GUIDANCE AND MANUFACTURER’S DECLARATION
Important information regarding Electromagnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and
could create a potentially unsafe situation.
Technical Specifications
In order to regulate the requirements for EMC, with the aim to prevent unsafe product situations, the IEC/EN 60601-1-2 and IEC/EN 60601-1-11 standards have been implemented. These standards define the levels of immunity to electromagnetic interference as well as the maximum levels
of electromagnetic emissions for medical devices.
Revitive devices are intended for use in the home setting without the need for involvement of a clinical professional during treatment. On occasion the device may also be used in a hospital environment. In this environment use near the following equipment should be avoided:
• active High Frequency Surgical Equipment
• radio frequency shielded rooms for magnetic resonance imaging (where the intensity of Electro Magnetic Disturbances is high).
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.
WARNING: Use of accessories and cables other than those specified or provided by Actegy Ltd for this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
WARNING: Wireless communications equipment such as wireless network devices, mobile phones, cordless telephones and their base stations can affect this equipment and should be used no closer than 30 cm (12 inches) to any part of the Revitive Aerosure, including cables specified by Actegy Ltd. Otherwise, degradation of the performance of this equipment could result.
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
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