Ambu aScope 5 Broncho 4.2 Mode D'emploi page 4

1. Important information – Read before use
Read these Instructions for use carefully before using the aScope 5 Broncho. The Instructions for
use may be updated without further notice. Copies of the current version are available upon
request. Please be aware 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 which apply to the endoscope only
and system refers to information relevant for the aScope 5 Broncho and the compatible
Ambu displaying unit and accessories. Unless otherwise specified, endoscope refers to all
aScope 5 Broncho variants.
In this document the term aScope 5 Broncho refers to the Ambu® aScope™ 5 Broncho.
1.1. Intended use
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways
and tracheobronchial tree.
aScope 5 Broncho 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
Adult.
Intended use environment
For use in hospital environments.
1.2. Indications for use
The aScope 5 Broncho 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 minimises 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 sterilisation
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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