BTL-08 ABPM - Zone Medical
Contents
1. 14 PSU SUA ons ocene phe eget tate ce IDeHEad D MEL M LIU uM UM 15 BTL 08 SW system administrator 15 Adding a BTL 08 SW 15 Report MGA SM sis M MMM 16 Optoelectronic iriterface cable iiem i ne cie C Lee SER REL ER HAS ERARS ERR ERR ASAP Lane 16 Wireless Bluetooth 17 BTL 08 SW LICENSE AGREEMENT 18 CARE AND MAINTENANCE nanctus cun nan kun th ananas ou EAS Lo sS aasa REESE DAR DRR ESSA RS niaren SCAN SER RR NR RESP saca RE 20 7 idzadeud ijec 22 BTL PRODUCT WARRANTY INFORMATION 24 jize lellvun iiim 25 EMC INFORMATION ae E 26 MANUFACTURER 29 PAGE 3 OF 29 GENERAL CHARACTERISTICS OF THE DEVICE The BTL 08 ABPM ambulato2. Normal status 2 Night mode a time is displayed time is displayed LO CI L ug H moon sign is lit Blood pressure measurement Pumping for measurement initiated ri 5 current pressure mmHg Lt Ls Deflation during blood pressure Heart symbol blinking 1 measurement the current I tune with pulse measurement Li 4 pressure is displayed mmHg Z4 Z2 in progress Systolic value of just completed Diastolic value of just completed measurement mmHg e measurement mmHg a J Pulse rate value of just completed Blood pressure measurement Li X 5 measurement mec Li beats per minute by pressing a button Event marker set due to button The crossed battery symbol warns R NR push Oo 3 about low battery Cr T Communication with personal or computer Error code display 2 LCD check 4 Ern B all segments L 4 c are displayed n The recorder is switched off Battery voltage display 2 37 V oo 24 1 LS Please note that the BTL 08 ABPM might not meet its performance specifications if stored or used outside the specified environmental conditions PAGE 8 OF 29 5 1 5 2 WORKING WITH BTL 08 The recorder must be programmed with the BTL 08 ABPM software installed on the computer Once the pre programmed time is reached the reco
3. part of this manual may be reproduced saved in a research centre or transferred by any means incl electronic mechanic photographic or other records without previous approval from BTL Industries Limited BTL Industries Limited operates a policy of continuous development Therefore it reserves the right to make changes and improvements to the products without prior notice The content of this document is provided as it is Except as required by applicable law no warranties of any kind either expressed or implied are made in relation to the accuracy reliability or contents of this document BTL Industries Limited reserves the right to revise this document or withdraw it at any time without prior notice PAGE 29 OF 29
4. PRECAUTIONS FOR USE READ CAREFULLY e 5 RECOMMENDED USE OF AMBULATORY BLOOD PRESSURE RECORDS 6 USING THE BUTTONS le 6 DISD AY E E eee 8 WORKING WITH BTL 08 9 aisle IEEE 9 Connecting the BTL 08 recorder to the PC nne 9 step DY 5 sede 10 USING THE BIL 08 ABPM te Ire iit tei ae a epe esp ge 10 their applicatio re e tA eae bread me iE Re rie 11 PACCOSSOMOS sez T 12 BTL 08 SW EDITIONS AND SYSTEM REQUIREMENTS eese 13 Personal edition derlnition ii i Ure Eon Pci tede cni Pee La 13 Gomputer requiremieris ecrire teret Ee tege tle En kane exo Eee 13 INSTALLATION AND FIRST START eer ntu toD enun n tnu Enana aa naaraana snae RO ER Dae Ron UNA TERRSNSRmR S RE anaran 14 Installing BTL 08 SW Personal Edition sess 14 Installation results folders shortcuts and
5. Pulse rate measurement range 40 200 beat per minute Blood pressure measurement accuracy same measuring algorithm validated according to the BHS protocol Pressure sensor piezo resistive Inflation automatically controlled pump Safety maximum inflation 300 mmHg independent safety release valve Deflation and rapid air release automatic pressure release valve PAGE 25 OF 29 13 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 Directive and declaration of manufacturer Electromagnetic Emission BTL 08 ABPM is suitable for use in the specified electromagnetic environment The purchaser or user of BTL 08 ABPM should assure that it is used in an electromagnetic environment as described below Radiated and conducted RF Group 1 BTL 08 ABPM uses RF energy only for its internal function emission Therefore the emission is very low and not likely to cause any interference in nearby electronic equipment CISPR 11 Radiated and conducted Class B BTL 08 is suitable for use domestic emission establishments and in establishments directly connected to the low voltage power supply network which supplies CISPR 11 buildings used for domestic purposes Harmonic emission Not applicable IEC61000 3 2 Voltage fluctuations Flickers C
6. by default under the BTL folder there In this Start menu folder you will find a startup icon shortcut for BTL 08 ABPM SW another shortcut for BTL 08 ABPM SW Help and a third shortcut for the removal uninstallation of BTL 08 ABPM SW You can start BTL 08 ABPM SW either with the desktop startup icon or with the one in your Start menu PAGE 14 OF 29 7 3 7 3 1 7 3 2 FIRST START After a successful installation you can start BTL 08 ABPM SW with the proper startup icon shortcut When you first start BTL 08 ABPM SW you will be logged in as a BTL 08 ABPM SW system administrator and a first start wizard will guide you through the following steps to personalize your installation Welcome screen e Change BTL 08 SW system administrator settings BTL 08 SW user e Modify default report header Please note that these settings can be modified later during the regular use of BTL 08 ABPM SW but are necessary to start with from the beginning so some steps above are a must before you start BTL 08 ABPM SW SYSTEM ADMINISTRATOR SETTINGS After a welcome screen on first start up BTL 08 ABPM SW will ask for the BTL 08 ABPM SW system administrator s login name and password Please note that these can and maybe should differ from your general Windows administrator properties The input boxes for both the login name and the password will be admin by default Please change this to your preferred admin login
7. BTL 08 ABPM SW the setup wizard will locate it for you and will offer to install the new version to overwrite the old one This will not influence your database or any program settings they will be preserved from your previous installation This happens only if you install the new BTL 08 ABPM SW to the same folder where the old installation is located If you select another target folder you will have two different BTL 08 ABPM SW installations with independent databases which may cause confusion and should therefore be avoided Before you perform an upgrade as with all software it is advisable to create a safety backup of your existing installation In the next screen of the setup wizard you can choose a Start menu folder where setup will place the usual shortcuts for the SW a startup icon a help icon and an uninstallation icon By default this is the BTL folder of your Start menu After finishing the setup the installation will proceed Wait until you see a screen prompting you to finish the installation BTL 08 ABPM SW setup will place a startup icon on your desktop as well INSTALLATION RESULTS FOLDERS SHORTCUTS AND PROGRAMS After a successful installation BTL 08 ABPM SW Personal Edition setup places a startup icon a shortcut with the proper name and version number on you desktop The necessary files will by deafult be installed in a BTL folder under your Program Files folder Setup places a folder with a similar name in your Start menu
