Pulmodyne BiTrac Select Bedienungsanleitung

BiTrac Select
Full Face Mask with
Anti-Asphyxia
With Leak Elbow
22mm Female
Interchangeable Elbow
Compatible
Single Patient Use
2797
Latex Free
Caution:
Federal Law (USA) restricts this device to sale
by or on the order of a licensed physician.
Operating Specifications: 5°C to 40°C
at humidity range of 15% to 95%
Storage Specifications: -20°C to 60°C at
reltive humidity up to 95% non-condensing
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Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
Pulmodyne is a registered trademark of Pulmodyne, Inc. BiTrac MaxShield
and Bilevel Compatible are trademarks of Pulmodyne, Inc.
Intended Use
The BiTrac Full Face Mask is an accessory for use with CPAP or Bilevel systems
Obstructive Sleep Apnea (OSA) and/or ventilatory support. A minimum of >3.0cm of H2O at the mask is required.
Contraindications
1) This device should not be used on uncooperative or unresponsive patients.
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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. This mask does have an integral leak port; therefore a seperate exhalation device is not required.
2. This device is not suitable for providing life support ventilation.
3. Any unusual chest discomfort, shortness of breath, stomach distension, belching, severe headache, drying eyes, eye
pain, eye infections or blurred vision when receiving positive airway pressure or upon awakening should be reported
to the clinician.
4. To minimize risks of vomiting during sleep, avoid eating or drinking for three (3) hours before use.
5. If skin irritation develops, this may be due to excessive pressure or skin reaction or a combination of the two. Loosen
the headgear and/or try another mask or forehead pad size.
6. This CPAP mask should only be used with CPAP systems recommended by your physician or respiratory therapist.
A mask should not be used unless the CPAP system is turned ON and operating properly. The vent hole or holes
associated with the mask should never be blocked.
Explanation of the Warning: CPAP systems are intended to be used with special masks with connectors which have
vent holes to allow continuous flow of air out of the mask. When the CPAP machine is turned on and functioning
properly, new air from the CPAP machine flushes the exhaled air out through the attached mask exhalation port.
However, when the CPAP machine is not operating, enough fresh air will not be provided through the mask, and
exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances
lead to suffocation. This warning applies to most models of CPAP systems.
Before Use
Verify entrainment valve function on anti-asphyxia elbow:
• W ith the unit turned OFF, the entrainment valve flap should be open, allowing user to breathe room air.
• 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 mask.
• Do not block the opening on the entrainment valve.
• 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 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:
Medical Device
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Made in USA
used in the treatment of Adult
Figure A.
Figure B.
Figure C.
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