Pulmodyne BiTrac Vented Guia De Inicio Rapido

Intended use: The full face mask is an accessory for use with CPAP or Bilevel systems used in the treatment of adult Obstructive
Sleep Apnea (OSA) and/or ventilatory support. A minimum pressure of >3.0cm H
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 currently taking medication which may
cause vomiting.
Warnings:
1. This mask and vented swivel elbow has an integral leak port; therefore a separate exhalation device is not needed.
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 head
strap and/or try another mask or forehad pad size. Skin reaction may also be due to cleanliness. Refer to the cleaning instructions.
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.
Full Face Mask Discomforts and Corrective Actions:
The problems listed below may be indications that your mask needs to be replaced. You should seek the assistance of your dealer
when you notice one or more of the following:
• The cushion begins to tear
• The mask feels uncomfortable
• The parts show signs of wear, discoloration or cracking
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 vented anti-asphyxia elbow
• Do no block the opening on the entrainment valve.
• Check valve before each use for malfunction or blockage caused by patient secretions.
0086
Single Patient Use
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
T: +1.317.246.5505
F: +1.317.246.5501
www.pulmodyne.com
P
Made in USA
Full Face Mask with
Vented Anti-Asphyxia
22mm Male
O at the mask is required.
2
Typical Exhaust Flow / Pressure Performance
Flow
(lpm)
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
Elbow
of the Vent Swivel Elbow
Pressure
(cmH O)
2
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