HINGMED WBP-02A - User Manual

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1639
Hingmed
Wearable Ambulatory Blood Pressure Monitor
User Manual
WBP-02A Hospital
Shenzhen Hingmed Medical Instrument Co., Ltd.
VER：A/3
Date: Jan, 2020

Summary

Chapter 1 Preface

1.1 Brief Introduction of Ambulatory Blood Pressure Monitoring

Explains the purpose, benefits, and strengths of 24-hour ambulatory blood pressure monitoring compared to spot measurements.

Chapter 2 Safety Requirements

2.1 Intended Use

Details the intended applications and target patient population for the Hingmed Wearable Ambulatory Blood Pressure Monitor.

2.2 Contraindication

Lists contraindications and situations where the ABPM monitor should not be used due to potential risks.

2.3 Warnings

Highlights critical warnings and precautions to ensure safe and proper operation of the blood pressure monitor.

2.4 Notice

Covers notices regarding battery, training, measurement, energy conservation, and environmental protection.

Chapter 3 Product Introduction

3.1 Product Composition

Lists all accessories included in the Hingmed ABPM package, including the main unit, cuffs, and software.

3.2 Name and Function of Each Component

Describes the physical components of the ABPM monitor, its OLED display indicators, and operational symbols.

Chapter 4 Product Installation and Use

4.1 Battery Installation

Provides instructions on how to charge the device's internal lithium battery using the provided charger.

4.2 Wearing the Monitor

Guides on correctly wearing the ABPM cuff on the arm and preparing the patient for accurate measurements.

4.3 Installing Software System

Details the hardware requirements and step-by-step process for installing the necessary Hingmed PC software.

4.4 Execute Ambulatory Blood Pressure Study

Covers connecting the monitor, programming settings, starting/finishing measurements, and retrieving data.

Chapter 5 Troubleshooting and Maintenance

5.1 Troubleshooting

Provides a table of common error codes and their corresponding resolutions for troubleshooting the ABPM device.

5.2 Maintenance and Repairing

Outlines procedures for inspecting, cleaning, and performing routine maintenance on the ABPM monitor.

Chapter 6 Product Specifications

Chapter 7 EMC Information

Chapter 8 Warranty Card

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Hingmed WBP-02A Hospital Wearable Ambulatory Blood Pressure Monitor is a medical instrument designed for the automatic monitoring of human blood pressure over a specified period, typically 1-2 days, at set intervals. This device aims to provide a comprehensive understanding of blood pressure fluctuations throughout the day, which is crucial for accurate diagnosis and management of hypertension and hypotension. Unlike traditional ABPM devices that often involve a long air tube wrapped around the patient's body, the WBP-02A Hospital features a compact, lightweight, and integrated design that is worn directly on the arm without an external air tube. This design enhances patient comfort and minimizes motion tolerance, leading to more consistent measurements.

Function Description

The primary function of the WBP-02A Hospital is to measure systolic pressure, diastolic pressure, and pulse rate. These measurements are taken at different intervals over a 24-hour period, providing a detailed profile of the patient's blood pressure trends. The collected data can then be downloaded to a computer system via a USB cable. The accompanying Hingmed ABPM software system allows doctors to analyze these readings, aiding in diagnosis and treatment planning.

A key feature of the Hingmed WBP-02A is its ability to record the user's body position during blood pressure measurements. This information is particularly valuable for clinical research and the diagnosis of orthostatic hypertension, a condition where blood pressure is high only in standing or sitting postures but normal when lying down. By providing body position data, the monitor helps to reflect the patient's normal blood pressure situation more accurately under ambulatory conditions, which is extremely helpful for clinical diagnosis.

The device is especially useful for diagnosing various types of hypertension, including:

• White-coat hypertension: Where blood pressure is high in a clinical setting but normal outside of it.
• Masked hypertension: Where blood pressure is only high at certain times of the day and difficult to detect with office spot measurements.
• Morning surge hypertension: Characterized by a sudden rise in blood pressure after waking, or persistently high blood pressure at night and early morning.
• Nocturnal hypertension: High blood pressure during the night.
• Hypotension: Low blood pressure, which can cause dizziness or fainting, particularly in elderly individuals.

Beyond diagnosis, the WBP-02A also assists in:

• Eliminating measurement contingencies caused by factors like emotion, movement, eating, smoking, or drinking.
• Reflecting 24-hour blood pressure fluctuations more accurately.
• Improving hypertension diagnosis quality, especially for borderline hypertension patients.
• Guiding medication by evaluating drug efficacy, helping select drugs, and adjusting dosage and administration time.
• Providing data for target organ damage analysis, particularly for organs affected by hypertension.
• Predicting the time of sudden attacks of cardiovascular and cerebrovascular diseases.
• Offering important prognostic information, as patients with consistently high blood pressure over 24 hours tend to have higher mortality and incidence of cardiovascular disease.

