Resting and Stress Test ECG

Transcription

1 Operating Manual Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic Operating Features: > custo diagnostic version 3.7.x > Windows version (2000, XP, Vista) GEB 0121 DK 0905 Version /03/2009

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3 Operating Manual Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic 2009 custo med GmbH We point to the fact that this manual must not be partly or completely copied, reproduced in any form or translated into another language, without the previous written permission of custo med GmbH. The manufacturer reserves the right to modify the indications in this manual without prior notice. The current version can be downloaded from our Internet site: under Support, Downloads, Manuals. Contact data of the manufacturer: custo med GmbH Leibnizstr Ottobrunn Germany Phone: +49 (0) Fax: +49 (0) info@customed.de Internet:

4 Contents Introduction 01.1 Symbols on the Device Intended Use Symbols in the Operating Manual Safety Instructions 02.1 General Notes Operator Instructions and User Qualifications Safety Installations and Safe Working Information on EMC (Electromagnetic Compatibility) Maintenance (Regular Safety Checks) Exclusion of Liability Warranty Description of Device, Basic Instructions for Initial Operation 03.1 Scope of Delivery and Accessories Operation of custo cardio 100/110 BT (Bluetooth) custo diagnostic Basic Program Structure Device Connection and Installation Hygiene 04.1 Cleaning and Disinfection Approved Cleaning Agents and Disinfectants Carrying out an Examination 05.1 Preparing the Patient for the ECG Recording First Work Steps in custo diagnostic Recording of Resting ECG Monitoring and Electrode Control Record and End Resting ECG Editing Options during the Recording Process Print Recording Recording of Stress Test ECG Selection of Load Profile Monitoring and Electrode Control The Workspace at a Glance Hint for Manual Blood Pressure Measurement Start Recording, Resting Phase Stress Test Phase Recovery Phase and Ending of Recording Editing Options during the Recording Process Print Recording Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

5 06 07 Working with the Evaluation 06.1 Display Evaluation Evaluation of Resting ECG The Workspace at a Glance Navigation in the Evaluation Structure and Connection of the Viewing Modes Evaluation of Stress Test ECG The Workspace at a Glance Navigation in the Evaluation Structure and Connection of the Viewing Modes Confirm Evaluation Auxiliary Tools for Writing Reports Close Evaluation Archive Evaluations Product Information 07.1 Technical Data and System Requirements Support Manufacturer s Declaration on EMC (Electromagnetic Compatibility) EC Declarations of Conformity Shutdown, Storage and Transport Disposal Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 5

6 01 Introduction 01.1 Symbols on the Device Manufacturer: custo med GmbH, Leibnizstr. 7, Ottobrunn, Germany CE mark Follow the operating manual Separate collection of electric and electronic equipment, do not dispose with domestic waste Safety class designation of a medical electrical device according to DIN EN (type BF, defibrillation protected) 01.2 Intended Use custo cardio 100/110/130 is a 12-channel ECG device and serves for recording, analysing and evaluating ECG recordings in doctor s offices and hospitals. custo cardio 100/110/130 can be used without danger for patients carrying a pacemaker. The ECG recording is not affected by pacemaker pulses. custo cardio 100/110/130 is not suited for intra-cardiac application. 6 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

7 01.3 Symbols in the Operating Manual In this operating manual the following symbols are used for marking important information, comments and hints: INTERDICTIONS and undue behaviour, what you must not do in any case! BEWARE of situations which could result in personal or property damage NOTE important information and comments which you must absolutely observe Highlighted words in colour mark buttons or click paths to the described program part, e. g. Examination, Resting ECG Highlighted items Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 7

8 02 Safety Instructions 02.1 General Notes The observation of the safety instructions prevents from personal and property damages while using the device. This operating manual is an integral part of the product and must be kept close to the device. As operator/user of this device you should have read and understood this operating manual, particularly the safety instructions. Product Relevant Laws and Regulations This system is designed according to MDD 93/42/EWG (Medical Device Directive) class II a, and complies with safety class I or II (depending on the power supply unit), type BF (defibrillation protected), according to DIN EN Further devices which are part of the system must comply with the Standard for Safety of Information Technology Equipment (DIN EN 60950) and the Standard for Electro-Medical Devices (DIN EN ). The electrical installation of the rooms in which the system is operated must comply with the requirements of current safety norms Operator Instructions and User Qualifications As operator you are responsible for: Making sure that the operating staff get a technical briefing on the device and take note of the operating manual The intended application through trained, qualified staff The compliance with safety regulations, safety instructions, precautions for occupational medicine and accident prevention The observation of maintenance instructions The users must: Be briefed on the correct operation of the device, master required processes for handling, know the valid safety regulations for the operation of such devices and be informed about potential dangers. Only medically qualified staff are permitted to operate the device, e.g. medical secretaries, nurses, assistant medical technicians, physicians, etc. For users outside the Federal Republic of Germany, those measures for accident prevention, regulations and requirements apply which are valid in the respective country. 8 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

