Holter-ABPM Synchronous recording of ABPM and Holter ECG with custo screen 400 and custo diagnostic

Transcription

1 Operating Manual Holter-ABPM Synchronous recording of ABPM and Holter ECG with custo screen 400 and custo diagnostic Features: custo diagnostic V04 and higher for Windows GEB 0204 DK

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3 Operating Manual Holter-ABPM Synchronous recording of ABPM and Holter ECG with custo screen 400 and custo diagnostic 2017 custo med GmbH 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. The current version can be downloaded from our website: in the section SUPPORT, Manuals. Manufacturer s contact details: custo med GmbH Maria-Merian-Str Ottobrunn Germany Phone: +49 (0) Fax: +49 (0) info@customed.de Internet:

4 Table of contents Introduction 01.1 Symbols on the devices Intended use Symbols used in this Operating Manual Safety instructions 02.1 General notes Safety installations and safe working Information on EMC (Electromagnetic Compatibility) Maintenance (regular safety checks) Disclaimer Warranty Description of device, basic instructions for initial operation 03.1 Part names, components for Holter-ABPM recording Changing the custo screen 400 batteries, operating the device Charging the custo guard ECG transmitter custo diagnostic basic program structure Device connection and configuration Connection and set-up for infrared interface custo com IR Setting Holter-ABPM and Holter-ECG recorder Mode of operation of the custo screen 400 system Hygiene 04.1 Cleaning and disinfection Recommended cleaning agents and disinfectants Carrying out an examination 05.1 Overview of the work steps Patient instructions, operating the recorder Starting the Holter-ABPM recorder in custo diagnostic Program start, selecting the recorder Setting the Holter ECG parameters Selecting the custo guard ECG transmitter Setting the ABPM parameters Starting the recording Fitting the custo guard ECG transmitter ECG Monitoring Fitting the recorder to the patient Fitting for Holter-ABPM recording Fitting for Holter ECG recording Taking off the recorder and downloading the recording Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

5 06 07 Working with the evaluation 06.1 Opening the Holter-ABPM evaluation Structure of the Holter-ABPM evaluation Holter-ABPM evaluation pages Holter-ABPM overview Analysis Trend/ECG Examples ABPM overview Printing the evaluation Options for creating a Holter-ABPM printout Setting up the content of ABPM print pages Writing the report Ending the evaluation Archiving evaluations Product information 07.1 Measurement and status indication on the display Error codes and their causes Technical data and system requirements Support Manufacturer s Declaration regarding EMC (electromagnetic compatibility) according to IEC : EC Declaration of Conformity Putting out of operation, storage and transport Disposal Keyboard navigation and shortcuts in custo diagnostic Appendix MASTER COPY: Patient Diary for 24-Hour Recordings Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 5

6 01 Introduction 01.1 Symbols on the devices (custo screen 400, custo com IR, custo guard, custo charger single) Manufacturer: custo med GmbH, Maria-Merian-Str. 6, Ottobrunn, Germany CE mark Protection class classification of medical electrical equipment according to IEC (Type BF) The device is not suitable for newborn babies and infants. Non-ionising electromagnetic radiation, the device contains a HF-transmitter Illustration on the custo screen 400 recorder to indicate the direction of insertion for the SD card (custo flash card mini) IP65 Protection class of electrical equipment (protection against the ingress of foreign matter and spray water) Observe the Operating Manual Separate collection of electrical and electronic equipment, do not dispose with domestic waste 01.2 Intended use custo screen 400 is a Holter-ABPM recorder with an internal power supply, for the synchronous recording of ABPM and Holter on a patient. Recording can take up to 24 hours and it is used to assess the blood pressure characteristics, in combination with the ECG which was recorded as well. The 3-channel ECG signal is taken via the custo guard 3 ECG transmitter (includes the custo belt 3 electrode belt) in accordance with the Holter ECG standard. The ECG transmitter has an internal power supply and transmits the data to the custo screen 400 recorder via radio. The 3-channel ECG is received in the recorder via a radio interface. With custo screen 400, separate ABPM recordings (72 hours max.) OR Holter ECG recordings (24 hours max.) can be carried out. The type of recording is defined when the recorder is started in the medical operating system custo diagnostic. 6 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

7 custo screen 400 is perfectly safe for patients with a pacemaker. Pacemaker recognition is not possible with the device. Caution: The ECG recording may be affected by pacemaker pulses. The system is intended for use by trained specialist staff or physicians in clinics and medical practices. Patients are only allowed to use the recording device after receiving instruction by trained specialist staff. Patients who are not capable of understanding and following the instructions given are not allowed to use the device. This applies in particular to senile patients or patients suffering from dementia. The device is not suitable for unsupervised operation with unconscious patients (applies to recordings with ABPM). The system is not suitable for the electro-cardiographic monitoring of patients in accordance with IEC , e.g. for use in intensive care Symbols used in this Operating Manual This Operating Manual uses the following symbols to indicate important information, comments and tips: ACTIONS THAT ARE PROHIBITED or not allowed under any circumstances! WARNING used to indicate situations which, if not avoided, may result in personal injury and property damage NOTE provides important information which must be observed TIP contains practical information to assist you with your work Words highlighted in colour indicate buttons or click paths to the corresponding program point, e.g. Examination, ABPM Words highlighted in colour.. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 7

8 02 Safety instructions 02.1 General notes 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 should be kept ready to hand close to the device. As either the operator or user of this device you should have read and understood this Operating Manual, in particular the safety instructions. Laws and regulations applicable to the product This system is designed in accordance with Medical Device Directive 93/42/EEC, Class II a, and meets the requirements of protection class I or II (depending on the power supply unit used, the recorder and the ECG transmitter are devices with an internal power supply), type BF in accordance with IEC Other devices which are part of the system must meet the requirements of the Standard for Information Technology Equipment (IEC 60950) or the Standard for Electrical Medical Devices (IEC ). The electrical installations in the rooms in which the system is used must meet the requirements of the applicable safety standards (e.g. VDE 0100 Part 710). For users outside the Federal Republic of Germany, the respective national accident prevention measures, regulations and requirements apply Safety installations and safe working custo screen 400 must only be used in a technically perfect condition. Regularly carry out a visual inspection of the device and the associated components. Only use accessories approved by custo med. Installation of the system Portable socket outlets must not be placed on the ground. Portable multiple socket outlets which are supplied with the system are to be used only for supplying devices which are part of the system. Additional portable multiple socket outlets, lines and other equipment which are not part of the system, must not be connected to the system. When using a multiple socket outlet, the maximum permitted load is 3200 VA. Slots which are not used in the delivered system (portable multiple socket outlets) must be provided with covers. 8 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

9 Ambient conditions for the custo screen 400 system (Recorder and ECG transmitter) For the installation and the operation of the device the EMC notes (electromagnetic compatibility) in this operating manual must be observed, refer to chapter 07.5 Manufacturer's Declaration regarding EMC.... The custo screen 400 system is not suitable for use in rooms and/or areas with a risk of explosion. Strong electromagnetic sources in the immediate vicinity of the custo screen 400 system may result in recording errors. The custo screen 400 system must not be stored or used in the vicinity of X-ray equipment, diathermy units and magnetic resonance devices (MRT). Other electrical devices such as mobile phones or radio transceivers may impair the quality of the recording. The custo screen 400 recorder is not protected against the ingress of dust and spray water. custo screen 400 must be protected from moisture, dust, dirt and mechanical impact such as dropping or transport damage. The custo guard ECG transmitter is protected against the ingress of dust and spray water (IP65). It is not permitted to wear the device in a swimming pool or in the bath. The ECG transmitter must not be submersed. The custo guard ECG transmitter contains a lithium polymer battery. Any mechanical stress which is beyond the intended use must be avoided. Do not use force to open the device. The custo guard ECG transmitter may only be used in combination with the custo belt electrode belt or adhesive electrodes. Electrode belts from other manufacturers may change the band width and amplitude of the ECG signal which could result in a misdiagnosis. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 9

10 02 Safety instructions Patient safety Safety distances of devices to the patient 1.5 m 1.5 m 1.5 m 2.5 m 2.5 m 1.5 m 1.5 m 1.5 m Without medical protective devices, for example medical protector, the PC and all the non-medical devices connected to the system (e.g. the monitor and printer) must be set up and used at a distance of at least 1.5 m to the patient unit (see the orange area in the figure) as leakage currents may occur. Any non-medical devices and the patient must not be touched at the same time during the examination. During routine maintenance work on non-medical devices connected to the system the patient must not be touched (risk of electric shock). Make sure that the electrode contacts do not come into contact with other conductive parts. All results of the automatic analysis and the resulting unconfirmed reports produced by the system must be considered as suggestions only. For diagnosis and therapy purposes it is essential that the results are checked and assessed by a qualified physician. Notes on pacemaker detection With custo guard pacemaker detection is not possible. Any interference in the ECG signal may be interpreted as a pacemaker by mistake. Notes on blood pressure measurements with the custo screen 400 A permanent cuff pressure, e.g. from a bent cuff tube can cause injury to the patient. If the cuff pressure continues, the patient should open the Velcro fastening on the cuff or switch off the recorder. Compressing or reducing the cross section of the cuff tubes should be avoided. 10 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

