User's Manual

Tobii C-Series User’s Manual

Chapter 8 Appendices

With regard to the test specications specied in 6.2.1.10 EN 60 601-1-2

(2007) the cessation or interruption of any intended operation, even if

accompanied by an alarm, is allowed in the C-Series device due to it not

performing any safety critical operations.

Also with regard to the test specications specied in 6.2.1.10 EN 60 601-

1-2 (2007) errors of a displayed numerical value sufciently large to affect

diagnosis or treatment is not applicable for the C-Series device.

In order to maintain compliance as a Class 1 Medical device, the switches

that are used in combination with the C-Series device must fulll the

isolation requirements of IEC/EN 60601-1 based on 15 V DC. They must

be electrically oating switches (switches that are not grounded).

8.3.3 Industry Canada Statement

This device complies with Industry Canada licence-exempt RSS standard(s).

Operation is subject to the following two conditions: (1) this device may

not cause interference, and (2) this device must accept any interference,

including interference that may cause undesired operation of the device.

Le présent appareil est conforme aux CNR d’Industrie Canada applicables

aux appareils radio exempts de licence. L’exploitation est autorisée aux

deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage,

et (2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique

subi, même si le brouillage est susceptible d’en compromettre le

fonctionnement.

This device has been tested to the safety requirements for exposure

to radio waves (SAR) in RSS-102 to the General Public (Uncontrolled

Environment) limits (1.6W/Kg). The highest SAR value for the C8 device

is: 1.025 W/kg. The highest SAR value for the C12 device is 0.107 W/kg.

The highest SAR value for the C15 device is 0.16 W/kg. This device can be

operated safely with a minimum distance 0cm between the equipment and

the user’s body.

Ce dispositif a été testé aux exigences de sécurité pour l’exposition aux

ondes radio (SAR) dans le CNR-102 à le grand public (environnement non

contrôlé) des limites (1.6W/Kg). La valeur maximale mesurée est de SAR

pour le C8 dispositif est: 1.025 W/kg. La valeur maximale mesurée est de

SAR pour le C12 dispositif est: 0.107 W/kg. La valeur maximale mesurée