Pulmodyne BiTrac Select Guia De Inicio Rapido

Interchangeable
Anti-Asphyxia
Bronchoscopy Elbow
22mm Female
Single Patient Use
2797
Caution:
Federal Law (USA) restricts this device
to sale by or on the order of a licensed physician.
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.Pulmodyne.com
Interchangeable
Anti-Asphyxia
Bronchoscopy Elbow
22mm Female
Single Patient Use
2797
Caution:
Federal Law (USA) restricts this device
to sale by or on the order of a licensed physician.
M
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.Pulmodyne.com
Intended Use
The Interchangeable Anti-Asphyxia Bronchoscopy Elbow is an accessory to the BiTrac Select Full Face
Mask, which allows CPAP and Bilevel therapy to be delivered to the patient during a bronchoscopy
procedure. Use of this 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
Note
The Interchangeable Anti-Asphyxia Bronchoscopy Elbow is a temporary use elbow for use only during a
bronchoschopy procedure.
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
Warnings
1. This elbow should be used only during a Bronchoscopy procedure while in the presence of
2. This elbow does not have an integral leak port; therefore a separate exhalation device must be
3. This device is designed to be used only in conjunction with a BiTrac Select Full Face
Before Use
Verify entrainment valve function on Interchangeable Anti-asphyxia Bronchoscopy Elbow.
• With the unit turned OFF; the entrainment valve flap should be open, allowing user to
breathe room air
EN-Medical Device • 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 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
2. Gently pull the elbow from the mask. (Refer to Figure C.)
3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter
P
Bayonet Lock References:
Made in USA
Figure A.
Intended Use
The Interchangeable Anti-Asphyxia Bronchoscopy Elbow is an accessory to the BiTrac Select Full Face
Mask, which allows CPAP and Bilevel therapy to be delivered to the patient during a bronchoscopy
procedure. Use of this 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
Note
The Interchangeable Anti-Asphyxia Bronchoscopy Elbow is a temporary use elbow for use only during a
bronchoschopy procedure.
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
Warnings
1. This elbow should be used only during a Bronchoscopy procedure while in the presence of
2. This elbow does not have an integral leak port; therefore a separate exhalation device must be
3. This device is designed to be used only in conjunction with a BiTrac Select Full Face
Before Use
Verify entrainment valve function on Interchangeable Anti-asphyxia Bronchoscopy Elbow.
• With the unit turned OFF; the entrainment valve flap should be open, allowing user to
• Turn CPAP or Bilevel unit ON
EN-Medical Device
• 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 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
2. Gently pull the elbow from the mask. (Refer to Figure C.)
3. Gently press the desired Interchangeable Compatible Elbow into the mask adapter
P
Bayonet Lock References:
Made in USA
Figure A.
O at the mask is required.
2
medication which may cause vomiting.
trained medical personnel.
part of the circuit. Utilize the equipment manufacturer's recommended exhalation
port in the designed circuit.
Interchangeable Elbow compatible mask.
the elbow counter clockwise to disengage the bayonet lock (Refer to Figure B.)
ring and turn clockwise until fully seated. Do not use excessive force.
Figure B.
O at the mask is required.
2
medication which may cause vomiting.
trained medical personnel.
part of the circuit. Utilize the equipment manufacturer's recommended exhalation
port in the designed circuit.
Interchangeable Elbow compatible mask.
breathe room air
the elbow counter clockwise to disengage the bayonet lock (Refer to Figure B.)
ring and turn clockwise until fully seated. Do not use excessive force.
Figure B.
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 C.
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 C.
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