User's Guide

Ocus® User Guide version 3.0

Hermiankatu 6-8G, 33720 Tampere, Finland

22 CERTIFICATIONS

CE statement / EU Declaration of

Conformity

Grundium Ltd. hereby declares that this

device is in compliance with the essential

requirements and other relevant provisions

of EU regulation 2017/746.

Grundium Ocus® is an In Vitro diagnostic

Medical Device.

FCC ID:

2AQ5IOCUS1

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.

Any change or modification to the product not expressly approved by Grundium Oy could void the user's authority to operate the

device.

This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment.

This device has been SAR tested for FCC body and extremity limits. The maximum SAR value reported is 0.25W/kg.

ISED - IC:24290-OCUS1

This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development

Canada’s licence-exempt RSS(s).

Operation is subject to the following two conditions:

1.This device may not cause interference.

2.This device must accept any interference, including interference that may cause undesired operation of the device.

This equipment complies with ISED Canada radiation exposure limits set forth for an uncontrolled environment.

This device has been SAR tested for ISED Canada body and extremity limits. The maximum SAR value reported is 0.25W/kg.

Cet appareil contient des émetteurs / récepteurs exemptés de licence conformes aux RSS (RSS) d'Innovation, Sciences et

Développement économique Canada. Le fonctionnement est soumis aux deux conditions suivantes:

1. Cet appareil ne doit pas causer d'interférences.

2. Cet appareil doit accepter toutes les interférences, y compris celles susceptibles de provoquer un fonctionnement indésirable

de l'appareil.

Cet équipement est conforme aux ISED Canada des limites d’exposition aux rayonnements définies pour un environnement non

contrôlé.

Cet appareil a été testé SAR pour les limites du corps et des extrémités d'ISED Canada.

La valeur maximale de SAR rapportée est de 0.25W/kg.