Transonic HT331-FT - Warnings & Precautions

AU-OPR-AureFloFT-EN,
Rev H
v
Warnings & Precautions
√ The AureFlo
®
System is intended for the measurement of blood or liquid volume ow with Transonic
®
Perivascular Flowprobes in adult and pediatric patients:
● on non-aerated synthetic vessel grafts
● where surgery is medically indicated
● on major and peripheral arteries, veins and ducts
● at intraoperative sites which admit and retain ultrasonic couplant
● with minimal vessel manipulation or constriction (to avoid vessel spasm)
● where application does not unnecessarily lengthen surgical procedure
● for the measurement of blood volume ow with Clamp-on Flowsensors
● on exible tubing specic to the Flowsensor (never on arteries, veins)
● for non-aerated media which are transparent to ultrasound
Transonic Systems Inc.
®
disclaims responsibility for all other uses, and the user agrees to assume liability for
damages resulting from non-intended use or operator-error by the User or User’s associates.
√ The HT300 (-FT) Series Compatible Surgical Flowmeter and AureFlo
®
Monitor are intended for use only with
Transonic
®
Perivascular Flowprobes and Flowsensors designated for HT300 (-FT) Series Compatible Flowmeters.
AureFlo
®
system is intended to be used with a printer that is powered off the supplied DC patient isolation
transformer.
√ The AureFlo
®
System is not intended for use as the sole basis for diagnosis.
√ Rx Prescription Device: Federal law (USA) restricts this device to sale or use by or on the order of a physician.
√ To prevent unintended burns when using high frequency (HF) surgical equipment such as a electo-cautery device
or Bovie, keep the Flowprobe away from the grounding pad(s).
√ The HT300 (-FT) Series Compatible Surgical Flowmeter and AureFlo
®
Cart are IEC 60601 Class 1 instruments. Only
power cords supplied by Transonic
®
should be used.
√ The AureFlo
®
System should be positioned in such a manner as to provide unobstructed access to the power cord
connection.
√ To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective
earth.
√ Use only Transonic
®
approved accessories, cables or sensors. The use of non-Transonic approved accessories could
result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and
result in improper operation.
√ This equipment can be used anywhere in any hospital or clinic except near active HF surgical equipment or the
RF shielded room of an MRI magnetic imaging system where the intensity of EM disturbances is high.
√ If this equipment does come into range of high levels of EM disturbances the meter may:
● display incorrect ow values
● momentarily stop working and restart at the same volume reading on the meter
● stop working and need to be turned off and on again (very rare occurrence)
√ Safe and effective use of the Transonic
®
HT300 (-FT) Series Compatible Surgical Flowmeter depends on correct
application technique, adequate precaution and readiness for emergencies.
√ The AureFlo
®
Monitor, HT300 (-FT) Series Compatible Surgical Flowmeter and Transonic
®
Flowsensors are fragile.
They must be transported and stored at temperatures ranging from -10ºC to 50ºC.
√ Transonic
®
Perivascular Flowprobes may be used in pericardiac applications such as ascending aorta and
coronary graft ow measurement, but are neither designed nor approved for intracardiac ow measurement.
√ If the Flowprobes are used in patients suspected of having Creutzfeldt-Jakob or other prion diseases they should
be handled according to procedures given in the World Health Organization’s Guidelines.