IFU-3393 Rev C Instructions for Use, Fenom Pro
9
Electromagnetic Emissions
The emissions characteristics of this equipment make it suitable for use in hospitals and other healthcare settings
(CISPR 11 class A).
Electromagnetic Immunity
Fenom Pro has been tested to comply with the emission and immunity requirements described in IEC 60601-
1-2:2014 (4th Edition) General requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests and AIM 7351731:2017 Medical Electrical Equipment and
System Electromagnetic Immunity Test for RFID Readers.
Fenom Pro is not compatible with magnetic resonance systems, and is labeled as MR Unsafe. The Fenom Pro should
not be used in a room containing a magnetic resonance system or adjacent rooms to a magnetic resonance system.
Note: Sites should ensure that their security systems and other equipment do not interfere with Fenom Pro.
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DO NOT block device vents and ports while in use or while charging.
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DO NOT drop the device or subject it to strong impact.
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No modification of the Fenom Pro device, handpiece, or mouthpiece is allowed.
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DO NOT use Fenom Pro in the proximity of areas where volatile substances such as organic fluids or
disinfectants are being used. Special attention should be paid to aerosols and disinfection baths.
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DO NOT use Fenom Pro in the presence of flammable vapors or liquids
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Use of substances containing alcohol close to the Fenom Pro device may cause erroneous
measurement results. [3]
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Single-patient-use mouthpiece should be used immediately after opening.
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DO NOT reuse the single-patient-use mouthpiece on other patients.
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When not in use, the Fenom Pro device should be stored in the packaging provided.
(See Chapter 12: General Care.)
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DO NOT open, crush, heat above 140 °F/60 °C, or incinerate the lithium-ion battery in the device.
