BiTrac MaxShield Select™
Pediatric Interchangeable Standard
Elbow 22mm Female
Latex Free
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 MaxShield Select is a
Trademark of Pulmodyne Inc.
BiTrac MaxShield Select™
Pediatric Interchangeable Standard
Elbow 22mm Female
Latex Free
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 MaxShield Select is a
Trademark of Pulmodyne Inc.
®
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
Medical Device
Single Patient Use
P
Made in USA
®
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
Medical Device
Single Patient Use
P
Made in USA
Intended Use
The Interchangeable Standard Elbow is an accessory to the BiTrac MaxShield
Select™Pediatric Mask.
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 medication which may cause vomiting.
Warnings
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 MaxShield Select
Pediatric Interchangeable Elbow compatible 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.
Bayonet Lock References:
Figure B.
Figure A.
Intended Use
The Interchangeable Standard Elbow is an accessory to the BiTrac MaxShield Select™
Pediatric Mask.
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 medication which may cause vomiting.
Warnings
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 MaxShield Select
Pediatric Interchangeable Elbow compatible 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.
Bayonet Lock References:
Figure B.
Figure A.
Figure C.
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Figure C.
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