Eclipse 2 Users Manual Rev A

CONTENTS

4-5 IMPORTANT SAFETY INSTRUCTIONS Symbols used in Users Manual and on the Eclipse Personal Ambulatory Oxygen System

4-5

6 INDICATIONS FOR USE 6 CONTRAINDICATIONS 7-10 SAFETY GUIDELINES 7 Oxygen Therapy Safety Operating Safety

8-9

Power Cartridge Safety

10

INTRODUCTION TO YOUR ECLIPSE UNDERSTANDING THE CONTROLS AND FRONT PANEL

11-12 13-15

Description of the Eclipse

13

Control Panel Features

14

User-Controls

14

Front Panel Symbols

14

System Status Indicators

14-15

RECOMMENDED OPERATING ENVIRONMENTS The Proper Location OPERATING INSTRUCTIONS

16-17

Before Operating

18

Powering ON Your Eclipse

19

17 18-30

Operating Your Eclipse 27-30 31-32 ALERTS, ALARMS AND TROUBLESHOOTING STANDARD COMPONENTS AND OPTIONAL ACCESSORIES 33-35 36-38 CLEANING, CARE AND ROUTINE MAINTENANCE



Personal Ambulatory Oxygen System Users Manual

Important Safety Instructions Important Safety Instructions are shown Under the Following Headings: NOTE: SeQual® Technologies Inc. (SeQual) recommends that this Users Manual be

given to each user receiving an Eclipse Personal Ambulatory Oxygen System. This Users Manual provides all of the necessary information needed for a user, or caregiver, to successfully operate the Eclipse.

WARNING

Important safety information for hazards that might cause serious injury.

CAUTION

Important information for preventing damage to the Eclipse.

DO NOT: Information needing special attention. Important! Clarifying information, specific instructions, or user reference information.

Symbols Used in the Users Manual and on the Eclipse Refer to this section for an explanation of the symbols and the Warnings that accompany them.

“Read Instructions”: Please consult the Users Manual instructions provided with the product. “Attention or Caution”: Indicates important information that requires the user to take special precautions when certain conditions are present. “No Smoking or Open Flames”: The use of oxygen requires that special care be taken to reduce the risk of fire. Materials that burn in air, and even some materials that will not burn in air, are easily ignited and burn more rapidly in high concentrations of oxygen. For safety concerns, all possible sources of ignition must be kept away from the Eclipse and preferably out of the room in which it is being used. Smoking in the proximity of an operating Eclipse is dangerous, and can permanently damage the device and void the warranty. “Use No Oils or Grease”: Indicates important information about the possibility of spontaneous and violent ignition that may occur if oils, grease or other petroleum based substances come into contact with oxygen under pressure.



IPXO

Drip Proof Equipment-IPX0: The Eclipse enclosure does not provide protection against the harmful effects of the ingress of liquids. (IPX0, per IEC 60529)

IPX1

Drip Proof Equipment-IPX1: The Eclipse AC and DC Power Supplies provide protection against the harmful effects of the ingress of liquids. (IPX1, per IEC 60529) IEC Icon for DC Power (Input) “Type B Equipment”: Indicates equipment providing a particular degree of protection against electric shock, particularly regarding:

A

• Allowable leakage current; • Reliability of the protective earth connection (grounding). “Amperes” “Alternating Current” “Audible Alarm”: An audible indicator is provided to announce a reduction in oxygen concentration or when the power has been interrupted or lost. “ON/OFF”: Powers the device ON and OFF, but does not directly disconnect the mains power. “Increase Flow Setting”: Increases the flow setting in 0.5 increments each time the button is pressed. “Decrease Flow Setting”: Decreases the flow setting in 0.5 increments each time the button is pressed. “Flow Mode”: Activates either Continuous Flow Mode or Pulse Flow Mode Operation. “External Power is Present Indicator”: Indicates the presence of external power to operate the Eclipse. “Power Cartridge Status Gauge”: Shows the amount of charge remaining in the Power Cartridge. “Power Cartridge Symbol”: The symbol on the Power Cartridge (Battery).

02

“Oxygen Output”: The port from which the oxygen flows and where the tubing or interface (standard nasal cannula, OxyCannula™ or OxyMask™) is attached. THE U.S. FEDERAL AVIATION ADMINISTRATION (FAA) HAS APPROVED THIS DEVICE FOR USE ONBOARD COMMERCIAL AIRCRAFT.



