Pulmodyne BiTrac Select Guia De Inicio Rapido

BiTrac Select™
Interchangeable
Standard 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
Pulmodyne is a registered trademark of Pulmodyne, Inc.
BiTrac Select and BiTrac Select MaxShield are trademarks of
Pulmodyne, Inc.
BiTrac Select™
Interchangeable
Standard 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
Pulmodyne is a registered trademark of Pulmodyne, Inc.
BiTrac Select and BiTrac Select MaxShield are trademarks of
Pulmodyne, Inc.
Intended Use
The Interchangeable Standard Bronchoscopy Elbow is an accessory to the BiTrac Select Full
Face Mask and the BiTrac Select MaxShield™ 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.
Note
The Interchangeable Standard Bronchoscopy Elbow is a temporary use elbow for use only
during a bronchoschopy procedure.
Contraindications
Warnings
Operating Specifications:
5°C to 40°C at humidity range
of 15% to 95%
Storage Specifications:
-20°C to 60°C at relative Use of Interchangeable Elbow Feature:
humidity up to 95% non-
condensing
Bayonet Lock References:
EN-Medical Device
P
Made in USA
Intended Use
The Interchangeable Standard Bronchoscopy Elbow is an accessory to the BiTrac Select Full
Face Mask and the BiTrac Select MaxShield™ 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.
Note
The Interchangeable Standard Bronchoscopy Elbow is a temporary use elbow for use only
during a bronchoschopy procedure.
Contraindications
Warnings
Operating Specifications:
5°C to 40°C at humidity range
of 15% to 95%
Storage Specifications:
-20°C to 60°C at relative Use of Interchangeable Elbow Feature:
humidity up to 95% non-
condensing
Bayonet Lock References:
EN-Medical Device
P
Made in USA
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 elbow should be used only during a bronchoscopy procedure while in the
presence of trained medical personnel.
2. Use only with a ventilator equipped with adequate alarms and safety systems for
ventilator failure. This elbow does not include an anti-asphyxia valve that would
allow a patient to breathe if the ventilator failed.
3. This elbow 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 designed circuit.
4. This device is designed to be used only in conjunction with a BiTrac Select Full
Face or BiTrac MaxShield Select Interchangeable Elbow compatible mask.
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 elbow should be used only during a bronchoscopy procedure while in the
presence of trained medical personnel.
2. Use only with a ventilator equipped with adequate alarms and safety systems for
ventilator failure. This elbow does not include an anti-asphyxia valve that would
allow a patient to breathe if the ventilator failed.
3. This elbow 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 designed circuit.
4. This device is designed to be used only in conjunction with a BiTrac Select Full
Face or BiTrac MaxShield Select Interchangeable Elbow compatible mask.
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 A.
Figure C.
Figure B. Figure C.
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