OMBRA 105510 Table Top Compressor Instruction Manual

OMBRA 105510 Table Top Compressor

INFO

OVERVIEW

• A Power Cord
• B Air Filter Cover
• C Air Outlet
• D Nebulizer Cup Holder
• E Power Switch
• F Air Vents

INTENDED USE

• The compressor is intended to be used to deliver compressed air to a jet or pneumatic nebulizer. It is to be used by patients aged 18 months and older. The environments of use include hospitals, clinics, and the home.
• The clinical benefit is to enable the delivery of aerosol medication with compatible nebulizers by providing compressed air to power a jet or pneumatic nebulizer in order to convert liquid medication into an aerosol, so it can be inhaled into the lungs.
• The compressor has been designed to be used with the AeroEclipse XL BAN Nebulizer. For use with other nebulizers, please refer to the specifications section.
• If you have concerns regarding the use of the compressor, please speak with your healthcare provider.

Warnings

• Do not leave the compressor unattended with children. Contains small parts that can cause choking.
• For your safety, do not change or alter the equipment. It can be unsafe to use accessories, detachable parts and materials not described here.
• Only use the power supply cable that is provided.
• Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Avoid using the compressor next to or stacked with other equipment. This could cause the equipment to work incorrectly. If such use is required, watch the compressor and the other equipment to make certain that they work correctly.
• Do not use portable RF communications equipment (e.g. peripherals such as antenna cables and external antennas) closer than 30 cm (12”) to any part of the compressor. This includes cables. Otherwise, the performance of the equipment could degrade.

Cautions

• Children are not to set up and operate the compressor.
• Be mindful of children nearby when using the compressor.
• Care is required to ensure the compressor is not pulled off the table by tugging on the power cord (A) or nebulizer tube.
• The tubing and power cord present a strangulation hazard.

Note

• Electromagnetic disturbances may result in a reduction in the compressor output or complete failure of the compressor to provide essential performance.

INSTRUCTIONS FOR USE

1. Place the compressor on a clean, flat surface or tabletop.
   • Caution: Do not cover the air vents (F) or operate the compressor while it is in the carrying case. Overheating will occur which can damage the compressor. Stop using the compressor if there is visible damage.
   • Warning: Do not position the compressor so that it is hard to use the plug on the power supply cord.
2. Check that the power switch (E) is in the ‘OFF’ position ( 2A ). Plug the compressor into an electrical outlet.
3. Set up the nebulizer according to its instructions.
   • Note: The nebulizer cup holder (D) can be used to hold it before treatment is to begin (00).
4. Switch on the compressor ( 2B ). Start the treatment according to the nebulizer instructions.
5. Switch off the compressor when finished with the treatment(2A).
6. Disconnect the nebulizer tubing from the air outlet (C) on the compressor.
7. Unplug and store the compressor. Clean the nebulizer according to its instructions.

Warning: The plug of the power supply cord must be used to fully detach AC power to the compressor.

CLEANING

Compressor

• Prior to cleaning the compressor, ensure that it is unplugged from the electrical outlet. Use a damp cloth to wipe the exterior of the housing. Never use harsh cleaners or chemical sprays directly on the compressor or the power switch (E). Do not immerse the compressor or power cord (A) in water or cleaners.

Nebulizer

• Clean according to its instructions.

DISINFECTION

• The compressor can be disinfected each day.
• Follow the cleaning instructions. Use any of the following methods to disinfect the outside of the compressor.
• Wipe the case, switch, and handle with a tissue dipped in one of the following:
• 70 % isopropyl alcohol
• 1: 50 bleach to water solution (1 tablespoon (15 ml) bleach in 3¼ cups (800 ml) water)
• 3Mt SoluPrept Solution
• Wipe the case, switch, and handle with PDlt Super Sani-Clotht Germicidal Disposable Wipe. Follow the disinfectant instructions for use.
• Allow to air dry for 5 to 10 minutes.

STORAGE

• The compressor can be stored in the carry case or similar protected environment. The carry case has sufficient room to store a nebulizer as well. Always store the compressor out of reach of children and pets.

MAINTENANCE

• The compressor is equipped with an air filter that will slowly change color with use. The original filter is bright white, but it will slowly turn grey with use. The air filter should be changed every year, or sooner if visual inspection indicates. The compressor should never be used without the proper air filter installed. Spare air filters are provided with the compressor and extras can be ordered.

To change the filter (4):

1. Grasp the air filter cover (B) and turn counterclockwise at approximately 90 degrees.
2. Pull the air filter cover (B) out.
3. Remove the filter from the air filter cover (B) and insert a new filter in its place.
4. Place the air filter cover (B) back into the compressor and turn clockwise approximately 90 degrees to tighten.

Warnings

• The air filter cover (B) and filter are small parts that are a choking risk for children.
• Do not perform servicing and maintenance while the compressor is in use.
• The power supply cord is not serviceable.

Notes

• Dispose of the old filter in the garbage. Do not wash or reuse.
• There is no other needed maintenance. There are no parts inside the compressor that require periodic lubrication or adjustment. Do not open the compressor housing for any reason.
• Basic safety description: Basic safety is assured since there is a very low risk of physical hazards, such as electrocution, burns, or mechanical hazards.
• Basic safety monitoring method: No basic safety monitoring is required for the medical equipment.

DISPOSAL

• Do not dispose of unsorted municipal trash. Please consult local laws and regulations for proper disposal.

SPECIFICATIONS

• Technical data on electromagnetic compatibility can be obtained from Trudell Medical International.

PROTECTION AGAINST INGRESS

• The IP Code, or Ingress Protection Code, indicates how well the compressor housing protects the compressor’s internal wires and pump from accidental contact and water. The compressor is designed to prevent a child’s fingers from touching inside (the ‘2’ of IP21) and to resist accidental dripping water (the ‘1 ‘of IP21 ).

REORDER NUMBERS

• AeroEclipse XL BAN Nebu lizer (Includes: AeroEclipse XL BAN Nebu I sizer with 1 055130101 0 mouthpiece, EZ Twist Tubing, instructions for use)
• Air Filters , (5 pack) 10554493050

Meaning of Symbols

1. Temperature
2. Humidity
3. Atmospheric conditions
4. Class II
5. Indoor use only
6. Disposal of Electrical & Electronic Equipment (WEEE Directive)
7. Consult instructions for use
8. Type BF Applied Part (mouthpiece)
9. Consult instructions for the use of safety information
10. Medical Equipment Compressor Nebulizer with Respect to Electrical Shock Fire and Mechanical Hazards
    • Only in accordance with IEC/EN 60601-1, CAN/CSA C22.2 No. 601.1, and UL60601-1.
11. Do not open. Warranty void if seal is broken.
12. Single patient – multiple use
13. Part number
14. Quantity
15. Operating Conditions
16. Storage/Transport Conditions

• Trudell Medical International
• 725 Baransway Drive, London, Ontario, Canada N5V 5G4
• +1-519-455-4862
• info@trudellmed.com
• www.trudellmed.com
• Trudell Healthcare Solutions
• 758 Baransway Drive, London, Ontario, Canada N5V 5J7
• customerservice@trudellhs.com
• www.trudellhs.com
• REF 105510
• REF 105544
• 105747-001 E. 2023-04-21.
• trademarks and registered trademarks of Trudell Medical International (MI).
• © TMI 2019, 2021, 2023. All rights reserved.

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