Aktiia Bracelet Benutzerhandbuch - Seite 13
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EN ISO 10993-10: 2010: Biological evaluation of medical devices. Tests for irritation and skin sensitization
EN IEC 60601-1:2006/A1:2013: Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
EN IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for basic safety and essen-
tial performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
IEC 60601-1-11:2015: Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical sys-
tems used in the home healthcare environment
IEC 62471:2006: Photobiological safety of lamps and lamp systems
EN ETSI 301 489-1, V 2.1.1: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part
1: Common technical requirements
EN ETSI 301 489-17, V3.2.0: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part
17: Specific conditions for Broadband Data Transmission Systems
EN ETSI 300 328, V2.1.1: Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz
ISM band and using wide band modulation techniques
18. FCC statement
FCC CAUTION
Changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Note
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not in-
stalled and used in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
•
Reorient or relocate the receiving antenna.
•
Increase the separation between the equipment and receiver.
•
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
•
Consult with the dealer or an experienced radio/TV technician for help.
This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets
the FCC radio frequency (RF) Exposure Guidelines. This equipment has very low levels of RF energy that are
deemed to comply without testing of specific absorption ratio (SAR).
Printed copies are uncontrolled - Check you are using the latest version
P01_0020 - USER MANUAL
Version: 2
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