3B MEDICAL STRATUS 5 STR1005 (01) PDF Document

Please adhere to the following special notes and warnings when using your 3B MEDICAL STRATUS 5 STR1005:

Special Notes:

• Please read the user manual carefully before using this product and save it for future reference.

• The 3B MEDICAL STRATUS 5 STR1005 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 a patient experiences an adverse reaction, contact a 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 3B MEDICAL STRATUS 5 STR1005 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 (Warning):

• Special attention should be paid to reducing the risk of fire when using oxygen therapy. Any material that is flammable in the air becomes extremely combustible and burns quickly when the oxygen concentration is high. For safety reasons, all ignition sources 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.

To ensure the best performance from your 3B MEDICAL STRATUS 5 STR1005, please follow these tips:

• The Stratus 5 should remain upright during use and storage.

• Operate the Stratus 5 in a clean environment. Excessive dust and moisture can affect 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 flow meter turned off or less than “0”.

• The Stratus 5 will make an exhaust sound and vent hot air from the bottom of the unit during operation; please do not block the vent. Blocking the vent increases the risk of fire.

• 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 these occur, contact your equipment provider.

• 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, as this is a fire hazard.

• Do not overfill the humidifier 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 not connect the concentrator in parallel or series with other oxygen concentrators or oxygen therapy devices.

• Only use the Stratus 5 power cord made specifically for this device.

• Oxygen therapy is a prescription. Flow rates are patient specific. Please do not change your flow without consulting your physician.

• This machine is designed to supplement oxygen, not for first aid or to sustain life.

• Avoid creating sparks near medical oxygen equipment, including static sparks generated by friction.

• Always unplug the Stratus 5 when performing any routine maintenance to avoid electric shock.

• 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, defibrillation, X-ray (gamma ray), infrared radiation, and transient electromagnetic fields, 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 affected.

• This oxygen concentrator cannot be stacked with other equipment, as this may result in improper operation.

• Do not use the 3B MEDICAL STRATUS 5 STR1005 while bathing. If the patient requires continuous O2, the 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.

The main parts of the 3B MEDICAL STRATUS 5 STR1005 are:

• Humidifier Band: Secures the humidification bottle to the Stratus 5.

• Oxygen outlet: The port from which the oxygen flows.

• Oxygen flow meter: Indicates the liters per minute (lpm) of oxygen flowing from the oxygen outlet port.

• Power switch: “I” indicates the unit is running. “O” indicates the power is off and oxygen is no longer being delivered.

• Intake filter: Filters dust particles. This filter must not be removed by the patient.

• Filter Access Panel: Allows authorized personnel to access the intake filter.

Operating Environmental Conditions:

• Operating Temperature: 50-99°F

• Operating Relative Humidity: 20%RH – 65%RH

• Operating Pressure atmosphere: 80kPa ~ 101kPa

• The operating environment should be dry, well-ventilated, and not dusty. Avoid electromagnetic interference when possible.

Storage and Transportation Environment:

• The product must be placed upright and vertical during transportation.

• Transport & Storage Temperature: -30°C to 70°C.

• Transport & Storage Relative Humidity: 15-95%RH, No condensation.

• Transport & Storage Pressure Atmosphere: 500-1060hPa.

*Device operation above or outside of the voltage, LPM, temperature, and humidity values specified may decrease oxygen concentration levels.

*When the nominal pressure of the oxygen output port is zero, the oxygen concentration is 93%±5% under the operating environment and rated flow rate. At flow rates from 1 to 5 L/min, the oxygen concentration remains between 90% and 96%.

Warning: Do not use extension cords or electrical adapters.

1. Select a location that allows the concentrator to draw in room air without being restricted. Make sure the device is at least 12 inches away from walls, furniture, and curtains that could impede adequate airflow to the device.

2. Do not place the device near any heat source.

3. Plug the power cord into a grounded electrical outlet.

4. Follow step A or B depending on humidifier use:

A. If you are not using a humidifier:

I) Connect a cannula to the oxygen outlet.

B. If you are using a humidifier, follow the steps below:

I). Remove the humidifier bottle from its package.

II). Unscrew the lid in a counterclockwise direction, remove the humidification cup, fill with the proper amount of distilled water, and then tighten the lid clockwise. Note: Please use distilled water only, replace it daily, and do not overfill the humidifier.

III). Install the humidifier with water in the hook and loop fastener on the top of the Stratus 5 according to the diagram.

IX). Secure the humidifier using the humidifier band.

X). Connect the PVC hose to the oxygen outlet and humidifier inlet according to the diagram.

XI). Attach the cannula to the humidifier.

5. Turn on the power switch.

6. Adjust the oxygen output flow to prescribed liters per minute by centering the flow meter ball on the proper number. Note: The flow meter adjustment knob increases the flow rate counterclockwise and decreases the flow rate clockwise.

7. Always turn off the Stratus 5 when not using.

Warning: It is important to unplug the device before you perform any cleaning.

Cleaning the Air Intake Filter:

The air intake filter should be cleaned weekly, or more frequently if environmental conditions are less than optimal.

1. Remove the air intake cover on the side of the Stratus 5 and take out the sponge mesh filter.

2. Rinse the sponge mesh thoroughly using clean water, then allow it to air dry completely.

3. Once dry, replace the filter and air intake cover.

TIP: Having a second sponge mesh filter allows for quick replacement while the other filter is drying.

Cleaning Your Stratus 5 and Accessories:

1. Cannula: Wash your cannula daily with mild soap and water and allow it to air dry. Your cannula should be replaced once a month.

2. Body of the Stratus 5: To clean the body of the Stratus 5, wipe with a damp towel; mild soap may be used. Do not submerge the Stratus 5.

3. Humidification bottle: The humidifier water should be replaced every day with distilled water. Cleaning and disinfection should be done at least weekly with mild soap and water, then allowing it to air dry. To disinfect, use one part white vinegar and one part distilled water. Once yearly replacement of the humidifier bottle is recommended.

The 3B MEDICAL STRATUS 5 STR1005 has an audible alarm and LED indicators. Here is a guide to the LCD indications:

Note:

1. When troubleshooting multiple alarms, they will alternate. Alarms and indicators depend on the highest priority. All of the above alarms are technical alarms. Within 3 minutes after power on, oxygen concentration less than 82% will not trigger an alarm.

2. When troubleshooting alarms, identify failure type from LCD and contact your equipment provider immediately.

3. The alarm system recommended test interval is 18 months.

To solve common problems with electromagnetic compatibility:

• Operate in strict accordance with the instructions of the Stratus 5 series oxygen concentrator instruction manual to ensure that the device is not subject to electromagnetic interference.

• Keep other devices away from this device to reduce the effects of electromagnetic interference.

• The effect of electromagnetic interference can be mitigated by adjusting the relative position/mounting angle between the device and other devices.

• Reduce electromagnetic interference by changing the wiring location of other device power/signal cables.

• Reduce electromagnetic interference by changing the power path of other devices.

The 3B MEDICAL STRATUS 5 STR1005 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. To help prevent electromagnetic interference, maintain a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.