11 Regulatory Information
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This suction unit is equipped with an AC/DC Adapter Charger allowing operation on any AC voltage (100-240 VAC, 50/60Hz).
However the correct power cord must be used to connect adapter to wall power.
Regulatory Information
Classification
This product is in compliance with the essential requirements of Council Directive 93/42/EEC Medical Device Directive, as
amended by Council Directive 2007/47/EC, class IIa
The product is in compliance with Council Directive 2011/65/EU on restriction of the use of certain hazardous substances (RoHS
2).
• Electrically powered medical suction equipment for field and transport use, according to ISO10079-1:1999
• High flow/High vacuum, 50 – 550+ mmHg
• Not suitable for the use in the presence of flammable liquids or gases.
• Internally powered/class I equipment type BF, according to IEC 60601-1
• Protection class IPI2 and standard power supply
• Intermittent Operation: 30 minutes on, 30 minutes off
Certifications
IEC 60601-1 : 1988 (2nd edition); IEC 60068-2-6/IEC 60068-2-64/IEC 60068-2-27/IEC 60068-2-31; CAN/CSA-C22.2 No.
601.1-M90, 2005; UL 60601-1, EN 60601-1-2 : 2007, EN ISO 10079-1 : 2009 (Except requirement of 500 ml volume in claim
59.11.1, due to the 300 ml Canister option)
Standards
Cat. No. 880052/880062: Meets RTCA/DO-160G - Section 21 Category M (for battery operation only; commercial aircraft,
airborne equipment).
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