Ambu aScope 사용 설명서 지침 - 페이지 5

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NOTES

• The information given in these instructions serves only to instruct in the correct handling of the system.

• Ambu is not responsible for any damage to the system resulting from incorrect use.

• Read these safety instructions carefully and keep them for later reference.

• Dispose of the Ambu® aScope™ in a safe manner in accordance with local guidelines for medical waste that includes electronic components.

• At the end of product life open the Ambu® aScope™ Monitor, remove the batteries and dispose of them in accordance with local guidelines.

• The batteries should only be removed from the Ambu® aScope™ Monitor at disposal.

• The batteries are not changeable.

• To avoid risk of contamination, the Ambu® aScope™ cable should not lie on the floor.

• During start up of the Ambu® aScope™ Monitor flickering can appear on the screen for less than one second.

• For single patient use only. Use on other patient can cause cross infection. Do not soak rinse, or sterilize this device as these procedures may leave

harmful residues or cause malfunction of the device. The design and material used are not compatible with conventional cleaning and sterilization

procedures.

2. Intended Use

The Ambu® aScope™ is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask dur-

ing non-difficult and difficult intubation procedures. The Ambu® aScope™ achieves its purpose by providing the user with a visual confirmation of where

the tip of the Ambu® aScope™ is in the human anatomy. The flexible tip of the Ambu® aScope™ allows the user to guide the ETT in the desired direction.

The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.

Topical anesthetics can be administered via a channel with a luer connector.

3. System Parts

Before you install and use the system, please ensure that the following items are available:

Ambu® aScope™ - Single Patient Use device:

1. Ambu® aScope™

Ambu® aScope™ Monitor - Reusable device:

2. Ambu® aScope™ Monitor

3. Monitor bracket (for attaching the monitor on e.g. an I.V. pole)

4. Power supply and adaptors.

Monitor power supply manufacturer: GlobTek, Inc.

Monitor power supply part number: GS-1883(RE)

5. Cable for video out

6. Instruction for Use

aScope™

Ambu

Single Patient Use Flexible Intubation Scope

Instruction for use

492 810 000 v.1.0.0

Printed in Malaysia