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It should be recognized that the use of active endotherapy instruments may interfere with
the normal endoscopic image and this interference is not indicative of a malfunction of 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, then 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,
then examine the integrity of the product and conclude if 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, then examine the product to conclude if there are any
missing parts.
In case of corrective actions needed (step 1 to 3) act according to local hospital procedures.
Disconnect
Disconnect the endoscope from the displaying unit 10 . The aScope 5 Broncho HD is a single-
use device. Do not soak rinse, or sterilize this device as these procedures may leave harmful
residues or cause malfunction of the device. The design and materials used are not compatible
with conventional cleaning and sterilization procedures.
Disposal 11
The used aScope 5 Broncho HD is considered contaminated after use and must be disposed
of in accordance with local guidelines for 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.
– ISO 8600-1 Endoscopes – Medical endoscopes and endotherapy devices –
Part 1: General requirements.
4.2. aScope 5 Broncho HD specifications
Insertion cord
Bending section
[°]
1
Insertion cord diameter
[mm, (")]
Maximum diameter of
insertion portion [mm, (")]
Distal tip diameter [mm, (")]
12
aScope 5 Broncho HD
5.0/2.2
195
,195
5.0 (0.20) Ø 5.0 ± 0.2 (0.008)
max. Ø 5.7 (0.22)
5.4 (0.21) Ø 5.4 ± 0.08 (0.003)
aScope 5 Broncho HD
5.6/2.8
195
,195
5.6 (0.22) Ø 5.6 ± 0.2 (0.008)
max. Ø 6.3 (0.25)
6.0 (0.24) Ø 6.0 ± 0.08 (0.003)
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