- ページ 4

医療機器 Ambu 480500000のPDF 取扱説明書をオンラインで閲覧またはダウンロードできます。Ambu 480500000 10 ページ。 Ascope 5 broncho sampler set (part 2 of 2)

1. Important information – Read before use

Read these Instructions for Use carefully before using the aScope™ 5 Broncho Sampler Set�

These instructions contain part 2 of 2 of the instructions for the use of the aScope™ 5 Broncho

Sampler Set:

•

Part 1 of 2: Basic procedures using the aScope™ 5 Broncho�

•

Part 2 of 2: Fluid sampling using the BronchoSampler 60 with the aScope™ 5 Broncho�

Before initial use, it is essential for operators to have received sufficient training in clinical

endoscopic techniques and to be familiar with the intended use, contraindications, warnings

and cautions mentioned in these Instructions for Use� 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�

There is no warranty on the aScope™ 5 Broncho Sampler Set�

In these Instructions for Use, the term BronchoSampler 60 refers to the closed loop fluid

sampling system to be used with the aScope™ 5 Broncho as part of the aScope™ 5 Broncho

Sampler Set� The term aScope BronchoSampler™ 60 SC refers to the sample container alone�

See section 2�1� for more information�

1.1. Intended use

aScope 5 Broncho Sampler Set enables aspiration and collection of fluid samples�

Bronchoscopic fluid sampling via techniques such as Broncho Alveolar Lavage (BAL) and

Bronchial Wash (BW)� The collected specimens undergo microbiological and cytological

laboratory analyses for diagnosis and/or surveillance of suspected respiratory infections,

interstitial lung diseases or lung cancer�

1.3. Contraindications

None known for fluid sampling using the BronchoSampler 60� For basic procedures using the

aScope™ 5 Broncho, please refer to the Instructions for Use part 1 of 2�

For warnings and cautions related to the use of aScope™ 5 Broncho, please refer to the

Instructions for Use part 1 of 2�

WARNINGS

1�

For single-use only� The sample container is not intended to be reprocessed or reused,

even when used on the same patient or procedure� Failure to ensure this may cause

contamination of the sample and lead to misdiagnosis�

CAUTIONS

1�

Do not use the aScope BronchoSampler 60 SC in a centrifuge, as this may cause the

container to break or leak�

2�

Do not transport the aScope BronchoSampler 60 SC in a pneumatic tube system,

as this may cause the container to leak