natus XLTEK Protektor32, Instructions For Use Manual

Page: 14 / 81

Instructions for Use XLTEK Protektor32
12
Only equipment approved to
IEC950
, IEC
60601-1
or a similar safety standard may be
connected to the VGA port on the Protektor32. The final system must be configured to meet
the requirements for safety of medical systems prescribed by IEC 60601-1-1 .
Exposure to excessive sound can cause temporary and even permanent hearing loss.
Long-term exposure to excessive light can cause temporary and even permanent changes
in visual acuity.
Patient electrical isolation is ensured when all peripherals (headphones, printer, goggles,
monitor) attached to the Protektor32 are
Xltek
-approved. The final system configuration
must meet the requirements of
IEC60601-1
for safety of medical systems.
If you choose to attach a VGA display other than the model supplied by
Xltek
, it MUST
either meet IEC
60601-1
or the leakage current requirements for your jurisdiction.
Protektor32 with the Electro-Surgical Units (ESU) – Guidelines
Follow the safety guidelines below to ensure proper use of Protektor 32 with the Electro-Surgical Unit.
Failing to follow these guidelines may result in skin burns to the patient, and /or damage to the Protektor
32 unit.
1. When ESU is active, keep the ESU pencil away from the Acquisition box and stimulation
electrodes.
2. Use as large as possible patient ground electrode connected to the Protektor32 ground input.
3. Do not place Protektor32 ground electrode(s) in close proximity to the ground return electrode for
the ESU. Do not connect the ESU ground electrode to the Protektor32 ground.
4. Ensure that the dispersive pad for the ESU has a good electrical contact with the patient.
Although certain ESUs have a mechanism for checking the quality of contact, always visually
inspect the dispersive pad to ensure that it is properly applied.
Do not activate the electrosurgical unit for extended periods of time, unless the ESU
electrode is in direct contact with the patient.
Output Waveforms
The output waves from the Protektor32 are required to electrically stimulate the patient and evoke a
response. These waves have no D.C. component and are limited to ±400V and 100 mA on the standard
electrical stimulators, ±500V and 1500mA on the TCeMEP stimulator, and ±10V and 40mA on the
surgical probe stimulators. Since there is no D.C. component to the output, there are no specific
precautions which need to be taken with regard to a D.C. component.
If the load impedance exceeds the voltage limit for a given current, the stimulation output is attenuated in
proportion to the resistance. Typical loads would be in the range of 500 Ohms to 10 kOhms. The