11 The cuff must not be placed on wounds, open areas or areas where surgery has been carried out recently. Blood pressure measurements may impair the function of other medical devices which are attached to the patient near the blood pressure cuff. Ensure that the brief interruption of the blood circulation due to the measurement method does not affect the patient permanently. Ensure that the intervals between the blodd pressure measurements are sufficient. The results of blood pressure measurements may be influenced by: the patient's position (lying down, standing, sitting), movement, the general health of the patient, heart rate-related or ventricular events as well extreme temperatures and relative humidity. Observe the operating conditions and the patient instructions. The device is not protected against the potential impact of high-frequency (HF) surgery devices. Do not use damaged batteries in any circumstance. If the custo screen 400 will not be used for an extended period, remove the batteries. If any liquid has been spilled onto the device, remove the batteries or rechargeable batteries immediately and send the device to your authorised custo med dealer or custo med. custo flash card mini memory card For recordings with custo screen 400 use the original memory card (custo flash card mini) only. Do not save any other non-examination data on the custo flash card mini. The parts of a custo screen 400 system (ECG transmitter, recorder, custo flash card mini) must stay together for the whole of the examination and must not be swapped with parts of other custo screen 400 systems. Please ensure that the device and recording data are always clearly allocated to the patient. Hygiene For cleaning and disinfection observe the legal requirements and the current state of technology. Use only cleaning agents and disinfectants approved by custo med for cleaning and disinfection. Clean and disinfect your device in accordance with the specifications given in Chapter 04 Hygiene. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 11

12 02 Safety instructions System and data security The device must only be used with the supplied custo med software (custo diagnostic). As the operator you are responsible for ensuring regular data backups (patient databases, evaluations etc.) and system backups. We recommend that you backup the data at the latest before new installations, updates and far-reaching system configurations. custo diagnostic new installations, updates and system configurations may only be performed by your authorised custo med dealer. Only change data generated in custo diagnostic within custo diagnostic itself and not in your EPR system (Electronic Patient Record) or your hospital information system (HIS). custo med does not accept any responsibility for any changes to data in your EPR system or your HIS which were made after the export from custo diagnostic. To ensure the safe operation of custo diagnostic, deactivate the screensaver and energy management options on your PC. Set up your operating system in such a way to prevent the PC from being switched off either accidentally or automatically during the examination (standby mode/ idle mode). custo connect When you use custo connect to integrate additional medical devices in the custo med system, for automatic PDF printouts from the connected medical device, check whether the PDF file belongs to the current patient. Do not trigger any PDF printouts in other programs during the PDF printout in the connected medical device. When you use custo connect to integrate additional medical devices in the custo med system, on starting the connected medical device check whether the patient name was taken over correctly. 12 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

13 Data management in custo diagnostic: Assign evaluation (allocate evaluation) If an examination was conducted with incorrect patient data, the evaluation can be subsequently allocated to the correct patient. Make sure that the evaluation is definitely allocated to the correct patient. An incorrect allocation can lead to a misdiagnosis. Please note that data which has already been exported to an external system (e.g. surgery IT system) cannot be changed. custo diagnostic is preset with the Assign evaluation function deactivated; however it can be reactivated via user rights if necessary. Only the Supervisor can configure the user rights. If the Assign evaluation function is activated, it can be found in the evaluation search or in open evaluations in the Options menu. We recommend configuring user rights in custo diagnostic so that only authorised persons can execute the Assign evaluation function. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 13

14 02 Safety instructions 02.3 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. For connecting the device to other equipment, only specially screened cables supplied by custo med may be used Maintenance (regular safety checks) The operator is responsible for maintenance. The operator must ensure that the device is checked for proper condition at the latest every two years. The functionality and the state of accessories must be checked at regular intervals. If damaged and/ or heavily soiled, the complete system must no longer be used. Any interventions in the existing system, changes to system components, enhancements as well as internal cleaning and repairs may only be performed by your authorised custo med dealer or custo med. Technical safety check After each system or device repair, modification or conversion, a technical safety check must be performed by your authorised custo med dealer. Technical measurement check For custo screen 400 a technical measurement check must be carried out every two years. Please contact your authorised custo med dealer Disclaimer The manufacturer is not responsible for improper operation, failure to comply with the safety instructions and non-observation of specifications due to negligence. custo med only assumes responsibility for the safety and reliability of the device if all changes, enhancements, repairs and any other work on the device and/or system have been performed by an authorised custo med dealer or custo med and the Operating Manual has been observed during device operation. 14 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

15 02.6 Warranty Our product philosophy is committed to providing you with faultless products which meet your expectations. Should you have reason to complain we aim to rectify any defects immediately or provide a replacement delivery. This does not include damage that can be attributed to usual wear and tear, improper use, unauthorised modification of parts and the use of violent force. Only use original spare parts and accessories from custo med even after the end of the warranty period. This is the only way to ensure the safe and problem-free operation of your device. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 15

16 03 Description of device, basic instructions for initial operation 03.1 Part names, components for Holter-ABPM recording custo screen 400 Holter-ABPM recorder, including SD card (custo flash card mini) Standard blood pressure cuff Carrying case for custo screen 400 Carrying belt Batteries (set of 3) type AA Mignon, 1.5 Volt 16 custo guard 3 (3-channel ECG transmitter) custo belt 3 (3-channel electrode belt) custo charger single (charger for custo guard) Power supply unit for custo charger single Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

17 Starter kit custo com IR infrared interface incl. USB connection cable, type B mini (data transmission between PC and recorder) USB card reader (not shown) Accessories for ECG recording Bag for custo guard Neck strap for bag Cable adapter for disposable adhesive electrodes Accessories for blood pressure measurements Tip: custo screen protect hygiene set For increased hygiene and comfort when wearing the blood pressure cuff we recommend the use of custo screen protect non-woven pads. The non-woven pad is worn underneath the blood pressure cuff with the fluffy side on the skin and the protective layer facing away from the skin. A custo screen protect hygiene set contains six washable non-woven pads. Other blood pressure cuff sizes: Small cm, XL cm, XXL cm, Standard without retainer, XXL without retainer USB cable for connection to a PC custo screen protect hygiene set Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 17

18 03 Description of device, basic instructions for initial operation 03.2 Changing the custo screen 400 batteries, operating the device Inserting the batteries or rechargeable batteries Open the battery compartment as shown on the left and insert three standard batteries. The direction of insertion is shown on the drawings inside the battery compartment. Functional elements on the device On-Off switch: for switching the recorder on and off I = on 0 = off Infrared interface for data transmission between custo screen 400 and a PC Connection for blood pressure cuff Card slot for mini SD card Function key for starting and stopping measurements Display to show results and error messages (refer to chapters 07.1 and 07.2) 18 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

19 03.3 Charging the custo guard ECG transmitter IMPORTANT: Charge the custo guard ECG transmitter before using it for the first time! Connect the charger to the mains. Only use the power unit supplied for the charger. The charger is ready for operation when the LED on the charger lights up orange. On the custo charger single, the LED is next to the connection for the power supply unit plug. Place the custo guard ECG transmitter on the charger. The direction of insertion follows the shape of the housing. The LED in the ECG transmitter (in the centre of the custo med logo) indicates the charging status. Remove the ECG transmitter from the charger when it is fully charged. custo guard LED states (when the ECG transmitter is in the charger) LED red custo guard is being charged LED green Charging is completed, custo guard is fully charged For technical reasons an ECG transmitter which is indicated as fully charged (green LED) during removal, may indicate the charge status (red LED) again when it is removed and re-inserted in the charger. Charging and running time Charging will take a maximum of 2 hours (when it is fully discharged). The maximum running time is approx. 2 days when recording 3 ECG channels. We recommend charging the ECG transmitter after every recording. Clean and dry the ECG transmitter before placing it on the charger. Soiled or damp ECG transmitters will damage the charger contacts over time. There must be no ingress of moisture into the charger. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 19