8. Do not install more than one BTL 08 ABPM SW on the same computer The edition is available on the installation CD accompanying a BTL monitoring system INSTALLING BTL 08 ABPM SW PERSONAL EDITION Insert your installation CD into your CD drive and provided the auto run feature is not disabled you will see a start screen If the auto run feature is disabled open the CD folder and run double click the setup exe program A typical installation wizard will start Before you install BTL 08 ABPM SW you need to go through the typical steps as follows Choose language to install Accept license agreement e Choose target folder of installation Choose Start menu folder for start up icon placement The default installation language of BTL 08 ABPM SW will be that of your Windows system if such a language version of BTL 08 ABPM SW is available but setup offers you to choose another language from a list To install this SW you must first carefully read and accept the license agreement which you can also read at the end of this manual Then you can select the options you wish to install necessary components include the BTL 08 ABPM SW itself Then you will be asked to select the target folder of the installation BTL 08 ABPM SW will by default be installed in your Program Files folder in a BTL subfolder and finally a subfolder with the appropriate BTL 08 ABPM SW release version information If you have a previously installed earlier version of
9. PAGE 17 OF 29 BTL 08 ABPM SW LICENSE AGREEMENT IMPORTANT READ CAREFULLY This License Agreement is a legal agreement between you either an individual or a single legal entity and BTL Industries Ltd for the BTL 08 ABPM SW which includes computer software SOFTWARE and may contain accompanying data carrier printed material and on line or electronic documentation By installing copying or otherwise using the SOFTWARE you agree to be bound by the terms and all the information and conditions described in this Agreement If you do not agree to the terms of this Agreement promptly return the unused SOFTWARE to the place from which you obtained it SOFTWARE LICENSE The SOFTWARE is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties The SOFTWARE is licensed not sold GRANT OF LICENSE This Agreement grants you the following rights Software You may install and use one copy of the SOFTWARE only on one computer Storage Network Use You may also store or install a copy of the SOFTWARE on a storage device such as a network server used only to install or run the SOFTWARE on your other computers over an internal network DESCRIPTION OF OTHER RIGHTS AND LIMITATIONS Limitations on Reverse Engineering Decompilation and Disassembly You may not reverse engineer decompile or disassemble the SOFTWARE Separation of Components The SOFTWARE is licensed as a single pr
10. by pressing the START button shortly The result with a manual measurement marker will be stored in the memory of the device Typical causes for this use dizziness pain angina pectoris or headache palpitation Switching the device off Press and hold the START button for more than 10 seconds then release it when two horizontal segments appear on the LCD this way BTL 08 ABPM will be switched off If you do not release the button in 2 seconds after the two horizontal segments appeared the recorder will return to normal operation This feature helps to avoid unintended power off The device can only be switched on manually While the recorder is switched off normal functions are not available even prescheduled measurements will not be triggered Therefore switching off the device is only necessary in case of valid reasons Switching the device on BTL 08 ABPM is switched on to normal operation if the START button is pressed and held for more than 3 seconds If the device is switched off no other functions are available LCD check Press and hold the START button to light up all segments of the LCD to check if they all work correctly Battery voltage check Press and hold the START button for more than 5 seconds to display battery voltage on the LCD e g 2 64 equal to 2 64 V After checking the voltage please release the button because after additional 5 seconds the device may turn off The unit will then return to displaying time Th
11. guidelines Actual conditions may vary PAGE 27 OF 29 Recommended separation distance BTL 08 ABPM is intended to be used in electromagnetic environment with controlled RF disturbances The purchaser or user of BTL 08 ABPM may help to reduce electromagnetic disturbances by defining the separation distance between the transportable or mobile RF telecommunication equipment transmitters and BTL 08 ABPM depending on the highest output power of the telecommunication equipment Separation distance in function of frequency of the transmitter m The highest output 150KHz 80MHz 80MHz 800MHz 800MHz 2 5GHz power of the transmitter W d 3 5 V4NP 3 5 E NP 7 E NP If this table does not contain the highest output power of the transmitter the d separation distance m can be calculated by the formula depending on the frequency of the transmitter where P is the rated highest output power of the transmitter W 1 note in case of frequency 80MHz or 800 MHz the formula for the higher range is applicable 2 note These are guidelines Actual conditions may vary PAGE 28 OF 29 14 MANUFACTURER This product is manufactured in accordance with the EU Medical Devices Directive by BTL Industries Ltd 161 Cleveland Way Stevenage Hertfordshire SG1 6BU United Kingdom E mail sales btInet com http www btlnet com For service please contact the service department at service btlnet com
12. name and password to prevent system security problems Write your preferred admin login and password down on a piece of paper and lock it away in a safe place Do not lose the System administrator s login and password or you will be unable to access indispensable functions such as adding new users changing data access levels The system administrator cannot view medical measurement data nor edit reports If you use BTL 08 ABPM SW Personal Edition on your computer which only you have access to in a well protected environment it may seem overly cautious and therefore be annoying to have to use a password protection in BTL 08 ABPM SW Therefore it is possible to allow zero length password for users in the admin settings screen by removing the tickmark from the password required box This does not mean that users cannot use a password if they like it just means they may choose to leave the password empty ADDING A BTL 08 ABPM SW USER Because his tasks are mainly administrative and technical the BTL 08 ABPM SW system administrator by definition cannot open and view medical measurement data Therefore it is necessary to create at least one normal user in BTL 08 ABPM SW sometimes this is called a user account More users can be added by the system administrator later the first startup procedure lets you that is requires you to create only one The bold labels in this screen show that the last name login name and password fields are necessary to
