Seca ct330 Instructions For Use Manual
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Seca ct330 Instructions For Use Manual

Resting & stress ecg and seca diagnostic 5.9
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Instructions for Use
Resting & Stress ECG with seca ct330/331
and seca diagnostic 5.9

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Summary of Contents for Seca ct330

  • Page 1 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9...
  • Page 2 Distribution: seca Ltd. 40 Barn Street Birmingham West Midlands B5 5QB Phone: 0121 643 9349 Fax: 0121 633 3403 Email: info.uk@seca.com All contact details at www.seca.com seca product names: seca ct330/331 (12-lead PC ECG device) seca diagnostic (medical PC software)

  • Page 3: Table Of Contents

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Table of Contents Safety ....................5 General notes ................5 1.1.1 Symbols used in this Operating Manual ..... 5 1.1.2 Laws and regulations applicable to the product ..6 1.1.3...
  • Page 4 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.6.2 Opening an evaluation via the evaluation menu ..61 Resting ECG evaluation ............62 3.7.1 Evaluation structure ..........62 3.7.2 Navigation in the evaluation ........63 3.7.3...

  • Page 5: Safety

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Safety General notes 1.1.1 Symbols used in this Operating Manual Safety warning symbol, in case of dangerous situations with high and medium risk level, which may result in...

  • Page 6: Laws And Regulations Applicable To The Product

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 1.1.2 Laws and regulations applicable to the product INFORMATION: Strict compliance with the safety instructions protects against personal injury and property damage during device operation. These Instructions for Use are designed to accompany the product and must be kept ready to hand close to the device.

  • Page 7: Disclaimer

    You can also contact custo med GmbH directly at any time. We will be happy to put you in touch with your authorised seca sales partner and forward your request.

  • Page 8: Safety Installations And Safe Working

    Strong electromagnetic sources in the immediate vicinity of the seca ct330/331 device/system may result in recording errors. The seca ct330/331 device/system must not be stored or used in the vicinity of X- ray equipment, diathermy units or magnetic resonance devices (MRT).
  • Page 9 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 It is not permitted to wear the devices in a swimming pool, in the sauna, bathtub, shower or similar wet rooms. Do not submerge the seca devices.

  • Page 10: Patient Safety

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 1.2.3 Patient safety Fig. 1: Safety distances at the patient area 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...
  • Page 11 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 seca diagnostic The device must only be used with the supplied seca software (seca diagnostic). As the operator you are responsible for ensuring regular data backups (patient databases, evaluations etc.) and system backups.

  • Page 12: Information On Emc (Electromagnetic Compatibility)

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 1.2.5 Information on EMC (Electromagnetic Compatibility) The use of other accessories, other converters and leads than those indicated, except for the converters and leads sold by custo med as spare parts for inner components, can lead to increased electromagnetic emissions or to a reduced electromagnetic immunity of the system.

  • Page 13: Safety Instructions For Resting And Stress Ecgs

    (HF) surgical devices. seca ct330/331 must not be used in the vicinity of HF surgical devices. Use of the seca ct330/331 in conjunction with life-support equipment is not permitted. The device is not suitable for intensive care or as an alarm system for life-sustaining body functions.

  • Page 14: Residual Risks Resting And Stress Ecg

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Residual risks resting and stress ECG CAUTION Allergic reactions on the skin due to substances in adhesive electrodes (acrylate adhesive, Ag/AgCl). Clarify further procedure with the physician before recording.

  • Page 15: Hardware

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Hardware Intended use seca ct330/331 is a 12-channel PC ECG device designed for the creation, analysis and evaluation of ECG recordings in medical practices and hospitals.

  • Page 16: Indications And Contraindications

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 2.1.1 Indications and contraindications Indications Resting ECG Sauer, G., Andresen, D., Cierpka, R., Lemke, B., Mibach, Suspected cardiovascular system disorder (e.g. MI, CHD, cardiac → F., Perings, Ch., & Vaerst, R.

  • Page 17: Device Types And Functions

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Diagnosed electrolyte disorder → Arterial hypertension (syst. 200, diast. > 110 mmHg) → Tachyarrhythmia or bradyarrhythmia → Hypertrophic obstructive cardiomyopathy and other outflow tract → obstructions Higher-degree atrioventricular blockage →...

  • Page 18: Symbols On The Devices And Packaging

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Symbols on the devices and packaging Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany Distributor: seca Ltd., 40 Barn Street, Birmingham, West Midlands, B5 5QB, UK...

