Ambu aScope Gastro Manual De Instrucciones página 14

4. Device specifications
4.1. Standards applied
The endoscope conforms with:
– IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance�
– 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�
– IEC 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the basic
safety and essential performance of endoscopic equipment�
– ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process�
– ISO 8600-1 Endoscopes – Medical endoscopes and endotherapy devices – Part 1:
General requirements�
4.2. Technical device specifications
No. Product specification
1 Insertion section dimensions
1�1 Bending angle
Up:
Down:
Left:
Right:
1�2 Max� insertion portion
outer diameter
1�3 Distal tip diameter
1�4 Working length
2 Working channel
2�1 Min� working channel width
3 Optics
3�1 Field of view
3�2 Direction of view
3�3 Depth of field
3�4 Illumination method
4 Connections
4�1 The insufflation/rinsing
connector connects to a
medical grade CO₂ insufflator
4�2 The suction connector
connects to a vacuum source
4�3 The auxiliary water inlet
connects to an auxiliary
irrigation pump
14
aScope Gastro
210°
90°
100°
100°
10�4 mm / 0�41'' / 31�2 Fr 12 mm / 0�47'' / 36�0 Fr
9�9 mm / 0�39'' / 29�7 Fr
103 cm / 40�6''
aScope Gastro
2�8 mm / 0�11" / 8�4 Fr
140°
0° (forward pointing)
3 – 100 mm / 0�12 – 3�94"
LED
Max� 80 kPa / 12 psi (relative pressure)
Max� -76 kPa / -11 psi (relative pressure)
Max� 500 kPa / 72�5 psi (relative pressure)
aScope Gastro Large
210°
120°
100°
100°
11�5 mm / 0�45'' / 34�5 Fr
aScope Gastro Large
4�2 mm / 0�17" / 12�6 Fr