Pulmodyne BiTrac SE Select Bedienungsanleitung

Pulmodyne
Interchangeable
Standard Nebulizer
Attachment Elbow
22mm Female
2797
Latex Free
Single Patient Use
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
Interchangeable
Standard Nebulizer
Attachment Elbow
22mm Female
2797
Latex Free
Single Patient Use
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 Standard Nebulizer Attachment Elbow is an accessory to the BiTrac Select
Full Face Mask. 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
When NOT in use ensure the nebulizer adapter port is sealed.
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 humidity up to
95% non-condensing
EN-Medical Device
Bayonet Lock References:
P
Made in USA
®
Intended Use
The Interchangeable Standard Nebulizer Attachment Elbow is an accessory to the BiTrac Select
Full Face Mask. 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
When NOT in use ensure the nebulizer adapter port is sealed.
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 humidity up to
95% non-condensing
EN-Medical Device
Bayonet Lock References:
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 for a nebulizer treatment 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 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 designed circuit.
4. This device is designed to be used only in conjunction with a BiTrac Select Full
Face Interchangeable Elbow compatible mask.
5. To avoid aerosolized medication coming in contact with the eyes, the
Interchangeable Standard Nebulizer Attachment Elbow should NOT be used on
the BiTrac Select Max Shield mask.
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.
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 for a nebulizer treatment 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 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 designed circuit.
4. This device is designed to be used only in conjunction with a BiTrac Select Full
Face Interchangeable Elbow compatible mask.
5. To avoid aerosolized medication coming in contact with the eyes, the
Interchangeable Standard Nebulizer Attachment Elbow should NOT be used on
the BiTrac Select Max Shield mask.
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.
Figure A.
Figure B. Figure C.
Figure B. Figure C.
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