  • Page 19: Technical Data And System Requirements

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Technical data and system requirements seca ct330/331 Number of ECG channels Frequency response 0 to 0.262 * Sampling frequency [HZ] Sampling frequency 1000, 2000, 4000, 8000, 16000 (USB), 32000 (USB) [Hz] Sampling rate 1.0 / 0.5 / 0.25 / 0.125 / 0.0625 (USB) / 0.03125 (USB) [ms]...
  • Page 20 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Technical requirements for the operation of seca diagnostic seca diagnostic SERVER, hardware and operating system The seca diagnostic server is designed for operation on any →...
  • Page 21 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Software requirements for the operation of seca diagnostic seca diagnostic SERVER Approved operating systems (64-bit Windows only): Microsoft Windows 11 64 bit (for small environments only) →...

  • Page 22: Shutdown, Storage, Transport, Disposal

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Shutdown, storage, transport, disposal Shutdown and storage Clean and disinfect the devices and their components before putting → them out of operation. Make sure that the storage location is dust-free, dry and away from →...

  • Page 23: Components For The Recording

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Components for the recording seca ct330 (with USB connectivity) seca ct330 (with USB connectivity), ECG device → with 10-wire patient cable with banana plugs → Not shown: seca diagnostic medical PC software for ECG diagnostic assistance →...

  • Page 24: Device Operation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Device operation 2.6.1 Display and control elements On/off button The device is switched on and off with the large button in the middle To switch on, keep the button pressed for at least one second.
  • Page 25 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Status display 1) Operating time rechargeable battery & Bluetooth operation, 4 Information about the device status is displayed via LEDs kHz sampling rate: max. 10 h.

  • Page 26: Sequences After Switching On

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 2.6.2 Sequences after switching on Immediately after switching on (keep the on/off button pressed for at least 1 s), all LEDs light up. The device starts and can be used.

  • Page 27: Power Supply

    The connection is located on the lower edge of the device housing If seca ct331 is connected to a switched-on PC via USB cable, the device is charged automatically. Charging via USB universal power supply is also possible. Connect the seca ct331 to the universal USB power supply and plug in the power adapter.

  • Page 28: Procedure Of An Examination

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Procedure of an examination INFORMATION Prerequisite for an examination: proper installation, configuration and commissioning of the system by your authorized seca dealer. Resting ECG Ensure that the ECG device is connected to the PC and that power →...

  • Page 29: Attaching The Recorder To The Patient

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Attaching the recorder to the patient 2.8.1 Positions of the electrodes Thoracic wall resting and stress ECG, standard according to Wilson V1 (C1) 4th intercostal space at the right sternal border...

  • Page 30: Notes On Stress With Treadmill

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 2.8.2 Notes on stress with treadmill The patient should ideally be wearing running shoes or trainers. → The patient should not hold on to the handles of the treadmill during →...

  • Page 31: Safe Use Of Treadmills

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 2.8.3 Safe use of treadmills WARNING Risk of injury due to changes in acceleration, speed or incline of the treadmill. Unexpected, abrupt stopping or starting of the treadmill can cause injury to the patient.

  • Page 32: Software

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Software seca diagnostic program structure The seca diagnostic program is divided into three areas: User, Patient and Examination. This structure ensures that you can always recognise who (which user) is carrying out what type of examination with whom (which patient).

  • Page 33: Seca Ct330/331 Connection To The Pc

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 seca ct330/331 connection to the PC IMPORTANT: Prerequisite - seca diagnostic is installed on your PC and ready for operation. The seca devices and components may only be connected to the PC after seca diagnostic has been installed.
  • Page 34 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Device configuration for resting and stress ECG Start seca diagnostic. → Open the screen Examination, Resting ECG or Stress ECG, → Settings, Device , ECG Device The ECG device is shown in the “ECG devices”...

  • Page 35: Connecting And Configuring Seca Ct331 (Bluetooth)

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.2.2 Connecting and configuring seca ct331 (Bluetooth) To use the USB port, perform the steps for configuring the USB port, see 3.2.1 Setting up seca ct330 (USB), p.
  • Page 36 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Device configuration for resting and stress ECG Start seca diagnostic. → Open the screen Examination, Resting ECG or Stress ECG, → Settings, Device , ECG Device The ECG device is shown in the “ECG devices”...