20 03 Description of device, basic instructions for initial operation 03.4 custo diagnostic basic program structure The program is divided into three areas User, Patient and Examination. This structure ensures that you can always recognize who (which user) is carrying out what type of examination with whom (which patient). You can go to the main menus of each area by clicking on User, Patient or Examination. In the User main menu, the system users can be created and managed. The user administration can be used to allocate user rights and control user-specific settings, e.g. the creation of a separate patient database for each user. The Patient main menu is used for patient administration. Its most important functions include Search for Patient, New Patient and Search Evaluation. The Examinationmain menu lists all the examination types which can be carried with custo diagnostic. The modules you do not own are deactivated this can be recognised by the light grey font. This menu is also linked to the Settings area. This area is for making cross-program, examination-related and user-specific settings. 20 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

21 03.5 Device connection and configuration Requirement: custo diagnostic is installed on your PC and ready for operation 1). The custo med devices and components may only be connected to the PC after custo diagnostic has been installed. The required device drivers are installed using the custo diagnostic standard set-up or via targeted selection during the custo diagnostic set-up Connection and set-up for infrared interface custo com IR Connect the infrared interface custo com IR to your PC 2). The device drivers are installed automatically. Check in the Windows device manager which COM connection is allocated to custo com IR so that you can enter it in custo diagnostic. To do this, right-click the Workplace icon or the Computer icon from your Windows user interface, then Manage in the context menu, there click on Device Manager (left-hand side of the window). On the right-hand side of the window, open the menu point Connections (COM and LTP) and write down the connection for custo com IR, e.g. (COM5). In custo diagnostic, open the page Examination, Settings, Connection, Device. In the device area, select IrDa, custo com IR and, in the Connection area select the corresponding COM port from the device manager. By clicking on Save your data will be applied. 1) custo screen 400 and custo com IR in combination with existing custo diagnostic software: custo screen 400 is downward compatible and can also be started as an ABPM-recorder in older custo diagnostic versions. Holter-ABPM recordings with custo screen 400 are only possible from custo diagnostic 4.1 onwards. The driver for the infrared interface custo com IR is included in the custo diagnostic set-up from version onwards. If you have an older version of custo diagnostic and you don t want to carry out a custo diagnostic set-up a manual driver installation must be carried out for the custo com IR infrared interface. Please contact your authorised custo med dealer. 2) Using other infrared interfaces: custo screen 400 can also be connected via older infrared interfaces, such as custo com USB or JetEye, to your PC. The connection and configuration procedure is identical to the one for the custo com IR. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 21

22 03 Description of the device, basic instructions for initial operation Setting Holter-ABPM and Holter-ECG recorder 3) Holter-ABPM recordings are started via the infrared interface custo com IR (Option custo screen 400) and downloaded in custo diagnostic via mini SD card (flash card option). Therefore both options must be set up and saved here. Connect the USB card reader to your PC. The device driver is installed automatically. In custo diagnostic, open the page Examination, Holter, Settings, Connection, Device. Select the Holter-ABPM recording device. To do this, activate the options 3) flash card and custo screen 400. The flash card option refers to the custo flash card mini (mini SD card). This card is inserted in the custo screen 400 recorder during recording and is used for data storage. The recorded data is downloaded to custo diagnostic via the USB card reader. To enable this process, the drive path of the USB card reader and/or the custo flash card mini directory must be selected in the Directory area. To do this, click on the... button at the end of the line and select the custo flash card mini directory (identified as CUSTO FLASH in the file browser when the card has been inserted in the USB card reader). Clicking on OK will apply the selection. With the custo screen 400 option select the infrared interface custo com IR in the Interface area. Save your input. The device is ready for operation. The configuration as ABPM recorder is shown in the Operating Manual ABPM with custo screen 300/400 and custo diagnostic. 22 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

23 03.6 Mode of operation of the custo screen 400 system Technical processes: ECG transmission to a PC (monitoring) When the custo guard ECG transmitter is attached to the patient, the ECG transmitter takes the ECG signal from the patient and sends it to the custo screen 400 recorder via radio. The custo screen 400 recorder receives the ECG signal and transmits it to the PC via the infrared interface. There, the ECG signal is displayed in custo diagnostic. Recorder start via the infrared interface Technical processes: Saving data during recording During recording the custo screen 400 recorder saves the ECG signal and the results of the blood pressure measurements on the mini SD card. The recorder must not be put down during recording. After recording the mini SD card is removed from the recorder and inserted in the USB card reader. From there, the recording is downloaded to custo diagnostic and displayed as an evaluation. Downloading the evaluation via the mini SD card Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 23

24 04 Hygiene 04.1 Cleaning and disinfection Important notes Use only cleaning agents and disinfectants recommended by custo med. Unsuitable agents may damage the device. Observe the manufacturer s specifications (e.g. regarding dosage and contact times). The devices must never be immersed in liquids or cleaned with too much water. custo screen 400 recorder Make sure that the exterior of the device is always aesthetic and clean. Wipe the device using a damp cleaning cloth and a mild (acid-free!) cleaning agent or a suitable disinfectant. Cleaning agents and disinfectants must not be sprayed directly on or into the device. Blood pressure cuff The blood pressure cuff should be cleaned from dirt and sweat after every use. Please observe the information on the package insert of the blood pressure cuff. The cuff tube, especially the BNC plug must not be immersed in liquids under any circumstances. Cleaning and disinfection: Clean the cuff with a damp cloth. If required, remove the bladder and wash the cuff cover with soapy water or a disinfectant solution. The cuff can be disinfected with the following disinfectants: Cidex, Sporicidin, Mikrozid, 70% isopropyl alcohol, ethanol 70%, Buraton fluid. After disinfecting the cuff, rinse under clear water and air dry. Sterilisation: The cuff can be sterilised with ethylene oxide (EtO) gas. After sterilisation the parts that were exposed to EtO must be aired; all relevant regulations and safety precautions must be complied with. Do not autoclave. custo guard ECG transmitter, cable adapter for adhesive electrodes Clean the custo guard ECG transmitter and cable adapter after each examination. custo guard and cable adapters can be cleaned with a soft, lint-free cleaning cloth which has been dampened with a suitable disinfectant. The contacts must not be soiled or damaged. 24 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

25 custo charger for ECG transmitter The charger can be wiped with a soft, lint-free cleaning cloth. The contacts must not be soiled or damaged. This can lead to an impairment of the charging function. Washing instructions for textiles custo belt electrode belt, bag and neck strap for ECG transmitter, carrying case and belt for custo screen 400 recorder Machine washable at 40 Do not use bleach. Do not iron. Do not tumble dry. The textiles listed above can be machine washed at up to 40 degrees. In addition, we recommend a quick disinfection with alcohol after each use. The custo belt electrode belt can be washed in the washing machine up to 30 times. The custo belt must not be reused after it has been used on infectious patients Recommended cleaning agents and disinfectants custo screen 400 recorder, custo belt electrode belt and textiles: all disinfectants approved for medical use which are exclusively alcohol-based (e.g. propanol, ethanol). Approved disinfectants for blood pressure cuff refer to Chapter 04.1 Cleaning and disinfection, Blood pressure cuff section. custo guard ECG transmitter, cable adapter for adhesive electrodes: Bacillol cleaning tissues (Bode) Only use alcohol-based disinfectants! Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 25

26 05 Carrying out an examination 05.1 Overview of the work steps Refer to the Operating Manual for custo screen 300/400 START Patient instructions, operating the recorder Patient instructions Start Holter-ABPM recorder in custo diagnostic for: Starting the recorder for: Holter-ABPM (combi) via infrared 24h Holter ECG via infrared ABPM via infrared Applying ECG transmitter ECG monitoring Fitting the custo screen 400 recorder to the patient. Fitting the recorder to the patient Fitting the blood pressure cuff Fitting the blood pressure cuff Blood pressure test measurement Blood pressure test measurement DOWNLOADING Remove recorder and accessories from the patient Removing the recorder from the patient Downloading recording in custo diagnostic as: Downloading the recording as: Holter-ABPM (combi) via card reader 24h Holter ECG via card reader ABPM via infrared Ending evaluation Ending evaluation 26 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

