6.2
Warning notes
Natus Medical Denmark ApS ICS products are not designed to be used in conjunction with any devices not approved by
Natus Medical Denmark ApS. Summation of combined unapproved parts could result in increased electrical leakage. All
parts of ICS AirCal are suitable for use within the patient environment.
1. For the sake of safety, and in order not to void the warranty, the ICS AirCal should only be serviced by authorized ser-
vice personnel. In case of defects, please make a detailed description of the defect(s) and contact your supplier.
Do not use a defective instrument.
2. Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the
instrument and it may result in a risk of electrical shock to the user or patient.
3. To avoid the risk of electric shock, this equipment must only be connected to a mains supply with protective ground.
4. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
5. 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.
6. The equipment can be disposed of as normal electronic waste according to local regulations.
7. For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be
identical to the type supplied with the system.
8. Never place the delivery head speculum into a patient's ear without first attaching the outer disposable speculum.
The speculum should be carefully placed into the patient's ear. Avoid excessive force or deep insertion as it could res-
ult in injury.
9. ICS AirCal is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The
customer or user of the ICS AirCal can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment.
10. Immediately discontinue use of the equipment if skin irritation or discomfort occurs.
11. Only distilled water should be used when filling or refilling the water reservoir. Using common water from the tap will
result in mineral deposits and will harm the ICS AirCal.
12. The default settings are recommended in order to deliver a stimulus that will produce a response comparable to
water irrigation. Prolonged duration beyond 60 seconds or alternative temperature settings may result in patient dis-
comfort.
13. Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards
(i.e.IEC 950 for data processing equipment and IEC 60601-1 for medical equipment.) Furthermore all configurations
shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal
input part or signal output part configures a medical system, and is therefore, responsible that the system complies
with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or
your local representative.
14. The ICS AirCal irrigator 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 AirCal
irrigator may be interfered with by other equipment with CISPR emission requirements.
15. The use of accessories and cables other than those specified in the Accessories list of this manual may result in
increased emissions or decreased immunity of the ICS AirCal irrigator.
16. We recommend that the device should not be stacked with other equipment (except with the ICS Chartr 200
VNG/ENG, as described in section
or placed in a poorly ventilated space as this may affect the
Otometrics - ICS AirCal
23
6 ICS AirCal System Safety
