Nasal Mask with
Vented Elbow
22mm Male
Latex Free
Single Patient Use
Cleaning Instructions
Made in USA
Caution:
Federal Law (USA) restricts this device to sale by or on
the order of a licensed physician.
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
T: +1.317.246.5505
F: +1.317.246.5501
www.pulmodyne.com
Cleaning Instructions:
Note: You do not have to remove the mask forehead pad or
connector from the mask before cleaning it, but you may want to do
so to clean the parts more thoroughly.
1. Remove the head strap from the mask. Disconnect the mask,
connector and tubing.
2. With a soft cloth, gently wash the mask, forehead pad, head strap
and connector in a solution of warm water and mild shampoo or
dish detergent. DO NOT use any cleaners containing conditioners
or moisturizers as these will leave a residue. Be sure to
thoroughly clean the mask cushion flaps.
3. Rinse thoroughly and air dry only.
4. If the mask cushion or forehead pad still seem oily, wash them
again.
Cleaning Warnings:
1. Do not Pasteurize
2. Do not gas, cold or steam sterilize.
Head Strap with Clip Cleaning Instructions:
1.
Hand or machine wash in warm water with a mild detergent.
2.
Do not use bleach, alcohol, cleaning solutions, moisturizers or
conditioners.
3.
Rinse thoroughly and air dry only.
4.
Inspect for deterioration or damage and replace as needed.
5.
Slight re-adjustment of clips on Head Strap after washing may
be needed.
Operating Specifications: 5°C to 40°C at humidity range of 15% to 95%
Storage Specifications: -20°C to 60°C at relative humidity up to 95%
non-condensing
P
C
0086
Intended use: The nasal mask and accessories (mask, forehead
pads and headgear) are used with and attached to a positive
pressure air source, CPAP or Bilevel equipment, and has the
Indications for Use consistent with Indications for Use of the
equipment to which it is attached.
Warnings:
1. This mask and vented swivel
elbow has an integral leak
port; therefore a separate
exhalation device is not
needed.
2. At low CPAP pressures the
flow through the exhalation
port may be inadequate to
clear all exhaled gas from the tubing. Some rebreathing may
occur.
3. If skin irritation develops, this may be due to excessive pressure
or skin reaction or a combination of the two. Loosen the head
strap and/or try another mask or forehad pad size. Skin reaction
may also be due to cleanliness. Refer to the cleaning
instructions.
4. This CPAP mask should only be used with CPAP systems
recommended by your physician or respiratory therapist. A mask
should not be used unless the CPAP system is turned ON and
operating properly. The vent hole or holes associated with the
mask should never be blocked.
Explanation of the Warning: CPAP systems are intended to be
used with special masks with connectors which have vent holes
to allow continuous flow of air out of the mask. When the CPAP
machine is turned on and functioning properly, new air from the
CPAP machine flushes the exhaled air out through t he attached
mask exhalation port. However, when the CPAP machine is not
operating, enough fresh air will not be provided through the mask,
and exhaled air may be rebreathed. Rebreathing of exhaled air
for longer than several minutes can in some circumstances lead
to suffocation. This warning applies to most models of CPAP
systems.
Nasal Mask Discomforts and Corrective Actions:
The problems listed below may be indications that your mask needs
to be replaced. You should seek the assistance of your dealer when
you notice one or more of the following:
• The cushion begins to tear
• The mask feels uncomfortable
• The parts show signs of wear, discoloration or cracking
LIMITED WARRANTY
• Pulmodyne, Inc. warrants that the product will remain free from
defects for a period of 3 months by proof of date of purchase
from the original owner with lot number and return of the
defective product.
• We do not offer a warranty if instructions are not followed, used
or handled incorrectly, improper cleaning, negligence, normal
wear and tear.
• This warranty does not cover cost for loaner and rental product,
any transportaiton, any taxes or duty, and labor, and other
related costs or other losses.
• Replacement of the defective part shall be the sole remedy.
Typical Exhaust Flow / Pressure Performance
of the Vent Swivel Elbow
Flow
(lpm)
Pressure
(cmH
O)
2