  • Page 37: Connecting Training Devices For Stress Ecg

    Make a note of the serial port number, see Windows Device → PCI plug-in card with serial Manager. The number of the serial port will be needed later in seca ports. diagnostic. Some devices (e.g., ergometer ec5000 and treadmill er2100) can be →...

  • Page 38: Configuring A Training Device For Stress Ecg

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.2.4 Configuring a training device for stress ECG In seca diagnostic, open the screen Examination, Stress ECG, → Settings, Device , Training device Select the previously set Ergometer or Treadmill →...

  • Page 39: Extended Ecg Settings

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.2.5 Extended ECG settings Changing the ECG colour scheme: The ECG colours are preset in seca diagnostic and can be changed under Examination, Settings, System, ECG colour. Click on Save to apply your changes.
  • Page 40 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Maximum load: The maximum load achieved is displayed in the evaluation and in the printout and is used for comparison with the target load. The criteria for determining the maximum load are defined on the screen Examination, Stress ECG, Settings, Diagnostic, Calculation.

  • Page 41: Perform Resting Ecg Recording

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Perform resting ECG recording Procedure with SystmOne or EMIS Health connection seca diagnostic can be connected to the SystmOne or EMIS Health practice management software. In this case, the first steps for performing an examination are carried out in SystmOne or EMIS Health, e.g.
  • Page 42 Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 INFORMATION: The necessary steps for recording and analysing ECG data in seca diagnostic are shown without a surgery IT system or HIS connection Apply the ECG device to the patient.
  • Page 43 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Monitoring and electrode control The patient's ECG signal is displayed on the screen, but not yet recorded (monitoring). Work steps before starting: Change the type of Lead if necessary.
  • Page 44 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Automatic ECG - Autostart button Click on Autostart to start the automatic recording. → The default setting for the duration of automatic recording is ten →...
  • Page 45 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Editing options during the recording process Mark ECG automatically: Clicking the Mark button automatically → marks the last six seconds of the recording. A dialogue box opens Tip: Keyboard shortcut “Change...
  • Page 46 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 TIP: Text modules for specifying marked parts Application: If a marking is made during recording, the “Markings” dialogue box appears. The marked parts will be automatically specified by pressing the corresponding key (e.g., F5) or a previously configured...

  • Page 47: Resting Ecg Rhythm Strips

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Resting ECG rhythm strips During resting ECG recordings, additional rhythm strips can be recorded. These are ECG sections of any duration during which the recording can be manually controlled. The “Rhythm strip” function can...

  • Page 48: Perform Stress Ecg Recording

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Perform stress ECG recording Procedure with SystmOne or EMIS Health connection seca diagnostic can be connected to the SystmOne or EMIS Health practice management software. In this case, the first steps for performing an examination are carried out in SystmOne or EMIS Health, e.g.
  • Page 49 Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 INFORMATION: The necessary steps for recording and analysing ECG data in seca diagnostic are shown without a surgery IT system or HIS connection Apply the ECG device to the patient.
  • Page 50 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Profile selection The profile selection opens. → Select a stress profile . The list contains predefined profiles for → ergometer (with watt specifications) and treadmill. Set the training device for the recording.
  • Page 51 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Selecting ECG device If several ECG devices are connected to the workstation, the “Select → ECG Device” dialogue box is displayed. Select the ECG device and click on Confirm →...
  • Page 52 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Recommended settings for stress test ECG with treadmill: Under Options activate: Mains filter and Ergo filter . The → Ergo filter is only required if strong movement artifacts are to be expected, e.g., when using a treadmill.
  • Page 53 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Options menu Turning on and off the automatic blood pressure measurement Trigger an additional BP measurement or F7 Tip: Keyboard shortcuts Dialogue box for entering an unconfirmed report...
  • Page 54 Manual blood pressure measurement You are regularly requested to measure blood pressure. Enter the values in seca diagnostic. Click on Blood pressure or the “F9” in the Options menu and enter the values. Confirm to apply your input. Entering lactate (“F10”), SPO2 (“F11”) and Borg (“F12”) values works in the same way.
  • Page 55 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Resting phase The resting phase begins after Start. This phase proceeds according to the settings in the profile selection, it has a minimum duration of ten seconds.
  • Page 56 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 TIPP: Text modules for entering the reason for end Application: The text modules are called using the keyboard (F5 to F12) in the “Reason for termination” dialogue or by clicking on the corresponding button.
  • Page 57 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Editing options during the recording process Mark ECG automatically: Clicking the Mark button automatically → marks the last six seconds of the recording. A dialogue box opens...
  • Page 58 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 TIP: Text modules for specifying marked parts Application: If a marking is made during recording, the “Markings” dialogue box appears. The marked parts will be automatically specified by pressing the corresponding key (e.g., F5) or a previously configured...

