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BTL-08 ABPM
USER’S MANUAL
PAGE 1 OF 29
100PL01/12/2008EN
Related Manuals for BTL BTL-08 ABPM
Summary of Contents for BTL BTL-08 ABPM
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Page 1
BTL-08 ABPM USER‘S MANUAL PAGE 1 OF 29 100PL01/12/2008EN… -
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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… -
Page 3: Table Of Contents
USING THE BUTTONS ……………………..6 Display …………………………..8 WORKING WITH BTL-08 ABPM……………………9 Rules of monitoring ……………………….9 Connecting the BTL-08 ABPM recorder to the PC………………9 Monitoring step by step ……………………..10 USING THE BTL-08 ABPM SW……………………10 Cuffs and their application……………………… 11 Accessories…………………………
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Page 4: General Characteristics Of The Device
All 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.
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Page 5: Important Information — Precautions For Use — Read Carefully
• 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…
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Page 6: Recommended Use Of Ambulatory Blood Pressure Records
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.
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Page 7
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. -
Page 8: Display
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.
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Page 9: Working With Btl-08 Abpm
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.
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Page 10: Monitoring Step By Step
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.
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Page 11: Cuffs And Their Application
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.
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Page 12: Accessories
(1) pouch for recorder, with shoulder and waist straps one (1) normal adult size cuff 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…
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Page 13: Btl-08 Abpm Sw Editions And System Requirements
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.
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Page 14: 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. 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.
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Page 15: First Start
Users can – in fact, they are strongly advised to – change their password when they log in to BTL-08 ABPM 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.
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Page 16: Report Header
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.
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Page 17: Wireless Bluetooth Connection
BTL-08 ABPM SW. 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, then click on the appearing Bluetooth settings button.
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Page 18: 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.
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Page 19
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 20: Care And Maintenance
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.
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Page 21
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 enable reliable operation. A small crossed battery sign on the LCD shows low battery voltage. -
Page 22: Safety Of The Device
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 using the device and contact the authorised BTL service centre.
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Page 23
• 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. -
Page 24: Btl Product Warranty Information
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.
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Page 25: Technical Parametres
12 TECHNICAL PARAMETRES Power supply: Blood pressure measurement method: 2 AA rechargeable NiCd or NiMH batteries or 2 oscillometric AA alkaline batteries Blood pressure maximum storage: Display: over 600 measurements liquid-crystal Pressure measurement range: Data storage: 0-300 mmHg internal solid state memory Static accuracy: Data transmission: ±…
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Page 26: Emc Information
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…
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Page 27
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. -
Page 28
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. -
Page 29: Manufacturer
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.
4.1
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.
Please note that the BTL-08 ABPM might not meet its performance specifications if stored or used outside the
specified environmental conditions.
Normal status:
time is displayed.
Blood pressure measurement
initiated.
Deflation during blood pressure
measurement, the current
pressure is displayed [mmHg].
Systolic value of just completed
measurement [mmHg].
Pulse rate value of just completed
measurement
[beats per minute].
Event marker set due to button
push.
Communication with personal
computer.
Error code display.
The recorder is switched off.
PAGE 8 OF 29
Night mode:
time is displayed,
moon sign is lit.
Pumping for measurement
current pressure [mmHg].
Heart symbol blinking
in tune with pulse: measurement
in progress.
Diastolic value of just completed
measurement [mmHg].
Blood pressure measurement
cancelled
by pressing a button.
The crossed battery symbol warns
about low battery.
LCD check:
all segments
are displayed.
Battery voltage display (2.37 V).
Table of Contents for BTL BTL-08 ABPM:
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PAGE 14 OF 29 7 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. 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. 7.1 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
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PAGE 29 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: [email protected] http://www.btlnet.com For service, please contact the service department at [email protected]. No part of this manual may be reproduced, saved in a research centre or transfer
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PAGE 3 OF 29 CONTENTS 1 GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………… 4 2 IMPORTANT INFORMATION – PRECAUTIONS FOR USE – READ CAREFULLY……………………………….5 3 RECOMMENDED USE OF AMBULATORY BLOOD PRESSURE RECORDS ……………………………………… 6 4 USING THE BUTTONS …………………………………………………………………………………………………………………. 6 4.1
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PAGE 12 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 cuff 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 strap
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PAGE 4 OF 29 1 GENERAL CHARACTERISTICS OF THE DEVICE The BTL-08 ABPM ambulatory blood pressure recorder is manufactured by BTL Industries Ltd. The BTL-08 ABPM SW has been developed by BTL Industries Ltd. All 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 licen
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PAGE 16 OF 29 7.3.3 REPORT HEADER In this screen of the first start wizard it is possible to change 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. 7.4 OPTOELECTRONIC INTERFACE CABLE To register a recorder as a key device, check electrod
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PAGE 6 OF 29 • Blood pressure measurements determined with the algorithm of the BTL-08 ABPM 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 Devi
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PAGE 7 OF 29 Manual blood pressure measurement If it seems necessary, the patient can start an additional, manual blood pressure measurement 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. I
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PAGE 10 OF 29 5.3 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: 1. Inform your patient about monitoring rules well in advance. 2. Start the BTL-08 ABPM p
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PAGE 22 OF 29 10 SAFETY OF THE DEVICE 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. •
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PAGE 18 OF 29 8 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 desc
Questions, Opinions and Exploitation Impressions:
You can ask a question, express your opinion or share our experience of BTL BTL-08 ABPM device using right now.
(Ocr-Read Summary of Contents of some pages of the BTL BTL-08 ABPM Document (Main Content), UPD: 15 June 2023)
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8, PAGE 8 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 unexpe…
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6, PAGE 6 OF 29 • Blood pressure measurements determined with the algorithm of the BTL-08 ABPM 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 Validatio…
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1, PAGE 1 OF 29 BTL-08 ABPM USER‘S MANUAL 100PL01/12/2008EN
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24, PAGE 24 OF 29 11 BTL 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 no…
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4, PAGE 4 OF 29 1 GENERAL CHARACTERISTICS OF THE DEVICE The BTL-08 ABPM ambulatory blood pressure recorder is manufactured by BTL Industries Ltd. The BTL-08 ABPM SW has been developed by BTL Industries Ltd. All 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 pr…
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28, BTL BTL-08 ABPM PAGE 28 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 functi…
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18, PAGE 18 OF 29 8 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…
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14, BTL BTL-08 ABPM PAGE 14 OF 29 7 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. 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. 7.1 INSTALLING BTL-08 ABPM SW PERSONAL EDITION Insert your installation CD into…
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25, PAGE 25 OF 29 12 TECHNICAL PARAMETRES Power supply: 2 AA 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 °C Humid…
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27, PAGE 27 OF 29 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% U T (>95% dip) for 0.5 cycle; 40% U T (60% dip) for 5 cycles; 70% U T (30% dip) for 25 cycles; <5% U T (>95% dip) for 5 sec. Not applicable Mains power quality is that of a typical commercial and/or hospital environment. If t…
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22, PAGE 22 OF 29 10 SAFETY OF THE DEVICE 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…
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21, PAGE 21 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 incorr…
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11, PAGE 11 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 p…
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5, PAGE 5 OF 29 2 IMPORTANT INFORMATION – PRECAUTIONS FOR USE – READ CAREFULLY ! 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 …
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15, BTL BTL-08 ABPM PAGE 15 OF 29 7.3 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 • Change BTL-08 ABPM SW system administrator settings • Add a BTL-08 ABPM SW user • Modif…
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