3B Medical Stratus 5 User manual

USER MANUAL
CE 0123
OXYGEN CONCENTRATOR
www.3Bproducts.com

Symbol Key
MARK DEFINITION
Power on
Power o
Follow Instruction for Use
No smoking
Caution, consult accompanying documents.
Class Ⅱ (Double Insulated)
Type BF Applied Part
CE certication mark
AC Power
Stacking Limit by Number
This Way Up
Fragile, handle with care
Keep dry
Temperature limit
No open ames
IP21 Drip Proof Equipment
Consult instructions for use
Stand-by
Warning, electricity
0123
I
IP21
I
IP21
I
IP21
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SPECIAL NOTES
• Please read this manual carefully before using this product and save it for future
reference.
• If you need assistance with this manual, Please contact your local DME or home
health provider
• The Stratus 5 is a prescription device. Use only the liter setting prescribed for you.
• It is always recommended for critically ill patients to have a backup oxygen source
in case of malfunction.
• If patient experiences an adverse reaction contact physician or call 911 immediately.
• In case of machine malfunction, contact the home medical equipment provider; do
not attempt to disassemble the Stratus 5.
• The Stratus 5 is not intended as life support, it is for supplemental oxygen use
only. Patients with special needs may be unable to understand the alarm features
and should be well supervised while using an oxygen concentrator.
• The Stratus 5 is for single patient use.
• Do not adjust the flowmeter float beyond the red line position. Long-term use out
of range will reduce the efficiency of the oxygen generator.
SAFETY NOTICE
Please read the following information carefully before
Operating the oxygen concentrator
Warning
Special attention should be paid to reducing the risk of re when using oxygen
therapy. Any material that is ammable in the air becomes extremely combustible and
burns quickly when the oxygen concentration is high. For safety reasons, all ignitions
should be kept away from the oxygen concentrator.
Oil, grease or petroleum substances are prone to strong spontaneous combustion
when exposed to oxygen under pressure. These materials must be kept away from oxygen
concentrators, cannulas, connections, and other oxygen concentrator components. Do
not use any lubricant unless recommended by 3B MEDICAL, INC. Do not smoke while
using an oxygen concentrator.
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Tips for Optimal Performance of the Stratus 5
• The Stratus 5 should remain upright during use and storage.
• The Stratus 5 should be operated in a clean environment. Excessive dust and moisture can
aect optimal performance.
• Environmental temperatures for operation should remain between 50°F and 99°F. •
• The Stratus 5 should not be moved while in operation.
• The Stratus 5 should not be turned on with the ow meter turned o or less than “0”.
• The Stratus 5 will make an exhaust sound while in operation.
• The Stratus 5 will vent hot air from the bottom of the unit; please do not block the vent.
Blocking the vent increases risk of re.
• The Stratus 5 should be used for 30+ minutes at each session.
Running the concentrator for short bursts can damage the components over time.
• Do not use the Stratus 5 if the power cord is damaged, the concentrator has fallen or has been
submerged in water.
• If any of the above occurs, the unit is working incorrectly or abnormally, please contact your
DME or home health company.
• Do not move the Stratus 5 by pulling the power cord.
• Do not insert foreign objects into any openings.
• Do not block inlets, vents or exhaust ports of the Stratus 5.
• Do not place the Stratus 5 on soft surfaces such as beds, sofas, blankets or cushions, this is a
re hazard.
• Do not overll the humidier water bottle. This may cause water to enter the cannula or oxygen
outlet port.
• Please place the Stratus 5 at least 15 inches away from walls, curtains and other solid surfaces.
• Do not stack objects on top of the Stratus 5.
• Do not use parts, accessories, or equipment not approved by 3B MEDICAL, INC.
• Do connect the concentrator in parallel or series with other oxygen concentrators or
oxygen therapy devices.
• Only use the Stratus 5 power cord made specically for this device.
• Oxygen therapy is a prescription. Flow rates are patient specic. Please do not change your ow
without consulting your physician.
• This machine is designed to supplement oxygen, not for rst aid or to sustain life.
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• Avoid creating sparks near medical oxygen equipment, including static sparks generated by
friction.
• Extended use in sub-optimal conditions can aect oxygen purity. This may cause oxygen levels
lower than the patient requires.
