User manual ABPM-05, ABPM-04 and BlueBP-05 ambulatory blood pressure monitors with CardioVisions software (from version 1.
Table of contents 1.Recommended use of ambulatory blood pressure monitors ............................................... 5 2.Devices .............................................................................................................................. 5 ABPM-05 and BlueBP-05 ................................................................................................. 5 ABPM-04 .......................................................................................................................
Important information on ABPM-05, ABPM-04 and BlueBP-05 systems. Read carefully, please. This symbol on a Meditech recorder is a warning that you should read the accompanying documentation (this manual). ABPM-05, ABPM-04 and BlueBP-05 ambulatory blood pressure monitors and CardioVisions software are manufactured and developed by Meditech Ltd.
Blood pressure measurements determined with the algorithm of an ABPM05, ABPM-04 or a BlueBP-05 recorder on adults are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method Korotkoff phase V, within the limits prescribed by the American National Standard for Electronic or Automated Sphygmomanometers.
Recommended use of ambulatory blood pressure monitors 1. Indications for ambulatory blood pressure monitoring The following indications are listed in the European Society of Hypertension recommendations for ambulatory blood pressure measurement, 2003.
On the front side of the housing, there is the LCD, the buttons of the device and a sticker displaying the name of the device. The ABPM-05 device can be connected to the serial or USB port of a Windows compatible PC with an optoelectronic interface. The socket is positioned on the opposite side from the cuff connector. BlueBP-05 can be connected to a Windows based PC with a Bluetooth adapter. Patients can start extra blood pressure readings or mark events.
4. Using the buttons On the front side of ABPM-05 and BlueBP-05, below the LCD, you can find three buttons: START button is marked by a triangle, EVENT button is marked by a heart and DAY/NIGHT button, which is marked by a crescent moon. If the device operates, each button press is accompanied by a short beeping sound. On the front side of ABPM-04 there is the unmarked START and the EVENT button, which is marked by a circle. Each button press is accompanied by a short beeping sound.
Marking the time of going to bed and rising from bed – ABPM-05and BlueBP-05 only If the DAY/NIGHT shift function is disabled during programming, the patient can press the DAY/NIGHT button to mark the time of going to bed (in the evening) and rising from bed (in the morning). Manual DAY/NIGHT shift – ABPM-05 and BlueBP-05 only If this function is enabled during the programming, the patient can manually shift the measurement frequency period (day or night) by pressing the DAY/NIGHT button.
Systolic value of just completed measurement (mmHg) The blood pressure measurement is cancelled by pressing a button.
Information displayed on ABPM-04 LCD screen only: Rectangle blinking: measurement is progress (mmHg) Battery voltage display (5,37V) Communication with a personal computer LCD check: all segments are displayed Low battery voltage (three dots below) 10
6.
Please note that the device may not meet its performance specifications if stored or used outside the specified environmental conditions. Both measuring and LCD display in kPa is available in ABPM-05 device only. This is an option which can be selected in the software. The unit of measurement can be changed later in the database. 7.
8. Safety concerns Electric shock hazard protection Each ABPM recorder meets the relevant shock hazard protection standards. ABPM-05 and BlueBP-05 operates with two 1.5V AA batteries or two 1.2V AA rechargeable batteries, while ABPM-04 uses four 1.5V AA batteries or four 1.2V rechargeable batteries. This excludes all electric shock hazards, even in the unlikely case of multiple device errors.
BlueBP-05 is capable of wireless communication with the computer using Bluetooth technology. For successful communication, you need a properly connected and installed Bluetooth adapter. ABPM-05, ABPM-04: communication with an optical interface cable Steps to follow for the first connection: - Locate a free 9-pin serial port (also called RS232) or USB port (often labelled ) on your computer. - Take the optoelectronic interface unit with the optical cable out of package.
If you wish to use a BlueBP-05 with Bluetooth under Windows XP SP 2, follow the steps below. With other Windows versions, please refer to the documentation of the Bluetooth device used in your computer. a) Open the Tools - Options dialog of CardioVisions and select the Communication category. Select the type of the recorder, then click on the appearing Bluetooth settings button. In the appearing dialog, click on the Connect setup button to go to the next step.
8. Apply the cuff to the patient with the device placed in the pouch. 9. Give the patient diary to the patient along with detailed instructions about the rules and the use of the device. Manual programming (ABPM-05 only) ABPM-05 can be programmed without a PC by using the device buttons. Programming options Plans are stored in the inbuilt memory of the device and they cannot be changed.
10 second delay state 3. measurement plan: 30/30 minute day/night intervals 1. measurement plan: 15/30 minute day/night intervals Programming is in progress: blinking signal Rules of monitoring - Inform the patient about the goal and expected results of the monitoring. Provide an event diary and inform him about the rules to observe. - Put the device into the pouch. The patient should fit the adjustable straps of the pouch. - Wearing a thin shirt under the cuff is recommended.
10. Remove the unit and the cuff from the returned patient. 11. Ask for the patient diary and ask the patient for any events, symptoms, observations or complaints. 12. Start the software and select the proper recorder type. 13. Connect the device to the PC and transfer the collected data from the recorder to your database. In CardioVisions software select ABPM-05, ABPM-04 or BlueBP-05 from the device types and click on Device/Read data from xxx, where xxx indicates the name of the selected device.
