Custo Med custo cardio 400 BT Operating Manual
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Custo Med custo cardio 400 BT Operating Manual

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Operating Manual
Resting and stress ECG
custo cardio 400 accu
custo diagnostic 5.8
CMA 0019 ∙ DK 2133 ∙ Version 1 ∙ 2022/10/25

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  • Page 1 Operating Manual Resting and stress ECG custo cardio 400 accu custo diagnostic 5.8 CMA 0019 ∙ DK 2133 ∙ Version 1 ∙ 2022/10/25...
  • Page 2 This operating manual may not be copied in its entirety or in part, duplicated in any form or by any means or translated into another language without the prior written consent of custo med GmbH. The manufacturer reserves the right to change the information in this operating manual without prior notice.

  • Page 3: Table Of Contents

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Table of Contents Safety ....................5 1.1 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 Disclaimer ....................
  • Page 4 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.1 custo diagnostic program structure ............. 46 3.2 custo cardio 400 accu connection to the PC ..........47 3.2.1 Connecting and configuring custo cardio 400 ....... 47 3.2.2 Further device settings for custo cardio 400 ........

  • Page 5: Safety

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 personal injuries IMPORTANT: absolutely necessary working steps...

  • Page 6: Laws And Regulations Applicable To The Product

    As either the operator or user of this device you should have read and understood the Operating Manual, in particular the safety instructions. Should serious incidents occur in connection with a custo med product, they must be reported by the user and/or patient to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

  • Page 7: Disclaimer

    Internet at: www.customed.de, under Contact, Distributors. You can also contact custo med GmbH directly at any time. We will be pleased to provide you with information about your authorised custo med distributor or contact your authorised custo med distributor and forward your queries.

  • Page 8: Safety Installations And Safe Working

    1.2.2 Ambient conditions, handling of the devices Emissions The custo med devices/systems are not suitable for use in rooms or areas with a risk of explosion. For installation and operation of the devices/systems, the EMC (electromagnetic compatibility) instructions in the Operating Manual must be observed.
  • Page 9 Do not remove battery compartment covers or other covers during use. USB cable Some custo med devices have a USB cable. This cable must not be kinked. Do not step on the USB cable, only roll up the cable loosely and allow it to hang freely during operation.

  • Page 10: Patient Safety

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 currents can occur.

  • Page 11: System And Data Security

    IT system or your hospital information system (HIS). custo med does not accept any responsibility for any changes to data in your IT system or your HIS which were made after the export from custo diagnostic.
  • Page 12 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Allocation of case and job numbers If case or job numbers are manually entered into the system or they are changed in the system, there is a risk of confusing patients and subsequent misdiagnosis if an incorrect entry is made by a user.

  • Page 13: Information On Emc (Electromagnetic Compatibility)

    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 14: Safety Instructions For Resting And Stress Ecgs

    Safety instructions for resting and stress ECGs The device must be protected from dust and liquids. The custo med ECG devices are 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.

  • Page 15: Residual Risks Resting And Stress Ecg

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Residual risks resting and stress ECG CAUTION Skin irritations and hematomas due to negative pressure. Skin irritations and hematomas due to negative pressure possible during operation with higher suction levels. →...

  • Page 16: Hardware

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Hardware Intended use custo cardio 400 accu is a 12-channel PC ECG device designed for the creation, analysis and evaluation of ECG recordings in medical practices and hospitals. custo cardio 400 accu has an integrated electrode application system.

  • Page 17: Device Types And Functions

    Device types and functions Type Connection to PC Power supply custo cardio 400 BT USB (3 m) and Bluetooth 2.1 EDR 12 V power supply custo cardio 400 accu USB (3 m) and Bluetooth 2.1 EDR Lithium polymer battery, 12 V power supply unit CMA 0019 ∙...

  • Page 18: Symbols On The Devices And Packaging

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Symbols on the devices and packaging Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany Date of manufacture (YYYY-MM, e.g., 2022-01) CE mark Serial number Follow the Operating Manual!

