BTL BTL-08 ABPM User manual

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BTL-08 ABPM
USER‘S MANUAL
100PL01/12/2008EN

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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.

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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 Display..........................................................................................................................................................8
5 WORKING WITH BTL-08 ABPM....................................................................................................................9
5.1 Rules of monitoring.......................................................................................................................................9
5.2 Connecting the BTL-08 ABPM recorder to the PC........................................................................................9
5.3 Monitoring step by step...............................................................................................................................10
5.4 USING THE BTL-08 ABPM SW..................................................................................................................10
5.5 Cuffs and their application...........................................................................................................................11
5.6 Accessories.................................................................................................................................................12
6 BTL-08 ABPM SW EDITIONS AND SYSTEM REQUIREMENTS................................................................13
6.1 Personal edition definition...........................................................................................................................13
6.2 Computer requirements ..............................................................................................................................13
7 INSTALLATION AND FIRST START...........................................................................................................14
7.1 Installing BTL-08 ABPM SW Personal Edition............................................................................................14
7.2 Installation results: folders, shortcuts and programs...................................................................................14
7.3 First Start ....................................................................................................................................................15
7.3.1 BTL-08 ABPM SW system administrator settings.................................................................................. 15
7.3.2 Adding a BTL-08 ABPM SW user.......................................................................................................... 15
7.3.3 Report header........................................................................................................................................16
7.4 Optoelectronic interface cable.....................................................................................................................16
7.5 Wireless Bluetooth connection....................................................................................................................17
8 BTL-08 ABPM SW LICENSE AGREEMENT ...............................................................................................18
9 CARE AND MAINTENANCE........................................................................................................................20
10 SAFETY OF THE DEVICE............................................................................................................................22
11 BTL PRODUCT WARRANTY INFORMATION ............................................................................................24
12 TECHNICAL PARAMETRES .......................................................................................................................25
13 EMC INFORMATION....................................................................................................................................26
14 MANUFACTURER........................................................................................................................................29

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1GENERAL 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 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.
• Suspected white-coat hypertension
• Suspected nocturnal hypertension
• To establish dipper status
• Resistant hypertension
• Elderly patient
• As a guide to antihypertensive drug treatment
• Type 1 diabetes
• Hypertension of pregnancy
• Evaluation of hypotension
• Autonomic failure
Contraindications
• Non-cooperative patients, unconscious or otherwise incapable patients
• Patients requiring urgency / emergency cardiac care
• Patients with coagulation disturbances (for ABP monitoring)
• Patients with serious mobility or other impairments without supervision
• Children without supervision; children younger than 8 years

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2IMPORTANT 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
• 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 with 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.

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• 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
Devices.
3RECOMMENDED 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.
Stepwise pressure deflation ensures quality
measurements, 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.
4USING 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.

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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. 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. The 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.

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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.
Normal status:
time is displayed.
Night mode:
time is displayed,
moon sign is lit.
Blood pressure measurement
initiated.
Pumping for measurement
current pressure [mmHg].
Deflation during blood pressure
measurement, the current
pressure is displayed [mmHg].
Heart symbol blinking
in tune with pulse: measurement
in progress.
Systolic value of just completed
measurement [mmHg].
Diastolic value of just completed
measurement [mmHg].
Pulse rate value of just completed
measurement
[beats per minute].
Blood pressure measurement
cancelled
by pressing a button.
Event marker set due to button
push.
The crossed battery symbol warns
about low battery.
Communication with personal
computer.
Error code display.
LCD check:
all segments
are displayed.
The recorder is switched off. Battery voltage display (2.37 V).
Please note that the BTL-08 ABPM might not meet its performance specifications if stored or used outside the
specified environmental conditions.

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5WORKING WITH BTL-0 ABPM
The recorder must be programmed with the BTL-08 ABPM software installed on the computer. Once the pre-
programmed time is reached, the recorder will commence operating automatically and perform blood pressure
measurements based on the monitoring plan. To obtain reliable BP readings, certain rules must be observed.
5.1 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. It is 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 should 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.
5.2 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 serial number and the firmware version of the device.

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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 program, select the BTL-08 ABPM recorder type.
3. Enter new patient data or select patient from the database.
4. Create a monitoring plan with respect to the patient's lifestyle.
5. Insert two fully charged, AA size batteries into the battery compartment and check their voltage.
6. Connect the recorder to the computer.
7. Send the monitoring plan from the computer to the recorder unit.
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 usage of the device.
--- 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 the 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.
5.4 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
th
chapter.
In summary, BTL-08 ABPM SW lets you:
• manage (select, initialize and read data from) recorders
• browse patients and the results of monitoring sessions in a database
• view, edit and analyze data in a recording
• create, save and print a freely editable report.