Publicidad
1. Important Information – Read Before Use
Read these safety instructions carefully before using the aScope 3. 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 3. Before initial use of
the aScope 3, 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 3.
In this document aScope 3 refers to instructions which applies to the scope only and aScope 3
system refers to information relevant for the aScope 3 and the aView monitor and accessories.
Unless specified otherwise, aScope 3 refers to all aScope 3 variants.
1.1. Intended Use
The aScope 3 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 3 is for use in a hospital environment. The aScope 3 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:
aScope 3 Slim 3.8/1.2
aScope 3 Regular 5.0/2.2*
aScope 3 Large 5.8/2.8
*aScope 3 Regular 5.0/2.2 is identical to aScope 3 5.0/2.2.
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 3 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 3 prior to insertion.
2.
aScope 3 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 3, as this may result in patient injury or
damage to the aScope 3.
4.
Do not use the aScope 3 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 3 as it is a single-use device. Reuse of the
product can cause contamination, leading to infections.
6.
The aScope 3 is not to be used when delivering highly flammable anaesthetic gases to
the patient. This could potentially cause patient injury.
7.
The aScope 3 is not to be used in a MRI environment.
8.
Do not use the aScope 3 during defibrillation.
9.
Only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.
4
Minimum ETT
Minimum
inner diameter
DLT size
5.0 mm
37 Fr
6.0 mm
41 Fr
7.0 mm
-
EA minimum working
channel width
up to 1.2 mm
up to 2.0 mm
up to 2.6 mm
Publicidad