  • Page 19: Technical Data And System Requirements

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Technical data and system requirements custo cardio 400 accu 1) In standby mode, the pump and valve are deactivated. Number of ECG channels Communication via USB/BT Frequency response 0 to 0.262 * Sampling frequency [HZ] and manual configuration of Sampling frequency...
  • Page 20 For proper operation it is necessary to use the operating system/software combinations tested and approved by custo med for the respective custo diagnostic version (also custo diagnostic server and client for custo diagnostic 5). These can be obtained from the authorised custo med dealer or directly from custo med.
  • Page 21 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Recommended system requirements Computer Intel Core i3-CPU with HD graphics 4400, 4 GB RAM, 256 GB SSD or SSHD (for single-user workstations 2TB HDD), 1 GBit network connection (for single-user workstations), fanless Dual-DVI (or DP) graphics card (for CPET) We recommend the current Windows version with all updates.

  • Page 22: Putting Out Of Operation, Storage, Transport, Disposal

    Make sure that the storage location is dust-free, dry and away from direct sunlight. → After a long period of non-operation, the devices may only be used again if a technical safety check has been carried out by your authorised custo med distributor. Transport →...

  • Page 23: Components For The Recording

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Components for the recording custo cardio 400 accu ECG application system 6 electrode suction tubes, length 1.45 m 4 electrode suction tubes, length 1.65 m Electrode “hair”, optionally other versions Spacer 2-fold Spacer 3-fold Extension arm custo move for custo cardio 400 accu incl.

  • Page 24: Mounting, Preparing The Device

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Mounting, preparing the device 2.6.1 Getting to know the operating elements on the custo move extension arm Operating elements on the custo move extension arm Fig. 3: custo move extension arm for custo cardio 400 accu Bracket for custo cardio 400 accu with safety bar USB connection Power cable...

  • Page 25: Mounting The Custo Move Extension Arm

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.6.2 Mounting the custo move extension arm Mounting the bracket for custo move extension arm IMPORTANT: The bracket for the custo move extension arm is included in the scope of delivery of the extension arm.
  • Page 26 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Inserting the custo move extension arm into the bracket → Thread the rotation collar onto the USB and power cable. The recess in the rotation collar points to the lower end of the extension arm. →...
  • Page 27 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Inserting the custo cardio 400 accu into the custo move extension arm → Pull the safety bar backwards → Insert the custo cardio 400 accu into the bracket on the extension arm from above →...

  • Page 28: Operating The Custo Move Extension Arm

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.6.3 Operating the custo move extension arm Using the swivel range, rotating custo move: → Bring the rotation collar into the “swivel position”. The rectangular element inside the rotation collar must be at the upper right edge of the bracket. The swivel range can be used.

  • Page 29: Removing The Custo Move Extension Arm, Disassembly

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.6.4 Removing the custo move extension arm, disassembly Disassembly, removing custo move from the bracket → Remove the custo cardio 400 accu from the custo move extension arm. →...

  • Page 30: Attaching Electrode Suction Tubes To The Device

    Attach the coding stickers to the ends of the electrode suction tubes → Stickers “C1 to C6” on the shorter electrode suction tubes: with custo cardio 400 BT 1.20 m long, with custo cardio 400 accu 1.45 m long. → The stickers “R, L, F and N”...

  • Page 31: Device Operation

    The custo cardio 400 accu device type has a lithium polymer battery located on top of the housing . The battery is permanently mounted and cannot be removed. To replace the battery, contact your authorized custo med dealer. INFORMATION: Observe the operating and storage conditions and only use the power supply unit supplied for charging.

  • Page 32: Restoring Shipping Mode

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Loading and running times Charging time approx. 4.5 hours at 1.5 A charging current in standby, extended charging time during simultaneous operation, e.g. cleaning Running time approx. 9 hours (at suction level 3), depending on the suction level and leakages the running time varies!! IMPORTANT: Fully charge custo cardio 400 accu before first use.

  • Page 33: Safety Mode

    INFORMATION Prerequisite for an examination: proper installation, configuration and commissioning of the system by your authorized custo med dealer. The display and operating elements are located in the front area of the bottom of the housing. The display and operating elements provide feedback on the device status with different light states.

  • Page 34: States Of The Suction Level And Status Display

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.7.5 States of the suction level and status display During operation, when performing an ECG recording, the suction level and status display provides information about the current operating mode. With custo cardio 400 accu the suction level and status display also shows the battery charging status.
  • Page 35 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Charging status display in energy-saving mode Green Battery charging level over 80 % Blue Battery charging level between 20 % and 80 % Purple Battery charging level below 20 % Charging level warning during operation If the charging level is below 20 %, the suction level indicator lights up...

