Use Instructions

DRAFT 2/12/2019 SPW 27
REACH and Warning Statement
Thresholds and Substances of Very High Concern (SVHCs) are defined in Article 7 and 57 of Regulation (EC) No
1907/2006 (REACH Regulation). This article contains a substance on the Candidate List in a concentration above 0.1%
(w/w), namely: 4-Nonylphenol, branched and linear -substances with a linear and/or branched alkyl chain
with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances
which include any of the individual isomers or a combination thereof. This substance is completely enclosed in the
device, and does not pose a safety concern during use.
EMC Compliance and Warning Statement
 IEC 60601-1-2: 2014
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of
the FCC Rules and with the limits of the standard for medical devices, IEC 60601-1-2, suitable for use in all
environments including domestic. The unit also complies with the requirements of EN 60601-1-2, providing the
presumption of compliance to the European Union’s Medical Device Directive2007/42/EC. The limits are designed to
provide reasonable protection against harmful interference in a typical medical installation. This equipment generates,
uses, and can radiate radio-frequency energy, (such as wireless home networks, mobile phones, cordless telephones
and their base stations, and walkie-talkies), and, if not installed and used in accordance with the manufacturer’s
instructions, may cause harmful interference to other devices in the vicinity. Use of this equipment adjacent to or
stacked with other equipment should be avoided because it could 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 sTMS mini, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result. However, there is no guarantee that interference will
not occur in a particular installation. If this equipment causes interference with other devices, which may be
determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
 Reorient or relocate the device receiving the interference.
 Increase the separation between the equipment.
 Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
 Consult the manufacturer or field service technician for help.