except for the converters and leads sold by seca as spare parts for inner components can lead to increased electromagnetic emissions or to a reduced electromagnetic immunity of the system For connecting the device to other equipment only specially screened cables supplied by seca must be used 11 2 Safety instructions 12 02 5 Maintenance regular safety checks The operator is responsible for maintenance The operator must ensure that the device is checked for proper condition at the latest every two years The functionality and the state of accessories must be checked at regular intervals If damaged and or heavily soiled the complete system must no longer be used All interventions in the existing system changes to system components enhancements as well as internal cleaning and repairs may only be per formed by your authorised seca dealer or seca Technical safety check After each system or device repair modification or conversion a technical safety check must be performed by your authorised seca dealer 02 6 Disclaimer The manufacturer is not responsible for improper operation failure to com ply with the safety instructions and non observation of specifications due to negligence seca will only assume responsibility for the safety and reliability of the seca CT 320 321 when all changes en
37. n the Start Mark button you can determine the length of the marking yourself The marking continues to run until you click on the Stop Mark button A dialogue appears for specifying printing and saving the marked part E pE E ieee mmm O mme H ae F Marking bt A S f 3 carotid artery measurement Nise j 00 12 d F5 Carotid F9 E oat Ap F5 Carotid ss besch F6 Arrythmia F10 ER SE H F6 Arrythmia F7 Fii j F7 H n TEL EO EEEEEECIE EE A F8 F12 EE F8 m E Printout ek Printout H 12 Channel H F H 12 Channel bo Net Overview S EEHEHE Overview d ET Channeli vi mm s i0 Channel i i i Channel2 ei V3 4 mmfmvV 3 a i Channel2 gt V3 kasel Loss ess HH panen EE Channel 3 V5 a jamar ansa Channel 3 el V5 a St re Print Confirm Cancel See Sn Bay See Enp Print es ay 2 i o kr kr FCI Dn 300 800 800 800 799 800 800 ECG 00 22 6 Pause O Mark Start Mark 2 Options E Orrin Continue 8J Viewing and marking ECG measuring HF during a pause Clicking on Pause will stop the screen display The recording continues to run and is displayed on one channel fig right The scroll bar can be used to scroll through the current recording The tools Mark Measure HR and Calliper can be found at the top ri
38. nents must be disposed of in a proper manner in compliance with applicable regulations that is in accordance with the valid laws governing electrical and electronic waste The device must not be disposed of as normal domestic waste The original packaging is recyclable cardboard waste paper d 44 51 Product information cardio Seca cardio New Resting ECG Show Evaluation 07 6 Keyboard navigation and shortcuts Use the quick links in the main navigation the keyboard navigation and the keyboard shortcuts to enable fast and convenient working Quick links in the main navigation Examination LEFT CLICK RIGHT CLICK User master data Evaluation search Call last patient Call last patient Examination main menu Evaluation last displayed User a klen Mustermann Franz O 10 1960 51 Resting ECG OC Examination LEFT CLICK RIGHT CLICK User master data Al the patient s evaluations Patient master data Evaluation last displayed Examination main menu of this examination Keyboard navigation When you press the Alt key the initial letter of all the buttons on a screen page is underlined Pressing an initial letter in combination with the Alt key triggers the corresponding button User Seca ala E Examination Resting ECG Show Comparison Assign Evaluation Settings 52 Generally accepted keyboard sh
