1. Important Information – Read Before Use
Read these safety instructions carefully before using the aScope 4 Broncho. The Instruction 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 aScope 4
Broncho. Before initial use of the aScope 4 Broncho, it is essential for operators to have received
sufficient training in clinical endoscopic techniques and to be familiar with the intended use,
warnings, cautions, indications and contraindications mentioned in these instructions.
There is no warranty on the aScope 4 Broncho.
In this document
aScope 4 Broncho
refers to instructions which applies to the scope only and
aScope 4 Broncho system
refers to information relevant for the aScope 4 Broncho and the aView
monitor and accessories. Unless specified otherwise, aScope 4 Broncho refers to all aScope 4
Broncho variants.
1.1. Intended Use
The aScope 4 Broncho endoscopes have been designed to be used with the aView monitor,
endotherapy accessories and other ancillary equipment for endoscopy within the airways
and tracheobronchial tree.
1.2. Indications for Use
The aScope 4 Broncho is for use in a hospital environment. The aScope 4 Broncho is a single-use
device designed for use in adults. It has been clinically evaluated for the following
endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA) sizes:
Minimum ETT
inner diameter
Minimum
DLT size
EA minimum working
channel width
aScope 4 Broncho Slim 3.8/1.2
5.0 mm
37 Fr
up to 1,2 mm
aScope 4 Broncho Regular 5.0/2.2
6.0 mm
41 Fr
up to 2.0 mm
aScope 4 Broncho Large 5.8/2.8
7.0 mm
-
up to 2.6 mm
There is no guarantee that instruments selected solely using this minimum instrument channel width will be
compatible in combination.
1.3. Warnings and Cautions
Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment.
Ambu is not responsible for any damage to the system or patient injury
resulting from incorrect use.
WARNINGS
1. aScope 4 Broncho 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
aScope 4 Broncho prior to insertion.
2. aScope 4 Broncho 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.
3. Do not use active endoscopic accessories such as laser probes and electrosurgical
equipment in conjunction with the aScope 4 Broncho, as this may result in patient injury
or damage to the aScope 4 Broncho.
4. Do not use the aScope 4 Broncho if it is damaged in any way or if any part of the
functional check (see section 4.1) fails.
5. Do not attempt to clean and reuse the aScope 4 Broncho as it is a single-use device.
Reuse of the product can cause contamination, leading to infections.
6. The aScope 4 Broncho is not to be used when delivering highly flammable anaesthetic
gases to the patient. This could potentially cause patient injury.
7. The aScope 4 Broncho is not to be used in a MRI environment.
8. Do not use the aScope 4 Broncho during defibrillation.
9. Only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.
4
