Operation Manual

MEDRAD
®
Salient Operation Manual 7
♦ Patient injury could occur if the on-screen manual fill controls are used when the patient is
connected. This could cause injury to the patient by delivery of contrast or blood extraction and may
require the procedure to be repeated.
♦ A possible explosion risk exists if the injector is used in the presence of flammable anaesthetics
with air or oxygen or nitrous oxide.
♦ Regular maintenance should be performed. To ensure that the injector stays properly calibrated and
that all primary and backup systems are functioning properly, yearly safety checking is
recommended. Contact your local Imaxeon Service Representative for further information.
♦ Electromagnetic interference. The injector must be installed in a suitable EMC environment
according to the following:
♦ Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
♦ To maintain compliance with EN IEC 60601-1-2 EMC compatibility requirements, do
not substitute cables or connectors not recommended by the manufacturer as
emissions or decreased immunity to interference may result causing erratic operation.
♦ Plug the injector directly into properly grounded ac power outlet. Do not use an extension power
cord or adapter. Since the injector power cord supplies a safety ground to the injector during
charging, using an extension cord will compromise the ground quality and the injector could become
unsafe.
♦ US/Canada Installations only. Grounding reliability can only be achieved when this equipment
is connected to an equivalent receptacle marked "Hospital Only" or "Hospital Grade".
♦ Protective earth conductor. Should the integrity of the external protective conductor in the installation
or its arrangement be in doubt, the injector must be operated from the internal power source.
♦ Connection to other equipment. Injectors bearing the CE mark and having accessory
equipment connected to the interface connectors must be certified according to the IEC
60601-1 standard. Furthermore, all configurations of injectors with attached accessory equipment
must comply with system standard EN IEC 60601-1-1. Anyone who connects additional equipment
to the signal input or output part configures a medical system and is therefore responsible that the
system complies with requirements of the system standard EN 60601-1-1. To obtain on-site
consulting or consulting references, contact local Imaxeon Service Representative.
♦ A biological hazard may result if fluids, in particular blood or bodily fluids, to come into contact
with the injector. Fluid ingress could also adversely affect the function of the injection. Clean
the injector immediately.
♦ Accessible parts. The operator should not contact the heat maintainer connector and the patient at the
same time.
♦ Use only the specified Imaxeon heat maintainer (DC022) with the MEDRAD
®
Salient injector. Do
not connect any other device to the injector heat maintainer connector.
♦ Cease use of faulty components – if a component appears to be faulty, e.g. RCU screen or heat
maintainer, cease use until further investigation can be carried out.
♦ Changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.
CAUTIONS
♦ Removal of covers may allow access to dangerous voltages. There are no user-serviceable parts in the
injector. Contact your local Imaxeon Service Representative for correct maintenance procedures, do not
remove any covers or disassemble the injector in any way. Inspect the injector periodically for loose or
frayed cables, loose covers, and signs of cracks, dents or loose hardware. Refer all injector servicing to
authorised Imaxeon service representatives.
♦ Shock hazard when cleaning. In order to avoid shock and prevent damage to the injector, always
disconnect the injector from line power before cleaning. Ensure that the injector is completely dry
before reconnecting to line power.