EN
8
The Ambu® aScope™ Monitor function conforms with:
- Council Directive 93/42/EEC concerning Medical Devices.
- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- EN 60601-1-1 Medical electrical equipment – Part 1-1 General requirements for safety – Collateral standard: Electromagnetic compatibility -
Requirements for test.
The Ambu® aScope™ power supply conforms with:
- Council Directive 93/42/EEC concerning Medical Devices.
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- EN 60601-1-1 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Electromagnetic compatibility -
Requirements for test.
7. Technical product specifications
Ambu® aScope™
Optical System
Field of View 80°
Direction of View 0° (forward viewing)
Depth of Field 2mm ~ 50 mm (0.1 – 1.968 inch)
Illumination method LED (LTW-C282DS5-SE)
Insertion cord
Distal tip maximum temperature 39°C (102.2°F)
(in ambient room temperature 23°C/73.4°F)
Bending section Up 120°; down 120° (please be aware that the bending
section radius can be affected if the insertion cord is
not kept straight).
Maximum width of inserted portion 5.4mm (0.21”)
Minimum ET-tube (inner diameter) 6.0mm
Working length 630mm (24.8”)
Scope
Total length 830mm (32.7”)
Luer channel (inner diameter) 0.8mm (0.03”)
Luer channel entry Luer connector
Operating environment
Temperature 10 ~ 40°C (50 ~ 104°F)
Relative humidity 30 ~ 85%
Storage
Temperature 10 ~ 40°C (50 ~ 104°F)
Relative humidity 30 ~ 85%
Sterilisation
Method of sterilisation EO
Table 1 - Specification for the Ambu® aScope™
Ambu® aScope™ Monitor
Dimensions
Width 19 6 mm ( 7.76” )
Height 160mm (6.30”)
Thickness 142mm (5.60”)
Weight 115 0 g ( 2 . 5 l b s)