3001002 Rev. P
Page 5
Section 1
Indications, Warnings and Cautions
Make sure all Disposable Patient Circuit connections have been properly secured.
The cartridge, disposable water path and delivery tube are labeled as
single patient use
only and
must be replaced after 30 days use on a single patient: do not attempt to sterilize or reuse and
follow all local and federal regulations for disposal. Outside the USA follow national or international
regulations.
Failure to utilize sterile water supply or clean gas supply may increase risk of bacterial contamination.
• Use aseptic technique.
• Gas supply must be clean dry medical grade gas to prevent harm to the patient and prevent
damage to the Precision Flow®
Precision Flow
®
is not a Continuous Positive Airway Pressure (CPAP) device.
There are no
controls to deliver or monitor airway pressure. Precision Flow® should not be used to deliver
pressure in a closed system.
Never connect the unit to a patient until it reaches set point temperature (temperature display stops
flashing). Allow the unit to warm-up to purge condensate and prevent patient discomfort due to cold
or partly humidified gas.
Additional patient monitoring is necessary if the Precision Flow® is used to give supplementary oxygen.
The Precision Flow
®
is not MRI compatible.
The unit is provided with a Hospital Grade power cord. Do not use any other cord.
Do not use
extension cords
. For grounding reliability, the cord
must
be connected to an equivalent receptacle
marked “Hospital Grade” or “Hospital Only”. If any doubt exists as to the grounding connection,
do
not
operate the device.
Medical electrical equipment needs special precautions regarding electromagnetic radiation. Portable
and mobile RF communications equipment can affect medical equipment and should not be used
near the Precision Flow
®
The back-up battery is designed for temporary use only, when AC power to the unit has been
interrupted. After the battery is fully discharged the device will not operate and patient gas flow will
cease. There are no alarms or display indicators after the battery has discharged. The battery is not
intended for patient transport.
General Cautions
Read and understand this manual prior to operating the system.
Clamp water supply when not in use, including Standby mode, to prevent damage by water ingress.
Aseptic techniques (including hand washing and avoiding touching connection points) and Standard
Precautions should always be followed when handling medical equipment. Standard Precautions
should always be followed when coming into contact with patients
Do not cover the unit; blocking the vent may damage the unit.
Do not:
• Immerse the Precision Flow
®
in water.
• Steam or gas sterilize the Precision Flow
®
.
• Wipe with bleach.
Flexible sterile water bags are recommended. If rigid or semi-rigid bottles are used, a Vapotherm
approved venting bottle cap must be used.
NOTE
: The Precision Flow
®
may be operated with limited performance at gas inlet pressures as low
as 4 psi (28 kPa). However, for the full specified range of gas flows and oxygen percentages, both
gas inlet pressures must be 40 psi (276 kPa) or above. Precision Flow has not been tested for use
in Field transport. When used with approved ancillary equipment the Precision Flow may be used for
transferring patients within the hosiptal.
