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volution O X Y G E N C O N S E R V E R OM-900 PRODUCT INFORMATION AND INSTRUCTIONS NOTE: Healthcare Equipment Providers shall provide the end user with instructions for use and instructions for determining gas cylinder contents. NOTE: The gauge face may be different on actual unit.
TABLE OF CONTENTS Important Information to Record............2 Disassembly Instructions..............Symbol Definitions................Caring for Your Conserver..............Important Safeguards, Dangers, Warnings and Cautions....Troubleshooting................... Introduction..................Oxygen Cylinder Duration..............Intended Use................Information for Home and Healthcare Providers........ Contraindications............... Disinfection Between Patients..........Important Parts.................. Disinfection Intervals..............
SYMBOL DEFINITIONS DANGER! Consult Instructions for Use Humidity Limit Danger indicates an imminently hazardous situation which, if not avoided, Temperature Limits Consult accompanying documents will result in death or serious injury. Prescription Only Type B F Applied Parts WARNING! Warning indicates a potentially Contains Natural No Smoking hazardous situation which, if not avoided,...
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WARNING: Warning indicates a potentially DANGER: Danger indicates an imminently hazardous situation which, if not avoided, will hazardous situation which, if not avoided, result in death or serious injury. will result in death or serious injury. • Oxygen will not burn; how e ver, it does vigorously •...
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WARNING (Cont.) WARNING (Cont.) • The conserver must: • Before using this unit, m ake certain that your hands are free of oil, grease or other contaminants, and that the cylinder Be used only after one or more settings have •...
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CAUTION: Caution indicates a potentially WARNING (Cont.) hazardous situation which, if not avoided, may result in propertydamage or minor injury or both. • Do not use the device or accessories in an environment • Prevent water or any other liquid substances from entering with electromagnetic equipment such as CT scanners, the unit.
It requires two (2) 1.5 volt AA alkaline batteries for operation. PURPOSE: The EVOLUTION OM-900 electronic oxygen conserver includes a combination of a low-pressure regulator and an oxygen conserver. It is designed for use with a cylinder as an ambulatory oxygen system and is capable of delivering a specific amount of supplemental oxygen at the optimal point in the breathing cycle.
USER QUALIFICATION: Prior to beginning therapy, patients must be given instruction by qualified personnel in how to operate this unit. Func tions that are frequently used include: • I talling the device by connecting to a portable oxygen cylinder post valve . •...
IMPORTANT PARTS 1 . Low Battery Indicator Light: The EVOLUTION incorporates a visua l indicator li ght that alerts you when a battery change is needed.The following signal w ill be displayed as your batteries become depleted. Blinking Red Light- Low battery energy level. Replace batteries. Cannula Connection 2 .
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IMPORTANT PARTS (cont.) WARNING: Fire Hazard Lint and dust can contaminate the oxygen path and create a fire hazard. Keep all oxygen connections clean and free from lint and dust. 6 . Battery Holder : This compartment holds two (2) AA-size alkaline batteries. 7 .
STANDARD PRODUCT ORDER NUMBER DESCRIPTION OM-900 Electronic oxygen conserving device with CGA 870 post connection REPLACEMENT PARTS ORDER NUMBER DESCRIPTION SEAL-100 870 Post Seal Washer (Gasket) SETTING UP YOUR CONSERVER WARNING: Fire Hazard Before using this unit, m ake certain that your hands are free of oil, grease and other contaminants, and that the cylinder is secure in an upright position.
ASSEMBLY AND USE WARNING: Fire Hazard • Make certain that your hands are free of oil, grease and other contaminants. • Inspect the unit to ensure the seal washer (gasket) is in good working condition and attached to the inlet nozzle. •...
SETUP I NSTALLING/CHANGING ALKALINE BATTERIES: The EVOLUTION uses advanced technology that prolongs battery life through efficient power use. With normal use of four (4) hours per day at any setting, your batteries should last a minimum of 2 years. Two (2) AA alkaline batteries are packaged in the box with your E VOLUTION.
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SETUP (Continued) ASSEMBLY INSTRUCTIONS: STEP 1: Loosen the cylinder attachment knob. STEP 2: Lower the EVOLUTION conserver over any CGA-870 post-valve cylinder with the alignment pins toward the holes on the cylinder neck [see Fig. B]. STEP 3: Line up the two pins and the seal washer (gasket) with the corresponding holes on the cylinder post valve.
INSPECTION BEFORE EACH USE STEP 1: Examine the outside of the cylinder and regulator assembly for debris, oils or grease and noticeable signs of damage, dents or dings, corrosion, excessive heat or fire damage, pressure leak or any other sign of damage that might cause a cylinder to be unacceptable or unsafe for use.
OPERATING INSTRUCTIONS: STEP 1: Make sure that the EVOLUTION selector knob is set to the “ PULSE ” position before opening the oxygen source valve. Battery saving technology has eliminated the need for an "OFF" position. The unit will go to " Sleep Mode" after three minutes of non-use.
OPERATING INSTRUCTIONS (Continued): STEP 7 : When finished using the system, close the oxygen cylinder valve and continue breathing through th e nasal cannula until no further oxygen is detected and the gauge reads “empty”. STEP 8 : Remove the nasal cannula. STEP 9: When not in use, store in a clean, dry location.
TROUBLESHOOTING PROBLEM PROBABLE CAUSE SOLUTION Software needs to be reset . Open the battery door and remove the batteries. Wait 10 seconds. Replace the batteries and close the battery door. Dead batteries . Replace batteries. Batteries installed incorrectly (reversed). Make sure battery polarity is correct. Unit does not pulse.
(10) times per minute. Please refer to the table below as a guide. INFORMATION FOR HOME AND HEALTHCARE PROVIDERS DISINFECTION BETWEEN PATIENTS: Drive Medical recommends that at least the following procedures be completed by an appropriately trained individual (i.e., biomedical technician, equipment technician, respiratory therapist, nurse) between uses by different patients.
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If the device is operating properly, it is ready to be used by another patient. If the device is not operating properly, the provider should return the device to Drive Medical for service. NOTE : There is no portion of the gas pathways through the conserver that could be contaminated with...
DISINFECTION INTERVALS : WARNING: Do not attempt to open or remove enclosure. There are no user-serviceable internal components. NOTE: The disinfection process can only be performed by an appropriately trained individual. MAINTENANCE The oxygen conserver does not need maintenance through the expected service life of the product. The device has an expected service life of 5 years, which is based on 1460 hours/year of use under normal operating and storage conditions.
SPECIFICATIONS Deviation of delivered oxygen per breath = +/- (1 ml/breath + 10% of the set initial value per breath) Tested per ISO 80601-2-67:2014 Sec 201.12.1.101 Continuous Flow Rate Setting cf = 2 LPM +/- 0.4 LPM Tolerance on measurements = +/- 1 5 % (including measurement uncertainty) All volumes and flows are expressed at STPD (standard temperature and pressure, dry)
Technical Description How the device functions: The EVOLUTION includes a combination of a low-pressure regulator and an oxygen conserver. It is designed for use with a cylinder as an ambulatory oxygen system and is capable of delivering a precise amount of supplemental oxygen at the optimal point in the breathing cycle.
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