Philips Respironics Pico Traditional Nasal Mask

Intended Use

This nasal mask is intended to provide an interface for the administration of CPAP or bi-level therapy in patients. The mask is intended for single-patient use in the home environment or for multi-patient use in a hospital/institutional environment. The mask should be used in patients (>30 kg) prescribed with CPAP or bi-level positive airway pressure therapy.

• This mask has built-in exhalation. A separate exhalation device is not required.
• The mask is not made from natural rubber latex or DEHP.

Symbols

• Warning or Caution
• Not made with natural rubber latex
• X1 - Resistance control for System One
• Advice

Warnings

• This mask is not suitable for ventilatory support for life.
• Wash by hand before use. Check if the mask is damaged or worn (cracked, dented, torn, etc.). Remove and replace damaged parts if necessary.
• Some users may experience skin reddening, irritation, or discomfort. If this occurs, discontinue use and contact your healthcare professional.
• Consult a doctor or dentist if you experience toothache, gum pain, or jaw pain. Mask use may worsen existing dental problems.
• Consult a doctor if you experience any of the following symptoms while using the mask or after removing it: dry eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if symptoms persist.
• Do not block or cover the exhalation ports.
• Do not overtighten the headgear straps. Watch for signs of overtightening, such as excessive redness, sores, or swelling of the skin around the mask seal. Loosen the headgear straps to relieve the problem.
• This mask is intended for use with CPAP or bi-level positive airway pressure therapy systems recommended by your healthcare professional or respiratory therapist. Do not wear the mask if the CPAP or bi-level positive airway pressure therapy system is not turned on and functioning properly. Do not block or attempt to seal the exhalation port.
• Explanation of Warning: CPAP systems are intended for use with special masks with ports that have vents to allow continuous airflow out of the mask. When the CPAP system is turned on and functioning properly, fresh air from the CPAP system blows exhaled air out through the exhalation port attached to the mask. However, when the CPAP system is not functioning, insufficient fresh air will be delivered to the mask, and rebreathing of exhaled air may occur. This warning applies to most CPAP system models.
• If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating. Explanation of Warning: When the device is not operating and the oxygen flow is turned on, the oxygen delivered into the vent tubing may accumulate inside the device. Oxygen accumulated inside the device may lead to a fire hazard.
• With a fixed flow of supplemental oxygen, the inspired oxygen concentration will vary depending on the pressure settings, the patient's breathing rate, the mask and leak characteristics.
• At low CPAP or EPAP pressures, the flow through the exhalation port may be inadequate to clear all exhaled gas from the circuit. Rebreathing of exhaled air may occur.
• To connect the exhalation device, it is necessary to adjust the therapy pressure level to compensate for increased leak.

Features

Diagram showing the mask components with labels:

• A - Crown strap
• B - Top strap with tabs
• C - Bottom strap with tabs
• D - Nasal cushion
• E - Swivel
• F - Quick-release tube connection
• G - Swivel with built-in exhalation ports (do not block)
• H - Mask frame

Before Use

• Read and understand the entire manual before using the mask.
• Manually wash the entire mask [wash symbol].
• Wash your face. Do not use a moisturizer/lotion on your hands or face.
• Check if the mask is damaged or worn. Discard and replace damaged or worn parts.

Cleaning Instructions

Before first use, hand wash the entire mask [wash symbol]. Non-fabric parts should be hand washed daily. Fabric parts should be hand washed weekly.

1. Hand wash in warm water with liquid dish soap.

• Caution: Do not use bleach, alcohol, cleaning solutions containing bleach or alcohol, or cleaning solutions containing conditioners or moisturizers.
• Do not put fabric parts in a clothes dryer.
• Any deviation from this manual may affect product performance.
• Check the entire mask for damage or wear (cracked, dented, torn, etc.). Remove and replace parts if necessary.
• Rinse thoroughly. Air dry completely before use. Ensure the mask is completely dry before use. Lay fabric parts flat or hang to dry.

Dishwasher Cleaning

In addition to hand washing, the mask can be cleaned in a dishwasher once a week.

• Caution: Use only liquid dishwasher detergent to wash the mask.
• Remove the headgear. Do not wash the headgear in a dishwasher.
• Separate the cushion and frame and wash on the top rack of the dishwasher.
• Air dry. Ensure the mask is dry before use.
• Warning: Check if the mask is damaged or worn (cracked, dented, torn, etc.). Remove and replace parts if necessary.

Disinfection in Healthcare Settings

For multi-patient use in a hospital/institutional environment, process the mask after each patient according to the Disinfection Instructions. These instructions can be found online at www.healthcare.philips.com or by contacting Philips Respironics customer service at +1-724-387-4000 or Respironics Deutschland at +49 8152 93060.

