3
DM00003 Rev D
SYSTEM
MANUAL
4 Safety
Read this manual carefully before using the Trackit M for the first time to familiarize yourself with its operation. This
manual is part of the product and must be available anytime. Use the device only for the intended purpose. Pay
attention to all warnings, advice, and notes provided in this manual. To avoid the possibility of injury to the patient or
user, damage to your system or data loss, always observe these safety precautions during the system operation.
Two signs are used to define potentially harmful conditions, or conditions or procedures capable of causing damage.
Warning
sign indicates a situation or procedures that may be dangerous for the patient and/or user.
Caution
sign indicates a situation or procedures that may cause equipment damage or its improper
usage.
4�1 Warnings for the Trackit M
This system should only be operated by personnel having a sufficient amount of training and
experience according to all local regulations and guidelines.
This system should only be used for patient examination by personnel who have fully familiarized
themselves with the system and the processes and procedures contained in this manual, including all
warnings and caution statements.
The Photic Stimulator is classified as a Group 2 instrument under ISO 15004-2. In the event of
an electrical failure that turns the Photic Stimulator on at full brightness and at continuous wave
stimulation (i.e., the photic stimulator turns on and remains on for more than 16 seconds), the light
emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater
the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity
will exceed the safety guideline after 36 minutes.
All use of this system with a photic stimulator must be under the supervision of a physician, as photic
stimulation can result in seizure activity in the patient. Stop all photic stimulation if abnormal seizure
waveforms are detected to prevent the patient from having a seizure.
Do not perform studies involving hyperventilation techniques with patients having severe heart,
respiratory, or cerebrovascular disease.
To ensure patient safety, connect the patient electrodes only after the system is fully turned on.
Safety