SpiroConnect Operators Manual
MedChip Solutions Ltd.
Page 27 of 31
001.105.GBR Issue 1.12
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the
SpiroConnect
The SpiroConnect is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the SpiroConnect can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and SpiroConnect as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d
=1.2
√
P
80 MHz to 800 MHz
d
=1.2
√
P
800 MHz to 2,5 GHz
d
=2.3
√
P
0.01
0,12
0,12
0,23
0.1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d
in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where
P
is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Changes or modifications to the SpiroConnect that are not expressly approved by MedChip
Solutions can cause EMC issues with this or other equipment.
The SpiroConnect is compliant with Directive 1999/5/EC (RTTE) and Standards EN 301 489-
1 v1.8.1 and EN60601-1-2 electromagnetic compatibility but can be affected by cellular
phones and by electromagnetic interference exceeding levels specified in EN 50082-1:1992
Hereby, MedChip Solutions Limited declares that the radio equipment type SpiroConnect is
in compliance with Directive 2014/53/EU (RED). The full text of the EU declaration of
conformity is available at the following internet address:
http://www.medchipsolutions.com/certificates
18
IT Network
The connection of the SpiroConnect to a PC running SDM software constitutes an IT Network.
The SpiroConnect transmits spirometry results to, and receives instructions from, a PC via a Bluetooth
connection. The connection is between the SpiroConnect internal Bluetooth transceiver and a Bluetooth
transceiver to USB converter (dongle) connected to a USB port on the PC. The Bluetooth connection offers
security and encryption, and the packet protocol used for transport ensures data integrity.
The PC requirements are listed in the Specification section.
Failure of the Bluetooth link will result in the inability to perform a spirometry test.
It is the responsibility of the user to identify risks resulting from changes to the IT Network including changes
to the IT Network configuration, connection or disconnection of additional items to or from the IT Network,
and updating or upgrading equipment connected to the IT Network.
19
Applied Parts
SpiroConnect
Disposable mouthpiece or filter
