Users Manual Part 4

Guidance and manufacturer's declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
FCC
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.
Caution: The user is cautioned that changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.
SAR
The device is designed and tested to meet the applicable limits for radio frequency (RF)
exposure established by the Federal Communications Commission (U.S.A.) Specific
Absorption Rate; (SAR) refers to the rate at which the body absorbs RF energy.
The minimum allowable SAR distance is 5 mm, and the maximum allowable SAR limit is 4.0 W/kg,
averaged over 10 gram of tissue for the device.
L’appareil est conçu et testé pour respecter les limites applicables aux fréquences radio (RF)
exposition établie par la Federal Communications Commission (États-Unis).
Taux d'absorption; (SAR) fait référence à la vitesse à laquelle le corps absorbe de l'énergie RF.
La distance DAS minimale autorisée est de 5 mm et la limite DAS maximale admissible est de 4,0 W
/ kg, avec une moyenne de 10 grammes de tissu pour le périphérique.
EMC (Electromagnetic Compatibility)
The device complies with the International Electrotechnical Commission standards (IEC 60601-
1-2: 2014) for electromagnetic compatibility as listed in the tables below. Follow the guidance
in the tables for use of the device in a Professional Healthcare Environment.