COMPASSHEALTH NEB-SOCCER Soccer Ball Nebulizer User Manual

User Manual
Compressor Nebulizer
NEB-SOCCER
SOCCER-TRU
SOCCER-TRUWB-PB

NEB-SOCCER Soccer Ball Nebulizer

CAUTION ­Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.
Manufactured for Compass Health Brands.

INTRODUCTION

The Soccer Ball Nebulizer Compressor System is a medical device designed to deliver medicine prescribed by a physician to the airways of the lungs. The Nebulizer Set and the Air Compressor combined provides aerosol mist for inhalation by the patient for medical treatment only.

Statement of Indication for Use
The Soccer Ball Nebulizer Compressor is including an AC powered air compressor that provides a source of compressed air for use with a jet nebulizer in a home health care setting. The compressor provides a maximum flow rate of 8 Lpm that can be connected to is used in conjunction with a jet (pneumatic) nebulizer with the same performance specifications to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The patient population is determined by the nebulizer to which it is connected.
The disposable nebulizer cup is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. The disposable nebulizer cup is disposable, single-patient- use and intended for use with pediatric (5 years and older) and adult patient.
The Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. The Reusable Jet Nebulizer is intended for use with pediatric (2 years and older) and as defined by the prescribed medication and adult patients in hospital/ institutional settings, home care use, schools, and long term care facilities.

IEC SYMBOLS

| Attention – Consult Instruction Guide| | Type BF equipment- applied part
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| Consult instructions for use| | Double Insulated
| Alternating Current| | Serial Number
| This device contains electrical and/or electronic equipment that must be recycled per EU Directive 2012/19/EU-Waste Electrical & Electronic Equipment

IMPORTANT SAFEGUARDS

When using electrical products, especially when children are present, basic safety precautions should always be followed.
Read all instructions before using. Important information is highlighted by these terms:

DANGER­
Urgent safety information for hazards that will cause serious injury or death.
WARNING­
Important safety information for hazards that might cause serious injury.
CAUTION­
Information for preventing damage to the product.
NOTE­ Information to which you should pay special attention.

READ ALL INSTRUCTIONS BEFORE USING

DANGER
To reduce the risk of electrocution:

1. Always unplug this product immediately after using.
2. Do not use while bathing.
3. Do not place or store product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug immediately.

WARNING
To reduce the risk of burns, electrocution, fire or injury to persons:

1. The product should never be left unattended when plugged in.

2. Close supervision is necessary when this product is used by, on, or near children or physically incapacitated individuals.

3. Use this product only for its intended use as described in this guide. Do not use attachments not recommended by the manufacturer.

4. Never operate this product if:
   a. It has a damaged power cord or plug.
   b. It is not working properly.
   c. It has been dropped or damaged.
   d. It has been dropped into water. Return the product to an authorized Dealer or Service Provider for examination and repair.

5. Keep the power cord away from heated surfaces.

6. Never block the air openings of the product or place it on a soft surface, such as a bed or couch, where the air openings may be blocked. Keep the air openings free of lint, hair, and the like.

7. Never use while drowsy or asleep.

8. Never drop or insert any object into any opening or hose.

9. Do not use outdoors. This product is for household use only.

10. Do not use in an oxygen enriched environment.

11. Do not operate unit in a backpack or carrying bag.

12. Care should be taken when this product is used in the vicinity of other electronic equipment concerning the possible interference between them. They may need to be moved apart.

This is a home use desktop device and it is not intended to be used as a portable device.

WORK PRINCIPLE

This unit is compact, simple to operate and convenient to carry It uses a non- oil lubricating, single-cylinder piston pump to create air pressure. The air flow created by the Air Compressor comes out of the jet outlet and then enters the Nebulizer Set. The main air flow into and out of the air compressor unit is illustrated in Figure 1 below.

