Ambu aScope Gastro Manual De Instrucciones página 4

1. Important information – Read before use
Read the Instructions for Use (IFU) carefully before using the Ambu® aScope™ Gastro or Ambu®
aScope™ Gastro Large� These instructions describe the function, setup and precautions related
to operating the Ambu® aScope™ Gastro or Ambu® aScope™ Gastro Large� Please be aware that
these instructions do not describe clinical procedures� Prior to use of the Ambu® aScope™ Gastro
or Ambu® aScope™ Gastro Large, 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 or Ambu® aScope™ Gastro Large� In this document Ambu® aScope™
Gastro and Ambu® aScope™ Gastro Large refer to instructions which apply to the endoscopes
only, while system often refers to information relevant for the Ambu® aScope™ Gastro or
Ambu® aScope™ Gastro Large in combination with 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 endoscope refers to the Ambu® aScope™ Gastro and Ambu® aScope™
Gastro Large and displaying unit refers to Ambu® aBox™ 2.
1.1. Intended use
The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic
access to and examination of the upper gastrointestinal anatomy� The endoscope 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 endoscope is intended to be used in adults; this means patients with the age of 18 years
or above� The endoscope 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 endoscope, when used with the compatible displaying unit, enables visualization,
examination, and endoscopic intervention of key anatomical structures in the upper
gastrointestinal (GI) tract, particularly esophagus, 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
endoscope is a sterile single-use medical device�
1.5. Warnings and cautions
WARNINGS
1� For single use only� Do not reuse, reprocess or resterilize as these processes may leave
harmful residues or cause malfunction of the endoscope� Reuse of the endoscope may
cause cross-contamination potentially leading to infections�
2� Confirm that the opening of the insufflation/rinsing valve is not blocked or covered,
and that the insufflation pressure does not exceed the given limit� If gas is excessively
insufflated into the patient this may result in patient pain, bleeding, perforation and/or
gas embolism�
3� Prior to use always perform an inspection and functionality check according to sections
3�1 and 3�4� Do not use the device if the endoscope 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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