Ambu aScope 4 Broncho Large, Инструкция по эксплуатации

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1. Important information – Read before use
Read these safety instructions carefully before using the aScope 4 Broncho Sampler Set.
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 endoscope and BronchoSampler. Before initial use of the Sampler Set, it is
essential 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 on the sampler set.
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 available for sampler set.
1.1. Intended use
aScope 4 Broncho Sampler Set consists of sterile, single-use, flexible endoscope with sample
containers (aScope BronchoSampler), intended for endoscopic procedures and examination
within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-
on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW)
procedure which enables aspiration and collection of fluid sample(s) from the bronchial or
alveolar part of the lung.
It is designed for use in adults and intended for use in a hospital environment. It is intended to
provide visualization via Ambu Displaying Unit.
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
Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment.
Ambu is not responsible for any damage to the system or patient injury
resulting from incorrect use.
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.