39. nsmitter W d 3 5 U1 VP d 3 5 E1 VP d 7 E1 VP 0 01 0 04 0 04 0 08 0 1 0 11 0 11 O22 1 0 35 0 35 0 70 10 111 1 11 2 22 100 3 50 3 50 7 00 For transmitters whose maximum nominal power is not indicated in the above table the recommen ded protective distance d can be determined in meters m using the equation affiliated with the corresponding column P is the maximum nominal power of the transmitter in watt W according to the indications of the manufacturer of the transmitter COMMENT 1 With 80 MHz and 800 MHz the higher frequency range is valid COMMENT 2 These guidelines may not apply in every case The propagation of electromagnetic variables is influ enced by absorptions and reflections of buildings objects and people 48 07 3 EC Declaration of Conformity Konformitatserklarung declaration of conformity Certificat de conformit Dichiarazione di conformit Declarati n de conformidad Overensstemmelsesattest F rs kran om verensst mmelse Konformitetserkl ring vaatimuksenmukaisuusvakuutus Verklaring van overeenkomst Declara o de conformidade AnAwon uuBaAT TNTAG Prohl en o shod Vastavusdeklaratsioon Megfelel s gi nyilatkozat Atitikties patvirtinimas Atbilstibas apliecin jums O wiadczenie o zgodno ci Izjava o skladnosti Vyhl senie o zhode Onay belgesi Das 12 Kanal PC EKG Ger t The 12 channel PC ECG L appareil ECG 12 canaux connectable un ordinateur L elettrocardiograf
40. nt Emission Measurements Compliance Electromagnetic Environment Guidelines HF emissions according to CISPR11 Group 1 seca CT 320 321 uses HF energy only for its internal function Its level of HF emission is there fore very low and is unlikely to be sufficient to interfere with other electronic devices HF emissions according to CISPR11 Class B seca CT 320 321 is suitable for use in all estab lishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonics according to IEC61000 3 2 Not applicable Voltage fluctuations flickers according to IEC61000 3 3 Not applicable Manufacturer s Declaration electromagnetic immunity The seca CT 320 321 ECG device is designed for operation in the electromagnetic environment stated below The customer or user of seca CT 320 321 should make sure that it is used in such an environment Immunity Tests Electrostatic discharge ESD according to IEC 61000 4 2 Fast transient electric interference factors bursts according to IEC 61000 4 4 Surges according to IEC 61000 4 5 Voltage drops short time interruptions and fluctuations in the supply voltage according to IEC 61000 4 11 Magnetic field with supply frequency 50 60 Hz according to IEC 61000 4 8 IEC 60601 Test Level 6 kV contact discharge 8 kV air discharge 2 kV for net wires 1 kV
41. o 12 canali per PC El aparato PC ECG de 12 canales 1 2 kanal pc EKG apparatet 1 2 kanals PC EKG apparat PC EKG apparatet med 12 kanaler 12 kanavainen PC EKG laite Het 12 kanaals PC ECG apparaat O aparelho de ECG para PC de 12 canais H ovokeurn HKT 12 kavaAiwv H Y 12 kanalovy PC EKG p stroj 12 kanaliga EKG arvutiseade A 12 csatorn s sz m t g pes EKG k sz l k 12 kan lu EKG datoram piesl dzama ier ce 12 kanalu datora EKG ierice 12 kanatowy komputerowy aparat EKG 12 kanalna PC EKG naprava 12 kanalovy PC EKG pr stroj 12 Kanal PC EKG Cihaz seca 320 49 Product information 50 Konformit tserkl rung declaration of conformity Certificat de conformit Dichiarazione di conformit Declarati n de conformidad Overensstemmelsesattest F rs kran om verensst mmelse Konformitetserkl ring vaatimuksenmukaisuusvakuutus Verklaring van overeenstemming Declara o de conformidade AnAwon uuBaAT TNTAG Prohl en o shod Vastavusdeklaratsioon Megfelel s gi nyilatkozat Atitikties patvirtinimas Atbilstibas apliecin jums O wiadczenie o zgodno ci Izjava o skladnosti Vyhl senie o zhode Onay belgesi Das 12 Kanal PC EKG Ger t The 12 channel PC ECG L appareil ECG 12 canaux connectable un ordinateur L elettrocardiografo 12 canali per PC El aparato PC ECG de 12 canales 1 2 kanal pc EKG apparatet 1 2 kanals PC EKG apparat PC EKG apparatet med 12 kanaler 12 kanavainen PC EKG laite Het
