6.8 Explanation of symbols

Symbols on the device

On the device or power supply, you may find the following symbols (nonrestrictive list):

Indicates the device meets the requirements of the applicable EC directives/regulations.
Indicates compliance with Part 15 of the FCC rules (Class A or Class B).
Indicates the device is approved according to the UL Recognition regulations.

MEDICAL – GENERAL MEDICAL EQUIPMENT

AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY

IN ACCORDANCE WITH ANSI/AAMI AS60601-1:2005/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14

Indicates the device is approved according to the UL regulations for Canada and US.
Medical –general medical equipment as to electrical shocks, fire and mechanical hazards only in accordance with standards: ANSI/AAMI ES 60601-1:2005/(R)2012; CSA CAN/CSA-C22.2 NO. 60601-1:14; Also certified UL60950-1 (E92049).
Indicates the device is approved according to the UL Demko regulations.
Indicates the device is approved according to the CCC regulations.
Indicates the device is approved according to the VCCI regulations.
Indicates the device is approved according to the KC regulations.
Indicates the device is approved according to the BSMI regulations.
Indicates the device is approved according to the PSE regulations.
Indicates the device is approved according to the RCM regulations.
Indicates the device is approved according to the EAC regulations.
Caution: Federal law (United Stated of America) restricts this device to sale by or on the order of a licensed healthcare practitioner.
Indicates the device is approved according to the BIS regulations.
Indicates the device is approved according to the INMETRO regulations.
Indicates the device meets the requirements of the UK MDR 2002 (as amended).
Indicates the USB connectors on the device.
Indicates the DisplayPort connectors on the device.
Indicates the legal manufacturer.
Indicates the manufacturing date.
Indicates the entity importing the medical device into the locale.
Indicates the temperature limitations[5] for the device to safely operate within specs.
Indicates this is a Medical Device.
Indicates the device serial number.
Indicates the device part number or catalogue number.
Indicates the Unique Device Identifier.
Indicates the Authorised Representative for the European Union.
Indicates the Authorised Representative for Switzerland.
Warning: dangerous voltage
Caution
Consult the Instructions For Use.
Consult the Instruction For Use on website address that is provided as eIFU indicator.
Indicates this device must not be thrown in the trash but must be recycled, according to the European WEEE (Waste Electrical and Electronic Equipment) directive.
Indicates Direct Current (DC).
Indicates Alternating Current (AC).
Stand-by
Equipotentiality
or Protective earth (ground)
Symbols on the box

On the box of the device, you may find the following symbols (nonrestrictive list):

Indicates a device that can be broken or damaged if not handled carefully when being stored.
Indicates a device that needs to be protected from moisture when being stored.
Indicates the storage direction of the box. The box must be transported, handled and stored in such a way that the arrows always point upwards.
or Indicates the maximum number of identical boxes which may be stacked on each other, where “n” is the limiting number.
or Indicates the weight of the box and that it should be carried with two persons.
Indicates that the box should not be cut with a knife, a cutter or any other sharp object.
Indicates the temperature limits[6] to which the device can be safely exposed when being stored.
Indicates the range[6] of humidity to which the device can be safely exposed when being stored.
Indicates the range[6]of atmospheric pressure to which the device can be safely exposed when being stored.

[5] Values for xx and yy can be found in the technical specifications paragraph.

[6] Values for xx and yy can be found in the technical specifications paragraph.