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5. Technical Product Specifications
5.1. Standards Applied
The aScope 3 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 3 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 3 Slim
aScope 3 Regular
130
,130
150
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
37
41
600 (23.6)
600 (23.6)
aScope 3 Slim
aScope 3 Regular
1.2 (0.047)
2.0 (0.079)
aScope 3 Slim/Regular/Large
10 ~ 40 (50 ~ 104)
10 ~ 25 (50 ~ 77)
30 ~ 85
80 ~ 109
aScope 3 Large
,130
140
5.8 (0.23)
6.2 (0.24)
6.3 (0.25)
7.0
-
600 (23.6)
aScope 3 Large
2.6 (0.102)
,110
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