42. od can be found in the Operating Man ual of the charger The charging time is 2 to 3 hours Reinsert the charged battery so that the contacts of the battery and seca CT 321 come into contact Close the battery cover 03 3 seca cardio 150 basic program structure The program is divided into three areas User Patient and Examination This structure ensures that you can always recognize who which user is carrying out what type of examination with whom which patient The main menus of each area can be reached by clicking on User Patient or Examination Cardio n Resting ECG Supervisor Select User Spirometry Group New User Edit User Settings Cancel In the User main menu the users of the system can be created and mana ged The user administration can be used to allocate user rights and con trol user specific settings e g the creation of a separate patient database for each user The Patient main menu is used for patient management Its most important functions include Search for Patient New Patient and Search Evaluation The Examination main menu is linked to the Settings area This area is for making cross program examination related and user specific settings 17 Description of device initial operation 18 03 4 Connecting the ECG device to the PC Precondition seca cardio 150 is installed on your PC and ready for operation The seca devices an
43. open the desired evaluation select it from the list and click on the Show Evaluation button or double click on the evaluation If you want to use the same search criteria for the next search activate the Save Selection option User seca 2 m x Patient Examination z Examinations Eam Date Patient E Resting ECG 2 Resting er 29 02 2012 Mustermann IN CIE gt Resting EC 29 02 2012 Mustermann Franz en p confirmed B Yes E No locked 0 lees CT No printed D Yes No compressed K Yes _ No archived A Yes No shifted S Yes TT No exported X C Yes No preconfirmed R _ Yes _ No imported E C Yes No imported I L Yes No transferred V C Yes No Satellite sys L _ Yes _ No Filter properties AND OR Period all e from to Physician i l al Physician ID f 4 Department zl Number evaluations 3 ITT Social security L Private patient C Chief physician treatmer C Viewed today already Show Evaluation 6 L Save selection Ka IW Search automatically 5 Print Evaluation List Export List of Evaluations Search Evaluation 4 Cancel Opening an evaluation via the examination main menu Open the examination main menu via Examination Resting ECG and then click on Show Evaluation SE 10 10 1960 The patient search s
44. ortcuts E End Cancel Confirm continue Program Information User main menu Patient main menu Examination main menu Patient master data of the selected patient All examinations of the selected patient List of recently opened evaluations same as clicking on the arrow button at top right List of recently opened evaluations Evaluation search Create system report service e mail 53 Generally accepted keyboard shortcuts for open evaluation Report dialogue Medication input dialogue Call comparison Call trend Call print Call settings Call Options menu Resting ECG keyboard shortcuts during the recording Start the recording E m Ku O End the recording Increase amplitude Decrease amplitude QO oO F9 Blood pressure input dialogue 1 Keyboard shortcuts will only work if the corresponding button is available on the screen page 2 This keyboard shortcut is also available in the evaluation display 54 55 Medical Scales and Measuring Systems since 1840 seca gmbh amp co kg Hammer Steindamm 9 25 22089 Hamburg Germany Telephone 49 40 20 00 00 0 Fax 49 40 20 00 00 50 info seca com All contact data under www seca com GEB 0160 DK 1161 V002 20 02 2012 seca operates worldwide with headquarters in Germany and branches in France United Kingdom North America Switzerland China Japan Mexico Austria Poland and U A E Precision for health
45. ously clicked Measurement button changes to ECG By clicking on ECG you can return to the previous ECG viewing mode Comparison Measurement Averaged complexes of several evaluations aVF mz anran 7 ES H ja St EEN EE ve Score Rb e par CS A ALAS ST 0 14 ST 0 04 j J 0 14 J 0 04 i i i 1 v3 Er Aee A V4 a vas EEO ER Sek i III aVF au CH ai aus j AE T Sait ut v5 e gien eegen Ve geg ST 0 03 ST 0 08 J 0 03 J 0 09 V6 Ji AEE IT Le SSES 800 800 800 M 4 Comparison ECG Overview Comparison Measurement Singl 33 Working with the evaluation seca cardio 06 2 4 Overview of evaluation pages User seca d a La 10 10 1960 51 Y Evaluation of 29 02 2012 16 26 Mustermann Franz Patient Examination Resting ECG a b HR 75 Channel 7 12 Channel a mmfmv 4 10 a mm s 7 50 a Mouse si Zoom a Main filter 00 01 00 02 00 03 00 04 00 05 00 06 1 me Liz SEI BKS RRRRRRRRARR eet SOO esl Ha Li Ten SE hee II CSCO es CONSE a Lal sec SEN HANS HHH A HH III SEH eo be T7 k Hee eee RECESS E affer e ee See aen Hi SS aVR aVL aVF Vi V2 V3 V4 VM 5 a i f S NAHH VOR peri NEE A DE KE IS AN SR Ve D P A ee eg me es a A Ee anne