  • Page 59: Opening Evaluations

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Opening evaluations 3.6.1 Opening an evaluation via the evaluation search To open the evaluation search right-click on the Patient button → 1) The evaluation search can be...
  • Page 60 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Advanced search, creating filter sets The Advanced search is used to create filter sets and to quickly → select search criteria (e.g., examination, properties, time period) Reference between the end By setting certain search criteria, the search is narrowed down.

  • Page 61: Opening An Evaluation Via The Evaluation Menu

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.6.2 Opening an evaluation via the evaluation menu Open the examination main menu via → Examination, Resting ECG or Stress ECG. Click on Show evaluation →...

  • Page 62: Resting Ecg Evaluation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Resting ECG evaluation 3.7.1 Evaluation structure ECG evaluation is divided into two main areas: ECG and Measurement. The ECG screen is preset as the start screen, and the Measurement screen can be set as the start screen as an alternative if required.

  • Page 63: Navigation In The Evaluation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.7.2 Navigation in the evaluation At the bottom of the screen there are buttons for opening other evaluation screens. The labelling of the buttons changes as soon as you switch to another evaluation screen.

  • Page 64: Resting Ecg Evaluation Screens

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.7.3 Resting ECG evaluation screens ECG start screen Setting options for the ECG display Mouse functions for precise viewing and measuring of the ECG Tip: Keyboard shortcuts...
  • Page 65 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Options menu The scope and contents of the options menu change depending on which screen of the evaluation you are on. On the Measurement screen, for example, you can activate the display of ST values in the options menu and set which markers are to be displayed in the summary complexes.

  • Page 66: Resting Ecg With Additional Function Sport Ecg

    A resting ECG recording can be viewed in the context of a “sports ECG” in the case of competitive sports patients. In seca diagnostic, it is taken into account that competitive athletes may have a different heart anatomy. The results of the automatic analysis are evaluated differently for competitive athletes than for patients who do not fall into the category of competitive athletes.
  • Page 67 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Display and control elements in the Sport ECG Fig. 38: Sport ECG evaluation view Recorded ECG Sum complex Table of measured values Unconfirmed report Status indicator with graphical representation of the evaluation...

  • Page 68: Stress Ecg Evaluation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Stress ECG evaluation 3.8.1 Evaluation structure ECG evaluation is divided into two main areas: ECG and Measurement. The ECG screen is preset as the start screen, and the Measurement screen can be set as the start screen as an alternative if required.

  • Page 69: Navigation In The Evaluation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.8.2 Navigation in the evaluation At the bottom of the screen there are buttons for opening other evaluation screens. The labelling of the buttons changes as soon as you switch to another evaluation screen.

  • Page 70: Screens Of The Stress Ecg Evaluation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.8.3 Screens of the stress ECG evaluation ECG start screen 1) The PWC predicted values are preset in seca diagnostic Setting options for ECG display and can be changed on the...
  • Page 71 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Options menu The scope and contents of the options menu change depending on which screen of the evaluation you are on. On the Measurement screen, for example, you can activate the display of ST values in the options menu and set which markers are to be displayed in the summary complexes.

  • Page 72: Confirming The Evaluation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Confirming the evaluation Unconfirmed report and report The unconfirmed report is opened by right-clicking on the evaluation interface. Select Report in the context menu. Enter your details in the text field .
  • Page 73 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 For Stress ECG: Unconfirmed report with Duke Treadmill Score In order to display the Duke Treadmill Score, some settings are required in seca diagnostic, see 3.2.5 Extended ECG settings, p.

  • Page 74: 3.10 Optional: Reporting With Approval Process

    . The reporting is documented in the evaluation information (context menu). The approval process must be activated in the Settings and in the seca service center for each user and project. The user rights must be set to match the workflow. Contact seca.

  • Page 75: Screens Of The Stress Ecg Evaluation

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 3.11 Ending the evaluation Click on End (bottom right) in the evaluation. The End dialogue opens. The status of an evaluation is defined here. Assigning properties (status of the evaluation) in the End dialogue makes it easier to find evaluations in the evaluation search.

  • Page 76: Hygiene

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Hygiene Important notes Only use recommended cleaning agents and disinfectants. Unsuitable agents may damage the device. Under no circumstances should the device be immersed into liquid or cleaned too wet.

