Intended Use; Indications For Use - Ambu aScope BronchoSampler Instrucciones De Uso

1. Important Information – read before use
Read these safety instructions carefully before using the aScope BronchoSampler™. 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 pre-
cautions related to the operation of the aScope BronchoSampler™. Before initial use of the aScope
BronchoSampler™, it is essential for operators to have received sufficient training in clinical endoscopic techniques
and to be familiar with the intended use, cautions and indications mentioned in these instructions.

1.1. Intended Use

aScope BronchoSampler™ is a sterile single-use device designed as an add-on to aScope™ 4 Broncho during a
Broncho Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure. aScope BronchoSampler™ is in combination
with an aScope 4 Broncho device designed to enable aspiration and collection a fluid sample(s) from the bron-
chial or alveolar part of the lung.

1.2. Indications for Use

aScope BronchoSampler™ is for use in a hospital environment. aScope BronchoSampler™ is a single-use
device designed for use in adults.
1.3. Cautions
Failure to observe these 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.
CAUTIONS
1. For single use only. Use on other patients can cause cross contamination. Do not soak, rinse, or sterilize this
device as these procedures may leave harmful residues or cause malfunction of the device.
2. Only to be used by skilled professionals trained in clinical endoscopic techniques and procedures.
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