27 05.2 Patient instructions, operating the recorder Operating the recorder The recording day selected should be as normal as possible (not a holiday, no outof-the-ordinary events). The recorder (switched on) and the cuff must also be worn during the night. On the day of the recording no x-rays must be taken. Sources of interference such as electrical stimulation devices must be avoided. Each measurement is announced with a beep (unless this function is deactivated in custo diagnostic). Using default settings, the measurements are performed every 15 minutes during the day and every 30 minutes during the night. The recorder must be protected against extreme cold, heat, moisture, dirt and mechanical impact. No showers, no visits to the swimming pool and sauna. The custo flash card mini must not be removed from the recorder during the recording. ABPM: Preventing incorrect measurements The arm to which the cuff is fitted must be kept still during measuring. Any physical activity must be stopped. When measurement has failed, a new measurement is automatically performed after two minutes. If several measurements fail during recording (in particular, E6, E21-24 and E25-28) it must be checked if the cuff is still positioned correctly. The marker should be located on the brachial artery and the cuff should be positioned on the arm in such a way that approximately two fingers fit between the cuff and the arm. If any problems occur during recording If any problems occur during recording, e.g. if the cuff pressure is too high, the patient must contact the physician. The patient can stop the measurement at any time by pressing the function key or by opening the Velcro fastening of the cuff. Holter ECG: Correct fitting of the ECG transmitter If the ECG transmitter is removed during recording, it must be ensured that it is aligned correctly when it is refitted: the custo med logo ( C ) and the writing on the ECG belt must be fitted in the direction of reading. If it is fitted incorrectly the ECG signal will not be directed correctly. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 27

28 05 Carrying out an examination 05.3 Starting the Holter-ABPM recorder in custo diagnostic The steps necessary to record and evaluate Holter-ABPM data in custo diagnostic are shown without a surgery IT system or HIS connection. This chapter shows the standard procedure for starting the recorder. Additional functions such as the risk stratification will only be mentioned briefly Program start, selecting the recorder Please ensure that the infrared interface is connected to the PC and ready for operation and that the SD card is inserted in the recorder. Start custo diagnostic and log in with your user name and password, if required. Click on Examination, Holter, New Holter. The screen for setting the recording parameters is displayed. Select custo screen 400 as Holter Recorder. 1) Information on the Start Later function: When the function Start Later is used, a patient will not be selected normally. The function Start Later is used for setting up a recorder in advance and anonymously, before a patient is present. The recording parameters are transmitted to the recorder during the start procedure (without any patient data). After the data transmission the recorder is switched off. The recording will only start when the recorder is switched on again. After the recording, when the recorder is received, the evaluation must be allocated to a patient immediately or the device must be identified with patient data. Always ensure that the device and recording data are always clearly allocated to the patient Setting the Holter ECG parameters Set the analysis parameters for ECG recording. Select a set of analysis parameters which has already been saved, e.g. Standard or create a new set. With the Edit button, the analysis parameters can be re-defined and saved. With the buttons 1 to 4 more pages with analysis parameters can be opened. Pacemaker: must be deactivated (not available with custo guard). Print diary: Printing out the patient diary during the start procedure. Rechargeable battery: activate if custo screen 400 is operated with rechargeable batteries. Autostart with patient: This enables the selection of a patient, if the recorder is started via the Start Later button 1). With Save as... the set parameters can be saved with a new name and made available for more recordings. With Save the original parameters are overwritten. 28 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

29 Selecting the custo guard ECG transmitter To enable a data transmission between the ECG transmitter and the custo screen 400 recorder during recording, the devices must be connected to each other. This is done by saving the serial number of the ECG transmitter to be used in the recorder. To save it, click on Change in the custo guard ECG area. On the right-hand side of the screen a list of ECG transmitters is displayed. Find the serial number of the ECG transmitter to be used on the rear of the housing 2) and select this serial number in the list on the screen. If the ECG transmitter you need is not included in the 3) list, start a search via Search guards. 2) The serial number of the ECG transmitter can be found at the rear of the housing: The serial numbers on the ECG transmitter and in custo diagnostic, in the custo guard ECG area must be identical. If you are only working with one custo screen 400 system or there is only one ECG transmitter skip work steps to. The serial numbers on the ECG transmitter and in custo diagnostic must always be checked, refer to. Later, when starting (Start Now / Start Later), the serial number of the ECG transmitter from the custo guard ECG area is transferred to the recorder 4). 3) Via the Add button ECG transmitters can be added manually to the list. 4) Safety information for ECG recording: If the function Start Later is used, the recorder and the allocated ECG transmitter must be stored together until it is fitted to the patient. If an incorrect ECG transmitter which is allocated to a different recorder is fitted to the patient, the ECG will not be recorded as there is no connection between the recorder and the ECG transmitter. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 29

30 05 Carrying out an examination 5) If only a Holter ECG is recorded, the option ABPM must be deactivated (no further settings required). 6) The software module Risk stratification is part of screen professional and is not included as standard. Risk stratification is used to determine the 10-year risk of severe cardiovascular disease for the patient The risk is calculated from the severity level of the blood pressure and the cardiovascular risk factors of the patient. The blood pressure severity results from the ABPM recording. The risk factors must be entered in custo diagnostic at the start of the recording or during the evaluation. 7) The procedure for selecting a patient is described on the following page, in the section Start Now Setting the ABPM parameters For a Holter-ABPM recording the option ABPM must be selected 5). Set the start parameters for the blood pressure measurements: select a set of parameters that has already been saved, e.g. Standard or create a new set. The day and night phases and the measuring intervals of the selected set are displayed below the selection field. With the Edit button, the start parameters can be re-defined and saved. Day, night and additional phases can be set here. In the repeat measurements area you can set whether another measurement is to be carried out if the limit values are exceeded or not achieved. Beep: Emits a signal tone before each measurement so that the patient can prepare him/herself. Display results: After each measurement, the measurement results are shown on the recorder display. With Save as... the set parameters can be saved with a new name and made available for more recordings. With Save the original parameters are overwritten. If risk stratification 6) is used, set the patient's risk factors here. To do this, click on Set Risk Factors. Then select the patient for whom you want to set the risk factors 7). When the patient is selected, the dialogue for entering the risk factors is displayed. By clicking on Confirm the entry is saved and the risk entry dialogue is closed. 30 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

31 BEFORE YOU START: insert new batteries or fully charged batteries into the recorder. Always use complete rechargeable battery sets (do not mix low batteries with fully charged/new batteries) Starting the recording Switch the custo screen 400 recorder on. Once it has been switched on, place the recorder in front of the infrared interface (at a distance of approx cm). Click on Start Now or Start Later 8) (bottom left on the screen). Sequence for Start now The patient search screen appears 9). Select a patient for the examination. Enter the patient's name or the first letter of their name into the input fields of the patient search screen. Select the patient from the list below the input fields and confirm your selection by clicking on the Select Patient button. You can also select the patient by double clicking on the corresponding name. 8) Here a patient does not need to be selected (unless Autostart with Patient has been selected) and the ECG monitoring screen is not displayed. Switch off the recorder when the data transmission is complete. The recorder and the ECG transmitter must be stored together until the transmitter is fitted to the patient. 9) The patient does not need to be selected when a patient has been selected during the selection of the risk factors for the risk stratification. The transmission of the recording parameters is triggered immediately. If the patient does not yet exist in your database, click on the New Patient button. Enter the patient data. The fields marked with an asterisk are mandatory. Save the details to enter the patient in your database. Data transmission When the patient has been selected, the recording parameters and patient data are transferred to the recorder. If the message Please activate the ABPM recorder! appears during the data transmission, press the round function key next to the display to activate the recorder. If the connection was successful, PC will be displayed on the recorder display. The Monitoring screen is opened. Fit the custo guard ECG transmitter to the patient and check the ECG signal on the screen Monitoring (These work steps will be described on the following pages). Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 31

32 05 Carrying out an examination 05.4 Fitting the custo guard ECG transmitter L Fitting with custo belt electrode belt The ECG transmitter is fitted to the upper part of the patient's body with the custo belt electrode belt. The skin must be free from grease and toiletries. The electrode belt must be set up so that it fits tightly and the contact surfaces make good contact, but that the patient is not impaired or that breathing is not interrupted. The contact surfaces on the inside of the electrode belt must not be soiled. Soiling will affect the quality of the ECG. If you cannot achieve a good ECG signal with the belt position shown, change the position of the ECG transmitter. Move the ECG transmitter slightly to the left or to the right and watch the ECG signal. CAUTION: The electrode contact surface must always be in contact with the skin. Please ensure that there are no textiles between the electrode and the skin (e.g. excess length of electrode belt or belt loop). R 3 R 1) The two snap fastener contacts of an ECG lead have different diameters. Only one end of the ECG lead will fit onto the ECG transmitter contacts. For fitting, try both ends, if required. Do not use force. L Fitting with cable adapter for adhesive electrodes The ECG transmitter can also be worn in a bag around the neck: Attach the cable adapters to the ECG transmitter. The cable adapters are fastened to the snap fastener contacts with the designations R, L and 3. 1) Attach the electrodes (e.g. custo sensive) to the cable adapters. Place the ECG transmitter in the bag and close the bag. Attach the neck strap to the bag. Adjust the neck strap to the required length. Clean the electrode contact points, the skin must be free from grease and toiletries. Remove the protective films from the electrodes. Stick the electrodes to the chest, refer to figure. 3 To prepare the electrode contact points we recommend the use of custo prep ECG preparation cream. Rub the skin areas to which the electrodes will be attached lightly with custo prep. We also recommend the use of custo sensive ECG electrodes (latex-free, PVC-free, skin-friendly, permeable to air and moisture). 32 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

