Custo Med custo guard holter Operating Manual
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Custo Med custo guard holter Operating Manual

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Operating Manual
Holter
custo guard holter
custo diagnostic 5.9
CMA 0037 ∙ DK 2244 ∙ Version 001 ∙ 2024/01/10

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Summary of Contents for Custo Med custo guard holter

  • Page 1 Operating Manual Holter custo guard holter custo diagnostic 5.9 CMA 0037 ∙ DK 2244 ∙ Version 001 ∙ 2024/01/10...
  • 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

    2.10 Patient instructions, handling of the device ..........42 Software .................... 44 3.1 custo diagnostic program structure ............. 44 3.2 custo guard holter connection to the PC ............ 45 3.3 Performing a holter recording ............... 47 3.3.1 Select device for recording ..............47 3.3.2 Selecting and configuring analysis parameters ......
  • Page 4 3.3.5 Transferring the recording parameters to the device ....51 3.3.6 Monitoring - control and improve electrode system ....52 3.4 Work aid “custo guard holter status viewer” ..........53 3.5 Read in and display the recording ..............54 3.6 Opening evaluations ..................56 3.6.1 Opening an evaluation via the evaluation search ......

  • Page 5: Safety

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 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:...

  • 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 Holter ∙ custo guard holter 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...

  • 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 Holter ∙ custo guard holter 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 Holter

    If patients experience discomfort during a recording, they must contact their physician. The custo med Holter systems are perfectly safe for patients with a pacemaker. In Holter systems without pacemaker detection, disturbances in the ECG signal may be incorrectly interpreted as a pacemaker.

  • Page 15: Residual Risks Holter

    Safety Hardware Software Hygiene Holter ∙ custo guard holter Residual risks holter DANGER Risk of strangulation due to neck strap, cable adapter and ECG cable guard. → Do not leave infants or small children unattended during recording. → Store out of reach of children when not in use.
  • Page 16 Safety Hardware Software Hygiene Holter ∙ custo guard holter CAUTION Skin irritations and skin injuries caused by custo wing electrodes Applying custo wing electrodes to injured skin areas causes skin irritation and impairs wound healing. Patients with skin diseases or blood coagulation disorders may suffer skin injuries when custo wing electrodes are removed.

  • Page 17: Hardware

    Holter ∙ custo guard holter Hardware Intended use custo guard holter is a wearable Holter recording device with an internal power supply, and is used to record a 3-channel ECG signal in accordance with Holter standards. custo guard holter includes pacemaker detection. In addition to the ECG signal, the patient’s movement data (walking, running, prone, seated, etc.) is also...

  • Page 18: Indications And Contraindications

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 2.1.1 Indications and contraindications Indications for Holter ECG Sauer, G., Andresen, D., Cierpka, R., Lemke, B., Mibach, F., → Symptoms that may be related to arrhythmias Perings, Ch., & Vaerst, R. (2005).

  • Page 19: Overview Holter Software And Recorder

    4) custo screen 300 is a pure ABPM recorder. If it is connected to the patient at the same time as a custo med holter recorder, the two recordings are displayed as a combined evaluation due to the common recording period.

  • Page 20: Symbols On The Devices And Packaging

    Software Hygiene Holter ∙ custo guard holter Symbols on the devices and packaging custo guard holter, ECG cable guard 3/4, custo guard base 1/6, custo wing adaptor, custo wing single-use adhesive electrodes Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany...
  • Page 21 Safety Hardware Software Hygiene Holter ∙ custo guard holter Lot designation Minimum shelf life, for use until (MM YYYY, e.g. 10 2021) Single-use article, do not reuse Temperature limit Keep dry CMA 0037 ∙ DK 2244 ∙ Version 001 ∙ 2024/01/10 ∙ www.customed.de...

  • Page 22: Technical Data And System Requirements

    Hardware Software Hygiene Holter ∙ custo guard holter Technical data and system requirements custo guard holter ECG recording device 1) The battery runtime depends on the age of the battery. After Number of ECG channels 500 or more charge cycles, the...
  • Page 23 Safety Hardware Software Hygiene Holter ∙ custo guard holter custo guard base charging and communication unit Model: 1-slot 6-slot Power supply Max. charging current 130 mA 6 * 130 mA = max. 780 mA Dimensions (L * W * H) approx.
  • Page 24 Safety Hardware Software Hygiene Holter ∙ custo guard holter 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. 200 Ohm...
  • Page 25 Safety Hardware Software Hygiene Holter ∙ custo guard holter Technical requirements for the operation of custo diagnostic custo diagnostic SERVER, hardware and operating system → custo diagnostic server is designed to run on any hardware or virtualised systems. → The PC hardware or the virtualised environment must meet the minimum requirements of the operating system used.
  • Page 26 Safety Hardware Software Hygiene Holter ∙ custo guard holter Software requirements for the operation of custo diagnostic custo diagnostic SERVER Approved operating systems (64-bit Windows only): → Microsoft Windows 11 64 bit (recommended for small environments only) → Microsoft Windows Server 2019 →...

  • Page 27: 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 28: Components For The Recording

    Components for the recording custo guard holter, 3-channel holter recording device custo wing adaptor (for single-use adhesive electrodes) custo wing single-use adhesive electrodes for custo guard holter custo guard base 1 charging and communication unit Micro USB cable 2.0 1.5 m...

  • Page 29: Charging Process

    In storage mode, no LED display appears when charging the custo guard holter device. The storage mode is deactivated when custo guard holter is connected to custo diagnostic for the first time. 2.6.1 How to work with custo guard base 1 Fig.3: Charging custo guard holter...

  • Page 30: How To Work With Custo Guard Base 6

    Connect the custo guard base 6 charging and communication unit to the PC via the USB-mini-cable. → As soon as custo guard holter devices are placed on the custo guard base 6 charging and communication unit, they are available in the custo diagnostic software interface.

  • Page 31: Loading Process For Unlimited Recordings

    (beep) every 15 minutes. custo guard holter must be recharged within these 8 hours. If custo guard holter is not charged within these 8 hours, the device switches off - however, the device can still be charged within the next 24 hours and recording resumed.

  • Page 32: Display And Control Elements

    Display and control elements 2.7.1 Start and marker key The custo guard holter recording device has a start and marker function. Both functions are activated by firmly tapping the upper part of the housing in the area of the custo med logo...

  • Page 33: Status Display

    2.7.3 Acoustic signals When starting the custo guard holter device, it emits a beep. This applies for all start options in the custo diagnostic Holter software (Start now, Start later/manually, Automatic start at a specified time). Manual markers set during recording are confirmed via a short beep.

  • Page 34: Procedure Of An Examination

    If the recording is to be started manually, firmly double-tap the custo guard holter device at the desired start time. → Instruct the patient in the correct use of the custo guard holter device, 2.10 Patient instructions, handling of the device, p. After the recording →...

  • Page 35: Attaching The Recorder To The Patient

    Holter ∙ custo guard holter Attaching the recorder to the patient There are various methods of putting the custo guard holter on the patient. A suitable method can be selected for the patient’s specific anatomy. Normally, the custo guard holter is put on with the custo wing electrodes. For larger/wider patients, putting the device on with the ECG cable guard 3/4 is recommended –...

  • Page 36: Attaching To Patient With Custo Wing Electrodes

    → Apply the two custo wing adaptor connectors to the snap button contacts of the custo guard holter. Press the custo wing adaptor and the custo guard holter together with your forefinger and thumb until the snap button contacts engage →...

  • Page 37: Attaching To Patient With Ecg Cable Guard 3

    (alternatively, custo ECG cable guard 3l with cable lengths of 460 bis 495 mm can be used): → Press custo guard holter firmly onto the four contact points of the ECG cable guard 3 →...

  • Page 38: Attaching To Patient With Ecg Cable Guard 4

    – the cables can reach further. ECG cable guard 4 allows recording of two independent channels. → Press the custo guard holter firmly onto the four contact points of the ECG cable guard 4 → Attach the electrodes to the cable ends.

  • Page 39: Attaching To Patient With Custo Belt Electrode Belt

    “3” = custo belt green snap button → custo guard holter “L” = custo belt yellow snap button Fig. 14: Attaching the custo guard holter to the patient with custo belt 3 CMA 0037 ∙ DK 2244 ∙ Version 001 ∙ 2024/01/10 ∙ www.customed.de...

  • Page 40: Length Adjustment Custo Belt

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 2.9.5 Length adjustment custo belt Opening and closing the custo belt To open the custo belt, remove the strap from the black plastic hook. To close the custo belt, reapply the strap to the black plastic hook.
  • Page 41 Safety Hardware Software Hygiene Holter ∙ custo guard holter Adjustment from medium length to minimum length Hold the slider with your left hand and pull the elastic excess length completely to the right through the slider until the slider is again between the black plastic hook and the wide point of the material.

  • Page 42: Patient Instructions, Handling Of The Device

    Otherwise, ECG recording is not possible. Patients should contact their physician’s practice for assistance in reattaching the electrodes. custo belt: If the custo guard holter is removed from the electrode belt during recording, ensure that it is reapplied correctly: →...
  • Page 43 Safety Hardware Software Hygiene Holter ∙ custo guard holter CAUTION Skin irritations due to production residues with custo belt → Wash custo belt before first use to remove any production residues and restore the initial condition of the medical device.

  • Page 44: Software

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 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 45: Custo Guard Holter Connection To The Pc

    In storage mode, no LED display appears when charging the custo guard holter device. The storage mode is deactivated when custo guard holter is connected to custo diagnostic for the first time. → Connect the custo guard base charging and programming unit to the PC with the USB cable.
  • Page 46 Holter ∙ custo guard holter Preparing the Bluetooth connection (for monitoring) A Bluetooth connection between the custo guard holter ECG device and the custo diagnostic workstation is required for the ECG monitoring in custo diagnostic (e.g. to check ECG quality before recording). Requirements: Windows 10 and Bluetooth Low Energy.

  • Page 47: Performing A Holter Recording

    In the right half of the screen, all available custo guard holter devices connected to the PC are displayed in a list → In the right half of the window, select the custo guard holter device to be used for recording . By clicking on a list entry , the corresponding device in the custo guard base flashes briefly (for approx.

  • Page 48: Selecting And Configuring Analysis Parameters

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.3.2 Selecting and configuring analysis parameters → Select a set of holter parameters, e.g. Standard , or create a new set: Edit → Edit: Buttons 1 - 5 contain additional pages of analysis parameters.

  • Page 49: Set Derivation, Start Type And Duration

    Set derivation, start type and duration → Depending on the method of application, the ECG derivations 1) custo guard holter calculated differently. Specify how custo guard holter is applied to the derivations in custo diagnostic: with custo belt: F, T1, T2; patient with ECG cable guard 3: I, II, III;...

  • Page 50: Selecting A Patient For The Recording

    (beep) every 15 minutes. custo guard holter must be recharged within these 8 hours. If custo guard holter is not charged within these 8 hours, the device switches off - however, the device can still be charged within the next 24 hours and recording resumed.

  • Page 51: Transferring The Recording Parameters To The Device

    Transferring the recording parameters to the device → The recording parameters and patient data are then transmitted to the custo guard holter device. Depending on the type of recorder start, the custo guard holter device then provides various visual and acoustic feedback signals: ...

  • Page 52: Monitoring - Control And Improve Electrode System

    F, T1, T2; Examination, Holter, Monitoring. with ECG cable guard 3: I, II, III; → Place the custo guard holter device on the patient, see 2.9 Attaching the with custo wing: A, B, C; recorder to the patient, p.

  • Page 53: Work Aid "Custo Guard Holter Status Viewer

    → If several custo guard holter devices are connected to the PC (via custo guard base 6), a device is identified by clicking on the list entries in the “custo guard holter status viewer”. The battery LED of the corresponding custo guard holter flashes quickly (for approx.

  • Page 54: Read In And Display The Recording

    Select the appropriate device type. Fig. 23: Read in recording immediately or later → If custo guard holter was selected as the device type, a dialogue for selecting the custo guard holter device appears . The custo guard holter...
  • Page 55 Safety Hardware Software Hygiene Holter ∙ custo guard holter → For recordings without patient data: If the holter recording device was started without patient data, the recording must be assigned to a patient at this point. → Optional further dialogues: Further dialogues can follow, depending on the device type or software version, for example: “Evaluation Start Time”...

  • Page 56: Opening Evaluations

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 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 57 Safety Hardware Software Hygiene Holter ∙ custo guard holter 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 58: Opening An Evaluation Via The Evaluation Main Menu

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.6.2 Opening an evaluation via the evaluation main menu → Open the examination main menu via Examination, Holter. → Click on Show evaluation → The patient search screen appears. Select the patient whose evaluation Tip for entries in the patient you want to open.

  • Page 59: Evaluation Structure

    Safety Hardware Software Hygiene Holter ∙ custo guard holter Evaluation structure Start screen page “holter overview”: 24-hour graph (trend) with a tabular summary of all events. Further screen pages of the evaluation: Beat class analysis: Trend & ECG: ECG examples:...

  • Page 60: Workflow For Writing The Report For An Evaluation

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.7.1 Workflow for writing the report for an evaluation Getting to the report in five steps Holter Overview screen: Check quality and rhythm, exclude ECG (Options, Exclusion). Analysis screen: Check, rename, summarise templates/beat classes (N/V/A) ...

  • Page 61: Context Menu

    Excel and PDF export of the evaluation. → ABPM Combined recording of the Holter ECG and ABPM. Only with custo screen 300/310 in combination with a custo med Holter ECG device → RR variability (Heart Rate Variability/HRV) Graphical representation of the heart rate variability.
  • Page 62 Safety Hardware Software Hygiene Holter ∙ custo guard holter guard holter (up to 7 days). Only with custo flash 500/510/510V and custo guard holter → ST analysis → Total ECG Full-page representation of the ECG, view of the complete recording →...

  • Page 63: Screens Of The Evaluation

    Safety Hardware Software Hygiene Holter ∙ custo guard holter Screens of the evaluation 3.8.1 Holter overview 24 hours graph (trend) 1) The present events are sorted by severity in descending order. HR average (dark blue, between HR maximum and minimum), results...

  • Page 64: Analysis

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.8.2 Analysis On the Analysis page, the beat classes of the recording can be checked, 1) custo diagnostic settings for summarized and reassigned. All recorded QRS complexes are summarized into beat classes: To specify the number of beat classes in an beat classes.
  • Page 65 Safety Hardware Software Hygiene Holter ∙ custo guard holter Editing options on the Analysis page Display and editing levels: → Analysis screen page: all beat classes of the evaluation → Compressed class: selected class with assigned classes → Single complexes: single beats of the previously selected class The individual levels are opened by double-clicking on a class or by clicking on the Show all button.

  • Page 66: Trend/Ecg

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.8.3 Trend/ECG 24 hours graphic (trend) with zoom function 1) About the mouse functions: Movement data (e.g., upright, resting (right), walking, ...); Measure RR intervals: By clicking in the ECG signal, a line...

  • Page 67: Examples

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.8.4 Examples Sample preview with an ECG example for every event 1) Editing, deleting and Additional information on the selected example. Selection by mouse restoring examples: After you Delete examples, the undo click.

  • Page 68: Further Standard Functions

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.8.5 Further standard functions Comparison Comparison (button always bottom left) of two evaluations of a patient, each with trend, HR summary and events. By clicking on an event button, the event is displayed in the graphic. The date lines above the tables can be opened with a mouse click to display further evaluations of the patient.
  • Page 69 Safety Hardware Software Hygiene Holter ∙ custo guard holter Trend/ECG An interactive table detailing all events over the entire recording period and ECG in relation to the cursor position in the table. Each event is represented in the form of a black line in the table. Click on the black lines to display the corresponding position in the ECG.
  • Page 70 Holter-ABPM evaluation A Holter-ABPM recording can be performed with custo screen 400 or also with a separate custo med holter recorder and an ABPM recorder. If you perform an ABPM recording in addition to the holter recording, you can open both recordings as a combined evaluation in custo diagnostic (time offset <...

  • Page 71: Professional Functions

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.8.6 Professional functions Heart rate variability HRV (options, HRV) 1) Values for HRV: Graphical representation of HRV (view: 24 hours) NN intervals: Time between Buttons for displaying HRV for 24h, day, night, 1 hour...
  • Page 72 Safety Hardware Software Hygiene Holter ∙ custo guard holter AF Diagnostics (Options, AF Diagnostics) AF diagnostics is used for conclusive and reliable detection of atrial fibrillation and atrial flutter. Detection is based on P wave diagnostics and rhythm analysis. The path to obtaining conclusive AF diagnostics consists of five steps, the first three of which are for identification and the last two for verification.
  • Page 73 Safety Hardware Software Hygiene Holter ∙ custo guard holter Pacemaker analysis (Options, Pacemaker) You can open the Pacemaker analysis page via the Options menu with the Pacemaker or by clicking on the number of pacemaker beats on the evaluation overview screen page.

