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3001002 Rev. P
Section 1 Indications, Warnings and Cautions
General Indications & Contraindications.
Primary Indications:
Precision Flow® is intended for use to add warm moisture to breathing gases from an external
source for administration to a neonate/infant, pediatric and adult patients in the hospital,
subacute institutions, and home settings. It adds heat and moisture to a blended medical air/
oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral
oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Contraindications:
General:
Any situations in which humidification is contra-indicated (see American Association of
Respiratory Care Clinical Practice Guidelines).
Specific to Nasal Cannula:
Patients with occluded or defective nares should not use the system.
Warnings and Cautions
A
Warning
indicates that a situation may occur which is potentially harmful to the patient or user.
A
Caution
indicates a condition that may lead to equipment damage, malfunction, or
inaccurate operation. A Note indicates a point of emphasis to make operation more efficient or
convenient.
Please take the time to familiarize yourself with the warnings, cautions, and notes listed in this
manual. They cover safety considerations, special requirements, and regulations.
The user of this product shall have sole responsibility for any malfunction due to operation
or maintenance performed by anyone not trained by Vapotherm staff or official training
documentation.
When handling any part of the Precision Flow®, always follow hospital infection control
guidelines and Standard Precautions. Vapotherm also recommends that users follow the
Centers for Disease Control (CDC) publications: Guidelines for Maintenance of In-Use
Respiratory Therapy Equipment and Guidelines for Prevention of Nosocomial Pneumonia.
General Warnings
Federal Law (U.S.) restricts the sale of this device to, or by the order of any physician. This
device should be used ONLY by a trained operator.
This is a humidification device generally used for providing continuous flows of breathing gas.The
Precision Flow™ is not a ventilator and should not be used as life support.
Oxygen supports combustion; this device should not be used near or around open flames, oil, or
grease, or flammables.
Service on the device should only be performed by qualified, certified service technicians.
To prevent injury, do not attempt to do any service to the Precision Flow® while a patient is
connected to the device.
If the device is damaged or not working properly, do not use. Contact Vapotherm or your
authorized Vapotherm representative.
Do not operate if power cord is damaged.
The device should not be turned on and left unattended if not on a patient.
Do not use the Precision Flow® in or around water, other than the water bag that feeds the
system.
Prior to use, the Precision Flow® should be positioned and secured to a sturdy IV pole with the
base of the unit no more than 40” (102cm) above the floor to reduce risk of tipping.
