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otometrics ICS Impulse USB - Critical Safety Warnings and Precautions

otometrics ICS Impulse USB
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4. A Class 2 Laser product is used for calibration. The laser beam projects from the front of the goggles onto a solid sur-
face.
Caution Do not look directly at the lasers. Use of controls or adjustments, or performance of procedures
other than those specified herein, may result in hazardous radiation exposure.
5. It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example,
anti-static carpeting is recommended.
6. No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the Intended Use
section of this manual.
7. The device can be disposed of as normal electronic waste, according to local regulations.
8. For safety reasons, accessories connected to the equipment's outlet fittings must be identical to the type supplied
with the system.
9. The device is disconnected from the mains by removing the USB cable.
10. Do not touch non-medical parts, such as the laptop/computer or printer and the patient at the same time.
11. Exposure to electromagnetic fields can result in interference with the process of recording correct measurements. ICS
Impulse System camerasand gyroscopes are sensitive to electrical disturbances. Avoid static discharges and elec-
tromagnetic fields.
12. No defibrillators or high-frequency surgical equipment should be applied to the patient when connected to the ICS
Impulse System at any time.
13. Immediately discontinue use of the equipment if skin irritation or discomfort occurs.
14. Installation of any third party software (applications, programs, or utilities) other than those specified by GN Oto-
metrics can compromise the safety or effectiveness of this system.
15. The ICS Impulse System needs to be installed and put into service according to the EMC information provided in this
manual. Portable and mobile RF communications equipment can affect medical electrical equipment. The ICS Impulse
System may be interfered with by other equipment with CISPR emission requirements.
16. The use of accessories and cables other than those specified for this device may result in increased emissions or
decreased immunity of the ICS Impulse System. Refer to the accessories list in the Reference Manual.
17. The ICS Impulse System should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, the equipment or system must be observed to verify normal operation in the configuration in
which it will be used.
18. A small cooling fan is inside the goggles housing. In the unlikely event of the cooling fan vent being blocked, the tem-
perature of the goggles surface in contact with the patient may rise to 42.2° C.
Otometrics - ICS Impulse USB
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20 Warning notes

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