Intended Use
The Interchangeable Anti-Asphyxia with Leak Elbow is an accessory to the BiTrac MaxShield
Select™ Pediatric Mask. A minimum pressure of >3.0cm of 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 taking medication which may cause vomiting.
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 designed to be used only in conjunction with a BiTrac MaxShield Select
Pediatric Interchangeable Elbow compatible mask.
Before Use
Verify entrainment valve function on Interchangeable Anti-Asphyxia Elbow
•
With the valve 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 elbow
• Check the 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:
1 of 15
Pediatric Interchangeable
Anti-Asphyxia
With Leak Elbow
22mm Male
Interchangeable Elbow
Compatible
2746C 07-01-2021
Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac
MaxShield Select are trademarks of Pulmodyne, Inc.
Made in USA
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
M
P
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
Latex Free
Single Patient Use
Made in USA
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
M
P
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
Latex Free
Single Patient Use
Pediatric Interchangeable
Anti-Asphyxia
With Leak Elbow
22mm Male
Interchangeble
Elbow Compatible
BiTrac MaxShield
Select
™
BiTrac MaxShield
Select
™
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 A.
Figure B.
Figure C.
Intended Use
The Interchangeable Anti-Asphyxia with Leak Elbow is an accessory to the BiTrac MaxShield
Select™ Pediatric Mask. A minimum pressure of >3.0cm of 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 taking medication which may cause vomiting.
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 designed to be used only in conjunction with a BiTrac MaxShield Select
Pediatric Interchangeable Elbow compatible mask.
Before Use
Verify entrainment valve function on Interchangeable Anti-Asphyxia Elbow
•
With the valve 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 elbow
• Check the 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:
1 of 15
Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac
MaxShield Select are trademarks of Pulmodyne, Inc.
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 A.
Figure B.
Figure C.
Medical Device
Medical Device
2746C 07-01-2021
Summary of Contents for BiTrac MaxShield Select
Page 15: ...Notes 15 of 15 Notes 15 of 15 ...