9 02.3 Safety Installations and Safe Working custo cardio 100/110/130 is allowed to be operated in technically flawless condition only. Carry out a visual inspection of the device and the cables regularly, particularly of the patient cable. Only use accessories approved by custo med. The device is only defibrillation-protected with the manufacturer s patient cable. Only use patient cables with defibrillation resistance of 10 KΩ for custo cardio 130. If defibrillation occurs, take note of the manufacturer s indications regarding the safe and correct use of the defibrillator. Defibrillation has a disturbing impact upon the ECG recording. The recovery time of custo cardio 100/110/130 is less than ten seconds. Assembly of the System Power bars must not be put on the floor. Power bars delivered with the system, only serve for supplying devices which are part of the system. Additional power bars, wires and resources which are not parts of the system, must not be connected to the system. When using a power bar, the maximum permissible load is 3200 VA. Slots within the supplied system which are not used (power bars) must be closed with device cover plates. Environmental Conditions, Handling custo cardio 100/110/130 is not suited for the operation in explosive rooms and/or areas. Strong electromagnetic sources in the near vicinity of custo cardio 100/110/130 may lead to faulty measurements (e. g. HF electrosurgical instruments, mobile phones, inductions cookers). The device must not be operated simultaneously with HF surgical devices. The device must be protected against the intrusion of humidity, dust or dirt and against mechanical impacts such as fall or transport damages. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 9

10 02 Safety Instructions Patient Safety 1.5 m Safety distances between the patient and the devices 1.5 m 1.5 m 2.5 m 2.5 m 1.5 m 1.5 m 1.5 m Without medical safety devices, e.g. medical protector, the PC and all nonmedical connected instruments (e.g. monitor and printer) of the system must be installed and operated in a distance of at least 1.5 m to the patient seat (see orange area in the illustration) because leakage current might occur. When coupling it with other devices, it must be assured that there is no danger due to the accumulation of leakage power. During routine maintenance works on non-medical devices of the system, the patient must not be touched (danger of electric shock). See to it that the electrode contacts do not get in touch with other conductive parts. All reports of the system must be considered as suggestions only. For diagnosis and therapy the control and evaluation of the results through a qualified physician is indispensable. custo cardio 100/110 BT (Bluetooth) Handling of Lithium Ion Accumulator Remove the accumulator if the device is not used for a longer time. Use only the supplied charger for recharging the accumulator. The accumulator must be protected against extreme temperatures, fire and humidity. It is not allowed to immerse it in liquids. Take note of the operation and storage conditions. Avoid strong shocks and do not drop the accumulator. The accumulator must not be decomposed, modified or short-circuited. 10 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

11 Hygiene When cleaning and disinfecting, the legal prescriptions and the current state of the art of technology must be considered. Use only cleaning and disinfecting agents approved by custo med. Clean and disinfect your device according to the instructions in chapter 04 Hygiene. Display of the ECG signal in custo diagnostic If electrodes detach from the patient during an ECG recording or if the electrode contact is too weak, a red signal line will be displayed on the corresponding ECG channel in custo diagnostic. Below the ECG recording a hint will appear (in red letters), indicating which electrodes are concerned. Reattach them. The appearance of red signal lines in custo diagnostic does in no case mean asystole in a patient. custo diagnostic provides pacemaker detection. Here, the pacemaker pulse from the ECG signal (in two channels at least) is detected and then projected into the ECG recording as an (artificial) spike, precisely timed. However, with the pacemaker detection in custo diagnostic the pulse width of the pacemaker is not being calculated. System and Data Security The device must only be operated with the supplied custo med software (custo diagnostic). As operator of the system you are responsible for data backups (e.g. patient databases, evaluations, etc.) and system backups. We recommend carrying out a data and system backup before effecting new installations, updates and fundamental system configurations at the latest. custo diagnostic new installations, updates and system configurations must only be effected through your authorised custo med dealer. Modify data generated in custo diagnostic only in custo diagnostic and not in your EPR system (Electronic Patient Record) or your HIS (Hospital Information System). custo med does not assume any responsibility for potential changes to the data which are made after the export from custo diagnostic in your EPR system or HIS. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 11

12 02 Safety Instructions In order to assure a safe operation of custo diagnostic, disable the screen saver and the energy management in your Windows operating system. Install your Windows operating system in a way that neither accidental nor auto-matic switching off of the PC or notebook during the examination is possible. (Standby mode / sleep mode) Information on EMC (Electromagnetic Compatibility) The use of other accessories, other converters and wires than the ones indicated, except for the converters and wires 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 must be used. You will find further information on this subject under 07.3 Manufacturer s Declaration on EMC (Electromagnetic Compatibility) Maintenance (Regular Safety Checks) The operator is responsible for maintenance. The operator has to make sure that the device is checked for proper condition every two years at the latest. The functionality and the condition of the accessories must be controlled at regular intervals. In the event of damages and/or coarse pollution the complete system is no longer allowed to be operated. All interventions into the existing system, changes to system components, extensions as well as interior cleaning and repairs must only be carried out by your authorised custo med dealer or by custo med. Technical Safety Controls After each repair, modification or conversion of the system or device a technical safety control through your authorised custo med dealer must be carried out. 12 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

13 02.6 Exclusion of Liability The manufacturer is not liable for improper use, failure to observe the safety instructions and negligent disregard of guidelines. custo med will only assume responsibility for the safety and reliability of the custo cardio 100/110/130 if all changes, extensions, repairs and other works on the device and/or system are effected by authorised custo med dealers or by custo med and if the operating manual is being followed Warranty It is our product philosophy to supply faultless products only, matching your expectations. However, if you have legitimate complaints, we will be anxious to remove the defects immediately or to provide a compensation delivery. Excluded are damages due to usual wear and tear, usage for purposes other than intended, unauthorised modification of parts and severe force effects. Even after the guarantee expires, use original spare parts and accessories by custo med exclusively. Solely in this case a safe and faultless operation of your device will be assured. Warranty periods 12 months custo cardio 100/110/130 USB/BT without warranty ECG electrodes Carrying bag Carrying belt (length 127 cm) Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 13

14 03 Description of Device, Basic Instructions for Initial Operation 03.1 Scope of Delivery and Accessories USB cable for connection to the PC custo cardio 100 active ECG cable ECG electrodes Blue Sensor (bag, 50 units) Neoprene carrying bag for custo cardio 100 Carrying belt (length 127 cm) USB cable for connection to the PC custo cardio 110 active ECG cable with banana plugs 14 ECG electrodes Blue Sensor for banana plugs (bag, 60 units) Neoprene carrying bag for custo cardio 110 Carrying belt (length 127 cm) Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

15 custo cardio 100/110 BT (Bluetooth) Bluetooth 2.0 USB Adapter Charger for cardio 100/110 BT with power supply unit Accumulator for cardio 100/110 BT (2 pieces), (not illustrated) custo cardio 100 BT: ECG electrodes Blue Sensor (bag, 50 units) custo cardio 110 BT: ECG electrodes Blue Sensor for banana plugs (bag, 60 units) Neoprene carrying bag for custo cardio 100/110 BT Carrying belt (length 127 cm) USB cable for connection to the PC Hints regarding the electrodes We recommend using high-quality ECG electrodes exclusively (see scope of delivery). custo cardio 130 ECG-PC-module with 15-pole ECG input jack for connecting suction equipment or a patient cable Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 15

16 03 Description of Device, Basic Instructions for Initial Operation 03.2 Operation of cardio 100/110 BT (Bluetooth) Power Button The button on the right side of the housing serves for turning on and off the device. Turn on the device only shortly before the beginning of the recording and turn it off directly after recording. The maximum operating period is 4 hours afterwards the accumulator must be changed or recharged. LED Display If the device is switched on, the lower LED will inform you on the capacity of the accumulator: Green: Accumulator is full or discharged up to 30 % Orange: Accumulator is discharged over 30 % Red: Accumulator must be changed If the lower LED blinks red after turning on, the accumulator must be immediately removed from the device and be recharged. The upper LED shows if the Bluetooth connection between device and PC is active. When starting an ECG recording process, the Bluetooth connection between device and PC is being installed and the upper LED is flashing blue. The precondition is that the Bluetooth interface has been correctly installed (see 03.4 Device Connection and Installation). If there is no connection the LED will not be illuminated. Recharging the accumulator Hint: It is a lithium ion accumulator without memory effect. You can recharge the accumulator at any time without having to consider discharging times. Push the battery case backwards with your thumb and remove the accumulator. Put the accumulator into the supplied charger. You will find the description for recharging the accumulator in the operating manual of the charger. Charging time is 2 to 3 hours. Reinsert the recharged accumulator in a way that the contacts of accumulator and custo cardio 100/110 collide. Close the battery case. 16 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

