THERAGUN Halo User Manual page 37

Document Name User manual
Model Theragun halo
All the user directly contracting materials for main device housing and output
contacts in this device are bio-compatible for its intended use. They are complied
with bio compatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10
(Irritation and Sensitization).
The has been tested and found to comply with the electromagnetic compatibility
(EMC) limits for medical device to IEC 60601-1-2: 2007. These limits are
designed to provide reasonable protection against harmful interference in a
typical medical installation.
CAUTION:
Do not apply the device near any devices with Electromagnetic Interference
(EMI), such as cell phones, Magnetic Resonance Imaging (MRI), computerized
axial tomography (CT), diathermy, Radio Frequency Identification (RFID), etc. or
MR environment. EMI, RF devices or MR environment may affect the normal
function of the device or would cause user injury.
Manufacturer's declaration – electromagnetic immunity
1* WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally."
2* WARNING: Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation."
3* WARNING: 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 ME
equipment, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result."
Document No. TG - HALO
Rev 4 0
- 003
37