G-Lab MD2200 - User Manual

DIGITAL AUTOMATIC
WRIST BLOOD PRESSURE MONITOR
INSTRUCTION MANUAL
MODEL No.: MD2200
Version: 1
TABLE OF CONTENTS
INTRODUCTION...............................................................................1
COMPLIANCE...................................................................................1
SYMBOLS........................................................................................2
IMPORTANT NOTES.....................................................................3-5
DEVICE DESCRIPTION.....................................................................6
BATTERY INSTALLATION.................................................................7
SETTING DATE AND TIME................................................................8
BEFORE TAKING A MEASUREMENT................................................ 9
APPLYING WRIST CUFF...................................................................9
SELECT USER................................................................................10
PERFORMING BLOOD PRESSURE MEASUREMENT......................11
RECALL AVERAGE AND PREVIOUS MEASUREMENT DATA...........12
DELETE MEASUREMENT DATA......................................................13
WHO CLASSIFICATION INDICATOR...............................................14
ABOUT IRREGULAR HEARTBEAT ...................................................15
ABOUT BLOOD PRESSURE............................................................15
TROUBLESHOOTING......................................................................16
TECHNICAL SPECIFICATION.......................................................... 17
APPENDIX I...............................................................................18-19
APPENDIX II..............................................................................20-21
APPENDIX III..................................................................................22
APPENDIX IV..................................................................................23

Summary

INTRODUCTION

Indication for use

Device is for medical professionals or home users to measure systolic and diastolic blood pressure.

COMPLIANCE

SYMBOLS

IMPORTANT NOTES

DEVICE DESCRIPTION

BATTERY INSTALLATION

SETTING DATE AND TIME

BEFORE TAKING A MEASUREMENT

APPLYING WRIST CUFF

SELECT USER

PERFORMING BLOOD PRESSURE MEASUREMENT

RECALL AVERAGE AND PREVIOUS MEASUREMENT DATA

DELETE MEASUREMENT DATA

WHO CLASSIFICATION INDICATOR

ABOUT IRREGULAR HEARTBEAT

ABOUT BLOOD PRESSURE

TROUBLESHOOTING

TECHNICAL SPECIFICATION

APPENDIX I

Guidance and manufactures declaration - electromagnetic emission

Manufacturer's declaration on electromagnetic emission compliance according to CISPR 11.

APPENDIX II

Guidance and manufactures declaration - electromagnetic immunity

Manufacturer's declaration on electromagnetic immunity compliance according to IEC 60601.

APPENDIX III

Recommended separation distances

Recommended separation distances for RF equipment based on transmitter power and frequency.

APPENDIX IV

FCC Compliance Information

Details FCC Part 15 compliance for Class B digital devices, including warnings and measures.

5-YEAR LIMITED WARRANTY

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Maintenance Features

The G.LAB MD2200 is a digital automatic wrist blood pressure monitor designed for both home users and healthcare professionals. It utilizes a non-invasive oscillometric method to quickly and easily measure systolic and diastolic blood pressure, as well as pulse rate. The device automatically saves measurement data, allowing users to review average and individual readings at any time.

Function Description:

The MD2200 measures systolic blood pressure (SYS), diastolic blood pressure (DIA), and pulse rate (PUL). It features a clear LCD display that shows the date, time, user selection (User 1 or User 2), memory record number, average data, systolic pressure, diastolic pressure, pulse rate, and various indicators. These indicators include a pressure bar, heart mark, irregular heartbeat indicator, battery indicator, and symbols for pressurizing and releasing air. The device also incorporates a WHO Classification Indicator, which provides a visual snapshot of blood pressure classification based on World Health Organization (WHO) standards. An Irregular Heartbeat (IHB) detection function alerts users to potential cardiac arrhythmias.

