Appendix; Electromagnetic Compatibility - Bosch vivatmo pro Instructions For Use Manual

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11 Appendix

Important information regarding electromagnetic compatibility (EMC).

Hereby, Bosch Healthcare Solutions GmbH, declares that the radio equipment type Vivatmo pro is in compliance with Directive

2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:

https://www.vivatmo.com/en/service-support/additional-information.html

Vivatmo pro complies with EN60601-1-2:2015 with the objective to avoid insecure product situations. This standards regulate

the levels of immunity against electromagnetic interferences and the maximum electromagnetic emission values for medical

equipment. Vivatmo pro manufactured by the company complies with the standard guidance and manufacturer's declaration

– electromagnetic emissions EN60601-1-2:2015 both in terms of immunity and of emissions and does therefore not need any

service and maintenance regarding EMC and ESD over lifetime. Vivatmo pro basestations with a date of manufacture before 1st

November 2018 comply with EN 61326-1:2013 for EMC.

WARNING

Note that portable and mobile HF communication systems may interfere with this device. Do not staple

or use the device close to mobile phones or other devices generating electrical or electromagnetic

fields. This could result in malfunction of the medical device and may create a potentially insecure situ-

ation. Portable RF communication devices (including peripherals such as antenna cables and external

antennas) are not to be used closer than 30 cm next to any part of the Vivatmo pro system.

The Vivatmo pro is intended for use in professional healthcare facility environment. The customer or the user of

Vivatmo pro should assure that it is used in such an environment.

Instructions for use

Appendix

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