Pulmodyne BiTrac Select 313-9001W Manual

BiTrac Select™
Full Face Mask with Anti-Asphyxia
Nebulizer Attachment Elbow
22mm Female
Interchangeable Elbow Compatible
Intended Use
The BiTrac 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 of >3.0cm of H
Note
When NOT in use ensure the nebulizer adapter port is sealed.
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.
Warnings
1. This elbow should be used only for a nebulizer treatment while in the presence of trained medical personnel.
2. 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.
3. This device is not suitable for providing life support ventilation.
4. 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.
5. To minimize risks of vomiting during sleep, avoid eating or drinking for three (3) hours before use.
6. If skin irritation develops, this may be due to excessive pressure or skin reaction or a combination of the two. Loosen the headgear and
or try another mask or forehead pad size.
7. 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.
8. To avoid aerosolized medication coming in contact with the eyes, the Interchangeable Anti-Asphyxia Nebulizer Attachment Elbow should
NOT be used on the BiTrac Select MaxShield mask.
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.
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.
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac Select and Bilevel Compatible are
trademarks of Pulmodyne, Inc.
Latex Free
O at the mask is required.
2
Bayonet Lock References:
P
Single Patient Use
Caution: Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
Figure A.
Made in USA
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
Figure B. Figure C.
Medical Device
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