BDDF00171 Issue 4
19/39
BD Alaris™ MRI Capsule
Operating Precautions
Operating Precautions
Operating Environment
• Users of the MRI Capsule should read all instructions in this manual before using this
medical device .
• The MRI Capsule is suitable for various establishments, including those directly connected
to the public low-voltage power supply network .
• When setting up the MRI Capsule, an assessment of any potential hazards associated
with the routing of electrical leads and infusion lines should be made . Where appropriate,
mitigations should be identified and implemented .
• The MRI Capsule should only be used with compatible BD products and accessories .
• While being used for patient therapy, each MRI Capsule should be dedicated to the care of
a single patient .
• This MRI Capsule is not intended to be used in the presence of a flammable anaesthetic
mixture with air or oxygen or nitrous oxide .
Electromagnetic Compatibility and Interference
M
• This MRI Capsule is protected against the effects of external interference, including high
energy radio frequency emissions, magnetic fields and electrostatic discharge (for example,
as generated by electrosurgical and cauterising equipment, large motors, portable radios,
cellular telephones etc .) and has been tested to relevant standards for electromagnetic and
radio frequency interference . Where variations of the standards exist, additional testing to
meet these requirements have been completed .
• If the door of the MRI Capsule is open, and the Pumps are infusing, portable
communication devices should be used no closer than 30cm from the MRI Capsule .
Otherwise degradation of the performance of the Pumps could result .
• The MRI Capsule is a Class IIb device . When Alaris™ Infusion Pumps are attached and
operational, the system becomes a Class IIb system .
• This MRI Capsule is a Class IIb device . Therefore, its RF emissions are very low and are
not likely to cause any interference with the nearby electronic equipment . However, this
MRI Capsule emits a certain level of electromagnetic radiation which is within the levels
specified by IEC/EN60601-2-24 and IEC/EN60601-1-2 (where applicable) . If however the
MRI Capsule interacts with other equipment, measures should be taken to minimise the
effects, for instance by repositioning or relocation .
• The emissions characteristics of the MRI Capsule make it suitable for use in industrial areas
and hospitals (CISPR 11 class A) . If it is used in a residential environment (for which CISPR
11 class B is normally required) the MRI Capsule might not offer adequate protection to
radio-frequency communication services . The user might need to take mitigation measures,
such as re-locating or re-orientating the MRI Capsule .
• Therapeutic Radiation Equipment: Do not use the MRI Capsule in the vicinity of
any Therapeutic Radiation Equipment . Levels of radiation generated by the radiation
therapy equipment such as a Linear Accelerator, may severely affect functioning of the
MRI Capsule . Please consult manufacturer’s recommendations for safe distance and
other precautionary requirements . For further information, please contact your local BD
representative .
• Magnetic Resonance Imaging (MRI): The Pumps contain ferromagnetic materials which
are susceptible to interference with magnetic field generated by the MRI devices . Therefore,
the MRI Capsule should be used within the specified safe distance only . This safe distance
should be established in accordance with the manufacturers’ recommendations regarding
electromagnetic interference (EMI) . Alternatively, contact your local BD representative for
further guidance .
