LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08
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Other equipment should not be stacked on-top of or in direct-contact with the OptoMonitor 3
system, otherwise there is risk of improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
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Use of accessories, transducers, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
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Improper installation of the OptoMonitor 3 or other equipment may lead to interference of
OptoMonitor 3 function, even if that other equipment complies with CISPR EMISSION
requirements.
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When connecting to healthcare facility network, such as DICOM, connection shall be isolated.
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When connecting video output signal to an external device, connection shall be made with a
shielded cable. Connection shall also be isolated to provide protection against leaking current.
The user is responsible for compliance with the requirements of standard IEC 60601-1.
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OPM3 system must not be serviced or maintained while in use with the patient
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Assembly of OptoMonitor as part of a Medical Equipment System as well as modifications
during actual service life shall be evaluated based on the requirements of IEC-60601-1
Cautions
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To ensure patient safety, use only parts and accessories specified in this manual.
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At the end of its service life, the equipment, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such products. If you have any
questions concerning disposal of the equipment, please contact OpSens or personnel authorized
by OpSens.
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Radio transmitting equipment, cellular phones and strong emission sources such as high
frequency surgical equipment are capable of interfering with the proper performance of the
equipment. For this reason, make sure that all external devices operated in the vicinity of the
OptoMonitor 3 comply with the relevant EMC requirements.
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Before connecting the equipment to the power line, check that the voltage and frequency
ratings of the power line are the same as those indicated on the OptoMonitor 3 label or in this
manual.
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Always install or carry the equipment properly to avoid damage caused by drop, impact, strong
vibration, or other mechanical force.
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Maintain at least 5 cm (2”) of clearance above the Optical Unit to ensure proper ventilation.
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Always leave the protective caps on the optical connector on the Handle Unit when the system
is not in use. Do not put any sharp object into the optical connector.
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Only OpSens’ pressure guidewire is intended to be connected to the optical connector on the
Handle Unit.
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Each OptoWire is matched with its unique cable and Gauge Factor Connector (where applicable)
supplied in the same package. OptoWire cable and Gauge Factor Connector (where applicable)
must be inserted into the Handle Unit to allow proper operation.
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External equipment intended for connection to Pa INPUT, Pa/Pd OUTPUT or other connectors,
shall comply with relevant IEC standard (e.g. IEC 60601 series for medical electrical equipment).
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Ensure the interface cables delivered with OptoMonitor 3 are compatible with the Cathlab
Hemodynamic System which is to be used with the OptoMonitor 3.
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Ensure to set proper pressure averaging (see section 5.6).
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OptoMonitor 3 is protected against the effects of a discharge of a defibrillator.
OptoWire readings may be temporarily affected by defibrillation.
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Ensure OptoMonitor 3 Handle Unit is not used in sterile environment.