ILLUSTRATION OF PARTS

NEB-SOCCER Components (Disposable Nebulizer components for Adults and Children 5 Years and Older)

1. Mouthpiece
2. Medication Cup
3. Connection Tubing
4. Tube Connector
5. Air Openings| 6. Power Switch
7. Filter & Cover
8. Resevoir Tube
9. T-Adapter
10. Aerosol Mask
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SOCCER-TRU & SOCCER-TRUWB-PB Reusable Jet Nebulizer Components (For Adults and Children 2 Years and Older)

1. Mouthpiece
2. Cap with Valve
3. Nebulizer Insert| 4. Medicine Cup
5. Connection Tubing
6. Aerosol Mask
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GETTING STARTED

1. Check to ensure the following components of the nebulizer are enclosed:
   • Compressor unit
   • Tubing and accessories (see pages 5 for illustration of parts)

2. It is recommended to keep extra tubing, accessories and air filters on hand at all times in case original parts become lost, damaged, or soiled.

CAUTION
If you did not receive the components listed in this manual, please contact the dealer where you purchased your nebulizer.

SETTING UP THE NEBULIZER COMPRESSOR AND NEBULIZER ACCESSORIES
CAUTION
Tubing and accessories are NOT sterile from package. Prior to initial operation, the nebulizer should be thoroughly cleaned.

1. Wash hands with soap and warm water and dry completely with a clean towel.

2. Place the compressor on a clean, dust-free, stable and flat surface. Check the filter monthly or every 10 ­ 12 treatments and replace if dirty, clogged, or wet to ensure proper operation.

3. Make sure tubing and accessories have been cleaned and/or disinfected before first use and after last daily treatment. Refer to the Cleaning and Disinfecting Tubing and Accessories section on page 9.

4. Remove the nebulizer cap by twisting counter-clockwise until it stops and lift up (Figure 3-1). Be sure that the cone is put inside the bottom section

5. Fill nebulizer cup with medication from unit dose vial, eye dropper, or syringe. Do not fill more than 5 ml per treatment (Figure 3-2).

6. Close the nebulizer cap and turn clockwise until it is tightened (Figure 3-3).

7. If using the mask (optional), press it directly into the nebulizer cap (Figure 4). If using the mouthpiece, attach it firmly into the nebulizer cap. The cap is designed to fit tightly (Figure 4).

8. If using reusable jet nebulizer reference Figure 5 for instructions.
   Directions For Use:
   1. Wash hands with soap and warm water.
   2. Remove the nebulizer cup cap by twisting counter-clockwise until it stops (Fig 1). Lift up on the cap.
   3. Fill nebulizer cup with prescribed medication (Fig 2). DO NOT fill more than 8mVtreatment.
   4. Place the cap back into the container with 0 e the medication and turn clockwise until it is locked into place (Fig 3). Attach mouthpiece to component marked “1”.
   5. Connect tubing to circular port at the bottom of the cup marked “2”.

9. Attach one end of the tubing firmly onto the air outlet on the back of the compressor unit. It is important that the tubing be pushed all the way onto the air outlet. The tubing is designed to fit tightly (Figure 6-1).

10. Firmly press the other end of the tubing onto the bottom of the nebulizer cup (Figure 6-2).

11. Plug the power cord into an appropriate electrical outlet. ( DO NOT use with power strips or extension cords). Make sure at this stage, the power switch is at “OFF” status.

12. Press power switch to “ON” status to begin your prescribed treatment. (DO NOT run unattended). When treating children, adult supervision required.

13. When treatment is finished, shut off the unit and unplug it from the electrical outlet.

WARNING!

• The exterior surfaces of the unit and the air outlet connector may become slightly warm to the touch during use. Warm air can also be felt exiting the vents on the sides of the case of the unit. This is normal.
• Never operate if this unit has a damaged cord or plug, has been dropped in any way, immersed into water or if it does not work properly. Return it to a service center for repair.
• If any abnormality occurs, discontinue use immediately until the unit has been examined and repaired.
• Always unplug the product immediately after use.
• Never allow the power supply cord to be pulled, jerked, strained, twisted or severely bent, especially at the plug connections. Damage will occur at the high cord carefully for longer life.
• Never block the air openings of the main unit or place it where the air openings may be obstructed.
• Safety overload: DO NOT exceed 30 minutes of continuous operation.

OPERATION

To operate the compressor Nebulizer, do the following:

1. Plug in the Compressor, but do not connect the Nebulizer Set.
2. Make sure that the air filter is attached to the Compressor.
3. Turn on the power switch.
4. After the Compressor runs properly for 1-2 minutes, connect the jet outlet of the Compressor to the inlet of the Nebulizer Set
5. Begin treatment according to your physician’s instructions.
6. Inhale and exhale naturally. Be sure to stop when the medicine is used up.
7. When you have finished, turn the air compressor unit off before you disconnect the air hose.

WARNING ­ Do not use near flammable objects or locations near explosive materials.
WARNING ­ Nebulizer Set with DISPOSABLE accessory for single patient single use only.

COMPRESSOR NEBULIZER CLEANING

1. Clean the compressor accessories with distil. water.
2. Completely immerse the accessories in 70/30 Isopropyl Alcohol.
3. Soak the accessories in the alcohol for approximately 30 minutes.
4. Wash and rinse the accessories with warm (approximately 122°F/50°C) distilled water.
5. Shake out excess water and dry the accessories with a clean, soft towel or leave the accessories to air-dry.
6. Make sure the accessories and other cleaned parts are completely dry and store in a dry, sealed container.

DANGER­
Do not submerge in water; doing so will result in compressor damage.

FILTER CHANGE

Compass Part No. for Filter is CIF-NEB-5

1. Filter should be changed every 6 months or sooner if filter discolors.
2. Remove filter by grasping it firmly and pulling out of the unit. Discard old filter.
3. Replace with a new filter. Additional filters should be purchased from your Compass provider.
4. Push new filter into position.

CAUTION­
Do not reuse or wash filter or substitute any other material such as cotton for an air-inlet filter. It will result in compressor damage.

MAINTENANCE

To keep your Compressor Nebulizer working properly, please do follow the instructions in above mentioned cleaning and disinfection processes. If experiencing a problem regarding the device, such as the device cannot be turned on, noise being too loud, no medicine being dispersed, or water drops forming in the air hose, please proceed to the “TROUBLESHOOTING” guide on the page 12.

NOTE­
If the problem persists after the above basic maintenance, any further maintenance must be performed by a qualified Compass provider or authorized service center. Please refer to the contact information in the last page of this manual.

DANGER­
­Electric shock hazard. Do not remove compressor cabinet. All disassembly and maintenance must be done by a qualified Compass provider.

SPECIFICATIONS

Air Compressor Nebulizer Machine Features

WARNING:
Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
This product complies with the following electromagnetic compatibility standard: IEC 60601-1-2:2nd Edition.
This is a home use desktop device and it is not intended to be used as a portable device.

TROUBLESHOOTING GUIDE

physician to the Medicine Container
The cap is not attached properly| Reattach the cap
Water Drops are formed in the air hose| The medicine was over-full| Adjust the amount of medicine in the Medicine Container to the appropriate level, connect the air hose to the Air Compressor, and turn the unit on
The Nebulizer Kit was washed but not dried| Open and close the Nebulizer Kit repeatedly until the drops disappear

NOTE­
Please contact your COMPASS provider for assistance in case you have any other difficulties.

ELECTROMAGNETIC COMPATIBILITY

The information contained in this section (such as separation distances) is in general specifically written with regard to Soccer Ball Nebulizer. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.

General Notes:
Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this document and the remainder of the instructions for use this device.
Portable and mobile RF communications equipment can affect medical electrical equipment. Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or accessories may adversely impact safety, performance and electromagnetic compatibility (increased emission and decreased immunity).
Care should be taken if the equipment is used adjacent to or stacked with other equipment; if adjacent or stacked use is inevitable, the equipment should be observed to verify normal operation in the configuration in which it will be used.
The MODEL will continue to provide air to the nebulizer when exposed to the electromagnetic disturbance levels described below.

Electromagnetic Emissions

This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that is used in such an environment.

Emissions| Compliance according to| Electromagnetic environment
RF emissions (CISPR 11)| Group 1| The equipment 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.*
CISPR Emissions Classification| Class B| The equipment is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions (IEC 61000-3-2)| Class A
Voltage fluctuations / flicker (IEC 61000-3-3)| Complies

Electromagnetic Immunity

This equipmen t is intended  for use in  the electromagnetic environment specified  below. The
user of th is equipment shou Id assure that is used in such an environment .

