1
Wisp Pediatric Nasal Mask
Instructions for use -
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1 Safety Information
Intended Use
This mask is intended to provide an interface for application of non-invasive ventilation, including
CPAP and bi-level therapy, to patients. The mask is for single patient use in the home and multi-
patient use in the hospital/institutional environment. The mask is to be used on patients greater
than 10 kg/22 lbs (>10 kg/22 lbs) for whom CPAP, bi-level therapy, or non-invasive ventilation has
been prescribed.
Note:
This mask is not made with natural rubber latex, DEHP or BPA.
Contraindications
This mask is not intended for patients who are dependent on mechanical ventilation for their
life support.
Warnings
•
When using this mask, it is the responsibility of the healthcare professional to ensure proper device
set-up in accordance with patient condition, including the use of proper alarms.
•
Appropriate patient monitoring and alarms should be used for patients who are unable to remove the
mask themselves to assure the mask and tubing remain in place during therapy.
•
The use of nasal or full face masks applies forces on the head and may affect cranial facial growth
patterns. Regular Healthcare professional assessment is recommended when using this mask.
•
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.
•
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.
•
Discontinue use and consult your healthcare professional if any of the following symptoms occur:
tooth, gum, or jaw soreness. Use of a mask may aggravate an existing dental condition.
•
The mask material should be away from eyes.
•
Do not overtighten the headgear straps. Watch for signs of overtightening, such as excessive
redness, sores or bulging skin around the edges of the mask. Loosen the headgear straps to alleviate
symptoms.
•
Do not block or seal off the exhalation ports.