17 03.3 custo diagnostic Basic Program Structure The program is divided into three areas User, Patient and Examination. This structure always allows to recognise who (which user) with whom (which patient) is carrying out which kind of examination. The main menus of the corresponding areas can be accessed by clicking on User, Patient or Examination. In the main menu of the screen area User, the users of the system can be created and administrated. The user administration allows to grant user rights and to control user-specific settings, e. g. the implementation of a proper patient database for each user. In the main menu of the area Patient, the patient administration takes place. Among the most important functions are Search Patient, New Patient and Search Evaluation. In the main menu of the area Examination, all types of examinations which are possible with custo diagnostic are listed. All modules which you do not possess are inactive this can be distinguished due to the light grey font. In this menu you can also access the area Settings. There program-wide, examination-related and user-specific settings can be established. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 17

18 03 Description of Device, Basic Instructions for Initial Operation 03.4 Device Connection and Installation Installing the USB Connection Connect custo cardio 100/110/130 to your PC. Power supply is provided via the USB cable. The driver installation for the new hardware starts automatically. Select the option Search Driver automatically. With the buttons Next and Finish you control the installation process. Start custo diagnostic and define custo cardio 100/110/130 as device in the system settings. You can access the corresponding page via Examination, Settings, Interface, Device. Select the item cardio 100 in the area Device. Select the item USB in the area Interface. Your inputs will be taken over with Save. Device Selection for Resting and Stress Test ECG Open the page Examination, Resting ECG or Stress Test ECG, Settings, Device, Device Connection. Select cardio 100 in the area ECG Device Assignment. Your inputs will be taken over with Save. Your device is ready for operation. 18 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

19 Installing the Bluetooth connection The precondition for installing the Bluetooth connection in custo diagnostic is that the driver for the Bluetooth 2.0 USB adapter as well as the Bluetooth environment are installed on your PC and that the Bluetooth 2.0 USB adapter is connected to the PC. Installation and configuration will be carried out by your authorised custo med dealer. Open the page Examination, Settings, Interface, Device in custo diagnostic. Select the item cardio 100 in the area Device and the item Autom. BT-COM search in the area Interface. Your inputs will be taken over with Save. Open the page Examination, Settings, Interface, i.s. medical band. Click on the button Open on the left top in order to open the interface. Turn on custo cardio 100/110 BT and afterwards click on the button Search. A dialogue will open in which all available Bluetooth devices are searched and displayed. Select custo cardio 100/110 from the list and click on Confirm. cardio 100/110 is being displayed in the table on the page i.s. medical band. Your inputs will be taken over with Save. Device Selection for Resting and/or Stress Test ECG Proceed as described under Installing the USB Connection, Device Selection for Resting and Stress Test ECG. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 19

20 04 Hygiene 04.1 Cleaning and Disinfection Important Specifications Use only cleaning and disinfecting agents approved by custo med. Unsuitable agents might damage the device. Consider the manufacturer s instructions (e. g. regarding dosage and residence times). Cleaning agents and disinfectants must not be sprayed on or into the device. Under no circumstances must the device be immersed in liquids or be washed with too much water. The device must not be connected to a voltage source while being cleaned. Cleaning of Surface See to it that the device is always clean and aesthetic from outside. If there is dirt, rub off the surfaces slightly with a damp cloth and a mild (acid-free!) cleaning agent. Carrying bag and belt (custo cardio 100/110) can be washed in the washing machine at 30 C with a mild detergent, however must not be put into a dryer Approved Cleaning Agents and Disinfectants Disinfectants Bacillol AF (Bode) Mikrozid AF Liquid (Schülke & Mayr) Cleaning of Surface Mild soap, neutral cleaning agent Edisonite Classic (Merz Hygiene) 20 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

