Software .................... 34 3.1 custo diagnostic program structure ............. 34 3.2 custo cardio 300 connection to the PC ............35 3.2.1 Connecting and configuring custo cardio 300 USB ...... 35 3.2.2 Connecting and configuring custo cardio 300 Bluetooth .... 37 3.2.3 Connecting training devices for stress ECG ........
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 3.6.1 Opening an evaluation via the evaluation search ......59 3.6.2 Opening an evaluation via the evaluation main menu ....61 3.7 Resting ECG evaluation ................... 62 3.7.1 Evaluation structure ................62 3.7.2 Navigation in the evaluation ..............
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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. This Operating Manual is designed to accompany the product and must be kept ready to hand close to the device.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 1.1.3 Disclaimer The manufacturer will not be held liable for improper operation, non- compliance with safety instructions and negligently skipped instructions. custo med only assumes responsibility for the safety and reliability of the device...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Safety installations and safe working 1.2.1 Putting into operation, setup custo med systems must only be used in a technically perfect condition. Regularly carry out a visual inspection of the devices and their associated components.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Rechargeable batteries Some custo med devices contain an integrated lithium polymer battery (permanently installed in the housing). Any mechanical stress which is beyond the intended use must be avoided. Do not use force to open the devices.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 1.2.4 System and data security IMPORTANT: Patient data must be handled in accordance with the legal requirements of the respective country (this includes the General Data Protection Regulation (GDPR)). custo diagnostic offers functions to help you meet these requirements (e.g., user administration, password assignment).
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
300 has no protection against possible influences from high- frequency (HF) surgical devices. custo cardio 300 must not be used in the vicinity of HF surgical devices. Use of the custo cardio 300 in conjunction with life-support equipment is not permitted.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Resting and stress ECG ∙ custo cardio 300 Hardware Intended use custo cardio 300 is a 12-channel PC ECG device designed for the creation, analysis and evaluation of ECG recordings in medical practices and hospitals. The device must be operated by suitably trained and qualified personnel in medical practices, laboratories, rehab centres and hospitals.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Symbols on the devices and packaging Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany Serial number Order number/designation Unique Device Identifier Lot designation Medical device Follow the Operating Manual!
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Technical data and system requirements custo cardio 300 Number of ECG channels Frequency response 0 to 0.262 * Sampling frequency [HZ] Sampling frequency 1000, 2000, 4000, 8000, 16000 (only with USB), 32000 (only...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 custo wing single-use adhesive electrodes Dimensions max. 61 * 34 mm (L * W) Height without connection 0.9 mm Gel type Hybrid gel Sensor silver/silver chloride (Ag/AgCl) Contact resistance max.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 General system requirements Operating system The custo diagnostic software is only suitable for installation on Microsoft Windows systems. custo diagnostic 5 is a client/server combination. The custo diagnostic 5 server can only run on 64-bit systems.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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),...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Putting out of operation, storage, transport, disposal Putting out of operation and storage → Clean and disinfect the devices and their components before putting them out of operation.
USB connection cable A-A, 3 m → AAA batteries (only for BT-B version) → USB universal power supply (for charging custo cardio 300 BT-A) → Bluetooth 4.0 USB adapter (connection of BT version to PC) → USB extension cable A-A, 1.8 m (for the Bluetooth 4.0 USB adapter) →...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 (custo med “C”). To switch on, keep the button pressed for at least one second.
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→ yellow: medium → red: low If custo cardio 300 BT-A (version with rechargeable battery) is being charged, the LED flashes and indicates the charging status with the corresponding colour. If the LED flashes red quickly: recharge battery / change battery USB connection between device and PC: if the connection is established, the LED lights up green.
An ECG recording can be triggered not only via the software interface, but also by pressing the on/off button on the device. For this, custo diagnostic must be configured accordingly, a patient must be selected and custo cardio 300 must be connected to custo diagnostic. The following recording types are possible: →...
