Ambu aScope 4 Broncho Large, Instructions For Use Manual

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EN
13
Disposal 11
The sampler set is for single-use only. This means that all components must be disposed
of once opened and unused components cannot be saved for later use. The disposal must
be in accordance with local guidelines for collection of infected medical devices with
electronic components.
5. Technical product specifications
5.1. Standards applied
The aScope 4 Broncho Sampler Set 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.
– ISO 8600-1: Endoscopes - Medical endoscopes and endotherapy devices – Part 1:
General requirements.
– EN 14254: In Vitro Diagnostic medical devices – Single-use receptacles for the collection of
specimens, other than blood, from humans.
5.2. aScope 4 Broncho Sampler Set specifications
Insertion cord aScope 4 Broncho Regular aScope 4 Broncho Large
Bending section
1
[°]
180 ,180 180 ,160
Insertion cord diameter
[mm, (”)] 5.0 (0.20) 5.8 (0.23)
Distal tip diameter [mm, (”)] 5.4 (0.21) 6.3 (0.25)
Maximum diameter of
insertion portion [mm, (”)] 5.5 (0.22) 6.3 (0.25)
Minimum endotracheal
tube size (ID) [mm] 6.0 7.0
Minimum double lumen tube
size (ID) [Fr] 41 -
Working length [mm, (”)] 600 (23.6) 600 (23.6)
Working channel
aScope 4 Broncho Regular aScope 4 Broncho Large
Minimum instrument channel
width
2
[mm, (”)]
2.0 (0.079) 2.6 (0.102)
Storage aScope 4 Broncho Regular/Large Sampler Set
Recommended storage
temperature
3 [°C, (°F)]
10 ~ 25 (50 ~ 77)
Relative humidity [%] 30 ~ 85
Atmospheric pressure [kPa] 80 ~ 109
Optical system aScope 4 Broncho Regular/Large
Field of View [°] 85
Depth of Field [mm] 6 - 50
Illumination method LED