Proper Mask Fitting

Diagrams illustrating mask fitting steps:

1. Size: The cushion should fit the width of the nose without blocking the nostrils. The top of the cushion can be placed between the bridge and the tip of the nose [arrow pointing to nose bridge].
2. Swivel: Turn as a key to detach [swivel symbol].
3. Headgear tab: Peel off the headgear tab to unfasten [tab symbol].
4. Headgear: Slide the headgear over your head [head symbol].
5. Cushion: Position the cushion over your nose [nose symbol].
6. Swivel: Press onto the mask frame to connect [connect symbol].
7. Headgear tab: Press the headgear tab to reattach [reattach symbol].
8. Headgear: Evenly adjust the top straps [upward arrow].
9. Headgear: Evenly adjust the bottom straps [downward arrow].
10. Note: Do not overtighten the straps.
11. The location of the crown strap may vary depending on head size. Adjust the crown strap for a comfortable fit [comfort symbol].

Using the Mask

1. Connect the flexible tubing (supplied with the CPAP or bi-level positive airway pressure device) to the quick-release swivel.
2. Turn on the therapy device. Lie down. Breathe normally.
3. Change positions while sleeping. Adjust until comfortable. If there is excessive air leak, make final adjustments. Some air leak is normal.

Quick-Release Tube Connection

The swivel is equipped with a quick-release connection for CPAP tubing. Pull the quick-release connection, and it will detach from the swivel and the tubing will loosen [release symbol].

Comfort Tips

• The most common mistake is overtightening the straps. The straps should be loose and comfortable. If your skin swells around the mask or you see red marks on your face, loosen the straps.
• Reposition the mask by pulling it directly away from your face and carefully placing it back into position.

Removing the Mask

Detach one of the bottom swivels or unfasten one of the headgear tabs. Pull the headgear forward over your head.

Disassembly/Assembly

Diagrams showing disassembly and assembly:

• Removing the headgear [disassembly symbol]: Peel off the tabs and pull them through the openings in the mask frame or swivel.
• Removing the cushion [disassembly symbol]: Detach the cushion from the frame.
• Attaching the cushion [assembly symbol]: Align the cushion size indicator (S/M, L, XL) on its bottom side with the bottom edge of the frame. Press the cushion onto the frame until it clicks into place.
• Attaching the headgear [assembly symbol]: Hold the top straps together with the crown strap aligned. Note: The Philips Respironics logo should be on the outside back of the straps when they are correctly attached.
• Thread the top straps through the top opening of the mask frame.
• Thread the bottom straps through the bottom openings of the mask frame or swivels.
• Fold the ends back and press the tabs onto the straps.

Mask Resistance Control for Philips Respironics System One

When this mask is used with a Philips Respironics System One device, it provides optimal resistance compensation. The mask's resistance value is X1 and should be set by the supplier.

• Compare the mask with the device. Refer to the device manual if the values do not match.
• System One is not compatible with masks that use a separate exhalation device.

Specifications

• Warning: Technical specifications for the mask are provided for the healthcare professional to determine if it is compatible with the CPAP or bi-level positive airway pressure device. If not used according to these specifications or if used with incompatible devices, the mask may be uncomfortable, the seal may be ineffective, optimal therapy may not be achieved, and leaks or variations in leak rate may affect device performance.

Pressure-Flow Curve

A graph showing the relationship between flow rate and pressure.

• Flow Rate (SLPM) on the y-axis
• Pressure (cm H₂O) on the x-axis

Pressure Drop

• At 50 SLPM: 0.4
• At 100 SLPM: 1.4

Dead Space

• S/M: 60 ml
• L: 72 ml
• XL: 80 ml

Sound Levels

• A-weighted sound power level: 27 dBA
• A-weighted sound pressure level at 1 m: 19 dBA

Disposal

Dispose of in accordance with local regulations.

Storage Conditions

• Temperature: -20°C to 60°C
• Relative humidity: 15% to 95% non-condensing

Limited Warranty

Respironics, Inc. warrants its mask systems (including the mask frame and cushion) (the "Product") to be free from defects in workmanship or materials for a period of ninety (90) days from the date of sale (the "Warranty Period"). If the Product fails to perform under normal use during the Warranty Period and the Product is returned to Respironics within the Warranty Period, Respironics will replace the Product. This warranty is non-transferable and applies only to the original purchaser of the Product. The sole remedy for breach of the foregoing warranty shall be replacement of the Product.

This warranty does not cover damage caused by accident, misuse, abuse, negligence, modification, failure to use or maintain the Product in accordance with the conditions of normal use and in accordance with the conditions set forth in the Product literature, and other defects not related to materials or workmanship.

This warranty shall not apply to any Product that has had repairs or alterations made to it by anyone other than Respironics. Respironics disclaims all liability for economic loss, loss of profits, overhead or other consequential, incidental, special or indirect damages arising from any sale or use of the Product. Some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

THIS WARRANTY IS IN LIEU OF ALL OTHER EXPRESS WARRANTIES. FURTHERMORE, ANY IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IS HEREBY EXPRESSLY DISCLAIMED. SOME JURISDICTIONS DO NOT ALLOW THE DISCLAIMER OF IMPLIED WARRANTIES, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS ACCORDING TO THE LAWS APPLICABLE IN YOUR JURISDICTION.

To exercise your rights under this limited warranty, contact your authorized local Respironics representative or Respironics Inc. at 1001 Murry Ridge Lane, Murrysville, Pennsylvania 15668, USA or Respironics Deutschland GmbH & Co KG, Gewerbestraße 17, 82211 Herrsching, Germany.