RespShop Opus360 Nasal Pillows Mask Instruction Manual

RespShop Opus360 Nasal Pillows Mask

Product Information

Specifications:

• Intended for multiple-patient or single-patient adult use
• Designed for individuals requiring CPAP or Bi-level ventilator treatment
• Suitable for home, hospital, or clinical settings

Product Usage Instructions

Operating Instructions:

1. Inspect the mask for damage before each use. Replace any damaged parts.
2. Check the vent holes for blockages and ensure the air path is clear.
3. Failure to follow operating instructions may affect mask performance and safety.

Warnings & Cautions:

• Use the mask only with recommended CPAP or Bi-Level equipment.
• Do not block vent holes associated with the mask.
• Discontinue use if discomfort, irritation, or allergic reactions occur.
• Avoid using the mask if feeling nauseous or vomiting.

Mask Fitting:

1. Remove Plastic Cover from Silicone Pillows.
2. Insert Silicone Pillows into nostrils and slide Headgear Straps over your head.
3. Adjust Side Straps and Top Straps for secure fit.
4. Connect mask to CPAP/Bi-Level machine at prescribed pressure.

Fitting Tips:

• If leaks occur, reposition Silicone Pillows for a better seal.
• Do not over-tighten headgear straps.
• If leaks persist, try a different Silicone Pillow size provided.

Disassembly for Cleaning:

1. Remove Silicone Pillows from Mask Frame.
2. Detach Headgear Assembly from Mask Frame by slipping out Side Straps.
3. Remove Ball Elbow from Mask Frame with a rotating motion.
4. Separate Male Swivel from Female Swivel.

Cleaning Your Mask at Home:
Provide relevant cleaning instructions here.

FAQ:

• Q: Can I use the mask without a CPAP or Bi-Level machine?
  A: No, the mask should only be used with the recommended equipment turned on and operating properly.

• Q: How do I know if the mask is the correct size for me?
  A: The package includes three sizes of Silicone Pillows to help you find the best fit. Adjust as needed for comfort and seal.

The Opus™360 Nasal Pillows Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level ventilator treatment in the home, hospital, or other clinical setting.

Operating Instructions

• The operating pressure range of the mask is 3-25 cm H2O.
• The operating temperature range of the mask is 5-40ºC (40-104ºF).
• Before using the mask each time:
  1. Inspect it for damage. If there is any visible deterioration (cracking, tears etc) do not use and seek replacement part(s).
  2. Inspect the vent holes. Do not use if blocked.
  3. Make sure the air path through the mask is clear.
     Note: Failure to follow the operating instructions above may compromise the performance and safety of the mask.

Warnings & Cautions

• This mask should be used only with CPAP or Bi-Level equipment recommended by your physician or respiratory therapist. A mask should not be used unless the CPAP or Bi-Level machine is turned on and operating properly. The vent holes associated with the mask should never be blocked.
• Explanation of Warning: CPAP and Bi-Level machines are intended to be used with special masks which have exhalation ports to allow continuous flow of air out of the mask. When the CPAP/Bi-Level machine is turned on and functioning properly, new air from the CPAP/Bi-Level machine flushes the exhaled air out through the mask exhalation ports. However, when the CPAP/Bi-Level machine is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed.
• Re-breathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation.
• Discontinue use if discomfort or irritation occurs, and consult your Healthcare Provider.
• Discontinue using the mask if there is an allergic reaction to any part of the mask.
• Consult your physician if this occurs.
• Do not use the mask if vomiting or feeling nauseous.
• US Federal Law restricts this device to sale by, or on order of, a physician.
• The mask must be reprocessed if it is used between patients. For details, see the Multi-Patient Reprocessing Instructions section.

