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BIO-MED DEVICES TV-100 - User Manual

BIO-MED DEVICES TV-100
104 pages
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Bio-Med Devices Inc.
TV-100 Operator's Manual
Catalog Number: 5501
Revision: 041122
61 Soundview Road, Guilford, CT 06437
Telephone: 800-224-6633
Fax: 203-458-0440
Website: www.biomeddevices.com

Table of Contents

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Summary

About this Manual

Scope and Intended Use

Defines the purpose and target users of the TV-100 ventilator.

Organization of this Manual

Outlines the structure and content of the operator's manual.

Symbols and Abbreviations

Symbols Reference

Lists and describes various symbols used on the TV-100 and in the manual.

Abbreviations List

Provides definitions for abbreviations commonly used in the TV-100 manual.

Safety Information

Safety Statement and Conventions

Details the safety statement and document conventions for warnings, cautions, and notices.

Warnings and Cautions

Lists important warnings, cautions, and notices for operating the TV-100.

Contact and Maintenance

Contact Information

Provides contact details for Bio-Med Devices, Inc. and its European representative.

Recommended Maintenance Schedule

Outlines the schedule and recommended procedures for preventative maintenance.

Chapter 1: Installation

1.1 Unpacking and Accessories

Instructions for unpacking the TV-100 and a list of included accessories.

1.4 Batteries

Overview of the TV-100's rechargeable smart lithium ion batteries.

1.4.2 Battery Installation and Initial Charge

Step-by-step procedure for installing and charging the TV-100 batteries.

1.5 Patient Circuit Connection

Details on how to properly connect the patient circuit to the TV-100.

Chapter 2: Principles of Operation

2.1 General Overview

Provides a detailed description of the TV-100 ventilator's operational theory.

2.4 Ventilation Controls

Explains various controls for setting ventilation parameters.

2.5 Ventilation Modes

Details the different ventilation modes available on the TV-100.

Chapter 3: User Interface

3.1 Physical Interface

Describes the physical layout and components of the TV-100 device.

3.2 Graphical User Interface (GUI)

Overview of the TV-100's graphical user interface and navigation.

3.2.1 Startup and Basic Setup

Details the device startup sequence and the basic setup process.

3.2.5 Main Page

Describes the main display screen showing ventilator parameters.

3.2.6 Parameters

Explains how to adjust settable patient parameters and change modes.

3.2.7 Alarms Page

Details the alarms page for monitoring and setting alarm parameters.

3.2.11 Tools Page

Menu for configuring, adjusting, and testing ventilation features.

Chapter 4: Performance Checkout Procedures

4.1 General Overview

Provides an overview of the checkout procedures to ensure proper operation.

4.2 Touchscreen Calibration

Procedure for calibrating the TV-100's touchscreen interface.

4.3 Oxygen Calibration

Procedure for calibrating the oxygen sensor and supply.

4.4 Leak Test

Procedure for performing a leak test on the patient circuit.

4.5 Compliance Measurement

Procedure for measuring the static compliance of the connected patient circuit.

4.7 Resistance Measurement

Procedure to measure the pressure differential across the patient circuit.

Chapter 5: Alarm Handling

5.1 General Overview

Describes how to recognize, acknowledge, and correct ventilator alarm conditions.

5.2 High Priority Alarms

Details high priority alarms indicating potential device failure or serious danger.

5.4 Alarm Silence and Alarm Inhibition

Explains how to silence or inhibit alarms temporarily using the physical alarm button.

5.6 Alarm Parameter Ranges and Alarm Limits

Lists the ranges and limits for various alarm parameters.

Chapter 6: Troubleshooting

Troubleshooting Guide

Provides a guide to identify symptoms, possible causes, and corrective actions for issues.

Chapter 7: Specifications

7.1 Specifications

Lists the technical specifications of the TV-100 ventilator.

7.2 Operating and Storage; Shipping Environment

Specifies the environmental conditions for operation, storage, and shipping.

7.5 Pneumatic Characteristics

Details the pneumatic characteristics and performance of the TV-100.

7.7 AC Adapters and Inverters

Requirements for connecting the TV-100 to AC adapters and inverters.

7.8 EMC Compatibility

Information regarding electromagnetic compatibility (EMC) requirements and guidance.

7.9 Device Lifetime & End-of-Life Disposal

Information on the estimated device lifetime and proper end-of-life disposal procedures.

Addendum A

Additional Information per IEC 60601-1 & 60601-1-8 Standards

Provides additional information related to IEC 60601-1 and 60601-1-8 standards.

BIO-MED DEVICES TV-100 Specifications

General IconGeneral
CategoryMedical Equipment
TypeVentilator
ModelTV-100
ManufacturerBIO-MED DEVICES
ModesAssist/Control, SIMV, CPAP
Tidal Volume Range50 to 2000 mL
PEEP0 to 20 cm H2O
Inspiratory Time0.3 to 3.0 seconds
Oxygen Concentration21 to 100%
AlarmsHigh pressure, low pressure, apnea, power failure
Dimensions12 x 9 x 6 inches

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