Therabody TheraFace PRO, Руководство пользователя

Страница: 18 / 104

17
EN
1. This device is Class II equipment with type BF applied part. It complies with Medical
Electrical Safety Standards (IEC 60601-1).
2. This device is also compliant with Medical EMC Standard (IEC 60601-1-2).
3. All the user directly contracting materials for the main device housing and output
contacts in this device are biocompatible for its intended use. They comply with
biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation
and Sensitization).
Safety, EMC & Bio-compatibility
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.
The TheraFace PRO 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.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation. Changes
or modifications not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
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. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can 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:
FCC compliance statement
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
• Consult the dealer or an experienced radio/TV technician for help.