Ambu aScope Duodeno Manual Del Usuario página 5

in a patient who is fully anticoagulated or therapeutically dosed anti-platelet agents.
Following conditions may as well contraindicate ERCP and need to be qualified:
• Patient has suffered a prior severe allergic reaction to ERCP contrast medium.
• Unstable cardiopulmonary, neurologic or cardiovascular status of the patient.
• Severe uncorrected coagulopathy.
1.4. Clinical Benefits
Single-use application minimises the risk of cross-contamination of the patient.
1.5. 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
Indicate 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
provided in sterile packaging, 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 as well as a malfunction of the device.
• 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 1.000 ml 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 to always have another
endoscope available and ready for use to avoid any unnecessary delays due to
equipment failure or malfunction.
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