Dantec Clavis User Guide
5
ISO 15223-1
Symbol 5.1.3
The manufacture date is adjacent to this symbol.
IPX1
Ingress of liquids: The Clavis Unit is classified as an ordinary equipment
regarding ingress of liquids; it is not drip-proof, splash-proof, or watertight.
Protection from dripping water from above device for at least 10 minutes
according to IEC 60529.
Medical device listing mark for U.S. and Canada by Intertek Testing Service.
The device is not user serviceable.
Battery type.
Rx Only
CAUTION: USA Federal law restricts this device to sale or on the order of a
licensed medical physician.
Medical
Device
Medical Device.
Indicates that the item is a medical device.
ISO 15223-1
Symbol 5.3.7
Indicates the upper and lower limits of temperature to which the medical device
can be safely exposed. The temperature is indicated adjacent to the horizontal
lines.
ISO 15223-1
Symbol 5.3.8
Indicates the upper and lower limits of humidity limitation to which the medical
device can be safely exposed. The humidity limitation is indicated adjacent to the
horizontal lines.
Dantec®CLAVIS™ device.
Carton.
ISO 15223-1
Symbol 5.2.8
Do not use if package is damaged.
Referenced standards
ISO 15223-1:2016: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety
