Intended Use - Ambu aScope 3 Slim Manual Del Usuario

1. Important information – Read before use
Read these safety instructions carefully before using the endoscope. The Instruction 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 endo-
scope. Before initial use of the endoscope, it is essential for operators to have received suffi-
cient training in clinical endoscopic techniques and to be familiar with the intended use, warn-
ings, cautions, indications and contraindications mentioned in these instructions.
There is no warranty on the endoscope.
In this document endoscope refers to instructions which applies to the scope only and system
refers to information relevant for the endoscope and the displaying unit and accessories. Unless
specified otherwise, endoscope refers to all endoscope variants.

1.1. Intended use

The endoscope 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 pathol-
ogy. 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 pro-
vided to the patient during the procedure.
5. Do not use in patients with malignant arrhythmia, unstable cardiac status, acute myo-
cardial infarction 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 anaes-
thetic 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 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 Ambu 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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