Indications For Use - Pulmodyne AccuPAP Instrucciones De Uso

DESCRIPTION:
The AccuPAP Positive Airway Pressure therapy system is a non-sterile Single Patient Use, respiratory therapy device. The AccuPAP Positive Airway
Pressure therapy system has the ability to provide supplemental oxygen when supplied by compressed oxygen.
The AccuPAP system consists of:
1. Positive Airway Pressure Device
• Ambient air entrainment orifice
• Supply gas inlet connection
• Pressure monitoring port with cap
2. Patient interface - mouthpiece
3. 7 foot supply tubing for connecting the AccuPAP to the source gas.

INDICATIONS FOR USE:

The AccuPAP is a Positive Airway Pressure therapy system that is indicated for the prevention
or reversal of atelectasis. The AccuPAP Positive Airway Pressure therapy system is for patients who are capable of following directions. It may also
be used to optimize delivery of
aerosolized medication when utilized with a small volume nebulizer.
CONTRAINDICATIONS:
Although no absolute contraindications to the use of PAP Therapy have been reported, the
following should be carefully evaluated before a decision is made to initiate therapy:
• Inability to tolerate increased work of breathing
• Intracranial pressure (ICP) >20mm Hg
• Recent facial, oral or skull surgery or trauma
• Esophageal surgery
• Untreated pneumothorax
• Known or suspected tympanic membrane rupture or other middle ear pathology
• Hemodynamic instability
• Acute sinusitis
• Epistaxis
• Active hemoptysis
• Nausea
WARNINGS:
1. Use of this device at excessive pressures may have adverse effects. Expert clinical judgment should be exercised in the selection of
settings for each individual patient.
2. DO NOT OCCLUDE AMBIENT AIR ENTRAINMENT ORIFICE.
3. DO NOT EXCEED 15 LPM GAS INPUT.
Adverse reactions may include:
Increased work of breathing that may lead to hypoventilation and
hypercarbia; increased cranial pressure; cardiovascular compromise; myocardial ischemia;
decreased venous return; air swallowing with increased risk of vomiting and aspiration;
claustrophobia; skin break down and discomfort if used in conjunction with a mask; and
pulmonary barotrauma.
PRECAUTIONS:
1. DO NOT AUTOCLAVE.
2. DO NOT IMMERSE COMPLETELY IN ANY LIQUID.
3. DO NOT DISASSEMBLE EXCEPT FOR MOUTHPIECE OR TUBING.
INSTRUCTIONS FOR USE:
1. Set-up:
a. Connect one end of tubing (supplied with the device) to a 0-15 LPM flow meter that is connected to a 50-60 psi regulated medical air or
oxygen (if prescribed) supply source.
b. Connect the other end of the tubing to the device's supply gas inlet connection.
c. If pressure monitoring is not being done, seal port with attached pressure monitoring port cap.
d. Attach the mouthpiece to the rounded patient interface end of the device.
2. Initial Flow Meter Setting:
a. Instruct the patient to relax while performing diaphragmatic breathing.
b. Set initial flow rate to 8 LPM on the air or oxygen supply source flow meter. Adjust flow meter to desired level as needed.
c. Set the desired airway pressure to the desired expiratory airway pressure.
d. Place mouthpiece in patient's mouth and instruct patient to breathe easily against the pressure from the device.
e. Slow inhalations and exhalations by the patient will maintain adequate airway pressure during the breathing cycle.
f. Maintain breathing through the AccuPAP Positive Airway Pressure Therapy System to accomplish clinical goals.
g. Several repetitions may be needed to ensure that individual patient needs are being met.
3. AccuPAP Procedure:
a. Ensure the flow meter is set as identified in previous steps.
b. If tolerated, have patient sit with elbows resting comfortably on table.
c. Place mouthpiece lightly into mouth.
• Be sure patient maintains a tight seal on the mouthpiece during therapy.
• Recommend the use of a nose clip, if necessary.
d. Instruct the patient to breathe diaphragmatically.
e. Perform breathing through the device as recommended. AccuPAP Positive Airway Pressure Therapy System is intended to be used on an
intermittent basis (not for prolonged periods of time).
f. Repeat steps b to e as prescribed.