Personal Ambulatory Oxygen System Users Manual

Indications for Use THE ECLIPSE IS INDICATED FOR THE ADMINISTRATION OF SUPPLEMENTAL OXYGEN. THE DEVICE IS NOT INTENDED FOR LIFE SUPPORT NOR DOES IT PROVIDE ANY PATIENT MONITORING CAPABILITIES. YOUR PHYSICIAN HAS PRESCRIBED A SPECIFIC OXYGEN FLOW SETTING TO MEET YOUR INDIVIDUAL NEEDS. RECOMMENDED OXYGEN FLOW SETTINGS SHOULD BE ADJUSTED ONLY UNDER THE ADVICE OF A PHYSICIAN

WARNING

FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

Contraindications WARNING

WARNING

WARNING

WARNING



THE ECLIPSE IS NOT INTENDED FOR LIFE SUPPORTING OR LIFE SUSTAINING APPLICATIONS, NOR DOES IT PROVIDE ANY PATIENT MONITORING CAPABILITIES.

IN CERTAIN CIRCUMSTANCES, THE USE OF NONPRESCRIBED OXYGEN CAN BE HAZARDOUS. THIS DEVICE SHOULD ONLY BE USED WHEN PRESCRIBED BY A PHYSICIAN.

NOT FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS.

AS WITH ANY ELECTRICALLY POWERED DEVICE, THE USER MAY EXPERIENCE PERIODS OF NON-OPERATION AS A RESULT OF ELECTRICAL POWER INTERRUPTION, OR THE NEED TO HAVE THE ECLIPSE SERVICED BY A QUALIFIED TECHNICIAN. THE ECLPISE IS NOT APPROPRIATE FOR ANY PATIENT WHO WOULD EXPERIENCE ADVERSE HEALTH CONSEQUENCES AS THE RESULT OF SUCH TEMPORARY INTERRUPTION.

WARNING

Use of an oxygen mask, other than the Southmedic™ OxyMask, at low flows (1-3 LPM) is contraindicated due to the possibility of rebreathing exhaled carbon dioxide.

Safety Guidelines This section of the manual provides Warnings and Cautions that apply to hazards or unsafe practices that could result in serious injury or property damage. Keep the Eclipse and the power cord away from hot surfaces or open flames. DO NOT use the Eclipse if it has a damaged power cord or plug. Your Eclipse should be located in a well-ventilated area to allow for adequate air intake. Avoid the intake of airborne pollutants, smoke and fumes. ONLY use this device with accessories specified by, or recommended by, SeQual Technologies Inc. If the Eclipse has been dropped, damaged or exposed to water please contact your home care provider for inspection or possible repair of the device. DO NOT drop or insert any objects into any opening on the device. DO NOT block the air inlet or the exhaust vent of the Eclipse when it is on a soft surface, such as a carpet, bed, couch, chair or automobile seat. DO NOT cover the device with a blanket, towel or quilt, etc. DO NOT overfill the optional humidifier. Fill the optional humidifier with water only to the level shown by the manufacturer of the humidifier. When using the Eclipse in any vehicle, be sure it is properly secured, belted or otherwise restrained.



Personal Ambulatory Oxygen System Users Manual

Safety Guidelines (continued) WARNING

WARNING

WARNING

WARNING

WARNING



DO NOT remove the cover. There are no user-serviceable parts inside the device. Only qualified service personnel should remove the cover of the device.

DO NOT operate the device, components or accessories on wet surfaces or in standing water and DO NOT submerse or expose to water. The Eclipse cover does not provide protection against the harmful effects of the ingress of liquids. Electrical shock or damage to the device may occur.

Protect electrical power cords from sharp edges. Electrical shock and serious physical injury may occur.

Only use the SeQual supplied AC Power Supply and DC Power Supply with your Eclipse. Use of any other AC or DC Power Supply may be hazardous, cause serious damage to your Eclipse and will void the warranty.

Availability of an alternate, or back-up, source of supplemental oxygen is recommended in case of a power outage or a mechanical failure of the device.

WARNING

WARNING

The Power Cartridge may explode and cause potential injury if exposed to a fire, or disposed of in a fire.

DO NOT short-circuit the Power Cartridge’s metal contacts with metallic objects, such as keys or coins. This may cause sparks or excessive heat to be generated.

CAUTION

Always disconnect AC Power Supply from the wall before disconnecting the AC Power Supply Plug from the Eclipse.

CAUTION

Locate oxygen supply tubing and all power cords in a manner to prevent tripping hazards.

CAUTION

CAUTION

DO NOT place the Eclipse in a small, enclosed space, such as a bathroom or closet, with the oxygen cannula or tubing leading out of the enclosed space.