• If you feel your oxygen therapy is not sucient please contact your physician. DO NOT attempt
to change your prescribed liter ow.
• The power plug must be unplugged while the Stratus 5 concentrator is not in use.
• Contact the physician immediately, if the patient or caregiver nds insucient oxygen supply.
Do not adjust the oxygen ow unless directed by a physician or healthcare professional.
• Always unplug the Stratus 5 when performing any routine maintenance to avoid electric shock.
Maintenance
The 3B Stratus 5 is designed to minimize routine maintenance. Yearly maintenance must be
performed by an authorized dealer or certied personnel only.
Radio frequency interference
• The use of portable communication equipment near the oxygen concentrator may cause
interference to the machine.
• This product cannot be used in environments such as electrocautery, electrosurgery,
debrillation, X-ray (gamma ray), infrared radiation and transient electromagnetic elds, including
magnetic resonance (MRI) and radio interference.
• Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be more than 12 inches from any part of the equipment.
Otherwise, the performance of the device may be aected.
• This oxygen concentrator cannot be stacked with other equipment.
This may result in improper operation.
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Water Safety
• Do not use while bathing. If the patient requires continuous O2, the Stratus 5 concentrator must
be placed at least 10 feet from the bathroom.
• Do not touch the oxygen concentrator while wet. Do not use or store this oxygen concentrator
near liquids or other electrically conductive materials.
• Do not touch the Stratus 5 if it should fall into water or other conductive liquid. If this should
occur, unplug the power cord immediately.
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Table of Contents
• Symbol Key. .........................................2
• Special Notes ........................................4
• Safety Notice.........................................5
Chapter 1: Introduction..................................9
• Intended Use.........................................9
• About Stratus 5 .......................................9
• Parts of Oxygen Concentrator ...........................9
• Accessories Equipment and Spare Parts ..................10
• Workow Chart ......................................10
Chapter 2: Conditions of Use ............................10
• Operating Environment ................................10
• Storage and Transportation Environment ..................11
• Classication........................................11
• Parameter Conguration...............................12
Chapter 3: Operating Instructions ........................13
Chapter 4: Cleaning and Maintenance ....................15
Chapter 5: Alerts and Troubleshooting ....................16
• LCD Indication ......................................17
• Troubleshooting Guide ................................18
Chapter 6: Implementing Standards and Waste Disposal.....19
• Executive Standards ..................................19
• Waste Disposal ......................................19
Appendix A: EMC Information ...........................19
Appendix B: Circuit Diagram ............................23
Chapter 7: Warranty Information .........................24
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Chapter 1: Introduction
Your physician has prescribed an oxygen concentrator set at a specic ow setting to meet your
needs. DO NOT change the ow settings unless your health care professional tells you to do so.
Please read and understand this entire manual before using the device.
Intended Use
The 3B Medical Stratus 5 Oxygen Concentrator is intended to provide supplemental oxygen to
persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining.
About Stratus 5
The Stratus 5 produces concentrated oxygen from room air for delivery to a patient requiring
low ow oxygen therapy. The oxygen from the air is concentrated using a molecular sieve and a
pressure swing adsorption process. Your home care provider will show you how to operate the
concentrator and will be available to answer any questions.
Parts of Oxygen Concentrator
• Humidier Band: The humidier band secures the humidication bottle to the Stratus 5.
• Oxygen outlet: the oxygen ows from this port
• Oxygen ow meter: The ow meter indicates the liters per minute (lpm) that the oxygen is
owing from the oxygen outlet port
• Power switch
“ I ” indicates the unit is running
• “ O ” indicates the power is o and oxygen is no longer being delivered to the patient
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Intake lter: lters dust particles, this lter must not be removed by the patient
Filter Access Panel: allows authorized personnel to access the intake lter
Accessory Equipment and Spare Parts
Please use only 3B MEDICAL, INC. accessories and spare parts for this device
Workow Chart
Chapter 2: Conditions of Use
Operating Environmental
• Operating Temperature: 50-99° F
• Operating Relative Humidity: 20%RH-65%RH
• Operating Pressure atmosphere: 80kPa ~ 101kPa
• The operating environment should be dry and well ventilated. The Stratus 5 should never be run
in environments that are dusty. Avoid electromagnetic interference when possible
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