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MESI mTABLET ABI User Manual

MESI mTABLET ABI
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Instructions
for Use
MESI mTABLET ABI
Ankle-Brachial Index
ISO 9001 Q-1664
ISO 13485 M-049
MTABSYSABI

Table of Contents

Questions and Answers:

MESI mTABLET ABI Specifications

General IconGeneral
CategoryMedical Equipment
Display10.1-inch
Resolution1920 x 1200
RAM4 GB
Storage64 GB
Battery LifeUp to 8 hours
ConnectivityWi-Fi, Bluetooth
Weight600 g
Operating SystemAndroid
Camera5MP rear, 2MP front
PortsUSB-C, 3.5 mm audio jack
CertificationsCE
Applicationpatient monitoring

Summary

SAFETY AND LEGAL RECOMMENDATIONS

Legal Information

All rights reserved. This publication may not be reproduced or used for any purpose other than as instructions.

Safety Information and Measures

Recommendations to avoid injury, setup by authorized personnel, access control, and local safety compliance.

PRODUCT DESCRIPTION

Package Contents

Lists the equipment included in the MESI mTABLET ABI diagnostic system package.

Intended Use of the System

Describes the system's purpose for screening patients for Peripheral Arterial Disease (PAD/LEAD).

TECHNICAL SPECIFICATIONS

MESI TUBELESS CUFF UNIT (CUFFMD) Specifications

Details dimensions, power, battery, cuff sizes, classification, operating conditions, measurement specs, and connectivity.

Tubeless Blood Pressure Cuff Modules

Describes the four adult tubeless blood pressure cuff modules included.

QUICK MEASURING GUIDE

Preparation for Measurement

Steps and notes before starting a measurement, including pairing, assembly, and patient prep.

Performing the ABI Measurement

Step-by-step guide to performing the ABI measurement.

Reviewing Measurement Results

How to review and interpret measurement results on the system.

DETAILED INSTRUCTIONS

First Time Use Procedures

Initial setup, activation, battery status check, pairing, and cuff attachment/detachment.

Patient Management

How to select or add a patient to the system.

Performing an ABI Measurement

General guidance on patient positioning, cuff placement, and conducting the measurement.

Reviewing and Interpreting ABI Results

How to view results, interpret waveforms, graphs, and detect PAD.

Device Controls and Indicators

Information on the multifunctional button, LED indicators, and their functions.

MAINTENANCE

Battery Charging and Lifespan

Instructions on charging the battery, its capacity, and product lifespan.

Cleaning and Disinfection

Guidelines for cleaning and disinfecting the device and cuffs.

Product Storage and Inspection

Information on storing the device and mandatory periodic safety inspections.

GENERAL WARNINGS

Patient Safety Precautions

Crucial warnings to prevent patient injury during use, including cuff placement and usage restrictions.

Measurement and Device Operation Warnings

Warnings on measurement procedures, device handling, power supply, and environmental conditions.

Maintenance and Functioning Warnings

Warnings related to device maintenance, calibration, and potential radio interference.

ERRORS

Measurement Detection Errors

Errors related to oscillation detection, patient movement, inflation/deflation, and calculations.

Module and Battery Errors

Errors concerning cuff module connectivity, pairing, battery status, and cuff recognition.

TROUBLESHOOTING

Common Troubleshooting Scenarios

Solutions for unexpected results, indicator issues, cuff inflation failures, and noises.

Warranty Information

Information about the device's warranty period and how to make claims.

STANDARD COMPLIANCE

Complied Standards and Declarations

Lists complied standards, manufacturer declaration on EMC, and electromagnetic environment guidance.

IMPORTANT LABELS

Essential Performance and Label Explanations

Defines essential performance and explains important symbols and labels on the device.

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