5. Technical Product Specifications
5.1. Standards Applied
The aScope 4 Broncho function conforms with:
– Council Directive 93/42/EEC concerning Medical Devices.
– IEC 60601-1 ed 2 Medical electrical equipment – Part 1: General requirements for safety.
– IEC 60601-1 ed 3.1 Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance.
– IEC 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the
safety of endoscopic equipment.
– ISO 8600-1: Optics and photonics - Medical endoscopes and endotherapy devices - Part 1:
General requirements.
– IEC 60601-1-2: Medical electrical equipment – Part 1-2 General requirements for safety –
Collateral standard: Electromagnetic compatibility - Requirements for test.
– ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a
risk management process
5.2. aScope 4 Broncho Specifications
Insertion portion
aScope 4
Broncho Slim
aScope 4
Broncho Regular
aScope 4
Broncho Large
Bending section
1
[°]
180 ,180
180 ,180
180 ,160
Insertion cord diameter
[mm, (”)]
3.8 (0.15)
5.0 (0.20)
5.8 (0.23)
Distal end diameter [mm, (”)]
4.2 (0.16)
5.4 (0.21)
6.2 (0.24)
Maximum diameter of
insertion portion [mm, (”)]
4.3 (0.17)
5.5 (0.22)
6.3 (0.25)
Minimum endotracheal tube
size (ID) [mm]
5.0
6.0
7.0
Minimum double lumen
tube size (ID) [Fr]
37
41
-
Working length [mm, (”)]
600 (23.6)
600 (23.6)
600 (23.6)
Channel
aScope 4
Broncho Slim
aScope 4
Broncho Regular
aScope 4
Broncho Large
Minimum instrument
channel width
2
[mm, (”)]
1.2 (0.047)
2.0 (0.079)
2.6 (0.102)
Storage and transportation
aScope 4 Broncho Slim/Regular/Large
Transportation temperature
[°C, (°F)]
10 ~ 40 (50 ~ 104)
Recommended storage
temperature
3
[°C, (°F)]
10 ~ 25 (50 ~ 77)
Relative humidity [%]
30 ~ 85
Atmospheric pressure [kPa]
80 ~ 109
EN
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