33 05.5 ECG Monitoring ECG Monitoring is used to check the ECG signal. This screen is opened automatically after the start procedure (Start Now button). As soon as the ECG transmitter is fitted to the patient (refer to chapter 05.4 Fitting the custo guard ECG transmitter), the patient's ECG is displayed on the screen 1). 1) If Monitoring had been closed in the meantime, this screen can be opened again via Examination, Holter, Monitoring. The custo screen 400 recorder may have to be activated for data transmission. Press the function key next to the display. To receive the ECG signal, the custo screen 400 recorder must be switched on and in front of the infrared interface (at a distance of approx cm) and the distance between the patient and the recorder must not be more 3 metres. Please ensure that the line of sight between the ECG transmitter and the recorder is free. Check the ECG quality. If required, change the position of the electrode belt, e.g. move it slightly to the left or to the right. Functions on the screen Monitoring: Stop Recorder: Ends the recording. Restart: Existing recording is deleted, then it re-starts with the recording parameters and patient data which had already been set Pause: Screen display is stopped, e.g. to take a closer look at the ECG section that is currently displayed ECG Monitoring is closed with the End button. For Holter-ABPM recordings a blood pressure test measurement is carried out afterwards. This is only possible when the Monitoring screen is closed and there is no connection between the recorder and the PC ( PC no longer appears on the recorder display). Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 33

34 05 Carrying out an examination 05.6 Fitting the recorder to the patient Fitting for Holter-ABPM recording For a Holter-ABPM recording the patient wears the custo guard ECG transmitter and the blood pressure cuff together with the custo screen 400 recorder. Fitting the blood pressure cuff Fit the cuff to the left upper arm, two to three cm below the armpit. Fit the cuff in such a way that the marking is on the brachial artery. The cuff must not be too tight. You should be able to fit approximately two fingers between the arm and the cuff. Please ensure that you select the correct cuff size for the patient. The cuffs are marked with the arm circumference for which they are suitable, e.g. standard cm. Route the cuff tube from the left shoulder over the right shoulder to the right hip. This is were the recorder will be attached later. Fix the cuff and the tube to the patient. This will prevent failed measurements due to the incorrect position of the cuff or the tube. Use professional fixing aids with little adhesive residue. Fitting belt and carrying case Attach the carrying case to the carrying belt. Place the carrying belt on the patient. The bag should be on the patient's right hip. Place the recorder which needs to be switched on in the carrying bag and close it with the Velcro fastening. Connect the cuff tube to the recorder as shown. Test measurement Press the function key to carry out a test measurement. Please ensure that the patient keeps still during the measurement. In case of a failed measurement improve the fit of cuff and tube. If the test measurement was successful, the patient and the recorder will be ready for recording. 34 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

35 Fitting for Holter ECG recording CAUTION: Simplified fitting for Holter-ECG recordings only, blood pressure cuff is not used. Attach the carrying case to the carrying belt. Place the carrying belt on the patient. Place the switched on recorder in the carrying case and close it with the Velcro fastening. For a Holter ECG recording the patient wears the custo guard ECG-transmitter together with the custo screen 400 recorder. During the recording, the distance between the custo screen 400 recorder and the patient must not be more than 3 metres. Therefore, the recorder should always be carried on the body. If the recorder is taken off, this can cause gaps in the ECG recording. Please note that the ECG transmitter cannot save an ECG. The ECG is sent to the recorder which is within radio range and saved on the mini SD card there. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 35

36 05 Carrying out an examination 05.7 Taking off the recorder and downloading the recording Take the recorder off the patient after the recording: Remove the cuff tube from the recorder Take the recorder out of the carrying case and switch it off Remove the carrying belt, cuff and fixing aids from the patient Remove the ECG transmitter and electrodes and adhesive residue, if required Remove the custo flash card mini from the recorder: Press slightly on the edge of the card, DO NOT use force to pull on the card! Insert the custo flash card mini in den USB-card reader (the recording data is downloaded from the card, not via infrared) Open custo diagnostic... In custo diagnostic, click on Examination, Holter, Download Data. The Workflow after downloading data dialogue appears. There you can determine whether the recording is to be analysed and displayed Now or Later. Now button: The recording is analysed during the downloading process and then displayed. Later button: The recording is stored without analysis in the Task List. The Task List is suitable for downloading several recorders in a short period of time. To make recordings available from the Task Manager, open the Task List via the Examination Main Menu. Activate the Analysis option and start the process (Start button). After the analysis the recordings can be opened. When using several recorder types the Select Holter Recorder dialogue appears. Select the flash card option. Click on Confirm to start the download. 36 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

37 The evaluation is displayed (Now button) or stored in the Task Manager (Later button). The blood pressure curve is faded in and out with the Blood Pressure button. To close an evaluation, click on End and, in the End dialogue on Confirm. Preparation for the next examination Clean and disinfect the recorder, cuff, ECG transmitter, electrode belt and accessories as described in chapter 04 Hygiene. Remove the batteries from the recorder. Charge the batteries fully. Charge the ECG transmitter as described in chapter 03.3 Charging custo guard ECG transmitter. IMPORTANT: Only insert clean and dry ECG transmitters in the charger. Soiled or damp ECG transmitters will damage the charger contacts over time. There must be no ingress of moisture into the charger. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 37

38 06 Working with the evaluation 06.1 Opening the Holter-ABPM evaluation custo diagnostic offers different options to open an evaluation, e.g. via the evaluation search or the main menu of the respective examination (in this case, Holter). Opening an evaluation via the evaluation search. This opens the evalu- Click with the right mouse-button on the Patient button ation search. In the Examination area, enter what type of examination you are searching for, e.g. Holter-ABPM (Combi). In the Properties area you can define more search criteria. If you set the property Confirmed to No, you will receive a list of all evaluations which are not yet confirmed a kind of To-Do list. To start the search, click on Search Evaluation or activate Search automatically. This option triggers an automatic search in your database whenever the search criteria are changed. Reference between End dialogue and search screen The right part of the screen displays a list of all the evaluations which correspond to the activated search criteria. To open the required evaluation, select it from the list and click on the Show Evaluation button or double-click on the evaluation. If you want to use the same search criteria for the next search, activate the Save Selection option. In order to make proper use of the search screen, the correct examination status must be defined in the End dialogue when closing an examination. Example: An examination can only be found in the search screen with the property confirmed set to No if the status Evaluation confirmed is NOT selected in the End dialogue. 38 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

39 Opening an evaluation via the examination main menu Open the Holter main menu via Examination, Holter and click on Show Evaluation. The patient search screen appears. In this screen select the patient whose evaluation you want to open. Enter the patient's name or the first letter of their name into the input fields of the patient search screen. Select the patient from the list below the input fields and confirm your selection by clicking on the Select Patient button. You can also select the patient by double clicking on the corresponding name. A list containing all the evaluations of the patient is then displayed. Select the required evaluation from the list and open it by double-clicking or via the Show Evaluation button. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 39

40 06 Working with the evaluation 06.2 Structure of the Holter-ABPM evaluation Holter-ABPM overview: ECG and blood pressure curve, all ECG events in a table (Examination, Holter, Show Evaluation...) blue text: custo tera software, Holter functions green text: custo screen software, ABPM functions Beat Class Analysis Trend & ECG ECG examples Evaluation comparison Options menu, more pages: ABPM ABPM overview (View mode single or hourly values, with or without risk assessment) RR variability Measured value Table Heart Rate Turbulence Histogram (sys./dia., day/night) Total ECG Evaluation comparison Options menu, more pages: To return to the Holter-ABPM view (Holter, custo tera), close the ABPM view with the End button. The report is entered in the Holter/ ABPM view and saved. Invalid measurements Recorder info Long-term-Trend 40 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

41 Example for the procedure for evaluation and confirmation Possible standard procedure Shortened procedure Starting point: Holter-ABPM Overview Analysis: Control and editing of the beat classes/templates Examples Control and editing of the ECG examples Holter-ABPM Overview: Checking changes and events Trend & ECG: to view the events in context Will be opened in the Holter-ABDM view via Options, ABPM ABPM: Checking the blood pressure measurements, e.g. using trend graphics, measured values, risk assessments, report The ABPM view is closed with the End button. Enter Report (via context menu) Print... (Options menu) Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 41

