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Summary of Contents for Rhythm Healthcare LM10A
- Page 1 ITEM # LM10A 10L STATIONARY OXYGEN CONCENTRATOR...
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Page 2: Warnings
• Child Safety: Use extra caution when oxygen equipment is around children. Keep them at a safe distance to prevent misuse, tampering, or choking hazards from small parts. • Pet Safety: Keep pets away from the LM10A 10L Stationary Oxygen Concentrator. Bites, scratches, or contact with pet waste can damage the unit. -
Page 3: Table Of Contents
TABLE OF CONTENTS WARNINGS ........................2 INTRODUCTION ......................4 IMPORTANT SAFEGUARDS ..................5, 6 Introduction ......................5 Intended Use ......................5 Indications and Contraindications ..............5-6 PNEUMATIC DIAGRAM ....................7 IMPORTANT PARTS OF YOUR CONCENTRATOR ............8-10 SETTING UP YOUR OXYGEN CONCENTRATOR ............11, 12 BEFORE OPERATING YOUR OXYGEN CONCENTRATOR ........... -
Page 4: Introduction
INTRODUCTION INDICATIONS FOR USE — The Oxygen Concentrator provides supplemental low-flow oxygen therapy for patients in the home, nursing homes, patient care facilities, and similar settings. This device is not intended to be life-sustaining and does not offer any patient monitoring capabilities. Patient group: Adult, geriatric and pediatric. -
Page 5: Important Safeguards
The LM10A 10L Stationary Oxygen Concentrator provides supplemental oxygen to patients who are in need of supplemental oxygen as indicated and prescribed by their health care provider. The LM10A 10L Stationary Oxygen Concentrator can be used in the home or a healthcare facility. It is not intended to sustain or support life. - Page 6 Inspect the power cord and plug prior to use. If damage is present, do not utilize the LM10A 10L Stationary Oxygen Concentrator. If the above damage is present, please contact your Provider.
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Page 7: Pneumatic Diagram
PNEUMATIC DIAGRAM FOR REFERENCE Oil Free Air Air Inlet Filter Intake Silencer Compressor Coding Tube Pressure Regulating Valve Throttling Bridge Molecular Sieve A Oxygen One Way Valve Solenoid Valve Sensor Molecular Sieve B Pressure Pressure Equalizing Valve Nitrogen Sensor Exhaust Muffler Bacterial Nitrogen... -
Page 8: Important Parts Of Your Concentrator
IMPORTANT PARTS OF YOUR CONCENTRATOR Familiarize yourself with your oxygen concentrator before operating. Before using this product, ensure you have the following items: • 1 x User Manual • 1 x 10L Stationary Oxygen Concentrator • 1 x Humidifier Bottle •... - Page 9 IMPORTANT PARTS OF YOUR CONCENTRATOR - CONTINUED Figure 1 1. Oxygen Outlet 2. Display Monitor 3. Power Indicator Light (Green) 4. Normal Oxygen Indicator Light (Green: O2 over 82%) 5. Low Oxygen Indicator Light (Yellow: After 2 Minutes of O2 less than 82% or Pressure Failure) 6.
- Page 10 Liters per minute oxygen flow. Turn the flow rate knob until the float ball rises to the line of the prescribed flow rate. Center the float ball on the line. Never set the flow higher than 10 L/Min. Air Inlet Filter (LM10A-ILF) Small Mesh Screen (LM10A-42) Large Mesh...
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Page 11: Setting Up Your Oxygen Concentrator
SETTING UP YOUR OXYGEN CONCENTRATOR 1. Place the LM10A 10L Stationary Oxygen Concentrator in an area free of lint, dust and direct light sources including sunlight. These conditions may degrade the performance of the device. Portable and mobile RF communication equipment may affect the performance of the LM10A 10L Stationary Oxygen Concentrator, and there may be strong electromagnetic interference when using, such as near mobile phones, microwave ovens, etc. - Page 12 SETTING UP YOUR OXYGEN CONCENTRATOR - CONTINUED NASAL CANNULA Connect the cannula to the oxygen outlet (described further in the next section) and position the nasal cannula on your face, as shown below (Figure 4, 5, 6, 7), and breathe normally through your nose.
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Page 13: Before Operating Your Oxygen Concentrator
BEFORE OPERATING YOUR OXYGEN CONCENTRATOR 1. Before operating your unit always check to ensure the Small and Large Mesh Screens (located on the back of your unit) are clean. Proper cleaning of the mesh screens is discussed in the “Caring and Periodic Maintenance”... - Page 14 BEFORE OPERATING YOUR OXYGEN CONCENTRATOR - CONTINUED NOTE: Normal operation environment: Temperature 41°F to 104°F (5°C to 40°C) , Humidity: ≤80%, Atmospheric pressure 86 to 106kpa (10.3 to 15.4 PSI). The time required for the machine to warm up from minimum storage temperature -30°F (-34°C) to be ready for intended use is at least 75 minutes; from its maximum storage temperature of 50°F (10°C) after use to its readiness, the time required is about 30 minutes.
- Page 15 (0) line. 6. Once confirmed, the LM10A 10L Stationary Oxygen Concentrator is ready for use. Properly position the nasal cannula (see Figure 5) and allow a 2-minute warm-up period for the device to reach the specified performance levels..