Important Technical Specifications:

• Model No.: MD2200
• Display: LCD Display
• Measurement Method: Non-invasive, Oscillometric method
• Measurement Range:
  • Systolic Blood Pressure: 50-250 mmHg
  • Diastolic Blood Pressure: 30-200 mmHg
  • Pulse Rate: 40-180 beats/minute
• Accuracy:
  • Pressure: +/-3 mmHg
  • Pulse Rate: +/-5% of reading
• Resolution:
  • Pressure: 1 mmHg
  • Pulse Rate: 1 beat / minute
• Memory: 240 records (120 for each of 2 users)
• Dimensions: Approx. 3.3" x 3" x 0.6” (84 x 77 x 15mm)
• Wrist Cuff Circumference Range: 5.3" - 9.1" (13.5 - 23cm)
• Operating Temperature: 41°F to 104°F (5°C to 40°C)
• Operating Humidity: 15 to 93% RH
• Storage Temperature: -13°F to 158°F (-25°C to 70°C)
• Storage Humidity: up to 93% RH
• Operation, storage and transport atmospheric pressure: 700hPa to 1060hPa
• Power Source: 2 x 1.5V AAA alkaline batteries
• Classification: Application part Type BF, Class II equipment
• Compliance: Conforms to European Medical Device Directive 93/42/EEC, EN ISO 81060, EN 1060, EN 60601, ISO 81060-2, and IEC 80601-2-30 standards.

Usage Features:

• User Selection: The device supports two users (User 1 and User 2), each with dedicated memory storage for 120 measurement records. Users can easily switch between profiles.
• Date and Time Setting: The device allows setting the time display format (12h or 24h), year, month, day, hour, and minute. This ensures accurate time-stamping of measurements.
• Cuff Application: The wrist cuff is designed for easy application. Users are instructed to bare their left wrist, position the cuff approximately 1cm (1/2 inch) below the palm, and fasten it firmly but not too tightly. Proper positioning at heart level is crucial for accurate readings.
• Measurement Process:
  1. Turn on the device using the Start/Stop key.
  2. The cuff deflates to remove residual air.
  3. The memory record number appears.
  4. The cuff inflates, and the device measures blood pressure and pulse rate. The pressurize indicator, pressure bar, and current cuff pressure are displayed. A heart mark flashes with each detected heartbeat.
  5. Upon completion, systolic pressure, diastolic pressure, and pulse rate are displayed and automatically stored. The cuff deflates.
  6. The device automatically turns off after 1 minute of inactivity or can be manually turned off.
• Memory Recall: Users can view the average of the last three measurements and scroll through previous measurement data from most recent to oldest.
• WHO Classification Indicator: A visual bar on the display indicates the blood pressure classification (Optimal, Normal, High Normal, Mild Hypertension, Moderate Hypertension, Severe Hypertension) based on WHO guidelines.
• Irregular Heartbeat Detection: The device displays an irregular heartbeat indicator if it detects variations in heartbeat during measurement, prompting users to consult a physician if this occurs frequently.

Maintenance Features:

• Battery Installation: The device uses 2 x 1.5V AAA alkaline batteries. Users are guided to correctly insert batteries, ensuring proper polarities. A battery level indicator alerts users when batteries are low (E6 error).
• Cleaning: The device and cuff should be cleaned carefully with a dry, soft cloth or a cloth dampened with water. Aggressive solvents like alcohol, benzene, or thinner should not be used.
• Storage: Avoid folding the cuff tightly for long periods to prevent damage. Store the device away from strong knocks, extreme temperatures, high humidity, direct sunlight, dust, or chemicals. Do not place heavy objects on top of the device.
• Troubleshooting: The manual provides a comprehensive troubleshooting guide for common issues like no display, error codes (E1-E6), and continuous re-inflation, offering probable causes and corrective actions.
• Service Life: The device is designed for a long service life, with a recommendation for inspection every 2 years to ensure proper functioning and accuracy.
• Disposal: Used equipment, parts, batteries, and accessories should be disposed of according to applicable local regulations to prevent environmental pollution.
• Warranty: The G.LAB MD2200 comes with a 5-year limited warranty covering defects in materials and workmanship, excluding batteries and accessories. Warranty service can be obtained by contacting Aceso Healthcare Products Customer Service.

G-Lab MD2200 Specifications

General

Brand	G-Lab
Model	MD2200
Category	Blood Pressure Monitor
Language	English