13. new and old batteries do not use damaged batteries Many personal computers do not meet certain shock hazard protection standards or strict safety regulations applicable to medical devices Therefore during the computer based use of BTL recorders keep at least a 2 meter distance between patient and computer This is the required minimum safety distance BTL 08 ABPM recorders communicate using a plastic optical cable whose 4 m standard and up to 10 m optional length allows for the required safety distance The plastic optical cable ensures perfect electric separation and reduces the effects of external electric noise It does not conduct electricity Biocompatibility To avoid infection risks and for general hygienic reasons the device cuff and tubing should never contact the patient s skin directly PAGE 22 OF 29 Hazardous materials Used batteries qualify as hazardous waste and should be disposed of properly BTL recorders do not contain any materials qualified as pharmaceutical substance or tissue of animal origin They emit no material hazardous to humans Risk of incorrect diagnosis The basic intended use of BTL 08 ABPM recorders is to record blood pressure and pulse rate values Patients should be informed about rules of cooperative behaviour proper handling of the recorder used and expected results of monitoring in advance BTL 08 ABPM recorders only provide data to support diagnostic decisions of a qualified physician they
14. proceed others are optional If the password required checkbox has been unchecked in the previous screen it is possible to leave the password box here empty technically this is known as a zero length password In this case the label of the password box will not be bold With the create icon on desktop checkbox it is possible to create a personalized BTL 08 ABPM SW start up icon on the Windows desktop with the name of the user just added here The properties of such an icon will include the user s login name so if BTL 08 ABPM SW is started with such a personalized shortcut icon the user will only have to type a password or if the password is empty a shortcut so personalized will log the user in directly to BTL 08 ABPM SW Please note that this can mean a serious data security risk if anyone else other than the intended user has access to the computer so use this possibility of comfort with extra caution only Users can in fact they are strongly advised to change their password when they log in to BTL 08 SW for the first time with the password originally selected by the system administrator during user account creation If they choose to use no password protection that is an empty zero length password Users can change their password any time using the New password command of the Tools menu in BTL 08 ABPM SW PAGE 15 OF 29 7 3 3 7 4 REPORT HEADER In this screen of the first start wizard it is possible to change
15. BIL 08 ABPM USER S MANUAL BEFORE YOU START This manual has been written for the owners and operators of the BTL 08 ABPM products It contains general instructions on operation precautionary practices and maintenance While we would like you to start using your equipment right away we encourage a thorough reading of this manual in order to fully understand the operational features of your product All of us at BTL wish you every success with your BTL 08 system We pride ourselves on being as responsive as possible to our customer s needs Your suggestions and comments are always welcome since we believe an ongoing relationship with our customers is critically important to our future product line Please call us or email us your suggestions Please remember to complete the warranty registration form printed in this manual The warranty form should be returned to us no later than 30 days following installation of your equipment to initiate warranty protection Again thanks for being a BTL customer In the event of a problem or if you require service please make an initial call to your local distributor who will decide whether to refer the problem to our office PAGE 2 OF 29 CONTENTS 4 1 5 1 5 2 5 3 5 4 5 5 5 6 6 1 6 2 7 1 7 2 7 3 7 3 1 7 3 2 7 3 3 7 4 7 5 10 11 12 13 14 GENERAL CHARACTERISTICS OF THE 4 IMPORTANT INFORMATION
16. TWARE 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 NO OTHER WARRANTIES BTL DISCLAIMS ALL OTHER WARRANTIES EITHER EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WITH REGARD TO THE RECORDER UNIT ANY ACCESSORY OR OTHER ACCOMPANYING HARDWARE AND THE BTL 08 ABPM SW NO LIABILITY FOR CONSEQUENTIAL DAMAGES IN NO EVENT SHALL BTL BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF BUSINESS PROFITS BUSINESS INTERRUPTION LOSS OF BUSINESS INFORMATION LOSS OF DATA OR ANY OTHER PECUNIARY LOSS ARISING OUT OF THE USE OR INABILITY TO USE THIS PRODUCT EVEN IF BTL HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES PAGE 19 OF 29 CARE AND MAINTENANCE Protection and cleaning BTL 08 ABPM ambulatory blood pressure recorders are not specially protected against spills or ingression of water or other liquids Do not immerse the recorder in water or any cleaning fluid and protect it from spills and splashes Do not expose it to heavy rain or steam and do not wear it in a wet environment e g shower bath or swimming pool In case of minor effects of a w
17. d also mark the time of going to bed and rising from bed with the DAY NIGHT button They may interrupt any single blood pressure measurement if necessary by pressing any button 9 Should the batteries run down during a monitoring session they can be simply replaced Monitoring will continue and data will not be lost 10 Patients should never measure anybody else s blood pressure with an ABP recorder during an ambulatory blood pressure monitoring session CONNECTING THE BTL 08 ABPM RECORDER TO THE PC Please connect the optical interface which was delivered with the device to the USB port of the PC The other side of the interface cable which is a two point plastic connection should be connected to the socket of the BTL 08 ABPM in a way that the red plastic ring is directed to the lower side of the device Start the BTL 08 ABPM software and open the Options menu then click on the Communication tab on the left side of the screen On the appearing window select BTL 08 ABPM on the right side and then click on the USB icon In case of a serial port please provide the ID of the serial port COM port to which you connected the device If you are unable to do so then tick the Auto search com port option In order to check the communication please connect the device to the PC charged batteries device switched on in the above mentioned way and then click on the Test button If the communication was successful then the software will display the ser