The device is powered by a built-in rechargeable Lithium battery, eliminating the need for daily replacement of AA batteries, which is common in some other ABPM devices.

Usage Features

The WBP-02A is designed for ease of use, with a clear OLED screen displaying essential information such as historical memory, automatic measurement status, system time, heartbeat symbol, measurement time, and battery volume.

• Wearing the Monitor: The monitor is worn on the upper arm. Users must select the correct cuff size, ensuring the "Index" arrow falls between the "Max" and "Min" range indicators. The cuff should be positioned 2-3 cm above the elbow, with the artery sign aligned with the arm artery and the cuff tube pointing upwards. Incorrect cuff size can lead to measurement errors.
• Single Measurement: A single measurement can be initiated by pressing the "start/stop" button (the middle button). After the measurement, data can be viewed on the OLED screen, and historical data can be browsed using the forward or backward buttons.
• Automatic Monitoring: For 24-hour ambulatory studies, the device is programmed using the Hingmed ABPM software on a computer. After connecting the monitor via USB, users input patient information and set measurement parameters, including time types (Daytime, Nighttime, Special time), maximum pressure limits, keyboard and display settings, alarm thresholds for systolic and diastolic blood pressure, and measurement intervals. The software allows for flexible programming of multiple independent intervals (e.g., 5, 10, 15, 20, 30, 45, 60, 90, 120 minutes).
• Patient Preparation: Patients are advised to avoid overstress, excitement, and muscle tension before and during measurements. During inflation, the measurement arm should be kept slightly away from the body and remain still. If the cuff-wrapped arm is bent, it should remain bent; stretching the arm can cause rapid pressure changes and disturb the measurement.
• Data Retrieval and Analysis: After a monitoring period, the monitor is reconnected to the computer, and the data is transmitted to the Hingmed ABPM software. The software automatically displays the data and allows for comprehensive analysis and reporting. Reports can be generated in various formats, including print, preview, and PDF, showing historical data curves, statistics, histograms, pie charts, correlations, and hourly averages.
• Safety and Warnings: Users are instructed on how to stop operation if abnormal measurements occur or if discomfort is experienced. The monitor should not be used on children under 3 years old, near X-ray tomography devices, or in the presence of inflammable anesthetics. It is also not intended for use with defibrillation equipment, on wounds, or over limbs with IV injections, intravascular access, or A-V shunts. The device is not intended to be sterilized or used in an oxygen-rich environment.

Maintenance Features

Proper maintenance is essential for the long-term safe and efficient operation of the WBP-02A.

• Regular Inspection: Visually check the monitor and cuff for any broken parts or damages. If any damage is found, the monitor should not be used, and the distributor or service department should be contacted.
• Calibration: The monitor requires calibration at least once every two years to ensure accuracy.
• Cleaning: The monitor should not be disinfected or immersed in any fluid or strong detergents, cleaning agents, or solvents. A soft, damp cloth can be used to remove dirt and dust. If the unit accidentally gets wet, it should be dried in a well-ventilated place before use.
• Cuff Cleaning: The cuff and bladder can be cleaned using a mild detergent. The bladder, along with its fixing board, should be removed from the cuff before washing. After drying, the bladder is reinserted, and the monitor is reinstalled onto the cuff.
• Cuff Separation and Assembly: The manual provides detailed step-by-step instructions with pictures on how to separate the monitor from the cuff for cleaning or replacement, and how to reassemble it correctly. This involves holding specific positions and applying force in designated directions to detach and reattach the main unit from the cuff's fixing clips.
• Battery Care: The built-in Lithium battery should not be replaced without authorization. When the battery runs low, it should be recharged using the special quick charger provided with the WBP-02A package. The monitor should be kept away from high-temperature places and direct sunlight, with environmental temperatures not exceeding 60°C. If the battery cannot be charged or discharges quickly, after-sale support should be consulted.
• Disposal: Scrapped batteries, cuffs, cables, and main units should be handled properly in compliance with local environmental regulations.
• Troubleshooting: The manual includes a troubleshooting guide with error codes and corresponding descriptions and resolutions, such as retightening the cuff for loose connections, keeping calm for excessive motion, or contacting service for system errors. If the memory is full, the device will display an error (EC48), requiring data upload and reprogramming to clear the memory.

The WBP-02A is designed to store a maximum of 300 readings. Once storage is full, the monitor cannot save new data until it is programmed again, which also deletes historical data, emphasizing the importance of retrieving data before reprogramming.

HINGMED WBP-02A Specifications

General

Model	WBP-02A
Measurement Method	Oscillometric
Accuracy (Pressure)	±3 mmHg
Power Source	4 x AA batteries or AC adapter
Memory	Yes
Display	LCD
Type	Upper Arm
Measurement Range (Pulse)	40-180 bpm
Accuracy (Pulse)	±5%