User's Manual

With regard to the test specifications specified 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 I-Series device due to it not performing any safety critical
operations.
Also with regard to the test specifications specified in 6.2.1.10 EN 60 601-1-2 (2007) errors of a displayed numerical value
sufficiently large to affect diagnosis or treatment is not applicable for the I-Series device.
In order to maintain compliance as a Class 1 Medical device, the switches that are used in combination with the I-Series device
must fulfill the isolation requirements of IEC/EN60601-1 based on 15 V DC. They must be electrically floating switches
(switches that are not grounded).
B3 Industry Canada Statement
Low-power license-exempt radio communication devices (ICES-003)
De faible puissance exempts de licence des appareils de communication radio (CNR-210)
a. Common information
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.
b. Operation in 2.4 GHz band
To prevent radio interference to the licensed service, this device is intended to be operated indoors and installation
outdoors is subject to licensing.
a. Informations communes
Son fonctionnement est soumis aux deux conditions suivantes:
1. Ce dispositif ne peut causer des interférences, et
2. Ce dispositif doit accepter toute interférence, y compris les interférences qui peuvent causer un mauvais
fonctionnement du dispositif.
b. Le fonctionnement en bande de 2,4 GHz
Pour prévenir les interférences radioélectriques aux services sous licence, cet appareil est destiné à être exploité à
l'intérieur et à l'extérieur d'installation est soumise à licence.
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 I–12 device is 0.501 W/kg. The highest SAR value
for the I–15 device is 0.017 W/kg. This device can be operated safely with a minimum distance 0 cm 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 de SAR pour le I–12 dispositif est: 0.501 W/
kg. La valeur maximale mesurée de SAR pour le I–15 dispositif est: 0.017 W/kg. Ce dispositif peut être exploité en toute sécurité
avec un 0cm distance minimale entre le matériel et les corps de l’utilisateur.
This Class B digital apparatus complies with Canadian ICES-003.
Cet appareil numérique de la classe B est conforme à la norme CNR-210 du Canada.
B4 CE Statement
This equipment complies with the requirements relating to electromagnetic compatibility, EN 300386 class B for ITE, the
essential protection requirement of Council Directive 2004/108/ECon the approximation of the laws of the Member States
relating to electromagnetic compatibility and R&TTE Directive 1999/5/ECto meet the regulation of the radio equipment and
telecommunications terminal equipment.
B5 Standards
The Tobii Device complies with the following standards:
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Appendix B Compliance Information
Tobii I-Series User’s manual v.1.0.4 - en-US