18. do not automatically provide a diagnosis of any kind During the evaluation of recorded blood pressure values possible artefacts due to external disturbances motion artefacts and electrical noise should be observed and handled with caution PAGE 23 OF 29 11 PRODUCT WARRANTY INFORMATION 1 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 2 ACCESSORIES WARRANTY The non disposable accessories delivered with the recorder unit will be free from defects in materials and workmanship under normal use and service for a period of one 1 year from the date of receipt This warranty does not cover disposable accessories packaging materials accumulators and batteries cuffs or any of their components 3 CUFF WARRANTY The cuff s if delivered with a recorder unit will be free from defects in materials and workmanship under normal use and service for a period of six 6 months from the date of receipt This warranty covers the cuff s delivered with a recorder unit exclusively 4 SOFTWARE WARRANTY The BTL 08 ABPM software under normal use will perform substantially in accordance with the accompanying written electronic documents for a period of ninety 90 days from the date o
19. e device to the PC and then transfer collected data from the recorder to your database 14 Analyze the blood pressure profile 15 Create and print a report USING THE BTL 08 ABPM SW The BTL 08 ABPM SW package provides means to handle BTL ambulatory blood pressure recorders as well as the data collected by such recorders From BTL 08 ABPM SW it is possible to initialize program a recorder and transfer read collected data from a recorder to your computer BTL 08 ABPM SW stores data transferred to the computer in its database for easy future access The database offers user access control organizing patient data in folders similar in appearance to those used for normal document storage but with a high degree of safety for sensitive medical data It also offers a comfortable archive and restore feature for a safe backup of large size recordings BTL 08 ABPM SW provides detailed graphical and tabular displays of recorded data a comprehensive set of editing features and full statistical analysis all in a highly customizable user interface Its efficient report generator and editor can create standard reports automatically but also allows for free editing of any report component like a word processor More about BTL 08 ABPM SW is in 6 chapter In summary BTL 08 ABPM SW lets you e manage select initialize and read data from recorders e browse patients and the results of monitoring sessions in a database view edit and analyze data in a reco
20. e voltage for fully charged accumulators should be over 2 5 V and for fresh alkaline batteries over 3 V Set a patient event marker The patient can mark any event without starting a manual blood pressure measurement by pressing the MEDICATION button briefly Typical causes for this use are taking medicine The patient should be instructed to record the reason for setting an event marker in a diary Mark time of going to bed and rising from bed If this function is disabled during programming the patient can press the DAY NIGHT button to mark the times of going to bed in the evening and rising from bed in the morning Manual DAY NIGHT shift If this function is enabled during the programming then the patient can manually shift the measurement frequency period day or night by pressing the DAY NIGHT button The shift is available in the two hour period before the prescheduled shift PAGE 7 OF 29 4 1 DISPLAY BTL 08 ABPM will show important status information as well as the process and result of individual readings on its LCD The most important displays are listed here In addition to these most important displays a lot of extraordinary situations and errors have their own code displayed on the LCD These codes are stored together with recorded data and they are listed in the BTL 08 ABPM program This helps service personnel to identify causes of an unexpected behaviour result or error
21. en click on the appearing Bluetooth settings button In the appearing dialog click on the Connect setup button to go to the next step In the appearing dialog you can see BTL recorders which have already been added to your computer Place fresh batteries into the new BTL 08 ABPM Plus recorder and make it Bluetooth discoverable Press the START and the MEDICATION button simultaneously for longer than 3 seconds then release them The recorder remains discoverable for a minute then switch back to stand by mode If the recorder switches back to standby mode make it discoverable again After this you have made the recorder discoverable click on the Add button If there is a moving torch the PC searches for Bluetooth devices Should the recorder switch back to stand by mode due to a timeout make it discoverable again then click on the Add button After the search the found devices are listed The name of the recorder is BTL 08ABPM where this is the last four digits of the serial number found on the back of the recorder Selecting the appropriate recorder the OK button becomes active please click on it As authentication key PIN please enter the last four digits of the serial number After entering the PIN click on the Finish button Wait until the system installs and configures the new Bluetooth device By clicking on the Test button you can check the communication Make the recorder discoverable before the test as described above
22. en younger than 8 years PAGE 4 OF 29 IMPORTANT INFORMATION PRECAUTIONS FOR USE READ CAREFULLY e BTL 08 ABPM recorders should not be used if any of the following cases apply patients without an indication for ambulatory blood pressure monitoring non cooperative patients patients in any way unable to operate a recorder as intended patients requiring urgency emergency cardiac care unconscious or otherwise incapable patients patients with serious mobility impairments without supervision patients with coagulation disturbances children without supervision children under the age of 8 years No user serviceable parts inside BTL recorders contain high complexity electronic and fine mechanical components If you have any problems please refer your recorder to qualified service personnel Take care to avoid blocking the air flow in the tube of the cuff and twisting the tube Make sure the cuff and its tubing or the lead wires do not cause strangulation or a circulation problem Should the patient experience arm numbness or pain remaining after any blood pressure reading is completed the cuff should be removed to avoid permanent vascular or neural injury Though the blood pressure measurement algorithm used in BTL 08 ABPM recorders has been tested and found to function properly on patients with atrial fibrillation or other common arrhythmias the oscillometric blood pressure measurement method is generally recommended for use only wi
