Riester ri-medic Manual De Instrucciones página 25

For units that are Bluetooth® enabled, the following EU and FCC regulatory information applies:
EU Regulatory Information
The transmitter module manufactured by Mitsumi and incorporated into the rimedic BP module has been approved in accordance
with the R&TTE directive.
FCC Regulatory Information
FCC RF Interference Statement:
This equipment has been tested and found to comply with the limits 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 radiates radio frequency energy and, if not installed and used in accordance with the in-
structions, may cause harmful interference to radio communication. 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 of 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.
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 device contains
FCC-ID P00WML-C40.
FCC RF Exposure Statement:
This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the
specific operation instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating icon-
junction with any other antenna or transmitter. This mobile modular transmitter must have a separation distance of at least 20
cm between the antenna and the body of the user or nearby persons. With a separation distance of 20 cm or more, the MPE limits
are well above the potential this module is capable of producing.
Note: Unauthorized modifications will void the authority to use this equipment.
13. STANDARDS COMPLIED WITH
Standards: UL60601-1, CAN/CSA C22.2 601-1,
IEC 60601-1,
IEC 60601-1-2 (EMC),
IEC 60601-1-4,
AAMI SP10:2002
Meets EN-1060-1, Specification for non-invasive sphygmomanometers – Part 1: General requirements and EN 1060-3, Non-inva-
sive Sphygmomanometers – Part 3. Supplementary Requirements for Electro-Mechanical BP Measuring Systems"
Classification: Protection against electric shock: Class II (for non-battery version), Internally Powered Equipment (for battery
version); Applied parts: Type BF; Mode of operation: Continuous
Safety Requirements
Clinical grade BP measurement accuracy defined by fully meeting the requirements of:
AAMI SP-10 2002
EN 1060-4
25