SeQual Technologies ECLIPSE 1000 User Manual

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SeQual Technologies Inc.

REV.

CO No.

D017

D120

D250

D319

D324

File Name

6112_X5

ECLIPSE™

Model 1000

User Manual

PN 6112

Rev X5

01/06

DESCRIPTION

Initial Design Release

Update manual to remove

facemasks

Update to current design

SCR001 – Pulse Mode

breath detection

Doc. Number

Revision:

6112

REL. DATE

11/16/01

11/22/04

8/4/05

12/23/05

1/5/06

Page:

PREP. BY

APPR. BY

SWB

PJJ

WJB

PJJ

WJB

PSA

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Page 1 SeQual Technologies Inc. ECLIPSE™ Model 1000 User Manual PN 6112 Rev X5 01/06 REV. CO No. DESCRIPTION REL. DATE PREP. BY APPR. BY D017 Initial Design Release 11/16/01 D120 Update manual to remove 11/22/04 facemasks D250 Update to current design...
Page 2: Table Of Contents
ONTENTS ......................3 MPORTANT SAFETY INSTRUCTIONS Symbols ............................3 ..........................5 NDICATIONS FOR ..........................5 ONTRAINDICATIONS ..........................6 AFETY UIDELINES Oxygen Therapy Safety ........................ 6 Operating Safety ........................... 7 Power Cartridge Safety......................... 8 ECLIPSE O ................. 9 NTRODUCTION TO YOUR XYGEN YSTEM ................
Page 3: Important Safety Instructions
Important Safety Instructions Important Safety Instructions are shown Under the Following Headings: SeQual® Technologies Inc. (SeQual) recommends that this User Manual be given to each patient receiving an Eclipse™ Oxygen System. This User Manual describes all the necessary information in order for a patient or caregiver to operate the Eclipse. WARNING Important safety information for hazards that might cause serious injury.
Page 4 "Type B Equipment": Equipment providing a particular degree of protection against electric shock, particularly regarding: - Allowable LEAKAGE CURRENT; - Reliability of the protective earth connection. “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.
Page 5: Indications For Use
NDICATIONS FOR ECLIPSE OXYGEN S YSTEM IS INDICATED FOR THE ADMINISTRATION OF SUPPLEMENTAL OXYGEN HE DEVICE IS NOT INTENDED FOR LIFE SUPPORT NOR DOES IT PROVIDE ANY PATIENT MONITORING CAPABILITIES OUR PHYSICIAN HAS PRESCRIBED A SPECIFIC OXYGEN FLOW RATE SETTING TO MEET YOUR INDIVIDUAL NEEDS ECOMMENDED OXYGEN FLOW RATES SHOULD BE ADJUSTED ONLY UNDER THE ADVICE OF A PHYSICIAN...
Page 6: Safety Guidelines
AFETY UIDELINES This section of the manual provides warnings and cautions that apply to hazards or unsafe practices that could result in personal injury or property damage. XYGEN HERAPY AFETY "Read Instruction Manual": DO NOT operate this oxygen system without first reading and understanding this manual.
Page 7: Operating Safety
Your oxygen system should be located in a well-ventilated area to allow for adequate air intake and to avoid the intake of airborne pollutants and fumes. • Only use this device with accessories designed or recommended by SeQual Technologies Inc. • If oxygen system has been dropped, damaged or exposed to water, contact your dealer/provider for examination or repair.
Page 8: Power Cartridge Safety
CAUTION Locate oxygen tubing and Power Supply cords to prevent tripping hazards. CAUTION DO NOT place ECLIPSE in a small, enclosed space, such as a bathroom or closet, with cannula leading out of the enclosed space. OWER ARTRIDGE AFETY WARNING This Power Cartridge may explode and cause potential injury if exposed to or disposed of in a fire.
Page 9: Introduction To Your Eclipse Oxygen System
ECLIPSE O NTRODUCTION TO YOUR XYGEN YSTEM This User Manual will inform you about the use and care of the ECLIPSE Oxygen System and its accessories. Thoroughly read all the information in this manual in its entirety before operating your ECLIPSE. Contact your dealer/provider for proper training in the use of this device. OUR PHYSICIAN HAS PRESCRIBED SUPPLEMENTAL OXYGEN AS PART OF A TREATMENT PLAN ONG TERM OXYGEN THERAPY IS NOW WIDELY ACCEPTED AS THE STANDARD...
Page 10: Understanding The Controls And Front Panel
NDERSTANDING THE CONTROLS AND FRONT PANEL DESCRIPTION OF THE ECLIPSE The key features of the ECLIPSE Oxygen System and control panel are important items to become familiar with. Control Panel Service Port (Not for Patient Use) Handle Air Inlet Filter Oxygen Cart Insert Outlet Port...
