Table of Contents
Advertisement
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
CAUTION:
•
No connections to other systems or components are to be made to the
OPTIS Integrated Next except through the Connector Panel. No
connections are to be made through the Connector Panel except as
described in this manual. 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 the
OPTIS Integrated Next has formed a medical 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 Guidewire and the Wi-Box AO Transmitter are intended to
be used with the OPTIS Integrated Next wireless receivers.
•
To connect to the correct Wi-Box AO Transmitter, you must select the
room where the system is being used. The first time you connect to a
room, you must enter the room's information into the system. Refer to
the installed software User Manual for more information.
Mechanical Enclosure
WARNING:
•
Do not use the OPTIS Integrated Next if it has been dropped or in
another way exposed to mechanical or electrical damage or if liquids
have penetrated the housing, or the user or patient may be exposed to
electrical shock or faulty readings may appear. Contact your supplier for
further action.
•
Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such
use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
CAUTION:
•
Ensure that all ventilation holes are unblocked to avoid system
overheating and false readings.
Electrical
WARNING:
•
Electrical Shock Hazard - Do not remove OPTIS Integrated Next covers.
To avoid electrical shock, use only the power cord supplied with the
system and connect only to properly grounded wall outlets. Refer to
"System Setup" and "Safety Information" for electrical safety information.
•
The main power remains switched on when the system is in Standby
mode. Avoid direct or indirect (e.g., via the operator) conductive
connection between other electrical equipment and the OPTIS Integrated
Next. 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 PressureWire Guidewire and the
OPTIS Integrated Next.
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
Warnings and Precautions
17
Advertisement
Table of Contents
