LKC TECHNOLOGIES RETeval - Operational Precautions and EMC

Regulatory and Safety Information
RET eval Device User Manual 89
Contact your distributor or LKC if changes in performance are noted.
Essential performance
The RET eval device is neither life supporting nor life sustaining nor is it a primary diagnostic
device, its function is to aid a physician in making a diagnosis in combination with other data and
in light of the physician’s knowledge and experience, as such the RET eval device has no Essential
Performance as pertains to risk.
Operating environment
Temperature: 10
o
C – 35
o
C (50
o
F – 95
o
F)
Humidity: 10% – 90% non-condensing
Air pressure: 62 kPa – 106 kPa (-80 m / -260 feet – 4000 m / 13,000 feet)
Lifetime
The lifetime of the device is 7 years or 10,000 test protocols performed, whichever comes first.
The manufacture date of the device can be found on the device labels. The number of protocols
performed will appear on the System / Settings / About screen beginning after the first 200
protocols have been performed.
LKC will service RET eval devices that are within their lifetime. Firmware updates and support
may require an annual subscription service after the initial one year warranty period.
The expected battery life is at least 1 year. If the RET eval device fails to hold a charge, a new
battery can be ordered.
Sensor Strips are single use only. Sensor Strips are not to be reused because (1) they may not
stick well upon reuse, causing an excessively high electrode impedance and therefore noisy
results, and (2) the biological risk associated with reuse across patients has not been analyzed.
Precautions
• All servicing of this equipment is to be performed by LKC Technologies, Inc. or by a center
approved by LKC Technologies, Inc.
• Medical Electrical Equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the EMC
information provided herein.
• Portable and mobile RF communications equipment can affect RET eval performance.
• Do not connect the patient to a high frequency (HF) surgical equipment
simultaneously with the RET eval , as it may result in burns at the site of the electrodes
and may damage the RET eval .
• Operation of the RET eval in close proximity to a shortwave or microwave therapy
equipment may produce instability in the RET eval recordings.