Custo Med screen 300 Operating Manual
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Custo Med screen 300 Operating Manual

Ambulatory blood pressure measurement abpm
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Operating Manual
Ambulatory Blood Pressure
Measurement ABPM
custo screen 300/310
custo diagnostic 5.8
CMA 0016 ∙ DK 2130 ∙ Version 1 ∙ 2022/10/25

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Summary of Contents for Custo Med screen 300

  • Page 1 Operating Manual Ambulatory Blood Pressure Measurement ABPM custo screen 300/310 custo diagnostic 5.8 CMA 0016 ∙ DK 2130 ∙ 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

    2.10 Patient instructions, handling of the device ..........34 Software .................... 36 3.1 custo diagnostic program structure ............. 36 3.2 custo screen 300/310 connection to the PC ..........37 3.3 Performing an ABPM recording ..............38 3.4 Downloading the ABPM recorder ..............41 3.5 Opening evaluations ..................
  • Page 4 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.8.1 Overview “Standard” ................49 3.8.2 Overview “Central Blood Pressure” ..........51 3.8.3 Evaluation screen “Table” ..............53 3.8.4 Evaluation screen “Diagram” ............. 54 3.8.5 Evaluation screen “Comparison” ............55 3.8.6 Evaluation screen “Trend”...

  • Page 5: Safety

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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...

  • 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 Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 Ambulatory Blood Pressure Measurement (Abpm)

    The system is not suitable for unsupervised use with unconscious patients. Never use damaged batteries or rechargeable batteries. If custo screen 300/310 is not to be used for a prolonged period of time, remove the batteries. If liquid has been spilled on the device, remove the batteries or the rechargeable batteries immediately and send the device for inspection to your authorised custo med distributor or custo med.

  • Page 15: Residual Risks Ambulatory Blood Pressure Measurement (Abpm)

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Residual risks Ambulatory Blood Pressure Measurement (ABPM) DANGER Choking hazard due to small parts → Keep small parts away from children. DANGER Risk of strangulation due to cuff tube and carrying strap.

  • Page 16: Hardware

    Hardware Intended use custo screen 300/310 is an ABPM recorder with an internal power supply which is used to record and evaluate the blood pressure behaviour of a patient (from age of 10 years on). The recording time can last for up to 72 hours. The recorder types custo screen 300/310 are characterised by different functions, The system is perfectly safe for use by patients with a pacemaker.

  • Page 17: Indications And Contraindications

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 2.1.1 Indications and contraindications ABPM indications Indications for home blood pressure measurement or ambulatory blood pressure recording: → Suspected white coat hypertension (isolated office hypertension) → Grade 1 hypertension in the office →...

  • Page 18: Recorder Types And Functions

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 2.1.2 Recorder types and functions custo screen ... Recorder functions pediatric APBM recording, max 72 h ✓ ✓ ✓ ✓ Holter-ABDM-recording, max. 24 h – – ✓...

  • Page 19: Symbols On The Devices And Packaging

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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) Medical device Unique Device Identifier Serial number...

  • Page 20: Technical Data And System Requirements

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Technical data and system requirements custo screen 300/310 1) Meets the requirements of the ESH International Protocol Measurement method Oscillometric measuring method 2010 >Automatic zero adjustment 2) Ref: Invasive Validation of...
  • Page 21 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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.
  • Page 22 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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),...

  • Page 23: 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 24: Components For The Recording

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Components for the recording custo screen 300/310 ABPM recorder Cuff D-ring standard, additional cuff sizes available Carrying case for the ABPM recorder Carrying belt 127 cm, optionally 155 cm Batteries (set of 3) Mignon 1.5 Volt, type AA...
  • Page 25 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 TIP: custo screen protect hygiene set, six washable fleece pads – for more hygiene and comfort when wearing the blood pressure cuff. Worn underneath the cuff with the soft side on the skin.

  • Page 26: Device Operation

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Device operation 2.6.1 Inserting the batteries or rechargeable batteries → Open the battery compartment as shown. → Insert three commercially available batteries. → The insertion direction is shown on the drawings in the battery compartment.

  • Page 27: Display And Control Elements

    Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 2.6.2 Display and control elements On-off switch, I = on, 0 = off Infrared interface for data transfer between custo screen 300/310 and Cuff port (BNC) Function key, for starting and stopping measurements Display, for showing results and messages Fig.

  • Page 28: Elements In The Display

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 2.6.3 Elements in the display → Sys: Systolic blood pressure → Dia: Diastolic blood pressure → P: Pulse → Battery: Lights up if the batteries are weak...

