Warnings - Sentec IPV 1 Instruction Manual

Warnings

A WARNING indicates the possibility of injury, death, or other serious adverse reaction
associated with the use or misuse of the device.
General Warnings
Alteration/Assembly
Before Using
Equipment
Breathing Circuits
Patient Interface
Guidelines
Infection Control
Pre-Use Checks
Setup
Residual Risk/
Information to the
Patient
4
• Before use, read the instruction manual.
• The IPV® 1 system shall not be used as a life support device.
Supplemental oxygen must be prescribed for patients for whom it is
indicated, and the O2 saturations should be monitored.
• An IPV® treatment mobilizes secretions. Drainage techniques (such
as controlled coughing) are particularly important for patients with
reduced ability to spontaneously cough.
• Do not use with uncooperative patients.
• The intended user must continue to monitor the patient for
progression of symptoms and re-evaluate the indications for therapy.
• For neonates, use higher frequencies and carefully adjust amplitude
from zero to desired effect. Always monitor neonates and young
children during treatment.
Carefully follow assembly instructions outlined in this instruction manual.
Assembly deviation/alteration could cause the IPV® 1 to malfunction.
The IPV® 1 system cannot be used in an MRI environment.
Before activating the IPV® 1, be sure to complete pre-checks to ensure
proper operation.
Do not substitute any other breathing circuit for the Phasitron® 5 UC
breathing circuit. Do not change the configuration of the breathing circuit.
The Phasitron® 5 UC breathing circuit is specifically designed for use with
the IPV® 1. Do not use any third-party circuits as their use has not been
tested by Percussionaire; performance and safety cannot be guaranteed.
Do not use a mouthpiece during IPV® 1 therapy for patients less than five
years of age. Make sure mask is appropriately sized, covering mouth and
nose but not the eyes, and not overlapping the chin.
Instructions in the manual are suggested guidelines for trained respiratory
therapists and clinicians working under a supervising physician.
Carefully select settings based on clinical judgment, the needs of the
patient, and the benefits, limitations, and characteristics of IPV® 1. Always
follow hospital or institutional protocols.
Dirty or contaminated equipment is a potential source of infection. Never
attempt to reuse single-patient components or accessories between
patients. The Phasitron® 5 UC breathing circuit is single patient. Replace the
entire circuit when it cannot be clean "as new. "
Complete pre-use checks before starting therapy on a patient. Do not use
the device if any problems are noted. Contact a qualified service
technician. Failure to comply could cause injury or death to the patient.
Ensure the patient circuit is oriented correctly. Carefully follow setup
directions given in the instructions for use.
The patient must notify the physician and the RN (Registered Nurse) or
the RRT (Registered Respiratory Therapist) if they experience increased
shortness of breath; significant changes in heart rate or rhythm, blood
pressure, or skin color; marked diaphoresis; fatigue; or emesis.