Ambu aScope 5 Broncho Bedienungsanleitung Seite 12

Do not open the tip of the endotherapy instrument or extend the tip of the endotherapy instrument
from its sheath while the instrument is in the working channel, as this could damage both the
endotherapy instrument and the endoscope.
Insertion of active endotherapy instruments 7d
Active endotherapy instruments should always be operated as specified in the respective
manufacturer's Instructions for Use. Users must always be familiar with safety precautions and
guidelines on the proper use of active endotherapy instruments, including use of adequate
personal protective equipment.
Do not activate an endotherapy instrument in the working channel until the instrument distal
end can be seen in the image.
Note that the use of active endotherapy instruments may interfere with the normal endoscopic
image. This interference does not indicate that there is a malfunction in the endoscopic system.
A variety of factors can affect the quality of the endoscopic image during use of active
endotherapy instruments. Factors such as intensity, high power setting, close distance of
the instrument probe to the endoscope tip and excessive tissue burning can each adversely
influence image quality.
Withdrawal of the endoscope 8
When withdrawing the endoscope, make sure that the control lever is in the neutral position.
Slowly withdraw the endoscope while watching the live endoscopic image.
3.3. After use
Visual check 9
1. Are there any missing parts on the bending section, lens, or insertion cord? If yes, take
corrective action to locate the missing part(s).
2. Is there any evidence of damage on the bending section, lens, or insertion cord? If yes,
examine the integrity of the product and determine whether there are any missing parts.
3. Are there cuts, holes, sagging, swelling or other irregularities on the bending section,
lens, or insertion cord? If yes, examine the product to determine whether there are any
missing parts.
If corrective actions are needed (step 1 to 3), act according to local hospital procedures.
Disconnection
Disconnect the endoscope from the display unit 10 . The aScope 5 Broncho is a single-use
device. Do not soak rinse, or sterilize this device, as such actions could leave harmful residues
or cause the device to malfunction. The design and materials used are not compatible with
conventional cleaning and sterilization procedures.
Disposal 11
The used aScope 5 Broncho is considered contaminated after use and must be disposed of in
accordance with local guidelines for the collection of infected medical devices with electronic
components.
4. Technical product specifications
4.1. Standards applied
The endoscope conforms with:
– EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
– EN 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the basic
safety and essential performance of endoscopic equipment.
– IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
requirements and tests.
– ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process.
– ISO 8600-1 Endoscopes – Medical endoscopes and endotherapy devices – Part 1:
General requirements.
12