EN
6
NOTE
Advises owner/operator about important information on the use of this equipment.
GENERAL WARNINGS
- Do not use the aScope 3 system if it is damaged in any way.
- Perform a functional check before using the aScope 3 system (see section 4). Do not use the aScope 3 system if any part of the functional check fails.
- Do not attempt to clean and reuse the aScope 3 on another patient as it is a single-use device.
- The aScope 3 system is not to be used when delivering highly flammable anaesthetic gases to the patient. This could potentially cause patient injury.
- The aScope 3 system is neither MRI safe nor MRI compatible.
- Do not use the aScope 3 system during defibrillation.
- When handling the patient do not simultaneously touch the aView power socket or docking connector.
- Only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.
- Excessive force should never be used when operating aScope 3.
- Patients should be adequately monitored at all times during use.
- Always watch the live endoscopic image on the aView when advancing or withdrawing the scope 3, operating the bending section or suctioning.
Failure to do so may harm the patient.
- The aScope 3 system may cause interference or disrupt equipment operations nearby. It may be necessary to adopt procedures for mitigation,
such as reorientation or relocation of the equipment or shielding of the room in which it is used.
GENERAL CAUTION
- Be careful not to damage the insertion cord or distal tip when using sharp devices such as needles in combination with the aScope 3.
- Be careful when handling the distal tip of the insertion cord and do not allow it to strike other objects, as this may result in damage to the equipment.
The lens surface of the distal tip is fragile and visual distortion may occur.
- Do not exert excessive force on the bending section as this may result in damage to the equipment. Examples of inappropriate handling of the
bending section include:
- Manual twisting.
- Operating it inside an ETT or in any other case where resistance is felt.
- Inserting it into a preshaped tube or a tracheostomy tube with the bending direction not aligned with the curve of the tube.
- US federal law restricts these devices for sale only by, or on the order of, a physician.
- Keep the aScope 3 handle and the aView dry during preparation, use and storage.
- The batteries in aView are not changeable and must only be removed upon disposal.
- Portable electronic equipment may affect the normal function of the aScope 3 system
GENERAL NOTES
Have a suitable backup system readily available for immediate use so the procedure can be continued if a malfunction should occur.
Ambu is not responsible for any damage to the system or patient resulting from incorrect use.
2. System Parts
CAUTION
The aScope 3 system consists of the parts described in section 2. They may only be replaced by Ambu authorized parts. Failure to comply with this
may reduce safety and efficiency.
2.1. System Parts
Before you install and use the system please ensure that the following items are available:
