User's Guide

104 105
6. Essential Performance
7. Wireless communication
* DATA Security
* Declaration of EMC compatibility
* FCC Notice
The Insulin infusion pump maintains insulin delivery accuracy in the specified environmental conditions.
The Diabecare DANA-i system ensure data security via proprietary means and ensure data
integrity using error checking processes, such as cyclic redundancy checks.
The Diabecare DANA-i insulin pump is intended for use in the electromagnetic environment
and comply with the United States Federal Communications Commission and international
standards for electromagnetic compatibility.
The Diabecare DANA-i Insulin Pump FCC ID: VF9DANAI4
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 has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the 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 and, if not installed and used in
accordance with the instructions, 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 to
correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into 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.
Caution
Changes or modifications not expressly approbed by the party responsible for compliance
could void the users authority to operate the equipment.
Electromagnetic emissions
Emissions test Compliance Electromagnetic environment
RF emissions
EN 55011
Group 1
The Diabecare DANA-i insulin pump uses RF
energy only for its internal function.
Therefore, its RF emissions are very low and
are not likely to cause any interference in
nearby electronic equipment.
RF emissions
EN 55011
Class B
The Diabecare DANA-i insulin pump is
suitable for use in all establishments,
including domestic establishments and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purpose.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Not applicable
NOTE The preceding statement is required by IEC 60601-1-2 for Group 1, Class B
devices. However, since the Diabecare DANA-i insulin pump is battery powered, its
emissions will not be affected by the establishment power supply.