23. enable reliable operation A small crossed battery sign on the LCD shows low battery voltage 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 properly charged high capacity AA rechargeable or two new long life AA alkaline batteries into the compartment as shown in the polarity drawing Close the compartment PAGE 21 OF 29 10 ATTENTION General safety precautions Carefully read the service instructions before the first activation of the device The device should only be used under the control of a physician who determined the indication All personnel using this device must be knowledgeable in the servicing technique maintenance and verification of the device and about the principles of safe work with the device Place the device out of direct sunlight and out of reach of strong electromagnetic fields to avoid undesirable interactions In case of undesirable interactions place the device away from source of disturbance or contact the authorised BTL service centre Before every use examine the device properly loose cables damaged cable insulation functions of the display etc and in case of any discrepancy stop using the device and contact the authorised BTL service centre If the behaviour of the device shows any divergences from the function procedure described in the instruction manual stop
24. et environment wipe off water drops with a dry cloth Keep the recorder in a normal dry room for at least one hour before use if condensation is suspected In case of ingress of water in the recorder remove batteries from the unit and refer the unit to authorized service Never place a recorder unit in a disinfecting or sterilizing machine A recommended means of cleaning is to wipe the recorder with a disinfectant cleaning tissue e g Henkel Ecolab Incides or a similar product Alternatively wipe with a slightly damp cloth then dry it with an antistatic tissue Do not expose recorders to extreme heat or radiation including long exposure to direct strong sunlight Regular checks warranty service Verification of pressure measurement accuracy is recommended biannually BTL 08 ABPM recorders are covered by a two year warranty under general warranty conditions of BTL Industries Ltd see relevant section This warranty does not cover any malfunction or defects arising from improper use the use of inadequate accessories accident theft or use of the device outside operating environmental specifications or intended measurement range Removing the closing label from the back side of the device voids this warranty There are no user serviceable parts inside BTL recorders they contain high complexity electronic and fine mechanical components If you have any problems please refer the recorder to qualified service personnel Contact BTL or your distribut
25. f four 4 AA rechargeable batteries one 1 battery charger one 1 CD with BTL 08 ABPM SW and with user manual recorder package one 1 BTL 08 ABPM recorder unit one 1 pouch for recorder with shoulder and waist straps one 1 normal adult size cuff Accessories may vary from place to place PAGE 12 OF 29 6 1 6 2 BTL 08 ABPM SW EDITIONS AND SYSTEM REQUIREMENTS PERSONAL EDITION DEFINITION BTL 08 ABPM SW Personal Edition can be installed on a single computer and used only by one user at a time The use of ABPM devices is possible with an unlimited number of recorders COMPUTER REQUIREMENTS BTL 08 ABPM SW can be installed on most Windows based personal computers but please check before installation whether your computer meets the following requirements Minimum Requirements Suggested Configuration CPU 350 MHz Pentium Il 2 GHz P4 or equivalent RAM 64 MB 512 MB VGA 800x600 16 bit color 1024x768 16 bit color HDD about 40 MB for the software disk space for database OS Windows 98 SE Me 2000 XP The disk space necessary for the database depends on recorder type number of patients and number of examinations Typically it takes 75 MB to store 1000 ABPM recordings without reports ABPM recordings are small PAGE 13 OF 29 7 1 7 2 INSTALLATION AND FIRST START As with any software installation you need a proper access level to the computer on which you want to install BTL 08 ABPM SW
26. f receipt This warranty is valid at the service address of BTL Industries Ltd unless otherwise displayed upon a commercial invoice or any other valid business document duly signed by the supplier and the recipient of the BTL product If such business document displaying a certain site for warranty validity cannot be presented this warranty is valid at BTL HQ office in Plovdiv Bulgaria This warranty does not cover any malfunction or defects of the recorder unit or any of its accessories arising from improper use the use of inadequate accessories accident theft or use of the recorder unit outside its operating environmental specifications and intended measurement range Removing the closing label from the back side of the recorder unit or opening the unit any other way voids this warranty EXCLUSION OF BIOHAZARD BTL will not accept for repair potentially infectious products or accessories especially pouches and cuffs that might have been in direct contact with the patient and could not be or potentially were not properly disinfected even within the warranty period If a problem occurs within the warranty period such accessories will be replaced without any physical inspection reserving the rights to hold an inspection when found necessary NO OTHER WARRANTIES BTL disclaims all other warranties expressed or implied including but not limited to implied warranties of merchantability and fitness for a particular purpose with regard to
27. g into the USB socket on the computer It is advisable not to disconnect the optoelectronic interface unit from the computer if it is used on that computer regularly 4 Connect the recorder to the optical cable Connect the small optical plug at the free end of the optical cable into the socket on the the device matching red mark on cable to red mark on recorder labels Insert and push it gently until it clicks in place Simply pull to remove Do not pull the cable itself always handle the plug A recorder so connected is ready for communication with the BTL 08 ABPM SW If you do not use the USB port for other purposes it is advisable to connect the interface unit as described above only once during first installation Then the interface unit with the optical cable is constantly connected to the computer and only the free end of the optical cable has to be inserted in the socket on the recorders to establish the connection The interface unit converts optical signals to electric ones and vice versa The twin optical cable transfers optical signals between the interface unit and the recorder The cable is flexible but it is sensitive to overfolding and to cutting forces If you fold the optical cable in too small radius or if a strong cutting force e g by the edge of a drawer is applied to it the optical cable may become optically distorted which might result in communication errors In the BTL 08 ABPM SW click the Tools menu click the Opt
28. ial number and the firmware version of the device PAGE 9 OF 29 5 3 5 4 MONITORING STEP BY STEP Before you begin you must have the BTL 08 ABPM software properly installed and configured on your computer and the recorder correctly connected To program your recorder you will need a BTL optical interface cable properly connected to your USB port and the communication port correctly selected in the BTL 08 ABPM software A successful monitoring session consists of the following steps Inform your patient about monitoring rules well in advance Start the BTL 08 ABPM program select the BTL 08 ABPM recorder type Enter new patient data or select patient from the database Create a monitoring plan with respect to the patient s lifestyle Insert two fully charged AA size batteries into the battery compartment and check their voltage Connect the recorder to the computer Send the monitoring plan from the computer to the recorder unit Apply the cuff to the patient with the device placed in the pouch Give the patient diary to the patient along with detailed instructions about the rules and the usage of the device ox co Or o m Monitoring session typically 24 hours 10 Remove the unit and 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 BTL 08 ABPM program and select the BTL 08 ABPM recorder type 13 Connect th
