Ambu aScope 4 Broncho Serie Mode D'emploi page 4

1. Important information – Read before use
Read these safety instructions carefully before using the aScope 4 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,
warnings, cautions and indications mentioned in these instructions.
There is no warranty on the endoscope.
In this document endoscope refers to instructions which applies to the endoscope only and system
refers to information relevant for the aScope 4 Broncho and the compatible Ambu displaying unit
and accessories. Unless specified otherwise, endoscope refers to all aScope 4 Broncho variants.
1.1. Intended use
The aScope 4 Broncho is a sterile, single-use, flexible endoscope intended for endoscopic
procedures and examination within the airways and tracheobronchial tree.
The endoscope is intended to provide visualization via Ambu displaying unit.
The endoscope is intended for use in a hospital environment. It is designed for use in adults.
1.2. Contra indications
None known.
1.3. Clinical benefits
Single use application minimises the risk of cross-contamination of the patient.
1.4. Warnings and cautions
WARNINGS
1. 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.
2. The endoscope images must not be used as an independent diagnostic of any
pathology. Physicians must interpret and substantiate any finding by other means and
in the light of the patient's clinical characteristics.
3. Do not use active endoscopic accessories such as laser probes and electrosurgical
equipment in conjunction with the endoscope, as this may result in patient injury or
damage to the endoscope.
4. The device should not be used if adequate supplemental oxygenation cannot be
provided to the patient during the procedure.
5. The user must exercise professional judgement when deciding whether a bronchoscopy
procedure will be appropriate for patients with the following conditions, since they have
a higher rate of serious complications; malignant arrhythmia, unstable cardiac status,
acute myocardial infraction within 4-6 weeks, refractory hypoxemia, bleeding diathesis
or severe thrombocytopenia if biopsy is indicated.
6. Do not use the endoscope if it is damaged in any way or if any part of the functional
check (see section 4.1) fails.
7. 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.
8. The endoscope is not to be used when delivering oxygen or highly flammable
anaesthetic gases to the patient. This could potentially cause patient injury.
9. The endoscope is not to be used in a MRI environment.
10. Do not use the endoscope during defibrillation.
11. Only to be used by skilled physicians trained in clinical endoscopic techniques
and procedures.
12. Do not use excessive force when advancing, operating or withdrawing the endoscope.
13. Patients should be adequately monitored at all times during use.
14. Always watch the live endoscopic image on the displaying unit when advancing or
withdrawing the endoscope, operating the bending section or suctioning. Failure to
do so may harm the patient.
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