Ambu aScope 4 Broncho Slim Bedienungsanleitung Seite 11

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
– ISO 594-1: Conical fittings with 6% (Luer) taper for syringes, needles and certain other
medical equipment – Part 1: General requirements.
5.2. aScope 4 Broncho Specifications
Insertion portion
Bending section [°]
1
Insertion cord diameter
[mm, (")]
Distal end diameter [mm, (")]
Maximum diameter of
insertion portion [mm, (")]
Minimum endotracheal tube
size (ID) [mm]
Minimum double lumen
tube size (ID) [Fr]
Working length [mm, (")]
Channel
Minimum instrument
channel width [mm, (")]
2
Storage and transportation
Transportation temperature
[°C, (°F)]
Recommended storage
temperature [°C, (°F)]
3
Relative humidity [%]
Atmospheric pressure [kPa]
aScope 4 aScope 4
Broncho Slim Broncho Regular
180 ,180 180
3.8 (0.15) 5.0 (0.20)
4.2 (0.16) 5.4 (0.21)
4.3 (0.17) 5.5 (0.22)
5.0 6.0
35 41
600 (23.6) 600 (23.6)
aScope 4 aScope 4
Broncho Slim Broncho Regular
1.2 (0.047) 2.0 (0.079)
aScope 4 Broncho Slim/Regular/Large
10 ~ 40 (50 ~ 104)
10 ~ 25 (50 ~ 77)
30 ~ 85
80 ~ 109
aScope 4
Broncho Large
,180 180 ,160
5.8 (0.23)
6.2 (0.24)
6.3 (0.25)
7.0
-
600 (23.6)
aScope 4
Broncho Large
2.6 (0.102)
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