Warnings And Cautions; Warnings - Sunoptic Technologies Pro300 Bedienungsanleitung

2.

WARNINGS AND CAUTIONS

Use of this device may present hazards to the user or patient. Before operating device, please read
this manual thoroughly and follow all warnings, cautions, and instructions. The words warning, caution,
and note carry special meaning and are described below:
WARNING: Indicates risks to safety of a patient or user. Failure to follow warnings may result in injury
to the patient or user.
CAUTION: Indicates risks of improper use or damage to the device. Failure to follow cautions may result
in loss of function or damage to the device.
NOTE: Indicates special information to clarify instructions or present additional useful information.
The WARNING, CAUTION, and NOTE symbols in this manual are intended to alert the user of important
operating and maintenance instructions.

2.1. Warnings

To avoid injury to the user, patient, or damage to the device, please heed the following warnings:
•
Failure to follow instructions in this manual may lead to serious injury or damage to the device.
Read this manual thoroughly, especially the warnings, and be familiar with its contents before
using the device.
•
This device is designed to be used by a qualified physician, having complete knowledge of its
use and of the procedure being performed.
•
The device is NOT to be used in an oxygen-rich environment.
•
This device produces a concentrated light beam, and this high energy density is retained through
any connected light guides or instruments. The output of a connected instrument left in close
proximity or contact with tissue or flammable materials presents the risk of injury or fire. Qualified
personnel must determine a safe working distance and intensity setting for each application. The
device should never be unattended while on.
•
This device should be installed and tested prior to use. A preoperative check should be performed
prior to administration of patient anesthesia to ensure all desired functions are operational and
there are no signs of damage.
•
This device is intended to illuminate a surgical site; the user is responsible for determining if
interruption of light output, including effects from electromagnetic disturbances, will create an
unacceptable risk. If such a determination is made, alternate arrangements, such as a standby
or backup device, should be made by the user to reduce the risk. It is recommended to have a
backup device on-hand.
•
This device must be connected to a supply mains with protective earth to reduce risk of electric
shock.
•
This device must not share the same electrical outlet or grounding with life support or life
sustaining equipment. In the case of electrical failure, the device may draw excessive power from
the supply circuit and interrupt service to other equipment on that same supply circuit.
•
An uninterruptible supply circuit is recommended.
•
Always set up the device in a location with adequate ventilation (airflow). Insufficient ventilation
may cause the device to overheat and shut down or create risk of fire. Always set up the device
so the appliance inlet is easily accessible.
•
Do not use the device in the presence of flammable liquids, gases, or other materials susceptible
to ignition due to electrical sparking.
•
This device should be used only with type BF endoscopic instruments which have been certified
according to IEC 60601-1 for medical equipment and IEC 60601-2-18 for endoscopic equipment.
•
All equipment connecting to this device must be classified as medical equipment. Additional
information processing equipment connected to the device as a medical system must be
determined by the operator if all equipment complies with the appropriate end-product standards
(such as IEC 60950 or IEC 60065 and the Standard for Medical System, IEC 60601-1-1).
LIT-263 Sunoptic Technologies
Rev. A
Symbol indicates type BF equipment.
®
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(English)