Ambu 624001000US Gebrauchsanweisung Handbuch - Seite 4

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1. Important information – Read before use

Read these instructions for use carefully before using the aScope 5 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,

indications, warnings, cautions, and contraindications mentioned in these instructions.

There is no warranty on the endoscope.

In this document endoscope refers to instructions which apply to the endoscope only

and system refers to information relevant for the aScope 5 Broncho and the compatible

Ambu displaying unit and accessories. Unless otherwise specified, endoscope refers to all

aScope 5 Broncho variants.

In this document the term aScope 5 Broncho refers to the Ambu® aScope™ 5 Broncho.

aScope 5 Broncho is intended for endoscopic procedures and examination within the airways

and tracheobronchial tree.

aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit,

and to allow passing of endotherapy instruments via its working channel.

Intended patient population

Adult.

Intended use enviroment

For use in hospital enviroments.

None known.

Single-use application minimises the risk of cross-contamination of the patient.

WARNINGS

1. Only to be used by healthcare professionals trained in clinical endoscopic techniques

and procedures. Failure to comply with this may result in patient injury.

2. 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.

3. In order to avoid contamination, do not use the endoscope if the product sterilisation

barrier or its packaging is damaged.

4. 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.

5. Do not use the endoscope or an endotherapy instrument if it is damaged in any way or

if any part of the functional check fails (see section 4.1.) as failure to comply may result

in patient injury.

6. In order to promptly detect events of desaturation, patients should be monitored at all

times during use.

7. If any malfunction occurs during the endoscopic procedure, stop the procedure

immediately to avoid patient injury and withdraw the endoscope.