Transmitter Light Indicators; Compliance With Regulatory Requirements - Radi PressureWire Aeris Manual

TRANSMITTER LIGHT INDICATORS

Light indicators
Green steady light
Green pulsating light
proportional to blood pressure
Yellow steady light
Green pulsating light &
Yellow slow blinking light
Yellow fast blinking light

COMPLIANCE WITH REGULATORY REQUIREMENTS

Hereby, Radi Medical Systems AB, declares that this PressureWire® is in
compliance with the essential requirements and other relevant provisions of Medical
Device Directive (93/42/EEC), Radio and Telecommunications Terminal Directive
(199/5/EC) and QSR
Guidance and manufacturer's declaration - electromagnetic emissions
PressureWire® system is intended for use in the electromagnetic environment specified below. The
customer or the user of PressureWire® system should assure that it is in such an environment.
Emission test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations
/flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity
The PressureWire® system is intended for use in the electromagnetic environment specified below.
The customer or the user of the PressureWire® system should assure that it is in such an
environment.
Explanation
Transmitter on
Normal operation
PressureWire® disconnected from transmitter.
Re-insert PressureWire® firmly into transmitter.
Battery level low
It is recommended to finish case or to exchange
PressureWire®.
Error. Possible cause:
o Battery level too low for operation
o Internal error
Attempt restart by removing PressureWire from
body and turn the transmitter off and on again.
Compliance
Group 1
Class B
Class A
Complies
Electromagnetic environment -
guidance
The PressureWire® system uses RF energy only
for its internal function. Therefore, its RFemissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The PressureWire® system is suitable for use in all
establishments including domestic establishments
and those directly connected to the public low-
voltage power supply network that supplies building
for domestic purposes.
11(17)