SurroSense® PROTECT – Instructions for Use
Version 0.8 – February 2019
©2019 Orpyx Medical Technologies Inc. - All rights reserved. All trademarks and registered trademarks are the property of their respective owners.
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CANADIAN COMPLIANCE STATEMENT
This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science
and Economic Development Canada license-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.
L'émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR
d'Innovation, Sciences et Développement économique 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;
2) L'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible
d'en compromettre le fonctionnement.
INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA STATEMENT
Complies with the Canada ICES-003 Class B specifications. Cet appareil numerique de la classe B
est comforme à la norme NMB-003 du Canada. This device complies with RSS 210 of Industry Canada.
OTHER STANDARDS AND COMPLIANCE
The SurroSense
®
PROTECT smart insole system is in compliance with the following standards
IEC 60601-1-2:2013: Medical Electrical Equipment – Part 1: General Requirements for Safety IEC
60601-1