CAUTIONS
Indicate a potentially hazardous situation which, if not avoided, may result in minor
or moderate injury. It may also be used to alert against unsafe practices or potential
equipment damage.
General
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US federal law restricts this device for sale only by, or on the order of, a physician.
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Keep the aScope™ Duodeno dry during preparation, use and storage.
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The aScope™ Duodeno is not intended to be repaired. If defective, the aScope™
Duodeno should be returned to Ambu. For more information please refer to Section 6.
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Electromagnetic interference may occur on this device near equipment marked
with the following symbol or other portable and mobile RF (radio frequency)
communications equipment, such as cellular phones. If electromagnetic interference
occurs, mitigation measures may be necessary, such as reorienting or relocating this
device, or shielding the location.
Unpacking and Placing the Endoscope
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Do not use a knife or another sharp instrument to open the pouch or cardboard box.
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Place the aScope™ Duodeno on a level surface while unpacking. Dropping the
aScope™ Duodeno could damage it.
Prior to Use
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To prevent the patient from biting the endoscope, it is recommended that a
mouthpiece is placed in the patient's mouth before inserting the endoscope.
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Never use a mouthpiece that is deformed, damaged or shows other irregularities,
otherwise, patient injury and/or equipment damage may occur.
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To prevent the patient from breaking one or more teeth, make sure there are no teeth
that are not permanently capped or no missing teeth, prior to examination.
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To prevent the patient of losing a dental prosthesis, make sure the patient removes it
prior to examination.
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Do not allow the suction canister to fill completely. The suction canister must be
changed after each examination. Using a filled suction canister may lead to loss of the
suction function, loss of cooling or malfunction of the suction pump.
Operating the Endoscope
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Be careful not to damage the insertion tube or distal end when using sharp devices in
combination with the aScope™ Duodeno. The endoscope connector will disconnect
from the endoscope connector socket on the aBox Duodeno and the endoscopic
image will be lost.
•
Be careful when handling the distal end of the insertion tube and do not allow it to
strike other objects, as this may result in damage to the equipment. The lens surface
at the distal end is fragile and visual distortion may occur.
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Do not coil the insertion tube or the umbilicus in a diameter of less than 12 cm.
Equipment damage may result if so.
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Do not attempt to bend the endoscope's insertion section with excessive force.
Otherwise, the insertion section may be damaged.
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Do not twist or bend the bending section with your hands. Equipment damage
may result if so.
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The endoscope's suction valve and insufflation/rinsing valve cannot be removed
from the control section. Pressing, pulling, or twisting them with excessive force can
break the switches and/or cause water leaks.
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The endoscope's insufflation and rinsing valves cannot be removed from the control
section. Pressing, pulling, or twisting them with excessive force can break the
switches and/or valves which will lead to loss of functionality.
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