Pulmodyne BiTrac Select Bedienungsanleitung

Interchangeable
Anti-Asphyxia
With Leak Elbow
22mm Female
Pulmodyne Inc.
M
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
2797
*European Union
EN-Medical Device
Latex Free
Caution:
Federal Law (USA) restricts this device to sale by
or on the order of a licensed physician.
Interchangeable
Anti-Asphyxia
With Leak Elbow
22mm Female
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
2797
*European Union
EN-Medical Device
Latex Free
Caution:
Federal Law (USA) restricts this device to sale by
or on the order of a licensed physician.
Intended Use
The Interchangeable Anti-Asphyxia with Leak Elbow is an accessory to the BiTrac Select™
Full Face Mask and BiTrac MaxShield™ Mask. Use of the elbow with these masks is an
accessory for use with CPAP and Bilevel systems used in the treatment of adult Obstructive
Sleep Apnea (OSA) and/or ventilator support. A minimum pressure of >3.0cm of H
mask is required.
Contraindications
Warnings
Before Use
Verify entrainment valve function on Interchangeable Anti-Asphyxia Elbow
P
Use of Interchangeable Elbow Feature:
Bayonet Lock References:
Single Patient Use
Made in USA
Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac Select and
BiTrac Select MaxShield are trademarks of Pulmodyne, Inc.
Intended Use
The Interchangeable Anti-Asphyxia with Leak Elbow is an accessory to the BiTrac Select™
Full Face Mask and BiTrac MaxShield™ Mask. Use of the elbow with these masks is an
accessory for use with CPAP and Bilevel systems used in the treatment of adult Obstructive
Sleep Apnea (OSA) and/or ventilator support. A minimum pressure of >3.0cm of H
mask is required.
Contraindications
Warnings
Before Use
Verify entrainment valve function on Interchangeable Anti-Asphyxia Elbow
P
Use of Interchangeable Elbow Feature:
Bayonet Lock References:
Single Patient Use
Made in USA
Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac Se-
lect and BiTrac Select MaxShield are trademarks of Pulmodyne, Inc.
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.
1. This mask does have an integral leak port; therefore a separate exhalation device is
not required.
2. This device is designed to be used only in conjunction with a BiTrac Select Full
Face or BiTrac MaxShield Interchangeable Elbow compatible mask.
• 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
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.
Figure B.
Figure A.
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.
1. This mask does have an integral leak port; therefore a separate exhalation device is
not required.
2. This device is designed to be used only in conjunction with a BiTrac Select Full
Face or BiTrac MaxShield Interchangeable Elbow compatible mask.
• 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
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.
Figure B.
Figure A.
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%
Figure C.
non-condensing
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%
Figure C.
non-condensing
O at the
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O at the
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