29. ions command and in the appearing Options dialog select Communication on the left On the right panel select the required recorder type then select the BTL USB option as appropriate for the interface unit you have connected to the computer To check communication connect the recorder with batteries in it and switched on to the recorder end of the optical cable select the required port number or enable the Auto search com port checkbox and then click the Test button PAGE 16 OF 29 7 5 WIRELESS BLUETOOTH CONNECTION BTL 08 ABPM Plus is a recorder with wireless communication It operates with Bluetooth R technology Most up to date computers today come with in built Bluetooth capability or are easily extendible using a small USB Bluetooth dongle Bluetooth functionality works seamlessly in Windows XP Service Pack 2 or newer releases but it can be usually added to older Windows versions as well Windows XP Help as well as the documentation of Bluetooth dongles contains detailed information how wireless devices can be used and this is described in detail in BTL 08 ABPM SW Help as well However if you use the above mentioned devices you may need the following information during the first startup procedure after the installation of BTL 08 ABPM SW 1 If you wish to use a wireless Bluetooth capable BTL recorder open the Tools Options dialog of BTL 08 ABPM SW and select the Communication category Select the type of the recorder th
30. measurements cause bloodshots torpidity or pain in the hand the cuff should be removed from the arm and disconnected from the recorder Such occurrence should be reported to the physician at once but latest after the monitoring session BTL 08 ABPM recognizes and functions with three different cuff sizes Please set the appropriate cuff size to be used during the programming of the device Attention inappropriate setting of the cuff size may lead to device malfunctioning which is inconvenient for the patient and may lead to an unsuccessful measurement Name Bladder dimensions Sleeve dimensions Arm circumference range Normal adult 12 5 x 22 5 cm 16 52 24 32 Small adult child 6 x 28 5 cm 9 x 41 cm under 24 cm Large adult 14 5 x 32 cm 16 x 70 cm 32 42 cm When properly applied the end of the sleeve the one closer to the tube should fall in the indicated range The cuff is the component which by definition of the relevant standard is protected against a defibrillator discharge Caution Substitution of a cuff different from that supplied might result in measurement error and or in certain cases cause damage to the main recorder unit PAGE 11 OF 29 5 6 ACCESSORIES set one 1 plastic case one 1 BTL 08 ABPM recorder unit one 1 serial or USB interface unit with twin optical cable one 1 pouch for recorder with shoulder and waist straps one 1 normal adult size cuf
31. oduct Its component parts may not be separated for any purposes Rental You may not rent or lease the SOFTWARE from anyone except from BTL or an authorized representative of BTL Demonstration You may only demonstrate SOFTWARE if all the information described in this Agreement is disclosed to third parties Software Transfer You may not transfer any of your rights under this Agreement to any other party without the prior written consent of BTL Industries Ltd Termination Without prejudice to any other rights BTL may terminate this Agreement if you fail to comply with the terms and conditions of this Agreement If such event occurs you must destroy all copies of the SOFTWARE and all of its components COPYRIGHT All title and copyrights in and to the SOFTWARE the accompanying electronic and printed materials and any copies of the SOFTWARE are owned by BTL Industries Ltd The SOFTWARE is protected by copyright laws and international treaty provisions therefore you must treat the SOFTWARE like any other copyrighted material except that you are allowed to make a copy of the software only for control and evaluation purposes You may not copy the printed materials accompanying the SOFTWARE PAGE 18 OF 29 MISCELLANEOUS This Agreement is governed by the laws of Hungary Should you have any questions concerning this Agreement please contact BTL Industries Ltd LIMITED WARRANTY BTL Industries Ltd guarantees that a the SOF
32. omplies BTL 08 ABPM is suitable for use in establishments directly connected to a public low voltage mains network 1 61000 3 3 Directive and declaration of manufacturer Electromagnetic immunity BTL 08 ABPM is suitable for use in the specified electromagnetic environment The purchaser or user of BTL 08 ABPM should assure that it is used in an electromagnetic environment as described below Immunity test IEC601 1 2 test level Electromagnetic environment level Electrostatic discharge 6KV contact 8KV air Floors are wood concrete or ceramic tile or ESD floors are covered with synthetic material 8KV air and the relative humidity is at least 30 IEC 61000 4 2 percent Electrical fast transient 2 for power supply Not applicable Mains power quality is that of a typical burst lines commercial and or hospital environment IEC 61000 4 4 1KV_ for input output lines Surge 1KV differential mode Not applicable Mains power quality is that of a typical commercial and or hospital environment IEC 61000 4 5 2 common mode PAGE 26 OF 29 Voltage dips short 596 Ur gt 95 dip for Not applicable interruptions and 0 5 cycle voltage variations on power supply input lines 4095 Ur 6096 dip for 5 cycles IEC 61000 4 11 70 Ur 30 dip for 25 cycles lt 5 Ur gt 95 dip for 5 sec Power frequency 50 60Hz magnetic field IEC 61000 4 8 Note is the nominal voltage of mains Main
33. or for service information Roll out BTL 08 ABPM recorders include an internal NiCd coin cell which may fall under the category of hazardous waste and should be disposed of properly The device should be handled at roll out as normal electronic waste Bateries BTL 08 ABPM ambulatory blood pressure recorders operate with two 1 5V AA batteries or two 1 2V AA rechargeable batteries Use only standard long life alkaline batteries or standard NiCd or NiMH rechargeable batteries of the proper size Do not use lithium batteries Do not mix different battery types do not mix new and old batteries Never use batteries of low or unknown quality or pre used batteries as they may not cover the power needs of the recorder and they may damage the recorder or they may contain acidic electrolytes which may leak and corrode electronic components Never use batteries damaged in any way Should the batteries run down during a monitoring session they can be replaced Monitoring will continue and data will not be lost If you do not use the recorder it is advisable to remove batteries since they may run down due to the constant small power consumption of the integrated circuits of the device Data in the recorder are not lost even if batteries run down or are removed Used batteries may fall under the category of hazardous waste and should be disposed of properly Important It is strongly recommended to use freshly charged accumulators or new batteries with ever
