Intended Use/Indications For Use; Intended Patient Population - Ambu aScope Gastro Instrucciones De Uso

1. Important Information – Read Before Use!
Read the Instructions for Use (IFU) carefully before using the aScope™ Gastro. These
instructions describe the function, set-up and precautions related to operating the
aScope Gastro. Please be aware that these instructions do not describe clinical procedures.
Prior to use of the aScope Gastro, it is important for operators to have received sufficient
training in clinical endoscopic techniques and to be familiar with the intended use,
warnings, cautions, indications and contraindications mentioned in these instructions.
There is no warranty for the aScope Gastro. In this document aScope Gastro refers to
instructions which apply to the endoscope only, while system often refers to information
relevant for the aScope Gastro and the compatible aBox™ 2 displaying unit and accessories.
The Instructions for Use may be updated without further notice. Copies of the current
version are available upon request.

1.1. Intended Use/Indications For Use

The aScope Gastro is a sterile, single-use, flexible gastroscope intended to be used
for endoscopic access to and examination of the upper gastrointestinal anatomy. The
aScope Gastro is intended to provide visualization via a compatible Ambu displaying
unit and to be used with endotherapy accessories and other ancillary equipment.

1.2. Intended Patient Population

The aScope Gastro is intended to be used in adults; this means patients with an age of
18 years or above. The aScope Gastro is used in patients with indications in the upper
gastrointestinal anatomy requiring visualization and/or examination with flexible
gastroscopy and use of endoscopic accessories and/or equipment.
1.3. Contraindications
No known contraindications.
1.4. Clinical Benefits
The aScope Gastro when used with the compatible aBox 2 displaying unit enables
visualization, examination and endoscopic intervention of key anatomical structures in
the upper GI tract, particularly esophagus, gastroesophageal junction, stomach, pylorus,
duodenal bulb and descending duodenum.
High-definition imaging technology will enable endoscopists to view finer mucosal
and vascular details.
The risk of patient cross-contamination is eliminated, as compared to reusable
endoscopes, as the aScope Gastro is a sterile single-use medical device. Also, the risk of
anaphylactic shock associated with exposure to high level disinfectants (as is possible
when using reprocessed scopes) is eliminated.
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