User Guide
14. Installation of any third party software (applications, programs, or utilities) other than those specified by Natus
Medical Denmark 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.
19. Warning notes:
When connecting equipment to the USB connectors, the following must be considered:
•
•
Note 1: The ICS Impulse system is a part of an medical electrical system. When assembling an medical
electrical system , the person carrying out the assembly must take into account that connecting other
equipment that does not comply with the same safety requirements as the ICS Impulse system may lead
to a reduction in the overall safety level of the system. The ICS Impulse system is designed to ensure com-
pliance with requirements in EN 60601-1 or IEC 60601-1 (2005), 3. ed. when the PC, printer, etc. are
placed out of reach of the patient, i.e. not closer than approx. 1.5 meters/5 ft.
22
Definition of symbols
ICS Impulse
System
58
Equipment must be certified to relevant EN/IEC safety standards, e.g. EN/IEC 60950.
Use of connected equipment in a patient environment, see Note 1. Ensure that the medical elec-
trical system complies with the requirements of EN 60601-1 or IEC 60601-1 (2005), 3. ed.
CAUTION: Laser radiation. Do not stare into beam. Class 2 laser product.
Consult user manual for warnings and cautions.
Follow instructions for use.
Otometrics - ICS Impulse USB
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