REFA FAMILY USER MANUAL
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Limitations of use
2.2
Limitations of use
Under federal law (only applicable to the USA) this product may only be sold
by or on the order of a researcher or licensed practitioner.
The product may only be used under the constant supervision of or on the
instructions of a researcher or other authorized professional.
The product is NOT intended for:
critical patient monitoring
use in life support systems
The product is NOT to be:
used near MRI equipment
exposed to ionizing radiation
used on subjects undergoing electro surgery
used in oxygen rich environments (concentration > 25 % at 1 atm)
The product is NOT:
suitable for use in an inflammable mixture of anesthetics or agents and air,
oxygen or nitrous oxide
defibrillator proof
suitable for sterilization
Do not use, store or transport the product outside the specified environmental
conditions, this may damage the product.
Do not store or use in environments with Magnetic Resonance Imaging (MRI)
equipment, or equipment capable of emitting diagnostic levels of ionizing radiation.
Apart from the above, there are no contra-indications. There are no known side effects from the use of
this product.
Safety measures and warnings
2.3
Warnings
IEC60601-1 compliance is the responsibility of the end user. To ensure
compliance to IEC60601-1, the system must meet the following conditions:
The PC and peripherals (e.g. USB hubs) must comply with
IEC60950 or equivalent, and must be located outside the subject
environment (the subject environment is defined as the area
within 1.5 m (6 ft around and 7.5 ft above) of the subject;
AND
The enclosure leakage current from any device within the
subject environment, including any parts of equipment which
extend into that environment, is not more than 0.1 mA in normal
condition and 0.5 mA in single fault conditions.
The required low enclosure leakage current may be achieved by
powering the PC and peripherals from an isolation transformer.
It is not recommended that the equipment be connected to other
non-isolated monitoring equipment or communication networks.
In this event it is the end user's responsibility to ensure
compliance with IEC60601-1.