300 with integrated rechargeable battery is charged via the USB cable. The connection is located on the lower edge of the device housing If custo cardio 300 is connected to a switched-on PC via USB cable, the device is charged automatically. Charging via USB universal power supply is also possible.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 CAUTION Skin irritations and skin injuries caused by custo wing electrodes The application of custo wing electrodes to injured areas of the skin leads to skin irritations and impairs wound healing.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
Notes on stress with treadmill INFORMATION: For stress ECG with treadmill we recommend the use of custo cardio 300 with ergometry cable, carrying case as well as custo wing electrodes. → The patient should ideally be wearing running shoes or trainers.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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).
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 custo cardio 300 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.
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→ Open the screen Examination, Resting ECG or Stress ECG, Settings, Device , ECG Device → The ECG device is shown in the “ECG devices” section: cardio 300 → If it is not displayed, click Scan (search process). → Select the device: cardio 300 →...
There, click on Devices and Printers, Add Device. → The ECG device is found. → Select the entry custo cardio 300 in the “Add device” dialogue box and click Next. → The device is added without pairing code. CMA 0018 ∙ DK 2132 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de...
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→ Open the screen Examination, Resting ECG or Stress ECG, Settings, Device , ECG Device → The ECG device is shown in the “ECG devices” section: cardio 300 → If it is not displayed, click Scan (search process). → Select the device: cardio 300 →...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 →...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 →...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 3.2.5 Extended ECG settings Changing the ECG colour scheme: The ECG colours are preset in custo diagnostic and can be changed under Examination, Settings, System, ECG colour. Click on Save to apply your changes.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Automatic ECG – Autostart button → Click on Autostart to start the automatic recording. → The default setting for the duration of automatic recording is ten seconds. →...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Fig. 23: 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: →...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 →...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 →...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 →...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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)
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Display and control elements in the Sport ECG Fig. 37: Sport ECG evaluation view Recorded ECG Sum complex Table of measured values Unconfirmed report Traffic light image with graphical representation of the evaluation...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 .
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 3.10 Optional: Reporting with approval process If custo diagnostic is used with approval process, authorised persons with corresponding user rights can save pre-reports of other persons as a report...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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! Washing with a disinfectant: →...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 Disposal of 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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.
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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 →...
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Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 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...
IEC 61000-3-2 Not applicable Voltage fluctuations/flickers IEC 61000-3-3 Not applicable Manufacturer’s declaration – electromagnetic immunity custo cardio 300 meets the test levels specified here. Phenomenon EMC standard / test method IMMUNITY TEST LEVEL Static electricity discharge (ESD) IEC 61000-4-2 ± 8 kV contact discharge ±...
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Recommended protective distances between portable and mobile RF telecommunication devices and custo cardio 300 custo cardio 300 is designed for use in an electromagnetic environment in which the RF transients can be controlled. The user can help avoid electromagnetic interference by maintaining the minimum distance between...
Resting and stress ECG ∙ custo cardio 300 EC Declaration of Conformity Simplified declaration of conformity custo cardio 300 complies with the requirements of the Medical Device Directive 93/42/EEC or Medical Device Regulation (EU) 2017/745 and Directive 2011/65/EU. Hereby custo med declares that the radio device type(s) custo cardio 300 BT;...
Description Complementary parts Part no. Quantity/pc. Carrying bag custo cardio 300 incl. belt 12213 USB connection cable A-A, 3 m for custo cardio 300 12221 USB universal power supply for custo cardio 300 12212 Battery AAA LR03 Micro 1.5V 20033 Bluetooth 4.0 USB adapter...
Safety Hardware Software Hygiene Resting and stress ECG ∙ custo cardio 300 List of Figures Fig. 1: Safety distances at the patient area Fig. 2: custo cardio 300 part designation Fig. 3: custo cardio 300 Status display Fig. 4: Electrode control after switching on Fig.
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