42 06 Working with the evaluation 06.3 Holter-ABPM evaluation pages Holter-ABPM overview In the overview, up to 24 hours of a recording are displayed. To open the ABPM evaluation 24 h graphic (trend) with HR and blood pressure curve HR average, results from the average heart rate per minute The blood pressure curve is faded in via the BP button With the Zoom button, one hour of the graph is shown enlarged (30 min. before and after the cursor) The ABPM evaluation is opened via Options, Blood Pressure Event log If you click on one of the Events, e.g. VBP, vertical orange lines will appear in the 24 h graph (trend) which indicate when the selected event occurred. The selected event is marked in the overview table with orange lettering and the button pressed. To display another event, click on the button of the desired event. The height of the orange lines in combination with the scale on the right-hand side of the screen provides information on the number of occurrences within one minute. 42 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

43 Night phase The area which is highlighted in light grey in the graph shows the night phase in the recording. The start and end can be changed using the arrows above the graph. Navigation in the 24 h graph Double-click on any position in the 24 h graph (trend) to go to the Trend/ECG page. The position that you clicked on is shown enlarged below the 24 h graph. This method is suitable for viewing specific events in the ECG. By clicking on the Overview button you can return to the Holter-ABPM or Holter overview. menu, with the Blood Pres- Open ABPM evaluation The ABPM evaluation can be opened via the Options sure button. Tabular overview: Summary with the number of all cardiac activities, average HR and blood pressure values List of the existing heart-rate related events List of the existing ventricular events The existing events are sorted in descending order by severity. For each event information is provided on how often it occurred during the recording, in some cases including the maximum value and the time of the maximum value. Navigation options in the tabular overview By double-clicking on any Event button (refer to ) the Trend/ECG can be opened. By clicking on Number/Maximum Value/Time of an Event all Examples of the event can be opened. The examples are ECG sections which contain the corresponding event. Buttons for opening additional evaluation pages Comparison of two evaluations for a patient Analysis graphic representation of all beat classes of the evaluation Trend/ECG 24 h graph in combination with an enlarged ECG Examples overview with several ECG sections for each event Options menu with additional functions for editing the ECG (Options custo tera professional: RR variability and HRT) Prints the evaluation in accordance with the system settings End close the evaluation The context menu The context menu is opened by right-clicking on the evaluation. The report dialogue can be called here. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 43

44 06 Working with the evaluation Analysis (Analysis button in the overview) Number of the selected class Beat classes with normal QRS complexes (N); Navigate within (N) with Next / = scroll forward/backward by one page Beat classes with changed QRS complexes (V); Navigate within (V) with Next / = scroll forward/backward by one page Button for showing the artefact classes (A) Complete ECG Occurrences of the selected beat class are marked in red Scrollbar for navigating through the entire recording; = Go to the next occurrence, = Continuous scrolling Buttons for showing the RR distances, the heart rate or the class numbering below the ECG Button for showing single complexes of the selected class (e.g. for moving single complexes to other classes) Buttons for opening additional evaluation pages Labelling of classes Numbering of the class (numbered in ascending order, 1 to max. 256) Annotation: Normal (N), VPB (V), Artefact (A) or Pacemaker (S) Number of single complexes in the class Percentage relative to the number of all QRS-complexes recorded 44 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

45 Editing options on the Analysis page All the recorded QRS complexes are summarised in beat classes. The classes are sorted by the criteria Normal (N), VPB (V), Artefact (A) and pacemaker (S), if applicable. The Analysis page shows all the classes of the recording. At this point you can check, summarise and reallocate the classes. Summarising beat classes Select the beat classes you want to summarise with the right mouse button and click with the right mouse button on the numbering (top left) of one of the selected beat classes. The selected beat classes are summarised in the beat class with the lowest numbering. To cancel the numbering, click again with the right mouse button on the numbering of one of the selected beat classes. Changing the allocation of a beat class To change the allocation (N/V/A/S) of a beat class, continue to left-click the letter on the top right in the corresponding beat class until the correct allocation is shown. You can also change the allocation of several beat classes at the same time. Select the desired classes with the right mouse button and continue to click in one of the selected classes with the right mouse button on the letter until the correct allocation is shown. Keyboard shortcuts: The allocation of one or several classes can also be changed by pressing the letters N, V, A and S on your keyboard. Moving single complexes of a beat class To show the single complexes of a beat class select a beat class and click on the Single complex button. To move single complexes to another beat class, select one or several single complexes (left mouse key and Shift key) and click on the Move button. A dialogue appears in which you can select the beat class to which you want to move the selection. Click on the Confirm button to execute out the change. Applying changes When you change to a different evaluation page, all changes you made on the Analysis page, will be applied automatically. The ECG is analysed again taking your changes into account. Alternatively, you can execute the New Analysis function on the Analysis page in the Options menu. A dialogue appears informing you that the evaluation is currently being re-analysed. Click on Confirm to start the process. With Cancel the changes are discarded. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 45

46 06 Working with the evaluation Trend/ECG (Trend/ECG button in the overview) Trend (24 h graph) with zoom function Enlarged ECG display Pull-down menu for selecting an event The selected event is marked in red in the enlarged ECG The centrally positioned letters in the ECG show the type of event In the trend (24 h graph) the selected event is marked with orange lines. The height of the lines in combination with the scale on the right-hand side of the screen shows the number of events per minute Mouse functions Mark, Change, Time or Measure Reduced ECG (e.g. 15 min/page) with identification of the selected event Tabular display of the events with highlighted maximum values ST measurement Scrollbar for navigating in the ECG signal Display of the RR distances, heart rate or beat classes underneath the ECG Changing the amplitude size, moving the zero line, resetting the changes 46 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

47 Note on opening the Trend/ECG page When you double-click on an event button in the overview, the Trend/ECG page is shown with the clicked event marked in red. Event-related navigation on the Trend/ECG page By dragging the scrollbar (below the ECG) across the entire length of the recording you can obtain an overview enabling you to quickly access artefacts and ranges without a signal. When you click the buttons, the program automatically goes to the previous or next occurrence of the selected event. The selected event is marked in red in the ECG. Via the pull-down menu more events can be selected. When you click the buttons, the ECG is shown constantly across the screen. Instead of clicking the buttons below the ECG, you can also use the arrow keys on your keyboard to navigate to specific events in the ECG. Editing options on the Trend/ECG page The mouse function menu contains various tools such as Measure, Mark and Change. Use the two arrow buttons to switch between the tools. The tool currently shown in the Mouse Function field is active and can be used in the ECG. Measuring of RR distances When you click in the ECG signal, a red line appears the starting point of your measurement. Additional lines appear when you drag the mouse to the left or right. Click to fix the distances between the lines. The lines disappear when you click again. Marking ECG sections (e.g. for highlighting events) To mark an ECG section, drag the red cursor in the ECG signal across an ECG section. When you release the cursor, a dialogue appears in which you can name the marking and then print it or save it as an episode in the evaluation. Episodes are stored with the examples. Changing events To edit a beat or an event (e.g. changing a VPB to an artefact), double-click on the corresponding position in the ECG. A dialogue appears in which you can correct the original allocation. Click on Confirm to apply the change. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 47

48 06 Working with the Evaluation Examples (Examples button in the overview) Example preview with ECG sections for each event Additional information on the selected ECG section, example sections are selected with a mouse click. The header of the selected section has a black background. Button for deleting the selected ECG section Button for showing all the examples of the selected event Editing and navigation options Opening the Trend/ECG page Double-click in an ECG section to open the Trend/ECG page with the corresponding position in the ECG. The event is marked in red. Click on the Examples button to return to the example preview. Changing the allocation of examples In the context menu you can change the allocation of examples. Select a section, open the context menu and click on the Change button. In the Edit beat dialogue select the desired event. In this dialogue you can also rename or reallocate the entire example group of the selected example or delete the selected example. Click on Confirm to apply the changes. 48 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

49 ABPM overview (can be opened in the Holter-ABPM overview, via Options, Blood Pressure) Setting page contents: Single/hourly values with/without risk assessment 1) Heart rate curve (orange) and blood pressure curve (green) Controller for changing the night phase (grey area) Cursor for the targeted selection of points in the blood pressure curve, output of the values in the Cursor section of the table Table with mean blood pressure values and the number of measurements Fading in and out of the limit value lines in the blood pressure curve Risk assessment including the 10-year risk of severe cardiovascular disease for the patient 2) Buttons for opening additional evaluation pages Menu Options with more evaluation pages (e.g. Print..., Export, Failed Measurements, Recorder Information, Long-term Trend) Print with system settings Closing the ABPM evaluation, back to Holter-ABDM The unconfirmed report is opened by right-clicking on the evaluation interface. In the context menu, select Report. The unconfirmed report for the ABPM is applied automatically in the Holter-ABPM view when the ABPM evaluation is exited. 1) The software module Risk stratification is part of screen professional and is not included as standard. 2) The risk is calculated from the severity level of the blood pressure and the cardiovascular risk factors of the patient. The blood pressure severity results from the ABPM recording. The risk factors must be entered in custo diagnostic at the start of the recording or during the evaluation. This is done via the Set Risk Factors button. The risk for the patient will only be displayed if risk factors have already been set. Via the ABPM standard values button a tabular overview with the definition and classification of blood pressure severity can be opened. The applicable severity level is marked. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 49

