CAIRE FreeStyle Comfort User Manual

FreeStyle
®
Comfort
™
User Manual (English)

CAIRE FreeStyle Comfort Specifications

General

Device Type	Portable Oxygen Concentrator
Oxygen Flow	Pulse Dose
FAA Approved	Yes
Storage Temperature	-4°F to 140°F (-20°C to 60°C)
Weight	5 lbs (2.3 kg)
Flow Settings	1 to 5
Battery Duration	Up to 8 hours (depending on flow setting)
Noise Level	43 dBA
Operating Altitude	Up to 10, 000 feet (3, 048 meters)
Oxygen Output	Up to 1050 mL per minute
Power Supply	AC/DC and battery
Oxygen Purity	93% ± 3%
Operating Temperature	41°F to 104°F (5°C to 40°C)
Humidity Range	10% to 95% (non-condensing)
Recharge Time	Approximately 3.5 hours for the standard battery

Summary

User Controls and Status Indicators

Graphical Symbols Overview

Explains graphical symbols for equipment and safety signs.

Regulatory Compliance Information

Information on compliance with EU directives for medical devices.

Internal Device Symbols

Explains internal symbols used on the device, like 'Keep away from flammable materials'.

Safety Signs and Colors

Safety colors and signs with their meanings and registration numbers.

Understanding the Oxygen Concentrator

Physician-Prescribed Oxygen Therapy

Unpacking Your FreeStyle Comfort

Getting to Know Your FreeStyle Comfort

Device Views and Display Information

Top View of the FreeStyle Comfort

Shows the top view of the FreeStyle Comfort with labeled controls.

Display Screen on Battery Power

Describes the display screen when the unit is powered by battery.

Display Screen on AC/DC Power

Describes the display screen when the unit is powered by AC/DC.

Critical Safety Instructions and Warnings

Safety Instructions Definitions

Highlights critical safety instructions and definitions.

Contraindications and Indications for Use

Lists when not to use the device and its intended purposes.

General Safety Guidelines

Provides essential safety guidelines and warnings for operation.

General Warnings and Precautions

Operation and Maintenance Warnings

Warnings for operating the device, handling batteries, and maintenance.

Important Operational Warnings

Cannula Replacement and Care

Guidance on cannula replacement and general equipment care.

Storage and Operational Notes

Travel and Storage Precautions

Advises on handling the device during transport and storage.

Important Operational Notes

Provides key notes on battery installation, filter maintenance, and operation.

Technical Specifications

Operating Instructions: Setup Guide

Carrying Bag and Strap Installation

Instructions for placing the unit into its carrying bag.

Shoulder Strap Installation

Steps to attach and use the shoulder strap.

Operating Instructions: Usage Guide

Flow Setting and Breathing Instructions

Instructions for setting flow and breathing with the device.

Pulse Volume Data Table

Table showing pulse volume by breath rate and setting.

Power Supply and Battery Management

Battery Management Procedures

Instructions for removing, installing, and checking the battery.

Battery Performance and Charging Details

Battery Operating Duration

Details the battery life and durations for different settings.

Battery Charging and Service Life

Information on charging and the expected lifespan of the battery.

AC Power Connection and Usage

DC Power Connection and Usage

Cleaning and Routine Maintenance Procedures

Air Intake Filters and Battery Care

Instructions for cleaning filters and caring for the battery pack.

Battery Pack Storage Recommendations

Recommendations for storing the battery pack.

Cleaning Procedures and Cannula Replacement

Cleaning the Unit and Battery Pack

Detailed instructions for cleaning the unit and battery pack.

Cannula Replacement Guidance

Guidance on replacing the nasal cannula.

Alarm Conditions - Part 1

Alarm Conditions - Part 2

Alarm Conditions - Part 3

Alarm Conditions - Part 4

Troubleshooting Common Issues

Travel Information and Airplane Mode

FAA Regulations and Airplane Mode Activation

FAA rules for batteries and how to enable airplane mode.

Accessories and Carrying Bag Usage

List of Available Accessories

Lists standard and optional accessories for the FreeStyle Comfort.

Carrying Bag and Strap Installation

Instructions for using the carrying bag and shoulder strap.

Disposal and Material Information

Proper Disposal and Material Composition

Guidance on disposal and lists materials in contact with the operator.

EMC Emissions Testing Results

Information on electromagnetic emissions and compatibility.

Electromagnetic Immunity Guidance

Electromagnetic Immunity and RF Separation Distances

RF Separation Distances and Device Classification

RF Separation Distance Calculations

Recommended distances for RF communication equipment.

Device Classification and Safety Standards

Details the device classification, safety standards, and IP rating.