Mask Parts

• A. Mask Frame
• B. Silicone Pillows
• C. Male Swivel
• D. Tube Anchoring Strap
• E. Ball Elbow
• F. Flexitube
• G. Female Swivel
• H. Top Strap
• I. Back Strap
• J. Side Strap
• K. Top Buckle
• L. Back Buckle

Fitting Your Mask

1. Remove Plastic Cover from Silicone Pillows (B).
2. Hold the Mask Frame (A) with one hand and the Back Strap (I) with the other hand.
3. Insert the Silicone Pillows (B) into your nostrils and slide the Headgear Straps (H, I) over your head.
4. Adjust the Side Straps (J) so that the Top Strap (H) is directly above each ear.
5. Adjust the Back Straps (I) and then the Top Straps (H) so that the Headgear sits just above each ear. The Silicone Pillows (B) should rest securely in your nostrils.
6. Connect the mask to the CPAP/Bi-Level machine set at the prescribed pressure.

FITTING TIPS

• If leaks occur, try repositioning the Silicone Pillows (B) in your nostrils to get a better seal. You may need to readjust the Headgear Straps. Do not over-tighten the headgear straps. If leaks still occur you may need a different Silicone Pillow size (Three sizes are provided).
• The Flexitube (F) can be fixed in three positions or left free, see Mask Assembly Item 4 for details.

Disassembly for Cleaning

1. Remove Silicone Pillows (B) from the Mask Frame (A).

2. Remove Headgear Assembly from the Mask Frame (A). This is done by slipping the Side Straps (J) out of the hooks on the Mask Frame (A).

3. Remove the Ball Elbow (E) from the Mask Frame (A).
   Note: For easiest removal, use a rotating motion as shown.

4. Remove Male Swivel (C) from Female Swivel (G).

Cleaning Your Mask at Home

After each use:

1. Wash Mask Frame (A), Silicone Pillows (B), Flexitube Assembly (E, F, G) and Male Swivel (C) in pure soap dissolved in lukewarm water. Do not soak for more than 10 minutes.
2. Rinse thoroughly with fresh water, ensuring that all soap residue is removed.
3. Leave all parts to dry out of direct sunlight before reassembling.

Weekly:

1. Hand-wash the Headgear Assembly in pure soap dissolved in lukewarm water.
2. Rinse thoroughly with fresh water, ensuring that all soap residue is removed.
3. Air dry out of direct sunlight before reassembly.

Cautions

• Do not store the mask in direct sunlight.
• Do not wash the mask in the dishwasher.
• Do not clean the mask with products containing alcohol, anti-bacterial agents, antiseptic, bleach, chlorine or moisturizer.

Note: Failure to follow the cleaning instructions may compromise the performance and safety of the mask and shorten its life.

Mask Assembly

1. Push the Male Swivel (C) into the Female Swivel (G).

2. Push the Ball Elbow (E) into the socket on the Mask Frame (A).
   Note: For easiest insertion, ensure that the Ball Elbow (E) is angled as shown.

3. Slip the Headgear Side Straps (J) into the hooks on the Mask Frame (A).

4. Fix the Flexitube (F) in your desired location:

5. Top: Thread the Tube Anchoring Strap (D) through the Top Buckle (K) and fasten around the Flexitube (F).

6. Left/Right: Wrap Tube Anchoring Strap (D) around the Headgear Side Strap (J) and the Flexitube (F) and fasten.
   Note: The Flexitube (F) can also be left free.

7. Push the Silicone Pillows (B) into Mask Frame (A).

Headgear Assembly
Note: The Headgear Assembly does not need to be disassembled for cleaning.

1. Lay out the Headgear and Buckles as shown.
2. Thread the Top Straps (H) through the Top Buckle (K) and fasten back on themselves. Repeat with the Back Straps (I) and Back Buckle (L).
3. Fold the Side Straps (J) back on themselves.

Technical Specifications

Exhaust Flow
The Opus™360 Nasal Pillows Mask has an air exhaust system that vents the expelled CO2 through a group of fine holes in the front of the Elbow.
These holes mustn’t be blocked by any object. This controlled leak ensures exhaled CO2 is expelled from the mask.

