Pulmodyne BiTrac Select MaxShield Instrucciones De Uso página 2

Intended Use
The BiTrac MaxShield mask is an accessory for use with CPAP or Bilevel systems for ventilatory
support.
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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 unable to remove the mask or are 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. 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 designated circuit.
3. This device is not suitable for providing life support ventilation.
4. 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.
5. To minimize risks of vomiting during sleep, avoid eating or drinking for three (3) hours before use.
6. 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.
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:
Figur A. Figur B. Figur C.
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