Adverse Events; General Notes; System Description; System Parts - Ambu aScope 4 RhinoLaryngo Intervention Instrucciones De Uso

14. The distal tip of the endoscope may get warm due to heating from the light emission
part. Avoid long periods of contact between the distal tip of the device and the mucosal
membrane as sustained contact with the mucosal membrane may cause mucosal injury.
15. Insert the syringe completely into the working channel port before instilling fluid.
Failure to do so may result in the fluid spilling from the working channel port.
CAUTIONS
1. Have a suitable backup system readily available in case a malfunction should occur.
2. Be careful not to damage the insertion cord or distal tip. Do not allow other objects
or sharp devices such as needles to strike the endoscope.
3. US federal law restricts these devices for sale only by, or on the order of, a physician.
4. The color representation of blue dye might be impaired on the live endoscopic image.
5. Operating the aScope 4 RhinoLaryngo Intervention with reverse grip of the handle will
cause an image on the display that is upside down.

1.5. Adverse events

Potential adverse events in relation to
flexible rhinolaryngoscopy (not exhaustive):

1.6. General notes

If, during the use of this device or as a result of its use, a serious incident has occurred, please
report it to the manufacturer and to your national authority.

2. System description

The endoscope can be connected to the compatible displaying unit. For information about the
compatible displaying unit, please refer to its Instruction for use.

2.1. System parts

Endoscopes
aScope 4 RhinoLaryngo Intervention is not available in all countries. Please contact your
local sales office.
Product name
aScope 4 RhinoLaryngo Intervention
2.2. Product compatibility
The aScope 4 RhinoLaryngo has been designed to be used in conjunction with:
Displaying unit
– Ambu aView
– Ambu aView 2 Advance
Endoscopic accessories
– Suctioning tubes of inner diameter between 6,5 and 9,5 [mm].
– Standard 6% conical Luer syringe up till 50ml.
– Adaptor compatible with working channel port and standard 6% conical Luer lock syringes.
– Endoscopic accessories labeled for diameter (ID) 2.2 mm or less.
– Tracheostomy tubes size 6 or larger.
Epistaxis, Laryngospasm, Damage to vocal
cords, Damage to mucosa, Gag reflex,
Pain/discomfort, Desaturation.
Part numbers:
512001000 aScope 4 RhinoLaryngo Intervention
Colour Outer diameter
[mm]
Green min 5.0; max 5.5
Inner diameter
[mm]
min 2.0