Title:
DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE
DCO#:
00271
Document#:
870-00001-01
Originating Author:
E Keate
Modifying Author:
R. Massie
Date Created:
9/04/2018
Date Modified:
05/28/2020
Revision:
AR
Page
159 of 175
This device complies with part 15 of the FCC Rules. Operation is subject to the following 2 conditions:
•
This device may not cause harmful interference.
•
This device must accept any interference received, including interference that may cause undesired
operation.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to Part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses, and can radiate radio frequency
energy. If not installed and used in accordance with the instructions, it may cause harmful interference to
radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is encouraged to try and correct the
interference by one or more of the following measures:
•
Reorient or relocate the receiving antenna.
•
Increase the distance between the equipment and the receiver.
•
Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
•
Consult the dealer or an experienced radio/TV technician for help.
Dictum Health is not responsible for any radio or television interference caused by unauthorized
modification of the devices included with this product, or the substitution or attachment of connecting
cables and equipment other than specified by Dictum Health. The correction of interference caused by
such unauthorized modification, substitution, or attachment will be the responsibility of the user.
European Union
The Bluetooth radio contained within this equipment complies with the essential requirements of the
European Union R&TTE Directive (2014/53/EU).
22.3
Guidance and EMC Manufacturer’s Declaration
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical
equipment.
22.4 EMC Compliance
This device complies with IEC EN 60601-1-2:2012.
•
All medical electrical equipment must be installed and put into service in accordance with the EMC
information provided in this document.
•
Portable and mobile RF communications equipment can affect the behavior of medical electrical
equipment.
The device complies with all applicable and required standards for electromagnetic interference.
•
It does not normally affect nearby equipment and devices.
•
It is not normally affected by nearby equipment and devices.
•
It is not safe to operate the monitor in the presence of high-frequency surgical equipment.
•
It is good practice to avoid using the device in extremely close proximity to other equipment.
22.5 Emissions and Immunity Information