  • Page 29: Error Codes And Causes

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 2.6.4 Error codes and causes Error when reading or writing the time → Internal double-layer capacitor (energy storage for the time) discharged → Insert batteries, switch device on Limit values are fallen below or exceeded →...
  • Page 30 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Pressure increase is too fast → Cuff tube is kinked, valve system is clogged → Align the cuff tube → If error still occurs, customer service Discharge period is too long →...

  • Page 31: Procedure Of An Examination

    Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Procedure of an examination Prepare the equipment for recording: → custo screen 300/310 with fresh batteries or freshly charged rechargeable batteries → Cuff in the appropriate size → Optional with custo screen protect fleece pad →...

  • Page 32: Attaching The Recorder To The Patient

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Attaching the recorder to the patient Attaching the blood pressure cuff Make sure to select the correct cuff size for the patient. Each cuff contains information for which arm circumference it is suited, e.g., standard 24 –...

  • Page 33: Patient Information: Removing And Attaching The Device

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Patient information: Removing and attaching the device IMPORTANT: The ABPM recorder must be taken off if you plan to shower or bathe during an ABPM recording lasting several days. Do not get the device wet.

  • Page 34: Patient Instructions, Handling Of The Device

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 2.10 Patient instructions, handling of the device Handling of the recorder The recording period selected should be as normal as possible (not a holiday, no out-of-the-ordinary events).
  • Page 35 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 DANGER Choking hazard due to small parts → Keep small parts away from children. DANGER Risk of strangulation due to cuff tube and carrying strap. → Do not leave small children unattended during recording.

  • Page 36: Software

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 37: Custo Screen 300/310 Connection To The Pc

    Press Save to accept your entries. used with the infrared → The infrared interface is ready for operation. custo screen 300/310 can be interfaces custo com IR and connected to the PC via the infrared interface. custo multi com. Fig. 7: Select a device connection...

  • Page 38: Performing An Abpm Recording

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Performing an ABPM recording NOTE ON THE PROCEDURE: The steps necessary to carry out and evaluate an ABPM examination in custo diagnostic are shown without a surgery IT system or HIS connection.
  • Page 39 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Setting the start parameters → Recorder custo screen ... → Set the start parameters for the blood pressure measurements: select previously saved start parameters, such as Standard or create new start parameters.
  • Page 40 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 IMPORTANT: Insert fresh batteries or freshly charged rechargeable batteries into the recorder before starting. Always use complete battery sets (do not mix weak batteries with freshly charged/new batteries).

  • Page 41: Downloading The Abpm Recorder

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Downloading the ABPM recorder Remove the recorder from the patient: → detach the cuff tube from the recorder, → take the recorder out of its case and switch it off.
  • Page 42 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Evaluation overview, incoming control and printout → After downloading the recording, the evaluation overview is automatically displayed. The standard overview contains the heart rate trend blood pressure trend...
  • Page 43 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Printing the evaluation Click on Print to print the evaluation according to the system settings. The print settings for ABPM evaluations are located on the screen page Examination, ABPM, Settings, Print, Printed pages.

  • Page 44: Opening Evaluations

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Opening evaluations 3.5.1 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 45 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 46: Opening An Evaluation Via The Evaluation Main Menu

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.5.2 Opening an evaluation via the evaluation main menu → Open the examination main menu via Examination, ABPM. → 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 47: Evaluation Structure

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Evaluation structure The most important screen pages of an ABPM evaluation are the Overview, the Table of measured values and the Diagrams. From these three screen pages, the Comparison can be opened at any time to compare the current evaluation with a previous one.

  • Page 48: Navigation In The Evaluation

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Navigation in the evaluation The buttons for opening the various evaluation screens are located at the bottom of the screen. The button for the screen that is currently opened is pressed.

  • Page 49: Screens Of The Evaluation

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Screens of the evaluation 3.8.1 Overview “Standard” Fig. 22: Overview, Standard Set view: single values/hourly values and screen page content, here standard (or risk stratification, central blood pressure)
  • Page 50 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Fig. 23: Options menu Options menu → Print...: Change print settings for the current printout → Export of the evaluation, e.g., Excel, PDF, e-mail or to a directory →...

  • Page 51: Overview "Central Blood Pressure

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.8.2 Overview “Central Blood Pressure” IMPORTANT: only with custo screen 310 and for patients aged 18 and above! Information on recordings with central blood pressure Evaluations with central blood pressure are only possible with custo screen 310.
  • Page 52 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 1) With custo screen 310 multi- day recordings with up to 72 hours are possible. Only up to 24 hours of a recording are displayed in the coordinate system.

