Nasal Mask with
Standard Elbow
22mm Female
Intended Use
The Pulmodyne BiTrac Nasal mask and accessories (mask, forehead pad and head strap) are
used with and attached to a positive pressure air source, CPAP or Bilevel equipment, and has the
Indications for Use consistent with the Indications for Use of the equipment to which it is attached.
Warnings
1) This mask does not have an integral leak port; therefore a separate exhalation device
must be part of the circuit. Utilize the equipment manufacturer's recommended
exhalation port in the designated circuit.
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 forehead pad size.
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 the 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.
Latex Free
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
M
Pulmodyne
2055 Executive Drive
Indianapolis, IN 46241 USA
www.Pulmodyne.com
Single Patient Use
C
2797
P
QNET BV
Hommerterweg 286
6436 AM Amstenrade
The Netherlands
Medical Device
Made in USA
1 of 15