IEC 60601-
1:2005+AMD1:2012
EN 60601-
1:2006+A1:2013
Applied part type BF
Complies with Type BF requirements of IEC 60601-1:2005+AMD1:2012 and EN 60601-
1:2006+A1:2013.
93/42/EEC
CE marking of conformity
Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EU).
UL classification marking
MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in
accordance with:
IEC 60601-1-6:2010+AMD1:2013
ANSI/AAMI ES60601-1:2005 + A1:2012
CAN/CSA-C22.2 NO. 60601-1:14
CAN/CSA-C22.2 No. 60601-1-6:11(R16)
Located on Front Panel. Power on/off switch
Located on Back Panel. Port for Foot Switch
Located on Back Panel. Port for ICS VNG/ENG system
Located on Back Panel. Port for Computer (used for firmware upgrades and future development)
Located on Back Panel. Priming Switch for Water Reservoir
ISO 15223-1
Symbol 5.4.2
Do not reuse.
Indicates a medical device that is intended for one use, or for use on a single patient during a single
procedure.
(Related to specific accessories)
EN 50419
Electronic equipment covered by the Directive 2012/19/EU on waste electrical and electronic equip-
ment (WEEE).
All electrical and electronic products, batteries, and accumulators must be taken to separate collection
at the end of their working life. This requirement applies in the European Union. Do not dispose of
these products as unsorted municipal waste.
You can return your device and accessories to Natus Medical Denmark ApS, or to any Natus
Medical Denmark ApS supplier. You can also contact your local authorities for advice on disposal.
22
Otometrics - ICS AirCal
6 ICS AirCal System Safety