DO NOT expose the device to temperatures outside of the specified range of operating or storage temperatures as this may damage the device.



Personal Ambulatory Oxygen System Users Manual

Power Cartridge Safety WARNING

10

DO NOT disassemble, puncture, or crush the Power Cartridge. Power Cartridge electrolytes may be toxic if swallowed and can be harmful to skin and eyes. Keep the Power Cartridge away from children.

WARNING

Use of a damaged Power Cartridge may cause personal injury.

WARNING

Exposing the Power Cartridge to water or other liquids may cause personal injury.

CAUTION

DO NOT expose the Power Cartridge to temperatures above 140° F (60°C), such as in a vehicle parked in the sun on a hot day.

CAUTION

Charging the Power Cartridge below 50 F° (10° C) or above 104° F (40° C) may degrade the performance of the Power Cartridge.

CAUTION

DO NOT drop the Power Cartridge or expose it to mechanical shock.

CAUTION

Only use the Power Cartridge for its intended purpose.

INTRODUCTION TO YOUR

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Personal Ambulatory Oxygen System Users Manual

This Users Manual will inform you about the use and care of the ECLIPSE, its standard components and the optional accessories. Please read thoroughly all of the information in this manual before operating your Eclipse. Contact your home care provider for proper training on the use and care of this device. YOUR PHYSICIAN HAS PRESCRIBED SUPPLEMENTAL OXYGEN AS PART OF A TREATMENT PLAN. LONG-TERM OXYGEN THERAPY (LTOT) IS NOW WIDELY ACCEPTED AS THE STANDARD TREATMENT FOR CHRONIC HYPOXIA CAUSED BY CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). LTOT HAS BECOME MORE VERSATILE IN RECENT YEARS DUE TO THE DEVELOPMENT OF NEW OXYGEN CONCENTRATORS. THE ECLIPSE IS AN OXYGEN CONCENTRATOR THAT MAKES IT EASIER FOR YOUR PHYSICIAN TO SELECT A MODALITY OF LTOT THAT MEETS YOUR INDIVIDUAL LIFESTYLE NEEDS. THE ECLIPSE MAY BE USED IN THE HOME, AN INSTITUTION, A MOTOR VEHICLE OR IN A COMMERCIAL AIRPLANE. THE USE OF THE ECLIPSE IN HOSPITALS SHOULD INCLUDE THE USE OF THE OPTIONAL SEQUAL HOSPITAL GRADE POWER CORD. YOUR PHYSICIAN HAS PRESCRIBED SPECIFIC OXYGEN FLOW SETTINGS TO MEET YOUR INDIVIDUAL CLINCIAL NEEDS. THESE FLOW SETTINGS ARE DETERMINED BY THE AMOUNT OF OXYGEN YOU NEED AT REST, DURING EXERCISE AND WHEN TRAVELING. RECOMMENDED OXYGEN FLOW SETTINGS SHOULD BE ADJUSTED ONLY UNDER THE ADVICE OF YOUR PHYSICIAN.

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Understanding the Controls and Front Panel DESCRIPTION OF THE ECLIPSE 2 Become familiar with the key features of the Eclipse and the user control panel. Control Panel

Service Port Handle

(Not for Patient Use)

External Power Receptacle

Air Inlet Filter

Oxygen Outlet Port

Cart Insert Screw Power Cartridge

Power Cord Retainer Simplified User Instructions (Under Base)

Exhaust Vent

Power Cartridge Latch

FRONT

Main/Rating Label (Under Base)

BACK

Input/Output Connections Oxygen Outlet Port

Oxygen supply tubing or a cannula is attached to this port.

Air Inlet Filter

Ambient air is drawn into the device through the air inlet located at the top and rear of the device. This air inlet filter prevents dust and debris from entering the Eclipse and should be cleaned regularly.

Service Port

This connection allows qualified service personnel to diagnose and monitor the Eclipse performance. It is not intended for the user.

External Power Receptacle

The Eclipse AC or DC Power Supply power cords may be connected to this receptacle.

Exhaust Vent

Exhaust air from the Eclipse leaves the device from this vent.

Power Cord Retainer

Retainer to secure the Power Cord.

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Personal Ambulatory Oxygen System Users Manual

Understanding the Controls and Front Panel (continued)

User Controls And System Status Indicators The Eclipse user control panel displays important operating information. This section will help you understand this operating information. Green, Yellow, and Red Indicators on the front panel indicate the operating condition of the device. For additional information on these indicators see the Alerts, Alarms and Troubleshooting Table in this manual.