34. rder will commence operating automatically and perform blood pressure measurements based on the monitoring plan To obtain reliable BP readings certain rules must be observed RULES OF MONITORING 1 Inform the patient about the goal and expected results of the monitoring Provide an event diary and rules to observe 2 Patients can fit the recorder comfortably with the adjustable straps 3 Itis advisable to wear a thin shirt under the ABP cuffs This does not influence the accuracy of blood pressure measurement but it prevents problems caused by long time wear of the cuff sweat itching soreness etc 4 The cuff should be properly placed and connected 5 Patients should avoid excess movement during blood pressure measurements They should hold their arm loose slightly away from their chest 6 Should the blood pressure measurements cause bloodshots torpidity or pain in the hand the cuff should be removed from the arm immediately and disconnected from the recorder Such occurrence should be reported to the physician latest after the monitoring session 7 Patients should not remove the recorder even at night By loosening the straps they can avoid problems when turning in their sleep The recorder does not disturb most patients at night 8 Patients may start extra blood pressure measurements with the START button of the BTL 08 ABPM recorder They should mark events such as taking medication with the MEDICATION button They shoul
35. rding create save and print a freely editable report PAGE 10 OF 29 5 5 CUFFS AND THEIR APPLICATION It is advisable to wear a thin shirt or blouse under the cuff This does not influence the accuracy of blood pressure measurements but it prevents possible problems caused by long time wear sweating itching etc Place the cuff on the upper arm so that the rubber tube points towards the patient s shoulder and the bladder is placed above the brachial artery if possible Contrary to the usual placement with the tube pointing downwards the advantage is that the patient can wear a loose jacket over the cuff Connect the rubber tube of the cuff into the air plug connector which you can find on the long edge closer to the buttons of the BTL 08 ABPM recorder Connect the cuff turning it clockwise with slight pressure Note It is recommended that the cuff be applied as tightly as acceptable for the patient A too loose cuff will cause much longer blood pressure measurement times and possibly aborted measurements With an overly loose cuff the recorder must pump to tighten the cuff on the arm and then it must reach the pressure necessary for measurement This causes considerable inconvenience for the patient and results in less data for evaluation If the patient removes the cuff for a period during the monitoring session it should be re applied with appropriate tightness with help from another person if necessary Should blood pressure
36. ry blood pressure recorder is manufactured by BTL Industries Ltd The BTL 08 ABPM SW has been developed by BTL Industries Ltd title and copyrights in and to the BTL 08 ABPM SW the accompanying electronic and printed materials and any copies of the BTL 08 ABPM SW are owned by BTL Industries Ltd The BTL 08 ABPM SW is protected by copyright laws and international treaty provisions For details please read the software license agreement BTL recorders working with the BTL 08 ABPM SW described in this manual including ambulatory blood pressure ABP recorders BTL 08 ABPM and BTL 08 ABPM Plus Both are manufactured by BTL Industries Ltd Indications for ambulatory blood pressure monitoring The following indications are listed in the European Society of Hypertension recommendations for ambulatory blood pressure measurement 2003 e Suspected white coat hypertension e Suspected nocturnal hypertension To establish dipper status Resistant hypertension Elderly patient e As a guide to antihypertensive drug treatment e Type 1 diabetes e Hypertension of pregnancy Evaluation of hypotension e Autonomic failure Contraindications Non cooperative patients unconscious or otherwise incapable patients e Patients requiring urgency emergency cardiac care e Patients with coagulation disturbances for ABP monitoring e Patients with serious mobility or other impairments without supervision e Children without supervision childr
37. s power quality is that of a typical commercial and or hospital environment If the user of BTL 08 requires CLINICAL UTILITY during power mains interruptions it is recommended that parts of the BTL 08 ABPM system where applicable be powered from an uninterruptible power supply Power frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and or hospital environment Directive and declaration of manufacturer Electromagnetic immunity BTL 08 ABPM is suitable for use in the specified electromagnetic environment The purchaser or user of BTL 08 ABPM should assure that it is used in an electromagnetic environment as described below Immunity test IEC601 1 2 test level Electromagnetic environment level Conducted RF 3Ver Not applicable IEC 6100 4 6 150KHz 80MHz Radiated RF 3V m IEC 61000 4 3 80MHz 2 5GHz Portable and mobile RF communications equipment are used no closer to any part of BTL 08 ABPM including cables than the Recommended Separation Distance calculated the formula written below Recommended Separation distance d 9 5 V4 NP d 8 5 3V m VP 80MHz 800MHz d 7 3V m VP 800MHz 2 5GHz where P is the highest radiated power disclosed by the manufacturer of transmitter W d is the recommended separation distance m 1 note in case of frequency 80MHz or 800 MHz the formula for the higher range is applicable 2 note These are
38. th special caution in patients with arrhythmias Parkinson s disease or other diseases with tremor Always consult a physician for the interpretation of the blood pressure measurements Note that any blood pressure recording may be affected by the body position the physiological condition of the patient and other factors BTL 08 ABPM is an internally powered type CF device Protection vs ingress of water none Mode of operation continuous The device is not protected against defibrillators or other high frequency surgical equipments PAGE 5 OF 29 e Blood pressure measurements determined with the algorithm of the BTL 08 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 The algorithm used in the BTL 08 ABPM fulfills the requirements of the British Hypertension Society Validation Protocol for Automated Blood Pressure Measuring Devices RECOMMENDED USE OF AMBULATORY BLOOD PRESSURE RECORDS The BTL 08 ABPM device is a compact lightweight monitoring unit typically worn by the patient for 24 hours BTL 08 ABPM is a compact lightweight device which operates with two AA size accumulators or batteries The memory is capable of storing 600 measurements START button Stepwise pressure deflation ensures quality measuremen