  • Page 53: Evaluation Screen "Table

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.8.3 Evaluation screen “Table” Fig. 25: Table of measured values List of all single measurements (or average values per hour), summary total/day/night (the line “valid measurements” shows proportion of valid measurements), average, minimum and maximum values for the entire recording.

  • Page 54: Evaluation Screen "Diagram

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.8.4 Evaluation screen “Diagram” Fig. 26: Diagrams Here you can see at a glance how large the percentage of measurements inside (green) and outside (orange) the limit values is. The percentage of erroneous measurements (grey) can optionally be shown.

  • Page 55: Evaluation Screen "Comparison

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.8.5 Evaluation screen “Comparison” Fig. 27: Comparison Comparison of two evaluations for a patient. More evaluations can be selected using the arrow keys . Click on the Evaluation...

  • Page 56: Evaluation Screen "Trend

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.8.6 Evaluation screen “Trend” Fig. 28: Trend To be opened via Options, Trend. Long-term trend displaying all blood pressure evaluations for a patient. The selected value, e.g. Ps/Pd total...

  • Page 57: Dialogue "Automatic Report

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.8.7 Dialogue “Automatic report” Fig. 29: Automatic report To be opened via Context menu, Auto. Report. The automatic report is created from the day average values, the drop of the day-night average values and the proportion of measurements that are above the limit values.

  • Page 58: Printing The Evaluation

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Printing the evaluation Fig. 30: Print preview The printout is done via the Print button or via Options, Printing ... (print menu of the evaluation, to change the contents for the current printout). The Print preview can be opened via the print menu (Printing ...).

  • Page 59: Confirming The Evaluation

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 60: Optional: Reporting With Approval Process

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.11 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...

  • Page 61: Ending The Evaluation

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 62: Risk Stratification

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13 Risk stratification IMPORTANT: Risk stratification can only be applied to patients over 16 years of age. The “Risk stratification” software module is part of the “professional” software and is not included in the standard version.

  • Page 63: Configuring Workflows

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.1 Configuring workflows Fig. 36: Settings for risk stratification → Start custo diagnostic and open the screen page Examination, ABPM, Settings, Menu/Functions, Workflow. → Enable or disable risk stratification. If the option is not selected, custo diagnostic will not perform risk stratification.

  • Page 64: Defining Evaluation Guidelines

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.2 Defining evaluation guidelines With custo diagnostic standard configuration, risk stratification is performed 1) International risk according to the DHL guidelines (German Hypertension League). Risk stratification is based on data...

  • Page 65: Print Settings For Risk Stratification

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.3 Print settings for risk stratification The contents of the ABPM print pages are defined under Examination, ABPM, Settings, Print, Print pages in custo diagnostic. To print the results of risk...

  • Page 66: Recorder Start With Risk Stratification

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.4 Recorder start with risk stratification INFORMATION: If the risk factors are not entered or checked at this point, this step must be carried out later. The start procedure for a recording with risk stratification corresponds to the standard procedure, see 3.3 Performing an ABPM recording, p.

  • Page 67: Downloading An Evaluation With Risk Stratification

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.5 Downloading an evaluation with risk stratification The download procedure corresponds to the standard procedure, 3.4 Downloading the ABPM recorder, p. 41. After the download the evaluation overview is displayed.

  • Page 68: Evaluation Overview With Risk Stratification

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.6 Evaluation overview with risk stratification Opening an ABPM evaluation with risk stratification works in the same way as a 1) The risk is calculated from standard evaluation. The evaluation overview contains the following display...

  • Page 69: If The Risk Stratification Is Not Displayed

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.7 If the risk stratification is not displayed... If the evaluation does not yet contain risk stratification, this may be because: → Not enough valid blood pressure measurements are available. In this case, risk stratification is not possible (14 valid measurements during day phase are required for the risk stratification).

  • Page 70: Unconfirmed Report With Risk Stratification

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.8 Unconfirmed report with risk stratification To open the unconfirmed report, right-click on the evaluation interface. In the context menu, select Report. The unconfirmed report contains a summary of the blood pressure behaviour, the results of the risk stratification and a trend analysis which compares the current results with the previous report (if available).

  • Page 71: Definition Of The Blood Pressure Severity Grades

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.13.9 Definition of the blood pressure severity grades Risk stratification is performed based on the risk factors of the patient and the blood pressure severity calculated from the recorded values. A table with the blood pressure severity grades can be viewed by clicking on the ABPM Classification button.

