BTL BTL-08 ABPM - User Manual

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Summary

BEFORE YOU START

Introduction to the User Manual

Welcomes users and explains the manual's purpose for understanding the BTL-08 ABPM system.

GENERAL CHARACTERISTICS OF THE DEVICE

Indications for Ambulatory Blood Pressure Monitoring

Lists clinical conditions for which ABPM is indicated, based on hypertension recommendations.

Contraindications for Use

Lists patient groups or conditions where ABPM monitoring is not recommended or requires caution.

IMPORTANT INFORMATION - PRECAUTIONS FOR USE

Usage Restrictions and Critical Safety Warnings

Details cases where the device should not be used and critical safety advice for operation.

RECOMMENDED USE OF AMBULATORY BLOOD PRESSURE RECORDS

Device Overview and Measurement Method

Describes the BTL-08 ABPM device, its components, memory capacity, and measurement method.

USING THE BUTTONS

Button Functions and Device Operations

Explains how to use the START, MEDICATION, and DAY/NIGHT buttons for various functions like measurements, marking events, and shifts.

DISPLAY

LCD Indicators and Status Symbols Explained

Details the meaning of various symbols and readings shown on the device's LCD screen for status and results.

WORKING WITH BTL-08 ABPM

Rules of Monitoring and Patient Guidance

Provides essential guidelines for patients and operators to ensure successful monitoring sessions and patient comfort.

Connecting the Recorder to the PC

Step-by-step instructions for establishing a wired connection between the ABPM recorder and a computer using an interface cable.

MONITORING STEP BY STEP

Procedure for a Complete Monitoring Session

Outlines the sequential steps for conducting a typical 24-hour ABPM monitoring session, from preparation to data retrieval.

USING THE BTL-08 ABPM SW

Software Capabilities and Data Management

Describes the functions of the BTL-08 ABPM software for programming, data transfer, analysis, and reporting.

CUFFS AND THEIR APPLICATION

Cuff Selection and Proper Application Technique

Details the different cuff sizes, their application, and important considerations for accurate measurements and patient comfort.

ACCESSORIES

Included Set and Package Contents

Lists the standard accessories included with the BTL-08 ABPM recorder package for complete functionality.

BTL-08 ABPM SW EDITIONS AND SYSTEM REQUIREMENTS

Computer System Requirements for Software

Specifies the minimum and recommended hardware and OS configurations for installing and running the BTL-08 ABPM software.

INSTALLATION AND FIRST START

Software Installation Guide

Provides detailed instructions for installing the BTL-08 ABPM SW Personal Edition on a computer.

Initial Setup and Administrator Configuration

Guides through the first launch of the software, including administrator login, settings, and user creation.

OPTOELECTRONIC INTERFACE CABLE

Connecting the Recorder via Cable

Detailed steps for physically connecting the ABPM recorder to the computer using the optoelectronic interface cable for data transfer.

WIRELESS BLUETOOTH CONNECTION

Bluetooth Device Pairing and Setup

Instructions for establishing a wireless connection between the ABPM recorder and the computer using Bluetooth technology.

BTL-08 ABPM SW LICENSE AGREEMENT

Software Usage Terms and Conditions

Outlines the legal terms and conditions for using the BTL-08 ABPM software, including copyright and limitations.

CARE AND MAINTENANCE

Device Protection and Cleaning Procedures

Provides guidance on how to protect the device from damage, spills, and proper cleaning methods.

Battery Management and Replacement

Details battery types, usage recommendations, charging, and the process for replacing batteries to ensure optimal performance.

SAFETY OF THE DEVICE

General and Specific Safety Guidelines

Covers essential safety precautions, handling advice, warnings regarding electrical safety, biocompatibility, and hazardous materials.

BTL PRODUCT WARRANTY INFORMATION

Warranty Coverage and Exclusions

Specifies the warranty periods and terms for the recorder unit, accessories, and software, along with common exclusions.

TECHNICAL PARAMETRES

Device Specifications and Performance Ranges

Lists the technical specifications of the BTL-08 ABPM, including power supply, display, data storage, measurement ranges, and accuracy.

EMC INFORMATION

Electromagnetic Compatibility (EMC) Guidelines

Provides information on electromagnetic emission and immunity requirements, and recommended separation distances for RF equipment.

MANUFACTURER

Company and Contact Information

Contains the contact details, address, and website of the manufacturer, BTL Industries Ltd.

The BTL-08 ABPM is an ambulatory blood pressure recorder manufactured by BTL Industries Ltd., designed for 24-hour monitoring of blood pressure. It is a compact, lightweight device that operates with two AA size accumulators or batteries. The device's memory can store up to 600 measurements. It uses a stepwise pressure deflation method to ensure quality measurements, even in the presence of environmental factors. The BTL-08 ABPM SW (software) is developed by BTL Industries Ltd. and is protected by copyright laws and international treaty provisions.

Function Description:

The BTL-08 ABPM records blood pressure and pulse rate values, providing data to support diagnostic decisions by a qualified physician. It does not automatically provide a diagnosis. The device is intended for use in ambulatory blood pressure monitoring (ABPM) and is indicated for suspected white-coat hypertension, nocturnal hypertension, establishing dipper status, resistant hypertension, elderly patients, as a guide to antihypertensive drug treatment, Type 1 diabetes, hypertension of pregnancy, evaluation of hypotension, and autonomic failure.