50 06 Working with the evaluation 06.4 Printing the evaluation Options for creating a Holter-ABPM printout 3) To execute the print jobs, open the Task List via the Examination Main Menu. Click on Examination, Task List. Select a task from the list and click on Print or on Print All. Printing in accordance with the system settings (Print button) Individually compiled printing pages for current printing, via Options, Print... (the settings will not be applied permanently) Collecting print orders in the task list 3) for batch processing at a later stage (via Options, Print..., Print Task ). Fig.: Print menu for the configuration of the current printing task (Options, Print... ) Setting options on the page Options, Print... Compiling the contents for the printout Printer selection Amplitude size of the ECG signals on the printout Button for saving the print job in the task list Preview of the compiled print pages Button for starting the printout Button for closing the print menu To ensure that the results of the blood pressure evaluation are printed, the options With BP Trend and ABPM must be selected in the Print page section (on pages 1 and 2). You can find the system settings for Holter-ABPM and Holter print pages on the page Examination, Holter, Settings, Print. To apply changes to the system settings, click on Save. 50 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

51 Print Preview Print Preview is opened via Options, Print..., Print Preview. Zoom in and out of page Scroll forward/back Start printing Close print preview, back to the print settings Setting up the content of the ABPM print pages The print pages of an ABPM evaluation are set up in custo diagnostic on the page Examination, ABPM, Settings, Print, Content. The selected content is applied for the Holter-ABPM print if the option ABPM has been selected in the Holter-ABPM print settings. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 51

52 06 Working with the evaluation 06.5 Writing the report The unconfirmed report can be opened by rightclicking on the evaluation interface. In the context menu, select Report. Enter your data in the white text field. When you click on Confirm your input is saved and the evaluation gets the Confirmed status (see End dialogue ). In the event that your report text is not yet complete but you want to save it nevertheless, without reaching Confirmed status, reset the evaluation Confirmed status in the End dialogue. Text modules for writing reports On the page Examination, Holter, Settings, Diagnostic, Report text modules for writing a report can be created. A total of four groups with up to eight text modules can be stored. The text modules are called in the Report dialogue using keyboard commands (F5 to F12). A text module can be created from normal text as well as variables. When using a text module in the Report dialogue, the actual value from the evaluation is used instead of the variable and is automatically inserted in the report text. The structure of a variable (e.g. heart rate, The Shortcuts for export values button provides you with a list containing all the available variables. The Predefined Report Modules button provides you with a completed set of text modules. The text modules can be changed and extended. If the text modules should be shown in the Report dialogue, make sure that the Enable option is activated. Alternatively, the text modules can be shown in the Report dialogue via the Show modules button. There is also the option of entering a text or a userdefined report text (also as normal text and variables), which will be automatically shown in each report. The predefined text can be changed later in the Report dialogue. Save your input. 52 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

53 06.6 Ending the evaluation On the Evaluation page, click on the End button (bottom right of the screen). The end dialogue is opened. Here the status of an evaluation is defined. Assigning properties (e.g. confirmed/not confirmed) makes it easier to find evaluations in the evaluation search. Confirmed evaluation A confirmed evaluation can be reset to not confirmed by deselecting the option Evaluation confirmed, e.g. if the report text has not been completed yet. Printed Indicates if the evaluation has been printed. Locked After reporting has been completed by an authorised person, set the status of the evaluation to Locked. After that, the evaluation can still be viewed, but no longer changed. Click on Confirm to close the evaluation Archiving evaluations (optional) Archiving is not a data backup (copy), instead your evaluations are just moved to another storage location. Take adequate measures to backup data within your archive at regular intervals in order to avoid data loss. Archiving is used to save recordings on a long-term basis. During archiving, the evaluations are moved to a directory on your hard disc, which you can then save on a data carrier (CD, DVD, etc.). The archiving functions can be found under Patient, Edit Database. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 53

54 07 Product information 07.1 Measurement and status indication on the display Display elements on the display Sys: Systolic blood pressure Dia: Diastolic blood pressure P: Pulse Battery: Lights up when battery power is low If blood pressure measuring is successful... systolic value, diastolic value and pulse are displayed three times in succession During the data transfer between the recorder and the PC... PC is shown on the display (the light-emitting diode of the infrared interface custo com IR flashes) If a measurement fails... an error code is shown on the display, e.g. E06 54 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

55 07.2 Error codes and their causes Blood pressure values exceed limit values Sys: < 70 mmhg > 270 mmhg, Dia: < 40 mmhg > 155 mmhg, Sys - Dia: < 15 mmhg, HF: < 35/min > 220/min Measurement is repeated automatically Pressure release rate outside of the defined limits Cause: Valve leaking and/or defective Customer Service Measurement interrupted/disturbed Cause: too many movement artefacts Fit the cuff carefully, keep the arm steady during measurement Battery voltage too low Insert new or fully charged batteries into the recorder Pressure rises too slowly Cause: Cuff leaking (defective), valve leaking Check the cuff (sealing ring in the connection in good condition/present?) Customer Service Pressure rises too quickly Cause: Cuff tube bent, valve system blocked Align the cuff tube otherwise, contact Customer Service Release period too long Cause: Cuff tube bent, valve defective Customer service, if multiple occurrences during a recording Error during determination of diastolic value Cause: Cuff incorrectly fitted or oscillations too weak, marking on the cuff is not on the artery Fit the cuff carefully, keep the arm steady during measurement Error during determination of systolic value Cause: Systolic value is above the pumping pressure, movement artefacts Fit the cuff carefully, keep the arm steady during measurement If a measurement fails, it will be repeated after two minutes. If an error occurs which is not listed here, switch the device off and back on again. Repeat the required work step. If the error persists, please contact your authorised custo med dealer. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 55

56 07 Product information 07.3 Technical data and system requirements Technical data for the custo screen 400 Measuring method Oscillometric measuring procedure, automatic zero balancing Measuring range Heart rate beats / min Systolic blood pressure mmhg Diastolic blood pressure mmhg Max. number of measurements 512 Max. recording time 72 hours for ABPM recordings 24 hours for Holter-ABPM recordings Duration of a measurement approx. 30 seconds Measuring intervals can be set in the software, between 5 and 90 minutes. Default: during the day every 15 minutes, during the night every 30 minutes Cuff pressure 300 mmhg max. Cuff sizes Small (children) cm Standard (scope of delivery) cm XL cm XXL cm Data transmission custo com IR infrared interface with USB port (IrDA standard) mini SD card for Holter-ABPM recordings Power supply 3 x 1.5 Volt, type AA batteries, 3 rechargeable Ni-MH batteries, 1.2 Volt, 1500 mah min. Operating conditions Temperature +10 C C Atmospheric humidity % rh Air pressure hpa Transport and storage Temperature -20 C C conditions Atmospheric humidity % rh Air pressure hpa Dimensions Size approx. 100 * 66 * 26 mm (L * W * H) Weight approx. 112 g (incl. batteries) Classification Device with internal power supply Class IIa Type BF IEC , IEC to , IEC Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

57 custo guard 3 ECG transmitter Number of ECG channels 3 Sampling rate 125 Hz 3-dB band width ECG amplifier 0.5 Hz Hz Radio frequency band ISM 2.4 GHz Radio transmission power 1 mw maximum Radio performance stationary frequency Radio range approx. 3 m Connection to the PC via a custo screen 400 recorder and custo com IR infrared interface Power supply Rechargeable lithium-polymer battery with 105 mah Battery run time approx. 2 days when recording 3 channels approx. 60 days on standby Charging time of battery approx. 2 hours (after a full discharge) Status indication LED for charge status Dimensions approx. 70 * 42 * 12 mm (L * W * H) Weight 27 g Ingress Protection Rating IP65 Operating conditions Temperature +10 C C Atmospheric humidity % rh Air pressure hpa Transport and storage Temperature -20 C C conditions Atmospheric humidity % rh Air pressure hpa Classification Device with internal power supply, Class IIa, Type BF IEC , IEC custo belt 3 electrode belt Length 680 mm 1400 mm (without stretching) Width max. 50 mm, min. 29 mm Composition PA, biocompatible in accordance with EN ISO Oeko-Tex Standard100 Alternative to custo belt ECG cable adapter, length approx. 300 mm custo charger single charger and power supply unit Power supply 5 V (only use the power supply unit included with the delivery!) max. charge current 80 ma Dimensions 80 * 49 * 33 mm (L * W * H) Operating conditions Temperature +10 C C Atmospheric humidity % rh Air pressure hpa Transport and storage Temperature -20 C C conditions Atmospheric humidity % rh Air pressure hpa Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 57