  • Page 36: Device States In Standard Operation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.7.6 Device states in standard operation Energy saving mode The On/Off button flashes blue and the charging status is shown in the suction level and status display. Briefly pressing the On/Off button puts custo cardio 400 accu into standby mode.

  • Page 37: Further States And Special Functions

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.7.7 Further states and special functions Changing the operating mode If a USB connection is available, this will be prioritized over the wireless connection due to the higher data rate. The connection can only be changed by the device (e.g.
  • Page 38 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Cleaning the electrode suction tubes The cleaning function should be used regularly, e.g. always at the end of a working day. Pressing the cleaning button causes the moisture to be blown out of the electrode suction tubes for a longer period of time.

  • Page 39: Custo Cardio 400 Accu Troubleshooting

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.7.8 custo cardio 400 accu troubleshooting In the event of an error, the custo cardio 400 accu suction level display lights up yellow or red. The cause of a warning display is stored in the custo cardio 400 accu error log file and can be viewed there.
  • Page 40 → If this error still occurs or if the red light indicator appears during cleaning, contact your authorised custo med dealer. Fig. 24: Pressure in the system too high Warning indicator lights up red Defect on the device. The device must be sent in for repair. Contact your authorised custo med dealer.

  • Page 41: Procedure Of An Examination

    INFORMATION Prerequisite for an examination: proper installation, configuration and commissioning of the system by your authorized custo med dealer. Resting ECG → Ensure that the ECG device is connected to the PC and that power is supplied to the device.
  • Page 42 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu CAUTION Skin irritations and hematomas due to negative pressure. Skin irritations and hematomas due to negative pressure possible during operation with higher suction levels. → Ensure that the suction level is set correctly. →...

  • Page 43: Attaching The Recorder To The Patient

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Attaching the recorder to the patient 2.9.1 Positions of the electrodes Thoracic wall resting and stress ECG, standard according to Wilson V1 (C1) 4th intercostal space at the right sternal border V2 (C2) yellow 4th intercostal space at the left sternal border...

  • Page 44: Notes On Stress With Treadmill

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.9.2 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 recording.

  • Page 45: Safe Use Of Treadmills

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 2.9.3 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 46: Software

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Software custo diagnostic program structure The custo 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 47: Custo Cardio 400 Accu Connection To The Pc

    IMPORTANT: Prerequisite - custo diagnostic is installed on your PC and ready for operation. The custo med devices and components may only be connected to the PC after custo diagnostic has been installed. The required device drivers are installed on the PC via the custo diagnostic standard setup or by specific selection during the custo diagnostic setup.
  • Page 48 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Device configuration for resting and stress ECG → Start custo diagnostic. → Open the screen Examination, Resting ECG or Stress ECG, Settings, Device , ECG Device → The ECG device is shown in the “ECG devices”...

  • Page 49: Further Device Settings For Custo Cardio 400

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.2.2 Further device settings for custo cardio 400 The settings for the device pump (suction power, etc.) can also be found under Examination, Resting ECG or Stress ECG, Settings, Device , ECG Device Suction power Level 3 is the default setting for resting ECG, level 5 is the default setting for...

  • Page 50: Connecting Training Devices For Stress Ecg

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.2.3 Connecting training devices for stress ECG → Connect the training device to the PC with the supplied cable (serial port) 1) The number of serial ports on →...

  • Page 51: Configuring A Training Device For Stress Ecg

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.2.4 Configuring a training device for stress ECG → In custo diagnostic, open the screen Examination, Stress ECG, Settings, Device , Training device → Select the previously set Ergometer or Treadmill →...

  • Page 52: Extended Ecg Settings

    1 * 1 mm, the large boxes 5 * 5 mm. To ensure the graph paper is correctly displayed on the screen, the screen diagonal of the monitor must be specified in the custo service center. Contact your authorized custo med dealer. Resting ECG, automatic ECG procedures: Under Examination, Resting ECG, Settings, Menu/Functions, Workflow procedures for automatic ECG recordings can be set in the “Automatic ECG”...
  • Page 53 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 54: Perform Resting Ecg Recording

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Perform resting ECG recording NOTE on the procedure The steps necessary to record and evaluate ECG data in custo diagnostic are shown without a surgery IT system or HIS connection. →...
  • Page 55 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Monitoring and electrode control The patient's ECG signal will be shown on the display but not recorded (monitoring). Work steps before the start: → Change the type of lead if necessary.
  • Page 56 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Automatic ECG – Autostart button → Click on Autostart to start the automatic recording. → The default setting for the duration of automatic recording is ten seconds. →...
  • Page 57 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 for naming, Tip: Keyboard shortcut “Change printing and saving the marking amplitude (mm/mV)".
  • Page 58 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 text module button.

