Aircraft Medical McGRATH MAC EMS Gebruikershandleiding - Pagina 5
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1.4 Regulatory
This product complies with EN 60601-1 and EN 60601-1-2 safety standards. The CE mark
indicates that it meets the requirements of European Council Directives 93/42/EEC and
2007/47/EC concerning medical devices.
The McGRATH® MAC Disposable Laryngoscope Blades are classified as type BF applied parts
in accordance with section 8.3 of EN60601-1:2006
The user must contact their Aircraft Medical agent or distributor to arrange responsible
disposal and compliance with Waste Electrical and Electronic Equipment regulations
applicable, and any similar future environmental regulation applicable (including but not
limited to Directives 2002/95/EC and 2002/96/EC as implemented in the country of use).
The device is regulated in the USA under FDA Regulation Number 868.5540 and device listed under
the name McGRATH® MAC.
"McGRATH" is a registered trademark of Aircraft Medical Limited.
"Aircraft" is a registered trademark of Aircraft Medical Limited.
"CameraStick" is a trademark of Aircraft Medical Limited.
Only personnel trained in and licensed to perform intubation with a laryngoscope may use this device.
CAUTION : FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A LICENSED PRACTITIONER
1.5 Environmental
Operating Conditions:
• 10ºC to 40ºC ambient
• Relative Humidity 10% to 50%
• Atmospheric Pressure 700hPa to 1060hPa
• Category 2 Pollution Degree 2
Storage & Transport Conditions:
• -10ºC to +70ºC ambient
• Relative Humidity 10% to 90%
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