1. Important Information – Read Before Use
Read the safety instructions carefully before using the Ambu® aScope™ 4 RhinoLaryngo
Intervention. 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 operations of aScope 4 RhinoLaryngo Intervention.
Before initial use of the aScope 4 RhinoLaryngo Intervention it is essential for operators to have
received sufficient training in clinical endoscopic techniques and to be familiar with the intended
use, warnings and cautions mentioned in these instructions.
In this Instruction for Use, the term
endoscope
refers to instructions for aScope 4 RhinoLaryngo
Intervention, and
system
refers to aScope 4 RhinoLaryngo Intervention and the compatible
Ambu monitor. This Instruction for Use applies for the endoscope and information relevant for
the system.
1.1. Intended Use
The endoscope is a sterile, single-use, flexible endoscope intended for endoscopic procedures
and examination within the nasal lumens and upper airway anatomy. The endoscope is
intended to provide visualization via a monitor.
The endoscope is intended for use in a hospital environment. It is designed for use in adults.
1.2. Warnings and Cautions
Failure to observe these warning and cautions may result in patient injury or damage to
the equipment.
Ambu is not responsible for any damage to the system or patient resulting from incorrect use.
WARNINGS
1. Only to be used by physicians, trained in clinical endoscopic techniques and procedures.
2. The endoscope is a single-use product 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. Do not soak, rinse, or sterilize this device as these procedures may leave harmful
residues or cause malfunction of the device. Reuse of the endoscope can cause
contamination, leading to infections.
4. Do not use the endoscope if the sterilisation barrier or its packaging is damaged.
5. Do not use the endoscope if it is damaged in any way or if the preuse check fails
(see section 4.1).
6. The images must not be used as an independent diagnostic of any pathology.
Physicians must interpret and substantiate any finding by other means and in the light
of the patient's clinical characteristics.
7. Do not use active endoscopic accessories such as laser probes and electrosurgical
equipment in conjunction with the endoscope, as this may result in patient injury or
damage to endoscope.
8. The endoscope is not to be used when delivering highly flammable anaesthetic gases
to the patient. This could potentially cause patient injury.
9. Always watch the live endoscopic image on the compatible monitor during suctioning.
Failure to do so may harm the patient.
10. Patients should be adequately monitored at all times. Failure to do so may harm the patient.
11. Always make sure that the bending section is in a straight position when inserting and
withdrawing the endoscope. Do not operate the bending lever and never use excessive
force, as this may result in injury to the patient and/or damage to the endoscope.
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