ON/OFF Button (Green) Indicator: This button powers the device ON or powers it OFF. The Green Indicator is illuminated when the device is powered ON.

Increase or Decrease Flow Setting Button: Use these buttons to set the flow to your prescribed level.

Flow Mode Button and Indicator: The Eclipse contains a button to toggle between Continuous Flow and Pulse Flow mode. The Pulse Flow mode allows a significant increase in the duration-of-use time the device can operate from the Power Cartridge. When the Pulse Flow Mode is activated, the green Flow Mode Indicator illuminates and a pulse of oxygen is delivered with each inspiratory effort. When the pulse of oxygen is delivered, the flow mode indicator turns off. Changes in flow mode should only be made on the recommendation of your physician.

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ALERT (Yellow) Indicator - Low and Medium Priority Alerts: When illuminated, this indicates a low priority awareness condition or Caution. Continue to use your system and refer to the Alerts, Alarms, and Troubleshooting Table for the proper response. A flashing yellow indicates a medium priority alert. A prompt response is necessary.

ALARM (Red) Indicator – High Priority Alarms: Indicates a high priority alarm condition. An immediate response is necessary. Refer to the Alerts, Alarms, and Troubleshooting Table and contact your home care provider.

Buzzer: An audible alarm (or buzzer) is used to alert you to the operating condition of the device, either a warning or failure, and to confirm a valid key press by the user.

Flow Setting Indicator: This is the main focus on your control panel. Your home care provider will correctly set your prescribed flow for either the Continuous Flow Mode (LPM) and/or your Pulse Flow Mode settings. DO NOT change these settings unless it is with the recommendation and under the order of your physician. Each time you power the device ON, the previous flow mode and flow setting has been saved and will be used at start-up.

Power Cartridge Status Gauge: This indicator displays the charge remaining in the Power Cartridge. When the Power Cartridge is fully charged all 4 gray bars are illuminated. Each gray bar represents approximately 25% of the total Power Cartridge charge. When the Power Cartridge is being charged, the charge indicator bars will blink in a waterfall-type fashion. If the Power Cartridge is not installed, or if it is improperly installed, the Power Cartridge Status Gauge will not be illuminated.

External Power is Present Indicator: When the Eclipse is properly plugged in and is using the AC or DC Power Supply, this indicator will appear on the User Control Panel.

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Personal Ambulatory Oxygen System Users Manual

Recommended Operating Environments The following chart provides important information concerning the recommended operating environments, or operating conditions, for proper use of the device.

Operating Temperature

50º F to 104º F (10º C to 40º C)

Operating Humidity

10% - 95% at an 82.4° F (28° C) dew point

Transport/Storage Temperature

-4º F to 140º F (-20º C to 60º C) Humidity: Up to 95% Non-Condensing

Electrical

Use no extension cords. Use no electrical outlets controlled by a switch.

Altitude

0 – 13,123 feet (0 - 4,000 meters)

Placement

DO NOT block the air inlet or the exhaust vent. Place device a minimum of 3 inches (7.5 cm) away from walls, draperies, furniture, etc.)

Environment

Must be smoke, pollutant, and fume free.

Operating Time

24-hours per day when connected to an external AC or DC power source.

NOTE: When moving the Eclipse from an extreme temperature environment, please allow time for your device to acclimate to the recommended operating temperature environment.

WARNING

16

Operating your Eclipse outside of the recommended operating temperature environment may negatively impact device performance, may cause damage to the device and will void the warranty if this occurs.

The Proper Placement Select a location for the device that avoids the intake of smoke, fumes and pollutants. Correct placement of the device should allow intake of air through the air inlet filter at the back and rear of the cabinet and allow exhaust air to freely leave the exhaust vent at the bottom of the device. Locate the device such that the alarms can be heard. Position the oxygen supply tubing in such a way that it does not kink or occlude. DO NOT locate the device near flammable materials or cleaning agents or in the direct path of any heat source, such as a stove, range, heat register or car heater. Keep the Eclipse at least five (5) feet (1.5 m) away from hot, sparking objects or open flames.

CAUTION

Locate the device in a well-ventilated area that provides adequate air movement. Periodically check if air is being prevented from entering or exiting the device by obstructions such as furniture, draperies, bedding, clothing or pets.

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Personal Ambulatory Oxygen System Users Manual

Operating Instructions BEFORE OPERATING This users manual serves as your reference to help you operate and maintain the device. If you have any questions or concerns please call your home care provider, qualified representative, or SeQual Technologies Inc. Important! DO NOT attempt to operate the Eclipse without first reading the Safety Guidelines section of this manual. Please follow all of the operating instructions. Please observe all Warnings on the device and in the users manual. In order to reduce the risk of fire, personal injury and serious damage to the Eclipse, please observe all of the safety precautions.