The device features an LCD display, START, MEDICATION, and DAY/NIGHT buttons. The START button initiates a manual blood pressure measurement, displays battery voltage, and can be used to switch the device on or off. The MEDICATION button allows patients to mark events without starting a measurement, such as taking medicine. The DAY/NIGHT button, if enabled during programming, allows patients to mark times of going to bed and rising, or manually shift the measurement frequency period (day or night). Any button can be pressed to interrupt a blood pressure measurement, causing immediate cuff deflation.

The BTL-08 ABPM SW allows for programming the recorder, transferring collected data to a computer, and analyzing blood pressure profiles. It stores data in a database with user access control and offers graphical and tabular displays, editing features, statistical analysis, and a report generator.

Important Technical Specifications:

Power supply: 2 AA rechargeable NiCd or NiMH batteries or 2 AA alkaline batteries.
Display: Liquid-crystal.
Data storage: Internal solid-state memory, capable of storing over 600 measurements.
Data transmission: Via USB optical cable at 115200 Baud.
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, Humidity 10 - 95% (non-condensing).
Size: 70 x 99 x 30 mm.
Weight: Approximately 240 g (batteries included).
Blood pressure measurement method: Oscillometric.
Pressure measurement range: 0-300 mmHg.
Static accuracy: ± 3 mmHg or ± 2% of measured value (stability: 2 years).
Blood pressure measurement range (actual): 30-260 mmHg.
Pulse rate measurement range: 40-200 beats 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.
Device type: Internally powered type CF device.
Protection against ingress of water: None.
Mode of operation: Continuous.
Protection against defibrillators: Not protected.

Usage Features:

Patient Information: Patients should be informed about monitoring rules and provided with an event diary.
Cuff Application: A thin shirt or blouse should be worn under the cuff. The cuff should be placed on the upper arm with the rubber tube pointing towards the patient's shoulder and the bladder above the brachial artery. The cuff should be applied with appropriate tightness to avoid aborted measurements.
Cuff Sizes: The device recognizes and functions with three cuff sizes: Normal adult (24-32 cm arm circumference), Small adult (child) (under 24 cm arm circumference), and Large adult (32-42 cm arm circumference). Inappropriate cuff size setting can lead to malfunctioning.
Battery Check: Battery voltage can be checked by pressing and holding the START button for more than 5 seconds. Fully charged accumulators should be over 2.5 V, and fresh alkaline batteries over 3 V.
Event Marking: Patients can mark events (e.g., taking medication) using the MEDICATION button and mark bedtimes/wake times using the DAY/NIGHT button.
Manual DAY/NIGHT Shift: If enabled, patients can manually shift measurement frequency periods.
Communication with PC: The device connects to a PC via an optoelectronic interface cable (USB or serial) or wirelessly via Bluetooth (for BTL-08 ABPM Plus). The software allows for programming the monitoring plan and transferring collected data.
Software Features: The BTL-08 ABPM SW manages recorders, browses patient data, views, edits, and analyzes recordings, and generates customizable reports.
Bluetooth Connection (BTL-08 ABPM Plus): To connect wirelessly, place fresh batteries, make the recorder discoverable by simultaneously pressing START and MEDICATION buttons for over 3 seconds, then use the "Add" button in the software. The authentication key (PIN) is the last four digits of the serial number.

Maintenance Features:

Cleaning: The recorder is not protected against water ingress. Do not immerse it in water or cleaning fluid. Wipe off water drops with a dry cloth. Clean with a disinfectant cleaning tissue or a slightly damp cloth, then dry with an antistatic tissue. Do not expose to extreme heat or radiation.
Battery Replacement: The device uses two 1.5V AA or 1.2V AA rechargeable batteries. Use only standard long-life alkaline or NiCd/NiMH rechargeable batteries. Do not mix battery types or new and old batteries. Remove batteries if the recorder is not used for a long period. Data is not lost when batteries are removed.
Backup Cell: If the recorder is not used for a long time, the internal clock's backup cell may discharge. Keep freshly charged batteries in the recorder for at least one day to recharge it.
Warranty: The main recorder unit has a two-year warranty. Non-disposable accessories have a one-year warranty. Cuffs have a six-month warranty. The software has a ninety-day warranty. Removing the closing label from the back of the recorder voids the warranty.
Service: No user-serviceable parts inside. Refer problems to qualified service personnel or the local distributor.
Disposal: Used batteries and the internal NiCd coin cell should be disposed of as hazardous waste. The device itself should be handled as normal electronic waste at roll-out.
Calibration: Verification of pressure measurement accuracy is recommended biannually.
Safety Distance: During computer-based use, maintain at least a 2-meter distance between the patient and the computer due to potential shock hazards and strict safety regulations for medical devices. The optical cable ensures electrical separation.
Biocompatibility: The device, cuff, and tubing should never directly contact the patient's skin to avoid infection risks and for general hygienic reasons.
Hazardous Materials: BTL recorders do not contain pharmaceutical substances or tissue of animal origin and emit no material hazardous to humans.