In order to change batteries, take the recorder out of the holder pouch and remove the battery compartment cover on the back-side. Place two/four properly charged, high capacity AA rechargeable or two/four new, long-life AA alkaline batteries into the compartment as, then close the compartment. 11. Cuffs and their application It is advisable to wear a thin shirt or blouse under the cuff.
12. Using CardioVisions software The CardioVisions software package provides means to handle Meditech ambulatory blood pressure and ECG recorders. With CardioVisions it is possible to initialize (programme) a recorder, check ECG signal quality of an ECG recorder applied to a patient in real time mode, and transfer (read) collected data from a recorder to your computer. CardioVisions stores data transferred to the computer in its database for easy future access.
Suggested CPU: 2 GHz P4 or equivalent RAM: 512 MB VGA: 1024x768 @ 16 bit color LAN: 100 Mbit/s HDD: about 40 MB for the software + disk space for database2 Operating system: Windows 98 SE / Me / 2000 / XP/ Windows 7 Please note that certain features of CardioVisions require a lot of calculations, so the faster your computer is, the shorter time you will need to get a 24-hour ECG recording analyzed.
- Welcome screen - System Administrator settings Your default login name and password is admin/admin. Default settings can be modified here. Reminder: the system administrator cannot see medical data, as it is only the user who has access to measurements.
Here you are required to create a user account by filling in the empty spaces, but at least the bold entries. Creating a user is necessary to see medical data. - Modify the default report header In this screen you can change the report header data, which can be seen on the top of all printed report pages. - Registration Registration is not necessary for ABP monitors. This function is for other devices only. You can quit by 'Finish' button.
Installing CardioVisions Network Edition If you wish to access CardioVisions functions from several workstations in a computer network, you have to install CardioVisions Network Edition. The installation procedure looks quite similar to that of the Personal Edition (see above), but the result is quite different.
Backup Creating a backup from CardioVisions database is strongly recommended to prevent data loss. It is advised to create a backup often, monthly, weekly or even daily depending on the frequency of the software usage. The function is available both for the User (Tools/Backup) and for the System Administrator (Tools/System administrator tools/Backup and restore).
3.) After clicking ’Tools/Archive examinations from the selected folder’, a new panel will appear on your screen, which will inform you about the number and the size of the measurements in the folder and the size of your destination drive. Select the folder in the destination directory in which you want the examinations to be saved. You should type in or select the name of the destination directory to archive to the hard disc. 4.
database. To open the examination like this, the program will ask the destination route of the archived data. If you have saved the data on the hard disc, just simply select the source file. After archiving your files to a PC, you can copy data to a CD or DVD as well. If you choose this solution, write the name of the disc into the ’Label’ field in order you can open the archived files easily later.
13. Meditech product warranty information (a) RECORDER WARRANTY. The main recorder unit will be free from defects in materials and workmanship under normal use and service for a period of two (2) years from the date of receipt. This warranty covers the recorder unit only. This warranty does not cover any accessories that might come with the recorder unit. (b) ACCESSORIES WARRANTY.
14. CardioVisions software license agreement Important – read carefully: This License Agreement is a legal agreement between you (either an individual or a single legal entity) and Meditech Ltd. for the CardioVisions software, which includes computer software (SOFTWARE) and may contain accompanying data carrier, printed material and 'on-line' or electronic documentation.
Miscallaneous This Agreement is governed by the laws of Hungary. Should you have any questions concerning this Agreement, please contact Meditech Ltd. Limited warranty Meditech Ltd. guarantees, that (a) the SOFTWARE under normal use will perform substantially in accordance with the accompanying written/electronic documents for a period of ninety (90) days, and all supplementary hardware will be free from defects in materials and workmanship under normal use for one (1) year from the date of receipt.
15. EMC information Medical electrical equipment should be used with precautions according to EMC, and must be installed according to the EMC notices disclosed in this manual as mobile RF transceivers could adversely affect it. Electromagnetic emission Meditech ambulatory blood pressure monitors are suitable for use in the specified electromagnetic environment. The purchaser or user of the device should assure that they are used in an electromagnetic environment as described below.
Electromagnetic immunity Meditech ambulatory blood pressure monitors are suitable for use in the specified electromagnetic environment. The purchaser or user of Meditech products should assure that they are used in an electromagnetic environment as described below.
ABPM-05 ABPM-04 BlueBP-05 Power frequency (50/60Hz) magnetic field IEC 61000-4-8 3A/m 3A/m Power frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and/or hospital environment. Note: UT is the nominal voltage of mains.
Radiated RF BlueBP-05 IEC 61000-4-3 3V/m 80MHz-2,5GHz 3V/m Recommended Separation distance: d=[3,5/V1]√P d=[3,5/3V/m]√P (80MHz – 800MHz) d=[7/3V/m]√P (800MHz – 2,5GHz) where: P is the highest radiated power disclosed by the manufacturer of transmitter [W] and d is the recommended separation distance [m]. You may observe disturbance nearby any of those equipment which has the following indication: f) Note: in case of frequency 80MHz or 800 Mhz, the formula for the higher range is applicanle.