21 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 21

22 05 Carrying out an Examination 05.1 Preparing the Patient for the ECG recording Resting ECG Make sure that your patient is lying comfortably, is relaxed and is not cold Clean and if necessary shave the points where the electrodes are to be attached Attach the electrodes to the patient Check if custo cardio 1xx is connected to the PC Start custo diagnostic, select examination and patient The patient should not move and not talk during the recording process Stress Test ECG When using an ergometer, take care of an optimum seat position of the patient Clean and if necessary shave the points where the electrodes are to be attached Attach the electrodes to the patient Wait some minutes so that the contact between skin and electrodes can develop optimally Apply the blood pressure cuff Check if custo cardio 1xx is connected to the PC Start custo diagnostic, select examination, patient and load profile 22 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

23 Electrode Attachment Points for Resting and Stress Test ECG C1 C2 C3 C4 C5 C6 R L MCL Total view Resting ECG Standard N F Precordial, Standard AAL CAL Resting ECG: Extremities R red Right arm L yellow Left arm F green Left leg N black Right leg L R Stress Test ECG: Extremities R red Right on the back, above the shoulder blade L yellow Left on the back, above the shoulder blade F green Left in the lower back area N black Right in the lower back area F N Resting and Stress Test ECG: Precordial Standard C1 red-white C2 yellow-white C3 green-white C4 brown-white C5 black-white C6 purple-white In 4th ICS 1) on the right sternal border In 4th ICS 1) on the left sternal border Left on the 5th rib between C2 and C4 In 5th ICS 1) on the left midclavicular line (MCL) On the left anterior axial line on the level of C4 (AAL) On the left central axial line on the level of C4 (CAL) C5 C6 1) ICS: intercostal space C1 C2 C3 C4 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 23

24 05 Carrying out an Examination 05.2 First Work Steps in custo diagnostic Start custo diagnostic and log in if required, click either on: Examination, Resting ECG, Record ECG or: Examination, Stress Test ECG, Record Stress Test ECG The patient search form is opened. There, select a patient for the examination. Enter the patient s name or parts of it into the form. The patient can be chosen from the list under the input fields. Confirm your selection with the button Select Patient. You can also select a patient by double-clicking on the patient s name in the list. If the patient is not in your database, click on New Patient. Enter the patient data and click on Save. Further work steps: 05.3 Recording of Resting ECG Page Recording of Stress Test ECG Page Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

25 05.3 Recording of Resting ECG Monitoring and Electrode Control As soon as the electrodes have been attached, the patient s ECG signal is being displayed on the monitor (monitoring). The signal is not yet being recorded. Check if all electrodes are attached optimally. Open the dialogue Electrode Control by clicking on Electrodes (only in case of USB connection). If electrodes are marked bad, the contact should be improved. Before starting the recording, set the desired filters. You find them in the menu Options. Record and End Resting ECG Hint: You have to record at least 10 seconds of the ECG signal. A recording cannot be ended before that period. Automatic Recording (Button Auto Start ): By clicking on Auto Start the automatic recording starts. The standard setting for the duration of automatic recording is ten seconds *). After the expiration of ten seconds the recording is automatically terminated, saved, measured and displayed as evaluation. *) Tip for the individual setting of auto start recordings: You can modify the duration of an auto start recording under Examination, Resting ECG, Settings, Menu/Functions, Menu/Functions in the area Automatic ECG. Manual Control of Recording (button Start ): If you want to perform a recording without time limitation (e. g. because of suspected irregularities), you have to activate the recording with Start. By clicking on End you stop and close the recording. Click on Confirm in the End Dialogue so that the recording will be saved, measured and displayed as evaluation. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 25

26 05 Carrying out an Examination Editing Options during the Recording Process Marking ECG sections Automatic Marking By clicking on the button Marking the last six seconds are being marked automatically. A dialogue opens up for specifying, saving and printing the marked part. Manual Marking With the button Mark on you can determine the length of the marking yourself. The marking is being performed until you click on Mark off. A dialogue opens up for specifying, saving and printing the marked part. Functions during a Recording Pause By clicking on Pause the screen display is stopped. The recording continues to run and is being displayed on one channel. By means of the scroll bar the present recording. you can scroll through On the top right under mouse function, the functions Marking and Measure HR are provided. With Continue you get back to the normal view of the recording. Print Recording Click on Print. From the point of clicking a screen page of the ECG signal is being printed. The printout contains 4.5 to 9 sec of the ECG signal, depending on the display speed. 26 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