WARNING

CAUTION

18

Protect the Eclipse and the AC and DC Power Supplies from all fluid spills or fluid drips to avoid possible shock hazards.

Always check that the Air Inlet and the Exhaust Vent of the device are not blocked and that the Air Inlet Filter is clean before using your device.

POWERING ON YOUR ECLIPSE The Eclipse is a lightweight portable and stationary source of supplemental oxygen. The device is capable of being operated directly from three different power sources: (1) AC Power Supply, (2) DC Power Supply and (3) Rechargeable Power Cartridge (Battery).

(1) AC Power Supply

(2) DC Power Supply

(3) Rechargeable Power Cartridge (Battery)

The Eclipse charges the optional Power Cartridge when external power (AC or DC) is present and when the Power Cartridge temperature is below a safe charging temperature. When external power is disconnected, the device will automatically switch over to the Power Cartridge, if installed and charged. When external power is restored, by plugging into an AC or DC outlet, the device will accept power from the external power source and replenish the Power Cartridge while operating the device if adequate AC or DC power is available. Proper connection of the AC or DC Power Supply requires aligning the power plug with the recessed external power receptacle of the device. The recessed external power receptacle is located on the right side of the device when facing the user control panel. Push the power plug into the recessed receptacle.

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Personal Ambulatory Oxygen System Users Manual

Operating Instructions (continued) WARNING

WARNING

DO NOT use any power cord if it is damaged or frayed. Improper use of the Power Cord may result in a fire or electrical shock hazard.

DO NOT touch the Power Compartment metal connectors inside the cabinet with the Power Cartridge removed when the device is connected to an external AC or DC power source. This may result in an electrical shock!

(1) AC POWER SUPPLY: The Eclipse includes a universal AC Power Supply for use at home, or wherever standard AC power is available. To connect to an AC power source, be sure the AC Power Supply device cord is securely inserted into the recessed power receptacle on the side of the device and that the AC power cord from the AC Power Supply is plugged into a grounded AC outlet. When the device is plugged in properly, a green indicator on the AC Power Supply will light and the External Power is Present Indicator, will appear on the user control panel.

CAUTION

CAUTION

CAUTION

20

The AC power cords used with the Eclipse must meet the electrical requirements of the country where the device is used.

Use only with a grounded, 3-pin receptacle. DO NOT remove the grounding pin from the power cord. Use only with SeQual supplied power cords.

DO NOT connect the Eclipse to an extension cord or to an electrical outlet controlled by a switch.

CAUTION

Always unplug the AC Power Cord from the wall before disconnecting the plug from the Eclipse.

(2) DC POWER SUPPLY: A DC Power Supply allows the system to operate from DC outlets,

such as those found in motor vehicles. You will need to determine the fuse rating in your motor vehicle. It will be either a 15 AMP or a 20 AMP fuse rating. This is accomplished by consulting your motor vehicle’s Operator’s Manual or, by examining the fuse box in the vehicle. Once you have confirmed the motor vehicle’s fuse rating, set the switch on the DC Power Supply to the appropriate fuse rating setting. Note: Use the 10 AMP position on the DC Power Supply for a 15 AMP vehicle fuse rating and use the 15 AMP position for a 20 AMP or greater vehicle fuse rating. Start your vehicle. Insert the DC cord into the recessed power receptacle on the side of the device. Next, insert the DC Power Supply plug into the DC power outlet in your motor vehicle. When the device is properly connected and receiving power from the DC power source, a green indicator light on the Power Supply and on the External Power is Present Indicator, on the control panel will illuminate.

WARNING

WARNING

WARNING

Secure the Eclipse and the DC Power Supply in your vehicle and be sure there is adequate air flow to the device and that the air inlet and exhaust vents are not blocked. Blocking of the air inlet or exhaust vent may impair device performance.

DO NOT leave the Eclipse or DC Power Supply plugged into the vehicle without the engine running or attempt to start the vehicle while the DC Power Supply is connected to the vehicle. Doing so will drain the vehicle’s battery.

If the vehicle’s DC power source drops below 11.5 Volts (brownout condition) the Eclipse will revert to Power Cartridge operation (if the Power Cartridge (battery) is present). The External Power is Present Indicator may remain on.

Note: When operating the device from a DC power supply, it is recommended that the Pulse Flow Mode be used. This will help conserve motor vehicle battery life. Consult with your physician if you do not have a prescribed pulse flow setting.

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