Immunity against| IEC   60601- 1-2  test level| Complianc  level (of this device)| Electromagnetic environment
electrostatic   discharge, ESD
(IEC 61000-4-2)| contact discharge: ± 6 kV air discharge: ± 8 kV| ±8 kV
± 15 kV| The relative  humidity  should  be at least 5 %
electrical fast transients I bursts
(IEC 61000-4-4)| power supply lines:± 2 kV longer input I output lines: ± I kV| ± 2 kV
± I kV| Mains  power  quality  should  be that   of   a   typical commercial, hospital or home environment.
surges  on   AC  n1a1ns lines
(IEC 61000-4-5)| Common mode: ± 2 kV differential mode:± I  kV| ± 2 kV
± I kV| Mains  power  quality  should  be that   of   a   typical commercial, hospital or home environment.
power frequency magnetic field 50/60 Hz (IEC 61000-4-8)| 3 Alm| 30 A/m| Equipment which emits high levels of power line magnetic fields  (in  excess of  30A/m) shou ld be kept at a distance to reduce the like) ihood of interference..
Warning keep Soccer Ball Nebu lizer away from sources of high levels of power line magnetic fields (in excess of 30 Alm) to reduce the likelihood of interference.
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voltage dips and short interruptions on   AC mai ns input lines
(IEC 61000-4- 11)| dip >95%, 0.5 periods
dip 60%, 5 periods
dip 30%, 25 periods
dip >95%, 5 seconds| >95%,       0.5
per.
60%, 5 per.
30%, 25 per.

95%, 5 sec.| Mains power should be that of a typical commercial. hospital or home environment. If  you reqmres continued  operation during power mains inte1ruptions it 1s recommended that the Soccer Ball Nebulizer be powered from an uninterruptible power supply.ensure

This equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
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Conducted RF
rf coupled into lines(IEC 61000-4-6)
Radiated rf (IEC 61000-4-3)| 3 V rms 150 kHz to 80
MHz outside ISM bands
6 VRMS 150 kHz to 80
MHz inside ISM bands
3 V/m 80 MHz – 2.7 GHz| 3 Vrms
6 Vrms
10 V/m| Portable and mobile RF communications equipment should
be used no closer to any part of the, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below.
Recommended separation distance
d=1.2ÖP
d=0.58/ÖP 80 MHz to 800 MHz
d=0.70ÖP 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the  compliance level in each frequency range b .
Interference may occur in the
vicinity of equipment marked with
the following symbol:

NOTE 1 : At 80 MHz and 800 MHz, 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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.
b Over the frequency range 150kHz to 80 MHz field strengths should be less than 3 V/m

Recommended separation distances between portable and mobile RF communications equipment and the equipment
The Soccer Ball Nebulizer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended below, according to the maximum

output power of the communications equipment.

Rated maximum output power of transmitter W| Separation distance according to frequency of transmitters In meters
---|---
150 kHz -80 MHz
| 80 MHz to 800MHz
| 800 MHz to 2.5 GHz

0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23

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.

LIMITED WARRANTY

Compass Health Brands offers a limited five (5) year warranty on the compressor unit. We warrant that the compressor unit and its parts will be free from defects in workmanship and materials for a period of five (5) years from the date of original purchase.
This warranty does not extend to failures resulting from accident, misuse, abuse, alteration, use of unauthorized service, parts or cleaning solutions, or failure to comply with the User’s Manual.
lf the warranted equipment should fail during the warranty period, Compass Health Brands, at our option, will repair or replace parts at issue, provided the claim is bona fide. It shall be the responsibility of the purchaser to pack and return the equipment in a manner to avoid shipping damage. The shipment must be prepaid to us. This warranty covers the cost of labor incurred in the removal or replacement of the warranted component parts at us only.

SERVICE AND REPAIR

If you should have any questions about this nebulizer, please contact an authorized Compass Health Brands dealer. Do not open or disassemble the compressor unit at any time. This will void the warranty. If the unit is malfunctioning, discontinue use immediately and return to the original provider for repair or replacement. Please dispose of this nebulizer in accordance with local, municipal, state, and federal law of electronic devices.

NOTES

Manufactured for/Fabricado por:
Compass Health Brands Corp.
Middleburg Heights, OH 44130
www.compasshealthbrands.com
Phone/Telefono: 800.376.7263
Made in China/Hecho en China
42_NEB-SOCCER_00 ©2023

References

• Home Medical Products For Seniors, Elderly, Surgery Patients

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