Ambu aScope Gastro Instrucciones De Uso página 4

1. Important information – Read before use!
Read the Instructions for Use (IFU) carefully before using the Ambu® aScope™ Gastro.
These instructions describe the function, setup and precautions related to operating the
Ambu® aScope™ Gastro. Please be aware that these instructions do not describe clinical
procedures. Prior to use of the Ambu® 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 Ambu® aScope™ Gastro. In this document
Ambu® aScope™ Gastro refers to instructions which apply to the endoscope only, while
system often refers to information relevant for the Ambu® aScope™ Gastro and the
compatible Ambu® aBox™ 2 displaying unit and accessories. The IFU may be updated
without further notice. Copies of the current version are available upon request.
In this document, the term aScope Gastro refers to the Ambu® aScope Gastro™ and aBox 2
refers to Ambu® aBox™ 2.
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 endotherapy 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 gastrointestinal (GI) tract, particularly oesophagus, gastroesophageal junction,
stomach, pylorus, duodenal bulb and descending duodenum. High-definition imaging
technology will enable endoscopists to view mucosal and vascular structures. The risk of
endoscope-related patient cross-contamination is eliminated compared to reusable
endoscopes, as the aScope Gastro is a sterile single-use medical device.
1.5. Warnings and cautions
WARNINGS
1. For single-use only. Do not reuse, reprocess or resterilise as these processes may
leave harmful residues or cause malfunction of the aScope Gastro. Reuse of the
aScope Gastro may cause cross-contamination potentially leading to infections.
2. Confirm that the opening of the insufflation/rinsing valve is not blocked.
If the opening is blocked, gas is fed continuously and patient pain, bleeding,
perforation and/or gas embolism can result.
3. Prior to use always perform an inspection and functionality check according to
sections 4.1 and 4.4. Do not use the device if the aScope Gastro or its packaging
is damaged in any way or if the functionality check fails, as this can lead to
patient injury or infection.
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