EN
1.4
Warnings And Cautions
Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment. Ambu is not responsible for any damage to the system or patient injury resulting from
incorrect use.
Warnings
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious
injury.
Connection of Devices
•
Do not connect non-medical grade devices to the endoscope. Connection of devices that
are not medical grade (IEC 60601 conform) could have negative impact on the safety
of the system. Connect only medical grade equipment to the endoscope. For detailed
information consult the IFU of the aBox™ Duodeno.
Single-Use & Cross-Contamination
•
The endoscope described in this IFU is a single-use medical device. Since it is packaged as
sterile, it must be properly handled (by using aseptic technique) and stored to ensure the
sterile packaging is not breached prior to use.
•
Do not attempt to clean and reuse the aScope™ Duodeno as it is a single-use device
and cannot be reprocessed. Reuse of the product can cause contamination, leading to
infections.
•
Do not use the aScope™ Duodeno if the product sterilization barrier or its packaging is
damaged.
•
A new bottle of sterile water with at least 1000ml in volume should be used for each
procedure. Using an opened bottle of water may lead to cross-contamination or infection.
•
To guard against dangerous chemicals and potentially infectious material during the
procedure and danger of unintentional diathermy burns, wear personal protective equipment
such as eyewear, face mask, moisture-resistant clothing, and chemical and electrical-resistant
gloves that fit properly and are long enough so that your skin is not exposed. Please note that
a new pair of gloves is required prior to each procedure.
Preparation for Use
•
Before endoscopy, remove any metallic objects (watch, glasses, necklace, etc.) from the
patient. Performing high-frequency cauterization treatment while the patient is wearing
metallic objects may cause burns on the patient in areas around the metallic objects.
•
Using an endoscope that is not functioning properly or is suspected to be defective may
compromise patient or operator safety and could potentially result in severe equipment
damage.Inspect the endoscope for damages prior to use. Check the functionality of the
endoscope prior to use. Be sure always to have another endoscope available and ready for
use to avoid any unnecessary delay due to equipment failure or malfunction.
Operator Instructions
•
Do not strike, hit, or drop the endoscope’s distal end, insertion tube, bending section,
control section, umbilicus, and/or endoscope connector. Also, do not bend, pull, or twist
the endoscope’s distal end, insertion tube, bending section, control section, umbilicus, or
endoscope connector with excessive force. The endoscope may be damaged and could
cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the
endoscope to fall off inside the patient.
•
Do not stare directly into the distal end of the endoscope and avoid patient eye contact
with the distal end of the endoscope while the examination light is ON. Keep your eyes
away from the distal end when inserting endoscopic accessories as eye injury could
potentially result.
•
No modification of this equipment is allowed.
•
Do not leave the endoscope illuminated before and after examination otherwise the LEDs
could be directed toward to the opened eyes of the sedated patient and can cause retina
burns.
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