11 regulatory information – Laerdal Compact Suction Unit (LCSU) 4 User Manual

Page 16

Advertising
background image

11 Regulatory Information

English

16

International Travel
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 to adapter 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

• 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)

Advertising