Page 11: Control Panel Features
Control Panel Features The ECLIPSE displays important operating information using the icons, numbers and visual indicators on the control panel. This section will help you understand these features. ON/OFF Alert Alarm Indicator (green) Indicator (yellow) Indicator (red) LPM Flow Rate Setting ON/OFF (2 digits) (green) Button...
Page 12: System Status Indicators
System Status Indicators The ECLIPSE control panel displays important operating information. This section will help you understand these features. Green, Yellow, and Red indicators on the front panel indicate the operating condition of the system. For more information on the indicators, see the Alarm Conditions and Troubleshooting table.
Page 13: Recommended Operating Environments
ECOMMENDED PERATING NVIRONMENTS The following information recommends certain boundaries that will allow the ECLIPSE Oxygen System to operate at its full potential. Operating 50º F to 104º F (10º C to 40º C) Temperature Operating Humidity 10% - 95% at a 82.4° F (28° C) dew point -4º...
Page 14: Operating Instructions
PERATING NSTRUCTIONS EFORE PERATING Your SeQual dealer/provider or authorized service representative will demonstrate how to operate the oxygen system. This manual serves as a supplemental reference to help you operate and maintain the unit. If you have any further questions or problems call your SeQual dealer/provider or authorized service representative.
Page 15 WARNING DO NOT use any cord if damaged. Improper use of the power cord may result in a fire or electrical shock hazard. WARNING DO NOT touch the Power Cartridge cavity connectors with the Power Cartridge removed while the unit is connected to an external power source. This may result in electrical shock.
Page 16 TYPICAL FLOW RATES AVAILABLE FOR EACH FUSE SETTING 10 AMP 15 AMP Setting Continuous Pulse Continuous Pulse Actual performance may vary dependent upon usage conditions and vehicle. When operating in the 10 AMP switch position, flow rate settings above 2.0 LPM continuous flow will automatically switch to 2.0 LPM continuous flow when the DC Power Supply is connected.
Page 17 To remove the Power Cartridge, push up on the release lever on the Power Cartridge. The Power Cartridge will slide out so that you can grasp it for removal. Power Cartridge Capacity: The capacity of the Power Cartridge is lit up on the control panel.
Page 18: Operating Your Eclipse System
YPICAL OWER ARTRIDGE ECHARGE The typical time to recharge your Power Cartridge to achieve 80% capacity from a fully discharged Power Cartridge is 1.4 hours to 5.0 hours, dependent upon the flow setting. If the Power Cartridge is too warm, charging will not begin until it sufficiently cools. The Power Cartridge may not charge or the charge time may increase when operating from the DC Power Supply set in the 10 AMP position.
Page 19 ECLIPSE PERATING Step 1: Locating your ECLIPSE. • Place the ECLIPSE in a well-ventilated place so that the air inlet and exhaust have clear access. • Position the ECLIPSE so that any alarm can be heard. • Check to see if the air inlet filter is in place before using. If the air inlet filter needs to be cleaned, wash with soapy water and allow drying before using.
Page 20 • Pulse Flow Mode Operation: o Pulse Flow Mode should only be used under the direction of a qualified clinician or physician. o When operating in Pulse Flow Mode, an alarm will beep after 15 seconds if inspiration is not detected. If another 15 seconds elapses and no inspiration is detected, the unit will switch to Continuous Flow Mode at the last Continuous Flow Mode rate setting used.
Page 21: Alarm Conditions And Troubleshooting
LARM ONDITIONS AND TROUBLESHOOTING The table shows possible alarm conditions and suggests appropriate responses. If any other alarms occur, call your authorized SeQual dealer/provider. Green Yellow Audible What to do Condition Indicator Indicator Indicator Alarm Wait. The system typically “Warming Up. takes 3 - 5 minutes to reach None Please Wait.”...
Page 22 (CON’T) LARM CONDITIONS AND ROUBLESHOOTING YMPTOM ROBABLE AUSE EMEDY ECLIPSE does not power on No Power Cartridge installed Install Power Cartridge or plug when On/OFF button is pressed into external power Power Cartridge is discharged Plug into external power Malfunction Contact your dealer/provider No Oxygen Blocked or kinked tubing...
Page 23: Accessories