27 05.4 Recording of Stress Test ECG Selection of Load Profile Select a load profile in the area Profile. The selection list includes profiles for ergometers (with wattage indications) and treadmill. After having selected, click on Start in order to begin with the monitoring. You can modify the predefined profiles. By clicking on Save the predefined profile is overwritten. Clicking on Save as... allows to save the modified profile under a new name. With the button New you can create new profiles. The values in the area Alarm can be set freely and have to be activated if required. Ergometer Profile Treadmill Profile Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 27

28 05 Carrying out an Examination Monitoring and Electrode Control As soon as the electrodes have been attached, the patient s ECG signal is being displayed on the monitor (monitoring). The signal is not yet being recorded. Check if all electrodes are attached optimally. Open the dialogue Electrode Control by clicking on Electrodes (only in case of USB connection). If electrodes are marked bad, the contact should be improved. Before starting the recording, set the desired filters. You find them in the menu Options. *) Tip for quickly opening the input dialogue: Press the key... > F9 for blood pressure inputs > F10 for lactate inputs > F11 for SPO2 input The Workspace at a Glance Menu Options Turning on and off the automatic blood pressure measurement Activating an additional blood pressure measurement Dialogue for entering a report Dialogue for entering the blood pressure (in case of manual measurement) *) Dialogue for entering the lactate values *) Dialogue for entering the oxygen saturation in the blood *) Quick new start of ergometry without previous profile selection Recognition of pacemaker spikes with pacemaker patients Removes disturbances generated by the power supply unit Flattens disturbances of the ECG signal (e. g. in the event of amyostasia) Balances fluctuations in the ECG signal s zero line Signal tone with each heart beat Alarm signals when surpassing the maximum ST, HR or blood pressure values Click on Start in order to start the recording. 28 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

29 Important Display and Control Elements for Recording Display of heart rate and blood pressure, countdown of the current level Increasing the current load and / or increase in 25 wattage steps *) Graphic display of the load profile and heart rate curve Blood pressure curve, according to the measured values Setting of ST point, display of summary complex (selection of channel via buttons left in front of the ECG signal) Buttons for fading in the ST trend in various views *) The size of the steps for manual change of load and increase in the recording can be set on the page Examination, Stress Test ECG, Settings, Menu/Functions, ECG Monitor in the area Manual Load Change. Hint for Manual Blood Pressure Measurement You are regularly requested to measure your blood pressure. Enter the measured values in custo diagnostic. Therefore, click on Blood Pressure in the menu Options or press key F9 and enter the values. Your inputs will be taken over with Save. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 29

30 05 Carrying out an Examination Start Recording, Resting Phase By starting the ECG recording (with Start ) the resting phase begins. It takes ten seconds without blood pressure measurement. With blood pressure measurement the resting phase takes at least one minute. The duration can be set individually when selecting the profile. Stress Test Phase Subsequently, the stress test phase begins and proceeds according to the selected profile. Complement Unconfirmed Report during Recording You can complement the (unconfirmed) report during the recording process already. It is opened with Report in the menu Options. Enter your information in the white text field. It is saved with Confirm. Click on Recovery Phase in order to end the stress test phase. This step is only necessary if Manual End has been set in the profile selection. Recovery Phase and Ending of Recording The recovery phase also proceeds according to the selected profile and is terminated by clicking on End. The recording is automatically saved, measured and displayed as evaluation. With the button End you close the evaluation display. The End Dialogue is opened. There, click on Confirm. 30 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

31 Editing Options during the Recording Process Marking ECG Sections Automatic marking By clicking on the button Marking the last six seconds are automatically being marked. A dialogue opens up to for specifying, saving and printing the marked part. Functions during a Recording Pause By clicking on Pause the screen display is stopped. The recording continues to run and is shown on one channel. With the help of the scroll bar through the previous recording. you can scroll With the red line in the ECG display mark ECG sections. you can With Continue you get to the normal view of the recording again. Print Recording Click on Print. From the point of clicking a screen shot of the ECG signal is being printed. The printout includes 4.5 to 9 sec of the ECG signal, depending on the display speed. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 31

32 06 Working with the Evaluation 06.1 Display Evaluation Open the Evaluation Search with a right click on Patient. Activate the desired search criteria in the form for evaluation search (Examinations and their properties) The most important search criterion In the screen area Properties, you must absolutely set the option confirmed on No. All non confirmed evaluations will be shown. Option Save Selection Activate this option if you always want to search with the set preferences. Option Search Automatically With this function the evaluations are searched automatically, without a further click on Search Evaluation, and presented in the list on the right screen half. Select and Open Evaluation Choose the desired examination from the list or clicking on Show Evaluation and open it by double-clicking Further Work Steps: 06.2 Evaluation of Resting ECG Page Evaluation of Stress Test Page Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

