Standards Applied - Ambu aScope 5 Broncho HD Bedienungsanleitung

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
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.
5. Technical product specifications

5.1. 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.
5.2. aScope 5 Broncho HD specifications
Insertion cord
Bending section [°]
1
Insertion cord diameter
[mm, (")]
Maximum diameter of
insertion portion [mm, (")]
Distal tip diameter [mm, (")]
Minimum endotracheal
tube size (ID) [mm]
Working length [mm, (")]
Rotary function
Depth marks
Working channel
Instrument channel
width [mm, (")]
2
Minimum instrument channel
width [mm, (")]
2
Storage
Recommended storage
temperature [°C, (°F)]
3
Relative humidity [%]
Atmospheric pressure [kPa]
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)
6.0
600 (23.6) ± 10 (0.39)
120
O
5 cm
aScope 5 Broncho HD
5.0/2.2
2.2 (0.09)
min. Ø 2.05 (0.08)
aScope 5 Broncho HD 5.0/2.2 and HD 5.6/2.8
10 – 25 (50 – 77)
10 – 85
50 – 106
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)
7.0
600 (23.6) ± 10 (0.39)
120
O
5 cm
aScope 5 Broncho HD
5.6/2.8
2.8 (0.11)
min. Ø 2.65 (0.10)
13