Ambu aScope 5 Broncho HD 5.0/2.2 Mode D'emploi page 4

1. Important information – Read before use
Read these instructions for use carefully before using the aScope 5 Broncho HD. The Instructions
for use may be updated without further notice. Copies of the current version are available upon
request. Note that these instructions do not explain or discuss clinical procedures. They describe
only the basic operation and precautions related to the operation of the endoscope. Before
initial use of the endoscope, it is essential for operators to have received sufficient training in
clinical endoscopic techniques and to be familiar with the intended use, indications, warnings,
cautions, and contraindications mentioned in these instructions. There is no warranty on
the endoscope.
In this document endoscope refers to instructions that apply to the endoscope only and
system refers to information relevant for the aScope 5 Broncho HD and the compatible Ambu
displaying unit and accessories. Unless otherwise specified, endoscope refers to all aScope 5
Broncho HD variants.
In this document the term aScope 5 Broncho HD refers to the Ambu® aScope™ 5 Broncho HD.
1.1. Intended use
aScope 5 Broncho HD is intended for endoscopic procedures and examination within the airways
and tracheobronchial tree.
aScope 5 Broncho HD is intended to provide visualization via a compatible Ambu displaying
unit, and to allow passing of endotherapy instruments via its working channel.
Intended patient population
Adults.
Intended use environment
For use in hospital environments.
1.2. Indications for use
aScope 5 Broncho HD is intended for oral, nasal and percutaneous intubation and flexible
bronchoscopy procedures, in any clinical situation where intubation applies or in which a
clinician expects that bronchoscopy will have a substantial diagnostic or therapeutic impact.
1.3. Contraindications
None known.
1.4. Clinical benefits
Single-use application minimizes the risk of cross-contamination of the patient.
1.5. Warnings and cautions
WARNINGS
1. Only to be used by healthcare professionals trained in clinical endoscopic techniques
and procedures. Failure to comply with this may result in patient injury.
2. The endoscope is a single-use device and must be handled in a manner consistent with
accepted medical practice for such devices in order to avoid contamination of the
endoscope prior to insertion.
3. In order to avoid contamination, do not use the endoscope if the product sterilization
barrier or its packaging is damaged.
4. Do not attempt to clean and reuse the endoscope as it is a single-use device. Reuse of
the product can cause contamination, leading to infections.
5. Do not use the endoscope or an endotherapy instrument if it is damaged in any way or
if any part of the functional check fails (see section 4.1. as failure to comply may result
in patient injury).
6. In order to promptly detect events of desaturation, patients should be monitored at all
times during use.
7. If any malfunction occurs during the endoscopic procedure, stop the procedure
immediately to avoid patient injury and withdraw the endoscope.
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