Latex Free
MaxShield™ Mask with
Anti-Asphyxia
With Leak Elbow
22mm Female
Interchangeable Elbow
Compatible
BiTrac Select
™
Intended Use
The BiTrac MaxShield™ mask is an accessory for use with CPAP or Bilevel systems
for ventilatory support. A minimum
of >3.0cm of H
2O
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 taking medication which may
cause vomiting, have nocturnal vomiting, hiatal hernia or impaired cardiac sphincter function.
3) This mask may not be suitable for use on patients with the following conditions: glaucoma, recent eye surgery or dry
eyes.
Warnings
1) This mask has an integral leak port that provides a continuous leak path in the patient circuit. It is recommended
that the circuit have an additional exhalation device. You may need to adjust the pressure level and oxygen therapy
to compensate for the additional leak of the exhalation device.
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) Make sure the mask and headgear are the correct size for the patient’s face. If excessive discomfort is experienced,
adjust the mask and head gear. If the discomfort continues, consider an alternative mask.
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.
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 mask.
• Do not block the opening on the entrainment valve.
• Check valve before each use for malfunction or blockage caused by patient secretions.
Use of Interchangeable Elbow Feature:
1. Remove the existing elbow from the mask by holding the adapter ring and twisting the elbow counter clockwise
to disengage the bayonet lock (Refer to Figure B.)
2. Gently pull the elbow from the mask. (Refer to Figure C.)
3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter ring and turn clockwise until
fully seated. Do not use excessive force.
Bayonet Lock References:
Operating Specifications:
5°C to 40°C
at humidity range of 15% to 95%
Storage Specifications:
-20°C to
60°C at reltive humidity up to 95% non-
condensing
Made in USA
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
P
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
Single Patient Use
Pulmodyne is a registered trademark of
Pulmodyne, Inc. BiTrac MaxShield
is a registered trademark of Pulmodyne,
Inc.
2434D-08-11-2020
C
2797
1
Figure A.
Figure B.
Figure C.
EN
-Medical Device