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Page 16: Caring And Periodic Maintenance
WARNING: Do not lubricate fittings, connections, tubing, or other accessories of the oxygen concentrator to avoid the risk of fire and burns. WARNING: Do not attempt to operate the unit without the Air Inlet Filter (LM10A-ILF) the Bacterial Filter (LM10A-BF), the Small Mesh Screen (LM10A-42) and the Large Mesh Screen (LM10A-43) in place. - Page 17 NOTE: THE FOLLOWING PROCEDURES SHOULD ONLY BE PERFORMED BY A QUALIFIED SERVICE TECHNICIAN. 1. Disconnect the power cord before opening the concentrator and remove all dust deposits inside the cabinet with an appropriate vacuum cleaner and replace the Bacterial Filter (LM10A-BF) with each Compressor servicing. 2. AIR INLET FILTER (LM10A-ILF) Inspect the Air Inlet Filter in between patients and replace if needed.
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Page 18: Alarm And Alert System
ALARM AND ALERT SYSTEM 1. The LM10A 10L Stationary Oxygen Concentrator includes a Technical alarm system with visual LED indicators, audible alarms and Error Codes displayed on the screen, which monitors the state of the device and alerts of abnormal operation, loss of essential performance or failures. -
Page 19: Minor Troubleshooting
Check the Air Inlet Filter, Small and Large Mesh Screens. If the Mesh Screens are dirty, please follow the cleaning instructions on page 16. Inspect the Air Inlet Filter (LM10A-ILF) Air filter is blocked. in between patients and replace if needed. Change this filter if torn, damaged, as needed, or every three years. -
Page 20: Specifications
7 10 ± 10% L/Min kPa) Outlet Pressure in Normal Conditions 130 - 150kPa, 18-22 PSI LM10A 10L Stationary Oxygen Concentrator/115: 115VAC, Electrical Rating 60Hz, 650VA Oxygen Percentage ≥90 ± 3% @10 L/Min after warm-up period of 2 minutes. - Page 21 SPECIFICATIONS - CONTINUED The following two charts about temperature, flow rate and oxygen concentration are for reference. 25 °C 10 °C 40 °C 77 °F 50 °F 104 °F 10 LMP 8 LMP 5 LMP 4 LMP 3 LMP 2 LMP 1 LMP...
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Page 22: Symbols
SYMBOL SYMBOLS Warning - Describes a hazard or unsafe practice that can result in severe bodily injury, death, or property damage Caution – Describes a hazard or unsafe practice that can result in minor bodily injury or property damage Consult the accompanying documents Type BF Equipment Class II Equipment, double insulated Do not use oil or grease... - Page 23 SYMBOLS - CONTINUED Manufacturer Proper disposal of waste of electrical and electronic equipment required European CE mark with Notified Body No.2460 FRAGILE - Contents of the transport package are fragile therefore it shall be handled with care. THIS WAY UP - Indicates correct upright position of the transport package. Ingress Protection - Protected against finger access to hazardous parts;...
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Page 24: Limited Warranty
(typically the healthcare provider), unless contractually specified otherwise. This warranty is limited to the Buyer of new equipment purchased directly from Rhythm Healthcare, LLC, or one of its Providers, Distributors, or Agents. Rhythm Healthcare, LLC’s obligation under this warranty is limited to product repair (parts and labor) at its factory or at an Authorized Service Center. -
Page 25: Electromagnetic Information
Equipment or System to perform its intended use without disturbing other Equipment and Systems or non-medical electrical equipment. The LM10A 10L Stationary Oxygen Concentrator is intended for use in the electromagnetic environment specified below. The customer or the user of the Concentrator should assure that it is used in such environment. - Page 26 ELECTROMAGNETIC INFORMATION - CONTINUED Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions test Compliance Electromagnetic environment-guidance RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
- Page 27 ELECTROMAGNETIC INFORMATION - CONTINUED Table 3: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Test Frequency IEC 60601-1-2 Compliance Band (MHz) Service Modulation (MHz) Test Level (V/m) level (V/m) Pulse 380 –390 TETRA 400 Modulation 18 Hz FM ± 5 kHz GMRS 460, FRS 430 –470 deviation...
- Page 28 ELECTROMAGNETIC INFORMATION - CONTINUED Table 4: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
- Page 29 ELECTROMAGNETIC INFORMATION - CONTINUED Table 5: Recommended Separation Distances Between Portable and Mobile RF communications equipment and the EQUIPMENT or SYSTEM – For EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING. Recommended separation distances between portable and mobile RF communications equipment and the OXYGEN CONCENTRATOR The OXYGEN CONCENTRATOR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 30: Fda 510(K)
FDA 510(K) This device has been cleared by the U.S. Food and Drug Administration (FDA) under 510(k) number K240840 RETURN AND DISPOSAL This device must not be disposed of with household waste. It contains electrical and/or electronic components that should be recycled in accordance with local regulations. Non-infectious used accessories (e.g., nasal cannulas) may be disposed of as regular residential waste. - Page 31 Rhythm Healthcare, LLC Clearwater, FL 33762 Email: contactus rhythmhc.com Website: www.rhythmhc.com V1: 4/2/25...
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