(4) ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.

Transmit Energy

Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.

Software

Software shall also be deemed to be an active device.

Devices classified by this rule are mostly electrical equipment used in surgery such as lasers and surgical generators. In addition, there are devices for specialised treatment such as radiation treatment.

Other examples, categorized by type of energy source, include:

• Electrical and/or magnetic and electromagnetic energy – Muscle stimulators and external bone growth stimulators, TENS devices and eye electromagnets, electrical acupuncture
• Thermal energy – Cryosurgery equipment
• Mechanical energy – Powered dermatomes, powered drills and dental hand pieces
• Light – Phototherapy for skin treatment and for neonatal care
• Sound – Hearing aids
• Ultrasound – Equipment for physiotherapy

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