  • Page 72: Spot Measurement

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 3.14 Spot measurement IMPORTANT: Only with custo screen 310! The “spot measurement” function can only be used for patients aged 18 and over. A spot measurement is a single blood pressure measurement showing the pulse wave and the central blood pressure.
  • Page 73 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Carry out spot measurement → Make sure that the infrared interface is ready for operation. → Start custo diagnostic and log in. → Click on Examination, ABPM, Spot measurement.

  • Page 74: Hygiene

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 75: Hygienic Reprocessing

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Hygienic reprocessing custo screen 300/310 → Reprocessing type: wipe disinfection Carrying case and belt → Reprocessing type: disinfectant washing in the washing net Blood pressure cuff IMPORTANT: Never autoclave.

  • Page 76: Recommended Cleaning Agents And Disinfectants

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 77: Disposal Of Contaminated Consumables

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 78: Appendix

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Appendix Limit values for adults Limit values brachial (Ps/Pd) Day phase Night phase Systole Diastole Systole Diastole 135 mmHg 85 mmHg 120 mmHg 75 mmHg Limit values central (cPs/cPd)

  • Page 79: Limit Values For Children And Adolescents

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Limit values for children and adolescents To work with limit values for children and adolescents up to 16 years , they 1) S2k Guideline Pediatric Nephrology and Pediatrics: must be selected on the Examination, ABPM, Settings, Diagnostic, Limit values Arterial Hypertension (2013).
  • Page 80 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Definition of hypertension in automatic findings 1) S2k Pediatric Nephrology and Pediatrics Guideline: Based on the limit values described on the following pages, the following Arterial Hypertension (2013).
  • Page 81 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Table 1: Standard values for oscillometric ABPM in children by gender and body length. Boys Systolic blood pressure [mmHg] Diastolic blood pressure [mmHg] Mean arterial pressure (MAP) [mmHg]...
  • Page 82 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Table 2: Standard values for oscillometric ABPM in children by gender and age. Boys Systolic blood pressure [mmHg] Diastolic blood pressure [mmHg] Mean arterial pressure (MAP) [mmHg]...
  • Page 83 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Girls Systolic blood pressure [mmHg] Diastolic blood pressure [mmHg] Mean arterial pressure (MAP) [mmHg] 24-hours Night 24-hours Night 24-hours Night [years] P90 P95 P99 P90 P95 P99 P90 P95 P90 P90 P95 P99 P90 P95 P99 P90 P95 P99 P90 P95 P99 P90 P95 P99 P90 P95 P99...

  • Page 84: Abbreviations In The Evaluation

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Abbreviations in the evaluation Brachial systolic blood pressure Brachial diastolic blood pressure Central systolic blood pressure Central diastolic blood pressure Pulse wave velocity AugP Augmentation pressure Increase in arterial blood pressure due to reflected pulse wave.

  • Page 85: Keyboard Navigation And Shortcuts

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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 86 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 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...

  • Page 87: Manufacturer's Declaration Regarding Emc

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Manufacturer’s declaration regarding EMC Electromagnetic compatibility according to DIN EN 60601-1-2:2016-05 Manufacturer's declaration – electromagnetic emissions Emission measurements EMC standard / test method Compliance RF emissions CISPR11...
  • Page 88 Recommended protective distances between portable and mobile RF telecommunication devices and custo screen 300/310 custo screen 300/310 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 89: Ec Declaration Of Conformity

    Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 EC Declaration of Conformity Simplified declaration of conformity custo screen 300/310 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;...

  • Page 90: Product Components And Accessories

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Product components and accessories Description Product designation Part no. Quantity/pc. custo screen 300 recorder 58020 custo screen 310 recorder 58022 Description Accessories Part no. Quantity/pc. Cuff Wrap small, child...

  • Page 91: List Of Figures

    Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 List of Figures Fig. 1: Safety distances at the patient area Fig. 2: custo screen 300/310 part designation Fig. 3: custo screen protect Fig. 4: custo screen 300/310 Opening the battery compartment Fig.
  • Page 92 Safety Hardware Software Hygiene Ambulatory Blood Pressure Measurement ABPM ∙ custo screen 300/310 Fig. 51: Exceeded limit values in the table Fig. 52: Limit values button in the overview Fig. 53: Limit values for children and adolescents Fig. 54: Note for the assessment of children up to 16 years of age...
  • Page 93 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...

This manual is also suitable for:

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