33 06.2 Evaluation of Resting ECG The Workspace at a Glance Functions for modifying the ECG display Mouse functions for detailed viewing and measuring of the ECG signal (zoom, analysis, measure HR, measure, marking) Buttons for piloting further viewing modes Button for printing the evaluation according to the standard settings Button for closing the evaluation Menu for individual combination of a printout Dialogue for manual input of blood pressure values New analysis of the ECG for setting back manual changes, amendments in the report remain Automatic creation of a new report after manual changes in the ECG recording Turn on and off the anti-drift filter for compensating fluctuations of the zero line Fading in trends and measured values Fading in and out pacemaker spikes Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 33

34 06 Working with the Evaluation Navigation in the Evaluation If you change from your initial screen to another viewing mode, you get back to the original viewing mode by clicking on the same button. Example: You click on Measurement in the evaluation. You access the Measurement screen and the button Measurement changes to ECG. With a click on ECG you get back to the previous viewing mode. Structure and Connection of the Viewing Modes The ECG evaluation is divided into two main areas ECG and Measurement. From the subpages of the two areas the main page of the other area can be accessed at any time. Intitial point: ECG *) Measurement Summary complexes (SC) of the current evaluation ECG overview Overview of complete ECG, display of two channels Single complex Summary complex of a channel and vector loop Zoom Magnified view of a channel (double-click on ECG) Measured values Tabular display of all parameters (ECG) Comparison of current and further evaluation (SC) Comparison Summary complexes of several evaluations in comparison *) Start page can be set under Examination, Resting ECG, Settings, Menu/Functions, Menu/Functions in the screen area Show Evaluation 34 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

35 View: Comparison (ECG Evaluation > Compare) The current evaluation is compared to another one; View: Measurement (ECG Evaluation > Compare > Measurement) Summary complexes of the current evaluation in comparison to others; Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 35

36 06 Working with the Evaluation View: Measurement (ECG Evaluation > Measurement) Summary complexes of the current evaluation; View: Measured values (ECG Evaluation > Measurement > Measured Values) Tabular summary of all measured values; 36 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

37 View: Single complex (ECG Evaluation > Measurement > Single Complex) Summary complex of one channel of the current evaluation and vector loop; View: ECG Overview (ECG Evaluation > ECG Overview) Overview of the complete ECG, display of two channels; Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 37

38 06 Working with the Evaluation 06.3 Evaluation of Stress Test ECG *) Tip for quickly opening the input dialogues: Press the key... > F9 for blood pressure input > F10 for lactate input > F11 for SPO2 input The Workspace at a Glance Functions for modifying the ECG display Mouse functions for exact viewing and measuring of the ECG signal (zoom, analysis, measure HR, measure, marking) Load profile with HR and blood pressure curve PWC (Pulse Working Capacity) and MET compared to predicted value Buttons for piloting further viewing modes Button for printing the evaluation with standard settings Button for closing the evaluation Menu for individual combination of a printout Excel export of the evaluation Display of blood pressure, lactate and oxygen saturation values *) Fading in of trend charts for the most important values New analysis of ECG for setting back manual changes, amendments in the report remain Anti-drift filter for compensating fluctuations of the zero line Fade in and out of trend curves (, ) on the right screen border Navigation in the Evaluation If you change from your initial screen to another viewing mode, you get back to the original viewing mode by clicking on the same button. Example: You click on Measurement in the evaluation. You access the Measurement screen and the button Measurement changes to ECG. With a click on ECG you get back to the previous viewing mode. 38 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

39 Structure and Connection of the Viewing Modes The ECG evaluation is divided into two main areas ECG and Measurement. From the subpages of the two areas the main page of the other area can be accessed at any time. Initial point ECG *) Measurement Summary complexes of the current evaluation Comparison of current and further evaluation (SC) Comparison Summary complexes of several evaluations in comparison (ECG) Comparison Comparison of two total views in 2-channel-display Single complex **) Summary complex of a channel and vector loop ECG overview Overview of complete ECG, display of two channels Measured values Tabular display of all parameters Step comparison Comparison of two steps of the current evaluation Step comparison Summary complex of 6 steps in comparison Zoom Magnified view of a channel (double click on ECG) *) Start page can be set under Examination, Stress Test ECG, Settings, Menu/Functions, Menu/Functions in the screen area Show Evaluation **) Accessible by double-clicking on a summary complex or via Measurement, Measured Values, Single Complex Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 39