46. raged complex of a channel of all measured values and vector loop Further pages in the Options menu Events Heart Rate Variability Scatter diagram Graphic for accessing Histogram graphics for Graphic representation events SDNN5 ANN5 pNN5O of Heart Rate Variability e g VPB in the ECG rMSSD PSD in the form of a cloud 32 06 2 2 Comparing several evaluations from one patient The current evaluation can be compared to other evaluations of the patient using the Comparison button The comparison pages can only be opened if additional ECG evaluations from the patient are available The Evalua tion button will bring you back to the single view Start page ECG Complete ECG e g 12 channel display Start page Measurement Averaged complexes of all channels Comparison ECG Comparison of current and further evaluations View 2 x complete ECG e g 12 channel display Comparison Report Direct comparison of available reports up to four report texts on one screen page 06 2 3 Note on navigation in the evaluation The buttons for opening further evaluation pages are located on the lower edge of the screen The labelling of the buttons changes as soon as you switch to a different evaluation page The button that has been clicked always contains the name of the page you just left Example You click on the Measurement button in the evaluation view ECG start page You go to the the Measurement screen and the previ
47. seca CT 320 321 and seca cardio 150 Operating Manual Precision for health Table of contents 01 02 03 04 Introduction 01 1 Symbols on the device ccc ences 4 01 2 Intended use 4 01 3 Symbols used in this manual 000 0 00 5 Safety instructions 02 1 Generalnotes 6 02 2 Operator instructions and user requirements aacaaaaaaaaa 6 02 3 Safety installations and safe workimg cee 7 02 4 Information on EMC Electromagnetic Compatibility 11 02 5 Maintenance regular safety check 12 BERT Min TEE 12 02 7 Waranty EE 13 Description of device initial operation 03 1 Part names components for ECG recordmg 14 03 2 Operation of seca CT 321 with Bluetooth connectivity 16 03 3 seca cardio 150 basic program structure 000 000 00002 17 03 4 Connecting the ECG device to the PC 03 4 1 ECG device with USB port 0000 0000 00 18 03 4 2 ECG device with Bluetooth connection 19 03 4 3 Selecting ECG device for resting ECG 21 Hygiene 04 1 Cleaning and disinfection 0 0 000 0 00 ccc 22 04 2 Recommended cleaning agents and disinfectants 23 OS Carrying out an examination 05 1 Preparing the patient examination procedure 24 05 2 Electrode applcanon ananuna nurni rarr errre rnn 25 05 3 First work steps in seca cardio In 26 05 4 Recording resting ECG
48. seca CT 321 sct 10010 9 sct 10010 Microsoft Stack enable a Search O Remove Rename Interface Log Off Properties D O End To establish the Bluetooth connection double click on the device name inthe table In the open dialogue go to the Connection tab and click on Connect After the connection has been established the message Serial connection is enabled End will appear End the dialogue If the Bluetooth connection was successful between the PC and seca CT 321 the LED on the device will light blue Save your input and close the i s medical band page with End Restart the program to transfer the changed parameters to the configuration database cted Devices Settings Name Workstation seca CT 3215 enable 03 4 3 Selecting ECG device for Resting ECG H In seca cardio 150 select Examination Resting ECG Settings Connection Device Select seca CT 32x from the list under ECG Device Click on the Save button at bottom left to apply your input Close the page with End button at bottom right The device is ready for operation NNN NM Resting ECG Z Print General Export Connection Gp Diagnostic d gt E Device lt gt ECG Device v seca ct 32x a TI QRS Trigger 21 d Hygiene 22 A 04 1 Cleaning and disinfection Important notes Use only cleaning agents and disinfectants recommended by seca Unsuitable agents may dam