39. the default report header data to show data you would like to see on top of all printed report pages When you click the Next button after entering your report header details BTL 08 ABPM SW will create the user settings the demo data and personalized icons Therefore it is not possible to use the Back button after you click Next here OPTOELECTRONIC INTERFACE CABLE To register a recorder as a key device check electrode placement send a monitoring plan to the recorder or transfer collected medical data to the computer the recorder has to be connected to the computer Steps to follow for the first connection 1 Locate a USB port often labeled amp amp on your computer 2 Take the optoelectronic interface unit with the optical cable out of the package In case of the serial interface cable the interface unit is integrated in the serial plug with the optical cable The USB interface unit has a small USB plug similar to a USB pen drive with an oblique socket for the independent optical cable 3 Connect the interface unit to the port If you have a USB port on your computer and you have a serial optoelectronic interface use a USB to serial converter If you have a USB port on your computer and a USB type optoelectronic interface from BTL insert one end of the optical cable into the miniature oblique optical socket on the USB interface dongle matching the red marks on the cable and on the interface label then insert the USB plu
40. the recorder unit any accessory or other accompanying hardware and the BTL 08 ABPM software NO LIABILITY FOR CONSEQUENTIAL DAMAGES In no event shall BTL be liable for any special incidental indirect or consequential damages whatsoever including without limitation damages for loss of business profits business interruption loss of business information loss of data or any other pecuniary loss arising out of the use of or inability to use the recorder unit its accessories and or the BTL 08 ABPM software even if BTL has been advised of the possibility of such damages PAGE 24 OF 29 12 TECHNICAL Power supply 2AA rechargeable NiCd or NiMH batteries or 2 AA alkaline batteries Display liquid crystal Data storage internal solid state memory Data transmission on USB optical cable 115200Baud PC interface special optoelectronic serial or USB interface Operating environment Temperature 10 45 C Humidity 10 95 non condensing Atmospheric pressure 70 106 kPa Storage conditions Temperature 20 50 Humidity 10 95 non condensing Size 70 x 99 x 30 mm Weight app 240 g batteries included Blood pressure measurement method oscillometric Blood pressure maximum storage over 600 measurements Pressure measurement range 0 300 mmHg Static accuracy 3 mmHg or 2 of measured value stability 2 years Blood pressure measurement range 30 260 mmHg
41. ts even if disturbing environmental factors occur You may find the battery compartment and the rating label on the backside housing The serial number is placed on the rating label however it is also stored electronically in the solid state memory of the device 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 device can be connected to the serial or USB port of an IBM compatible PC with an optoelectronic interface which has its socket positioned on the opposite side from the cuff connector Patients can start extra blood pressure readings or mark symptomatic events DAY NIGHT button Cuff connection USING THE BUTTONS On the front side of the housing below the LCD you may find three buttons the START button the MEDICATION button and the DAY NIGHT button If the device is turned on then every button press is accompanied by a short beeping sound Cancel a blood pressure measurement The patient can interrupt a blood pressure measurement by pressing a button at any time while the cuff is inflated This will result in immediate fast cuff deflation Such interruption is limited to the measurement in progress only and has no effect on further operation This function is available with all three buttons PAGE 6 OF 29 Manual blood pressure measurement If it seems necessary the patient can start an additional manual blood pressure measurement
42. using the device and contact the authorised BTL service centre If the device shows any signs of defects or you are in doubt about its correct operation stop the it immediately If you cannot detect the source of doubts even after careful reading through the instruction manual appeal to the authorised service department of the BTL device without delay If the device is used contrary to this instruction manual or it is used despite the device showing functional divergences from this instruction manual then the user is responsible for any damage caused by the device The device does not radiate or does not use any toxic materials during its operation storage and transport under the given conditions This device must be kept out of reach of the children The device does not include any components to be reparable by the user except the replacement kit Do not remove any covers from the device Repairs must always be provided by the authorised BTL service centre Electric shock hazard protection BTL 08 ABPM recorders meet relevant shock hazard protection standards BTL 08 ABPM recorders operate with two 1 5V AA batteries or two 1 2V AA rechargeable batteries This excludes all electric shock hazards even in the unlikely case of multiple device errors Use only standard long life alkaline batteries or standard NiCd or rechargeable batteries of the proper size Do not use lithium batteries Do mix different battery types do not mix
43. y patient so that batteries do not run down during monitoring even in case of very high blood pressure values and or a long monitoring session After inserting batteries in BTL 08 ABPM recorders it is advised to check their voltage before programming the recorders Do not start a new monitoring session with low batteries The typical voltage for two fully charged rechargeable batteries should be over 2 5 V and for fresh alkaline batteries over 3 V It is possible to check battery voltage with the START button Please check the Using the buttons section for more details PAGE 20 OF 29 Important If a recorder is not used for a long period the in built backup cell ensuring the operation of the internal clock may get discharged In this case keep freshly charged batteries in the recorder for at least one day this will recharge the backup cell It is possible to use the recorder afterwards If the backup cell is not properly charged the internal clock may work incorrectly and the recorder may not start measurements in due time Two sets of rechargeable batteries and a charger are by default included in the complete set Please refer to the relevant product descriptions when charging batteries A set of properly charged high capacity batteries will enable an BTL 08 ABPM recorder to perform 250 blood pressure measurements during a 24 48 hours long monitoring session If you opt to use alkaline batteries choose high capacity long life products to
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