  • Page 77: Hygienic Reprocessing

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Hygienic reprocessing seca ct330/331 Reprocessing type: wipe disinfection → Patient cable 10-lead with banana plug Reprocessing type: wipe disinfection → Carrying case and belt Reprocessing type: disinfectant washing in the washing net →...

  • Page 78: Recommended Cleaning Agents And Disinfectants

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Recommended cleaning agents and disinfectants Wipe disinfection: Meliseptol® Wipes sensitive (B.Braun) → Meliseptol® Foam pure (B.Braun), use a soft, lint-free cloth for this → purpose. Observe the manufacturer's instructions! →...

  • Page 79: Contaminated Consumables

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Contaminated consumables Contaminated consumables such as adhesive electrodes (single-use items) are considered as waste with special requirements regarding collection and disposal from an infection prevention perspective. They must be disposed of in a safe and proper manner.

  • Page 80: Appendix

    The PWC values indicates the physical ability of a patient at a specific heart rate. The PWC value is specified in watt/kg (body weight). In seca diagnostic, the PWC value is determined for a heart rate of 130, 150 and 170.
  • Page 81 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Calculation of the target load seca diagnostic offers three different calculation options for calculating the target load at maximum workload: “according to Rost & Hollmann”, “according to Wonisch et al.” and “according to Reiterer”. The setting can be found on the Examination, Stress ECG, Settings, Diagnostic, Reference values screen.
  • Page 82 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Target load according to Reiterer (1975), for men Age (years) 20 – 24 25 – 29 30 – 34 35 – 39 40 – 44 45 – 49 50 –...
  • Page 83 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Target load according to Reiterer (1975), for women Women Age (years) 20 – 24 25 – 29 30 – 34 35 – 39 40 – 44 45 –...
  • Page 84 F12 key. Values between 0 and 30 can be entered for each of the musculature, breathing and pain categories. This can be based on, for example, the CR10 Borg scale or the RPE Borg scale. seca diagnostic does not specify a specific Borg scale.
  • Page 85 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Duke Treadmill Score In order to display this value in seca diagnostic, some settings are required, see 3.2.5 Extended ECG settings, p. Calculation Duke score = Test duration - 5 * ST segment deviation - 4 * TAI...

  • Page 86: Keyboard Navigation And Shortcuts

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Keyboard navigation and shortcuts Use the quick access, keyboard control and keyboard shortcuts to work quickly and conveniently. Quick links in the main navigation Left click Change user password →...
  • Page 87 Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Keyboard shortcuts General shortcuts Enter Confirm Tabulator Cursor jumps to next input field (patient menu) Ctrl H User main menu Ctrl P Patient main menu Ctrl U...

  • Page 88: Manufacturer's Declaration Regarding Emc

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Manufacturer’s declaration regarding EMC Electromagnetic compatibility according to DIN EN 60601-1-2:2022-01 Cable lengths of the patient leads and the USB cables Patient leads: gray: approx. 1050 mm (R, L, N, F), approx. 700 mm (C1 - C6) Manufacturer's declaration –...
  • Page 89 12 inches (30 cm) of the manufacturer's designated parts and leads of the seca ct330/331 device. Failure to observe this warning can compromise the performance of the device.

  • Page 90: Ec Declaration Of Conformity

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 EC Declaration of Conformity Simplified declaration of conformity seca ct330/331 complies with the requirements of the Medical Device Regulation (EU) 2017/745 and Directive 2011/65/EU. Hereby, custo med declares that the radio device type(s) custo...

  • Page 91: Product Components And Accessories

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 Product components and accessories Description Product designation Part no. Quantity/pc. seca ct330 (USB version) 12054 seca ct331 (Bluetooth version with rechargeable 12056 battery) Description Accessories Part no.

  • Page 92: List Of Figures

    Instructions for Use Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9 List of Figures Fig. 1: Safety distances at the patient area Fig. 2: seca ct330/331 Status display Fig. 3: Electrode control after switching on Fig. 4: Recording progress Fig.
  • Page 93 Distribution: seca Ltd. 40 Barn Street Birmingham West Midlands B5 5QB Phone: 0121 643 9349 Fax: 0121 633 3403 Email: info.uk@seca.com All contact details at www.seca.com seca product names: seca ct330/331 (12-lead PC ECG device) seca diagnostic (medical PC software)

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Ct331

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