  • Page 74: Optional Functions

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.8.7 Optional functions ANS diagnostics (Options menu, ANS diagnostics) 1) The relationship between the two areas of influence during ANS diagnostics provides an overview of the balance of the autonomic nervous the night can be interpreted as system.

  • Page 75: Printing The Evaluation

    Safety Hardware Software Hygiene Holter ∙ custo guard holter Printing the evaluation Alternative ways to create a printout: 1) To execute print jobs saved in the Job Manager, click on → Printout according to the system settings using the Print button.

  • Page 76: Confirming The Evaluation

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.10 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 77: 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 78: Ending The Evaluation

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 3.12 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 79: Hygiene

    Holter ∙ custo guard holter 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. Cleaning agents and disinfectants must not be sprayed directly onto or into the device.

  • Page 80: Hygienic Reprocessing

    Safety Hardware Software Hygiene Holter ∙ custo guard holter Hygienic reprocessing custo guard holter, custo wing adaptor, ECG cable guard 3/4 → Reprocessing type: wipe disinfection WICHTIG: Do not store moist ECG transmitters in the charging and communication unit. Only place dry devices in the charging and...

  • Page 81: Recommended Cleaning Agents And Disinfectants

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 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: →...

  • Page 82: Disposal Of Contaminated Consumables

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 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.

  • Page 83: Appendix

    Safety Hardware Software Hygiene Holter ∙ custo guard holter Appendix Calculation methods in the Holter Beat identification Beat identification in custo diagnostic is carried out using the VES identification algorithm from Kraft et al (2023): Kraft, D., Bieber, G., Jokisch, P., & Rumm, P.
  • Page 84 Safety Hardware Software Hygiene Holter ∙ custo guard holter Information on changes in the ST segment ST segment analysis takes place on two analysed leads. There are no calibration signals. For the ST segment, the user can select the following from the detection criteria for the ST segment changes: →...
  • Page 85 Safety Hardware Software Hygiene Holter ∙ custo guard holter INFORMATION: Depending on the recording device and electrode application system, the derivations are named differently in custo diagnostic. custo flash 5xx: I, II, III custo guard holter with... custo wing: A, B, C...

  • Page 86: Ecg Derivations For Custo Belt 3

    Safety Hardware Software Hygiene Holter ∙ custo guard holter ECG derivations for custo belt 3 Fig. 47: ECG derivations custo belt 3 Custo belt 3 has three electrodes of which two (R and L) are located in frontal position and the third can be positioned in either a lateral or dorsal direction.

  • Page 87: Keyboard Navigation And Shortcuts

    Safety Hardware Software Hygiene Holter ∙ custo guard holter 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 88 Safety Hardware Software Hygiene Holter ∙ custo guard holter 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 Examination main menu Ctrl A...
  • Page 89 Safety Hardware Software Hygiene Holter ∙ custo guard holter Shortcuts in the Sample Preview screen Arrow keys Move inside the examples Itm1 Selection cursor jumps to first example Selection cursor jumps to last example Page up scroll up one page...

  • Page 90: Manufacturer's Declaration Regarding Emc

    IEC 61000-3-2 Not applicable Voltage fluctuations/flickers IEC 61000-3-3 Not applicable Manufacturer’s declaration – electromagnetic immunity custo guard holter 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 ±...
  • Page 91 Recommended protective distances between portable and mobile RF telecommunication devices and custo guard holter custo guard holter 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...

  • Page 92: Ec Declaration Of Conformity

    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 93: Product Components And Accessories

    LM506 Bluetooth 4.0 USB adapter 55050 USB extension cable 1.8m, plug A-socket A 16018 custo clean CA3, hygienic bag for the custo guard holter 40010 50 pieces with ECG cable guard 3 custo clean WA, hygienic bag for the custo guard holter...

  • Page 94: List Of Figures

    Fig. 12: ECG cable guard 4 with custo guard holter Fig. 13: custo guard holter with ECG cable guard 4 on the patient Fig. 14: Attaching the custo guard holter to the patient with custo belt 3 Fig. 15: custo diagnostic main menu Fig.
  • Page 95 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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