WiZARD SM01008 210 Nasal Mask with Headgear Instruction Manual

A WIZARD 210 Nasal Mask

WiZARD 210 Exhaust Flow

Pressure (cm H2O)

Intended Use

The WiZARD 210 Nasal Mask is intended for use in the home environment, hospitals and care facilities by adult patients (more than 30 kg) for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

Caution

US Federal law restricts this device to sale by or on the order of a physician.

Warnings

• The vent holes must be kept clear.
• Follow all precautions when using supplemental oxygen. Oxygen flow must be turned off when the flow generator is not operating.
• Use your mask as prescribed by your physician. It should be used only together with the appropriate flow generator equipment (CPAP or bi-level device) to ensure optimum therapy.
• Contact a health care professional if you experience ANY adverse reaction to the use of the mask.

Symbols

Caution                                       Consult instructions for use
Reference number                                          Lot number
  Date of manufacture                      Use by
Temperature limitation                                    Humidity limitation
  Does not contain latex                          Medical prescriptions
  Manufacturer                           Authorized representative in the European Community

Before Use

• Read the instructions completely.
• Hand-wash the mask.
• Inspect the mask for damage or wear. Do not use if damaged.

Fitting the Mask

1. Remove plastic cover from the silicon cushion (A-2).
2. Lightly hold the mask with the cushion over the nose and pull the headgear (A-7) on over the head.
3. Hook the plastic buckles (A-6) of the lower straps on the mask frame
4. Adjust upper headgear straps to a comfortable fit. The cushion should lightly touch the face.
5. Adjust lower headgear straps to a comfortable fit. The lower straps will rest below the ears.
6. Connect the tubing to your flow generator (CPAP or bi-level machine) and turn on the airflow.
7. If necessary, adjust the headgear to eliminate any leaks without over-tightening the straps.
8. To remove the mask and the headgear, simply unhook both buckles from the mask frame (A-1) and pull the upper head strap over your head.

Cleaning the Mask in the Home Environment

• Detach the air tubing, unhook the buckles and unthread the upper headgear straps. It is not necessary to remove the buckles from the headgear.
• Remove the silicone cushion and the forefront pad (A-3).
• Hand-wash all parts with mild soap or diluted dishwashing detergent and warm water (ca. 30°C). Remove all facial oils from the cushion. Use a bristle brush to clean the air vents.
• Rinse all parts thoroughly.
• Leave to air dry before re-assembling.

Do not use bleach, chlorine, alcohol, scented oils or aromatic based solutions. These solutions may damage the mask, cause cracks and reduce the life of the product. Do not iron the headgear.

Reprocessing the Mask between Patients

For cleaning and disinfection instruction in hospitals and care facilities for multi-patient use, please contact your mask provider to get it.

Assembling the Mask

1. Attach the forehead pad by pushing two protruding points into the slot of the frame.
2. There are three palpable fixation points at each vertex of the triangular mask cushion. Assemble the cushion by starting with slots at these three vertexes of the silicon onto the mask frame. Push firmly together.
3. Place the headgear on a flat surface with the shiny side (dark gray side) upside. Thread the upper headgear straps through the hooks on the mask frame and ensure the Velcro is outside.

Technical Specifications

Note: The mask system does not contain latex, PVC or DEHP materials.

Exhaust Flow

The mask has vent holes to protect against rebreathing.

Pressure (cmH2O)          4       8        12       16       20
Flow (L/Min)                  15    24       30       35       40

Refer the Pressure-Flow Curve to Fig 3 on the front page.

Mask Dead Space
XS 70 ml       S 89 ml      M 107m1        L 118 ml

Therapy Pressure Range
4-20 cmH2O

Resistance (pressure drop)
at 50 1/min: 0.4 cm/H20               at 100 1/min: 2.0 cm/H20

Operating Range
+5°C to +35°C (+41°F to +95°F)
15% to 95% relative humidity non condensing

Storage and transport
-15°C to +60°C (+5°F to +140°F)
10% to 90% relative humidity non condensing
Store the mask in a dry place out of direct sunlight.

Disposal

Your mask does not contain any hazardous substance and may be disposed of with your normal household waste.

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