BDDF00122 Issue 3
21/36
Alaris™ Gateway Workstation v1.3.x
Operating Precautions
Operating Precautions
Operating Environment
• Users of the Workstation should read all instructions in this manual before using this medical device .
• The Workstation is suitable for all establishments, including those directly connected to the public low-
voltage power supply network . The Workstation is designed for use in the hospital environment, not a road
ambulance or home health care environments .
• When setting up a Workstation, an assessment of any potential hazards associated with the routing
of electrical leads and infusion lines should be made . Where appropriate, mitigations identified and
implemented .
• The Workstation should only be used with compatible BD products, accessories, infusion bags and
disposables .
• While being used for patient therapy, each Workstation should be dedicated to the care of a single patient .
Where an auxiliary Workstation is used, this should be dedicated to the same patient as the primary
Workstation to which it is connected .
• This Workstation is not intended to be used in the presence of a flammable anaesthetic mixture with air or
oxygen or nitrous oxide .
• The Workstation does not support antivirus software . It is the Hospital’s responsibility to ensure that the
network is secure .
• Special instructions for isolation room:
– Use with the nurse-call feature in order to make alarms visible outside of the room
– Exclude use of the Alaris GW Volumetric Pumps, which are not fully compatible with the
Workstation nurse call .
Electromagnetic Compatibility and Interference
M
• This Workstation 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 IEC/EN60601-1-2 and ETSI EN 301 489-17 (where applicable) .
• The Workstation is a CISPR II Group 1 Class A device . When Alaris Infusion Pumps are attached and
operational, the system becomes a CISPR II Group 1 Class A system .
• This Workstation is a CISPR II Group 1 Class A equipment and uses RF energy only for its internal function
in the normal product offering . Therefore, its RF emissions are very low and are not likely to cause any
interference with the nearby electronic equipment . However, this Workstation emits a certain level of
electromagnetic radiation which is within the levels specified by IEC/EN60601-2-24, IEC/EN60601-1-2
and ETSI EN 301 489-17 (where applicable) . If however the Workstation interacts with other equipment,
measures should be taken to minimise the effects, for instance by repositioning or relocation .
•
Therapeutic Radiation Equipment:
Do not use the Workstation 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 Workstation . Please consult manufacturer’s
recommendations for safe distance and other precautionary requirements . For further information, please
contact your local BD representative .
MR
•
Magnetic Resonance Imaging (MRI):
The Workstation contains ferromagnetic materials which are
susceptible to interference with magnetic field generated by the MRI devices . Therefore, the Workstation is
considered not to be MRI compatible . If use of the Workstation within an MRI environment is unavoidable,
then BD highly recommends securing the Workstation at a safe distance from the magnetic field outside
the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the Workstation;
or MRI image distortion . This safe distance should be established in accordance with the manufacturers’
recommendations regarding electromagnetic interference (EMI) . For further information, please refer to
the product technical service manual (TSM) . Alternatively, contact your local BD representative for further
guidance .
•
Accessories:
Do not use any non-recommended accessory with the Workstation . The Workstation is
tested and compliant with the relevant EMC claims only with the recommended accessories . Use of any
accessory, transducer or cable other than those specified by BD may result in increased emissions or
decreased Workstation immunity .
• The Workstation features an optional radio frequency IEEE 802 .11n Wireless Local Area Network interface
(Universal Dual Band Wireless Internet Adapter) . When fitted, the Workstation must emit electromagnetic
energy in order to perform its intended function . Nearby electronic equipment may be affected .
• In some circumstances the Workstation may be affected by an electrostatic discharge through air at
levels above 15kV; or by radio frequency radiation above 10V/m . If the Workstation is affected by this
external interference, it will remain in a safe mode and alerts the user by generating a combination of
visual indicators and audible tones . Should any encountered alarm condition persist, even after user
intervention, it is recommended to replace that particular Workstation and quarantine for the attention of
Qualified Service Personnel .
• Portable and mobile RF communications equipment can affect other, nearby medical electrical equipment .