CCESSORIES Use of certain oxygen administration accessories not specified for use with WARNING this oxygen system may impair the performance. ONLY use recommended oxygen delivery accessories. There are many different types of oxygen tubing, cannula, and humidifiers. The following accessories are recommended to be used with your ECLIPSE Oxygen System. Refer to the “Maintenance”...
Page 24 Power Cartridge – The rechargeable Power Cartridge supplied with your ECLIPSE is capable of providing you with battery operation depending on your prescribed flow rate. Your Power Cartridge will be recharged when the ECLIPSE is connected to the AC Power Supply or the DC Power Supply, if adequate power is available.
Page 25: Cleaning , Care And Routine Maintenance
LEANING ARE AND OUTINE AINTENANCE Routine Maintenance A trained technician will carry out all routine maintenance at least once a year or as needed. Your dealer/provider will perform inspections and maintenance, of the compressor, filters, alarms, 9V battery, Power Cartridge and other internal parts as needed. DO NOT disassemble the ECLIPSE or attempt to perform any routine WARNING maintenance other that what is described in the Patient Cleaning and Care...
Page 26 cabinet. DO NOT use denatured alcohol or apply liquid spray or aerosol cleaners. Humidifier – If used, clean your humidifier daily to reduce possibility of contamination. Replace humidifier monthly or as recommended by the manufacturer or your dealer/provider. Cart – Before cleaning the cart, remove the ECLIPSE. Use a damp (not soaking wet) cloth or sponge and mild detergent solution to clean the Cart.
Page 27: Echnical Ata
ECHNICAL 1 to 6 setting in Pulse Flow Mode Flow Rate Settings 0.5 to 3.0 LPM in Continuous Flow Mode 90% ± 3% at sea level for all flow setting Oxygen Concentration Oxygen Concentration Green Light = Normal Operation Indicator Yellow Light = Warning or Caution, less than 85% ±...
Page 28 Device Classification IEC Class I, Type B Applied Part Transport/Storage Temperature: -4° F (-20° C) to +140° F (+60° C) Requirements Humidity: up to 95% Non-Condensing Back pressure Effect on Flow None Indicator Altitude 0 - 13,123 feet (0 – 4000 meters) Pulse Flow Mode •...
Page 29: Summary Of All Warnings And Cautions
UMMARY OF ALL WARNINGS AND CAUTIONS WARNING EDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN WARNING THE ECLIPSE IS NOT INTENDED FOR LIFE SUPPORTING OR LIFE SUSTAINING APPLICATIONS, NOR DOES IT PROVIDE ANY PATIENT MONITORING CAPABILITIES WARNING N CERTAIN CIRCUMSTANCES...
Page 30 objects, such as keys or coins. It may cause sparks or excessive heat. WARNING 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.
Page 31 WARNING AVAILABILITY OF AN ALTERNATE SOURCE OF OXYGEN IS RECOMMENDED IN CASE OF POWER OUTAGE OR MECHANICAL FAILURE CONSULT YOUR . DO NOT IGNORE PHYSICIAN FOR THE TYPE OF BACK UP SYSTEM REQUIRED ALARMS. WARNING Use of certain oxygen administration accessories not specified for use with this oxygen system may impair the performance.
Page 32 CAUTION DO NOT expose the Power Cartridge to temperatures above 140° F (60°C), such as in a vehicle parked in the sun or on a hot day. CAUTION Charging the Power Cartridge below 50 F° (10° C) or above 104° F (40° C) may degrade the performance.
Page 33 CAUTION Store the Power Cartridge in a cool, dry place when not in use. CAUTION DO NOT leave your ECLIPSE or your Power Cartridge in your vehicle or in a trunk during a hot day. CAUTION The ECLIPSE system can only work with a SeQual Power Cartridge. Use of another Power Cartridge or Battery may damage the unit, present a risk of fire or explosion and will void the warranty.
Page 34: Lectromagnetic Ompatibility
LECTROMAGNETIC OMPATIBILITY This equipment has been tested and found to comply with the limits for medical devices to the IEC60601-1-2: 2001-09 Electromagnetic Compatibility standard. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed according with the instructions, may cause harmful interference to other devices in the vicinity.
Page 35: Disposal Of Equipment And Accessories
Fax: + 44 1763 222049 Dealer/provider Name and Address: Physician Name and Address: SeQual® and ECLIPSE™ are registered marks of SeQual Technologies Inc., San Diego, CA 92121 Salter Labs® is a registered mark of Salter Labs, Arvin, CA 92303 File Name Doc. Number Revision:...

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