Pulmodyne BiTrac SE Select Bedienungsanleitung

Interchangeable
Standard 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.
Interchangeable
Standard 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 Standard Elbow is an accessory to the BiTrac Select™ Full Face
Mask and BiTrac MaxShield Select™ 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.
Contraindications
Warnings
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 Select is a Trademark
of Pulmodyne Inc.
®
Intended Use
The Interchangeable Standard Elbow is an accessory to the BiTrac Select™ Full Face
Mask and BiTrac MaxShield Select™ 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.
Contraindications
Warnings
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 Select is a Trademark
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. Use only with a ventilator equipped with adequate alarms and safety systems for
ventilator failure. This mask does not include an anti-asphyxia valve that would
allow a patient to breathe if the ventilator failed.
2. 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.
3. This device is designed to be used only in conjunction with a BiTrac Select Full
Face or BiTrac MaxShield 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.
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. Use only with a ventilator equipped with adequate alarms and safety systems for
ventilator failure. This mask does not include an anti-asphyxia valve that would
allow a patient to breathe if the ventilator failed.
2. 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.
3. This device is designed to be used only in conjunction with a BiTrac Select Full
Face or BiTrac MaxShield 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.
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 B. 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 B. Figure C.
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