  • Page 59: Resting Ecg Rhythm Strips

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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.

  • Page 60: Perform Stress Ecg Recording

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Perform stress ECG recording NOTE on the procedure The steps necessary to record and evaluate ECG data in custo diagnostic are shown without a surgery IT system or HIS connection. →...
  • Page 61 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 62 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Fig. 43: Select ECG device Monitoring and electrode control The patient's ECG signal will be shown on the display but not recorded (monitoring). Work steps before the start: →...
  • Page 63 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Recommended settings for stress test ECG with treadmill: → Under Options activate: Mains filter , Muscle 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 64 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 Dialogue box for entering the blood pressure (with manual Additional BP measurement measurement) or F9...
  • Page 65 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Display and control elements (view after starting) Setting options for ECG display Buttons for controlling and editing the ECG recording Tip: Keyboard shortcuts Heart rate and blood pressure, countdown of the current level Change current load and increase for ergometer profiles or speed and Change load or speed slope for treadmill profiles...
  • Page 66 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Stress phase The stress phase then begins. This phase proceeds according to the profile. Manual load changes can be made at any time. The Next Stage button can be used to end the current load level and start the next load level.
  • Page 67 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu TIPP: Text modules for entering the reason for termination 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. Configuring text modules: Select Examination, Stress ECG, Settings, Diagnostic, Reason for End to configure text modules for entering a reason for termination.
  • Page 68 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 for naming, printing and saving the marking →...
  • Page 69 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 text module button.

  • Page 70: Opening Evaluations

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 configured in the custo →...
  • Page 71 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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) . By setting Reference between the end certain search criteria, the search is narrowed down.

  • Page 72: Opening An Evaluation Via The Evaluation Main Menu

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.6.2 Opening an evaluation via the evaluation main menu → Open the examination main menu via Examination, Resting ECG or Stress ECG. → Click on Show evaluation →...

  • Page 73: Resting Ecg Evaluation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 74: Navigation In The Evaluation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 75: Resting Ecg Evaluation Screens

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.7.3 Resting ECG evaluation screens ECG start screen Setting options for ECG display Mouse functions for precise viewing and measuring of the ECG signal (Zoom, Analysis, Measure HR, Measure, Marking) Further evaluation screens Print evaluation Button for closing the evaluation...
  • Page 76 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 77: Resting Ecg With Additional Function Sport Ecg

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.7.4 Resting ECG with additional function Sport ECG The Sport ECG function is not part of the standard software and can be purchased optionally. A resting ECG can be viewed in the context of “Sport ECG” in the case of patients who participate in competitive sports.
  • Page 78 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Display and control elements in the Sport ECG Fig. 57: Sport ECG evaluation view Recorded ECG Sum complex Table of measured values Unconfirmed report Traffic light image with graphical representation of the evaluation Notes on further recommended examinations Reset changes in the unconfirmed report Confirm the unconfirmed report and adopt as report...

  • Page 79: Stress Ecg Evaluation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 80: Navigation In The Evaluation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 81: Screens Of The Stress Ecg Evaluation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 3.8.3 Screens of the stress ECG evaluation ECG start screen 1) The PWC predicted values are preset in custo diagnostic Setting options for ECG display and can be changed on the Mouse functions for precise viewing and measuring of the ECG signal screen Examination, Stress ECG, (Zoom, Analysis, Measure HR, Measure, Marking)
  • Page 82 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 83: Confirming The Evaluation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Confirming the evaluation Unconfirmed report and report To open the unconfirmed report, right-click on the evaluation interface. In the context menu, select Report. Enter your data in the text field .

  • Page 84: Optional: Reporting With Approval Process

    The approval process must be activated in the Settings and in the custo service center for each user and project. The user rights must be set to match the workflow. Contact your authorised custo med dealer or custo med. INFORMATION:...

