EN
7
Symbol
Indication
Symbol of Class II equipment. Only relevant for Ambu® aScope™ Charger
Only for indoor use. Only relevant for Ambu® aScope™ Charger
CE mark. The product complies with the EU Council directive concerning
Medical Devices 93/42/EEC.
Reference Number
Lot Number, Batch Code
Serial Number
Use By, followed by YYYY-MM
Sterile Product, Sterilisation by ETO. Only applicable for the Ambu® aScope™.
Single Use product, do not reuse
Warning
Consult Instruction for use
Year of Manufacture, followed by YYYY
Waste Bin symbol, indicating that waste must be collected according to local regulation and
collection schemes for disposal of batteries. Only applicable for the Battery inside the Monitor.
Waste Bin symbol, indicating that waste must be collected according to local regulation and
collection schemes for disposal of electronic and electrical waste (WEEE). Only applicable for
the Monitor.
Li-ion
Battery type Lithium ion. Only applicable for the battery inside the Ambu® aScope™ Monitor
Re-chargeable battery. Only applicable for the battery inside the Ambu® aScope™ Monitor
Tested to comply with FCC Standards- Medical Equipment
6. Standards applied
The Ambu® aScope™ 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.
- 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 594-1: Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements.