Oxygen/Pressure Port Connector
If pressure readings and/or additional oxygen are required, an Oxygen/Pressure Port Connector is available (Code 900HC452).

1. Connect the large end of the Connector (T) to the Male Swivel (C) on the mask and the small end of the Connector to the Main Breathing Tube (R).
2. Open the Port Cap(s) (P) and place the Pressure and/or Oxygen Tube (S) firmly over the Port(s) (Q).

(The two Ports are identical; either Port may be used for oxygen or pressure measurement. Only remove the Port Cap from Ports that are being used.)

• Note: At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient’s breathing pattern, mask selection, and the leak rate.
• Warning: If oxygen is used with CPAP/Bi-Level machine, the oxygen flow must be turned off when the CPAP/Bi-Level machine is not operating.
• Explanation of Warning: When the CPAP/Bi-Level device is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the CPAP/Bi-Level machine enclosure. Oxygen accumulated in the CPAP/Bi-Level machine enclosure will create a risk of fire.
• Warning: Do not smoke while using or in the vicinity of someone using oxygen with this mask.
• Warning: Do not use Polyvinyl Chloride (PVC) Pressure and/or Oxygen Tubing. Use Silicone Tubing instead.
• Explanation of Warning: Contact with PVC can cause premature cracking of ports.

Opus™360 Nasal Pillows Mask
Multi-Patient Cleaning Instructions
Your Opus™360 Nasal Pillows Mask is provided assembled and ready for patient use. To reuse between patients please follow the guidelines below.

Cleaning / De-soiling
Before disinfecting, disassemble all components from the Mask Frame (the Headgear Assembly, Flexitube Assembly, Silicone Pillows and Male Swivel). Clean all surfaces of the mask and components thoroughly with a mild detergent solution and a soft-bristled brush. Ensure all visible soil is removed. Rinse thoroughly under running potable water to remove the detergent solution.

Failure to properly clean this device may result in inadequate disinfection.

High Level Disinfection Parameters

THE OPUS™ 360 NASAL PILLOW MASK HAS BEEN VALIDATED TO WITHSTAND 20 CYCLES OF THE ABOVE PARAMETERS. DO NOT USE IF DAMAGED.
Note: Failure to follow the cleaning instructions may compromise the performance and safety of the mask and shorten its life.
Contact your local Healthcare Provider for additional information.

INTERNATIONAL PO Box 14 348, Panmure, Auckland 1741, New Zealand
Tel: +64 9 574 0100
Fax: +64 9 574 0158
Email: info@fphcare.com
Website: www.fphcare.com

AUSTRALIA
Tel: +61 3 9879 5022
Fax: +61 3 9879 5232

AUSTRIA
Tel: 0800 29 31 23
Fax: 0800 29 31 22

BENELUX
Tel: +31 78 644 0924
Fax: +31 78 644 0914

CHINA
Tel: +86 (20) 3205 3486
Fax: +86 (20) 3205 2132

FRANCE
Tel: +33 1 6446 5201
Fax: +33 1 6446 5221

GERMANY
Tel: +49 7182 93777 0
Fax: +49 7182 93777 99

INDIA
Tel: +91 80 4123 6041
Fax: +91 80 4123 6044

IRISH REPUBLIC
Tel: 1800 409 011

ITALY
Tel: +39 06 7839 2939
Fax: +39 06 7814 7709

JAPAN
Tel: +81 3 3661 7205
Fax: +81 3 3661 7206

MIDDLE EAST
Tel: +9 71 4 360 0849
Fax: +9 71 4 368 8110

SPAIN
Tel: +34 902 013 346
Fax: +34 902 013 379

SWITZERLAND
Tel: 0800 83 47 63
Fax: 0800 83 47 54

UK (EU Authorised Representative)
Tel: +44 1628 626 136
Fax: +44 1628 626 146

Northern Ireland
Tel: +0800 132 189

USA
Tel: +1800 446 3908
or +1 949 453 4000
Fax: +1 949 453 4001

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