Philips Respironics DreamWear Instructions For Use Manual

Philips Respironics DreamWear Instructions For Use Manual

Full face mask

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DreamWear
Full Face Mask
Instructions for use - e
1 Safety Information
Intended Use
This mask is intended to provide an interface for application of CPAP
or bi-level therapy to patients. The mask is for single patient use in the
home or multi-patient use in the hospital/institutional environment. The
mask is to be used on patients (>66lbs/30kg) for whom CPAP therapy
or bi-level therapy has been prescribed.
Caution: U.S. Federal law restricts this device to sale by or on the
order of a physician.
Note: This mask is not made with natural rubber latex or DEHP.
Contraindications
This mask is not for use on patients with the following conditions:
recent eye surgery or dry eyes, hiatal hernia, excessive reflux, impaired
cough reflex, and impaired cardiac sphincter function. This mask is
not for use on patients who are dependent on mechanical ventilation
for their life support. This mask is not for use on patients who are
taking a prescription drug that induces vomiting, or on patients who
are uncooperative, unresponsive or unable to remove the mask by
themselves.
Warnings
• Use of this mask while the system is not on and operating may
cause rebreathing of exhaled air. Rebreathing of exhaled air for
longer than several minutes can in some circumstances lead to
suffocation.
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Summary of Contents for Philips Respironics DreamWear

  • Page 1 DreamWear Full Face Mask Instructions for use - e 1 Safety Information Intended Use This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.
  • Page 2 • Discontinue use and contact your healthcare professional if any of the following symptoms occur: skin redness, irritation, discomfort, blurred vision, or drying of the eyes. • Discontinue use and consult your healthcare professional if any of the following symptoms occur: unusual chest discomfort, shortness of breath, severe headache, eye pain or eye infections.
  • Page 3: What's In The Package

    2 What’s in the Package A Headgear B Magnetic headgear clip C Mask frame fabric sleeves (optional) D Mask cushion (available in S, M, L, MW) E Mask frame (available in small (SM), medium (MED), large (LG)) F Elbow with built-in exhalation (do not block) G Tubing quick release (may remain in the CPAP hose)
  • Page 4 Back of the Cushion Front of the Cushion H Guards I Magnetic Clips J Flaps K Large Holes (Two) in the Cushion (do not block) L Small Holes in the Cushion (do not block)
  • Page 5: Before Use

    3 Before Use DAILY BEFORE USE VERIFY FOR SAFETY 1. Look at the front of your mask cushion. 2. Find the two large holes. 3. Find the flaps. The flaps are clear, thin pieces that sit on the guards behind the holes. 4.
  • Page 6: Achieving The Right Fit

    Contact your healthcare provider for additional information. Philips Respironics DreamStation Mask Type and System One Resistance Control Settings Using your mask with a Philips Respironics DreamStation or System One device provides optimal comfort. The provider sets this value (X1) on your device.
  • Page 7 Putting on the Mask 1. With the mask assembled (see Assembly section), place the cushion under the nose. b 2. Position the frame on the top of your head. c Tip: For proper sizing, see Cushion Sizing and Mask Frame Selection sections.
  • Page 8 Mask Frame Sizing • Medium (MED) frame • Small (SM) frame • Large (LG) frame The medium (MED) mask frame will comfortably fit most faces. If the MED frame does not fit your face, contact your healthcare provider to see if a small (SM) or large (LG) mask frame would better suit your needs.
  • Page 9: Cleaning Instructions

    Tip: If the mask frame falls forward on the head and is too close to your eyes you may need a larger mask frame. Using the Mask 1. Connect the CPAP tubing (included with the CPAP device) to the tubing quick release on the elbow. 2.
  • Page 10: Assembly And Disassembly

    Caution: Do not use bleach, alcohol, cleaning solutions containing bleach or alcohol, or cleaning solutions containing conditioners or moisturizers. Dishwashing Instructions In addition to hand washing, the mask may be cleaned in the dishwasher once a week. Caution: Use a mild liquid dish washing detergent only to wash the mask.
  • Page 11: Multi-Patient Use

    5. Headgear: Slide the headgear top strap tabs into the slots on the mask frame and fold backwards. Attach the magnetic headgear clips. Note: The Philips Respironics logo will be on the outside and facing up when correctly assembled. Disassembly 1.
  • Page 12: Specifications

    Specifications The technical specifications of the mask are provided for your healthcare professional to determine if it is compatible with your CPAP or bi-level therapy device. Warning: Use outside of these specifications may result in ineffective therapy The pressure flow curve shown below is an approximation of expected performance.
  • Page 13 Deadspace (mL) Frame size: S: 176.3 S: 179.3 S: 182.2 M: 182.7 M: 185.7 M: 188.6 Cushion size: L: 201.3 L: 204.3 L: 207.2 MW: 185.2 MW: 188.2 MW: 191.1 Sound Levels (dBA) A-weighted Sound Power Level 24.0 A-weighted Sound Pressure Level at 1 m 16.5 Disposal Dispose of in accordance with local regulations.
  • Page 14: Symbols Glossary

    8 Symbols Glossary Symbol Title and Meaning Reference Philips Respironics DreamStation Mask Type and System One Resistance Control Value Indicates the therapy device comfort setting. Prescription device Caution: U.S. federal law restricts this device by or on the order of a physician.
  • Page 15 Symbol Title and Meaning Reference Reorder number ISO 7000-2493 Indicates the manufacturer’s catalogue Symbol 5.1.6, number so the medical device can be ISO 15223-1 identified. Operator’s manual; operating ISO 7000-1641 instructions Symbol 5.4.3, Consult instructions for use. ISO 15223-1 Wash by hand ISO 7000-3125 Indicates that cleaning the textile article is allowed only by washing by hand.
  • Page 16: Limited Warranty

    9 Limited Warranty Respironics, Inc. warrants that its mask systems (including mask frame and cushion) (the “Product”) shall be free from defects of workmanship and materials for a period of ninety (90) days from the date of purchase (the “Warranty Period”). If the Product fails under normal conditions of use during the Warranty Period and the Product is returned to Respironics within the Warranty Period, Respironics will replace the Product.
  • Page 17 Philips Respironics’ liability shall be limited, at the option of Philips Respironics, to the replacement or repair of the Product or the supply of an equivalent Product. 8. To exercise your rights under this warranty, contact your local authorised Philips Respironics dealer.
  • Page 18 Alternatively, you can make a claim under this warranty by contacting Philips Respironics directly at: Philips Electronics Australia Limited, 65 Epping Road, North Ryde NSW 2113, Australia. Tel: 1300 766 488, Email: prcontact@philips.com. 9. The following statement is provided to a Buyer who is a “consumer” under the Australian Consumer Law: Our goods come with guarantees that cannot be excluded under the Australian Consumer Law.

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