Pulmodyne BiTrac MaxShield Select Instrucciones De Uso página 2

Intended Use
The BiTrac MaxShield Select™ mask is an accessory for use with CPAP or Bilevel systems for ventilatory support. A minimum of
>3.0cm of H 0 at the mask is required.
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Contraindications
1. This device should not be used on uncooperative or unresponsive patients.
2. This device may not be suitable for use on patients taking medication which may cause vomiting, have 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 has an integral leak port that provides a continuous leak path in the patient circuit. It
is recommended that the circuit have an additional exhalation device. You may need to adjust
the pressure level and oxygen therapy to compensate for the additional leak of the exhalation
device.
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.
Acheiving the Proper Fit:
1. Use the size guide to measure the size of the patients face.
2. The inside cushion should rest above the eyebrow and directly below the bottom lip. Refer to Figure 1.
3. When the correct size is acheived place the proper size mask on the patient.
4. Place mask on patients face, and pull the bonnet overhead.
5. Clip the mask into place and adjust the straps. Refer to Figure 2.
6. Continue with CPAP therapy per your protocols.
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:
Fitting Guide References:
XXS
Figure 1
Figure A.
Figure 2
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
Figure B.
XS
Figure 1
XS
XXS
Figure C.
Figure 2