Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
M
Intended use:
The full face mask is an accessory for use with CPAP or
Bilevel systems used in the treatment of adult Obstructive Sleep Apnea
(OSA) and/or ventilatory support. A minimum pressure of >3.0cm H
2
O at
the mask is required.
Contraindications:
1. This device should not be used
on uncooperative or unresponsive
patients.
2. This device may not be suitable
for use on patients unable to
remove the mask or are currently
taking medication which may cause
vomiting.
Warnings:
1. This mask and vented swivel elbow has an integral leak port;
therefore a separate exhalation device is not needed.
2. This device is not suitable for providing life support ventilation.
3. Any unusual chest discomfort, shortness of breath, stomach
distension, belching, severe headache, drying eyes, eye pain,
eye infections, or blurred vision when receiving positive airway
pressure or upon awakening should be reported to the clinician.
4. To minimize risks of vomiting during sleep, avoid eating or
drinking for three (3) hours before use.
5. 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.
6. 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 the 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.
Full Face 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.
Full Face Mask
with Vented
Anti-Asphyxia
Elbow
22mm Male
Caution:
Federal Law (USA) restricts this device
to sale by or on the order of a licensed
physician.
Made in USA
7845F-06-03-2021
Before Use:
Verify entrainment valve function on anti-asphyxia elbow:
•
With the unit turned OFF, the entrainment valve flap should be open,
allowing user to breathe room air.
•
Turn CPAP or Bilevel unit ON.
•
The flap valve should close, allowing the user to receive airflow from the
unit.
•
If the valve does not function in this manner, replace the vented anti-
asphyxia elbow
•
Do no block the opening on the entrainment valve.
•
Check valve before each use for malfunction or blockage caused by
patient secretions.
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.
Latex Free
Single Patient Use
Cleaning Instructions
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
EN
-Medical Device
