Pulmodyne BiTrac SE MaxShield Select Guia De Inicio Rapido

BiTrac SE
MaxShield Select
Pediatric Mask
with Standard Elbow
22mm Female
Interchangeable Elbow
Compatible
Single Patient Use
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
For more information regarding our trademarks
visit: www.pulmodyne.com/ip
Intended Use
The BiTrac SE MaxShield Select™ mask is an accessory for use with CPAP or Bilevel systems for ventilatory support.
Contraindications
TM
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. 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
Latex Free
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.
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
Made in USA
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.
Fitting Guide References:
Figure 1
Bayonet Lock References:
Figure A.
XXS
Figure 2
XXS
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. Figure C.
XS
Figure 1
Figure 2
XS