Pulmodyne BiTrac Select MaxShield Guia De Inicio Rapido

BiTrac Select MaxShield
MaxShield Mask with
Anti-Asphyxia
Elbow 22mm Female
Interchangeable Elbow Compatible
Single Patient Use
Latex Free
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
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
is a trademark of Pulmodyne, Inc.
Intended Use
The Pulmodyne BiTrac MaxShield mask is an accessory for use with CPAP or Bilevel systems for ventilatory support. A minimum pressure of >
3.0cm H 2 O at the mask is required.
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, have
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nocturnal vomiting, hiatal hernia or impaired cardiac sphincter function.
3) This mask may not be suitable for use on patients with the following conditions: glaucoma, recent eye surgery or dry eyes.
Warnings
1) 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 designated circuit.
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) Make sure the mask and headgear are the correct size for the patient's face. If excessive discomfort is experienced, adjust the mask and
head gear. If the discomfort continues, consider an alternative mask.
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:
• With 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
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excessive force.
Bayonet Lock References:
Made in USA
EN-Medical Device
Figure A. Figure B. Figure C.