Declarations

FOR USA

FCC warning statement:
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.
  • This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
  • Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

FOR CANADA

“This device complies with Industry Canada’s licence-exempt RSSs. 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.”

Please see Section 8.4 of RSS-Gen Issue 4 for further information.

Signifier Medical Technologies Limited

The Triangle, 6th Floor, Hammersmith Grove, Hammersmith,
London, W6 0LG, UK

Email: [email protected]
www.exciteosa.com

Distributed in the USA by

Signifier Medical Technologies LLC
175 Highland Avenue Needham MA 02492

+1844 MILDOSA (+1844 645 3672)

EC REP

Advena Ltd. Tower Business Centre, 2nd Flr., Tower Street, Swatar, BKR 4013 Malta

This product is Manufactured by Signifier Medical Technologies

in compliance with Medical Device Standards and Quality Standards: ISO 13485:2016