Table of Contents
Advertisement
14
Ultiri™ Measurement System Operation Manual – 600327583 Rev. A
Warnings, Precautions, and Limitations
Warnings
•
No modification of this equipment is allowed.
•
Prior to use, please review the installed software User Manual and the
Instructions for Use supplied with the Ultiri™ Measurement System,
Wi-Box™ AO Transmitter, and the PressureWire™ X Guidewire for more
information on warnings, limitations, cautions, and set-up instructions.
•
Appropriate anticoagulant and vasodilator therapy must be used during
the procedure as needed.
•
The operator should not touch Ultiri Measurement System non-CF
connectors (or other non-medical equipment) and the patient or patient
leads at the same time. Conductive connection may cause leakage
currents to induce ventricular fibrillation.
•
High frequency surgical equipment must not be used on a patient at the
same time as the PressureWire X Guidewire and the Ultiri Measurement
System.
•
Do not use this device for any conditions contraindicated for use of
compatible guide wires.
•
Inside the catheterization laboratory only port-powered USB drives may
be connected to the USB port. Connecting externally powered devices to
the USB port in the patient vicinity may compromise electrical isolation
and cause patient injury.
•
External equipment intended for connection to signal output or other
connectors shall comply with relevant IEC standard (e.g., IEC 60601
series for medical electrical equipment). In addition, all such
combinations of systems shall comply with the standard IEC 60601-1,
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance. Any person who connects external
equipment to signal output, or other connectors, has formed a system
and is therefore responsible for compliance of the system with the
requirements of IEC 60601-1. If in doubt contact a qualified technician.
Only the PressureWire X Guidewire and the Wi-Box AO Transmitter are
intended to be used with the Ultiri Measurement System wireless
receivers.
•
Connecting to External Equipment - When used in the patient
environment, all equipment connected to the Ultiri Measurement System
must meet the requirements for medical isolation according to the
IEC 60601 safety standards. Connection of equipment that does not
follow relevant IEC standards (e.g., IEC 60601 series for medical electrical
equipment) may lead to patient injury or death.
•
The HDMI output is not isolated. External equipment which is connected
to this output must provide isolation against leakage current. The user is
responsible for compliance with the requirements of standard IEC 60601-1,
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance.
Advertisement
Table of Contents
