LKC TECHNOLOGIES RETeval - Emissions, Immunity, and RF Guidance

Regulatory and Safety Information
RET eval Device User Manual 90
• WARNING: To avoid the risk of electric shock, avoid accidental contact between an
electrode connected to the RET eval and other conductive parts (e.g., metal) before
applying the electrode to the patient. For example, connect electrodes to the patient
before plugging them into the RET eval or use Sensor Strip electrodes.
• Input overload can occur in proximity to defibrillator or electrocautery devices.
• The eyecup should be cleaned after each patient.
• This device is not protected against the ingress of water and should not be used in the
presence of liquids which may enter the device.
• This device is not suitable for use in the presence of a flammable anesthetic mixture of
air, or with oxygen or nitrous oxide.
• Do not connect the RET eval device to the docking station while measuring a patient! This
will compromise the quality of recordings and subject isolation.
• Do not modify this equipment without authorization of the manufacturer.
• Do not use batteries from other sources, as it may result in a hazard such as excessive
temperatures, fire, or explosion.
• Do not use the device in direct sunlight. Strong ambient light may affect results.
• Use only the provided power brick with this device. The power brick provided is a 5 VDC
1.2 A medical grade power supply, part number GTM41076-0605, made by GlobTek Inc.
• To simultaneously disconnect all mains supply, remove the power brick from the mains
outlet.
• Only connect the RET eval device to PCs that have passed the safety standard for
information technology equipment IEC 60950-1, EN 60950-1, UL 60950-1 to ensure the
safety of the USB electrical connection.
Electromagnetic compatibility (EMC)
The RET eval device should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the device should be observed to verify normal operation
in the configuration in which it will be used.
WARNING: Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation. Use
of most commercial electrodes with leads 1 meter or less long should work.
Guidance and Manufacturer’s Declaration – Emissions
The RET eval device is intended for use in the electromagnetic environment specified below.
The customer or user of the RET eval device should ensure that it is used in such an environment.