40 06 Working with the Evaluation View: Trends (ECG Evaluation > Options > Trends) Trend charts of the most important values further values via Selection; View: Comparison (ECG Evaluation > Compare) Comparison of the current evaluation with another one; 40 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

41 View: Measurement (ECG Evaluation > Measurement) Summary complexes of the current evaluation; View: Step comparison (ECG Evaluation > Measurement > Step Comparison) Summary complexes of six steps in comparison; Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 41

42 06 Working with the Evaluation View: Measured values (ECG Evaluation > Measurement > Measured Values) Tabular display of all measured values; View: Step comparison (ECG Evaluation > Step comparison) ECG signal of two steps in comparison; 42 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

43 View: ECG overview (ECG Evaluation > ECG Overview) Overview of complete ECG, display of two channels; View: Zoom (ECG Evaluation > Double-click on ECG with mouse function Zoom) Magnified view of a channel; Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 43

44 06 Working with the Evaluation 06.4 Confirm Evaluation The unconfirmed report is opened with a right mouse click on the evaluation screen. Select Report in the context menu. Enter your data in the white text field. They are saved with Confirm and the unconfirmed report becomes a report. If your report text is not yet ready and is to be saved nevertheless without reaching the status of a report, set back the status Confirmed when closing the evaluation Auxiliary Tools for Writing Reports Under Examination, Resting ECG or Stress Test ECG, Settings, Diagnostics, Reports, text modules for a report can be created. The modules are recalled via key commands when writing a report. The basic structure of a text module Your inputs will be taken over with Save. 44 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH

45 06.6 Close Evaluation The evaluation is closed with End. The End Dialogue is opened. Here, the status of an examination can be modified. Confirmed A confirmed evaluation can be set back to not confirmed by deselecting the option Confirmed. Hint for the status of the report and evaluation: The status not confirmed serves as a search criterion when searching evaluations for which the physician has not yet given his/her final confirmation. Set the property confirmed on No when searching an evaluation. The list of all not confirmed evaluations will show you what still has to be done. Locked (finalized document) Signalises that the works on an evaluation have been terminated and has the effect of a writeprotection when reopening the evaluation. You close the examination with Confirm Archive Evaluations Archiving evaluations serves for obtaining memory capacity on your hard disk. You find the archiving functions under Patient, Edit Database. Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH 45

46 07 Product Information 07.1 Technical Data and System Requirements Technical Data custo cardio 100/110/130 Frequency response Hz Deviation < 1,5% Time constant 3.2 sec Sampling rate 1.0ms / 1000 Hz for extremities and chest wall 0.25ms / 4000 Hz for pacemaker A/D converter 24 Bit Input impedance > 50 MΩ Amplitude quantification 0.3 μv/bit CMRR > 70 db Impedance measurement *) at all electrode leads (not N) with automatic quality indication Defibrillation protection Electrical strength 5000 V Recovery time after defibrillation < 10s Power supply *) via USB cable Energy consumption While recording max. 2.5 Watts EDP connection *) USB (cable length 2.5 m) Bluetooth coverage up to 10 metres, depending on environmental conditions Software, additional functions Power filter (custo diagnostic) Muscle filter AD filter (Antidrift) Pacemaker recognition Operating conditions Temperature +10 C C Air humidity % rh Air pressure hpa Transport and storage Temperature -20 C C conditions Air humidity % rh Air pressure hpa Dimensions Size cardio 100/110 approx. 160 * 85 * 25 mm (L * W * H) Size cardio 130 approx. 160 * 78 * 32 mm (L * W * H) Weight cardio 100/110 approx. 300 g Weight cardio 130 approx. 430 g Patient cable 100/100 approx m (extremity leads) approx m (precordial leads) Classification Safety class II (custo cardio 100/110/130 USB) Safety class III (custo cardio 100/110 Bluetooth) Class IIa Type BF defibrillation protected (not intra-cardiac) DIN EN DIN EN DIN EN *) Does not apply to cardio 100/110 BT (Bluetooth) 46 Resting and Stress Test ECG with custo cardio 100/110/130 and custo diagnostic GEB 0121 DK 0905 Version /03/2009 custo med GmbH