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1. Important information – read before use
NOTE
Read these safety instructions carefully before using the aScope 3 system. The Instructions for use may be updated without further notice. Copies
of the current version are available upon request.
WARNING
- 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.
- 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.
1.1. Instructions
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 system. Before initial use of the aScope 3 system, it is essential for operators to have received sufficient training in clinical endo-
scopic techniques and to be familiar with the intended use, warnings, cautions, notes, indications and contraindications mentioned in these instructions.
1.2. 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.
1.3. Indications for use
The aScope 3 system is for use in a hospital environment.
The aScope 3 is a single-use device designed for use in adults and children. It has been clinically evaluated for the following minimum endotracheal tubes
(ETT) and double lumen tubes (DLT) sizes:
Minimum ETT inner diameter
Minimum DLT size
aScope 3 Slim 3.8/1.2
aScope 3 5.0/2.2
5.0mm
6.0mm
37Fr
41Fr
Endoscopic accessories designed for a minimum working channel width up to 1,2 mm can be used with the aScope 3 Slim 3.8/1.2 .Endoscopic accessories
designed for a minimum working channel width1 up to 2.0 mm can be used with the 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.
WARNING
Do not use active endoscopic accessories such as laser probes and electrosurgical equipment in conjunction with the aScope 3 system, as this may result
in patient injury or damage to aScope 3 system.
1.4. Warnings, Cautions and Notes
Throughout these instructions, appropriate warnings, cautions and notes are given describing potential safety hazards associated with the use of the
aScope 3 system. The information given in these instructions serves only to instruct in the correct handling of the system.
Throughout these instructions, the following definitions are used:
WARNING
Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the aScope 3 system.
CAUTION
Alerts the user to the possibility of a problem with the aScope 3 system associated with its use or misuse. Such problems include aScope 3 system
malfunction, aScope 3 system failure, damage to the aScope 3 system or damage to other property.