58 07 Product information System requirements Operating system Windows XP (x64) Windows Vista (x64) Windows 7 (x64) Windows Server 2003 (x64) Windows Server 2008 (x64) Windows Server 2008 R2 older versions are not supported PC The PC hardware should meet the minimum requirements of the operating system used. Provide additional RAM (256 MB) for custo diagnostic. Please ensure that there is sufficient space on the hard disk for the custo diagnostic evaluations. File sizes for evaluations Holter: approx. 15 MB (max. 60 MB) ABPM: approx. 1 MB (max. 2 MB) Holter-ABPM: approx. 20 MB (max. 25 MB) Resting ECG: approx. 200 KB (approx. 10 seconds ECG) Stress ECG: approx. 6 MB (approx. 20 minutes ECG) CPET: refer to stress test ECG Spirometry: approx. 50 KB (max. 256 KB) Rehab: approx. 6 MB (approx. 45 min. of training) Hardware & connections DVD or CD-ROM drive USB port 58 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

59 07.4 Support If you have any questions or problems which are not dealt with here, please do not hesitate to contact your authorised custo med dealer. A list of the authorised custo med dealers can be found in the Internet under in the category CONTACT, Dealers. 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 dealer or contact your authorised custo med dealer and forward your queries. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 59

60 07 Product information 07.5 Manufacturer's Declaration regarding EMC (electromagnetic compatibility) according to IEC :2007 Manufacturer s Declaration electromagnetic emissions The custo screen 400 Holter-ABPM recorder (consisting of ABPM recorder and ECG transmitter) is designed for operation in the electromagnetic environment stated below. The customer or user of custo screen 400 should ensure that it is used in such an environment. Emission Measurements HF emissions according to CISPR11 HF emissions according to CISPR11 Harmonics according to IEC Voltage fluctuations/flickers according to IEC Compliance Group 2 Class B Not applicable Not applicable Electromagnetic Environment - Guidelines custo screen 400 must emit electromagnetic energy to ensure its intended function. Electronic devices nearby may be affected. custo screen 400 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Manufacturer s Declaration electromagnetic immunity The custo screen 400 Holter-ABPM recorder (consisting of ABPM recorder and ECG transmitter) is designed for operation in the electromagnetic environment stated below. The customer or user of custo screen 400 should ensure that it is used in such an environment. Immunity Tests Electrostatic discharge (ESD) according to IEC IEC Test Level Compliance Level ± 6 kv contact discharge ± 8 kv air discharge Electromagnetic Environment - Guidelines ± 6 kv contact discharge ± 8 kv air discharge Floors should be made of wood or concrete or be equipped with ceramic tiles. If the floor is provided with synthetic material, the relative air humidity must be at least 30 %. The quality of the supply voltage should correspond to the one of a typical business or clinical environment. Fast transient electric interference factors/bursts according to IEC Surges according to IEC ± 2 kv for net wires ± 1 kv for input and output wires ± 1 kv push-pull voltage ± 2 kv push-push voltage Not applicable Not applicable The quality of the supply voltage should correspond to the one of a typical business or clinical environment. Voltage drops, short-time interruptions and fluctuations in the supply voltage according to IEC < 5 % U T for 0.5 period (> 95 % drop) 40 % U T for 5 periods (60% drop) 70 % U T for 25 periods (30% drop) < 5 % U T for 5 s (> 95 % drop) 3 A/m Not applicable The quality of the supply voltage should correspond to the one of a typical business or clinical environment. If the user of custo screen 300/400 requires continued function, even if interruptions to the energy supply occur, it is recommended to supply custo screen 300/400 from an interruption-free power supply. Magnetic field with supply frequency (50/60 Hz) according to IEC A/m Magnetic fields with net frequency should correspond to the typical values, as can be found in business and clinical environments. NOTE: U T is the net AC voltage before applying the test levels 60 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

61 Manufacturer s Declaration electromagnetic immunity The custo screen 400 Holter-ABPM recorder (consisting of ABPM recorder and ECG transmitter) is designed for operation in the electromagnetic environment stated below. The customer or user of custo screen 400 should ensure that it is used in such an environment. Immunity Tests IEC Test Level Compliance Level Electromagnetic Environment - Guidelines Portable and mobile radio sets should not be used at a closer distance to the device including the leads than the recommended protective distance which is determined according to the equation of transmitting frequency. Recommended protective distance: Conducted HF transients according to IEC V Effective value 150 KHz to 80 MHz [U 1 ] V Not applicable d = (3,5/U1) P d = (3,5/E 1 ) P 80 MHz to 800 MHz Radiated HF transients according to IEC V/m 80 MHz to 2.5 GHz 3 V/m d = (7/E 1 ) P 800 MHz to 2.5 GHz with P as the nominal power of the transmitter in watt (W) according to the indications of the transmitter manufacturer and d as the recommended protective distance in meters (m). According to an examination on-site a) the field strength of stationary radio transmitters should be inferior to the compliance level with regard to all frequencies. In the vicinity of devices carrying the following symbol, interferences are possible: COMMENT 1: With 80 MHz and 800 MHz the higher frequency range is valid. COMMENT 2: These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by absorptions and reflections of buildings, objects and people. a) The field strength of stationary transmitters, such as e.g. base stations of mobile phones and mobile transmitting stations, amateur radio stations, AM and FM broadcasting as well as television networks cannot be exactly predetermined theoretically. In order to determine the electromagnetic environment regarding the stationary transmitters, a study of the location should be considered. If the measured field strength exceeds the abovementioned compliance levels at the location where the device is used, the device should be watched in order to prove the intended functions. If unusual performance features are observed, it may be necessary to take additional measures, for example reorienting or relocating the device. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 61

62 07 Product information Recommended protective distances between portable and mobile HF telecommunication devices and custo screen 400 custo screen 400 has been designed for operation in an electromagnetic environment in which the HF transients can be controlled. The user can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device depending on the output rating of the communication device, as indicated below. Protective distance depending on the transmitting frequency in m Nominal power of the transmitter 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz W d= (3.5/U1) P d= (3.5/E 1 ) P d= (7/E 1 ) P 0.01 Not applicable Not applicable Not applicable Not applicable Not applicable For transmitters whose maximum nominal power is not indicated in the above table, the recommended protective distance d can be determined in meters (m), using the equation affiliated with the corresponding column. P is the maximum nominal power of the transmitter in watt (W) according to the indications of the manufacturer of the transmitter. COMMENT 1: With 80 MHz and 800 MHz the higher frequency range is valid. COMMENT 2: These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by absorptions and reflections of buildings, objects and people. 62 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

63 07.6 EC Declaration of Conformity Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 63

64 07 Product information 07.7 Putting out of operation, storage and transport Putting out of operation and storage Clean and disinfect custo screen 400 and its components before putting it out of operation. Make sure that the storage location is dust-free, dry and away from direct sunlight. Transport Clean and disinfect custo screen 400 and its components before transport. Use the original packaging for transport. This is a sensitive piece of electronic equipment. If unavailable, pack the device in such a way that it is protected against impact, moisture and dust. The device must comply with the operating conditions when it is put into operation again, e.g. operating temperature (refer to 07.5 Technical Data...). Ambient conditions for storage and transport (custo screen 400 system) Temperature: Air humidity: Air pressure: C % rh hpa 07.8 Disposal The device and all its components must be disposed of in a proper manner in compliance with applicable regulations (that is, in accordance with the valid laws governing electrical and electronic waste). The device must not be disposed of as normal domestic waste. The original packaging can be recycled. (cardboard/paper). 64 Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH

65 07.9 Keyboard navigation and shortcuts in custo diagnostic 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 User master data Call last patient Examination main menu RIGHT-CLICK Evaluation search Call last patient Evaluation last displayed LEFT-CLICK User master data Patient master data Examination main menu RIGHT-CLICK All the patient s evaluations Evaluation last displayed of this examination Keyboard navigation When you press the Alt key, the initial letter of all the buttons on a screen page will be underlined. Pressing an initial letter in combination with the Alt key triggers the corresponding button. Holter-ABPM with custo screen 400 and custo diagnostic GEB 0204 DK 1650 Version custo med GmbH 65