natus XLTEK Protektor32, Instructions For Use Manual

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XLTEK Protektor32 Instructions for Use
7
Safety Information
The Protektor32 System is intended for use ONLY by qualified individuals who have received training
on this device. Read carefully this manual and make sure you fully understand all warnings and
cautions , and the procedures to follow before operating the Protektor32 system.
For
TcMEP
specific
warnings
and
cautions,
refer to the section
“Using the TcMEP Module on
Protektor 32” in this manual.
Critical Warnings and Cautions
The Protektor32 is intended for use ONLY by qualified individuals who have received
training on this device. This user/service manual should be read and understood fully
before commencing use of the product.
Use of the Protektor32 high-current stimulator for transcranial stimulation can cause bite-
related injury. It is imperative that effective preventative measures be implemented
BEFORE using the device for this purpose.
General Warnings
It is the responsibility of the institution where the Protektor32 unit is installed to ensure that
the requirements of I
EC60601.1.1-M92 - Collateral Standard: Safety Requirements for
Medical Electrical Systems are fulfilled in the particular installation.
Non-medical electrical equipment (printers and computers) complying with the appropriate
IEC or ISO safety standards may be directly connected to the Protektor32 serial and
network ports for data-transfer functions only if both the Protektor32 and the equipment are
outside of the patient environment and no patient-applied parts are connected to the
patient.
For further details on how to comply with this standard regarding non-
Xltek supplied
printers or VGA monitors, please consult the standard or contact Xltek Technical Support
at 1-800-303-0306 or OTS@natus.com .
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Connecting electrical equipment to a MULTIPLE SOCKET OUTLET (MSO) effectively
leads to creating a MEDICAL ELECTRICAL (ME) SYSTEM and the result can be a
reduced level of safety. For the requirements that are applicable to an ME SYSTEM,
please refer to IEC 60601-1 Ed. 3.1.
Connection of a patient to high-frequency surgical equipment (electrocautery) and to an
electromyograph or evoked response equipment simultaneously may result in burns at the
site of the electrical stimulator or biopotential input part electrodes and possible damage to
the electrical stimulator or biological amplifiers.