49. tooth connectivity On off switch The switch on the right side of the housing switches the device on and off Only switch on the device immediately before the start of re cording and switch it off again directly after the recording is completed The maximum operation duration is 4 hours after which the rechargeable battery will need to be replaced or charged When the device is switched on the lower LED indicates the charge status of the battery Green 100 65 Orange 65 35 Red lt 35 If the lower LED flashes red after switch on the rechargeable battery must be immediately re moved from the device and charged The upper LED indicates whether the Blue tooth connection is active between the device and the PC At the start of an ECG recording the Bluetooth connection is established between the device and the PC and the upper LED lights blue The precondition for this is that the Blue tooth connection has been installed correctly see 03 4 Connecting the ECG device to the PC If no connection has been established the LED will not light Note on the rechargeable battery The rechargeable lithium ion battery does not have memory effect The battery can be charged at any time irrespective of the discharging times Charging the rechargeable battery With your thumb slide the battery cover back and take out the battery Insert the battery into the supplied charger A description of the charg ing meth
50. transmitters such as e g base stations of mobile phones and mobile transmitting stations amateur radio stations AM and FM broadcasting as well as television networks cannot be exactly predetermined theoretically In order to determine the electromagnetic environment regarding the stationary transmitters a study of the location should be considered If the measured field strength exceeds the above mentioned compliance levels at the location where the device is used the device should be watched in order to prove the intended functions If unusual performance features are observed it may be necessary to take additional measures for example reorienting or relocating the device b Over the frequency range from 150 kHz to 80 MHz the field strength should be inferior to 10 V m 47 Product information Recommended protective distances between portable and mobile HF telecommunication devices and seca CT 320 321 seca CT 320 321 is designed for the operation in an electromagnetic environment in which the HF transients can be controlled The user can help avoid electromagnetic interferences by maintaining the minimum distance between portable and mobile HF telecommunication devices transmitters and the device depending on the initial performance of the communication device as indicated below Protective distance depending on the transmitting frequency in m Nominal power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz of the tra
51. ve 93 42 EEC Class lla and meets the requirements of protection class or Il depending on the power supply unit used seca CT 321 meets the requirements of protection class Il device with an internal power supply type BF defibrillation protected according to IEC 60601 1 Other devices which are part of the system must meet the requirements of the Standard for Information Technology Equipment IEC 60950 and the Standard for Electrical Medical Devices IEC 60601 1 The electrical installations in the rooms in which the system is used must meet the requirements of the applicable safety standards 02 2 Operator instructions and user requirements As the operator you are responsible for Ensuring that the operating personnel have been instructed in the technical use of the device and they have read the Operating Manual The device is used as intended by suitably trained specialist staff Compliance with the safety regulations and safety instructions provisions for safety at work and accident prevention regulations Compliance with the maintenance instructions Users must meet the following requirements Knowledge of the correct use of the device Command of the required device handling processes Knowledge of the safety regulations applicable when using such devices Understanding of the potential hazards The device may only be used by medical specialist staff e g physician s assistants nurses assistant medical technicians phys
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