  • Page 85: Ending The Evaluation

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 86: Hygiene

    Resting and stress ECG ∙ custo cardio 400 accu Hygiene Important notes Only use cleaning agents and disinfectants recommended by custo med. Unsuitable agents may damage the device. Under no circumstances should the devices be immersed in liquid or cleaned too wet.

  • Page 87: Hygienic Reprocessing

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Hygienic reprocessing custo cardio 400 accu → Reprocessing type: surface cleaning and/or wipe disinfection IMPORTANT: The cleaning cloth must not be dripping wet. Moisture must not enter the connections of the ECG device under any circumstances. Do not clean the golden contact pins in the connections of the electrode leads.
  • Page 88 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Non-critical areas: Procedure for quick disinfection (wipe disinfection). The electrodes can be classified as a non-critical medical device if they only come into contact with intact skin. →...
  • Page 89 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Cleaning the electrode suction tubes For hygienic use, for maintenance of the device and for consistent quality of the ECG recordings, the excess moisture must be blown out of the electrode suction tubes regularly.

  • Page 90: Recommended Cleaning Agents And Disinfectants

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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! Procedure according to DGKH certificate: →...

  • Page 91: Disposal Of The Electrodes

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Disposal of the electrodes The electrodes can be sent to custo med for disposal. CMA 0019 ∙ DK 2133 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de...

  • Page 92: Appendix

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Appendix Values and formulas in the ECG evaluation Isoelectric segments within the QRS complex. The isoelectric segments within the QRS complex are included in the Q, R, or S waves.
  • Page 93 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Calculation of the target load custo diagnostic offers two different calculation options for calculating the target load at maximum workload: “standard” and “according to Prof. Froelicher”. The settings can be found under Examination, Stress ECG, Settings, Diagnostic, Reference values.
  • Page 94 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu BORG values for stress ECG When performing a stress ECG, it is possible to enter BORG values during recording. BORG values are used to evaluate the subjective perceived exertion and were established by the Swedish physiologist Gunnar Borg in the Borg scale named after him.

  • Page 95: Keyboard Navigation And Shortcuts

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu 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 Left click →...
  • Page 96 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Keyboard shortcuts General shortcuts Enter Confirm Tabulator Cursor jumps to next input field (patient menu) Ctrl I Program information Ctrl H User main menu Ctrl P Patient main menu Ctrl U Examination main menu Ctrl A...

  • Page 97: Manufacturer's Declaration Regarding Emc

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Manufacturer’s declaration regarding EMC Electromagnetic compatibility according to DIN EN 60601-1-2:2016-05 Lead lengths Electrode suction tubes: approx. 1200 mm, approx. 1450 mm, approx. 1650 mm USB cable: approx.
  • Page 98 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Recommended protective distances between portable and mobile RF telecommunication devices and custo cardio 400 accu custo cardio 400 accu is designed for use in an electromagnetic environment in which the RF transients can be controlled.

  • Page 99: Ec Declaration Of Conformity

    2011/65/EU. Hereby custo med declares that the radio device type(s) custo cardio 300 BT; custo cardio 400 BT; custo cardio 400 accu; custo screen 400; custo watch; custo guard 1/3/LR; custo guard holter; custo com RF; custo com RF LR is/are in compliance with Directive 2014/53/EU.

  • Page 100: Product Components And Accessories

    85082 Cable hook for custo move extension arm 85083 Bracket for custo move extension arm incl. mounting 12931 material Universal bracket for custo cardio 400 BT / accu 85068 Wall mounting set 85079 LM506 Bluetooth 4.0 USB adapter 55050 USB extension cable 1.8 m, A-to-A...

  • Page 101: List Of Figures

    Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu List of Figures Fig. 1: Safety distances at the patient area Fig. 2: custo cardio 400 accu part designation Fig. 3: custo move extension arm for custo cardio 400 accu Fig.
  • Page 102 Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 400 accu Fig. 51: Select patient Fig. 52: Evaluation Resting ECG, ECG screen Fig. 53: Evaluation Resting ECG, Measurement screen Fig. 54: Evaluation Resting ECG, ECG start screen Fig. 55: Resting ECG evaluation, Options menu Fig.
  • Page 103 GmbH Maria-Merian-Str. 6 85521 Ottobrunn, Germany Phone: +49 (0) 89 710 98-00 Fax: +49 (0) 89 710 98-10 info@customed.de www.customed.de...

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