Regulatory Information - Laerdal LCSU 4 Manuel D'utilisation

10 Regulatory Information

International Travel
This suction unit is equipped with an AC/DC Adapter Charger allowing operation on any AC voltage (100-240 VAC, 50/60Hz).
Regulatory Information
Classification
• Electrically powered medical suction equipment for field and transport use, according to ISO10079-1.
• 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 IP33 and standard power supply
- Protected against solid foreign objects of 2.5 mm Ø and greater. (Already translated in LSU)
- Protected against spraying water.
• Intermittent Operation: 30 minutes on, 30 minutes off
Certifications
Cat. No. 880052/880062: Meets RTCA/DO-160G - Section 21 Category M (for battery operation only; commercial aircraft,
airborne equipment).
Electromagnetic Conformity
LCSU 4 is intended for use in the following environments: Professional Healthcare Facility environment, Home Healthcare
environment and Emergency Medical Services environment.
Essential performance of the LCSU 4 is identified as connection of the patient hose to the exhaust outlet. This is prevented by
coding of the outlet. EMC disturbances cannot affect this behavior.
No particular actions are required to maintain safety and performance with regard to electromagnetic disturbances for the expected
service life.
Warnings
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating
normally.
• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could
result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper
operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the LSU, including cables specified by the Laerdal Medical. Otherwise, degradation
of the performance of this equipment could result.
16